摘要
目的:比较中国药典与美国药典溶出度判定方法的不同。方法:依据《中国药典》2020版二部“磷酸苯丙哌林片”标准检验该片剂溶出度,首先以其限度70%为例说明中美药典溶出度判定方法的严格程度、效率高低及其风险性,并将溶出度初试数值在限度附近的样品分别按中国药典及美国药典溶出度判定标准加大样本量继续判定,比较判定方法不同对判定结论所产生的影响。结果:按中国药典判定初试合格、美国药典判定初试不合格的样品,加大样本量按中国药典继续判断时则出现了合格、不合格和需复试三种情况,而按美国药典溶出度判定方法判定后则出现了不合格和合格两种情况,可见美国药典加大样本量的同时,可以减少误判的可能。结论:溶出度判定标准项下中国药典要求严于美国药典,效率高于美国药典,但判定的风险性高于美国药典。建议中国药典溶出度判定标准中增大结果判断的样本量,从严控制产品质量,引导企业进行技术提高。
Objective:To study on the differences between Chinese Pharmacopoeia and United States Pharmacopoeia dissolution acceptance criteria.Methods:According to the“Benproperine Phosphate Tablets”standard of the 2020 version of“Chinese Pharmacopoeia”,the dissolution of the tablets was tested.The first,the degree of rigor,efficiency and risk between Chinese Pharmacopoeia and United States Pharmacopoeia dissolution acceptance criteria were illustrated by the case of the limit of 70%.The samples with the initial dissolution of the dissolution test in the vicinity of the limit were determined according to the Chinese Pharmacopoeia and the US Pharmacopoeia dissolution criteria,and the influences of the determination method on the judgment conclusion were compared.Results:The samples of the first test passed according to the Chinese Pharmacopoeia and the initial test failed according to the United States Pharmacopoeia were increased in the sample size according to the Chinese Pharmacopoeia to continue to judge,there were qualified, unqualified and need to re-test three cases. And according to United States Pharmacopoeia, there were qualified, unqualified two cases. We can see that increasing the sample size in the United States Pharmacopoeia can reduce the possibility of miscarriage of justice.Conclusion: Chinese Pharmacopoeia is more stricter than United States Pharmacopoeia, which is more efficient than United States Pharmacopoeia, but the risk is higher than United States Pharmacopoeia. It is suggested that Chinese Pharmacopoeia dissolution criteria should increase the sample size to determine the result in a strict control of product quality, and guide enterprises to improve technology.
作者
信长颖
刘文乔
于新颖
周润宏
寻延滨
刘利群
Xin Changying(Heilongjiang Institute for Drug Control,Harbin 150088)
出处
《黑龙江医药》
CAS
2023年第1期67-70,共4页
Heilongjiang Medicine journal
关键词
磷酸苯丙哌林片
中国药典
美国药典
溶出度
判定方法
Benproperine Phosphate Tablets
Chinese Pharmacopoeia
United States Pharmacopoeia
Dissolution
Acceptance Criteria
