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目的:建立生皮散的质量控制方法及标准。方法:采用薄层色谱法对制剂中的药物进行鉴别;采用高效液相色谱法对制剂中三七的有效成分三七皂苷R_1、人参皂苷Rb_1和人参皂苷Rg_1进行含量测定。结果:薄层鉴别方法专属性强,重复性好,空白无干扰;三七皂苷R_1在0.216~1.512μg范围内线性关系良好;三七皂苷Rg_1在0.818~5.726μg范围内线性关系良好;三七皂苷Rb_1在0.816~5.712μg范围内线性关系良好。平均加样回收率为100.57%,RSD=1.32%。结论:建立的生皮散质量标准,其定性定量方法操作简便、专属性强、准确可靠,可以有效控制生皮散的质量。
Objective: To establish the quality control method and standard of peel powder. Methods: The drugs in the preparation were identified by TLC. The content of notoginsenoside R 1, ginsenoside Rb 1 and ginsenoside Rg 1 were determined by HPLC with HPLC. Results: The identification method of TLC was of high specificity, good repeatability and no interference in blank. The linear relationship of notoginsenoside R_1 in the range of 0.216 ~ 1.512 μg was good. The calibration curve of notoginsenoside Rg_1 was linear in the range of 0.818 ~ 5.726 μg. Saponin Rb_1 showed good linearity in the range of 0.816 ~ 5.712μg. The average recovery was 100.57%, RSD = 1.32%. Conclusion: The established quality standards for raw peel, its qualitative and quantitative method is simple, proprietary, accurate and reliable, can effectively control the quality of peel bulk.