壮阳春胶囊质量标准研究  

Study on Quality Standard for Zhuangyangchun Capsules

作　　者：许亚静 谭洪泉[2] 赫玉芳 南敏伦 

机构地区：[1]吉林省中研药业有限公司,吉林长春130012 [2]吉林省四平市食品药品检验所,吉林四平136000 [3]吉林天药现代中药科技有限公司,吉林长春130012

出　　处：《黑龙江医药》2008年第5期37-39,共3页Heilongjiang Medicine journal

摘　　要：目的:建立壮阳春胶囊的定性定量方法。方法:采用TLC法对处方中肉苁蓉、何首乌进行了定性鉴别;采用HPLC法,色谱柱为Shim-pack(岛津)C_(18)(150×4.6mm,5μm),以乙睛-0.2%磷酸水(19:81)为流动相;检测波长为320nm,流速1mL.min^(-1),柱温25℃,进样量10μL,对方中制何首乌所含2,3,5,4'-四羟基二苯乙烯-2-O-β-D -葡萄糖苷进行了含量测定。结果:壮阳春胶囊中肉苁蓉、何首乌薄层色谱鉴别特征明显,专属性强;壮阳春胶囊中2,3,5,4'-四羟基二苯乙烯-2-O-β-D-葡萄糖苷的含量测定线性范围为0.05μg～0.50μg(r=1.0000),平均回收率为99.51%(RSD=1.91%,n=6)。结论:薄层色谱鉴别和含量测定方法准确可行,重复性好,可有效地控制壮阳春胶囊的质量。Objective： To study the quality standard of Zhuangyangchun Capsules.Methods： TLC was used to identify Herba Cistanches, Rodix Polygoni Multiflori Poaeparata Cum Succo Glycines Sotae were identified, the content of 2, 3, 5, 4＇ - tetrahydroxystilbene - 2 - O- β - D - glucopyranoside in Rodix Polygoni Multiflori Paaeparata Cure Succo Glycines Sotae .in the tables was determined by HPLC, Shim- pack（SHIMADZU）C18 column（ 150× 4.6mm, 5μm）was used,The mobile phase was used.Acetonitrile- 0.2% phosphoric acid （ 19： 81）, the detection wavelength was at 320 nm, column temperature at 25℃ .the flow rate was 1 mL·min^-1 ,and the injection volume was 10μL.Results：The linear range of 2, 3, 5, 4＇-tetrahydroxystilbene- 2-O- β- D - glucopyranoside was 0.05μg -0.50μg（r = 1.0000）.The average recovery was 99.51% with RSD 1.91% （n = 6）. Conclusion： The method is simple .The result is accurate and the reproducibility is good. It can be used as the quality control methods for Zhuangyangchun Capsuletes.

关 键 词：壮阳春胶囊 质量标准 高效液相色谱法 2 3 5 4’-四羟基二苯乙烯-2-O—β—D-葡萄糖苷 

分 类 号：R284.1[医药卫生—中药学]