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采用单因素法筛选了盐酸氟西汀肠溶片片芯、隔离层包衣液和肠溶衣包衣液的处方。结果表明,片芯中的关键辅料羟丙甲纤维素E50、羧甲淀粉钠和微晶纤维素的用量分别为5%、15%和25%,黏合剂宜采用5%淀粉浆。以5%欧巴代Y-1-7000水分散体对所得片芯包隔离衣层,增重为1%,再以5%聚丙烯酸树脂L30D-55(含5%单硬脂酸甘油酯和1%甘露醇)包肠溶衣层,增重为3%。所得制品在0.1 mol/L盐酸中2 h累积释放率≤5%,在pH 6.8缓冲液中30 min释放完全。3批制品的体外释放曲线均与参比制剂(Prozac Weekly胶囊)相似,相似因子(f2)均大于50。
The single-factor method was used to screen the formulation of fluoxetine hydrochloride enteric-coated tablets, isolation coating and enteric coating. The results showed that the dosage of hypromellose E50, sodium starch glycolate and microcrystalline cellulose were 5%, 15% and 25%, respectively, and 5% starch paste was recommended as the binder. The resulting cores were covered with a 5% aqueous dispersion of Opadry Y-1-7000 with a weight gain of 1% and then with 5% polyacrylic resin L30D-55 (containing 5% glycerol monostearate and 1% mannitol) enteric coating, weight gain of 3%. The resulting product had a cumulative release rate of ≤5% in 0.1 mol / L hydrochloric acid for 2 h and was completely released in pH 6.8 buffer for 30 min. The in vitro release profiles of all three batches were similar to those of the reference formulation (Prozac Weekly Capsule) and the similarities (f2) were all greater than 50.