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通过 WHO 推荐的稳定性研究评估提取物的货架期,包括色谱和生物活性分析。

Assessment of shelf-life of extract through WHO recommended stability study involving chromatographic and biological activity analyses.

机构信息

Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala, India.

出版信息

Nat Prod Res. 2021 Sep;35(18):3108-3113. doi: 10.1080/14786419.2019.1682578. Epub 2019 Oct 29.

Abstract

Stability study on extract under WHO recommended accelerated and long-term conditions for 6 and 30 months, respectively was carried out by taking gymnemagenin as a marker and by evaluating antidiabetic activity through different models. Gymnemagenin was not detected in any stability sample indicating that gymnemic acids (GAs) remain stable in the extract under the test conditions. The extract and its GA rich fraction exhibited mild α-glucosidase inhibitory activity (18-27%) that remained same during the study. Neither hypoglycemic nor anti-hyperglycemic effect was induced by the extract in normal rats in oral glucose tolerance test. The extract and GA rich fraction showed significant antidiabetic activity in alloxan-induced diabetic rats that remained same in all stability samples. Based on these findings, a shelf-life of at least 30 months is suggested for extract under long-term conditions, and gymnemagenin as a marker for shelf-life assessment of products derived from the plant.

摘要

在 WHO 推荐的加速和长期条件下,分别对 提取物进行了为期 6 个月和 30 个月的稳定性研究,以 Gymnemagenin 作为标志物,并通过不同的模型评估其抗糖尿病活性。在任何稳定性样品中均未检测到 Gymnemagenin,表明在测试条件下,Gymnemic acids (GAs) 在提取物中保持稳定。提取物及其富含 GAs 的部分表现出温和的 α-葡萄糖苷酶抑制活性(18-27%),在研究期间保持不变。在口服葡萄糖耐量试验中,提取物对正常大鼠既没有降血糖作用,也没有抗高血糖作用。提取物和富含 GAs 的部分在所有洛沙平诱导的糖尿病大鼠中均表现出显著的抗糖尿病活性,在所有稳定性样品中均保持不变。基于这些发现,建议在长期条件下,提取物的保质期至少为 30 个月,Gymnemagenin 可作为该植物来源产品保质期评估的标志物。

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