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小剂量片剂的含量均匀度对临床的疗效和用药的安全有很大关系。为更有效地控制小剂量片剂的含量,近年来各国药典都在不断扩大检测小剂量片剂均匀度的品种,并对测定方法、判断标准进行改进。中国药典1985年版规定:将样品10片中每片的含量与10片平均含量作比较进行判断;中国药典1990年版将小剂量片剂均匀度的判断标准修改为:将10片含量的平均值,标准差及标示量与均值之差的绝对值三者结合来判断结果;USP ⅩⅩⅡ版则依据平均值、标准差和相对标准差三者结合进行判断。该文按上述三种方法和判断标准对国内六个厂家11批样品的含量均匀度进行考察。
Low-dose tablet content uniformity of clinical efficacy and safety of medication has a great relationship. In order to more effectively control the content of low-dose tablets, the pharmacopoeias of various countries in recent years are continuously expanding the varieties for testing the uniformity of small-dose tablets and improving the determination methods and criteria. Chinese Pharmacopoeia 1985 edition provides: the content of each sample of 10 tablets and 10 average content compared to judge; Chinese Pharmacopoeia 1990 edition will judge the uniformity of small doses of tablets as: the average content of 10, Standard deviation and the absolute value of the difference between the labeled amount and the average of the three combined to determine the results; USP Ⅹ Ⅹ version is based on the average, standard deviation and the relative standard deviation of the combination of three judgments. According to the above three methods and judging criteria, this paper examines the content uniformity of eleven batches of samples of six domestic manufacturers.