论文部分内容阅读
目的:对小柴胡颗粒制剂的多波长HPLC图谱及药材-制剂谱峰匹配进行分析。方法:对来自3个生产厂家的9个批次(每厂3个批次)及自行配制的3个批次的小柴胡颗粒进行多波长HPLC图谱分析;采用HPLC法检测不同厂家及批次小柴胡颗粒中相应成分的含量。结果:在220、260、280、320 nm 4个波长条件下,3个生产厂家及自制小柴胡颗粒的3个批次之间制剂的HPLC图谱相似度相比差异相对较小,而不同厂家的制剂之间,甲厂制剂与自制制剂在4个波长下相似度在0.9以上,乙、丙两厂制剂除了在280 nm波长条件下相似度在0.9以上,在其他3个波长条件下相似度均低于0.9。在220、260、280、320 nm 4个波长下,甘草、柴胡、黄芩和党参与小柴胡颗粒HPLC图谱分别有5、5、18、2个色谱匹配峰;小柴胡颗粒制剂来源不同,制剂中的黄芩苷和甘草酸含量之间也存在差异。各种小柴胡颗粒制剂中均未检测到柴胡皂苷a、柴胡皂苷d、苍术内酯Ⅲ、阿魏酸、党参炔苷。结论:该研究采用多个波长下评价药材与制剂HPLC图谱谱峰匹配及活性组分相似度,为全面实现中成药的质量控制提供了一种新方法。
OBJECTIVE: To analyze the multi-wavelength HPLC profile of Xiaochaihu Granules and the peak-match of drug-preparation. Methods: Three batches of Xiaochaihu granules from 9 batches (3 batches per plant) and 3 batches from 3 manufacturers were analyzed by multi-wavelength HPLC. Hu granules in the corresponding content of the content. Results: Under the four wavelengths of 220, 260, 280 and 320 nm, the HPLC profiles of three manufacturers and three batches of self-made Xiaochaihu granules showed relatively small differences in the similarity of HPLC profiles. However, The similarity between preparations and homemade preparations at four wavelengths was above 0.9. The similarities between preparations at two wavelengths were 0.9 or more, except for the similarity at 280 nm. The similarities at the other three wavelengths Below 0.9. The HPLC chromatograms of Glycyrrhiza uralensis, Radix Bupleuri, Radix Scutellariae and Radix et Rhizoma Corydalis have 5, 5, 18 and 2 chromatographic peaks respectively at 4 wavelengths of 220, 260, 280 and 320 nm. There is also a difference between baicalin and glycyrrhizic acid content. All kinds of Xiaochaihu granule preparations were not detected saikosaponin a, saikosaponin D, atractylodes lactone Ⅲ, ferulic acid, Codonopin. Conclusion: In this study, the peak matching and the similarity of active components in HPLC spectra of medicinal materials and preparations were evaluated under multiple wavelengths, which provided a new method for the quality control of Chinese patent medicines.