不同厂家乙肝扶正胶囊的产品质量研究  

Study on the quality of Yigan Fuzheng Capsules from different manufacturers

作　　者：凌英蓉[1] 郭彬[1] 吴丽萌[2] 陈光龙[2] 

机构地区：[1]深圳市中医院药剂科,广东深圳518033 [2]深圳市宝安区人民医院药剂科,广东深圳518101

出　　处：《中国医药导报》2009年第12期53-54,共2页China Medical Herald

摘　　要：目的:实验研究不同厂家生产的乙肝扶正胶囊的产品质量,为医院用药提供参考。方法:采用HPLC法测定5家厂的乙肝扶正胶囊中的大黄素含量。色谱柱为Phenomsil BDS柱(250mm×4.6mm,5μm),流动相为甲醇-0.1%磷酸溶液(80∶20),流速为1.0ml/min,检测波长为254nm,柱温为30℃。结果:大黄素对照品检测浓度在0.010～0.500μg/ml范围内线性关系良好(r=0.9988),平均回收率为99.00%,RSD≤1.05%。5家乙肝扶正胶囊每粒大黄素含量在0.198～0.304mg之间,质量尚可。结论:5家厂乙肝扶正胶囊大黄素含量每粒在0.198mg以上,但高低相差53.53%(P<0.01),产品质量有极明显差异。Objective：The experiment was performed to study the quality of Yigan Fuzheng Capsules from different manufacturers, so as to provide advice of drug selection in clinical medication for hospitals.Methods：Emodin content of Yigan Fuzheng Capsules from 5 different manufacturers were determined by HPLC.A Phenomsil BDS column（250 mm×4.6 mm, 5 μm） was used with the mobile phase consisted of methanol-0.1%phosphoric acid solution（80 ∶20） at the flow rate of 1.0 ml/min, the detection wavelengh was 254 nm, the temperature was 30℃.Result：The linear range of Emodin content was 0.010-0.500 μg/ml（r=0.998 8）, the average recovery was 99.00%（RSD≤1.05%）.Emodin content of each YiGan Fuzheng Capsules from 5 different manufacturers was 0.198-0.304 mg, with fine quality.Conclusion：Emodin content of each Yigan Fuzheng Capsules from 5 different manufacturers was above 0.198 mg, but the difference between the maximum and minimum was observed to be 53.53%（P〈0.01）, the quality of each product was quite different from one another.

关 键 词：HPLC法 不同厂家 乙肝扶正胶囊 大黄素含量 

分 类 号：R927.11[医药卫生—药学]