基于质量常数评价方法研究泽泻饮片的等级

目前,对于饮片等级的评价主要从外观性状以及指标成分含量2个角度入手,另外可能会增加2015年版《中国药典》中所设定的检查项,但存在检测项目较多或者设定指标不够科学等问题。基于此,该研究拟建立泽泻饮片的质量常数等级评价体系,为规范该饮片的市场流通、保证其临床用药的安全有效提供参考,同时,为其他饮片的等级评价提供参考和借鉴。从不同药厂收集18批泽泻饮片样品,检测各样品的形态参数,测定泽泻饮片中23-乙酰泽泻醇B的含量,计算质量常数与相对质量常数等参数。结果显示,18批泽泻饮片的质量常数为0. 390～2. 076。若将18批泽泻饮片分为3个等级,以最大质量常数的80%为一等,50%～80%为二等,其余为三等来进行饮片的等级划分,确定一等泽泻饮片质量常数≥1. 66,二等泽泻饮片质量常数≥1. 04且<1. 66,三等泽泻饮片质量常数<1. 04。该文建立的质量常数评价方法客观、可行,且操作非常简便,可用于泽泻饮片的等级划分,为控制该饮片的质量提供了参考方法,并为其他饮片的等级评价提供了借鉴。

Exploration of objective quality evaluation parameter of Alismatis Rhizoma decoction pieces

To establish a quality constant evaluation system of Alismatis Rhizoma decoction pieces,in order to provide reference for regulating the market circulation of this decoction pieces. A total of 18 batches of Alismatis Rhizoma decoction pieces were collected from different pharmaceutical factories,and the morphological parameters of each sample were tested. The content of alisol B 23-acetate in Alismatis Rhizoma decoction pieces was determined by HPLC in the 2015 edition of Chinese Pharmacopoeia,and the parameters such as quality constant and relative quality constant were calculated. The quality constant range of 18 batches of Alismatis Rhizoma decoction pieces was 0. 390-2. 076. If 18 batches of Alismatis Rhizoma decoction pieces were divided into 3 grades,taking 80% of the maximum quality constant as first grade,50% to 80% as second grade,and the rest as third grade,then the quality constant of firstgrade samples was ≥1. 66,the quality constant of second-grade samples was ≥1. 04 and <1. 66,and the quality constant of third-grade samples was <1. 04. The established quality constant evaluation method is objective and feasible,which can be used to classify the grade of Alismatis Rhizoma decoction pieces and provide a reference method to control the quality of this decoction pieces.