复方降糖滴丸质量标准研究

Study on Quality Standard of Compound Jiangtang Dripping Pills

关键词:  复方降糖滴丸  质量标准  薄层色谱法  高效液相色谱法

Key words:  compound Jiangtang dripping pills  quality standard  TLC  HPLC

摘要:

目的 建立复方降糖滴丸的质量标准。方法 采用薄层色谱法对滴丸中的栀子、绞股蓝进行定性鉴别，HPLC测定滴丸中栀子苷的含量，采用UV分别测定绞股蓝总皂苷和总多糖的含量。结果 定性鉴别结果斑点圆整，分离度好，易于鉴别；栀子苷的线性范围为3.99~255.20 μg·mL^-1，r=0.999 8，回收率为99.4%，RSD为2.9%；绞股蓝总皂苷的线性范围为17.00~134.00 μg·mL^-1，r=0.999 5，回收率为98.4%，RSD为2.9%；绞股蓝总多糖线性范围为12.56~62.80 μg·mL^-1，r=0.999 3，回收率为98.9%，RSD为2.4%。结论 本试验首次建立了复方降糖滴丸的质量标准，方法简便、准确、专属性强，可用于复方降糖滴丸的质量控制。

Abstract:

OBJECTIVE To establish a method for the quality control of compound Jiangtang dripping pills. METHODS Gardenia jasminoides Ellis, Gynostemma Pentaphyllum were identified by TLC. The content of geniposide was determined by HPLC. UV was used for determination of gypenoside and total polysaccharides. RESULTS The studies on the quality control showed that the characteristics for identification by TLC were distinct and the spots could be determined. Geniposide had a good linearity over the concentration range of 3.99-255.20 μg·mL^-1(r=0.999 8), the average recovery was 99.4% with RSD of 2.9%. The liner regression for gypenoside was obtained over the range of 17.00-134.00 μg·mL^-1(r=0.999 5), the average recovery was 98.4% with RSD of 2.9%. The liner regression for total polysaccharides was obtained over the range of 12.56-62.80 μg·mL^-1(r=0.999 3) and the average recovery was 98.9% with RSD of 2.4%. CONCLUSION These methods are simple, accurate and can be used for the quality control of compound Jiangtang dripping pills.