哈药祛风阿德尔阿斯盘蜜膏质量标准研究  

Establishment of quality standard for Kazak medicine wind-dispelling medicine ader asipan honey ointment

作　　者：汪晶[1,3] 许欢 江阿古丽·艾山 李筱婧 陈斌[1,3] 木拉提·克扎衣别克 黄一平[1,3] WANG Jing;XU Huan;JangagulAsen;LI Xiaojing;CHEN Bin;KIZAIBEK Murat;HUANG Yi-ping(Nanjing University of Chinese Medicine,Nanjing 210046,China;TCM Hospital of Ili Kazakh Autonomous Prefecture,Xinjiang Yining 835000,China;Jiangsu Province Academy of Traditional Chinese Medicine,Key Laboratory for Traditional Chinese Medicine Drug Release System under State Administration of Traditional Chinese Medicine Nanjing 210028,China)

机构地区：[1]南京中医药大学附属中西医结合医院,江苏 南京 210046 [2]伊犁哈萨克自治州中医医院,新疆 伊宁 835000 [3]江苏省中医药研究院,国家中医药管理局中药释药系统重点研究室,江苏 南京 210028

出　　处：《中国民族医药杂志》2019年第10期36-39,共4页Journal of Medicine and Pharmacy of Chinese Minorities

基　　金：国家自然科学基金项目（项目编号：81803756）;国家中医临床研究基地开放课题（项目编号：JD201710）;江苏省中医药研究院战略合作课题（项目名称：祛风阿德尔阿斯盘蜜膏的研制与开发）;新疆地产中药民族药新药研发项目（编号：XJHPHY-2010-YH）

摘　　要：目的:建立哈药祛风阿德尔阿斯盘蜜膏的质量标准,探索蜜膏制剂质量控制方法。方法:采用薄层色谱法对蜜膏中的骆驼蓬草、延胡索、大黄及黄柏进行定性鉴别;采用高效液相色谱法测定蜜膏中延胡索乙素的含量,色谱柱为X-Bridge C18,流动相为乙腈-0.1%磷酸溶液(三乙胺调pH)等度洗脱,流速为1mL/min,柱温为25℃,检测波长为280nm,进样量为10μL。结果:4种药材的TLC供试品色谱与对照品及对照药材在相应的位置上呈现相同斑点或荧光;延胡索乙素在4.4~220μg·mL^-1范围内呈现良好的线性关系(R=0.9992),精密度、稳定性、重复性的RSD均小于3%,平均回收率为98.67%(RSD=2.1%,n=9),三批制剂中延胡索乙素的平均含量为0.0555mg/g。结论:本文建立的质量标准简便、稳定、可靠,为祛风阿德尔阿斯盘蜜膏的质量控制提供了科学依据。Objective:To establish the quality standard for Kazak medicine wind-dispelling medicine ader asipan honey ointment,and to explore the quality standard method about honey ointment.Method:TLC was used to qualitative identification of Peganum harmala L,Corydalis rhizoma,Rhei radix et rhizome and Phellodendri chinensis cortex.Tetrahydropalmatine was determined by HPLC.The determination was based on X-bridge C18 column with mobile phase consisted of acetonitrile -0.1% phosphoric acid solution(trimethylamine was used to regulate pH).The detection wavelength was set at 280 nm,column temperature was 25℃ and the flow rate was 1 mL/min.Results:Four medicinal materials had showed the same spot or fluorescence at the corresponding position with reference substance and control medicinal materials.The Tetrahydropalmatine had a good linear relation with the range of 4.4~220μg·mL^-1.The RSD of precision,stability and reproducibility tests were all less than 3%.The average recovery was 98.67%(RSD=2.1%,n=9).The average content of tetrahydropalmatine in three samples was 0.0555 mg/g.Conclusion:The method of quality control was easy,stable and reliable and it can provide scientific reference for Kazak medicine wind-dispelling medicine ader asipan honey ointment.

关 键 词：祛风阿德尔阿斯盘 蜜膏 质量标准 

分 类 号：R293.6[医药卫生—民族医学]