2004～2007年上海市医院制剂中抽验不合格制剂质量问题分析

Analysis on the Quality Problems of Shanghai Hospital Preparations from 2004 to 2007

目的:为促进医院制剂质量的提高提供参考。方法:通过查询《上海市药品、医疗器械质量公告》信息,对2004～2007年上海市医院制剂抽验不合格情况进行汇总,并对其存在的主要质量问题进行分析。结果:统计的抽检不合格医院制剂共105批,其中外用制剂74批(占70.5%),内服制剂17批(占16.2%),无菌制剂14批(占13.3%),涉及剂型19种;不合格项目以装量不合格为最常见,占总数的34.5%,其次为性状(15.4%)、含量(15.4%)、pH值(13.6%)和微生物限度(8.2%)等;多数抽验不合格制剂都与制剂包装容器及工艺有关。结论:建议相关部门针对上述问题加大对医院制剂的监管力度。

OBJECTIVE： To provide reference for the enhancing of the quality of hospital preparations. METHODS： The disqualified reports on Shanghai hospital preparations published in ＂Shanghai drug and medical equipment quality bulletin＂ between 2004 and 2007 were collected to investigate the main quality problems. RESULTS： A total of 105 batches （19 dosage forms were covered） of unqualified preparations were reported in spot checks, of which, 74 （70.5%） were external preparations, 17 （16.2%） oral preparations, and 14 （13.3%） sterility preparations. The common unqualified items include package amount （34.5%）, description （15.4%）, content （15.4%）, pH value （13.6%）, and microbial limit （8.2%） . The major quality problems were related to package containers and technology. CONCLUSIONS： It is suggested that the concerned department to tighten control on quality of hospital preparations aimed at the above- mentioned problems.