愈合王制剂质量标准的建立  

Study on the Quality Standard for Yuhewang Preparation

作　　者：莎日娜[1] 何春龙[2] 那生桑[2] 

机构地区：[1]内蒙古医科大学第二附属医院药剂科,呼和浩特010030 [2]内蒙古医科大学药学院

出　　处：《中国药师》2016年第11期2165-2167,共3页China Pharmacist

摘　　要：目的:建立愈合王中马齿苋的鉴别方法和4种维生素的含量测定方法。方法:采用薄层色谱法鉴别马齿苋,采用高效液相色谱法测定维生素的的含量,色谱柱为Agilent XDB C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.05%庚烷磺酸钠(磷酸调p H到3.0)(15∶85),检测波长为273 nm,流速:1.0 ml·min^(-1),柱温:35℃,进样量:20μl。结果:薄层鉴别斑点清晰,分离度良好,且阴性对照无干扰。维生素C在80.60~403.00μg·ml^(-1)范围内,烟酰胺在20.10~100.50μg·ml^(-1)范围内,维生素B6在20.36~101.80μg·ml^(-1)范围内,维生素B2在12.24~61.20μg·ml^(-1)范围内,与峰面积呈良好的线性关系。维生素C、烟酰胺、维生素B6和维生素B2回收率分别为99.34%,99.64%,99.29%和99.09%,RSD分别为0.98%,0.20%,1.23%和1.48%。结论:所建方法简便、准确,重复性好,可用于愈合王的质量控制。Objective： To establish the methods for the identification of purslane and the determination of four vitamins in Yuhe-wang. Methods： The identification of purslane was carried out by TLC. An Agilent XDB C18 column （250 mm×4.6 mm,5μm） was used. The mobile phase was aeetonitrile-0.05% sodium 1-beptanesulfonate（ pH was adjusted to 3.0 by phosphoric acid） （15：85 ）. The detection wavelength was 273 nm, the flow rate was 1.0 ml·min^-1, and the column temperature was 25~C. Results： The TLC spots were clear with high resolution, while the negative sample showed no interference. The linearity of the vitamins was established within the concentration range of 80.60-403.00μg·ml^-1 for vitamin C, 20.10-100.50μg·ml^-1 for nieotinamide, 20.36-101.80μg·ml^-1 for vitamin Be and 12.24-61.20μg·ml^-1 for vitamin B2. The average recovery of vitamin C, nieotinamide, vitamin Be and vi- tamin B2 was 99.34% （RSD =0.98% ）, 99.64% （RSD =0.20% ）, 99.29% （RSD = 1.23% ） and 99.09% （RSD = 1.48% ）, respectively. Conclusion： The established method is simple and accurate with good reproducibility, which can be used for the quality control of Yuhewang.

关 键 词：愈合王 马齿苋 维生素 薄层色谱法 高效液相色谱法 

分 类 号：TQ460.72[医药卫生—药物分析学]