Quality Evaluation of Ass-hide Gelatin in Danggui Yangxue Pill by UPLC-MS
DU Xiao-juan1, WANG Bing1, XIE Yao-xuan1, ZENG Li-na1, SU Chang1, MA Shuang-cheng2*, KANG Shuai2, WANG Shu-hong1*
1. NMPA Key Laboratory for Quality Research and Evaluation of Traditional Chinese Medicine, Shenzhen Institute for Drug Control, Shenzhen 518057, China; 2. NMPA Key Laboratory for Quality Research and Evaluation of Traditional Chinese Medicine, National Institutes for Food and Drug Control, Beijing 100050, China
Abstract:OBJECTIVE To establish an analysis method for specific identification of ass-hide gelatin in Danggui Yangxue Pill. METHODS The UPLC-MS/MS was used to establish the identification of ass-hide gelatin、 equine-hide gelatin and content determination of marker peptides for Danggui Yangxue Pill. The sample was analyzed on UPLC coupled with triple quadrupole mass spectrometry after digesting 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 methodological evaluation showed that this method had good linearity, specificity, stability, repeatability and durability.Ass-hide gelatin was detected out in 11 batches of samples, while equine-hide gelatin was detected in 9 batches and 7 batches below the content limit. The series methods established in this paper provide technical support for the evaluation of the Chinese medicine preparations containing ass-hide gelatin. CONCLUSIONT The present method is specific, precise, reliable, and suitable for quality evaluation of ass-hide gelatin in Danggui Yangxue Pill.
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DU Xiao-juan, WANG Bing, XIE Yao-xuan, ZENG Li-na, SU Chang, MA Shuang-cheng, KANG Shuai, WANG Shu-hong. Quality Evaluation of Ass-hide Gelatin in Danggui Yangxue Pill by UPLC-MS. Chinese Pharmaceutical Journal, 2022, 57(6): 413-419.
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