肤康合剂制备及质量控制  

Preparation and Quality Control of Fukang Mixture

作　　者：张先平[1] 李珩[1] 林捷 李桃容[3] 

机构地区：[1]长江大学附属第一医院,湖北荆州434000 [2]荆州市第三人民医院,湖北荆州434000 [3]荆州市中心医院,湖北荆州434020

出　　处：《中国中医药信息杂志》2012年第11期46-48,共3页Chinese Journal of Information on Traditional Chinese Medicine

摘　　要：目的研制肤康合剂,并建立该制剂的质量控制方法。方法采用薄层色谱法鉴别肤康合剂中黄芩、白花蛇舌草,高效液相色谱法测定制剂中黄芩苷、芍药苷的含量。色谱柱:Agilent EclipseXDB-C18柱(250 mm×4.6 mm,5μm)。黄芩苷流动相为甲醇-2%醋酸(55∶45),流速1.0 mL/min,检测波长315 nm;芍药苷流动相为甲醇-水(35∶65),流速0.8 mL/min,检测波长230 nm。柱温为常温,灵敏度为0.08 AUFS,进样量20μL。结果薄层色谱能明显检出黄芩、白花蛇舌草。制剂中黄芩苷和芍药苷的含量分别为2.103～2.145 g/L、1.569～1.650 g/L。黄芩苷进样量在0.54～4.32μg范围内呈良好线性关系,平均回收率为99.80%,RSD=1.76%(n=6);芍药苷进样量在0.14～0.70μg范围内呈良好线性关系,平均回收率为99.10%,RSD=1.08%(n=6)。结论该制备工艺简单,质量控制方法准确可靠、重复性好。Objective To prepare Fukang mixture and establish its quality control method.Methods Scutellaria and Hedyotis diffusa Willd in Fukang mixture were identified by TLC,and the contents of baicalin and paeoniflorin in the preparation were determined by HPLC.Agilent EclipseXDB-C18 column（250 mm×4.6 mm,5 μm） was used.The mobile phase for baicalin consisted of methanol-2% acetic acid（55∶45） at the flow rate of 1.0 mL/min,and the detection wavelength was 315 nm.The mobile phase for paeoniflorin consisted of methanol-water（35∶65） at the flow rate of 0.8 mL/min,and the detection wavelength was 230 nm.The column temperature was at room temperature and the sensitivity was 0.08 AUFS,the injection volume was 20 μL.Results Scutellaria and Hedyotis diffusa Willd could be obviously identified by TLC,and baicalin and paeoniflorin in the preparation were 2.103-2.145 g/L and 1.569-1.650 g/L respectively.Baicalin showed a good linear relationship at the range of 0.54-4.32 μg,the average recovery was 99.80% with RSD=1.76%（n=6）.Paeoniflorin showed a good linear relationship at the range of 0.14-0.70 μg,the average recovery was 99.10% with RSD=1.08%（n=6）.Conclusion The preparation technology of Fukang mixture is simple,and the quality control method is accurate and reliable with good reproducibility.

关 键 词：肤康合剂 质量控制 薄层色谱法 高效液相色谱法 黄芩苷 芍药苷 

分 类 号：R284.1[医药卫生—中药学]