盐酸西替利嗪片的质量分析

Quality Analysis of Cetirizine Hydrochloride Tablets

目的分析盐酸西替利嗪片的质量。方法依据内蒙古自治区监督抽验计划要求,按法定检验方法,对检验结果进行统计分析。结果按法定检验方法检验24批次检品,23批检品合格,合格率为95.8%,1批不合格检品的不合格项目为溶出度。结论盐酸西替利嗪片质量整体质量一般,体现在溶出度差异大,含量均匀度A+2.2S值偏大,生产企业生产工艺需要改进,个别检验项目检验方法需要进一步完善。

Objective To analyze the quality situation of cetirizine hydrochloride tablets. Methods According to the requirements of sampling inspection program in Inner Mongolia, test results were statistically analyzed. Results A total of 24 batches of test articles were examined according to the legal test methods. 23 batches were qualified with the qualified rate of 95.8%.The unqualified item of 1 batch was dissolution. Conclusion The quality of cetirizine hydrochloride tablets is average because of a significant difference in dissolution and a higher A+2.2 S of content uniformity. The production process of manufactures needs to be improved, and the test method of individual items required to be perfected.