About Authors:
Kapil Sharma*, Priyanka Sharma
Yaresun Pharmaceutical Pvt. Ltd.,
India.
*pharma_kapil@rediffmail.com
ABSTRACT
Herbalism is a traditional medicinal or folk medicine practice based on the use of plants and plant extracts. Many plants synthesize substances that are useful to the maintenance of health in humans and other animals because herbal medicine have harmless advantages. Humans, and even neanderthals, have used plants to treat their ailments for at least tens of thousands of years; most likely even longer than that. The first written accounts of the use of herbs originate in china, although all other civilizations from the ancient world were using plants as natural remedies for their ailments. Western herbal medicine dates back to ancient greece and its famous doctors like hippocrates and galen.The 15th to 17th centuries were the most popular time for herbalism in europe. Herbal remedies are still relatively popular today, mainly due to the fact that they are regarded as harmless because they are natural. So this paper describe basic information involved in preparation of herbal remedies for internal use and for external useand gives a detail account about standardization and evaluation in formulations of herbal drugs.
Reference Id: PHARMATUTOR-ART- 1455
INTRODUCTION
Herbalism is a traditional medicinal or folk medicine practice based on the use of plants and plant extracts. Herbalism is also known as botanical medicine, medical herbalism, herbal medicine, herbology, and phytotherapy. The scope of herbal medicine is sometimes extended to include fungal and bee products, as well as minerals, shells and certain animal parts.1
Many plants synthesize substances that are useful to the maintenance of health in humans and other animals. These include aromatic substances, most of which are phenols or their oxygen-substituted derivatives such as tannins. Many are secondary metabolites, of which at least 12,000 have been isolated — a number estimated to be less than 10% of the total. In many cases, substances such as alkaloids serve as plant defense mechanisms against predation by microorganisms, insects, and herbivores. Many of the herbs and spices used by humans to season food yield useful medicinal compounds.
Herbal medicine, sometimes referred to as Herbalism, Botanical medicine or Herbology, is the use of plants, in a wide variety of forms, for their therapeutic value. Herb plants produce and contain a variety of chemical compounds that act upon the body and are used to prevent or treat disease or promote health and well-being.
Advantages of Herbal Medicine1
1. Herbal medicine have long history of use and better patient tolerance as well as acceptance.
2. Medicinal plants have a renewable source, which is our only hope for sustainable supplies of cheaper medicines for the world growing population.
3. Availability of medicinal plants is not a problem especially in developing countries like India having rich agro-climatic, cultural and ethnic biodiversity.
4. The cultivation and processing of medicinal herbs and herbal products is environmental friendly.
5. Prolong and apparently uneventful use of herbal medicines may offer testimony of their safety and efficacy.
6. Through out the world, herbal medicine has provided many of the most potent medicines to the vast arsenal of drugs available to modern medical science, both in crude form and as a pure chemical upon which modern medicines are structured.
Role of Herbal Medicine in Modern Human Society2
Botánicas, such as this one in Jamaica Plain, Massachusetts, cater to the Latino community and sell herbal cures and folk medicine alongside statues of saints, candles decorated with prayers, lucky bamboo, and other items.
The use of herbs to treat disease is almost universal among non-industrialized societies.] A number of traditions came to dominate the practice of herbal medicine at the end of the twentieth century:
· The "classical" herbal medicine system, based on Greek and Roman sources
· The Siddha and Ayurvedic medicine systems from various South Asian Countries
· Chinese herbal medicine (Chinese herbology)
· Unani-Tibb medicine
· Shamanic herbalism: a catch-all phrase for information mostly supplied from South America and the Himalayas
Many of the pharmaceuticals currently available to physicians have a long history of use as herbal remedies, including opium, aspirin, digitalis, and quinine. The World Health Organization (WHO) estimates that 80 percent of the world's population presently uses herbal medicine for some aspect of primary health care. Pharmaceuticals are prohibitively expensive for most of the world's population, half of which lives on less than $2 U.S. per day. In comparison, herbal medicines can be grown from seed or gathered from nature for little or no cost. Herbal medicine is a major component in all traditional medicine systems, and a common element in Siddha, Ayurvedic, homeopathic, naturopathic, traditional Chinese medicine, and Native American medicine.
BIOLOGICAL BACKGROUND2,3
All plants produce chemical compounds as part of their normal metabolic activities. These are arbitrarily divided into primary metabolites, such as sugars and fats, found in all plants, and secondary metabolites, compounds not essential for basic function found in a smaller range of plants, some useful ones found only in a particular genus or species. Pigments harvest light, protect the organism from radiation and display colors to attract pollinators. Many common weeds, such as nettle, dandelion and chickweed, have medicinal properties.The functions of secondary metabolites are varied. For example, some secondary metabolites are toxins used to deter predation, and others are pheromones used to attract insects for pollination. Phytoalexins protect against bacterial and fungal attacks. Allelochemicals inhibit rival plants that are competing for soil and light. Plants upregulate and downregulate their biochemical paths in response to the local mix of herbivores, pollinators and microorganisms. The chemical profile of a single plant may vary over time as it reacts to changing conditions. It is the secondary metabolites and pigments that can have therapeutic actions in humans and which can be refined to produce drugs. Plants synthesize a bewildering variety of phytochemicals but most are derivatives of a few biochemical motifs.
Alkaloids contain a ring with nitrogen. Many alkaloids have dramatic effects on the central nervous system. Caffeine is an alkaloid that provides a mild lift but the alkaloids in datura cause severe intoxication and even death.
Phenolics contain phenol rings. The anthocyanins that give grapes their purple color, the isoflavones, the phytoestrogens from soy and the tannins that give tea its astringency are phenolics.
Terpenoids are built up from terpene building blocks. Each terpene consists of two paired isoprenes. The names monoterpenes, sesquiterpenes, diterpenes and triterpenes are based on the number of isoprene units. The fragrance of rose and lavender is due to monoterpenes. The carotenoids produce the reds, yellows and oranges of pumpkin, corn and tomatoes.
Glycosides consist of a glucose moiety attached to an aglycone. The aglycone is a molecule that is bioactive in its free form but inert until the glycoside bond is broken by water or enzymes. This mechanism allows the plant to defer the availability of the molecule to an appropriate time, similar to a safety lock on a gun. An example is the cyanoglycosides in cherry pits that release toxins only when bitten by a herbivore.
The word drug itself comes from the Dutch word "droog" (via the French word Drogue), which means 'dried plant'. Some examples are inulin from the roots of dahlias, quinine from the cinchona, morphine and codeine from the poppy, and digoxin from the foxglove. The active ingredient in willow bark, once prescribed by Hippocrates, is salicin, which is converted in the body into salicylic acid. The discovery of salicylic acid would eventually lead to the development of the acetylated form acetylsalicylic acid, also known as "aspirin", when it was isolated from a plant known as meadowsweet. The word aspirin comes from an abbreviation of meadowsweet's Latin genus Spiraea, with an additional "A" at the beginning to acknowledge acetylation, and "in" was added at the end for easier pronunciation. "Aspirin" was originally a brand name, and is still a protected trademark in some countries. This medication was patented by Bayer AG.
Few Examples of plants used as medicine2
Few herbal remedies have conclusively demonstrated any positive effect on humans, possibly due to inadequate testing. Many of the studies cited refer to animal model investigations or in-vitro assays and therefore cannot provide more than weak supportive evidence.
Aloe vera has traditionally been used for the healing of burns and wounds. A systematic review (from 1999) states that the efficacy of aloe vera in promoting wound healing is unclear, while a later review (from 2007) concludes that the cumulative evidence supports the use of aloe vera for the healing of first to second degree burns.
Agaricus blazei mushrooms may prevent some types of cancer.
Artichoke (Cynara cardunculus) may reduce production cholesterol levels according to in vitro studies and a small clinical study.
Blackberry (Rubus fruticosus) leaf has drawn the attention of the cosmetology community because it interferes with the metalloproteinases that contribute to skin wrinkling.
Black raspberry (Rubus occidentalis) may have a role in preventing oral cancer.
Boophone (Boophone disticha) This highly toxic plant has been used in South African traditional medicine for treatment of mental illness . Research demonstrate in vitro and in vivo effect against depression.
Butterbur (Petasites hybridus) Calendula (Calendula officinalis) has been used traditionally for abdominal cramps and constipation. In animal research an aqueous-ethanol extract of Calendula officinalis flowers was shown to have both spasmolytic and spasmogenic effects, thus providing a scientific rationale for this traditional use. There is "limited evidence" that calendula cream or ointment is effective in treating radiation dermatitis.
Cranberry (Vaccinium oxycoccos) may be effective in treating urinary tract infections in women with recurrent symptoms.
Echinacea (Echinacea angustifolia, Echinacea pallida, Echinacea purpurea) extracts may limit the length and severity of rhinovirus colds; however, the appropriate dosage levels, which might be higher than is available over-the-counter, require further research.
Elderberry (Sambucus nigra) may speed the recovery from type A and B influenza. However it is possibly risky in the case of avian influenza because the immunostimulatory effects may aggravate the cytokine cascade.
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PREPARATION HERBAL REMEDIES8-10,15
We think of many kinds of remedies which we could benefit from herbs, but the best way to get cured by herbs is by planting them around your garden or keeping small herb plants inside your home, just by smelling their fragrance it will show positive effects in your body. The best way though is to consume them and these days we are eating quite a lot of herbs in our daily foods like, parsley in salads, dill in fish, marjoram in pizza, mint with lamb, horseradish with beef, basil with pasta and garlic with most of the foods we eat. These herbs are easily absorbed into our digestive system and other parts of the body.
Preparations for internal use
Apart from consuming herbs into our body system through food, it can be consumed through tea, tinctures and tablets.
Infusions
Infusions are made in a similar fashion like one makes a cup of tea the normal way. The doses are 1 ounce or 25 grams of dried herbs, or 2 ounce or 50 grams of fresh herbs, should be added to 1pint or 600 ml of water, which is at boiling point. You can make adjustments in the measurement to suit your taste buds so that you make it a regular habit to drink the tea. You can put herbs in a warm teapot, add boiling water, cover for ten minutes, and strain and drink it. If the person is suffering from any chronic disease, then one cup of tea should be consumed three times a day and if the condition is quite acute, then one cup of tea should be consumed 6 times a day. An infusion can be stored in the fridge till about two days maximum. Herbs (for example comfrey), which have a high content of mucilage, should be prepared in the same way, but with cold water. Infusions are mostly taken hot but only in cases like treating urinary system, the infusion should be drunk lukewarm to cold.
To make sure you drink the infusions religiously you can add more herbs to make it tastier. Many types of herbs can be blended to make a tasty brew and aromatic herbs can be added too. Mints, lemon balm, lemon verbena, fennel, licorice and lavender are aromatic herbs, which can be added to more bitter herbs to make the infusion more drinkable for both adults and children too.
Decoctions
Decoctions are preparations from hard woody parts of plants like barks, roots, rhizomes, seeds and nuts. They are quite similar to infusions and require more heat in preparing it and imparting their constituents into the water. To prepare decoctions, you have to break or hammer barks, roots, etc. with a mortar and pestle. You could also chop them if they are fresh, and put them in a pan of water and start boiling, cover the pan with a lid and simmer for 10 minutes and then strain. The measurement of the water can go over a pint per ounce of herb, in case some of the liquid is evaporated during simmering. The measurements of decoctions and infusions are the same.
Syrups
Children mostly like syrups and if it is prescribed to an adult, then the dose should be doubled. 2 teaspoons 3 times a day is prescribed for any chronic problems and twice the dose for acute health problems. Infusions and decoctions can be added to the syrup, mix 12 ounce or 325 grams of sugar into 600ml of liquid and heat till the sugar has dissolved. Cool and store the syrup in a refrigerator. Once you weigh the infusion or decoction you can add a quarter of its weight of honey into it. This should be heated slowly and brought down to a thick liquid, and remove the scum that can form on top of the liquid mixture.
There is another preparation, where you have to pour 1pint of water and start boiling it, add over 2.5 lbs or 1,25 kg of brown sugar and start stirring it over low heat till the sugar dissolves completely and the solution is boiling. After it is removed from the heat, add 1 part of herbal tincture to 3 parts of syrup and set aside.
Tinctures
Tinctures are extracted from herbs, which are very concentrated, and they are mostly used in mixture of water and alcohol, so that their constituents are extracted for various remedies and they also act as preservatives. The ratio of water and alcohol depends on what is prescribed for the person. 25 per cent of alcohol is utilized for simple glycosides and tannins and 90% of alcohol is required for gums and resins.
To prepare a tincture, use 1 part of dry herb to 5 parts of liquid and if they are fresh herbs, then you can use 1 part of herbs to 2 parts of liquid. Place all the herbs in a big jar and pour the alcohol and water in it, leave it aside to macerate shaking it 2 times a day for 2 weeks only. Press out the liquid and throw the herbs. Although, the discarded herbs should not be thrown; they can be used for good compost. Store in dark bottles or glass jars kept away from heat and light and make sure they are labeled.
If you are making tincture at home, then you can use brandy, gin and vodka, these are undiluted alcohol drinks. To make the mixture tastier, glycerol or glycerin can be added. Glycerin can give a sweet taste to the extracts and could be enjoyed while drinking it. Equal parts of water and glycerin are used for dried herbs, 80% of glycerol or glycerine is used for fresh, watery herbs like borage. If the condition is chronic, then there is a standard dose of 1 teaspoon of tincture diluted with a little water 3 times a day and if the condition is more acute then it is every 2 hours. Children should be given half the dose, while babies adult dose. Tincture can be stored for almost two years though it is time consuming should be given quarter of the to prepare it, but the advantage is that it can be stored and consumed in small quantities. Tinctures are also used to prepare gargles, mouthwash, lotions and douches. In a cup of water use half to one teaspoon 2-3 times a day for chronic problems, and for acute problems it is taken every 2 hours.
Suppositories
Suppositories can be prepared with ease at home itself, add finely powdered dried herbs to melted cocoa butter and pour this mixture into moulds, allow it to cool for some time. You can store it in the refrigerator and it can be packed in aluminum foil also.
Suppositories can cure people suffering from local and systemic problems. They can pass the alimentary canal and can be absorbed into the system of the body. The herbal remedy goes directly into the blood stream, through the mucosa of the rectum.
Tablets and capsules
Though herb tablets and capsules are available in herbal shops or health food shops, it can easily be made at home too. The capsules can be made at home by utilizing gel capsules and filling them with the herb mixtures. If you use a capsule maker, then you can make larger quantities and the process is much easier. There are two standard capsule sizes, which are 0 and 00. Size 0 can hold approximately 0.35 grams of powdered mixture for a person to consume 3 tablets to be taken 3 times a day according to the dose. Size 00 can hold 0.5 grams of the powdered mixture for two capsules to be taken 3 times a day on a daily basis.
Preparations for external use
The skin is a highly absorbent layer of the body, which can be used to absorb any herbal preparation on it. The remedy is carried by very small capillaries under the layer of the skin into the blood stream and around the body. The skin can be easily used as a pathway for the remedy to reach the body.
Herbal baths
A warm bath with fragrance and herbal medicines in it could be quite good experience and made easy especially if it is for treating children and babies. You can fill a muslin bag with fresh or dried herbs and leave it under the tap. Strong herb infusions can also be added to bath water, and you can soak in it for about 15 -20 minutes. You can also drop a few droplets of herbal oil to the bath water, but if the bath is for babies and kids or for people with sensitive skin, then they should be diluted first and then added to the bath water. When taking a herbal bath the pores of the skin are opened by the warm water allowing the remedy to go inside the body. Volatile oils can be inhaled through the nose and mouth and then paves a way to the bloodstream. It is through the nose, the oils sends messages to the nerves, then to the brains, and only then it makes the person relax mentally and emotionally. Oils like lavender, chamomile and ylang ylang are good for healing and have a good aroma. Rosemary is also relaxing and can stimulate a smooth blood flow to the brain and increase alertness in the person.
Hand and foot baths
Hands and feet are the most sensitive parts of the human body. All the nerves end up on the hands and feet and even though the skin is thick they can absorb any herbal constituents into it with total ease and allow it to pass into the blood stream.
Mustard footbaths are known to be an old English remedy which is used to cure colds and flu, poor circulation of the body and arthritis. Well known French herbalist Maurice Messegue who recommends in most of the remedy books, that foot bath are to be taken 8 minutes in the evening and hand baths for 8 minutes in the morning.
Hand and footbaths can be done on babies and children too, but they can stay in the water for half the time, which is prescribed for adults, which is like 4 minutes in the morning and 4 minutes in the evening.
Salves and creams
Herbs are macerated in oil to make a simple mixture of salve. Put 16 ounce or 450ml of olive oil and 2 ounce or 50 grams of beeswax into a dish, which is heat proof. Add as many herbs as you can till the mixture is covered and leave it on low heat for a few hours in a bain-marie. In low heat the remedy is allowed to get absorbed into the oil. Now strain the mixture through a muslin cloth and discard the left over herbs and pour the oil into jars, the oil will soon solidify inside the jar as it cools down.
You can also make creams for make up by adding tincture, infusions and decoctions. You could add a few drops of remedy oil bought from a pharmacist, into any water-based cream and use it.
Ointment
Ointments consist of only fats or oils and are not water based like creams and salves. Creams blend into the skin while ointments form their own layer on the skin. Ointments are most appropriate when the skin is soft and weak or when the skin needs added moisture or some kind of protection like in the instance of diaper rash. Ointments were previously made by animal fat, but these days’ petroleum jelly and paraffin wax are being used.
To prepare an ointment, you have to melt the petroleum jelly or paraffin wax over a pan of water, which is at boiling point, add the herbs and leave it on heat for 2 hours till the herbs become crispy. Transfer the mixture into a jelly bag or cheesecloth tightened with a rubber band or a string and pours the mixture till the rim of the jar. You must wear rubber gloves when working on this mixture and make sure you pour the mixture into the jar while it is warm, as it can solidify as soon as it starts cooling.
Poultices
Poultice is a dampened mixture, which is applied on the part of the body, which needs the remedy. Fresh or dried herbs are used as poultice. They are placed between two pieces of gauze and applied on the area, which is to be cured .If you are using fresh leaves, stems or roots, then you should break them or crush them before utilizing them. If dried herbs are being used, then a little warm water can be added to the herbs, which are either finely chopped or powdered. After the mixture is ready to use, and then spread the paste into gauze. Bind the gauze poultice to the area which is affected, a light cotton bandage can be used for this purpose and after binding it to the affected area, you can keep it warm with a hot water bottle. Cabbage leaves can also be used in this manner to cure pains like arthritic joints and engorged breasts. There is a bran poultice, which is good in curing mastitis.
Compresses
Compresses are very useful for conditions like period pains, backaches, inflame joints or varicose veins and headaches. You can take a clean cloth or a towel and soak it in hot or cold infusion or decoction or in water with a few drops of oil, which are prescribed for you. Wring out the water and apply the towel over the affected part of the body, repeat this for some time and you will find a lot of relief from the pain.
Liniments
Liniments are oils for rubbing on the body to relieve any muscular pain, they are used for massage, for the stimulation of the muscles and ligaments of the body and they can cure any pain, which is caused by inflammation, or any other injury. The mixture is an extract of herbs with an oil base or alcohol base, or they could be a mixture of herbal oils and alcohol tinctures. They can be easily absorbed into the skin and get transferred into the affected part of the body. Liniments are mostly made of stimulating oils or cayenne to increase the circulation of the affected part of the body.
Oils
Essential oils are a product of aromatic plants, which cannot be extracted at home; it has to go through a method called steam distillation. These oils can be purchased from health foodshops. If you are keen on making herbal oils at home, then you can infuse finely chopped herbs into pure vegetable oils. Oils like almond oil, sunflower oil and olive oil can be used for this purpose. This process can take approximately two weeks.
Place the herbs and pour the oil into a tight fitting glass jar and make sure you keep it covered. Place the jar by the windowsill where a lot of sunlight can come in and make sure you shake it everyday. After two weeks, once the oil has absorbed the constituents, filter this mixture through a muslin cloth and store it in an air tight dark colored bottle.
Oils are generally used for massages and it is mostly used on babies and children A few drops of essential oil diluted into a base oil could be perfect for a massage. 5-10 drops of oil into a bowl of hot water can be inhaled, a few drops of aromatic oil in water can be sprayed around the room which could also act like a disinfectant, and a few drops of oil inside a facial steamer could do some wonders for the skin.
Infused oils
Massage oils, ointments and creams consist of active plant ingredients, which are used externally. Infused oils can be preserved up to one year if kept properly in a cool and dark place, but making small and fresh quantities of infused oils are more effective. There are two types of technique to make infused oils. The hot process is best suited for comfrey, chickweed or rosemary. The cold process is most appropriate for marigold and St. John’s wort. The process for the cold infused oil can be repeated by using new herbs and the oil, which is infused once, can be set aside for storage for few weeks. In the process of hot infusion: put the oil and the herb into a glass bowl placed over a pan of boiling water or in a double saucepan and let it cook for 3 hours. Once the mixture is ready pour it into a jelly bag or cheesecloth fitted tightly to the rim of the wine press and strain the mixture into the jar. In the process of cold infusion: fill a big jar full of herbs and pour oil into it covering the herbs completely. Close the lid tightly and leave it on a window, which has lot of sunlight coming in or in a green house for about 2-3 weeks. Once the mixture is ready pour it into a jelly bag or cheesecloth secured with an elastic band to the rim of the jug. Squeeze the oil through the bag and you can repeat this process a few more times with newer herbs added to it and after few weeks it can be strained again and set aside for storage.
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STANDARDISATION AND EVALUATION OF HERBAL DRUG FORMULATIONS
Need of Standardizations5,6
In recent years there is a spurt in the interest regarding survival of Ayurvedic forms of medication. In the global perspective, there is a shift towards the use of medicine of herbal origin, as the dangers and the shortcoming of modern medicine have started getting more apparent, majority of Ayurvedic formulation are prepared from herbs.
It is the cardinal responsibility of the regulatory authorities to ensure that the consumers get the medication, which guarantee. Purity, safety, potency and efficacy. This duty is discharged by the regulatory authorities by rigidity following various standards of quality prescribed for raw materials and finished products in pharmacopoeias controlling manufacturing formulate through the use of formularies and manufacturing operation through statutory imposed “Good manufacturing practices”. All these procedure logically would be apply to all type of medication whether included in modern system of medicine or one of the traditional system such as Ayurvedic system of medicine. Unfortunately the Ayurvedic pharmacopoeias and the formulary have been exempted from the standard attained by present day. Modern medicine, which is continuously undergoing metabolic changes and improvements in the standard of purity, safety and efficacy. Thus maintaining the quality of Ayurvedic medication becomes the sole responsibility of the manufacture.
Herbal Drug Standardization and Evaluation:8-10
“Standardization” expression is used to describe all measures, which are taken during the manufacturing process and quality control leading to a reproducible quality. It also encompasses the entire field of study from birth of a plant to its clinical application. It also means adjusting the herbal drug preparation to a defined content of a constituent or a group of substances with known therapeutic activity respectively by adding excipients or by mixing herbal drugs or herbal drug preparations. “Evaluation” of a drug means confirmation of its identity and determination of its quality and purity and detection of its nature of adulteration. Standardization of herbal drugs is not an easy task as numerous factors influence the bio efficacy and reproducible therapeutic effect. In order to obtain quality oriented herbalproducts, care should be taken right from the proper identification of plants, season and area of collection and their extraction and purification process and rationalizing the combination in case of polyherbal drugs.
The Standardization of crude drug materials includes the following steps:-
1. Authentication: - Each and every step has to be authenticated.
a) Stage of collection.
b) Parts of the plant collected.
c) Regional status.
d) Botanical identity like phytomorphology, microscopical and histological analysis (characteristic of cell walls, cell contents, starch grains, calcium oxalate crystals, trichomes, fibers, vessels etc).
(6) Various histological parameter studies are:-
1. Leaf constant: - Palisade ratio, Vein islet number, Vein termination, Stomatal number, and Stomatal index.
2. Trichomes.
3. Stomata.
4. Quantitative microscopy.
5. Taxonomical identity.
6. Foreign matter.
7. Organoleptic evaluation.
8. Ash values and extractive values.
9. Moisture content determination.
10. Chrometographic and spectroscopic evaluation.
11. Heavy metal determination.
12. Pesticide residue.
13. Microbial contamination.
14. Radioactive contamination.
The herbal formulation in general can be standardize schematically as to formulate the medicament using raw materials collected from different localities and a comparative chemical efficacy of different batches of formulation are to be observed. The preparations with better clinical efficacy are to be selected. After all the routine physical, chemical and pharmacological parameters are to be checked for all the batches to select the final finished product and to validate the whole manufacturing process.
The stability parameters for the herbal formulations which include physical, chemical and microbiological parameters are as follow:
Physical parameters include color, odor, appearance, clarity, viscosity, moisture content, pH, disintegration time, friability, hardness, flow ability, flocculation, sedimentation, settling rate and ash values.
Chemical parameters include limit tests, chemical tests, chemical assays etc.
Chromatographic analysis of herbals can be done using TLC, HPLC, HPTLC, GC, UV, GC-MS, fluorimetry etc.
Microbiological parameters
include total viable content, total mold count, total enterobacterial and their count. Limiters can be utilized as a quantitative or semi quantitative tool to ascertain and control the amount of impurities like the reagents used during abstraction of various herbs, impurities coming directly from the manufacturing vessels and from the solvents etc.
Standardization of herbal drugs
Commercial production of herbal medicines and their trade are fast growing sector of industry today, due t6o increasing demand of medicinal plants; the supply line is adversely affected leading to the adulteration and substitution for genuine drugs.
Fluorescence quenching:- When a plant extract is spotted on a fluorescent silica gel layer and exposed to UV light, it appears as spot on a fluorescent background, thus causing quenching and is directly proportional to concentration of the extract. Silica gel GF plate was used as an adsorbent for fluorescence quenching. Solvents taken- hexane toluene, ether, ethyl acetate, butanol, methanol and water.
Use of fingerprinting and marker compounds for identification and standardization of botanical drugs:- Chemical and chromatographic techniques may be used to aid in identification of an herbal material or extract. Chromatographic technique such as HPLC, TLC, GC and capillary electrophoresis and spectroscopic methods such as IR, NMR, and UV-may also be used for fingerprinting. DNA fingerprinting has been widely used in many species, e.g. DNA fingerprinting of Panax species and their adulterants. Marker compounds may be used to help identify herbal materials, set specifications for raw materials, standardize botanical preparations during all aspects of manufacturing processes and obtain stability profiles.
Densitometric thin layer chromatographic determination of aescin in an herbal medicinal product containing Asculum and Vitis dry extract:- A TLC method is developed to analyze the total saponin content, also referred to as the aescin content, in an herbal medicinal product containing two dry extract in capsules. After a purification step using C solid phase extraction, the samples are analyzed on a silica gel HPTLC plate with the upper layer of a mixture of acetic acid/water/butanol(10/40/50v/v/v) as the mobile phase. Spots are visualized by spraying with anisaldehyde reagent and heating the plate for 5-10 min.(100-105oc) and measured at a wavelength of 535 nm.
Determination of stigmasterol, beta-sitosterol and stigmastanol in oral dosage forms using HPLC with evaporative light scattering detection: - A validated and repeatable HPLC method with online evaporative light scattering was developed for the analysis of two sterols, stegmasterol, beta-sitosterol and a stanol found to be common in many herbal formulations and health care supplements. This method was used to assay commercially available products formulated as oral dosage forms purported to contain African potato and associated sterols and stanol.
Elemental analysis of herbal preparations for traditional medicines by neutron activation analysis with the kO standardization method: - Medicinal herb preparations prescribed for specific treatment purposes were purchased from markets and were analysed by instrumental neutron activation analysis with kO standardization. 500-700 mg of each sample was palletized under a pressure of six tones and irradiated together with monitors for alpha and neutron flux ratio determination for about 6h in a thermal flux of 2.29 x 10(12) n/cm2/s.
Liquid chromatography UV-determination and liquid chromatography-atmospheric pressure chemical ionization mass spectrometric characterization of sitosterol and stigmasterol in soyabean oil:- A narrow bore HPLC-UV method was developed for the analysis of two of the more abundant naturally occurring phytosterols in vegetable oils: sitosterol and stigmasterol. The method enabled detection of the compounds at a concentrationof0.42 µ/ml and quantization at concentration of 0.52 and 0.54 µ/ml for sitosterol and stigmasterol, respectively.
Simultaneous determination of cinnamaldehyde, eugenol and paeonol in traditional Chinese medicinal preparations by capillary GC-FID: - A capillary GC method was established for simultaneous determination of cinnamaldehyde(CNMD), eugenol(EL) and paeonol(PL) in two traditional Chinese herbal medicinal preparations, Weitongding tablet (WTDT) and Guifu Dihuang pill (GDHP). The assays were based on a programmed temperature GC in a 30 m x 0.53 mm capillary column with nitrogen as carrier and FID detector. Good linearity were obtained over ranges of 0.45-0.452 mg/l CNMD, 0.31-0.625 mg/l EL, and 0.30-610 mg/l PL, respectively.
HPTLC fingerprinting of marketed formulation containing Shankhpushpi: - These are the important Ayurveda formulations used for perinatal care of mother and child health. Standardization of churnas was carried out by organoleptic study, phytochemical analysis; qualitative organic and inorganic analysis, thin layer chromatography, UV- visible spectrophotometer and HPLC fingerprint studies. Qualitative organic analysis of both the churnas revealed the presence of alkaloids, steroids, phenols, tannins, glycosides, resins, saponins and flavonoids.
Evalution of herbal drugs14,15
Biological parameter (bioassay):- It is well established that the biological potency of the herbal constituents is due to not one but a mixture of bioactive plant constituents and the relative properties of a single bioactive compound can vary from batch to batch while the biological activity remains within the desirable limits. (1) Some of the examples are:_
a. Evaluation of adaptogenic activity profile of herbal preparation: - Adaptogens help the body to come up with stress and enhance general health and performance. AVM is an herbal formulation. Composition- Emblica officinalis, Withania somnifera, Asparagus racemosus, Ocimum sanctum, Tribulus terrestris and Piper longum. AVM shows significant antistress, immunomodulatory and anabolic activities in different animal models there by proving a promising adaptogen.
b. Evaluation of antioxidant activity of herbal products: - A new test method for measuring the antioxidant power of herbal products, based on solid phase spectrophptometry using tetrabenzo-b, f, j, n, l, 5, 9, 13- tetraazacy- clohexadecin- Cu (II) complex immobilized on silica gel is proposed. The method represents an alternative to the mostly used scavenging capacity assays. The method was approved in the analysis of the most popular herbal beverages and drugs Echinacea determined spectrophotometrically.
c. Evaluation of microbial contamination reduction on plants through technological process of decoction and spray dry: - The technological process of raw material has many stages, generally, adverse to microbial growth, but its complete elimination depends on the initial and work condition utilized. The aim of this work was to verify the microbial contamination, such as extractive solution (SE) and spray dried extract (PSA) with the purpose of evaluating the decrease of contamination after the decoction and the spray dry. The microbiological analysis of the products was performed by total plate count and MPN coliform.
d. Evaluation of nitric oxide scavenging activity of selected medicinal plants used in inflammatory diseases: - Four traditional medicinal plants, namely Ventilago madraspatana Gaertn., Rubia cordifolia Linn., Lanatana camara Linn. And Morinda citrifolia Linn. Were selected for a study on the inhibition of nitric oxide (NO), a key mediator in the phenomenon of inflammation, signifying the presence of effective anti-inflammatory constituents therein. Plant samples were extracted with different solvents for evaluation of their inhibitory activity on NO produced in vitro from sodium nitroprusside, and in LPS- activated murine peritoneal macrophages, ex-vivo.
e. The lipid peroxidation inhibitory activity:- The reaction mixture contained mice liver homogenate (0.2 ml, 10% w/v) in 0.15 KCl, KCl (0.1 ml, 150 µm), Tris buffer (0.4 ml, Ph 7.5) and various concentration of test extracts. In vitro lipid peroxidation was initiated by addition of Feso4.7H2O (0.1 ml, 10 µm). The reaction mixture was incubated at 37o for 1 h. After the incubation period, reaction was terminated by addition of thiobarbituric acid (TBA-2 ml, 0.8%) and by heating the contents for 15 min. for development of colored complex. The tubes were then centrifuged at 4000 rpm for 10 min. and cooled. The % inhibition of lipid peroxidation was determined by comparing the results of test compound with those of control not treated with extracts by monitoring the color intensity at 532 nm. Gallic acid was used as a positive control.
Evaluation of marketed polyherbal antidiabetic formulatios using biomarker charantin: - Charantin is one of the phytoconstituents present in Momordica charantia. It is well known to possess antihyperglycaemia, anticholesterol, immunosuppressive, antiulcerogenic, antispermatogenic and androgenic activities. HPTLC method is fast, precise, sensitive and reproducible with good recoveries for standardization of polyherbal formulations. The recovery values of charantin were found to be about 98.89%.
In vivo and in vitroevaluation of hair growth potential of Shoe flower: - The leaves and flowers of Hibiscus rosa-sinensis are used as promoters of hair growth and as an aid in healing of ulcers. Petroleum ether extract of leaves and flowers of the plant was evaluated for the potential growth in vivo andin vitro methods. In vivo, 1% extract of leaves and flowers in liquid was applied topically over the shaved skin of albino rats and monitored and assessed for 30 days. The length of hair and different cyclic phases of hair follicles, like anagen and telogen phases were determined at different time periods. In vitro, the hair follicles from albino rat neonates were isolated and cultured in DMEM supplemented with 0.01 mg/ml petroleum ether extract of leaves and flowers. It is concluded that the leaf extract, when compared to flower extract, exhibits more potency on hair growth.
Clinical evaluation to assess the safety and efficacy of coded herbal medicine “Dysmo-off” versus allopathic medicine “Diclofenac sodium” for the treatment of primary dysmenorrhoea: - The clinical study on primary dysmenorrhoea to comparatively examine the coded herbal drug formulation “Dysmo-off” with authentic allopathic medicine “Diclofenac sodium”. A random controlled clinical trial was conducted. These evaluations were based on verbal rating scale so as to ascertain the rate of analgesic effects on dysmenorrhoeic pain. The patients were randomly allocated with the ratio of 1:2 for controlled treatment with (NSAIDS) (n=40) received Diclofenac sodium tablets twice daily for 4 days (50 mg one day prior to and three days after the menstruation), and test treatment with Dysmo-off (n=80) received powdered Dysmo-off twice daily for 4 days (5 g one day prior to and three days after the menstruation). Treatment lasted for 4 consecutive menstrual cycles. Haemoglobin, ESR and ultrasound were measured at baseline during study. All subjects were clinically studied.
Thermographic evaluation: - In the present study, the authors used thermography to evaluate the effects of herbal formulations based on “Sho” scientifically. In the cases that were suitable for Keishibukuryogan, the so called Keishibukuryogan Sho, a significant skin temperature rise was observed in the upper half of the body after the intake of Keishibukuryogan. In a case that was suitable for Hochuekkito, a marked elevation of skin temperature spread through the upper trunk. It suggested that thermography is useful for an objective evaluation of Sho in Kampo medicines, and for identification of the action site of the herbal formulation.
Biochemical evaluation: - Most of the herbal drugs are a mixture of a number of ingredients. Their cumulative effect increases the efficacy of the drug in curing the diseases. Muthu Marunthu is an herbal formulation comprising of eight various plant ingredients, and has been claimed to possess anticancer effect. It was observed that the growth rate in rats was normal and there was no change in blood parameters such as glucose, urea, proteins, cholesterol and also in the activities of pathophysiological enzymes such as lactate dehydrogenase (LDH), gluconate oxaloacetate transaminase (GOT), glutamate pyruvate transaminase (GPT), alkaline and acid phosphatase after Muthu Marunthu administration. The tumor weight was found to be reduced in methylcholanthrene induced fibrosarcoma rats after Muthu Marunthu treatment.
Evaluation of Kutaj-Ghanavati for alkaloidal principles:- Kutaj-Ghanavati is a reputed Ayurvedic preparation used in dysentery and diarrhea. It contains water extract of Kurchi bark and fine powder of aconite roots. It was evaluated quantitatively and qualitatively employing TLC and titrimetric method. In TLC study no interference of Kurchi and Aconite alkaloids with one another in their respective solvent systems. The formulation was found to contain all alkaloids of Kurchi and Aconite.
Organoleptic evaluation: - Organoleptic evaluation of food products plays an important role in judging the censoring acceptability or rejection of food items in the market. Effect of various treatments (blanching, pricking, and lye treatment), sugar concentration (50%, 60%, 70%) and storage on the color scores; flavor scores; texture scores of intermediate moisture apricots. The overall acceptability of the products was significantly higher in 70% sugar syrup but these scores decreased as the storage period advanced.
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WHO Guidelines for Quality Standardized Herbal Formulations
a.Quality control of crude drugs material, plant preparations and finished products.
b.Stability assessment and shelf life.
c.Safety assessment; documentation of safety based on experience or toxicological studies.
d. Assessment of efficacy by ethnomedical informations and biological activity evaluations.
The bioactive extract should be standardized on the basis of active principles or major compounds along with the chromatographic fingerprints (TLC, HPTLC, HPLC and GC). The standardization of crude drug materials include the following steps:
1.Authentication (Stage of collection, parts of the plant collected, regional status, botanical identity like phytomorphology, microscopical and histological analysis, taxonomical identity, etc.)
2.Foreign matter (herbs collected should be free from soil, insect parts or animal excreta, etc.)
3.Organoleptic evaluation (sensory characters – taste, appearance, odor, feel of the drug, etc.)
4.Tissues of diagnostic importance present in the drug powder.
5. Ash values and extractive values.
6.Volatile matter
7.Moisture content determination
8. Chromatographic and spectroscopic evaluation. TLC, HPTLC, HPLC methods will provide qualitative and semi quantitative information about the main active constituents present in the crude drug as chemical markers in the TLC fingerprint evaluation of herbals (FEH). The quality of the drug can also be assessed on the basis of the chromatographic fingerprint.
9.Determination of heavy metals – e.g. cadmium, lead, arsenic, etc.
10.Pesticide residue – WHO and FAO (Food and Agricultural Organization) set limits of pesticides, which are usually present in the herbs. These pesticides are mixed with the herbs during the time of cultivation. Mainly pesticides like DDT, BHC, toxaphene, aldrin cause serious side-effects in human beings if the crude drugs are mixed with these agents.
11.Microbial contamination – usually medicinal plants containing bacteria and molds are coming from soil and atmosphere. Analysis of the limits of E. coli and molds clearly throws light towards the harvesting and production practices. The substance known as afflatoxins will produce serious side-effects if consumed along with the crude
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