基于液相-质谱联用技术对保胎灵制剂中阿胶标准提升研究  

Standard Promotion Research of Ass-hide Gelatin in Baotailing Preparation by UPLC-MS

作　　者：谌宇 伍勋 施思 卢智玲 Chen Yu;Wu Xun;Shi Si;Lu Zhiling(Hanghou Institute for Food and Drug Control,Hangzhou 310017,China)

机构地区：[1]杭州市食品药品检验研究院,杭州310017

出　　处：《中国药师》2022年第11期2015-2019,共5页China Pharmacist

基　　金：浙江省药品监督管理局科技计划(编号:2021022)。

摘　　要：目的:建立高效液相色谱-串联质谱(UPLC-MS/MS)测定保胎灵制剂中阿胶定性及定量的研究方法,为原料阿胶质量及投料情况提供技术支持。方法:采用胰蛋白酶对保胎灵制剂进行酶解,利用UPLC-MS/MS,在电喷雾离子化(ESI+)模式下,进行多反应监测(MRM),并进行阿胶专属鉴别及阿胶特征多肽含量测定。结果:驴源多肽A_(1),A_(2)在0.050 2~1.225 0μg·ml^(-1),0.052 4~1.310 0μg·ml^(-1)范围内线性关系良好(r≥0.999),29批保胎灵制剂均检出阿胶,但14批低于阿胶特征多肽含量拟定限度。结论:所建立的方法准确可靠,专属性强,可用于保胎灵制剂中阿胶的质量评价。Objective: To establish an analysis method for specific identification of ass-hide gelatin in Baotailing preparation. Methods: The UPLC-MS/MS was used to perform the identification of ass-hide gelatin and content determination of marker peptides for Baotailing preparation. The sample was analyzed by UPLC coupled with triple quadrupole mass spectrometry after digested by trypsin. Choosing the characteristic molecular peaks as target ion pair, collagen marker peptides were detected by mass spectrometry with positive electrospray ionization and multiple reaction monitoring(MRM). Results: The linear ranges of peptide A_(1),A_(2)were 0.050 2-1.225 0 μg·ml^(-1),0.052 4-1.310 0 μg·ml^(-1),respectively(r≥0.999). Ass-hide gelatin was detected in 29 batches of samples, while that in 14 batches was below the content limit. Conclusion: The presented method is specific, precise and reliable, and suitable for the quality evaluation of ass-hide gelatin in Baotailing preparation.

关 键 词：保胎灵制剂 阿胶 特征多肽 液相-质谱联用技术 

分 类 号：TQ460.72[医药卫生—药物分析学]