CN106975056A - 一种中药微生物发酵制剂及制备方法和应用 - Google Patents
一种中药微生物发酵制剂及制备方法和应用 Download PDFInfo
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Abstract
本发明涉及发酵微生物中药制剂领域,具体来说是一种预防或治疗冠心病、心肌炎、高血压性心脏病的药物,本发明还涉及该制剂的制备方法和应用,所述的发酵中药制剂包括下述中药原料:葛根,蚕蛹,三七,川穹,银杏叶,丹参,西红花,石菖蒲,地龙,黄芪,乳香,没药,当归,黑木耳,桃仁,泽泻,槐花,木香,桂枝,赤芍,降香,毛冬青,郁金,牛膝,桑枝,蒲黄,琥珀,黄连,细草,朱砂,冰片,珍珠母,人工牛黄,人参,龙骨,麦冬,甘草,地黄,红花,水蛭的中药原料药混合所得。该制剂具有宁心安神、活血化瘀、行气止痛、固本培元、平衡阴阳的功效。
Description
技术领域
本发明涉及发中药微生物发酵制剂,具体来说是一种中药微生物发酵制剂及其制备方法和应用。
背景技术
心脏病是一类比较常见的循环***疾病。循环***由心脏、血管和调节血液循环的神经体液组织构成,循环***疾病也成为心血管病,能显著的影响患者的劳动力。心脏病包括风湿性心脏病、先天性心脏病、高血压性心脏病、冠心病等各种心脏病。中医认为“心主血,肺主力”。近些年来心脏病发病比例越来越高,俨然成为危害全球健康的杀手之一。
发明内容
本发明的目的是提供一种治疗心脏病的发酵中药制剂,主治心脏病,同时可治疗因心脏病引发的并发症。
为实现上述目的,本发明采用的技术方案为:
一种中药微生物发酵制剂:将侧耳与中药原料药混合发酵所得,所述中药原料药按重量份数计:葛根10-100份,蚕蛹10-100份,三七10-100份,川穹10-100份,银杏叶10-100份,丹参10-100份,西红花10-100份,石菖蒲10-100份,地龙10-100份,黄芪10-100份,乳香6-60份,没药6-60份,当归6-60份,黑木耳6-60份,桃仁6-60份,泽泻6-60份,槐花6-60份,木香6-60份,桂枝6-60份,赤芍6-60份,降香6-60份,毛冬青4-40份,郁金4-40份,牛膝4-40份,桑枝4-40份,蒲黄4-40份,琥珀4-40份,黄连2-20份,细草2-20份,朱砂2-20份,冰片2-20份,珍珠母2-20份,人工牛黄2-20份,人参2-20份,龙骨2-20份,麦冬2-20份,甘草2-20份,地黄2-20份,红花2-20份,水蛭2-20份;侧耳占中药原料质量的5%-10%;
所述侧耳为Pleurotus sp.,已于2014年4月14日保藏在“中国微生物菌种保藏管理委员会普通微生物中心”,保藏编号为CGMCC No.9060。
侧耳已在CN 105412739A(申请号201410480058.0,申请日2014年09月18日)中公布。
本发明中药原料药按重量份数计优选为:葛根50-100份,蚕蛹50-100份,三七50-100份,川穹50-100份,银杏叶50-100份,丹参50-100份,西红花50-100份,石菖蒲50-100份,地龙50-100份,黄芪50-100份,乳香30-60份,没药30-60份,当归30-60份,黑木耳30-60份,桃仁30-60份,泽泻30-60份,槐花30-60份,木香30-60份,桂枝30-60份,赤芍30-60份,降香30-60份,毛冬青20-40份,郁金20-40份,牛膝20-40份,桑枝20-40份,蒲黄20-40份,琥珀20-40份,黄连10-20份,细草10-20份,朱砂10-20份,冰片10-20份,珍珠母10-20份,人工牛黄10-20份,人参10-20份,龙骨10-20份,麦冬10-20份,甘草10-20份,地黄10-20份,红花10-20份,水蛭10-20份。
本发明中药原料药按重量计最优选为:葛根100g,蚕蛹100g,三七100g,川穹100g,银杏叶100g,丹参100g,西红花100g,石菖蒲100g,地龙100g,黄芪100g,乳香60g,没药60g,当归60g,黑木耳60g,桃仁60g,泽泻60g,槐花60g,木香60g,桂枝60g,赤芍60g,降香60g,毛冬青40g,郁金40g,牛膝40g,桑枝40g,蒲黄40g,琥珀40g,黄连20g,细草20g,朱砂20g,冰片20g,珍珠母20g,人工牛黄20g,人参20g,龙骨20g,麦冬20g,甘草20g,地黄20g,红花20g,水蛭20g。
所述中药微生物发酵制剂的制备方法为:
(1)按重量份数计,取葛根10-100份,蚕蛹10-100份,三七10-100份,川穹10-100份,银杏叶10-100份,丹参10-100份,西红花10-100份,石菖蒲10-100份,地龙10-100份,黄芪10-100份,乳香6-60份,没药6-60份,当归6-60份,黑木耳6-60份,桃仁6-60份,泽泻6-60份,槐花6-60份,木香6-60份,桂枝6-60份,赤芍6-60份,降香6-60份,毛冬青4-40份,郁金4-40份,牛膝4-40份,桑枝4-40份,蒲黄4-40份,琥珀4-40份,黄连2-20份,细草2-20份,朱砂2-20份,冰片2-20份,珍珠母2-20份,人工牛黄2-20份,人参2-20份,龙骨2-20份,麦冬2-20份,甘草2-20份,地黄2-20份,红花2-20份,水蛭2-20份的中药原料药混合,磨粉至数目大于100目,得到中药混合细粉,待用;
(2)取步骤(1)的中药原料药与侧耳混合发酵后,得到发酵物,将发酵物干燥、磨成细粉即得到中药微生物发酵制剂;
所述步骤(2)侧耳接种量为中药原料的5%-10%,并在温度为37-65℃、湿度为80%-98%条件下发酵1-7天,得到中药微生物发酵制剂。
所述侧耳(Pleurotus sp.),已于2014年4月14日保藏在“中国微生物菌种保藏管理委员会普通微生物中心”,保藏编号为CGMCC No.9060。
所述中药微生物发酵制剂可制成散剂、片剂、丸剂、胶丸、胶囊剂、乳剂、糖浆或口服液。
所述中药微生物发酵制剂的应用:作为制备预防或治疗治疗心脏病、冠心病、心肌炎、高血压性心脏病的药物的应用。
本发明的发酵中药制剂是参照君臣佐使的中药组方原则所设计的现代中药。采用的原料药的功效如下所示:
葛根中的葛根素能显著增加缺血组织的血液供应量,有B1受体阻断作用,可明显减慢心瘁,降低心肌氧耗量,能减轻心肌缺血,限制和缩小心肌梗塞范围,抗快速心律失常,能降低胆固醇和血粘度,抑制血小板聚集,改善微循环。
川穹中的川穹嗪能扩张冠状动脉,增加冠状动脉血流量,改善心肌的血氧供应,并降低心肌的耗氧量;川穹嗪可扩张脑血管,降低血管阻力,显著增加脑及肢体血流量,改善微循环。
丹参和三七结合用于治疗冠心病、心绞痛等心血管疾病。研究表明,丹参和三七具有扩张冠状动脉血管、增加动脉血流量、激活超氧化歧化酶等药理功效。
上述中药中葛根,蚕蛹,三七,川穹,银杏叶,丹参,西红花,石菖蒲,地龙,黄芪,作为主药,其他药物作为辅药;主要和辅药混合可更有效的提高各自成分的作用;同时可将辅药中各类成分按照6:4:2的质量比例混合,即辅药1:辅药2:辅药3为6:4:2,其中辅药1为乳香,没药,当归,黑木耳,桃仁,泽泻,槐花,木香,桂枝,赤芍,降香;辅药2为毛冬青,郁金,牛膝,桑枝,蒲黄,琥珀,;辅药3为黄连,细草,朱砂,冰片,珍珠母,人工牛黄,人参,龙骨,麦冬,甘草,地黄,红花,水蛭;将中药按照10:6:4:2的科学配伍比例,可有效将各中药成分间的相辅相成作用发挥极致,进而再将微生物在其中进行发酵,所得发酵物在经侧耳发酵后吸取中药同时发酵产生的有益物质能够更好的作为预防或治疗心脏病、冠心病、心肌炎、高血压性心脏病,同时可治疗因心脏病引发的并发症,治疗胸闷气短,呼吸困难,全身水肿,四肢无力等症状。
本发明的有益效果在于:
1.本发明具有清热,降火,排毒功效。葛根所含的黄酮类化合物有降血脂作用,能降低血清胆固醇,降低甘油三脂,安神活血化瘀,行气止痛,固本培元,平衡气血有很好功效。
2.本发明提供的治疗心脏病的发酵中药制剂,在治疗、治愈心脏病方面有很好的效果,同时,对因心脏病引起的并发症也有很好的疗效,在治疗心脏病的同时,治愈并发症,可长期单独或者配合其他药物使用,无毒副作用,对身体机能的恢复有很好的效果,配制方法操作简单,可进行大规模生产。
具体实施方式
以下实施例用于进一步详细描述本发明,但不构成对本发明的限制,本发明的具体数据绝非仅限于这些实施例。
一、药物制备
实施例1
1.按重量数计,取葛根100g,蚕蛹100g,三七100g,川穹100g,银杏叶100g,丹参100g,西红花100g,石菖蒲100g,地龙100g,黄芪100g,乳香60g,没药60g,当归60g,黑木耳60g,桃仁60g,泽泻60g,槐花60g,木香60g,桂枝60g,赤芍60g,降香60g,毛冬青40g,郁金40g,牛膝40g,桑枝40g,蒲黄40g,琥珀40g,黄连20g,细草20g,朱砂20g,冰片20g,珍珠母20g,人工牛黄20g,人参20g,龙骨20g,麦冬20g,甘草20g,地黄20g,红花20g,水蛭20g的中药原料混合粉碎,过100目筛,制成中药混合细粉,待用。
2.侧耳活化:采用接种环挑取侧耳菌丝接于PDA固体培养基,在20℃、培养120小时,得到侧耳纯培养单菌落。
3.将上述活化的侧耳接种到步骤1中药原料中,并在温度为65℃、湿度为98%条件下发酵7天,得到发酵产物,活化的侧耳占中药原料质量的10%。
4.上述发酵产物烘干、粉碎,过100目筛,所得细粉为中药微生物发酵制剂。
所述侧耳(Pleurotus sp.),已于2014年4月14日保藏在“中国微生物菌种保藏管理委员会普通微生物中心”,保藏编号为CGMCC No.9060,保藏单位地址为北京市朝阳区北辰西路1号院3号。
实施例2
1.按重量份数计,取葛根10份,蚕蛹10份,三七10份,川穹10份,银杏叶10份,丹参10份,西红花10份,石菖蒲10份,地龙10份,黄芪10份,乳香6份,没药6份,当归6份,黑木耳6份,桃仁6份,泽泻6份,槐花6份,木香6份,桂枝6份,赤芍6份,降香6份,毛冬青4份,郁金4份,牛膝4份g,桑枝4份g,蒲黄4份g,琥珀4份g,黄连2份g,细草2份g,朱砂2份g,冰片2份g,珍珠母2份g,人工牛黄2份g,人参2份g,龙骨2份g,麦冬2份g,甘草2份g,地黄2份g,红花2份g,水蛭2份g,混合粉碎,过100目筛,混匀制成中药混合细粉。
2.侧耳活化:采用接种环挑取侧耳菌丝接于PDA固体培养基,在30℃、培养100小时,得到侧耳纯培养单菌落。
3.将上述活化的侧耳接种到步骤1中药原料中,并在温度为60℃、湿度为98%条件下发酵7天,得到发酵产物,活化的侧耳占中药原料质量的5%。
4.上述发酵产物烘干、粉碎,过100目筛,所得细粉为中药微生物发酵制剂。
所述侧耳(Pleurotus sp.),已于2014年4月14日保藏在“中国微生物菌种保藏管理委员会普通微生物中心”,保藏编号为CGMCC No.9060,保藏单位地址为北京市朝阳区北辰西路1号院3号。
实施例3
1.按重量数计,取葛根50g,蚕蛹50g,三七50g,川穹50g,银杏叶50g,丹参50g,西红花50g,石菖蒲50g,地龙50g,黄芪50g,乳香30g,没药30g,当归30g,黑木耳30g,桃仁30g,泽泻30g,槐花30g,木香30g,桂枝30g,赤芍30g,降香30g,毛冬青100g,郁金100g,牛膝100g,桑枝100g,蒲黄100g,琥珀100g,黄连10g,细草10g,朱砂10g,冰片10g,珍珠母10g,人工牛黄10g,人参10g,龙骨10g,麦冬10g,甘草10g,地黄10g,红花10g,水蛭10g,混合粉碎,过100目筛,混匀制成中药混合细粉。
2.侧耳活化:采用接种环挑取侧耳菌丝接于PDA固体培养基,在35℃、培养70小时,得到侧耳纯培养单菌落。
3.将上述活化的侧耳接种到步骤1中药原料中,并在温度为65℃、湿度为90%条件下发酵5天,得到发酵产物,活化的侧耳占中药原料质量的8%。
4.上述发酵产物烘干、粉碎,过100目筛,所得细粉为中药微生物发酵制剂。
所述侧耳(Pleurotus sp.),已于2014年4月14日保藏在“中国微生物菌种保藏管理委员会普通微生物中心”,保藏编号为CGMCC No.9060,保藏单位地址为北京市朝阳区北辰西路1号院3号。
二、临床前试验
急性毒性试验(小白鼠最大耐受量):
观察本实验提供的中药微生物发酵制剂以小白鼠所能接受的最大剂量灌胃给药产生的毒性反应和死亡情况,测定小白鼠的最大耐受剂量,为临床用药的安全性体统动物急性毒性实验参考。
受试药物为上述实施例1制备的散剂,将其用蒸馏水配制成37.5%浓度(g/ml)供试验用。受试动物为昆明种封闭群小白鼠,体重18-22g,由中国医科大学实验动物中心提供,实验动物合格证号:辽实条合字1号与辽实质合字008。
(1)取小白鼠20只,雌雄各半,禁食不禁水17小时,称体重;
(2)按剂量1ml/20gBW的容积24小时内给药两次,间隔8小时,相当每次剂量为18.75g/kg,日累积剂量为37.5g/kg,给药后常规饲养,观察7天;
结果受试动物健康,未发现受试动物死亡或由药物中毒引起的异常变化。即表明本发明提供的制剂小白鼠灌胃给药的最大耐受量大于或等于37.5g/kg·日,大于或等于临床承认每日试用量0.2g/kg·日的187.5倍,参照中药急性毒性实验要求(中华人民共和国***:新药审批办法《有关中药部分的修订和补充规定》,1992年9月1日起施行),临床试用4g/次,日服2-3次是安全的。
三、临床疗效
病例1:胡某,男,43岁,心脏病症状为心脏有杂音,心率失常,心慌气短。服用本发明中药治疗2个月后,心慌气短症状消失,后又连续治疗3个月后症状基本消失,至今无复发。
病例2:宋某,女,59岁,患心脏病3年,服用本发明中药治疗3个月后见效,又连续治疗6个月后身体逐渐康复,呼吸、活动均有明显改善。
病例3:李某,女,50岁,经常感到胸闷,心慌,呼吸困难,服用本发明中药后胸闷减轻,呼吸通畅,连续服用本发明的药物后,到医院检测一切正常,随访至今没有复发。
综上所述,本发明所述发酵微生物中药制剂对心脏病、心脏病、冠心病、心肌炎、高血压性心脏病患者治愈率很高,效果非常明显,且无毒副作用,用药方便,安全可靠。
Claims (7)
1.一种中药微生物发酵制剂,其特征在于:将侧耳与中药原料药混合发酵所得,所述中药原料药按重量份数计:葛根10-100份,蚕蛹10-100份,三七10-100份,川穹10-100份,银杏叶10-100份,丹参10-100份,西红花10-100份,石菖蒲10-100份,地龙10-100份,黄芪10-100份,乳香6-60份,没药6-60份,当归6-60份,黑木耳6-60份,桃仁6-60份,泽泻6-60份,槐花6-60份,木香6-60份,桂枝6-60份,赤芍6-60份,降香6-60份,毛冬青4-40份,郁金4-40份,牛膝4-40份,桑枝4-40份,蒲黄4-40份,琥珀4-40份,黄连2-20份,细草2-20份,朱砂2-20份,冰片2-20份,珍珠母2-20份,人工牛黄2-20份,人参2-20份,龙骨2-20份,麦冬2-20份,甘草2-20份,地黄2-20份,红花2-20份,水蛭2-20份;侧耳占中药原料质量的5%-10%;
所述侧耳为Pleurotus sp.,已于2014年4月14日保藏在“中国微生物菌种保藏管理委员会普通微生物中心”,保藏编号为CGMCC No.9060。
2.按权利要求1所述的中药微生物发酵制剂,其特征在于:所述中药原料药按重量份数计:葛根50-100份,蚕蛹50-100份,三七50-100份,川穹50-100份,银杏叶50-100份,丹参50-100份,西红花50-100份,石菖蒲50-100份,地龙50-100份,黄芪50-100份,乳香30-60份,没药30-60份,当归30-60份,黑木耳30-60份,桃仁30-60份,泽泻30-60份,槐花30-60份,木香30-60份,桂枝30-60份,赤芍30-60份,降香30-60份,毛冬青20-40份,郁金20-40份,牛膝20-40份,桑枝20-40份,蒲黄20-40份,琥珀20-40份,黄连10-20份,细草10-20份,朱砂10-20份,冰片10-20份,珍珠母10-20份,人工牛黄10-20份,人参10-20份,龙骨10-20份,麦冬10-20份,甘草10-20份,地黄10-20份,红花10-20份,水蛭10-20份。
3.按权利要求2所述的中药微生物发酵制剂,其特征在于:所述中药原料药按重量计:葛根100g,蚕蛹100g,三七100g,川穹100g,银杏叶100g,丹参100g,西红花100g,石菖蒲100g,地龙100g,黄芪100g,乳香60g,没药60g,当归60g,黑木耳60g,桃仁60g,泽泻60g,槐花60g,木香60g,桂枝60g,赤芍60g,降香60g,毛冬青40g,郁金40g,牛膝40g,桑枝40g,蒲黄40g,琥珀40g,黄连20g,细草20g,朱砂20g,冰片20g,珍珠母20g,人工牛黄20g,人参20g,龙骨20g,麦冬20g,甘草20g,地黄20g,红花20g,水蛭20g。
4.一种权利要求1所述的中药微生物发酵制剂的制备方法,其特征在于:
(1)按重量份数计,取葛根10-100份,蚕蛹10-100份,三七10-100份,川穹10-100份,银杏叶10-100份,丹参10-100份,西红花10-100份,石菖蒲10-100份,地龙10-100份,黄芪10-100份,乳香6-60份,没药6-60份,当归6-60份,黑木耳6-60份,桃仁6-60份,泽泻6-60份,槐花6-60份,木香6-60份,桂枝6-60份,赤芍6-60份,降香6-60份,毛冬青4-40份,郁金4-40份,牛膝4-40份,桑枝4-40份,蒲黄4-40份,琥珀4-40份,黄连2-20份,细草2-20份,朱砂2-20份,冰片2-20份,珍珠母2-20份,人工牛黄2-20份,人参2-20份,龙骨2-20份,麦冬2-20份,甘草2-20份,地黄2-20份,红花2-20份,水蛭2-20份的中药原料药混合,磨粉至数目大于100目,得到中药混合细粉,待用;
(2)取步骤(1)的中药原料药与侧耳混合发酵后,得到发酵物,将发酵物干燥、磨成细粉即得到中药微生物发酵制剂;
所述侧耳(Pleurotus sp.),已于2014年4月14日保藏在“中国微生物菌种保藏管理委员会普通微生物中心”,保藏编号为CGMCC No.9060。
5.按权利要求4所述的制备方法,其特征在于:所述步骤(2)侧耳接种量为中药原料的5%-10%,并在温度为37-65℃、湿度为80%-98%条件下发酵1-7天,得到中药微生物发酵制剂。
6.按权利要求4所述的制备方法,其特征在于:最终所得中药微生物发酵制剂可制成散剂、片剂、丸剂、胶丸、胶囊剂、乳剂、糖浆或口服液。
7.一种权利要求1所述的中药微生物发酵制剂在治疗治疗心脏病、冠心病、心肌炎、高血压性心脏病的药物的应用。
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