CAJ | 학술논문

目的制备纳米骨架型辛伐他汀固体制剂,并对其处方进行优化,以增加辛伐他汀的体外溶出度. 方法以胶体与药物比值( A)、聚合物和药物比值( B)、胶体种类( C)、聚合物种类( D)作为4个因素,因素A与B的3个水平分别为1:1、1:3、1:5,因素C的3个水平分别为A200、A300、A200+A300(1:1),因素D的3个水平分别为PVP、Eudragit L100、Eudragit L100-55,采用正交试验设计法进行试验安排,以各制剂在pH6. 8磷酸盐缓冲液(含0. 3% SDS)中辛伐他汀的溶出度为评价指标,进行处方优化. 结果本实验所优化的纳米骨架型辛伐他汀固体制剂的处方为:药物:A200+A300:PVP为1:3:3,该处方中辛伐他汀体外溶出速率最快. 结论与辛伐他汀片剂(舒降之?)相比,按照最优制备的纳米骨架型辛伐他汀固体制剂可显著增加药物的体外溶出度.
목적 제비납미골가형신벌타정고체제제,병대기처방진행우화,이증가신벌타정적체외용출도. 방법 이효체여약물비치( A)、취합물화약물비치( B)、효체충류( C)、취합물충류( D)작위4개인소,인소A여B적3개수평분별위1:1、1:3、1:5,인소C적3개수평분별위A200、A300、A200+A300(1:1),인소D적3개수평분별위PVP、Eudragit L100、Eudragit L100-55,채용정교시험설계법진행시험안배,이각제제재pH6. 8린산염완충액(함0. 3% SDS)중신벌타정적용출도위평개지표,진행처방우화. 결과 본실험소우화적납미골가형신벌타정고체제제적처방위:약물:A200+A300:PVP위1:3:3,해처방중신벌타정체외용출속솔최쾌. 결론 여신벌타정편제(서강지?)상비,안조최우제비적납미골가형신벌타정고체제제가현저증가약물적체외용출도.
Objective In order to increase the dissolution of simvastatin in vitro, a novel nano-matrix solid drug delivery system of simvastatin was prepared and the formulation was optimized. Methods The formulations were optimized by orthogonal experimental design, the ratio of colloid to drug(A), the ratio of polymer to drug( B) , types of colloid( C) and polymer( D) as the four factors and the three levels settled as 1:1, 1:3, 1:5 for A and B, A200, A300, A200+A300 for C, PVP, Eudragit L100, Eudragit L100-55 for D, the dissolution of simvastatin in vitro in the medium of pH 6. 8 phosphalated buffer (0. 3 % SDS) as the evaluation index. Results The optimized formulation was as follow:drug:A200+A300:PVP=1:3:3. The dissolution of simvastatin in the optimized formulation was the best. Conclusion Compared with the tablet ( shujiangzhi? ) , nano-matrix drug delivery system of simvastatin prepared according to the optimized formulation could significantly increase the drug dissolution in vitro.