CAJ | 학술논문

目的：探讨薄膜包衣对西罗莫司( SRL)滴丸溶出度及稳定性的影响，以证实薄膜包衣的作用及合理性。方法：选用欧巴代?为SRL滴丸的包衣材料进行包衣；对其体外释药及稳定性进行考察，并与未包衣的SRL滴丸进行比较。结果：与未包衣滴丸相比，在相同时间内，薄膜包衣SRL滴丸的体外释药量明显降低(P<0.05)，而稳态释药速率并无显著影响(P>0.05)；高湿条件下(75%±5%)包衣SRL滴丸的吸湿性显著下降，在强光环境中(4500 lx ±500 lx)，包衣SRL滴丸的稳定性也较好，而在高温条件下(40℃±2℃)，稳定性无显著提高。结论：欧巴代薄膜包衣可明显提高SRL滴丸的稳定性，而对其药物溶出无显著性影响。
목적：탐토박막포의대서라막사( SRL)적환용출도급은정성적영향，이증실박막포의적작용급합이성。방법：선용구파대?위SRL적환적포의재료진행포의；대기체외석약급은정성진행고찰，병여미포의적SRL적환진행비교。결과：여미포의적환상비，재상동시간내，박막포의SRL적환적체외석약량명현강저(P<0.05)，이은태석약속솔병무현저영향(P>0.05)；고습조건하(75%±5%)포의SRL적환적흡습성현저하강，재강광배경중(4500 lx ±500 lx)，포의SRL적환적은정성야교호，이재고온조건하(40℃±2℃)，은정성무현저제고。결론：구파대박막포의가명현제고SRL적환적은정성，이대기약물용출무현저성영향。
Objective:To study the effect of membrane-coating on dissolution and stability of sirolimus ( SRL) dropping pills to prove the effect and rationality of the coating process. Methods:Opadry was used as the coating material for SRL dropping pills. Com-pared with those of uncoated SRL dropping pills, the dissolution and stability of membrane-coating SRL dropping pills were studied in vitro. Results:Compared with that of uncoated SRL dropping pills, the drug release amount of membrane-coating SRL dropping pills was lower (P<0. 05), however, the stable release rate showed no significant difference (P>0. 05). After the membrane-coating, the stability of SRL dropping pills was notable enhanced under high humidity (75% ± 5%) and strong light (4500lx ± 500lx) conditions, however, the stability showed no improved under high temperature(40℃ ± 2℃) condition. Conclusion: The membrane-coating can enhance the stability of SRL dropping pills without significant effect on drug release in vitro.