CN115089670B - 一种治疗伤风咳嗽的药物及其制备工艺 - Google Patents
一种治疗伤风咳嗽的药物及其制备工艺 Download PDFInfo
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Abstract
本发明公开了一种治疗伤风咳嗽的药物及其制备工艺,属于中药及中药制剂技术领域。所述治疗伤风咳嗽的药物,原料按质量份数计,包括:麻黄10~15份、款冬花8~12份、桑白皮20~25份、川贝母20~25份、薏苡仁30~40份、党参13~16份、桑叶6~10份和甘草20~30份。本发明通过合理调配各味中药,使所述治疗伤风咳嗽药物的药方散寒而不助热,解表而不伤正,对于伤风咳嗽,不管是寒咳还是热咳都有非常好的效果。同时,所述治疗伤风咳嗽药物的制备工艺简单,仅通过水提取,即可得到各药物中的有效成分,无需其他昂贵溶剂,大大降低了生产成本,推广价值高。
Description
技术领域
本发明涉及中药及中药制剂技术领域,特别涉及一种治疗伤风咳嗽的药物及其制备工艺。
背景技术
伤风咳嗽是由外感风邪引起的咳嗽。风邪善动不居,具有轻扬、升发、向上、向外的特性,故为阳邪,伤于风者,上先受之。因风性开泄,凡寒、湿、暑、燥、热诸邪,常依附于风而侵犯人体,从而形成外感风寒、风湿、风热、风燥等证。
伤风咳嗽分风寒咳嗽和风热咳嗽,风寒咳嗽是由机体感受风寒、肺气失宣所致的咳嗽;风热咳嗽由机体感受风热之邪,肺失清肃所致的咳嗽。
现有的治疗伤风咳嗽的中药组方,多为分症治疗,或针对风热咳嗽,或针对风寒咳嗽。因而提供一种适应性更广,疗效上佳的治疗伤风咳嗽的药物,是本领域亟待解决的技术问题。
发明内容
本发明的目的在于提供一种治疗伤风咳嗽的药物及其制备工艺。通过合理调配各味中药,使所述治疗伤风咳嗽药物的药方散寒而不助热,解表而不伤正,对于伤风咳嗽,不管是寒咳还是热咳都有非常好的效果。
为实现上述目的,本发明提供了如下技术方案:
本发明技术方案之一:提供一种治疗伤风咳嗽的药物,原料按质量份数计,包括:麻黄10~15份、款冬花8~12份、桑白皮20~25份、川贝母20~25份、薏苡仁30~40份、党参13~16份、桑叶6~10份和甘草20~30份。
优选地,所述治疗伤风咳嗽的药物原料按质量份数计,包括:麻黄12份、款冬花12份、桑白皮25份、川贝母23份、薏苡仁35份、党参14份、桑叶8份和甘草25份。
本发明技术方案之二:提供一种上述治疗伤风咳嗽的药物的制备方法,包括以下步骤:先将麻黄、款冬花、桑白皮、川贝母、薏苡仁、党参、桑叶和甘草加水浸泡,然后进行回流提取,分离提取液,重复回流提取的步骤,合并提取液,浓缩,即得治疗伤风咳嗽的药物。
优选地,所述加水浸泡的加水质量为所有药材质量总和的8~12 倍,浸泡时间为1~1.5h。
优选地,所述回流提取为采用冷凝回流提取,提取温度为 90~100℃,时间为1.5~2h。
优选地,所述浓缩为将所述提取液浓缩至相对密度为1.05~1.1。
本发明技术方案之三:提供一种治疗伤风咳嗽的糖浆剂的制备方法,包括以下步骤:将根据上述治疗伤风咳嗽的药物的制备方法制得的治疗伤风咳嗽的药物与单糖浆混合均匀,加水调节相对密度至 1.15~1.20,即得治疗伤风咳嗽的糖浆剂。
优选地,所述治疗伤风咳嗽的药物与所述单糖浆的质量比为 (1~2):(16~17)。
优选地,所述单糖浆为质量分数为85%的蔗糖水溶液。
本发明技术方案之四:提供一种根据上述治疗伤风咳嗽的糖浆剂的制备方法制得的治疗伤风咳嗽的糖浆剂。
本发明所用中药材如下:
麻黄,味辛、微苦,性温;归肺经、膀胱经;有发汗解表,宣肺平喘,利水消肿之功效。
款冬花,味辛、微甘,性温;归肺经;有润肺下气,化痰止咳之功效。
桑白皮,味甘、辛,性寒;归肺、脾经;有泻肺平喘,利水消肿之功效。
川贝母,味苦、甘,性微寒;归肺、心经;有清热润肺,化痰止咳,散结消痈之功效。
薏苡仁,味甘、性微寒;归脾、胃、肺经;有利水消肿、健脾祛湿、清热排脓、抗炎镇痛之功效。
党参,味甘,性平;归脾、肺经;有补中,益气,生津之功效。
桑叶,味苦、甘,性寒;归肺、肝经;有疏散风热,清肺润燥,平肝明目,凉血止血之功效。
甘草,味甘,性平;归心、肺、脾、胃经;有补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药之功效。
肺主气,气得温则宣和,得寒则否涩,虚则气不足而为寒所迫,并聚上肺间,不得宣发,故令咳而短气也;本方中川贝母降利肺气,通腑降痰,党参补肺气。肺金本清,虚则问,甘苦清之;本方以桑白皮清肺热、止咳平喘,川贝母润心肺、化痰。针对风寒咳嗽,本方以款冬花润肺散寒、平喘止咳,薏苡仁补肺健脾、袪风排湿。针对风热咳嗽,本方以麻黄发汗解表、宣肺止咳,桑叶疏散风热、清肺润燥。本方中的甘草能够调和诸药,和解药方。麻黄、款冬花、桑白皮、川贝母、薏苡仁、党参、桑叶、甘草诸药合用,共奏宣肺将气,祛痰止咳之功。
本发明的有益技术效果如下:
本发明提供了一种治疗伤风咳嗽的药物,组方包括麻黄、款冬花、桑白皮、川贝母、薏苡仁、党参、桑叶和甘草,通过合理配伍,使得该中药复方散寒而不助热,解表而不伤正,所述治疗伤风咳嗽的药物既能治疗风热咳嗽又能治疗风寒咳嗽。
本发明提供的治疗伤风咳嗽的药物的制备工艺简单,仅通过水提取,即可得到各药物中的有效成分,无需其他昂贵溶剂,大大降低了生产成本。
本发明还提供了将所述治疗伤风咳嗽的药物制备成糖浆剂的制备工艺,将该治疗伤风咳嗽的药物制成糖浆剂,能够有效改善药物口感,使患者易于接受,推广价值高。
具体实施方式
现详细说明本发明的多种示例性实施方式,该详细说明不应认为是对本发明的限制,而应理解为是对本发明的某些方面、特性和实施方案的更详细的描述。应理解本发明中所述的术语仅仅是为描述特别的实施方式,并非用于限制本发明。
另外,对于本发明中的数值范围,应理解为还具体公开了该范围的上限和下限之间的每个中间值。在任何陈述值或陈述范围内的中间值,以及任何其他陈述值或在所述范围内的中间值之间的每个较小的范围也包括在本发明内。这些较小范围的上限和下限可独立地包括或排除在范围内。
除非另有说明,否则本文使用的所有技术和科学术语具有本发明所述领域的常规技术人员通常理解的相同含义。虽然本发明仅描述了优选的方法和材料,但是在本发明的实施或测试中也可以使用与本文所述相似或等同的任何方法和材料。
关于本文中所使用的“包含”、“包括”、“具有”、“含有”等等,均为开放性的用语,即意指包含但不限于。
实施例1
治疗伤风咳嗽的糖浆剂制备:
(1)将麻黄12份、款冬花12份、桑白皮25份、川贝母23份、薏苡仁35份、党参14份、桑叶8份和甘草25份加入到提取罐中,再加入各中药质量之和10倍量的纯化水,常温下浸泡1h;然后加热至100℃,冷凝回流提取1.5h,过滤;滤渣放入提取罐,加入浸泡时 60%质量的水,加热至100℃,冷凝回流提取1.5h,过滤,合并滤液,减压浓缩至滤液相对密度为1.1(20℃),即得治疗伤风咳嗽的药物;
(2)取步骤(1)制备的治疗伤风咳嗽的药物1份,加入16份质量分数为85%的蔗糖水溶液,搅拌均匀,然后利用新沸过的冷水将混合物的相对密度调节至1.18(20℃),制得治疗伤风咳嗽的糖浆剂。
实施例2
治疗伤风咳嗽的糖浆剂制备:
(1)将麻黄10份、款冬花8份、桑白皮25份、川贝母20份、薏苡仁30份、党参16份、桑叶10份和甘草20份加入到提取罐中,再加入各中药质量之和8倍量的纯化水,常温下浸泡1.5h;然后加热至100℃,冷凝回流提取1.5h,过滤;滤渣放入提取罐,加入浸泡时 60%质量的水,加热至100℃,冷凝回流提取1.5h,过滤,合并滤液,减压浓缩至滤液相对密度为1.05(20℃),即得治疗伤风咳嗽的药物;
(2)取步骤(1)制备的治疗伤风咳嗽的药物2份,加入17份质量分数为85%的蔗糖水溶液,搅拌均匀,然后利用新沸过的冷水将混合物的相对密度调节至1.15(20℃),制得治疗伤风咳嗽的糖浆剂。
实施例3
治疗伤风咳嗽的糖浆剂制备:
(1)将麻黄15份、款冬花12份、桑白皮20份、川贝母25份、薏苡仁40份、党参13份、桑叶6份和甘草30份加入到提取罐中,再加入各中药质量之和12倍量的纯化水,常温下浸泡1h;然后加热至90℃,冷凝回流提取2h,过滤;滤渣放入提取罐,加入浸泡时60%质量的水,加热至90℃,冷凝回流提取2h,过滤,合并滤液,减压浓缩至滤液相对密度为1.08(20℃),即得治疗伤风咳嗽的药物;
(2)取步骤(1)制备的治疗伤风咳嗽的药物1份,加入17份质量分数为85%的蔗糖水溶液,搅拌均匀,然后利用新沸过的冷水将混合物的相对密度调节至1.20(20℃),制得治疗伤风咳嗽的糖浆剂。
将本发明实施例1制备的治疗伤风咳嗽的糖浆剂用于临床研究方案:
一、病例选择标准
1.风热咳嗽诊断标准
发热重,恶寒轻,有汗,头痛,鼻塞,流脓涕,喷嚏,咳嗽,吐痰黄稠,咽部红肿疼痛,口干而渴,舌质红苔薄白或薄黄,脉浮数。
2.风寒咳嗽诊断标准
恶寒重、发热轻、头痛无汗、肢节酸痛、鼻塞、流清涕、喉痒咳嗽、咳痰清稀、舌苔薄白、脉浮紧。
二、试验病例标准
1.病例纳入标准
符合本病诊断及中医辩证标准,病程不超过3天者,可纳入试验病例。
2.排除病例标准(包括不适应症或剔除标准)
(1)重度营养不良或伴有其它心血管,肝,肾和造血系统及严重全身性疾患者,精神疾病患者,对本发明所述治疗伤风咳嗽的糖浆剂过敏者。
(2)化脓性扁桃体炎,支气管炎、毛细支气管炎、肺炎等病患者。
(3)不符合纳入标准,未坚持服药,中途换药或加药,无法判断疗效或资料不全等影响疗效或安全性判断者。
三、观测指标
1.安全性观测
(1)一般体检项目;
(2)血、尿、便常规化验;
(3)心、肝、肾功能检查。
2.疗效性观测
(1)症状:发热、恶寒、鼻部症状、咳嗽,咽部症状,全身情况。
(2)体征:体温、咽、扁桃体检查,舌象,脉象,指纹等。
(3)实验室常规检查:白细胞总数及分类计数,尿常规,大便常规。
(4)呼吸道分泌物或鼻咽拭子送细菌培养。
四、疗效判断标准
1.痊愈:服药24~48小时内,体温恢复正常,证侯消失,指标恢复正常。
2.显效:服药24~48小时内,体温恢复正常,主要证侯大部分消失,异常理化指标接近正常。
3.有效:服药48~72小时内,体温恢复正常,主要证侯部分消失,异常理化指标有所改善。
4.无效:不符合以上标准者。
五、统计方法
所有纳入病例均填写统一的病历及观察登记表,每天服用实施例 1所制备的治疗伤风咳嗽的糖浆剂。1~14岁患者每次10mL,一日2 次,14岁以上患者每次10mL,一日3次,3天为一疗程,服药期间,停服其它止咳药物。另设风热咳嗽和风寒咳嗽对照组,风热咳嗽对照组服用川贝枇杷糖浆,风寒咳嗽对照组服用半夏止咳糖浆,疗程结束,再做各项检查,分别进行统计分析,汇总治疗结果。
453例病例临床观察
本次临床观察中,风热咳嗽265例,其中1~14岁病例136例, 14岁以上病例129例,男130例,女135例;风寒咳嗽188例,其中1~14岁病例102例,14岁以上病例86例,男96例,女92例。
风热咳嗽265例中135例服用实施例1组制备的治疗伤风咳嗽的糖浆剂;130例服用川贝枇杷糖浆(对照组)。两组的年龄、性别基本相同,疗效统计见表1。
风寒咳嗽188例中95例服用实施例1组制备的治疗伤风咳嗽的糖浆剂;93例服用半夏止咳糖浆(对照组)。两组的年龄、性别基本相同,疗效统计见表1。
表1各组疗效统计结果
从表1中可以看出,本发明制备的治疗伤风咳嗽的糖浆剂无论是针对风热咳嗽还是风寒咳嗽,具有较高的有效率,且疗效优于本领域常规的治疗风热咳嗽或风寒咳嗽糖浆剂。
以上所述的实施例仅是对本发明的优选方式进行描述,并非对本发明的范围进行限定,在不脱离本发明设计精神的前提下,本领域普通技术人员对本发明的技术方案做出的各种变形和改进,均应落入本发明权利要求书确定的保护范围内。
Claims (2)
1.一种治疗伤风咳嗽的糖浆剂的制备方法,其特征在于,步骤如下:
(1)将麻黄12份、款冬花12份、桑白皮25份、川贝母23份、薏苡仁35份、党参14份、桑叶8份和甘草25份加入提取罐中,再加入各中药质量之和10倍量的纯化水,常温下浸泡1h;然后加热至100℃,冷凝回流提取1.5h,过滤;滤渣放入提取罐,加入浸泡时60%质量的水加热至100℃,冷凝回流提取1.5h,过滤,合并滤液,减压浓缩至滤液相对密度为20℃下1.1,得到治疗伤风咳嗽的药物;
(2)取步骤(1)制备的治疗伤风咳嗽的药物1份,加入16份质量分数为85%的蔗糖水溶液,搅拌均匀,然后利用新沸过的冷水调节相对密度至20℃下1.18,制得治疗伤风咳嗽的糖浆剂。
2.一种根据权利要求1所述的制备方法制得的治疗伤风咳嗽的糖浆剂。
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