CN1857666A - 一种治疗老年期痴呆的中药制剂 - Google Patents
一种治疗老年期痴呆的中药制剂 Download PDFInfo
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Abstract
本发明涉及一种治疗老年期痴呆的中药制剂，它以黄芪、天麻、茯苓、石菖蒲、人参、枸杞、益智仁、(熟)地黄、知母、川牛膝、川芎、山药、淫羊藿、远志和郁金为原料。本发明主要治疗老年期痴呆，并可有效预防老年期痴呆，具有见效快，疗效好，无毒副作用的优点。
Description
技术领域
本发明涉及一种治疗老年期痴呆的中药制剂，是一种治疗老年期痴呆以中草药为原料的中成药。属于中药领域。
背景技术
老年期痴呆又称老年痴呆病，是老年期常见的一组慢性进行性精神衰退性疾病。目前认为，老年期痴呆是由于慢性或进行性大脑结构的器质性损害引起的高级大脑功能障碍的一组症侯群，是患者在意识清醒的状态下出现的持久的全面的智能减退，表现为记忆力、计算力、判断力、注意力、抽象思维能力、语言功能减退，情感和行为障碍，独立生活和工作能力丧失。据“研究结果发现广州市城区75岁及以上老人中痴呆患病率为8.9％，男女的患病率分别为2.91％和13.11％。75～79岁老人的患病率为4.85％，80～84岁的为9.16％。85岁及以上的为26.14％。老年性痴呆患病率为7.49％，其中男性和女性分别为2.01％和11.36％，75～79岁、80～84岁和85岁及以上年龄段的老年性痴呆患病率分别为3.28％、7.93％和25.13％，三个年龄段老人血管性痴呆患病率则分别为1.47％、0.94％和0.27％。75～84岁老人的痴呆和老年性痴呆患病率，低于上海报道的结果12.33～15.19％及10.95～13.29％，但明显高于武汉、北京等调查结果。85岁以上老人痴呆和老年性痴呆患病率则稍高于上海90年研究结果。
老年期痴呆属于中医学的“呆证”、“癫证”、“善忘”、“痴呆”、“郁证”等范畴。中医学认为老年期痴呆的病位在脑，与心肝脾肾功能失调密切相关。年高正气亏虚及七情所伤、情志失调是本病的重要病因，主要病因为精、气、血亏损不足，使髓海失充、脑失所养及风、火、痰、瘀诸邪内阻，上扰清窍，清窍受蒙，终致神明失用，痴呆遂生。其病理性质是本虚标实，临床多见虚实夹杂证。西医认为老年性痴呆的病因目前尚未完全阐明。几种主要假说如下：(一)家族遗传史，(二)感染假说，(三)免疫假说，(四)胆碱系统缺陷，(五)脑损伤假说等。
中医认为本病乃本虚标实之证，临床上以虚实夹杂者多见。因而辨证当以虚实或脏腑失调为纲领，分清虚实，辩明主次。在治疗上虚者补之，实者泻之。解郁散结、补虚益损是治疗大法。中医辨证治疗可分为：髓海不足，肝肾亏损，脾肾两虚，心肝火旺，痰浊阻窍，气滞血瘀等症型。西医治疗老年期痴呆由于病因未明，目前尚无特效治疗药物和方法。
发明内容
本发明是在传统的中医辨证治疗的基础上结合现代最新科研成果研制而成的。本发明的目的是提供一种老年期痴呆的中药制剂，具有疗效确切、安全方便、副作用小、价格低廉的特点。
本发明是由下述重量配比的原料制成的：
黄芪3～12份 (熟)地黄1.5～6份 郁金0.5～2份
茯苓1.5～6份 石菖蒲1.5～6份 人参0.5～2份
枸杞1.5～6份 益智仁1.5～6份 天麻1.5～6份
知母1.5～6份 川牛膝1.5～6份 川芎1.5～6份
山药1.5～6份 淫羊藿1.5～6份 远志1，5～6份
本发明的优选配方各原料的重量配比是：
黄芪5～7份 (熟)地黄2～4份 郁金0.8～1.2份
茯苓2～4份 石菖蒲2～4份 人参0.8～1.2份
枸杞2～4份 益智仁2～4份 天麻2～4份
知母2～4份 川牛膝2～4份 川芎2～4份
山药2～4份 淫羊藿2～4份 远志2～4份
本发明的最佳配方各原料的重量配比是：
黄芪6份 (熟)地黄3份 郁金1份
茯苓3份 石菖蒲3份 人参1份
枸杞3份 益智仁3份 天麻3份
知母3份 川牛膝3份 川芎3份
山药3份 淫羊藿3份 远志3份
本发明中的药物机理如下：
黄芪 性味甘、温。归肺、脾经。具有益卫固表，利水消肿，托毒，生肌的功效。用于内伤劳倦、脾虚泄泻、脱肛、气虚血脱、崩带、自汗、盗汗、血痹、浮肿、痈疽不溃或溃之不敛及一切气衰血虚之症。《抗癌中药药理与应用》第1074页。
天麻 性味甘、平。归肝经。具有息风、定惊的功效。可治疗眩晕眼黑、头风头痛、肢体麻木、半身不遂、语言蹇涩、小儿惊痫动风等。《中药大辞典》第316页。
郁金 性味辛、苦、凉。归心、肺、肝经。具有行气解郁、凉血破瘀、利胆退黄、清心除烦的功效。可治疗胸腹胁肋诸痛、失意癫狂、热病神昏、吐血、衄血、尿血、妇女倒经、黄疸、动脉硬化等。《抗癌中药药理与应用》第794页。
茯苓 性味甘、平、淡。归心、肺、脾、肾经。具有渗湿利水、益脾和胃、宁心安神的功效。可治疗小便不利、水肿胀满、痰饮咳逆、脑悸、便溏泄泻、心神不安、惊悸、失眠、健忘、遗精、淋浊、脾虚、停饮不食、脘闷、三阴疟疾、发热不愈、止虚亡阳等。《抗癌中药药理与应用》第898页。
石菖蒲 性味辛、苦、温。归心、胃经。具有化湿开胃、开窍豁痰、镇静安神、辟秽杀虫、降血压、解痉、抗菌消炎、解毒、理气、活血的功效。可治疗癫痫、痰热惊厥、热病神昏、健忘、气闭耳聋、心胸烦闷、风寒湿痹、胃痛、脘腹胀满、肠炎、痢疾、慢性支气管炎、小儿肺炎、痰涎闭塞、神志不清、痈疽癣疥、跌打损伤等。《抗癌中药药理与应用》第399页。
人参 性味甘、微苦、平。归脾、肺、心、胃经。具有大补元气、补脾益肺、生津、安神的功效。可治疗体虚欲脱、肢冷脉微、脾虚食少、反胃吐食、大便滑泄、津伤口渴、久病虚羸、惊悸失眠、阳痿宫冷、尿频、妇女崩漏、小儿慢惊、心力衰竭、心原性休克、神经衰弱、一切气血津液不足之症。《抗癌中药药理与应用》第26页。
枸杞 性味甘、平。归肝、肾经。具有滋补肝肾、益精明目的功效。可治疗肝肾阴亏、腰膝酸软、头晕、目眩、目昏多泪、虚劳咳嗽、消渴、遗精、血虚萎黄、神经衰弱、肝炎、疖肿、冻疮、烫伤、褥疮、慢性萎缩性胃炎、胃、十二指肠球部溃疡等。《抗癌中药药理与应用》第869页。
益智仁 性味辛、温。归脾、肾经。具有温脾止泻、暖肾固精缩尿的功效。可治疗脾寒泄泻、腹中冷痛、口多垂涎、肾虚遗尿、小便频数、遗精白浊等。《抗癌中药药理与应用》第1048页。
(熟)地黄 性味甘、微温。归肝、肾经。具有滋阴补血、益精填髓的功效。可治疗肝肾阴虚、腰膝酸软、骨蒸潮热、盗汗遗精、内热消渴、血虚萎黄、心悸怔忡、月经不调、崩漏下血、眩晕、耳鸣、须发早白等。《抗癌中药药理与应用》第514页。
知母 性味苦、甘、寒。归肺、胃、肾经。具有清热泻火，生津润燥的功效。可治疗外感热病、高热烦渴、结核病发热、肺热咳嗽、骨蒸潮热、内热消渴、肠燥便秘，小便不利、糖尿病等。《抗癌中药药理与应用》第817页。
川牛膝 性平，味甘微苦，无毒。归肝、肾经。具有祛风、利湿、通经、活血的功效。可治疗风湿腰膝疼痛、脚痿筋挛、血淋、尿血、妇女经闭、症瘕等。《中药大辞典》第228页。
川芎 性味辛、香。归肝、胆、心包经。具有活血行气，祛风止痛的功效。可治疗月经不调，经闭痛经，难产，瘀阻疼痛，症瘕腹痛，胸胁刺痛，寒痹筋挛，跌扑肿痛，风热头痛，风湿痹痛，疮疡肿痛，胎衣不下，脑缺血，冠心病，心绞痛，动脉粥样硬化，高血压，放疗，化疗所致白细胞减少症，青少年近视眼，维生素E缺乏症，感冒头晕，外用塞鼻治疟疾等。《抗癌中药药理与应用》第171页。
山药 性味甘、平。归脾、肺、肾经。具有补脾养胃、生津益肺、补肾涩精的功效。可治疗气虚衰弱、脾虚泄泻、久痢、肺虚咳嗽、消渴、肾虚遗精、带下、小便频数、糖尿病、遗尿、慢性肾炎、慢性肠炎等。《抗癌中药药理与应用》第137页。
淫羊藿 性味辛、甘、温。归肝、肾经。具有补肾壮阳、祛风除湿、强筋骨的功效。可治疗阳痿不举、小便淋沥、筋骨挛急、半身不遂、腰膝无力、风湿痹痛、四肢不仁、更年期高血压症、神疲健忘、神经衰弱、骨髓炎等。《抗癌中药药理与应用》第1143页。
远志 性味苦、辛、温。归心、肾、肺经。具有安神益智、祛痰、消肿的功效。可治疗痰饮、神昏、咳嗽、失眠、惊悸、健忘、梦遗、痈疽疮肿等。《抗癌中药药理与应用》第620页。
本发明遵循中医“君臣佐使”的组方原则，用黄芪、天麻、人参和益智仁为君药，茯苓、枸杞(熟)地黄、知母、川牛膝、山药、淫羊藿为臣药，远志、石菖蒲、郁金和川芎为佐使药。诸药相和共具益气健脾、滋阴补血、开窍豁痰、安神益智的功效，治疗和预防老年期痴呆，疗效确切，无毒副作用，服用方便，价格低廉。
本发明的中药制剂，在制备成药剂时可加入药物可接受的载体，所述药物可接受的载体可以是：淀粉、蔗糖、乳糖、甘露糖醇、硅衍生物、纤维素类及其衍生物、藻酸盐、明胶、聚乙烯吡咯烷酮、甘油、土温80、琼脂、碳酸钙、碳酸氢钙、表面活性剂、聚乙二醇、环糊精、β-环糊精、磷脂类材料、高岭土、滑石粉、硬脂酸钙、硬脂酸镁等。
本发明的中药制剂可以是任何可药用的剂型，这些剂型包括：片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、胶囊剂、硬胶囊剂、软胶囊剂、口服液、口含剂、颗粒剂、冲剂、丸剂、散剂、膏剂、丹剂、混悬剂、粉剂、溶液剂、注射剂、栓剂、软膏剂、硬膏剂、霜剂、喷雾剂、滴剂、贴剂。本发明的制剂，优选的是口服剂型，如：片剂、胶囊剂、口服剂、口含片、颗粒剂、冲剂、丸剂、散剂、混悬剂、粉剂、溶液剂、滴剂、滴丸剂。更优选的中药制剂是胶囊剂、片剂、颗粒剂。
本发明药物临床使用结果表明，有如下优点：
1、本发明选用的中草药各组份符合中华人民共和国药品管理法之规定，利用各味中药的综合作用治疗和预防老年期痴呆，无化学甜味剂，对人体无毒无害。经动物急性毒性实验表明被实验的动物未见任何毒性反应，其主要脏器也无明显的改变，小鼠对本发明药物的最大耐受量为50g生药/kg，是临床人用量的170倍，药物安全可靠。
2、本发明无须煎煮，无苦涩感，药中富含蛋白质，葡萄糖，葡萄糖醛酸，挥发油，果胶，果糖，有机酸，卵磷脂，维生素，氨基酸，还含皂甙，植物甾醇和钙等多种微量元素，利于人体吸收，增强体质，且服用方便。
3、本发明可有效的治疗老年期痴呆，预防老年期痴呆也有很好的疗效，大大提高了患者的生存质量和时间，有较高的治愈康复效果。
下面通过临床应用例进一步说明本发明药物对治疗老年期痴呆的治疗效果。
老年期痴呆疗效判定标准(《中药新药临床研究指导原则》郑筱萸主编中国医药科技出版社2002年5月第一版第98页)。
1、临床痊愈 肾阴虚症的症状、体征消失或基本消失；征候积分减少≥95％。
2、显效 症状、体征明显改善，征候积分减少≥70％。
3、好转 症状、体征均有好转，征候积分减少≥30％。
4、无效 症状 体征无明显改善，甚或加重，征候积分减少不足30％。
经临床试验结果如下；治疗老年期痴呆患者50例，男性22例，女性28例，年龄为70～90岁。服用实施例1胶囊剂，每次2-10粒，每日三至四次，温开水送下，饭前半小时服用。一个月为一个疗程，连续服用三个疗程观察疗效。痊愈18例占36％，显效22例占44％，有效6例占12％，无效4例占8％，总有效率达92％。经三个疗程治疗后，患者记忆障碍、抽象思维障碍及其他神经系统症状等均有明显改善。且病人无任何不良反应，三大常规化验及肝肾功能检测未发现异常。
具体实施方式
实施例1 胶囊剂 按下述重量称取原料：
黄芪6份 (熟)地黄3份 郁金1份
茯苓3份 石菖蒲3份 人参1份
枸杞3份 益智仁3份 天麻3份
知母3份 川牛膝3份 川芎3份
山药3份 淫羊藿3份 远志3份
制备方法是先取人参和天麻干燥粉碎至120～200目细粉，再取黄芪、茯苓、石菖蒲、枸杞、益智仁、(熟)地黄、知母、川牛膝、川芎、山药、淫羊藿、远志和郁金加水煎煮两次，第一次1.5～2小时，第二次0.5～1小时，合并两次煎液，滤过，滤液浓缩至80度～85度时，相对密度1.08～1.10的清膏，加入乙醇使清膏含醇量达70％，静置24小时，回收乙醇，在50度～55度时浓缩至相对密度1.30～1.32的清膏，再将清膏与人参和天麻细粉混匀，干燥，粉碎成细粉，装入胶囊。每粒装0.3克，通常饭前半小时口服，温开水送下，一次2～10粒，一日三至四次，一个月为一个疗程。
实施例2 片剂 按下述重量称取原料：
黄芪6份 (熟)地黄3份 郁金1份
茯苓3份 石菖蒲3份 人参1份
枸杞3份 益智仁3份 天麻3份
知母3份 川牛膝3份 川芎3份
山药3份 淫羊藿3份 远志3份
制备方法是先取人参和天麻干燥粉碎至120～200目细粉，再取黄芪、茯苓、石菖蒲、枸杞、益智仁、(熟)地黄、知母、川牛膝、川芎、山药、淫羊藿、远志和郁金加水煎煮两次，第一次1.5～2小时，第二次0.5～1小时，合并两次煎液，滤过，滤液浓缩至80度～85度时，相对密度1.08～1.10的清膏，加入乙醇使清膏含醇量达70％，静置24小时，回收乙醇，在50度～55度时浓缩至相对密度1.30～1.32的清膏，再将清膏与人参和天麻细粉混匀，干燥，粉碎成细粉，加入适量淀粉、乙醇制粒，干燥后，加入适量硬脂酸镁，压片，包糖衣即得。通常饭前半小时口服，温开水送下，一次2～10片，一日三至四次，一个月为一个疗程。
实施例3 颗粒剂 按下述重量称取原料：
黄芪6份 (熟)地黄3份 郁金1份
茯苓3份 石菖蒲3份 人参1份
枸杞3份 益智仁3份 天麻3份
知母3份 川牛膝3份 川芎3份
山药3份 淫羊藿3份 远志3份
制备方法是先取人参和天麻干燥粉碎至120～200目细粉，再取黄芪、茯苓、石菖蒲、枸杞、益智仁、(熟)地黄、知母、川牛膝、川芎、山药、淫羊藿、远志和郁金加水煎煮两次，第一次1.5～2小时，第二次0.5～1小时，合并两次煎液，滤过，滤液浓缩至80度～85度时，相对密度1.08～1.10的清膏，加入乙醇使清膏含醇量达70％，静置24小时，回收乙醇，在50度～55度时浓缩至相对密度1.30～1.32的清膏，再将清膏与人参和天麻细粉混匀，干燥，粉碎成细粉，加入适量蔗糖和可溶性淀粉，乙醇制粒，干燥后装袋即得。通常饭前半小时温开水冲服，一次1～3袋，一日三至四次，一个月为一个疗程。
Claims (6)
1、一种治疗老年期痴呆的中药制剂，其特征在于它是由下述重量配比的原料制成的：
黄芪3～12份 (熟)地黄1.5～6份 郁金0.5～2份
茯苓1.5～6份 石菖蒲1.5～6份 人参0.5～2份
枸杞1.5～6份 益智仁1.5～6份 天麻1.5～6份
知母1.5～6份 川牛膝1.5～6份 川芎1.5～6份
山药1.5～6份 淫羊藿1.5～6份 远志1.5～6份
2、根据权利要求1所述的一种治疗老年期痴呆的中药制剂，其中各原料的重量配比是：
黄芪5～7份 (熟)地黄2～4份 郁金0.8～1.2份
茯苓2～4份 石菖蒲2～4份 人参0.8～1.2份
枸杞2～4份 益智仁2～4份 天麻2～4份
知母2～4份 川牛膝2～4份 川芎2～4份
山药2～4份 淫羊藿2～4份 远志2～4份
3、根据权利要求1所述的一种治疗老年期痴呆的中药制剂，其中各原料的重量配比是：
黄芪6份 (熟)地黄3份 郁金1份
茯苓3份 石菖蒲3份 人参1份
枸杞3份 益智仁3份 天麻3份
知母3份 川牛膝3份 川芎3份
山药3份 淫羊藿3份 远志3份
4、权利要求1-3的中药制剂，是适合药用的各种剂型。
5、权利要求4的中药制剂是片剂、胶囊剂、口服剂、口含片、颗粒剂、冲剂、丸剂、散剂、混悬剂、粉剂、溶液剂、滴剂、滴丸剂。
6、权利要求4的中药制剂是胶囊剂、片剂、颗粒剂。
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