以标准汤剂为基准的猕猴桃根配方颗粒量值传递研究

Study on quantitative transfer relationship of Radix Actinidiae Chinensis formula granules based on standard decoction

目的通过HPLC法建立猕猴桃根饮片、标准汤剂、配方颗粒的特征图谱,并同时测定指标成分含量。以标准汤剂中出膏率、儿茶素含量及特征图谱为基准,研究配方颗粒的量值传递规律。方法收集15批猕猴桃根饮片,制备标准汤剂,测定出膏率。建立猕猴桃根饮片、标准汤剂和配方颗粒的HPLC指纹图谱,标定特征峰,对特征峰进行归属。测定猕猴桃根饮片、标准汤剂及配方颗粒中儿茶素含量,计算转移率。以出膏率、指纹图谱共有峰传递数、儿茶素含量及转移率为主要评价指标,分析其量值传递规律。结果15批猕猴桃根标准汤剂的出膏率在3.9%~6.3%范围内;特征图谱标定了6个特征峰,指认峰2为原儿茶酸、峰4为儿茶素;猕猴桃根饮片、标准汤剂及配方颗粒均检测出6个特征峰,且相对保留时间均在规定范围内;猕猴桃根饮片中儿茶素含量为0.4%~1.4%,猕猴桃根配方颗粒中儿茶素含量为3.8%~4.9%;其饮片-标准汤剂转移率为13.6%~38.3%,饮片-配方颗粒转移率为15.5%~21.2%。结论猕猴桃根饮片、标准汤剂及成品颗粒之间的质量传递具有较好的移行性,配方颗粒与标准汤剂也具有良好的相关性和一致性,表明猕猴桃根的制备工艺合理可行。

Objective To establish a high-performance liquid chromatography(HPLC)characteristic spectrum of Radix Actinidiae Chinensis decoction pieces,standard decoction and formula granules;To simultaneously determine the contents of index components;To study the transfer law of formula granules based on the extraction amount,content of Catechin and characteristic spectrum of standard decoction.Methods 15 batches of Radix Actinidiae Chinensis decoction pieces were collected,the standard decoction was prepared,and the extraction amount was measured.The HPLC fingerprints of decoction pieces,standard decoction and formula granules were established,and the characteristic peaks were calibrated and attributed.The content of Catechins in decoction pieces,standard decoction and formula granules was measured,and the transfer rate law was calculated.The yield rate,the common peak transmission number of fingerprints,the content and the transfer rate were the main evaluation indexes,and the law of the transmission of the magnitude value was analyzed.Results The paste yield of 15 batches of Radix Actinidiae Chinensis standard decoction ranged from 3.9%-6.3%.A total of 4 characteristic peaks were calibrated in the feature map,and peak 2 was identified as Protocatechuic acid and peak 4 as Catechin;6 characteristic peaks were detected in Actinidia chinensis Planchon decoction pieces,standard decoction and formula granules,and their relative retention times were all within the specified range.The content of Catechins in Radix Actinidiae Chinensis decoction pieces was 0.4%-1.4%,which was 3.8%-4.9%in formula granules.The transfer rate of decoction pieces-standard decoction was 13.6%-38.3%,and the decoction-formula granules was 15.5%-21.2%.Conclusions The mass transfer between Radix Actinidiae Chinensis decoction pieces,standard decoction and formula granules has a good migration.The formula granules also have a good correlation and consistency with the standard decoction,which indicating that the preparation process of Radix Actinidiae Chinensis is reasonable and feasible.