CN117338864A - 一种消食健脾组合物及其制备方法与应用 - Google Patents
一种消食健脾组合物及其制备方法与应用 Download PDFInfo
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- CN117338864A CN117338864A CN202311376191.7A CN202311376191A CN117338864A CN 117338864 A CN117338864 A CN 117338864A CN 202311376191 A CN202311376191 A CN 202311376191A CN 117338864 A CN117338864 A CN 117338864A
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- Medicines Containing Plant Substances (AREA)
Abstract
本发明涉及医药技术领域,具体公开了一种消食健脾组合物及其制备方法与应用。本发明的组合物包括:鸡内金提取物、山楂提取物、陈皮提取物、半夏提取物、木香提取物、丁香提取物、茯苓提取物、甘草提取物、苍术提取物、枳实提取物、厚朴提取物和白胡椒提取物;所述陈皮提取物、木香提取物和枳实提取物的质量比为(6.8‑7.2):(2.8‑3.2):1;所述陈皮提取物、茯苓提取物、厚朴提取物、半夏提取物、苍术提取物、甘草提取物的质量比为(6.8‑7.2):(2.8‑3.2):(2.8‑3.2):(2.8‑3.2):(2.8‑3.2):(2.8‑3.2)。本发明组合物可制备外用型中药组合物保健贴剂,适用于婴幼儿的理气健脾、化湿和胃。
Description
技术领域
本发明涉及医药技术领域,具体地说,涉及一种消食健脾组合物及其制备方法与应用。
背景技术
消化不良、脾胃不和是儿童在发育的过程中,常常出现的健康问题。儿童由于脾胃尚未发育完全,消化不良的发病率高于其他人群,主要表现症状是挑食、厌食、胀气、盗汗哭闹、大便不畅,这样对身体发育会有很大的负面影响,特别是对更小的婴幼儿人群。
针对消化不良、脾胃不和,现有的中药配方从健脾、消食、祛湿、理气导滞方面进行治疗,但并不十分适用于脾胃虚弱的婴幼儿;且儿童年龄太小,依从性不高,口服的消食健脾制剂,很难得到孩子的配合,甚至会产生逆反和抗拒心理,而且是药三分毒,用药不当也可能产生副作用。为此,本领域也开发出了一些可通过敷贴进行治疗的方法,但市场上贴剂大多是生药材直接粉碎敷用,成分吸收不充分,其疗效和使用肤感仍有待提高,因此需要进一步研究效果更佳、更适于婴幼儿娇嫩皮肤应用的产品。
发明内容
本发明的目的之一是提供一种适用于小儿的消食健脾的外用型中药组合物及其制备的保健贴剂。
为了实现该目的,本发明的技术方案如下:
一种组合物,其包括:鸡内金提取物、山楂提取物、陈皮提取物、半夏提取物、木香提取物、丁香提取物、茯苓提取物、甘草提取物、苍术提取物、枳实提取物、厚朴提取物和白胡椒提取物;
所述陈皮提取物、木香提取物和枳实提取物的质量比为(6.8-7.2):(2.8-3.2):1;
所述陈皮提取物、茯苓提取物、厚朴提取物、半夏提取物、苍术提取物、甘草提取物的质量比为(6.8-7.2):(2.8-3.2):(2.8-3.2):(2.8-3.2):(2.8-3.2):(2.8-3.2)。
本发明组方按照中药配伍原则,诸药合用,可达到理气健脾、化湿和胃的保健作用。方中,鸡内金健运脾胃,消化积滞;山楂功擅助脾健胃,尤擅消肉食油腻之积,陈皮在理气的同时又具健脾的功效,三者同为君药;木香、厚朴、丁香、枳实理气和中,行气除胀,退粪下行,健脾和胃,共为臣药;半夏调理脾胃、茯苓调节肠胃及帮助消化、苍术健胃安脾、白胡椒散寒健胃,同为佐药。甘草补脾益气,调和诸药,为使药。诸药配伍,共奏理气健脾、化湿和胃之功。
其中,鸡内金是指家鸡的砂囊内壁,系消化器官,用于研磨食物,该品为传统中药之一,消食健胃助消化,涩精止遗。可以促进胃液分泌,提高胃酸度及消化力,使胃运动功能明显增强,胃排空加快。用于消化不良、遗精盗汗等症,效果极佳,故而以“金”命名。
山楂,归入脾、胃、肝经,具有消积食健脾胃的功效。
陈皮,入脾、胃、肺经,具有理气健脾,调中,燥湿,化痰的作用。主治脾胃气滞之脘腹胀满或疼痛、消化不良。
半夏,是中医治疗脾胃病使用最为频繁的扛鼎之药,具有燥湿化痰、降逆止呕,消痞散结的功效。半夏泻心汤是《伤寒论》中调理脾胃的经典方剂之一。
木香行肝经气,治心腹一切气,膀胱冷痛,呕逆反胃,霍乱泄泻痢疾,健脾消食。
丁香暖脾胃而行气滞,具有健胃消胀、促进排气的功效,减轻因胃部发酵产生的呃逆、反胃与口气不佳,可用于打嗝和因消化不良引起的腹胀、腹泻、呕吐、口臭等症。
茯苓味甘、淡、性平无毒,入心、脾、肺,肾四经,具有渗湿利水,益脾胃保肾,安神生津等功效。
甘草补脾益气,调和诸药。
苍术归脾、胃、肝经。主治燥湿健脾、主湿困脾胃、胞痞腹胀、食欲不振、能健胃安脾等。
枳实归脾、胃经。《药品化义》:“枳实专泄胃实,开导坚结,故主中脘以治血分,疗脐腹间实满,消痰癖、祛停水、逐宿食、破结胸、通便闭、非此不能也”。
厚朴归脾、胃、大肠经。对食积气滞、腹胀便秘、湿阻中焦等疾病有治疗作用。
白胡椒的药用价值稍高一些,调味作用稍次,它的味道相对黑胡椒来说更为辛辣,因此散寒、健胃功能更强。
本发明经研究发现,陈皮是理气药中,极少数有健脾作用的中药,因此陈皮可以长久服,不会伤脾,反而能够健脾。除了陈皮,在理气药中,木香也有行气,止痛,健脾的功效。而枳实有理气的功效,药效很猛,使用后可以很快起作用,但久用会产生破气之虞,使患者不想吃饭、厌食。在本方中,将陈皮与木香、枳实以特定比例配合,效果最好,既可发挥功效,且药效发作很快,又可缓解枳实带来的副作用。
此外,本发明还研究发现,陈皮、茯苓、厚朴、半夏、苍术有燥湿的功效,用药量大或久的话,湿从大便排出,有可能会引起腹泻。甘草不仅具有补气调脾的功效,而且具有调和诸药的作用,可以平衡各药间的药性。故而在本方中,将陈皮、茯苓、厚朴、半夏、苍术、甘草以特定比例配合使用,在保证理气健脾、化湿和胃的功效前提下,同时减少了腹泻的发生可能。
本发明主要组分为中药提取物而不是生药材,更利于吸收。
本发明的组合物还包括蜂蜜和甘油。
本发明特别采用蜂蜜作为基质凝缩营养成分,更易吸收。蜂蜜在作为各组分粘合剂的同时还可以调节胃肠功能,促进消化。甘油温和不刺激,既能作为其他药物溶剂,又具有滋润保湿的作用。
优选本发明的组合物中,所述陈皮提取物、木香提取物和枳实提取物的质量比为7:3:1。
所述陈皮提取物、茯苓提取物、厚朴提取物、半夏提取物、苍术提取物、甘草提取物的质量比为7:3:3:3:3:3。
本发明的组合物包括:鸡内金提取物5-12份、山楂提取物5-12份、陈皮提取物6-12份、半夏提取物1-5份、木香提取物1-5份、丁香提取物4-10份、茯苓提取物1-7份、甘草提取物1-7份、苍术提取物1-7份、枳实提取物0.1-3份、厚朴提取物1-5份和白胡椒提取物0.2-6份、蜂蜜80-130份和甘油40-80份。
优选包括:鸡内金提取物6-10份、山楂提取物6-10份、陈皮提取物6.8-7.2份、半夏提取物2.9-3.1份、木香提取物2.9-3.1份、丁香提取物6-8份、茯苓提取物2.9-3.1份、甘草提取物2.9-3.1份、苍术提取物2.9-3.1份、枳实提取物0.8-1.2份、厚朴提取物2.9-3.1份和白胡椒提取物1-2份、蜂蜜95-110份和甘油60-75份;
更优选,鸡内金提取物8份、山楂提取物8份、陈皮提取物7份、半夏提取物3份、木香提取物3份、丁香提取物6份、茯苓提取物3份、甘草提取物3份、苍术提取物3份、枳实提取物1份、厚朴提取物3份和白胡椒提取物2份、蜂蜜100份和甘油63份。
本发明还提供一种制备上述组合物的方法,其包括:
(1)将鸡内金提取物、山楂提取物、陈皮提取物、半夏提取物、木香提取物、丁香提取物、茯苓提取物、甘草提取物、苍术提取物、枳实提取物、厚朴提取物和白胡椒提取物混合均匀,获得预混物;
(2)将所述预混物和蜂蜜、甘油混合均匀。
本发明另提供一种上述组合物或方法制备获得的组合物在制备理气健脾、化湿和胃产品中的应用;优选,所述产品为贴剂,更优选所述贴剂应用于婴幼儿。
本发明中婴幼儿的年龄在0.5-6岁之间。
本发明再提供一种贴剂,其包括所述组合物或方法制备获得的组合物。
本发明还提供一种制备上述贴剂的方法,其包括将所述组合物复合在无纺布贴表面的步骤;优选,每个无纺布贴上复合有1.8-2.2g所述组合物。
本发明的有益效果至少在于:
本发明提出的组合物适用于制备外用型中药组合物保健贴剂,可通过特定穴位的贴敷,起到理气健脾、化湿和胃的保健作用。特别适用于消化不良、食欲减退、腹胀等不适的亚健康儿童。
而且所加成分都是内服有助消化功效的药材,采用内病外治的方法,可以增加小儿的依从性。
具体实施方式
下面将结合实施例对本发明的优选实施方式进行详细说明。需要理解的是以下实施例的给出仅是为了起到说明的目的,并不是用于对本发明的范围进行限制。本领域的技术人员在不背离本发明的宗旨和精神的情况下,可以对本发明进行各种修改和替换。
下述实施例中所使用的实验方法如无特殊说明,均为常规方法。下述实施例中所用的材料、试剂等,如无特殊说明,均可从商业途径得到或按本领域常规方法制备。
本发明具体实施方式部分所用鸡内金提取物、山楂提取物、陈皮提取物、半夏提取物、木香提取物、丁香提取物、茯苓提取物、甘草提取物、苍术提取物、枳实提取物、厚朴提取物、白胡椒提取物均为市场购买。具体信息参见表1。
表1原料来源
实施例1
本实施例提供一种外用型中药组合物保健贴剂,具体配方如下表2所示。
表2
制备方法如下:
1、称量配方量的鸡内金、山楂、陈皮、半夏、木香、丁香、茯苓、甘草、苍术、枳实、厚朴、白胡椒提取物,过80目筛,并充分混匀。加入配方量的蜂蜜和甘油,搅拌均匀,制成涂料,保温40℃备用;
2、将上述涂料称量2g放入无纺布贴制成贴剂。
实施例2
本实施例提供一种外用型中药组合物保健贴剂,具体配方如下表3所示。
表3
序号 | 物料名称 | 添加量(份) |
1 | 鸡内金提取物 | 10 |
2 | 山楂提取物 | 10 |
3 | 陈皮提取物 | 6.8 |
4 | 半夏提取物 | 2.9 |
5 | 木香提取物 | 2.9 |
6 | 丁香提取物 | 8 |
7 | 茯苓提取物 | 2.9 |
8 | 甘草提取物 | 2.9 |
9 | 苍术提取物 | 2.9 |
10 | 枳实提取物 | 1.0 |
11 | 厚朴提取物 | 2.9 |
12 | 白胡椒提取物 | 1 |
13 | 蜂蜜 | 97 |
14 | 甘油 | 65 |
制备方法同实施例1。
实施例3
本实施例提供一种外用型中药组合物保健贴剂,具体配方如下表4所示。
表4
序号 | 物料名称 | 添加量(份) |
1 | 鸡内金提取物 | 6 |
2 | 山楂提取物 | 6 |
3 | 陈皮提取物 | 7.2 |
4 | 半夏提取物 | 3.1 |
5 | 木香提取物 | 3.1 |
6 | 丁香提取物 | 7 |
7 | 茯苓提取物 | 3.1 |
8 | 甘草提取物 | 3.1 |
9 | 苍术提取物 | 3.1 |
10 | 枳实提取物 | 1.0 |
11 | 厚朴提取物 | 3.1 |
12 | 白胡椒提取物 | 1.5 |
13 | 蜂蜜 | 110 |
14 | 甘油 | 75 |
制备方法同实施例1。
对比例1
本对比例提供一种外用型中药组合物保健贴剂,具体配方与制备方法与实施例1相同,区别仅在于,不添加木香提取物和枳实提取物,改为添加11份陈皮提取物。
对比例2
本对比例提供一种外用型中药组合物保健贴剂,具体配方与制备方法与实施例1相同,区别仅在于,不添加陈皮提取物和枳实提取物,改为添加11份木香提取物。
对比例3
本对比例提供一种外用型中药组合物保健贴剂,具体配方与制备方法与实施例1相同,区别仅在于,不添加陈皮提取物和木香提取物,改为添加11份枳实提取物。
对比例4
本对比例提供一种外用型中药组合物保健贴剂,具体配方与制备方法与实施例1相同,区别仅在于,木香提取物的用量改为2份、枳实提取物的用量改为2份,使得陈皮提取物、木香提取物和枳实提取物的总用量不变,但比例变为7:2:2。
对比例5
本对比例提供一种外用型中药组合物保健贴剂,具体配方与制备方法与实施例1相同,区别仅在于,以等量的枳壳替代配方中的木香提取物。
对比例6
本对比例提供一种外用型中药组合物保健贴剂,具体配方与制备方法与实施例1相同,区别仅在于,茯苓提取物的用量改为2份、半夏提取物的用量改为4份,使得陈皮提取物、茯苓提取物、厚朴提取物、半夏提取物、苍术提取物、甘草提取物的总用量不变,但比例变为7:2:3:4:3:3。
实验例临床应用
病例来源:
患者资料:参照《中医病证诊断疗效标准》中关于“积滞”的有关诊断依据,随机收集小儿积滞乳食停滞证患儿156例,年龄在0.5-6岁之间,病程10-60天,男孩75名,女孩78名;
诊断标准:
西医诊断标准参照最新的《儿童功能性胃肠病罗马IV》制定的FAP NOS的标准制定;中医诊断标准依据汪受传主编的《中医儿科学》和《中医疾病诊断疗效标准》中的腹痛(乳食积滞)诊断依据及证候分析标准制定。
具体西医诊断标准:
(1)发作性或持续性腹痛,不只是在生理情况时发作(如进食);
(2)不符合肠易激综合征、功能性消化不良或腹型偏头痛的诊断标准;
(3)经适度的评估,症状不能完全用其他的疾病情况来解释;
(4)病程≥2个月,至少每月发作4次。
具体中医诊断标准:
(1)主症:脘腹胀满、按之痛甚、嗳腐吞酸、不思饮食。
(2)次症:失气频作,腹痛欲泻、泻后痛减,或伴有呕吐酸馊、夜卧不安、大便臭秽和时时啼哭等症。
(3)舌脉:舌红苔厚腻,脉沉滑。
(4)诊断依据:主症必备2项,并有次症至少1项,参考舌脉特点,即可辨为此证。
治疗方法和疗效评价:
神阙穴是胚胎发育时期腹壁的最晚闭合处,此处皮肤的血管分布非常丰富,有利于药物的透皮吸收而发挥药效。因此,选择神阙穴作为本发明的给药部位。先用湿毛巾擦洗神阙穴位周围皮肤,将本发明贴剂拆封后慢慢将保护层撕下,贴敷于神阙穴位上,每天2次,每次贴敷5小时,7天为一疗程。患者等量随机分为9组,每组17名,分别使用实施例1-3和对比例1-6配方所制作的贴剂。
疗效评定标准:
依据《中药新药临床研究指导原则》进行疗效评价:①痊愈:症状消失或基本消失。综合疗效指数≥95%;②显效:症状明显减轻,大部分体征消失,70%≤综合疗效指数<95;③有效:症状减轻,部分体征消失,30%≤综合疗效指数小于70%;④无效:症状体征无明显改善,综合疗效指数<30%。
使用尼莫地平法计算综合疗效指数:综合疗效指数=(治疗前积分-治疗后积分)*100%/治疗前积分。
4个疗程结束后,统计治疗结果,见表5。
表5
组别 | 痊愈 | 显效 | 有效 | 无效 | 总有效率 |
实施例1 | 13 | 2 | 1 | 1 | 94.1% |
实施例2 | 11 | 2 | 2 | 2 | 88.2% |
实施例3 | 9 | 3 | 2 | 3 | 82.4% |
对比例1 | 7 | 2 | 3 | 5 | 70.6% |
对比例2 | 3 | 5 | 1 | 8 | 52.9% |
对比例3 | 2 | 4 | 3 | 8 | 52.9% |
对比例4 | 8 | 1 | 2 | 6 | 64.7% |
对比例5 | 8 | 2 | 2 | 5 | 70.6% |
对比例6 | 8 | 2 | 1 | 6 | 64.7% |
由上表数据可见,实施例有效率均高于对比例,其中实施例1效果最好。另外,治疗期间,采用本发明实施例中组合物的组别未发生刺激、过敏、腹泻和其他任何不良反应。而对比例1-2中由于未添加枳实提取物,导致产品起效时间相对慢,有3名患者出现胀气现象;对比例3中由于未添加陈皮和木香,反而增加了枳实的用量,导致有5名患者有脾胃不适以及厌食的现象发生;对比例4-5由于陈皮提取物、木香提取物、枳实提取物比例变化导致2名患者出现脾胃不适的现象;对比例6由于陈皮提取物、茯苓提取物、厚朴提取物、半夏提取物、苍术提取物、甘草提取物比例变化,导致4名患者出现了腹泻症状。
为了进一步探讨其功效,本发明通过其对小鼠炭末推进长度及推进率影响的实验研究,验证了其具有增强肠胃蠕动促进胃肠动力的作用。
选取体重为20±2g的小白鼠110只(雌雄各半)进行造模。需造模的110只小鼠采用不规则喂养,即单日进食,双日禁食,以打乱正常的饮食规律,自由饮水。同时在每升饮用水中加入10mol/L HCL 10mL,以破坏胃内酸碱环境。于造模第3周开始在保持造模条件不变的情况下,分别给药,给药期间持续造模。
将上述模型组小鼠随机分为11组,每组10只,分别为:模型空白组、模型试验组(实施例1-3、对比例1-6)和江中牌健胃消食片对照组。
对上述模型组小白鼠进行腹部脱毛处理,修剪腹部体毛,使用8%硫化钠进行脱毛,脱毛面积保持一致,约为2x2cm,脱毛后的小鼠需要饲喂1天后进行试验。
在实验过程中如果给药部位有绒毛长出,应用眼科剪刀修剪后再用药。将实施例1-3、对比例1-6配方制作成的组合物涂料及对照组(江中牌健胃消食片50份碾碎,加甘油63份、蜂蜜100份调成膏状),分别涂抹相同量(1g)于小鼠脱毛部位,覆以纱布,用胶布固定6h以上,每日早晚1次,连续给药2周。模型空白组每天涂抹生理盐水。
末次涂抹药物前禁食12h,末次给药30min后用50g/L炭末阿拉伯耆胶混悬液体,以10ml/kg给所有小鼠灌胃,25min后处死。取小肠(幽门至回盲肠部),测量炭末推进长度(幽门至炭末前沿距离)及小肠全长,按公式计算炭末推进率。
炭末推进率=(幽门至炭末前沿距离/小肠全长)*100%。
结果见表6。
表6
由上表数据可见,与模型空白组相比,实施例1-3和对比例1-6小肠炭末推进率均高于模型空白组,其中实施例1-3小肠炭末推进率均高于对比例1-6,而且实施例1的推进率最高,接近健胃消食片对照组的小肠推进率。由此可说明按照实施例1组方的贴剂促进肠胃蠕动的效果最好。
虽然,上文中已经用一般性说明及具体实施方案对本发明作了详尽的描述,但在本发明基础上,可以对之作一些修改或改进,这对本领域技术人员而言是显而易见的。因此,在不偏离本发明精神的基础上所做的这些修改或改进,均属于本发明要求保护的范围。
Claims (10)
1.一种组合物,其特征在于,包括:鸡内金提取物、山楂提取物、陈皮提取物、半夏提取物、木香提取物、丁香提取物、茯苓提取物、甘草提取物、苍术提取物、枳实提取物、厚朴提取物和白胡椒提取物;
所述陈皮提取物、木香提取物和枳实提取物的质量比为(6.8-7.2):(2.8-3.2):1;
所述陈皮提取物、茯苓提取物、厚朴提取物、半夏提取物、苍术提取物、甘草提取物的质量比为(6.8-7.2):(2.8-3.2):(2.8-3.2):(2.8-3.2):(2.8-3.2):(2.8-3.2)。
2.根据权利要求1所述的组合物,其特征在于,还包括蜂蜜和甘油。
3.根据权利要求1或2所述的组合物,其特征在于,所述陈皮提取物、木香提取物和枳实提取物的质量比为7:3:1。
4.根据权利要求1-3任一项所述的组合物,其特征在于,所述陈皮提取物、茯苓提取物、厚朴提取物、半夏提取物、苍术提取物、甘草提取物的质量比为7:3:3:3:3:3。
5.根据权利要求1-4任一项所述的组合物,其特征在于,包括:鸡内金提取物5-12份、山楂提取物5-12份、陈皮提取物6-12份、半夏提取物1-5份、木香提取物1-5份、丁香提取物4-10份、茯苓提取物1-7份、甘草提取物1-7份、苍术提取物1-7份、枳实提取物0.1-3份、厚朴提取物1-5份和白胡椒提取物0.2-6份、蜂蜜80-130份和甘油40-80份。
6.根据权利要求5所述的组合物,其特征在于,包括:鸡内金提取物6-10份、山楂提取物6-10份、陈皮提取物6.8-7.2份、半夏提取物2.9-3.1份、木香提取物2.9-3.1份、丁香提取物6-8份、茯苓提取物2.9-3.1份、甘草提取物2.9-3.1份、苍术提取物2.9-3.1份、枳实提取物0.8-1.2份、厚朴提取物2.9-3.1份和白胡椒提取物1-2份、蜂蜜95-110份和甘油60-75份;
优选,鸡内金提取物8份、山楂提取物8份、陈皮提取物7份、半夏提取物3份、木香提取物3份、丁香提取物6份、茯苓提取物3份、甘草提取物3份、苍术提取物3份、枳实提取物1份、厚朴提取物3份和白胡椒提取物2份、蜂蜜100份和甘油63份。
7.一种制备权利要求1-6任一项所述的组合物的方法,其特征在于,包括:
(1)将鸡内金提取物、山楂提取物、陈皮提取物、半夏提取物、木香提取物、丁香提取物、茯苓提取物、甘草提取物、苍术提取物、枳实提取物、厚朴提取物和白胡椒提取物混合均匀,获得预混物;
(2)将所述预混物和蜂蜜、甘油混合均匀。
8.权利要求1-6任一项所述的组合物或权利要求7所述的方法制备获得的组合物在制备理气健脾、化湿和胃产品中的应用;优选,所述产品为贴剂,更优选所述贴剂应用于婴幼儿。
9.一种贴剂,其特征在于,包括权利要求1-6任一项所述的组合物或权利要求7所述的方法制备获得的组合物。
10.一种制备权利要求9所述的贴剂的方法,其特征在于,包括将所述组合物复合在无纺布贴表面的步骤;优选,每个无纺布贴上复合有1.8-2.2g所述组合物。
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