盐酸胺碘酮胶囊的体外溶出度考察

Study on the extracorporeal dissolution rate of national dragon's blood capsules

目的比较不同厂家、不同批次盐酸胺碘酮胶囊的体外溶出度,为其质量控制提供依据。方法采用转篮法分别测定不同厂家、不同批次的盐酸胺碘酮胶囊,对平均累积溶出百分率进行方差分析。结果不同厂家、不同批次的盐酸胺碘酮胶囊体外溶出度有非常显著性差异(P<0.01)。结论建议有关标准增加盐酸胺碘酮胶囊的体外溶出度测定,以保证临床疗效。

Objective To determine extracorporeal dissolution rate of national dragon's blood capsule, and to control its quality.Method The extracorporeal dissolution rate of national dragon's blood capsule was determined by UV-spectrum method.The wavelength was 284nm.Then obtained average percentage of accumulated dissolution rate was processed using variance analysis. Results The dissolution parameters had significant difference between national dragon's blood capsules from same factory but different group(P<0.05), and had very significant difference from different factories(P<0.01).Conclusion Dissolution rate test is needed for controlling the quality of national dragon's blood capsules.