CN113144105A - 一种治疗老年痴呆症的中药制剂及其制备方法 - Google Patents
一种治疗老年痴呆症的中药制剂及其制备方法 Download PDFInfo
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Abstract
本发明属于中药技术领域，具体涉及一种治疗老年痴呆症的中药制剂及其制备方法。所述制剂包括以重量份计的以下成分：三七10‑20份、黄芪10‑20份、淫羊藿10‑20份、刺五加10‑15份、天麻5‑15份、灵芝5‑15份、蝉蜕5‑10份、何首乌10‑15份、石菖蒲10‑15份、红花10‑15份、远志5‑15份、法夏5‑15份、酸枣仁10‑15份、龟板5‑15份、熟地黄5‑15份和甘草5‑15份。按重量份配比称取上述药物，分别烘干，混合粉碎后过筛，加入蜂蜜调制成蜜丸即得。本发明配伍科学合理，适用于患有老年痴呆症后出现的智力减退，思维迟滞，健忘乱语病症，疗效显著，无副作用，服用方便，经济实惠。
Description
技术领域
本发明属于中药技术领域，具体涉及一种治疗老年痴呆症的中药制剂及其制备方法。
背景技术
老年痴呆症也即阿尔兹海默症，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。目前治疗老年痴呆的药物一般有乙酰胆碱前体物、卵磷脂、三氟拉嗪等，副作用明显，需要改进。
发明内容
针对以上技术问题，本发明的目的是提供一种治疗老年痴呆症的中药制剂及其制备方法，对老年痴呆症疗效显著，无副作用，服用方便，经济实惠。
为了实现上述目的，本发明采用如下技术方案：
一种治疗老年痴呆症的中药制剂，包括以重量份计的以下成分：三七10-20份、黄芪10-20份、淫羊藿10-20份、刺五加10-15份、天麻5-15份、灵芝5-15份、蝉蜕5-10份、何首乌10-15份、石菖蒲10-15份、红花10-15份、远志5-15份、法夏5-15份、酸枣仁10-15份、龟板5-15份、熟地黄5-15份和甘草5-15份。
进一步地，所述治疗老年痴呆症的中药制剂包括以重量份计的以下成分：三七12-18份、黄芪12-18份、淫羊藿12-18份、刺五加10-13份、天麻8-12份、灵芝8-12份、蝉蜕7-9份、何首乌10-13份、石菖蒲12-15份、红花12-15份、远志8-12份、法夏8-12份、酸枣仁10-12份、龟板8-12份、熟地黄8-12份和甘草8-12份。
优选地，所述治疗老年痴呆症的中药制剂包括以重量份计的以下成分：三七15份、黄芪15份、淫羊藿15份、刺五加12份、天麻10份、灵芝10份、蝉蜕8份、何首乌12份、石菖蒲12份、红花12份、远志10份、法夏10份、酸枣仁12份、龟板10份、熟地黄10份和甘草10份。
上述治疗老年痴呆症的中药制剂的制备方法包括以下步骤：
(1)按重量份配比称取上述药物，将所述药物分别烘干；
(2)将烘干后的药物混合粉碎后过筛；
(3)在药物粉末中加入蜂蜜进行调制，制成蜜丸后密封保存，即得所述中药制剂。
进一步地，所述步骤(2)中粉碎后过100-120目筛。
进一步地，所述步骤(3)中蜂蜜的用量为药物粉末总质量的40-50％。
与现有技术相比，本发明具有如下有益效果：
本发明配伍科学合理，具有清热降压，消肿定痛，散瘀止血，补脾升阳，生津止渴，祛风通痹，熄风止痉，宣肺利咽，滋养肝肾，补益阴血，清热除烦，宁心安神，燥湿化痰，祛痰止咳，补肾健骨，填精益髓的效果，适用于患有老年痴呆症后出现的智力减退，思维迟滞，健忘乱语病症，疗效显著，无副作用，服用方便，经济实惠。
本发明一种治疗老年痴呆症的中药制剂，应用中药的药理效果如下：
三七：清热降压，消肿定痛，散瘀止血。
黄芪：补脾升阳，资生化源，生津止渴。
滛羊霍：辛甘性温，补肾阳，益精血，强筋骨。
刺五加：补中益精，调节内分泌和神经，抗衰老。
天麻：祛风通痹，熄风止痉。
灵芝：解毒，保肝，治疗神经衰弱、心律失常等各种心脏病，防止药物对肝脏的损坏。
蝉蜕：宣肺利咽，疏风清热，定惊解痉。
何首乌：滋养肝肾，补益阴血，清热除烦。
石菖蒲：宁心安神，交通心肾。
红花：活血化瘀，祛瘀止痛。
远志：宁心安神，祛痰消肿。
法夏：燥湿化痰，和胃。
酸枣仁：宁心安神，养心补肝。
龟板：滋阴潜阳，补肾健骨，养心安神。
熟地黄：养血滋阴，补精益髓。
甘草：调和诸药。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚，下面将结合本发明实施例，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
以下实施例中所使用的材料均可自常规途径购买得到。
实施例1
一种治疗老年痴呆症的中药制剂，包括以重量份计的以下成分：三七10份、黄芪20份、淫羊藿10份、刺五加15份、天麻15份、灵芝5份、蝉蜕10份、何首乌10份、石菖蒲15份、红花10份、远志15份、法夏5份、酸枣仁15份、龟板5份、熟地黄15份和甘草15份。
实施例2
一种治疗老年痴呆症的中药制剂，包括以重量份计的以下成分：三七20份、黄芪10份、淫羊藿20份、刺五加10份、天麻5份、灵芝15份、蝉蜕5份、何首乌15份、石菖蒲10份、红花15份、远志5份、法夏15份、酸枣仁10份、龟板15份、熟地黄5份和甘草5份。
实施例3
一种治疗老年痴呆症的中药制剂，包括以重量份计的以下成分：三七12份、黄芪18份、淫羊藿12份、刺五加13份、天麻12份、灵芝12份、蝉蜕7份、何首乌11份、石菖蒲14份、红花13份、远志8份、法夏12份、酸枣仁11份、龟板12份、熟地黄8份和甘草8份。
实施例4
一种治疗老年痴呆症的中药制剂，包括以重量份计的以下成分：三七18份、黄芪12份、淫羊藿18份、刺五加11份、天麻8份、灵芝8份、蝉蜕9份、何首乌13份、石菖蒲12份、红花14份、远志12份、法夏8份、酸枣仁12份、龟板8份、熟地黄12份和甘草12份。
实施例5
一种治疗老年痴呆症的中药制剂，包括以重量份计的以下成分：三七15份、黄芪15份、淫羊藿15份、刺五加12份、天麻10份、灵芝10份、蝉蜕8份、何首乌12份、石菖蒲12份、红花12份、远志10份、法夏10份、酸枣仁12份、龟板10份、熟地黄10份和甘草10份。
制备例
实施例1-5所述治疗老年痴呆症的中药制剂的制备方法包括以下步骤：
(1)按重量份配比称取上述药物，将所述药物分别用烘干机烘干；
(2)将烘干后的药物混合用粉碎机粉碎后过100-120目筛；
(3)在药物粉末中加入其总质量的40-50％蜂蜜进行调制，制成蜜丸后密封保存，即得所述中药制剂。
下面结合临床实验数据具体说明本发明的有益效果：
1、一般资料
1.1发明人2017年1月-2019年7月随机选取150例老年痴呆症病例，随机分为：5个治疗组，1个对照组，每组均为25例。其中5个治疗组均为男20例，女5例；年龄60-80岁；病程1-10年，症状记分10-28分。对照组男20例，女5例；年龄60-82岁；病程1-10年，症状记分10-28分。两组患者的性别、年龄、病程、病情等一般资料经统计学分析无显著性差异(P＞0.05)，具有可比性。
1.2诊断标准：美国神经病学会第四版《精神疾病诊断与统计手册(DSM-IY)》，中老年性痴呆的诊断标准：
(1)发生多方面认知缺陷，表现多如下两面者：
记忆缺损(学习新信息的能力缺损或不能回忆以前所学到的信息)；
至少有如下认知障碍之一：失语、失认、失用、执行管理能力的障碍。
(2)上述表现导致社交或职业功能的缺损，并可发现这些功能明显不如从前。
(3)病程的起病特点是逐渐起病，持续衰退。
(4)上述认知缺陷并非由下列原因引起：
其他导致记忆或认知进行性缺陷的中枢神经系情况，如：心血管疾病；
原因已明的导致痴呆的全身疾病。
(5)并非由于除谵妄所致。
(6)并非重症抑郁或精神分裂所致。
1.3纳入标准
(1)符合美国精神障碍对痴呆临床诊断标准，MMSE评分均在10-24分之间，文化程度均在初中以上，属于轻中度老年痴呆，将伴有严重性神经交流疾病患者，严重性心脏、肝肾疾病均排除。
(2)均伴有记忆障碍、失用及判断力障碍等症状。
(3)年龄为60-80岁。
(4)同意参加实验，签署知情同意书。
2、试验方法
2.1治疗方法
对照组：患者口服盐酸多奈哌齐(天津力生药业生产每片5mg)5mg，睡前10min服用。
治疗组：在对照组基础上配合本发明按照实施例配制的中药制剂，服用时，用温开水冲服，每次6g，每天3次，60天一个疗程。
治疗期间忌浓茶、咖啡、辛辣刺激食物。一个疗程后统计两组疗效。
2.2观察项目：观察患者三多一少症状的改善，并在实验前后对患者进行尿糖测定和血糖测定。
3、疗效标准与治疗结果
3.1疗效标准
显效：主要症状基本恢复，神志清楚，定位准确，回答问题正确，反应灵敏，生活自理，能进行一般社会活动。
有效：主要精神症状有所减轻或部分消失，生活基本自理，回答问题基本正确，但反应迟钝，智力、人格仍有障碍；主要精神状态无加重，生活自理情况变化不明显，反应迟钝，智力、人格仍有障碍，但无加重。
无效:主要症状无改变，病情有发展生活不能自理，回答问题不正确，神志痴呆。
疗效评定：采用中医智能综合评分法，记忆力(6分)，定向力(4分)，思维能力(4分)，计算力(4分)，情感活动(3分)，二便功能(3分)，日常生活能力(4分)。
结果：疗效评定标准根据患者治疗前治疗后MMSE评分增减情况进行疗效评定。
治疗指数＝(治疗后积分-治疗前积分)/治疗前积分×100％
显效：治疗指数≥20％
有效：治疗指数≥12％
无效：治疗指数＜12％
恶化：治疗指数＜-12％
证候疗效判断标准：
显效：积分增加＞8分或为28分
有效：积分增加4-7份
无效：积分增加＜3分
全部病例经本发明中药制剂为主治疗一个疗程，按上述标准进行治疗前后的对照比较，以判定疗效。
3.2治疗统计结果见表1
表1两组疗效比较
| 组别 | 例数 | 显效 | 有效 | 无效 | 总有效率 |
| 实施例1 | 25 | 9 | 10 | 6 | 76％ |
| 实施例2 | 25 | 8 | 11 | 6 | 76％ |
| 实施例3 | 25 | 7 | 12 | 6 | 76％ |
| 实施例4 | 25 | 8 | 11 | 6 | 76％ |
| 实施例5 | 25 | 9 | 11 | 5 | 80％ |
| 对照组 | 25 | 5 | 7 | 13 | 48％ |
可见，本发明优选实施方案制得的药物能够安全有效治疗老年痴呆症，有效率显著高于对照例。本发明组成科学，原料丰富，价格低廉，互相支持，诸药合用共奏活血化瘀，开窍醒志之功效。用药安全，具有较好的临床效用。
根据上述临床试验数据，结合本发明治疗老年痴呆症的中医学机理分析和本领域公知常识，本领域技术人员容易推知，运用本发明中的药材，在其常规用量范围内取值，即“三七10-20份、黄芪10-20份、淫羊藿10-20份、刺五加10-15份、天麻5-15份、灵芝5-15份、蝉蜕5-10份、何首乌10-15份、石菖蒲10-15份、红花10-15份、远志5-15份、法夏5-15份、酸枣仁10-15份、龟板5-15份、熟地黄5-15份和甘草5-15份。”,可以取得与本发明优选实施方式制得的药物类似的效果。
Claims (6)
1.一种治疗老年痴呆症的中药制剂，其特征在于，包括以重量份计的以下成分：三七10-20份、黄芪10-20份、淫羊藿10-20份、刺五加10-15份、天麻5-15份、灵芝5-15份、蝉蜕5-10份、何首乌10-15份、石菖蒲10-15份、红花10-15份、远志5-15份、法夏5-15份、酸枣仁10-15份、龟板5-15份、熟地黄5-15份和甘草5-15份。
2.根据权利要求1所述的一种治疗老年痴呆症的中药制剂，其特征在于，包括以重量份计的以下成分：三七12-18份、黄芪12-18份、淫羊藿12-18份、刺五加10-13份、天麻8-12份、灵芝8-12份、蝉蜕7-9份、何首乌10-13份、石菖蒲12-15份、红花12-15份、远志8-12份、法夏8-12份、酸枣仁10-12份、龟板8-12份、熟地黄8-12份和甘草8-12份。
3.根据权利要求2所述的一种治疗老年痴呆症的中药制剂，其特征在于，包括以重量份计的以下成分：三七15份、黄芪15份、淫羊藿15份、刺五加12份、天麻10份、灵芝10份、蝉蜕8份、何首乌12份、石菖蒲12份、红花12份、远志10份、法夏10份、酸枣仁12份、龟板10份、熟地黄10份和甘草10份。
4.如权利要求1-3任一项所述的治疗老年痴呆症的中药制剂的制备方法，其特征在于，包括以下步骤：
(1)按重量份配比称取上述药物，将所述药物分别烘干；
(2)将烘干后的药物混合粉碎后过筛；
(3)在药物粉末中加入蜂蜜进行调制，制成蜜丸后密封保存，即得所述中药制剂。
5.根据权利要求4所述的一种治疗老年痴呆症的中药制剂的制备方法，其特征在于，所述步骤(2)中粉碎后过100-120目筛。
6.根据权利要求4所述的一种治疗老年痴呆症的中药制剂的制备方法，其特征在于，所述步骤(3)中蜂蜜的用量为药物粉末总质量的40-50％。
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