降脂减肥片的质量控制研究

Quality control of Jiangzhi Jianfei Tablets

目的:建立高效液相色谱法测定降脂减肥片(何首乌、葛根、三七、丹参)中2,3,5,4′-四羟基二苯乙烯-2-O-β-D葡萄糖苷,葛根素,人参皂苷Rg1,人参皂苷Rb1,三七皂苷R1和丹酚酸B含量方法。方法:色谱柱均为ODS C18柱。何首乌:以乙腈-水(25∶75)为流动相,流速为1 mL/min,检测波长为320 nm。葛根:以甲醇-水(25∶75)为流动相,流速为1 mL/min,检测波长为250 nm。三七:以乙腈-水为流动相,流速为1 mL/min,检测波长为203 nm;丹参:以甲醇-乙腈-甲酸-水(30∶10∶1∶59)为流动相,流速为1 mL/min,检测波长为286 nm。结果:2,3,5,4′-四羟基二苯乙烯-2-O-β-D葡萄糖苷进样量在0.476μg^4.760μg范围内与峰面积线性关系良好(r=0.999 6),方法的平均回收率为100.07%,RSD为1.08%(n=6)。葛根素进样量在0.168 96μg^1.689 6μg范围内与峰面积线性关系良好(r=0.999 8),方法的平均回收率为99.43%,RSD为1.66%(n=6)。人参皂苷Rg1进样量在0.724μg^7.240μg范围内与峰面积线性关系良好(r=0.999 8),人参皂苷Rb1在0.728μg^7.280μg范围内与峰面积线性关系良好(r=0.999 9),三七皂苷R1在0.23μg^2.30μg范围内与峰面积线性关系良好(r=0.999 8),平均回收率为101.17%,RSD为2.08%(n=6)。丹酚酸B进样量在0.306μg^3.060μg范围内与峰面积线性关系良好(r=0.999 9),方法的平均回收率为102.39%,RSD为2.60%(n=6)。结论:以上4药材的含量测定采用高效液相色谱法简便、准确、重复性好,可作为降脂减肥片的含量测定方法。

AIM ： To establish the methods of determining 2,3,5,4＇-tetrahydroxystilbene-2-O-β-D-glycoside, puerain; ginsengnoside Rg1, ginsengnoside Rb lets （Radix Polygoni multiflori, Radix Puerariae , notoginsengnoside R1, and salvianolic B in Jiangzhi Jianfei Tablobatae, Radix et Rhizoma Notoginseng, Radix et Rhizoma Salviae miltiorrhizae, etc） with HPLC. METHODS： All chromatogram columns used were ODS columns. The mobile phase of acetonitrile-wate （25 ： 75 ） was chosen for 2,3,5,4＇-tetrahydroxystilbene-2-β-D-glycoside. The flow rate was 1.0 mL/min. The detection wavelength was at 320 nm. The mobile phase of methanol-water （25 ： 75 ） was chosen for puerain. The flow rate was 1.0 mL/min. The detection wavelength was at 250 nm. The mobile phase of acetonitrile-water was chosen for ginsengnoside Rg1, ginsengnoside Rb1 and notoginsengnoside R1. The flow rate was 1.0 mL/min. The detection wavelength was at 203 nm. The mobile phase of methanol-acetonitrile-methane acid-water （30 ： 10 ： 1 ： 59） was chosen for salvianolic B. The flow rate was 1.0 mL/min. The detection wave- length was 286 nm. RESULTS： The linear rangers were 0. 476 μg -4. 760 μg（r =0.999 6） for 2,3,5,4＇-tetra- hydroxystilbene-2-15-D-glycoside, 0. 168 96 μg - 1. 689 6 μg （r =0. 999 8） for puerain, 0. 724 μg -7. 240 μg （r = 0. 999 8） for ginsengnoside Rg1 , 0. 728 μg - 7. 280 μg （ r = 0. 999 9） for ginsengnoside Rb1 , 0.23 μg - 2.30 μg （ r = 0. 999 8 ） for notoginsengnoside R1 , 0. 306 μg - 3. 060 μg （ r = 0. 999 9） for salvianolic B. Their average recoveries were 99.43% （RSD = 1.08% , n = 6）, 99.43% （RSD = 1.66% , n = 6）, 101.17% （RSD = 2.08% , n = 6）, and 102.39% （RSD = 2.60% , n = 6） , respectively. CONCLUSION ： These methods of determining components in four kinds of herbs are simple, accurate, reproducible and can be used for quality control of Jiangzhi Jianfei Tablets.