FORMULATION AND EVALUATION OF POLYHERBAL CAPSULES FOR ANTIDIABETIC ACTIVITY

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1 WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES Anita et al. SJIF Impact Factor Volume 4, Issue 08, Research Article ISSN FORMULATION AND EVALUATION OF POLYHERBAL CAPSULES FOR ANTIDIABETIC ACTIVITY Anita Singh* 1 and Anil Waldia 2 1 Department of Pharmaceutical Sciences Kumaun University Bhimtal. 2 Devsthali Vidyapeeth College of Pharmacy, Rudrapur. Article Received on 20 June 2015, Revised on 09 July 2015, Accepted on 29 July 2015 *Correspondence for Author Anita Singh Department of Pharmaceutical Sciences Kumaun University Bhimtal. ABSTRACT Normally, herbal products are known for their inherent property i.e. free from side effects, adverse effects and are economic, which will be beneficial for the people of many countries. Keeping this in the view herbal plants were selected. These plants are one of the traditional medicinal plants used for diabetes. The main aim of this research work was to formulate and evaluate capsule formulation of ethanolic extract. The most important challenges faced by herbal formulations are their lack of complete evaluation, but evaluation is necessary to ensure the quality and purity of the herbal products, hence capsule containing poly herbal ethanolic extracts were tested for various parameters. The evaluation parameters including uniformity of weight, disintegration time and other quality control tests such as in- vitro release studies. KEYWORDS: Hydro- Ethanolic extract, medicinal plants, quality control, In-vivo studies, In- vitro release, antidiabetic activity. 1. INTRODUCTION The Indigenous system of medicine comprises of Ayurveda, Unani and Siddha. These system comprised of many crude materials and herbal formulations. Traditional Medicines are derived from plants mainly and used by about 60% of the world s population. [1,2] The World Health Organization (WHO) has listed 21,000 plants, which are used for medicinal purposes around the world. Among these 2500 species are in India, out of which 150 species are used commercially on a fairly large scale. [3] In the last few years there has been an exponential growth in the field of herbal medicine and these drugs are gaining popularity both in developing and developed countries because of their natural origin and less side effects. Due Vol 4, Issue 08,

2 to the presence of some other phyto-constituents the possibility of adverse effects or toxic effects are less. Researchers in the last century identified and isolated Salicin, a glycoside as active principle. [4, 5] From salicin, salicylic acid was obtained and finally used in aspirin synthesis. Aspirin is known to cause gastric irritation and hypersensitivity. But when the plant extract is used does not cause gastric irritation, most probably due to the presence of tannins. Many Western drugs used today also originated from natural plant sources. For instance, metformin, an oral prescription glucose-lowering drug for diabetes, was initially derived from a flowering plant called Galega officinalis. [6] 2. MATERIAL AND METHODS 2.1 Material Used Table.1.1: Herbal Drugs Used In Proposed Polyherbal Drug Formulation Common Name Botanical Name Family Part Used Daruharidra Berberis aristata Berberidaceae Root Finger millet Eleusine coracana Poaceae Seeds Lady s Finger. Abelmoschus esculentus Malvaceae Fruits Indian gooseberry Syzygium cumuni Myrtaceae. Seeds Guduchi. Tinospora cordifolia Menis permaceae Stems 2.2. Extraction Of Poly Herbal 50% hydro-ethanolic extract: The Research work was initiated with 50% hydro-ethanolic extract. Further 50% hydro-ethanolic extract was subjected for phytochemical screening, and then in-vivo antidiabetic activity of the extract was evaluated and then the capsules are formulated Preparation Of Poly-Herbal Capsule Containing Poly Herbal Extract: Accurately weighed 6 g of extract was taken, and mixed with 4.8 g of adsorbent (MgO & CaCO 3 ) in the ratio of 1:1 using trituration method. After trituration, blend was passed through sieve no- 26.The fine powder so obtained was filled in capsule shell (#0) with the help of hand operated capsule filling machine. [7,8] Table 1.2. Composition of poly-herbal capsule Ingredients Amount gm/capsule Amount gm/20 capsules Poly-herbal Extract(hydro-ethanolic) Magnesium Oxide Calcium Carbonate Vol 4, Issue 08,

3 3. EVALUATION OF POLY-HERBAL CAPSULES 3.1 Preparation Of Calibration Curve For the preparation of standard curve, stock solution of 1000 μg/ml concentration was prepared and it was then serially diluted with water to get 50, 60, 100, 200, 300, 400 up to 500 μg/ml. The absorbances of the solutions were measured against distilled water as blank at 260 nm using UV spectrophotometer. The absorbance values were plotted against concentration (μg/ml) to obtain the standard calibration curve. Table 3: Calibration curve of Poly-herbal extract Conc (µg/ml) Absorbance (260nm) Fig. 1. Calibration curve of Poly-herbal extract 3.2. Weight Variation Of Capsules This weight variation requirement measures the variability in the amount of powder contained in each capsule. Twenty capsules were randomly selected and weighed to determine the average weight and were compared with individual capsule weight. The percentage weight variation was calculated as per Indian Pharmacopoeia (2010) Specification. The capsule shall not be less than 90% and not more than 110% of the theoretically calculated weight of each unit. [9] Vol 4, Issue 08,

4 3.3. Disintegration Test Generally, the test is useful as a quality assurance tool for conventional dosage forms. The efficacy of a drug or dosage form is solely dependent on the rate which formulation (capsule) disintegrates in the patient s gastrointestinal tract. For performing disintegration test six randomly selected capsules were taken. The tablet disintegration test apparatus was used. The disintegration assembly was maintained at temperature 37 ºC±2 ºC. The capsule was placed in each tube which was then suspended in the beakers which contains simulated gastric fluid (SGF, ph 1.2, without pepsin) to move up and down for 30 minutes. The disintegration test is a measure of the time required under a given set of conditions in which selected capsules were disintegrated into particles which will pass through a 10 mesh screen within a specified time In-Vitro Dissolution Studies- In Some Cases Dissolution is considered as a tool for predicting rate of absorption and bioavailability in some cases, replacing clinical studies to determine bioequivalence of drug. The Paddle Type Dissolution Apparatus (Electro Lab 6 basket dissolution apparatus), containing 900 ml of SGF solution was taken into the jar as dissolution medium and temperature was maintained at 37 ºC±2 ºC. The paddle was rotated at 50 rpm for 30 minutes. 5ml of the dissolution medium was withdrawn at predetermined intervals and fresh dissolution medium was replaced. The samples withdrawn were analyzed by U.V. Spectrophotometer (Shimadzu 1800, Kyoto) at 260nm. 4. RESULTS & DISCUSSION 4.1 Weight Varriation As per Indian Pharmacopoeial Specification, capsules with an average weight between mg, the percentage deviation should not more than ± 7. 5 % Disintegration Test- The capsule passed the test as no residue of drug was remained. The disintegration time was noted as 18 minutes. Table.4. In Vitro Dissolution Studies Time Conc. Amt Amt Amt Abs (min) (µg/ml) (mg/5ml) (mg/ml) (mg/900ml) CDR %CDR Vol 4, Issue 08,

5 *CDR= Cumilative Drug Release Fig.3. In Vitro Dissolution of Poly-herbal Capsule 5. CONCLUSION The Poly- Herbal capsules were formulated for anti diabetic activity using (optimized ratio) hydro-ethanolic (50% ethanol) extract of traditional medicinal plants. The evaluation parameters were found within limit. The percentage deviation for weight variation was not more than ± 7. 5 % & disintegration time was observed as 18 minutes. In vitro release studies show that 98% herbal drug was release in 30 minutes. This poly herbal formulation may be beneficial for diabetic patients in future. 6. ACKNOWDGEMENT I sincerely thanks Devsthali Vidyapeeth Collage of Pharmacy, Rudrapur, Uttarakhand for providing me all the facilities for conducting my research work. 7. REFERENCES 1. Baynes J.W., Thorpe S.R. The role of oxidative stress in diabetic complications. Curr. Opin. Endocrinol., 1997; 3: Lipinski B. Pathophysiology of oxidative stress in diabetes mellitus. J. Diabet. Complications., 2001; 15: Kubish H.M., Vang J., Bray T.M., Phillips J.P. Targeted over expression of Cu/Zn superoxide dismutase protects pancreatic beta cells against oxidative stress. Diabetes., 1997; 46: Vol 4, Issue 08,

6 4. Ivorra, M.D., M. Paya and A. Villar. A review of natural products and plants as potential antidiabetic drugs. J. Ethnopharmacol., 1989; 27: Oliver, B.B. and G.R. Zahnd,. Plant with oral hypoglycemic action. Quart. J. Crude Drug Res., 1979; 17: Aguilara, F.J.A., R.R. Ramos, S.P. Gutierrez, A.A. Contreras, C.C.C. Weber and J.L.F. Saenz. Study of the antihyperglycemic effect of plants used as antidiabeties. J. Ethanopharmacol., 1998; 61: R. Bansal, N. Ahmad and J.R. Kidwai, Effects of oral Administration of Eugenia jambolana Seeds and chloropropamide on blood glucose level and pancreatin cathepsin B in Rat. Indian J of Biochem and Biophys, 1981; 18: P.K. Mahapatra, M. Pal, A.K.N. Chaudhari, D. Chakraborty, A. Basu, Preliminary studies on glycemic effect of Syzyginium Cumini seeds. IRCS medical Science Biochemistry, 1985; 13(7): Indian Pharmacopoeia, Ministry Of Helth and Family Welfare, 4 th edn., Controller of publication, Delhi, 2010; A-84: Vol 4, Issue 08,