维他敏胶囊质量控制方法研究

目的建立维他敏胶囊的质量控制标准。方法采用薄层色谱法对制剂中的人参、黄芪、茵陈、苦地丁进行定性鉴别；采用高效液相色谱法对制剂中山豆根的有效成分氧化苦参碱和苦参碱进行含量测定。结果薄层色谱斑点清晰、分离良好，阴性对照无干扰；氧化苦参碱、苦参碱质量浓度分别在200．00，100．00，50．00，25．00，12．50，6．25μ／mL和202．00，101．00，50．50，25．25，12．625，6．3125μg／mL范围内与峰面积呈良好的线性关系，r分别为1．000和0．9998，平均回收率分别为98．56％和99．90％，RSD分别为2．48％和2．94％。结论薄层色谱法和高效液相色谱法可同时用于维他敏胶囊的质量控制。

Study on Quality Control of Weitamin Capsule

Objective To study and establish the quality control method of Weitamin Capsule. Methods Radix Ginseng, Radix Astragali, Herba Artemisiae Scopariae, Herha Corydalis Bungeanae were identified by thin layer chromatography （TLC）. The content of oxymatrine and matrine, the main effective component from Radix Sophorae Tonkinensis in the capsule, were determined by high performance liquid chromatography（HPLC）. Results The qualitative identification chromatogram spots were clear, separated well, and the negative control showed no interference. The quantification method had the linearity in the range of 6. 25 - 200. 00 μg/mL for oxymatrine, r = 1. 000 and 6. 312 5 -202. 00 μg/mL for matrine, r=0. 999 8, respectively. The average recovery rates were 98.56%, 99.90% and RSD was 2.48%, 2.94% respectively. Conclusion The methods can be used for the identification and quantification of the preparation.