摘要
目的通过反向工程研究盐酸伊立替康注射液生产工艺中乳酸投料量。方法乳酸辅料主要由单乳酸和乳酰乳酸组成,稀释后直接进行高效液相色谱-紫外分光光度法(HPLC-UV)分析可确定单乳酸和乳酰乳酸的比例,经碱加热预处理后再采用HPLC-UV分析可确定总乳酸量,精密度和准确度良好。结果原研药中乳酸含量与美国食品药物管理局(FDA)说明书处方一致,但原研药中乳酰乳酸含量仅为实验自制的25%,需予以关注。结论反向工程技术的应用可解决乳酸投料问题,并为工艺开发提供指导,保证产品一致性,规避产品开发风险。
Objective To study the feeding amount of lactic acid in the production process of irinotecan hydrochloride injection by reverse engineering.Methods The lactic acid adjuvant was mainly composed of monolactic acid and lactyl-lactic acid.After dilution,high performance liquid chromatography-ultraviolet spectrophotometry(HPLC-UV)analysis could be used to determine the ratio of monolactic acid and lactyl-lactic acid.After pretreatment with alkali heating,HPLC-UV analysis could be used to determine the total lactic acid content with good precision and accuracy.Results The content of lactic acid in the original drug was consistent with the FDA’s instructions,but the content of lactyl-lactic acid in the original drug was only 25%of the experimental self-made product,which needed attention.Conclusion The application of reverse engineering technology can solve the problem of lactic acid feeding,provide guidance for process development,ensure product consistency,and avoid product development risks.
作者
付强
刘青
徐兴志
王志云
陆伟跃
FU Qiang;LIU Qing;XU Xingzhi;WANG Zhiyun;LU Weiyue(Zhejiang Huahai PharmaceuticalCo.,Ltd.,Taizhou,Zhejiang,China 317007;School of Pharmacy,FudanUniversity,Shanghai,China 201203;Institute of Pharmaceutical Science,China Pharmaceutical University,Nanjing,Jiangsu,China 210009)
出处
《中国药业》
CAS
2020年第5期60-62,共3页
China Pharmaceuticals
关键词
仿制药反向工程
盐酸伊立替康注射液
乳酸
乳酰乳酸
高效液相色谱-紫外分光光度法
reverse engineering
irinotecan hydrochloride injection
lactic acid
lactyl-lactic acid
high performance liquid chromatography-ultraviolet spectrophotometry
