论文部分内容阅读
采用概率统计计算方法找到符台一定质量要求的制剂批单剂含量总体均值和标准差的轨迹,进行近似并确定了二次抽样范围,从而制订出一个以标示量为参考值、二次抽样的计量型含量均匀度检查新方案;然后用蒙特卡洛即统计模拟方法为该方案在4个不同允许废品率下绘制抽样特性(OC)曲线,同时统计平均样本容量,并与几个国家药典典型的含量均匀度检查法的对应指标比较;最后讨论了新方案的准确性、灵活性和在控制生产上的实用性等问题。
Probability and statistics were used to find the trajectory of the overall mean and standard deviation of the single dose of formulation batches of certain quality requirements of Fu-Tai Station, and the range of subsamples was approximated and the subsample size was determined. Thus, a standard Then, a Monte Carlo statistical simulation method was used to draw the sampling curve (OC) curve of the program under four different allowable rejection rates. Meanwhile, the average sample size was calculated and compared with several typical national pharmacopoeia Content uniformity test of the corresponding indicators of comparison; Finally, the new program accuracy, flexibility and practicality in the control of production and other issues.