浅析《中国药典》(2020版)中阿奇霉素颗粒标准的变化

Preliminary Analysis on the Changes in the Specification for Azithromycin Granules in Chinese Pharmacopoeia(2020)

目的:浅析阿奇霉素颗粒标准在《中国药典》(2020版)中的变化。方法:按照《中国药典》(2020版)与《中国药典》(2015版)不同的判定标准,比较5批不同生产企业的阿奇霉素颗有关物质结果的变化,考察5批样品按《中国药典》(2020版)标准新增项目溶出度数据。结果:由于标准不同,对5批不同厂家的阿奇霉素颗粒的有关物质测定结果的判定发生改变,新增项目溶出度结果都符合规定。结论:《中国药典》(2020版)中阿奇霉素颗粒标准体系更完善,判定标准更具体全面,更能保证其质量。

Objective:To analyze the changes in the specification for azithromycin granules in Chinese Pharmacopoeia(ChP)(2020).Methods:To compare the results of related substances contained in the 5batches azithromycin granules from different manufactures by the methods specified in ChP(2020)and ChP(2015),and to investigate dissolution of the 5 batches of samples by the new method added to ChP(2020).Results:The testing results of related substances of the 5 batches azithromycin granules from different manufactures were different because different specification were employed,and the results of dissolution were in compliance with ChP(2020).Conclusion:The specification for azithromycin granules in ChP(2020)is more perfect,specific and comprehensive to ensure the quality.