依折麦布包合物口腔崩解片的制备及体外溶出
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摘要
目的:制备依折麦布包合物口腔崩解片,对其质量进行评价。方法:依折麦布与HP-β-CD用旋转蒸发法制成包合物,正交法选择崩解剂后制成口腔崩解片,考察包合物崩解片的体外溶出度。结果:依折麦布包合物包封率和载药量分别为71.12%、18.52%,以MCC、PVPP、L-HPC为崩解剂制成的崩解片累积溶出度101.49%。结论:选定的方法和辅料可用于制备依折麦布HP-β-CD包合物口腔崩解片,体外溶出符合要求。
Objective:To prepare the orally disintegrating tablets of ezetimibe inclusion complex and quality evaluation of it.Methods:The ezetimibe was prepared HP-β-CD inclusion complex with rotary evatoration,the disintegrating agent was determined by orthogonal design method, In Vitro dissolving were examined of orally disintegrating tablets of ezetimibe inclusion complexes.Results:The encapsulation efficiency and drug loading capacity of ezetimibe inclusion complex was 71.12%、18.52%,the cumulative dissolution with MCC、PVPP、L-HPC as material preparation of orally disintegrating tablets is 101.49%.Conclusion:The selected accessory can be used for the preparation of orally disintegrating of ezetimibe inclusion complex and up to the standard of In Vitro dissolving.
Objective:To prepare the orally disintegrating tablets of ezetimibe inclusion complex and quality evaluation of it.Methods:The ezetimibe was prepared HP-β-CD inclusion complex with rotary evatoration,the disintegrating agent was determined by orthogonal design method, In Vitro dissolving were examined of orally disintegrating tablets of ezetimibe inclusion complexes.Results:The encapsulation efficiency and drug loading capacity of ezetimibe inclusion complex was 71.12%、18.52%,the cumulative dissolution with MCC、PVPP、L-HPC as material preparation of orally disintegrating tablets is 101.49%.Conclusion:The selected accessory can be used for the preparation of orally disintegrating of ezetimibe inclusion complex and up to the standard of In Vitro dissolving.
引文
[1]陈玉环,文轶,林丽莉.依折麦布辅助治疗对冠心病合并高胆固醇血症患者颈动脉粥样硬化斑块的影响[J].现代医院,2015,15(1):53-55.
[2]方钊,蒋学俊,陶波,等.依折麦布及其应用的进展[J].广西医学,2017,38(7):983-986.
[3]王娜,车晓侠,李楠.相溶解度法研究羟丙基-β-环糊精对淫羊藿苷的增溶作用[J].西北药学杂志,2013,28(6):617-618.
[4]崔颖,耿立坚,赵瑛.氯氮平HP-β-环糊精包合物及其口腔崩解片的制备与评价[J].中南药学,2015,13(12):1277-1281.
[5]周洁,蒋曙光,周建平.卡维地洛羟丙基-β-环糊精包合物的制备与评价[J].中国现代应用药学,2012,29(6):516-519.
[6]王璐璐,郑稳生,陈少华,等.棓丙酯-羟丙基-β-环糊精包合物的研制[J].中国新药杂志,2013,22(11):1337-1340.
[7]MULYE S P,JAMADAR S A,KAREKAR P S,et al.Improvement in physicochemical properties of ezetimibe using a crystal engineering technique[J].Power Tech-nology,2012,222(5):131-138.
[8]程静,张友智.盐酸黄连素HP-β-环糊精包合物及其口腔崩解片的制备与评价[J].解放军药学学报,2016,32(5):387-391.
[9]Minura K,Kanada K,Uchida S,et al.Formulation study for orally disintegrating tablet using partly pregelatinized starch binder[J].Chem Pharm Bull(Tokyo),2011,59(8):564-569.
[10]邱思捷.高效液相法测定依折麦布片的含量[J].广州化工,2012,40(16):134-135.
[11]国家药典委员会.中华人民共和国药典(四部)[S].北京:中国医药科技出版社,2015:121-124.
[12]蔡双霜,黄华,陈莉.羟丙基-β-环糊精的应用发展[J].中国药业,2008,17(10):78-79.
[13]易蕾,程德珍.硫辛酸口腔崩解片的制备及质量研究[J].中国药房,2015,26(28):3983-3985.
[2]方钊,蒋学俊,陶波,等.依折麦布及其应用的进展[J].广西医学,2017,38(7):983-986.
[3]王娜,车晓侠,李楠.相溶解度法研究羟丙基-β-环糊精对淫羊藿苷的增溶作用[J].西北药学杂志,2013,28(6):617-618.
[4]崔颖,耿立坚,赵瑛.氯氮平HP-β-环糊精包合物及其口腔崩解片的制备与评价[J].中南药学,2015,13(12):1277-1281.
[5]周洁,蒋曙光,周建平.卡维地洛羟丙基-β-环糊精包合物的制备与评价[J].中国现代应用药学,2012,29(6):516-519.
[6]王璐璐,郑稳生,陈少华,等.棓丙酯-羟丙基-β-环糊精包合物的研制[J].中国新药杂志,2013,22(11):1337-1340.
[7]MULYE S P,JAMADAR S A,KAREKAR P S,et al.Improvement in physicochemical properties of ezetimibe using a crystal engineering technique[J].Power Tech-nology,2012,222(5):131-138.
[8]程静,张友智.盐酸黄连素HP-β-环糊精包合物及其口腔崩解片的制备与评价[J].解放军药学学报,2016,32(5):387-391.
[9]Minura K,Kanada K,Uchida S,et al.Formulation study for orally disintegrating tablet using partly pregelatinized starch binder[J].Chem Pharm Bull(Tokyo),2011,59(8):564-569.
[10]邱思捷.高效液相法测定依折麦布片的含量[J].广州化工,2012,40(16):134-135.
[11]国家药典委员会.中华人民共和国药典(四部)[S].北京:中国医药科技出版社,2015:121-124.
[12]蔡双霜,黄华,陈莉.羟丙基-β-环糊精的应用发展[J].中国药业,2008,17(10):78-79.
[13]易蕾,程德珍.硫辛酸口腔崩解片的制备及质量研究[J].中国药房,2015,26(28):3983-3985.