CN107281418B - 一种药物组合物及其制备方法和用途 - Google Patents
一种药物组合物及其制备方法和用途 Download PDFInfo
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- CN107281418B CN107281418B CN201710476767.5A CN201710476767A CN107281418B CN 107281418 B CN107281418 B CN 107281418B CN 201710476767 A CN201710476767 A CN 201710476767A CN 107281418 B CN107281418 B CN 107281418B
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Abstract
本发明提供了一种药物组合物,它是由含有下述重量配比的原料制备而成:芡实0.5‑1.5份,山药0.5‑1.5份,莲子0.05‑0.15份,百合0.1‑1份,白芷0.5‑1.5份,佛手0.5‑1.5份,紫苏叶0.1‑1份,薄荷0.1‑1份,淡豆豉0.05‑0.15份,桔梗0.5‑1.5份,薏苡仁0.05‑0.15份,大枣0.1‑1.5份,赤小豆0.005‑0.02份,陈皮0.05‑0.15份,白扁豆0.005‑0.02份,麦芽0.05‑0.15份,化橘红0.05‑0.15份,山楂0.05‑0.15份,桃仁0.05‑0.15份。本发明还提供了该组合物的制备方法和用途。本发明组合物临床缓解或治疗小儿呼吸***疾病、保护脾胃效果明显,应用前景良好。
Description
技术领域
本发明涉及一种药物组合物及其制备方法和用途。
背景技术
随着社会经济的发展,优生优育的观念,儿童健康为人们的关注焦点。呼吸道疾病和消化***疾病为儿童的常见发病趋向。且对于脾胃虚弱的儿童,通常呼吸道的感染会直接引起消化***的问题,如常见的易感儿童出现胃肠型感冒的特点。鼻为呼吸道的第一线,在1项对于西部地区的流行病学调查中发现,变应性鼻炎的发生率占到30%以上,其次针对10年内我国变应性鼻炎的回顾性分析,显示其发病率呈稳定状态。变应性鼻炎是由致敏源引起的免疫***释放炎症因子的***反应性疾病,与小儿哮喘关系密切,早在研究中发现,患有过敏性鼻炎的患儿哮喘的发生率高于其他为患有变应性鼻炎的患儿。再而,随着二胎政策的开放,医疗技术的发展,剖宫产的数量逐年增长,在1项近年黄金美对于剖宫产与患儿过敏性鼻炎及哮喘的流行病学调查中发现,剖宫产与小儿变应性鼻炎和哮喘有关,且有家族过敏史的患儿更为明显。故而患有呼吸道疾病的儿童数量庞大,且容易伴随消化***疾病。
随着社会经济的发展,城市化进程的加快和环境的污染,儿童的过敏性疾病呈逐年增高的趋势,过敏性鼻炎表现为大量清水样涕,喷嚏等,后期迁延可引起慢性鼻-鼻窦炎,鼻息肉等疾病。影响智力发育和身体发育,孩子长期患鼻炎,呼吸阻塞会使大脑缺氧而引起头昏嗜睡、注意力无法集中、学习成绩下降等,对孩子的大脑,包括认知能力、记忆力和心理活动有显着的影响。另外因呼气不畅,孩子会用嘴呼吸,还会直接刺激咽腔导致咽炎,长此以往会使孩子嘴唇变厚,牙齿向外发育,导致面部畸形。而西医对于儿童的变应性鼻炎使用抗组胺、激素和减充血剂等对症处理为主,但长期反复使用会导致鼻甲萎缩,鼻腔干燥等不良反应。中医对于变应性鼻炎及慢性鼻-鼻窦炎治疗效果较佳且无其他副作用。
儿童体质中医认为易虚易实,易寒易热,且年幼无法表达,故称“儿科”为“哑科”,疾病的发生实证则发生迅猛,虚症要监护人细心发现医生仔细查体才能得以诊断,而不能迅速的进行治疗。故而未病先防比发病即治在儿科更为重要。且翻阅西医对于变应性鼻炎及哮喘等呼吸***疾病指南以消除过敏原,对症用药为主。且***反应性疾病反复发作,多为长期服药,儿童给药困难,如雾化等也多不配合,难以有效治疗。
国内市场有针对儿童脾胃虚弱的产品如“肥儿粉”,“健脾膏”,但其仅针对出现脾胃虚弱症状的患儿,不能用于因感染呼吸道疾病,肺气虚弱影响脾胃的患儿,目前尚缺少针对儿童变应性鼻炎,慢性鼻-鼻窦炎进行长期干预的产品。
发明内容
本发明的目的在于提供一种能够缓解或/和治疗小儿呼吸***疾病、兼顾脾胃运化,治疗儿童肺气不通,鼻塞,脾胃虚弱问题的药物组合物及其制备方法和用途。本发明提供了一种药物组合物。
本发明提供了一种药物组合物,它是由含有下述重量配比的原料制备而成:
芡实0.5-1.5份,山药0.5-1.5份,莲子0.05-0.15份,百合0.1-1份,白芷0.5-1.5份,佛手0.5-1.5份,紫苏叶0.1-1份,薄荷0.1-1份,淡豆豉0.05-0.15份,桔梗0.5-1.5份,薏苡仁0.05-0.15份,大枣0.1-1.5份,赤小豆0.005-0.02份,陈皮0.05-0.15份,白扁豆0.005-0.02份,麦芽0.05-0.15份,化橘红0.05-0.15份,山楂0.05-0.15份,桃仁0.05-0.15份。
其中,它是由下述重量配比的原料制备而成:
芡实1份,山药1份,莲子0.1份,百合0.5份,白芷0.5份,佛手0.5份,紫苏叶0.5份,薄荷0.2份,淡豆豉0.1份,桔梗1份,薏苡仁0.1份,大枣0.1份,赤小豆0.01份,陈皮0.1份,白扁豆0.01份,麦芽0.1份,化橘红0.1份,山楂0.1份,桃仁0.1份。
其中,所述山药为淮山药;所述陈皮为炒陈皮;所述麦芽为炒麦芽;所述山楂为焦山楂。
其中,它是由所述原料的原生药粉,或水或有机溶剂提取物为活性成分,加上可接受的辅料或者辅助性成分制备成常用的口服制剂。
其中,所述口服制剂是膏剂、颗粒剂、粉剂、片剂、胶囊剂、口服液。
其中,所述颗粒剂由下述配比的原辅料制备而成:
芡实1份,淮山药1份,莲米0.1份,百合0.5份,白芷0.5份,佛手0.5份,紫苏叶0.5份,薄荷0.2份,淡豆豉0.1份,桔梗1份,薏苡仁0.1份,大枣0.1份,赤小豆0.01份,炒陈皮0.1份,白扁豆0.01份,炒麦芽0.1份,化橘红0.1份,焦山楂0.1份,桃仁0.1份,熟米粉7份,白砂糖2份。
本发明还提供了上述组合物的制备方法,它是将所述原料打粉、或加入水或有机溶剂提取,加入可接受的辅料或辅助性成分制备而成。
其中,它包括如下步骤:
a)取芡实、淮山药、莲米、百合、白芷、佛手、紫苏叶、薄荷、淡豆豉、桔梗、薏苡仁、大枣、赤小豆、炒陈皮、白扁豆、炒麦芽、化橘红、焦山楂、桃仁,混合打粉,过筛后,备用;
b)取大米,烘焙、打粉、过筛后,与步骤a过筛后的原料混合;
c)加入白砂糖或其它可接受的辅料或辅助性成分制备成常用的制剂。
本发明还提供了上述组合物在制备缓解或/和治疗小儿呼吸***疾病、消化***疾病、肺脾两虚的药品中的用途。
本发明还提供了上述组合物在制备缓解或/和治疗小儿鼻炎、鼻-鼻窦炎、反复上呼吸道感染、食欲不振、夜啼夜惊的药品中的用途。
小儿脏气清灵,纯阳之体,易虚易实,易寒易热,先天肾气不足,肺卫失固,后天失于运化,风邪外感,鼻窍不通。对于小儿的鼻部病症改善,应从肺脾肾三方面入手,健脾助运化,固肺抵抗外邪,补肾养先天。芡实甘平以补脾止泻,涩而益肾固精,药性平和,归脾肾两经。《素问.刺法论》曰:欲令脾实…宜甘宜淡。山药甘平,《神农本草经》卷1谓其“主伤中,补虚羸…补中益气力,长肌肉,久服耳目聪明”,为平补脾胃之品,两药共为君药,白芷辛温解表,宣通鼻窍。佛手辛行温通,行气化湿,薄荷通窍醒神,紫苏叶温通经脉,助阳化气,合用以芳香行气,温通固肺,通利鼻窍,共为臣药。《冯氏锦囊秘录》卷5“桔梗入肺,能升能降。所以通天气于地道,而无痞塞之忧也”桔梗宣开肺气,通利水道,载诸药上行而成培土生金之工,为佐药。莲子肉甘平而涩,长于补脾厚肠胃,涩肠止泻,山楂、麦芽消食化积,合用能健脾开胃,增进食欲。扁豆甘平补中,健脾化湿,薏仁甘淡微寒,健脾利湿,陈皮、化橘红辛温苦降之性更增本方行气健脾,燥湿和胃之效。诸药合用,既能通窍行气温阳肺,又能健脾消积和胃祛湿,补益肾气。从而标本兼治改善小儿鼻部疾患。
本发明提供的组合物可以同时改善儿童呼吸***疾病如变应性鼻炎、慢性鼻-鼻窦炎、鼻塞等,反复感冒、哮喘等,兼顾脾胃运化,治疗儿童肺气不通,脾胃虚弱的问题,恢复脾胃功能,对患儿夜啼夜惊症状也有效果,填补了市场空白。本发明为药食同源中药材组成,临床应用效果明显,无其他添加剂,安全可靠,可长期服用,而且符合儿童传统饮食习惯,口感好,小儿接受度高,本发明还具有生产工艺简单、成本低、便于携带等优点。
具体实施方式
下面以实施例作进一步说明,但本发明不局限于这些实施例。
实施例1本发明组合物的制备
处方内容:芡实1g,淮山药1g,莲子0.1g,百合0.5g,白芷0.5g,佛手0.5g,紫苏叶0.5g,薄荷0.2g,淡豆豉0.1g,桔梗1g,薏苡仁0.1g,大枣0.1g,赤小豆0.01g,炒陈皮0.1g,白扁豆0.01g,炒麦芽0.1g,化橘红0.1g,焦山楂0.1g,桃仁0.1g。
工艺:
1、按处方称取药材平铺于烤箱,先行预热烤箱,用120摄氏度恒温烤制30min,每隔10min翻动1次,保证药材烤制均匀,至药材表面微焦黄后取出。
2、将烤好后的药材取出后晾至常温,打粉,并过100目筛。
3、大米低温烘焙后打粉,过100目筛,按比例(加入7g)与药粉混合。
4、过筛后药粉与熟米粉混合再放入烘箱60-65度进行烘干,避免药粉或熟米粉结块。
5、添加辅料白砂糖:将白砂糖用打粉机打碎后过100目筛,按2g/日剂量与药粉及米粉一同添加。
临床:1日1次,1次15~30克,用沸水冲开调至糊状服用。可长期服用,最短疗程为15天。
实施例2本发明组合物的制备
处方:芡实0.5g,山药0.5g,莲子0.05g,百合0.1g,白芷0.5g,佛手0.5g,紫苏叶0.1g,薄荷0.1g,淡豆豉0.05g,桔梗0.5g,薏苡仁0.05g,大枣0.1g,赤小豆0.005g,陈皮0.05g,白扁豆0.005g份,麦芽0.05g,化橘红0.05g,山楂0.15g,桃仁0.15g。
制备工艺:同实施例1的制备工艺。
实施例3本发明组合物的制备
处方:芡实1.5g,山药1.5g,莲子0.15g,百合1g,白芷1.5g,佛手1.5g,紫苏叶1g,薄荷1g,淡豆豉0.15g,桔梗1.5g,薏苡仁0.15g,大枣1.5g,赤小豆0.02g,陈皮0.15g,白扁豆0.02g,麦芽0.15g,化橘红0.15g,山楂0.05g,桃仁0.05g。
制备工艺:同实施例1的制备工艺。
实施例4本发明组合物的制备
处方:同实施例1的处方。
制备工艺:按处方称取各原料药,粉碎,过筛,加入熟米粉7g,白砂糖2g,混合均匀,分装,即得。
以下通过试验例具体说明本发明的有益效果。
试验例1本发明药物组合物的临床观察
1、一般资料
59例,均为成都中医药大学附属医院儿科门诊及住院患儿,且符合1987年全国小呼吸道会议制定的诊断标准。
诊断标准:
①0~2岁反复上呼吸道感染每年/7次;
②3~5岁反复上呼吸道感染每年/6次;
③6~14岁反复上呼吸道感染每年/5次。
反复上呼吸道感染的概念:反复上呼吸道感染多是病毒感染所致,它是上呼吸道反复发作的一种炎症反应,临床症状以反复发热、流鼻涕、打喷噴、咳嗽、咽红、扁桃体肿大等为主要表现。
对照组29例,脱落1例。男13例,女14;年龄6个月~10岁,平均4.8岁,每年发作次数为5~13次。治疗组30例,男16例,女14,年龄7个月~10岁,平均5.2岁,每年发作次数为6~13次。两组病程均为0.4~2年。两组患儿在性别、年龄及病程方面差异无统计学意义(P<0.05),具有可比性。
2、治疗方法
对照组:对症治疗(如退热处理、止咳化痰、补液等治疗,在有细菌感染的情况下,可给与抗生素治疗。注:常规抗生素的使用对本病的病程并无影响《儿科学》)。
治疗组在常规治疗下给予小儿健脾固肺营养羹(即本发明实施例1方法制备的组合物)每次1包,每日1次,用开水冲服,连续服用3月。
3、疗效标准
显效:服药3个月疗程结束后半年内,发作次数较治疗前减少2/3以上,发作时症状明显减轻,疗程明显缩短。
有效:服药3个月疗程结束后半年内发病次数较前减少1/2以上,发病时症状减轻,疗程缩短。
无效:治疗后发病次数减少不足1/2,发病时症状及疗程均无明显改善。
总有效率为显效+有效。
4、结果
表1治疗组与对照组的治疗结果比较
由表1可见,使用本发明药物组合物的治疗组对儿童反复呼吸道感染的总有效率高达86.7%,显著优于对照组的55.5%,说明本发明药物组合物对儿童反复呼吸道感染具有优良的治疗效果。
试验例2本发明药物组合物的感官评价
一、添加不同糖分的口感比较
该产品为儿童产品,不建议使用添加剂,且本发明实施例1制备的组合物为粉剂,不适宜用麦芽糖及蜂蜜矫味,对不同种类的糖进行添加比较。分别一日处方量中添加白糖2g、红糖2g、冰糖2g进行口感对比,结果见表2。
表2添加不同糖分的产品口感
可见,添加不同种类的糖对本发明组合物的口感影响较大,其中,使用白糖2g时,开水冲调后气味焦香,呈深褐色糊状,口感细腻,清香自然,甘甜稍有回苦,与芝麻糊相似,口感佳;而添加其它糖类时均不佳,例如添加红糖,口感苦;添加冰糖时,微苦,口感稍黏腻。
二、添加不同用量白糖的口感比较
该产品为儿童产品,不建议使用添加剂,加入白糖进行矫味,同时对白糖的添加量进行优化。分别一日处方中加入0.5g、1g、1.5g、2g、2.5g白糖对其原有苦味和现有甜度进行对比,结果见表3。
表3添加不同量白糖的产品口感
可见,白糖用量不同,对本发明组合物的口感均有影响,其中,使用白糖2g时,苦味消失,甜度适宜,口感最佳。
因此,本发明组合物口感佳,适于儿童食用。
综上,本发明组合物配伍合理,可以用于缓解儿童呼吸***疾病引起的各种症状,尤其对儿童反复呼吸道感染的疗效显著,临床治愈率高;而且本发明组合物安全性好,口感佳,小儿接受度高,为临床提供了一种新的药物选择。
Claims (6)
1.一种缓解或/和治疗小儿呼吸***疾病的药物组合物,其特征在于:它是由原料药芡实、山药、莲子、百合、白芷、佛手、紫苏叶、薄荷、淡豆豉、桔梗、薏苡仁、大枣、赤小豆、陈皮、白扁豆、麦芽、化橘红、山楂、桃仁的原生药粉,或水或有机溶剂提取物为活性成分,加上可接受的辅料或者辅助性成分制备成常用的口服制剂;
所述辅料或者辅助性成分为熟米粉和白砂糖;
所述原辅料的重量配比为:芡实1份,山药1份,莲子0.1份,百合0.5份,白芷0.5份,佛手0.5份,紫苏叶0.5份,薄荷0.2份,淡豆豉0.1份,桔梗1份,薏苡仁0.1份,大枣0.1份,赤小豆0.01份,陈皮0.1份,白扁豆0.01份,麦芽0.1份,化橘红0.1份,山楂0.1份,桃仁0.1份,熟米粉7份,白砂糖2份;
所述山药为淮山药;所述陈皮为炒陈皮;所述麦芽为炒麦芽;所述山楂为焦山楂。
2.根据权利要求1所述的组合物,其特征在于:所述口服制剂是膏剂、颗粒剂、粉剂、片剂、胶囊剂、口服液。
3.权利要求1或2所述组合物的制备方法,其特征在于:它是将所述原料打粉、或加入水或有机溶剂提取,加入可接受的辅料或辅助性成分制备而成。
4.根据权利要求3所述组合物的制备方法,其特征在于:它包括如下步骤:
a)取芡实、淮山药、莲子、百合、白芷、佛手、紫苏叶、薄荷、淡豆豉、桔梗、薏苡仁、大枣、赤小豆、炒陈皮、白扁豆、炒麦芽、化橘红、焦山楂、桃仁,混合打粉,过筛后,备用;
b)取大米,烘焙、打粉、过筛后,与步骤a过筛后的原料混合;
c)加入白砂糖或其它可接受的辅料或辅助性成分制备成常用的制剂。
5.权利要求1或2所述组合物在制备缓解或/和治疗小儿呼吸***疾病、消化***疾病、肺脾两虚的药品中的用途。
6.权利要求1或2所述组合物在制备缓解或/和治疗小儿反复上呼吸道感染的药品中的用途。
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