盐酸溴己新注射剂的质量标准研究

Study on the quality standards of bromhexin hydrochloride injections

目的:评价盐酸溴己新注射剂(粉针、输液和水针)的质量标准现状及存在的问题。方法:采用法定检验方法结合药物含量测定及杂质分析等探索性研究进行各药品企业样本的研究。结果:粉针的统一标准主要对水分(或者干燥失重)检查、有关物质检查和含量测定等项目进行,研究结果表明,统一后的粉针制剂执行标准有效、可行;输液制剂标准中可能存有争议的5-羟甲基糠醛检查,UV法更简便、快速;而水针制剂的国家标准许久未更新,但新获批的企业更新标准值得推荐。结论:粉针制剂标准方面,众多获批企业标准统一后的现行质量标准可以有效评价本制剂的质量,输液制剂标准的5-羟甲基糠醛检查建议保持现行的UV法,而水针制剂的国家标准建议尽快更新。

Objective：To evaluate the quality standard status of bromhexin hydrochloride injections（including sterilized powder for injection and liquid for injection）and existing problems.Methods：The statutory testing methods were used,combined with the exploratory research such as assay,impurity analysis and so on.Samples from various pharmaceutical enterprises were examined.Results：For sterilized powder,the items of Loss On Drying or Water,Related Substances and Assay were mainly integrated in harmonization of drug standards,and the research showed the new implementation standard of sterilized powder after harmonization was effective and practicable.UV method was simpler and faster than HPLC for the determination of 5-hydroxymethylfurfural in bromhexine hydrochloride and glucose injection.For bromhexine hydrochloride injection,the national drug standard was too early,and the new approved update standard of one pharmaceutical enterprise was worthy of recommendation.Conclusion：The new harmonized drug standards of bromhexin hydrochloride for injection was satisfied with the effective quality control;UV method was still preferred for the determination of 5-hydroxymethylfurfural in bromhexine hydrochloride and glucose injection;and the national drug standard of bromhexine hydrochloride injection was urgently needed to be updated.