国产红霉素肠溶片的质量分析  

Quality analysis of domestic erythromycin enteric-coated tablets

作　　者：武建卓[1] 李雪[1] 张蔚 丁子珊 洪建文[1] Wu Jian-zhuo;Li Xue;Zhang Wei;Ding Zi-Shan;Hong Jian-wen(Guangdong Institute for Drug Control, Guangzhou 510663)

机构地区：[1]广东省药品检验所,广州510663

出　　处：《中国抗生素杂志》2019年第3期308-312,共5页Chinese Journal of Antibiotics

摘　　要：目的对国产红霉素肠溶片的质量现状进行分析。方法按照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,统计分析检验结果。结果按法定标准检验抽取317批次样品,合格率为99.1%,不合格项目为溶出度和含量。探索性研究发现国产红霉素肠溶片整体溶出速率较参比制剂慢,其原因可能与处方中的崩解剂和肠溶衣材料有关;对红霉素杂质来源进行归属,发现与工艺水平相关的指征性杂质D,应在质量标准中加以控制。结论目前国内红霉素肠溶片整体质量一般,建议进一步完善质量标准,在仿制药质量和疗效一致性评价工作中充分考虑处方合理性和工艺稳定性,不断提高产品质量。Objective To analyze and evaluate the quality situation of domestic erythromycin enteric-coated tablets. Methods According to the general requirements of national assessment programs, status standard methods combined with exploratory researches were used to evaluate the quality of erythromycin enteric-coated tablets. Results According to the statutory standards for the examination of the 317 batches of samples, the qualified rate was 99.1% and the unqualified items were dissolution and assay. The results showed that the dissolution rate of domestic erythromycin enteric-coated tablets was lower, compared with the reference preparation. The probable causes were disintegrating agents and enteric coating materials. The sources of erythromycin impurities were determined. Impurity D which was related to the process level should be controlled in drug standard. Conclusion The quality of domestic erythromycin enteric-coated tablets was generally good. The standard needs to be improved. Rationality of prescription and stability of the production process should be fully considered in evaluation of quality and efficacy consistency.

关 键 词：红霉素肠溶片 质量分析 溶出度 有关物质 

分 类 号：R978.1[医药卫生—药品] R917[医药卫生—药学]