连三叶触变凝胶剂的质量标准研究  

Study on Quality Standard of Lian San Ye Thixotropic Gel

作　　者：方文棋 廖景光 刘帝灵 王超[3] 林丽 郑淑慧[5] 张军[3] 

机构地区：[1]广东容大生物股份有限公司,广东清远511500 [2]广州市番禺区何贤纪念医院,广东广州510006 [3]广州中医药大学新药开发研究中心,广东广州510006 [4]中山市第二人民医院,广东中山528306 [5]中山大学附属第一医院转化医学研究中心,广东广州510080

出　　处：《中药新药与临床药理》2017年第3期368-371,共4页Traditional Chinese Drug Research and Clinical Pharmacology

基　　金：广东省应用型科技研发专项资金项目(2016B020239005);广东省中医药管理局项目(20171196);广东省自然科学基金-博士启动(2014A030310059)

摘　　要：目的建立连三叶触变凝胶剂的质量标准。方法采用薄层色谱法(TLC)对连三叶触变凝胶剂中的黄连、三白草、鸡冠花进行鉴别;采用高效液相色谱法(HPLC)测定制剂中盐酸小檗碱含量。结果本品TLC鉴别专属性强,阴性对照无干扰。HPLC检测盐酸小檗碱在0.046 7~0.700 5μg·mL^(-1)范围内呈良好的线性关系(r=1.000 0),平均回收率为96.06%,RSD=0.76%(n=6)。结论本研究所建的方法简便可行、结果准确可靠,可用于连三叶触变凝胶剂的质量控制。Objective To establish the quality standard for Lian San Ye Thixotropic Gel （LSYTG）. Methods Rhizoma Coptidis, Rhizoma seu Herba Saururi Chinensis, Infloreseentia Celosiae Cristatae in LSYTG were identified by thin layer chromatography（TLC）. The content of berberine hydrochloride in the preparation was determined by high performance liquid chromatography（HPLC）. Results TLC identifieation method was specific and the negative control had no interference. The content of berberine hydrochloride showed a good linearity in the range of 0.046 7-0.700 5μg·mL^-1（r=1.000 0） and the average reeovery was 96.06 %（RSD=0.76 %, n=6）. Conclusion The method is simple, feasible, accurate with high specificity. It can be used for the quality control of LSYTG.

关 键 词：连三叶触变凝胶剂 盐酸小檗碱 薄层色谱 高效液相色谱 质量标准 

分 类 号：R284.1[医药卫生—中药学]