王鹏娇;舒阳;张敏;姜楠;高秀丽;
WANG Pengjiao;SHU Yang;ZHANG Min;JIANG Nan;GAO Xiuli;School of Pharmacology,Guiyang Medical College;Guizhou Changsheng Drug Industry Limited Liability Company;

• 1:贵阳医学院药学院
• 2:贵州长生药业有限责任公司

摘要(Abstract)：

目的:建立杀菌止痒洗剂中苦参碱含量的高效液相色谱(HPLC)测定方法,并用此方法对杀菌止痒洗剂进行稳定性考察。方法:采用Diamonsil-C18色谱柱,流动相为乙腈-水-三乙胺(97∶3∶0.2,pH3.5)、检测波长207 nm、流速1.0 mL/min、柱温为25℃,稳定性研究采用加速试验和长期试验。结果:苦参碱在0.081 88~32.752 0μg时与峰面积呈良好的线性关系(r=0.999 9),平均加样回收率为99.2%,RSD=0.69%;杀菌止痒洗剂经过6个月加速实验和12个月长期实验,苦参碱含量无明显变化。结论:所建立的HPLC方法能很好地分离、检测杀菌止痒洗剂中苦参碱,并能评价杀菌止痒洗剂的稳定性。
Objective: To establish HPLC method for determination of matrine in Shajunzhiyang lotion,and determine the stability of the sample.Methods: The HPLC method was carried out on Diamonsil-C 18 column using acetonitrile-water-triethylamine(adjust the pH to 3.5 by phosphoric acid) as mobile phase,and the detection wavelength was 207 nm,the flow rate was 1.0 mL / min and the temperature of column was 25 ℃.The stability of Shajunzhiyang lotion was studied with accelerated test and long-term test.Results: In the results by HPLC method the calibration curve for matrine was linear in the range of 0.081 88 ~ 32.752 0 μg(r = 0.999 9).The average recovery was 99.2%,RSD was 0.69%(n = 6).No significant change of matrine content was found in Shajunzhiyang lotion after 6-month accelerated test and 12-month long-term test.Conclusion: This HPLC method is convenient,precise and reliable for determination of matrine in Shajunzhiyang lotion,and the stability of the lotion is good.

关键词(KeyWords)： 苦参碱;色谱法,高压液相;杀菌止痒洗剂;药物稳定性
sophocarpidine;chromatography,high pressure liquid;Shajunzhiyang lotion;drug stability

Abstract:

Keywords:

基金项目(Foundation): 贵阳市科技局计划项目(201120718号);贵阳市科技局计划项目(201120429号)

作者(Author): 王鹏娇;舒阳;张敏;姜楠;高秀丽;
WANG Pengjiao;SHU Yang;ZHANG Min;JIANG Nan;GAO Xiuli;School of Pharmacology,Guiyang Medical College;Guizhou Changsheng Drug Industry Limited Liability Company;

Email:

DOI: 10.19367/j.cnki.1000-2707.2013.05.011

参考文献(References)：

• [1]余家奇,杨忠兰.杀菌止痒洗剂的质量标准研究[J].中成药,2005(8):900-903.
• [2]喻征兵.妇炎消洗剂的稳定性考察[J].齐鲁药事,2010(11):660-661.
• [3]张志华,冯燕,毕秀丽.持续稳定性考察工作对制剂质量管理的重要性[J].齐鲁药事,2012(7):429-431.
• [4]吴勇梅.医院中药制剂质量稳定性监测[J].中国现代药物应用,2011(12):73-74.
• [5]陈磊,刘怡,梁生旺.苦参化学成分研究[J].广东药学院学报,2011(5):471-473.
• [6]卢荣枝,李运景.RP-HPLC法测定妇洁洗剂中苦参碱的含量[J].中国药师,2010(1):142-143
• [7]国家药典委员会.中华人民共和国药典(一部)[M].北京:化学工业出版社,2010,附录VI B.

文章评论(Comment)：