吗替麦考酚酯口服制剂评价性抽验结果分析

Results Analysis of Evaluative Selective Acceptance Test for Mycophenolate Mofetil Oral Preparations

目的:评价国产吗替麦考酚酯口服制剂的质量现状及存在问题。方法:按国家评价性抽验计划总体要求,采用法定检验方法结合探索性研究方法对6个厂家的60批次吗替麦考酚酯胶囊和9个厂家的86批次分散片的溶出度、有关物质、水分、胶囊壳中铬含量、Z-吗替麦考酚酯和含量测定等进行检验,并对检验结果进行统计分析。结果:146批样品按法定标准和新制定的标准检验和新制定的标准合格率均为100.0%。结论:国产吗替麦考酚酯口服制剂总体质量状况良好,但与原研样品相比仍有一定的提高空间。此次评价发现"一药多标"问题明显,标准不统一,无法对不同药厂的样品进行客观评价。应制订新的吗替麦考酚酯分散片质量标准。

Objective:To investigate the testing quality of mycophenolate mofetil oral preparations in 2015 to provide reference for improving the homogeneity and stability of the product quality.Methods:According to the general requirements of evaluative selective acceptance test project,60 batches of mycophenolate mofetil capsules from 6 manufacturers and 86 batches of dispersible tablets from 9 manufacturers were tested by using statutory test methods combined with the exploratory research in respects of dissolution,related substance,moisture,chromium content in capsule shell,Z-mycophenolate mofetil and content determination,etc.The inspection results were analyzed statistically.Results:The qualification rate of mycophenolate mofetil oral preparations was 100.0%according to the legal standards.The qualification rate of mycophenolate mofetil oral preparations was 100.0%according to the new standards as well.Conclusion:According to the present standards,the quality status of levofloxacin is good with low unqualified rate.But the standards for the same species are not uniform,so it is impossible to objectively evaluate the samples from different pharmaceutical factories.The study formulated a new quality standard for mycophenolate mofetil dispersible tablets,which should be included in the quanlity control standard of the preparation.