摘要
目的 筛选适合渗透型丙烯酸树脂EudragitRS10 0膜控释包衣的增塑剂。方法 通过测定膜玻璃化转变温度 (Tg)、膜水化前后两种状态的力学性能 ,研究不同增塑剂的增塑效率 ;用溶出度和水平扩散池法考察增塑剂从介质中溶出 ;用加速试验考察贮存时增塑剂的损失。结果 Tg显示EudragitRS10 0具较强增塑剂相容性 ,水溶性增塑剂三醋酸甘油酯 (TR)和水不溶性增塑剂邻苯二甲酸二丁酯 (DBP)等均有较高增塑效率 ;膜水化前后力学性能变化显著 ,水溶性增塑剂遇介质从膜中快速溶出使湿膜脆碎 ,而水不溶性增塑剂则相对稳定 ;于 (4 0± 1)℃、相对湿度 (RH)75 %下贮存 40d ,膜TR损失达 6 46 % ,而DBP仅损失 0 2 9%。结论 DBP等水不溶性增塑剂是较理想的EudragitRS10
AIM To screen plasticizers type in free controlled release coating membranes of osmotic acrylic resin Eudragit RS100. METHODS The efficiency of plasticizations was evaluated with respect to different types and levels of plasticizers by measuring glass transition temperature and mechanical properties of membranes in the dry and wet state. The leaching of plasticizers in simulated intestinal fluid was investigated by a dissolution method and a horizontal diffusion cell method. The loss of plasticizers was determined by using accelerated tests method. RESULTS The glass transition temperatures of plasticized Eudragit RS100 membranes suggest that Eudragit RS100 has good compatible with plasticizers and that triacetin and dibutyl phthalate have stronger plasticizers efficiency. The mechanical properties of the polymeric membranes before and after hydrated vary markedly. The water soluble plasticizers leached from the membranes during exposure to the aqueous medium, while the water insoluble plasticizers were almost completely retained within the wet membranes. The plasticizers amounts in the membranes demonstrated a triacetin loss of 6 46% and a dibutyl phthalate loss of 0 29% from the initial amount added after 40 days in (40±1)℃ and 75% RH conditions. CONCLUSION The water insoluble plasticizers such as dibutyl phthalate are more suitable to Eudragit RS100 controlled released coating membranes.
出处
《药学学报》
CAS
CSCD
北大核心
2001年第12期937-941,共5页
Acta Pharmaceutica Sinica
