不同厂家乙肝扶正胶囊产品质量差异分析

目的实验研究不同厂家生产的乙肝扶正胶囊的产品质量,提供医院用药参考。方法采用HPLC法测定5个厂家的乙肝扶正胶囊中大黄素含量,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99.10%,RSD≤1.06%。结果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。

Analysis of quality different of Yigan Fuzheng capsule from different manufacturers

Objective The experiment was performed to study the quality of Yigan Fuzheng capsule from different manufacturers, so as to provide advice of drug selection in clinical medication for hospitals. Methods Emodin content of Yigan Fuzheng capsule from 5 different manufacturers was determined by HPLC. The linear range of Emodin control was 0. 010- 0. 500 μg/ml （ r = 0. 9988） , average recovery was 99.10% （ RSD ≤ 1. 06% ） Results Emodin content of each Yigan Fuzheng capsule from 5 different manufacturers was 0. 198-0. 304 mg, with fine quality. Conclusion Emodin content of each Yigan Fuzheng capsule from 5 different manufacturers was above 0. 198 mg, but difference between the maximum and minimum was observed to be 53.53% （P 〈0.01 ）, the quality of each product is quite different from one another.