注射用盐酸地尔硫[艹卓]无菌方法适用性试验研究及市场质量考查

Applicabilty test of aseptic methods and study on market quality of diltiazem hydrochloride for injection aseptic method

目的:建立适用于生产企业的注射用盐酸地尔硫[艹卓]无菌适用性方法,并对3个生产企业的34批次样品进行检验,根据检验结果对注射用盐酸地尔硫[艹卓]的质量现状进行分析。方法:依据《中国药典》2015年版四部微生物限度相关内容,采用0.9%无菌氯化钠溶液作为溶剂,并用0.1%无菌蛋白胨溶液300 ml进行冲洗。结果:方法适用性试验中在规定时间内各试验菌均正常生长;对抽取的34批样品进行无菌检查,结果均符合规定,合格率为100%。结论:建立了适用于生产单位的注射用盐酸地尔硫[艹卓]无菌适用性方法,注射用盐酸地尔硫[艹卓]的整体质量情况较好且稳定。

Objective:A sterile suitability method for diltiazem hydrochloride injection was established,and 34 batches of samples from 3 manufacturers were tested.The quality status of diltiazem hydrochloride for injection was analyzed based on the test results.Methods:According to《Chinese Pharmacopeia》2015,0.9%sterile sodium chloride solution was used as the solvent,and 300 ml 0.1%sterile peptone solution was used for washing.Results:In the applicability test of the methods,all the tested bacteria grew normally within the specified time.The 34 batches of samples were tested for sterility,and the results all met the requirements,with a qualified rate of about 100%.Conclusion:A sterile suitability method for diltiazem hydrochloride injection was established,and the overall quality of diltiazem hydrochloride for injection was excellent and stable.