HPLC法测定复方苦木消炎片中穿心莲内酯溶出度
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摘要
目的:建立复方苦木消炎片中穿心莲内酯溶出度的测定方法,并对市售产品进行溶出度的测定。方法:采用高效液相色谱法测定穿心莲内酯的溶出度。用500 ml 0.2%十二烷基硫酸钠为溶出介质,使用转篮法在100 r·min~(-1)的转速下进行溶出度的试验,于45 min取样测定。结果:穿心莲内酯的浓度在0.37-3.70μg·ml~(-1)范围内呈良好的线性关系(r=0.999 8),回收率为99.4%,RSD为0.22%(n=6)。在45 min取样测定,复方苦木消炎片中穿心莲内酯的溶出度不低于标示量的80%。结论:本方法简便,结果准确可靠,可用于复方苦木消炎片中穿心莲内酯的溶出度的测定。
Objective:To establish a method for the dissolution determination of andrographolide in compound Kumu Xiaoyan tablets and determine the dissolution of a marketed product.Method:Andrographolide was detected by an HPLC method.0.2%Sodium lauryl sulfate(500ml) was used as the dissolution medium.A suspended basket method with a stirring rate of 100 r ? min~(-1) was used, and the sampling time was 45min.Result:The dissolution of andrographolide showed good linearity within the range of 0.37-3.70 μg ? ml~(-1)(r = 0.999 8).The recovery was 99.4%(RSD = 0.22%,n = 6).In the sampling time,the dissolution of andrographolide was not below 80%of the labeled contenl.Conclusion:The method is simple with great stability and accuracy,which can be used in the dissolution determination of andrographolide in compound Kumu Xiaoyan tablets.
Objective:To establish a method for the dissolution determination of andrographolide in compound Kumu Xiaoyan tablets and determine the dissolution of a marketed product.Method:Andrographolide was detected by an HPLC method.0.2%Sodium lauryl sulfate(500ml) was used as the dissolution medium.A suspended basket method with a stirring rate of 100 r ? min~(-1) was used, and the sampling time was 45min.Result:The dissolution of andrographolide showed good linearity within the range of 0.37-3.70 μg ? ml~(-1)(r = 0.999 8).The recovery was 99.4%(RSD = 0.22%,n = 6).In the sampling time,the dissolution of andrographolide was not below 80%of the labeled contenl.Conclusion:The method is simple with great stability and accuracy,which can be used in the dissolution determination of andrographolide in compound Kumu Xiaoyan tablets.
引文
1于娟.田明,芦达.HPLC法测定复方苦水消炎片吋.穿心莲以穿心莲内酯和脱水穿心莲内酯的含量[J].中华医药杂志.2005.5(3):23-24
2李璟,王立峰,薛兰.HPLC法测定复方苦水消炎片中脱水穿心莲内酯的含量[J].中国中医药信息杂志,2006.13(12):50—51
3徐柳韧.复方苦木消炎片薄层鉴别和脱水穿心莲内酯含量测定研究[J].中成药,2004.26(12):1003-1006
4湛伯祥.HPLC法测定妇科干金分散片中穿心莲内酯的含量[J].中医药导报,2009.15(6):85-s6
5卫生部药品标准[S].中药成方制剂.第6册.1992.118-119
6中国药典[S].2010年版.二部.附录XC.85-87
7冯柞臻.捧小平,官东秀.穿心莲内醋的捉取及其含量测定研究进展[J].中国药业,2005.14(10):70-72
8赵宏荣,王立英.HPLC法测定复方苦木消炎颗粒中脱水穿心莲内酯含量[J].中国执业药师,2010,7(11):36-38
9牛其云.李传河.秦增贵,等.HPLC法测定穿心莲片中穿心莲内酯的含量[J].齐鲁药事,2004,23(10):22-23
10郭炎荣.路玫.SPE-HPLC法测定清火栀麦片中穿心莲内酯和脱水穿心莲内酯的含量[J].中国试验方剂学杂志,2004.14(8):17-19
11宋英.宋崎,周小初.等.穿心莲滴丸中穿心莲内酯的体外溶出度研究[j].中国试验方剂学杂志.2008,14(10):11-13
12周兰,赵朝伟.穿心莲内酯片的体外溶山度研究[J].中国药业,2005.14(8):57-58
2李璟,王立峰,薛兰.HPLC法测定复方苦水消炎片中脱水穿心莲内酯的含量[J].中国中医药信息杂志,2006.13(12):50—51
3徐柳韧.复方苦木消炎片薄层鉴别和脱水穿心莲内酯含量测定研究[J].中成药,2004.26(12):1003-1006
4湛伯祥.HPLC法测定妇科干金分散片中穿心莲内酯的含量[J].中医药导报,2009.15(6):85-s6
5卫生部药品标准[S].中药成方制剂.第6册.1992.118-119
6中国药典[S].2010年版.二部.附录XC.85-87
7冯柞臻.捧小平,官东秀.穿心莲内醋的捉取及其含量测定研究进展[J].中国药业,2005.14(10):70-72
8赵宏荣,王立英.HPLC法测定复方苦木消炎颗粒中脱水穿心莲内酯含量[J].中国执业药师,2010,7(11):36-38
9牛其云.李传河.秦增贵,等.HPLC法测定穿心莲片中穿心莲内酯的含量[J].齐鲁药事,2004,23(10):22-23
10郭炎荣.路玫.SPE-HPLC法测定清火栀麦片中穿心莲内酯和脱水穿心莲内酯的含量[J].中国试验方剂学杂志,2004.14(8):17-19
11宋英.宋崎,周小初.等.穿心莲滴丸中穿心莲内酯的体外溶出度研究[j].中国试验方剂学杂志.2008,14(10):11-13
12周兰,赵朝伟.穿心莲内酯片的体外溶山度研究[J].中国药业,2005.14(8):57-58