骨康颗粒质量标准研究  

Study on Quality Standard for Gukang Granules

作　　者：刘传统 祁红[1] 

机构地区：[1]石门县人民医院,湖南常德415300

出　　处：《中国药师》2013年第10期1470-1473,共4页China Pharmacist

摘　　要：目的:制定骨康颗粒质量标准。方法:采用薄层色谱法鉴别补骨脂、续断、牛膝,高效液相色谱法测定淫羊藿苷、补骨脂素、异补骨脂素的含量。色谱柱:大连依利特Hypersil ODS2(150mm×4.6mm,5μm),流动相:甲醇-乙腈-水(5:25:70)、乙腈.水(30:70);流速:1ml·min^(-1);检测波长:270nm、246nm;柱温:35℃。结果:TLC色谱能明显检出补骨脂、牛膝、续断。淫羊藿苷、补骨脂素、异补骨脂素分别在0.112~0.336μg(r=0.9996)、0.073~0.220μg(r=0.9998)、0.076~0.229(r=0.9997)范围内呈现良好线性关系,淫羊藿苷的平均回收率为98.87%(RSD=1.73%);补骨脂素、异补骨脂素的平均回收率分别为100.57%(RSD=1.47%)和100.38%(RSD=1.26%)。结论:本方法简便,准确,重现性好,可用于本品的质量控制。Objective： To establish the quality standard for Gukang granules. Method： TLC was used for the identification offruc- tus psoraleae, radix dipsaci and achyranthes. An HPLC method was applied in the content determination of icariin, psoralen and isop- soralen. The chromatographic column was a Dalian Elite Hypersil ODS2（ 150 mm ×4.6 mm,5 μm）, the mobile phase was methanol- acetonitri!e-water （5 ： 25 ： 70 ）. for icariin, and acetonitrile-water （ 30 ： 70 ） for psoralen and isopsoralen. The flow rate was 1.0 ml ·min-1, the detection wavelength was 270nm and 246nm, respectively and the column temperature was 35℃. Result： The TLC could detect fructus psoraleae, radix dipsaci and achyranthes. Icariin, psoralen and isopsoralen showed good linear relationship within the range of 0.112-0. 336 μg（ r = 0. 999 6）, 0. 073-0. 220 μg（ r = 0. 999 8 ） and 0. 076-0. 229 μg（ r = 0.999 7）, respectively. The aver- age recovery was 98.87% （RSD = 1.73% ）, 100.57% （RSD = 1.47% ） and 100.38% （ RSD = 1.26% ）, respectively. Conclusion： The method is simple, accurate and repeatable, and can be used in the quality control of Gukang granules.

关 键 词：骨康颗粒 淫羊藿苷 补骨脂素 异补骨脂素 高效液相色谱 薄层色谱 含量测定 

分 类 号：TQ460.72[医药卫生—药物分析学]