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[吴茱萸临床配方颗粒与临床汤剂等效关系的方法学研究]

[Methodological studies on equivalent relationship between granule for clinical prescription and clinical decoction of fructus evodiae].

作者信息

Wang Zhi-min, Hong Yu-mei, Wang Wei-hao, Wang Jin-yu, Gao Hui-min

机构信息

Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2007 Jun;32(12):1149-54.

PMID:17802873
Abstract

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.

摘要

目的

以吴茱萸为示范对象,研究临床配方颗粒与临床汤剂之间的等效关系。

方法

以吴茱萸碱、吴茱萸次碱、吴茱萸因、总生物碱及干浸膏率为指标,比较临床配方颗粒与临床汤剂的等效比例关系,按照临床用法制备十批对照汤剂作为评价标准,以常用的吴茱萸炮制品,如盐制吴茱萸、甘草制吴茱萸为研究对象,最后通过药理试验进行验证。

结果

所有炮制品临床配方颗粒与临床汤剂的等效比例约为2,药理评价表明该比例无显著差异。

结论

该等效比例模型可在生产中参考。但必须注意,不同中药材可能有不同的等效比例,应根据其工艺和生产条件进一步研究,最终需通过临床试验重新验证。

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