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医学硕士论文

洛索洛芬钠渗透泵型控释片的研究医学硕士论文

时间:2013-1-12 19:22:13  作者:60论文网  来源:www.60lw.com  查看:70  评论:0
目 录 
中文摘要 ……………………………………………………………………… 1
英文摘要 ……………………………………………………………………… 3
英文缩略词 …………………………………………………………………… 5
前言 …………………………………………………………………………… 6
第一章 处方前研究及体外分析方法的建立 
1 仪器与试药 ………………………………………………………………… 13
2 方法与结果 ………………………………………………………………… 13
2.1 处方前研究 ……………………………………………………………… 13
2.1.1 洛索洛芬钠的溶解度…………………………………………………… 13
2.1.2 洛索洛芬钠在不同释放介质中的稳定性……………………………… 14
2.1.3 表观油水分配系数的测定……………………………………………… 14
2.2 含量测定方法的建立……………………………………………………… 15
2.2.1 检测波长的确定………………………………………………………… 15
2.2.2 色谱条件与系统适应性………………………………………………… 16
2.2.3 洛索洛芬钠对照品溶液的制备………………………………………… 17
2.2.4 标准曲线的制备………………………………………………………… 17
2.2.5 精密度试验……………………………………………………………… 18
2.2.6 稳定性试验……………………………………………………………… 19
2.2.7 重复性试验……………………………………………………………… 19
2.2.8 回收率试验……………………………………………………………… 20
2.2.9 洛索洛芬钠渗透泵片的含量测定……………………………………… 20
2.3 释放度测定方法的建立…………………………………………………… 21
2.3.1 检测波长的确定………………………………………………………… 21
2.3.2 标准曲线的制备………………………………………………………… 22
2.3.3 精密度试验……………………………………………………………… 22
2.3.4 释放介质中的稳定性…………………………………………………… 23
2.3.5 回收率试验……………………………………………………………… 23
2.3.6 释放度测定方法………………………………………………………… 24
3 讨论 ………………………………………………………………………… 24
4 小结 ………………………………………………………………………… 25
第二章 洛索洛芬钠渗透泵型控释片制备工艺的研究 
1 仪器与试药 ………………………………………………………………… 26
2 方法与结果 ………………………………………………………………… 26
2.1 洛索洛芬钠渗透泵型控释片的制备工艺及工艺流程图 ……………… 26
2.1.1 制备工艺………………………………………………………………… 26
2.1.2 工艺流程图……………………………………………………………… 27
2.2 洛索洛芬钠渗透泵型控释片的单因素考察……………………………… 27
2.2.1 片芯处方的单因素考察………………………………………………… 27
2.2.2 包衣液处方的单因素考察……………………………………………… 32
2.2.3 体外释放条件对药物释放的影响……………………………………… 36
2.3 正交试验优化处方………………………………………………………… 38
2.4 处方的确定………………………………………………………………… 40
2.5 处方与工艺重复性考察…………………………………………………… 41
2.6 释药曲线的拟合…………………………………………………………… 41
2.7 释药机理的初步研究……………………………………………………… 42
3 讨论 ………………………………………………………………………… 42
4 小结 ………………………………………………………………………… 44
第三章 洛索洛芬钠渗透泵型控释片的质量控制及稳定性研究 
1 仪器与试药 ………………………………………………………………… 45
2 方法与结果 ………………………………………………………………… 45
2.1 外观性状…………………………………………………………………… 45
2.2 释放度检查………………………………………………………………… 46
2.2.1 方法学考察……………………………………………………………… 46
2.2.2 释放曲线的绘制………………………………………………………… 46
2.2.3 释放度限度的确定……………………………………………………… 46
2.3 样品的含量测定及其限度………………………………………………… 46
2.4 有关物质分析方法的建立………………………………………………… 47
2.4.1 色谱条件………………………………………………………………… 47
2.4.2 最低检测限和定量限的确定…………………………………………… 47
2.4.3 降解产物对主药测定的影响…………………………………………… 47
2.4.4 洛索洛芬钠渗透泵型控释片有关物质检查…………………………… 48
2.5 洛索洛芬钠渗透泵型控释片初步稳定性研究…………………………… 48
2.5.1 考察项目与检测方法…………………………………………………… 48
2.5.2 影响因素试验…………………………………………………………… 49
2.5.3 加速试验………………………………………………………………… 50
3 讨论 ………………………………………………………………………… 51
4 小结 ………………………………………………………………………… 52
第四章 洛索洛芬钠渗透泵型控释片在大鼠体内初步药动学研究  
1 仪器与试药 ………………………………………………………………… 53
2 方法与结果 ………………………………………………………………… 53
2.1 受试制剂与参比制剂……………………………………………………… 53
2.2 实验动物…………………………………………………………………… 53
2.3 给药方案及血样采集……………………………………………………… 53
2.4血浆样品的处理和测定…………………………………………………… 54
2.5 体内分析方法的建立……………………………………………………… 54
2.5.1 色谱条件………………………………………………………………… 54
2.5.2 方法的专属性…………………………………………………………… 54
2.5.3 标准曲线的制备………………………………………………………… 55
2.5.4 精密度试验……………………………………………………………… 56
2.5.5 样品回收率试验………………………………………………………… 56
2.5.6 血浆样品稳定性考察…………………………………………………… 57
2.6 血药浓度测定结果………………………………………………………… 58
2.7 相对生物利用度…………………………………………………………… 61
3 讨论 ………………………………………………………………………… 61
4 小结 ………………………………………………………………………… 62
全篇小结 ……………………………………………………………………… 63
参考文献 ……………………………………………………………………… 64
综述 …………………………………………………………………………… 68
个人简历 ……………………………………………………………………… 80
致谢 …………………………………………………………………………… 81参考文献
[1] Vishal G, Verma S, Arun N, etal. Osmotically controlled drug delivery[J]. Drug Deliv Tech, 2005, 5(7): 68.
[2] 唐星.口服缓控释制剂[M].北京:人民卫生出版社,2007:228-236.
[3] 柴洪帆,徐文进,刘利,等.水杨酸钠微多孔渗透泵控释片的研制[J].广东药学院学报,2008, 24 (3): 208-213.
yzc666|亚洲城官网_www.yzc666.com Liu L, Ku J, Khang G, et al.Nifedipine controlled delivery by sandwiched osmotic tablet system [J].J Control Release, 2000, 68(2):145-156.
yzc666为您提供一个稳定安全的娱乐场所,yzc666亚洲城让您工作之余不再寂寞无聊,www.yzc666.com点击进入唯一官网会有意想不到的惊喜哦. Schultz P, Kleinebudde P. A new multiparticulate delayed release system PartⅠ: Dissolution properties and release mechanism [J]. J Control Release, 1997, 47(2):181-189.
yzc666,yzc666亚洲城,www.yzc666.com Schultz P, Tho I, Kleinebudde P. A new multiparticulate delayed release system PartⅡ: Coating formulation and properties of free films [J]. J Control Release, 1997, 47(2):191-199.
[7] 吴宁苹,张小平,焦长宽,等.双氯芬酸钠缓释微丸胶囊的制备 [J].中国现代应用药学杂志,2001,18(4):290-292.
[8] 赵丽华,邹若飞,涂学君.口服渗透泵型药物制剂的研究进展[J].安徽医药,2006,10(5):373-375.
[9] 曹国良,谭建国,张志宏,等.长春西汀双层渗透泵控释片的制备及体外释放度考察 [J].沈阳药科大学学报,2007,24(9):524-527,531.
[10] 王文苹,谢秀琼,杨大坚,等.常用亲水膨胀材料性能及其用于推拉式渗透泵片的初步研究 [J].中国中药杂志,2009,34(18):2319-2321.
[11] 吴蘅,杨星钢,张志宏,等.大剂量难溶性药物苯扎贝特渗透泵片的研制 [J].中国药学杂志,2008,43(20):1574-1578.
[12] 何燕,潘卫三.灯盏花素双层渗透泵控释片的制备及体外释放度 [J].华西药学杂志,2009,24(1):25-27.
[13] 陈存香,李三鸣,李红菊,等.法莫替丁单室单层渗透泵片的制备[J].中国新药杂志,2007,16(13):1035-1038.
[14] 吴琼.硝苯地平控释片拜心通在高血压治疗中的应用[J].国外医学,生理病理科学与临床分册,1997,17(2):183-185.
[15] Gan Y, Pan WS, Wang MC, et al.Cyclodextrin complex osmotic tablet for glipizide delivery [J].Drug Dev Ind Pharm, 2002, 28(8):1015-1021.
[16] Okimoto K, Tokunaga Y, Ibukia R, et al.Applicability of (SBE) 7m-β-CD in controlled-porosity osmotic pump tablets (OPTs)[J].Int J Pharm, 2004, 286(22):81-88.
[17] 刘辉,张宜,符旭东,等.布地奈德固体分散体增溶型渗透泵片的研制及其释药机制 [J].中国药师,2009,12(1):5-8.
[18] Prabakaran D, Singh P, Kanaujia P, et al.Effect of hydrophilic polymers on the release of diltiazem hydrochloride from elementary osmotic pumps [J].Int J Pharm, 2003, 259:173-179.
[19] Prabakaran D, Singh P, Kanaujia P, et al.Controlled porosity osmotic pumps of highly aqueous soluble drug containing hydrophilic polymers as release retardants[J].Pharm Dev Technol, 2004, 9(4):435.
[20] Shanbhag A, Barclay B, Koziara J, et al.Application of cellulose acetate butyrate-based membrance for osmotic drug delivery [J].Cellulose, 2007, 14:65.
[21] Garg A, Gupta M, Bhargava HN. Effeet of formulation parameters on the release characteristics of propranolol from asymmetric membrane coated tablets [J].J Pharm Biopharm, 2007, 67(3): 725-731.
[22] Altinkaya SA, Ozbas B. Modeling of asymmetric membrane formation by dry-casting method [J].J Membr Sci, 2004, 230(1-2): 71-89.
[23] Altinkaya SA, Yenal H, Ozbas B. Membrane formation by dry-cast process Model validation through morphological studies [J].J Membr Sci, 2005, 249(1-2): 163-172.
[24] Altinkaya SA, Yenal H. In vitro drug release rates from asymmetric-membrane tablet coatings: Predicition of phase-inversion dynamics [J].Biochem Eng J, 2006, 28(2): 131-139.
[25] Philip A, Pathak K. Osmotic flow through asymmetric membrane ameans for controlled delivery of drugs with varying solubility [J]. AAPS Pharm Sci Tech, 2006,
7(3): 56.
[26] Wang CY, HoH O, Lin LH, et al. Asymmetric membrane capsules for delivery of poorly water-soluble drugs by osmotic effects [J]. Int J Pharm, 2005, 297(2): 89.
[27] Prabakaran D, Singh P, Jaganathan KS, et al. Osmotically regulated asymmetric capsular systems for simultaneous sustained delivery of anti-tubercular drugs [J]. J Controlled Release, 2004, 95:239.
[28] Zhang Y, Zhang Z R, Wu F. A novel pulsed-release system based on swelling and osmotic pumping mechanism[J]. J Controlled Release, 2003, 89:47-55.
[29] Prabakaran D, Singh P, Kanaujia P, et al. Modified push-pull osmotic system for simultaneous delivery of theophylline and salbutamol development and in vitro characterization [J]. Int J Pharm, 2004, 284(1-2):95.
[30] Liu H, Yang XG, Nie SF, et al. Chitosan-based controlled porosity osmotic pump for colon-specific delivery system: screening of formulation variables and in vitro investigation [J]. Int J Pharm, 2007, 332:115,124.
[31] 陈凯,吕子明,潘卫三,等.洛伐他汀渗透泵片的制备及体外释药影响因素的考察 [J].中国新药杂志,2006,15(14):1183-1187.
[32] 高国义,刘志东,解江纯.格列齐特渗透泵片在Beagle犬体内的药动学[J].中国新药与临床杂志,2009,28(7): 518-522.
[33] 王文苹,谢秀琼,杨大坚,等.口服渗透泵控释给药系统研究新进展[J].中国中药杂志,2008,33(5):598-602.参考文献
[1] Vishal G, Verma S, Arun N, etal. Osmotically controlled drug delivery[J]. Drug Deliv Tech, 2005, 5(7): 68.
[2] 唐星.口服缓控释制剂[M].北京:人民卫生出版社,2007:228-236.
[3] 柴洪帆,徐文进,刘利,等.水杨酸钠微多孔渗透泵控释片的研制[J].广东药学院学报,2008, 24 (3): 208-213.
yzc666|亚洲城官网_www.yzc666.com Liu L, Ku J, Khang G, et al.Nifedipine controlled delivery by sandwiched osmotic tablet system [J].J Control Release, 2000, 68(2):145-156.
yzc666为您提供一个稳定安全的娱乐场所,yzc666亚洲城让您工作之余不再寂寞无聊,www.yzc666.com点击进入唯一官网会有意想不到的惊喜哦. Schultz P, Kleinebudde P. A new multiparticulate delayed release system PartⅠ: Dissolution properties and release mechanism [J]. J Control Release, 1997, 47(2):181-189.
yzc666,yzc666亚洲城,www.yzc666.com Schultz P, Tho I, Kleinebudde P. A new multiparticulate delayed release system PartⅡ: Coating formulation and properties of free films [J]. J Control Release, 1997, 47(2):191-199.
[7] 吴宁苹,张小平,焦长宽,等.双氯芬酸钠缓释微丸胶囊的制备 [J].中国现代应用药学杂志,2001,18(4):290-292.
[8] 赵丽华,邹若飞,涂学君.口服渗透泵型药物制剂的研究进展[J].安徽医药,2006,10(5):373-375.
[9] 曹国良,谭建国,张志宏,等.长春西汀双层渗透泵控释片的制备及体外释放度考察 [J].沈阳药科大学学报,2007,24(9):524-527,531.
[10] 王文苹,谢秀琼,杨大坚,等.常用亲水膨胀材料性能及其用于推拉式渗透泵片的初步研究 [J].中国中药杂志,2009,34(18):2319-2321.
[11] 吴蘅,杨星钢,张志宏,等.大剂量难溶性药物苯扎贝特渗透泵片的研制 [J].中国药学杂志,2008,43(20):1574-1578.
[12] 何燕,潘卫三.灯盏花素双层渗透泵控释片的制备及体外释放度 [J].华西药学杂志,2009,24(1):25-27.
[13] 陈存香,李三鸣,李红菊,等.法莫替丁单室单层渗透泵片的制备[J].中国新药杂志,2007,16(13):1035-1038.
[14] 吴琼.硝苯地平控释片拜心通在高血压治疗中的应用[J].国外医学,生理病理科学与临床分册,1997,17(2):183-185.
[15] Gan Y, Pan WS, Wang MC, et al.Cyclodextrin complex osmotic tablet for glipizide delivery [J].Drug Dev Ind Pharm, 2002, 28(8):1015-1021.
[16] Okimoto K, Tokunaga Y, Ibukia R, et al.Applicability of (SBE) 7m-β-CD in controlled-porosity osmotic pump tablets (OPTs)[J].Int J Pharm, 2004, 286(22):81-88.
[17] 刘辉,张宜,符旭东,等.布地奈德固体分散体增溶型渗透泵片的研制及其释药机制 [J].中国药师,2009,12(1):5-8.
[18] Prabakaran D, Singh P, Kanaujia P, et al.Effect of hydrophilic polymers on the release of diltiazem hydrochloride from elementary osmotic pumps [J].Int J Pharm, 2003, 259:173-179.
[19] Prabakaran D, Singh P, Kanaujia P, et al.Controlled porosity osmotic pumps of highly aqueous soluble drug containing hydrophilic polymers as release retardants[J].Pharm Dev Technol, 2004, 9(4):435.
[20] Shanbhag A, Barclay B, Koziara J, et al.Application of cellulose acetate butyrate-based membrance for osmotic drug delivery [J].Cellulose, 2007, 14:65.
[21] Garg A, Gupta M, Bhargava HN. Effeet of formulation parameters on the release characteristics of propranolol from asymmetric membrane coated tablets [J].J Pharm Biopharm, 2007, 67(3): 725-731.
[22] Altinkaya SA, Ozbas B. Modeling of asymmetric membrane formation by dry-casting method [J].J Membr Sci, 2004, 230(1-2): 71-89.
[23] Altinkaya SA, Yenal H, Ozbas B. Membrane formation by dry-cast process Model validation through morphological studies [J].J Membr Sci, 2005, 249(1-2): 163-172.
[24] Altinkaya SA, Yenal H. In vitro drug release rates from asymmetric-membrane tablet coatings: Predicition of phase-inversion dynamics [J].Biochem Eng J, 2006, 28(2): 131-139.
[25] Philip A, Pathak K. Osmotic flow through asymmetric membrane ameans for controlled delivery of drugs with varying solubility [J]. AAPS Pharm Sci Tech, 2006,
7(3): 56.
[26] Wang CY, HoH O, Lin LH, et al. Asymmetric membrane capsules for delivery of poorly water-soluble drugs by osmotic effects [J]. Int J Pharm, 2005, 297(2): 89.
[27] Prabakaran D, Singh P, Jaganathan KS, et al. Osmotically regulated asymmetric capsular systems for simultaneous sustained delivery of anti-tubercular drugs [J]. J Controlled Release, 2004, 95:239.
[28] Zhang Y, Zhang Z R, Wu F. A novel pulsed-release system based on swelling and osmotic pumping mechanism[J]. J Controlled Release, 2003, 89:47-55.
[29] Prabakaran D, Singh P, Kanaujia P, et al. Modified push-pull osmotic system for simultaneous delivery of theophylline and salbutamol development and in vitro characterization [J]. Int J Pharm, 2004, 284(1-2):95.
[30] Liu H, Yang XG, Nie SF, et al. Chitosan-based controlled porosity osmotic pump for colon-specific delivery system: screening of formulation variables and in vitro investigation [J]. Int J Pharm, 2007, 332:115,124.
[31] 陈凯,吕子明,潘卫三,等.洛伐他汀渗透泵片的制备及体外释药影响因素的考察 [J].中国新药杂志,2006,15(14):1183-1187.
[32] 高国义,刘志东,解江纯.格列齐特渗透泵片在Beagle犬体内的药动学[J].中国新药与临床杂志,2009,28(7): 518-522.
[33] 王文苹,谢秀琼,杨大坚,等.口服渗透泵控释给药系统研究新进展[J].中国中药杂志,2008,33(5):598-602.

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