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目的:制备两面针缓释微丸。方法:采用离心造粒粉末层积法制备两面针微丸。主要考察因素有主机转盘转速、喷浆泵转速、供粉速度、喷枪雾化条件、抛光时间、包衣层增重。首先制备两面针药材提取物与微晶纤维素含药素丸,并在此基础上进行丙烯酸树脂水分散体(Eudragit NE30D)包衣,并对包衣微丸的释药特征进行探讨。结果:在微丸起模过程中主机转速、粘合剂的加入速度和加入量、喷枪喷雾条件对起模微丸的收率具有较为显著的影响。在成丸的工艺过程中,对微丸收率影响的主要因素为喷浆速度与供粉速度,微丸成丸的最佳工艺参数为:两面针药材提取物与微晶纤维素的比例是8∶1,粘合剂为4%羟丙基甲基纤维素,主机转速250 r/min,鼓风流量12×20 L/min,喷气压力为0.5 MPa,喷气流量为12 L/min,浆泵转速为16 r/min,供粉速度为50 r/min。3批样品放大试验,测得含药微丸、包衣微丸的收率分别是94.2%、96.4%,两面针缓释微丸胶囊体外释药行为较好地符合0级方程。结论:采用离心造粒法在优化的工艺条件下可制得表面光滑、圆整度高的两面针缓释微丸。
Objective: Preparation of two-way needle sustained-release pellets. Methods: Two-sided needle pellets were prepared by centrifugal granulation powder layering. The main factors to be investigated are the rotating speed of the host turntable, the speed of the shotcrete pump, the speed of the powder supply, the atomizing condition of the spray gun, the polishing time and the weight gain of the coating. Firstly, two-sided needle medicinal material extract and microcrystalline cellulose containing medicinal pellets were prepared, and then coated with an aqueous solution of acrylic resin (Eudragit NE30D), and the drug release characteristics of the coated pellets were discussed. Results: The main engine speed, the adding speed of the adhesive and the addition amount of the adhesive during the process of pellet dieting, spray gun spray conditions have a significant impact on the yield of the pellet. In the pill process, the main factors affecting the yield of pellets are the spraying speed and the feeding speed. The optimum process parameters of the pellet pellets are as follows: the ratio of the two-sided needle medicinal material extract to the microcrystalline cellulose is 8: 1 binder, 4% hydroxypropyl methylcellulose binder, main engine speed 250 r / min, blow air flow 12 × 20 L / min, jet pressure 0.5 MPa, jet flow 12 L / min, The pump speed is 16 r / min and the feed rate is 50 r / min. Three batches of sample amplification test, the measured drug-containing pellets, coated pellets yield was 94.2%, 96.4%, two-way needle release capsules in vitro release behavior better in line with the 0 equation. Conclusion: Centrifugal granulation method can be made under the optimized process conditions.