四妙君逸软膏成分的HPLC指纹图谱研究
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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 chromatography of the main ingredients in Simiao Junyi ointment.The conditions were as follows:the chromatographic column was Ultimate C_(18)-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 Junyi ointment were separated from each other perfectly,and the optimal fingerprint chromatography was obtained.Though the methodology examination,the indicators such as precision,stability and repeatability of the method were all promising,and the fingerprint chromatography 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 quality control of Simiao Junyi ointment.Conclusion:The HPLC fingerprint chromatography of Simiao Junyi ointment can be used as an analysis method for the quality control of Simiao Junyi ointment,which provides reference for the quality control standard for the finished product.
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 chromatography of the main ingredients in Simiao Junyi ointment.The conditions were as follows:the chromatographic column was Ultimate C_(18)-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 Junyi ointment were separated from each other perfectly,and the optimal fingerprint chromatography was obtained.Though the methodology examination,the indicators such as precision,stability and repeatability of the method were all promising,and the fingerprint chromatography 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 quality control of Simiao Junyi ointment.Conclusion:The HPLC fingerprint chromatography of Simiao Junyi ointment can be used as an analysis method for the quality control of Simiao Junyi ointment,which provides reference for the quality control standard for the finished product.
引文
1何永恒,鲁龙生,王晓艳.四妙君逸软膏用于肛肠病术后止痛促愈的临床研究[J].湖南中医药大学学报,2010,30(11):51-54
2 何永恒,胡响当.用于肛肠病术后镇痛的四妙君逸软膏组方研究[J].中华中医药杂志,2010,25(10):1694-1697
3 田振国,韩宝.中国肛肠病研究心得集[M].北京:中医古籍出版社,2011
4 陈光宇,何群,何永恒,等.HPLC法测定四妙君逸软膏中三七皂苷R1、人参皂苷Rg1、人参皂苷Rb1[J].中成药,2013,35(7):1465-1470
5 鲁海燕.四妙君逸软膏换药用于肛肠病术后镇痛的毒理学实验研究[D].长沙:湖南中医药大学硕士学位论文,2009
6 张湘杰.四妙君逸软膏换药用于肛肠病术后镇痛的药理学实验研究[D].长沙:湖南中医药大学硕士学位论文,2009
7 何群,韩军涛,陈光宇,等.四妙君逸软膏与散剂离体透皮特性的比较研究[J].中成药,2012,34(6):1052-1056
8 彭思源,何群,陈光宇,等.四妙君逸软膏制剂处方筛选研究[J].中成药,2015,37(11):2544-2546
9 金艺淑,何群,何永恒,等.正交试验优选四妙君逸软膏提取工艺[J].中国药房,2011,22(7):603-605
10 许腊英,万芳,付文强,等.不同产地茯苓中萜类成分的HPLC指纹图谱研究[J].湖北中医药大学学报,2007,9(3):41-42
2 何永恒,胡响当.用于肛肠病术后镇痛的四妙君逸软膏组方研究[J].中华中医药杂志,2010,25(10):1694-1697
3 田振国,韩宝.中国肛肠病研究心得集[M].北京:中医古籍出版社,2011
4 陈光宇,何群,何永恒,等.HPLC法测定四妙君逸软膏中三七皂苷R1、人参皂苷Rg1、人参皂苷Rb1[J].中成药,2013,35(7):1465-1470
5 鲁海燕.四妙君逸软膏换药用于肛肠病术后镇痛的毒理学实验研究[D].长沙:湖南中医药大学硕士学位论文,2009
6 张湘杰.四妙君逸软膏换药用于肛肠病术后镇痛的药理学实验研究[D].长沙:湖南中医药大学硕士学位论文,2009
7 何群,韩军涛,陈光宇,等.四妙君逸软膏与散剂离体透皮特性的比较研究[J].中成药,2012,34(6):1052-1056
8 彭思源,何群,陈光宇,等.四妙君逸软膏制剂处方筛选研究[J].中成药,2015,37(11):2544-2546
9 金艺淑,何群,何永恒,等.正交试验优选四妙君逸软膏提取工艺[J].中国药房,2011,22(7):603-605
10 许腊英,万芳,付文强,等.不同产地茯苓中萜类成分的HPLC指纹图谱研究[J].湖北中医药大学学报,2007,9(3):41-42