中国药师
中國藥師
중국약사
CHINA PHARMACIST
2014年
9期
1451-1453,1454
,共4页
右旋酮洛芬%肠溶微丸%流化床包衣
右鏇酮洛芬%腸溶微汍%流化床包衣
우선동락분%장용미환%류화상포의
Dexketoprofen%Enteric-coated pellets%Fluid-bed coating
目的：制备右旋酮洛芬肠溶微丸，并考察其在0.1 mol·L-1盐酸溶液和pH 6.8磷酸缓冲液( PBS)中的释放情况。方法：采用流化床包衣技术，在空白糖丸芯上依次包主药层、隔离层和肠溶衣层，制备成肠溶衣微丸；以上药率为指标，考察HPMC浓度和主药上药浓度；观察是否粘连、颗粒大小均一度和表面色泽均匀与否等综合指标，采用正交试验优选包衣工艺条件；与普通肠溶片比较在PBS中的释放情况。结果：制得的微丸上药均匀、上药率高、外观圆整有光泽；确定HPMC浓度和主药上药浓度分别为5%和15%，优选出最佳包衣工艺条件为物料温度为36℃、雾化压力为1.0 bar及喷枪速度为0.8 ml · min-1；在盐酸溶液中2 h的释放量小于10%，在PBS中的释放度高于普通肠溶片。结论：所制右旋酮洛芬肠溶微丸工艺可行，具有良好的耐酸性和体外释放度。
目的：製備右鏇酮洛芬腸溶微汍，併攷察其在0.1 mol·L-1鹽痠溶液和pH 6.8燐痠緩遲液( PBS)中的釋放情況。方法：採用流化床包衣技術，在空白糖汍芯上依次包主藥層、隔離層和腸溶衣層，製備成腸溶衣微汍；以上藥率為指標，攷察HPMC濃度和主藥上藥濃度；觀察是否粘連、顆粒大小均一度和錶麵色澤均勻與否等綜閤指標，採用正交試驗優選包衣工藝條件；與普通腸溶片比較在PBS中的釋放情況。結果：製得的微汍上藥均勻、上藥率高、外觀圓整有光澤；確定HPMC濃度和主藥上藥濃度分彆為5%和15%，優選齣最佳包衣工藝條件為物料溫度為36℃、霧化壓力為1.0 bar及噴鎗速度為0.8 ml · min-1；在鹽痠溶液中2 h的釋放量小于10%，在PBS中的釋放度高于普通腸溶片。結論：所製右鏇酮洛芬腸溶微汍工藝可行，具有良好的耐痠性和體外釋放度。
목적：제비우선동락분장용미환，병고찰기재0.1 mol·L-1염산용액화pH 6.8린산완충액( PBS)중적석방정황。방법：채용류화상포의기술，재공백당환심상의차포주약층、격리층화장용의층，제비성장용의미환；이상약솔위지표，고찰HPMC농도화주약상약농도；관찰시부점련、과립대소균일도화표면색택균균여부등종합지표，채용정교시험우선포의공예조건；여보통장용편비교재PBS중적석방정황。결과：제득적미환상약균균、상약솔고、외관원정유광택；학정HPMC농도화주약상약농도분별위5%화15%，우선출최가포의공예조건위물료온도위36℃、무화압력위1.0 bar급분창속도위0.8 ml · min-1；재염산용액중2 h적석방량소우10%，재PBS중적석방도고우보통장용편。결론：소제우선동락분장용미환공예가행，구유량호적내산성화체외석방도。
Objective:To prepare dexketoprofen enteric-coated pellets and explore the drug release rate respectively in 0. 1 mol· L-1 hydrochloric acid and phosphate buffered saline(PBS,pH 6. 8). Methods:Dexketoprofen enteric-coated pellets were prepared u-sing fluid-bed coating technology, the blank sugar pellets were coated with drug layer, isolation layer and enteric layer in order. Drug-loading rate as the index, the optimal concentrations of HPMC and drug were screened. Such indicators as adhesion, pellet uniform and surface color as the indices, the coating process was optimized by orthogonal experiment. Drug release in PBS of the enteric-coated pel-lets and the common enteric-coated tablets were compared. Results:The prepared pellets showed the properties of uniform drug load-ing, high drug-loading rate, complete round shape and lustrous appearance. The concentration of HPMC and drug was 5% and 15%, respectively. The optimal coating process was as follows:the material temperature was 36℃, the atomization pressure was 1. 0 bar and the airbrush rate was 0. 8 ml·min-1 . The drug release of the pellets in hydrochloric acid was below 10% in 2 hours, while the release in PBS was greater than that of the common enteric-coated tablets. Conclusion: The prepared enteric-coated pellets are feasible in technology, and exhibit satisfactory acid endurance and drug release in vitro.
