目的分析不同厂家珍珠明目滴眼液及珍珠液中蛋白多肽类成分的差异,为保证原料药生产工艺的稳定性,有效地控制珍珠明目滴眼液的质量提供参考依据。方法采用UPLC-Q-TOF MS正离子模式进行分析,鉴定珍珠明目滴眼液及珍珠液中的肽类成分,Acquity UPLC BEH C18(50 mm×2.1 mm,1.7μm)色谱柱,乙腈-0.1%甲醇水溶液作为流动相;柱前衍生化HPLC-DAD法测定珍珠明目滴眼液中16种氨基酸。结果不同生产企业的珍珠明目滴眼液及珍珠液中多肽的相对分子质量(MW)、16种氨基酸分别占总氨基酸量的百分比差异较大。5家企业中3家的原料药珍珠液中肽的MW均小于2 000,另2个厂家珍珠液中肽的MW为500~4 746,以大于2 000的肽为主。7个厂家的珍珠明目滴眼液样品中,2个厂家样品中肽的MW以2 000~4 000为主,并含有4 000以上的肽,另5个厂家样品中不含4 000以上的肽。7个厂家的珍珠明目滴眼液中16种氨基酸质量浓度相对总氨基酸质量浓度的百分比差异较大,2个厂家采用酸/酶水解工艺的珍珠液中脯氨酸与丙氨酸质量浓度的比值>1,5个厂家采用水直接提取工艺的二者比值小于1。结论建议修订珍珠液质量标准,明确制备工艺为水直接提取,确保滴眼液中的有效成分多肽(MW在500~5 000),珍珠液及珍珠明目滴眼液质量标准增加检查项脯氨酸与丙氨酸质量浓度的比值及定量测定项氨基酸总量,以有效控制珍珠明目滴眼液的质量,确保其有效性。 OBJECTIVE: To analyze the differences of the peptide compositions of pearl eyesight and pearl liquid from different manufacturers, and to provide reference for controlling the stability of the raw material medicine production process and controlling the quality of pearl eyesight eye drops effectively. Methods The UPLC-Q-TOF MS was used to analyze the peptide components in the Pearl Eye Drops and Pearls. The samples were separated on a Acquity UPLC BEH C18 (50 mm × 2.1 mm, 1.7 μm) % Methanol aqueous solution as mobile phase; and 16 kinds of amino acids in Pearl Mingmu Eye Drops by HPLC-DAD method before column derivatization. Results The relative molecular weight (MW) and the percentage of 16 kinds of amino acids of pearl eyesight pearl liquid and pearl liquid from different manufacturers differed greatly among the total amino acid contents. Three of the five companies had peptide MW of less than 2 000 in the pearl liquid drug solution. Peptides in the pearl liquid from the other two manufacturers had a MW of 500-4,746, with peptides larger than 2,000. Among the seven manufacturers of pearl eyesight eye drops samples, the MW of the peptides in the two manufacturers was mainly from 2 000 to 4 000 and contained more than 4 000 peptides, while the other 5 samples contained no more than 4 000 Peptide. There were significant differences in the percentages of 16 amino acid concentrations relative to total amino acid concentrations in the seven manufacturers’ pearl eyesight eye drops. The two manufacturers used the acid / enzyme hydrolysis process to determine the concentrations of proline and alanine in the pearl fluid Ratio> 1, 5 manufacturers using direct extraction of water ratio between the two is less than 1. Conclusions It is suggested that the quality standard of pearl liquid should be revised and the preparation process should be directly extracted by water to ensure that the active ingredient of the active ingredient in the eye drops has a MW of 500-5000 and that the quality standards of pearl liquid and pearl eye drops increase. Acid and alanine mass concentration ratio and quantitative determination of the total amount of amino acids in order to effectively control the quality of pearl eyesight eye drops to ensure its effectiveness.