About Authors: Amit Tamiya (M.Pharm), Dr. Gopal Rai,
Department of Pharmacology Shri Ram Institute of Technology,
Jabalpur (M.P.), India
Reference ID: PHARMATUTOR-ART-1078
Abstract
In the recent time the science is proved the new aspects of herbal medicine, as therapy to treat disease, known as phytotherapy, is to be developed. It include the nutritional sciences, in it the phytochemicals that are ingested in the form of complex mixtures that are incompletely characterized in the past whose scientific study is being performed. The new methodologies developed in the area of nutritional sciences can inform phytotherapy research, opportunities for observational studies. Randomized clinical trials of single - herb interventions are relatively easy to justify its pharmacological effect. However, phytotherapy is the natural therapy, using lifestyle advice, nutrition and individually use of the combination of herbs, for the restoring the homeostasis. Now the clinical trial evaluated, this approach is useful in a wide range of conditions, Central nervous system, Hepatoprotective, mental disorder including chronic disease, associated with the human being.
Introdution
Herbal medicine, is the natural system of medicine that has been practiced for more than 5000 years. Ayurveda is a Sanskrit word and its meaning is “science of life or practice of longevity” this system of health care was conceived and developed by the Rishis and natural scientist through centuries of observation, discussion and medications based on trial and error.
Herbs are the major components in all indigenous preparations of traditional medicine and common element in ayurveda, homoeopathic, naturopathic and native medicinal Indian herbal medicine emphasizes prevention of disease, rejuvenation of our body systems and it extends the life span and makes healthy life in balance and harmony. From ancient time to present, people through out the world have maintained a vast and intimate knowledge of native plants. The plant kingdom has provided an end less source of medicinal plants, first used in crude form then as herbal teas, syrups, infusions, ointments liniments, and powders.
Herbal Drug Development
It is an aspect of pharmacology to know how plants are used for their medicinal potential. From the point of view of drug development, the important aspects are to justify the correct part of the plant which have the active chemical constituent essential for the pharmacological activity, Preliminary phytochemical screening, The selection of solvents, extraction process , an other methodology are the important aspect to evaluate the pharmacological activity of plant .
A quick look at the activities tested reveals a very wide spectrum. Such as, anti-diabetic activity, and anti-oxidant, anti-anxiety and anti-asthma to anti-malarial. Experimental model included, for behavioral study is Elevated plus maze , Y –maze , light and dark test for CNS activity, For Anti inflammatory activity cotton palate induced paw edema, for CVS activity the isolated frog heart muscle, is most suitable animal model, All plants under investigation produced significant CNS activity.
This very brief analysis highlights the major activity that was reported in the various plants, and also gives information regarding the problem that arising during the drug development research. [1]
The plant itself is the source of the biggest challenge and the correct choice underpins the beginning of success. [2] From identification, to method and site of harvesting, the part being used, the processing, standardization, purity and the final formulation, all have to be taken into consideration. [3] Special attention must also be paid to standardization of the compound, using markers if possible, bio-active markers the extract should authenticated and standardized, the information is inadequate from a drug development point of view. Far more details are required to be furnished and generation of this information is crucial to further studies. This leads to successful drug development. [4]
In conventional drug development, the safety and toxicity, is of the chemical is influences the property of chemical substance to becomes a medicine. In the case of plants, especially those used in traditional medicine how much toxicity testing is required. According to ICMR Guidelines [5] the plants divided into three categories: Category I includes those plants or extracts about which a lot is known in ancient literature or the plant may actually be in use by physicians of the traditional system of medicine. In such cases, the extent of toxicity testing required is less. When an extract of a plant or a compound isolated from the plant has to be clinically evaluated for a therapeutic effect not originally described in the texts of traditional systems, or, the method of preparation is different from tradition, it is described as belonging to Category II. It is recommended that this type of extract has to be treated as a new substance or a new chemical entity and the same type of acute, sub acute and chronic toxicity data has to be generated as required .by the regulatory authority for synthetic products before it is cleared for clinical evaluation. Category III is new extracts and they are also treated as NCEs. The LD50 studies by utilizing all resources on plants extracts must be appropriate.
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The sample size, the study design, controls, the inclusion and exclusion criteria and the choice of efficacy and safety variables and end points. The standard of clinical research is the randomized, controlled clinical trial design. Such studies are difficult with herbal medicines. It is the expectation about the herbals that is the best a mixture of multiple chemicals in concentrations that are unknown from where the study should be initiated or better than the synthetic chemicals, The selection of placebo is also an important pharmacological aspect,–to match the colour, flavor and consistency of the herbal material is challenging. While determining the inclusion criteria, it appears necessary to consider such factors as the nature or constitution of the participant, that can influence the drug response. [6] Sometimes, due to skepticisms or over eagerness, patients are not responding to conventional medicine are included in the study. These studies are difficult on the herbal medicine, also the eligibility criterion, the chances of success of any the herbal therapy become low. Selecting hard end-points and variables for clinical evaluation of herbal medicines is also not too good, especially with the medicines that not too much effective, than placebo. And also when compare ring the symptom complexes as described in traditional medicine there is often a response seen.
Apart from these considerations regarding study design, the plant material with which t the clinical trial is being performed also need special attention. This is especially essential when long term studies are planned where shelf life and stability of the formulation, also the packaging and transport of the material. While choosing the correct dose for clinical studies, extrapolation of a dose recommended in the traditional medicine proves a useful approach, as with most of the herbs pre-clinical data in terms of both safety and efficacy is not available and more importantly, pharmacokinetic data is missing completely. The formulation, another tricky issue, should be selected carefully. Ethical issues also must. With herbal drugs. Evidence to justify the use of herbal medicines in mainstream medicine is therefore missing to be some potential benefit, further studies are required. What needs to be done? A focused “drug development”. It is noted that the Government of India, through its various programs to develop a standardized and safe herbal product. Also the research is in under progress ranging from diabetes to “liver protective” and cancer to AIDS. To summaries therefore, a national level focused drug development program is required. [7]
HERBS USED FOR THEIR PHARMACOLOGICAL POTENTIAL
Vitex negundo
Common name Nirgundi.
Taxonomical Description
Biological name Vitex negundo Linn
Kingdom Plantae
Order Lamiales
Family Lamiaceae
Genus Vitex
Species V. negundo. [27,60]
Chemical Constituent
Vitexi Lactone and casticin.The pentacyclic triterpenoid, Betulinic and Ursolic acid isolated from leaves from leaves of vitex negundo. [8, 11]
Medicinal Uses
The leaves are aromatic, tonic and vermifuge.
A decoction of leaves is given with the long pepper in catarrhal fever with heaviness of head and dullness of hearing.
A pillow stuffed with the leave of nirgundi is placed under the head in the treatment of headache.
The juice of leaves is used in the worms from the ulcer.
The leaves are discutent, and useful in dispersing swelling of joints from acute rheumatism. & test from suppressed gonorrhea.
The plant is used for the treatment of snake bite. In case of snake bite the the bruised root, bark and leaves are applied to the wounds. [8, 9, 10]
The dried leaves are smoked for the relief of headache & the dried fruit act as vermifuge. [27]
Reported Pharmacological Activity
Activity on Central Nervous System
The dried leaves of Vitex negundo was extracted with petroleum ether. The active fraction of the extract was separated by column chromatographic technique, to study analgesic, anti-consultant and sedative-hypnotic activities. The leaf extract potentiated the sedative-hypnotic effect of pentobarbitone and diazepam significantly in a dose dependent manner, the extract showed significant analgesic activity and prolonged the analgesia. Whereas, the anti-convulsant activity was found only at high dose. [12]
CNS activity of V. negundo Linn with the methanol extracts was reported on mice. Result the significant decrease in the convoulsion in mice and produced a marked analgesia. [19] Anxiolytic activity was reported in experimental model of anxiety in mice by using Ethenolic Extract of root of Vitex negundo Linn. The behavioral study was performed on Elevated plus maze and light dark exploration test. The extract significantly increased the percent time spent and increase the number of entries in the open arm. [20]
Analgesic and Anti-Inflammatory
Analgesic and anti inflammatory activity was reported in hydro alcoholic extract of leaf of vitex negundo Linn. The analgesic activity studied by acetic acid induced writhing test in mice for assessing peripheral analgesic effect and tail immersion test in mice for assessing central analgesic effect. The anti-inflammatory activity was studied by using the models of carrageenan-induced rat paw edema and carrageenan induced granuloma pouch in rats for assessing the effect on acute and sub acute inflammations respectively. Isolated rat uterus was used to study the involvement of prostaglandins in the analgesic and anti-inflammatory activities. The leaf extract have both central and peripheral analgesic action, also possesses anti-inflammatory activity which was more pronounced on sub acute inflammation. [21]
The primilenery study of anti inflammatory activity of Vitex negundo, Zingiber officinale and Tinospora cordifoliya, was reported on carrageenan induced hind paw edema and cotton pellet granuloma in rats. Hind paw edema was produced by sub planter injection of carrageenan and paw volume was measured plethysmometrically. Cotton pellet granuloma was produced by implantation of sterile cotton in each axilla under ether anesthesia. The animals were treated with Zingiber officinale, Vitex negundo, Tinospora cordifolia and the standard drugs Acetylsalicylic acid and Phenylbutazone. Zingiber officinale, Vitex negundo and Tinospora cordifolia possess anti-inflammatory effects in both acute and sub acute inflammation. [22]
The Anti inflammatory and analgesic activity of mature fresh leaves of Vitex negundo Linn. Were reported by orally treated water extract in carrageenan induced ret paw oedema model and tail flick method. The leaves showed a significant analgesic and anti inflammatory activity. [23]
The antinoceceptive activity and effect of it on oxidative stress. Was evaluated by Ethenolic extrect.of fresh leaves of Vitex negundo Linn with acetic acid induced writhing in mice and tail flick test in mice. The leaf extract produced significant analgesia in dose dependent response. [24]
The Antioxidant and Anti inflammatory activity of Vitex negundo was reported by subjecting the plant for methenolic extract that cause the significant reduction in edema of carrageenan induced rets paw edema method. The extract also exhibits a significant antioxidant activity. [25]
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Anti-Microbial Activity
The Essential oil composition and anti bacterial study of Vitex negundo Linn extracts were reported. The essential oil is obtained from hydro distillation of fresh leaves, fruit & flowers the extract were evaluated for antibacterial potential against S.aureous, B.subtilus, and E.coli bacterial strain. Ethyl acetate and ethanol extract show prominent antibacterial action. Leaves oil were found to most active against E.coli. [26]
The Anti fungal activity of fruits of Vitex negundo Linn was evaluated with petroleum ether extract. And examined against fungal strains, Candida albicans, Candida glabrata, Aspergillus flavus, Microsporum canis and Fusarium solani. Ethanol extract of fruit seeds showed significant activity against Fusarium solani and moderate response against Microsporum canis with no effect on Candida albicans. [28]
Activity on Cardiovascular System
The cardio tonic effect of aqueous extract of leaves of Vitex negundo Linn was evaluated. The leaves are believed to antioxidant property so it tend to used for the protection of cardio vascular system., The cardio vascular effect of leaves of Vitex negundo were studied by isolated frog heart perfusion technique. The leaf extract showed the significant cardio tonic effect on heart muscle. [29]
Terminalia arjuna
Common name Arjun bark, Arjun
Taxonomical Description
Biological name Terminalia arjuna.
Kingdom Plantae
Order Myrtales
Family Combretaceae
Genus Terminalia
Species T. arjuna [27,61].
Chemical Constituent
Tannin, Triterpenod, Saponin, Arjunolic acid, Beta setosterol, ellagic acid, and Arjunic acid, arjunine, arjunitine.
Medicinal Use
Arjuna bark is a cardio tonic in septic, febrifugal and anti dysenteric .Diuretic and tonic.
Hypotensive action with vasodilatation and decreased heart rate. [30-37]
Reported Pharmacological Activity
Activity on Central Nervous System
The anti stresses activity of plant geriforate powder. Consisting T.arjuna, in mice was evaluated in the powder form of the drug in aqueous solution in forced swim experimental animal model .The result showed the significant effect of the drug in diminish the anxiety. [38]
The terpenoid glycoside from the bark of termenalia arjuna was isolated by chromatographic technique and investigated the pharmacological behavior on muscle tissue, and have a marked effect on lowering the contraction on the isolated frog muscle preparation. [39]
The anti anxiety and analgesic activity was evaluated with ethanolic extract of Datura stramonium (leaves), Terminalia arjuna (bark), Withania somnifera (root) in mice using Elevated plus-maze apparatus, light/dark apparatus were used , the extract exhibit the significant action to decrease the anxiety and inflammation, and prolong the analgesia with the standard drug. [40]
Anti Inflammatory, Anti Nociceptive and Immunomodulatory
The antiinflammatory, antinociceptive, immunomodulatory activity of Termenelia arjuna rox bark powder was evaluated in mice. The powered extract was significant effect in dicrese the inflammation and produces the analgesic effect with immunomodulatory action. [41]
Activity on Cardio Vascular System
The mechanism of action of cardio protective drug (Bark) Terminalia arjuna effect of traditional constituent on the process of respiratory oxy burst was evaluated by using Alcoholic Extract. Arjungenin was found to be most active as direct free radical scavenger and inhibitor for the hypochlorous acid production followed by its glucoside that was almost 50% active. [42]
The anti athergonic activity of Ethanolic Fraction of Terminalia arjuna Bark was reported on Hypercholesterolemic Rabbits. This study was conducted to determine the effect of ethanolic fraction of T. arjuna on blood lipids and atherosclerosis in rabbits fed with high fat diet. Result show that T. arjuna extract can effectively prevent the progress of atherosclerosis. [43]
Anti Oxidant and Anti Dyslipidemic Activity
The anti oxidant and antidyslipidemic activity of different fraction of T. arjuna stem bark were evaluated with the use of petroleum ether, solvent ether, ethanol and water as a solvent. The lipid lowering activity of these four fractions was evaluated in vivo in two models viz, triton WR-1339 induced hyperlipemia in rats as well as fructose rich high fat diet fed diabetic- dyslipidemic hamsters the result show that only petroleum ether extract have significant lipid lowering effect. [44]
The effect of T. arjuna stem bark on antioxidant status were reported in liver and kidney of alloxan induced diabetic ret. The study was examined the effect of ethanolic extract of Terminalia arjuna Stem bark in alloxan induced diabetic rats and its lipid per oxidation, enzymatic and no enzymatic activity was investigated in the liver and kidney tissues. The extract produced significant reduction in lipid per oxidation. [45]
Ocimum sanctum
Common name Holy basil, Tulsi
Taxonomical Description
Biological name Ocimum sanctum
Kingdom Plantae
Order Lamiales
Family Lamiaceae
Genus Ocimum
Species O.tenuiflorum. [27,62]
Chemical constituents
Volatile oil, Euginol, Carvacrol, and Eugenol -methyl –ether, caryophilin.
In seed, fixed oil, Alkaloids, glycoside, saponin., tannin, vitamin–C, Malic, Citric and tartaric acid. [30]
Medicinal use
The juice and volatile oil is used as anti bacterial and insecticidal.
Leave s used as stimulant, aromatic, anticatheral, spasmolytic, and diaphoretic, and in skin disease, also used to cure ear-ache .and as immunomodulatory agent. [30, 46]
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Reported Pharmacological Activity
Activity on Central Nervous System
The Controlled programmed trial of Ocimum sanctum leaf on generalized anxiety disorders was evaluated by the use of ethenolic extract. The result show that the plant extract significantly attenuated generalized anxiety disorders and also attenuated its correlated stress and depression. [47]
Antioxidant and Neuro Protective
The Anti oxidant and neuro protective effect of Methenolic extract of Ocimum sanctum was evaluated on transient cerebral ischemia and long term cerebral hypo perfusion. The treatment of plant extract significantly prevented hypo perfusion-induced functional and structural disturbances. The results show that plant may be useful in treatment of cerebral reperfusion injury and cerebrovascular insufficiency states. [48]
Analgesic Activity
The potential effect of O.sanctum was evaluated in vincristine-induced naturopathic pain in rats. In it the ameliorative potential of Ocimum sanctum and its saponin rich fraction in vincristine-induced peripheral naturopathic pain in rats, were discovered, the Peripheral neuropathy was induced in rats by administration of vincristine sulfate The mechanical hyperalgesia, cold allodynia, Paw heat hyperalgesia and cold tail hyperalgesia were assessed by performing the pinprick, acetone, hot plate and cold tail immersion tests, The extract were prepared from soxhelt extraction from hydro alcoholic extraction using methanol and water The plant extract have a marked effect to minimize the pain and inflammation in dose dependent manner. [49]
Anti Apoptotic and Cardio Protective
The Anti apoptotic and cardio protective effect of an herbal combination was evaluated in rats with experimental myocardial infraction. The hydro alcoholic extract of O.sanctum, W. somnifera and C. longa have prominent efficacy to limit the myocardial injury and have significant anti apoptotic action. [50]
Hepatoprotective
The hepato protective activity was evaluated with the aqueous extract and steam distilled oil obtained from O. sanctum Linn against ethanol-induced cell damage in HepG2 cells Results of this study indicated that plant extract have significant action to restore the morphological changes in hepatic cells to normal. [51]
Anti Cataract Activity
The anti cataract activity was reported in O.sanctum in Selenite-Induced Cataractogenic Changes and Prevents Rat Lens Opacification. Aqueous extract possesses potential anticataract activity. And have action on restoration of the antioxidant defense system and inhibition of protein insolubilization of rat lenses as well. [52]
Antimicrobial Activity
The poly herbal preparation of O. sanctum, D. quercifolia, and A. squamosa in the prevention of sexually transmitted disease. was reported using different solvent hexane, benzene, chloroform, ethyl acetate, acetone, 70% ethanol, distilled water, and distilled hot water, the result of this study indicate that poly herbal preparation have significant antimicrobial action against N. gonorrhoeae. [53]
Chemo Preventive Activity
The chemo preventive effect of Ocimum sanctum seed oil was reported against subcutaneously injected 20-methylcholanthrene induced-fibro sarcoma tumors in the mice. [54]
Cassia occidentalis
Common name Barikasondi, Chakunda, Kasonda.
Taxonomical Description
Biological name Cassia occidentalis
Kingdom plantae
Order Fabales
Family Fabaceae (Pea family)
Genus Senna
Species Senna occidentalis. [27,63]
Chemical Constituent
Anthraquinone glycoside.Rhein, aloe-emodin, Stoll, Kaempferol, Phytosterol, salicylic acid, crysophenic acid, calcium oxalate.
Medicinal Use
Root of the plant is used in the Ring worm, Elephantiasis, also to cure cough, Hiccough, Asthma, snake bite, Heal wound, Purgative, Tonic. [27,30, 55,56]
Reported Pharmacological Activity
Toxic Effect on Different Organ System
The sub acute in toxication by senna occidentalis seed; is reported in rat in the long term consumption. The experimental group showed lethargy, weakness, recumbency, depression and emaciation. Histopathological study showed fiber degenerations in the skeletal and cardiac muscles. Vacuolar degeneration in the liver parenchyma was observed and, mild nefrosis in the kidney, in the PCT.tubules.All of these alterations occurred in a dose-dependent fashion. [57]
Purgative
The purgative effect of seed extract of Cassia occidentalis seed is evaluated on the longitudinal smooth muscle contractions of the rat ileum. The extract increased the force of spontaneous muscle contractions in a concentration-dependent manner. [58]
Hepato Protective Activity
Hepatoprotective activity of leaves of Cassia occidentalis against paracetamol and ethyl alcohol intoxication is evaluated in rats.The hepato protective effect of aqueous-ethanolic extract of leaves of Cassia occidentalis was studied on rat liver damage induced by paracetamol and ethyl alcohol by monitoring serum transaminase, alkaline phosphates, serum cholesterol, serum total lipids and histopathological alterations. The extract of leaves of the plant produced significant hepatoprotection. [59]
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59. Jafri M.A., Javed Kalim, Hepatoprotective activity of leaf of C.occidentalis against paracetamol and ethyl alcohol intoxication in rat.Journal of ethenopharmacology 1999;66:355-361.
60.V.negundo information from https://en.wikipedia.org/wiki/Vitex_negundo Retrieved 2010-11-05.
61.T. arjuna information from https://en.wikipedia.org/wiki/Terminalia_arjuna Retrieved2010-11-05
62.O. tenuiflorum from https://en.wikipedia.org/wiki/Ocimum_tenuiflorum Retrieved2010-11-05
63.C. occidentalis information from https://en.wikipedia.org/wiki/Cassia_(legume) Retrieved2010-11-05
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