杭白菊标准汤剂质量标准研究及应用

Research and application of quality standard for standard decoction of Chrysanthemi Flos

中药标准汤剂是经过标准化工艺制备,可用于评价如汤剂、配方颗粒等用药形式质量的参照物。为研究确定杭白菊标准汤剂质量评价方法及其应用,该实验选用10批杭白菊药材,以标准化工艺参数制备杭白菊标准汤剂。选用性状、相对密度、pH、出膏率、转移率、指纹图谱等参数作为杭白菊标准汤剂质量评价方法。并将建立的杭白菊标准汤剂质量评价方法应用于市售2种菊花配方颗粒的检测中。结果表明杭白菊标准汤剂为浅黄褐色的澄清水溶液,相对密度为1.007~1.011,pH5.37~5.56,出膏率19.93%,平均出膏率23.6%~29.69%;转移率以绿原酸计平均56.2%,木犀草苷平均57.4%,3,5-O-二咖啡酰基奎宁酸平均30.6%。指纹图谱相似度在0.864~0.989。此质量评价方法全面考察了标准汤剂的质量。说明得到的杭白菊标准汤剂质量可靠,有代表性。可用于评价标化其他用药形式。

Standard decoction of traditional Chinese medicine（TCM） is prepared by standardized process,and can be used as references to evaluate the quality of dosage forms such as decoction and dispensing granules. In order to determine the quality evaluation method for standard decoction of Chrysanthemi Flos and investigate its application,10 batches of white chrysanthemum of Hangzhou were collected to prepare the standard decoction of white chrysanthemum of Hangzhou with standardized process parameters. Parameters such as traits,relative density,pH value,extraction ratio,transfer rate and fingerprint were selected as the indexes for quality evaluation. The established quality evaluation method for standard decoction of Chrysanthemi Flos was applied in the detection of two types of commercial Chrysanthemum dispensing granules. The results showed that the standard decoction of Chrysanthemi Flos was a clear yellow-brown aqueous solution; the relative density was 1. 007-1. 011; the pH value was between 5. 37-5. 56; the average extraction ratio was 23. 6%,ranging from 19. 93% to 29. 69%; the average transfer ratewas 56. 2% in terms of chlorogenic acid,57. 4% in terms of luteoloside and 30. 6% in terms of 3,5-O-dicaffeoylquinic acid. Fingerprint similarity was between 0. 864-0. 989. The method showed good precision,stability and repeatability in fingerprint analysis,indicating reliable and representative results for standard decoction of Chrysanthemi Flos,and it can be used to evaluate and standardize other dosage forms.