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采用空白丸芯上药和流化床包控释衣制备盐酸伪麻黄碱缓释小丸,再包以盐酸非索非那定药层和隔离层,得标题胶囊。引入质量源于设计(Qb D)理念,采用Box-Behnken Design-响应面法(BBD-RSM)优化盐酸伪麻黄碱缓释小丸的关键参数,即羟丙甲纤维素(HPMC)隔离层增重、控释层包衣液中乙基纤维素(EC)与HPMC的质量比及控释层增重。结果表明,缓释小丸的隔离层增重为2%、EC与HPMC比例为350∶1、控释层增重为17.5%时,其中的盐酸伪麻黄碱释放符合拟定的释放标准。由此制备的复方缓释胶囊符合拟定的标准,工艺稳定、可行。
The preparation of pseudoephedrine hydrochloride sustained-release pellets with blank pill core drug and fluidized bed controlled release coating, and then coated with fexofenadine hydrochloride and isolation layer to obtain the title capsule. (QbD) was introduced to optimize the key parameters of pseudoephedrine hydrochloride sustained-release pellets by Box-Behnken Design-Response Surface Methodology (BBD-RSM), that is, the weight gain of hypromellose (HPMC) The mass ratio of ethylcellulose (EC) to HPMC in the layer of coating solution and weight gain of controlled release layer. The results showed that the released release of pseudoephedrine hydrochloride in the sustained-release pellets was 2%, the ratio of EC to HPMC was 350:1, and the weight gain of the controlled-release layer was 17.5%. The prepared sustained-release compound capsules meet the proposed standard, the process is stable and feasible.