CN104258269A - 用于治疗慢性阻塞性肺疾病的药物制剂 - Google Patents
用于治疗慢性阻塞性肺疾病的药物制剂 Download PDFInfo
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Abstract
本发明提供了一种用于治疗慢性阻塞性肺疾病的药物制剂,其原料药包括丹参、仙鹤草、黄精、莪术、桂枝、浙贝母、桑白皮、芡实、百眼藤、皂角刺、老鹳草、百味参、麦瓶草、白酒草、天冬、北风草、枇杷叶、知母、北沙参、麻黄、瓜蒌、巴戟天、乳香、墨旱莲和沙棘。该药物制剂治疗效果好,可以提高患者的治愈率,不良反应少,值得推广应用。
Description
技术领域
本发明涉及中医药技术领域,尤其涉及一种用于治疗慢性阻塞性肺疾病的药物制剂。
背景技术
慢性阻塞性肺疾病(chronic obstructive pulmonary disease,COPD)是一种可以预防和治疗的呼吸系统常见疾病,其特征是持续存在的气流受限,并呈进行性发展,由于患病人数逐年增多、死亡率高、社会经济负担加重,因此对COPD的有效防治已成为一个重要的公共卫生问题,其是目前世界上第六大致死性疾病,世界卫生组织(WHO)预计到2020年,它将成为世界范围内第五大负担的疾病。
目前普遍认为COPD以气道、肺实质和肺血管的慢性炎症为主,其进行性的加重常与呼吸道感染相关;患者多反复使用抗生素,对多种抗生素产生耐药,临床症状不易控制,疗效局限,故单纯西医长期治疗COPD效果随病程的加长而减弱,目前没有一种西药药物可以阻止COPD患者肺功能长期下降。因此,寻找有效地治疗药物以减轻COPD的炎症,改善肺功能,减轻气道重塑是目前医学界迫切需要解决的问题。
另外,西医对COPD虽然具有确切疗效,但其长期反复使用广谱抗生素、茶碱类药物及支气管扩张剂会造成胃黏膜屏障受损,肠道菌群失调、移位,致使消化吸收功能障碍等副作用,且维持时间短。因此患者治疗后生存质量较差。
中医学虽然没有慢性阻塞性肺疾病这一病名,但根据其典型的临床表现,中医将其归属于“咳嗽”、“喘证”、“哮病”、“痰饮”“、肺胀”等范畴。其病因复杂,概言之有外感、内伤两大类,外感为六淫外邪侵袭肺系;内伤为饮食不当、情志失调、劳欲久病等导致肺气上逆,宣降失司或气无所主,肾失摄纳而成。病变首先在肺,继则影响脾、肝、肾,后期病及于心;因肺主气、司呼吸,主表卫外,外邪多首先犯肺,导致肺气宣降不利,上逆为咳,升降失常则喘,久则肺虚,卫外失职,六淫之邪反复袭肺,诱发本病的发生;若肺病及脾,子盗母气,脾失健运,则肺脾两虚,气虚痰盛;肺为气之主,肾为气之根,若久病肺虚及肾,金不生水,致肾气衰惫,肺不主气,肾不纳气,则气喘日益加重,呼吸短促难续,吸气尤为困难,动则尤甚。
该病变首先在肺,继则影响脾、肾,后期病及于心。脾为后天之本,“脾胃一伤,百病乃生”,“脾胃俱虚,纳化皆难,元气斯弱,百邪易侵”,“肺为贮痰之器,脾为生痰之源”,“肺气伤而不清也......脾湿动而为痰也”,可见脾与肺关系密切,李东垣提出了“脾胃一虚,肺气先绝”之论。中医五行理论中,脾属土,肺属金,五行生克中土生金,故脾为肺之母,两者可以互相影响。
根据中医治疗理论,本发明以健脾补肾、益气活血、清肺祛痰为治疗原则,本发明提供一种用于治疗慢性阻塞性肺疾病的药物制剂,其治疗效果好,可以提高患者的治愈率,不良反应少,值得推广应用。
发明内容
本发明所要解决的技术问题是提供一种用于治疗慢性阻塞性肺疾病的药物制剂,其治疗效果好,可以提高患者的治愈率,不良反应少,值得推广应用。
为解决上述技术问题,本发明提供了一种用于治疗慢性阻塞性肺疾病的药物制剂,其原料药包括丹参、仙鹤草、黄精、莪术、桂枝、浙贝母、桑白皮、芡实、百眼藤、皂角刺、老鹳草、百味参、麦瓶草、白酒草、天冬、北风草、枇杷叶、知母、北沙参、麻黄、瓜蒌、巴戟天、乳香、墨旱莲和沙棘。
其中,所述药物制剂中各原料药的重量分别为:丹参35g~45g、仙鹤草10g~20g、黄精30g~40g、莪术25g~35g、桂枝15g~25g、浙贝母20g~30g、桑白皮15g~25g、芡实20g~30g、百眼藤15g~25g、皂角刺10g~20g、老鹳草15g~25g、百味参25g~35g、麦瓶草20g~30g、白酒草20g~30g、天冬35g~45g、北风草15g~25g、枇杷叶15g~25g、知母25g~35g、北沙参30g~40g、麻黄15g~25g、瓜蒌10g~20g、巴戟天15g~25g、乳香10g~20g、墨旱莲25g~35g和沙棘15g~25g。
其中,所述药物制剂中各原料药的重量分别为:丹参35g~40g、仙鹤草10g~15g、黄精30g~35g、莪术25g~30g、桂枝15g~20g、浙贝母20g~25g、桑白皮15g~20g、芡实20g~25g、百眼藤15g~20g、皂角刺10g~15g、老鹳草15g~20g、百味参30g~35g、麦瓶草25g~30g、白酒草25g~30g、天冬40g~45g、北风草20g~25g、枇杷叶20g~25g、知母30g~35g、北沙参35g~40g、麻黄20g~25g、瓜蒌15g~20g、巴戟天20g~25g、乳香15g~20g、墨旱莲30g~35g和沙棘20g~25g。
其中,所述药物制剂中各原料药的重量分别为:丹参40g、仙鹤草15g、黄精35g、莪术30g、桂枝20g、浙贝母25g、桑白皮20g、芡实25g、百眼藤20g、皂角刺15g、老鹳草20g、百味参30g、麦瓶草25g、白酒草25g、天冬40g、北风草20g、枇杷叶20g、知母30g、北沙参35g、麻黄20g、瓜蒌15g、巴戟天20g、乳香15g、墨旱莲30g和沙棘20g。
其中,所述药物制剂可以制备成颗粒剂和胶囊剂。
本发明还提供了上述药物制剂的制备方法,当所制备的药物制剂为颗粒剂时,具体为:
第一步,取黄精、芡实、百味参、天冬、北沙参和墨旱莲,分别粉碎,按上述重量混合,将混合均匀后的混合物溶解于醇浓度为85%~95%的乙醇中,每100g混合物对应的乙醇的添加量为300g,浸渍24小时~36小时,随后采用渗漉法以每分钟1~2ml的速度缓缓渗漉,收集渗漉液,渗漉液静置过夜,过滤,过滤液除去溶剂,粉碎并干燥,获得第一粉末;
第二步,将桂枝、浙贝母、百眼藤、白酒草、知母、瓜蒌分别粉碎,按上述重量混合,每100g获得的混合均匀后的混合物放入400ml酒精度为50℃~60℃的白酒中,密封浸泡15~20天,随后煮沸1小时~3小时,静置12小时,过滤,获得的滤液浓缩至去除所有的白酒,粉碎并干燥,获得第二粉末,滤渣备用;
第三步,将佘下组分分别粉碎,按上述重量混合,获得混合物,每300g该混合物,加入1L~2L水,加热煎煮3小时~5小时,煎煮液过滤,滤渣与第二步获得的滤渣混合,每300g混合的滤渣加入1L~2L水,加热煎煮2小时~4小时,煎煮液过滤,将过滤后的滤液浓缩至去除所有的水,粉碎病干燥,获得第三粉末;
第四步,将第一粉末、第二粉末、第三粉末混合,将混合的粉末加入相对于混合粉末质量的质量百分比20%~30%蔗糖粉,以醇浓度为75%~85%乙醇制软材,用摇摆式颗粒机制粒,在60℃下烘干,整粒,得药物颗粒剂,分袋盛装,每袋10g。
本发明还提供了上述药物制剂的制备方法,当所制备的药物制剂为颗粒剂时,具体为:
第一步,取黄精、芡实、百味参、天冬、北沙参和墨旱莲,分别粉碎,按上述重量混合,将混合均匀后的混合物溶解于醇浓度为85%~95%的乙醇中,每100g混合物对应的乙醇的添加量为300g,浸渍24小时~36小时,随后采用渗漉法以每分钟1~2ml的速度缓缓渗漉,收集渗漉液,渗漉液静置过夜,过滤,过滤液除去溶剂,粉碎并干燥,获得第一粉末;
第二步,将桂枝、浙贝母、百眼藤、白酒草、知母、瓜蒌分别粉碎,按上述重量混合,每100g获得的混合均匀后的混合物放入400ml酒精度为50℃~60℃的白酒中,密封浸泡15~20天,随后煮沸1小时~3小时,静置12小时,过滤,获得的滤液浓缩至去除所有的白酒,粉碎并干燥,获得第二粉末,滤渣备用;
第三步,将佘下组分分别粉碎,按上述重量混合,获得混合物,每300g该混合物,加入1L~2L水,加热煎煮3小时~5小时,煎煮液过滤,滤渣与第二步获得的滤渣混合,每300g混合的滤渣加入1L~2L水,加热煎煮2小时~4小时,煎煮液过滤,将过滤后的滤液浓缩至去除所有的水,粉碎病干燥,获得第三粉末;
第四步,将第一粉末、第二粉末、第三粉末混合,获得的混合物与淀粉混合均匀,每100g混合产物加入的淀粉量为100g,加醇浓度为25%的乙醇制粒,所加入的乙醇的质量相当于混合产物与淀粉的混合物质量的0.1~0.2倍,将颗粒干燥,加入硬脂酸镁,硬脂酸镁的重量相当于混合产物与淀粉的混合物质量的0.01~0.02倍,混合均匀,装入要用胶囊中,获得胶囊剂。
本发明的有益效果:
本发明提供的用于治疗慢性阻塞性肺疾病的药物制剂治疗效果好,可以提高患者的治愈率,不良反应少,值得推广应用。
具体实施方式
本发明提供了一种用于治疗慢性阻塞性肺疾病的药物制剂,其原料药包括丹参、仙鹤草、黄精、莪术、桂枝、浙贝母、桑白皮、芡实、百眼藤、皂角刺、老鹳草、百味参、麦瓶草、白酒草、天冬、北风草、枇杷叶、知母、北沙参、麻黄、瓜蒌、巴戟天、乳香、墨旱莲和沙棘。
进一步,所述药物制剂仅由上述原料药构成。
所述药物制剂中各原料药的重量分别为:丹参35g~45g、仙鹤草10g~20g、黄精30g~40g、莪术25g~35g、桂枝15g~25g、浙贝母20g~30g、桑白皮15g~25g、芡实20g~30g、百眼藤15g~25g、皂角刺10g~20g、老鹳草15g~25g、百味参25g~35g、麦瓶草20g~30g、白酒草20g~30g、天冬35g~45g、北风草15g~25g、枇杷叶15g~25g、知母25g~35g、北沙参30g~40g、麻黄15g~25g、瓜蒌10g~20g、巴戟天15g~25g、乳香10g~20g、墨旱莲25g~35g和沙棘15g~25g。
进一步优选,所述药物制剂中各原料药的重量分别为:丹参35g~40g、仙鹤草10g~15g、黄精30g~35g、莪术25g~30g、桂枝15g~20g、浙贝母20g~25g、桑白皮15g~20g、芡实20g~25g、百眼藤15g~20g、皂角刺10g~15g、老鹳草15g~20g、百味参30g~35g、麦瓶草25g~30g、白酒草25g~30g、天冬40g~45g、北风草20g~25g、枇杷叶20g~25g、知母30g~35g、北沙参35g~40g、麻黄20g~25g、瓜蒌15g~20g、巴戟天20g~25g、乳香15g~20g、墨旱莲30g~35g和沙棘20g~25g。
最优选,所述药物制剂中各原料药的重量分别为:丹参40g、仙鹤草15g、黄精35g、莪术30g、桂枝20g、浙贝母25g、桑白皮20g、芡实25g、百眼藤20g、皂角刺15g、老鹳草20g、百味参30g、麦瓶草25g、白酒草25g、天冬40g、北风草20g、枇杷叶20g、知母30g、北沙参35g、麻黄20g、瓜蒌15g、巴戟天20g、乳香15g、墨旱莲30g和沙棘20g。
所述药物制剂可以制备成颗粒剂和胶囊剂。
本发明还提供了上述药物制剂的制备方法,当所制备的药物制剂为颗粒剂时,具体为:
第一步,取黄精、芡实、百味参、天冬、北沙参和墨旱莲,分别粉碎,按上述重量混合,将混合均匀后的混合物溶解于醇浓度为85%~95%的乙醇中,每100g混合物对应的乙醇的添加量为300g,浸渍24小时~36小时,随后采用渗漉法以每分钟1~2ml的速度缓缓渗漉,收集渗漉液,渗漉液静置过夜,过滤,过滤液除去溶剂,粉碎并干燥,获得第一粉末;
第二步,将桂枝、浙贝母、百眼藤、白酒草、知母、瓜蒌分别粉碎,按上述重量混合,每100g获得的混合均匀后的混合物放入400ml酒精度为50℃~60℃的白酒中,密封浸泡15~20天,随后煮沸1小时~3小时,静置12小时,过滤,获得的滤液浓缩至去除所有的白酒,粉碎并干燥,获得第二粉末,滤渣备用;
第三步,将佘下组分分别粉碎,按上述重量混合,获得混合物,每300g该混合物,加入1L~2L水,加热煎煮3小时~5小时,煎煮液过滤,滤渣与第二步获得的滤渣混合,每300g混合的滤渣加入1L~2L水,加热煎煮2小时~4小时,煎煮液过滤,将过滤后的滤液浓缩至去除所有的水,粉碎病干燥,获得第三粉末;
第四步,将第一粉末、第二粉末、第三粉末混合,将混合的粉末加入相对于混合粉末质量的质量百分比20%~30%蔗糖粉,以醇浓度为75%~85%乙醇制软材,用摇摆式颗粒机制粒,在60℃下烘干,整粒,得药物颗粒剂,分袋盛装,每袋10g。
本发明还提供了上述药物制剂的制备方法,当所制备的药物制剂为颗粒剂时,具体为:
第一步,取黄精、芡实、百味参、天冬、北沙参和墨旱莲,分别粉碎,按上述重量混合,将混合均匀后的混合物溶解于醇浓度为85%~95%的乙醇中,每100g混合物对应的乙醇的添加量为300g,浸渍24小时~36小时,随后采用渗漉法以每分钟1~2ml的速度缓缓渗漉,收集渗漉液,渗漉液静置过夜,过滤,过滤液除去溶剂,粉碎并干燥,获得第一粉末;
第二步,将桂枝、浙贝母、百眼藤、白酒草、知母、瓜蒌分别粉碎,按上述重量混合,每100g获得的混合均匀后的混合物放入400ml酒精度为50℃~60℃的白酒中,密封浸泡15~20天,随后煮沸1小时~3小时,静置12小时,过滤,获得的滤液浓缩至去除所有的白酒,粉碎并干燥,获得第二粉末,滤渣备用;
第三步,将佘下组分分别粉碎,按上述重量混合,获得混合物,每300g该混合物,加入1L~2L水,加热煎煮3小时~5小时,煎煮液过滤,滤渣与第二步获得的滤渣混合,每300g混合的滤渣加入1L~2L水,加热煎煮2小时~4小时,煎煮液过滤,将过滤后的滤液浓缩至去除所有的水,粉碎病干燥,获得第三粉末;
第四步,将第一粉末、第二粉末、第三粉末混合,获得的混合物与淀粉混合均匀,每100g混合产物加入的淀粉量为100g,加醇浓度为25%的乙醇制粒,所加入的乙醇的质量相当于混合产物与淀粉的混合物质量的0.1~0.2倍,将颗粒干燥,加入硬脂酸镁,硬脂酸镁的重量相当于混合产物与淀粉的混合物质量的0.01~0.02倍,混合均匀,装入要用胶囊中,获得胶囊剂。
所述各原料药的药理如下:
丹参:味苦,性微寒,归心、肝经,具有活血调经,祛瘀止痛,凉血消痈,清心除烦,养血安神的功效,主治月经不调,经闭痛经,症瘕积聚,胸腹刺痛,热痹疼痛,疮疡肿痛,心烦不眠;肝脾肿大,心绞痛等证。
仙鹤草:拉丁名Agrimoniae Herba,味苦、涩,性平,归心、肝经,具有收敛止血,止痢杀虫的功效,主治各种出血之证,例如:吐血、尿血、便血、崩漏、咯血、衄血,赤白痢疾,劳伤脱力,痈肿,跌打,创伤出血等证。
黄精:味甘,性平,入肺、脾、肾经,具有养气养阴,健脾润肺,益肾填精的作用,用于脾胃气阴亏虚,食少无力,阴虚肺燥,干咳少痰,阴虚内热之消渴,肾虚精亏、阳痿遗精、头晕耳鸣、目昏眼花等证。
莪术:味辛、苦,性温,入肝、脾经,具有破血行气,消积止痛的功效,用于气滞血瘀所致的症瘕痞块,胸腹瘀痛,闭经,痛经,脘腹胀痛,跌打损伤,血瘀肿痛等证。
桂枝:拉丁名cinnamomi ramulus,为樟科植物肉桂干燥嫩枝,味辛、甘,性温,归心、肺、膀胱经,具有发汗解肌,温经通脉,助阳化气,散寒止痛的作用,温经通脉,横通肢节,用于外感风寒表证,不论有汗、无汗均可应用,亦用于风湿痹痛、胃寒腹痛、经闭、痛经,风湿痹痛,肩臂肢节冷痛等证,痰饮证和膀胱蓄水,心脾阳虚,水湿内停,胸胁胀满,咳逆头晕等痰饮证。
浙贝母:味苦,性寒,入肺、心经,具有清热化痰,散结解毒的功效,主治风热咳嗽,肺痈喉痹,瘰疬,疮疡肿毒等证。
桑白皮:味甘,性寒,入肺经,具有泻肺平喘,利水消肿的作用,为泻肺行水之常用药物之一,主要用于热邪郁肺、气逆不降之喘咳气急,多痰,色黄,痰饮内停,胸阳不宣之胀满咳逆,肺气失宣、水汽不行至水肿喘满,小便不利,利胆,生津,散结等证。
芡实:味甘,涩,性平。归脾、肾经。具有益肾固精,补脾止泻,祛湿止带的功能,主治梦遗滑精,脾虚泄泻,脾虚白浊,带下等证。
百眼藤:为茜草科巴戟天属植物细叶巴戟天的全株,味甘,性凉,具有清热止咳,和胃化湿,散瘀止痛的功效,主治感冒咳嗽,百日咳,消化不良,湿疹,跌打损伤,腰肌劳损等证。
皂角刺:味辛,性温,归肺经,主治痈疽肿毒,瘰疬,疮疹顽癣,产后缺乳,胎衣不下,疠风等证。
老鹳草:味辛、苦,性平,归肝、肾、脾经,具有祛风湿,通经络,止泻利的功效,用于风湿痹痛,麻木拘挛,筋骨酸痛,泄泻痢疾等证。
百味参:为百合科粉条儿菜属植物穗花粉条儿菜的全草,味辛、微苦,性温,归肺、脾经,具有补虚敛汗,止血的功效,主治体虚自汗,盗汗,神经衰弱,吐血,便血等证。
麦瓶草:味甘、微苦,性凉,归肺、肝经,具有养阴清热,止血调经的功效,主治吐血、咳血、尿血、月经不调、徐老咳嗽等证。
白酒草:味苦,辛,性寒,具有清热止痛,祛风化痰的功效,主治喉炎,肺炎,咽喉肿痛,扁桃体炎等证。
天冬:味甘、苦,性寒,归肺、肾经,具有养阴润燥,清肺生津的功效,主治燥热咳嗽,阴虚劳嗽,阴虚火旺,肾精不固之遗精、早泄及虚火上炎之咽喉肿痛,热病津伤口渴,内热消渴肠燥便秘等证。
北风草:味苦;微辛;性平,具有清肺;明目;解毒的功效,主治肺热咳嗽;胸痛;咽喉肿痛;目赤青盲;乳痈;湿疹;跌打损伤等证。
枇杷叶:味苦,性微寒,归肺,胃经,具有清肺止咳,降逆止呕的功效,本品苦寒,能清肺热,降肺气以止咳,常用于治疗肺热咳嗽、痰多色黄,可降胃气而止呕逆,用于胃热引起的呕逆,治疗口干消渴,肺风面疮,粉刺。
知母:拉丁名Anemarrhenae Rhizoma,味苦、甘,性寒,入肺、胃、肾经,有泻热除烦,滋阴润燥、清肺止咳的作用,主治外感热病,高热烦躁,肺热燥咳,内热消渴等症状;其苦寒质润,性沉降,既能清热,又能生津,善治温热病邪入气分,热盛伤津;也用于治疗消渴症;痰热壅肺而喘,肺燥咳嗽,痰少不利;阴虚火旺,虚火上炎等证。
北沙参:性微寒,味甘、微苦,具有养阴清肺,益胃生津的功效,主治肺热燥咳、劳嗽痰血、热病津伤口渴等证。
麻黄:味辛、微苦,性温,入肺、膀胱经,具有发寒解表,宣肺平喘,利水消肿的作用,主要用于外感风寒之发热无汗等表实证;风湿性痹痛;寒邪犯肺或热邪壅肺至咳喘气逆,水肿,小便不利等证。
瓜蒌:味甘,微苦,性寒,入肺、胃、大肠经,具有清热化痰、宽胸散结,润肠通便的功效,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,大便秘结等证。
巴戟天:味辛、甘,性温,归肝、肾经,具有补肾助阳;强筋壮骨;祛风除湿的功效,主治肾虚阳痿;遗精早泄;少腹冷痛;小便不禁;宫冷不孕;风寒湿痹;腰膝酸软;风湿肢气等证。
乳香:味辛、苦、性温,归心、肝、脾经,具有活血,行气、止痛的功效,主治瘀阻气滞的脘腹疼痛,风湿痹痛,跌打损伤,痛经,产后腹痛等证。
墨旱莲:拉丁名Ecliptae Herba,味甘、酸,性寒,归肝、肾经,起到补益肝肾,凉血止血的功效,主治肝肾阴虚所致头晕目眩、视物昏花,腰膝酸软;适宜于阴虚有热者,胃中积热之吐血,热伤肺络之咳血等证。
沙棘:味酸;涩;性温,具有止咳化痰;健胃消食;活血散瘀的功效。主治咳嗽痰多;肺脓肿;消化不良;食积腹痛;胃痛;肠炎;闭经;跌打瘀肿等证。
本发明提供的用于治疗慢性阻塞性肺疾病的药物制剂更优选用于治疗慢性阻塞性肺疾病急性加重期。
以下采用实施例来详细说明本发明的实施方式,借此对本发明如何应用技术手段来解决技术问题,并达成技术效果的实现过程能充分理解并据以实施。
实施例1 颗粒剂1
取黄精35g、芡实25g、百味参30g、天冬40g、北沙参35g和墨旱莲30g分别粉碎,混合,将混合均匀后的混合物溶解于醇浓度为95%的乙醇中,每100g混合物对应的乙醇的添加量为300g,浸渍24小时,随后采用渗漉法以每分钟2ml的速度缓缓渗漉,收集渗漉液,渗漉液静置过夜,过滤,过滤液除去溶剂,粉碎并干燥,获得第一粉末,将桂枝20g、浙贝母25g、百眼藤20g、白酒草25g、知母30g、瓜蒌15g分别粉碎,混合,每100g获得的混合均匀后的混合物放入400ml酒精度为50℃~60℃的白酒中,密封浸泡20天,随后煮沸3小时,静置12小时,过滤,获得的滤液浓缩至去除所有的白酒,粉碎并干燥,获得第二粉末,滤渣备用,将丹参40g、仙鹤草15g、莪术30g、桑白皮20g、皂角刺15g、老鹳草20g、麦瓶草25g、北风草20g、枇杷叶20g、麻黄20g、巴戟天20g、乳香15g和沙棘20g分别粉碎,混合,获得混合物,每300g该混合物,加入2L水,加热煎煮5小时,煎煮液过滤,滤渣与前面获得的滤渣混合,每300g混合的滤渣加入2L水,加热煎煮4小时,煎煮液过滤,将过滤后的滤液浓缩至去除所有的水,粉碎病干燥,获得第三粉末,将第一粉末、第二粉末、第三粉末混合,将混合的粉末加入相对于混合粉末质量20%蔗糖粉(质量百分比),以醇浓度为85%乙醇制软材,用摇摆式颗粒机制粒,在60℃下烘干,整粒,得药物颗粒剂,分袋盛装,每袋10g。
实施例2 颗粒剂2
取黄精30g、芡实20g、百味参30g、天冬40g、北沙参35g和墨旱莲30g分别粉碎,混合,将混合均匀后的混合物溶解于醇浓度为95%的乙醇中,每100g混合物对应的乙醇的添加量为300g,浸渍24小时,随后采用渗漉法以每分钟2ml的速度缓缓渗漉,收集渗漉液,渗漉液静置过夜,过滤,过滤液除去溶剂,粉碎并干燥,获得第一粉末,将桂枝15g、浙贝母20g、百眼藤15g、白酒草25g、知母30g、瓜蒌15g分别粉碎,混合,每100g获得的混合均匀后的混合物放入400ml酒精度为50℃~60℃的白酒中,密封浸泡20天,随后煮沸3小时,静置12小时,过滤,获得的滤液浓缩至去除所有的白酒,粉碎并干燥,获得第二粉末,滤渣备用,将丹参35g、仙鹤草10g、莪术25g、桑白皮15g、皂角刺10g、老鹳草15g、麦瓶草25g、北风草20g、枇杷叶20g、麻黄20g、巴戟天20g、乳香15g和沙棘20g分别粉碎,混合,获得混合物,每300g该混合物,加入2L水,加热煎煮5小时,煎煮液过滤,滤渣与前面获得的滤渣混合,每300g混合的滤渣加入2L水,加热煎煮4小时,煎煮液过滤,将过滤后的滤液浓缩至去除所有的水,粉碎病干燥,获得第三粉末,将第一粉末、第二粉末、第三粉末混合,将混合的粉末加入相对于混合粉末质量20%蔗糖粉(质量百分比),以醇浓度为85%乙醇制软材,用摇摆式颗粒机制粒,在60℃下烘干,整粒,得药物颗粒剂,分袋盛装,每袋10g。
实施例3 颗粒剂3
取黄精35g、芡实25g、百味参25g、天冬35g、北沙参30g和墨旱莲25g分别粉碎,混合,将混合均匀后的混合物溶解于醇浓度为95%的乙醇中,每100g混合物对应的乙醇的添加量为300g,浸渍24小时,随后采用渗漉法以每分钟2ml的速度缓缓渗漉,收集渗漉液,渗漉液静置过夜,过滤,过滤液除去溶剂,粉碎并干燥,获得第一粉末,将桂枝20g、浙贝母25g、百眼藤20g、白酒草20g、知母25g、瓜蒌10g分别粉碎,混合,每100g获得的混合均匀后的混合物放入400ml酒精度为50℃~60℃的白酒中,密封浸泡20天,随后煮沸3小时,静置12小时,过滤,获得的滤液浓缩至去除所有的白酒,粉碎并干燥,获得第二粉末,滤渣备用,将丹参40g、仙鹤草15g、莪术30g、桑白皮20g、皂角刺15g、老鹳草20g、麦瓶草20g、北风草15g、枇杷叶15g、麻黄15g、巴戟天15g、乳香10g和沙棘15g分别粉碎,混合,获得混合物,每300g该混合物,加入2L水,加热煎煮5小时,煎煮液过滤,滤渣与前面获得的滤渣混合,每300g混合的滤渣加入2L水,加热煎煮4小时,煎煮液过滤,将过滤后的滤液浓缩至去除所有的水,粉碎病干燥,获得第三粉末,将第一粉末、第二粉末、第三粉末混合,将混合的粉末加入相对于混合粉末质量20%蔗糖粉(质量百分比),以醇浓度为85%乙醇制软材,用摇摆式颗粒机制粒,在60℃下烘干,整粒,得药物颗粒剂,分袋盛装,每袋10g。
实施例4 胶囊剂1
取黄精35g、芡实25g、百味参30g、天冬40g、北沙参35g和墨旱莲30g分别粉碎,混合,将混合均匀后的混合物溶解于醇浓度为95%的乙醇中,每100g混合物对应的乙醇的添加量为300g,浸渍24小时,随后采用渗漉法以每分钟2ml的速度缓缓渗漉,收集渗漉液,渗漉液静置过夜,过滤,过滤液除去溶剂,粉碎并干燥,获得第一粉末,将桂枝20g、浙贝母25g、百眼藤20g、白酒草25g、知母30g、瓜蒌15g分别粉碎,混合,每100g获得的混合均匀后的混合物放入400ml酒精度为50℃~60℃的白酒中,密封浸泡20天,随后煮沸3小时,静置12小时,过滤,获得的滤液浓缩至去除所有的白酒,粉碎并干燥,获得第二粉末,滤渣备用,将丹参40g、仙鹤草15g、莪术30g、桑白皮20g、皂角刺15g、老鹳草20g、麦瓶草25g、北风草20g、枇杷叶20g、麻黄20g、巴戟天20g、乳香15g和沙棘20g分别粉碎,混合,获得混合物,每300g该混合物,加入2L水,加热煎煮5小时,煎煮液过滤,滤渣与前面获得的滤渣混合,每300g混合的滤渣加入2L水,加热煎煮4小时,煎煮液过滤,将过滤后的滤液浓缩至去除所有的水,粉碎病干燥,获得第三粉末,将第一粉末、第二粉末、第三粉末混合,获得的混合物与淀粉混合均匀,每100g混合产物加入的淀粉量为100g,加醇浓度为25%的乙醇制粒,所加入的乙醇的质量相当于混合产物与淀粉的混合物质量的0.1倍,将颗粒干燥,加入硬脂酸镁,硬脂酸镁的重量相当于混合产物与淀粉的混合物质量的0.01倍,混合均匀,装入要用胶囊中,获得胶囊剂。
实施例5 毒理学试验
选取ICR小鼠60只,分成空白对照组和治疗组,每组30只。
实验药物
小鼠灌胃本发明实施例1制备的颗粒剂1。
小鼠急性毒性实验
将治疗组小鼠按照上面的方法给药,将颗粒剂1溶解在水中,制备成1g/ml的溶液灌胃,每次灌胃0.8ml/10g,空白对照组灌胃等量生理盐水,试验前禁食(不禁水)12h后,治疗组每天1次灌胃给药,连续14d,记录受试小鼠行为、活动、摄食量、体重、粪便、死亡等情况,未死亡小鼠于14d后处死进行尸检。
中药组合物80g(生药)/kg剂量给药的小鼠,当天见小鼠毛色光滑、粪便为褐色,质地较稀软,摄食、活动较少,第2天后小鼠活动、摄食量、体重增长、粪便等均恢复正常,与空白对照组比较无明显差异;且14d内无死亡及其他异常发生,两组同时处死后进行尸检,各主要脏器(心、肝、脾、肺、肾)经肉眼观察未见异常。
豚鼠反复给药毒性实验
将颗粒剂1溶解在水中,制备成1g/ml的溶液,将给药组豚鼠按照上面的方法给药,每次0.8ml/10g,空白对照组灌胃等量生理盐水,试验前禁食(不禁水)12h后,治疗组每天1次灌胃给药,连续5周,记录受试豚鼠行为、活动、摄食量、体重、粪便、死亡等情况,未死亡豚鼠于5周后处死进行尸检。
试验动物在整个试验期内行为活动、饮食、大小便和被毛色泽等情况未见明显异常,未见呕吐、流涎、流泪、呼吸困难等症状。试验期间有个别动物死亡,经笼旁及解剖学观察,死亡动物未见明显异常,为给药不当致死。
给药组动物给药后生长发育良好,体重增长与空白对照组比较未见明显异常。
试验结束后处死动物,立即解剖,肉眼观察大脑、心脏、肝脏、脾脏、肺脏、肾脏等主要器官,各器官表面光滑,无粘连,色泽正常,未见充血、肿胀、出血、坏死、粘连,胃肠无扩张,肠壁无水肿、出血、溃疡等异常现象。
心脏:心肌细胞横纹清晰,核居中,间质未见血管扩张及炎细胞浸润;心外膜、心内膜无异常。肝脏:肝细胞排列呈索状,肝小叶结构清楚,汇管区未见炎细胞浸润及纤维结缔组织增生,肝细胞多边形,浆丰富,核大而圆。脾脏:纤维包膜完整,无增厚,脾小体清晰可见,小梁结构正常,红髓、白髓清楚,未见变性、坏死及炎细胞浸润。肺脏:细支气管结构完整,层次清楚,肺泡壁结构完整,肺间隔及支气管完好无损,腔内无明显渗出物,未见变性、坏死及炎细胞浸润。肾脏:肾脏皮质、髓质、肾小球结构正常,肾小球细胞数未增多,毛细血管管腔无扩张,肾小管上皮细胞、肾间质未见异常。大脑:组织结构正常,神经细胞、神经胶质细胞形态正常,各层神经元细胞无明显异常。
上述试验证明本发明提供的中药组合物无毒性,适于安全应用。
实施例6 临床资料
一般资料
选择2011年10月至2013年9月入住本科的COPD急性加重期患者160例,参照中华人民共和国卫生部《慢性阻塞性肺疾病诊断标准(2010-301)》。将160例患者随机分为治疗组及对照组,治疗组80例,男性43例,女性37例,平均年龄60.18±2.91岁;对照组80例,男性46例,女性34例,平均年龄58.19±2.26岁。两组均排除合并有哮喘、高血压、冠心病、心律失常、心衰、糖尿病以及需要机械通气的患者;两组患者在性别、年龄、病程等方面均无显著性差异(P>0.05)。
治疗方法
对照组:用抗炎、解痉、化痰、能量、必要时吸氧等常规治疗。治疗组在对照组的基础上口服本发明实施例1制备的颗粒剂,将其溶解在水中,配置成1g/ml的溶液,口服,每日3次,每次100ml,10d一个疗程,观察一个疗程。
疗效标准
参照国家中医药管理局颁布的《中医临床病诊断疗效标准》。临床痊愈:咳嗽、咳痰、呼吸困难等症状及肺部啰音皆消失。显效:咳嗽、咳痰、呼吸困难等症状明显好转,肺部啰音消失或明显减轻。好转:咳嗽、咳痰、呼吸困难等症状好转,肺部啰音减少。无效:咳、痰、呼吸困难等症状无改变或减轻不明显,以及肺部啰音无减少或增多。
实验室检查
以肺功能、血气分析及其他实验检查,作为治疗效果评估的参考指标。
统计学方法
计量资料采用表示,组间比较采用χ2检验,所有资料均采用SPSS12.0统计软件处理。
治疗结果
两组临床疗效比较,结果见表1。
表1 两组治疗后临床疗效比较
组别 | 例数 | 临床痊愈 | 显效 | 好转 | 无效 |
治疗组 | 80 | 53(66.3%) | 20(25.0%) | 7(8.8%) | 0(0.0%) |
对照组 | 80 | 21(26.3%) | 36(45.0%) | 23(28.8%) | 0(0.0%) |
从表1可以看出,本发明中药制剂配合西药使用,治疗效果要明显好于对照组。
两组患者肺功能测定比较,结果见表2。
表2 两组治疗前后FEV1、FEV1/FVC比较
从表2可以看出,治疗组和对照组在治疗之前FEV1、FEV1/FVC无显著差异,治疗之后与治疗之前差异明显(P<0.05),治疗之后治疗组的FEV1、FEV1/FVC值均高于对照组(P<0.05)。
两组患者血气分析检测比较,结果见表3。
表3两组治疗前后PaO2、PaCO2比较
从表2可以看出,治疗组和对照组在治疗之前PaO2、PaCO2无显著差异,治疗之后与治疗之前差异明显(P<0.05),治疗之后治疗组的PaO2显著高于对照组(P<0.05),PaCO2显著低于对照组(P<0.05)。
所有上述的首要实施这一知识产权,并没有设定限制其他形式的实施这种新产品和/或新方法。本领域技术人员将利用这一重要信息,上述内容修改,以实现类似的执行情况。但是,所有修改或改造基于本发明新产品属于保留的权利。
以上所述,仅是本发明的较佳实施例而已,并非是对本发明作其它形式的限制,任何熟悉本专业的技术人员可能利用上述揭示的技术内容加以变更或改型为等同变化的等效实施例。但是凡是未脱离本发明技术方案内容,依据本发明的技术实质对以上实施例所作的任何简单修改、等同变化与改型,仍属于本发明技术方案的保护范围。
Claims (7)
1.一种用于治疗慢性阻塞性肺疾病的药物制剂,其特征在于:原料药包括丹参、仙鹤草、黄精、莪术、桂枝、浙贝母、桑白皮、芡实、百眼藤、皂角刺、老鹳草、百味参、麦瓶草、白酒草、天冬、北风草、枇杷叶、知母、北沙参、麻黄、瓜蒌、巴戟天、乳香、墨旱莲和沙棘。
2.如权利要求1所述的药物制剂,其特征在于:各原料药的重量分别为丹参35g~45g、仙鹤草10g~20g、黄精30g~40g、莪术25g~35g、桂枝15g~25g、浙贝母20g~30g、桑白皮15g~25g、芡实20g~30g、百眼藤15g~25g、皂角刺10g~20g、老鹳草15g~25g、百味参25g~35g、麦瓶草20g~30g、白酒草20g~30g、天冬35g~45g、北风草15g~25g、枇杷叶15g~25g、知母25g~35g、北沙参30g~40g、麻黄15g~25g、瓜蒌10g~20g、巴戟天15g~25g、乳香10g~20g、墨旱莲25g~35g和沙棘15g~25g。
3.如权利要求1或2所述的药物制剂,其特征在于:各原料药的重量分别为丹参35g~40g、仙鹤草10g~15g、黄精30g~35g、莪术25g~30g、桂枝15g~20g、浙贝母20g~25g、桑白皮15g~20g、芡实20g~25g、百眼藤15g~20g、皂角刺10g~15g、老鹳草15g~20g、百味参30g~35g、麦瓶草25g~30g、白酒草25g~30g、天冬40g~45g、北风草20g~25g、枇杷叶20g~25g、知母30g~35g、北沙参35g~40g、麻黄20g~25g、瓜蒌15g~20g、巴戟天20g~25g、乳香15g~20g、墨旱莲30g~35g和沙棘20g~25g。
4.如权利要求1至3所述的药物制剂,其特征在于:各原料药的重量分别为丹参40g、仙鹤草15g、黄精35g、莪术30g、桂枝20g、浙贝母25g、桑白皮20g、芡实25g、百眼藤20g、皂角刺15g、老鹳草20g、百味参30g、麦瓶草25g、白酒草25g、天冬40g、北风草20g、枇杷叶20g、知母30g、北沙参35g、麻黄20g、瓜蒌15g、巴戟天20g、乳香15g、墨旱莲30g和沙棘20g。
5.如权利要求1至4所述的药物制剂,其特征在于:所述药物制剂可以制备成颗粒剂和胶囊剂。
6.权利要求1至4所述药物制剂的制备方法,其特征在于:当所制备的药物制剂为颗粒剂时,具体为,
第一步,取黄精、芡实、百味参、天冬、北沙参和墨旱莲,分别粉碎,按上述重量混合,将混合均匀后的混合物溶解于醇浓度为85%~95%的乙醇中,每100g混合物对应的乙醇的添加量为300g,浸渍24小时~36小时,随后采用渗漉法以每分钟1~2ml的速度缓缓渗漉,收集渗漉液,渗漉液静置过夜,过滤,过滤液除去溶剂,粉碎并干燥,获得第一粉末;
第二步,将桂枝、浙贝母、百眼藤、白酒草、知母、瓜蒌分别粉碎,按上述重量混合,每100g获得的混合均匀后的混合物放入400ml酒精度为50℃~60℃的白酒中,密封浸泡15~20天,随后煮沸1小时~3小时,静置12小时,过滤,获得的滤液浓缩至去除所有的白酒,粉碎并干燥,获得第二粉末,滤渣备用;
第三步,将佘下组分分别粉碎,按上述重量混合,获得混合物,每300g该混合物,加入1L~2L水,加热煎煮3小时~5小时,煎煮液过滤,滤渣与第二步获得的滤渣混合,每300g混合的滤渣加入1L~2L水,加热煎煮2小时~4小时,煎煮液过滤,将过滤后的滤液浓缩至去除所有的水,粉碎病干燥,获得第三粉末;
第四步,将第一粉末、第二粉末、第三粉末混合,将混合的粉末加入相对于混合粉末质量的质量百分比20%~30%蔗糖粉,以醇浓度为75%~85%乙醇制软材,用摇摆式颗粒机制粒,在60℃下烘干,整粒,得药物颗粒剂,分袋盛装,每袋10g。
7.权利要求1至4所述药物制剂的制备方法,其特征在于:当所制备的药物制剂为颗粒剂时,具体为:
第一步,取黄精、芡实、百味参、天冬、北沙参和墨旱莲,分别粉碎,按上述重量混合,将混合均匀后的混合物溶解于醇浓度为85%~95%的乙醇中,每100g混合物对应的乙醇的添加量为300g,浸渍24小时~36小时,随后采用渗漉法以每分钟1~2ml的速度缓缓渗漉,收集渗漉液,渗漉液静置过夜,过滤,过滤液除去溶剂,粉碎并干燥,获得第一粉末;
第二步,将桂枝、浙贝母、百眼藤、白酒草、知母、瓜蒌分别粉碎,按上述重量混合,每100g获得的混合均匀后的混合物放入400ml酒精度为50℃~60℃的白酒中,密封浸泡15~20天,随后煮沸1小时~3小时,静置12小时,过滤,获得的滤液浓缩至去除所有的白酒,粉碎并干燥,获得第二粉末,滤渣备用;
第三步,将佘下组分分别粉碎,按上述重量混合,获得混合物,每300g该混合物,加入1L~2L水,加热煎煮3小时~5小时,煎煮液过滤,滤渣与第二步获得的滤渣混合,每300g混合的滤渣加入1L~2L水,加热煎煮2小时~4小时,煎煮液过滤,将过滤后的滤液浓缩至去除所有的水,粉碎病干燥,获得第三粉末;
第四步,将第一粉末、第二粉末、第三粉末混合,获得的混合物与淀粉混合均匀,每100g混合产物加入的淀粉量为100g,加醇浓度为25%的乙醇制粒,所加入的乙醇的质量相当于混合产物与淀粉的混合物质量的0.1~0.2倍,将颗粒干燥,加入硬脂酸镁,硬脂酸镁的重量相当于混合产物与淀粉的混合物质量的0.01~0.02倍,混合均匀,装入要用胶囊中,获得胶囊剂。
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