CN114699384A - 一种药物掩味方法、药物及其应用 - Google Patents
一种药物掩味方法、药物及其应用 Download PDFInfo
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- CN114699384A CN114699384A CN202210285234.XA CN202210285234A CN114699384A CN 114699384 A CN114699384 A CN 114699384A CN 202210285234 A CN202210285234 A CN 202210285234A CN 114699384 A CN114699384 A CN 114699384A
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Abstract
本发明揭示了一种药物掩味方法、药物及其应用。所述药物掩味方法包括:提供粘合剂溶液和包衣悬浮液,所述粘合剂溶液包含聚合物粘合剂和溶剂,所述包衣悬浮液包含包衣聚合物、塑化剂和抗粘剂;利用所述粘合剂溶液,使用流化床或高速剪切湿法对中药微粉或中药提取物粉末进行造粒处理,制得中药或中药提取物粒子;利用所述包衣悬浮液对所述中药或中药提取物粒子进行包衣处理,以在所述中药或中药提取物粒子上包裹聚合物膜,从而制得中药掩味粒子。由本发明提供的药物掩味方法制备的包衣中药药材释放颗粒在口腔中不会释放有效成份,病人感觉不到苦味,且该掩味方法可以用于不同种类的中药或中药混合物的掩味。
Description
技术领域
本发明属于中药制剂技术领域,具体涉及一种药物掩味方法、药物及其应用。
背景技术
中药是中华民族的瑰宝和中华文化传承的表现。中药现代化是国家医药政策的重点之一。在中药现代化的过程中,传统中药的粉化是基础研究和工业化的主流方向之一。现在市场上已经有很多中药粉剂和中药提取物粉末,这些粉末可以起到保健、治病的目的。例如,龙胆草,又称龙胆花,可以清热燥湿,泻肝胆火。其广泛用于湿热黄疸、阴肿阴痒、湿疹瘙痒、目赤、耳聋、胁痛、口苦、惊风抽搐等症状。再例如,黄连是另外一味常用中药,其可以用来消炎退火、治疗眼病、皮肤病,甚至糖尿病、失眠等症状。很多中药已经流传了上千年。
但是不少中药味道非常苦,例如上面提到的龙胆草和黄连等。据《中华本草》所载1700多种寒热药性明确的中药中,味苦药共有1000多种,占比超过60%。长期服用苦味中药容易伤及脾胃。未成年人对苦味的耐受度更低。为了提高病人的依从性,更好地推广中药,有必要对苦味中药进行掩味,做到良药不苦口。随着国家对中医中药的重视,为了更好地进行中药现代化,同时提高患者对中医制剂的依从性和临床疗效,非常有必要开发具有普适性的掩味方法和制剂。
掩味的方法有多种,例如添加甜味剂和矫味剂、物理包埋喷干、和环糊精形成内吞包合物、离子交换树脂吸附等。由于很多中药复合搭配使用,在剂型中包括多种生物活性成份,其中苦味成份的来源比较复杂。因此,很难发现一种普适的掩味技术,可以掩盖此类中药系统中的苦味。在中药掩味领域的研究工作依然有限。
发明内容
本发明的主要目的在于提供一种药物掩味方法、药物及其应用,以克服现有技术中存在的不足。
为实现前述发明目的,本发明实施例采用的技术方案包括:
本发明实施例提供了一种药物掩味方法,包括:
提供粘合剂溶液和包衣悬浮液,所述粘合剂溶液包含聚合物粘合剂和溶剂,所述包衣悬浮液包含包衣聚合物、塑化剂和抗粘剂;
利用所述粘合剂溶液,使用流化床或高速剪切湿法对中药微粉或中药提取物粉末进行造粒处理,制得中药或中药提取物粒子;
利用所述包衣悬浮液对所述中药或中药提取物粒子进行包衣处理,以在所述中药或中药提取物粒子上包裹聚合物膜,从而制得中药掩味粒子。
进一步地,所述粘合剂溶液包含5-35wt%聚合物粘合剂。
进一步地,所述包衣悬浮液包含5-40wt%包衣聚合物。
进一步地,所述聚合物粘合剂与中药微粉或中药提取物粉末的重量比为1-15%∶1。
进一步地,所述包衣聚合物与中药微粉或中药提取物粉末的重量比为5-75%∶1。
进一步地,所述塑化剂与包衣聚合物的重量比为5-35%∶1。
进一步地,所述抗粘剂与包衣聚合物的重量比为15-25%∶1。
本发明实施例提供了一种中药掩味粒子,它是由上述的方法制得。
本发明实施例提供了一种药物,包含上述的中药掩味粒子。
本发明实施例还提供了上述的中药掩味粒子在制备口服药物中的用途,所述口服药物包括口服冲剂、咀嚼片、口崩片或口服悬浮液中的应用。
本发明实施例还提供了一种药物组合物,包括上述的中药掩味粒子,以及,药学上可接受的载剂。
进一步地,所述药学上可接受的载剂包括填充剂、崩解剂、粘合剂、流动剂、润滑剂、甜味剂、香精或悬浮液稳定剂中的任意一种或多种的组合。
进一步地,所述药物组合物中中药掩味粒子的含量为20-70wt%。
进一步地,所述填充剂在药物组合物中的含量为5-40wt%。
进一步地,所述崩解剂在药物组合物中的含量为2-15wt%。
进一步地,所述粘合剂在药物组合物中的含量为2-10wt%。
进一步地,所述流动剂在药物组合物中的含量为0.1-1wt%。
进一步地,所述润滑剂在药物组合物中的含量为0.2-1.5wt%。
进一步地,所述甜味剂在药物组合物中的含量为0.1-1wt%。
进一步地,所述香精在药物组合物中的含量为0.1-1wt%。
进一步地,所述悬浮液稳定剂在药物组合物中的含量为1-10wt%。
与现有技术相比,本发明具有如下有益效果:
(1)本发明药物掩味方法,采用造粒、包衣工艺,优选医药级包衣材料来进行粘合、包衣,本工艺过程简单有效;其中,造粒可以提高中药粉末的流动性,使包衣过程更有效、快速,包衣后的中药药材释放颗粒在口腔中不会释放有效成份,没有苦味,应用范围广,易于具有吞咽困难的病人服用,例如老龄和儿童病人,且该制备方法可以用于不同种类的中药或中药混合物的掩味。
(2)本发明药物掩味方法,造粒过程中使用的部分粘合剂可以为水溶性或水不溶性高分子,可以影响最终产品中药活性分子的释放;流化床和湿法造粒参数调整和粘合剂量的改变可以有效调控中药粒子的粒径、形状,如在粘合剂中加入崩解成分,可以提高粒子的崩解速率;包衣主体聚合物成分有控制药物释放的功能,可以保证药物分子在口腔中不释放、不和味蕾接触,使病人感觉不到苦味,吞咽后在肠胃中速释或缓释,从而产生疗效;包衣时间长短和喷射速度可以有效控制包衣层厚度和包衣粒子的尺寸,从而实现有效掩味和控制药物释放动力学。
(3)本发明中药掩味粒子可以进一步加工制得冲剂、咀嚼片、口崩片、口服液等,该方法步骤少,载药量可控,质量有保障,适合生产放大,且冲剂、咀嚼片、口崩片、口服液这些剂型和传统的片剂和胶囊相比,更易于服用;例如口崩片可以负载非处方药和处方药,其在口腔内溶解而不需要吞咽整个药片,对于患有吞咽困难的患者,口崩片可作为替代剂型,其不需要水即可服用。
具体实施方式
本发明实施例的一个方面提供了一种药物掩味方法,包括:
提供粘合剂溶液和包衣悬浮液,所述粘合剂溶液包含聚合物粘合剂和溶剂,所述包衣悬浮液包含包衣聚合物、塑化剂和抗粘剂;
利用所述粘合剂溶液,使用流化床或高速剪切湿法对中药微粉或中药提取物粉末进行造粒处理,制得中药或中药提取物粒子;
利用所述包衣悬浮液对所述中药或中药提取物粒子进行包衣处理,以在所述中药或中药提取物粒子上包裹聚合物膜,从而制得中药掩味粒子。
在一些优选实施例中,所述粘合剂溶液包含5-35wt%聚合物粘合剂。
在一些优选实施例中,所述包衣悬浮液包含5-40wt%包衣聚合物。
在一些优选实施例中,所述溶剂可以包括水、乙醇、丙酮、异丙醇等中的任意一种或多种的组合,但不局限于此。
在一些优选实施例中,所述聚合物粘合剂与中药微粉或中药提取物粉末的重量比为1-15%∶1。
在一些更为优选的实施例中,所述聚合物粘合剂可以包括聚乙烯基吡咯烷酮、乙烯基吡咯烷酮和醋酸乙烯酯共聚物、羟丙基甲基纤维素、羟丙基纤维素、甲基纤维素、明胶、海藻酸钠、水溶性淀粉、聚乙烯醇-乙二醇接枝共聚物、卡波普等中的任意一种或多种的组合,但不局限于此。
在一些更为优选的实施例中,所述中药微粉或中药提取物粉末的来源可以包括八角莲、八爪金龙、巴山虎、拔毒草、霸王鞭、白背叶、白丁香、白粉藤、白花果、白花藤、白兰花、白蔹、白枪杆、白屈菜、白芍、白头翁、白杨叶、白朱砂莲、山总管、百日草、柏树根、火炮子、半夏曲、蓖麻叶、蝙蝠藤、遍山红、薄叶黄芩、苍耳、川黄芩、苍术、藏青果、草龙根、草玉梅、柴胡、长年兰、三七、常春藤、车桑子、齿叶草、赤地榆、山芍药、牛尾蒿、山茉莉、樗木叶、川麻黄、穿地龙、穿根藤、穿心莲、青皮树、椿白皮、刺盖草、鸡冠麻、蒺藜、猪毛菜、叶耳草、鸡爪连、大白药、扁竹兰、大风药、大黄、苦参、黄连、苦菜、黄芩、栀子、葶苈子、枳实、龙胆草、苍术、木通、厚朴、黄柏、排风藤根、白毛藤、银杏叶、八仙草连翘、夏枯草、马钱子、黄根、防己藤、青蒿、银柴胡、草麻黄、独活、满山红、杓儿菜、苦参、木通、龙胆草、大苦草、荨麻、青根、地丁、白芷、马钱子、黑及草、红刺藤、七叶胆、狮尾草、千金藤、凤仙、青蒿、苦麻、瓜子莲、藤三七、天王七、散血莲、白粉蕨、青藤香、羊角藤、金不换、小鱼眼草、水香草、洋地黄、吴茱萸等中的任意一种或多种的组合,但不局限于此。
在一些优选实施例中,所述包衣聚合物与中药微粉或中药提取物粉末的重量比为5-75%∶1。
在一些更为优选的实施例中,所述包衣聚合物可以包括乙基纤维素、醋酸纤维素、醋酸邻苯二甲酸纤维素、醋酸丁酸纤维素、羟丙基甲基纤维素邻苯二甲酸酯、羧甲基乙基纤维素、羟丙基甲基醋酸琥珀酸酯、聚乙酸乙烯酯/聚乙烯基吡咯烷酮、甲基丙烯酸和乙基甲基丙烯酸酯共聚物、丁基甲基丙烯酸酯-2-二甲基氨基乙基甲基丙烯酸酯-甲基丙烯酸甲酯共聚物、甲基丙烯酸甲酯和二乙氨乙基甲基丙烯酸酯共聚物、聚丙烯酸酯聚合物、壳聚糖等中的任意一种或多种的组合,但不局限于此。
在一些优选实施例中,所述塑化剂与包衣聚合物的重量比为5-35%∶1。
在一些更为优选的实施例中,所述塑化剂可以包括邻苯二甲酸二乙酯、三乙酸甘油酯、单辛酸甘油酯和柠檬酸三乙酯、邻苯二甲酸二丁酯、邻苯二甲酸二乙酯、邻苯二甲酸二环己酯、邻苯二甲酸丁二醇酯、邻苯二甲酸丁二醇酯、硬脂酸丁酯、蓖麻油、柠檬酸三乙酯、柠檬酸乙酰三丁酯、癸二酸二丁酯、柠檬酸三丁酯、三醋精、聚乙二醇、丙二醇等中的任意一种或多种的组合,但不局限于此。
在一些优选实施例中,所述抗粘剂与包衣聚合物的重量比为15-25%∶1。
在一些更为优选的实施例中,所述抗粘剂可以包括滑石粉、高岭土等中的任意一种或两种,但不局限于此。
本发明实施例的另一个方面提供了一种中药掩味粒子,它是由上述的方法制得。
本发明实施例的另一个方面还提供了一种药物,包含上述的中药掩味粒子。
本发明实施例的另一个方面还提供了上述的中药掩味粒子在制备口服药物中的用途,所述口服药物包括口服冲剂、咀嚼片、口崩片或口服悬浮液中的应用。
本发明实施例的另一个方面还提供了一种药物组合物,包括上述的中药掩味粒子,以及,药学上可接受的载剂。
在一些优选实施例中,所述药学上可接受的载剂可以包括填充剂、崩解剂、粘合剂、流动剂、润滑剂、甜味剂、香精、悬浮液稳定剂等中的任意一种或多种的组合,但不局限于此。
在一些优选实施例中,所述药物组合物中中药掩味粒子的含量为20-70wt%。
在一些优选实施例中,所述填充剂在药物组合物中的含量为5-40wt%。
在一些更为优选的实施例中,所述填充剂可以包括乳糖、甘露醇、蔗糖、预糊化淀粉、微晶纤维素、碳酸钙等中的任意一种或多种的组合,但不局限于此。
在一些优选实施例中,所述崩解剂在药物组合物中的含量为2-15wt%。
在一些更为优选的实施例中,所述崩解剂可以包括交联羧甲基纤维素钠、羧甲基淀粉钠、交联聚乙烯吡咯烷酮等中的任意一种或多种的组合,但不局限于此。
在一些优选实施例中,所述粘合剂在药物组合物中的含量为2-10wt%。
在一些更为优选的实施例中,所述粘合剂可以包括水、乙醇、可溶性淀粉、羧甲基纤维素钠、羟丙基纤维素、甲基纤维素、乙基纤维素、羟丙基甲基纤维素、明胶、聚乙烯吡咯烷酮、聚乙烯醇-乙二醇接枝共聚物、卡波普等中的任意一种或多种的组合,但不局限于此。
在一些优选实施例中,所述流动剂在药物组合物中的含量为0.1-1wt%。
在一些更为优选的实施例中,所述流动剂可以包括二氧化硅纳米粒子,但不局限于此。
在一些优选实施例中,所述润滑剂在药物组合物中的含量为0.2-1.5wt%。
在一些更为优选的实施例中,所述润滑剂可以包括微粉硅胶、硬脂酸镁、硬脂酸钠、硬脂酸锌、滑石粉、植物油乙二醇共聚物、聚乙二醇等中的任意一种或多种的组合,但不局限于此。
在一些优选实施例中,所述甜味剂在药物组合物中的含量为0.1-1wt%。
在一些更为优选的实施例中,所述甜味剂可以包括糖精、阿斯巴甜、三氯蔗糖、安赛蜜K、纽糖、塔格糖、木糖醇等中的任意一种或多种的组合,但不局限于此。
在一些优选实施例中,所述香精在药物组合物中的含量为0.1-1wt%。
在一些更为优选的实施例中,所述香精可以包括薄荷、桔子、葡糖、草莓、甜橙、樱桃、柠檬、奶油、香草、巧克力、杏仁、蓝莓等中的任意一种或多种的组合,但不局限于此。
在一些优选实施例中,所述悬浮液稳定剂在药物组合物中的含量为1-10wt%。
在一些更为优选的实施例中,所述悬浮液稳定剂可以包括羧甲基纤维素钠、羧甲基淀粉钠、水溶性淀粉、羟丙基甲基纤维、聚乙烯醇、聚乙烯及吡咯烷酮、交联聚乙烯基吡咯烷酮、黄原胶、壳聚糖、海藻酸钠、明胶、卡波普等中的任意一种或多种的组合,但不局限于此。
本发明实施例提供的药物掩味方法,采用造粒、包衣工艺,优选医药级包衣材料来进行粘合、包衣,本工艺过程简单有效;其中,造粒可以提高中药粉末的流动性,使包衣过程更有效、快速,包衣后的中药掩味粒子在口腔中不会释放有效成份,没有苦味,应用范围广,易于具有吞咽困难的病人服用,例如老龄和儿童病人,且该制备方法可以用于不同种类的中药或中药混合物的掩味。
下面将结合本发明实施例,对本发明实施例中的技术方案进行详细的描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动的前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1黄连提取物造粒包衣
称取30克聚乙烯基吡咯烷酮K30,加入到170克超纯水中,搅拌充分溶解制得重量浓度为15%的粘合剂溶液。
称取500克黄连提取物(盐酸小檗碱含量10%),投入到流化床中,顶部喷射粘合剂溶液造粒,喷射速度:10-15克/分钟,干燥空气温度:45-70度,干燥空气流速:20-40立方米/小时,样品温度:30-40度,完成造粒后,样品过65目筛。
将造粒样投入流化床,采用底部喷射方式包衣,包衣溶液喷射速度为3-10克/分钟,干燥空气温度:55-70度,干燥空气流速:30-40立方米/小时,样品温度:40-45度;包衣完成后,提升样品温度到60度,热处理1小时。
包衣后的黄连提取物基本没有苦味。
实施例2苦参提取物掩味
称取500克苦参提取物,投入到流化床中,顶部喷射粘合剂溶液造粒,喷射速度:10-15克/分钟,干燥空气温度:45-70度,干燥空气流速:20-40立方米/小时,样品温度:30-40度,完成造粒后,样品过65目筛。
将造粒样投入流化床,采用底部Wurster喷射方式包衣,包衣溶液喷射速度为3-10g/分钟,干燥空气温度:45-65度,干燥空气流速:25-35立方米/小时,样品温度:35-45度;包衣完成后,提升样品温度到50度,热处理0.5小时。
包衣后的苦参提取物基本没有苦味。
实施例3盐酸小檗碱掩味
称取羟丙基甲基纤维素(METHOCELTM E5LV)24克,加入到276克的热水中,磁力搅拌,制得重量浓度为8%的粘合剂溶液。
称取500克盐酸小檗碱微粉,投入到流化床中,顶部喷射粘合剂溶液造粒,喷射速度:10-15克/分钟,干燥空气温度:45-70度,干燥空气流速:20-40立方米/小时,样品温度:30-40度,完成造粒后,样品过65目筛。
将造粒样投入流化床,采用底部喷射方式包衣,包衣悬浮液喷射速度为3-10克/分钟,干燥空气温度:45-65度,干燥空气流速:25-40立方米/小时,样品温度:35-50度;包衣完成后,提升样品温度到60度,热处理0.5小时。
包衣后的盐酸小檗碱基本没有苦味。
实施例4三黄粉提取物掩味
称取低分子量壳聚糖105克,加入到1200克的醋酸水溶液(1%)中,并加入15克三醋精(TAC),搅拌制得包衣溶液。
称取150克大黄提取物,150克黄连提取物,150克黄芪提取物,投入高速剪切造粒机中,设置高速搅拌速度100RPM,剪切速度1200RPM,将粘合剂溶液泵入,速度为55克/分钟。继续搅拌剪切5分钟,取出湿粒,过20目筛,流化床干燥30分钟,干燥温度:40-60度,空气流速:35立方米/小时,干燥后过65目筛。
将造粒样投入流化床,采用顶部喷射方式包衣,包衣溶液喷射速度为3-10克/分钟,干燥空气温度:45-65度,干燥空气流速:25-40立方米/小时,样品温度:35-50度,包衣完成后,提升样品温度到60度,热处理0.5小时。
包衣后的三黄粉提取物粒子基本没有苦味。
实施例5穿心莲提取物掩味
称取聚乙烯基吡咯烷酮和醋酸乙烯酯的共聚物(PlasdoneTM S-630)20克,加入到100克的超纯水中,磁力搅拌下,制得重量浓度为16.7%的粘合剂溶液。
称取700g水,加入氢氧化钠3.1克搅拌溶解,并加入十二烷基磺酸钠2.8克,并在搅拌下加入羟丙基甲基纤维素乙酸琥珀酸酯(AquaSolveTM HPMCAS-L)98克,充分分散,加入三柠檬酸乙酯(TEC)24克,搅拌制得包衣溶液。
称取400克穿心莲提取物(50%)微粉和10克PlasdoneTM S-630充分混合,投入高速剪切造粒机中,设置高速搅拌速度80-100RPM,剪切速度1000-1500RPM,将粘合剂溶液泵入,速度为50g/分钟,继续搅拌剪切5分钟。取出湿粒,过20目筛,流化床干燥30分钟,干燥温度:40-60度,空气流速:35立方米/小时,干燥后过65目筛。
将造粒样投入流化床,采用顶部喷射方式包衣,包衣溶液喷射速度为3-10克/分钟,干燥空气温度:45-55度,干燥空气流速:25-40立方米/小时,样品温度:35-50度,包衣完成后,提升样品温度到60度,热处理0.5小时。
包衣后的穿心莲提取物粒子基本没有苦味。
实施例6三七粉提取物掩味
称取羟丙基淀粉(Lycoat RS780)30克,加入到220克的热水中,磁力搅拌下加入硬脂酸三甘油酯(GMS)2.7克,制得粘合剂溶液。
称取甲基丙烯酸甲酯/甲基丙烯酸二乙氨基乙酯共聚物乳液(Smartsea130D)500克,加入450克超纯水,加热混合30克柠檬酸三丁酯(TBC)和3克丁基化羟基甲苯(BHT),然后加入到聚合物乳液中,制得包衣溶液。
称取500克三七粉提取物,投入到流化床中,顶部喷射粘合剂溶液造粒,喷射速度:10-15克/分钟,干燥空气温度:45-70度,干燥空气流速:20-40立方米/小时,样品温度:30-40度,完成造粒后,样品过65目筛。
将造粒样投入流化床,采用顶部喷射方式包衣,包衣悬浮液喷射速度为3-10克/分钟,干燥空气温度:45-65度,干燥空气流速:25-40立方米/小时,样品温度:35-50度,包衣完成后,提升样品温度到60度,热处理1小时。
包衣后的三七粉提取物基本无刺激味。
包衣后的中药提取物可以用于制备不同的口服剂型,例如口服颗粒冲剂,咀嚼片,口崩片,口服液等。每一种中药都可以用于不同口服剂型的制备,例如黄连包衣颗粒可以制成口服冲剂,咀嚼片,口崩片,口服液。下面的实施例中只列出了其中一种。
实施例7黄连口服冲剂
本实施例以掩味后的黄连颗粒(实施例1)为基础,加入甜味剂、稳定剂、香精或其他辅料等制得口服冲剂,例如可以加入糖精、阿斯巴甜、三氯蔗糖、安赛蜜K、纽糖、塔格糖、木糖醇、柠檬酸钠、聚乙二醇、交联聚乙烯基吡咯烷酮、丙二醇、对羟基苯甲酸丙酯、山梨醇、三氯蔗糖、明胶、羧甲基纤维素钠、羟丙基甲基纤维素、微晶纤维素、变性淀粉钠、黄原胶、果味香精等中的一种或多种。
下表列出其中一个具体实施例。该配方包含柠檬酸、樱桃香精、羧甲基纤维素钠、蔗糖、山梨糖醇、聚乙二醇-丙二醇共聚物(Poloxamer 407)、黄原胶。配料表见表一。
表一:黄连口服冲剂配料表
原料 | 百分比 |
黄连提取物掩味颗粒(实施例1) | 50-70 |
柠檬酸 | 1-5 |
樱桃香精 | 0.2-2 |
羧甲基纤维素钠 | 2-5 |
蔗糖 | 5-10 |
山梨糖醇 | 1-10 |
聚乙二醇-丙二醇共聚物(Poloxamer 407) | 3-6 |
黄原胶 | 2-5 |
以上配料可以包装成3-10g/袋,加温水冲服。
实施例8苦参咀嚼片
咀嚼片是现代药物制剂的一种剂型,病人在口腔中嚼碎后服用。因为可以加入甜味剂、香精、颜色等辅料,还可以制成各种形状,所以很受儿童病人欢迎。因咀嚼后吞咽,对具有吞咽困难的病人是非常友好的,该剂型可以解决吞咽困难的问题。
本实施例包含苦参提取物掩味颗粒(实施例2)、填充剂、果味香精、甜味素、流动促进剂、润滑剂等。填充剂可以是结晶纤维素、小分子糖、淀粉、聚乙烯基吡咯烷酮等中的一种或多种。表二只给出其中一例。
表二:苦参咀嚼片配料表
表二中的所有原料混合均匀,压成直径12-14mm的圆型片剂,制片压力为5-30千牛,优选10-25千牛,再优选15-20千牛,每片重900-1200毫克。
实施例9盐酸小檗碱咀嚼片
本实施例包含盐酸小檗碱掩味颗粒(实施例3)、填充剂、果味香精、甜味素、流动促进剂、润滑剂等。填充剂可以是结晶纤维素、小分子糖颗粒、淀粉、聚乙烯基吡咯烷酮等中的一种或多种。表三只给出其中一例。
表三:苦参咀嚼片配料表
表三中的所有原料混合均匀,压成直径11-13mm的圆型片剂,制片压力为5-30千牛,优选10-25千牛,再优选15-20千牛,每片重800-1000毫克。
实施例10三黄口崩片
口崩片与传统药片不同,其可以在口腔中和唾液接触后自动崩解,因为不需要吞咽整个药片,口崩片可作为传统片剂的替代剂型,用于具有吞咽困难的人群,例如幼儿和老年住院患者。口崩片可以更快地崩解而释放出有效药物分子,因此比片剂或胶囊起效更快。口崩片的服用不需要水。
因为其在口腔中存在的时间较长,药物分子必须掩味。前面的实施例中包衣后的中药颗粒均可用于口崩片的制备。在口崩片中崩解剂非常重要。本专利中选择的崩解剂为羧甲基纤维素钠、变性淀粉钠、交联聚乙烯基吡咯烷酮中的一种或几种。为了进一步提高病人的体验感,加入了甜味剂和香精。
三黄粉提取物掩味(实施例4)和其他辅料混合、直压后得到三黄口崩片。其它辅料包括甘露醇、羧甲基纤维素钠、交联聚乙烯基吡咯烷酮、聚醋酸乙烯酯、微晶纤维素、纤维素钠、淀粉钠、香精、甜味素等。表四只列出一个具体实施例。
表四:三黄口崩片配料表
表四中的所有原料混合均匀,压成直径10-14mm的圆型片剂,每片重700-1000毫克。制片压力为5-30千牛,优选10-25千牛,再优选15-20千牛。控制崩解剂含量和压片压力,使崩解时间为30秒到60秒。
实施例11穿心莲口崩片
本实施例制备穿心莲口崩片。穿心莲掩味颗粒(实施例5)和其他辅料混合、直压后得到穿心莲口崩片。其它辅料包括甘露醇、羧甲基纤维素钠、交联聚乙烯基吡咯烷酮、聚醋酸乙烯酯、微晶纤维素、纤维素钠、淀粉钠、香精、甜味素等。表五只列出一个具体实施例。
表五:穿心莲口崩片配料表
表五中的所有原料混合均匀,压成直径10-14mm的圆型片剂,每片重700-1000毫克。制片压力为5-30千牛,优选10-25千牛,再优选15-20千牛。控制崩解剂含量和压片压力,使崩解时间为30秒到60秒。
实施例12三七液体悬浮液
口服液体悬浮液是由一种或多种药物的不溶性颗粒与其他辅料混合制成的混悬液,用于口服。本专利中的液体悬浮液中的活性中药成份为中药掩味颗粒。尽管在口腔中存在的时间较长,但中药成份并没有释放,所以患者感觉不到苦味。中药颗粒悬浮在溶剂中可形成易于吞咽的口服剂型。吞咽后,中药分子可以释放出来,并不影响中药分子的有效性吸收。
液体悬浮液的主要成份有掩味中药颗粒(实施例6)、稳定剂、增稠剂、防腐剂、香精、甜味剂等。该实施例中可以包含有聚乙二醇,聚乙烯基吡咯烷酮、交联聚乙烯基吡咯烷酮、羧甲基纤维素钠、环糊精、羟丙基甲基纤维素、果味香精,糖精钠、防腐剂等中的一种或多种。表六只列出一个具体实施例。
表六:三七液体悬浮液配料表
表六中的固体原料分散到水中,搅拌均匀,得到三七液体悬浮液。
此外,本案发明人还参照前述实施例,以本说明书述及的其它原料、工艺操作、工艺条件进行了试验,并均获得了较为理想的结果。
尽管已参考说明性实施例描述了本发明,但所属领域的技术人员将理解,在不背离本发明的精神及范围的情况下可做出各种其它改变、省略及/或添加且可用实质等效物替代所述实施例的元件。另外,可在不背离本发明的范围的情况下做出许多修改以使特定情形或材料适应本发明的教示。因此,本文并不打算将本发明限制于用于执行本发明的所揭示特定实施例,而是打算使本发明将包含归属于所附权利要求书的范围内的所有实施例。此外,除非具体陈述,否则术语第一、第二等的任何使用不表示任何次序或重要性,而是使用术语第一、第二等来区分一个元素与另一元素。
Claims (10)
1.一种药物掩味方法,其特征在于,包括:
提供粘合剂溶液和包衣悬浮液,所述粘合剂溶液包含聚合物粘合剂和溶剂,所述包衣悬浮液包含包衣聚合物、塑化剂和抗粘剂;
利用所述粘合剂溶液,使用流化床或高速剪切湿法对中药微粉或中药提取物粉末进行造粒处理,制得中药或中药提取物粒子;
利用所述包衣悬浮液对所述中药或中药提取物粒子进行包衣处理,以在所述中药或中药提取物粒子上包裹聚合物膜,从而制得中药掩味粒子。
2.根据权利要求1所述的药物掩味方法,其特征在于:所述粘合剂溶液包含5-35wt%聚合物粘合剂;和/或,所述包衣悬浮液包含5-40wt%包衣聚合物;和/或,所述溶剂包括水、乙醇、丙酮或异丙醇中的任意一种或多种的组合。
3.根据权利要求1所述的药物掩味方法,其特征在于:所述聚合物粘合剂与中药微粉或中药提取物粉末的重量比为1-15%∶1;和/或,所述聚合物粘合剂包括聚乙烯基吡咯烷酮、乙烯基吡咯烷酮和醋酸乙烯酯共聚物、羟丙基甲基纤维素、羟丙基纤维素、甲基纤维素、明胶、海藻酸钠、水溶性淀粉、聚乙烯醇-乙二醇接枝共聚物或卡波普中的任意一种或多种的组合;和/或,所述中药微粉或中药提取物粉末的来源包括八角莲、八爪金龙、巴山虎、拔毒草、霸王鞭、白背叶、白丁香、白粉藤、白花果、白花藤、白兰花、白蔹、白枪杆、白屈菜、白芍、白头翁、白杨叶、白朱砂莲、山总管、百日草、柏树根、火炮子、半夏曲、蓖麻叶、蝙蝠藤、遍山红、薄叶黄芩、苍耳、川黄芩、苍术、藏青果、草龙根、草玉梅、柴胡、长年兰、三七、常春藤、车桑子、齿叶草、赤地榆、山芍药、牛尾蒿、山茉莉、樗木叶、川麻黄、穿地龙、穿根藤、穿心莲、青皮树、椿白皮、刺盖草、鸡冠麻、蒺藜、猪毛菜、叶耳草、鸡爪连、大白药、扁竹兰、大风药、大黄、苦参、黄连、苦菜、黄芩、栀子、葶苈子、枳实、龙胆草、苍术、木通、厚朴、黄柏、排风藤根、白毛藤、银杏叶、八仙草连翘、夏枯草、马钱子、黄根、防己藤、青蒿、银柴胡、草麻黄、独活、满山红、杓儿菜、苦参、木通、龙胆草、大苦草、荨麻、青根、地丁、白芷、马钱子、黑及草、红刺藤、七叶胆、狮尾草、千金藤、凤仙、青蒿、苦麻、瓜子莲、藤三七、天王七、散血莲、白粉蕨、青藤香、羊角藤、金不换、小鱼眼草、水香草、洋地黄或吴茱萸中的任意一种或多种的组合。
4.根据权利要求3所述的药物掩味方法,其特征在于:所述包衣聚合物与中药微粉或中药提取物粉末的重量比为5-75%∶1;和/或,所述包衣聚合物包括乙基纤维素、醋酸纤维素、醋酸邻苯二甲酸纤维素、醋酸丁酸纤维素、羟丙基甲基纤维素邻苯二甲酸酯、羧甲基乙基纤维素、羟丙基甲基醋酸琥珀酸酯、聚乙酸乙烯酯/聚乙烯基吡咯烷酮、甲基丙烯酸和乙基甲基丙烯酸酯共聚物、丁基甲基丙烯酸酯-2-二甲基氨基乙基甲基丙烯酸酯-甲基丙烯酸甲酯共聚物、甲基丙烯酸甲酯和二乙氨乙基甲基丙烯酸酯共聚物、聚丙烯酸酯聚合物或壳聚糖中的任意一种或多种的组合。
5.根据权利要求3所述的药物掩味方法,其特征在于:所述塑化剂与包衣聚合物的重量比为5-35%∶1;和/或,所述塑化剂包括邻苯二甲酸二乙酯、三乙酸甘油酯、单辛酸甘油酯和柠檬酸三乙酯、邻苯二甲酸二丁酯、邻苯二甲酸二乙酯、邻苯二甲酸二环己酯、邻苯二甲酸丁二醇酯、邻苯二甲酸丁二醇酯、硬脂酸丁酯、蓖麻油、柠檬酸三乙酯、柠檬酸乙酰三丁酯、癸二酸二丁酯、柠檬酸三丁酯、三醋精、聚乙二醇或丙二醇中的任意一种或多种的组合;
和/或,所述抗粘剂与包衣聚合物的重量比为15-25%∶1;和/或,所述抗粘剂包括滑石粉或高岭土中的任意一种或两种。
6.一种中药掩味粒子,其特征在于,它是由权利要求1-5中任一项所述的方法制得。
7.一种药物,其特征在于包含权利要求6所述的中药掩味粒子。
8.权利要求6所述的中药掩味粒子在制备口服药物中的用途,所述口服药物包括口服冲剂、咀嚼片、口崩片或口服悬浮液中的应用。
9.一种药物组合物,其特征在于,包括:权利要求6所述的中药掩味粒子,以及,药学上可接受的载剂;
和/或,所述药学上可接受的载剂包括填充剂、崩解剂、粘合剂、流动剂、润滑剂、甜味剂、香精或悬浮液稳定剂中的任意一种或多种的组合。
10.根据权利要求9所述的药物组合物,其特征在于:所述药物组合物中中药掩味粒子的含量为20-70wt%;
和/或,所述填充剂在药物组合物中的含量为5-40wt%;所述填充剂包括乳糖、甘露醇、蔗糖、预糊化淀粉、微晶纤维素或碳酸钙中的任意一种或多种的组合;
和/或,所述崩解剂在药物组合物中的含量为2-15wt%;和/或,所述崩解剂包括交联羧甲基纤维素钠、羧甲基淀粉钠或交联聚乙烯吡咯烷酮中的任意一种或多种的组合;
和/或,所述粘合剂在药物组合物中的含量为2-10wt%;和/或,所述粘合剂包括水、乙醇、可溶性淀粉、羧甲基纤维素钠、羟丙基纤维素、甲基纤维素、乙基纤维素、羟丙基甲基纤维素、明胶、聚乙烯吡咯烷酮、聚乙烯醇-乙二醇接枝共聚物或卡波普中的任意一种或多种的组合;
和/或,所述流动剂在药物组合物中的含量为0.1-1wt%;和/或,所述流动剂包括二氧化硅纳米粒子;
和/或,所述润滑剂在药物组合物中的含量为0.2-1.5wt%;和/或,所述润滑剂包括微粉硅胶、硬脂酸镁、硬脂酸钠、硬脂酸锌、滑石粉、植物油乙二醇共聚物或聚乙二醇中的任意一种或多种的组合;
和/或,所述甜味剂在药物组合物中的含量为0.1-1wt%;和/或,所述甜味剂包括糖精、阿斯巴甜、三氯蔗糖、安赛蜜K、纽糖、塔格糖或木糖醇中的任意一种或多种的组合;
和/或,所述香精在药物组合物中的含量为0.1-1wt%;和/或,所述香精包括薄荷、桔子、葡糖、草莓、甜橙、樱桃、柠檬、奶油、香草、巧克力、杏仁或蓝莓中的任意一种或多种的组合;
和/或,所述悬浮液稳定剂在药物组合物中的含量为1-10wt%;和/或,所述悬浮液稳定剂包括羧甲基纤维素钠、羧甲基淀粉钠、水溶性淀粉、羟丙基甲基纤维、聚乙烯醇、聚乙烯及吡咯烷酮、交联聚乙烯基吡咯烷酮、黄原胶、壳聚糖、海藻酸钠、明胶或卡波普中的任意一种或多种的组合。
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