六应丸中牛黄品种和质量控制方法的研究  

Study on Quality Control for Calculus Bovis in Liuying Pills

作　　者：郝博[1] 曹帅[2] 夏晶[2] 季申[2] 

机构地区：[1]国家药典委员会,北京100061 [2]上海市食品药品检验所,上海201203

出　　处：《中国药品标准》2016年第2期99-102,共4页Drug Standards of China

基　　金：国家"重大新药创制"科技重大专项"十二五"计划课题(2012ZX09304-005);上海市科委"不同类型牛黄对含朱砂中成药的增效降毒机理研究"(课题编号ZR1428100)

摘　　要：目的:建立六应丸中牛黄质量的控制方法,切实保证投料用牛黄的质量和工艺的稳定性,为六应丸的疗效和应用安全提供保障。方法:采用高效液相色谱法测定样品中总胆红素及游离胆红素的含量,根据不同类型胆红素的含量综合评价其中牛黄的质量;色谱柱为Kromasil 100C_(18)(4.6 mm×150 mm,5μm),乙腈-1%冰醋酸(95∶5)为流动相,检测波长为450 nm。结果:游离胆红素和总胆红素的平均加样回收率分别为89.7%(RSD=4.97%,n=9)、96.6%(RSD=1.21%,n=9);胆红素在7.344~122.4μg·m L^(-1)浓度范围内线性关系良好(r=0.999 9)。结论:六应丸中游离胆红素和总胆红素的含量及比例能较好地体现投料用牛黄的品质;方法准确,专属性强,可有效保障六应丸的临床应用安全。Objective：To develop a method for quality control of Calculus Bovis in Liu ying Pills,that would be a way to ensure the ef-ficacy of the finished product through monitoring the quality of this raw material.Methods：The free bilirubin and total bilirubin were determined respectively by HPLC.A Kromasil 100？C18 column（ 4.6 mm ×150 mm,5 μm）was adopted with acetonitrile-1%acetic acid （95∶5） as the mobile phase,and the detection wavelength was 450 nm.Results：The average recoveries of free bilirubin and total bilirubin were 89.7%（ RSD=4.97%, n=9 ） and 96.6%（ RSD=1.21%, n=9 ） , respectively.The linear rang of bilirubin was 7.344-122.4 μg· mL^-1（r=0.999 9）.Conclusion： The method is accurate and specific, the quality of Calculus Bovis in Liuying Pills is reflected by the content and ratio of free bilirubin and total bilirubin..

关 键 词：六应丸 牛黄 质量控制 胆红素 

分 类 号：R921.2[医药卫生—药学]