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目的制定炎黄保肾胶囊的质量控制方法。方法采用HPLC法测定炎黄保肾胶囊中大黄酸、大黄素、大黄酚的含量,并制定含量限度。结果 HPLC法测得炎黄保肾胶囊中大黄酸、大黄素、大黄酚检测浓度分别在8.88~44.40μg·ml-1(r=0.9998)、2.28~11.40μg·ml-1(r=0.9998)、2.08~10.40μg·ml-1(r=0.9999)范围内与峰面积呈良好的线性关系,平均加样回收率为98.04%、99.20%、99.68%。结论该制剂制备工艺稳定,建立的含量测定方法简便、可靠,可用于该制剂的质量控制。
Objective To develop the quality control method of Yanhuang Baoshen Capsule. Methods The contents of rhein, emodin and chrysophanol in Yanhuang Baoshen Capsule were determined by HPLC and the content limits were established. Results The determination of rhein, emodin and chrysophanol in Yanhuang Baoshen Capsule by HPLC showed that the detection concentrations of rhein, emodin and chrysophanol were 8.88 ~ 44.40μg · ml-1 (r = 0.9998), 2.28 ~ 11.40μg · ml-1 2.08 ~ 10.40μg · ml-1 (r = 0.9999) and the peak area showed a good linear relationship, the average recovery was 98.04%, 99.20%, 99.68%. Conclusion The preparation of the preparation is stable and the established method for the determination of content is simple and reliable and can be used for the quality control of the preparation.