摘要
目的:考察复方五仁醇软胶囊18个月的稳定性。方法:采用薄层色谱法和HPLC法,五味子醇甲采用色谱柱ODS-C18,流动相甲醇-水(65∶35),检测波长250 nm,流速1.0 mL/min;芍药苷采用色谱柱ODS-C18,流动相乙腈-水(15∶85),检测波长230 nm,流速1.0 mL/min。结果:五味子醇甲在0.04 mg/mL^0.64 mg/mL范围内线性良好,r=0.999 8,平均回收率为98.76%(n=6),RSD=1.18%;芍药苷在0.05 mg/mL^0.80 mg/mL范围内线性良好,r=0.999 9,平均回收率为97.93%(n=5),RSD=1.68%。结论:复方五仁醇软胶囊在按市售的包装及贮藏条件下,18个月质量基本稳定;充分验证复方五仁醇软胶囊的质量标准具有可测性。
AIM： To research the stability of Compound Wurenchun Soft Capsule in 18 months. METHODS： TLC and HPLC methods were used. Schizandrol A was separated on a ODS-C18 column （Lichrospher ODS-C18, 4.6 mm×250 mm）, using methyl alcohol-water （65： 35） as the mobile phase, detected at 250 nm. The velocity of flow was 1.0 mL/min. Paeoniflorin was separated on a ODS-C column （ Lichrospher ODS-C18, 4.6 mm x 250 mm）, using acetonitrile-water-phophoric acid （15： 85） as the mobile phase, detected at 230 nm, the velocity of flow was 1.0 mL/min. RESULTS： There was a good linear relationship at the range of 0.04 mg/mL- 0.64 mg/ mL for schizandrol A（r = 0. 999 8）. The average recovery of schizandrol A was 98.76% （n = 6, RSD = 1.18% ）. There was a good linear relationship at the range of 0.05 mg/mL - 0.80 mg/mL for paeoniflorin （ r = 0. 999 9 ）. The average recovery of paeoniflorin was 97.93% （ n = 5, RSD = 1.68% ）. CONCLUSION ： In 18 months, the quality of Compound Wurenchun Soft Capsule is steady.
出处
《中成药》
CAS
CSCD
北大核心
2008年第4期539-543,共5页
Chinese Traditional Patent Medicine
