清热八味丸质量标准研究  

Quality Standard of Qingrebawei Pills

作　　者：刘学良 韩达斌 陈鹏 年永琪 汪永明 王永晶 刘海青 LIU Xueliang;HAN Dabin;CHEN Peng;NIAN Yongqi;WANG Yongming;WANG Yongjing;LIU Haiqing(Qinghai Center for Drug Evaluation and Inspection,Xining,Qinghai,China 810007)

机构地区：[1]青海省药品审评核查中心,青海西宁810007

出　　处：《中国药业》2022年第16期69-72,共4页China Pharmaceuticals

基　　金：青海省科技计划项目[2020-ZJ747]。

摘　　要：目的提升清热八味丸的质量标准。方法采用薄层色谱(TLC)法对人工牛黄、红花进行定性鉴别;采用高效液相色谱法同时测定制剂中胡黄连苷Ⅰ、胡黄连苷Ⅱ的含量,色谱柱为Hypersil-ODS柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.15%磷酸溶液(梯度洗脱),流速为1.0 mL/min,检测波长为266 nm,柱温为30℃,进样量为10μL。结果人工牛黄、红花的TLC图斑点清晰,分离度好,且阴性对照无干扰。胡黄连苷Ⅰ、胡黄连苷Ⅱ进样量分别在0.04258~0.8516μg(r=0.9998)和0.04360~0.8720μg(r=0.9997)范围内与峰面积线性关系良好;精密度、重复性、稳定性试验结果的RSD均小于1.30%,平均加样回收率分别为106.93%和98.34%,RSD分别为1.35%和1.18%(n=6)。结论该方法操作简便,结果准确,重复性好,可用于清热八味丸的质量控制。Objective To improve the quality standard of Qingrebawei Pills.Methods Bovis Calculus Artifatus and Carthami Flos were qualitatively identified by the thin-layer chromatography(TLC)method.The contents of picrosideⅠand picroside Ⅱ in the preparation were determined simultaneously by the high-performance liquid chromatography(HPLC)method,the chromatographic column was thermostatic Hypersil-ODS column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.15% phosphoric acid with gradient elution,the flow rate was 1.0 mL/min,the detection wavelength was 266 nm,the column temperature was 30℃,and the injection volume was 10μL.Results The TLC spots of Bovis Calculus Artifatus and Carthami Flos were clear with good separation,and the negative control had no interference.The linear ranges of picroside Ⅰ and picroside Ⅱ were 0.04258-0.8516μg(r=0.9998)and 0.04360-0.8720μg(r=0.9997),respectively.The RSDs of precision,repeatability and stability tests were lower than 1.30%,and the average recoveries of picroside Ⅰ and picroside Ⅱ were 106.93%and 98.34%with RSDs of 1.35% and 1.18%(n=6),respectively.Conclusion The method is simple,accurate and reproducible,which can be used for the quality control of Qingrebawei Pills.

关 键 词：清热八味丸 人工牛黄 红花 薄层色谱法 胡黄连苷Ⅰ 胡黄连苷Ⅱ 高效液相色谱法 含量测定 

分 类 号：R917[医药卫生—药物分析学] R927[医药卫生—药学]