氯尼达明微粉化片剂的处方研究  

Study on the formulation of micronized lonidamine tablets

作　　者：陈东宇[1] 宋俊生[1] 徐成[1] 

机构地区：[1]江苏吴中苏药医药开发有限责任公司,南京210009

出　　处：《药学与临床研究》2007年第1期32-34,共3页Pharmaceutical and Clinical Research

摘　　要：目的:氯尼达明水溶性差,本文旨在研制其微粉化片剂处方并考察其稳定性。方法:使用球磨机制备氯尼达明微粉化混合物,并以此添加适合的辅料制备片剂。结果:经过溶出度试验,制剂达到了《中国药典》对溶出度的要求。初步稳定性研究表明,该制剂在60℃、相对湿度75%、4500Lax光照条件下10天稳定。结论:研制的氯尼达明片达到了设计要求。Objective： Lonidamine is limited in their therapeutic value by properties such as low water solubility, poor bioavailability. In this work, we set to resolve this problem by preparing the micronized lonidamine tablet with appropriate adjuvants. Methods： Micronized lonidamine was made by using mall mill, and other adjuvants were screened to observe the optimal dissolution characteristics of the tablets. Results： The dissolution profiles obtained have shown to be accord with China Pharmacopia. The tablets were proved to be stable under light 4500 Lax, 75% RH and 60℃ for 10days. Conclusion： The solubility and the formulation achieve the design goal.

关 键 词：微粉化 氯尼达明 溶出度 

分 类 号：R944.4[医药卫生—药剂学]