玄参药材等级质量标准研究(Ⅰ)——基于肉桂酸含量的差异性

A study on the quality grade standards for Radix Scrophulariae I.-Based on the difference in the content of cinnamic acid

目的:从肉桂酸的含量差异性研究不同产地玄参的质量,为确定新的玄参等级质量标准提供依据。方法:根据《七十六种药材商品规格标准》将同一产地玄参药材分成3个等级,依照2015版药典标准对玄参内涵性指标进行评价,并建立HPLC法对不同产地不同等级玄参药材中肉桂酸进行含量测定。结果:所测定的13批玄参药材基本符合药典标准,不同产地不同等级玄参药材中肉桂酸的含量差异悬殊,同一产地玄参药材中肉桂酸含量与原有等级之间的关联性不具普遍性。结论:(1)在制定新等级质量标准时,不能笼统地将每个产地的玄参按大小和重量分成一、二、三等;(2)增加肉桂酸含量标准,建议肉桂酸含量标准定为一等品应>0.04%,二等品在0.04%~0.025%之间,三等品在0.025~0.015%之间,低于0.015则为不合格药材。

Objective： To investigate the quality of Radix Scrophulariae from different producing areas based on the difference in the content of cinnamic acid,and to provide a basis for developing new quality grade standards for Radix Scrophulariae. Methods： According to Standards for the Specification of 76 Medicinal Material Products,Radix Scrophulariae from the same producing area was classified into three grades,and related indices were evaluated according to the Chinese Pharmacopoeia（version 2015）. High-performance liquid chromatography was used for determining the content of cinnamic acid in Radix Scrophulariae with different grades from different producing areas. Results： The 13 batches of Radix Scrophulariae evaluated met the standards in the Chinese Pharmacopoeia,and there was a significant difference in the content of cinnamic acid between Radix Scrophulariae with different grades from different producing areas. The correlation between the content of cinnamic acid and the former grade of Radix Scrophulariae from the same producing area had no universality. Conclusion： It is not recommended to classify Radix Scrophulariae in each producing area into grades 1,2,and 3 based on size and weight alone during the development of new quality grade standards. The standard for the content of cinnamic acid should be increased,and the content of cinnamic acid should be 0. 04% for grade 1 products,0. 025% ~ 0. 04% for grade 2 products,and 0. 015% ~ 0. 025%for grade 3 products. Products with a content of cinnamic acid of 0. 015% should be considered unqualified.