|本期目录/Table of Contents|

[1]孙 璇,王婧斯,龚 莉,等.坎地沙坦酯片溶出度考察[J].天津医科大学学报,2014,20(03):247-251.
　Sun Xuan,Wang Jing-si,Gong Li,et al.Study on dissolution determination of candesartan cilexetil tablets[J].Journal of Tianjin Medical University,2014,20(03):247-251.
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《天津医科大学学报》[ISSN:1006-8147/CN:12-1259/R]

卷:
20卷
期数:
2014年03期
页码:
247-251
栏目:
技术与方法
出版日期:
2014-05-20

文章信息/Info

Title:
Study on dissolution determination of candesartan cilexetil tablets
文章编号:
1006-8147(2014)03-0247-05
作者:
 孙 璇1; 2; 王婧斯2; 龚 莉2; 郭金娟2; 刘照胜1
（1. 天津医科大学药学院，天津 300070；2. 天津泛博生物科技有限公司，天津 300384）
Author(s):
Sun Xuan1; 2 ;  Wang Jing-si2;  Gong Li2 ; Guo Jin-juan2 ;  Liu Zhao-sheng1
(1.School of Pharmacy, Tianjin Medical University, Tianjin 300070, China; 2.Tianjin Fineample Biotechnology Company, Tianjin 300384, China)
关键词:
坎地沙坦酯片; 溶出度; 含量测定; 方法比较
Keywords:
candesartan cilexetil;  dissolution;  quantitative determination;  methods comparison
分类号:
-
DOI:
-
文献标志码:
A
摘要:
目的: 考察坎地沙坦酯片（必洛斯）溶出度，建立其溶出度测定方法。方法: 根据美国FDA、《日本药局方》、《国家药典委员会》以及自拟的坎地沙坦酯片溶出方法，进行坎地沙坦酯片的溶出度测定，绘制累积溶出曲线，分析溶出结果，选择最佳溶出方法。结果: 自拟方法（以0.5%SDS作为溶出介质）与FDA、JP方法测定的累积溶出曲线一致；坎地沙坦酯在1~16 μg/mL浓度范围内线性关系良好（r=0.999 8），平均回收率为101.0%，RSD为0.76% (n=9)。结论: 自拟方法适用性强、应用范围广、简便易行，可用于坎地沙坦酯片溶出度的测定。
Abstract:
Objective: To establish effective method for the determination of the dissolution of candesartan cilexetil tablets. Methods: The method for dissolution determination of candesartan cilexetil tablets acquired by FDA, Japanese Pharmacopoeia, Chinese Pharmacopoeia and our experiment method was studied, respectively. The optimal determination method was selected to determine the dissolution of the Blopress tablets. Results: The dissolution curves of the our method and FDA, Japanese Pharmacopoeia were similar. The calibration curve was linear in the rage of 1-16 μg/mL. The average recoveries of candesartan cilexetil tablets was 101.0%, RSD=0.76%(n=9). Conclusion: Our experiment method is durable, simple, widely applicable, and can be used in the determination of candesartan cilexetil tablets.

参考文献/References:

[1] 刘桂芹.坎地沙坦酯的临床应用及其研究进展[J].现代中西医结合杂志, 2009,18(36):4592
[2] 吕向群.抗高血压新药坎地沙坦研究进展[J].中国药业,2005,14(5):77
[3] 陈凌，潘静薇，秦永文，等.坎地沙坦酯治疗轻中度高血压病人的疗效及安全性[J].药学服务与研究,2004,4(2):139
[4] 日本药局方[S].第16版.2011:545
[5] 国家药典委员会.(http://www.chp.org.cn/cms/home/)
[6] 国家药典委员会.中华人民共和国药典(二部)[S].2010版.北京:化学工业出版社,2010:附录ⅩC:附录85
[7] 谢沐风.溶出曲线相似性的评价方法[J].中国医药工业杂志,2009,40(4):308
[8] Center for Drug Evaluation and Research. Guidance for industry bio-availability and bioequiralences studies for orally administered drug products:General considerations[S].1999.10

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备注/Memo

备注/Memo:
作者简介 孙璇（1989-），女，硕士在读，研究方向：药分与药剂学；通信作者：刘照胜，E-mail:zhaoshengliu@souhu.com。
更新日期/Last Update: 2014-05-12