CN109464643A - 一种治疗慢性咳嗽的中药组合物及其制备方法 - Google Patents
一种治疗慢性咳嗽的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗慢性咳嗽的中药组合物及其制备方法,所述治疗慢性咳嗽的中药组合物包括下述原料制备而成:甘草、干姜、五味子、鹿茸。本发明的治疗慢性咳嗽的中药组合物,经过对药物组分的大量筛选、重组、尝试,采用传统中药材制备而成,患者用药更安全,并且无需用抗生素,不会使患者对抗生素产生耐药性,具有清热化痰、宽胸散结、祛风止咳等功效,并能够增强人体机理、提高免疫抗病能力,对慢性咳嗽有优异的治疗效果。
Description
技术领域
本发明涉及一种中药,尤其涉及一种治疗慢性咳嗽的中药组合物及其制备方法。
背景技术
由于人类生存环境的日益变化,由人类自身敏感性及环境污染所造成的呼吸系统疾病的发病率不断上升,其中咳嗽是呼吸系统疾病的常见症状之一。肺系疾患的主要证候之一就是咳嗽。
咳嗽是呼吸系统中最常见的症状之一,是人体的一种保护性反射动作,当呼吸道粘膜受到异物、炎症、分泌物或过敏性因素等刺激时,即反射性地引起咳嗽,有助于排除自外界侵入呼吸道的异物或分泌物、消除呼吸道刺激因子。咳嗽的不利作用,是可把气管病变扩散到邻近的小支气管,使病情加重。另外,持久剧烈的咳嗽可影响休息,还易消耗体力,并可引起肺泡壁弹性组织的破坏,诱发肺气肿。因此当发生咳嗽时必须抓紧时间治疗。
纵观历史,历代医家对于咳嗽都有不同见解。《黄帝内经》提出“五脏六腑皆令人咳,非独肺也”的论证”。《景岳全书》又论“咳嗽一证,窃见诸家立论大繁,皆不得其要,多致后人临证莫知所从,所以治难得效”。张景岳将咳嗽证由分为外感、内伤两类。《河间六书》中又提及“寒暑燥湿风火六气,皆令人咳”。咳嗽既是病又是证候,任何年龄均可发病,冬春季节多见。
目前临床上所使用的镇咳药大多是化学药品,及中药的复方制剂。化学药品按镇咳作用机理可分为中枢性和外周性镇咳药两类。中枢性镇咳药,大多是吗啡类生物碱及其衍生物,如可待因(甲基吗啡)。这类药物发现早、镇咳效应也较好,但具有依赖性,因此目前临床上应用较少。尽管在分析吗啡类生物碱构效关系的基础上经过改构或合成开发出一些依赖性较小的中枢镇咳药如右美沙芬(右甲吗啡),但在使用上也需要对其副作用给予充分的注意。外周性镇咳药,如那可丁等,多数也是生物碱类药物,服用时会产生恶心、心悸、头晕等不良反应。
慢性咳嗽是临床常见病,多发病,也是最常见的呼吸道疾病之一。慢性咳嗽临床定义为咳嗽时间持续在8周(也有学者认为3周)以上,又无明显肺疾病证据的咳嗽称为慢性咳嗽。该类患者中绝大多数患者胸部X光片检查无明显异常,临床就诊患者中咳嗽往往是患者惟一就诊症状。引起慢性咳嗽病因包括咳嗽变异型哮喘(CVA),鼻后滴流综合征(PNDs),嗜酸粒细胞性支气管炎(E),这些原因占了呼吸内科门诊慢性咳嗽比例的70-95%。其他病因较少见,但涉及面广,如慢性支气管炎、支气管扩张、支气管内膜结核、变应性咳嗽(AC)、心理性咳嗽等。该病发病人群中儿童发病率较高,成人以中年女性较多见。
目前,西药治疗咳嗽尽管能够治疗所叙述的病症,但是在实际使用过程中发现它们的效果并不是特别的理想;中医治疗咳嗽,不仅有很好的疗效,而且无副作用,是治疗咳嗽的最佳方案。
中医认为咳嗽的主要病因一是外感六淫之邪,如风、寒、暑、湿、燥、火;二是内伤于脏腑的功能失调引起的肺气不清,失于宣降,故而上逆作咳。而慢性咳嗽由于咳嗽日久,外感表症已不甚明显,大部分以内伤咳嗽居多,有一部分是由外感咳嗽演变而来。由于长期的咳嗽耗伤肺气和肺阴出现气阴两虚,肺失宣降,所以该类患者的基本病因应是气阴亏虚,本虚标实。
慢性咳嗽的治疗主要以中药为主,宜选用滋阴益气,润肺止咳的药物,常见药物主要有:石韦:清肺泄热;黄芪:《本草逢原》载“黄芪能补五脏诸虚”,其补肺益气、固表之功甚;南沙参:清热养阴,润肺止咳;麦冬:养阴润肺,用于气虚阴伤,自汗口渴,咳嗽久不止;桑叶:苦寒清泄肺热,甘寒益阴,凉润肺燥,用于燥热伤肺、干咳少痰;杏仁:宣肺止咳平喘;款冬花:润肺下气,化痰止嗽;百部:润肺下气止咳,用于新久咳嗽,肺痨咳嗽,百日咳。
发明内容
针对现有技术中的不足,养生治疗是最佳的固本培元的疗法,慢性咳嗽、慢性支气管炎,重点是增强人体机理、提高免疫抗病能力,本发明的目的是提供一种治疗慢性咳嗽的中药组合物。
本发明的另一目的是提供该治疗慢性咳嗽的中药组合物的制备方法。
本发明解决的技术方案是:
一种治疗慢性咳嗽的中药组合物,包括下述原料制备而成:甘草、干姜、五味子、鹿茸。
优选地,所述治疗慢性咳嗽的中药组合物,包括下述重量份的原料制备而成:甘草10-100份、干姜10-100份、五味子10-100份、鹿茸10-100份。
进一步优选地,所述治疗慢性咳嗽的中药组合物,包括下述重量份的原料制备而成:甘草75-85份、干姜55-65份、五味子55-65份、鹿茸10-15份。
一种药物制剂,由上述治疗慢性咳嗽的中药组合物与药学上可接受的辅料制成药物制剂,所述制剂形式为水剂、颗粒剂、片剂、胶囊、膏剂、丸剂或散剂。
上述治疗慢性咳嗽的中药组合物在制备固体饮料、保健品中的应用。
上述中药组合物的使用方式为口服或直肠给药。
本发明还提供了上述治疗慢性咳嗽的中药组合物的制备方法,包括以下步骤:
(1)将鹿茸,去除表面毛发,切成粒径小于5mm的颗粒,再用低温粉碎机并以液氮为研磨介质粉碎至200-500目,真空冷冻干燥,得到鹿茸粉;
(2)将甘草、干姜、五味子分别切成粒径小于5mm的颗粒,再分别用低温粉碎机并以液氮为研磨介质粉碎至100-300目,将粉碎后的甘草、干姜、五味子混合,得到混合料;将胃蛋白酶、胰蛋白酶、果胶酶、氯化钠、柠檬酸、混合料、水按质量比为1:(0.8-1.2):(0.8-1.2):(0.4-0.8):(0.05-0.15):(20-40):(400-600)混合,在温度为30-40℃以转速为100-300r/min搅拌提取1-2h,然后采用300-900目滤布过滤,得到提取液a和滤饼;将滤饼、酒石酸钠、多酚、体积分数65-75%乙醇水溶液按质量比为1:(0.005-0.015):(0.005-0.015):(15-25)混合,在温度为30-40℃进行超声提取50-90min,然后采用300-900目滤布过滤,得到提取液b;合并提取液a和提取液b得到混合提取液;将混合提取液在温度为45-55℃、绝对压强为0.005-0.02MPa真空浓缩至原体积的5-10%,真空冷冻干燥,得到提取物;
(3)将步骤(1)制备的鹿茸粉和步骤(2)制备的提取物混合,然后进行超高压灭菌,即得。
所述超声提取的超声功率为200-400W、超声频率为25-45kHz。
所述步骤(1)和步骤(2)中真空冷冻干燥的条件是控制物料厚度4-9mm,设定预冻温度为-20~-30℃,当样品温度降到设定温度后保持1.5-2.5h,设定升华温度为5-15℃,解析温度为30-40℃,绝对压强10-30pa,干燥时间为10-25h。
所述多酚为甘薯茎叶多酚、糖基修饰的多酚类化合物中的至少一种。进一步地,所述多酚为甘薯茎叶多酚、糖基修饰的多酚类化合物按质量比为1:(0.4-0.6)的混合物。
所述超高压灭菌的压力为400-700MPa,时间为10-25min。
本发明的有益效果是:
甘草,为豆科甘草属植物甘草Glycyrrhiza uralensis Fisch.的根和根状茎。野生品秋季采挖,栽培品于播种3~4年后,在秋季采挖,除去残茎,按粗细分别晒干;根及根状茎含有甘草甜素(glycyrrhizin,即甘草酸glycyrrhinic acid,C42H62O16)6~14%,为甘草的甜味成分,是一种三萜皂甙。药理作用:1.解毒作用:甘草甜素或其钙盐有较强的解毒作用,对白喉毒素、破伤风毒素有较强的解毒作用,对于一些过敏性疾患、动物实验性肝炎、河豚毒及蛇毒亦有解毒作用。其解毒作用机制可能是多方面的,通过物理、化学方式的沉淀、吸附与结合,加强肝脏的解毒机能以及甘草甜素的水解产物葡萄糖醛酸也是解毒作用的有效成分。2.抗炎及抗变态反应:甘草次酸对大白鼠的棉球肉芽肿、甲醛性浮肿,结核菌素反应、皮下肉芽囊性炎症均有抑制作用。甘草酸铵、甘草次酸钠能有效影响皮下肉芽囊性炎症的渗出期及增生期,其作用强度弱于或接近于可的松。甘草酸的各种制剂之抗炎作用,以琥珀酸盐的活性较高,但毒性亦大。甘草抗炎抗变态反应的原理尚未完全阐明。3.甘草有祛痰作用,能促进咽喉及支气管的分泌,使痰容易咯出。4.甘草次酸衍化物对豚鼠及猫的实验性咳嗽均有显著的镇咳作用。5.甘草的各种制剂对大白鼠实验性胃溃疡有明显的抑制作用。甘草的水提出物有保护胃粘膜,治疗胃溃疡的作用。据临床与药理研究室观察,甘草水提物能增加胃粘膜细胞的“已糖胺”成分,使胃粘膜不受伤害。6.对胃液分泌的影响:甘草流浸膏灌胃后,能吸附胃酸,故能降低胃酸浓度,但吸收后也能发挥作用。对基础分泌量亦有抑制作用。7.解痉:甘草煎剂、流浸膏对动物离体肠管均有抑制作用,对乙酰胆碱、氯化钡、组织胺等引起的肠痉挛有解痉作用。甘草对动物离体肠管及在体胃均有松驰作用。8.甘草对于动物实验性肝损伤,使其肝脏变性和坏死明显减轻,肝细胞内蓄积的肝糖元及核糖核酸含量大部恢复或接近正常,血清谷丙转氨酶活力显著下降,表明甘草具有抗肝损伤的作用。9.肾上腺皮质激素样作用:甘草能使多种动物的尿量及钠的排出减少,钾排出增加,血钠上升,血钙降低,肾上腺皮质小球带萎缩。甘草能使尿中游离型17-羟皮质类固醇排泄增加,结合型减少,小剂量表现胸腺萎缩,肾上腺重量增加,束状层幅度加宽,肾上腺维生素C含量降低等。甘草能显著增强和延长考的松的作用。甘草产生肾上腺皮质激素样作用的原理,有人认为甘草次酸的化学结构与肾上腺皮质激素相似,作用也相似,系一种直接作用;也有人认为是一种间接作用即甘草次酸抑制了肾上腺皮质固醇类在体内的破坏,因而血液中皮质类固醇含量相应增加,而呈现较明显的肾上腺皮质激素样作用。10.甘草有对抗乙酰胆碱的作用,并能增强肾上腺素的强心作用。11.抗癌:甘草次酸对于大白鼠实验性骨髓瘤及腹水肝瘤均有抑制作用。对小白鼠艾氏腹水癌均有抑制作用。12.甘草与芫花合用有相反作用:二者共浸组的毒性较分浸组显著增高,芫花与甘草同用,利尿、泻下作用受到抑制,能增强甘草毒性。
干姜,姜科植物姜Zingiber officinale Rosc.的干燥根茎。冬季采挖,除去须根及泥沙,晒干或低温干燥。趁鲜切片晒干或低温干燥者称为“干姜片”。性味:辛、热。归经:归脾、胃、肾、心、肺经。功能主治:干姜温中散寒,回阳通脉,燥湿消痰;用于脘腹冷痛,呕吐泄泻,肢冷脉微,痰饮喘咳。
五味子,为木兰科植物五味子Schisandra chinensis(Turcz.)Baill.或华中五味子Schisandra sphenanthera Rehd.et Wils.的干燥成熟果实。前者习称“北五味子”,后者习称“南五味子”。秋季果实成熟时采摘,晒干或蒸后晒干,除去果梗及杂质。性味:酸、甘,温。归经:归肺,心、肾经。功能主治:收敛固涩,益气生津,补肾宁心;用于久嗽虚喘,梦遗滑精,遗尿尿频,久泻不止,自汗,盗汗,津伤口渴,短气脉虚,内热消渴,心悸失眠。
鹿茸,为鹿科动物梅花鹿Cervus nippon Temminck或马鹿Cervus elaphusLinnaeus的雄鹿未骨化密生茸毛的幼角。前者习称“花鹿茸”,后者习称“马鹿茸”。夏、秋二季锯取鹿茸,经加工后,阴干或烘干。性味:甘、咸,温。归经:归肾、肝经。功能主治:壮肾阳,益精血,强筋骨,调冲任,托疮毒;用于阳痿滑精,宫冷不孕,羸瘦,神疲,畏寒,眩晕耳鸣耳聋,腰脊冷痛,筋骨痿软,崩漏带下,阴疽不敛。
本发明的治疗慢性咳嗽的中药组合物,经过对药物组分的大量筛选、重组、尝试,采用传统中药材制备而成,患者用药更安全,并且无需用抗生素,不会使患者对抗生素产生耐药性,具有清热化痰、宽胸散结、祛风止咳等功效,并能够增强人体机理、提高免疫抗病能力,对慢性咳嗽有优异的治疗效果。
具体实施方式
实施例中各原料介绍:
胃蛋白酶由广东万康药业有限公司提供,型号为食品级,酶活力为10万U/g。
胰蛋白酶由江苏佰耀生物科技有限公司提供,型号为食品级,酶活力为5万U/g。
果胶酶由江苏佰耀生物科技有限公司提供,型号为食品级,酶活力为5万U/g。
氯化钠,CAS号:7647-14-5。
柠檬酸,CAS号:77-92-9。
甘草由亳州市药草香药业有限公司提供,原产地甘肃。
干姜由河北金叶子药业有限公司提供,原产地广西。
五味子由亳州市信远中药科技有限公司提供,原产地辽宁。
鹿茸由长春市益健生物科技有限公司提供,产品名称:梅花鹿茸,原产地吉林长春。
糖基修饰的多酚类化合物按照申请号为201210519507.9的中国专利中实施例1所示方法制备。
酒石酸钠,CAS号:51307-92-7。
低温粉碎机由江阴市晖旭粉体机械制造有限公司,型号:450型。
甘薯茎叶多酚按照申请号为201310325014.6的中国专利中实施例8所示方法制备。
实施例1
治疗慢性咳嗽的中药组合物,包括下述重量份的原料制备而成:甘草80份、干姜60份、五味子60份、鹿茸10份。
上述治疗慢性咳嗽的中药组合物的制备方法,包括以下步骤:
(1)将鹿茸,去除表面毛发,切成粒径3mm的颗粒,再用低温粉碎机并以液氮为研磨介质粉碎至300目,真空冷冻干燥,得到鹿茸粉;
(2)将甘草、干姜、五味子分别切成粒径3mm的颗粒,再分别用低温粉碎机并以液氮为研磨介质粉碎至200目,将粉碎后的甘草、干姜、五味子混合,得到混合料;将胃蛋白酶、胰蛋白酶、果胶酶、氯化钠、柠檬酸、混合料、去离子水按质量比为1:1:1:0.55:0.1:25:500混合,在温度为37℃以转速为150r/min搅拌提取1.5h,然后采用600目滤布过滤,得到提取液a和滤饼;将提取液a在温度为50℃、绝对压强为0.01MPa真空浓缩至原体积的10%,真空冷冻干燥,得到提取物;
(3)将步骤(1)制备的鹿茸粉和步骤(2)制备的提取物混合,然后进行超高压灭菌,即得。
所述超声提取的超声功率为300W、超声频率为40kHz。
所述步骤(1)和步骤(2)中真空冷冻干燥的条件是控制物料厚度7mm,设定预冻温度为-25℃,当样品温度降到设定温度后保持2h,设定升华温度为10℃,解析温度为35℃,绝对压强20pa,干燥时间为20h。
所述多酚为甘薯茎叶多酚。
所述超高压灭菌的压力为600MPa,时间为20min。
实施例2
治疗慢性咳嗽的中药组合物,包括下述重量份的原料制备而成:甘草80份、干姜60份、五味子60份、鹿茸10份。
上述治疗慢性咳嗽的中药组合物的制备方法,包括以下步骤:
(1)将鹿茸,去除表面毛发,切成粒径3mm的颗粒,再用低温粉碎机并以液氮为研磨介质粉碎至300目,真空冷冻干燥,得到鹿茸粉;
(2)将甘草、干姜、五味子分别切成粒径3mm的颗粒,再分别用低温粉碎机并以液氮为研磨介质粉碎至200目,将粉碎后的甘草、干姜、五味子混合,得到混合料;将胃蛋白酶、胰蛋白酶、果胶酶、氯化钠、柠檬酸、混合料、去离子水按质量比为1:1:1:0.55:0.1:25:500混合,在温度为37℃以转速为150r/min搅拌提取1.5h,然后采用600目滤布过滤,得到提取液a和滤饼;将滤饼、酒石酸钠、多酚、体积分数70%乙醇水溶液按质量比为1:0.01:0.012:20混合,在温度为35℃进行超声提取60min,然后采用600目滤布过滤,得到提取液b;合并提取液a和提取液b得到混合提取液;将混合提取液在温度为50℃、绝对压强为0.01MPa真空浓缩至原体积的10%,真空冷冻干燥,得到提取物;
(3)将步骤(1)制备的鹿茸粉和步骤(2)制备的提取物混合,然后进行超高压灭菌,即得。
所述超声提取的超声功率为300W、超声频率为40kHz。
所述步骤(1)和步骤(2)中真空冷冻干燥的条件是控制物料厚度7mm,设定预冻温度为-25℃,当样品温度降到设定温度后保持2h,设定升华温度为10℃,解析温度为35℃,绝对压强20pa,干燥时间为20h。
所述多酚为甘薯茎叶多酚。
所述超高压灭菌的压力为600MPa,时间为20min。
实施例3
治疗慢性咳嗽的中药组合物,包括下述重量份的原料制备而成:甘草80份、干姜60份、五味子60份、鹿茸10份。
上述治疗慢性咳嗽的中药组合物的制备方法,包括以下步骤:
(1)将鹿茸,去除表面毛发,切成粒径3mm的颗粒,再用低温粉碎机并以液氮为研磨介质粉碎至300目,真空冷冻干燥,得到鹿茸粉;
(2)将甘草、干姜、五味子分别切成粒径3mm的颗粒,再分别用低温粉碎机并以液氮为研磨介质粉碎至200目,将粉碎后的甘草、干姜、五味子混合,得到混合料;将胃蛋白酶、胰蛋白酶、氯化钠、混合料、去离子水按质量比为1:1:0.55:25:500混合,在温度为37℃以转速为150r/min搅拌提取1.5h,然后采用600目滤布过滤,得到提取液a和滤饼;将滤饼、酒石酸钠、多酚、体积分数70%乙醇水溶液按质量比为1:0.01:0.012:20混合,在温度为35℃进行超声提取60min,然后采用600目滤布过滤,得到提取液b;合并提取液a和提取液b得到混合提取液;将混合提取液在温度为50℃、绝对压强为0.01MPa真空浓缩至原体积的10%,真空冷冻干燥,得到提取物;
(3)将步骤(1)制备的鹿茸粉和步骤(2)制备的提取物混合,然后进行超高压灭菌,即得。
所述超声提取的超声功率为300W、超声频率为40kHz。
所述步骤(1)和步骤(2)中真空冷冻干燥的条件是控制物料厚度7mm,设定预冻温度为-25℃,当样品温度降到设定温度后保持2h,设定升华温度为10℃,解析温度为35℃,绝对压强20pa,干燥时间为20h。
所述多酚为甘薯茎叶多酚。
所述超高压灭菌的压力为600MPa,时间为20min。
实施例4
治疗慢性咳嗽的中药组合物,包括下述重量份的原料制备而成:甘草80份、干姜60份、五味子60份、鹿茸10份。
上述治疗慢性咳嗽的中药组合物的制备方法,包括以下步骤:
(1)将鹿茸,去除表面毛发,切成粒径3mm的颗粒,再用低温粉碎机并以液氮为研磨介质粉碎至300目,真空冷冻干燥,得到鹿茸粉;
(2)将甘草、干姜、五味子分别切成粒径3mm的颗粒,再分别用低温粉碎机并以液氮为研磨介质粉碎至200目,将粉碎后的甘草、干姜、五味子混合,得到混合料;将混合料、酒石酸钠、多酚、体积分数70%乙醇水溶液按质量比为1:0.01:0.012:20混合,在温度为35℃进行超声提取60min,然后采用600目滤布过滤,得到提取液b;将提取液b在温度为50℃、绝对压强为0.01MPa真空浓缩至原体积的10%,真空冷冻干燥,得到提取物;
(3)将步骤(1)制备的鹿茸粉和步骤(2)制备的提取物混合,然后进行超高压灭菌,即得。
所述超声提取的超声功率为300W、超声频率为40kHz。
所述步骤(1)和步骤(2)中真空冷冻干燥的条件是控制物料厚度7mm,设定预冻温度为-25℃,当样品温度降到设定温度后保持2h,设定升华温度为10℃,解析温度为35℃,绝对压强20pa,干燥时间为20h。
所述多酚为甘薯茎叶多酚。
所述超高压灭菌的压力为600MPa,时间为20min。
实施例5
治疗慢性咳嗽的中药组合物,包括下述重量份的原料制备而成:甘草80份、干姜60份、五味子60份、鹿茸10份。
上述治疗慢性咳嗽的中药组合物的制备方法,包括以下步骤:
(1)将鹿茸,去除表面毛发,切成粒径3mm的颗粒,再用低温粉碎机并以液氮为研磨介质粉碎至300目,真空冷冻干燥,得到鹿茸粉;
(2)将甘草、干姜、五味子分别切成粒径3mm的颗粒,再分别用低温粉碎机并以液氮为研磨介质粉碎至200目,将粉碎后的甘草、干姜、五味子混合,得到混合料;将胃蛋白酶、胰蛋白酶、果胶酶、氯化钠、柠檬酸、混合料、去离子水按质量比为1:1:1:0.55:0.1:25:500混合,在温度为37℃以转速为150r/min搅拌提取1.5h,然后采用600目滤布过滤,得到提取液a和滤饼;将滤饼、酒石酸钠、多酚、体积分数70%乙醇水溶液按质量比为1:0.01:0.012:20混合,在温度为35℃进行超声提取60min,然后采用600目滤布过滤,得到提取液b;合并提取液a和提取液b得到混合提取液;将混合提取液在温度为50℃、绝对压强为0.01MPa真空浓缩至原体积的10%,真空冷冻干燥,得到提取物;
(3)将步骤(1)制备的鹿茸粉和步骤(2)制备的提取物混合,然后进行超高压灭菌,即得。
所述超声提取的超声功率为300W、超声频率为40kHz。
所述步骤(1)和步骤(2)中真空冷冻干燥的条件是控制物料厚度7mm,设定预冻温度为-25℃,当样品温度降到设定温度后保持2h,设定升华温度为10℃,解析温度为35℃,绝对压强20pa,干燥时间为20h。
所述多酚为糖基修饰的多酚类化合物。
所述超高压灭菌的压力为600MPa,时间为20min。
实施例6
治疗慢性咳嗽的中药组合物,包括下述重量份的原料制备而成:甘草80份、干姜60份、五味子60份、鹿茸10份。
上述治疗慢性咳嗽的中药组合物的制备方法,包括以下步骤:
(1)将鹿茸,去除表面毛发,切成粒径3mm的颗粒,再用低温粉碎机并以液氮为研磨介质粉碎至300目,真空冷冻干燥,得到鹿茸粉;
(2)将甘草、干姜、五味子分别切成粒径3mm的颗粒,再分别用低温粉碎机并以液氮为研磨介质粉碎至200目,将粉碎后的甘草、干姜、五味子混合,得到混合料;将胃蛋白酶、胰蛋白酶、果胶酶、氯化钠、柠檬酸、混合料、去离子水按质量比为1:1:1:0.55:0.1:25:500混合,在温度为37℃以转速为150r/min搅拌提取1.5h,然后采用600目滤布过滤,得到提取液a和滤饼;将滤饼、酒石酸钠、多酚、体积分数70%乙醇水溶液按质量比为1:0.01:0.012:20混合,在温度为35℃进行超声提取60min,然后采用600目滤布过滤,得到提取液b;合并提取液a和提取液b得到混合提取液;将混合提取液在温度为50℃、绝对压强为0.01MPa真空浓缩至原体积的10%,真空冷冻干燥,得到提取物;
(3)将步骤(1)制备的鹿茸粉和步骤(2)制备的提取物混合,然后进行超高压灭菌,即得。
所述超声提取的超声功率为300W、超声频率为40kHz。
所述步骤(1)和步骤(2)中真空冷冻干燥的条件是控制物料厚度7mm,设定预冻温度为-25℃,当样品温度降到设定温度后保持2h,设定升华温度为10℃,解析温度为35℃,绝对压强20pa,干燥时间为20h。
所述多酚为甘薯茎叶多酚、糖基修饰的多酚类化合物按质量比为1:0.5混合得到的混合物。
所述超高压灭菌的压力为600MPa,时间为20min。
测试例1
将实施例的治疗慢性咳嗽的中药组合物进行祛痰动物试验。具体结果见表1。
1材料
实验动物用昆明种小鼠70只,体重20±2g,雌雄各半,随机分为7组,每组10只,分为6组实验组和1组对照组,管理相同。
2方法
实验组1-6分别取实施例1-6治疗慢性咳嗽的中药组合物3g加30℃温开水27g制成药液,用药液连续灌胃给药7天,每天灌胃用药量为10g药液/kg体重,于第7天给药后,立即腹腔注射5%的酚红溶液0.1mL/10g,40分钟后脱臼处死各组小鼠,逐层剥离气管,并剪下甲状软骨到气管分支处的一段气管,将其放入5%碳酸氢钠溶液2.0mL中,待酚红完全渗出后,离心取上清液,用分光光度计于波长545nm处,测其上清液OD值,进而根据酚红标准曲线,测算酚红的含量,取平均值。对照组每天灌胃生理盐水,每天灌胃用药量为10g生理盐水/kg体重。比较各组测试结果,通过统计学分析方法得P<0.05。
表1:祛痰动物试验结果表
测试例2
为了测定本发明的免疫增强作用,将实施例的治疗慢性咳嗽的中药组合物进行免疫脏器指数测试。具体结果见表2。
1材料
实验动物用昆明种小鼠70只,体重20±2g,雌雄各半,随机分为7组,每组10只,分为6组实验组和1组对照组,管理相同。
2方法
第1组为对照组,每只小鼠每天灌胃0.2g生理盐水。第2-7组每只小鼠每天分别灌胃实施例1-6治疗慢性咳嗽的中药组合物3g加30℃温开水27g制成的药液0.2g;受试时间为7d。受试结束后禁食16h,称体重后脱颈椎处死,取胸腺称重,对各受试小鼠的胸腺脏器指数进行检测。胸腺脏器指数=胸腺质量(mg)/小鼠体重(g)。比较各组测试结果,通过统计学分析方法得P<0.05。
表2:免疫脏器指数数据表
测试例3
临床试验:李某、年龄35岁,赵某、年龄27岁,症状均符合中华医学会呼吸病学分会哮喘学组2009年颁布的《咳嗽的诊断与治疗指南》(草案)中慢性咳嗽的诊断标准,每日服用治疗慢性咳嗽的中药组合物3g加30℃温开水27g制成的药液,用药量为10g药液/kg体重,连续服用2周后二人咳嗽消失,相关症状及舌、脉象明显改善。
Claims (10)
1.一种治疗慢性咳嗽的中药组合物,其特征在于,包括下述原料制备而成:甘草、干姜、五味子、鹿茸。
2.一种治疗慢性咳嗽的中药组合物,其特征在于,包括下述重量份的原料制备而成:甘草10-100份、干姜10-100份、五味子10-100份、鹿茸10-100份。
3.如权利要求2所述治疗慢性咳嗽的中药组合物,其特征在于,包括下述重量份的原料制备而成:甘草75-85份、干姜55-65份、五味子55-65份、鹿茸10-15份。
4.一种药物制剂,其特征在于,由如权利要求2或3所述治疗慢性咳嗽的中药组合物与药学上可接受的辅料制成药物制剂,所述制剂形式为水剂、颗粒剂、片剂、胶囊、膏剂、丸剂或散剂。
5.如权利要求1-3中任一项所述治疗慢性咳嗽的中药组合物在制备固体饮料、保健品中的应用。
6.如权利要求1-3中任一项所述治疗慢性咳嗽的中药组合物的制备方法,其特征在于,包括以下步骤:
(1)将鹿茸,去除表面毛发,切成粒径小于5mm的颗粒,再用低温粉碎机并以液氮为研磨介质粉碎至200-500目,真空冷冻干燥,得到鹿茸粉;
(2)将甘草、干姜、五味子分别切成粒径小于5mm的颗粒,再分别用低温粉碎机并以液氮为研磨介质粉碎至100-300目,将粉碎后的甘草、干姜、五味子混合,得到混合料;将胃蛋白酶、胰蛋白酶、果胶酶、氯化钠、柠檬酸、混合料、水按质量比为1:(0.8-1.2):(0.8-1.2):(0.4-0.8):(0.05-0.15):(20-40):(400-600)混合,在温度为30-40℃以转速为100-300r/min搅拌提取1-2h,然后采用300-900目滤布过滤,得到提取液a和滤饼;将滤饼、酒石酸钠、多酚、体积分数65-75%乙醇水溶液按质量比为1:(0.005-0.015):(0.005-0.015):(15-25)混合,在温度为30-40℃进行超声提取50-90min,然后采用300-900目滤布过滤,得到提取液b;合并提取液a和提取液b得到混合提取液;将混合提取液在温度为45-55℃、绝对压强为0.005-0.02MPa真空浓缩至原体积的5-10%,真空冷冻干燥,得到提取物;
(3)将步骤(1)制备的鹿茸粉和步骤(2)制备的提取物混合,然后进行超高压灭菌,即得。
7.如权利要求6所述治疗慢性咳嗽的中药组合物的制备方法,其特征在于,所述超声提取的超声功率为200-400W、超声频率为25-45kHz。
8.如权利要求6所述治疗慢性咳嗽的中药组合物的制备方法,其特征在于,所述步骤(1)和步骤(2)中真空冷冻干燥的条件是控制物料厚度4-9mm,设定预冻温度为-20~-30℃,当样品温度降到设定温度后保持1.5-2.5h,设定升华温度为5-15℃,解析温度为30-40℃,绝对压强10-30pa,干燥时间为10-25h。
9.如权利要求6所述治疗慢性咳嗽的中药组合物的制备方法,其特征在于,所述多酚为甘薯茎叶多酚、糖基修饰的多酚类化合物中的至少一种。
10.如权利要求6所述治疗慢性咳嗽的中药组合物的制备方法,其特征在于,所述超高压灭菌的压力为400-700MPa,时间为10-25min。
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