七叶皂苷钠胶囊的质量控制  

Investigation on quality control of sodium aescinate capsules

作　　者：张伟[1] 翟国松[1] 刘琳婕[1] 孙丹璐[1] 杨亚军[1] 李冰[1] 何仲贵[1] 

机构地区：[1]沈阳药科大学药学院,沈阳110016

出　　处：《药物分析杂志》2008年第1期104-107,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立测定七叶皂苷钠胶囊中总七叶皂苷钠、七叶皂苷钠 A 和七叶皂苷钠 B 的含量测定方法。方法:采用滴定法测定七叶皂苷钠胶囊中总七叶皂苷钠的含量;采用高效液相色谱法测定七叶皂苷钠 A 和七叶皂苷钠 B 的含量,色谱柱为 Hy—perclone—C_(18)柱(4.6mm×250 mm,5μm),流动相为磷酸溶液-乙腈(56:44),流速为1mL·min^(-1),紫外检测波长为220 nm。结果:总七叶皂苷钠浓度在1～5 mg·mL^(-1)内线性关系良好(r=0.9997);低、中、高浓度的平均回收率(n=3)为99.9%,99.6%,101.3%。七叶皂苷钠 A 浓度在38.6～309.2μg·mL^(-1)内线性关系良好(r=0.9999);低、中、高浓度的平均回收率(n=3)为98.9%,100.5%,99.3%。七叶皂苷钠 B 浓度在28.2～225.5μg·mL^(-1)内线性关系良好(r=0.9996);低、中、高浓度的平均回收率(n=3)为99.4%,100.1%,99.7%。结论:本法准确、可靠,灵敏度高,可作为本品的质量控制方法。Objective：To establish the methods for the determination of sodium aescinate, sodium aescinate A and sodium aescinate B in sodium aescinate capsules, nethods：Titrate method was utilized to determine the content of sodium aescinate in sodium aescinate capsules. Sodium aescinate A and sodium aescinate B were determined by HPLC method. A Hyperclone -C18 column（4. 6 mm× 250 mm ,5μm） was adopted with mobile phase of phosphoric acid solution- acetonitrile （56： 44）. The flow rate was 1 mL · min^-1 with UV detection wavelength at 220 nm. Results： Sodium aescinate had good linearity （ r = 0. 9997 ） within the range of 1 - 5 mg· mL ^- 1 ; The average recoveries（n =3） were 99. 9% ,99. 6% and 101.3%. Sodium aescinate A had good linearity（ r =0. 9999） within the range of 38.6 - 309. 2μg ·mL^-1 ;The average recoveries（ n = 3 ） were 98.9% , 100. 5% and 99. 3%. Sodium aescinate B had good linearity（ r =0. 9996） within the range of 28.2 -225.5μg· mL^-1 ;The average recoveries（ n =3） were 99. 4%, 100. 1% and 99. 7%. Conclusion：This method is accurate, reliable, sensitive and suitable for the quality control of this preparation.

关 键 词：七叶皂苷钠 质量控制 滴定法 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]