CN116077601B - 一种清热止咳化痰的含片及其制备方法 - Google Patents
一种清热止咳化痰的含片及其制备方法 Download PDFInfo
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- CN116077601B CN116077601B CN202310366836.2A CN202310366836A CN116077601B CN 116077601 B CN116077601 B CN 116077601B CN 202310366836 A CN202310366836 A CN 202310366836A CN 116077601 B CN116077601 B CN 116077601B
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Abstract
本发明属于保健品技术领域,具体公开了一种清热止咳化痰的含片及其制备方法。所述含片的制作方法如下:取川贝母、百部、紫菀、乌梅、地骨皮、百合、远志、罗汉果、甘草处理得到提取物粉末,取雪梨处理得到雪梨粉;将提取物粉末与雪梨粉混合后加入微囊包覆液,经过微胶囊造粒仪处理得到微囊化中药组合物;取微囊化中药组合物与稀释剂混合,制湿粒,干燥,再加入硬脂酸镁混合,压片,即得。本发明制备的清热止咳化痰的含片原料配方精简、合理,具有清咽润喉的保健作用,可以很好的发挥清热泻火、止咳化痰的功效。
Description
技术领域
本发明属于保健品技术领域,具体涉及一种清热止咳化痰的含片及其制备方法。
背景技术
采用天然中药材作为原料加工的各类含片,是清咽润喉类产品的主要剂型之一,它可以直接并较长时间地作用于咽喉患处,对缓解咽喉不适效果明显,能瞬间起到舒适效果、见效快。同时,含片便于存储和携带,服用方便,很适合现在快节奏的生活。
雪梨是一种常见水果,其肉嫩白如雪,爽口多汁,香甜可口,具有清热养阴、生津润燥、止咳化痰的作用。对于呼吸道感染诱发的咽喉干痒、疼痛、消痰降火均有良效。雪梨既可以生吃,也可以蒸煮,尤其适合秋季食用。雪梨也富含苹果酸、柠檬酸、维生素、胡萝卜素等成分,可以用于补充人体所需营养。川贝母是百合科贝母属植物的干燥鳞茎,常用作中药保健品的原料,具有清热润肺、化痰止咳的作用,对干咳少痰、肺虚久咳、痰少咽燥等均有良效。川贝炖雪梨就是一种利用川贝、雪梨、冰糖做成的民间经典药膳,有清热、止咳、化痰的效果。
中国专利CN104432049A公开了一种基于超微粉碎的川贝雪梨含片及其制备方法,包括以下步骤:将麦冬、百合、款冬花煎煮,上清液制得麦冬混合超微冻干粉;新鲜雪梨加冰糖煎煮,上清液制得雪梨超微冻干粉;将川贝母经过超微粉碎制得川贝母超微粉;将麦冬混合超微冻干粉、雪梨超微冻干粉、川贝母超微粉、稀释剂淀粉、糊精、甘露醇、硬脂酸镁混合均匀,以乙醇作为润湿剂制成软料,经过挤压制粒、干燥,整理,压片得到川贝雪梨含片;该专利得到的含片口感和润喉效果良好,其中采用超微粉直接处理川贝母,省去提取操作,虽然简化了工艺,但是相应的也使得含片中中药活性成分含量偏低,使用效果受到影响;此外现有的这类含片多是将中药成分与辅料直接压片制得,未对其中的中药活性成分进行任何保护处理,储存过程中易受到环境和储存时间的影响。
发明内容
针对上述现有技术中存在的不足,本发明旨在提供一种清热止咳化痰的含片及其制备方法,以雪梨、川贝母搭配百部、紫菀、乌梅、地骨皮、百合、远志、罗汉果、甘草作为原料,经过煎煮提纯、微囊化包覆处理后再加入稀释剂压片制成,很好的实现对中药组合物中消炎消肿、抑菌杀菌等抗氧化活性成分的包覆保护效果,降低储存过程中环境及储存时间对含片功效的不利影响。
一种清热止咳化痰的含片的制备方法,包括以下步骤:
(1)称取20-30重量份川贝母、20-30重量份百部、10-30重量份紫菀、10-30重量份乌梅、10-20重量份地骨皮、10-15重量份百合、10-15重量份远志、5-15重量份罗汉果、5-15重量份甘草,粉碎,加水煎煮,浓缩,干燥,得到提取物粉末;将雪梨榨汁,梨渣加水煎煮,过滤,将滤液与梨汁合并,浓缩,干燥,得到雪梨粉;
(2)将提取物粉末与雪梨粉混合均匀得到中药组合物,再加入微囊包覆液混合均匀,经过微胶囊造粒仪处理后,干燥,得到微囊化中药组合物;
(3)称取50-70重量份微囊化中药组合物与30-50重量份稀释剂混合均匀,制湿粒,干燥,整粒,再加入1-2重量份硬脂酸镁混合均匀,压片,得到所述清热止咳化痰的含片。
病原菌侵袭、物理或化学刺激、周围环境、气候变化等原因均可能引发咽喉不适,另外睡眠不足、过度疲劳、免疫力下降等自身因素也会诱发咽喉粘膜刺激受损,出现咽喉干燥、有异物感、干咳有痰等症状。
本发明制备的清热止咳化痰的含片,以雪梨、川贝母搭配百部、紫菀、乌梅、地骨皮、百合、远志、罗汉果、甘草作为原料,其中,雪梨能治风热、润肺、降火、解毒、消痰,有润肺清燥、止咳化痰、养血生肌的作用。川贝母能清热润肺、化痰止咳,对于肺热燥咳、阴虚劳嗽、肺虚久咳、痰少咽燥等有效果。百部润而不燥,能润肺下气、止咳定喘、消痰,具有降低呼吸中枢兴奋性从而抑制咳嗽反射达到镇咳的作用。紫菀能润肺下气、消痰止咳,对于痰湿蕴于肺部,阻滞肺部气机引起的咳嗽、气喘、痰多等效果较好。乌梅能敛肺、生津、止咳,对于肺虚久咳、虚热消渴等效果较好。地骨皮能清肺降火,对于阴虚潮热、肺热咳嗽有效果。百合能养阴润肺、下气止咳、清热降火,还具有宁心安神、调理肠胃、美容养颜的功效。远志能安神益智、祛痰、消肿,主要配合化痰。罗汉果具有清肺利咽、化痰止咳、润肠通便的功效。甘草具有补脾益气、清热解毒、缓急止痛、祛痰止咳的功效。此外甘草还有两方面重要的作用,一是修复皮肤和粘膜,帮助因咳嗽受损的粘膜尽快恢复,二是调和药性,解中药原料的草木微毒。本发明各种原料配伍精当,作用相辅相成,共同起到疏风清热、润肺益气、平喘止咳、消痰解毒的作用。
优选的,一种清热止咳化痰的含片的制备方法,包括以下步骤:
(1)称取20-30重量份川贝母、20-30重量份百部、10-30重量份紫菀、10-30重量份乌梅、10-20重量份地骨皮、10-15重量份百合、10-15重量份远志、5-15重量份罗汉果、5-15重量份甘草,清洗、沥干后粉碎过筛,得到原料粉末;向原料粉末中加入原料粉末质量5-10倍的水,煮沸后煎煮1-2h,重复1-3次,合并煎煮液,减压浓缩后喷雾干燥,得到提取物粉末;将雪梨清洗后榨汁,过滤得到梨汁和梨渣;向梨渣中加入梨渣质量2-5倍的水,煮沸后煎煮2-4h,过滤,将滤液与上述梨汁合并,减压浓缩后喷雾干燥,得到雪梨粉;
(2)将提取物粉末与雪梨粉混合均匀得到中药组合物,再加入微囊包覆液混合均匀,经过微胶囊造粒仪处理后,干燥,得到微囊化中药组合物;
(3)称取50-70重量份微囊化中药组合物与30-50重量份稀释剂混合均匀,采用乙醇水溶液作为润湿剂制成软材,制湿粒,干燥,整粒,再加入1-2重量份硬脂酸镁混合均匀,压片,得到所述清热止咳化痰的含片。
优选的,所述提取物粉末与雪梨粉按质量比为5-8:1。
优选的,所述中药组合物与微囊包覆液按质量比1:15-20。
优选的,所述乙醇水溶液的浓度为70wt%。
优选的,所述微囊包覆液的制备方法为:
将5-10重量份羟丙基二淀粉磷酸酯加入50-70重量份水中混合均匀,再加入2-4重量份双氧水加热反应,结束后沉淀,干燥,得到羰基化淀粉磷酸酯;在氮气环境下,将1-2重量份酪氨酸、0.3-0.6重量份L-谷胱甘肽与3-6重量份羰基化淀粉磷酸酯加入50-70重量份水中混合均匀,加热反应,结束后沉淀,干燥,得到接枝淀粉磷酸酯;将2-4重量份接枝淀粉磷酸酯、0.5-1.5重量份海藻酸钠、0.2-0.4重量份磷酸钠、0.5-0.8重量份尿素添加到50-70份水中混合均匀,加入反应,结束后沉淀,干燥,得到改性淀粉磷酸酯;将1-2重量份改性淀粉磷酸酯加入到90-120重量份水中混合均匀,得到所述微囊包覆液。
本发明首先对羟丙基二淀粉磷酸酯进行氧化使其含有足够的羰基基团,为后续通过氨基与羰基的反应引入酪氨酸与L-谷胱甘肽结构提供便利。酪氨酸与L-谷胱甘肽中含有的羧基和羟基可以增加接枝淀粉磷酸酯中活性基团的数量,提高其抗氧化性和水溶性,增强保护作用,同时羧基和羟基对中药组合物中活性成分具有较强的吸附作用,很好的实现对其消炎消肿、抑菌杀菌等抗氧化活性成分的包覆保护效果。为了进一步提高对中药组合物中的水溶性活性成分的包覆效果,本发明采用海藻酸与接枝淀粉磷酸酯通过磷脂化反应发生交联,利用海藻酸的分子结构能结合水分子形成稳定的三维网络结构这一特点,从而将水溶性活性成分纳入网络结构中,在干燥除水后包裹住剩余的水溶性活性成分。此外海藻酸结构中也含有丰富的羧基和羟基对改性淀粉磷酸酯的吸附包覆效果也有一定的提升。
优选的,所述微囊包覆液的制备方法为:
将5-10重量份羟丙基二淀粉磷酸酯加入50-70重量份水中混合均匀,再加入2-4重量份双氧水在50-55℃下搅拌1-3h,结束后加入80-100重量份无水乙醇沉淀,冷冻干燥,得到羰基化淀粉磷酸酯;在氮气环境下,将1-2重量份酪氨酸、0.3-0.6重量份L-谷胱甘肽与3-6重量份羰基化淀粉磷酸酯加入50-70重量份水中混合均匀,在45-50℃下搅拌6-8h,结束后加入80-100重量份无水乙醇沉淀,冷冻干燥,得到接枝淀粉磷酸酯;将2-4重量份接枝淀粉磷酸酯、0.5-1.5重量份海藻酸钠、0.2-0.4重量份磷酸钠、0.5-0.8重量份尿素添加到50-70份水中混合均匀,在65-70℃下搅拌1-3h,结束后加入80-100重量份无水乙醇沉淀,冷冻干燥,得到改性淀粉磷酸酯;将1-2重量份改性淀粉磷酸酯加入到90-120重量份水中混合均匀,得到所述微囊包覆液。
优选的,所述双氧水的浓度为15-20wt%。
优选的,所述微胶囊造粒仪的振动频率1000Hz、电极电压500V、气压200mbar,喷嘴口径400μm、流速8mL/min。
优选的,所述稀释剂由木糖醇、D-山梨糖醇与异麦芽糖醇组成;所述木糖醇、D-山梨糖醇与异麦芽糖醇的质量比为3-5:3-5:1。
木糖醇、D-山梨糖醇与异麦芽糖醇作为稀释剂,可以保持含片的甜、酸、苦味强度平衡,提高含片的风味和香气。此外在体内不转化为葡萄糖,不会影响血糖值。硬脂酸镁作为常用的润滑剂、助流剂,作用优良,可以改善颗粒的流动性,使压片后的片面光洁美观。
本发明还提供了一种采用上述方法制备得到的清热止咳化痰的含片。
本发明的有益效果:本发明的含片以雪梨、川贝母搭配百部、紫菀、乌梅、地骨皮、百合、远志、罗汉果、甘草作为原料,经过煎煮提纯、微囊化包覆处理后再加入稀释剂压片制成,原料配方精简、合理,具有清热泻火、止咳化痰的功效。尤其是,本发明微囊化包覆处理很好的实现了对中药组合物中消炎消肿、抑菌杀菌等抗氧化活性成分的包覆保护效果,降低储存过程中环境及储存时间对含片功效的不利影响。
具体实施方式
下面结合具体实施方式对本发明的上述发明内容作进一步的详细描述,但不应将此理解为本发明上述主题的范围仅限于下述实施例。
采用的部分原料介绍如下:
羟丙基二淀粉磷酸酯,CAS:53124-00-8,食品级,购于河北创之源生物科技有限公司。
L-谷胱甘肽,CAS:70-18-8,食品级,购于曼顿生物科技(深圳)有限公司。
海藻酸钠,CAS:9005-38-3,食品级,购于南通添香生物工程有限公司。
实施例1
一种清热止咳化痰的含片的制备方法,包括以下步骤:
(1)称取25重量份川贝母、25重量份百部、20重量份紫菀、20重量份乌梅、15重量份地骨皮、13重量份百合、12重量份远志、10重量份罗汉果、10重量份甘草,清洗、沥干后粉碎过20目筛,得到原料粉末;向原料粉末中加入原料粉末质量8倍的水,煮沸后煎煮1.5h,重复2次,合并煎煮液,减压浓缩后喷雾干燥,得到提取物粉末;将雪梨清洗后榨汁,过滤得到梨汁和梨渣;向梨渣中加入梨渣质量3倍的水,煮沸后煎煮2.5h,过滤,将滤液与上述梨汁合并,减压浓缩后喷雾干燥,得到雪梨粉;
(2)将提取物粉末与雪梨粉按质量比为7:1混合均匀得到中药组合物;将中药组合物与微囊包覆液按质量比1:18混合均匀,经过微胶囊造粒仪处理后冷冻干燥,得到微囊化中药组合物;其中微胶囊造粒仪的振动频率1000Hz、电极电压500V、气压200mbar,喷嘴口径400μm、流速8mL/min;
(3)称取60重量份微囊化中药组合物与40重量份稀释剂混合均匀,所述稀释剂由木糖醇、D-山梨糖醇、异麦芽糖醇按质量比4:4:1组成;采用70wt%乙醇水溶液作为润湿剂制成软材,20目筛制湿粒,干燥,整粒,再加入1.5重量份硬脂酸镁混合均匀,压片,得到所述清热止咳化痰的含片。
所述微囊包覆液的制备方法为:
将8重量份羟丙基二淀粉磷酸酯加入60重量份水中混合均匀,再加入3重量份双氧水在52℃下搅拌2h,结束后加入90重量份无水乙醇沉淀,冷冻干燥,得到羰基化淀粉磷酸酯;所述双氧水的浓度为18wt%;在氮气环境下,将1.5重量份酪氨酸、0.5重量份L-谷胱甘肽与5重量份羰基化淀粉磷酸酯加入60重量份水中混合均匀,在46℃下搅拌7h,结束后加入90重量份无水乙醇沉淀,冷冻干燥,得到接枝淀粉磷酸酯;将2.5重量份接枝淀粉磷酸酯、1重量份海藻酸钠、0.3重量份磷酸钠、0.7重量份尿素添加到60份水中混合均匀,在68℃下搅拌2h,结束后加入90重量份无水乙醇沉淀,冷冻干燥,得到改性淀粉磷酸酯;将1.5重量份改性淀粉磷酸酯加入到100重量份水中混合均匀,得到所述微囊包覆液。
实施例2
一种清热止咳化痰的含片的制备方法,包括以下步骤:
(1)称取20重量份百部、20重量份川贝母、10重量份紫菀、10重量份乌梅、10重量份地骨皮、10重量份百合、10重量份远志、5重量份罗汉果、5重量份甘草,清洗、沥干后粉碎过20目筛,得到原料粉末;向原料粉末中加入原料粉末质量5倍的水,煮沸后煎煮1h,重复1次,合并煎煮液,减压浓缩后喷雾干燥,得到提取物粉末;将雪梨清洗后榨汁,过滤得到梨汁和梨渣;向梨渣中加入梨渣质量2倍的水,煮沸后煎煮2h,过滤,将滤液与上述梨汁合并,减压浓缩后喷雾干燥,得到雪梨粉;
(2)将提取物粉末与雪梨粉按质量比为5:1混合均匀得到中药组合物;将中药组合物与微囊包覆液按质量比1:15混合均匀,经过微胶囊造粒仪处理后冷冻干燥,得到微囊化中药组合物;其中微胶囊造粒仪的振动频率1000Hz、电极电压500V、气压200mbar,喷嘴口径400μm、流速8mL/min;
(3)称取50重量份微囊化中药组合物与30重量份稀释剂混合均匀,所述稀释剂由木糖醇、D-山梨糖醇、异麦芽糖醇按质量比3:3:1组成;采用70wt%乙醇水溶液作为润湿剂制成软材,20目筛制湿粒,干燥,整粒,再加入1重量份硬脂酸镁混合均匀,压片,得到所述清热止咳化痰的含片。所述微囊包覆液的制备方法与实施1相同。
实施例3
一种清热止咳化痰的含片的制备方法,包括以下步骤:
(1)称取30重量份百部、30重量份川贝母、30重量份紫菀、30重量份乌梅、20重量份地骨皮、15重量份百合、15重量份远志、15重量份罗汉果、15重量份甘草,清洗、沥干后粉碎过20目筛,得到原料粉末;向原料粉末中加入原料粉末质量10倍的水,煮沸后煎煮2h,重复3次,合并煎煮液,减压浓缩后喷雾干燥,得到提取物粉末;将雪梨清洗后榨汁,过滤得到梨汁和梨渣;向梨渣中加入梨渣质量5倍的水,煮沸后煎煮4h,过滤,将滤液与上述梨汁合并,减压浓缩后喷雾干燥,得到雪梨粉;
(2)将提取物粉末与雪梨粉按质量比为8:1混合均匀得到中药组合物;将中药组合物与微囊包覆液按质量比1:20混合均匀,经过微胶囊造粒仪处理后冷冻干燥,得到微囊化中药组合物;其中微胶囊造粒仪的振动频率1000Hz、电极电压500V、气压200mbar,喷嘴口径400μm、流速8mL/min;
(3)称取70重量份微囊化中药组合物与50重量份稀释剂混合均匀,所述稀释剂由木糖醇、D-山梨糖醇、异麦芽糖醇按质量比5:5:1组成;采用70wt%乙醇水溶液作为润湿剂制成软材,20目筛制湿粒,干燥,整粒,再加入2重量份硬脂酸镁混合均匀,压片,得到所述清热止咳化痰的含片。所述微囊包覆液的制备方法与实施例1相同。
实施例4
一种清热止咳化痰的含片的制备方法,包括以下步骤:
(1)称取25重量份川贝母、25重量份百部、20重量份紫菀、20重量份乌梅、15重量份地骨皮、13重量份百合、12重量份远志、10重量份罗汉果、10重量份甘草,清洗、沥干后粉碎过20目筛,得到原料粉末;向原料粉末中加入原料粉末质量8倍的水,煮沸后煎煮1.5h,重复2次,合并煎煮液,减压浓缩后喷雾干燥,得到提取物粉末;将雪梨清洗后榨汁,过滤得到梨汁和梨渣;向梨渣中加入梨渣质量3倍的水,煮沸后煎煮2.5h,过滤,将滤液与上述梨汁合并,减压浓缩后喷雾干燥,得到雪梨粉;
(2)将提取物粉末与雪梨粉按质量比为7:1混合均匀得到中药组合物;将中药组合物与微囊包覆液按质量比1:18混合均匀,经过微胶囊造粒仪处理后冷冻干燥,得到微囊化中药组合物;其中微胶囊造粒仪的振动频率1000Hz、电极电压500V、气压200mbar,喷嘴口径400μm、流速8mL/min;
(3)称取60重量份微囊化中药组合物与40重量份稀释剂混合均匀,所述稀释剂由木糖醇、D-山梨糖醇、异麦芽糖醇按质量比4:4:1组成;采用70wt%乙醇水溶液作为润湿剂制成软材,20目筛制湿粒,干燥,整粒,再加入1.5重量份硬脂酸镁混合均匀,压片,得到所述清热止咳化痰的含片。
所述微囊包覆液的制备方法为:
将8重量份羟丙基二淀粉磷酸酯加入60重量份水中混合均匀,再加入3重量份双氧水在52℃下搅拌2h,结束后加入90重量份无水乙醇沉淀,冷冻干燥,得到羰基化淀粉磷酸酯;所述双氧水的浓度为18wt%;在氮气环境下,将2重量份酪氨酸与5重量份羰基化淀粉磷酸酯加入60重量份水中混合均匀,在46℃下搅拌7h,结束后加入90重量份无水乙醇沉淀,冷冻干燥,得到接枝淀粉磷酸酯;将2.5重量份接枝淀粉磷酸酯、1重量份海藻酸钠、0.3重量份磷酸钠、0.7重量份尿素添加到60份水中混合均匀,在68℃下搅拌2h,结束后加入90重量份无水乙醇沉淀,冷冻干燥,得到改性淀粉磷酸酯;将1.5重量份改性淀粉磷酸酯加入到100重量份水中混合均匀,得到所述微囊包覆液。
实施例5
一种清热止咳化痰的含片的制备方法,包括以下步骤:
(1)称取25重量份川贝母、25重量份百部、20重量份紫菀、20重量份乌梅、15重量份地骨皮、13重量份百合、12重量份远志、10重量份罗汉果、10重量份甘草,清洗、沥干后粉碎过20目筛,得到原料粉末;向原料粉末中加入原料粉末质量8倍的水,煮沸后煎煮1.5h,重复2次,合并煎煮液,减压浓缩后喷雾干燥,得到提取物粉末;将雪梨清洗后榨汁,过滤得到梨汁和梨渣;向梨渣中加入梨渣质量3倍的水,煮沸后煎煮2.5h,过滤,将滤液与上述梨汁合并,减压浓缩后喷雾干燥,得到雪梨粉;
(2)将提取物粉末与雪梨粉按质量比为7:1混合均匀得到中药组合物;将中药组合物与微囊包覆液按质量比1:18混合均匀,经过微胶囊造粒仪处理后冷冻干燥,得到微囊化中药组合物;其中微胶囊造粒仪的振动频率1000Hz、电极电压500V、气压200mbar,喷嘴口径400μm、流速8mL/min;
(3)称取60重量份微囊化中药组合物与40重量份稀释剂混合均匀,所述稀释剂由木糖醇、D-山梨糖醇、异麦芽糖醇按质量比4:4:1组成;采用70wt%乙醇水溶液作为润湿剂制成软材,20目筛制湿粒,干燥,整粒,再加入1.5重量份硬脂酸镁混合均匀,压片,得到所述清热止咳化痰的含片。
所述微囊包覆液的制备方法为:
将8重量份羟丙基二淀粉磷酸酯加入60重量份水中混合均匀,再加入3重量份双氧水在52℃下搅拌2h,结束后加入90重量份无水乙醇沉淀,冷冻干燥,得到羰基化淀粉磷酸酯;所述双氧水的浓度为18wt%;在氮气环境下,将1.5重量份酪氨酸、0.5重量份L-谷胱甘肽与5重量份羰基化淀粉磷酸酯加入60重量份水中混合均匀,在46℃下搅拌7h,结束后加入90重量份无水乙醇沉淀,冷冻干燥,得到接枝淀粉磷酸酯;将1.5重量份接枝淀粉磷酸酯加入到100重量份水中混合均匀,得到所述微囊包覆液。
实施例6
一种清热止咳化痰的含片的制备方法,包括以下步骤:
(1)称取25重量份川贝母、25重量份百部、20重量份紫菀、20重量份乌梅、15重量份地骨皮、13重量份百合、12重量份远志、10重量份罗汉果、10重量份甘草,清洗、沥干后粉碎过20目筛,得到原料粉末;向原料粉末中加入原料粉末质量8倍的水,煮沸后煎煮1.5h,重复2次,合并煎煮液,减压浓缩后喷雾干燥,得到提取物粉末;将雪梨清洗后榨汁,过滤得到梨汁和梨渣;向梨渣中加入梨渣质量3倍的水,煮沸后煎煮2.5h,过滤,将滤液与上述梨汁合并,减压浓缩后喷雾干燥,得到雪梨粉;
(2)将提取物粉末与雪梨粉按质量比为7:1混合均匀得到中药组合物;将中药组合物与微囊包覆液按质量比1:18混合均匀,经过微胶囊造粒仪处理后冷冻干燥,得到微囊化中药组合物;其中微胶囊造粒仪的振动频率1000Hz、电极电压500V、气压200mbar,喷嘴口径400μm、流速8mL/min;
(3)称取60重量份微囊化中药组合物与40重量份稀释剂混合均匀,所述稀释剂由木糖醇、D-山梨糖醇、异麦芽糖醇按质量比4:4:1组成;采用70wt%乙醇水溶液作为润湿剂制成软材,20目筛制湿粒,干燥,整粒,再加入1.5重量份硬脂酸镁混合均匀,压片,得到所述清热止咳化痰的含片。
所述微囊包覆液的制备方法为:
将2.5重量份羟丙基二淀粉磷酸酯、1重量份海藻酸钠、0.3重量份磷酸钠、0.7重量份尿素添加到60份水中混合均匀,在68℃下搅拌2h,结束后加入90重量份无水乙醇沉淀,冷冻干燥,得到改性淀粉磷酸酯;将1.5重量份改性淀粉磷酸酯加入到100重量份水中混合均匀,得到所述微囊包覆液。
测试例1
止咳作用评价:选取50只体重18-22g的ICR小鼠,随机分成5组,雌雄各半。分别为空白对照组(生理盐水)、阳性药物对照组(20mg右美沙芬/kg)、实施例1制备的清热止咳化痰的含片高剂量组(6g剂量/kg)、实施例1制备的清热止咳化痰的含片中剂量组(3g剂量/kg)、实施例1制备的清热止咳化痰的含片低剂量组(1.5g剂量/kg),每天1次,连续7天,末次给药后1h,取0.2mL浓度为25wt%浓氨水加入到20mL小烧杯,立即用倒置的1000mL大烧杯盖住,将小鼠分别置于大烧杯中,刺激小鼠20s,观察5min内小鼠咳嗽情况,记录咳嗽次数并计算咳嗽抑制率。并且,按照上述试验方法对常温避光储存12个月后的实施例1制备的清热止咳化痰的含片进行止咳作用评价。咳嗽抑制率%=(1-剂量组咳嗽次数/空白对照组咳嗽次数)×100%。
表1清热止咳化痰的含片的咳嗽抑制率
可以看出,相比于空白对照组,本发明实施例1制备的清热止咳化痰的含片具有显著的止咳作用,可以达到与右美沙芬药物相当的效果。本发明各原料配伍合理,作用相辅相成,共同起到疏风清热、润肺益气、平喘止咳、消痰解毒的作用。同时,本发明实施例1制备的清热止咳化痰的含片在储存12个月后仍能保持很好的功效,这是因为微囊化中药组合物可以实现对中药组合物中活性成分的包覆保护效果,从而降低储存时间及环境对含片功效的不利影响。
测试例2
微囊化中药组合物的包覆效果:分别称取实施例1及实施例4-6制备的微囊化中药组合物2.5g,充分研磨后加入10mL二甲苯进行萃取,再用滤纸过滤,重复进行3遍上述萃取、过滤步骤,每次萃取15min,使壁材和芯材完全分离。使用真空干燥箱对过滤前后的滤纸进行干燥,称重。过滤前滤纸的重量记为g0,过滤后滤纸和滤渣的重量记为g1,则壁材的重量为g1-g0,包覆率%=[1-(g1-g0)/2.5]×100%。
表2微囊化中药组合物的包覆率
可以看出,相比于实施例4-6,实施例1的微囊化中药组合物的包覆效果最好,这是因为实施例1采用的改性淀粉磷酸酯先对羟丙基二淀粉磷酸酯进行氧化使其含有足够的羰基基团,为后续通过氨基与羰基的反应引入酪氨酸与L-谷胱甘肽结构提供便利。酪氨酸与L-谷胱甘肽中含有的羧基和羟基可以增加接枝淀粉磷酸酯中活性基团的数量,提高其抗氧化性和水溶性,增强保护作用,同时羧基和羟基对中药组合物中活性成分具有较强的吸附作用,很好的实现对其消炎消肿、抑菌杀菌等抗氧化活性成分的包覆保护效果。为了进一步提高对中药组合物中的水溶性活性成分的包覆效果,再采用海藻酸与接枝淀粉磷酸酯通过磷脂化反应发生交联,利用海藻酸的分子结构能结合水分子形成稳定的三维网络结构这一特点,从而将水溶性活性成分纳入网络结构中,在干燥除水后包裹住剩余的水溶性活性成分。此外海藻酸结构中也含有丰富的羧基和羟基对改性淀粉磷酸酯的吸附包覆效果也有一定的提升。
以上详细描述了本发明的较佳具体实施例。应当理解,本领域的普通技术人员无需创造性劳动就可以根据本发明的构思作出诸多修改和变化。因此,凡本技术领域中技术人员依本发明的构思在现有技术的基础上通过逻辑分析、推理或者有限的实验可以得到的技术方案,皆应在由权利要求书所确定的保护范围内。
Claims (6)
1.一种清热止咳化痰的含片的制备方法,其特征在于,包括以下步骤:
(1)取川贝母、百部、紫菀、乌梅、地骨皮、百合、远志、罗汉果、甘草,粉碎,加水煎煮,浓缩,干燥,得到提取物粉末;将雪梨榨汁,梨渣加水煎煮,过滤,将滤液与梨汁合并,浓缩,干燥,得到雪梨粉;
(2)将提取物粉末与雪梨粉混合均匀得到中药组合物,再加入微囊包覆液混合均匀,经过微胶囊造粒仪处理后,干燥,得到微囊化中药组合物;
(3)取微囊化中药组合物与稀释剂混合均匀,制湿粒,干燥,整粒,再加入硬脂酸镁混合均匀,压片,得到所述清热止咳化痰的含片;
步骤(1)中各原料的重量份为:20-30重量份川贝母、20-30重量份百部、10-30重量份紫菀、10-30重量份乌梅、10-20重量份地骨皮、10-15重量份百合、10-15重量份远志、5-15重量份罗汉果、5-15重量份甘草;
所述微囊包覆液的制备方法为:
将羟丙基二淀粉磷酸酯氧化,得到羰基化淀粉磷酸酯,再与酪氨酸、L-谷胱甘肽接枝反应,得到接枝淀粉磷酸酯,最后用海藻酸钠交联改性,得到改性淀粉磷酸酯,将改性淀粉磷酸酯与水混合均匀,得到所述微囊包覆液。
2.如权利要求1所述的清热止咳化痰的含片的制备方法,其特征在于,步骤(3)中各组分的重量份为:50-70重量份微囊化中药组合物、30-50重量份稀释剂、1-2重量份硬脂酸镁。
3.如权利要求1所述的清热止咳化痰的含片的制备方法,其特征在于,所述提取物粉末与雪梨粉的质量比为5-8:1。
4.如权利要求1所述的清热止咳化痰的含片的制备方法,其特征在于,所述中药组合物与微囊包覆液的质量比1:15-20。
5.如权利要求1所述的清热止咳化痰的含片的制备方法,其特征在于,所述稀释剂由木糖醇、D-山梨糖醇与异麦芽糖醇组成。
6.一种清热止咳化痰的含片,其特征在于,采用如权利要求1-5中任一项所述的方法制备而成。
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