溶出度试验法在西咪替丁片有效晶型质量控制中的应用

Application of dissolution test on distinguishing crystal form A and B of cimetidine tablets

目的:建立能够区分不同晶型西咪替丁片剂的溶出度试验法。方法:采用相似因子作为评价指标,系统地研究在不同的溶出度条件下,不同晶型的溶出特性。结果:以 pH 6.8磷酸盐缓冲液900 mL 为溶出介质,转速为50 r·min^(-1)。在该溶出度试验法中,西咪替丁 A 晶型片剂可以在25 min 内全部溶出,而西咪替丁 B 晶型在25 min 内溶出量仅在40%～50%。结论:本方法可有效区分不同晶型西咪替丁片,为西咪替丁片的质量控制提供参考。

Objective：To establish a dissolution test to distinguish crystal form A and B of cimetidine tablets Method：The dissolution characteristics of cimetidine tablets were studied using different dissolution methods, the factor similitude was adopted as an index. Results ：900 mL of pH 6. 8 phosphate buffer was used as dissolution medium and apparatus was operated at the rate of 50 r · min^-1. In this dissolution method, cimetidine tablets with crystal form A could be dissolved completely,while cimetidine tablets with crystal form B could only be dissolved within 40% -50%. Conclusion ：The method can be used to distinguish crystal form A and B of cimetidine tablets.