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)+k S 和 接受的 k 值与不接受的 <> k _R 值，用蒙特卡洛模拟抽样和 EXCEL VBA 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.