CN112494443A - 精准缓释片及其制备方法 - Google Patents
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- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
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Abstract
本发明涉及药物缓释技术领域,尤其是精准缓释片及其制备方法;它包括荚膜、肠溶层和缓释层,三者的重量比为1:2:9;其中荚膜材质为吸水多糖。吸水多糖入口后吸收口水中的水分并快速形成包裹药片的一层润滑层,该结构与口腔、喉咙以及食道的粘膜均无法有效吸附,故在服用时可快速进入胃部;而后胃部的胃酸可将吸水多糖消化掉,但肠溶层在酸性环境下无法溶解,故药片可继续进入肠道,在肠道的偏碱性环境中肠溶层崩解,最后缓释层在肠道的漫长过程中缓缓释放主药。
Description
技术领域
本发明涉及药物缓释技术领域,尤其是精准缓释片及其制备方法。
背景技术
缓释片通常将主药与缓释骨架支持剂共同成型,服用后通过缓释骨架支持剂的缓慢崩解剥落来控制主药的释放速度。现有技术的不足在于:1、部分主药具有强烈的刺激气味或者味道,而缓释片通常在入口一刻就开始崩解释放,容易刺激感官,从而影响吞咽,甚至导致患者呕吐;2、部分主药对胃部具有强烈的刺激作用,缓释片在胃部的释放必然导致患者胃部不舒服,甚至导致胃痛、呕吐等;3、现有的缓释片不管采用何种制作方式,都有一定几率发生粘喉,也就是缓释片与水共服时,水进入胃部而缓释片粘附在喉咙区域或者食道的粘膜上。
发明内容
针对现有技术的不足,本发明提供一种使得主药精准在肠道缓慢释放的缓释片以及它的制作方法。
本发明的技术方案为:
精准缓释片,它包括荚膜、肠溶层和缓释层,三者的重量比为1:2:9;
其中荚膜材质为吸水多糖。
具体的,所述肠溶层材质为欧巴代。
具体的,所述缓释层为主药与HPMC高分子材料的混合物,两者的重量比为1:1。
精准缓释片的制备方法,它包括以下步骤:
步骤一,将主药与HPMC高分子材料混合均匀并过60目筛网,而后压片成缓释层;
步骤二,将缓释层放入流化床包衣锅内干燥十分钟,按照增重2/9的量称取欧巴代包衣预混剂,加水配置成7%溶液,匀质仪处理3个循环,开启流化床,喷雾直至包衣完成,干燥得到半成品;
步骤三,将半成品放入另一包衣锅内,按照增重1/11的量称取吸水多糖,加水配置成15%悬浊液,匀质仪处理3个循环,开启流化床,喷雾直至包衣完成,干燥,得到成品。
进一步地,所述吸水多糖的制备方法,包括以下步骤:
S1将9份重量份数的多磷酸溶于蒸馏水,并用氢氧化钠将pH调节到11.5;
S2将100份重量份数的羧甲基纤维素钠均匀投放到上述溶液中,待其凝结成凝胶;
S3将凝胶粉碎;
S4将粉碎的凝胶在120设施的温度下干燥150分钟,随后采用研磨机研磨到500微米粒度,得到半成品;
S5将6份重量份数的多磷酸与100份重量份数的水混合并调整pH为11.0作为水溶液;
S6将1份重量份数的半成品与10份重量份数的水溶液混合,而后使用干粉机将其干燥成粉末,得到成品。
本发明的有益效果为:吸水多糖入口后吸收口水中的水分并快速形成包裹药片的一层润滑层,该结构与口腔、喉咙以及食道的粘膜均无法有效吸附,故在服用时可快速进入胃部;而后胃部的胃酸可将吸水多糖消化掉,但肠溶层在酸性环境下无法溶解,故药片可继续进入肠道,在肠道的偏碱性环境中肠溶层崩解,最后缓释层在肠道的漫长过程中缓缓释放主药。
具体实施方式
下面结合具体实施方式作进一步说明:
精准缓释片,它包括荚膜、肠溶层和缓释层,三者的重量比为1:2:9;
其中荚膜材质为吸水多糖。
具体的,所述肠溶层材质为欧巴代。
具体的,所述缓释层为主药与HPMC高分子材料的混合物,两者的重量比为1:1。
精准缓释片的制备方法,它包括以下步骤:
步骤一,将主药与HPMC高分子材料混合均匀并过60目筛网,而后压片成缓释层;
步骤二,将缓释层放入流化床包衣锅内干燥十分钟,按照增重2/9的量称取欧巴代包衣预混剂,加水配置成7%溶液,匀质仪处理3个循环,开启流化床,喷雾直至包衣完成,干燥得到半成品;
步骤三,将半成品放入另一包衣锅内,按照增重1/11的量称取吸水多糖,加水配置成15%悬浊液,匀质仪处理3个循环,开启流化床,喷雾直至包衣完成,干燥,得到成品。
进一步地,所述吸水多糖的制备方法,包括以下步骤:
S1将9份重量份数的多磷酸溶于蒸馏水,并用氢氧化钠将pH调节到11.5;
S2将100份重量份数的羧甲基纤维素钠均匀投放到上述溶液中,待其凝结成凝胶;
S3将凝胶粉碎;
S4将粉碎的凝胶在120设施的温度下干燥150分钟,随后采用研磨机研磨到500微米粒度,得到半成品;
S5将6份重量份数的多磷酸与100份重量份数的水混合并调整pH为11.0作为水溶液;
S6将1份重量份数的半成品与10份重量份数的水溶液混合,而后使用干粉机将其干燥成粉末,得到成品。
将本发明得到的缓释片与市面缓释片(上海中西三维药业有限公司,氟比洛芬缓释片)进行吞咽实验:
邀请200名志愿者平均分成两组(a组服用缓释片为氟比洛芬缓释片,b组服用本发明获得的缓释片,两种缓释片等重)进行实验,实验内容为每日吞咽一次缓释片(根据组别不同,吞咽的缓释片为氟比洛芬缓释片或本发明获得的缓释片),共服用9天,然后记录是否发生粘喉现象(粘附口腔、喉咙或者食道都计算在内)。
统计结果如下表:
组别 | 发生粘喉次数 |
a | 19 |
b | 0 |
根据实验可知,本发明将吸水多糖结合在缓释片上确实减少了粘喉现象的发生。
胃液对吸水多糖的消化能力的实验:
将吸水多糖放入胃液模拟液体(1摩尔每毫升的盐酸溶液+1克每100毫升胃蛋白酶)中进行模拟消化。
第一步,将1克吸水多糖薄膜放入20克清水中;
第二步,将吸胀的吸水多糖薄膜放入250毫升胃液模拟液体中,开始计时,直至薄膜崩解成小于原面积10%的碎片。
计时结果:5秒。
上述实施例和说明书中描述的只是说明本发明的原理和最佳实施例,在不脱离本发明精神和范围的前提下,本发明还会有各种变化和改进,这些变化和改进都落入要求保护的本发明范围内。
Claims (5)
1.精准缓释片,其特征在于:它包括荚膜、肠溶层和缓释层,三者的重量比为1:2:9;
其中荚膜材质为吸水多糖。
2.根据权利要求1所述的精准缓释片,其特征在于:所述肠溶层材质为欧巴代。
3.根据权利要求2所述的精准缓释片,其特征在于:所述缓释层为主药与HPMC高分子材料的混合物,两者的重量比为1:1。
4.精准缓释片的制备方法,其特征在于:它包括以下步骤:
步骤一,将主药与HPMC高分子材料混合均匀并过60目筛网,而后压片成缓释层;
步骤二,将缓释层放入流化床包衣锅内干燥十分钟,按照增重2/9的量称取欧巴代包衣预混剂,加水配置成7%溶液,匀质仪处理3个循环,开启流化床,喷雾直至包衣完成,干燥得到半成品;
步骤三,将半成品放入另一包衣锅内,按照增重1/11的量称取吸水多糖,加水配置成15%悬浊液,匀质仪处理3个循环,开启流化床,喷雾直至包衣完成,干燥,得到成品。
5.根据权利要求4所述的精准缓释片的制备方法,其特征在于:包括以下步骤:
S1将9份重量份数的多磷酸溶于蒸馏水,并用氢氧化钠将pH调节到11.5;
S2将100份重量份数的羧甲基纤维素钠均匀投放到上述溶液中,待其凝结成凝胶;
S3将凝胶粉碎;
S4将粉碎的凝胶在120设施的温度下干燥150分钟,随后采用研磨机研磨到500微米粒度,得到半成品;
S5将6份重量份数的多磷酸与100份重量份数的水混合并调整pH为11.0作为水溶液;
S6将1份重量份数的半成品与10份重量份数的水溶液混合,而后使用干粉机将其干燥成粉末,得到成品。
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