CN104474292A - 一种防治流行性感冒的药物组合物及其制备方法 - Google Patents
一种防治流行性感冒的药物组合物及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种治疗流行性感冒的药物组合物及其制备方法与制药用途。药物组成为:荆芥5-100份、防风5-100份、香薷5-100份、紫苏5-100份、羌活5-100份、柴胡5-100份、马齿苋15-70份、十大功劳15-70份、蒲公英15-70份、黄连15-70份、黄柏15-70份、三叉苦15-70份、万寿菊15-70份、羊蹄草15-70份、岗梅根15-70份、天冬30-60份、石斛30-60份、玉竹30-60份、黄精30-60份、巴戟天30-60份、肉苁蓉30-60份。本发明的有益效果是:以中药为原料,发挥了中药毒副作用低的优势,对流感疾病起到预防和治疗的作用,安全、有效、廉价、易于广泛推广,具有较高的临床应用价值。
Description
技术领域
本发明涉及一种药物组合物及其制备方法与制药用途,尤其涉及一种治疗流行性感冒的药物组合物及其制备方法与制药用途。
背景技术
流行性感冒(简称流感)是流感病毒引起的急性呼吸道感染,也是一种传染性强、传播速度快的疾病。其主要通过空气中的飞沫、人与人之间的接触或与被污染物品的接触传播,典型的临床症状是:急起高热、全身疼痛、显著乏力和轻度呼吸道症状,一般秋冬季节是其高发期,所引起的并发症和死亡现象非常严重,该病是由流感病毒引起,可分为甲(A)、乙(B)、丙(C)三型,甲型病毒经常发生抗原变异,传染性大,传播迅速,极易发生大范围流行。
流行性感冒需要和普通感冒相区分,流感并不是流行起来的感冒,而是两种完全不同的疾病,流感是流感病毒感染引起的主要累及上呼吸道的全身性疾病。流感通常比感冒症状重,并发症更多,而且可以伴随肺炎等严重情况,死亡率也较高。据美国疾病预防控制中心(CDC)估计,在美国,因流感住院的患者每年20万人,死亡3.6万人。但是,病人到医院就诊,即使症状非常象“流感”,医生却很难下“流感”的诊断,只能下“流感样病例”的诊断,按照定义,只要体温(腋下温度)大于38°C,同时伴有至少一项呼吸道症状(比如:咽痛、咳嗽等),就可以诊断“流感样病例”,但是确诊“流感”需要“病原学诊断”,包括从呼吸道标本中培养出流感病毒或检测出流感病毒抗原,目前大多数综合医院都没有病原学检测的能力。
针对流行性感冒疾病,目前常见的治疗方法有对症治疗,即针对发热、头痛等症状予以退热、镇痛的治疗,以及抗病毒治疗,例如给予离子通道M2蛋白阻抑剂、神经氨酸酶抑制剂等药物,但对症治疗无法对流感疾病起到根治作用,效果较慢,抗病毒药物容易导致肾功能障碍患者的神经系统副作用,并极有可能引起其他系统例如呼吸系统的不良反应,应用范围受到极大的限制。因此,临床还是需要一种安全有效、毒副作用小且费用低廉的防治流感疾病的药物。
发明内容
为了解决以上技术问题,发明人提供了一种中药组方,通过内服该中药组合物起到预防和治疗流行性感冒疾病的作用,其具有疗效显著、副作用小、成本低、操作方法简便等优势。
流感的发病不仅是由于感受外邪侵袭,还与机体抗病能力低下有关,尤当气候失常、寒暖失调之时则更易发病。因其强烈传染性特点,属于中医中“疫病”的范畴,证候分型以风热犯卫证较多,其次为卫气同病证、风寒外束证最少,病位均在表,邪犯肺胃,治疗以解表祛邪为主,证见热毒内入证候时需注重清热解毒、透邪外出,同时还应着重提高患者自身免疫能力以增强其对疾病的抵抗能力。
本发明所述药物组合物包括(重量份数):荆芥5-100份、防风5-100份、香薷5-100份、紫苏5-100份、羌活5-100份、柴胡5-100份、马齿苋15-70份、十大功劳15-70份、蒲公英15-70份、黄连15-70份、黄柏15-70份、三叉苦15-70份、万寿菊15-70份、羊蹄草15-70份、岗梅根15-70份、天冬30-60份、石斛30-60份、玉竹30-60份、黄精30-60份、巴戟天30-60份、肉苁蓉30-60份。
原料药物优选重量份数为:荆芥15-90份、防风15-90份、香薷15-90份、紫苏15-90份、羌活15-90份、柴胡15-90份、马齿苋25-50份、十大功劳25-50份、蒲公英25-50份、黄连25-50份、黄柏25-50份、三叉苦25-50份、万寿菊25-50份、羊蹄草25-50份、岗梅根25-50份、天冬40-50份、石斛40-50份、玉竹40-50份、黄精40-50份、巴戟天40-50份、肉苁蓉40-50份。
原料药物更加优选重量份数为:荆芥50份、防风50份、香薷50份、紫苏50份、羌活50份、柴胡50份、马齿苋35份、十大功劳35份、蒲公英35份、黄连35份、黄柏35份、三叉苦35份、万寿菊35份、羊蹄草35份、岗梅根35份、天冬45份、石斛45份、玉竹45份、黄精45份、巴戟天45份、肉苁蓉45份。
方剂中荆芥、防风、香薷、紫苏、羌活、柴胡解表透邪,马齿苋、十大功劳、蒲公英,黄连、黄柏、三叉苦、万寿菊、羊蹄草、岗梅根清热解毒;天冬、石斛、玉竹、黄精、巴戟天、肉苁蓉滋阴、扶正祛邪,三者相合,清热解毒的同时滋阴扶正祛邪,能够有效治疗流行性感冒。
该药物组合物可以加入药剂学上常见的辅料制备成汤剂、片剂或软胶囊剂等。
汤剂的制备方法为:取上述原料药物混合放入砂锅,加水没过药面浸泡30分钟,大火煮沸后改文火煎煮30分钟,滤出药液,再加水煎煮20分钟,滤出药液,两次滤液合并即得;每日一剂,分早晚两次饭后服用。
其它剂型的制备方法为:按比例取原料药物加水煎煮、过滤得到滤液1,滤渣再次加水煎煮、过滤得到滤液2,合并两次滤液,浓缩,醇沉,过滤上清液,回收乙醇,浓缩得到浸膏,加入药剂学上常见的辅料制备成片剂或软胶囊剂。
其中加入原料药物8倍量水,第一次煎煮30min,过滤得到滤液1,滤渣加入原料药物6倍量水煎煮30min,过滤得到滤液2,合并两次滤液,浓缩至常温下相对密度为1.1-1.2的浓缩液,加入质量百分比浓度为95%以上的乙醇溶液使浓缩液含醇量达到60%进行醇沉,醇沉48小时后过滤上清液,回收乙醇,浓缩到常温下相对密度为1.3-1.4的浸膏,加入药剂学上常见的辅料制备成片剂或软胶囊剂。
本发明的有益效果是:以中药为原料,发挥了中药毒副作用低的优势,对流感疾病起到预防和治疗的作用,安全、有效、廉价、易于广泛推广,具有较高的临床应用价值。
具体实施方式
为了进一步理解本发明,下面结合实施例对本发明优选实施方案进行描述,但是应当理解,这些描述只是为进一步说明本发明的特征和优点,而不是对本发明权利要求的限制。
实施例1:汤剂
处方:荆芥50克、防风50克、香薷50克、紫苏50克、羌活50克、柴胡50克、马齿苋35克、十大功劳35克、蒲公英35克、黄连35克、黄柏35克、三叉苦35克、万寿菊35克、羊蹄草35克、岗梅根35克、天冬45克、石斛45克、玉竹45克、黄精45克、巴戟天45克、肉苁蓉45克。
制备方法:取上述原料药物混合放入砂锅,加水没过药面浸泡30分钟,大火煮沸后改文火煎煮30分钟,滤出药液,再加水煎煮20分钟,滤出药液,两次滤液合并即得。
服用方法:每日一剂,分早晚两次饭后服用。
实施例2:片剂
处方:荆芥15克、防风15克、香薷15克、紫苏15克、羌活15克、柴胡15克、马齿苋25克、十大功劳25克、蒲公英25克、黄连25克、黄柏25克、三叉苦25克、万寿菊25克、羊蹄草25克、岗梅根25克、天冬40克、石斛40克、玉竹40克、黄精40克、巴戟天40克、肉苁蓉40克。
制备方法:取上述原料药物混合,加入原料药物8倍量水,第一次煎煮30min,过滤得到滤液1,滤渣加入原料药物6倍量水煎煮30min,过滤得到滤液2,合并两次滤液,浓缩至常温下相对密度为1.1-1.2的浓缩液,加入质量百分比浓度为95%以上的乙醇溶液使浓缩液含醇量达到60%进行醇沉,醇沉48小时后过滤上清液,回收乙醇,浓缩到常温下相对密度为1.3-1.4的浸膏,喷雾干燥,加入和浸膏等量的糊精、蔗糖粉,混匀,过40目筛得到颗粒,干燥,压片,每片重0.5g。
服用方法:一日3次,每次3片;
实施例3:软胶囊剂
处方:荆芥90克、防风90克、香薷90克、紫苏90克、羌活90克、柴胡90克、马齿苋50克、十大功劳50克、蒲公英50克、黄连50克、黄柏50克、三叉苦50克、万寿菊50克、羊蹄草50克、岗梅根50克、天冬50克、石斛50克、玉竹50克、黄精50克、巴戟天50克、肉苁蓉50克。
制备方法:取上述原料药物混合,加入原料药物8倍量水,第一次煎煮30min,过滤得到滤液1,滤渣加入原料药物6倍量水煎煮30min,过滤得到滤液2,合并两次滤液,浓缩至常温下相对密度为1.1-1.2的浓缩液,加入质量百分比浓度为95%以上的乙醇溶液使浓缩液含醇量达到60%进行醇沉,醇沉48小时后过滤上清液,回收乙醇,浓缩到常温下相对密度为1.3-1.4的浸膏,干燥成粉,加入适量豆油、大豆磷脂、蜂蜡和聚乙二醇制备成混悬液,采用压制法制备软胶囊,每粒胶囊中含颗粒0.5g。
服用方法:一日3次,每次2粒;
实施例4:药物组合物对流行性感冒的治疗效果试验:
A、样本选择:
病例收集:以被确诊为流感的患者为试验对象。共收集患者120例,将其随机分为3组,每组40例。
疗效标准:
痊愈:治疗后感冒症状完全消失,饮食活动恢复正常;
有效:治疗后感冒症状明显减轻,饮食活动基本恢复正常;
无效:治疗前后症状基本没有改变。
、临床治疗:
治疗组1-3,分别服用实施例1-3的汤剂(每日一剂,分早晚两次饭后服用)、片剂(一日3次,每次3片)和软胶囊剂(一日3次,每次2粒),治疗2周。
、治疗效果观察:
实验结果:
可见,本发明的药物组合物对于流感疾病有明显的治疗作用。
、典型病例:
王某,男,22岁,咽痒、发热1天,伴咳嗽、咳淡黄色痰、量少,体温37.5℃,神清,双肺闻及干、湿性罗音;心、肝、肾功能均正常,诊断为流感。给予本发明实施例1的汤剂,每日一剂,分早晚两次饭后服用,连续服用10天后症状消失,体温恢复正常。
蔡某,男,30岁,咳嗽、咳痰、高热、乏力2日,气稍促,心律齐,体温39.1 c,两肺呼吸音粗,未及明显啰音,诊断为流感。给予本发明实施例3的软胶囊剂,一日3次,每次2粒,连续服用8天后感冒症状消失,体温恢复正常。
李某,男,50岁,感冒十余天,咳嗽有黄痰,量多,胸闷不欲食,食后自觉满闷食不下,二便正常,舌淡红苔薄,体温38℃,诊断为流感。给予本发明实施例2的片剂,一日3次,每次3片,连续服用2周后咳嗽等症状消失,体温恢复正常。
本发明内容仅仅举例说明了要求保护的一些具体实施方案,其中一个或更多个技术方案中所记载的技术特征可以与任意的一个或多个技术方案相组合,这些经组合而得到的技术方案也在本申请保护范围内,就像这些经组合而得到的技术方案已经在本发明公开内容中具体记载一样。
Claims (11)
1.一种用于治疗流行性感冒的药物组合物,其特征在于:包括下述药物按照重量份数制备而成:荆芥5-100份、防风5-100份、香薷5-100份、紫苏5-100份、羌活5-100份、柴胡5-100份、马齿苋15-70份、十大功劳15-70份、蒲公英15-70份、黄连15-70份、黄柏15-70份、三叉苦15-70份、万寿菊15-70份、羊蹄草15-70份、岗梅根15-70份、天冬30-60份、石斛30-60份、玉竹30-60份、黄精30-60份、巴戟天30-60份、肉苁蓉30-60份。
2.如权利要求1所述的药物组合物,其特征在于,原料药物的重量份数为:荆芥15-90份、防风15-90份、香薷15-90份、紫苏15-90份、羌活15-90份、柴胡15-90份、马齿苋25-50份、十大功劳25-50份、蒲公英25-50份、黄连25-50份、黄柏25-50份、三叉苦25-50份、万寿菊25-50份、羊蹄草25-50份、岗梅根25-50份、天冬40-50份、石斛40-50份、玉竹40-50份、黄精40-50份、巴戟天40-50份、肉苁蓉40-50份。
3.如权利要求2所述的药物组合物,其特征在于,原料药物的重量份数为:荆芥50份、防风50份、香薷50份、紫苏50份、羌活50份、柴胡50份、马齿苋35份、十大功劳35份、蒲公英35份、黄连35份、黄柏35份、三叉苦35份、万寿菊35份、羊蹄草35份、岗梅根35份、天冬45份、石斛45份、玉竹45份、黄精45份、巴戟天45份、肉苁蓉45份。
4.如权利要求1-3所述药物组合物,其特征在于可以加入药剂学上常见的辅料制备成汤剂、片剂、软胶囊剂等。
5.如权利要求4所述药物组合物,其特征在于,取上述原料药物混合放入砂锅,加水没过药面浸泡30分钟,大火煮沸后改文火煎煮30分钟,滤出药液,再加水煎煮20分钟,滤出药液,两次滤液合并即得。
6.如权利要求4所述药物组合物,其特征在于,按比例取原料药物加水煎煮、过滤得到滤液1,滤渣再次加水煎煮、过滤得到滤液2,合并两次滤液,浓缩,醇沉,过滤上清液,回收乙醇,浓缩得到浸膏,加入药剂学上常见的辅料制备成片剂或软胶囊剂。
7.如权利要求6所述药物组合物,其特征在于,其中加入原料药物8倍量水,第一次煎煮30min,过滤得到滤液1,滤渣加入原料药物6倍量水煎煮30min,过滤得到滤液2,合并两次滤液,浓缩至常温下相对密度为1.1-1.2的浓缩液,加入质量百分比浓度为95%以上的乙醇溶液使浓缩液含醇量达到60%进行醇沉,醇沉48小时后过滤上清液,回收乙醇,浓缩到常温下相对密度为1.3-1.4的浸膏,加入药剂学上常见的辅料制备成片剂或软胶囊剂。
8.一种制备如权利要求1-3所述任一药物组合物的方法,其特征在于:取上述原料药物混合放入砂锅,加水没过药面浸泡30分钟,大火煮沸后改文火煎煮30分钟,滤出药液,再加水煎煮20分钟,滤出药液,两次滤液合并即得。
9.一种制备如权利要求1-3所述任一药物组合物的方法,其特征在于:按比例取原料药物加水煎煮、过滤得到滤液1,滤渣再次加水煎煮、过滤得到滤液2,合并两次滤液,浓缩,醇沉,过滤上清液,回收乙醇,浓缩得到浸膏,加入药剂学上常见的辅料制备成片剂或软胶囊剂。
10.如权利要求9所述的制备方法,其特征在于:其中加入原料药物8倍量水,第一次煎煮30min,过滤得到滤液1,滤渣加入原料药物6倍量水煎煮30min,过滤得到滤液2,合并两次滤液,浓缩至常温下相对密度为1.1-1.2的浓缩液,加入质量百分比浓度为95%以上的乙醇溶液使浓缩液含醇量达到60%进行醇沉,醇沉48小时后过滤上清液,回收乙醇,浓缩到常温下相对密度为1.3-1.4的浸膏,加入药剂学上常见的辅料制备成片剂或软胶囊剂。
11.一种权利要求1-3所述组合物用于治疗流行性感冒的用途。
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