摘要
为了研究藿芪灌注液的稳定性,采用HPLC法测定藿芪灌注液中淫羊藿苷与黄芪甲苷含量,使用Wonda Sil C18柱(4.6 mm×250 mm,5μm),流动相:乙腈-水28∶72,柱温40℃,检测波长270 nm,进样量10μL,流速1.0 m L/min测定淫羊藿苷的含量;使用ZORBAX SB-C18柱(4.6 mm×150 mm,5μm),漂移管温度为90℃,载气流速为2.5 L/min,流动相:甲醇-水65∶35,柱温:40℃,流速:1 m L/min,用蒸发光散射检测器检测测定黄芪甲苷的含量。藿芪灌注液于高温60℃放置10 d,高湿度90%±5%放置10 d,经强光照射4500±500LX放置10 d,加速试验在温度40℃±2℃、相对湿度75%±5%的条件下放置6个月,长期试验在温度25℃±2℃、相对湿度60%±10%的条件下放置12个月,考察藿芪灌注液在不同条件存放后的性状、鉴别、p H、淫羊藿苷含量、黄芪甲苷含量以及无菌检查等项目的变化。结果表明,藿芪灌注液性质稳定,在不同条件存放后所有指标均未有明显变化,符合质量标准要求。
To by HPLC. The investigate the stability of Huoqi perfusion, the contents oficariin and astragaloside were determined separation of the icariin was achieved by a WondaSil -C18（4.6 mm×250 mm,5 μm） and mobile phase composed of acetonitrile - water（28：72 ）, the detection wavelength was 270 nm, the column temperature was 40 ℃ ,the injection volume of 10μL, the flow rate was 1.0 mL/min; The separation of the astragaloside was achieved by a ZORBAX SB - C18 （4.6 mm × 150 mm,5 μm） ,The drift tube temperature is 90 ℃ ,The carrier gas flow rate is 2.5 L/min and mobile phase composed of methanol - water （65：35 ） , the flow rate was 1.0 mL/min; the injection volume of 10 μL; the column temperature was 40 ℃, with evaporative light scattering detector. Huoqi Perfusionwas treated respectively with high temperature（60 ℃ ）for 10 d, high wet（ RH95% ± 5% ）for 10 days, high light （4500 ± 500LX ） for 10 days, accelerating testing （40 ℃± 2 ℃, RH75 % ± 5 % ） for six months, and a long -term testing （25 ℃ ±2 ℃ ,RH60% ± 10% ） for twelve months,and then the changes of characters, identification, pH,icariin, astragaloside and sterility test under different storage conditions were observed. All of the tested indexes of Huoqi Perfusion were consistent with the quality standards. The tested of Huoqi perfusion is stable and reliable.
作者
杨洪早
苗小楼
张世栋
董书伟
闫宝琪
桑梦琪
那立冬
王东升
严作廷
YANG Hong - zao MIAO Xiao - lou ZHANG Shi - dong DONG Shu - wei YAN Bao - qi SANG Meng - qi NA Li - dong WANG Dong - sheng YAN Zuo - ting(Lanzhou Institute of Animal Husbandry and Pharmaceutical Sciences , Chinese Academy of Agricultural Sciences , Key Laboratory of Veterinary Pharmaceutical Discovery , Ministry of Agriculture, Lanzhou 730050 , China College of Veterinary Medicine, Gansu Agricultural University, Lanzhou 730070, China)
出处
《中国兽药杂志》
北大核心
2017年第1期19-24,共6页
Chinese Journal of Veterinary Drug
基金
中国农业科学院科技创新工程项目(CAAS-ASTIP-2014-LIHPS-03)
"十二五"国家科技支撑计划重点课题(2012BAD12B03)
