CN111743992A - 参茸健脑胶囊及其制备方法 - Google Patents
参茸健脑胶囊及其制备方法 Download PDFInfo
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- CN111743992A CN111743992A CN202010585067.1A CN202010585067A CN111743992A CN 111743992 A CN111743992 A CN 111743992A CN 202010585067 A CN202010585067 A CN 202010585067A CN 111743992 A CN111743992 A CN 111743992A
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- parts
- ginseng
- brain
- root
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- Medicines Containing Plant Substances (AREA)
Abstract
本发明属于中药制剂技术领域，特别是涉及一种参茸健脑胶囊及其制备方法。由以下配比的中药材原料组成，炙黄芪125‑132份、人参95‑100份、鹿茸98‑105份、茯苓40‑43份、干姜38‑45份、当归35‑40份、杜仲38‑45份、桂枝40‑42份、白芍22‑26份、法半夏37‑42份、菟丝子35‑40份和炙甘草23‑27份；所述杜仲为盐制杜仲；所述菟丝子为酒治疗菟丝子。通过药物组份之间的协同作用，从而使其对脑萎缩患者的治愈率达到了92.64％，相比现有技术中的药物对脑萎缩具有更好的治疗效果。
Description
技术领域
本发明属于中药制剂技术领域，特别是涉及一种参茸健脑胶囊及其制备方法。
背景技术
脑萎缩是中老年期常见的一种慢性进行性的疾病，它是由于一种或多种原因导致脑供血供氧不足及脑组织体积缩少和脑细胞数目日渐减少引起记忆、思考、认知、理解、计算、学习、语言、判断支配等脑神经高级功能障碍的一组疾病。对小儿而言，脑萎缩往往继发于各种脑病，或者脑发育障碍。现有技术中的制剂对脑萎缩治疗效果差，毒副作用大。
发明内容
本发明提供了一种参茸健脑胶囊及其制备方法，解决了现有技术中的制剂对脑萎缩治疗效果差，毒副作用大的技术问题。
为了实现上述发明目的，本发明的一个方面，提供了一种参茸健脑胶囊，由以下配比的中药材原料组成，炙黄芪125-132份、人参95-100份、鹿茸98-105份、茯苓40-43份、干姜38-45份、当归35-40份、杜仲38-45份、桂枝40-42份、白芍22-26份、法半夏37-42份、菟丝子35-40份和炙甘草23-27份；所述杜仲为盐制杜仲；所述菟丝子为酒治疗菟丝子。
进一步的，所述参茸健脑胶囊由以下配比的中药材原料组成，炙黄芪125份、人参95份、鹿茸98份、茯苓40份、干姜38份、当归35份、杜仲38份、桂枝40份、白芍22份、法半夏37份、菟丝子35份和炙甘草23份。
进一步的，所述参茸健脑胶囊由以下配比的中药材原料组成，炙黄芪130份、人参100份、鹿茸100份、茯苓40份、干姜40份、当归40份、杜仲40份、桂枝40份、白芍25份、法半夏40份、菟丝子40份和炙甘草25份。
进一步的，所述参茸健脑胶囊由以下配比的中药材原料组成，炙黄芪132份、人参100份、鹿茸105份、茯苓43份、干姜45份、当归40份、杜仲45份、桂枝42份、白芍26份、法半夏42份、菟丝子40份和炙甘草27份。
本发明的另一方面，提供了一种制备参茸健脑胶囊的方法，包括以下步骤，(1)称取人参、鹿茸、干姜和当归，烘干，混合后粉碎成细粉，过筛；(2)将炙黄芪、茯苓、盐杜仲、桂枝、白芍、法半夏、酒制菟丝子和炙甘草混合后，以重量计加入8倍量的水煎煮2次，并浸泡30分钟，第一次煎煮2小时，第二次煎煮1.5小时；(3)合并两次煎煮药液、过滤，然后在-0.08～-0.09MPa，60～70℃浓缩滤液，至滤液相对密度在60℃达到1.30-1.35，得到清膏；(4)将步骤(1)得到的细粉混合物加入到步骤(3)得到的清膏中搅拌均匀，干燥、粉碎、过筛；(5)乙醇制粒、干燥、整粒、装胶囊，得到成品。
进一步的，酒制菟丝子的制备方法是，洗净菟丝子，置适当容器内，用黄酒拌匀，稍焖，上笼，用武火蒸至冒气1－2小时，下笼，待冷，取出，干燥。
本发明相比现有技术的有益效果：经过整体药物的组合使本发明相比现有技术中的脑萎缩治疗效果更好，依据脑萎缩诊断标准，经过检测判定，总有效率达到了92.6％，且经过临床试验未发现明显不良反应，经检查也未发现对肝、肾及造血系统产生不良影响。
具体实施方式
下面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。
本发明实施例的说明书和权利要求书中的术语“第一”和“第二”等是用于区别不同的对象，而不是用于描述对象的特定顺序。例如，第一参数集合和第二参数集合等是用于区别不同的参数集合，而不是用于描述参数集合的特定顺序。
在本发明实施例的描述中，除非另有说明，“多个”的含义是指两个或两个以上。例如，多个元件是指两个元件或两个以上元件。
本文中术语“和/或”，是一种描述关联对象的关联关系，表示可以存在三种关系，例如，显示面板和/或背光，可以表示：单独存在显示面板，同时存在显示面板和背光，单独存在背光这三种情况。本文中符号“/”表示关联对象是或者的关系，例如输入/输出表示输入或者输出。
在本发明实施例中，“示例性的”或者“例如”等词用于表示作例子、例证或说明。本发明实施例中被描述为“示例性的”或者“例如”的任何实施例或设计方案不应被解释为比其它实施例或设计方案更优选或更具优势。确切而言，使用“示例性的”或者“例如”等词旨在以具体方式呈现相关概念。
肾为先天之本，主藏精，主生长发育与生殖，又主骨生髓，上充于脑，这是肾中精气具有促进机体生长发育功能的一个重要组成部分，肾中精气充盛，就能充养骨髓，则髓海得养，脑的发育才能健全，就能充分发挥其“精明之府”的功能。精气是构成人体的基本物质，也是人体生长发育及各种功能活动的物质基础，“先天之精”必须依赖“后天之精”的不断培育和充养，才能充分发挥其生理功能；而“后天之精”系由脾所化生，脾为后天之本，主运化，布精微，化水湿，生气血，但其要靠“先天之精”的活力资助，即有赖于命火之温煦才能生成，两者相互依存，相互为用，相互促进。若肾精不足，命火虚衰，不能温养脏腑组织，或脾气虚衰，运化无力，不能化生精微以滋养于肾，而致脾肾两虚，精气不足，髓海空虚，迁延日久，而致脑髓失于充养，诸虚百损变生本病。治疗当以补肾健脾，益气养血为要，直补先、后天之本，以达强身健脑之目的。
本发明药物组分中，人参、鹿茸同用，补气健脾，温壮肾阳，益精养血，共为君药。重用黄芪，助人参大补脾胃之气以化生精血；杜仲、菟丝子助鹿茸补益肝肾，填精补髓，共为臣药。君、臣药相伍，脾肾并补。佐以当归补养肝血，活血通经，润肠通便，使滋而不滞；白芍益阴养血，此两药与人参、黄芪同用，又阴阳气血并补；干姜温运脾阳、茯苓渗湿健脾、法半夏燥湿化痰，脾湿祛则脾健，湿浊不再困脾而发挥脾的正常运化功能；桂枝温通经脉，助阳化气，既可助当归活血通络，以健脑养脑，又可助茯苓、干姜、法半夏以祛湿痰，以上六味共为佐药。使以甘草调和诸药。诸药合用，共奏补肾健脾，益气养血，具有强身健脑之效。
本发明提供了一种参茸健脑胶囊，由以下配比的中药材原料组成，炙黄芪125-132份、人参95-100份、鹿茸98-105份、茯苓40-43份、干姜38-45份、当归35-40份、杜仲38-45份、桂枝40-42份、白芍22-26份、法半夏37-42份、菟丝子35-40份和炙甘草23-27份；所述杜仲为盐制杜仲；所述菟丝子为酒治疗菟丝子。
通过上述重量份数的药材的组合，从而使本实施例中所述的参茸健脑胶囊对脑萎缩的治疗效果高达92.6％，远远高于现有脑萎缩药物的治疗效果，且经过对试验对象的相关检测也并没有发现有不良影响及损害，满足药物安全性测试标准要求。
结合中医西医制定脑萎缩的诊断标准：
(1)至少在学习、注意力、记忆力、定向力中有两种能力发生障碍。
(2)至少在认识才能(计算、抽象观念、判断力、综合能力)中有一种发生障碍。
(3)至少在下列范围中有一种发生障碍：工作能力、与家属及同辈之间的良好的联系能力、社交能力。
(4)至少有下列大脑功能障碍的一个指征：CT扫描有大脑萎缩；异常脑电图，早期表现a节律的丧失以及电位降低，后期出现弥散性低至中电位Q活动，异常的慢活动在颞叶最为显著。
以诊断标准为依据制定疗效标准：
四项均恢复正常。
显效：(1)-(3)项全部正常，(4)项有显著改善。
有效：四项中有两项恢复正常，另两项中至少有一项改善。无效：上述四项均无改善。
从而根据上述标准来判定脑萎缩患者，以及根据最后的疗效标准来判定疗效。
临床试验中共选取68例患者作为试验对象，其中按照诊断标准，68例患者均为脑萎缩。本临床试验将遵循赫尔辛基宣言和中国有关新药临床试验研究规范、法规进行。临床试验方案需经研究负责单位医学伦理委员会审批后方可实施。研究者必须向受试者详细介绍有关临床研究的情况，并在试验前签署患者知情同意书。
临床资料：试验组中，68例中，男41例，女性27例；2岁以下23例，2～6岁21例，6～12岁14例，12岁以上共10例；合并有交通性脑积水者36例，合并梗阻性脑积水者18例，无脑积水者14例，伴有头痛者15例，伴癫痫者29例，伴呕吐者9例，伴肢体无力者63例，伴智力低下者59例。
试验过程中：口服参茸健脑胶囊，每日3次，一次4粒。
对照组68例中，男33例，女性35例；2岁以下12例，2～6岁26例，6～12岁18例，12岁以上共12例；合并有交通性脑积水者21例，合并梗阻性脑积水者14例，无脑积水者33例，伴有头痛者18例，伴癫痫者34例，伴呕吐者11例，伴肢体无力者61例，伴智力低下者53例。
对照组服用广西强寿药业生产的益智康脑丸，每日3次，一次2粒。
1个疗程为1个月，连服3个疗程后统计疗效。
主要指标疗效分析:对脑萎缩计分的治疗前后的绝对差值和相对差值(差值减少率)，组内采用配对T检验，组间采用差值比较，非正态分布者采用wilcoxon秩和检验：对两组治疗前后脑萎缩言语形式的障碍程度分级表计分的变化之比较，采用一般线性模型，重复测量AMOVA，以治疗前数据为协变量，考虑时间点效应进行试验组和对照组的比较。
次要指标疗效分析：对中医证侯计分、各种症状、体征、多动指数等也采用治疗前后绝对差值和相对差值比较，组内采用配对T检验，组间采用差值比较，非正态分布者采用Wilcoxon秩和检验。
参照上述疗效标准将统计结果制表如下。
统计结果如下表：
通过上表可以看出，服用现有技术中的益智康脑丸，虽然对部分患者的病情确有疗效，但是总有效率较低，治疗效果相对较差，仅仅有2人得到了痊愈。而本发明实施例中的配方产品，试验结果显示，对于本次试验对象，痊愈9例，显效28例，有效6例，无效5例，总有效率为92.6％。统计显示，除2例病人出现口干，咽红外，别无不良反应，也未发现对肝、肾功能及造血系统的影响，同时表明该品使用安全。
本发明实施例中治疗的典型病例：郑某，女，54岁，浙江衢州市人。2015年10月21日来我院住院治疗。患者5年前在一次劳动后出现双下肢无力，后病情逐渐加重，出现走路摇晃，步幅宽大，步速减慢，语言迟钝，吐词不清，饮水呛咳。2015年12月在衢州市人民医院诊治，做头颅CT提示“小脑萎缩”，给予“脑复新”、“步长脑心通”等药物治疗，疗效不显，以后患者渐渐出现不能独自上下楼梯，双手持物震颤，于2015年8月就诊于“浙江省第二人民医院”，做MRI显示“小脑脑干萎缩”，给予营养脑神经的药物(具体用药不详)治疗，疗效不显，病情仍呈加重趋势，遂来我院就诊。入院时患者症见：不能独自行走，扶走时两步距宽，步幅大，双手持物颤抖，语言欠流利，吐词不清，饮水呛咳，一般情况可。无家族遗传病史，无毒物接触史。查体示：四肢肌张力不高，双下肢肌力Ⅳ级，膝腱反射(++)，指鼻试验、轮替试验、跟-膝-胫试验不能完成，闭目直立试验睁眼闭眼均不能完成。入院诊断：橄榄-桥脑-小脑萎缩。治疗方案：给予参茸健脑胶囊口服。治疗3个月后，患者行走自然，步态协调，能自由上下楼梯，双手震颤消失，语言清晰流利，饮水呛咳症状消失，指鼻试验、轮替试验能够完成，闭目直立试验在睁眼时能完成，闭眼时略差。MRI检查，脑萎缩症状完全消失。带1个疗程药物(3个月)巩固治疗，没有再出现复发。
实施例1所述参茸健脑胶囊由以下配比的中药材原料组成，炙黄芪125g、人参95g、鹿茸98g、茯苓40g、干姜38g、当归35g、杜仲38g、桂枝40g、白芍22g、法半夏37g、菟丝子35g和炙甘草23g；所述杜仲为盐制杜仲；所述菟丝子为酒治疗菟丝子。
本实施例所述参茸健脑胶囊制备方法如下，(1)称取人参95g、鹿茸98g、干姜38g和当归35g，60℃鼓风干燥，混合后粉碎成细粉，用100目筛网过筛；(2)将炙黄芪125g、茯苓40g、盐杜仲38g、桂枝40g、白芍22g、法半夏37g、酒制菟丝子35g和炙甘草23g混合后，以重量计加入8倍量的水煎煮2次，并浸泡30分钟，第一次煎煮2小时，第二次煎煮1.5小时；(3)合并两次煎煮药液、过滤，然后在-0.08～-0.09MPa，60～70℃浓缩滤液，至滤液相对密度在60℃达到1.30-1.35，得到清膏；(4)将步骤(1)得到的细粉混合物加入到步骤(3)得到的清膏中搅拌均匀，干燥、粉碎、过筛；(5)乙醇制粒、干燥、整粒、装胶囊，装瓶、贴签、打码、入库保存。
所述酒制菟丝子的制备方法是，洗净菟丝子，置适当容器内，用黄酒拌匀，稍焖，上笼，用武火蒸至冒气1－2小时，下笼，待冷，取出，干燥。从而通过酒精的作用，更加有利于菟丝子有益成份入肝肾经。
实施例2所述参茸健脑胶囊由以下配比的中药材原料组成，炙黄芪130g、人参100g、鹿茸100g、茯苓40g、干姜40g、当归40g、杜仲40g、桂枝40g、白芍25g、法半夏40g、菟丝子40g和炙甘草25g。
本实施例所述参茸健脑胶囊制备方法如下，(1)称取人参100g、鹿茸100g、干姜40g和当归40g，60℃鼓风干燥，混合后粉碎成细粉，用100目筛网过筛；(2)将炙黄芪130g、茯苓40g、盐杜仲40g、桂枝40g、白芍25g、法半夏40g、酒制菟丝子40g和炙甘草25g混合后，以重量计加入8倍量的水煎煮2次，并浸泡30分钟，第一次煎煮2小时，第二次煎煮1.5小时；(3)合并两次煎煮药液、过滤，然后在-0.08～-0.09MPa，60～70℃浓缩滤液，至滤液相对密度在60℃达到1.30-1.35，得到清膏；(4)将步骤(1)得到的细粉混合物加入到步骤(3)得到的清膏中搅拌均匀，干燥、粉碎、过筛；(5)乙醇制粒、干燥、整粒、装胶囊，装瓶、贴签、打码、入库保存。
实施例3所述参茸健脑胶囊由以下配比的中药材原料组成，炙黄芪132g、人参100g、鹿茸105g、茯苓43g、干姜45g、当归40g、杜仲45g、桂枝42g、白芍26g、法半夏42g、菟丝子40g和炙甘草27g。
本实施例所述参茸健脑胶囊制备方法如下，(1)称取人参100g、鹿茸105g、干姜45g和当归40g，60℃鼓风干燥，混合后粉碎成细粉，用100目筛网过筛；(2)将炙黄芪132g、茯苓43g、盐杜仲45g、桂枝42g、白芍26g、法半夏42g、酒制菟丝子40g和炙甘草27g混合后，以重量计加入8倍量的水煎煮2次，并浸泡30分钟，第一次煎煮2小时，第二次煎煮1.5小时；(3)合并两次煎煮药液、过滤，然后在-0.08～-0.09MPa，60～70℃浓缩滤液，至滤液相对密度在60℃达到1.30-1.35，得到清膏；(4)将步骤(1)得到的细粉混合物加入到步骤(3)得到的清膏中搅拌均匀，干燥、粉碎、过筛；(5)乙醇制粒、干燥、整粒、装胶囊，装瓶、贴签、打码、入库保存。
以上实施例仅用于说明本发明的技术方案，而非对其进行限制；尽管参照前述实施例对被发明进行了详细的说明，但对于本领域的普通技术人员来说，依然可以对前述实施例所记载的技术方案进行修改，或者对其中部分技术特征进行等同替换；而对这些修改或者替换，并不使相应技术方案的本质脱离本发明所要求保护的技术方案的精神和范围。
Claims (6)
1.一种参茸健脑胶囊，其特征在于：由以下配比的中药材原料组成，炙黄芪125-132份、人参95-100份、鹿茸98-105份、茯苓40-43份、干姜38-45份、当归35-40份、杜仲38-45份、桂枝40-42份、白芍22-26份、法半夏37-42份、菟丝子35-40份和炙甘草23-27份；所述杜仲为盐制杜仲；所述菟丝子为酒治疗菟丝子。
2.根据权利要求1所述的参茸健脑胶囊，其特征在于：由以下配比的中药材原料组成，炙黄芪125份、人参95份、鹿茸98份、茯苓40份、干姜38份、当归35份、杜仲38份、桂枝40份、白芍22份、法半夏37份、菟丝子35份和炙甘草23份。
3.根据权利要求1所述的参茸健脑胶囊，其特征在于：由以下配比的中药材原料组成，炙黄芪130份、人参100份、鹿茸100份、茯苓40份、干姜40份、当归40份、杜仲40份、桂枝40份、白芍25份、法半夏40份、菟丝子40份和炙甘草25份。
4.根据权利要求1所述的参茸健脑胶囊，其特征在于：由以下配比的中药材原料组成，炙黄芪132份、人参100份、鹿茸105份、茯苓43份、干姜45份、当归40份、杜仲45份、桂枝42份、白芍26份、法半夏42份、菟丝子40份和炙甘草27份。
5.一种制备权利要求1至4中任一所述参茸健脑胶囊的方法，其特征在于：包括以下步骤，(1)称取人参、鹿茸、干姜和当归，烘干，混合后粉碎成细粉，过筛；(2)将炙黄芪、茯苓、盐杜仲、桂枝、白芍、法半夏、酒制菟丝子和炙甘草混合后，以重量计加入8倍量的水煎煮2次，并浸泡30分钟，第一次煎煮2小时，第二次煎煮1.5小时；(3)合并两次煎煮药液、过滤，然后在-0.08～-0.09MPa，60～70℃浓缩滤液，至滤液相对密度在60℃达到1.30-1.35，得到清膏；(4)将步骤(1)得到的细粉混合物加入到步骤(3)得到的清膏中搅拌均匀，干燥、粉碎、过筛；(5)乙醇制粒、干燥、整粒、装胶囊，得到成品。
6.根据权利要求5所述制备参茸健脑胶囊的方法，其特征在于：酒制菟丝子的制备方法是，洗净菟丝子，置适当容器内，用黄酒拌匀，稍焖，上笼，用武火蒸至冒气1－2小时，下笼，待冷，取出，干燥。
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