CN109481497B - 一种缓解口腔及咽喉不适的含片及其制备方法 - Google Patents
一种缓解口腔及咽喉不适的含片及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种缓解口腔及咽喉不适的含片及其制备方法,由下述重量份的原料制成:百药煎10‑20份,薄荷5‑20份,微晶纤维素10‑40份,甜味剂30‑95份,羧甲基淀粉钠2‑8份,淀粉0.5‑1.5份,清凉添加剂0.2‑0.6,硬脂酸镁0.1‑1.0份。本发明以具有清咽润喉功效的百叶煎和薄荷为原料,二者配伍使用,并通过添加剂的筛选,克服了百药煎酸涩难咽的缺点,制备得到的含片口感清凉冰爽,风味独特,具有较好的缓解口腔及咽喉不适的功效,是一种清咽利喉,功效与口感兼具的产品,能实现长期服用以舒缓口腔、咽喉等慢性病症的目的。
Description
技术领域
本发明涉及片剂领域,具体涉及一种缓解口腔及咽喉不适的含片及其制备方法。
背景技术
含片是指含于口腔中缓慢溶化,产生局部或全身作用的片剂。含片中的原料药物一般是易溶性的,主要起局部消炎、杀菌、收敛、止痛或局部麻醉等作用。
随着社会经济的快速发展,生活节奏的加快,心理压力的增大,自然环境的污染等,导致人们普遍性的出现口腔溃疡,咽喉不适等“现代文明病”。而百药煎主要用于肺热咳嗽,风火牙痛,口舌糜烂等症,非常适合用于改善口腔溃疡,咽喉不适等症。目前市面上已有一些含百药煎的清热利咽的产品,如:专利200810247013.3公开了一种由川贝母、诃子肉、百药煎等药材经打粉或提取,再压片所制得的,具有清热利咽功效的片剂;专利201610164749.9公开了一种由百药煎、夏枯草、女贞子等药材所制得的,具有明目润喉功效的保健茶;专利201510517278.0公开了由草河车、斩龙草、百药煎等药材所制得的,具有清热解毒,活血止痛等功效,对慢性咽炎有较好疗效的饮料。
然而现有的百药煎清咽利喉功效产品,酸涩难咽,口感较差,消费者体验感差;纵使产品具有一定的疗效,但难以实现口腔溃疡、慢性咽炎等需长期服药调理的患者对产品口感的需求。
发明内容
为了克服上述现有技术的不足,本发明的首要目的在于提供一种缓解口腔及咽喉不适的含片,该含片酸甜可口,清凉冰爽,风味独特,具有较好的缓解口腔及咽喉不适的功效。
本发明的另一目的在于提供上述缓解口腔及咽喉不适的含片的制备方法。
本发明是通过以下技术方案实现;
一种缓解口腔及咽喉不适的含片,由下述重量份的原料制成:百药煎10-20份,薄荷5-20份,微晶纤维素10-40份,甜味剂30-95份,羧甲基淀粉钠2-8份,淀粉0.5-1.5份,清凉添加剂0.2-0.6,硬脂酸镁0.1-1.0份。
作为本发明进一步优选的技术方案,所述一种缓解口腔及咽喉不适的含片,由下述重量份的原料制成:百药煎12.5份,薄荷10份,微晶纤维素20.5份,甜味剂63份,羧甲基淀粉钠4份,淀粉0.8份,清凉添加剂0.25份,硬脂酸镁0.5份,薄荷脑0.1份。
本发明中各原料的药理作用如下报述:
百药煎:性平,味酸、甘;归肺、胃经。清热化痰,生津止渴。用于肺热咳嗽,风火牙痛,口舌糜烂,风湿诸疮等症。百药煎由五倍子、茶叶经过发酵而得,产品中含有丰富的没食子酸,没食子酸具有抗炎、抗突变、抗氧化、抗自由基等多种生物学活性,同时具有抗菌抗病毒作用, 体外对金黄色葡萄球菌、绿脓杆菌、弗氏痢疾杆菌等有抑制作用,对流感病毒亦有一定抑制作用。
薄荷:性凉,味辛;归肺、肝经。疏散风热,清利头目,利咽,透疹,疏肝行气。可用于风热头痛,目赤,喉痹,口疮,胸胁胀闷等症。薄荷含有挥发性油、蛋白质、脂肪、碳水化合物、矿物质、维生素等成分。薄荷挥发油中的薄荷脑成分具有杀菌止痒功效,涂于局部可刺激神经而引起凉感,并抑制痛觉神经,还可舒缓呼吸道,具有清咽止咳功能。
本发明用百药煎和薄荷配伍使用,再配以其他辅料,可以明显改善产品的酸涩味,制备得到的含片酸甜可口,清凉冰爽,风味独特,可以快速缓解因口腔溃疡、咳嗽痰多或咽喉肿痛引起的不适。
本发明还公开了上述的一种缓解口腔及咽喉不适的含片的制备方法,包括如下步骤:
a)取薄荷,洗净,50℃以下低温干燥,粉碎成40-60目粉末,用超临界二氧化碳萃取,得薄荷油,备用;取百药煎,除去杂质,备用;
b)取超临界二氧化碳萃取后的薄荷,加入百药煎,加水提取两次,第一次加7-8倍量水,煎煮20-30分钟,第二次加6-7倍量水,煎煮20-30分钟,滤过,合并滤液,在60-80℃下减压浓缩到相对密度为1.06-1.10的清膏,采用喷雾干燥制备得到混合提取物,备用;
c)取薄荷脑,粉碎后过80-100目筛,备用;
d)取三氯蔗糖、蔗糖粉、微晶纤维素、甘露糖醇、羧甲基淀粉钠及b)中混合提取物,混合均匀,得到混合粉,备用;
e)取淀粉,加水制成淀粉浆,均匀倒入d)中的混合粉中,充分混匀,制成软材,后用摇摆制粒机制备得到颗粒,备用;
f)取步骤e)得到颗粒,加入硬脂酸镁,薄荷香精、茉莉花香精,以及c)中的薄荷脑,混合均匀,再均匀喷入a)中的薄荷油,得到颗粒混合物,备用;
g)取f)中的颗粒混合物,用压片机制备得到含片,即得。
本发明通过实验进一步优选了超临界二氧化碳萃取薄荷的工艺,所述超临界二氧化碳萃取的条件为:萃取釜压力20~25MPa,分离Ⅰ压力5~10 MPa,分离Ⅱ压力4~8 MPa,萃取温度为35~45℃,分离Ⅰ温度为45~55℃,分离Ⅱ温度为30~35℃,二氧化碳流量为20-30L/h,萃取时间为1.5-3小时。
为了更好地实现本发明的技术效果,本发明分别对糖药比、载药量、清凉度进行了优化研究,具体过程如下:
试验1:糖药比的筛选:
实验方法:
因百药煎原料味酸涩难咽,需加入适当调味剂改善口感,按下表百药煎与蔗糖粉进行配比,分别对口感进行感官分析(满分10分),确定较佳的糖药比(蔗糖粉:百药煎),具体结果如下表:
由实验数据可得,蔗糖粉与百药煎质量比在10.5-16.5时,产品酸甜适中,感官评分较高,尤其是当糖药比为13.5时,评分达到9.20,因此确定糖药比在10.5-16.5为优选范围。
试验2:载药量的筛选
实验方法:
在试验1糖药比的基础上,通过添加适量的甜味剂来替代蔗糖粉,以提高含片中百药煎的含量,提升产品的药效,其中三氯蔗糖甜度相当于600倍蔗糖甜度,甘露糖醇甜度相当于0.5倍蔗糖甜度,甘露糖醇虽然甜度较低,但是其具有较好的风味及口感,因此也作为备选原料进行筛选。
按下表分别取百药煎,破碎全部通过10目,加15倍水煎煮提取30分钟,提取液经浓缩后进行喷雾干燥,再按下表加入蔗糖粉、三氯蔗糖、甘露糖醇,得混合粉。分别取相同比例百药煎药材量的混合粉进行感官分析(满分10分),确定较佳的载药量(百药煎/混合粉),具体结果如下表:
由实验数据可得,蔗糖粉与百药煎质量比在13.5:1时,若全部选用蔗糖粉,载药量只有0.07,但是,通过甜度换算,使用部分甜味剂可以有效提高载药量,如试验序号3,所有蔗糖粉都用三氯蔗糖替代,载药量高达44.64,不过所得产品口感单薄,感官评分较低,因此在提高载药量的同时,也需提升产品的风味和口感。试验发现,蔗糖粉、三氯蔗糖及甘露糖醇的复配使用,能使载药量得到一定的提升,同时口感饱满,酸甜可口,带有清凉感,感官评分较高,尤其是7号,评分达到9.31,因此确定, 蔗糖粉、甘露糖醇和三氯蔗糖按25-45:9.8-48:0.19-0.22复配使用,优选蔗糖粉35份,三氯蔗糖0.2份,甘露糖醇27.6份。
试验3:清凉感的筛选:
实验方法:
清凉感能清新口气,舒缓咽喉不适,增强产品的药效作用。清凉感的产生主要是薄荷醇等物质刺激了皮肤上冷受体,经过神经传递到大脑,让大脑产生“温度低了”的错觉,因此,在处方中适当添加清凉感添加剂,可以提升产品清凉感。按下表比例进行配比,适当粉碎后再加麦芽糊精调整至100份,分别对清凉感进行感官分析(满分10分),确定较优的清凉感添加剂的比例,具体结果如下表:
由实验数据可得,冰片的感官评分较低,主要是冰片有清凉感,但单薄,不如薄荷脑的感官丰富,薄荷脑能提供丰富的咽喉清凉感,而薄荷香精和茉莉花香精则能很好的从气味上提供清香、清凉感,因此选择薄荷脑、薄荷香精及茉莉花香精复配作为清凉添加剂。从实验数据可以发现,薄荷香精0.1-0.3份,茉莉花香精0.05-0.15,薄荷脑0.05-0.15份时,产品具有较好的清凉感效果,更优选为薄荷香精0.2份,茉莉花香精0.05,薄荷脑0.1份。
与现有技术相比,本发明具有如下有益效果:
(1)本发明以具有清咽润喉功效的百叶煎和薄荷为原料,二者配伍使用,并通过添加剂的筛选,以蔗糖粉、三氯蔗糖、甘露糖醇复配使用,可以提高片剂载药量,保证产品疗效,同时尽可能改善口感,提高产品长期服用依从性;薄荷脑复配薄荷香精、茉莉花香精成清凉添加剂,不仅保持产品清凉感,同时提供清香口感,进一步改善了百药煎的酸涩味,制备得到的含片口感清凉冰爽,风味独特,具有较好的缓解口腔及咽喉不适的功效,是一种清咽利喉,功效与口感兼具的产品,能实现长期服用以舒缓口腔、咽喉等慢性病症的目的。
(2)本发明的制备工艺通过优化,薄荷原料预先采用超临界萃取方法提取挥发油,薄荷油均匀喷洒于颗粒表面,最大限度地保留了薄荷的特殊香气,并增强了清凉感。
具体实施方式
下面通过具体实施方式来进一步说明本发明,以下实施例为本发明具体的实施方式,但本发明的实施方式并不受下述实施例的限制。
本发明的原料均来源于市购。
实施例1:
原料配比:
百药煎12.5份,薄荷10份,微晶纤维素20.5份,蔗糖粉35份,甘露糖醇27.6份,羧甲基淀粉钠4份,淀粉0.8份,三氯蔗糖0.2份,薄荷香精0.2份,茉莉花香精0.05份,硬脂酸镁0.5份,薄荷脑0.1份。
其制备工艺包括如下步骤:
a)取薄荷,洗净,50℃以下低温干燥,粉碎成40-60目粉末,用超临界二氧化碳萃取,得薄荷油,备用;取百药煎,除去杂质,备用。
b)取超临界二氧化碳萃取后的薄荷,加入百药煎,加水提取两次,第一次加8倍量水,煎煮30分钟,第二次加6倍量水,煎煮30分钟,滤过,合并滤液,在70℃下减压浓缩到相对密度为1.06的清膏,采用喷雾干燥制备得到混合提取物,备用;
c)取薄荷脑,粉碎后过80-100目筛,备用;
d)取三氯蔗糖、蔗糖粉、微晶纤维素、甘露糖醇、羧甲基淀粉钠及b)中混合提取物,混合均匀,得到混合粉,备用;
e)取淀粉,加水制成淀粉浆,均匀倒入d)中的混合粉中,充分混匀,制成软材,后用摇摆制粒机制备得到颗粒,备用;
f)取步骤e)得到颗粒,加入硬脂酸镁,薄荷香精、茉莉花香精,以及c)中的薄荷脑,混合均匀,再均匀喷入a)中的薄荷油,得到颗粒混合物,备用;
g)取f)中的颗粒混合物,用压片机制备得到含片,即得。
实施例2:
原料药配比:
百药煎10份,薄荷20份,微晶纤维素39份,蔗糖粉20份,甘露糖醇25份,羧甲基淀粉钠3份,淀粉1份,三氯蔗糖0.19份,薄荷香精0.25份,茉莉花香精0.1份,硬脂酸镁0.8份,薄荷脑0.08份。
其制备工艺包括如下步骤:
a)取薄荷,洗净,50℃以下低温干燥,粉碎成40-60目粉末,用超临界二氧化碳萃取,得薄荷油,备用;取百药煎,除去杂质,备用。
b)取超临界二氧化碳萃取后的薄荷,加入百药煎,加水提取两次,第一次加7倍量水,煎煮25分钟,第二次加7倍量水,煎煮25分钟,滤过,合并滤液,在60℃下减压浓缩到相对密度为1.08的清膏,采用喷雾干燥制备得到混合提取物,备用;
c)取薄荷脑,粉碎后过80-100目筛,备用;
d)取三氯蔗糖、蔗糖粉、微晶纤维素、甘露糖醇、羧甲基淀粉钠及b)中混合提取物,混合均匀,得到混合粉,备用;
e)取淀粉,加水制成淀粉浆,均匀倒入d)中的混合粉中,充分混匀,制成软材,后用摇摆制粒机制备得到颗粒,备用;
f)取步骤e)得到颗粒,加入硬脂酸镁,薄荷香精、茉莉花香精,以及c)中的薄荷脑,混合均匀,再均匀喷入a)中的薄荷油,得到颗粒混合物,备用;
g)取f)中的颗粒混合物,用压片机制备得到含片,即得。
实施例3:
原料药配比:
百药煎17份,薄荷5份,微晶纤维素24份,蔗糖粉40份,甘露糖醇15份,羧甲基淀粉钠5份,淀粉0.9份,三氯蔗糖0.22份,薄荷香精0.3份,茉莉花香精0.08份,硬脂酸镁1份,薄荷脑0.1份。
其制备工艺包括如下步骤:
a)取薄荷,洗净,50℃以下低温干燥,粉碎成40-60目粉末,用超临界二氧化碳萃取,得薄荷油,备用;取百药煎,除去杂质,备用。
b)取超临界二氧化碳萃取后的薄荷,加入百药煎,加水提取两次,第一次加8倍量水,煎煮30分钟,第二次加7倍量水,煎煮20分钟,滤过,合并滤液,在80℃下减压浓缩到相对密度为1.10的清膏,采用喷雾干燥制备得到混合提取物,备用;
c)取薄荷脑,粉碎后过80-100目筛,备用;
d)取三氯蔗糖、蔗糖粉、微晶纤维素、甘露糖醇、羧甲基淀粉钠及b)中混合提取物,混合均匀,得到混合粉,备用;
e)取淀粉,加水制成淀粉浆,均匀倒入d)中的混合粉中,充分混匀,制成软材,后用摇摆制粒机制备得到颗粒,备用;
f)取步骤e)得到颗粒,加入硬脂酸镁,薄荷香精、茉莉花香精,以及c)中的薄荷脑,混合均匀,再均匀喷入a)中的薄荷油,得到颗粒混合物,备用;
g)取f)中的颗粒混合物,用压片机制备得到含片,即得。
对比例1:
原料药配比:
除蔗糖粉、三氯蔗糖、甘露糖醇、薄荷香精、茉莉花香精、薄荷脑用等量的麦芽糊精替代外,其余与实施例1一致。
百药煎12.5份,薄荷10份,微晶纤维素20.5份,羧甲基淀粉钠4份,淀粉0.8份,硬脂酸镁0.5份,麦芽糊精63份。
其制备工艺包括如下步骤:
a)取薄荷,洗净,50℃以下低温干燥,粉碎成40-60目粉末,用超临界二氧化碳萃取,得薄荷油,备用;取百药煎,除去杂质,备用。
b)取超临界二氧化碳萃取后的薄荷,加入百药煎,加水提取两次,第一次加8倍量水,煎煮30分钟,第二次加6倍量水,煎煮30分钟,滤过,合并滤液,在70℃下减压浓缩到相对密度为1.06的清膏,采用喷雾干燥制备得到混合提取物,备用;
c)取微晶纤维素、羧甲基淀粉钠、麦芽糊精及b)中混合提取物,混合均匀,得到混合粉,备用;
d)取淀粉,加水制成淀粉浆,均匀倒入c)中的混合粉中,充分混匀,制成软材,后用摇摆制粒机制备得到颗粒,备用;
e)取步骤d)得到颗粒,加入硬脂酸镁,混合均匀,再均匀喷入a)中的薄荷油,得到颗粒混合物,备用;
f)取e)中的颗粒混合物,用压片机制备得到含片,即得。
对比例2:
原料药配比:除蔗糖粉、甘露糖醇、三氯蔗糖、薄荷香精、茉莉花香精、薄荷脑用等量的麦芽糊精替代外,薄荷不提取挥发油,其余与实施例1一致。
百药煎12.5份,薄荷10份,微晶纤维素20.5份,羧甲基淀粉钠4份,淀粉0.8份,硬脂酸镁0.5份,麦芽糊精63份。
其制备工艺包括如下步骤:
a)取薄荷,洗净,50℃以下低温干燥,粉碎成40-60目粉末,备用;取百药煎,除去杂质,备用。
b)取薄荷、百药煎,加水提取两次,第一次加8倍量水,煎煮30分钟,第二次加6倍量水,煎煮30分钟,滤过,合并滤液,在70℃下减压浓缩到相对密度为1.06的清膏,采用喷雾干燥制备得到混合提取物,备用;
c)取微晶纤维素、羧甲基淀粉钠、麦芽糊精及b)中混合提取物,混合均匀,得到混合粉,备用;
d)取淀粉,加水制成淀粉浆,均匀倒入c)中的混合粉中,充分混匀,制成软材,后用摇摆制粒机制备得到颗粒,备用;
e)取步骤d)得到颗粒,加入硬脂酸镁,混合均匀,得到颗粒混合物,备用;
f)取e)中的颗粒混合物,用压片机制备得到含片,即得。
征集年龄为18-60岁的50名志愿者,分别对实施例1-3、对比例1-2所制备的缓解口腔及咽喉不适的含片进行感官鉴评,包括对其口感(酸甜度)、风味、清凉度、咽喉舒缓作用、长期服用意愿度等进行评分,每项10分,统计并计算均值;实验结果如下:
由实施例1与对比例1-2相比,对比例1中不添加矫味原料(蔗糖粉、三氯蔗糖、薄荷香精及薄荷脑),直接用麦芽糊精代替原有矫味原料,制备得到的含片虽然有一定的清凉度,对咽喉有较好舒缓作用,但人们长期服用意愿度较低,感官评分较低;对比例2中不添加矫味原料(蔗糖粉、三氯蔗糖、薄荷香精及薄荷脑),直接用麦芽糊精代替原有矫味原料,同时薄荷取消提取挥发油,制备得到的含片虽然对咽喉有较好舒缓作用,但风味滋味较差,感官评分最低;而实施例所制得的含片,具有较好的酸甜度,风味较佳,清凉度强,也有较强的咽喉舒缓作用,人们对长期服用以缓解口腔、咽喉等病症意愿度较高,感官评分较高。
本发明以薄荷与百药煎配伍使用,增强疗效,配以其他辅料,实现酸甜可口,清凉冰爽,可有效缓解咽喉不适,风味独特,具有较好的净化口腔、舒缓咽喉功效,是一种清咽利喉,功效与口感兼具的产品,能实现长期服用以舒缓口腔、咽喉等慢性病症的目的。
Claims (6)
1.一种缓解口腔及咽喉不适的含片,其特征在于,由下述重量份的原料制成:百药煎10-20份,薄荷5-20份,微晶纤维素10-40份,甜味剂30-95份,羧甲基淀粉钠2-8份,淀粉0.5-1.5份,清凉添加剂0.2-0.6,硬脂酸镁0.1-1.0份;所述清凉添加剂为薄荷香精、茉莉花香精和薄荷脑按0.1-0.3:0.05-0.15:0.05-0.15的复配物;所述甜味剂为蔗糖粉、甘露糖醇和三氯蔗糖按25-45:9.8-48:0.19-0.22的复配物。
2.根据权利要求1所述的一种缓解口腔及咽喉不适的含片,其特征在于,由下述重量份的原料制成:百药煎12.5份,薄荷10份,微晶纤维素20.5份,甜味剂63份,羧甲基淀粉钠4份,淀粉0.8份,清凉添加剂0.25份,硬脂酸镁0.5份,薄荷脑0.1份。
3.根据权利要求1或2所述的一种缓解口腔及咽喉不适的含片,其特征在于,所述清凉添加剂为薄荷香精、茉莉花香精和薄荷脑按0.2:0.05:0.1的复配物。
4.根据权利要求1或2所述的一种缓解口腔及咽喉不适的含片,其特征在于,所述甜味剂为蔗糖粉、甘露糖醇和三氯蔗糖按35:27.6:0.2的复配物。
5.根据权利要求1-4任一项所述的一种缓解口腔及咽喉不适的含片的制备方法,其特征在于,包括如下步骤:
a)取薄荷,洗净,50℃以下低温干燥,粉碎成40-60目细粉,用超临界二氧化碳萃取,得薄荷油,备用;取百药煎,除去杂质,备用;
b)取超临界二氧化碳萃取后的薄荷,加入百药煎,加水提取两次,第一次加7-8倍量水,煎煮20-30分钟,第二次加6-7倍量水,煎煮20-30分钟,滤过,合并滤液,在60-80℃下减压浓缩到相对密度为1.06-1.10的清膏,采用喷雾干燥制备得到混合提取物,备用;
c)取薄荷脑,粉碎后过80-100目筛,备用;
d)取三氯蔗糖、蔗糖粉、微晶纤维素、甘露糖醇、羧甲基淀粉钠及b)中混合提取物,混合均匀,得到混合粉,备用;
e)取淀粉,加水制成淀粉浆,均匀倒入d)中的混合粉中,充分混匀,制成软材,后用摇摆制粒机制备得到颗粒,备用;
f)取步骤e)得到颗粒,加入硬脂酸镁,薄荷香精、茉莉花香精,以及c)中的薄荷脑粉末,混合均匀,再均匀喷入a)中的薄荷油,得到颗粒混合物,备用;
g)取f)中的颗粒混合物,用压片机制备得到含片,即得。
6.根据权利要求5所述的一种缓解口腔及咽喉不适的含片的制备方法,其特征在于,步骤a)中,所述超临界二氧化碳萃取条件为:萃取釜压力20~25MPa,分离Ⅰ压力5~10 MPa,分离Ⅱ压力4~8 MPa,萃取温度为35~45℃,分离Ⅰ温度为45~55℃,分离Ⅱ温度为30~35℃,二氧化碳流量为20-30L/h,萃取时间为1.5-3小时。
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