文档介绍：www. zgys. org 研究简报
坎地沙坦酯片的制备及初步稳定性研究
1 1 2 1 1 1 1. 430070 2.
谢向阳李旸林雯陈晨廖祥茹陈鹰( 广州军区武汉总医院药剂科武汉; 湖北省黄石市
爱康医院检验科)
Box-Behnken
摘要目的:制备坎地沙坦酯片并优化处方,并对其进行初步稳定性考察。方法:采用试验设计,以填充剂配
% % % % min
比(X1 )、崩解剂(X2 , )和润滑剂(X3 , )用量为影响因素,以片重差异(Y1 , )、脆碎度(Y2 , )、崩解时限(Y3 , )、坎地沙
% f
坦酯溶出度(Y4 , )为片剂考察指标,得到最优处方;采用 2 相似因子法评价自制制剂和参比制剂在溶出介质中的体外溶出
行为。通过高温、高湿、光照试验初步考察制剂稳定性。结果:坎地沙坦酯片的最优处方组成为:填充剂一水乳糖与预交化淀
7: 1 5. 5% 0. 5% 4
粉比例为、崩解剂交联羧***纤维素钠占片重为,润滑剂硬脂酸镁占片重为。自制片剂和参比制剂在种溶
f 60. 62 73. 34 66. 95 68. 60
出介质中的累积溶出度相似因子 2 分别为, , , 。结论:制备的坎地沙坦酯片各项指标均符合规定,
工艺稳定可靠。
Box-Behnken
关键词坎地沙坦酯; 试验设计;脆碎度;崩解时限;溶出度
R944. 4 A 1008-049X 2015 04-0664-05
中图分类号: 文献标识码: 文章编号: ( )
Preparation and Preliminary Stability of Candesartan Cilexetil Tablets
Xie Xiangyang1 Li Yang1 Lin Wen2 Chen Chen1 Liao Xiangru1 Chen Ying1 1. Department of Pharmacy Wuhan General Hospi-
, , , , , ( ,
tal of Guangzhou mand Wuhan 430070 China 2. Department of Clinical Laboratory Huangshi Love and Health Hospital
, , ; ,
of Hubei Province
)
To prepare and optimize candesartan cilexetil tablets and study the stability preliminarily. The
ABSTRACT Objective: , Methods:
formula was optimized by Box-Behnken experiment design the ratio of lactose to pregelatinized starch the amount of disintegrant
, (X1 ),
% and the amount of lubricant % were selected as the independent variables and weight difference