摘要
目的通过比较晶型、杂质谱及其他法定检验项目的数据差异,研究静脉注射用奥美拉唑钠仿制制剂与参比制剂的质量一致性。方法采用X射线粉末衍射法测定原料药及制剂的晶型。按《中华人民共和国药典》2020年版二部标准,对7家企业生产的33批次40 mg规格的静脉注射用奥美拉唑钠进行检验,检验项目包括有关物质、碱度、溶液的澄清度与颜色、水分、装量差异、可见异物、不溶性微粒及含量测定,采用SPSS软件统计数据。结果各企业制剂均为无定形粉末,3家企业奥美拉唑钠原料药晶型与参比一致,但与奥美拉唑原料药晶型有差异。各企业杂质谱与参比无显著差异,碱度(1家)、溶液颜色(4家)、水分(2家)、平均装量(4家)、含量(1家)与参比有显著性差异。仅1家处方、晶型及各检验项目均与参比无显著性差异。结论仅有1家企业仿制制剂与参比制剂质量一致,提示企业需改进处方工艺,提高产品质量。
Objective To study the quality consistency between generic drugs and reference drugs of omeprazole sodium for intravenous injection by comparing the data on the crystal form,impurity profiles and other standard tests.Methods Thirty-three batches of omeprazole sodium for intravenous injection(40 mg)produced by seven enterprises were tested.The crystal form was studied using the X-ray powder diffraction method.Related substances,alkalinity,clarity and color of solution,water content,weight uniformity,visible particles,insoluble particles and assay were determined according to the standards specified by Chinese Pharmacopoeia(2020 edition).Data was statistically processed using SPSS software.Results Generic drugs and reference drugs were both amorphous powders.The crystal form of omeprazole sodium from three enterprises was the same as that of reference drugs,but different from that of omeprazole.The generic drugs were not significantly different from reference drugs in impurity profiles,but significantly different from reference drugs in alkalinity(1 enterprise),color of solution(4 enterprises),water content(2 enterprises),average weight(4 enterprises)and content(1 enterprise).Only the generic drugs produced by one enterprise were not significantly different from reference drugs in the prescription,crystal form and test data.Conclusion Only the generic drugs produced by one enterprise are of the same quality as reference drugs,which suggests that enterprises should improve its product quality by improving its production process.
作者
刘荷英
刘绪平
钟振华
裴昆
夏红英
程奇珍
王晨
LIU Heying;LIU Xuping;ZHONG Zhenhua;PEI Kun;XIA Hongying;CHENG Qizhen;WANG Chen(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Provincial Engineering Research Center of Drug and Medical Device Quality,Nanchang Jiangxi 330029,China;National Institutes for Food and Drug Control,Beijing 102629,China)
出处
《中国药物警戒》
2021年第7期614-619,共6页
Chinese Journal of Pharmacovigilance
基金
重大新药创制国家科技重大专项2017年度(2017zx09101001)
江西省药品监督管理局科技计划(2019yp11)。
关键词
奥美拉唑
一致性
晶型
杂质谱
质量
omeprazole
consistency
crystal form
impurity profile
quality
