奔豚颗粒提取工艺及质量标准研究

Study on Extraction Process and Quality Standard of Bentun Granule

目的：研究奔豚颗粒的提取工艺,并鉴定其质量标准。方法：采用L9（3^4）正交表,对煎煮时间、煎煮次数、加水量3个因素取3个水平,按表安排实验,得出最佳提取条件并进行验证试验。通过薄层色谱法对不同试验条件下的有效成分葛根素及芍药苷进行鉴定,确定该制剂的质量标准。结果：通过正交试验,确定最佳工艺为：第一次加10倍量水,煎煮2 h,2次8倍量水煎煮2 h,滤过,滤液浓缩至相对密度为1.30～1.35（60℃）的浸膏。结论：最佳工艺浸出物收率稳定,说明工艺较为合理。通过对奔豚颗粒中有效成分粉葛根和白芍的薄层色谱鉴别预试验,可对该制剂的有效成分进行质量控制。

Objective： To study the extraction process of bentun granule and determine its quality standard. Methods： By L9 （3^4） orthogonal table,to take 3 levels from 3 factors i. e. decocting time, decocting number and adding-amount of water, to arrange the experiments according to table and to obtain the optimal extraction conditions and carry out verification tests. The active ingredients under different experimental conditions i.e. puerarin and paeoniflorinniflorin were identified by TLC, and the detection standard of quality of this preparation was determined. Results： The optimal process determined through orthogonal test was： at the l st,to add 10 fold amount of water and to decoct 2h ; at 2nd, to add 8 fold amount of water and to decoct 2h ; filtering ; the filtered liquid was concentrated to the extract with relative density of 1.30 - 1.35 （60 ℃ ）. Conclusion ： The extract yield of optimal process is stable,which shows that the process is more reasonable. Through TLC identification and pre - test of active ingredients （i. e. radix puerariae powder and white peony root ）in bentun granule, we can determine that the detection of its active ingredients i. e. puerarin and paeoniflorinniflorin can control the quality whether this preparation contains the effective pharmaceutical ingredients.