双参饮片—标准汤剂—成品量值传递研究

Study on quantity and transfer relationship of Triplostegia glandulifera Wall.ex DC.pieces-standard decoction-finished product

为将少数民族用药双参开发成配方颗粒,建立双参饮片、标准汤剂与配方颗粒的高效液相色谱马钱苷酸含量测定方法及薄层色谱鉴别方法,并同时考察双参饮片—标准汤剂—配方颗粒的量值传递关系。采用安捷伦1260Ⅱ液相色谱仪与Waters Symmetry C_(18)柱(4.6 mm×250 mm, 5μm),以乙腈-0.1%磷酸溶液为流动相进行梯度洗脱,检测波长为240 nm,流速为1 mL/min,柱温为30℃,建立马钱苷酸含量测定方法;以乙酸乙酯-甲醇-水(10∶2∶1)为展开剂,置紫外光灯(254 nm)下检视,建立薄层鉴别方法;以出膏率、马钱苷酸含量、薄层鉴别图谱为主要评价指标,分析量值传递规律。结果表明:马钱苷酸含量测定、鉴别方法具有较高的稳定性、重复性及可信度;3批双参配方颗粒出膏率均值为18.7%,马钱苷酸含量均值为41.1 mg/g,马钱苷酸含量转移率均值为43.1%,均在15批标准汤剂均值±3SD范围内。马钱苷酸含量测定和薄层色谱鉴别方法可用于双参配方颗粒质量评价,为进一步开展双参配方颗粒研究提供数据基础,并促进少数民族用药现代化。

In order to develop Triplostegia glandulifera Wall.ex DC.into foromula granules,a high performance liquid chromatography method for determination and TLC identification of loganic acid in decoction pieces,standard decoction and formula granules of Triplostegia glandulifera Wall.ex DC.were established,and the quantity-value transfer relationship between Triplostegia glandulifera Wall.ex DC.pieces,standard decoction and formula granules was investigated.The Agilent 1260Ⅱhigh performance liquid chromatograph and Waters Symmetry C 18 column(4.6 mm×250 mm,5μm)were used with acetonitrile-0.1%phosphoric acid solution as the mobile phase,the column temperature of 30℃,the flow rate of 1 mL/min,and the detection wavelength of 240 nm to establish a gradient elution method.Using ethyl acetate-methanol-water(10∶2∶1)as developer,and examination under UV lamp(254 nm),a TLC identification method of Triplostegia glandulifera Wall.ex DC.was established.The transfer rule of the quantity value was analyzed by using the extract rate,the content of maggianin and the TLC as the main evaluation indexes.The results show that the method for the determination and identification of maggianin is stable,reproducible and reliable.The average yield of 3 batches is 18.7%,the average loganic acid content is 41.1 mg/g.and the average loganic acid content transfer rate is 43.1%,all within the mean value±3SD of 15 batches of standard decoction.Those methods for content determination of loganic acid and TLC identification can be used to evaluate the quality of Triplostegia glandulifera Wall.ex DC.formula granules,provide data basis for further research on Triplostegia glandulifera Wall.ex DC.formula granules,and promote the modernization of medicine for ethnic minorities.