耐力胶囊质量标准提高研究

The Research for Enhanced the Quality Standard of Naili Capsule

目的:建立显微法鉴定冬虫夏草及高效液相色谱法测定耐力胶囊中西洋参人参皂苷Rg_1、Re、Rb_1含量的测定方法。方法:采用稀甘油封片显微光镜观察耐力胶囊粉末中冬虫夏草粉末碎片;西洋参人参皂苷检测,色谱柱Thermo ODS-2Hypersil(5μm,4.6mm×250mm);以乙腈为流动相A,以0.1%磷酸溶液为流动相B,进行梯度洗脱;检测波长为203nm;柱温40℃;流速1mL·min^(-1)。结果:耐力胶囊中含有与冬虫夏草标准药材相同的粉末碎片;人参皂苷Rg_1在0.216~1.08μg范围内呈良好的线性关系,r=0.999 7,平均回收率为99.41%,RSD为1.04%(n=6);人参皂苷Re在0.864~4.32μg范围内呈良好的线性关系,r=0.999 5,平均回收率为99.51%,RSD为1.07%(n=6);人参皂苷Rb_1在1.616~8.08μg范围内呈良好的线性关系,r=0.999 6,平均回收率为98.56%,RSD为1.30%(n=6)。结论:所建立的鉴定方法及高效液相色谱法可以对耐力胶囊中冬虫夏草及西洋参人参皂苷Rg_1、Re、Rb_1进行检测,该方法可靠、简便、专属性强,可作为耐力胶囊的定量控制方法。

Objective：Observe Cordyceps powder by microscopic identification and establish a quantitative method for ginsenoside Rgl ,ginsenoside Re,ginsenoside Rbl in the Naili Capsule by HPLC. Methods： Closed cover glass used the dilute glycerin and Ob serve Cordyceps powder in Naili Capsule by microscopic identification. The measurement condition of the ginsenosides were used as follows：Thermo ODS 2 Hypersil（5μm,4.6mm×250mm） column,the mobile phase were Acetonitrile as A,1% phosphoric acid water as B,gradient elution. The UV detection wavelength was 250nm. Operating temperature was 40 ℃, and flow rate was 1 mL ·min^-1. Results：The linear range of ginsenoside Rg1 was in the range between 0. 216-1.08 μg （r=0. 999 7）. The average recovery of ginsenoside Rg1 was 99.41% with RSD of 1.04% （n=6）. The linear range of ginsenoside Re was in the range between 0. 864- 4.32μg （r=0. 999 5）. The average recovery of ginsenoside Re was 99.51 % with RSD of 1. 07% （n=6）. The linear range of ginsenoside Rb1 was in the range between 1. 616-8.08 μg （r 0. 9996）. The average recovery of ginsenoside Rb1 was 98.56% with RSD of 1.30 % （n= 6）. Conclusion. The study shown that the HPLC method could test the ginsenoside Rg1 , ginsenoside Re, ginsenoside Rb~ , and identified the Cordyceps powder in the Naili Capsule. This method is simple, highly specific, reliability, which can be used for the quality control of ginsenosides in the Naili Capsule.