醋酸奥曲肽制剂的质量一致性评价 - 中国药事.pdfVIP

486 中国药事 2017 年 5 月 第 31 卷 第 5 期 ·质量评价· 醋酸奥曲肽制剂的质量一致性评价 李茜，梅芊，刘英 （河南省食品药品检验所，郑州 450003） 摘要 目的：评价醋酸奥曲肽制剂的质量现状。方法：依据现行法定质量标准，对全国范围内的醋酸奥 曲肽进行检验，分析国内醋酸奥曲肽制剂的总体质量水平；并进一步开展了杂质谱、稳定性、醋酸盐、 辅料乳酸、渗透压及相容性等方面的探索性研究，更深入地综合评价其质量。结果：本次抽验涉及的 91 批醋酸奥曲肽制剂按法定标准检验，合格率为 100.0% ；探索性研究结果表明，国内企业的制剂有关物质 总体低于对照的醋酸奥曲肽注射液，制剂的杂质主要为降解杂质，冷冻干燥生产工艺可大大降低注射用 醋酸奥曲肽中的醋酸盐含量，对照醋酸奥曲肽注射液的辅料乳酸较好；制剂的渗透压与处方组成及处方 中甘露醇的量相关，中硼硅玻璃的金属离子迁移量较硼硅玻璃低。结论： 国产醋酸奥曲肽注射液质量状 况较好，而注射用醋酸奥曲肽因醋酸盐含量甚低，提示应注意该剂型工艺的合理性。本文探索性研究为 今后更严格地控制该产品的质量提供了参考。 关键词： 醋酸奥曲肽；质量评价；一致性评价；杂质谱；稳定性；醋酸盐；乳酸；相容性 中图分类号：R927 文献标识码：A 文章编号：1002-7777 2017)05-0486-09 （ doi:10.16153/j.1002-7777.2017.05.005 Quality Consistency Evaluation of Octreotide Acetate Injection Li Qian, Mei Qian, Liu Ying (Henan Provicial Institute of Food and Drug Control, Zhengzhou 450003, China) Abstract Objective: To evaluate the quality of octreotide acetate injection at present. Methods: According to the current quality standard, the domestic examination of octreotide acetate injection was conducted, and its overall quality was analyzed. Exploratory study was carried out, including impurity profiling, stability, acetate content, lactic acid, osmolarity and compatibility to further evaluate their quality. Results: According to current standard, all 91 batches of the samples were qualified; exploratory study results showed that those of the related substances of octreotide acetate injection of the domestic companies were lower than those of the reference octreotide acetate injection, and the main impurities were degradation impurities, the acetate content of the samples produced by freezing drying was very low, the lactic acid quality of reference octreotide acetate injection was better than that of the domestic samples, osmolarity was related to the prescription form and the amout mannitol, and the metal ion m