注射用特立帕肽体外生物学活性方法研究  

Study on in vitro biological activity of teriparatide for injection

作　　者：徐可铮 吕萍[1] 王绿音 张慧[1] 梁成罡[1] XU Ke-zheng;LV Ping;WANG Lv-yin;ZHANG Hui;LIANG Cheng-gang(Division of Hormone,National Institutes for Food and Drug Control,NHC Key Laboratory of Research on Quality and Standardization of Biotech Products,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院激素室,国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室,北京102629

出　　处：《中国新药杂志》2022年第21期2169-2173,共5页Chinese Journal of New Drugs

基　　金：国家“重大新药创制”科技重大专项资助项目(2018ZX09101001-003-004)。

摘　　要：目的:按照美国药典(USP)与《中华人民共和国药典》(CHP)生物制品生物活性方法验证指导原则,进行注射用特立帕肽体外生物学活性检测方法研究。方法:基于UMR106细胞生色底物法进行注射用特立帕肽生物学活性检测及方法学验证。结果:优化后的方法简便高效,可准确检测重组特立帕肽生物学活性。该方法专属性较好,2名实验员各进行3次独立日间、日内精密度检测,RSD均<20%。准确度和线性较好,对50%,60%,100%,120%和130%这5个不同浓度稀释组样品各进行3次回收率测定,相对效价平均值分别为(46±2.08)%,(51±6.03)%,(99±12.10)%,(113±3.79)%,(131±6.93)%;对应回收率平均值分别为(91±4.16)%,(86±10.05)%,(99±12.10)%,(94±3.16)%,(101±5.33)%,各组样品RSD均<20%,线性相关系数R~2=0.991 1。该方法具有较好的重复性、耐用性,12次独立重复实验RSD均<10%,对不同型号仪器检测、细胞代次、药物孵育时间等条件的改变均有较好的耐用性。结论:本研究所优化的方法能够满足特立帕肽的工艺控制和放行检验需求。Objective: To optimize and verify an in vitro biological activity detection method of teriparatide for injection based on the United States Pharmacopoeia. Methods: UMR106 cell enzyme labeling method was used to detect the biological activity of teriparatide for injection and the method was validated. Results: Two experimenters each conducted three independent interday and intraday tests, and the precision RSDs were all less than 20%. The accuracy and linearity were good. The recovery rates of the samples at concentrations of 50%, 60%, 100%, 120%, and 130% were determined for three times. The average relative titers were(46±2.08)%,(51±6.03)%,(99±12.10)%,(113±3.79), and(131±6.93)%, the corresponding average recoveries were(91±4.16)%,(86±10.05)%,(99±12.10)%,(94±3.16)%,(101±5.33) %, respectively, and the RSD of each group of samples was less than 20%. The linear correlation coefficient was 0.991 1. The RSD of 12 independent repeated experiments was less than 10%, and the durability was good for changes in conditions such as detection by different types of instruments, cell passages, and drug incubation time. Conclusion: The optimized method is simple and efficient and can accurately detect the biological activity of PTH. It also has good specificity, repeatability, and durability, which can meet the process control and release testing requirements of PTH.

关 键 词：特立帕肽 酶标法 生物学活性测定 方法学 

分 类 号：R917[医药卫生—药物分析学]