CN103933376A - 一种治疗慢性支气管炎的药物组合物 - Google Patents
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Abstract
本发明涉及一种用于治疗慢性支气管炎的药物组合物及其制法，由菊花、黄芩、橘红、桑叶、紫苏叶、蒲公英、枳壳、竹茹制成，剂型包括硬胶囊剂、片剂、颗粒剂，本发明目的在于提供一种有确切疗效的治疗慢性支气管炎的药物。
Description
技术领域
本发明属于医药领域，具体涉及一种治疗慢性支气管炎的药物组合物及其制备方法。
背景技术
众所周知，慢性支气管炎是呼吸系统常见病、多发病，是由多种细胞和细胞组分参与的气道慢性炎症性疾病。这种慢性炎症与气道高反应性相关，引起支气管平滑肌痉挛性收缩，血管扩张，粘膜水肿及分泌增加，导致可逆性气道阻塞的一种疾病。临床主要表现为发作性呼气困难并伴有哮鸣音、咳嗽和咳痰，常在夜间和清晨发作加剧。慢性支气管炎如不及时诊治，随病程的延长可产生气道不可逆性缩窄和气道重塑，严重者被迫采取坐位或呈端坐呼吸，干咳或咳大量白色泡沫痰，甚至出现发绀等。有些青少年，其哮喘症状表现为运动时出现胸闷、咳嗽和呼吸困难，为临床常见病。目前临床治疗主要是应用激素等方法控制，不仅费用高，且易复发，给患者带来了极大的经济及精神负担。
发明内容
本发明的发明目的是提供一种治疗慢性支气管炎的中药新药及其制备方法，以解除患者疾苦，创造良好的社会和经济效益。
本发明的治疗慢性支气管炎的药物组合物，按重量配比是：菊花180～220份、黄芩130～170份、橘红140～160份、桑叶180～220份、紫苏叶60～100份、蒲公英160～200份、枳壳100～140份、竹茹180～220份。
优选地：菊花200份、黄芩150份、橘红160份、桑叶200份、紫苏叶80份、蒲公英180份、枳壳120份、竹茹200份。
上述原料按药剂学上接受的方法制成硬胶囊剂、片剂、颗粒剂等，其中优选为颗粒剂。
以上药物组合物的制备方法为：取以上药物组合物原料药混匀，粉碎成10～20目粗颗粒，加水6倍，用微波萃取方法连续60℃萃取三次，萃取液进行离心分离，净浸液浓缩至相对密度为1.30～1.35的稠膏，真空干燥，干膏粉碎，加适宜辅料，制成相应的剂型。
本发明中的辅料可以是药剂学上可接受的任何赋形剂或载体。
本发明在中医药理论基础上，经过大量临床实践筛选所得。其配方简单、起效迅速、疗效显著、疗程短、不易复发。
菊花：散风清热、平肝明目。现代药学研究证明，菊花含有挥发油、腺嘌呤、胆碱、水苏碱、菊甙、氨基酸、黄酮类及微量维生素B1。挥发油含龙脑、樟脑、菊油环酮等。黄酮类有木犀草素-7-葡萄糖甙、大波斯菊甙、刺槐甙、丁二酸二甲基酰肼。菊花在体外对革兰氏阳性细菌、人型结核杆菌有某些抑制作用；菊花提取物对小鼠腹腔注射，能抑制毛细血管的通透性而有抗炎作用。
黄芩：清热燥湿、凉血安胎、解毒。现代药学研究证明，黄芩具有抗菌作用，对痢疾杆菌、伤寒杆菌、副伤寒杆菌、霍乱弧菌、大肠杆菌、变形杆菌、绿脓杆菌、葡萄球菌、溶血性琏球菌、肺炎双球菌、白喉杆菌等有抑制作用。黄芩还具有抗病毒作用，体外试验对乙型肝炎病毒DNA复制有抑制作用。
橘红：止咳化痰、平喘。现代药学研究证明，橘红含有枸橼、香叶醇、芳香醇、柚皮苷、新橙皮、枸橼苷等。对肺痨、支气管炎、长期胃痛、止咳化痰等有疗效。
桑叶：疏散风热、清肺润燥、清肝明目。现代药学研究证明，现代研究表明桑叶具有较强的抗炎作用。
紫苏叶：解表散寒、行气和胃。现代药学研究证明，紫苏叶具有抑菌作用，紫苏叶在试管内能抑制葡萄球菌生长。
蒲公英：清热解毒、消痈散结。现代药学研究证明，蒲公英具有抗菌作用，对金黄色葡萄球菌耐药菌株、溶血性链球菌有较强的杀菌作用。对肺炎双球菌、脑膜炎球菌、白喉杆菌、绿脓杆菌、痢疾杆菌、伤寒杆菌等及卡他球菌也有一定杀菌作用。
枳壳：破气、行痰、消积。现代药学研究证明，枳壳具有抗变态反应的作用。
竹茹：涤痰止呕、清热除烦。现代药学研究证明，竹茹含有对cAMP磷酸二酯酶抑制作用的成分：2，5-二甲氧基-对-羟基苯甲醛、丁香醛、松柏醛等。竹茹粉在平皿上对白色葡萄球菌、枯草杆菌、大肠杆菌及伤寒杆菌等均有较强的抗菌作用。
为了表明本发明药物对慢性支气管炎有治疗效果，本发明进行了以下的临床实验。
材料与方法
1.病例选择
1.1诊断标准
根据中华人民共和国卫生部制定的《中药新药临床研究指导原则》中制定的《中药新药治疗慢性支气管炎的临床研究指导原则》的诊断标准制定。
中医辨证标准肺气虚：病发时常以咳为主，咳声无力，多为单咳或有间歇咳，白天多于夜晚，痰量不多，多汗，恶风，易感冒，舌质正常或稍淡，舌苔薄白，脉弦细或缓细。肾阳虚：以动则气短为特征，病发时常咳声嘎涩，多为阵咳，夜多于昼，痰量较多，腰酸肢软，咳则遗尿，夜尿频多，头昏耳鸣，身寒肢冷，气短语怯，舌质淡胖，舌苔白滑润，脉多细。
1.2纳入标准
符合慢性支气管炎慢性迁延期诊断标准，中医辨证为肺气虚及肾阳虚的门诊及住院患者，年龄在18～70岁者均可纳入试验病例。
1.3排除病例标准
①经检查证实由结核，真菌，肿瘤，刺激性气体过敏等因素所致的慢性咳嗽，喘息患者。②慢性支气管炎并发严重心功能不全者。③合并有心血管，肝，肾和造血系统等严重原发疾病，精神病患者。④妊娠和哺乳期妇女，对本药过敏者。⑤凡不符合纳入标准，未按规定用药，无法判定疗效或资料不全等影响疗效或安全性判断者。
2.方法
共入选病例60例，其中治疗组30例，对照组30例。治疗组每日服用本发明实施例1颗粒剂，一次两袋，每日三次，疗程为1个月。对照组服用头孢丙烯(一次一片，一日两次)和痰咳净(一次两片，一日三次)，疗程为1个月。
3.疗效判定标准
根据中华人民共和国卫生部制定的《中药新药临床研究指导原则》中制定的《中药新药治疗慢性支气管炎的临床研究指导原则》的疗效标准，判断疗效。
显效：患者哮喘临床症状体征均消失，活动不受限，无夜间憋醒，无急性发作，肺功能正常。
有效：患者临床症状体征部分消失，偶有夜间憋醒及急性发作，跑步，快步走偶有胸闷、咳嗽，肺功能检查大致正常。
无效：临床症状体征及肺功能无改变。
4.统计学方法
所有数据均应用ssps17.0软件进行处理，并应用t检验、x2检验对数据进行处理，结果见表1。
表1对照组和观察组治疗效果对比
注：*与对照组比较P＜0.05
从以上结果可以看出，治疗组和对照组比较，两组之间差异有显著性，治疗组优于对照组。
具体实施例
实施例1菊花200g、黄芩150g、橘红160g、桑叶200g、紫苏叶80g、蒲公英180g、枳壳120g、竹茹200g。
本发明颗粒剂的制备方法：取以上药物组合物原料药混匀，粉碎成10～20目粗颗粒，加水6倍，用微波萃取方法连续60℃萃取三次，萃取液进行离心分离，净浸液浓缩至相对密度为1.30～1.35的稠膏，真空干燥，干膏粉碎，加入可压性淀粉、羧甲基纤维素钠、混匀过80目筛，加适量水制粒，60℃减压干燥，整粒，分装成100袋，即得。
实施例2菊花190g、黄芩155g、橘红160g、桑叶190g、紫苏叶90g、蒲公英190g、枳壳110g、竹茹210g。
本发明胶囊剂的制备方法：取以上药物组合物原料药混匀，粉碎成10～20目粗颗粒，加水6倍，用微波萃取方法连续60℃萃取三次，萃取液进行离心分离，净浸液浓缩至相对密度为1.30～1.35的稠膏，真空干燥，干膏粉碎，装入胶囊，即得。
实施例3菊花210g、黄芩160g、橘红140g、桑叶180g、紫苏叶70g、蒲公英160g、枳壳100g、竹茹180g。
本发明片剂的制备方法：取以上药物组合物原料药混匀，粉碎成10～20目粗颗粒，加水6倍，用微波萃取方法连续60℃萃取三次，萃取液进行离心分离，净浸液浓缩至相对密度为1.30～1.35的稠膏，真空干燥，干膏粉碎，加淀粉、滑石粉及硬脂酸镁适量，制粒，压制成片，包衣，即得。
Claims (6)
1.一种治疗慢性支气管炎的药物组合物，其特征在于：
按照重量份计，制成该药物组合物有效组分的原料为：菊花180～220份、黄芩130～170份、橘红140～160份、桑叶180～220份、紫苏叶60～100份、蒲公英160～200份、枳壳100～140份、竹茹180～220份。
2.如权利要求1所述的一种治疗慢性支气管炎的药物组合物，其特征在于：
按照重量份计，制成该药物组合物有效组分的原料为：菊花200份、黄芩150份、橘红160份、桑叶200份、紫苏叶80份、蒲公英180份、枳壳120份、竹茹200份。
3.如权利要求1所述的一种治疗慢性支气管炎的药物组合物，其特征在于：
所述药物组合物剂型为硬胶囊剂、片剂、颗粒剂。
4.如权利要求3所述的一种治疗慢性支气管炎的药物组合物，其特征在于：
所述药物组合物剂型为颗粒剂。
5.如权利要求1所述的一种治疗慢性支气管炎的药物组合物的制备方法，其特征在于：
该方法为：将所述原料药混匀，粉碎成10～20目粗颗粒，加水6倍，用微波萃取方法连续60℃萃取三次，萃取液进行离心分离，净浸液浓缩至相对密度为1.30～1.35的稠膏，真空干燥，干膏粉碎，加适宜辅料，制成相应的剂型。
6.如权利要求5所述的一种治疗慢性支气管炎的药物组合物的制备方法，其特征在于：
该方法为：取菊花200g、黄芩150g、橘红160g、桑叶200g、紫苏叶80g、蒲公英180g、枳壳120g、竹茹200g，将以上药物组合物原料药混匀，粉碎成10～20目粗颗粒，加水6倍，用微波萃取方法连续60℃萃取三次，萃取液进行离心分离，净浸液浓缩至相对密度为1.30～1.35的稠膏，真空干燥，干膏粉碎，加入可压性淀粉、羧甲基纤维素钠、混匀过80目筛，加适量水制粒，60℃减压干燥，整粒，分装成100袋。
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