基于2019年基本药物省抽专项红霉素制剂的质量分析及研究

Quality Analysis and Research of Erythromycin Preparations Based on Provincial Sampling of Essential Medicines in 2019

目的通过对2019年基本药物安徽省抽专项红霉素制剂的质量分析,评价红霉素制剂的抽检及产品质量情况,为今后该品种的监督抽检工作及质量标准的完善提出建议。方法按照评价性抽验要求,采用法定检验方法对抽样进行检验和结果的统计分析,同时开展了红霉素软膏剂微生物限度检验方法的探索性研究。结果根据法定检验标准,所检12批次的红霉素制剂均符合规定,且质量均一性良好。通过探索性研究,建立了红霉素软膏的微生物限度检验方法。结论红霉素制剂品种多样,建议进一步加大制剂的覆盖面和样品数量,加强质量评价性研究,不断提高药品监督抽检的实效。

OBJECTIVE Through the quality analysis of erythromycin preparations in Anhui Province in 2019,the sampling work and the quality of erythromycin preparations were evaluated.Some suggestions about the sampling work were puts forward,and the quality standard was also improved.METHODS According to the general requirements of national assessment programs,status standard methods were used to evaluate the quality of erythromycin preparations.At the same time,the microbial limit test method of erythromycin ointment was studied.RESULTS The results showed that 12 batches of erythromycin preparations conformed to the provisions and their qualities were relatively uniform.Through exploratory study,the microbial limit test method of erythromycin ointment was established.CONCLUSION The dosage forms of erythromycin were various,and it is necessary to increase the coverage of sampling preparation types.It is also important to strengthen the evaluation research and improve the effectiveness of drug supervision.