CN107126508A - 一种预防和治疗老年性痴呆的药物组合物及其制备方法 - Google Patents
一种预防和治疗老年性痴呆的药物组合物及其制备方法 Download PDFInfo
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Abstract
本发明是一种预防和治疗老年性痴呆的药物组合物及其制备方法,由熟地黄6‑30份,鲜地黄10‑50份,山药6‑30份,肉苁蓉6‑30份,楮实子6‑30份,枸杞子6‑30份,黄精3‑24份,丹参3‑24份,半夏3‑24份,陈皮3‑24份,茯苓3‑24份,鲜铁皮石斛3‑24份,三七1‑6份组成,制备方法是将熟地黄、山药、肉苁蓉、楮实子、枸杞子、黄精、丹参、半夏、陈皮、茯苓、鲜地黄、鲜铁皮石斛加水煎煮两次,每次20‑40分钟,精制浓缩,得干膏粉碎,掺入粉碎成细粉的三七,混匀,制成制剂。本发明制剂具有补肾益精,祛瘀化痰的功效,针对老年痴呆的病因进行治疗,改善症状,延缓病情的进展,并能起到预防老年性痴呆的作用。
Description
技术领域
本发明涉及药品,具体涉及一种预防和治疗老年性痴呆的药物组合物及其制备方法,属于药品技术领域。
技术背景
老年性痴呆,又名阿尔茨海默病(AD)是一种起病隐匿的进行性发展的神经系统退行性疾病。临床上以记忆障碍、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特征,病因迄今未明。阿尔茨海默病是老年人最常见的神经变性疾病,随着老年人寿命的增加,本病的发病率呈逐年上升趋势,65岁以上的老年人发病率高达5%,严重威胁老年人的健康,影响生活质量,并且造成沉重的家庭负担,成为老年人照料的社会问题的难点。
阿尔茨海默病属于中医“痴呆”范畴,病因常见于年迈或久病体虚、情志所伤致髓海失养,病理因素多以痰、虚、瘀为主,病理特征多本虚标实,其中以肾精亏虚,痰瘀内阻最为常见。近年来的临床研究表明,中医药治疗老年性痴呆显示出明显的优势,可多靶点起效,对于改善症状缓解病情进展方面有突出的优势。
发明内容
本发明的目的是为了提供一种预防和治疗老年性痴呆的药物组合物及其制备方法,针对老年性痴呆病因进行治疗,对于改善症状缓解病情进展方面有突出的优势。
本发明的目的通过以下技术方案实现:
一种预防和治疗老年性痴呆的药物组合物及其制备方法,其特征在于由下列重量份的原料药制成:熟地黄6-30份,鲜地黄10-50份,山药6-30份,肉苁蓉6-30份,楮实子6-30份,枸杞子6-30份,黄精3-24份,丹参3-24份,半夏3-24份,陈皮3-24份,茯苓3-24份,鲜铁皮石斛3-24份,三七1-6份。
本发明所述的一种预防和治疗老年性痴呆的药物组合物及其制备方法,其特征在于制备方法是将熟地黄、山药、肉苁蓉、楮实子、枸杞子、黄精、丹参、半夏、陈皮、茯苓、鲜地黄、鲜铁皮石斛加水煎煮两次,每次20-40分钟,精制浓缩,得干膏粉碎,掺入粉碎成细粉的三七,混匀,制成制剂。
以上各组份中,重量是以生药计算的,在本发明中,如重量以克为单位,该组成为成人一天的服用剂量。
以上各组成是按重量份作为配比的,在生产时可以按照相应的比例增大或减少,如大生产规模生产可以以千克或以吨为单位,重量可以增大或减少,但各组分之间的生药重量配比比例不变,成人一天的服用剂量不变。
本发明药物组合物可以采用中药制剂常规方法制成任何可药用的常规制剂,例如可将提取后粉碎混匀的半成品制成片剂、胶囊剂、丸剂、颗粒剂。
本发明预防和治疗老年性痴呆的药物组合物,功能补肾益精,祛瘀化痰。老年性痴呆属于中医“痴呆”范畴,病位在脑,与多个脏腑有关,以年高肾精亏损较为多见,夹杂痰、瘀等致病因素,造成老年人精血亏损,脑髓空虚,元神失用。故以熟地、鲜地黄、肉苁蓉、黄精为君药,补肾填精益髓;以山药、枸杞子、鲜铁皮石斛、楮实子为臣药,助君药补益肾精;以丹参、三七活血化瘀,以半夏、陈皮、茯苓健脾化痰,共为佐使;诸药合用,标本兼治,共奏补肾益精,祛瘀化痰之效。本发明根据导致老年痴呆的病因而制成,因此不仅可以起到治疗作用,还可以未病防病,通过补益肾精,起到预防老年性痴呆的效果。
本发明预防和治疗老年性痴呆,经长期临床应用证明疗效确切,安全性良好。
先按照以下方法制备本发明制剂:
颗粒1:
处方:熟地黄12kg,鲜地黄24 kg,山药12 kg,肉苁蓉12 kg,楮实子12 kg,枸杞子12kg,黄精9 kg,丹参9 kg,半夏9 kg,陈皮9 kg,茯苓9 kg,鲜铁皮石斛9 kg,三七3 kg。
将熟地黄、山药、肉苁蓉、楮实子、枸杞子、黄精、丹参、半夏、陈皮、茯苓、鲜地黄、鲜铁皮石斛加水煎煮两次,第一次加10倍量水,煎煮30分钟,第二次加8倍量水,煎煮30分钟,合并两次药液,滤过,取滤液,浓缩至相对密度1.10~1.15(60℃),加入乙醇使含醇量达到70%,沉淀,静置24小时,吸取上清液,回收乙醇,得醇沉液;将醇沉液浓缩,干燥,粉碎,掺入粉碎成细粉的三七,混匀,加入适量糊精,以乙醇液作为粘合剂制粒,干燥,制成颗粒剂24kg。
颗粒2:
处方:熟地黄12kg,生地黄(鲜地黄24 kg加工至干),山药12 kg,肉苁蓉12 kg,楮实子12 kg,枸杞子12 kg,黄精9 kg,丹参9 kg,半夏9 kg,陈皮9 kg,茯苓9 kg,铁皮石斛(鲜铁皮石斛9 kg加工至干),三七3 kg。
将熟地黄、山药、肉苁蓉、楮实子、枸杞子、黄精、丹参、半夏、陈皮、茯苓、生地黄、铁皮石斛加水煎煮两次,第一次加10倍量水,煎煮30分钟,第二次加8倍量水,煎煮30分钟,合并两次药液,滤过,取滤液,浓缩至相对密度1.10~1.15(60℃),加入乙醇使含醇量达到70%,沉淀,静置24小时,吸取上清液,回收乙醇,得醇沉液;将醇沉液浓缩,干燥,粉碎,掺入粉碎成细粉的三七,混匀,加入适量糊精,以乙醇液作为粘合剂制粒,干燥,制成颗粒剂24kg。
试验例一、本发明的药物组合物制备的颗粒剂治疗阿尔茨海默病的临床试验:
1、 一般资料
全部病例均选自住院病人,共观察90例,随机分为试验组1和试验组2、对照组。试验组1:男性12例,女性18例,年龄72.31±7.65岁,病程3.24±1.89年;试验组2:男性13例,女性17例,年龄71.47±7.52岁,病程3.65±2.01年;对照组:男性11例,女性19例,年龄73.02±7.87岁,病程3.63±1.75年;三组患者性别、年龄、病程等资料经统计学分析,差异均无统计学意义(P>0.05),具有可比性。
2、 治疗方案
试验组1:颗粒1,每日24g,分3次服用,早中晚各一次;
试验组2:颗粒2,每日24g,分3次服用,早中晚各一次;
对照组:盐酸多奈哌齐片(卫材中国药业有限公司,每粒5mg)口服,1次5mg,每日1次;
疗程:1个月。
3、 诊断标准:
选取病例均符合美国神经病学、语言障碍和卒中-老年性痴呆和相关疾病学(NNCDS-ADRDA)“很可能AD”诊断标准和《精神障碍诊断和统计手册》第4版修订(DSM-IV-TR)AD诊断标准;简易智能量表 (MMSE)评分:中学文化程度≤24分,小学≤20分,文盲≤17分,并可完成基本量表检查;年龄 65~90岁。
4、 疗效判定标准:
参照《中医病证诊断疗效标准》,疗效指数=(治疗前积分-治疗后积分)/治疗前积分×100%。
显效:主症大部分恢复,记忆认知功能基本得到改善,定向基本健全,问答切题,反应较好,生活可以自理,即疗效指数≥70%;
有效:主症部分恢复正常或者有所减轻,记忆认知功能稍改善,问答尚可 ,生活基本自理,但反应迟钝欠灵敏,即70%>疗效指数≥20%;
无效 :主症无改善或病情加重,即疗效指数<20%。
5、 结果:
表1 三组临床疗效比较
临床试验中未观察到与药物相关的不良反应。
结果表明:本发明颗粒疗效好于对照药盐酸多奈哌齐片;并且应用鲜地黄和鲜铁皮石斛制备的颗粒疗效好于干地黄和干铁皮石斛制备的颗粒;且本发明制剂安全性良好,说明本发明制剂治疗老年性痴呆安全有效。
具体实施方式
以下实施例重量是一人一日处方量的1000倍
熟地黄6-30份,鲜地黄10-50份,山药6-30份,肉苁蓉6-30份,楮实子6-30份,枸杞子6-30份,黄精3-24份,丹参3-24份,半夏3-24份,陈皮3-24份,茯苓3-24份,鲜铁皮石斛3-24份,三七1-6份。
实施例1:本发明药物颗粒剂的制备
按重量称取下列原料药
熟地黄6kg,生地黄24 kg,山药30 kg,肉苁蓉6 kg,楮实子6 kg,枸杞子24 kg,黄精12kg,丹参12 kg,半夏12 kg,陈皮24 kg,茯苓3 kg,铁皮石斛3 kg,三七6 kg。
将熟地黄、山药、肉苁蓉、楮实子、枸杞子、黄精、丹参、半夏、陈皮、茯苓、生地黄、铁皮石斛加水煎煮两次,第一次加10倍量水,煎煮20分钟,第二次加8倍量水,煎煮40分钟,合并两次药液,滤过,取滤液,浓缩至相对密度1.10~1.15(60℃),加入乙醇使含醇量达到70%,沉淀,静置24小时,吸取上清液,回收乙醇,得醇沉液;将醇沉液浓缩,干燥,粉碎,掺入粉碎成细粉的三七,混匀,加入适量糊精,以乙醇液作为粘合剂制粒,干燥,制成颗粒剂24kg。
实施例2:本发明药物胶囊剂的制备
按重量称取下列原料药
熟地黄30kg,生地黄50 kg,山药6 kg,肉苁蓉12 kg,楮实子18 kg,枸杞子30 kg,黄精3kg,丹参3 kg,半夏24 kg,陈皮12 kg,茯苓12 kg,铁皮石斛12 kg,三七1 kg。
将熟地黄、山药、肉苁蓉、楮实子、枸杞子、黄精、丹参、半夏、陈皮、茯苓、生地黄、铁皮石斛加水煎煮两次,第一次加12倍量水,煎煮30分钟,第二次加10倍量水,煎煮40分钟,合并两次药液,滤过,取滤液,浓缩至相对密度1.10~1.15(60℃),加入乙醇使含醇量达到70%,沉淀,静置24小时,吸取上清液,回收乙醇,得醇沉液;将醇沉液浓缩,干燥,粉碎,掺入粉碎成细粉的三七,混匀,加入适量糊精,以乙醇液作为粘合剂制粒,干燥,制成胶囊剂2.4万粒。
实施例3:本发明药物片剂的制备
按重量称取下列原料药
熟地黄18kg,生地黄10 kg,山药18 kg,肉苁蓉30 kg,楮实子30 kg,枸杞子6 kg,黄精24 kg,丹参24 kg,半夏3 kg,陈皮3 kg,茯苓24 kg,铁皮石斛24 kg,三七3 kg。
将熟地黄、山药、肉苁蓉、楮实子、枸杞子、黄精、丹参、半夏、陈皮、茯苓、生地黄、铁皮石斛加水煎煮两次,第一次加8倍量水,煎煮40分钟,第二次加8倍量水,煎煮20分钟,合并两次药液,滤过,取滤液,浓缩至相对密度1.10~1.15(60℃),加入乙醇使含醇量达到70%,沉淀,静置24小时,吸取上清液,回收乙醇,得醇沉液;将醇沉液浓缩,干燥,粉碎,掺入粉碎成细粉的三七,混匀,加入适量糊精,以乙醇液作为粘合剂制粒,干燥,制成片剂2.4万片。
实施例4:本发明药物丸剂的制备
按重量称取下列原料药
熟地黄12kg,生地黄24 kg,山药12 kg,肉苁蓉12 kg,楮实子12 kg,枸杞子12 kg,黄精9 kg,丹参9 kg,半夏9 kg,陈皮9 kg,茯苓9 kg,铁皮石斛9 kg,三七3 kg。
将熟地黄、山药、肉苁蓉、楮实子、枸杞子、黄精、丹参、半夏、陈皮、茯苓、生地黄、铁皮石斛加水煎煮两次,第一次加10倍量水,煎煮30分钟,第二次加8倍量水,煎煮30分钟,合并两次药液,滤过,取滤液,浓缩至相对密度1.10~1.15(60℃),加入乙醇使含醇量达到70%,沉淀,静置24小时,吸取上清液,回收乙醇,得醇沉液;将醇沉液浓缩,干燥,粉碎,掺入粉碎成细粉的三七,混匀,制成丸剂24kg。
Claims (2)
1.一种预防和治疗老年性痴呆的药物组合物及其制备方法,其特征在于:由下列重量份原料药制成:熟地黄6-30份,鲜地黄10-50份,山药6-30份,肉苁蓉6-30份,楮实子6-30份,枸杞子6-30份,黄精3-24份,丹参3-24份,半夏3-24份,陈皮3-24份,茯苓3-24份,鲜铁皮石斛3-24份,三七1-6份;制备方法是将熟地黄、山药、肉苁蓉、楮实子、枸杞子、黄精、丹参、半夏、陈皮、茯苓、鲜地黄、鲜铁皮石斛加水煎煮两次,每次20-40分钟,精制浓缩,得干膏粉碎,掺入粉碎成细粉的三七,混匀,制成制剂。
2.根据权利要求1的一种预防和治疗老年性痴呆的药物组合物及其制备方法,其特征在于:由下列重量份原料药制成:熟地黄12份,鲜地黄24份,山药12份,肉苁蓉12份,楮实子12份,枸杞子12份,黄精9份,丹参9份,半夏9份,陈皮9份,茯苓9份,鲜铁皮石斛9份,三七3份。
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