CN116492445A - 一种预防阿尔兹海默病的中药软胶囊及其制备方法 - Google Patents
一种预防阿尔兹海默病的中药软胶囊及其制备方法 Download PDFInfo
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Abstract
本发明提供了一种预防阿尔兹海默病的中药软胶囊及其制备方法，属于中药技术领域。本发明提供的软胶囊包括内容药物，所述内容药物由药物辅料和药物成分组成；按重量百分含量计，所述药物辅料由90％‑95％大豆油、4％‑7％蜂蜡和1％‑3％吐温‑80组成。本发明通过大豆油、蜂蜡和吐温‑80的相互协调作用，使软胶囊中内容药物的分散性、流动性、稳定性均具有很大的提升。
Description
技术领域
本发明涉及医药技术领域，特别涉及一种预防阿尔兹海默病的中药软胶囊及其制备方法。
背景技术
阿尔茨海默病(AD)，又译为阿兹海默病、老人失智症、阿尔茨海默病症、脑退化症，是一种持续性神经功能障碍，也是失智症中最普遍的成因，症状表现为逐渐严重的认知障碍(记忆障碍、学习障碍、注意障碍、空间认知机能、问题解决能力的障碍)，逐渐不能适应社会。治疗阿尔茨海默病的药物，主要包括奥拉西坦、吡拉西坦、胞二磷胆碱、多奈哌齐和石杉碱甲，但有些药物只能起到缓解病情的作用，并且毒副作用较大，因此，研发安全有效的新型AD治疗药物有着意义非凡的价值。
有研究表明，钩藤总碱具有抑制神经原纤维形成、拆解Aβ导致的纤维缠结以及改变AD小鼠模型的认知记忆缺陷等功能。异钩藤碱能够拮抗Aβ诱导的神经毒性，抑制Tau蛋白过度磷酸化、氧化应激、细胞凋亡及减少胶质细胞释放炎性因子等神经保护功能来有效减缓AD的发生发展进程。钩藤含药血清可对抗谷氨酸及过氧化氢造成的PC12神经细胞损伤。此外，对记忆及认知障碍小鼠也有一定的预防和治疗作用。
阿尔茨海默病的药物属于抗精神病类的药物，因此都会有一定的副作用，最常见的不良反应有腹泻、肌肉痉挛、乏力、恶心、呕吐和失眠，长期的服用可能会增加脑卒的风险和对肝肾功造成损害，可能会产生耐药性，最好可以通过中药来进行长期的治疗，中药对于人体的副作用是比较小的。西医治疗阿尔茨海默病主要从加强中枢胆碱能活动和减少β-淀粉样蛋白沉积2个方面进行治疗,但效果甚微。中医药因其多途径、多靶点的作用特点,在治疗AD等复杂的神经退行性疾病方面具有优势。
一般中药粉剂存在携带与服用不便、气味强烈、口感不佳的问题，普遍接受度较差；以及药物剂量难以控制，老年人会出现多服少服现象，而且加上老年人由于衰老导致难以下咽的问题，粉剂不易被接受。片剂速效性差，需要较长时间分解后才能被有效吸收。口服液有效期过短，稳定性差，配制更难控制，含糖量高，很多口服液需要加入糖等辅料来提高口感，这会增加患者的糖分摄入量。而软胶囊可以克服粉剂的强烈气味、不便携带、不便储存和药物剂量难控制的缺点，软胶囊可以克服片剂的吸收性较差、起效时间较长和剂量波动较大的缺点，软胶囊还可以克服配制较难控制、稳定性差、不耐储存和有效期过短的缺点。
中药粉末制成软胶囊比西药制成软胶囊要繁杂，中药粉末在药物辅料中分散性、沉降比、流动性和稳定性的影响因素较多，中药粉末制成软胶囊需要控制粉末的细度和均匀度，并且在辅料的选择及用量上更难选择，而且将中药配方制成软胶囊，能够很大程度的减少杂质、提高吸收速率、提高生物利用度等。
发明内容
有鉴于此，本发明目的在于提供一种预防阿尔兹海默病的中药软胶囊及其制备方法，本发明提供的中药软胶囊可以解决中药粉末在药物辅料中，分散不均匀、沉降比大、流动性差和稳定性差的问题。
为了实现上述目的，本发明提供以下技术方案：一种预防阿尔兹海默病的中药软胶囊，所述中药软胶囊包括内容药物，所述内容药物由药物辅料和药物成分组成；按重量百分含量计，所述药物辅料由90％-95％大豆油、4％-7％蜂蜡和1％-3％吐温-80组成。
优选地，所述药物成分与药物辅料的质量比为1:(0.8-1)。
优选地，按重量份数计，所述药物成分由以下原料制备得到：钩藤210-240份、竹茹210-240份、百合210-240份、茯苓210-240份、石膏140-160份、人参490-560份、生姜70-80份、陈皮210-240份、防风210-240份、菊花140-160份。
优选地，所述中药软胶囊还包括囊壳；所述囊壳由明胶、甘油、防腐剂和水制备得到。
进一步优选地，所述明胶、甘油、防腐剂和水的质量比为10:4:0.1:5。
本发明还提供了上述技术方案所述预防阿尔兹海默症的中药软胶囊的制备方法，包括以下步骤：
(1)将钩藤、竹茹、茯苓、石膏和人参采用水煎法进行提取，将得到的提取液进行蒸发、浓缩、干燥、研磨、过筛后得到浸膏粉；
(2)用超临界萃取法提取陈皮、生姜、百合、防风和菊花的挥发油；
(3)将蜂蜡加热溶解后与大豆油、吐温-80混合，冷却后加入浸膏粉和挥发油，搅拌均匀得到内容药物；
(4)将明胶加热充分溶解，然后加入甘油、防腐剂和水，得到囊壳，保温存放待用；
(5)将步骤(3)所得内容药物和步骤(4)所得囊壳用压制法制备胶囊。
优选地，步骤(1)所述提取时间为4-5h。
优选地，步骤(1)所述干燥温度为60℃，所述过筛为为过80-100目筛。
有益技术效果：本发明提供了一种预防阿尔兹海默病的中药软胶囊及其制备方法。本发明提供的软胶囊包括内容药物，所述内容药物由药物辅料和药物成分组成；按重量百分含量计，所述药物辅料由90％-95％大豆油、4％-7％蜂蜡和1％-3％吐温-80组成。通过大豆油、蜂蜡和吐温-80的相互协调作用，使软胶囊中内容药物的分散性、流动性、稳定性均具有很大的提升；本发明提供的软胶囊不良反应轻微，在稳定性和疗程上呈现出明显的优势，可以有效的预防阿尔茨海默病。
附图说明
图1为本发明提供的预防阿尔茨海默病的中药软胶囊的制备方法流程示意图；
图2为不同稀释剂对沉降比的影响图；
图3为不同量大豆油对体积沉降比的影响图；
图4为不同助悬剂对体积沉降比的影响图；
图5为不同量蜂蜡对体积沉降比的影响图；
图6为不同湿润剂对沉降比的影响图；
图7为不同量吐温-80对体积沉降比的影响图。
具体实施方式
本发明提供了一种预防阿尔兹海默病的中药软胶囊，所述中药软胶囊包括内容药物，所述内容药物由药物辅料和药物成分组成；按重量百分含量计，所述药物辅料由90％-95％大豆油、4％-7％蜂蜡和1％-3％吐温-80组成。
在本发明中，所述大豆油作为稀释剂，药物在大豆油中分散性和流动性较好，常见的稀释剂有棕榈油、PEG400，虽然分散性好，但流动性差，花生油沉降比高，但分散性差，分散不均匀，因此，选用大豆油能使药物具有较好的分散性和流动性；在助悬剂的选择上，常见的助悬剂有蜂蜡、单硬脂酸甘油酯和D-山梨醇，蜂蜡能使药物迅速分散均匀，并且能够降低沉降比，而单硬脂酸甘油酯和D-山梨醇使药物聚集不分散；在湿润剂选择上，常用吐温-80和司盘，但是综合考虑吐温-80作为湿润剂与大豆油和蜂蜡进行配比，能够进一步降低沉降比，提高稳定性，本发明通过大豆油、蜂蜡和吐温-80的相互协调作用，使制得的内容药物体积沉降比、分散性、流动性较好，且内容物稳定性最佳；在本发明中，所述药物辅料优选为95％大豆油、4％蜂蜡和1％吐温-80。
在本发明中，所述药物成分与药物辅料的质量比优选为1:(0.8-1)，更优选为1:0.9。在该比例下有利于药品制备工艺的稳定性、可靠性的提高，提高药物的生物利用度，且该比例下能使药物成分在药物辅料中分散性好，流动性好，能够提高药物稳定性和软胶囊的稳定性。
在本发明中，按重量份数计，所述药物成分优选为由以下原料制备得到：钩藤210-240份、竹茹210-240份、百合210-240份、茯苓210-240份、石膏140-160份、人参490-560份、生姜70-80份、陈皮210-240份、防风210-240份、菊花140-160份；更优选为钩藤225份、竹茹225份、百合225份、茯苓225份、石膏150份、人参525份、生姜75份、陈皮225份、防风225份、菊花150份。
优选地，所述中药软胶囊还包括囊壳；所述囊壳由明胶、甘油、防腐剂和水制备得到；所述明胶、甘油、防腐剂和水的质量比为10:4:0.1:5。
本发明还提供了上述技术方案所述预防阿尔兹海默症的中药软胶囊的制备方法，包括以下步骤：
(1)将钩藤、竹茹、茯苓、石膏和人参采用水煎法进行提取，将得到的提取液进行蒸发、浓缩、60℃干燥、研磨、过80-100目筛后得到浸膏粉；所述水煎法为将钩藤、竹茹、茯苓、石膏和人参粉碎，浸泡4-8小时后，在沸水中大火煎熬30min，后改用小火煎熬4-5h；在本发明中，将所述浸膏粉过80-100目筛，可以减小粒度，增加分散媒黏度，能有效地降低沉降比，提高混悬液的稳定性，药物成分在辅料中分散性更好；
(2)用超临界萃取法提取陈皮、生姜、百合、防风和菊花的挥发油；
(3)将蜂蜡加热溶解后与大豆油、吐温-80混合，冷却后加入浸膏粉和挥发油，搅拌均匀得到内容药物；
(4)将明胶加热充分溶解，然后加入甘油、防腐剂和水，得到囊壳，保温存放待用；
(5)将步骤(3)所得内容药物和步骤(4)所得囊壳用压制法制备胶囊。
以上组成的软胶囊在生产时可按照相应比例增大或减少，如大规模生产可以吨为单位，小规模生产也可以毫克为单位，重量可以增大或者减小，但各组成之间的重量配比的比例不变。
对于特殊病人，如重症或轻症，肥胖或瘦小的病人，可以相应调整组成的量的配比，药效不变。
为了更好地理解本发明，下面结合实施例进一步阐明本发明的内容，但本发明的内容不仅仅局限于下面的实施例。
实施例1
1)将钩藤225g，竹茹225g，茯苓225g，石膏150g，人参525g原料粉碎，浸泡4h，大火煎熬30分钟，小火煎熬4小时后将提取液进行蒸发、浓缩，60℃干燥、研磨、过80目筛后得到浸膏粉；
2)对生姜75g，陈皮225g，百合225g，防风225g，菊花150g采用超临界萃取法提取其中挥发油；
3)按配比取95％大豆油，4％蜂蜡，1％吐温-80，先将蜂蜡加热到70℃直至充分溶解，将大豆油、吐温-80和已溶解的蜂蜡混合，然后加入浸膏粉和挥发油，搅拌均匀，即得内容药物；
4)按质量比为10:4:0.1:5称取明胶、甘油、防腐剂和水，将明胶加热充分溶解，然后加入甘油、防腐剂和水，得到囊壳，保温存放待用；
5)将步骤3)所得内容药物和步骤4)所得囊壳用压制法制备胶囊。
用量：每个胶囊生药量为10g，每次服用1粒胶囊，一天服用三次。
实施例2
同实施例1，区别在于，将大豆油、蜂蜡、吐温-80的用量替换为90％大豆油，7％蜂蜡，3％吐温-80。
对比例1
同实施例1，区别在于，将大豆油替换为花生油，将蜂蜡替换为单硬脂酸甘油酯，将吐温-80替换为司盘。
对比例2
同实施例1，区别在于，将大豆油、蜂蜡、吐温-80的用量替换为98大豆油，1.5％蜂蜡，0.5％吐温-80。
将实施例1-2与对比例1-2的软胶囊进行性能测试，分别测试胶囊中内容药物的分散性、流动性、沉降比和内容药物的稳定性，测试结果如下:
(1)实施例1中按该药物辅料配比与内容药物混合后，药物能够迅速散开不聚集，流动性良好，沉降比高，药物稳定性良好。
(2)实施例2中按该药物辅料配比与内容药物混合后，与实施例1结果相似，药物能够迅速散开不聚集，流动性良好，沉降比高，药物稳定性良好。
(3)对比例1中按该药物辅料配比与内容药物混合后，与实施例1对比，药物沉降比高，但药物不能分散均匀，并且聚集在一起，流动性差，内容药物不稳定。
(4)对比例2中按该药物辅料配比与内容药物混合后，与实施例1对比，药物能够更快速的分散均匀，流动性好，沉降比较差，内涵药物稳定性没有实施例1好。
(5)对实施例1配得内容物进行验证，其能够稳定均一，能够满足发明需要。最终药物辅料配方选择大豆油为稀释剂，蜂蜡为助悬剂，吐温-80为湿润剂，其中大豆油为95％，助悬剂为4％，湿润剂为1％。
以上所述仅是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。
Claims (8)
1.一种预防阿尔兹海默病的中药软胶囊，其特征在于，所述中药软胶囊包括内容药物，所述内容药物由药物辅料和药物成分组成；按重量百分含量计，所述药物辅料由90％-95％大豆油、4％-7％蜂蜡和1％-3％吐温-80组成。
2.根据权利要求1所述的中药软胶囊，其特征在于，所述药物成分与药物辅料的质量比为1:(0.8-1)。
3.根据权利要求1所述的中药软胶囊，其特征在于，按重量份数计，所述药物成分由以下原料制备得到：钩藤210-240份、竹茹210-240份、百合210-240份、茯苓210-240份、石膏140-160份、人参490-560份、生姜70-80份、陈皮210-240份、防风210-240份、菊花140-160份。
4.根据权利要求1所述的中药软胶囊，其特征在于，所述中药软胶囊还包括囊壳；所述囊壳由明胶、甘油、防腐剂和水制备得到。
5.根据权利要求4所述的中药软胶囊，其特征在于，所述明胶、甘油、防腐剂和水的质量比为10:4:0.1:5。
6.权利要求1-5任一项所述中药软胶囊的制备方法，其特征在于，包括以下步骤：
(1)将钩藤、竹茹、茯苓、石膏和人参采用水煎法进行提取，将得到的提取液进行蒸发、浓缩、干燥、研磨、过筛后得到浸膏粉；
(2)用超临界萃取法提取陈皮、生姜、百合、防风和菊花的挥发油；
(3)将蜂蜡加热溶解后与大豆油、吐温-80混合，冷却后加入浸膏粉和挥发油，搅拌均匀得到内容药物；
(4)将明胶加热溶解，然后加入甘油、防腐剂和水，得到囊壳，保温存放待用；
(5)将步骤(3)所得内容药物和步骤(4)所得囊壳用压制法制备胶囊。
7.根据权利要求6所述的制备方法，其特征在于，步骤(1)所述提取时间为4-5h。
8.根据权利要求6所述的制备方法，其特征在于，步骤(1)所述干燥温度为60℃，所述过筛为过80-100目筛。
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