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目的:建立银丹心脑通胶囊的质量控制方法。方法:采用薄层色谱法(TLC)对制剂中丹参、天然冰片、三七、银杏叶进行鉴别;用高效液相色谱法(HPLC)测定丹参素钠的含量。结果:TLC图谱中各斑点清晰,分离度好,易于识别;丹参素钠在11.0～110.0mg.L-1范围内线性关系良好,平均回收率为99.27%(RSD为0.85%)。结论:本法简便、快速、灵敏度高、重复性好,可作为该制剂的质量控制方法。
Objective: To establish the quality control method of Yindan Xinnaotong Capsule. Methods: TLC was used to identify Salvia miltiorrhiza, natural borneol, Panax notoginseng and Ginkgo biloba leaves. The content of sodium danshensu was determined by high performance liquid chromatography (HPLC). RESULTS: The spots in TLC pattern were clear, the resolution was good, and it was easy to identify. The linear relationship was good in the range of 11.0-110.0 mg.L-1. The average recovery was 99.27% (RSD 0.85%). Conclusion: This method is simple, rapid, sensitive and reproducible. It can be used as a quality control method for the preparation.