目的： 通过研究中药复方清达颗粒标准汤剂质量指标,来优选工艺和制定质量标准。方法： 依据医疗机构煎药规范,制备清达颗粒15 批标准汤剂;采用UPLC 建立清达颗粒标准汤剂特征图谱;采用一测多评法对清达颗粒标准汤剂中各药味指标成分进行含量测定,通过对15 批次清达颗粒标准汤剂中出膏率、指标成分含量、转移率、特征图谱进行分析,建立清达颗粒标准汤剂物质基准。结果： 根据15 批清达颗粒标准汤剂测定结果,拟合建立清达颗粒标汤特征图谱对照图谱,清达标准汤剂中出膏率波动范围为13.92%~25.84%;清达标准汤剂天麻中天麻素、对羟基苯甲醇、巴利森苷及其衍生物总含量的波动范围为1.39%~2.90%,指标成分总含量转移率波动范围为50.64%~94.04%;钩藤中钩藤碱、异钩藤碱、去氢钩藤碱和异去氢钩藤碱总含量的波动范围为0.04%~0.20%,指标成分总含量的转移率波动范围为14.24%~61.88%;莲子心中莲心碱、甲基莲心碱和异莲心碱总含量的波动范围为0.17%~0.59%,指标成分总含量的转移率波动范围为13.44%~42.66%;黄芩中黄芩苷和汉黄芩苷总含量的波动范围为5.43%~10.09%,指标成分总含量转移率波动范围为33.67%~62.52%。结论： 本研究建立的清达颗粒标准汤剂质量指标合理,可用于清达颗粒工艺研究和质量标准制订。
Objective： To establish the Qingda granules technological research and quality standard by studying its quality index of the standard decoction. Methods： In the study,15 batches of Qingda granules standard decoction were prepared according to the decoction specifications of medical institutions. UPLC was used to establish the characteristic chromatogram of the Qingda granules standard decoction. Quantitative analysis of multi-components by single-marker（QAMS） method was used to determine the content of each index component in the Qingda granules standard decoction. The extraction rate,index component content,transfer rate and characteristic chromatograms of 15 batches of the Qingda granules standard decoction were analyzed to establish the material standard of Qingda granules standard decoction. Results： According to the determination results of 15 batches of Qingda granules standard decoction,the characteristic chromatogram of Qingda granules standard decoction was established. The fluctuation range of the ointment rate in Qingda granules standard decoction was 13.92%-25.84%. The fluctuation range of the total contents of gastrodin,p-hydroxybenzyl alcohol,barrisonin and their derivatives in Qingda granules standard decoction was 1.39%-2.90%. The fluctuation range of the transfer rate about the index components was 50.64%-94.04%,the fluctuation range of the total contents of rhynchophylline, isorhynchophylline,dehydrorhynchophylline and isodehydrorhynchophylline in rhynchophylline was 0.04%-0.20%,and the fluctuation range of the transfer rate about index components was 14.24%-61.88%,the fluctuation range of the total contents of lobeline,isolianthine and methylliensinine was 0.17%-066%,the fluctuation range of the total content of baicalin and wogonoside in Scutellariae Radix was 5.43%-10.09%,and the fluctuation range of the transfer rate of the total contents of the index components was 33.67%-62.52%. Conclusion： The quality index of Qingda granules standard decoction established in this study is reasonable and can be used for the process study and quality standard formulation of Qingda granules.
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