CN101125132A - 口服胰岛素肠溶胶囊及其制备方法 - Google Patents
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Abstract
本发明涉及一种口服胰岛素肠溶胶囊及其制备方法，原料采用胰岛素粉：每个胶囊10个单位；辅料药采用药用淀粉：每个胶囊0.09克淀粉颗粒，0.01克淀粉，胶囊采用普通肠溶性胶囊，将药用淀粉置混合机中，用淀粉浆制成软材，采用20目尼龙筛制粒，干燥后用18目筛整粒，转入混合车间放凉，筛出细粉，剩余的淀粉颗粒备用；2.将筛出的细粉与胰岛素细粉充分棍匀按递增法混合均匀再与步骤1中的制造的淀粉颗粒充分混匀；3.转入胶囊灌装车间，用自动胶囊充填机灌装；4.将灌装好的胶囊经打光处理后转入铝箔包装车间进行包装；5.铝塑后入包装室、包装，完毕后入冷藏库。本发明运用口服胰岛素肠溶胶囊治疗糖尿病，经济费用低，疗效好，服用方便，使患者避免打针之苦。
Description
技术领域：
本发明涉及一种口服胰岛素肠溶胶囊及其制备方法。
背景技术：
目前我国及全世界糖尿病的发病率呈上升超势，尤其是糖尿病引发的舍并症，严重成胁着人类的健康。口服胰岛素制剂至今尚没有被临床应用。病人应用的只是降糖药物：优降糖片，苯乙双胍片。最近几年上市的苦瓜胶囊，蜂胶胶囊-曾被称之谓″植物胰岛素″。不过人体调节血糖的只有胰岛素。降糖药，或″植物胰岛素″根本代替不了真正的胰岛素。长时间服用降糖药，存在耐药性问题，并且给肝脏，肾脏造成损害。有些患者在病情加重时没办法才使用了胰岛素针剂进行注射。在使用时很不方便，而且饱偿打针之苦，所以解决口服胰岛素投放市场是当务之急。 据考察及检索发现，国内外的一些专家，学者经过科研努力，发明一些高尖端的制备口服胰岛素的方法及工艺报请了专利。根据检索，为什么这么多的发明都没有被生产厂家接受，其主要原因在于生产工艺复杂，不容易控制，生产难度大，加之胰岛素原料本身的特性有两怕：怕温度高，怕在通过胃时易被胃酸及酶的作用而被破坏。所以没能大批量生产是主要原因。在临床上口服胰岛素制剂成为缺口。
发明内容：
本发明的目的是提供一种服用方便、治疗效果好的口服胰岛素肠溶胶囊。本发明的目的是通过以下方案实现的：本发明为一种口服胰岛素肠溶胶囊：原料采用胰岛素粉：每个胶囊10个单位；辅料药采用药用淀粉：每个胶囊0.09克淀粉颗粒，0.01克淀粉，胶囊采用普通肠溶性胶囊。该药的制备方法为：1、原料采用胰岛素粉：每个胶囊10个单位；辅料药采用药用淀粉：每个胶囊0.09克淀粉颗粒，0.01克淀粉，胶囊采用普通肠溶性胶囊，将药用淀粉置混合机中，用淀粉浆制成软材，采用20目尼龙筛制粒，干燥后用18目筛整粒，转入混合车间放凉，筛出细粉，剩余的淀粉颗粒备用；2、将筛出的细粉与胰岛素细粉充分混匀按递增法混合均匀再与步骤1中的制造的淀粉颗粒充分混匀；3、转入胶囊灌装车间，用自动胶囊充填机灌装；4、将灌装好的胶囊经打光处理后转入铝铂包装车间进行包装；5、铝塑后入包装室、包装，完毕后入冷藏库。口服胰岛素肠溶胶囊，采用了靶向给药方式，使用普通肠溶性胶囊作载体，把胰岛素直接送到小肠吸收。该种胶囊不受胃酸及酶的影响可直接通过胃到达小肠胶囊壳溶解后，将胰岛素释放出使之吸收。空心胶囊中有三种类型：1：胃溶性胶囊——就是这种胶囊灌装的药品，服用后在胃内溶解吸收。2：普通肠溶胶囊——灌装的药品服用后通过胃不被胃酸及酶的作用而破坏，在小肠被吸收。
3：结肠型肠溶胶囊——这种肠溶胶囊是装药经口服后通过胃不受胃酸及酶的作用而被破坏在大肠(结肠)内吸收。这几型药用胶囊国家对其都有规定指标，并有专门的胶囊生产厂家，所以采用普通肠溶性胶囊作载体，通过胃不被胃酸及酶所破坏，至小肠内吸收为目的，使胰岛素能完全发挥作用。自2003年-2006年期间，在医院门诊，应用自制的口服胰岛素肠溶胶囊给患者治疗，其病例124例，均收到很好效果，运用口服胰岛素肠溶胶囊治疗糖尿病，经济费用低，疗效好，服用方便，使患者避免打针之苦。
具体实施方式：
本发明为一种口服胰岛素肠溶胶囊，原料采用胰岛素粉：每个胶囊10个单位；辅料药采用药用淀粉：每个胶囊0.09克淀粉颗粒，0.01克淀粉，胶囊采用普通肠溶性胶囊。该药的制备方法为：1、原料采用胰岛素粉：每个胶囊10个单位；辅料药采用药用淀粉：每个胶囊0.09克淀粉颗粒，0.01克淀粉，胶囊采用普通肠溶性胶囊，将药用淀粉置混合机中，用淀粉浆制成软材，采用20目尼龙筛制粒，干燥后用18目筛整粒，转入混合车间放凉，筛出细粉，剩余的淀粉颗粒备用；2、将筛出的细粉与胰岛素细粉充分混匀按递增法混合均匀再与步骤1中的制造的淀粉颗粒充分混匀；3、转入胶囊灌装车间，用自动胶囊充填机灌装；4、将灌装好的胶囊经打光处理后转入铝铂包装车间进行包装；5、铝塑后入包装室、包装，完毕后入冷藏库。口服胰岛素肠溶胶囊，采用了靶向给药方式，使用普通肠溶性胶囊作载体，把胰岛素直接送到小肠吸收。贮存库及包装车间必须安装空调。使室内温度在1-10℃。
Claims (2)
1.一种口服胰岛素肠溶胶囊，其特征是：原料采用胰岛素粉：每个胶囊10个单位；辅料药采用药用淀粉：每个胶囊0.09克淀粉颗粒，0.01克淀粉，胶囊采用普通肠溶性胶囊。
2.按照权利要求1所述的一种口服胰岛素肠溶胶囊的制备方法，其特征是：1、原料采用胰岛素粉：每个胶囊10个单位；辅料药采用药用淀粉：每个胶囊0.09克淀粉颗粒，0.01克淀粉，胶囊采用普通肠溶性胶囊，将药用淀粉置混合机中，用淀粉浆制成软材，采用20目尼龙筛制粒，干燥后用18目筛整粒，转入混合车间放凉，筛出细粉，剩余的淀粉颗粒备用；2、将筛出的细粉与胰岛素细粉充分棍匀按递增法混合均匀再与步骤1中的制造的淀粉颗粒充分混匀；3、转入胶囊灌装车间，用自动胶囊充填机灌装；4、将灌装好的胶囊经打光处理后转入铝铂包装车间进行包装；5、铝塑后入包装室、包装，完毕后入冷藏库。
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2517135C2 (ru) * | 2008-05-07 | 2014-05-27 | Меррион Рисерч Iii Лимитед | Композиции пептидов и способы их получения |
| US8802114B2 (en) | 2011-01-07 | 2014-08-12 | Merrion Research Iii Limited | Pharmaceutical compositions of iron for oral administration |
| US8828431B2 (en) | 1999-02-22 | 2014-09-09 | Merrion Research Iii Limited | Solid oral dosage form containing an enhancer |
| US8883203B2 (en) | 2006-04-07 | 2014-11-11 | Merrion Research Iii Limited | Solid oral dosage form containing an enhancer |
| US9089484B2 (en) | 2010-03-26 | 2015-07-28 | Merrion Research Iii Limited | Pharmaceutical compositions of selective factor Xa inhibitors for oral administration |
| US10265384B2 (en) | 2015-01-29 | 2019-04-23 | Novo Nordisk A/S | Tablets comprising GLP-1 agonist and enteric coating |
| US10631564B2 (en) | 2015-06-19 | 2020-04-28 | University Of Southern California | Enterically coated microparticle compositions and methods for modified nutrient delivery |
| US10744070B2 (en) | 2015-06-19 | 2020-08-18 | University Of Southern California | Enteral fast access tract platform system |
-
2007
- 2007-07-25 CN CNA2007100725627A patent/CN101125132A/zh active Pending
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8828431B2 (en) | 1999-02-22 | 2014-09-09 | Merrion Research Iii Limited | Solid oral dosage form containing an enhancer |
| US8883203B2 (en) | 2006-04-07 | 2014-11-11 | Merrion Research Iii Limited | Solid oral dosage form containing an enhancer |
| US8883201B2 (en) | 2006-04-07 | 2014-11-11 | Merrion Research Iii Limited | Solid oral dosage form containing an enhancer |
| RU2517135C2 (ru) * | 2008-05-07 | 2014-05-27 | Меррион Рисерч Iii Лимитед | Композиции пептидов и способы их получения |
| US8999383B2 (en) | 2008-05-07 | 2015-04-07 | Merrion Research Iii Limited | Compositions of GnRH related compounds and processes of preparation |
| US9089484B2 (en) | 2010-03-26 | 2015-07-28 | Merrion Research Iii Limited | Pharmaceutical compositions of selective factor Xa inhibitors for oral administration |
| US8802114B2 (en) | 2011-01-07 | 2014-08-12 | Merrion Research Iii Limited | Pharmaceutical compositions of iron for oral administration |
| US10265384B2 (en) | 2015-01-29 | 2019-04-23 | Novo Nordisk A/S | Tablets comprising GLP-1 agonist and enteric coating |
| US10631564B2 (en) | 2015-06-19 | 2020-04-28 | University Of Southern California | Enterically coated microparticle compositions and methods for modified nutrient delivery |
| US10744070B2 (en) | 2015-06-19 | 2020-08-18 | University Of Southern California | Enteral fast access tract platform system |
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