咽喉清口含片HPLC特征图谱质量控制方法研究
|
摘要
目的考察建立咽喉清口含片高效液相色谱(HPLC)特征图谱质量控制方法。方法采用高效液相色谱法,色谱柱为Waters Symmetry C_(18)柱(4.6 mm×250 mm,5μm),流动相为乙腈-0.4%磷酸水溶液,梯度洗脱,检测波长为260 nm,流速为1.0 mL·min~(-1),柱温为30℃,测定10批次咽喉清口含片样品,并将所获得的色谱图导入国家药典委员会颁布的"中药色谱指纹图相似度评价系统(2012版)",经过多点校正和数据匹配生成色谱特征图谱共有模式,计算各批次样品图谱与标准图谱的相似度,并以色谱图中绿原酸峰为参照峰,计算各色谱峰相对保留时间。结果得到咽喉清口含片特征图谱共有模式,确认了20个共有特征峰。结论经过方法学验证,所建立方法稳定可行,可用于咽喉清口含片的质量控制。
Objective To establish a specific chromatograms method for Yanhouqing Buccal Tablets by HPLC.Methods Using an HPLC method with Waters Symmetry C_(18 ) column(4.6 mm×250 mm,5 μm),the mobile phase was a methanol-0.4% phosphoric acid solution,with gradient elution,the detection wavelength was 260 nm,the flow rate was 1.0 mL·min~(-1),and the column temperature was 30 ℃.In our experiment,10 batches of Yanhouqing Buccal Tablets were determined to gain the chromatograms,which were then imported to the Similarity Evaluation System of Chromatographic Fingerprint of Traditional Chinese Medicine(2012).By the similarity evaluation system,the common pattern of specific chromatogram was acquired,the similarity between sample chromatogram of each batch and common pattern chromatogram were figured out,afterwards the relative time of each common characteristic peaks to chlorogenic acid peak were also calculated.Results The specific chromatogram of Yanhouqing Buccal Tablets was acquired,20 common characteristic peaks were confirmed.Conclusion The method was stable and feasible,and can be applied to control the quality of Yanhouqing Buccal Tablets.
Objective To establish a specific chromatograms method for Yanhouqing Buccal Tablets by HPLC.Methods Using an HPLC method with Waters Symmetry C_(18 ) column(4.6 mm×250 mm,5 μm),the mobile phase was a methanol-0.4% phosphoric acid solution,with gradient elution,the detection wavelength was 260 nm,the flow rate was 1.0 mL·min~(-1),and the column temperature was 30 ℃.In our experiment,10 batches of Yanhouqing Buccal Tablets were determined to gain the chromatograms,which were then imported to the Similarity Evaluation System of Chromatographic Fingerprint of Traditional Chinese Medicine(2012).By the similarity evaluation system,the common pattern of specific chromatogram was acquired,the similarity between sample chromatogram of each batch and common pattern chromatogram were figured out,afterwards the relative time of each common characteristic peaks to chlorogenic acid peak were also calculated.Results The specific chromatogram of Yanhouqing Buccal Tablets was acquired,20 common characteristic peaks were confirmed.Conclusion The method was stable and feasible,and can be applied to control the quality of Yanhouqing Buccal Tablets.
引文
[1] 李一圣,李文周,卫平,等.咽喉清口含片治疗急性咽炎外感风热证的Ⅲ期临床试验[J].中成药,2017,39(2):266-272.
[2] 曾浩涛,李一圣,李文周,等.HPLC法测定咽喉清口含片中次野鸢尾黄素的含量[J].药学研究,2015,34(2):72-74.
[3] 国家药典委员会.中华人民共和国药典2015年版(一部)[S].北京:中国医药科技出版社,2015:285.
[4] 谢培山.中药指纹图谱在中药新药开发研究中的作用[J].中国新药杂志,2002,11(12):905-906.
[5] 罗国安,梁琼麟,王义明.中药指纹图谱--质量评价、质量控制与新药研发[M].北京:化学工业出版社,2009.
[6] 李晓兰.中药射干的研究概况[J].海峡药学,2003,15(5):72-74.
[7] 王钰乐,刘文,杨道斌,等.黄芩的谱效关系研究[J].中华中医药学刊,2017,35(12):3110-3113.
[8] 王金梅,姚辰,陆程灿,等.酒女贞子抗氧化谱效关系研究[J].中国药学杂志,2016,51(22):1907-1912.
[9] 潘杰,刘德胜,颜贵明.数据分析应用于中药谱效关系中的研究进展[J].中医药学报,2018,46(4):119-122.
[2] 曾浩涛,李一圣,李文周,等.HPLC法测定咽喉清口含片中次野鸢尾黄素的含量[J].药学研究,2015,34(2):72-74.
[3] 国家药典委员会.中华人民共和国药典2015年版(一部)[S].北京:中国医药科技出版社,2015:285.
[4] 谢培山.中药指纹图谱在中药新药开发研究中的作用[J].中国新药杂志,2002,11(12):905-906.
[5] 罗国安,梁琼麟,王义明.中药指纹图谱--质量评价、质量控制与新药研发[M].北京:化学工业出版社,2009.
[6] 李晓兰.中药射干的研究概况[J].海峡药学,2003,15(5):72-74.
[7] 王钰乐,刘文,杨道斌,等.黄芩的谱效关系研究[J].中华中医药学刊,2017,35(12):3110-3113.
[8] 王金梅,姚辰,陆程灿,等.酒女贞子抗氧化谱效关系研究[J].中国药学杂志,2016,51(22):1907-1912.
[9] 潘杰,刘德胜,颜贵明.数据分析应用于中药谱效关系中的研究进展[J].中医药学报,2018,46(4):119-122.