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目的:建立妇炎栓的质量标准。方法:采用TLC法对处方中苦参、蛇床子进行定性鉴别;用HPLC法测定主药黄柏中盐酸小檗碱的含量。结果:在TLC法中均能检出苦参和蛇床子。盐酸小檗碱在0.02~0.5μg范围内有良好的线性关系。平均回收率为100.2%,RSD为1.3%。结论:所建立的方法简单、准确、可靠,可作为控制该制剂的质量标准。
Objective: To establish the quality standard of Fuyan suppository. Methods: TLC method was used to qualitatively identify Sophora flavescens and Cnidium monnieri in the prescription; HPLC method was used to determine the content of berberine hydrochloride in the main drug Phellodendron. Results: Sophora flavescens and Cnidium spp. were detected in the TLC method. The berberine hydrochloride has a good linear relationship in the range of 0.02 to 0.5 μg. The average recovery was 100.2% and the RSD was 1.3%. Conclusion: The established method is simple, accurate and reliable, and can be used as a quality standard for controlling the preparation.