SURVEY ON DIABETES AND STANDARDIZATION OF POLYHERBAL FORMULATION

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About Authors:
1Shambhawi, *Sai Saraswathi V
1*Pharmaceutical Chemistry Division,
School of Advanced Sciences,
VIT-University, Vellore-632014,
Tamilnadu, India.
1shambhawi06@yahoo.co.in, * v.saisaraswathi@vit.ac.in

ABSTRACT :
Standardization of polyherbal formulation is important to validate the quality of drugs and to ensure that the consumers are getting medication which guarantees purity, safety, potency and efficacy. The present paper reports standardization of traditional ayurvedic liquid polyherbal antidiabetic formulation (Sucrogen) and diabetes survey for retrieving the information on medication along with the lifestyle of diabetic population. Sucrogen was standardized based on ayurvedic pharmacopeia physico-chemical properties, preliminary phytochemical tests, organoleptic characters, stability studies, microbial studies, TLC, HPLC, heavy metal estimation by AAS and flame photometry to fix the quality standard of this drug. Invitro anti-diabetics activity of the drug was determined using alpha amylase Inhibitory method.These studies resulted in a set of diagnostic characters essential for its standardization. The phytochemical constituents found to be present in raw materials used for the preparation of Sucrogen possibly helps in achieving the desirable therapeutic efficacy of the ayurvedic formulation.
OBJECTIVE
To do a general survey on diabetes and to standardize the polyherbal formulation consumed by the population of Jharkhand for the determination of purity and quality of drug

Reference Id: PHARMATUTOR-ART-1418

INTRODUCTION
Diabetes is a chronic disease where the glucose levels in body increases due to either insufficient insulin production or utilization. There are different types of diabetes namely type 1 diabetes, type 2 diabetes, gestational diabetes, diabetes insipidus, canine diabetes feline diabetes etc. Here we are dealing with type 2 diabetes where the body produces plenty of insulin but the cells are unable to utilize it. According to the year 2010 in India 50.8 million people have acquired the disease and according to International Diabetes Federation (IDF) it is estimated that by year 2030, 80.4 million people will acquire this disease. As per World Health Organization (WHO) 50% population consume herbal drug for diabetes. Oral antidiabetic drugs and insulin therapy are available for its treatment, but a trend of shifting to herbal drugs have been seen among people due to its low cost, effectiveness and less side effects. So in this modern medicine era it is important to standardize traditional drugs to justify its acceptability. The polyherbal formulation i.e. Sucrogen was available from the market. It is manufactured by Joysree Kutir Silpam, Deoghar, Jharkhand and consumed by Jharkhand population.

SURVEY
A general survey on diabetes in Jharkhand was done which gave us the idea of the medication and lifestyle followed by people of Jharkhand. It included online as well as field survey from hospitals and healthcares. The online link diabetessurvey.wordpress.com was made and was shared among our friends and relatives through mails and social network sites. Based on the result obtained we got to know the percentage of population having diabetes and whether they are undergoing ayurvedic, allopathy or homeopathy treatment and simultaneously ensured them the efficacy and purity of oral herbal drug.

 

STANDARDIZATION
To assess the quality of the formulation various standardization parameters studied were organoleptic, physicochemical properties, determination of pH, fluorescence analysis, preliminary phytochemical tests, density, viscosity, qualitative analysis by HPLC, TLC, microbial studies and estimation of metals by flame photometry, AAS. The organoleptic tests to determine the color, odor, taste and texture of the drug. Fluorescence studies will be carried to determine the characteristics under UV lamp.

MATERIALS AND METHODS
The formulation Sucrogen contains 13 ingredients which include:

Sanskrit/Hindi name

Biological name

        Family

Each 5ml contains

Methi

Trigonella foecum graceum

Fabaceae

200 mg

Jamun beej

Syzgium cumini

Myrtaceae

200 mg

Satavari

Asparagus racemosus

Asparagaceae

100 mg

Aswagandha

Withania somnifer

Solanaceae

100 mg

Neem

Azadirachta indica

Meliaceae

100 mg

Guduchi

Tinospora cordifolia

Menispermaceae

100 mg

Gokshura

Tribulus terrestris

Zygophyllaceae

50 mg

Harida

Curcuma longa

Zingiberaceae

50 mg

Nayantara

Catharanthus roseus

Apocynaceae

50 mg

Piashal

Terminalia tomentosa

Combretaceae

50 mg

Triphala(Haritaki,Vibhitaki,
Amalaki)

Terminalia chebula,

Terminalia bellirica,

Phyllanthus emblica

Combretaceae,

Combretaceae,

Phyllanthaceae

50 mg

Trikatu(Pippali,Maricha,
Sunthi)

Piper longum, Piper

nigrum, Zingiber officinale

Piperaceae, Piperaceae,

Zingiberaceae

50 mg

Kalamegha

Andrographis paniculata

Acanthaceae

50 mg

All tests were performed following standard protocols.

Organoleptic Tests
The color, odor, taste and texture were reported taking 5 ml of sample.

pH
The pH test was performed by the pH paper and by pH meter method. Took the sample in a beaker and added a drop on the pH paper. The color change was compared with the standard and reported. For pH meter method, standard solution of pH 4 was taken. Then immersed the electrode in the beaker containing sample and noted the observed pH.

Density
The density of the formulation was found by the specific gravity bottle method. A clean dry specific gravity bottle was taken and empty weight was taken using (w1) Filled the bottle with distilled water and took the weight (w2). Then filled the bottle with the sample and took the weight (w3). The density was calculated using the formula
Density = w3- w1÷ w2- w1

Viscosity
Viscometer was used to determine the viscosity. A stock solution of 1% was made and from that 0.1, 0.2 and 0.3% concentration of a solution was made. The viscosities of these solutions were found concordant readings by the formula
ρ = ts ÷ t

Where, t is the time taken by water and
ts is the time taken by sample

Solubility
The solubility in various polar and non polar solvents was observed. The solvents included were water, ethanol, methanol, petroleum ether, hexane, benzene and chloroform.

Stability studies
The drug was subjected to stability testing by keeping at room temperature, accelerated temperature (107?C), cool and cold temperature.

Preliminary Phytochemical tests
The preliminary phytochemical qualitative tests were done following standard protocols.

Fluorescence analysis
Fluorescence characters of the sample were determined with different chemical reagents under fluorescence, short range UV, long range UV and daylight. The sample was taken on a watch glass and treated with various reagents for the presence of fluorescence characters.

Metal analysis
Estimation of calcium, and potassium by flame photometry

Made a stock solution of 200 ppm of each metal to be analyzed and diluted to solutions of 100, 80, 60, 40 and 20 ppm. First calibrated with the standard solutions taking dilution factor as 1 and then estimated the sample. From the graph obtained reported the concentration of calcium, and potassium.

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