国产盐酸溴己新片与原研制剂质量比对研究
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摘要
目的:对国产盐酸溴己新片和原研制剂进行质量比对研究。方法:采用4种溶出介质测定溶出曲线及新建立的有关物质检测方法进行盐酸溴己新片质量比对研究。结果:溶出曲线比对表明,有1家国内企业产品与原研制剂具有溶出曲线相似性;杂质谱分析表明,国产制剂中的杂质主要是原料药中带入的未知杂质X,原研制剂中未检出未知杂质X。结论:控制原料药质量是提升国产制剂质量的主要因素,国内外原料药生产工艺存在差异。
Objective: To evaluate the quality of domestic bromhexine hydrochloride tablets and primary research preparations. Methods: The dissolution curves of the tablets and preparation in four dissolution media were compared. The quality of Bromhexine Hydrochloride Tablets was analyzed with the new related substances method. Results: The comparative study showed the dissolution curve of one domestic manufacturer was similar to that of the original manufacturer. Impurity profiles analysis showed that unknown impurity X which comes from API was the main reason to influence the purity level of domestic preparations, meanwhile, impurity X was not detected in primary research preparations. Conclusion: The quality of API was the main factor to influence the quality of domestic preparations. There was difference in manufacturing technique between foreign API and domestic API.
Objective: To evaluate the quality of domestic bromhexine hydrochloride tablets and primary research preparations. Methods: The dissolution curves of the tablets and preparation in four dissolution media were compared. The quality of Bromhexine Hydrochloride Tablets was analyzed with the new related substances method. Results: The comparative study showed the dissolution curve of one domestic manufacturer was similar to that of the original manufacturer. Impurity profiles analysis showed that unknown impurity X which comes from API was the main reason to influence the purity level of domestic preparations, meanwhile, impurity X was not detected in primary research preparations. Conclusion: The quality of API was the main factor to influence the quality of domestic preparations. There was difference in manufacturing technique between foreign API and domestic API.
引文
[1]吕长淮.盐酸溴己新片溶出度测定方法的研究[J].药物分析杂志,2008,28(10):1744-1746.
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[3]孙莉.HPLC法测定盐酸溴己新注射液含量及有关物质[J].安徽医药,2008(2):12(2):121-122.
[4]陈睿,田兰,刘惠军.高效液相色谱法测定盐酸溴己新及其片剂的含量和有关物质[J].药物分析杂志,2007,27(1):132-134.
[5]刘淑华,赵志刚.HPLC法测定盐酸溴己新及其片剂的含量[J].中国药事,2008,22(1):68-69.
[6]刘素英,冯素香,黄国稠,等.高效液相色谱法测定盐酸溴己新片的含量[J].广东药学院学报,2007,23(2):162-164.
[7]杨宏伟,张迪.HPLC法同时测定橘黄新啶片中枸橼酸喷托维林和盐酸溴己新的含量[J].中国药事,2009,23(9):914-916.
[8]张启明,谢沐风,宁保明,等.采用多条溶出曲线评价口服固体制剂的内在质量[J].中国医药工业杂志,2009,40(12):946-950.
[9]谢沐风.溶出曲线相似性的评价方法[J].中国医药工业杂志,2009,40(4):308-311.
[10]王成刚,张喆,王俊秋,等.盐酸溴己新片有关物质的质量分析[J].中国药学杂志,2013,48(4):304-308.
[11]赵连民.高效液相色谱法测定盐酸溴己新注射液的含量[J].中国当代医药,2010,17(8):112.
[12]郑凯,王玉红,杨阔.反相离子对高校液相色谱法测定盐酸溴己新及其片剂的含量[J].中国药业,2010,19(8),32-33.
[13]陈乃江.高效液相色谱法测定茶新那敏片中盐酸溴己新含量[J].中国药业,2009,18(8):35-36.
[14]庄旭琴,杨康群,李玉宝.高效液相色谱法测定克洛已新干混悬剂中头孢克洛及盐酸溴己新的含量[J].山西医药杂志,2008,37(10):923-924.
[15]蒲洁坤,张恺,郝晓飞,等.盐酸溴己新的合成[J].中国医药工业杂志,2013,44(9):846-847.
[2]丁洁,王伟宁,孙玲.Rp-HPLC法测定盐酸溴己新片含量及有关物质[J].药物分析杂志,2006,26(4):508-510.
[3]孙莉.HPLC法测定盐酸溴己新注射液含量及有关物质[J].安徽医药,2008(2):12(2):121-122.
[4]陈睿,田兰,刘惠军.高效液相色谱法测定盐酸溴己新及其片剂的含量和有关物质[J].药物分析杂志,2007,27(1):132-134.
[5]刘淑华,赵志刚.HPLC法测定盐酸溴己新及其片剂的含量[J].中国药事,2008,22(1):68-69.
[6]刘素英,冯素香,黄国稠,等.高效液相色谱法测定盐酸溴己新片的含量[J].广东药学院学报,2007,23(2):162-164.
[7]杨宏伟,张迪.HPLC法同时测定橘黄新啶片中枸橼酸喷托维林和盐酸溴己新的含量[J].中国药事,2009,23(9):914-916.
[8]张启明,谢沐风,宁保明,等.采用多条溶出曲线评价口服固体制剂的内在质量[J].中国医药工业杂志,2009,40(12):946-950.
[9]谢沐风.溶出曲线相似性的评价方法[J].中国医药工业杂志,2009,40(4):308-311.
[10]王成刚,张喆,王俊秋,等.盐酸溴己新片有关物质的质量分析[J].中国药学杂志,2013,48(4):304-308.
[11]赵连民.高效液相色谱法测定盐酸溴己新注射液的含量[J].中国当代医药,2010,17(8):112.
[12]郑凯,王玉红,杨阔.反相离子对高校液相色谱法测定盐酸溴己新及其片剂的含量[J].中国药业,2010,19(8),32-33.
[13]陈乃江.高效液相色谱法测定茶新那敏片中盐酸溴己新含量[J].中国药业,2009,18(8):35-36.
[14]庄旭琴,杨康群,李玉宝.高效液相色谱法测定克洛已新干混悬剂中头孢克洛及盐酸溴己新的含量[J].山西医药杂志,2008,37(10):923-924.
[15]蒲洁坤,张恺,郝晓飞,等.盐酸溴己新的合成[J].中国医药工业杂志,2013,44(9):846-847.