参蝎止痛胶囊质量标准研究*

作者：沈婷婷，陈清光，刘 瑾，张建伟

单位：上海中医药大学附属曙光医院，上海 201203

引用：引用：沈婷婷，陈清光，刘瑾，张建伟.参蝎止痛胶囊质量标准研究[J].中医药导报,2025,31(4):77-82,88.

DOI：10.13862/j.cn43-1446/r.2025.04.013

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摘要：目的：建立参蝎止痛胶囊的质量标准。方法：采用薄层色谱法对参蝎止痛胶囊中的三七、全蝎、炒土鳖虫进行定性鉴别；采用高效液相色谱法测定参蝎止痛胶囊中人参皂苷Rg1、三七皂苷R1、人参皂苷Rb1的含量。结果：薄层色谱试验结果显示供试品具有三七、全蝎、炒土鳖虫对照品及对照药材的特征斑点，且斑点清晰，阴性对照品无干扰。含量测定方法学试验中，被测组分的色谱峰分离度好，专属性强，方法学考察指标均符合要求。结论：本研究采用的薄层色谱法和高效液相色谱法操作简便、重复性好、结果可靠，可作为参蝎止痛胶囊质量标准的鉴别项和含量测定项。

关键词：参蝎止痛胶囊；质量标准；薄层色谱法；高效液相色谱法；含量测定

Abstract：

Objective: To establish a quality standard of Shenxie Zhitong Capsules (参蝎止痛胶囊). Methods: Thin-Layer Chromatography (TLC) was used to identify Sanqi (Notoginseng Radix Et Rhizoma), Quanxie (Scorpio) and Tubiechong (Eupolyphaga Steleophaga). High Performance Liquid Chromatography (HPLC) was used to determine the contents of Ginsenoside Rg1, Notoginsenoside R1, and Ginsenoside Rb1. Results: The TLC chromatogram of test solution showed characteristic spots of Sanqi (Notoginseng Radix Et Rhizoma), Quanxie (Scorpio) and Tubiechong (Eupolyphaga Steleophaga). The spots were clear and the negative reference had no interference. Compounds being examined showed high separation and good specificity in HPLC chromatogram, methodological inspections met requirements of content determination. Conclusion: The methods of TLC and HPLC had advantages of process simplicity and good repeatability that can be used to establish quality standard of Shenxie Zhitong Capsules.

Key words：Shenxie Zhitong Capsules; quality standard; thin-layer chromatography; high performance liquid chromatography; content determination

发布时间：2025-12-20

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