CN105614844B - 一种含有金雀花的食品、保健品或药物组合物 - Google Patents
一种含有金雀花的食品、保健品或药物组合物 Download PDFInfo
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- CN105614844B CN105614844B CN201510964113.8A CN201510964113A CN105614844B CN 105614844 B CN105614844 B CN 105614844B CN 201510964113 A CN201510964113 A CN 201510964113A CN 105614844 B CN105614844 B CN 105614844B
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Abstract
本发明提供了一种含有金雀花的止咳食品、保健品或药物组合物，其原料由如下重量配比的组分组成：金雀花∶枇杷叶∶昆仑雪菊＝(50％～70％)∶(15％～35％)∶(5％～25％)。本发明研究发现，将金雀花、枇杷叶和昆仑雪菊联合使用后，发挥了协同增效作用，止咳作用得到增强，优于三者的单独使用。基于上述研究，本发明提供了一种新的止咳组合物，为临床用药和保健治疗提供了新的选择。
Description
技术领域
本发明属于保健品领域，具体涉及一种含有金雀花的止咳食品、保健品或药物组合物。
技术背景
咳嗽是防御性呼吸反射，喉、气管和支气管内壁粘膜上皮内的感受器受到刺激时，冲动由迷走神经的传入纤维传至延髓，然后经传出神经到声门和呼吸肌等处，引起一系列协调而有次序的动作，是人身体的保护性反应，通过咳嗽可以将进入气管、支气管的异物、肺内的细菌及组织破坏产物排出，但频繁剧烈的咳嗽对人身体是有害的。镇咳药的作用方式有：①局部麻醉镇咳，局部麻醉呼吸道感受器和神经末梢，削弱局部刺激作用。②抗炎镇咳，通过抗炎作用减轻炎症对呼吸道的刺激。③解疫止咳，通过缓解支气管平滑肌疫挛，降低肺泡过度充气，减轻少肺牵张感受器的刺激而达到止咳。
金雀花又名金孔雀、金鹊花，属豆科碟形花亚科锦鸡儿属(CaraganachinensisTurcz.ex Maxim)，性味微温甜，具有滋阴、和血、健脾的功效。治劳热咳嗽、头晕腰酸、妇女气喘白带、小儿疳积、乳痈、跌打损伤等。目前金雀花主要用于观赏，也有少量食用，但产品不成规模，资源利用率极低。金雀花单用止咳作用有限，本发明拟开发金雀花的复方产品，以便增强产品实用性。
目前还未见将金雀花、枇杷叶和雪菊联合使用的相关报道；三者联合使用后，对组份的止咳功效影响也未有研究。
发明内容
本发明的目的在于提供一种基于金雀花的复方止咳组合物。本发明还提供了该组合物的制备方法和用途。
具体地，本发明提供了一种含有金雀花的食品、保健品或药物组合物，其原料由如下重量配比的组分组成：
金雀花∶枇杷叶∶雪菊＝(50～70)∶(15～35)∶(5～25)。
进一步地，其原料由如下重量配比的组分组成：
金雀花∶枇杷叶∶雪菊＝(55～65)∶(20～30)∶(10～20)。
本发明一个具体实施方式中，原料由如下重量配比的组分组成∶金雀花∶枇杷叶∶雪
菊＝60∶25∶15。
本发明各原料重量配比，均以干燥品计算，若是鲜品或含水品，可以根据含水量换算。
枇杷叶为枇杷(Eriobotryajaponica(Thumb.)Lindl.)的干燥叶，有清肺止咳、降逆止呕功效。现代研究证实其具有止咳平喘化痰、抗炎、抗病毒、降血糖等药理作用，主要有三萜酸类、黄酮类、倍半萜类、多酚类以及糖苷类化合物。
雪菊又名昆仑雪菊、蛇目菊，《本草纲目》谓其能除风热，益肾补阴，用治诸风头目，其旨深微。本草经疏：雪菊安肠胃，利五脉，调四肢，利气血者。历代药典中关于雪菊的药用价值记载颇多。中医认为：昆仑雪菊性凉，有疏风清热、健脑明目、解毒消肿等功效。并且雪菊对金黄色葡萄球菌、白喉杆菌及痢疾杆菌有较强的抑制作用，因此对肺炎、鼻炎、支气管炎、咽喉肿痛等有明显疗效，具有杀菌、抑菌、消炎、预防感冒和慢性肠炎的功效。
众所周知，枇杷叶是一味经典的止咳中药，本发明实验也表明枇杷叶具有良好的止咳活性，金雀花止咳功效不及枇杷叶。然而，本发明将金雀花与少量的枇杷叶、雪菊配伍使用后，在相同生药剂量下，其组合物止咳功效却优于枇杷叶，这说明三者组合使用发挥了协同增效作用，止咳功效明显提升。
其中，所述组合物为经口服用剂型。
进一步地，所述经口服用剂型选自口服液、颗粒剂、散剂、茶剂、丸剂、片剂或胶囊剂。
用于口服给药的固体剂型中，活性成分与至少一种常规惰性赋形剂(或载体)混合，如柠檬酸钠或磷酸二钙，或与下述成分混合：(a)填料或增容剂，例如，淀粉、乳糖、蔗糖、葡萄糖、甘露醇和硅酸；(b)粘合剂，例如，羟甲基纤维素、藻酸盐、明胶、聚乙烯基吡咯烷酮、蔗糖和阿拉伯胶；(c)保湿剂，例如，甘油；(d)崩解剂，例如，琼脂、碳酸钙、马铃薯淀粉或木薯淀粉、藻酸、某些复合硅酸盐、和碳酸钠；(e)缓溶剂，例如石蜡；(f)吸收加速剂，例如，季胺化合物；(g)润湿剂，例如鲸蜡醇和单硬脂酸甘油酯；(h)吸附剂，例如，高岭土；和(i)润滑剂，例如，滑石、硬脂酸钙、硬脂酸镁、固体聚乙二醇、十二烷基硫酸钠，或其混合物。胶囊剂、片剂和丸剂中，剂型也可包含缓冲剂。
固体剂型如片剂、糖丸、胶囊剂、丸剂和颗粒剂可采用包衣和壳材制备，如肠衣和其它本领域公知的材料。它们可包含不透明剂，并且，这种组合物中活性成分的释放可以延迟的方式在消化道内的某一部分中释放。可采用的包埋组分的实例是聚合物质和蜡类物质。必要时，活性成分也可与上述赋形剂中的一种或多种形成微胶囊形式。
用于口服给药的液体剂型，除了活性成分外，液体剂型可包含本领域中常规采用的惰性稀释剂，如水或其它溶剂，增溶剂和乳化剂，例如，乙醇、异丙醇、碳酸乙酯、乙酸乙酯、丙二醇、1，3-丁二醇、二甲基甲酰胺以及油，特别是棉籽油、花生油、玉米胚油、橄榄油、蓖麻油和芝麻油或这些物质的混合物等。
除了这些惰性稀释剂外，组合物也可包含助剂，如润湿剂、乳化剂和悬浮剂、甜味剂、矫味剂和香料。
除了活性成分外，悬浮液可包含悬浮剂，例如，乙氧基化异十八烷醇、聚氧乙烯山梨醇和脱水山梨醇酯、微晶纤维素、甲醇铝和琼脂或这些物质的混合物等。
用于肠胃外注射的组合物可包含生理上可接受的无菌含水或无水溶液、分散液、悬浮液或乳液，和用于重新溶解成无菌的可注射溶液或分散液的无菌粉末。适宜的含水和非水载体、稀释剂、溶剂或赋形剂包括水、乙醇、多元醇及其适宜的混合物。
用于局部给药的本发明化合物的剂型包括软膏剂、散剂、贴剂、喷射剂和吸入剂。活性成分在无菌条件下与生理上可接受的载体及任何防腐剂、缓冲剂，或必要时可能需要的推进剂一起混合。
其中，所述茶剂包括袋泡茶、茶块或煎煮茶，但不限于上述三种种类。
本发明还提供了上述食品、保健品或药物组合物的制备方法，它包括如下操作步骤：
(1)按配比取原料；
(2)将原料混合均匀后，加水提取，提取液加入适量辅料或辅助性成分制备得到食品、保健品或药物组合物。
本发明还提供了上述食品、保健品或药物组合物的另一种制备方法，它包括如下操作步骤：
(1)按配比取原料；
(2)将原料混合均匀后，醇水双提，提取物加入适量辅料或辅助性成分制备得到食品、保健品或药物组合物。
本发明还提供了上述组合物在制备止咳药物、保健品或食品中的用途。
本发明研究发现，单独使用金雀花有一定止咳作用，但其止咳功效不如枇杷叶，单独使用雪菊止咳功效甚微，然而，将三者联合使用后，在枇杷叶用量极低的情况下，却能够发挥强于枇杷叶(以及其余两味组份)的止咳作用，说明本发明组合物配方恰当，发挥了协同增效作用，增强了各单味药的止咳活性，为预防或治疗咳嗽提供了新的选择。
显然，根据本发明的上述内容，按照本领域的普通技术知识和手段，在不脱离本发明上述基本技术思想前提下，还可以做出其他多种形式的修改、替换或变更。
以下通过具体实施例的形式，对本发明的上述内容再做进一步的详细说明。但不应将此理解为本发明上述主题的范围仅限于以下的实施例。凡基于本发明上述内容所实现的技术均属于本发明的范围。
具体实施方式
实施例1：本发明组合物的制备
取金雀花、枇杷叶和雪菊，枇杷叶在使用前用粉碎机粉碎至雪菊大小的粒径，三者重量比为60％∶25％∶15％(均按干品计算)，混合后，加水煎煮提取2次，每次35min，合并提取液，即得汤剂。
实施例2：本发明组合物的制备
取金雀花、枇杷叶和雪菊，枇杷叶在使用前用粉碎机粉碎至雪菊大小的粒径，三者重量比为70％∶20％∶10％(均按干品计算)，混合后，依次用70％v/v乙醇、水回流提取2次，每次40min，乙醇提取液回收乙醇后与水提液合并，浓缩，加入适量糊精和微晶纤维素制备颗粒剂。
实施例3：本发明组合物的制备
取金雀花、枇杷叶和雪菊，枇杷叶在使用前用粉碎机粉碎至雪菊大小的粒径，三者重量比为50％∶30％∶20％(均按干品计算)，干燥、粉碎、混匀，加入适量微晶纤维素，混匀后，制备散剂。
实施例4：本发明组合物的制备
取金雀花、枇杷叶和雪菊，枇杷叶在使用前用粉碎机粉碎至雪菊大小的粒径，三者重量比为60％∶25％∶15％(均按干品计算)，干燥后，混合，制备袋泡茶。
实施例5本发明组合物止咳作用实验
1)实验药物：
A组：取金雀花、枇杷叶和雪菊共500g，枇杷叶在使用前用粉碎机粉碎至雪菊大小的粒径，三者重量比为60％∶25％∶15％(均按干品计算)，混合后，加温水浸泡3次，每次1h，合并提取液，浓缩后冷冻干燥得提取物A。分别将提取物A配置成0.30g/mL、0.90g/mL、2.70g/mL共高中低三个浓度溶液。
B组：取金雀花500g，加温水浸泡3次，每次1h，合并提取液，浓缩后冷冻干燥得提取物B，并将提取物B配置成0.90g/mL的溶液。
C组：取枇杷叶500g，粉碎后加温水浸泡3次，每次1h，合并提取液，浓缩后冷冻干燥得提取物C备用，并将提取物C配置成0.90g/mL的溶液。
的组：取昆仑雪菊500g，加温水浸泡3次，每次1h，合并提取液，浓缩后冷冻干燥得提取物D备用，并将提取物D配置成0.90g/mL的溶液。
2)实验过程
浓氨水是一种有刺激性气味的化学品，当动物吸入后，刺激呼吸道感受器，就引起咳嗽。因而，只要能抑制咳嗽中枢或降低呼吸道感受器敏感性的药物均有止咳作用。本实验通过让小鼠吸入氨水引起咳后，灌胃本配方提取物以观察止咳作用。
将80只ICR小鼠随机分为8组，每组10只，小鼠体重为20±0.5g。
对照组灌胃生理盐水0.3mL，阳性对照组盐酸吗啡注射液(0.30mg/mL)0.3mL，低剂量组A提取物(0.30g/mL)0.3mL，中剂量组A提取物(0.90g/mL)0.3mL，高剂量组A提取物(2.70g/mL)0.3mL，B、C、D提取物(0.90g/mL)0.3mL，连续3天。
末次给药后1小时，在倒扣的500mL烧杯中放入一棉球，注入0.4mL浓氨水，迅速将小鼠放入其中，5s后迅速取出小鼠，观察记录小鼠的咳嗽潜伏期和3min内咳嗽数。
3)本发明药物组合物对小鼠止咳作用的结果
表1 各提取物组对氨水引起咳嗽的小鼠止咳作用的影响
与空白组相比，*：p＜0.05；**：p＜0.01
表2 各提取物组对氨水引起咳嗽的小鼠潜伏期的影响
与空白组相比：#p＜0.05；##：p＜0.01
由表1和表2可知，本发明药物组合物中高剂量组对氨水引起的小鼠咳嗽具有止咳作用，且呈一定的剂量效应关系，与空白组有显著(p＜0.05)或者极显著性差异(p＜0.01)。
另外，单独使用相同浓度的金雀花、枇杷叶，在中剂量时虽然有止咳的作用，但其止咳作用显然不及三者的组合，这也证明本发明将金雀花、枇杷叶和雪菊使用后，发挥了协同增效作用，止咳作用得到提升。
Claims (8)
1.一种含有金雀花的食品、保健品或药物组合物，其特征在于：其原料由如下重量配比的组分组成：
金雀花∶枇杷叶∶雪菊＝(55～65)∶(20～30)∶(10～20)。
2.根据权利要求1所述的食品、保健品或药物组合物，其特征在于：其原料由如下重量配比的组分组成：
金雀花∶枇杷叶∶雪菊＝60∶25∶15。
3.根据权利要求1或2所述的食品、保健品或药物组合物，其特征在于：所述组合物为经口服用剂型。
4.根据权利要求3所述的食品、保健品或药物组合物，其特征在于：所述经口服用剂型选自口服液、颗粒剂、散剂、茶剂、丸剂、片剂或胶囊剂。
5.根据权利要求4所述的食品、保健品或药物组合物，其特征在于：所述茶剂为袋泡茶、茶块或煎煮茶。
6.权利要求1或2所述食品、保健品或药物组合物的制备方法，其特征在于：它包括如下操作步骤：
(1)按配比取原料；
(2)将原料混合均匀后，加水提取，提取液加入适量辅料或辅助性成分制备得到食品、保健品或药物组合物。
7.权利要求1或2所述食品、保健品或药物组合物的制备方法，其特征在于：它包括如下操作步骤：
(1)按配比取原料；
(2)将原料混合均匀后，醇水双提，提取物加入适量辅料或辅助性成分制备得到食品、保健品或药物组合物。
8.权利要求1～5任意一项所述组合物在制备止咳药物、保健品或食品中的用途。
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