Keywords

Pearl Eye Drops Pearl Liquid Peptide Uplc-Q-Tof Ms Amino Acid Rp-Hplc

Abstract

Objective To analyze the differences in protein and peptide components in Pearl Eye Drops and Pearl Liquid from different manufacturers, so as to provide a reference for ensuring the stability of the production process of raw materials and effectively controlling the quality of Pearl Eye Drops. Methods UPLC-Q-TOF MS positive ion mode was used for analysis to identify the peptide components in Pearl Eye Drops and Pearl Liquid. Acquity UPLC BEH C18 (50 mm¡Á2.1 mm, 1.7 ¦Ìm) chromatographic column, acetonitrile-0.1 % methanol aqueous solution was used as the mobile phase; pre-column derivatization HPLC-DAD method was used to determine 16 amino acids in Pearl Mingmu Eye Drops. Results The relative molecular weight (MW) of the polypeptides and the percentages of the 16 amino acids in the total amino acids in the Pearl Eye Drops and Pearl Liquid from different manufacturers were quite different. The MW of the peptides in the pearl liquid of 3 of the 5 companies are all less than 2000. The MW of the peptides in the pearl liquid of the other 2 manufacturers are 500~4746, and the MW of the peptides in the pearl liquid of the other 2 manufacturers are mainly peptides greater than 2000. Among the Pearl Eye Drops samples from 7 manufacturers, the MW of peptides in the samples of 2 manufacturers were mainly 2000~4000 and contained more than 4000 peptides, while the samples of the other 5 manufacturers did not contain MWs of more than 4000. Peptides. The mass concentration of 16 amino acids relative to the total amino acid mass concentration in the Pearl Eye Drops from 7 manufacturers has a large difference in percentage, and the mass concentrations of proline and alanine in the Pearl Liquid from 2 manufacturers using acid/enzyme hydrolysis process. The ratio is > 1, and the ratio between the two manufacturers using direct water extraction process is less than 1. Conclusion It is recommended to revise the quality standards of pearl liquid, clarify that the preparation process is direct extraction with water, ensure the active ingredient peptide (MW between 500~5000) in the eye drops, and add the inspection item proline to the quality standards of pearl liquid and pearl eyesight drops. The ratio of the mass concentration of acid to alanine and the total amount of quantitative amino acids are used to effectively control the quality of Pearl Eye Drops and ensure their effectiveness.

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Original research done by Ding Xiaoping, Hou Junjie, Tu Qijun, Xiao Ling, Fei Yiqin

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