CN100563654C - 一种地氯雷他定分散片及其制备方法 - Google Patents
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Abstract
本发明涉及地氯雷他定分散片及其制备方法，本发明地氯雷他定分散片包括地氯雷他定原料药和包衣材料以及辅料组成，辅料包括崩解剂、填充剂、水溶性赋形剂和吸附剂，每片分散片中含有0.1%～10%的地氯雷他定，包衣材料5%～20%，25%～50%的吸附剂，5%～15%的崩解剂，10%～30%的填充剂，25%～50%的水溶性赋形剂，0.5%～3%的香精，0.5%～3%的甜味剂，0.5%～1.5%的润滑剂；将地氯雷他定原料和包衣材料放入沸腾制粒机中进行包衣，得到包衣的地氯雷他定微粒；然后将包衣好的地氯雷他定微粒和辅料混合均匀，制软材，烘干，整粒，压片即得。
Description
技术领域
本发明涉及一种抗组胺药物地氯雷他定的剂型，尤其涉及地氯雷他定分散片及其制备方法。
背景技术
地氯雷他定为非镇静性的长效三环类抗组胺药，为氯雷他定的活性代谢物，可通过选择性地阻断外周H1受体，抑制各种过敏性致炎的化学介质的释放，如：抑制肥大细胞和嗜碱细胞释放组胺、前列腺素、白细胞介素等，缓解过敏性鼻炎或慢性特发性荨麻疹的相关症状。目前，地氯雷他定一般都为胶囊剂或普通片剂，用水吞服，由于这些剂型体积较大，不适合吞咽能力较弱的老人和小孩服用，还有在特殊环境下(如缺水)病人的服用。
发明内容
本发明的目的在于提供一种适合吞咽能力较弱的患者服用的抗组胺药物地氯雷他定分散片。
本发明的另一目的是提供了一种抗组胺药物地氯雷他定分散片的制备方法。
一种地氯雷他定分散片，由地氯雷他定微粒以及辅料组成，地氯雷他定微粒通过地氯雷他定原料和包衣材料放入沸腾制粒机中进行包衣得到，辅料由崩解剂、填充剂、水溶性赋形剂、吸附剂、香精、甜味剂和润滑剂组成，其中每片中含有0.1％～10％的地氯雷他定，包衣材料5％～20％，25％～50％的吸附剂，5％～15％的崩解剂，10％～30％的填充剂，25％～50％的水溶性赋形剂，0.5％～3％的香精，0.5％～3％的甜味剂，0.5％～1.5％的润滑剂。
上述的崩解剂为交联聚乙烯吡咯烷酮，交联羧甲基纤维素钠、低取代羟丙基纤维素、羧甲基淀粉钠中的一种或几种混合。
上述的填充剂为微晶纤维素、预胶化淀粉、可压性淀粉、羟丙甲纤维素或沉降法二氧化硅。
上述的水溶性赋形剂是具有粘合特性的可溶性多元醇。
上述的吸附剂为交联聚乙烯吡咯烷酮、微晶纤维素、淀粉、磷酸氢钙或沉降法二氧化硅。
上述的包衣材料为聚丙烯酸树脂E100、聚丙烯酸树脂NE30D、聚丙烯酸树脂II、聚丙烯酸树脂III、聚丙烯酸树脂IV、羟丙甲纤维素、羟丙纤维素或乙基纤维素。
本发明一种地氯雷他定分散片的制备方法包括如下步骤：
1)、将地氯雷他定原料和包衣材料放入沸腾制粒机中进行包衣，得到包衣的地氯雷他定微粒；
(2)、将包衣好的地氯雷他定微粒和辅料混合均匀，制软材，烘干，整粒，压片即得。
本发明一种地氯雷他定分散片，与以往的剂型相比较，由于添加了崩解剂，可以在口腔中能快速崩解并溶化，无沙砾感，容易随唾液吞咽入胃，所以比较适合吞咽力较弱的老人和小孩或在特殊环境下的病人服用(如缺水)，而且口味也较好。
具体实施方式
下面结合实施例对本发明作进一步的描述，但本发明并不受实施例的限制。
实施例1：地氯雷他定的原料包衣
称取原料：地氯雷他定 250g 乙基纤维素 25g
异丙醇 150ml 乙醇 850ml
将上述原料置于沸腾制粒机中，进行原料包衣，得到包衣地氯雷他定微粒。
实施例2：地氯雷他定的原料包衣
称取原料：地氯雷他定 250g EUDRAGITE100 25g
乙醇 1000ml
将上述原料置于沸腾制粒机中，进行原料包衣，得到包衣地氯雷他定微粒。
实施例3：地氯雷他定分散片的制备
1、按下述配方称取原料：
包衣地氯雷他定微粒 5g(以地氯雷他定计)
淀粉 54g 磷酸氢钙 16g
聚维酮K30 2g 羧甲淀粉钠 54g
微粉硅胶 1g 硬脂酸镁 1g
制得 1000片
2、用等量递增稀释法将包衣地氯雷他定微粒、磷酸氢钙、淀粉及羧甲淀粉钠混合均匀；
3、用10％聚维酮K30(70％的醇溶液)配制粘合剂，用18目筛将混合物制成均匀软材的湿颗粒；
4、湿颗粒于55℃烘干，然后用18目筛整粒，加入其他辅料，混匀，用适中压力压制片剂，每片重约0.1g。
实施例4：为了改善口味，还可以在分散片中添加香精、甜味剂和润滑剂。
1、按下述配方称取原料：
包衣地氯雷他定微粒 5g(以地氯雷他定计)
交联聚维酮 8.0g 微晶纤维素 37.0g
低取代羟丙纤维素 5.0g 甘露醇 40.0g
甜橙香精 1.0g 阿司帕坦 3.0g
微粉硅胶 1.25g 硬脂酸镁 1.0g
乙醇 适量
制得 1000片
2、取包衣的地氯雷他定微粒，称取配方量的交联聚维酮、微晶纤维素、低取代羟丙纤维素、甘露醇、硬脂酸镁、甜橙香精、阿司帕坦及微粉硅胶，混合均匀；
3、制软材，烘干，整粒，压片。
本发明一种地氯雷他定分散片，能在口腔中快速崩解，并溶化，无沙砾感，容易随唾液吞咽入胃。
Claims (6)
1.一种地氯雷他定分散片，其特征在于由地氯雷他定微粒以及辅料组成，地氯雷他定微粒通过地氯雷他定原料和包衣材料放入沸腾制粒机中进行包衣得到，辅料由崩解剂、填充剂、水溶性赋形剂、吸附剂、香精、甜味剂和润滑剂组成，其中每片中含有0.1％～10％的地氯雷他定，包衣材料5％～20％，25％～50％的吸附剂，5％～15％的崩解剂，10％～30％的填充剂，25％～50％的水溶性赋形剂，0.5％～3％的香精，0.5％～3％的甜味剂，0.5％～1.5％的润滑剂；所述的水溶性赋形剂是具有粘合特性的可溶性多元醇。
2.根据权利要求1所述的一种地氯雷他定分散片，其特征是崩解剂为交联聚乙烯吡咯烷酮，交联羧甲基纤维素钠、低取代羟丙基纤维素、羧甲基淀粉钠中的一种或几种混合。
3.根据权利要求1所述的一种地氯雷他定分散片，其特征是填充剂为微晶纤维素、预胶化淀粉、可压性淀粉、羟丙甲纤维素或沉降法二氧化硅。
4.根据权利要求1所述的一种地氯雷他定分散片，其特征是吸附剂为交联聚乙烯吡咯烷酮、微晶纤维素、淀粉、磷酸氢钙或沉降法二氧化硅。
5.根据权利要求1所述的一种地氯雷他定分散片，其特征是所述的包衣材料为聚丙烯酸树脂E100、聚丙烯酸树脂NE30D、聚丙烯酸树脂II、聚丙烯酸树脂III、聚丙烯酸树脂IV、羟丙甲纤维素、羟丙纤维素或乙基纤维素。
6.根据权利要求1所述的地氯雷他定分散片的制备方法，其特征是包括如下步骤：
(1)、将地氯雷他定原料和包衣材料放入沸腾制粒机中进行包衣，得到包衣的地氯雷他定微粒；
(2)、将包衣好的地氯雷他定微粒和辅料混合均匀，制软材，烘干，整粒，压片即得。
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| AU2005263958B2 (en) * | 2004-07-16 | 2011-04-14 | Cipla Limited | Anti-histaminic composition |
| CN102048682B (zh) * | 2009-10-31 | 2012-09-12 | 鲁南制药集团股份有限公司 | 一种氯雷他定的乳膏剂及其应用 |
| CN102940617A (zh) * | 2012-11-21 | 2013-02-27 | 北京润德康医药技术有限公司 | 一种地氯雷他定口腔分散膜剂 |
| CN104523644B (zh) * | 2015-01-27 | 2017-06-20 | 江苏联环药业股份有限公司 | 一种快速溶出的氯雷他定片剂及其制备工艺 |
| CN106880609A (zh) * | 2015-12-15 | 2017-06-23 | 北大方正集团有限公司 | 一种索非布韦分散片及其制备方法 |
| CN106822025A (zh) * | 2017-01-02 | 2017-06-13 | 佛山市腾瑞医药科技有限公司 | 一种地氯雷他定软胶囊制剂及其制备工艺 |
| CN106822047A (zh) * | 2017-02-15 | 2017-06-13 | 佛山市腾瑞医药科技有限公司 | 一种微孔膜控释包衣地氯雷他定微丸及其制备方法 |
| CN106860423A (zh) * | 2017-02-15 | 2017-06-20 | 佛山市腾瑞医药科技有限公司 | 一种地氯雷他定速释微丸制剂、制备方法 |
| CN106667922A (zh) * | 2017-02-16 | 2017-05-17 | 佛山市腾瑞医药科技有限公司 | 一种地氯雷他定固体分散体制剂及其制备方法 |
| CN107095853A (zh) * | 2017-04-01 | 2017-08-29 | 重庆康刻尔制药有限公司 | 一种口腔崩解片崩解剂组合及其使用方法 |
| CN108403649A (zh) * | 2018-04-10 | 2018-08-17 | 常州方圆制药有限公司 | 一种地氯雷他定片及其制备方法 |
| CN109925289B (zh) * | 2019-04-11 | 2021-05-25 | 海南普利制药股份有限公司 | 地氯雷他定分散片 |
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2003
- 2003-07-22 CN CNB031417434A patent/CN100563654C/zh not_active Expired - Lifetime
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| 分散片发展现状. 李国栋，魏华，仲明远.解放军药学学报，第15卷第6期. 1999 |
| 分散片发展现状. 李国栋，魏华，仲明远.解放军药学学报，第15卷第6期. 1999 * |
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