摘要
采用湿法制粒工艺制备阿托伐他汀钙(1)分散片。通过稳定性试验(25℃,相对湿度75%),以1含量和30 min时溶出率为指标,考察了处方中碳酸钙含量对1稳定性的影响。结果表明,碳酸钙含量为22%时片剂中1的稳定性和溶出率均较高。采用正交试验优化了分散片处方中崩解剂用量和加入方式,以及黏合剂用量。优化后1分散片崩解时间约100 s,溶出行为与市售品京舒相似。
The atorvastatin calcium（1） dispersible tablets were prepared by wet granulation method. The influence of calcium carbonate amount was investigated with drug content and dissolution at 30 min of 1 from the tablets stored under the conditions of 25 ℃ and relative humidity of 75% as indexes. The results showed that the tablets containing 22% calcium carbonate were rather stable and had a high dissolution rate. The amount and joining way of disintegrating agent and adhesive amount were optimized by orthogonal experiment. The optimal 1 dispersible tablets could disintegrate within 100 s, and the dissolution behavior of 1 was similar to the commercial product（Jing shu）.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2016年第4期430-432,共3页
Chinese Journal of Pharmaceuticals
关键词
阿托伐他汀钙
分散片
碳酸钙
稳定性
溶出
atorvastatin calcium
dispersible tablet
calcium carbonate
stability
dissolution
