醋酸奥曲肽注射液制备工艺研究  

Study on the Preparation Process of Octreotide Acetate Injection

作　　者：钟祥龙 张建松 付玉清 李新宇 张利香 ZHONG Xianglong;ZHANG Jiansong;FU Yuqing;LI Xinyu;ZHANG Lixiang(Shenzhen JYMed Technology Co.,Ltd.,Shenzhen 518118,China;Shenzhen Jianxiang Biopharmaceutical Co.,Ltd.,Shenzhen 518118,China)

机构地区：[1]深圳市健元医药科技有限公司,广东深圳518118 [2]深圳市健翔生物制药有限公司,广东深圳518118

出　　处：《山东化工》2024年第19期64-67,共4页Shandong Chemical Industry

摘　　要：目的:优化醋酸奥曲肽注射液制备工艺。方法:通过热处理技术对乳酸辅料进行预处理,并对预处理的pH值和热处理时间进行研究,优化制备工艺。对所制备醋酸奥曲肽注射液的含量、有关物质、乳酸含量及聚乳酸含量等关键质量属性进行检测和稳定性考察,并与参比制剂进行对比。结果:使用该工艺制备的醋酸奥曲肽注射液中乳酸相关杂质显著减少,辅料杂质出峰情况不劣于参比制剂,产品关键质量属性与参比制剂保持一致。结论:提供的醋酸奥曲肽注射液的制备工艺乳酸相关杂质含量低、工艺质量可控、经济实用。Objective:To optimize the preparation process of octreotide acetate injection.Methods:The lactic acid were pretreated by heat treatment technology,and the pH,heat treatment time of the pretreatment were studied to optimize the preparation process.The critical quality attributes such as its content,related substances,lactic acid content and polylactic acid content were tested and stabilized,and compared with the reference preparation.Results:The lactate-related impurities in octreotide acetate injection prepared by this process were significantly reduced,the peak of excipient impurities was not inferior to that of the reference preparation,and critical quality attributes of the product were consistent with reference preparation.Conclusion:The preparation process of octreotide acetate injection provided in this paper has low lactate-related impurity content,controllable process quality,and economic and practical.

关 键 词：醋酸奥曲肽 注射液 制备工艺 有关物质 质量评估 

分 类 号：TQ464.7[化学工程—制药化工] R914[医药卫生—药物化学]