CN106975030A - 一种发酵中药制剂及其制备方法和应用 - Google Patents

一种发酵中药制剂及其制备方法和应用 Download PDF

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CN106975030A
CN106975030A CN201710275242.5A CN201710275242A CN106975030A CN 106975030 A CN106975030 A CN 106975030A CN 201710275242 A CN201710275242 A CN 201710275242A CN 106975030 A CN106975030 A CN 106975030A
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parts
radix
chinese
root
preparation
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李兴尧
李业明
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Abstract

本发明涉及一种发酵中药制剂，属于中药领域，具体地说是一种治疗糖尿病的发酵中药制剂，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为将侧耳在中药原料中发酵所得，侧耳占中药原料混合物量的5％‑10％。本发明提供的发酵中药制剂，在治疗、治愈糖尿病方面有很好的效果，同时，对因糖尿病引起的并发症也有很好的疗效，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。

Description

一种发酵中药制剂及其制备方法和应用
技术领域
本发明涉及一种发酵中药制剂，属于中药领域，具体地说是一种以中草药为原料配制的发酵中药制剂，本发明还涉及该制剂的制备方法和在糖尿病药物中的应用。
背景技术
随着人民生活水平的日益提高，糖尿病患病率正急剧增加，已成为威胁人类身体健康的主要疾病之一。糖尿病是由不同病因(如遗传因素、免疫功能紊乱、微生物感染及其毒素、自由基、精神因素等)导致胰岛素绝对不足或相对不足的一类代谢紊乱综合症，主要包括1型(T1DM)和2型(T2DM)，其中以T2DM最为普遍。T1DM是一种自身免疫疾病，可能是由于自身免疫***破坏产生胰岛素的胰腺胰岛β细胞引起的。T1DM多发生于青少年。患者因胰岛素分泌缺乏，需要依赖外源性胰岛素补充以维持生命。T2DM的典型病症为多尿症、多饮症以及多食症。T2DM体内产生胰岛素的能力并非完全丧失，有的患者内胰岛素甚至产生过多，但是胰岛素的作用效果却大打折扣，因此患者体内的胰岛素是一种相对缺乏。目前认为T2DM主要发病原因是胰岛素抵抗(主要表现为高胰岛素血症，葡萄糖利用率降低)和胰岛素分泌不足的合并存在。
糖尿病的诊断一般不难，空腹血糖大于或等于7.0毫摩尔/升，和/或餐后两个小时血糖大于或等于11.1毫摩尔/升即可确诊。
针对糖尿病发病机制，市场上主流的抗糖尿病药物包括胰岛素和口服降糖药两大类，T1DM是因为缺乏胰岛素所致，所以需要以注射胰岛素的方式来治疗。T2DM主要是因为胰岛素抵抗及胰岛素相对缺乏引起的，则可以用下列药物治疗(1)通过作用于胰腺β细胞，促进胰岛素分泌的磺酰脲类药物，格列奈类药物和GLP-1类似物；(2)通过作用于二肽基肽酶4(DPP4)，抑制体内GLP-1的降解，提高GLP-1的水平，达到降低血糖目的的DPP4抑制剂；(3)通过作用于骨骼肌、脂肪组织，改善对胰岛素敏感性的双胍类药物和噻唑烷二酮类药物；(4)通过作用于小肠的各类α葡萄糖苷酶抑制剂；(5)通过抑制肾脏对葡萄糖的重吸收的钠-葡萄糖协同转运蛋白2抑制剂。以上药物很容易产生耐药性，长期、大量应用，会伴有肝、肾功能减退，缺氧性疾病，急性感染、胃肠道疾病等症状，而且治疗范围窄，治疗效果不彻底，治愈后很容易复发，相对成本费用高，服药时间长，不易从根本上解决问题。
糖尿病是以血糖增高为临床特征的常见内分泌代谢疾病，中医学根据其临床表现，宏观地统归为“消渴”，通过近年来的研究，对中医药治疗糖尿病的机制有了一定的认识，中医药可以通过促进胰岛素分泌、改善胰岛素抵抗、抑制胰高糖素分泌等途径降低血糖，通过抑制糖还原酶活性、抑制蛋白质非酶糖基化、活血化瘀、改善微循环、改善脂代谢等作用防治糖尿病慢性并发症，中医学防治糖尿病具有悠久的历史，积累了丰富的临床经验，形成了防治糖尿病***的理、法、方、药体系，具有现代西医无可比拟的优势。
糖尿病的治疗一直是医学上研究的重点，因西医上研发的药物本身具有的不足，中医上研制的中药制剂显得尤为重要，励志于在根本上治疗、治愈糖尿病。
发明内容
本发明的目的是提供一种治疗糖尿病的发酵中药制剂，主治糖尿病，同时可治疗因糖尿病引发的并发症。
为实现上述目的，本发明采用的技术方案为：
一种发酵中药制剂：将侧耳与中药原料混合发酵所得，所述中药原料按重量份数计：肉桂10-100份，铁皮石斛10-100份，天花粉10-100份，泽泻10-100份，葛根10-100份，猪苓10-100份，茯苓10-100份，苦瓜10-100份，山药10-100份，黄芪10-100份，知母6-60份，黄精6-60份，牡蛎6-60份，薏苡6-60份，桃仁6-60份，黄苓6-60份，地龙6-60份，内金6-60份，当归6-60份，甘草6-60份，僵蚕4-40份，白术4-40份，山枝子4-40份，益母草4-40份，地黄4-40份，地骨皮4-40份，仙灵脾4-40份，金蝉花4-40份，大黄2-20份，黄柏2-20份，苍术2-20份，菟丝子2-20份，沙苑子2-20份，党参2-20份，泽兰2-20份，牛蒡子2-20份，五味子2-20份，大枣2-20份，黄连2-20份，水蛭1-10份，麦冬1-10份，玄参1-10份，赤芍1-10份，太子参1-10份，牛膝1-10份，天门冬1-10份，乌梅1-10份；侧耳占中药原料药质量的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。
上述侧耳已在CN 105412739A(申请号201410480058.0,申请日2014年09月18日)中公布。
本发明中药原料按重量份数计优选为：肉桂50-100份，铁皮石斛50-100份，天花粉50-100份，泽泻50-100份，葛根50-100份，猪苓50-100份，茯苓50-100份，苦瓜50-100份，山药50-100份，黄芪50-100份，知母30-60份，黄精30-60份，牡蛎30-60份，薏苡30-60份，桃仁30-60份，黄苓30-60份，地龙30-60份，内金30-60份，当归30-60份，甘草30-60份，僵蚕20-40份，白术20-40份，山枝子20-40份，益母草20-40份，地黄20-40份，地骨皮20-40份，仙灵脾20-40份，金蝉花20-40份，大黄10-20份，黄柏10-20份，苍术10-20份，菟丝子10-20份，沙苑子10-20份，党参10-20份，泽兰10-20份，牛蒡子10-20份，五味子10-20份，大枣10-20份，黄连10-20份，水蛭5-10份，麦冬5-10份，玄参5-10份，赤芍5-10份，太子参5-10份，牛膝5-10份，天门冬5-10份，乌梅5-10份。
本发明中药原料按重量计最优选为：肉桂100g，铁皮石斛100g，天花粉100g，泽泻100g，葛根100g，猪苓100g，茯苓100g，苦瓜100g，山药100g，黄芪100g，知母60g，黄精60g，牡蛎60g，薏苡60g，桃仁60g，黄苓60g，地龙60g，内金60g，当归60g，甘草40g，僵蚕40g，白术40g，山枝子40g，益母草40g，地黄40g，地骨皮40g，仙灵脾40g，金蝉花40g，大黄40g，黄柏40g，苍术20g，菟丝子20g，沙苑子20g，党参20g，泽兰20g，牛蒡子20g，五味子20g，大枣20g，黄连10g，水蛭10g，麦冬10g，玄参10g，赤芍10g，太子参10g，牛膝10g，天门冬10g，乌梅10g。
所述发酵中药制剂的制备方法为：
(1)按重量份数计，取肉桂10-100份，铁皮石斛10-100份，天花粉10-100份，泽泻10-100份，葛根10-100份，猪苓10-100份，茯苓10-100份，苦瓜10-100份，山药10-100份，黄芪10-100份，知母6-60份，黄精6-60份，牡蛎6-60份，薏苡6-60份，桃仁6-60份，黄苓6-60份，地龙6-60份，内金6-60份，当归6-60份，甘草6-60份，僵蚕4-40份，白术4-40份，山枝子4-40份，益母草4-40份，地黄4-40份，地骨皮4-40份，仙灵脾4-40份，金蝉花4-40份，大黄2-20份，黄柏2-20份，苍术2-20份，菟丝子2-20份，沙苑子2-20份，党参2-20份，泽兰2-20份，牛蒡子2-20份，五味子2-20份，大枣2-20份，黄连2-20份，水蛭1-10份，麦冬1-10份，玄参1-10份，赤芍1-10份，太子参1-10份，牛膝1-10份，天门冬1-10份，乌梅1-10份的中药原料混合，磨粉至目数不大于150目，得到中药混合细粉，待用；
(2)取步骤(1)的中药原料混合物与侧耳混合发酵后,得到发酵物,将发酵物干燥、磨成细粉即得到发酵中药制剂；
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，得到发酵中药制剂。
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。
所得发酵中药制剂可制成散剂、片剂、丸剂、胶丸、胶囊剂、乳剂、糖浆或口服液。
所述发酵中药制剂的应用：在治疗糖尿病药物中的应用。
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：
党参双子叶植物纲，桔梗科，党参具有补中益气，健脾益肺的功效。综上所述，与党参补中益气、健脾功效相关的药理作用为调整胃肠运动功能、抗溃疡。增强机体免疫功能、增强造血功能、抗应激、强心、抗休克、调节血压、抗心肌缺血和抑制血小板聚集等作用。党参还具有益智、镇静、催眠、抗惊厥、养生等作用。
黄连原始花被亚纲，唐松草亚科，具有抗菌、抗肿瘤和抗心律失常等药理活性，具有清热燥湿、泻火解毒之功效。也具有抗菌、降血糖、抗肿瘤、保护胃黏膜等活性。
肉桂能够触发胰岛素信号转导，激活自身磷酸化的胰岛素受体，具有类似胰岛素的作用。
铁皮石斛不仅可以增强胰岛素活性，同时能显著降低血糖水平，使血正常；可促进循环、扩张血管、降低血胆固醇和甘油三脂；石斛既可以增加胰岛素分泌，又可以改善胰岛素抵抗，对于糖尿病合并症和并发症，糖尿病常合并高血压、高血脂，石斛的成分有助于改善高血压和高血脂的病理，从而调节血压和血脂。对于糖尿病并发白内障，服用石斛的好处除了石斛本身的降糖作用，还可以抗白内障，石斛抗白内障的作用主要通过减少高血糖导致的多个病理产物对晶状体的损害。
药泽泻属泽泻科，单子叶植物纲，被子植物门，现代医学研究，泽泻可降低血清总胆固醇及三酰甘油含量，减缓动脉粥样硬化形成；泽泻及其制剂现代还用于治疗内耳眩晕症、血脂异常、遗精、脂肪肝及糖尿病等。
天花粉别称栝楼根，属葫芦科，栝楼根中含一定量的蛋白质：天花粉蛋白。天花粉蛋白(Trichosanthin)是中期妊娠引产的有效蛋白质，同时其亦具有抗***活性及抗艾滋病(AIDS)的活性；蛋白质Karasurin对妊娠小鼠有强烈堕胎作用；蛋白质α-Momorcharin和β-Momorcharin具有引产、免疫抑制和抗肿瘤作用。尚分离出由289个氨基酸组成的蛋白质α-Trichosanthin、细胞毒蛋白Trichosanthin-ZG以及具有胰蛋白酶抑制活性的多肽等。栝楼根中含有糖类化合物即天花粉多糖，有明显的免疫调节作用，能增强免疫活性，具有显著的抗肿瘤和细胞毒活性。多糖主要由葡萄糖、半乳糖、果糖、甘露糖、木糖和少量蛋白质组成。从栝楼根水提取物中分离出5个具有降血糖活性的栝楼根聚糖(Trichosan)A、B、C、D、E。
上述中药中肉桂，铁皮石斛，天花粉，泽泻，葛根，猪苓，茯苓，苦瓜，山药，黄芪作为主药，其他药物作为辅药；主药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6:4:2:1的质量比例混合，即辅药1：辅药2：辅药3:辅药4为6:4:2:1，其中辅药1为知母，黄精，牡蛎，薏苡，桃仁，黄苓，地龙，内金，当归，甘草；辅药2为僵蚕，白术，山枝子，益母草，地黄，地骨皮，仙灵脾，金蝉花4-40；辅药3为大黄，黄柏，苍术，菟丝子，沙苑子，党参，泽兰，牛蒡子，五味子，大枣，黄连；辅药4为水蛭，麦冬，玄参，赤芍，太子参，牛膝，天门冬，乌梅；将中药按照10:6:4:2:1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治疗、治愈糖尿病的药物。
本发明的有益效果在于:
1.本发明制剂具有清热益气，养阴补肾，活血等疗效，针对糖脂代谢和胰岛B细胞功能及其他内分泌激素功能的作用机制，研制出的疗效高，无毒副作用的植物降糖药物。
2.本发明提供的治疗糖尿病的发酵中药制剂，在治疗、治愈糖尿病方面有很好的效果，同时，对因糖尿病引起的并发症也有很好的疗效，在治疗糖尿病的同时，治愈并发症，可长期单独或者配合其他药物使用,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。
3.本发明为纯发酵微生物中药制剂，无毒无副作用，安全可靠；另外，本发明在继承中药炮制学发酵法基础上，结合现代生物工程的发酵技术，利用侧耳对中药材进行发酵处理，增加了药物的疗效和利用率。
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，取肉桂100g，铁皮石斛100g，天花粉100g，泽泻100g，葛根100g，猪苓100g，茯苓100g，苦瓜100g，山药100g，黄芪100g，知母60g，黄精60g，牡蛎60g，薏苡60g，桃仁60g，黄苓60g，地龙60g，内金60g，当归60g，甘草60g，僵蚕40g，白术40g，山枝子40g，益母草40g，地黄40g，地骨皮40g，仙灵脾40g，金蝉花40g，大黄40g，黄柏40g，苍术20g，菟丝子20g，沙苑子20g，党参20g，泽兰20g，牛蒡子20g，五味子20g，大枣20g，黄连20g，水蛭10g，麦冬10g，玄参10g，赤芍10g，太子参10g，牛膝10g，天门冬10g，乌梅10g的中药原料药，将中药原料药混合后，磨粉至目数不大于150目，得到中药混合细粉，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，所得细粉为发酵中药制剂。
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CGMCCNo.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，取肉桂50份，铁皮石斛50份，天花粉50份，泽泻50份，葛根50份，猪苓50份，茯苓50份，苦瓜50份，山药50份，黄芪50份，知母30份，黄精30份，牡蛎30份，薏苡30份，桃仁30份，黄苓30份，地龙30份，内金30份，当归30份，甘草30份，僵蚕20份，白术20份，山枝子20份，益母草20份，地黄20份，地骨皮20份，仙灵脾20份，金蝉花20份，大黄20份，黄柏20份，苍术10份，菟丝子10份，沙苑子10份，党参10份，泽兰10份，牛蒡子10份，五味子10份，大枣10份，黄连10份，水蛭5份，麦冬5份，玄参5份，赤芍5份，太子参5份，牛膝5份，天门冬5份，乌梅5份中药原料药，将中药原料药混合后，磨粉至目数不大于150目，得到中药混合细粉，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90％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8％。
4.上述发酵产物烘干、粉碎，过100目筛，所得细粉为发酵中药制剂。
实施例3
1.按重量份数计，取肉桂10份，铁皮石斛10份，天花粉10份，泽泻10份，葛根10份，猪苓10份，茯苓10份，苦瓜10份，山药10份，黄芪10份，知母6份，黄精6份，牡蛎6份，薏苡6份，桃仁6份，黄苓6份，地龙6份，内金6份，当归6份，甘草6份，僵蚕4份，白术4份，山枝子4份，益母草4份，地黄4份，地骨皮4份，仙灵脾4份，金蝉花4份，大黄4份，黄柏4份，苍术2份，菟丝子2份，沙苑子2份，党参2份，泽兰2份，牛蒡子2份，五味子2份，大枣2份，黄连2份，水蛭1份，麦冬1份，玄参1份，赤芍1份，太子参1份，牛膝1份，天门冬1份，乌梅1份中药原料药，将中药原料药混合后，磨粉至目数不大于150目，得到中药混合细粉，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35℃、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80％条件下发酵7天，得到发酵产物。
4.上述发酵产物烘干、粉碎，过100目筛，所得细粉为发酵中药制剂。
二、临床试验
1.1糖尿病的诊断标准：根据WHO有关糖尿病的诊断标准(1996年)，空腹血糖大于或等于7.0毫摩尔/升，和/或餐后两个小时血糖大于或等于11.1毫摩尔/升即可确诊。
1.2糖尿病的临床表现：1型糖尿病多发生于青少年，起病急，症状明显且重，空腹时胰岛素低于5μIU/ml；2型糖尿病多见于成年人和老年人，多为肥胖体型，起病缓慢，症状较轻。表现症状多为“三多一少”，1.多尿，血糖升高后，大量的葡萄糖从肾脏排出，引起渗透性利尿，因此多尿，每日尿量可达到2-10L；2.多饮，因多尿原因，而身体内失水，从而多饮；3.多食，由于葡萄糖不能被机体充分利用而随尿液排出，导致机体热量来源不足，患者经常感觉饥饿，导致多食；4.消瘦，外周组织对葡萄糖利用障碍，脂肪、蛋白质分解增多，代谢失衡，因而患者逐渐消瘦，疲乏无力，加之失水，体重明显减轻。
1.3疗效判断标准：参照《中药新药临场研究指导原则》中的疗效标准：
显效：症状积分减少≥70％，FBG正常或下降40％以上，HbAlc正常或下降30％以上，TC、TG、LDL-C的改善在30％以上或恢复正常；
有效：症状积分减少≥30％，FBG正常或下降20％以上，HbAlc正常或下降10％以上，TC、TG、LDL-C较治疗前有所改善，但不足显效标准；
无效：临床症状无变化或加重或改善程度不足30％，实验室指标无变化或升高。
药剂使用方法：将本发明配制的中药制剂，服用药物1袋/次，3次/日，饭后半小时白开水送服，30日为一个疗程，治疗期间遵医嘱适当锻炼及控制饮食，治疗效果如表1。
表1治疗效果2000(例)
三、典型病例
病例1
王某，女，73岁被确诊为2型糖尿病，四年，表现为视网膜病变、眼底出血、视力模糊、皮肤瘙痒、四肢无力麻木、尿急、尿频、心慌气短、烦躁不安、乏力等症状，空腹血糖为20mmol/L，尿糖(4+)，服用本药方剂三个疗程后，视网膜病变、眼底出血、视力模糊、皮肤瘙痒、四肢无力麻木、尿急、尿频、心慌气短、烦躁不安、乏力等症状好转，血糖尿糖检查正常，继续服用至第五个疗程后又进行巩固治疗，全身病变完全消失，血糖降至7.0mmol，经过六年疗程的治疗，至今未发病。
病例2
姜某，男，65岁，浑身乏力，腰酸腿软病症状，经医院确诊为2型糖尿病，服用多种治疗药物，反复发作，出现了心脏病变、手脚冰冷、麻木、失眠、皮肤瘙痒等症状，服用本药剂后血糖，尿糖基本稳定，连续服用到第七个月后，临床上显示糖尿病基本恢复正常，并发症状逐渐好转消失，现已停服此药一年至今无复发。
病例3
战某，男，58岁，患糖尿病6年，血糖在10.6-17.8mmol/L之间，尿糖(5+)，并发症为冠心病变、皮肤瘙痒、下肢水肿、视力减退等症状，患病期间更换多种中西药物，病情反复，具有加重趋势，服用本药剂两个月，糖尿病好转，症状减轻，第三个月并发症基本消失，继续服用到第六个月后血糖正常，稳定半年回访很正常。

Claims (7)

1.一种发酵中药制剂，其特征在于：将侧耳与中药原料混合发酵所得，所述中药原料按重量份数计：肉桂10-100份，铁皮石斛10-100份，天花粉10-100份，泽泻10-100份，葛根10-100份，猪苓10-100份，茯苓10-100份，苦瓜10-100份，山药10-100份，黄芪10-100份，知母6-60份，黄精6-60份，牡蛎6-60份，薏苡6-60份，桃仁6-60份，黄苓6-60份，地龙6-60份，内金6-60份，当归6-60份，甘草6-60份，僵蚕4-40份，白术4-40份，山枝子4-40份，益母草4-40份，地黄4-40份，地骨皮4-40份，仙灵脾4-40份，金蝉花4-40份，大黄2-20份，黄柏2-20份，苍术2-20份，菟丝子2-20份，沙苑子2-20份，党参2-20份，泽兰2-20份，牛蒡子2-20份，五味子2-20份，大枣2-20份，黄连2-20份，水蛭1-10份，麦冬1-10份，玄参1-10份，赤芍1-10份，太子参1-10份，牛膝1-10份，天门冬1-10份，乌梅1-10份；侧耳占中药原料药质量的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.按照权利要求1所述的发酵中药制剂，其特征在于：所述中药原料按重量份数计：肉桂50-100份，铁皮石斛50-100份，天花粉50-100份，泽泻50-100份，葛根50-100份，猪苓50-100份，茯苓50-100份，苦瓜50-100份，山药50-100份，黄芪50-100份，知母30-60份，黄精30-60份，牡蛎30-60份，薏苡30-60份，桃仁30-60份，黄苓30-60份，地龙30-60份，内金30-60份，当归30-60份，甘草30-60份，僵蚕20-40份，白术20-40份，山枝子20-40份，益母草20-40份，地黄20-40份，地骨皮20-40份，仙灵脾20-40份，金蝉花20-40份，大黄10-20份，黄柏10-20份，苍术10-20份，菟丝子10-20份，沙苑子10-20份，党参10-20份，泽兰10-20份，牛蒡子10-20份，五味子10-20份，大枣10-20份，黄连10-20份，水蛭5-10份，麦冬5-10份，玄参1-10份，赤芍5-10份，太子参5-10份，牛膝5-10份，天门冬5-10份，乌梅5-10份。
3.按照权利要求2所述的发酵中药制剂，其特征在于：所述中药原料按重量计：肉桂100g，铁皮石斛100g，天花粉100g，泽泻100g，葛根100g，猪苓100g，茯苓100g，苦瓜100g，山药100g，黄芪100g，知母60g，黄精60g，牡蛎60g，薏苡60g，桃仁60g，黄苓60g，地龙60g，内金60g，当归60g，甘草40g，僵蚕40g，白术40g，山枝子40g，益母草40g，地黄40g，地骨皮40g，仙灵脾40g，金蝉花40g，大黄40g，黄柏40g，苍术20g，菟丝子20g，沙苑子20g，党参20g，泽兰20g，牛蒡子20g，五味子20g，大枣20g，黄连10g，水蛭10g，麦冬10g，玄参10g，赤芍10g，太子参10g，牛膝10g，天门冬10g，乌梅10g。
4.一种权利要求1所述的发酵中药制剂的制备方法，其特征在于：
(1)按重量份数计，取肉桂10-100份，铁皮石斛10-100份，天花粉10-100份，泽泻10-100份，葛根10-100份，猪苓10-100份，茯苓10-100份，苦瓜10-100份，山药10-100份，黄芪10-100份，知母6-60份，黄精6-60份，牡蛎6-60份，薏苡6-60份，桃仁6-60份，黄苓6-60份，地龙6-60份，内金6-60份，当归6-60份，甘草6-60份，僵蚕4-40份，白术4-40份，山枝子4-40份，益母草4-40份，地黄4-40份，地骨皮4-40份，仙灵脾4-40份，金蝉花4-40份，大黄2-20份，黄柏2-20份，苍术2-20份，菟丝子2-20份，沙苑子2-20份，党参2-20份，泽兰2-20份，牛蒡子2-20份，五味子2-20份，大枣2-20份，黄连2-20份，水蛭1-10份，麦冬1-10份，玄参1-10份，赤芍1-10份，太子参1-10份，牛膝1-10份，天门冬1-10份，乌梅1-10份的中药原料混合，磨粉至目数不大于150目，得到中药混合细粉，待用；
(2)取步骤(1)的中药原料混合物与侧耳混合发酵后,得到发酵物,将发酵物干燥、磨成细粉即得到发酵中药制剂；
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，得到发酵中药制剂。
6.按权利要求4所述的制备方法，其特征在于：最终所得发酵中药制剂可制成散剂、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所述制备的发酵中药制剂在治疗糖尿病药物中的应用。
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CN109090342A (zh) * 2018-08-29 2018-12-28 成都乾坤动物药业股份有限公司 发酵中药添加剂及其制备方法和使用方法
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