参芪降糖胶囊定性定量方法研究

目的：建立参芪降糖胶囊定性定量方法。方法采用TLC法对该制剂中的黄芪进行定性鉴别；采用高效液相梯度洗脱法对该制剂中人参皂苷Rg1、人参皂苷Re和人参皂苷Rd进行定量分析，采用 Waters SunFireTM C18色谱柱（4.6＆#215;150mm，5μm），以乙腈（A）-0.05％磷酸溶液（B）为流动相，梯度洗脱，洗脱程序为 A：0～30min，19％；30～35min，19％→24％；35～60min，24％→40％；60～65min，19％。流速1.0mL· min^ -1；检测波长为203nm；柱温30℃。结果 TLC法可鉴别出黄芪的特征斑点。 HPLC法测定的人参皂苷Rg1、人参皂苷Re和人参皂苷Rd分别在0.414～4.14μg（r＝0.9998），0.706～7.06μg（r＝0.9997）和0.417～4.17μg（r＝0.9998）的线性范围内呈良好的线性关系。平均加样回收率（ n＝9）分别为99.3％，98.8％，99.0％。结论本方法定性专属性强，定量准确高，操作严谨科学，重现性好，可进一步提高参芪降糖胶囊的现行质量标准，更好地控制药品质量。

Studies on qualitative and quantitative methods of Shenqijiangtang Cap-sules

OBJECTIVE To establish the qualitative and quantitative methods of Shenqijiangtang cap-sules.METHODS Radix Astagali was identified by TLC;the contents of ginsenoside Rg 1 ,ginsenoside Re and gin-senoside Rd in Shenqijiang tang capsules were determined by HPLC.The Waters SunFire TM C18 column （ 4.6 ＆#215; 150mm,5μm） was adopted with mobile phase of acetonitrile （A）-0.05% phosphoric acid solution （B）,eluted in gradient mode（0~30min,A：19%;30~35min,A：19%→24%;35~60min,A：24%→40%;60~65min,A：19%） at the flow rate of 1.0mL· min^ -1.The detection wavelength was set at 203nm and the column tenperature was 30℃.RESULTS The characteristic spots of Radix Astagali could be identified by TLC.The method had good linear re-lationship within the range of 0.414~4.14μg （ r=0.9998 ） for ginsenoside Rg 1 ,0.706~7.06μg （ r=0.9997 ） for ginsenoside Re and 0.417~4.17μg（ r=0.9998 ） for ginsenoside Rd.The average recoveries were 99.3%,98.8%, 99.0%,respectively.CONCLUSION This method is highly specific qualitative and quantitative accuracy with rig-orous and scientific operation and good repeatability.It can improve the existing quality standards of Shenqijiangtang capsules further and control the quality of medicines better.