天津市医院制剂抽检微生物限度检查结果及质量分析
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摘要
目的:依据《中国药典》2015年版,对抽检的41批医院制剂进行微生物限度检查和质量分析。方法:检验方法为制剂生产医院提供,并根据药典要求,对每批样品进行控制菌检查时均加入阳性对照。结果:抽检的41批医院制剂样品微生物限度检查,37批次检验结果均符合规定,1批次检验结果不符合规定,3批样品由于医院提供的微生物限度检查的方法依据为2010版《中国药典》,不符合现行药典要求,故而未做检验。结论:医院制剂微生物限度检查方面存在诸多问题,应引起各方重视。
Objective: To carry out the microbial limit tests and quality analysis of 41 batches of hospital preparations according to the Chinese Pharmacopeia 2015 edition. Methods: The examining methods were provided by the hospitals which manufactured the preparations. According to the requirements of the Chinese Pharmacopeia 2015 edition, positive controls were added in each patch of the samples for specific microorganisms test. Results: Among all the 41 batches of hospital preparations in microbial limit test, 37 batches met the test requirements, 1 batch did not meet the requirements and 3 batches were not tested, because the 3 batches of samples did not meet the requirement of The Chinese Pharmacopeia 2015 edition but were based on The Chinese Pharmacopeia 2010 edition. Conclusion: There existed many problems in the microbial limit test of hospital preparations, which should be paid more attention to by all parties.
Objective: To carry out the microbial limit tests and quality analysis of 41 batches of hospital preparations according to the Chinese Pharmacopeia 2015 edition. Methods: The examining methods were provided by the hospitals which manufactured the preparations. According to the requirements of the Chinese Pharmacopeia 2015 edition, positive controls were added in each patch of the samples for specific microorganisms test. Results: Among all the 41 batches of hospital preparations in microbial limit test, 37 batches met the test requirements, 1 batch did not meet the requirements and 3 batches were not tested, because the 3 batches of samples did not meet the requirement of The Chinese Pharmacopeia 2015 edition but were based on The Chinese Pharmacopeia 2010 edition. Conclusion: There existed many problems in the microbial limit test of hospital preparations, which should be paid more attention to by all parties.
引文
[1]国家食品药品监督管理局.国家食品药品监督管理局令第20号医疗机构制剂注册管理办法(试行)[S].2005.
[2]陈家润,江映珠,吴雪龙.广东省医疗机构制剂质量标准修订存在问题及对策[J].中国药事,2016,30(3):209-213.
[3]天津市医疗机构制剂规范[S].2016.
[4]中国药典:四部[S].2015:140-151.
[5]王文明,严振,张雷红,等.广东省医院制剂发展现状的调查分析[J].中国药房,2013,24(32):2986-2988.
[6]许月芳.医院药学人员发展前景SWOT的分析[J].解放军医院管理杂志,2015,22(12):1112-1113.
[7]曹健,王芳,张卿,等.医院制剂的微生物稳定性及其影响因素初探[J].中国医院用药评价与分析,2011,11(2):159-161.
[8]宋新文,庞德志,刘燕,等.616批医院制剂微生物限度检查结果分析[J].儿科药学杂志,2006,12(1):39-40.
[9]王彪,张翠莲,刘建茹,等.枸橼酸钾溶液微生物风险控制的改进与成效[J].中国药事,2017,31(12):1494-1496.
[10]杨平,曾蔚欣,时正媛,等.医院药师微生物限度检查培训的实践与体会[J].中国药师,2017,20(6):1114-1116.
[11]高波,迟丹怡,付文焕,等.从复旦大学附属华山医院制剂现状分析医院制剂存在的必要性[J].药学服务与研究,2014,14(3):207-210.
[2]陈家润,江映珠,吴雪龙.广东省医疗机构制剂质量标准修订存在问题及对策[J].中国药事,2016,30(3):209-213.
[3]天津市医疗机构制剂规范[S].2016.
[4]中国药典:四部[S].2015:140-151.
[5]王文明,严振,张雷红,等.广东省医院制剂发展现状的调查分析[J].中国药房,2013,24(32):2986-2988.
[6]许月芳.医院药学人员发展前景SWOT的分析[J].解放军医院管理杂志,2015,22(12):1112-1113.
[7]曹健,王芳,张卿,等.医院制剂的微生物稳定性及其影响因素初探[J].中国医院用药评价与分析,2011,11(2):159-161.
[8]宋新文,庞德志,刘燕,等.616批医院制剂微生物限度检查结果分析[J].儿科药学杂志,2006,12(1):39-40.
[9]王彪,张翠莲,刘建茹,等.枸橼酸钾溶液微生物风险控制的改进与成效[J].中国药事,2017,31(12):1494-1496.
[10]杨平,曾蔚欣,时正媛,等.医院药师微生物限度检查培训的实践与体会[J].中国药师,2017,20(6):1114-1116.
[11]高波,迟丹怡,付文焕,等.从复旦大学附属华山医院制剂现状分析医院制剂存在的必要性[J].药学服务与研究,2014,14(3):207-210.