Stability and shelf-life studies in Ayurvedic medicine: Triphala

Charles Dorni A Irudaya, Umamaheswari Venkatesan, Rokesh Srinivasan, Sridhar Moorthy, Subashini Subramaniyan
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Abstract

Triphala is a globally recognized polyherbal Ayurvedic medicine with abundant antioxidants. It is believed to boost the immune system, improve digestion, and address chronic ulcers. The tablets are specially designed for oral consumption and contain herbal ingredients known for their specific medicinal benefits. Storage conditions can significantly affect the shelf life of herbal tablets; therefore, it is essential to assess the stability of these tablets. According to ICH guidelines, Triphala tablets endured accelerated stability studies at 40 °C and a relative humidity (RH) of 75%±5 over a period of 6 months, with assessments conducted at the 2 nd , 4 th , and 6 th months. Various parameters, including organoleptic characteristics, physico-chemical properties, proximate composition, active phytochemical content, and microbiological load, were monitored during these intervals. The results of these analyses were taken into consideration when estimating the shelf life of Triphala Tablets. The extended shelf life estimate was determined by applying an accelerated deterioration rate of 10% for physico-chemical parameters. As a result, it was established that the Triphala tablets have an estimated shelf life of 4 years and 3 months.
阿育吠陀药的稳定性和保质期研究三叶草
Triphala 是一种全球公认的多草药阿育吠陀药,含有丰富的抗氧化剂。它被认为可以增强免疫系统、促进消化和治疗慢性溃疡。药片专为口服而设计,其中的草药成分因其特殊的药用功效而闻名。储存条件会严重影响草药片剂的保质期;因此,评估这些片剂的稳定性至关重要。根据 ICH 指南,Triphala 片剂在 40 °C 和相对湿度(RH)为 75%±5 的条件下进行了为期 6 个月的加速稳定性研究,分别在第 2 个月、第 4 个月和第 6 个月进行了评估。在此期间,对各种参数进行了监测,包括感官特性、物理化学特性、近似成分、活性植物化学成分含量和微生物量。在估算三七片的保质期时考虑了这些分析结果。对理化参数采用 10%的加速劣化率来确定延长的保质期。结果确定,三七片的保质期估计为 4 年零 3 个月。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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