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目的:比较10种常用对半分劈片剂的准确度并分析影响因素。方法:按分劈片单剂量给药的用药频度排序,选取10种分劈片准确称重。依照《美国药典》(USP)剂量单位一致性测量方法进行数据处理。结果:5种无刻线分劈片,重量RSD范围9.8%～17.5%,均未通过USP剂量单位一致性测试;4种有刻线分劈片RSD范围2.4%～7.4%,可通过或接近剂量单位一致性测试,有无刻线对分劈片的重量差异有显著影响。此外,还存在质地疏松易掉屑,质地坚硬易导致分劈不对称等情况。结论:分劈片的片形、刻线、质地及分劈方法对其分劈准确度均有一定影响。
OBJECTIVE: To compare the accuracy of 10 common semi-split tablets and analyze the influencing factors. Methods: According to the frequency of drug administration in single dose administration, 10 kinds of splitting tablets were selected for accurate weighing. Data processing was performed according to the USP Dosage Unit Conformance Measurement Method. Results: Five kinds of scoreless splits with a weight RSD range of 9.8% -17.5% did not pass the USP dose unit conformance test. Four kinds of score splits with 2.4% -7.4% RSD range could pass or approach Dosage unit consistency test, with or without scribing on the splitting of the weight difference has a significant impact. In addition, there are loose texture easy to get rid of crumbs, hard and easy to lead to splitting asymmetry and so on. Conclusion: The splitting slice, scribing, texture and splitting methods have some impact on the splitting accuracy.