蒺藜防白缓释滴丸质量标准的研究  

Quality standard for Jili Fangbai Sustained-Release Dropping Pills

作　　者：周丽娟[1] 梁亚奇 何勐[2] 丁孝良[2] 张维亚[2] 李敏[2] 

机构地区：[1]郑州大学附属郑州中心医院转化医学中心,河南郑州450007 [2]郑州大学附属郑州中心医院药学部,河南郑州450007

出　　处：《中成药》2016年第11期2395-2399,共5页Chinese Traditional Patent Medicine

基　　金：常州四药临床药学科研基金(CZSYJJ13026)

摘　　要：目的建立蒺藜防白缓释滴丸（蒺藜、防风、白芷等）的质量标准。方法 TLC法对蒺藜、当归和赤芍进行定性鉴别,HPLC法定量测定升麻素苷、5-O-甲基维斯阿米醇苷和欧前胡素的含有量,转篮法测定释放度。结果 TLC斑点清晰,专属性强,分离度好。升麻素苷、5-O-甲基维斯阿米醇苷和欧前胡素分别在1.602 0～112.14μg/m L（r=0.999 8）、1.396～139.60μg/m L（r=0.999 9）、0.707 2～70.72μg/m L（r=0.999 99）范围内线性关系良好,平均加样回收率分别为100.2%（RSD=0.99%）、99.85%（RSD=0.80%）、99.37%（RSD=1.04%）。在2、6、10 h,升麻素苷和5-O-甲基维斯阿米醇苷的累积释放度分别达到20%～40%、50%～70%、80%以上,有缓释效果。结论该方法快速简便,准确可靠,适用于蒺藜防白缓释滴丸的质量控制。AIM To establish the quality standard for Jili Fangbai Sustained-Release Dropping Pills（ a medication for vitiligo,containing Tribuli Fructus,Saposhnikoviae Radix,Angelicae Dahuricae Radix,etc.）. METHODS TLC was used for the qualitative identification of Tribuli Fructus,Angelicae Sinensis Radix and Paeoniae Radix Rubra. HPLC was applied to quantitatively determining the contents of prim-O-glucasylcimifugin,5-O-methylvisammiosode and imperatorin. And subsequently,the release rate was detected by stirring basket method. RESULTS The TLC spots were clear and well-separated,indicating the strong specificity. Prim-O-glucasylcimifugin,5-O-methylvisammiosode and imperatorin showed good linear relationships within the ranges of 1. 602 0-112. 14 μg / m L（ r = 0. 999 8）,1. 396-139. 60 μg / m L（ r = 0. 999 9） and 0. 707 2-70. 72 μg / L（ r =0. 999 99）,whose average recoveries were 100. 2%（ RSD = 0. 99%）,99. 85%（ RSD = 0. 80%） and 99. 37%（ RSD = 1. 04%）,respectively. In addition,for prim-O-glucasylcimifugin and 5-O-methylvisammiosode,their ob-vious sustained-release was proven by the respective 20%-40%,50%-70% and more than 80% accumulated release rates at 6 h,8 h and 10 h. CONCLUSION This simple,accurate and reliable method is suitable for the rapid quality control of Jili Fangbai Sustained-Release Dropping Pills.

关 键 词：蒺藜防白缓释滴丸 升麻素苷 5-O-甲基维斯阿米醇苷 欧前胡素 释放度 TLC HPLC 转篮法 

分 类 号：R927.2[医药卫生—药学]