摘要
目的:建立四妙君逸软膏HPLC指纹图谱分析方法,为制定其质量控制标准提供依据。方法:建立了分析四妙君逸软膏中主要成分的HPLC指纹图谱分离条件,即:色谱柱Ultimate C_(18)-ODS柱(250 mm×4.6 mm,5μm);流动相为乙腈-0.1%磷酸水;流速:1.0 ml·min^(-1);检测波长:280 nm;柱温:35℃,并且对色谱图中的共有峰进行了归属分析。结果:在筛选的最佳分离条件下进行梯度洗脱,四妙君逸软膏中各组分分离效果较好,可得到最优的指纹图谱;经方法学考察表明,所建立的HPLC指纹图谱分析方法精密度、稳定性、重复性均良好,指纹图谱清晰、可辨、易分析;初步确定四妙君逸软膏与四味药材指纹图谱共有峰之间的关系,为四妙君逸软膏的质量控制提供了重要依据。结论:四妙君逸软膏HPLC指纹图谱分析方法可作为质量控制的一项指标,供制订成品质量标准参考。
Objective ： To establish an analytical method for HPLC fingerprint chromatography of Simiao Junyi ointment to provide basis for the quality control standard. Methods： The separation conditions were established to obtain the HPLC fingerprint chromatog- raphy of the main ingredients in Simiao Junyi ointment. The conditions were as follows ： the chromatographic column was Ultimate C1s- ODS（250 mm ×4.6 mm,5 μm）, the mobile phase was acetonitrile-0.1% phosphate solution, the flow rate was 1.0 ml min-1 , the detection wavelength was 280 nm, and the column temperature was 35℃. The common peaks in the chromatography were analyzed for their belongings. Results： Gradient elution was performed under the above optimal separation conditions, the constituents in Simiao Ju- nyi ointment were separated from each other perfectly, and the optimal fingerprint chromatography was obtained. Though the methodolo- gy examination, the indicators such as precision, stability and repeatability of the method were all promising, and the fingerprint chro- matography could be seen clearly and was easy to be analyzed. The relationships between Simiao Junyi ointment and the common peaks of four medicinal materials in the fingerprint chromatography were preliminary determined, which provided important basis for the quali- ty control of Simiao Junyi ointment. Conclusion： The HPLC fingerprint chromatography of Simiao Junyi ointment can be used as an a- nalysis method for the quality control of Simiao Junyi ointment, which provides reference for the quality control standard for the finished product.
出处
《中国药师》
CAS
2017年第1期38-42,共5页
China Pharmacist
基金
湖南省科技厅计划项目(编号:2009SK3125)
长沙市科技局计划课题项目(编号:K1508030-31、K1003068-31)
关键词
四妙君逸软膏
高效液相色谱法
指纹图谱
成品质量标准
相似度
Simiao Junyi ointment
HPLC
Fingerprint chromatography
Quality control standard for finished product
Similarity
