CN104547706A - 一种治疗肺热咳嗽的药物组合物及其制备方法 - Google Patents
一种治疗肺热咳嗽的药物组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种由瓜蒌皮、麦冬、芦根、油茶油组成的药物组合物在制备用于治疗肺热咳嗽，及其制备方法。该药物组合物的重量配比为：瓜蒌皮7-25份，芦根6-30份，麦冬5-20份，油茶油3-10份。该药物的制备方法是:a)称取一定比例的麦冬干燥，磨成细粉，过150目，备用；b)瓜蒌皮与芦根按比例称量混合后加15-30倍水浸泡1-2小时，煎煮2-3小时，煎煮三次后，合并3次滤液滤过，冷却到室温,然后将滤液浓缩至相对密度为1.02～1.10的药液，加入60％-80％乙醇提纯2次，取上层清液，减压回收乙醇，澄清液浓缩至相对密度1.05-1.2,备用；c)直接购买的油茶油，称取一定比例的重量，备用；d)a加b混合均匀，喷人c，搅拌，真空干燥，磨细粉，过30目，干燥，混合整粒，备用；e)往d加入适量辅料，压片或制粒或装胶囊或制成丸剂。
Description
技术领域
本发明涉及一种治疗肺热咳嗽的药物组合物及其制备方法,属中药制剂技术领域，
背景技术
因外感风热犯肺，或风寒化热入肺，热邪壅盛所致的咳嗽(简称“肺热咳嗽”)，临床表现为咳嗽喘急，甚至鼻翼扇动、咳痰、痰黄稠量多、鼻塞、流涕、咽喉肿痛、头身疼痛，舌红苔黄燥，脉洪数有力。临床上一般使用蛇胆川贝散联合板蓝根冲剂、银翘解毒丸等进行治疗，但主要对症治疗，并未从根本上根除病因，容易引起病情反复。
瓜蒌皮为葫芦科植物栝楼TrichosantheskirilowiiMaxim.或双边栝楼Trichosan-thesrosthorniiHarms的干燥成熟果实的表皮。性味甘、微苦、寒；归肺、胃、大肠经；具有清热涤痰，宽胸散结的功效。用于肺热咳嗽，痰浊黄稠，胸痹心痛，结胸痞满，乳痈，肺痈，肠痈肿痛，大便秘结等病症。
芦根为禾本科植物芦苇新鲜或者干燥根茎，据《本草纲目》记载，芦根性寒,味甘，入肺,胃经，具有清热泻火,生津止渴,除烦,止呕,利尿之功效。常用于热病烦渴，肺热咳嗽，肺痈吐痰，胃热呕吐，热淋涩痛。作为中国传统药物，芦根在中医临床治疗中有着广泛的应用。
麦冬为百合科植物麦冬(沿阶草)Ophiopo份onjaponicus(Thunb.)Ker-份awl.的干燥块根。性味甘，微苦，微寒。归心、肺、胃经。具有养阴生津，润肺清心功效，主要用于肺燥干咳，虚痨咳嗽，津伤口渴，心烦失眠，内热消渴，肠燥便秘；咽白喉等。
油茶油为山茶科植物油茶CamelliaoleiferaAbel.的成熟种子用压榨法得到的脂肪油。性凉，味甘；具有清热化湿，杀虫解毒功效。
该药物组合物选择瓜蒌皮清热涤痰，宽胸散结为君药；芦根清热泻火,生津止渴为臣药；麦冬养阴生津，润肺清心为为佐药；油茶油引药入肺为使药；诸药合用发挥出清肺滋阴化痰的功效，根源上解除病因，从而根除病症。目前由瓜蒌皮，芦根，麦冬，油茶油组成的药物组合物在治疗肺热咳嗽方面尚无报道。本发明提供的组方简单，药材资源易得，价格便宜，能被广大病患所接受，且能有效地根除肺热咳嗽及其他症状，天然，副作用少。其制备工艺简单，成本低，适合工业化大生产。
发明内容
本发明的目的是提供一种治疗肺热咳嗽的药物组合物及其制备方法。
为了达到上述目的，本发明的一种治疗肺热咳嗽的药物组合物，其药物的重量配比为：瓜蒌皮7-25，芦根6-30份，麦冬5-20份，油茶油3-10份。
进一步优选地，所述药物组合物的原料组成及其重量比为：瓜蒌皮10-20份，芦根8-25份，麦冬7-18份，油茶油3-7份。
更进一步优选地，所述药物组合物的原料组成及其重量比为：瓜蒌皮15份，芦根12份，麦冬10份，油茶油5份。
更进一步优选地，所述药物组合物的剂型为片剂或胶囊剂或丸剂或颗粒剂，采用现有的工业化生产过程均能实现。
本发明的制备方法为：
a)称取一定比例的麦冬，干燥，磨成细粉，过150目，备用。
b)瓜蒌皮与芦根按比例称量混合，加15-30倍水浸泡，浸泡1-2小时，煎煮2-3小时，煎煮三次后，合并3次滤液滤过，合并滤液冷却到室温,然后将滤液浓缩至相对密度为1.02～1.10的药液，加入60％-80％乙醇提纯2次，取上层清液，减压回收乙醇，澄清液浓缩至相对密度1.05-1.2,备用。
c)直接购买的油茶油，称取一定比例，备用
d)a加b混合均匀，喷人c，搅拌，真空干燥，磨细粉，过30目，干燥，混合整粒，备用。
e)往d加入适量辅料,混合整粒后压片或装胶囊或制成丸剂或制成颗粒剂。
本发明的有益效果是：与其他现有的药物组合物相比较，其原材料丰富易得，组方更加简单，所含的成分更少，天然无副作用，治疗效果更佳优越。提供的制备方法简单易实施，成本低，适用于工业化大生产。
具体实施方式
下面结合具体实施方式，对本发明的权利要求作进一步的详细说明，但不构成对本发明的任何限制，任何在本发明权利要求范围内所做的有限的修改，仍在本发明的权利要求保护范围之内。
实施例一：
组合物：瓜蒌皮7份，芦根6份，麦冬5份，油茶油3份。
a)称取麦冬5份，干燥，磨成细粉，过150目，备用。
b)称取瓜蒌皮7份，芦根6份混合，加15倍水浸泡，浸泡1小时，煎煮2.5小时，煎煮三次后，合并3次滤液滤过，合并滤液冷却到室温,然后将滤液浓缩至相对密度为1.05的药液，加入70％乙醇提纯2次，取上层清液，减压回收乙醇，澄清液浓缩至相对密度1.1,备用。
c)称取5份油茶油，备用。
d)a加b混合均匀，喷人c，搅拌，真空干燥，磨细粉，过30目，干燥，混合整粒，备用。
e)往d加入1.8％预胶化淀粉、1.5％羧甲纤维素钠、2.1％羧甲基淀粉钠、1.7％硬脂酸镁,混合整粒后压片。
实施例二：
组合物：瓜蒌皮20份，芦根13份，麦冬15份，油茶油5份。
a)称取麦冬15份，干燥，磨成细粉，过150目，备用。
b)称取瓜蒌皮20份，芦根13份混合，加20倍水浸泡，浸泡1.5小时，煎煮2小时，煎煮三次后，合并3次滤液滤过，合并滤液冷却到室温,然后将滤液浓缩至相对密度为1.02的药液，加入60％乙醇提纯2次，取上层清液，减压回收乙醇，澄清液浓缩至相对密度1.05,备用。
c)称取油茶油5份，备用。
d)a加b混合均匀，喷人c，搅拌，真空干燥，磨细粉，过30目，干燥，整粒，备用。
e)往d加入适量蜜糖(已熬过的蜜糖，趁热加入)，混合搅拌，成丸，制成丸，装蜡壳。
实施例三：
组合物：瓜蒌皮25份，芦根30份，麦冬20份，油茶油10份。
a)称取麦冬20份，干燥，磨成细粉，过150目，备用。
b)称取瓜蒌皮25份，芦根30份混合，加30倍水浸泡，浸泡2小时，煎煮3小时，煎煮三次后，合并3次滤液滤过，合并滤液冷却到室温,然后将滤液浓缩至相对密度为1.1的药液，加入80％乙醇提纯2次，取上层清液，减压回收乙醇，澄清液浓缩至相对密度1.2,备用。
c)称取油茶油10份，备用.
d)a加b混合均匀，喷人c，搅拌，真空干燥，磨细粉，过30目，干燥，整粒，备用。
e)往d加入1.5％二氧化硅、15％微晶纤维素、3.6％羟甲基纤维素，混合整粒后装胶囊。
实施例四
组合物：瓜蒌皮15份，芦根12份，麦冬10份，油茶油5份。
a)称取麦冬10份，干燥，磨成细粉，过150目，备用。
b)瓜蒌皮15份，芦根12份混合，加26倍水浸泡，浸泡1.3小时，煎煮2.5小时，煎煮三次后，合并3次滤液滤过，合并滤液冷却到室温,然后将滤液浓缩至相对密度为1.05的药液，加入70％乙醇提纯2次，取上层清液，减压回收乙醇，澄清液浓缩至相对密度1.15,备用。
c)称取油茶油5份，备用
d)a加b混合均匀，喷人c，搅拌，真空干燥，磨细粉，过30目，干燥，整粒，备用。
e)往d加入3％乳糖、2.5％羧甲基纤维素钠、1％甘露醇,混合整粒干燥后,制成颗粒剂。
实施例五 药物临床疗效验证
临床志愿者选择：选择18-60周岁的肺热咳嗽患者，并告知本品功能主治及可能发生不适。共有志愿者270例参与，其中男性140例，女性130例，志愿者必须患有：咳嗽、咳痰、痰黄稠量多，舌红苔黄燥等。24小时内未用过相同功效的药物，非由细菌感染、结核、真菌、肿瘤、矽肺、及过敏等因素导致的咳嗽患者。
实验分组：试验组1-4组、对照组为蛇胆川贝散组。
治疗方法：
试验组，每天三次，每次服用一周为一个疗程，其中：
试验1组口服本发明实施例1的片剂，每次1片；
试验2组口服本发明实施例2的丸剂，每次1颗；
试验3组口服本发明实施例3的胶囊剂，每次1颗；
试验4组口服本发明实施例4的颗粒剂，每次5mg。
对照组：服用广西梧州制药(集团)股份有限公司生产的蛇胆川贝散，每天三次，每次一包，服用一周为一个疗程。
治疗效果评价：
治愈:咳嗽、咳痰消失及其他临床体征全部消失。
显效：咳嗽、咳痰消失或主要症状消除
有效:咳嗽减轻,痰量减少。
未愈:症状无明显改变。
试验结果，见表一
由表一所示：
试验1组：临床有效率为94.5％，临床治愈率47.3％，无效5.5％；
试验2组:临床有效率为96.5％，临床治愈率51.7％，无效3.5％；
试验3组:临床有效率为95.6％，临床治愈率53.4％，无效4.4％；
试验4组:临床有效率为98.3％，临床治愈率60％，无效1.7％；
对照组:临床有效率为94.2％，临床治愈率46.2％，无效5.8％。
结论：本发明提供的中药组合物具有治疗肺热咳嗽的作用，效果优于现有技术，且优于对对照组，即具有协同效果。
Claims (4)
1.一种治疗肺热咳嗽的药物组合物，其特征在于，所述药物组合物包括：瓜蒌皮7-25份，芦根6-30份，麦冬5-20份，油茶油3-10份。一种治疗咳嗽肺热咳嗽组合物的制备方法，其特征在于，依次包括下述步骤：
a)称取一定比例的麦冬干燥磨粉，备用；b)称取一定比例的瓜蒌皮与芦根浸泡、煎煮、煎煮三次、合并滤液过滤，浓缩，加入乙醇提纯，浓缩备用；c)直接购买的油茶油，称取一定比例，备用；d)a加b混合均匀，喷人c，搅拌，真空干燥，磨细粉，过30目，干燥，混合整粒，备用；e)往d加入适量辅料制成制剂。
2.根据权利要求1，步骤a)的特征在于：称取一定比例的麦冬，干燥，磨成细粉，过150目。
3.根据权利要求1，步骤b)的特征在于：瓜蒌皮与芦根按比例称量混合后加15-30倍水浸泡，浸泡1-2小时，煎煮2-3小时，煎煮三次后，合并3次滤液滤过，冷却到室温,然后将滤液浓缩至相对密度为1.02～1.10的药液，加入60％-80％乙醇提纯2次，取上层清液，减压回收乙醇，澄清液浓缩至相对密度1.05-1.2,备用。
4.根据权利要求1所述的一种治疗肺热咳嗽的药物，其特征是该药物的剂型为片剂或胶囊剂或丸剂或颗粒剂。
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