CN107737288B - 一种治疗过敏性哮喘的中药组合物及其制备方法 - Google Patents
一种治疗过敏性哮喘的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明涉及中医药领域，具体是一种治疗过敏性哮喘的中药组合物及其制备方法。所述中药组合物由以下重量份的原料组成：麻黄5~15份、杏仁5~15份、白萝卜10~25份、牛蒡子10~25份、白茅根10~25份、太子参5~15份、甘草10~15份、百部5~15份、灵芝5~15份、紫苏叶5~15份、土茯苓5~15份、半夏5~15份。本发明通过以上多种中药的合理配伍，有效的发挥了麻黄等的药用效果，工艺简单，适用范围广，无毒副作用。
Description
技术领域
本发明涉及中医药领域，具体是一种治疗过敏性哮喘的中药组合物及其制备方法。
背景技术。
哮喘是一种常见病、多发病，对人类健康造成了很多不利影响。目前全球哮喘患者约3亿人，我国哮喘患者约3000万，每年有近20万人死于哮喘。当前哮喘治疗一般使用糖皮质激素来控制气道的慢性炎症。然而，激素类药物只能减轻症状，无法针对哮喘的根本原因进行治疗，并且长期使用副作用较大。过敏性哮喘的发病机制复杂，是一种由嗜酸性粒细胞、T淋巴细胞等炎症细胞、肥大细胞、气道上皮细胞参与的气道慢性过敏反应炎症性疾病。现代社会带来的生活方式及环境上的变化，使得过敏性哮喘疾病有逐年增加的趋势。这不仅给日常生活带来诸多不便、造成精神痛苦、降低生活质量，而且持续时间长，有的成为难治之症，亦有导致死亡者。
麻黄为麻黄科植物草麻黄（Ephedra sinicaStapf）、中麻黄（Ephedra intermediaSchrenketC.A.Mey.）或木贼麻黄(Ephedra equisetinaBge.)的干燥草质茎。在我国主要分布于辽宁、内蒙古等省区，生长在丘陵山地、沙丘、干草原、荒滩等干燥地区。《神农本草经》中收载麻黄，其“主中风，伤寒头痛，温疟，发表出汗，去邪热气，止咳逆上气，除寒热，破症坚积聚。”麻黄在我国有悠久的药用历史，历代医家均作为发汗解表、宣肺平喘，利水消肿的药物使用。近年来，随着对麻黄的研究不断深入，有关麻黄非生物碱类成分的药理作用报道亦不断增多。这为进一步开发、利用麻黄资源提供了新的思路。前期研究中我们发现草麻黄中的非生物碱类成分草质素具有较强的激动GPR35受体的活性。目前GPR35 受体被认为是哮喘治疗的新靶标。
目前，以麻黄为味药的中药方剂并非针对过敏性疾病的治疗，而且多以麻黄汤、小青龙汤等汤剂比较常见，口服味道苦；而治疗哮喘的药物多以西药为主，副作用较大；研究表明麻黄中的非生物碱组分具有抑制卵白蛋白致敏大鼠过敏反应的作用，结合麻黄的抗过敏性作用，开发出治疗哮喘的药物，从而改善患者的生活质量具有重要的意义。
发明内容
本发明的目的在于提供一种用于治疗过敏性哮喘的中药组合物及其制备方法。
本发明的目的通过如下技术方案实现：
一种治疗过敏性哮喘的中药组合物，由以下重量份的原料组成：麻黄5~15份、杏仁5~15份、白萝卜10~25份、牛蒡子10~25份、白茅根10~25份、太子参5~15份、甘草10~15份、百部5~15份、灵芝5~15份、紫苏叶5~15份、土茯苓5~15份、半夏5~15份。
进一步地，上述治疗过敏性哮喘的中药组合物，包括以下重量份的原料：麻黄7~15份、杏仁7~15份、白萝卜10~20份、牛蒡子10~20份、白茅根10~20份、太子参7~15份、甘草10~15份、百部10~15份、灵芝7~15份、紫苏叶7~15份、土茯苓7~15份、半夏7~15份。
上述治疗过敏性哮喘的中药组合物的剂型为任意一种药学上可接受的剂型。
优选地，上述治疗过敏性哮喘的中药组合物的剂型为颗粒剂。
上述治疗过敏性哮喘的中药组合物的制备方法，包括以下步骤：
(1)按配比将麻黄、杏仁、白萝卜、牛蒡子、白茅根、太子参、甘草、百部、灵芝、紫苏叶、土茯苓、半夏漂洗后晾干，得到原料混合物；
(2)将步骤(1)中得到的原料混合物加水煎煮3次，每次煎煮2h，合并煎煮液，过滤，得到滤液；
(3)将步骤(2)中得到的滤液减压浓缩至稠膏状后干燥，得到提取物；
(4)在步骤(3)得到的提取物中加入辅料混合均匀，用摇摆式制粒机制粒，即得治疗过敏性哮喘的颗粒剂。
进一步地，上述治疗过敏性哮喘的中药组合物的制备方法，步骤(2)中煎煮时第一次加入原料混合物5倍质量的水，第二次加入原料混合物5倍质量的水，第三次加入原料混合物10倍质量的水。
进一步地，上述治疗过敏性哮喘的中药组合物的制备方法，步骤(3)中滤液浓缩时浓缩至比重为1.0~1.1或浓缩到滤液总质量的25~30%。
进一步地，上述治疗过敏性哮喘的中药组合物的制备方法，步骤(3)中干燥是喷雾干燥，喷雾干燥的进口温度为130~160℃，出口温度为95~105℃。
进一步地，上述治疗过敏性哮喘的中药组合物的制备方法，步骤(4)中所加辅料的量为提取物质量的1.5~2.0倍；所加辅料是果糖、可溶性淀粉与糊精按照质量比2:1:3的混合物。
进一步地，上述治疗过敏性哮喘的中药组合物的制备方法，步骤(4)使用摇摆式制粒机制粒时加入润滑剂十二烷基硫酸镁，且加入的量是提取物与辅料总质量的1.5%~2%。
本发明中，各中药原料药材的功效如下：
麻黄：发汗，平喘，利水。治伤寒表实，发热恶寒无汗，头痛鼻塞，骨节疼痛，咳嗽气喘。
杏仁：祛痰止咳，平喘，润肠。治外感咳嗽，喘满，喉痹。肠燥便秘。
白萝卜：下气消食，除痰润肺，解毒生津，和中止咳，利大小便。
牛蒡子：辛、苦，寒。归肺、胃经。功效与主治疏散风热，宣肺透疹，解毒利咽。用于风热感冒，咳嗽痰多，麻疹，风疹，咽喉肿痛，痒腮丹毒，痈肿疮毒。
白茅根：甘，寒。归肺、胃、膀肤经。功效与主治凉血止血，清热利尿。用于血热吐血，蛆血，尿血，热病烦渴，黄疽，水肿，热淋涩痛急性肾炎水肿。
太子参：甘、微苦，平。归脾、肺经。功效与主治益气健脾，生津润肺。用于脾虚体倦，食欲不振，病后虚弱，气阴不足，自汗口渴，肺燥干咳。
甘草：味甘；性平。归心、肺、脾、胃经。具有清热解毒、止咳祛痰、补脾和胃、调和诸药的功效。
百部：甘、苦，微温。归肺经。功效与主治润肺下气止咳，杀虫。用于新久咳嗽，肺瘩咳嗽，百日咳外用于头虱，体虱，烧虫病，阴痒。蜜百部润肺止咳。用于阴虚劳嗽。
灵芝：甘，平。归心、肺、肝、肾经。主治虚劳、咳嗽、气喘、失眠、消化不良，恶性肿瘤等。
紫苏叶：辛、微温，无毒。发表，散寒，理气，和营。治感冒风寒，恶寒发热，咳嗽，头痛无汗，气喘，胸腹胀满，呕恶腹泻，咽中梗阻，妊娠恶阻，胎动不安。
土茯苓：甘、淡，平。归肝、胃经。功效与主治除湿，解毒，通利关节。用于湿热淋浊，带下，痈肿，凛病，疥癣，梅毒及汞中毒所致的肢体拘挛，筋骨疼痛。
半夏：味辛、性温，归脾、胃、肺经燥湿化痰、降逆止呕、消痞散结化痰止咳、降逆止呕，对肺气肿、咳喘和百日咳等疾病都有显著治疗效果。
与现有技术相比，本发明有如下有益效果：
1.本发明所用主药麻黄发汗解表、宣肺平喘，杏仁助麻黄止咳平喘之功。牛蒡子辛苦寒，宣肺利咽、半夏辛温燥湿化痰止咳、白萝卜润肺化痰、和中止咳，三药在祛痰的同时增加止咳之力。苏叶理气止咳平喘、百部润肺下气止咳。太子参生津润肺且益气健脾、灵芝止咳平喘且补虚劳，白茅根甘寒入肺清肺胃之热，土茯苓，本草纲目曰其“健脾胃，去风湿”。诸药合用共奏止咳平喘、宣肺化痰、清热润肺、健脾补虚之效。本发明通过以上多种中药的合理配伍，有效的发挥了麻黄等的药用效果，工艺简单，适用范围广，无毒副作用。
2.中医认为，过敏究其根本乃“因虚致敏”，肺脾肾不虚则过敏自愈，所以治疗过敏性哮喘应以益肺健脾补肾为主。本发明将以上药物组合后，药效具有协同作用，起到开宣肺气、祛痰排脓、温中散寒、健脾补肾的作用，在消除临床症状的同时，纠正哮喘病人的过敏性体质，达到标本兼治，且无明显毒副作用。
3.本发明制成颗粒剂形式，中药煎提充分，携带使用方便。
具体实施方式
以下结合具体实施例对本发明做进一步说明。
实施例1
一种治疗过敏性哮喘的麻黄颗粒剂，包括以下重量份的原料组分：以重量g计，麻黄5、杏仁8、白萝卜12、牛蒡子12、白茅根12、太子参8、甘草8、百部8、灵芝8、紫苏叶8、土茯苓10、半夏8。
上述治疗过敏性哮喘的麻黄颗粒剂的制备方法，包括以下步骤：
（1）按配比称取麻黄5、杏仁8、白萝卜12、牛蒡子12、白茅根12、太子参8、甘草8、百部8、灵芝8、紫苏叶8、土茯苓10、半夏8组合物漂洗后晾干，得到原料混合物；
（2）将步骤（1）中得到的原料混合物加水煎煮3次，第一次加5倍质量的水，第二次加5倍质量的水，第三次加10倍质量的水，每次煎煮2h，合并煎煮液，过滤，得到滤液；
（3）滤液减压浓缩至比重1.0的稠膏状，喷雾干燥，进口温度为130℃，出口温度为95℃，得提取物，
（4）在提取物中加入乳糖24g、可溶性淀粉12g、糊精36g，混合均匀；取1g十二烷基硫酸镁润滑，之后用摇摆式制粒机制粒，即得治疗过敏性哮喘的麻黄颗粒剂。
实施例2
一种治疗过敏性哮喘的麻黄颗粒剂，以重量g计，麻黄7、杏仁10、白萝卜14、牛蒡子14、白茅根14、太子参10、甘草10、百部10、灵芝9、紫苏叶10、土茯苓10、半夏10。
上述治疗过敏性哮喘的麻黄颗粒剂的制备方法，包括以下步骤：
（1）按配比称取麻黄7、杏仁10、白萝卜14、牛蒡子14、白茅根14、太子参10、甘草10、百部10、灵芝9、紫苏叶10、土茯苓10、半夏10组合物漂洗后晾干，得到原料混合物；
（2）将步骤（1）中得到的原料混合物加水煎煮3次，第一次加5倍质量的水，第二次加5倍质量的水，第三次加10倍质量的水，每次煎煮2h，合并煎煮液，过滤，得到滤液；
（3）滤液减压浓缩至浓缩至比重为1.1的稠膏状，喷雾干燥，进口温度为160℃，出口温度为105℃，得提取物，
（4）在提取物中加入乳糖32g、可溶性淀粉16g、糊精48g，混合均匀；加入2g的十二烷基硫酸镁润滑，之后用摇摆式制粒机制粒，即得治疗过敏性哮喘的麻黄颗粒剂。
实施例3
一种治疗过敏性哮喘的麻黄颗粒剂，以重量g计，麻黄15、杏仁12、白萝卜18、牛蒡子16、白茅根17、太子参11、甘草14、百部12、灵芝10、紫苏叶13、土茯苓12、半夏11。
上述治疗过敏性哮喘的麻黄颗粒剂的制备方法，包括以下步骤：
（1）按配比称取麻黄15、杏仁12、白萝卜18、牛蒡子16、白茅根17、太子参11、甘草14、百部12、灵芝10、紫苏叶13、土茯苓12、半夏11组合物漂洗后晾干，得到原料混合物；
（2）将步骤（1）中得到的原料混合物加水煎煮3次，第一次加5倍质量的水，第二次加5倍质量的水，第三次加10倍质量的水，每次煎煮2h，合并煎煮液，过滤，得到滤液；
（3）滤液减压浓缩至浓缩至比重为1.1的稠膏状，喷雾干燥，进口温度为160℃，出口温度为105℃，得提取物，
（4）在提取物中加入乳糖38g、可溶性淀粉19g、糊精57g，混合均匀；加入3g的十二烷基硫酸镁润滑，之后用摇摆式制粒机制粒，即得治疗过敏性哮喘的麻黄颗粒剂。
动物毒性试验：
1.取实验小鼠60只，雌雄各半，体重150~190g，分别分为3组，每组各20只，每组小鼠体征良好，体重等生理表现无异常，具有可比性。
2.给两组小鼠分别使用本发明实施例1和2和3制备的治疗过敏性哮喘的麻黄颗粒剂溶解后灌胃给药，每天三次，连续服用一个月，在实验期间观察并记录所有小鼠的体征情况。
3.实验过程中所有小鼠的体征表现无异常，实验结束后未出现小鼠死亡情况，对每组小鼠中随机抽取5只进行解剖检查，主要器官均未发现异常，由实验结果可知，本发明的治疗过敏性哮喘的麻黄颗粒剂无明显毒性，可安全服药。
下面是本发明药物对于过敏性哮喘状态的调理改善临床观察统计资料：
1.病例选取：临床上选取确诊的过敏性疾病患者90例，年龄20~65岁，男性20例，女性70例，分为三组实验组，每组30例。
2.实验方法：给实验组分别使用本发明实施例1、实施例2、实施例3制备的颗粒剂，每日三次，每次10g，连续服药一个月，观察并记录患者的恢复情况。
3.疗效判定标准：
显效：过敏性哮喘临床症状消失，各项体征恢复正常，半年内未见复发；
有效：过敏性哮喘临床症状改善，患者相较服药之前各体征表现明显好转；
无效：病情无任何改善或加重。
4.实验数据统计：
5.实验结果：由以上实验数据可以看出，本发明制备的治疗过敏性哮喘的麻黄颗粒剂对于过敏性疾病的治疗的平均总有效率为95.6%，且90例患者未见任何不良反应，因此说明，本发明的治疗过敏性哮喘的麻黄颗粒剂是治疗过敏性疾病的安全有效药物，具有很好的临床推广意义。
Claims (9)
1.一种治疗过敏性哮喘的中药组合物，其特征在于，由以下重量份的原料药组成：麻黄5～15份、杏仁5～15份、白萝卜10～25份、牛蒡子10～25份、白茅根10～25份、太子参5～15份、甘草10～15份、百部5～15份、灵芝5～15份、紫苏叶5～15份、土茯苓5～15份、半夏5～15份。
2.如权利要求1所述的一种治疗过敏性哮喘的中药组合物，其特征在于，包括以下重量份的原料药：麻黄7～15份、杏仁7～15份、白萝卜10～20份、牛蒡子10～20份、白茅根10～20份、太子参7～15份、甘草10～15份、百部10～15份、灵芝7～15份、紫苏叶7～15份、土茯苓7～15份、半夏7～15份。
3.如权利要求1或2所述的一种治疗过敏性哮喘的中药组合物，其特征在于，所述中药组合物的剂型为任意一种药学上可接受的剂型。
4.如权利要求1或2所述的治疗过敏性哮喘的中药组合物的制备方法，其特征在于，包括以下步骤：
(1)按配比将麻黄、杏仁、白萝卜、牛蒡子、白茅根、太子参、甘草、百部、灵芝、紫苏叶、土茯苓、半夏漂洗后晾干，得到原料混合物；
(2)将步骤(1)中得到的原料混合物加水煎煮3次，每次煎煮2h，合并煎煮液，过滤，得到滤液；
(3)将步骤(2)中得到的滤液减压浓缩至稠膏状后干燥，得到提取物；
(4)在步骤(3)得到的提取物中加入辅料混合均匀，用摇摆式制粒机制粒，即得治疗过敏性哮喘的颗粒剂。
5.如权利要求4所述的治疗过敏性哮喘的中药组合物的制备方法，其特征在于，步骤(2)中煎煮时第一次加入原料混合物5倍质量的水，第二次加入原料混合物5倍质量的水，第三次加入原料混合物10倍质量的水。
6.如权利要求4所述的治疗过敏性哮喘的中药组合物的制备方法，其特征在于，步骤(3)中滤液浓缩时浓缩至比重为1.0～1.1或浓缩到滤液总质量的25～30％。
7.如权利要求4所述的治疗过敏性哮喘的中药组合物的制备方法，其特征在于，步骤(3)中干燥是喷雾干燥，喷雾干燥的进口温度为130～160℃，出口温度为95～105℃。
8.如权利要求4所述的治疗过敏性哮喘的中药组合物的制备方法，其特征在于，步骤(4)中所加辅料的量为提取物质量的1.5～2.0倍；所加辅料是果糖、可溶性淀粉与糊精按照质量比2:1:3的混合物。
9.如权利要求4所述的治疗过敏性哮喘的中药组合物的制备方法，其特征在于，步骤(4)使用摇摆式制粒机制粒时加入润滑剂十二烷基硫酸镁，且加入的量是提取物与辅料总质量的1.5％～2％。
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