解毒抗白颗粒剂的含量测定及初步稳定性研究  

Studies on the Content Determination and Preliminary Stability of Formulated Granules of Detoxification and Anti-Leukaemia

作　　者：李耀华[1] 蔡乐[1] 钟鸣 卢森华[1] 陈勇[1] 辛华[1] 

机构地区：[1]广西中医药大学,南宁530001 [2]广西民族医药研究院,南宁530001

出　　处：《中国实验方剂学杂志》2013年第3期97-100,共4页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：广西科技攻关课题(桂科攻0718002-2-12)

摘　　要：目的:建立解毒抗白颗粒的含量测定方法,并考察制剂的稳定性。方法:采用HPLC法对制剂中半枝莲有效成分野黄芩苷含量进行测定,色谱柱为C18柱(4.6 mm×250 mm,5μm),流动相为甲醇-0.1%磷酸溶液(34∶66),检测波长为335 nm;同时对三批样品进行了初步稳定性试验考察。结果:野黄芩苷进样量在0.260～2.60μg之间与峰面积值呈线性关系,r=0.999 9,平均回收率为100.7%,RSD 2.6%(n=6);初步稳定性试验表明,制剂在性状、粒度、水分、装量差异、溶解度和含量测定等方面均符合规定。结论:所建立的含量测定方法可行,制剂质量可控,稳定性良好。Objective： To create a determination method and to explore the preliminary stability of formulated granules of detoxification and anti-leukaemia. Method： HPLC was performed on a Cls column （4.6 mm ×250 mm, 5 μm） using methanol-0.1% H3 PO4 （34： 66） as the mobile phase at the detection wavelength of 335 nm to determine scutellarin of barbata. The preliminary stability of three batches samples was also investigated. Result： The linear range of scutellarin was 0. 260-2. 60μg. The mean recovery was 100. 7% with RSD 2. 6% （n = 6）. The preliminary stability tests showed that formulated granules met the specification in the appearance, size, moisture content, load difference, solubility and determination of compliance. Conclusion： The method of determination is feasible, formulated granules could be controlled in quality with good stability.

关 键 词：解毒抗白颗粒 野黄芩苷 初步稳定性 

分 类 号：R284.1[医药卫生—中药学]