a Multidisciplinary Research Unit , University Centre of Excellence in Research, Baba Farid University of Health Sciences , Faridkot , India .
Am J Drug Alcohol Abuse. 2019;45(2):208-216. doi: 10.1080/00952990.2018.1529181. Epub 2018 Nov 14.
A large part of the population of India prefers the traditional medicine (ayurvedic formulations) for primary health care. However, the effective quality control of herbal medicine is still a big challenge. Numerous reports indicate noncompliance with Compromised 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 misuse. The self-generated ethanol is responsible for extraction of active constituents and acts as a 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.
In this study, 20 formulations from 3 different manufacturers available as over-the-counter products were obtained and their ethanol contents were determined using gas chromatograph with flame ionization detector.
Statistically significant differences were noted in the ethanol content of various ayurvedic 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.
印度很大一部分人口更喜欢传统药物（阿育吠陀配方）进行基本医疗保健。然而，草药的有效质量控制仍然是一个巨大的挑战。大量报告表明，制造商不符合《良好生产规范（GMP）指南》，这可能导致不良反应或毒性作用。阿萨瓦和阿瑞什塔是经典的草药剂型，在生产过程中会发生发酵，从而产生乙醇。这些制剂中存在乙醇可能导致它们被滥用。自生的乙醇负责提取有效成分，并起到自我保存的作用。由于阿萨瓦和阿瑞什塔的制备程序相同，因此无论制造商如何，预计乙醇含量也应该相同。
本研究的目的是评估和比较市场上一些传统发酵的阿育吠陀配方的乙醇含量。
在这项研究中，从 3 家不同的制造商获得了 20 种作为非处方药的制剂，并使用带火焰离子化检测器的气相色谱仪来测定它们的乙醇含量。
不同阿育吠陀制剂的乙醇含量存在显著差异。本研究还成功开发了一种简单、耗时短、经济且经过验证的用于测定发酵阿育吠陀制剂中乙醇的气相色谱法。
研究过程中产生的数据反映了制造商对 GMP 指南的遵守情况不佳，因此质量严重受损，构成了安全隐患。
