pharma-biotech-2018-posters-abstracts

Page 74

conferenceseries

.com

Volume 8

Journal of Biotechnology & Biomaterials

ISSN: 2155-952X

Pharma Biotech 2018

December 10-11, 2018

December 10-11, 2018 | Rome, Italy

International Conference on

Pharmaceutical Biotechnology

Ethanol content in traditionally fermented ayurvedic formulations has compromised good

manufacturing practice regulations-compromised health

Mukesh Maithani

Guru Gobind Singh Medical College and Hospital-Baba Farid University of Health Sciences, India

large part of the population of India prefers the traditional medicine for primary healthcare. However, the effective quality

control of herbal medicine is still a big challenge. Numerous reports indicate noncompliance with good manufacturing

practice (GMP) guidelines by the manufacturers which may lead to adverse drug reactions or toxic effects. Asava and arishta

are the classical herbal dosage forms wherein fermentation occurs during production leading to the generation of ethanol. The

presence of ethanol in these preparations may lead to their abuse for the pleasure and enjoyment. The self-generated ethanol

is responsible for extraction of active constituents and acts as self-preservative. As the procedure for preparation for asava and

arishta is same, the ethanol content is also expected to be the same irrespective of the manufacturer. The objective of the present

study was to assess and compare the ethanol content of some traditionally fermented ayurvedic formulations available in the

market. Method in this study include 20 formulations from 3 different manufacturers available as over-the-counter (OTC)

product were obtained and their ethanol contents were determined using gas chromatograph (GC) fitted with flame ionization

detector (FID). Statistically significant differences were noted in the ethanol content of various formulations. A simple, less

time consuming, economic and validated gas chromatographic method for estimation of ethanol in fermented ayurvedic

formulations was also developed successfully in present study. The data generated during study reflected poor compliance of

GMP guidelines by the manufacturers and hence the quality is being grossly compromised posing a safety hazard.

J Biotechnol Biomater 2018, Volume 8

DOI: 10.4172/2155-952X-C8-110