CN100356918C - 一种治疗肠炎的鞣酸苦参总碱肠溶速释制剂 - Google Patents

一种治疗肠炎的鞣酸苦参总碱肠溶速释制剂 Download PDF

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CN100356918C
CN100356918C CNB2004100848229A CN200410084822A CN100356918C CN 100356918 C CN100356918 C CN 100356918C CN B2004100848229 A CNB2004100848229 A CN B2004100848229A CN 200410084822 A CN200410084822 A CN 200410084822A CN 100356918 C CN100356918 C CN 100356918C
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enteric
tannic acid
coated
quick releasing
formulation
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CN1628661A (zh
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吴筑华
吴超
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Abstract

本发明公开一种治疗肠炎的鞣酸苦参总碱肠溶速释制剂，是将鞣酸苦参总碱与无机或有机碱性辅料制成肠溶速释制剂，可以提高在肠内的溶出速度，防止在胃中释放后的恶心呕吐的胃不良反应。

Description

一种治疗肠炎的鞣酸苦参总碱肠溶速释制剂
本发明涉及一种用于治疗肠炎的原料药“鞣酸苦参总碱”制取的肠溶速释制剂。
鞣酸苦参总碱溶解度很小，其胶囊用于治疗非感染性肠炎。经口服在胃内崩解，有恶心呕吐的不良反应，尤对老人小孩不宜。
本发明采用的肠溶速释制剂，可避免鞣酸苦参总碱在胃内释放，从而避免对胃的刺激。在肠内可提高其溶出速度。
由于该药作用部位为肠道黏膜，因此在肠内的较快溶出有利于治疗作用。因为肠溶制剂在肠道的迟缓释放，有可能通过大便排除，而影响疗效。
肠溶速释制剂可以制为胶囊、颗粒、片剂。
其处方组成：
1.主药：鞣酸苦参总碱
2.加快主药释放的辅料：无机或有机碱性辅料如NaHCO3、Na2CO3、乙醇胺、枸橼酸钠等。
3.肠溶材料：肠溶胶囊、邻苯二甲酸醋酸纤维素、丙烯酸树脂II等。
处方中加入无机或有机碱性辅料，可加快主药的溶出速度，肠溶材料可以把主药制成胶囊或肠溶颗粒，肠溶包衣片。
经药学实验：用实验举例1中的鞣酸苦参总碱肠溶速释胶囊作对照。
1.人工胃液中：进行崩解检查及释放度测定：
鞣酸苦参总碱胶囊10分钟崩解，释放度80.18％。
鞣酸苦参总碱肠溶速释胶囊120分钟不崩解，释放度0％。
2.在按药典规定的肠溶模拟缓冲液中，经含量测定溶出度；
鞣酸苦参总碱肠溶速释胶囊20分钟，溶出度达到80％
鞣酸苦参总碱肠溶胶囊65分种，溶出度达到80％
鞣酸苦参总碱胶囊120分钟，溶出度达到0％
说明其可以加快在肠道的溶出而防止在胃中的释放，达到减少副作用，改进治疗效果的目的。
实施举例：
1.肠溶速释胶囊：鞣酸苦参总碱0.3g
碳酸氢钠0.1g
淀粉适量，制成颗粒装入肠溶胶囊
2.肠溶速释颗粒(片)
鞣酸苦参总碱0.3g
碳酸氢钠0.1g
糊精1g
淀粉1g
丙烯酸树指II号适量；
制成颗粒后，用肠溶辅料颗粒包衣。制成颗粒后，也可压片后包肠溶衣。

Claims (3)

1、一种治疗肠炎的鞣酸苦参总碱肠溶速释制剂，其特征在于：含有增加主药溶出度的无机或有机碱性辅料。
2、权利要求1所述的肠溶速释制剂，其特征在于：是治疗肠炎的肠溶胶囊、肠溶颗粒、肠溶片；在肠溶胶囊中：每粒含鞣酸苦参总碱0.3g，至少含有以下辅料：碳酸氢钠、淀粉。
3.权利要求1所述的肠溶速释制剂，其特征在于：含有增加主药溶出度的无机或有机碱性辅料是NaHCO3、Na2CO3、乙醇胺、枸橼酸钠。
CNB2004100848229A 2004-09-30 2004-09-30 一种治疗肠炎的鞣酸苦参总碱肠溶速释制剂 Active CN100356918C (zh)

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CN107125461A (zh) * 2016-02-29 2017-09-05 湖南晶天科技实业有限公司 一种饲料添加剂肠溶包衣单宁酸衍生物以及一种饲料

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002100391A1 (en) * 2001-06-08 2002-12-19 Smithkline Beecham P.L.C. Swallow tablet comprising paracetamol
CN1443535A (zh) * 2003-03-25 2003-09-24 南昌弘益科技有限公司 马来酸替加色罗口服制剂及其制备工艺——治疗肠易惹综合征

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002100391A1 (en) * 2001-06-08 2002-12-19 Smithkline Beecham P.L.C. Swallow tablet comprising paracetamol
CN1443535A (zh) * 2003-03-25 2003-09-24 南昌弘益科技有限公司 马来酸替加色罗口服制剂及其制备工艺——治疗肠易惹综合征

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
丙烯酸树脂在制备肠溶片中的应用 翁诗全.现代应用药学，第6卷第2期 1989 *
肠溶包衣材料在药物制剂中的应用 杜德才.中国药业，第10卷第5期 2001 *
肠溶片包衣材料改进 谢耀奎.中国医院药学杂志，第16卷第6期. 1996 *
鞣酸苦参碱胶囊 国家药典委员会.国家药品监督管理局 国家药品标准 化学药品地方标准上升国家标准，第6卷第1期 2002 *

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Address after: Dongfeng Pharmaceutical Industrial Park Wudang District 550018 Guizhou city of Guiyang province Guizhou wanshuntang Pharmaceutical Co. Ltd.

Co-patentee after: Wu Chao

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Address before: 550001 Guizhou city in Guiyang Province, southern silver Xintian Avenue Jia Garden 7 Building 8 floor (three units)

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Denomination of invention: A enteric coated quick release preparation of total alkaloids of tannic acid and Sophora flavescens for treating enteritis

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