CAJ | 학술논문

目的：：对西罗莫司( SRL)滴丸进行薄膜包衣,以期达到防潮的目的。方法：选用欧巴代?为SRL滴丸的包衣材料,对其使用溶剂、欧巴代浓度、增重及包衣工艺参数进行筛选,确定包衣处方及工艺；测定包衣SRL滴丸的临界相对湿度,并与未包衣SRL滴丸进行比较。结果：选用95%的乙醇作为溶剂系统,其中欧巴代的浓度为6.5%,增重为4%,进风温度为(35±2)℃,进液速度为12 ml·min-1,喷雾压力为3.0 MPa。包衣SRL滴丸的临界相对湿度为63.1%,明显高于未包衣SRL滴丸(36.1%)。结论：欧巴代薄膜包衣可明显提高SRL滴丸的防潮性能,有利于其稳定性。
목적：：대서라막사( SRL)적환진행박막포의,이기체도방조적목적。방법：선용구파대?위SRL적환적포의재료,대기사용용제、구파대농도、증중급포의공예삼수진행사선,학정포의처방급공예；측정포의SRL적환적림계상대습도,병여미포의SRL적환진행비교。결과：선용95%적을순작위용제계통,기중구파대적농도위6.5%,증중위4%,진풍온도위(35±2)℃,진액속도위12 ml·min-1,분무압력위3.0 MPa。포의SRL적환적림계상대습도위63.1%,명현고우미포의SRL적환(36.1%)。결론：구파대박막포의가명현제고SRL적환적방조성능,유리우기은정성。
Objective:To coat sirolimus ( SRL) dropping pills with a membrane to enhance the ability of moisture proof. Meth-ods:Opadry was chosen as the coating material. The solvent, concentration and weight gain of the coating membrane were defined, and the coating parameters were screened. The critical relative humidity ( CRH%) of membrane-coating SRL dropping pills was detec-ted and compared with that of SRL dropping pills without coating. Results: The formula and coating parameters of membrane-coating SRL dropping pills were as follows:95% ethanol was used as the solvent, Opadry concentration was 6. 5%, the weigh gain was 4%, the inlet air temperature was (35 ± 2)℃, the inlet fluid rate was 12 ml·min-1 and the spraying pressure was 3. 0 MPa. The CRH%of memebrane-coating SRLs dropping pills was 63. 1%, which was much higher than that of uncoated SRL dropping pills (36. 1%). Conclusion:The membrane-coating can enhance the moisture proof of SRL dropping pills, which is beneficial to the stability.