CN104547523A - 一种增强免疫力的药物及其制备方法 - Google Patents
一种增强免疫力的药物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种增强免疫力的药物组合物,所述药物由黄精、金樱子、杜仲、菟丝子、枸杞、太子参和淫羊藿制成,具有增强免疫力,抗疲劳、抗衰老的保健功效,且无毒副作用,疗效确切。
Description
技术领域
本发明涉及一种增强免疫力的药物及其制备方法,属于药品保健品的技术领域。
背景技术
免疫力是人体自身的防御机制,是人体识别和消灭外来侵入的任何异物 ( 病毒、细菌等 ) ;处理衰老、损伤、死亡、变性的自身细胞以及识别和处理体内突变细胞和病毒感染细胞的能力。现代免疫学认为,免疫力是人体识别和排除“异己”的生理反应。人体内执行这一功能的是免疫***。现代人在日常生活经受许多压力。工作繁忙,和同事以及领导关系处不好,家庭不和谐,社会交际中出现不愉快的互动都能造成精神压力。工业对于空气、水和食物的污染以及暴露于紫外线和其他辐射造成对人体的伤害。以上诸多原因使得现代人的免疫力越来越弱,身体极易招致细菌、病毒、真菌等感染,容易生病。然而经常患病,加重了机体的消耗,因此出现很多亚健康问题如:体质虚弱、营养不良、精神萎靡、疲乏无力、食欲降低、睡眠障碍等。很多让你生病、***吃药便成了家常便饭。长此以往会导致身体和智力发育不良,还易诱发重大疾病。因此增强免疫力,提高人体对病原的抵抗能力已成为当今人们日益重视的一个重大问题。随着人民生活水平和生活方式的不断改变,健康的概念已随着时代变迁有了新的含义,医学界人士越来越关注亚健康状态的存在,而改变这种状态单纯用化学药物由于副作用大,很难被人们接受,因此各种保健品应运而生,如各种保健食品、营养强化食品等,其配方和效果不一,而且多数都存在成份多、价格高、效果不尽人意等缺点,至今未有令人满意的增强免疫力的保健品。因此发明一种副作用小,疗效好,价格适中的增强免疫力的药物就很有现实意义。
发明内容
本发明的目的在于提供一种增强免疫力的药物及其制备方法。所述药物具有增强免疫力,抗疲劳、抗衰老的功效,且无毒副作用,疗效确切,
为解决以上技术问题,本发明采用以下技术方案实现:
一种增强免疫力的药物,按照重量份计算,主要由黄精10-100份、金樱子10-100份、杜仲10-100份、菟丝子5-80份、枸杞5-80份、太子参5-80份和淫羊藿5-80份及辅料制备而成。
具体地说,前述增强免疫力的药物,按照重量份计算,主要由黄精20-60份、金樱子15-50份、杜仲15-50份、菟丝子10-50份、枸杞10-50份、太子参20-40份和淫羊藿20-40份及辅料制备而成。
更具体地说,前述增强免疫力的药物,按照重量份计算,主要由黄精40份、金樱子30份、杜仲30份、菟丝子30份、枸杞30份、太子参30份和淫羊藿30份及辅料制备而成。
前述增强免疫力的药物的制备方法为:以上药材,与药物中可以接受的药用辅料进行组合,并按照常规的制备方法进行加工,制成相应的药物制剂。
具体地说,前述增强免疫力的药物的制备方法为:以上药材,加入6-14倍量的水煎煮1-5次,每次0.5-3小时,过滤,滤液合并,浓缩至浸膏,加入常规药用辅料,再按照常规方法制成不同的药物制剂。
更具体地说,前述增强免疫力的药物的制备方法为:以上药材,加水煎煮3次,第一次加12倍量的水煮2小时,第二次加10倍量的水煮1.5小时,第三次加10倍量的水煮1小时,过滤,滤液合并,浓缩至50-60℃时相对密度为1.20-1.25的浸膏,加入常规药用辅料,再按照常规方法制成不同的药物制剂
所述药物制剂为口服制剂,如胶囊剂、颗粒剂、片剂、煎膏剂、丸剂、口服液、糖浆剂、散剂或丹剂。
所述胶囊剂这样制备:以上药材,加水煎煮3次,第一次加12倍量的水煮2小时,第二次加10倍量的水煮1.5小时,第三次加10倍量的水煮1小时,过滤,滤液合并,浓缩至50-60℃时相对密度为1.20-1.25的浸膏,在60℃,0.1Mpa条件下干燥,粉碎成细粉,过80目筛,得A品,加入A品量5%的微粉硅胶和A品量5%的淀粉,用90%乙醇为润湿剂制颗粒,60℃干燥,填装胶囊,即得。
所述煎膏剂这样制备:以上药材,加水煎煮3次,第一次加12倍量的水煮2小时,第二次加10倍量的水煮1.5小时,第三次加10倍量的水煮1小时,过滤,滤液合并,浓缩至50-60℃时相对密度为1.20-1.25的浸膏,加入制成量20%的蜂蜜, 搅拌均匀,即得。
所述片剂这样制备:以上药材,加水煎煮3次,第一次加12倍量的水煮2小时,第二次加10倍量的水煮1.5小时,第三次加10倍量的水煮1小时,过滤,滤液合并,浓缩至50-60℃时相对密度为1.20-1.25的浸膏,在60℃,0.1Mpa环境下干燥,干燥后粉碎成细粉,过80目筛,加入制成量20%的淀粉和制成量3%的硬脂酸镁,用90%乙醇为润湿剂制颗粒,压片,包衣,即得。
本发明所述药物由黄精、金樱子、杜仲、菟丝子、枸杞、太子参和淫羊藿及辅料制备而成。其中,黄精为(学名:Polygonatum sibiricum),为黄精科植物黄精干燥的根,用于补脾,润肺生津。金樱子(学名:Rosa laevigata Michx. )为蔷薇科金樱子的果实拣去杂质,切两瓣,用水稍洗泡,捞出,闷润后除去残留毛刺,挖净毛、核,干燥。,酸涩;平;无毒,归肾;膀胱;大肠;脾;肺经,固精涩肠,缩尿止泻,用于滑精,遗尿,小便频数,脾虚泻痢,肺虚喘咳,自汗盗汗,崩漏带下。杜仲为杜仲科植物杜仲的干燥树皮,甘,温,归肝、肾经,有补肝肾,治腰脊酸疼,足膝痿弱,小便余沥,阴下湿痒,高血压、安胎的功效,杜仲具有清除体内垃圾,加强人体细胞物质代谢,防止肌肉骨骼老化,平衡人体血压,分解体内胆固醇,降低体内脂肪,恢复血管弹性,利尿清热,广谱抗菌,兴奋中枢神经,提高白血球药理作用。菟丝子为旋花科菟丝子干燥全草辛、甘、微温。归肝、肾、脾经。用于腰痛耳鸣,阳痿,遗精,消渴,不育,遗尿失禁,淋浊带下,头目昏暗,食少泄泻,胎动不安。枸杞为茄科植物宁夏枸杞Lycium barbarum L.的干燥成熟果实,甘,平。归肝、肾经。具有滋补肝肾,益精明目之功效。用于虚劳精亏,腰膝酸痛,眩晕耳鸣,阳萎遗精,内热消渴,血虚萎黄,目昏不明等病症。太子参为石竹科植物孩儿参(Pseudostellaria heterophylla (Miq.)Pax ex Pax et Hoffm.)的干燥块根,甘,微苦,微温,入肺、脾经,体润性和、补气生津,益气生津。主脾胃虚弱;食欲不振;倦怠无力;气阴两伤;干咳痰少;自汗气短;以及温病后期气虚津伤;内热口渴;或神经衰弱,心悸失眠,头昏健忘,小儿夏季热。淫羊藿性温味辛、甘。归肝、肾经。功能补肾阳,强筋骨,祛风湿。用于肾阳虚衰,阳痿遗精,筋骨痿软,风湿痹痛,麻木拘挛等病症。
上述药物组方,共奏增强免疫力,抗疲劳、抗衰老的功效,且无毒副作用,疗效确切,达到了发明目的。
处方中所含药材大多为水溶性成分,因此考虑到大生产的需要,从临床安全应用的角度出发,考虑采用水提取工艺得到提取液。用水作为提取液,不仅经济实惠,而且提取效果理想。加水量提取时间与次数均会影响有效成分的提出率,若加水量不足,则有可能造成溶媒不能浸过处方药材,而如果煎煮的时间不够,则药材成分没能充分提取出来,影响药材的浸出率。煎煮时间过长,温度过高,则会导致有效成分的分解。反而降低药材的提取率。发明人经过多次水煎煮提取条件的考察:煎煮次数、加水量和煎煮时间对浸膏得率(%)、淫羊藿苷(%)以及总多糖(%)的影响,确定本发明药物的提取条件为所有药材加水煎煮3次,第一次加12倍量的水煮2小时,第二次加10倍量的水煮1.5小时,第三次加10倍量的水煮1小时。
申请人对本发明进行了大量的研究,如下:
实验例1:药效学研究
一、本发明药物对脾指数和胸腺指数影响
1、实验动物:昆明种小鼠,雌雄各半,8周龄左右,体重25-30g。贵阳医学院实验动物中心提供,合格证号SCXK(黔)2002—0001。
2、实验药物:
2.1本发明药物按照以下方法进行制备:
处方:黄精40g、金樱子30g、杜仲30g、菟丝子30g、枸杞30g、太子参30g、淫羊藿30g。
工艺:以上药材,加水煎煮3次,第一次加12倍量的水煮2小时,第二次加10倍量的水煮1.5小时,第三次加10倍量的水煮1小时,过滤,滤液合并,浓缩至50-60℃时相对密度为1.20-1.25的浸膏,即得。
2.2阳性药物:扶正固本颗粒(山西振东开元制药有限公司)。
3、试验方法 :将50只昆明种小鼠(雌雄各半,8周龄左右.约25-30g)随机平均分成5组,采用灌胃给药( 具体给药量和分组方法见表 1),对照组给等量的生理盐水,给药 8 周后,考察各组对免疫器官的影响。考察指标为脾指数和胸腺指数,两者的增加有助于免疫力的增强,结果见表1。
注:与对照组比,*P<0.05,**P<0.001
与阳性药物组比,#P<0.05。
结论:与对照组相比本发明药物的3个剂量有统计意义的差异(P<0.05 ,P<0.01)。证明本发明药物有脾指数和胸腺指数的作用,进而增强免疫力;与阳性药物组相比,本发明中剂量组无显著差异(P>0.05),说明疗效相当。本发明高剂量有统计意义的差异(P<0.05)。本发明药物和阳性药物对体重影响不大。
二、本发明药物对小鼠血清溶血素的影响
1、实验动物:小鼠50 只,体质量18 ~22 g,雌雄各半。
2、试验药物:
2.1本发明药物同对脾指数和胸腺指数影响实验下的2.1项。
2.2阳性药物:扶正固本颗粒(山西振东开元制药有限公司)。
3、试验方法:将小鼠分为理盐水对照组、阳性药对照组、本发明药物低剂量组、中剂量组、高剂量组共5 组(具体的分组情况和给药剂量见表2),每组10 只。适应性饲养一日后开始给药。给药第3 天,每只小鼠腹腔注射 30% 的 SR-BC 致敏,致敏后4 d,末次给药 1 h 后摘眼球取血,净置 1 h,3 000 r/min 离心 10 min,分离血清,供测定。溶血素定量测定: 取稀释100 倍后血清1.0 mL加 30% SRBC 0.5 mL,10% 补体 1.0 mL 入反应管,置 37 ℃水浴保温 30 min 后,移至冰水浴中终止反应,2 000 r/min 离心 10 min,取上清液 1 mL放置 10 min,于 540 nm 处读取吸光度。实验结果见表2。
注:与空白组比较, *P<0.05,**P<0.001;
与阳性药物组比较#P<0.05。
结论:与对空白组相比本发明药物的3个剂量有统计意义的差异(P<0.05 );中剂量对小鼠血清溶血素的影响与阳性药物疗效相当,本实验结果表明本发明药物能增强小鼠溶血素形成的能力,提示其能增强抗原诱导循环抗体水平,从而实现增强机体的体液免疫力的作用;与阳性药物组相比,本发明药物高剂量统计意义的差异(P<0.05 )。
实验例2:急性毒性试验研究
1 实验方法
昆明种小鼠,经预试,给小白鼠一次灌胃本发明药物煎膏剂(制法同实验例1)均2mL/20g,未引起死亡,限于药物的浓度与给药体积不能增大,不能测出半数致死量(LD50),故进行最大耐受量测定实验。
选择健康昆明种小鼠20只,体质量(20±2)g,雌雄各半,于24小时内分2次灌服本发明药物煎膏剂,总计量达到100g/kg,此剂量相当于成人日服量的200倍。
2 实验结果
小鼠给药后观察7天,未见不良反应,全部健康活泼,体质量增加,无死亡。
与现有技术相比,本发明选用黄精、金樱子、杜仲、菟丝子、枸杞、太子参和淫羊藿组方,具有增强免疫力,抗疲劳、抗衰老的功效,方中各药均为药食同源和可作为保健食品用品种,且无毒副作用,疗效确切。达到了发明目的。
以下通过实施例进一步说明本发明,但不作为对本发明的限制。
具体实施方式:
实施例1:
处方:黄精40g、金樱子30g、杜仲30g、菟丝子30g、枸杞30g、太子参30g、淫羊藿30g。
工艺:以上药材,加水煎煮3次,第一次加12倍量的水煮2小时,第二次加10倍量的水煮1.5小时,第三次加10倍量的水煮1小时,过滤,滤液合并,浓缩至50-60℃时相对密度为1.20-1.25的浸膏,在60℃,0.4 Mpa条件下干燥,粉碎成细粉,过80目筛,得A品,加入A品量5%的微粉硅胶和A品量5%的淀粉,用90%乙醇为润湿剂制颗粒,60℃干燥,填装胶囊,每粒0.5g,即得胶囊剂。
用法用量:口服,每次2-4粒,一日3次。
实施例2:
处方:黄精40g、金樱子40g、杜仲20g、菟丝子30g、枸杞30g、太子参40g、淫羊藿5g。
工艺:以上药材,加水煎煮3次,第一次加12倍量的水煮2小时,第二次加10倍量的水煮1.5小时,第三次加10倍量的水煮1小时,过滤,滤液合并,浓缩至50-60℃时相对密度为1.20-1.25的浸膏,加入制成量20%的蜂蜜, 搅拌均匀,即得煎膏剂。
用开水冲服,一次10-15g,一日3次。
实施例3:
处方:黄精100g、金樱子20g、杜仲10g、菟丝子30g、枸杞30g、太子参80g、淫羊藿30g。
工艺:以上药材,加水煎煮3次,第一次加12倍量的水煮2小时,第二次加10倍量的水煮1.5小时,第三次加10倍量的水煮1小时,过滤,滤液合并,浓缩至50-60℃时相对密度为1.20-1.25的浸膏,在60℃,0.1 Mpa环境下干燥,干燥后粉碎成细粉,过80目筛,加入制成量20%的淀粉和制成量3%的硬脂酸镁,用90%乙醇为润湿剂制颗粒,压片,每片0.5g,包衣,即得片剂。
用法用量:口服,一次3-5片,一日3次。
Claims (10)
1. 一种增强免疫力的药物,其特征在于:按照重量份计算,主要由黄精10-100份、金樱子10-100份、杜仲10-100份、菟丝子5-80份、枸杞5-80份、太子参5-80份和淫羊藿5-80份及辅料制备而成。
2.如权利要求1所述的增强免疫力的药物,其特征在于:按照重量份计算,主要由黄精20-60份、金樱子15-50份、杜仲15-50份、菟丝子10-50份、枸杞10-50份、太子参20-40份和淫羊藿20-40份及辅料制备而成。
3.如权利要求2所述增强免疫力的药物,其特征在于:按照重量份计算,主要由黄精40份、金樱子30份、杜仲30份、菟丝子30份、枸杞30份、太子参30份和淫羊藿30份及辅料制备而成。
4.一种如权利要求1-3中任一项所述增强免疫力的药物的制备方法,其特征在于:以上药材,与药物中可以接受的药用辅料进行组合,并按照常规的制备方法进行加工,制成相应的药物制剂。
5.如权利要求4所述增强免疫力的药物的制备方法,其特征在于:以上药材,加入6-14倍量的水煎煮1-5次,每次0.5-3小时,过滤,滤液合并,浓缩至浸膏,加入常规药用辅料,再按照常规方法制成不同的药物制剂。
6.如权利要求5所述增强免疫力的药物的制备方法,其特征在于:以上药材,加水煎煮3次,第一次加12倍量的水煮2小时,第二次加10倍量的水煮1.5小时,第三次加10倍量的水煮1小时,过滤,滤液合并,浓缩至50-60℃时相对密度为1.20-1.25的浸膏,加入常规药用辅料,再按照常规方法制成不同的药物制剂。
7.如权利要求4-6中任一项所述增强免疫力的药物的制备方法,其特征在于:所述药物制剂为口服制剂,如胶囊剂、颗粒剂、片剂、煎膏剂、丸剂、口服液、糖浆剂、散剂或丹剂。
8.如权利要求7所述增强免疫力的药物的制备方法,其特征在于:所述胶囊剂这样制备:以上药材,加水煎煮3次,第一次加12倍量的水煮2小时,第二次加10倍量的水煮1.5小时,第三次加10倍量的水煮1小时,过滤,滤液合并,浓缩至50-60℃时相对密度为1.20-1.25的浸膏,在60℃,0.1 Mpa条件下干燥,粉碎成细粉,过80目筛,得A品,加入A品量5%的微粉硅胶和A品量5%的淀粉,用90%乙醇为润湿剂制颗粒,60℃干燥,填装胶囊,即得。
9.如权利要求7所述增强免疫力的药物的制备方法,其特征在于:所述煎膏剂这样制备:以上药材,加水煎煮3次,第一次加12倍量的水煮2小时,第二次加10倍量的水煮1.5小时,第三次加10倍量的水煮1小时,过滤,滤液合并,浓缩至50-60℃时相对密度为1.20-1.25的浸膏,加入制成量20%的蜂蜜, 搅拌均匀,即得。
10.如权利要求7所述增强免疫力的药物的制备方法,其特征在于:所述片剂这样制备:以上药材,加水煎煮3次,第一次加12倍量的水煮2小时,第二次加10倍量的水煮1.5小时,第三次加10倍量的水煮1小时,过滤,滤液合并,浓缩至50-60℃时相对密度为1.20-1.25的浸膏,在60℃,0.1Mpa环境下干燥,干燥后粉碎成细粉,过80目筛,加入制成量20%的淀粉和制成量3%的硬脂酸镁,用90%乙醇为润湿剂制颗粒,压片,包衣,即得。
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