射干地龙颗粒的含量测定及制剂稳定性研究  

Determination of Shegan Dilong Granules by RP-HPLC and the Study of its Stability

作　　者：辛蕊华[1] 谢家声[1] 郑继方[1] 罗永江[1] 李维[2] 王贵波[1] 罗超应[1] 李锦宇[1] 

机构地区：[1]中国农业科学院兰州畜牧与兽药研究所甘肃省中兽药工程技术研究中心甘肃省新兽药工程重点实验室,甘肃兰州730050 [2]兰州市疾病预防控制中心,甘肃兰州730030

出　　处：《中国畜牧兽医》2013年第7期29-33,共5页China Animal Husbandry & Veterinary Medicine

基　　金：“十二五”国家科技支撑计划项目资助(2011BAD34B03);中央级公益性科研院所基本科研业务费专项资金项目(1610322013015)

摘　　要：本试验旨在建立射干地龙颗粒中次野鸢尾黄素的含量测定方法及考察该制剂的稳定性,为制定该制剂质量标准中含量测定方法及保质期提供依据。采用反相高效液相色谱(RP-HPLC)法,色谱柱:GL Sciences Inertsil ODS-3(150mm×4.6mm,5μm),流动相:乙腈-0.2%磷酸溶液(39∶61),流速:1mL/min,检测波长:266nm,柱温:30℃,进样量:10μL;根据药典,采用强光照射试验、加速试验及长期稳定性试验考察射干地龙颗粒中次野鸢尾黄素含量的稳定性。试验结果表明,次野鸢尾黄素的含量在0.3422～86.60μg/mL范围内与峰面积呈良好的线性关系,r=0.9995(n=10),平均加样回收率为99.80%,RSD为1.50%(n=9);强光照射试验、加速试验及长期稳定性试验结果表明,该产品稳定性良好;此方法简便、灵敏、重现性好,可用于射干地龙颗粒中次野鸢尾黄素的含量测定,且该制剂的稳定性良好。The study was aimed to establish a method for determining Irisflorentin in Shegan Dilong granules and inspection for the stability of the preparation. RP-HPLC method was adopted and the GL Sciences Inertsil ODS-3 （150 mm×4.6 mm, 5 μm） was used. The mobile phase was acetonitrile-0.2% phosphoric acid solution （39～61）, with the flow rate of 1 mL/min. The detection wavelength was at 266 nm and the column temperature was 30 ℃. Under the high-light exposure experiment,ac- celerating experiment and room temperature storage observation, the results showed that the product was basically stable. The calibration curve of Irisflorentin was linear in the range of 0. 3422 to 86.60 μg/mL, r was 0. 9995 （n was 10）, the average re- covery rate was 99.80%, RSD was 1.50% （n was 9）. The method was simple, sensitive and accurate with good repeatability, which could be used for the quality control of Shegan Dilong granules and the preparation had a good stability.

关 键 词：反相高效液相色谱法 射干地龙颗粒 次野鸢尾黄素 稳定性 

分 类 号：S853.7[农业科学—临床兽医学]