苯磺酸氨氯地平片省级抽检质量考察分析

Quality Analysis of Amlodipine Besilate Tablets in Provincial Sampling Inspection

目的:对2018年浙江省内药品生产及流通领域55批次苯磺酸氨氯地平片的质量进行考察分析,评价本品的质量现状及存在问题。方法:将法定检验与探索性研究相结合,针对工艺处方对产品质量的影响等问题,采用X-射线衍射法和热重法分析晶型;采用激光粒度仪分析原料粒度;采用HPLC、LC/MS和GC/Q-TOF考察原料中可能存在的基因毒性杂质、进行手性分离、考察有关物质、溶出度及稳定性;采用近红外光谱扫描法建立近红外光谱库,为快速检验提供依据。结果:按法定标准检验,本品合格率100%,部分企业含量均一性较差。结论:本品种总体质量良好,探索性研究提示需完善有关物质检查方法,合理制定降解杂质以及其他杂质的限度,应考虑进一步提高对生产工艺的控制和改进。

Objective:To evaluate the current quality situation and problems of amlodipine besilate tablets by testing and analyzing 55 batches of samples collected from drug manufacturers and markets all over Zhejiang province in 2018.Methods:The prescribed examination was combined with exploratory research.As the formulation and preparation process had influences on the product quality,Xray powder diffractometry and thermal analysis were used to determine the crystal forms;a laser particle size analyzer was used to identify the particle size,and the possible genotoxic impurities,chiral separation,related substances,dissolution and stability of amlodipine besilate were studied by HPLC,LC/MS and GC/Q-TOF;NIR database was established by near-infrared spectroscopy(NIRS),which provided the basis for rapid test.Results:In accordance with the statutory standard,the qualified rate was 100%,while the products from some manufacturers had poor content uniformity.Conclusion:The general quality of the tablets is promising.The exploratory research suggests that it is urgent to improve the related substance detection in the standard and determine the reasonable limits for the degradation impurities and the other impurities to control the production process and the quality of some manufacturers.