CN114949031A - 一种用于改善脾胃功能、增强免疫力的中药组合物及应用 - Google Patents
一种用于改善脾胃功能、增强免疫力的中药组合物及应用 Download PDFInfo
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Abstract
本发明公开了一种用于改善脾胃功能、增强免疫力的中药组合物,该中药组合物由包括下述组分的原料制成:黄芪20~40份、党参10~20份,该中药组合物为所述原料的超微粉粉体的混合物,该超微粉粉体的混合物的制备方法包括以下步骤:步骤1、将所述原料进行初粉碎,过筛,得细粉;步骤2、得到的细粉在经低温干燥,然后在进行超低温超微粉碎,得到超微粉;步骤3、得到的超微粉混匀,过筛,得超微粉粉体粒径的超微粉。本发明提供的改善脾胃功能、增强免疫力的中药组合物对胃肠道疾病、免疫力低下的治疗具有显著的疗效,在随访过程中均未观察到治疗组患者存在复发;并且在验证其疗效过程中,未发现任何不良反应及毒副作用,值得临床推广运用。
Description
技术领域
本发明属于中医药领域,尤其涉及一种用于改善脾胃功能、增强免疫力的中药组合物及应用。
背景技术
中医认为:脾胃是后天之本,气血生化之源。脾胃是指脾经和胃经,脾胃五行属土,属于中焦,共同承担着化生气血的重任;脾与胃通过经脉相互络属而构成表里关系。胃主受纳,脾主运化,两者之间的关系是“脾为胃行其津液”,共同完成食物的消化吸收及其精微的输布,从而滋养全身,故称脾胃为“后天之本”。
脾主升,胃主降,相辅相成。脾气升,则水谷之精微得以输布;胃气降,则水谷及其糟粕才得以下行。故《临证指南医案》说:“脾宜升则健,胃宜降则和。”胃属燥,脾属湿,胃喜润恶燥,脾喜燥恶湿,两脏燥湿相济,阴阳相合,方能完成饮食物的传化过程。故《临证指南医案》又说:“太阴湿土得阳始运,阳明燥土得阴自安。”由于脾胃在生理上的相互联系,因而在病理上也是相互影响的。如脾为湿困,运化失职,清气不升,即可影响胃的受纳与和降,可出现食少,呕吐,恶心,脘腹胀满等症。若饮食失节,食滞胃脘,胃失和降,亦可影响及脾的升清与运化,可出现腹胀泄泻等症。《素问·阴阳应象大论》说:“清气在下,则生飧泄;浊气在上,则生真胀。”这是对脾胃升降失常所致病证的病理及临床表现的概括。
民以食为天。现代人生活节奏快、工作压力大,饮食作息不规律,时而暴饮暴食、时而挨饿吃的少,运动量少,使越来越多的人处于亚健康状态。长期饮食不节或长期酗酒、吸烟、过食辛甘厚味,饥饱失常,脾胃变得越来越虚弱,带来胃痛,饱胀,食欲减退,甚至呃逆,烧心等各种肠胃不适。如果长期得不到有效治疗或久治不愈,会引起胃肠粘膜发炎、溃烂、穿孔、甚至癌变。作为常见病、多发病、不仅使机体承受痛苦,而且还会在体内堆积毒素,阻断营养来源,使免疫力下降,造成严重的并发症,如肝、胆疾病、贫血、糖尿病、心脑血管疾病,性功能减退等。正可谓“脾胃不调,百病丛生”。
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。现代社会,很多疾病发生的深层原因是免疫力下降,人体免疫系统完善,则机体和谐、健康;反之机体受损,表现为易感染或者易生病状态。故提高人体免疫力尤为重要。
目前治疗胃病的药有很多,包括:(1)抑制胃酸分泌的药物主要用于胃痛、反酸、烧心的患者,常用的有奥美拉唑、泮托拉唑、雷贝拉唑、兰索拉唑等等。(2)促进黏膜修复的药物,常用的有康复新液、麦滋林、施林等等。(3)促进胃肠蠕动的药物,常用的有新络纳、吗丁啉等等。(4)中成药,常用的有胃尔康颗粒、气滞胃痛颗粒、胆胃康胶囊等等。这些药只能够消除表面疼痛症状,没有去除病症的根源,由于胃病为慢性病,长期服用胃药的话,不仅使胃的能力减弱,造成一些胃功能衰退的情况,而且会带来一系列不良反应,且很容易复发,常常难以根治。
CN 111558017 A公开了一种用于治疗胃病的中草药药丸及其制造方法,提供了一种用于治疗胃病的中草药药丸,包括三七、黄连等10味原料,混合后细火烘焙或暴晒干燥后粉碎,添加适量的蜂蜜制成的药丸。CN 112043806 A公开了一种治疗肠胃病中药组合物及其制备方法,包括灵芝孢子、赤灵芝孢子等12味原料,粉碎、超临界流体萃取、大孔吸附树脂、滤过、浓缩、搅拌、混合等过程制成。
上述专利主要关注传统工艺的制备方法,一方面,所用的原料不仅药味繁多,且不全是药食同源,不适用于食疗;另一方面,传统方法不仅制备、操作过程繁琐,需特定条件、费时,而且原料中挥发性成分易损失破坏,使药用资源造成大量隐性浪费,从而降低了药物临床疗效。
综上,如何提供一种能够有效改善脾胃功能、增强免疫力、标本兼治、无副作用且易于制备的中药组合物的是本领域亟需解决的问题。
发明内容
本发明的目的在于提供一种用于改善脾胃功能、增强免疫力的中药组合物,该中药组合物配方合理、药食同源、无毒副作用,且超低温处理最大限度的保留易挥发成分,保留药效物质基础的原始性。
为了达到上述目的,本发明提供如下技术方案:
首先,一种用于改善脾胃功能、增强免疫力的中药组合物,该中药组合物由包括下述组分的原料制成:黄芪20~40份、党参10~20份,该中药组合物为所述原料的超微粉粉体的混合物,该超微粉粉体的混合物的制备方法包括以下步骤:
步骤1、将所述原料进行初粉碎,过筛,得细粉;
步骤2、得到的细粉在经低温干燥,然后在进行超低温超微粉碎,得到超微粉;
步骤3、得到的超微粉混匀,过筛,得超微粉粉体粒径的的超微粉。
优选地,黄芪25~35份、党参12~18份。进一步,所述超微粉粉体粒径不大于75μm,优选地所述超微粉粉体粒径为25μm~58μm。
优选地,所述低温干燥的温度为:-20~-10℃。
优选地,所述低温干燥的温度为:-20~-10℃。
优选地,所述超低温超微粉碎的温度为:-35~-30℃。
其中,上述步骤1的原料进行初粉碎,可以先混合原料在粉碎,也可以先分别粉碎原料再混合。
本发明另一方面提供了治疗胃肠道疾病、免疫力低下的药物,该药物中包含所述的改善脾胃功能、增强免疫力的中药组合物;其中所述药物的剂型是颗粒或粉末。
本发明所述原料药的来源、成分和功能主治如下:
黄芪:为豆科植物蒙古黄芪(Astragalus membranaceus(Fisch.)Bge.var.mongholicus(Bge.)Hsiao)或膜荚黄芪(Astragalus membranaceus(Fisch.)Bge.)的干燥根。《中国药典》记载:黄芪,【性味】甘,微温。归肺、脾经。【功能主治】补气升阳,固表止汗,利水消肿,生津养血,行滞通痹,托毒排脓,敛疮生肌。用于气虚乏力,食少便溏,中气下陷,久泻脱肛,便血崩漏,表虚自汗,气虚水肿,内热消渴,血虚萎黄,半身不遂,痹痛麻木,痈疽难溃,久溃不敛。黄芪主要含有皂苷、黄酮、多糖以及氨基酸等几类成分。现代药理研究表明,黄芪水提物可使内皮细胞增殖、迁移,促进血管生成,在体外伤口愈合细胞爬行能力实验中能明显增加人脐静脉内皮细胞迁移,在内皮细胞成管过程中明显增加分支数量,增强血管内皮生长因子mRNA的表达;且黄芪水提物体内对大鼠左前降支冠状动脉结扎引起的心肌梗死有明显保护作用,减小梗死面积,增加毛细管和小动脉密度,同时体外能增加血管内皮生长因子蛋白水平。
党参:为桔梗科植物党参(Codonopsis pilosula(Franch.)Nannf.)、素花党参(Codonopsis pilosula Nannf.var.modesta(Nannf.)L.T.Shen)或川党参(Codonopsistangshen Oliv.)的干燥根。《中国药典》记载:党参,【性味】甘,平。归脾、肺经。【功能主治】健脾益肺,养血生津。用于脾肺气虚,食少倦怠,咳嗽虚喘,气血不足,面色萎黄,心悸气短,津伤口渴,内热消渴。党参植物化学成分复杂。迄今为止,国内外学者已经从党参属植物中分离并鉴定230多种化合物,包括生物碱类、炔类、萜类、黄酮类、木质素类、甾体类、糖类等成分。其中,生物碱类、聚炔类、木脂素类、黄酮类化合物和多糖被认为是主要的活性成分。药理作用丰富多样,现代药理研究表明,党参提取物具有保护神经细胞、提高学习记忆能力以及减轻阿尔兹海默病症状等神经系统保护作用;党参提取物具有调节血糖和血脂的作用;具有调节机体免疫平衡的作用;具有治疗胃溃疡、促进肠道推动、提高机体消化能力等作用;具有治疗心力衰竭、调节血细胞生长发育、增强造血功能、抑制血小板聚集等作用。具有抗菌、抗病毒作用,抗肿瘤作用。
本发明提供的改善脾胃功能、增强免疫力的中药组合物与传统的汤剂、相关保健食品相比,具有不可比拟的优势:(1)采用药材超微粉碎破壁工艺技术,粒径优选地25μm~58μm,使活性成分溶出速率更为快速,显著提升了药物的生物利用度和药效;(2)原料全成分利用,无损失;(3)药材利用率高,节约中药材资源;(4)制备工艺全过程采用低温或超低温处理,最大限度保留了原料中的挥发性成分;(5)采用本发明组合物治疗心脑血管疾病,其毒副作用小,标本兼职,疗效显著,成本低;(6)携带和应用更便捷。本发明配方具有补中益气,调理脾胃、补气益血、提高人体免疫力、强壮身体、延年益寿的功效,能够应用于急、慢性胃炎、胃十二指肠溃疡、胃肠神经官能症、慢性肠炎、腹泻、胸痹、虚咳,气喘,易疲劳,抵抗力差等症状,值得临床推广运用。
本发明提供的改善脾胃功能、增强免疫力的中药组合物对慢性胃炎,免疫力低下疗效,在随访过程中均未观察到治疗组患者存在复发;并且在验证其疗效过程中,未发现任何不良反应及毒副作用,值得临床推广运用。
具体实施方式
以下实施例用于说明本发明,但不用来限制本发明的范围。在不背离本发明精神和实质的情况下,对本发明方法、步骤或条件所作的修改或替换,均属于本发明的保护范围。
实施例1
原料:黄芪300g、党参100g。
制备方法:
首先将黄芪、党参药材原料进行挑拣清洗、切片、干燥;称取所述重量的原料黄芪和党参,45℃干燥,粗粉碎,过筛,得各自粗粉;经过-18℃低温干燥,-33℃再进行超低温超微粉碎,得各自超微粉,过筛,得不超过75μm的超微粉粉体粒径的各自超微粉,混匀超微粉,湿法制颗粒,包装,得到本发明的超微粉中药组合物的药物。
实施例2
原料:黄芪200g、党参100g。
制备方法:
首先将黄芪、党参药材原料进行挑拣清洗、切片、干燥;称取所述重量的原料黄芪和党参,45℃干燥,粗粉碎,过筛,得各自粗粉;经过-20℃低温干燥,-35℃再进行超低温超微粉碎,得各自超微粉,过筛,得不超过75μm的超微粉粉体粒径的各自超微粉,混匀超微粉,湿法制颗粒,包装,得到本发明的超微粉中药组合物的药物。
实施例3
原料:黄芪300g、党参200g。
制备方法:
首先将黄芪、党参药材原料进行挑拣清洗、切片、干燥;称取所述重量的原料黄芪和党参,50℃干燥,粗粉碎,过筛,得各自粗粉;经过-10℃低温干燥,-30℃再进行超低温超微粉碎,得各自超微粉,过筛,得不超过75μm的超微粉粉体粒径的各自超微粉,混匀超微粉,湿法制颗粒,包装,得到本发明的超微粉中药组合物的药物。
实施例4
原料:黄芪400g、党参150g。
制备方法:
首先将黄芪、党参药材原料进行挑拣清洗、切片、干燥;称取所述重量的原料黄芪和党参,35℃干燥,粗粉碎,过筛,得各自粗粉;经过-20℃低温干燥,-30℃再进行超低温超微粉碎,得各自超微粉,过筛,得不超过75μm的超微粉粉体粒径的各自超微粉,混匀超微粉,湿法制颗粒,包装,得到本发明的超微粉中药组合物的药物。
对照组实施例1
原料:黄芪500g、党参100g。
制备方法:
首先将黄芪、党参药材原料进行挑拣清洗、切片、干燥;称取所述重量的原料黄芪和党参,45℃干燥,粗粉碎,30目过筛,得各自粗粉;再粉碎,100目过筛,得各自不超过150μm细粉,混匀,湿法制颗粒,包装,即得。
对照组实施例2
原料:黄芪500g、党参100g。
制备方法:
以上两味,加水煎煮二次,第一次1.5小时,第二次1小时,合并煎液,滤过,滤液减压浓缩至相对密度约为1.25(70℃),加水至1000ml,搅匀,滤过,分装,即得。
分别对实施例1、实施例2、实施例3及实施例4所制中药组合物进行质量检验,检测结果如表1所示。
表1中药组合物质量检验结果
以下为本产品的应用效果描述:
(一)用于改善脾胃功能、增强免疫力的中药组合物对慢性胃炎的临床疗效观察
1.临床资料
选取性胃炎中医辨证属脾胃湿热证患者共140例,将入选的患者采用随机数字表按就诊先后顺序分别纳入治疗组80例和对照组60例。两组患者的性别、年龄、病程等一般资料无明显差异,P>0.05,无统计学意义,组间具有可比性。
2.诊断标准
西医诊断标准:慢性胃炎临床症状表现无特异性,常见症状为上腹部疼痛、腹胀、早饱、食欲减退,伴或不伴有烧心、反酸、呃逆、嗳气等,在诊断上主要通过胃镜下表现以及内镜下病理学检查,胃镜下可见胃黏膜充血水肿、红斑(点状、片状和条状)、出血点(斑)和/或糜烂(平坦型或隆起型)、渗出等基本表现;同时存在出血、粗大皱襞或胆汁反流等征象。本临床研究纳入病例主要根据患者临床症状以及胃镜下所见符合慢性浅表性胃炎胃镜诊断标准即可确诊。
中医诊断标准:本研究观察病例为慢性浅表性胃炎中医辨证属脾胃湿热证患者,参照《中药新药临床研究指导原则(试行)》以及慢性胃炎中西医结合诊疗共识意见,临床症状以脘腹胀满或疼痛为主症,次症为伴或不伴有不思饮食,嗳气吞酸,身重困倦,恶心呕吐,口淡乏味,可见舌质红,舌苔白腻或黄腻,脉滑或数。凡符合主症2项或主症1项加次症2项以上,舌脉基本符合者即可诊断。
3.纳入标准
符合西医诊断为慢性浅表性胃炎且符合中医辨证分型标准的患者,且年龄在18~65岁,知情同意且自愿加入本临床研究。
4.排除标准
不符合纳入标准的患者;伴有消化道溃疡、消化道肿瘤、幽门梗阻的患者;合并有严重心、肺、脑疾病以及患有精神类疾病的患者;妊娠期以及哺乳期女性。
5.治疗方法
治疗组1采用实施例1,治疗组2采用实施例2,治疗组3采用实施例3,治疗组4采用实施例4,2次/d,30g/次,以4周为一个疗程。对照组1采用对照组实施1;对照组2采用对照组实施例2;对照组3采用西医疗法,用药包括服用铝碳酸镁片1g/次,3次/日,多潘立酮50mg/次,3次/日;以4周为一个疗程。各组都以治疗1个疗程结束后进行疗效比较。
6.疗效评价方法
参照中国慢性胃炎共识意见以及慢性胃炎中西医诊疗意见设定的临床疗效标准进行疗效判定。对每例进行治疗前后的症候积分,然后统计积分,分别于治疗后,治疗后与治疗前比较症候积分的变化程度,疗效指数=(治疗前积分-治疗后积分)/治疗前积分×100%)。将观察得到的临床症状、体征以及疗效指数的变化情况,按照下述拟定疗效评价标准进行计算,评估疗效。
痊愈:临床症状全部或基本消失,胃镜下胃黏膜活动性炎症改变消失,慢性炎症好转达轻度,疗效指数≥95%;
显效:症状明显改善,胃镜下胃黏膜急性炎症改变基本消失,慢性炎症好转,70%≤疗效指数<95%者;
有效:症状明显改善,胃镜下胃黏膜病变面积缩小1/2以上,炎症有所好转,30%≤疗效指数<70%者;
无效:全身症状、胃镜检查均无明显改善甚至有加重迹象,疗效指数<30%者。
总有效率(%)=(痊愈+显效+有效)例数/入组数×100%。
7.统计学分析
各项数据采用统计学软件SPSS 22.0进行分析处理,计量资料采用样本均数±标准差表示;组间比较采用t检验;计数资料、组间率的比较采用非参数检验,P<0.05为差异具有统计学意义。
8.结果
结果见表2。
表2各组临床疗效比较
差异有统计学意义(P<0.05)。
9.结论
本发明提供的改善脾胃功能、增强免疫力的中药组合物对慢性胃炎脾胃湿热证治疗具有显著的疗效,在随访过程中均未观察到治疗组患者存在复发;并且在验证其疗效过程中,未发现任何不良反应及毒副作用,值得临床推广运用。
(二)用于改善脾胃功能、增强免疫力的中药组合物对提高免疫力的试验观察
1.实验1
1.1实验动物:裸鼠,雌雄各半,体重18~22g。
1.2实验分组:将小鼠分为7组,每组20只,分别施喂实施例1~4制备的粉末或颗粒、对照组实施例1~2制备的粉末或颗粒。
1.3给药方式:将粉末或颗粒调节至相当于生药浓度1g/ml,小鼠每天灌服生理盐水或浓缩浸膏0.2ml/20g体重,每天2次,连续2周。
1.4观察小鼠生理状况并在末次给药后2h,脱颈椎处死小鼠,称体重。
1.5实验结果:
给药后每天观察小鼠精神、活动、饮食、尿液、粪便情况,均未发现异常,眼、耳、口均未见分泌物。给药结束后,小鼠(平均)体重均有所上升,各组之间无明显差异,具体结果见表1。
表1小鼠(平均)体重变化情况
给药前(g)
组别 | 给药前(g) | 给药后(g) |
实施例1 | 19.5 | 20.8 |
实施例2 | 19.2 | 21.6 |
实施例3 | 18.8 | 19.2 |
实施例4 | 19.6 | 20.6 |
对照组1 | 20.4 | 20.9 |
对照组2 | 19.2 | 20.8 |
2.实验2
2.1步骤1~3同实验1。
2.2实验结束前的第4天免疫动物,用2%(v/v)绵羊红细胞腹腔注射0.2ml致敏动物,5天后测定左后足跖部厚度,接着于该处皮下注射20%(v/v)绵羊红细胞(20μl/鼠),注射后24小时测定左后足跖部厚度。
2.3实验结果:见表2。
表2对小鼠迟发型变态反应的影响
组别 | 足跖增厚(g) |
实施例1 | 0.79 |
实施例2 | 0.81 |
实施例3 | 0.78 |
实施例4 | 0.76 |
对照组1(对照1) | 0.50 |
对照组2(对照2) | 0.51 |
该实验的原理为绵羊红细胞可刺激T淋巴细胞增殖成致敏淋巴细胞,4天后,当再以绵羊红细胞攻击时,即可见攻击部位出现迟发型变态反应。
由表2数据可知,施用本发明提高免疫力的浸膏后小鼠的迟发型变态反应加强,说明其自身免疫力加强。
3.实验3
3.1受试者:60例免疫力低下患者,年龄在22~58岁。
3.2分组:将受试者分成2组,组1服用本发明实施例2的粉末或颗粒(将浸膏调节至相当于生药浓度2g/ml),每次服用10ml,每天服用2次;组2服用市售增强免疫力保健食品(蛋白粉),连续服用2个月。
3.3评价指标:
显效:免疫力明显提高,体质明显增强,四肢有力,精力充沛,脸色明显改善,色斑、肌肤暗沉等症状消失或明显改善,睡眠和消化等方面的亚健康状态明显改善;
有效:免疫力有所提高,体质有所增强,四肢较有力,精力和脸色均有一定好转,色斑、肌肤暗沉等症状有所改善,睡眠和消化等方面的亚健康状态也有所改善;
无效:症状及各项检查未见改善。
3.4结果:见表3。
表3受试结果
分组 | 例数 | 显效(例) | 有效(例) | 无效(例) | 有效率(%) |
1 | 30 | 24 | 4 | 2 | 93.3 |
2 | 30 | 8 | 12 | 10 | 66.7 |
由表3结果可知,本发明提高免疫力中药组合物的有效率可达93.3%,远远高于现有市售产品。
4.结论
本发明提供的改善脾胃功能、增强免疫力的中药组合物对提高免疫力具有显著的疗效,在随访过程中均未观察到治疗组患者存在复发;并且在验证其疗效过程中,未发现任何不良反应及毒副作用,值得临床推广运用。
本说明书中各个实施例的上述说明,使本领域专业技术人员能够实现或使用本发明。对这些实施例的多种修改对本领域的专业技术人员来说将是显而易见的,本文中所定义的一般原理可以在不脱离本发明的精神或范围的情况下,在其它实施例中实现。因此,本发明将不会被限制于本文所示的这些实施例,而是要符合与本文所公开的原理和新颖特点相一致的最宽的范围。
Claims (9)
1.一种用于改善脾胃功能、增强免疫力的中药组合物,其特征在于,该中药组合物由包括下述组分的原料制成:黄芪20~40份、党参10~20份,该中药组合物为所述原料的超微粉粉体的混合物,该超微粉粉体的混合物的制备方法包括以下步骤:
步骤1、将所述原料进行初粉碎,过筛,得细粉;
步骤2、得到的细粉在经低温干燥,然后在进行超低温超微粉碎,得到超微粉;
步骤3、得到的超微粉混匀,过筛,得超微粉粉体粒径的超微粉。
2.如权利要求1所述的改善脾胃功能、增强免疫力的中药组合物,其中,黄芪25~35份、党参12~18份。
3.如权利要求1或2所述的用于改善脾胃功能、增强免疫力的中药组合物,其特征在于,所述低温干燥的温度为:-20~-10℃。
4.如权利要求3所述的用于改善脾胃功能、增强免疫力的中药组合物,其特征在于,所述超低温超微粉碎的温度为:-35~-30℃。
5.如权利要求4所述的用于改善脾胃功能、增强免疫力的中药组合物,其特征在于,所述过筛的目数为:24目~65目过筛。
6.如权利要求5所述的改善脾胃功能、增强免疫力的中药组合物,其特征在于,所述超微粉粉体粒径不大于75μm。
7.如权利要求6所述的改善脾胃功能、增强免疫力的中药组合物,其特征在于,所述超微粉粉体粒径为25μm~58μm。
8.一种治疗胃肠道疾病、免疫力低下的药物,其特征在于该药物包含所述权利要求1至7中任一项权利要求所述的改善脾胃功能、增强免疫力的中药组合物。
9.如权利要求8所述的治疗胃肠道疾病、免疫力低下的药物,其特征在于,所述药物的剂型是颗粒或粉末。
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