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目的:制备卡托普利缓释微丸,并对其处方工艺因素进行考察。方法:选用尤特奇RS 30 D与尤特奇RL 30 D的混合物作为包农缓释材料,采用溶液层积法、流化床底喷方式,进行空白丸芯的上药和缓释包衣;并考察缓释聚合物尤特奇RS 30D与尤特奇RL 30D的不同比例、包衣增重,以及增塑剂用量对药物释放的影响。结果:当尤特奇RS 30D与尤特奇RL 30D的比例为4:1,包衣增重为10%,增塑剂用量为20%时,所制得的缓释微丸具有较好的缓释效果,在1、4和8 h的累积释放率分别为标示量的20%～35%,40%～65%和75%以上。结论:通过调整尤特奇RS 30D与尤特奇RL 30D之间的比例,或提高聚合物包衣增重等手段,能使卡托普利栽药微丸具备较理想的缓释效果。
OBJECTIVE: To prepare captopril sustained-release pellets and study its prescription factors. Methods: The mixture of Eudragit RS 30 D and Eudragit RL 30 D was used as the package-release material. The solution-laydown method and the fluidized bed bottom spray method were used to coat the blank pellets and the sustained-release coating ; And investigated the different proportions of the extended release polymers Eudragit RS 30D and Eudragit RL 30D, the weight gain of the coating, and the effect of plasticizer dosage on the drug release. RESULTS: When the ratio of Eudragit RS 30D to Eudragit RL 30D was 4: 1, the coating weight gain was 10% and the amount of plasticizer was 20%, the sustained-release pellets prepared had better The release rate of sustained-release effect was 20% -35%, 40% -65% and 75% of the labeled amount at 1,4 and 8 h, respectively. CONCLUSIONS: Captopril-loaded pellets have better sustained-release properties by adjusting the ratio between the Eudragit RS 30D and the Eudragit RL 30D or increasing the weight gain of the polymer coating.