溶出度检查计量判断方案的建立暨与计数方案的比较

To Establish a Criterion for Dissolution by Variables and Comparison with Criteria by Attributes

目的建立溶出度检查计量判断方案。方法用概率论与统计学推导不同样本量溶出度检查计量判断的计算公式A=|M-D|+α/(e|M-D|×b+1)+kS和接受的k值与不接受的kR值,用蒙特卡洛模拟抽样和EXCELVBA编程计算比较计量方案与计数方案的OC曲线与复试率曲线。结果计量方案判断标准最严格,《中国药典》(2005年版)计数方案次之,USP32计数方案最宽松;《中国药典》(2005年版)复试率最低,计量方案次之,USP32复试率最高;《中国药典》(2005年版)每次检验平均样本量为6.43,计量方案为7.82～7.98,USP32为11.60。结论计量方案可以控制溶出均匀度,判断标准优于计数方案。

OBJECTIVE To establish a criterion for dissolution by variables. METHODS To derive the criterion formula A=｜M-D｜＋α/（^e｜M-D｜×b＋1）＋kS by using probability theory and Statistics,and to compare between criteria by variables and by attributes. RESULTS The criterion by variables was the strictest one. The second was the criterion of Ch.P（2005）. The third was the criterion of USP32. The repeat test rates from low to high were Ch.P（2005）,Criterion by variables and USP32 respectively. The sample contents were 6.43,7.82-7.98,11.60 for Ch.P（2005）,Criterion by variables and USP32. CONCLUSION The criterion by variables could control the uniformity of dissolution,and was stricter than criteria by attributes.