中文摘要：

目的研究桂枝茯苓丸有效成分（肉桂酸、芍药苷和丹皮酚）与物质组的溶出相关性。方法桨法测定自制大/小蜜丸、水丸、浓缩丸和蜡丸,以及5个厂家浓缩丸的有效成分和物质组在不同溶出介质（p H1.2盐酸-氯化钠溶液、p H4.0醋酸盐缓冲液、p H6.8磷酸盐缓冲液和蒸馏水）中的溶出度,计算累积溶出率。最小二乘法评价有效成分与物质组的溶出相关性,f2相似因子计算和区分各种丸剂溶出曲线相似度以及物质组溶出曲线。结果 5种自制丸剂和5个厂家浓缩丸的溶出度共分别拟合出60条和72条直线,相关系数大于0.9者分别占98.3%和98.6%。不同厂家肉桂酸、芍药苷、丹皮酚和物质组的溶出度相似性分别为82.5%、80.0%、60.0%和77.5%,其中肉桂酸和芍药苷在p H1.2介质中的溶出相似性最低,丹皮酚在p H6.8介质中的溶出相似性最高,物质组在蒸馏水中的溶出相似性最低。结论桂枝茯苓丸有效成分与物质组溶出度具有较好的相关性,在相同实验条件下两者溶出曲线具有合适的区分力,物质组溶出度可代表该制剂整体成分的释放特征。

英文摘要：

AIM To study the dissolution correlations between active components（ cinnamic acid,paeoniflorin,paeonol） and materiomics of Guizhi Fuling Pills. METHODS The dissolution rates of active components and materiomics of self-made big / small honeyed pills,watered pills,concentrated pills,wax pills,as well as concentrated pills from five manufacturers in different dissolution solutions（ hydrochloric acid-sodium chloride solution at p H1. 2,acetate buffer solution at p H4. 0,phosphate buffer solution at p H6. 8,distilled water） were determined by paddle method,after which the accumulative dissolution rates were calculated. The dissolution correlations between active components and materiomics were evaluated by least square method,and the similarities of various kinds of pills’ dissolution profiles and materiomics’ dissolution profiles were calculated and distinguished by similarity factors（ f2）. RESULTS Total 60 and 72 lines were fitted in the dissolution rates of self-made five kinds of pills and concentrated pills from five manufacturers,whose correlation coefficients（ greater than 0. 9） accounted for 98. 3%and 98. 6%,respectively. The dissolution similarities of cinnamic acid,paeoniflorin,paeonol and materiomics from different manufacturers were 82. 5%,80. 0%,60. 0% and 77. 5%,respectively. Among them,the lowest values indicating dissolution similarities were found among cinnamic acid and paeoniflorin in p H1. 2 medium,and materiomics in distilled water,while that of the highest value was obtained from paeonol in p H6. 8 medium. CONCLUSION There exihibits good correlations between dissolution rates of active components and materiomics of Guizhi Fuling Pills,whose dissolution profiles can be appropriately distinguished under the same experiment conditions. The dissolution rate of materiomics can represent the releasing characteristics of overall components of this preparation.