盐酸双苯氟嗪单层芯渗透泵控释片的研制

目的:研制盐酸双苯氟嗪(DH)单层芯渗透泵控释片,并考察各因素对其体外释放度的影响。方法:以醋酸纤维素等为包衣材料制备DH单层芯渗透泵控释片,采用相似因子(f2)法考察片芯中助溶剂的种类、致孔剂聚乙二醇6000用量及包衣增重各因素对药物释放度的影响,确定最佳处方并进行验证。结果:各考察因素均为影响药物释放的主要因素(f2值均小于60),确定酒石酸3%和;丁所二制酸3(批6制5∶剂13在0)1为2助h内溶释剂药,采速用率醋基酸本纤恒维定素,呈与现聚良乙好二的醇零60级00(释1放0∶特1)征混(合r=作0为.99包6衣3)膜。组结成论,:致DH孔单剂层用芯量渗为透1泵0%控,释包片衣工增艺重稳为定,符合控释片要求。

Research and Preparation of Dipfluzine Hydrochloride Monolithic Osmotic Pump Controlled-release Tablets

OBJECTIVE： To prepare Dipfluzine hydrochloride （DH） monolithic osmotic pump controlled-release tablets and to investigate the effects of factors on drug release in vitro. METHODS： DH monolithic osmotic pump controlled-release tablets were prepared and coated with cellulose acetate. Similarity factor was used to study the influence of types of cosolvent, the amount of porosity-making agent PEG 6000, and thickness of coating on drug membrane release to determine and validate the optimal method. RESULTS： Above factors were all main influential factors of drug release （f2〈60）, the adjuvant solution were tartaric acid and succinic acid （65：130）, the composition of coating membrane were cellulose acetate and PEG 6000 （10：1）, the amount of PEG 6000 was 10%, the weight of coating membrane was 3%. 3 batches of prepared tablets released steadily in 12 h, showing zero-order release characteristics （r=0.996 3）. CONCLUSION： DH monolithic osmotic pump controlled-release tablets are stable in preparation technology and meet the requirements of controlled-release tablets.