CN1485034A - 利福昔明干混悬颗粒剂 - Google Patents
利福昔明干混悬颗粒剂 Download PDFInfo
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Abstract
一种利福昔明干混悬颗粒剂。其主要由作为活性成分的利福昔明和药用辅料以1∶5～35的重量比混合而成，药用辅料主要包括以1∶0.05～2的重量比混合的助悬剂和絮凝剂，助悬剂为微晶纤维素、甲基纤维素、羧甲基纤维素钠、羟丙基甲基纤维素、海藻酸钠、阿拉伯胶和果胶中的二种至三种，絮凝剂为枸橼酸盐、酒石酸盐、磷酸盐和氯化铝中的任意一种，其它辅料包括蔗糖、淀粉、甜味剂、防腐剂和调味剂等。本发明的干混悬颗粒剂比单一片剂等固体口服剂型具有吞服方便、药物与胃肠道的接触面积大，因而作用和吸收完全，从而可提高药品生物利用度等诸多优点，特别是其服用前可用水配成悬浮液，而且添加的甜味剂等还可改善普通药物的异味，因而十分适于老年及儿童患者服用。
Description
技术领域
本发明涉及药品领域，特别是涉及一种可治疗肠道疾病的利福昔明干混悬颗粒剂。
背景技术
利福昔明是利福霉素衍生物中应用广泛的新型抗生素，其可用于治疗由革兰氏阳性菌和革兰氏阴性菌而引起的急慢性肠感染，并可作为高血氨治疗的辅助药物。这种药物抗菌谱广，对胃肠道中的需氧菌或厌氧菌均有抗菌作用。其最大的特点是不被吸肠道吸收也不被胃液所纯化，即本品几乎无系统吸收，患者服用后在其小便和组织中检测不到药物浓度，而只是经大肠以其原型排泄，因而其毒副作用极低，尤其适宜治疗成人及儿童腹泻。中国专利申请号98106920就公开了一种利福昔明的用途，其是利用利福昔明来治疗患有严重形式的免疫抑制病人中因隐孢子虫病而引起的腹泻，由于该发明的适应症比较单一，因而应用的领域较窄；而目前临床上使用的利福昔明多为片剂，不易吞服，尤其不适于用于治疗吞咽存在困难的老年或儿童肠道感染患者。
发明内容
为了解决上述问题，本发明的目的在于提供一种服用方便、药物作用完全、生物利用度高、适应范围广且口感好的利福昔明干混悬颗粒剂。
为了达到上述目的，本发明提供的利福昔明干混悬颗粒剂主要由作为活性成分的利福昔明和药用辅料以1∶5～35的重量比混合而成，药用辅料主要包括以1∶0.05～2的重量比混合的助悬剂和絮凝剂，助悬剂为微晶纤维素、甲基纤维素、羧甲基纤维素钠、羟丙基甲基纤维素、海藻酸钠、阿拉伯胶和果胶中的二种至三种，絮凝剂为枸橼酸盐、酒石酸盐、磷酸盐和氯化铝中的任意一种；其它辅料包括蔗糖、淀粉、甜味剂、防腐剂和调味剂等。
本发明提供的利福昔明干混悬颗粒剂比单一片剂等固体口服剂型具有吞服方便、药物与胃肠道的接触面积大，因而作用和吸收完全，从而可提高药品生物利用度等诸多优点，特别是其服用前可用水配成悬浮液，而且添加的甜味剂等还可改善普通药物的异味，因而十分适于老年及儿童患者服用。
具体实施方式
为了增加本发明干混悬颗粒剂的漂浮性能，延长药物在胃肠道内的滞留时间，使吸收时间延长，从而减少用药量和减轻服药后给患者带来的毒副作用，提高治疗效果，在药物中加入了一些增加溶液粘度、降低药物微粒沉降速度的物质作为助悬剂；另外，加入的絮凝剂可使溶液中电解质浓度增加，适当改变溶液电位，并可使药物微粒不易聚结成块且分散良好。
实施例1
以1000袋利福昔明干混悬颗粒剂为基准，首先将200g利福昔明、65g羧甲基纤维素钠、30g微晶纤维素、65g果胶、90g枸橼酸钠和2250g蔗糖粉末置于粉状物料混合机中均匀混合30分钟，然后将此混合物放入压缩造粒机中进行干式压缩后制成橙黄色颗粒状制剂，最后进行分装，每袋含利福昔明200mg。
实施例2
以1000袋利福昔明干混悬颗粒剂为基准，首先将200g利福昔明、85g羧甲基纤维素钠、85g果胶、110g枸橼酸钠、500g蔗糖粉末、500g玉米淀粉、300g代糖山梨醇、30g作为调味剂的天然香橙和50g红甜菜置于粉状物料混合机中均匀混合30分钟，然后将此混合物放入压缩造粒机中进行干式压缩后制成橙黄色颗粒状制剂，最后进行分装，每袋含利福昔明200mg。
Claims (4)
1、一种利福昔明干混悬颗粒剂，其特征在于：所述的利福昔明干混悬颗粒剂主要由作为活性成分的利福昔明和药用辅料以1∶5～35的重量比混合而成，药用辅料主要包括以1∶0.05～2的重量比混合的助悬剂和絮凝剂，助悬剂为微晶纤维素、甲基纤维素、羧甲基纤维素钠、羟丙基甲基纤维素、海藻酸钠、阿拉伯胶和果胶中的二种至三种，絮凝剂为枸橼酸盐、酒石酸盐、磷酸盐和氯化铝中的任意一种。
2、根据权利要求1所述的利福昔明干混悬颗粒剂，其特征在于：所述的助悬剂优选羧甲基纤维素钠和微晶纤维素的混合物。
3、根据权利要求1所述的利福昔明干混悬颗粒剂，其特征在于：所述的絮凝剂优选枸橼酸盐。
4、根据权利要求1所述的利福昔明干混悬颗粒剂，其特征在于：所述的利福昔明干混悬颗粒剂还可包括蔗糖、淀粉、甜味剂、防腐剂和调味剂等其它辅料。
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA021310351A CN1485034A (zh) | 2002-09-26 | 2002-09-26 | 利福昔明干混悬颗粒剂 |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA021310351A CN1485034A (zh) | 2002-09-26 | 2002-09-26 | 利福昔明干混悬颗粒剂 |
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| Publication Number | Publication Date |
|---|---|
| CN1485034A true CN1485034A (zh) | 2004-03-31 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA021310351A Pending CN1485034A (zh) | 2002-09-26 | 2002-09-26 | 利福昔明干混悬颗粒剂 |
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| Country | Link |
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| CN (1) | CN1485034A (zh) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101836959A (zh) * | 2010-05-20 | 2010-09-22 | 山东达因海洋生物制药股份有限公司 | 一种制备几乎无苦味利福昔明干混悬剂的方法 |
| WO2011110930A2 (en) | 2010-03-10 | 2011-09-15 | Lupin Limited | Rifaximin ready-to-use suspension |
| CN102218078A (zh) * | 2011-04-19 | 2011-10-19 | 南京威泰珐玛兽药研究所有限公司 | 一种含有蒙脱石的利福昔明混悬液及其制备方法 |
| CN110623929A (zh) * | 2019-09-17 | 2019-12-31 | 南京臣功制药股份有限公司 | 一种利福昔明干混悬剂及其制备方法 |
-
2002
- 2002-09-26 CN CNA021310351A patent/CN1485034A/zh active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2011110930A2 (en) | 2010-03-10 | 2011-09-15 | Lupin Limited | Rifaximin ready-to-use suspension |
| US9211258B2 (en) | 2010-03-10 | 2015-12-15 | Lupin Limited | Rifaximin ready-to-use suspension |
| CN101836959A (zh) * | 2010-05-20 | 2010-09-22 | 山东达因海洋生物制药股份有限公司 | 一种制备几乎无苦味利福昔明干混悬剂的方法 |
| CN102218078A (zh) * | 2011-04-19 | 2011-10-19 | 南京威泰珐玛兽药研究所有限公司 | 一种含有蒙脱石的利福昔明混悬液及其制备方法 |
| CN102218078B (zh) * | 2011-04-19 | 2012-10-10 | 南京威泰珐玛兽药研究所有限公司 | 一种含有蒙脱石的利福昔明混悬液及其制备方法 |
| CN110623929A (zh) * | 2019-09-17 | 2019-12-31 | 南京臣功制药股份有限公司 | 一种利福昔明干混悬剂及其制备方法 |
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