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中国药典收载的胶囊剂、注射用无菌粉末的装量差异检查,片剂、栓剂、滴丸剂的重量差异检查,一都是用物理方法称重测定其重量差异来控制药物制剂含量均匀度的。测定方法简单但计算颇繁。若应用电子计算机进行处理则非常简便。本文介绍一种药物制剂均匀度检查的 BASIC 程序,它可直接应用于夏普 PC-1500、卡西欧 PB-700和IBM5550等微机。启动程序后依次输入药剂代号(胶囊剂与粉针剂为1;片剂、栓剂和滴丸为2)、供试品名称、批号、检查粒(瓶)数、差异限度标准(见表2)及称量数据(X_i)后,计算机即打印输出列有品名、批号、差异限度(D)、检查粒(瓶)数(N)、平均重量(M)、标准差(S)、允许重量范围、变异系数(CV)和结论的报告。本程序也适用于USP 用化学方法测定含量均匀度的数据处理。一、运算公式
Chinese Pharmacopoeia capsules, sterile powder for injection dosage differences in inspection, tablets, suppositories, pills weight difference check, one is the use of physical methods to determine the difference in weight to control the drug content uniformity of. The determination method is simple but the calculation is quite complicated. If the application of computer processing is very simple. This article presents a BASIC program for the uniformity of pharmaceutical preparations that can be used directly in microcontrollers such as the Sharp PC-1500, Casio PB-700 and IBM5550. After starting the procedure, enter the drug code (capsules and powder injection 1; tablets, suppositories and pills 2) for the name of the test, batch number, the number of tablets (bottle), the standard of variation (see Table 2) and After weighed data (X_i), the computer will print out the product name, batch number, variance limit (D), number of tablets (N), average weight (M), standard deviation (S), allowable weight range, Coefficient of variation (CV) and conclusions of the report. This procedure is also applicable to data processing in which the USP uses chemical methods to determine content uniformity. First, the formula