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目的:考察影响双氯芬酸钠乙基纤维素水性分散体包衣片体外释药的因素。方法:以乙基纤维素水性分散体为包衣材料、双氯芬酸钠为模型药物,考察增塑剂的用量、膜厚、后处理温度和时间对双氯芬酸钠包衣片体外释药的影响。结果:增塑剂用量越大释药越慢;用量不足时成膜不完全,药物释放快;用量过大,产生粘连现象。膜厚增加,药物释放慢;过厚则出现时滞现象。后处理温度增加,药物释放变慢,后处理温度一般选择高于最小成膜温度10℃左右。后处理时间增加,药物释放变慢,到达一定时间后,趋于稳定。结论:乙基纤维素水性分散体可作为缓释衣膜材料。增塑剂用量、衣膜厚度、后处理温度、后处理时间等因素均影响药物的释放
Objective: To investigate the factors affecting the in vitro release of diclofenac sodium ethylcellulose aqueous dispersion coated tablets. Methods: The aqueous dispersion of ethylcellulose as coating material and diclofenac sodium as model drug were used to investigate the effect of dosage of plasticizer, film thickness, post-treatment temperature and time on the in vitro release of diclofenac sodium coated tablets. Results: The larger the dosage of plasticizer, the slower the release of drug. When the dosage was insufficient, the film was incomplete and the release of drug was fast. The dosage was too large, causing the phenomenon of adhesion. Increased film thickness, drug release slow; too thick there is the phenomenon of lag. Post-treatment temperature increases, the drug release slows down, post-treatment temperature is generally higher than the minimum film-forming temperature of about 10 ℃. Post-treatment time increased, drug release slowed, reaching a certain time, tends to be stable. Conclusion: Ethylcellulose aqueous dispersions can be used as sustained-release membrane materials. Plasticizer dosage, film thickness, post-processing temperature, post-processing time and other factors are the impact of drug release