CN110339302A - 一种用于预防或治疗阿尔兹海默症的中药组合物 - Google Patents
一种用于预防或治疗阿尔兹海默症的中药组合物 Download PDFInfo
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Abstract
本发明公开了一种用于预防或治疗阿尔兹海默症的中药组合物，由以下重量份的原料制备而成：天麻1.5‑2.5份；五味子0.7‑1.3份；麦冬1.5‑2.5份。本发明通过三味药用原料的合理配比，具有协同增效功能，经实验验证该组合物对阿尔兹海默症动物模型的麻痹表型有显著抑制作用，可显著抑制Aβ过度表达引起的CL4176秀丽隐杆线虫麻痹，可用于阿尔兹海默症的预防或治疗，对于治疗阿尔兹海默症显效迅速，无毒副作用，用药期间对机体细胞、组织、器官功能、血象不造成任何影响。
Description
技术领域
本发明涉及医药领域，具体涉及一种用于预防或治疗阿尔兹海默症的中药组合物。
背景技术
阿尔茨海默病是一种非常复杂的神经退行性疾病，临床主要表现为进行性的记忆力和认知功能降低，以记忆障碍、失语、失用、失认、视空间技能损害、执行功能障碍以及人格和行为改变等全面性痴呆表现为临床主要表现特征。临床常应用药物作为其主要治疗手段，包括加兰他敏，美金刚，氟西汀等，但其因为只能控制患者病情，不能有效的逆转患者的病情。
学术界针对AD病发机制的研究存在较多争议，而β-淀粉样前蛋白级联假说是当前AD病发机制研究的主流学说，依据该学说β-淀粉样前蛋白在β-分泌酶和γ-分泌酶的作用下，生成β-淀粉样蛋白，随着β-淀粉样蛋白产生的增加和清除的减少，导致β-淀粉样蛋白在阿尔兹海默症患者脑内积累，在患者脑内可溶性的β-淀粉样蛋白数量增加，引起β-淀粉样蛋白自聚反应，从而生成有细胞毒性的寡聚物，进而引发一系列的病情反应。因此β-淀粉样蛋白是公认的筛选预防或治疗阿尔兹海默症的药物靶标。
目前，众多中医药学者注重于研发用于预防或治疗阿尔兹海默症的中药组合物，如专利号为WO2015/196401 A1《癫痫宁在制备预防或治疗阿尔兹海默病药物中的应用》，公开了蜘蛛香、石菖蒲、钩藤、牵牛子、千金子、缬草、甘松、薄荷脑等八味中药具有预防或治疗阿尔兹海默病的作用，这间接证实中药组合物预防或治疗阿尔兹海默病的可行性。
发明内容
本发明的目的在于提供一种用于预防或治疗阿尔兹海默症的中药组合物。
为实现上述目的，本发明采取的技术方案为：
一种用于预防或治疗阿尔兹海默症的中药组合物，由以下重量份的原料制备而成：
天麻1.5-2.5份；五味子0.7-1.3份；麦冬1.5-2.5份。
优选地，由以下重量份的原料制备而成：
天麻1.6-2.3份；五味子0.8-1.2份；麦冬1.6-2.3份。
优选地，由以下重量份的原料制备而成：
天麻2份；五味子1份；麦冬2份。
本发明提供了一种预防或治疗阿尔兹海默症的中药组合物的制备方法，包括以下步骤：
S1、按上述的配方称取天麻、五味子、麦冬；
S2、向称取的天麻、五味子、麦冬中加入6倍量水，煎煮1.5h，过滤，滤渣再加入4倍量水，煎煮1.5h,过滤，合并两次滤液，将滤液冷冻干燥，即得中药组合物提取物。
所述中药组合物可直接加入药学可接受的药用辅料，制成临床可应用的口服剂型。所述的药用辅料包括崩解剂、乳化剂、矫味剂、稀释剂、润滑剂、填充剂、粘合剂、润湿剂或其它的药用辅料；所述的口服剂型包括但不仅限于口服液，片剂，胶囊剂、颗粒剂。
口服液的制备过程如下：
按100mL口服液加入中药组合提取物15—20mg，加入蜂蜜5mg作为矫味剂,加入苯甲酸2mg作为防腐剂，其制备方法为：将称取的中药组合提取物加入蜂蜜进行充分的混合，后加入蒸馏水充分溶解，最后加入苯甲酸，搅拌均匀后，灭菌，灌装。
本发明方中所述天麻性甘，平，归肝经，具有息风止痉，平抑肝阳，祛风通络之功效，常用于小儿惊风，癫痫抽搐，破伤风，头痛眩晕，手足不遂，肢体麻木等症。方中五味子味酸、甘，性温，具有收敛固涩，益气生津，补肾宁心之功效。方中麦冬性甘，微苦，微寒，具有润肺清心、泻热生津、化痰止呕、治嗽行水之效，任何单一的药物均不能达到该处方所示之效果，通过三味药用原料的合理配比，具有协同增效功能结果见图1，经实验验证该组合物对阿尔兹海默症动物模型的麻痹表型有显著抑制作用，可显著抑制β-淀粉样前蛋白过度表达引起的 CL4176 秀丽隐杆线虫麻痹，可用于阿尔兹海默症的预防或治疗，对于治疗阿尔兹海默症显效迅速，无毒副作用，用药期间对机体细胞、组织、器官功能、血象不造成任何影响。
附图说明
图1为本发明的协同增效功能结果示意图；
图中：注：Control:空白对照组；TM:天麻单药；WWZ：五味子单药；MD:麦冬单药；FF1：处方复合物。
图2为实施例1-5实验结果；
图中：C:空白对照组；CF1:实施例1；CF2：实施例2；CF3：实施例3；CF4：实施例4；CF5：实施例5。
具体实施方式
下面结合具体实施例对本发明进行详细说明。以下实施例将有助于本领域的技术人员进一步理解本发明，但不以任何形式限制本发明。应当指出的是，对本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进。这些都属于本发明的保护范围。
实施例1
处方：天麻2kg,五味子1kg，麦冬2kg;
制法：
(1)按处方量称取天麻，五味子，麦冬，加入处方量6倍量水，煎煮1.5h，过滤，滤渣再加入4倍量水，煎煮1.5h,过滤，合并两次滤液，将滤液冷冻干燥，制得中药组合物提取物。
(2) 制备100mL的口服液
称取中药组合提取物15—20mg，加入蜂蜜5mg作为矫味剂，充分混合后，加入适量蒸馏水充分溶解，然后加入苯甲酸2mg作为防腐剂，搅拌均匀后，灭菌，灌装。
实施例2
处方：天麻1.5kg，五味子0.7kg，麦冬1.5kg。
制法：
（1）按处方量称取天麻，五味子，麦冬，加入处方量6倍量水，煎煮1.5h，过滤，滤渣再加入4倍量水，煎煮1.5h,过滤，合并两次滤液，将滤液冷冻干燥，制得中药组合物提取物，然后加入药学上的辅料制成胶囊剂。
实施例3
处方：天麻2.5kg，五味子1.3kg，麦冬2.5kg。
制法：与实施例1制法相同。
实施例4
处方：天麻2.3kg，五味子1.2kg，麦冬2.3kg。
制法：与实施例1的中药组合物提取物方法相同，然后加入药学上可接受的辅料，制成颗粒剂；10g/包。
实施例5
处方：天麻1.7kg，五味子1kg，麦冬1.6kg。
制法：与实施例1制法相同。
以下通过对比实验方法，进一步说明本发明的治疗效果。
1.线虫实验：
1.1 线虫模型制作：秀丽隐杆线虫株系 CL4176，基因型：smg-1 [myo-3p: : A-Beta(1-42): : let-851 3'（UTR) + rol-6(su1006)]，于15℃培养，温度升高至25℃时可诱导体内肌肉细胞内大量表达Aβ蛋白，致使出现麻痹行为。
1.2含有实施例中处方药培养基的制备：称取各实施例中的等量药物进行溶解，过滤除去滤渣，将滤液加入线虫培养基中，制备形成不同实施例处方的培养基。
1.3麻痹实验：将秀丽隐杆线虫转基因 CL4176 株系同步化后，计数小线虫的数量，分别接至含不同实施例处方药的培养基上（每个培养基上接约50个卵），将培养基放在15℃下恒温培养，待线虫长至 L3 期，将其转至25℃恒温培养箱中，诱导线虫肌肉细胞中聚集大量的β-淀粉样前蛋白，34h 后计数麻痹线虫数量，每 2 小时计数一次，直至所有的线虫均已麻痹，记录各药物处理组的线虫的麻痹曲线。用挑针触碰线虫时，线虫的身体不能整体移动或只有头部移动，则记为麻痹，考察不同实施例处方对阿尔兹海默症的疗效。
实验结果如图2所示，可见实施例1-5中的中药组合物可显著抑制β-淀粉样前蛋白毒性对 AD 线虫的损伤，证实各实施例处方对于阿尔兹海默症有较好的治疗效果。
2、动物实验
选择60只健康小鼠，体重20±5g，随机分为6组，制作成为小鼠老年痴呆模型，分别以实施例1-5制成的制剂进行给药，口服制剂灌胃给药0.4mL/10g，早晚各一次。给药15天后，对各组小鼠进行水迷宫实验，考察各实施例药物对于各组小鼠认知功能的影响。实验结果如表1所示。
表1
| 各组 | 剂量 | 穿越原平台的次 | 目的象限滞留时间百分比（%） |
| 阳性对照组 | 生理盐水10ml | 57 | 27 |
| 实施例1 | 0.4mL/10g | 103<sup>**</sup> | 72<sup>##</sup> |
| 实施例2 | 0.4mL/10g | 107<sup>**</sup> | 81<sup>##</sup> |
| 实施例3 | 0.4mL/10g | 98<sup>**</sup> | 78<sup>##</sup> |
| 实施例4 | 0.4mL/10g | 104<sup>**</sup> | 79<sup>##</sup> |
| 实施例5 | 0.4mL/10g | 101<sup>**</sup> | 82<sup>##</sup> |
注：与生理盐水对照组相比，穿越原平台的次数**P<0.01，目的象限滞留时间百分比##P<0.01
以上结果表明实施例1-5中的中药组合物对于小鼠的认知功能有较大的改善，各实施例处方可显著增强小鼠的记忆力，空间认知能力，证实实施例1-5对于阿尔兹海默症的治疗有较好的预后。
3、毒性试验
选择50只健康小鼠，体重20±5g，随机分为5组，分别以实施例1-5制成的制剂进行给药，口服制剂灌胃给药0.4mL/10g，早晚各一次。给药15天后，实施例1-5的小鼠未见有任何异常表现，饮食，活动良好，无一死亡，给药13周后，各组小鼠无异常表现，行为活泼，背毛光滑，饮食正常，平均体重达42g，血象、生化指标、脏器系数均无显著性差异。
另外选择实施例1-5的本发明组合物处方量制成的制剂，经家兔用药后的血压、心率、心电图、呼吸等一般药理试验，以及对分别在清醒和麻醉状态下的大鼠中枢神经功能影响试验，发现给药后动物的血压、心率、心电图、呼吸与用药前比，均无明显变化，且未见动物有兴奋或抑制现象。表明在本发明的处方范围内，用药安全。
以上对本发明的具体实施例进行了描述。需要理解的是，本发明并不局限于上述特定实施方式，本领域技术人员可以在权利要求的范围内做出各种变化或修改，这并不影响本发明的实质内容。在不冲突的情况下，本申请的实施例和实施例中的特征可以任意相互组合。
Claims (6)
1.一种用于预防或治疗阿尔兹海默症的中药组合物，其特征在于：由以下重量份的原料制备而成：
天麻1.5-2.5份；五味子0.7-1.3份；麦冬1.5-2.5份。
2.根据权利要求1所述的预防或治疗阿尔兹海默症的中药组合物，其特征在于：由以下重量份的原料制备而成：
天麻1.6-2.3份；五味子0.8-1.2份；麦冬1.6-2.3份。
3.根据权利要求1所述的预防或治疗阿尔兹海默症的中药组合物，其特征在于：由以下重量份的原料制备而成：
天麻2份；五味子1份；麦冬2份。
4.一种预防或治疗阿尔兹海默症的中药组合物的制备方法，其特征在于：包括以下步骤：
S1、按权利要求1-3任一项所述的配方称取天麻、五味子、麦冬；
S2、向称取的天麻、五味子、麦冬中加入6倍量水，煎煮1.5h，过滤，滤渣再加入4倍量水，煎煮1.5h,过滤，合并两次滤液，将滤液冷冻干燥，即得中药组合物提取物。
5.根据权利要求1所述的预防或治疗阿尔兹海默症的中药组合物，其特征在于：所述中药组合物可直接加入药学可接受的药用辅料，制成临床可应用的口服剂型。
6.根据权利要求5所述的预防或治疗阿尔兹海默症的中药组合物，其特征在于：所述的药用辅料包括崩解剂、乳化剂、矫味剂、稀释剂、润滑剂、填充剂、粘合剂、润湿剂或其它的药用辅料；所述的口服剂型包括但不仅限于口服液，片剂，胶囊剂、颗粒剂。
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