中药饮片与其对应配方颗粒浸出物含量比较分析

目的:探索中药配方颗粒标示量与所等同的中药饮片量之比值的科学性。方法:对14味根与根茎类、全草类、叶类、果实与种子类、花类中药饮片,按一般医院药剂室煎药的操作过程提取水溶性浸出物,计算其得率,与同品种中药配方颗粒的标示量所表示的得率进行比较,并参照该中药饮片在《中国药典》中的水溶性浸出物“含量测定”项下规定的得率进行分析。结果:中药饮片与其对应配方颗粒浸出物含量有显著性差异。结论:应参照《中国药典》规定的同品种药物浸出物含量限度,统一中药配方颗粒标示量与所等同的中药饮片量之比值。

Comparison of Extraction Content Between Chinese Medicinal Decoction Pieces and Their Medicinal Granula

OBJECTIVE: To explore whether it is scientific for the ratio between the labeled content of the Chinese medicinal granula and that of the Chinese medicinal decoction pieces. METHODS: Water-soluble extractives were obtained from 14 Chinese medicinal decoction pieces including radix et rhizoma, herbs, folia, fruits, seeds and flores in accordance with the decocting procedure defined in decoction room, and the yields were computed and compared with their counterparts labeled in the corresonding Chinese medicinal granula. The yields were analyzed in accordance with China Pharmacopeia regarding the yields for decoction pieces stipulated in the item of content determination for water-soluble extractives. RESULTS: There were significant differences between Chinese medicinal granula and Chinese medicinal decoction pieces in extraction content. CONCLUSION: The ratio between the labeled quantity of the Chinese medicinal granula and that of the corresponding Chinese medicinal decoction pieces should be unified in accordance with the extraction content limit of the corresponding drugs stipulated in China Pharmacopeia.