中国中药杂志

2007, (12) 1149-1154

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吴茱萸配方颗粒等效性研究
Methodological studies on equivalent relationship between granule for clinical prescription and clinical decoction of fructus evodiae

王智民;洪玉梅;王维皓;王锦玉;高慧敏;
WANG Zhi-min,HONG Yu-mei,WANG Wei-hao,WANG Jin-yu,Gao Hui-min(Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China)

摘要(Abstract):

目的:以吴茱萸为示范性研究对象,探索建立评价配方颗粒和临床煎剂间的等效比例关系。方法:以吴茱萸胺、吴茱萸次碱、吴茱萸内酯、吴茱萸总生物碱、出膏率为评价指标,以临床煎剂的煎煮方法制备的10批对照汤剂的平均值为临床煎剂的评价标准,以多个临床常用的炮制品为研究对象,比较配方颗粒和临床煎剂间的等效比例关系,并以药效指标进一步验证等效比的正确性。结果:通过系统的比较,配方颗粒和临床煎剂间的比例关系在吴茱萸各饮片间约为2,药效学比较证实该比例下的配方颗粒与相应饮片间的药效强度无显著差异。结论:该等效比计算模型可做为配方颗粒生产企业在换算等效关系时参考;但值得注意的是:药物不同,其等效比可能不同,应根据生产工艺、生产条件等进行深入研究,进而得到各药物的等效比,最终的等效比关系仍需临床验证的进一步肯定。
Objective:To investigate the equivalent relationship between granule for clinical prescription and clincal decoction by use of fructus evodiae as a demonstrated object.Method: Compared the equivalent ratio relationship of granule for clincal prescription and clincal decoction by determination of evodiamine,rutaecarpine,evodine,total alkaloids and dried extract ratio as markers,ten batches reference decoctions were prepared according to clinical usage as evaluation standards,common-use processed fructus evodiae products,such as salt-processed fructus evodiae,liquorice-proccesed fructus evodiae,as researching objects,and finally validated by pharmacological trials.Result: Equivalent ratios of granule for clical prescription to clincal decoction are about two in all processed products,and the pharmacological evaluation showed no siginificant difference in this ratio.Conclusion: This equivalent ratio model could be referenced in the production.But,it must be noticed that different herbal medicines perhaps have different equivalent ratio,which should be studied further according to its techniques and production conditions,and finally need to be revalidated by clinical trial.

关键词(KeyWords): 吴茱萸;中药炮制;配方颗粒;等效比
Fructus Evodiae;traditional Chinese medicine processing;granule for clinical prescription equivalent ratio relationship

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基金项目(Foundation): 国家“十五”科技攻关项目(2001BA701A37)

作者(Author): 王智民;洪玉梅;王维皓;王锦玉;高慧敏;
WANG Zhi-min,HONG Yu-mei,WANG Wei-hao,WANG Jin-yu,Gao Hui-min(Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China)

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