生脉胶囊质量标准研究

目的建立生脉胶囊的质量控制方法。方法采用薄层色谱（TLC）法对生脉胶囊中红参、麦冬、五味子进行定性鉴别;用高效液相色谱（HPLC）法测定其中人参皂苷Rg1和人参皂苷Re的总量,以Waters Nova-Pak C18柱（150mm×3.9mm,4μm）为色谱柱,以乙腈-0.1%（V/V）磷酸溶液（18∶82）为流动相,流速为1mL/min,检测波长为203nm,柱温为35℃。结果 TLC法专属性强;人参皂苷Rg1进样量在0.2512～7.5360μg范围内与峰面积线性关系良好（r=0.9999）,平均加样回收率为103.10%,RSD为1.39%（n=6）;人参皂苷Re进样量在0.2390～7.1700μg范围内与峰面积线性关系良好（r=0.9998）,平均加样回收率为99.14%,RSD为1.63%（n=6）。结论该方法可准确地对生脉胶囊进行定性、定量,适用于产品的质量控制。

Study on Quality Control Standard of Shengmai Capsules

Objective To establish the quality control standard of Shengmai Capsules. Methods Radix et Rhizoma Ginseng Rubra, Radix Ophiopogonis,Fructus Schisandrae Chinsnsis were qualitatively identified by TLC. The total amount of ginsenoside Rg1 and ginsenoside Re was determined by HPLC. The Waters Nova-Pak C18 column（150 mm × 3. 9 mm,4 μm） was adopted. The mobile phase was acetonitrile-0. 1% （ V / V） phosphoric acid（18 ∶ 82） at the flow rate of 1 mL /min. The detection wavelength was at 203 nm,the column temperature was 35 ℃ ,and the injection volume was 10 μL. Results The calibration curve of ginsenoside Rg1 was linear in the range of 0. 251 2-7. 536 0 μg（ r = 0. 999 9）. Its mean recovery rate was 103. 10% , RSD = 1. 39% （ n = 6）; the calibration curve of ginsenoside Re was linear in the range of 0. 239 0-7. 170 0 μg（ r = 0. 999 8）. Its mean recovery rate was 99. 14% , RSD = 1. 63% （ n = 6）. Conclusion This method is simple,reliable and accu-rate,which can be used to control the quality of Shengmai Capsules.