摘要
目的研制成一种新型鼠用十一酸睾酮缓释的硅橡胶睾丸假体，并对其进行体外释放实验验证其有效性。方法医用硅橡胶作为缓释型睾丸假体的药物控释载体材料，将其与十一酸睾酮粉剂结合，充分混匀后在成型模具中固化成椭圆型睾丸假体的药物区，为加强其缓释效果，在药物区外包裹双层硅橡胶控释层。结果本实验共研制3种剂型的十一酸睾酮缓释的硅橡胶睾丸假体，在体外实验中，3种剂型的睾丸假体到第7天时释放量趋于平稳，第7天后，分别每天释放100μg、200μg、300μg十一酸睾酮，且观察30d内，这3种剂型的十一酸睾酮缓释睾丸假体均可稳定释出各自恒定的剂量30d以上。结论新型双层控释层的十一酸睾酮缓释的硅橡胶睾丸假体建模和制作工艺简单，造价低廉，体外释放实验表明缓释效果良好，释放量稳定且可持续释放较长的时间。该十一酸缓释睾丸假体的体内有效性和安全性还需进一步动物实验研究。
Objective To develop a undecanoate testosterone sustained release silastic testicular prosthesis, and verify its effectiveness in vitro. Methods Medical silastic, as the controlled-release drug delivery materials of a sustained release testicular prosthesis, was mixed with testosterone undecanoate powder, then cured into the district of elliptic testicular prosthesis in the mold. In order to strengthen its sustained-release effect, the double silastic controlled-release layers were wrapped to the drug area outside. Results Three formulation undecanoate testosterone sustained released silastic testicular prostheses were developed in this study. In in vitro experiments, the three formulations of testicular prosthes were stabilized to release undecanoate on the 7th day.The daily release was 100 μg, 200 μg and 300 μg of testosterone undecanoate respectively and they could sustainable steady release during the 30 testing days. Conclusion Establishement of a new double release layer undecanoate sustained released silastic testicular prosthesis is simple and lower cost. It can sustainably release for a long time in release test in vitro. The efficacy and safety ofundecanoate sustained release testicular prosthesis needs to be further identified in animal experiments in vivo.
出处
《中国男科学杂志》
CAS
CSCD
北大核心
2012年第6期21-24,共4页
Chinese Journal of Andrology
基金
基金项目资助：上海市科委重大科研项目（基金编号09DJ1400400）资助
关键词
睾丸缺失
睾酮
睾丸假体
testis missing
testosterone
testicular prosthesis
