CN115531327B - 一种厄贝沙坦片及其制备方法 - Google Patents
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- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
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Abstract
本发明涉及药物制剂技术领域，公开了一种厄贝沙坦片及其制备方法。该片剂包括以下原料：厄贝沙坦、甘露醇、微晶纤维素、羟丙纤维素、羧甲基纤维素钙、硬脂酸镁、胃溶型包衣预混剂，厄贝沙坦经微粉化后粒径为D90≤40μm，制备方法采用干法制粒。本发明制备得到的厄贝沙坦片剂稳定性好、溶出曲线与原研拟合良好，生产工艺简单，适用于工业化生产。
Description
技术领域
本发明涉及药物制剂技术领域，具体涉及一种厄贝沙坦片及其制备方法。
技术背景
厄贝沙坦片为血管紧张素II(Angiotensin II，Ang II)受体抑制剂，通过选择性地阻断Ang II与AT1受体的结合，抑制血管收缩和醛固酮的释放，产生降压作用。我国高血压药物市场潜力巨大，由于人们的生活水平提高，工作竞争日益紧张，高血压患病人数大大增加，尤其在经济逐渐发展中的北方大部地区，高血压人群仍将扩大，降压药有较大的市场需求。
本品物料流动性差，为保证压片工序的生产顺利，会采用制粒工艺，市面产品一般采用湿法制粒工艺，但湿法制粒在批量较大的情况下，会分为多个亚批，存在批内差异较大的问题，并且湿法制粒工艺，能耗高，工艺相对复杂。本发明采用干法制粒工艺，既解决了物料的流动性，也能保证生产工艺的连贯性，具有工艺简单，批内差异小的优点。
发明内容
针对现有技术的不足，本发明提供一种厄贝沙坦片及其制备方法。通过特定的厄贝沙坦药物组合物以及特定的配比，进行干法制粒，解决了现有药物颗粒流动性不好、药物崩解不理想、药物溶出度低、稳定性差以及人体生物利用度不高等问题。
本发明的技术方案如下：
一种厄贝沙坦片及其制备方法，其特征在于，包含如下组分：
所述厄贝沙坦经微粉化后粒径范围为D90≤40μm，所述胃溶型包衣预混剂为欧巴代。
所述一种厄贝沙坦片及其制备方法，其特征在于，所述制备方法包括以下步骤：
(1)称量适当比例的厄贝沙坦、甘露醇、微晶纤维素、羟丙纤维素、羧甲纤维素钙，混合均匀；
(2)将步骤(1)得到的混粉干法制粒，制粒压力40～60bar，整粒，过14目筛；
(3)将步骤(2)得到的颗粒与处方量的硬脂酸镁置三维混合机进行总混；
(4)使用9mm圆形浅凹冲对步骤(3)得到的颗粒进行压片；
(5)使用胃溶型包衣预混剂对步骤(4)得到的片剂进行包衣，包衣增重2～4％。
有益效果
本发明采用干法制粒工艺，以特定干法制粒参数，特定比例的羧甲基纤维素钙为崩解剂，以硬脂酸镁为润滑剂，所制备的厄贝沙坦片具有工艺简单、成品稳定性好、溶出行为与参比制剂一致，体内与参比制剂等效的特点。
附图说明
图1为厄贝沙坦片溶出曲线。
具体实施方式
(一)制备工艺
实施例1：干法制粒
制备工艺
1)称量适当比例的厄贝沙坦(D90＝36μm)、微晶纤维素、甘露醇、羟丙纤维素、羧甲纤维素钙、混合均匀，采用干法制粒机进行制粒，制粒压力40-60bar，整粒目数14目；
2)将处方量硬脂酸镁与以上颗粒置三维混合机进行总混，混合频率30HZ，混合时间5min；
3)以9mm圆形浅凹冲进行压片；
4)以胃溶型包衣预混剂进行包衣，包衣增重2-4％。
对比例1：湿法制粒
制备工艺
1)称量适当比例的厄贝沙坦(D90＝36μm)、微晶纤维素、甘露醇、羟丙纤维素、羧甲纤维素钙置湿法制粒机混合5min，搅拌转速100rpm；
2)加入适量水进行制粒，搅拌转速100rpm，剪切速度2000rpm，制粒时间3min；
3)将湿法制得颗粒上流化床干燥，进风温度60℃，干燥至水分不得过2％；
4)将干燥颗粒以摇摆颗粒机进行整粒，筛网目数18目；
5)将处方量硬脂酸镁与以上颗粒置三维混合机进行总混，混合频率30HZ，混合时间5min；
6)以9mm圆形浅凹冲进行压片；
7)以胃溶型包衣预混剂进行包衣，包衣增重2-4％。
对比例2：粉末直压
制备工艺
1)称量适当比例的厄贝沙坦(D90＝36μm)、微晶纤维素、甘露醇、羟丙纤维素、羧甲基纤维素钙采用三维混合机混合，混合频率30HZ；混合时间15min。
2)将处方量硬脂酸镁置三维混合机进行总混，混合频率30HZ；混合时间5min。
3)以9mm圆形浅凹冲进行压片。
4)以胃溶型包衣预混剂进行包衣，包衣增重2～4％。
(二)物料流动性考察
取实施例1、对比例1和对比例2总混中间体检测物料休止角，评估物料流动性。结果见表1。
表1物料流动性对比
| 实施例 | 休止角 | 片重差异 |
| 实施例1 | 38.2 | ±1.2％ |
| 对比例1 | 39.2 | ±2.3％ |
| 对比例2 | 43.1 | ±3.5％ |
结果表明，实施例1采用干法制粒工艺，休止角最小(流动性最好)，片重差异最小。湿法制粒和粉末直压工艺物料流动性较差。
(三)稳定性考察
取实施例1、对比例1和对比例2的制备样品，按照制剂稳定性试验指导原则(中国药典2015年版四部9001)，模拟市售包装品进行加速稳定性考察，并于放置后的0个月、1个月、3个月和6个月取样，考察其外观性状、总杂，结果见表2。
表2稳定性对比
结果表明，实施例1和对比例2稳定性最佳，对比例2采用粉末直压工艺稳定性略差。
(四)溶出曲线考察
取实施例1、对比例1和对比例2的制备样品以及参比制剂，照溶出度与释放度测定法(中国药典2015年版四部0931中第二法)，以900mL，0.1mol/L盐酸为溶出介质，转速为50rpm，依法操作，分别在5、10、15、30min时，取样10mL，紫外分光光度法计算每片的溶出量。
表3溶出曲线对比
结果表明实施例1采用干法制粒工艺与参比制剂溶出曲线拟合良好，湿法制粒和粉末直压工艺能与参比制剂拟合，但相似性略差。
(五)临床生物等效性
实施例1样品与参比制剂进行生物等效性研究，结果表明本发明制备的厄贝沙坦片与参比制剂等效。
Claims (1)
1.一种厄贝沙坦片的制备方法，其特征在于，所述厄贝沙坦片由如下组分组成：
所述厄贝沙坦经微粉化后粒径范围为D90＝36μm，所述胃溶型包衣预混剂为欧巴代；
所述制备方法如下：
(1)称量处方量的厄贝沙坦、甘露醇、微晶纤维素、羟丙纤维素、羧甲纤维素钙，混合均匀；
(2)将步骤(1)得到的混粉干法制粒，制粒压力40～60bar，整粒，过14目筛；
(3)将步骤(2)得到的颗粒与处方量的硬脂酸镁置三维混合机进行总混，混合频率30HZ，混合时间5min；
(4)使用9mm圆形浅凹冲对步骤(3)得到的颗粒进行压片；
(5)使用胃溶型包衣预混剂对步骤(4)得到的片剂进行包衣，包衣增重2～4％。
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| CN1714794A (zh) * | 2004-06-28 | 2006-01-04 | 刘凤鸣 | 厄贝沙坦氢氯噻嗪分散片及其制备方法 |
| WO2011010316A1 (en) * | 2009-07-20 | 2011-01-27 | Hetero Research Foundation | Pharmaceutical compositions of irbesartan |
| CN103860511A (zh) * | 2012-12-09 | 2014-06-18 | 海南中济医药科技有限公司 | 一种含有厄贝沙坦和苯磺酸氨氯地平的药用组合物及其制备方法 |
| WO2016114725A1 (en) * | 2015-01-12 | 2016-07-21 | İlko İtaç Sanayi Ve Ticaret Anonim Şirketi | A stable bilayer pharmaceutical tablet compositions comprising fixed dose of irbesartan and amlodipine |
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