硫酸庆大霉素片的质量评价
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摘要
目的评价硫酸庆大霉素片的质量,并对质量标准进行完善。方法按法定标准检验与探索性研究相结合,对国家药品计划抽验的156批次样品与调研企业所得样品进行检验,通过对稳定性、有关物质、庆大霉素C组分与溶出行为的考察,对硫酸庆大霉素片的质量进行分析评价。结果法定标准检验结果显示156批次硫酸庆大霉素片合格率100.0%。探索性研究结果显示两家生产企业共8批次样品有关物质过高,同时庆大霉素C组分偏低,分析原因为企业采用不合格原料;稳定性实验结果表明本品稳定;企业间产品溶出行为差异较大,糖衣片批内溶出度RSD较大。结论综合法定标准检验与探索性研究实验,硫酸庆大霉素片质量总体一般。建议相关企业加强原料控制;建议糖衣片生产企业考察并优化处方生产工艺,改善药物溶出度。建议质量标准增订有关物质与庆大霉素C组分检查项,确保标准可控,以及用药安全有效。
Objective To evaluate the quality of gentamicin sulfate tablets, and improve the quality standards.Methods According to the combination of legal standard tests and the exploratory research, 156 batch samples from national drug plan and samples collected from survey enterprises were tested. The gentamicin sulfate tablets were analyzed through the investigation of the related substances, gentamicin C component, stability, and the dissolution.Results The legal test results showed that the pass rate of 156 batches of tablets was 100%. The results of the exploratory study showed the related substances of eight batches from two enterprises were too high and gentamicin C component was on the low side. The reason was the enterprises adopted unqualified raw materials. The stability test showed that the product was stable. The dissolving behavior of productions among the enterprises was different.The RSD of the dissolution of the same batch of sugar coated tablets was larger. Conclusion The quality of tablets was medium according to the current standard and the exploratory research. It was suggested that relevant enterprises strengthen material control. The sugar-coated tablets manufacturers should investigate and optimize prescription production process to improve drug dissolution. The current standard was recommended to add the related substances and the gentamicin C component to make sure that the standard is controllable to ensure safe and effective use of medicine.
Objective To evaluate the quality of gentamicin sulfate tablets, and improve the quality standards.Methods According to the combination of legal standard tests and the exploratory research, 156 batch samples from national drug plan and samples collected from survey enterprises were tested. The gentamicin sulfate tablets were analyzed through the investigation of the related substances, gentamicin C component, stability, and the dissolution.Results The legal test results showed that the pass rate of 156 batches of tablets was 100%. The results of the exploratory study showed the related substances of eight batches from two enterprises were too high and gentamicin C component was on the low side. The reason was the enterprises adopted unqualified raw materials. The stability test showed that the product was stable. The dissolving behavior of productions among the enterprises was different.The RSD of the dissolution of the same batch of sugar coated tablets was larger. Conclusion The quality of tablets was medium according to the current standard and the exploratory research. It was suggested that relevant enterprises strengthen material control. The sugar-coated tablets manufacturers should investigate and optimize prescription production process to improve drug dissolution. The current standard was recommended to add the related substances and the gentamicin C component to make sure that the standard is controllable to ensure safe and effective use of medicine.
引文
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[3]Satoko Y,Dominique F,Joseph D P.Structural origins of gentamicin antibiotic action[J].Embo J,1998,17(22):6437.
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[10]The Japanese European XVII[S].Ministry of Health,Labour and Welfare,2017:982-983.
[11]国家药典委员会.中华人民共和国(2010年版二部)[S].北京:中国医药科技出版社,2010:977-978.
[12]国家药典委员会.中华人民共和国(2015年版四部)[S].北京:中国医药科技出版社,2015:354-356.
[13]王嶽,方金瑞.抗生素[M].北京:科学出版社,1988:292.
[14]李少杰,姚永青,刘英.硫酸庆大霉素注射液质量评价[J].中国药事,2014,28(11):1231-1240.
[15]国家食品药品监督管理局网.普通口服固体制剂溶出度试验技术指导原则[EB/OL].[2005-02-05]http://samr.cfda.gov.cn/WS01/CL1616/114288.html.
[2]腾讯网.新闻中心之1 9 6 9年:抗菌素“庆大霉素”研制成功[EB/OL].[2009-07-10]http://news.qq.com/a/20090710/000851.htm.
[3]Satoko Y,Dominique F,Joseph D P.Structural origins of gentamicin antibiotic action[J].Embo J,1998,17(22):6437.
[4]刘英,王立萍.庆大霉素质量标准变迁对庆大霉素质量的影响[J].药物分析杂志,2014,34(2):207-214.
[5]国家药典委员会.中华人民共和国药典临床用药须知[M].2010年版.北京:中国医药科技出版社,2011:703.
[6]国家药典委员会.中华人民共和国(2015年版二部)[S].北京:中国医药科技出版社,2015:1324-1328.
[7]The United States Pharmacopoeia 40th Edition[S].Rockuille MD:The United States Pharmacopoeia Convention,2017:4391-4392.
[8]The British Pharmacopoeia 2017[S].British Pharmacopoeia Commission:2017(Ⅱ)1098-1100.
[9]European Pharmacopoeia 9.0[S].Strasbourg:European Direction for the Quality of Medicines,2017:2573-2574.
[10]The Japanese European XVII[S].Ministry of Health,Labour and Welfare,2017:982-983.
[11]国家药典委员会.中华人民共和国(2010年版二部)[S].北京:中国医药科技出版社,2010:977-978.
[12]国家药典委员会.中华人民共和国(2015年版四部)[S].北京:中国医药科技出版社,2015:354-356.
[13]王嶽,方金瑞.抗生素[M].北京:科学出版社,1988:292.
[14]李少杰,姚永青,刘英.硫酸庆大霉素注射液质量评价[J].中国药事,2014,28(11):1231-1240.
[15]国家食品药品监督管理局网.普通口服固体制剂溶出度试验技术指导原则[EB/OL].[2005-02-05]http://samr.cfda.gov.cn/WS01/CL1616/114288.html.