复方牛胎肝提取物片的批间一致性评价研究  

Study on inter batch consistency evaluation of Compound Embryonic Bovine Liver Extract Tablets

作　　者：段艳 Duan Yan(Beijing Institute for Drug Control(Beijing Center For Vaccine Control),NMPA Key Laboratory for Safety Research and Evaluation of Innovative Drugs,Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing 102206,China)

机构地区：[1]北京市药品检验研究院(北京市疫苗检验中心),国家药品监督管理局创新药物安全研究与评价重点实验室,中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《首都食品与医药》2024年第22期139-141,共3页Capital Food Medicine

摘　　要：目的 探索建立复方牛胎肝提取物片的批间一致性评价方法.方法 采用高效液相色谱(HPLC)法,以十八烷基硅烷键合硅胶(CAPCELL PAK C18 AQ,4.6mm×250mm,3μm)为填充剂;以0.1%甲酸溶液为流动相A,0.1%甲酸甲醇溶液为流动相B,梯度洗脱;流速为1.0mL/min;柱温30℃;检测波长为260nm.采用指纹图谱相似度评价系统软件(2.0版),建立了复方牛胎肝提取物片的批间一致性评价方法,并对三个厂家的9批产品进行相似度评价.结果 同一厂家样品的指纹图谱相似度较高,均在0.9以上.结论 所建立的批间一致性方法经方法学验证,可为复方牛胎肝提取物片的批间一致性评价提供参考.Objective To establish an inter batch consistency evaluation method for Compound Embryonic Bovine Liver Extract Tablets.Methods HPLC method was adopted.The determination was performed on CAPCELL PAK C18 AQ(4.6mm×250mm,3μm)column with mobile phase consisted of 0.1%Formic acid solution and Methanol-0.1%Formic acid solution(gradient elution)at the flow rate of 1.0mL/min.The column temperature was 30℃.The program wavelength was 260nm.Similarity Evaluation System for Chromatogram Fingerprint(v2.0)was used to establish the method and carry out similarity evaluation of 9 batches of Compound Embryonic Bovine Liver Extract Tablets.The chromatographic peaks were identified and 6 common peaks were calibrated.Results The similarities of Compound Embryonic Bovine Liver Extract Tablets from the same pharmaceutical manufacturer were all higher than O.9.Conclusion The established method is specific and reproducible,which can be used as a reference for inter batch consistency evaluation of Compound Embryonic Bovine Liver Extract Tablets.

关 键 词：复方牛胎肝提取物片 批间一致性 方法学研究 

分 类 号：R286[医药卫生—中药学]