摘要
目的评价盐酸溴己新片的有关物质现状及存在的问题。方法采用现行标准结合探索性研究对国内6家企业的95批样品进行考察,并对结果进行分析。结果采用标准方法检验,结果 95批样品均符合规定,杂质总量不超过0.4%;对国产片剂、原料和国外原研厂样品的探索性研究表明,国内6个厂家的所有样品共检出12个杂质,主要来源于原料,杂质种类和含量与原研厂样品存在差异;用LC-MS/MS对平均含量最高的未知杂质进行了结构推定,认为是原料的工艺杂质。结论国产盐酸溴己新片的有关物质总体质量较好,符合法定标准的限度规定;根据探索性研究结果,片剂杂质主要来源于原料。因此,从原料药源头改进是提高盐酸溴己新片质量水平的关键。
OBJECTIVE To evaluate the status of related substances in bromhexine hydrochloride tablets and to find the existing problems. METHODS 95 batches of samples from six domestic manufacturers were tested using statutory methods combined with exploratory research, and the results were evaluated by statistical analysis. RESULTS The related substances in 95 batches of brom hexine hydroehloride tablets met the requirement of current specification. The total amount was not more than 0.4%. The exploratory studies on domestic tablets, raw materials and tablets produced by original manufacturer revealed that 12 impurities were detected in the samples from six domestic manufacturers, which originated mainly from the raw material. The species and contents of the impurities in domestic samples were different with those in the product of original manufacturer. The structure of the unknown impurity with the high- est content was identified by LC-MS/MS, and it was judged to be produced in the manufacturing process of the raw material. CONCLUSION The related substances in domestic bromhexine hydrochloride tablets are in good control overall and have met the requirement of current statutory specification. The impurities originate mainly from the raw material, so improving the quality of the materials at the source is the critical factor for promoting the quality level of bromhexine hydrochloride tablets.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2013年第4期304-308,共5页
Chinese Pharmaceutical Journal
基金
国家食品药品监督局2009年抽验项目
关键词
盐酸溴己新片
有关物质
质量分析
bromhexine hydrochloride tablet
related substance
quality analysis
