CN111084878A - 一种用于肺及呼吸系统疾病的生物医药、医用全营养食品及制备方法 - Google Patents
一种用于肺及呼吸系统疾病的生物医药、医用全营养食品及制备方法 Download PDFInfo
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Abstract
本发明公开了一种用于肺及呼吸系统疾病的生物医药、医用全营养食品及制备方法,所述生物医药由以下重量份原料制备而成:太子参1~30份,冬虫夏草(或其人工培养品)0.5~29份,藿香叶1~49份,当归2~45份,杏仁4~54份,山药6~45份,泽泻7~42份,山茱萸8~46份,黄芪2~40份,甘草10-50份,金银花9-50份,姜1~29份、白术3~33份、胡萝卜1‑39份,白芷1‑39份,芦根1‑30份,百合1‑39份,胎盘0.5‑55份;本发明组方合理,通过提升患者的免疫和自身修复能力使疾病获得疗愈,在服药期间对患者无限制性要求,不影响患者的正常工作与生活。
Description
技术领域
本发明属于生物医药、医用食品技术领域,具体涉及一种用于肺纤维化、间质性、阻塞性肺病及肺癌等呼吸系统疾病的生物医药、医用食品及制备方法。
背景技术
肺及呼吸系统疾病发病率在我国已呈逐年上升的趋势,除与环境恶化如空气污染、食品污染、水污染,垃圾食品相关外,生活习惯和生活方式的改变等均是导致疾病升高的不可忽视的魁首。其高发病率及高病死率对人类的健康产生严重威胁。但因肺纤维化、间质性、阻塞性肺病及肺癌在病变早期症状、体征较隐匿,而一些肺及呼吸系统疾病早期症状也无明显特异性,甚至没有异常感觉,极易被忽视,当患者因气喘、消瘦、乏力等各种身体不适症状出现就诊时,大多已发展至进展期,累及临近器官、组织,使疾病丧失有效治疗期。
肺部疾病,主要包括肺纤维化、间质性、阻塞性肺病及肺癌等;所述呼吸系统疾病除前述肺部疾病外尚有鼻咽癌、喉癌等疾患。如果说肺癌除小细胞肺癌外,非小细胞肺癌尚有抗癌药、鼻咽癌、喉癌也算有抗癌药可用的话,而肺纤维化、间质性、阻塞性肺病则是无药可医,无药可治,是至今仍围绕医药学领域专家学者,緾缚医患双方的一大难题。
为解决诸如此类前述难题,本发明应运而生。其特征在于,本发明不但通过中医气血、经络学说及相关理论调理病患者的气机,为患者赢得修复机体的时机,还通过胎盘短肽,提升患者的免疫能力和自身修复能力,这也契合了当前新型冠状病毒肺炎中医中药治疗的理念,不但如此,本发明在提升患者的免疫能力与机体自身修复能力的同时,同时提供给患者各种营养要素、合理的营养,进而帮助患者最终战胜病魔,使患者健康得以恢复,获得高质量的生活。
事实上,对于肺纤维化、间质性、阻塞性肺病及鼻咽癌、咽喉癌、肺癌,尤其是肺纤维化、间质性、阻塞性肺病等除激素治疗外,在当前此类顽疾根本无药可医。即使是疾病能早期发现,也难以救治,更谈不上根除治疗。即使是用于改善症状的诸多治疗这类疾患的药物中,大多也只是以牺牲机体的“元气”为代价延缓症状,而诸如此类的治疗对患者来说无异于拆东墙补西墙,不但如此,且此类药大多数存在着组分复杂,从而导致产品对人体有多重复杂的作用、诸多副作用的缺点,大多需要长期服用,为患者所不能忍受;或价格太高,为患者所不能承受,或在服药期间对患者限制性要求太多,影响患者的正常工作与生活等等,尤其突出的缺点是不但不能使患者获得免疫与修复能力,使疾病呈进行性恶性进展状态,甚或造成较大的甚至是不可逆转的伤害。
肺纤维化、间质性、阻塞性肺病等疾患且无手术、放疗、化疗等有效的治疗措施,然而,即使是鼻咽癌、咽喉癌、肺癌等疾病,无论是单纯的手术,或单纯的放疗、化疗,和/或联合应用,对患者来说,都是不可小视的创伤和伤害,营养干预措施不得力或不恰当,都将不可避免地影响患者的预后及后期的生存质量与生活质量。
现代医学与中医理论均认为,合理的膳食及恰当的食疗养生对于肺纤维化、间质性、阻塞性肺病、鼻咽癌、咽喉癌、肺癌等肿瘤及恶性肿瘤、免疫及自体免疫等疾病有很好的治疗,和/或辅助治疗的效果,目前未见相关报道。医用食品,是不同于普通食品、保健品和药品的新型产品,是需要在医师、营养(医)师,和/或营养师指导下进行使用的一类具有特殊医学用途的食品;
本发明所说的生物医药,主要涉及生物产品、生物制备及最终制成的具有特殊生物活性的一类特殊生物药品。
发明内容
针对现有及技术的不足,本发明的目的在于提供一种用于肺及呼吸系统疾病的生物医药及医用全营养食品,本发明公开的生物医药及医用全营养食品用于治疗肺及呼吸系统疾病的生物医药,本发明组方合理,通过提升患者的有机体自身的免疫和自身的修复能力使疾病获得疗愈,在服药期间对患者无限制性要求,不影响患者的正常工作与生活;本发明的另一目的在于提供该生物医药及医用全营养食品的制备方法。
本发明是通过以下技术方案实现的:
一种用于肺及呼吸系统疾病的生物医药,由以下重量份原料,部分经粉碎、部分经提取有效物质及酶切后,制成临床上所能接受的剂型:太子参1~30份,冬虫夏草或其人工培养品0.5~29份,藿香叶1~49份,当归2~45份,杏仁4~54份,山药6~45份,泽泻7~42份,山茱萸8~46份,黄芪2~40份,甘草10-50份,金银花9-50份,姜1~29份,白术3~33份,胡萝卜1-39份,白芷1-39份,芦根1-30份,百合1-39份,胎盘0.5-55份。
一种用于肺及呼吸系统疾病的生物医药的制备方法,制备步骤如下:
按照上述的重量份配比,称取各原料备用;
(1)提油 取金银花、霍香叶、姜、白芷、当归、泽泻放入容器内,加水4~8倍重量,浸泡40~70分钟,水蒸气蒸馏2.5~3.5h,得到油水混合物,再对油水混合物进行分离,分离得到挥发油;以8~12倍重量β-环糊精包合挥发油,在60±5℃包合2小时,得到包合物;对蒸馏后的剩余物料进行液固分离,得到药渣和药液;
(2)提脂 将步骤(1)的药渣与杏仁、山茱萸、另包的拣净的胎盘用乙醇回流提取2次,第一次加10倍重量的浓度为60%-85%乙醇,回流提取1.5-2.5小时,过滤后的药渣再加8倍重量的浓度为60%-85%乙醇,回流提取1.5-2.5小时,合并两次提取液,并在负压状态下回收乙醇,直至提取液无醇味得到含脂溶性物质的液体;对回流后的剩余物料在负压状态下回收残留乙醇,直至无醇味,进行液固分离,得到药渣和药液;
(3)煎提 取太子参、黄芪,甘草,白术,胡萝卜,芦根,百合,另包的拣净的山药放入容器内,与步骤(2)的药渣、另包的拣净的胎盘混合,加水浸泡后,煎煮2次,每次各40~70分钟,第一次加8倍重量水浸泡,第二次加6倍重量水,煎煮前均浸泡40~70分钟,合并两次煎煮、过滤后的药液以及步骤(1)得到的药液,将混合后的药液浓缩至相对密度为1.10~1.15后进行低温干燥,收集干燥物备用;
(4)酶切 分取步骤(3)的另包的拣净的胎盘煎煮包,将冬虫夏草或其人工培养品及煎煮后的胎盘,分别充分干燥,经6000-100000转/小时超高速粉碎机将其微粉化;将微粉化后的冬虫夏草或其人工培养品、胎盘微粉,分别浆液化,将浆液化后的胎盘、冬虫夏草或其人工培养品微粉分别酶切,分取酶切获得的分子量≤3000Da的胎盘、冬虫夏草或其人工培养品短肽备用;
(5)取步骤(3)浓缩液干燥物及上述步骤获得的分子量≤3000Da的胎盘、冬虫夏草或其人工培养品短肽混合,再加入步骤(1)的包合物、步骤(2)的含脂溶性物质的液体、步骤(3)另包的拣净去皮的山药的干燥粉碎物,混合均匀后干燥使其微粉化,获得含水量≤5%的干燥微粉物;将此干燥微粉物制成制成临床上所能接受的剂型。
进一步的,步骤(3)所述浓缩的温度为75~80℃;所述的干燥的温度为75~80℃;
进一步的,骤(4)中所述酶切所用的酶,为食品级复合酶、食品用中性蛋白酶 FDG-2209、食品级高活力浓缩型中性蛋白酶FDG-2230、酸性蛋白酶APRL型FDY-2205、酸性蛋白酶APRS型FDG-2237、食品用碱性蛋白酶 FDG-2202、食品级高活力浓缩型碱性蛋白酶FDG-2227、碱性蛋白酶FDG-4001 、内切型蛋白酶FDY-2220、内切酶DNaseⅠ、内切酶DNaseⅡ、内切酶BamHI、内切酶phi29中的一种或两种以上混合。
进一步的,步骤(3)所述浓缩的温度为75~80℃;所述干燥的温度为75~80℃;步骤(4)所述酶切的温度为0-69℃,湿度为30-99%,光照强度为0-300Lx,离心搅拌机转速为9-75r/s;步骤(5)所述的干燥为冷冻干燥、或干燥塔内喷雾干燥,所述冷冻干燥温度则在-10℃以下至-45℃;喷雾干燥,干燥塔内的烘干压力为100~150Pa,干燥塔的进口温度为180±5℃,出口温度为80±5℃。
进一步的,步骤(3)所得的混合药液若不够澄清,应进行醇沉后再浓缩;步骤(4)所述酶切,为提高品质而加入磷脂,是指加入适量的磷脂,经超声振荡、搅拌,或射流等措施处理,使分子量≤3000Da的短肽包裹在磷脂脂质体中,方便获得分子量≤3000Da的短肽及短肽脂质体,提高产品品质,使产品获得更大的生物效应。
进一步的,步骤(5)所述的临床上所能接受的剂型包括固体饮料、粉剂、微粉剂、颗粒剂、散剂、溶液剂、混悬剂、凝胶剂、片剂或胶囊剂。
本发明的进一步改进方案为:
一种用于肺及呼吸系统疾病的医用食品,由以下重量份原料,部分经粉碎、部分经提取有效物质及酶切后,制成临床上所能接受的剂型:太子参1~30份,冬虫夏草或其人工培养品0.5~29份,藿香叶1~49份,当归2~45份,杏仁4~54份 ,山药6~45份,泽泻7~42份,山茱萸8~46份,黄芪2~40份,甘草10-50份,金银花9-50份,姜1~29份,白术3~33份,胡萝卜1-39份,白芷1-39份,芦根1-30份,百合1-39份,胎盘0.5-55份,由麦芽糊精0.9-49份,膳食纤维0.5-30份,中链甘油三酯0.01-55份,微量元素0.1-19份,水溶性维生素0.1-27份,脂溶性维生素0.1-5份,调味剂0.1-37份组成的肺病型全营养组件。
本发明的更进一步改进方案为:
一种用于肺及呼吸系统疾病的医用食品的制备方法,制备步骤如下:
按照上述的重量份配比,称取各原料备用;
(1)提油 取金银花、霍香叶、姜、白芷、当归、泽泻放入容器内,加水4~8倍重量,浸泡40~70分钟,水蒸气蒸馏2.5~3.5h,得到油水混合物,再对油水混合物进行分离,分离得到挥发油;以8~12倍重量β-环糊精包合挥发油,在60±5℃包合2小时,得到包合物;对蒸馏后的剩余物料进行液固分离,得到药渣和药液;
(2)提脂 将步骤(1)的药渣与杏仁、山茱萸、另包的拣净的胎盘用乙醇回流提取2次,第一次加10倍重量的浓度为60%-85%乙醇,回流提取1.5-2.5小时,过滤后的药渣再加8倍重量的浓度为60%-85%乙醇,回流提取1.5-2.5小时,合并两次提取液,并在负压状态下回收乙醇,直至提取液无醇味得到含脂溶性物质的液体;对回流后的剩余物料在负压状态下回收残留乙醇,直至无醇味,进行液固分离,得到药渣和药液;
(3)煎提 取太子参、黄芪,甘草,白术,胡萝卜,芦根,百合,另包的拣净的山药放入容器内,与步骤(2)的药渣、另包的拣净的胎盘混合,加水浸泡后,煎煮2次,每次各40~70分钟,第一次加8倍重量水浸泡,第二次加6倍重量水,煎煮前均浸泡40~70分钟,合并两次煎煮、过滤后的药液以及步骤(1)得到的药液,将混合后的药液浓缩至相对密度为1.10~1.15后进行低温干燥,收集干燥物备用;
(4)酶切 分取步骤(3)的另包的拣净的胎盘煎煮包,将冬虫夏草或其人工培养品及煎煮后的胎盘,分别充分干燥,经6000-100000转/小时超高速粉碎机将其微粉化;将微粉化后的冬虫夏草或其人工培养品、胎盘微粉,分别浆液化,将浆液化后的胎盘、冬虫夏草或其人工培养品微粉分别酶切,分取酶切获得的分子量≤3000Da的胎盘、冬虫夏草或其人工培养品短肽备用;
(5)取步骤(3)浓缩液干燥物及上述步骤获得的分子量≤3000Da的胎盘、冬虫夏草或其人工培养品短肽混合,再加入步骤(1)的包合物、步骤(2)的含脂溶性物质的液体、步骤(3)另包的拣净去皮的山药的干燥粉碎物以及肺病型全营养组件,混合均匀后干燥使其微粉化,获得含水量≤5%的干燥微粉物;将此干燥微粉物制成临床上所能接受的剂型。
进一步的,步骤(3)所述浓缩的温度为75~80℃;所述的干燥的温度为75~80℃;
进一步的,骤(4)中所述酶切所用的酶,为食品级复合酶、食品用中性蛋白酶 FDG-2209、食品级高活力浓缩型中性蛋白酶FDG-2230、酸性蛋白酶APRL型FDY-2205、酸性蛋白酶APRS型FDG-2237、食品用碱性蛋白酶 FDG-2202、食品级高活力浓缩型碱性蛋白酶FDG-2227、碱性蛋白酶FDG-4001 、内切型蛋白酶FDY-2220、内切酶DNaseⅠ、内切酶DNaseⅡ、内切酶BamHI、内切酶phi29中的一种或两种以上混合。
进一步的,步骤(3)所述浓缩的温度为75~80℃;所述干燥的温度为75~80℃;步骤(4)所述酶切的温度为0-69℃,湿度为30-99%,光照强度为0-300Lx,离心搅拌机转速为9-75r/s;步骤(5)所述的干燥为冷冻干燥、或干燥塔内喷雾干燥,所述冷冻干燥温度则在-10℃以下至-45℃;喷雾干燥,干燥塔内的烘干压力为100~150Pa,干燥塔的进口温度为180±5℃,出口温度为80±5℃。
进一步的,步骤(3)所得的混合药液若不够澄清,应进行醇沉后再浓缩;步骤(4)所述酶切,为提高品质而加入磷脂,是指加入适量的磷脂,经超声振荡、搅拌,或射流等措施处理,使分子量≤3000Da的短肽包裹在磷脂脂质体中,方便获得分子量≤3000Da的短肽及短肽脂质体,提高产品品质,使产品获得更大的生物效应。
进一步的,步骤(5)所述的临床上所能接受的剂型包括固体饮料、粉剂、微粉剂、颗粒剂、散剂、溶液剂、混悬剂、凝胶剂、片剂或胶囊剂。
各主要组分对于肺及呼吸系统等疾病的意义:
太子参:味甘、微苦;性平;入心、脾、肺三经。大补元气,补肺,健牌,补脾肺元气,止汗生津,定虚悸,益气健脾,生津润肺。用于脾虚体弱、病后虚弱、气阴不足、自汗口渴、肺噪干咳。治气虚肺燥,补脾土,消水肿,化痰止渴治肺虚咳嗽,脾虚食少,心悸自汗,精神疲乏,治胃弱消化不良,神经衰弱。治肺虚咳嗽,脾虚泄泻。补气益血,健脾生津。治病后体虚,肺虚咳嗽,脾虚腹泻,小儿虚汗,心悸,口干,不思饮食。
太子参,虽甚细如参条,短紧结实,而有芦纹,其力不下大参。太子参原指五加科植物人参之小者。现在商品则普遍用石竹科植物异叶假繁缕的块根,虽有滋补功用,但其力较薄。对机体具有适应原样作用,即能增强机体对各种有害刺激的防御能力。还可增强人体内的物质代谢。
补益脾肺;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,治气虚肺燥,补脾土,消水肿,化痰止渴。补脾肺元气,止汗生津,定虚悸。据《江苏植药志》记载,太子参用于治胃弱消化不良,神经衰弱效果满意;《中药志》:治肺虚咳嗽,脾虚泄泻。本品具有益气健脾,生津润肺等功效,用于脾虚体倦,食欲不振,病后虚弱,气阴不足,自汗口渴,肺燥干咳。
冬虫夏草:冬虫夏草性味甘平,入肺、肾二经。补虚损,益精气,止咳化痰。主治痰饮喘嗽,虚喘,痨嗽,咯血,自汗盗汗,阳痿遗精,腰膝酸痛,病后久虚,不复。保肺益肾,止血化痰,已劳嗽。主要用于补肺,壮肾阳,治痰饮喘嗽,具有补肺益肾,健脾醒胃,提高机体免疫功能,现代医学临床工作中多用于肺纤维化的治疗。
虫草及其菌丝体,能加强机体对病毒的清除能力,提高吞噬细胞或杀伤细胞的活性,从而增加对毒物的清除。虫草及其菌丝体还可以通过上调肝细胞生长因子(HGF)的表达,促进肝细胞再生,延缓慢性肝炎恶化的进程。虫草含有多种氨基酸、核苷类、微量元素等成分,可显著提高患者血浆白蛋白,抑制γ-球蛋白,调节免疫球蛋白,提高机体免疫力,增强机体修复能力,提升身体全面素质,减轻肝细胞炎症,减少病毒耐药的发生,根治病毒感染,改善患者的长期预后。冬虫夏草菌丝含有虫草多糖、麦角甾醇、D甘露醇、腺嘌呤等化学物质,对单核巨噬细胞、T淋巴细胞、B淋巴细胞及NK细胞都有刺激活化作用,且对淋巴细胞的转化有一定的作用。研究显示,CHB患者CD4 +、NK细胞减少,CD8 +细胞增多,CD4 +/CD8 +比值明显降低,使肝脏的星状细胞激活,引起肝脏组织向纤维化和病情迁延发展。冬虫夏草及其人工培养品可显著地提高细胞免疫功能,升高CD4 +、NK细胞,降低CD8 +,有效清除病原体;使患者IgG、IgM、IgA获得改善进而起到增强机体免疫力。对体液免疫功能具有显著的调整作用,提高机体对病原体的清除能力、抗病毒能力。
虫草酸,虫草菌素为一种特殊的多糖甙,具有增强人体的修复功能的特殊功效;冬虫夏草的膳食纤维,一方面能较好地调节并增强人的胃肠道功能,减少糖份、脂类和胆固醇的不合理吸收,另一方面,部分特殊的膳食纤维,在行使一般的膳食纤维对胃肠道功能的维护作用的同时,通过吸附人体摄入的过多的糖类、油脂和胆固醇从而起到调节并降低血糖、血脂和胆固醇的功效;有的又可被肠道益生菌分解为对人体有奇特功能的特殊成分。本发明的组方牢牢抓住并充分挖掘这一名贵药材对人体的特殊而奇特的药理作用。
传统医药和现代医药学对冬虫夏草的研究成果揭示,冬虫夏草及其人工培养品对人体具有:活血通络,调节并增强人的免疫功能;增强人体对外环境的适应能力和应激能力;提高人对各种刺激的抵抗能力、耐受力和适应性,而很少有副作用;
研究表明虫草可以阻止因慢性肝、肺损害而引起的肝纤维化形成,延迟病程进展,显著改善肝、肺功能。并通过增强机体的修复能力,使机体的因病原体引起的损伤得到修复,机体的疾病得以疗愈。中医于病主张“形神并重”,“五行说”与“经络论”体现了中医治病的整体观,讲究全面调理,标本兼治,而侧重于本。西医则侧重于形。临床实践则从治疗学角度验证了拥有数千年悠久历史的博大精深的祖国传统中医治病的整体观在治疗诸如肝、肺纤维化等免疫损伤导致的慢性、消耗性、自体免疫性疾病方面,具有现代西医无法替代的、也是无法比拟的有时甚至是“神奇”的功效。
藿香:为唇形科草本植物广藿香Pogostemincablin(Blanco)Benth.或藿香Agastacherugosus(Fisch.etMey)O.Ktze.的地上部份。由于藿香本身是一种具有芳香味的植物,全株都具有香味,所以常常将藿香与其他具有芳香味的植物进行搭配;
霍香。味辛、甘,气微温,可升可降,阳也,无毒。入肺、胃、脾经。定霍乱有神,止呕吐尤效,开胃消食,去臭气,利水肿。但亦可佐使,而不可为君臣。盖藿香逐邪甚速,未免耗气亦多,故佐气血之药往往取效,否则,无功耳。
或问藿香散暑气,子未言也,不知藿香虽散暑气,亦散真气也。用藿香以散暑,是犹执热以止热,余所以不言耳。虽霍乱亦暑症之一,然用藿香以定霍乱,实取其降气,非取其消暑,又不可不知也。
或问藿香为定喘奇方,而子何以未言,夫藿香定喘,乃言感暑气而作喘也,非藿香于治暑之外而更定喘也。余所以只言其治霍乱逐邪,而不言其定喘。夫喘症多生于虚,误认虚喘为实喘,下喉即便杀人。故不敢言藿香之定喘,实有微意耳。
藿香营养价值:藿香是高钙、高胡萝卜素食品,每100g嫩叶含水分72g、蛋白质8.6g、脂肪1.7g、碳水化合物10g、胡萝卜素6.38mg、维生素B1 0.1mg、维生素B20.38mg、尼克酸1.2mg、维生素C23mg、钙580mg、磷104mg、铁28.5mg、全草含芳香挥发油0.5%、油中主要为甲基胡椒酚(约占80%)、柠檬烯、α-蒎烯和β-蒎烯、对伞花烃、芳樟醇、I-丁香烯等,对多种致病性真菌,都有一定的抑制作用,芳香挥发油是制造多种中成药的原料。
藿香食用价值与方式:藿香的食用部位一般为嫩茎叶,其嫩茎叶为野味之佳品。可凉拌、炒食、炸食,也可做粥。藿香亦可作为烹饪佐料或材料。因其具有健脾益气的功效,是一种既是食品又是药品的烹饪原料,故某些比较生僻的菜肴和民间小吃中利用其丰富口味,增加营养价值。
《2010版药典1部》规定只有广藿香Pogostemon cablin(Blanco))Benth.的干燥地上部分可入药。枝叶茂盛时采割,日晒夜闷,反复至干。炮制:除去残根和杂质,先抖下叶,筛净另放;茎洗净,润透,切段,晒干,再与叶混匀。
霍香芳香化浊,和中止呕,发表解暑。用于湿浊中阻,脘痞呕吐,暑湿表证,湿温初起,发热倦怠,胸闷不舒,寒湿闭暑,腹痛吐泻,鼻渊头痛。
藿香有杀菌功能,口含一叶可除口臭,预防传染病,并能用作防腐剂。夏季用藿香煮粥或泡茶饮服,对暑湿重症,脾胃湿阻,脘腹胀满,肢体重困,恶心呕吐有效
霍香能化湿醒脾,辟秽和中,解暑,发表。用于湿阻脾胃、脘腹胀满、湿温初起、呕吐、泄泻、暑湿、发热恶寒、恶寒发热、胸脘满闷等症。《本草正义》记载:清芬微温,善理中州湿浊痰涎,为醒脾外胃,振动清阳妙品……霍乱心腹痛者,湿浊阻滞,伤及脾土清阳之气则猝然撩乱,而吐泻绞痛,芳香能助中州清气,胜湿辟秽,故为暑湿时令要药。藿香与厚朴、陈皮、大腹皮、桔梗、半夏、白芷、茯苓、苏叶、甘草配伍,治外感不正之气,内伤饮食,头痛发热,或霍乱吐泻,或发疟疾。用藿香叶、陈皮各半两,水二盏,煎一盏,温服,可使霍乱吐泻垂死者,服之回生。《本草纲目》记载:霍乱腹痛垂死者,用霍香同橘皮煎服;暑月,则同丁香、滑石末服;霍香为升降诸气,脾胃吐逆为要药。而《药品化义》描述:霍香其气方香,善行胃气,以此调中,治呕吐霍乱,以此快气,除秽恶痞闷。且香能和合五脏,若脾胃不和,用之助胃而进饮食,有醒脾开胃之功。《别录》:风水毒肿,去恶气,止霍乱心腹痛。
杏仁:苦,微温;有小毒。归肺、大肠经。降气止咳平喘,润肠通便。用于咳嗽气喘,胸满痰多,血虚津枯,肠燥便秘。
、镇咳、平喘作用
苦杏仁中含有苦杏仁苷,苦杏仁苷在体内能被肠道微生物酶或苦杏仁本身所含的苦杏仁酶水解,产生微量的氢氰酸与苯甲醛,对呼吸中枢有抑制作用,达到镇咳、平喘作用。《本草求真》记载“杏仁,既有发散风寒之能,复有下气除喘之力”。善止咳化痰而平喘,对肺系的主要病症咳嗽、痰多、喘息又有强烈的针对性,故古今医家将其作为肺系用药使用,无论内伤外感,新病痼疾,凡涉肺脏,多用之。采用豚鼠离体器官试验,杏仁水提取液能降低器官对氨水刺激的敏感性,对抗组胺、乙酰胆碱、氯化钡对气管平滑肌的兴奋作用,具有明显的止咳作用。采用SO2致咳法证明,给小鼠灌胃苦杏仁苷1mg/kg、10mg/kg、100mg/kg保持30min后,其对咳嗽频数的抑制率分别为26%、22.8%、25.3%。灌胃苦杏仁提取物48.3mg/kg的作用比等量苦杏仁苷强39.7%。苦杏仁因能促进肺表面活性物质(PS)的合成而有利于肺呼吸功能,苦杏仁不仅能促进PS的合成,而且可以改善各种有关肺的生理与生化指标(如肺均浆、肺水量、支气管灌洗中总磷脂及病理切片等)。
、抗肿瘤作用
20世纪初期苦杏仁苷首次从杏仁中分离出来,1920年在美国首次将苦杏仁苷用于治疗肿瘤。Ernest Krebs博士是第一个在美国将苦杏仁苷用于医药的人,并将它称为维生素B17。自20世纪50年代开始苦杏仁苷虽在美国、墨西哥等国家广泛流传用来治疗肿瘤,商品名为维生素B17或laetrile,但有关苦杏仁苷的抗肿瘤作用并未得到FDA的承认,在学术界一直存有争议,存在两种截然相反的看法。赞成的一方认为,苦杏仁苷是一种维生素B17,具有预防和治疗肿瘤的作用,并提出一些理论与试验数据。如认为肿瘤细胞无氧降解占优势,最终产物为乳酸,偏酸性环境有利于提高β-葡萄糖苷酶的活性,促使苦杏仁苷在肿瘤细胞中分解出较多的苯甲醛和氢氰酸,而产生对肿瘤细胞的选择性杀伤作用。与此相反的观点却认为,苦杏仁苷根本不是维生素,也没有抗癌作用,甚至还是有毒物质。有关苦杏仁苷的抗肿瘤作用虽仍在争论,但在包括比利时、德国、意大利、墨西哥以及菲律宾在内的20多个国家内,制造和使用苦杏仁苷是合法的。
有关杏仁的抗肿瘤疗效,国内外均有大量报道,但结果不尽一致。佐滕昭彦(1979年)报道杏仁热水提取物的粗剂对人子宫颈肿瘤JTC-26株的抑制率为50%-70%。方文龙等(1986年)的研究结果表明,苦杏仁提取物腹腔注射或灌胃,对肝癌和肉瘤180的抑制率为61.7%-77.1%。车文一等(1987年)试验结果表明,从苦杏仁中提取的抗肿瘤有效成分给移植性肝癌小鼠腹腔注射300mg/kg、400mg/kg、600mg/kg,其肿瘤抑制率分别为72.0%、60.8%、51.0%。给小鼠自由摄取苦杏仁,可抑制艾氏腹水癌细胞的生长,并使生存期延长。还有报道苦杏仁苷可以防治二甲基亚硝胺诱导的肝癌,使肿瘤灶缩小。但麦维岐等(1981年)从苦杏仁中提取苦杏仁苷(10%水溶液)进行动物试验,结果表明对小鼠肝癌、S180等均无抑菌活性。由NCI(美国癌症协会)发起的有关苦杏仁苷对癌症疗效的人类病例观察于1978年结束但并未得出明显的结论。美国于1982年进行了多种前沿性临床试验,认为laetrile没有治疗癌症的临床价值。
有关杏仁抗肿瘤机理的研究主要有以下几方面。
① 一部分学者认为癌细胞中含有大量β-葡萄糖苷酶,该酶能水解苦杏仁苷产生氢氰酸(HCN)、苯甲醛和葡萄糖。由于癌细胞缺少硫腈生成酶,该酶具有对HCN的解毒作用,使HCN变成无毒的硫腈化物,而正常细胞缺少β-葡萄糖苷酶而含有大量的硫腈生成酶。依据该理论,苦杏仁苷应该能够选择性杀死癌细胞,而对正常细胞几乎无害。
② 苦杏仁苷能帮助体内胰蛋白酶消化癌细胞的透明样黏蛋白膜,使体内白细胞更易接近癌细胞,并吞噬癌细胞。
③ 有人发现苦杏仁苷类似NaSCN和NaOCN能够影响胸腺嘧啶核苷进入肝瘤细胞DNA和肿瘤细胞对磷酸盐及氨基酸的吸收。
、抗炎、镇痛作用
脱脂苦杏仁的水提取物对乙酸所致的小鼠扭体反应和棉球所致的大鼠肉芽肿炎症的形成有抑制作用。用大鼠足关节浮肿法,静脉注射40mg/kg杏仁的水溶性蛋白质成分KR-A、KR-B5mg/kg时有抑制炎症作用。用小鼠萘醌致痛模型试验表明,KR-A或KR-B静脉给药5mg/kg时,抑痛率分别为40.7%和58.2%。它们对大鼠角叉菜胶性足肿,经口摄取的ED50分别为13.9mg/kg和6.4mg/kg。小鼠热板法和乙酸扭体法证实,苦杏仁苷有镇痛作用,但不同于吗啡的镇痛剂。苦杏仁苷分解产生的苯甲醛静安息香缩合酶作用生成安息香。安息香具有镇痛作用,因此国内有人用 苦杏仁治疗晚期肝癌可解除病人的痛苦,有的甚至不需服用止痛药。
、降血脂作用
临床报道,24名血脂为200~260的患者,每天给生杏仁100g作为主要脂肪源,3周后,血脂平均下降10.1%。85名高血脂患者每天服用75g大杏仁,连续服用4周,在停止服用后再继续观察4周。结果表明,大杏仁可以明显降低高血脂患者的血脂水平,其中以血清总胆固醇(TC)和低密度脂蛋白胆固醇(LDL-C)的下降最为明显,分别下降10.6%和8.1%,同时患者的高密度脂蛋白胆固醇(HDL-C)没有明显变化,载脂蛋白B(Apo B)明显下降,载脂蛋白A1(ApoA1)明显上升。Spiller(1990年)认为杏仁中的单不饱和脂肪酸有助于降低患者轻度升高的血脂,且无需严格限制饮食。
、降血糖作用
苦杏仁苷具有防治因抗肿瘤药阿脲引起的糖尿病的作用。采用阿脲诱发小鼠高血糖法证明,预先腹腔注射3g/kg苦杏仁苷48h后测血糖,结果表明苦杏仁苷可特异性地抑制阿脲所致的血糖升高,作用强度与血液中苦杏仁苷的浓度有关。
、对消化系统的作用
杏仁味苦下气,且富含脂肪油。脂肪油能提高肠内容物对黏膜的润滑作用,故杏仁有润肠通便之功能。苦杏仁苷在经酶作用分解形成氢氰酸的同时,也产生苯甲醛,后者可抑制胃蛋白酶的活性,从而影响消化功能。杏仁水溶性部分的胃蛋白酶水解产物以500mg/kg的剂量对四氯化碳处理的大鼠给药,发现它能抑AST、ALT水平和羟脯氨酸含量的升高,并抑制优球蛋白溶解时间的延长。杏仁水溶性部分的胃蛋白酶水解产物能抑制鼠肝结缔组织的增生,但不能抑制D-半乳糖胺引起的鼠AST、ALT水平升高。
、其他作用
根据肺合皮毛理论,在临床上对某些皮肤疾病可从宣肺法论治,配伍食用杏仁,常获捷效。现代研究证明,苦杏仁中所含的脂肪油可使皮肤角质层软化,润燥护肤,有保护神经末梢血管和组织器官的作用,并可抑杀细菌。此外,被酶水解所生成的HCN能够抑制体内的活性酪氨酸酶,消除色素沉着、雀斑、黑斑等,从而达到美容的效果。
赵素莲等研究发现,给小鼠肌内注射苦杏仁苷能明显促进小鼠NK细胞活性以及刺激T淋巴细胞的转化增殖。李春华等在同一实验动物观察了苦杏仁苷对肝枯否细胞吞噬功能的影响,又用Ag-NOR法观察了与肝枯否细胞rDNA活化作用的关系。结果表明,苦杏仁苷[3mg/(只·d)]对其吞噬功能以及对肝枯否细胞rDNA活化均有非常明显的促进作用,具有增强机体免疫的功能。苦杏仁苷具有抗突变作用,能减少由安乃近、灭滴灵、丝裂霉素C等引起的微核多染性红细胞的数量。
苦杏仁油还有驱虫、杀菌作用,体外试验对人蛔虫、蚯蚓有杀死作用,并对伤寒、副伤寒杆菌有抗菌作用。杏仁还具有抗蛲虫和滴虫感染,治疗再生障碍性贫血作用。苦杏仁苷在治疗兔血吸虫病性肝纤维化和四氯化碳所致大鼠肝纤维化时也显示出了明显的疗效,其作用机理与增加肝血流量,提高胶原酶对Ⅰ、Ⅲ、Ⅳ性胶原的降解活性,以及通过影响Ⅳ性胶原和板层素的代谢干扰了血窦毛细血管化的形成有关
苦杏仁苷的毒性与给药途径密切相关。苦杏仁苷经口服较大剂量会出现危险的氰化物中毒,而静脉给药则经尿排出而没有氰化物的产生。小鼠静脉注射LD50为25g/kg,而灌胃的LD50为0.887g/kg。大鼠静脉注射的LD50为25g/kg,腹腔注射为8g/kg,灌胃给药为0.6g/kg。小鼠、兔、犬静脉注射或肌内注射的最大而受剂量(MTD)均为3g/kg,而灌胃均为0.075g/kg。小鼠静脉注射苦杏仁苷0.5g/kg,动物100%存活,而相同剂量灌胃,48h内中毒死亡达80%。人口服苦杏仁苷4g/d持续半个月或静脉注射持续1个月,可见毒性反应,如剂量减至0.6-1.2g/d,则可避免毒性反应。
《本草纲目》:苦杏仁能散能降,故解肌、散风、降气、润燥、消积,治伤损药中用之。治疮杀虫,用其毒也。治风寒肺病药中,亦有连皮尖用者,取其发散也。
《长沙药解》:肺主藏气,降于胸膈而行于经络,气逆则胸膈闭阻而生喘咳,藏病而不能降,因以痞塞,经病而不能行,于是肿痛。苦杏仁疏利开通,破壅降逆,善于开痹而止喘,消肿而润燥,调理气分之郁,无以易此。其诸主治,治咳逆,调失音,止咯血,断血崩,杀虫NI,除ZHA刺,开耳聋,去目翳,平胬肉,消停食,润大肠,通小便,种种功效,皆其降浊消郁之能事也。
《本草求真》:苦杏仁,既有发散风寒之能,复有下气除喘之力,缘辛则散邪,苦则下气,润则通秘,温则宣滞行痰。苦杏仁气味俱备,故凡肺经感受风寒,而见喘嗽咳逆、胸满便秘、烦热头痛,与夫蛊毒、疮疡、狗毒、面毒、锡毒、金疮,无不可以调治。东垣论苦杏仁与紫菀,均属宣肺除郁开溺,而一主于肺经之血,一主于肺经之气;苦杏仁与桃仁,俱治便秘,而一治其脉浮气喘便秘,于昼而见;一治其脉沉狂发便秘,于夜而见。冯楚瞻论苦杏仁、栝萎,均属除痰,而一从腠理中发散以祛,故表虚者最忌;一从肠胃中清利以除
《本经疏证》:麻黄汤、大青龙汤、麻黄苦杏仁甘草石膏汤、麻黄加术汤、麻黄苦杏仁薏苡甘草汤、厚朴麻黄汤、文蛤汤,皆麻黄、苦杏仁并用,盖麻黄主开散,其力悉在毛窍,非借苦杏仁伸其血络中气,则其行反濡缓而有所伤,则可谓麻黄之于苦杏仁,犹桂枝之于芍药,水母之于虾矣。
《本草便读》:凡仁皆降,故(苦杏仁)功专降气,气降则痰消嗽止。能润大肠,故大肠气闭者可用之。考苦杏仁之性似无辛味,似乎止有润降之功,而无解散立力,但风寒外束,肺气壅逆,不得不用此苦降之品,使气顺而表方得解,故麻黄汤用之,亦此意耳。桃仁、苦杏仁,其性相似,一入肝经血分,一入肺经气分。至于解毒杀虫,彼此均可,在乎用者之神明耳
杏仁含有丰富的营养成分,特别富含蛋白质、脂肪、矿物质和维生素,营养价值很高。据有关资料介绍,干杏仁含水量约为5%。每1kg杏仁中,含蛋白质233.8g,脂肪464.2g,碳水化合物82g,热量5442千卡,粗纤维83.8g,灰分24g,钙1298mg,磷3520mg,钾1060mg,钠71mg,锌36.4mg,铜8.1mg,铁51mg,尼克酸23mg,硒156.5mg,胡萝卜素0.92mg,硫胺素1.38mg,核黄素6.54mg,镁2927mg,维生素E273.7mg,维生素C260mg等。100g杏仁与100ml牛奶相比可提供598千卡热量。100g杏仁与牛奶相比,所含钙比牛奶高3倍,钾高4倍,磷高6倍。镁有助于酶的活化和强化神经、肌肉的功能;锌是多种酶的成分;铜在提高酶活性、头发生长和色素沉着、结缔组织的发育和血红细胞形成中起着重要作用。杏仁所含蛋白质高于一般谷类作物二倍之多,其氨基酸的种类与谷物种类互补。甜杏仁中还含有水苏糖、杏仁球蛋白质等。杏仁是必需的多不饱和脂肪酸-亚油酸、镁和磷的极好来源,而且也是蛋白质、VE、钙、铁、锌、铜和B族维生素的良好来源。
甜杏仁,不含或仅含0.1%的苦杏仁苷。脂肪含量达45%~67%。苦杏仁,含有2%~4%苦杏仁苷。
杏仁有降气祛痰、止咳、平喘、润肠通便、治疗疥疮和消肿等营养
在中药中杏仁是一种缓泻,亦是治疗皮肤病的擦伤油膏的重要原料。杏仁中富含的优质蛋白质、脂肪及其他成分对人体有极其重要的作用,其主要功能表现为:解表宜肺、润肠、通便,润于血,行血脉,利气机,化水润,消食化积。研究发现杏仁液能降低气管对氨水刺激的敏感性,对抗组胺、乙酰胆碱、氯化钡对气管平滑肌和肠平滑肌的兴奋作用,并有加快大肠蠕动作用。杏仁油能抑制胆固醇的生物合成、抑制脂质沉积于血管壁、促使胆固醇排泻、预防动脉硬化、进而达到预防心脑血管病的作用。
甜杏仁和苦杏仁的营养保健功能各有侧重。
甜杏仁,性平,偏于滋润及养护肺气,作用缓和,其润肠通便之功效较苦杏仁更为显著。并能润肺,宽胃,祛痰止咳。适用于肺虚久咳或津伤、便秘等症。
苦杏仁,性属苦泄,善降气,入肺和大肠,具有止咳通便功能。
杏仁油中不饱和脂肪酸含量为95%左右,这些不饱和脂肪酸在人体内不仅不会产生脂肪积累,并且可以降低低密度脂蛋白和血清胆固醇的水平,有利于血管的软化,具有防治高血压、高血脂等心血管疾病的疗效。此外,杏仁油还有其独特的性质,杏仁油凝固点很低,在-10℃时仍能保持清亮的液态,-20℃时才凝结。因此,杏仁油不仅是世界著名的优质食用油,而且还是制作高级化妆品、高级润滑油和高级塑料溶剂的原料,具有十分重要的利用价值和经济价值。
杏仁蛋白中易消化的低分子清蛋白占蛋白总量的80%以上,较难消化的大分子球蛋白不到20%,其氨基酸构成比例接近于国际参考模式,因此杏仁蛋白是一种食用价值极高的植物蛋白。杏仁蛋白具有很好的功能特性,如凝胶性、黏性、发泡性、稳定性、乳化性和溶解性。 [1]
苦杏仁苷具有多种药理作用,如防癌抗癌、抗突变、镇咳平喘、镇痛,对于防治糖尿病也有一定疗效。日本、美国和墨西哥等国已生产了苦杏仁苷针剂、片剂、粉剂和苦杏仁苷的疗效食品添加剂等。 [1]
从苦杏仁脱毒产物中提取的天然苯甲醛在食品、化妆品、医药等方面用途广泛。
杏仁还可以加工成杏仁全粉、椒盐杏仁、果味杏仁、琥珀杏仁、杏仁罐头、杏仁乳、乳酸菌发酵杏仁饮料,以及杏仁花生复合乳、杏仁核桃复合乳、杏仁果汁乳等。杏仁具有特殊的香味,加入食品中能增添其光泽、亮度,增进食欲,因此杏仁还可以作为夹心面包、糕点、糖果、冷食、冷饮及酱菜等的精点配料。
当归:性甘、辛、温,无毒,归肝、心、脾经。《雷公炮制药性解》:入心、肝、肺三经。《汤液本草》:入手少阴、足太阴、厥阴经。全当归既能补血,又可活血,统称和血;当归身补血,当归尾破血。当归之补血;活血;调经止痛;润燥滑肠。主血虚诸证;月经不调;经闭;痛经;症瘕结聚;崩漏;虚寒腹痛;痿痹;肌肤麻木;肠燥便难;赤痢后重;痈疽疮疡;跌扑损伤。
祖国医学认为,当归味甘而重,故专能补血,其气轻而辛,故又能行血,补中有动,行中有补,为血中之要药。因而,它既能补血,又能活血,既可通经,又能活络。凡妇女月经不调,痛经,血虚闭经,面色萎黄,衰弱贫血,子宫出血,产后瘀血,例经(月经来潮时,出现口鼻流血)等妇女的常见病,都可以用当归治疗。当归是中医中的最常用药多用于煲汤,特别对贫血患者是最好的。还能显著促进机体造血功能,升高红细胞、白细胞和血红蛋白含量。
补血养血
当归味甘而重,故专能补血,为补血第一药,适用于心肝血虚证所致的面色苍白或萎黄、倦怠乏力、唇甲浅淡无华、头晕目眩、心悸失眠等症。当归与熟地、白芍、川芎配伍,组成补血代表方——“四物汤”,有调经补血之功,尤其适于产后血虚的调治。
润肠通便
中医认为精血同源,血虚者津液也不足,肠液亏乏易致大便秘结。当归可润肠通便,常与麻仁、苦杏仁、大黄合用治疗血虚便秘;与防风、川芎、芍药、大黄、薄荷叶、麻黄等组成防风通圣散,可泻热通便。
免疫作用
当归及其萃取物阿魏酸钠和当归多醣对单核-巨噬细胞系统有明显的刺激作用,对免疫功能低下的机体也有免疫调解和恢复作用。当归对健康人的淋巴细胞转化也有促进作用。
抗癌作用
当归可广泛用于各种肿瘤,尤其是妇科肿瘤,以气血停滞、瘀血凝聚者最宜。对血虚羸瘦的中晚期癌症或手术、放疗、化疗后正气虚弱之患者,亦可选用当归,以扶正抗癌。
当归煎剂对小鼠学习记忆具有明显的影响,用ㄚ迷宫法测定,当归能改善三氯化铝所致的痴呆,降低痴呆小鼠脑的过氧化酯质水准,和B型单胺氧化的活性,能治疗老年痴呆症。
当归更多的对机体有益作用表现略举如下所述。
1、对肺部的保护作用
当归可扩张大鼠肺动脉,降低急性缺氧性肺动脉高压。当归对慢性阻塞性肺病的肺动脉高压也有一定的降压作用。
2、平喘作用
中医认为,当归主治咳逆上气。现已证明,当归成分正丁烯夫内酯和藁本内酯对气管平滑肌具有松弛作用;并能对抗组胺-乙酰胆碱引起的支气管哮喘。改善血液循环作用
当归中的丁基苯酞可增加中脑动脉闭塞(MCAO)术后的软脑膜微动脉管径和血流速度,从而改善软脑膜微循环。脑缺血过程存在神经元凋亡,丁基苯酞还能使低糖低氧诱导的神经细胞凋亡过程减弱或停止,阻止脑梗死面积扩大。
3、抗炎和镇痛作用
当归对多种致炎剂引起的急性毛细血管通透性增高、组织水肿及慢性损伤均有显著抑制作用,且能抑制炎症后期肉芽组织增生,但不影响肾上腺及胸腺的重量,提示其抗炎作用不依赖于垂体—肾上腺系统。当归水提取物对腹腔注射醋酸引起的扭体反应表现出镇痛作用,其镇痛作用强度为乙酰水杨酸钠的1.7倍。
4、对肾脏的保护作用
当归对肾脏有一定的保护作用,能改善家兔肾缺血后肾小球滤过功能及肾小管重吸收功能,减轻肾损害,促进肾小管病变的恢复。
5、对心血管系统的作用
当归煎剂或流浸膏对离体蟾蜍心脏有抑制作用,剂量大时可使心跳停止于舒张期。当归对大鼠心肌缺血再灌注的心律失常具有保护作用,当归注射液0.6g/kg用于大鼠腹腔注射,能使早搏发生率和心律失常总发生率明显减少。
6、补血作用 当归多糖可通过直接和(或)间接途径激活造血微环境中的巨噬细胞、淋巴细胞等,也可刺激肌组织,促进其产生造血调控因子,进而促进功能造血干细胞粒细胞巨噬细胞集落成单位(CFU-GM)的增殖分化,刺激骨髓粒单系造血。
7、降血脂及抗实验性动脉粥样硬化作用
据江苏新医学院的研究资料,当归粉1.5g/kg对大鼠及家兔实验性高血脂症有降低血脂作用,其降血脂作用不是由于阻碍胆固醇的吸收所致。含5%当归粉的食物及相当于此量的当归油及其它提取物,对实验性动脉硬化大白鼠的主动脉病变有一定保护作用。沈阳军区总医院的报道表明复方当归注射液(当归、川芎、红花)能增强麻醉犬及离体兔心冠脉流量、预防垂体后叶素引起的T波增高及对抗其所致心率减慢,降低实验性高脂血兔甘油三酯。还能明显增高冠心病及脑动脉硬化病人纤维蛋白溶酶活性。
8、对血液系统的作用
当归一直被中医视为补血要药,用于贫血的治疗。曾有人认为,当归的补血作用可能与含维生素B12有关。也有研究表明,单味当归并不能显著地促进失血性贫血动物红细胞和血色素的恢复。
9、抑制血小板聚集作用。1980年尹钟沫等报告了当归及其成分阿魏酸时大鼠血小板聚集性和5一hT释放的影响。结果表明,当归水剂在试管内当浓度为200-500mg/ml,阿魏酸0.4-0.6mg/ml时抑制ADP和胶原诱导的大鼠血小板聚集。抑制率为38-88%,比阿斯匹要(36%)强。1992年宋芝娟等对当归抑制血小板聚集的机理作了进一步的报道,将猪血小板膜与20umol/Lv32p一ATP及不同含量的当归注射液(当归浸出液的灭菌水溶液,含当归5%)37℃反应5分钟,或完成整猪血小板与32pi及不同含量的当归注射液30℃孵育2h,32p标记的磷脂酰肌醇4-单磷酸通过薄层层析法分高,放射自显影响定位,液体内烁计数定量。结果表明,当归注射液可强烈抑制猪血小板膜磷脂酰肌醇磷酸化,并对32pi掺入完整血小板磷脂酰肌醇-4-单磷酸有抑制作用。推测当归能通过下面途径发挥其药理作用:当归注射液中的有效成分进入细胞后,通过抑制PI激酶的活性从而抑制PI向PIP的转化。PIP生成的减少导致PIP2生成亦减少,最后导致IP3、DG等第二信使的减少,从而抑制血小板聚集。寺泽等用血纤维蛋白质平板法观察证实,当归有轻度促进线溶作用。小管等观察证实,当归热水提取物中的乙酸乙酯可溶部分能显著地延长血凝时间。鸟居泵等发现当归热水提取物能阻止胶原诱发的血小板聚集,此抑制物质已知为腺苷。清水等查明当归提取物中的藁本内酯有抑制胶原诱发和血小板聚集活性。综上所述,当归抑制血小板聚集是多种活性成分的综合效果。
10、抗氧化和清除自由基的作用
当归对脑缺氧、缺血后再灌注脑组织脂质过氧化物增高有明显的抑制作用。所含的阿魏酸有直接减少H2O2含量,并与膜磷脂酰乙醇胺结合,通过直接消除自由基,抑制氧化反应和自由基反应等拮抗自由基对组织的损害。2、抗血栓作用
11、对造血系统的影响
早期的报道表明,当归水浸液给小鼠po能显著促进血红蛋白及红细胞的生成。其抗贫血作用可能与所含的维生素B12、烟酸、亚叶酸及生物素、叶酸等成分有关。较近的研究表明,阿魏酸钠有抗O2及H2O对红细胞的氧化作用,使膜脂质过氧化产物MDA减少,可明显降低由MDA引起的溶血作用。在阿魏酸钠存在下,镰刀型贫血患者红细胞脂质过氧化物MDA随阿魏酸钠浓度增加而减少,阿魏酸钠可明显降低补体溶血,抑制补体3b(C3b)与红细胞膜的结合;对补体激活及红细胞变性无影响。当归是中医补血、活血要药。实验研究证明,当归多糖能增加外周血红细胞、白细胞、血红蛋白及骨髓有核细胞数,这种作用特别是在外周血细胞减少和骨髓受到抑制时尤为明显。
当归多糖可能是当归中促进造血的有效成分之一。当归补血作用机理之一可能与当归多糖刺激CFU-S、造血祖细胞增殖、分化有关。1985年周京滋等观察了当归去挥发油后制成20%及40%(g/ml)的水浸出液对小鼠急性大失血后引起血虚的补血作用。结果显示,ig当归水浸液的血虚小鼠的血红蛋白(Hb)和红细胞(RBC)值均有明显增高,说明当归有极显著的生血作用。
抗炎作用:当归的抗炎作用机理主要涉及:
(1)、降低毛细血管通透性;
(2)、抑制PGE2的合成或释放。
此外,降低豚鼠补体旁路的溶血活性,也可能是其抗炎机制之一。
(16)神经系统抑制作用
当归对中枢神经系统的抑制作用早有报道。日本学者报道日本太和当归(An-gelicaacutilobaKitagalia)挥发油有镇静、催眠、镇痛、麻醉等作用。
在环境温度保持25-28℃时,藁本内酯98mg/kg、196mg/kg可显著缩短小鼠应用戊巴比妥钠35mg/kg的入睡时间(以翻正反射消失作为入睡指标)及显著延长睡眠作用的维持时间(以翻正反恢复并爬动两步为转醒指示)。
(17)抗菌作用
当归对体外痢疾、伤寒、副伤寒、大肠杆菌、白喉杆菌、霍乱弧菌及a、B溶血性链球菌等均有抗菌作用。Po该品可减少小鼠毛细血管通透性。外用能加速兔耳创面愈合,使局部充血、白细胞和纤维浸润,新生上皮再生,对局部组织有止血和加强末梢循环作用。说明当归有抗菌、消炎作用。临床可用于化脓性上颌窦炎、急性肾炎、骼静脉炎、硬皮病及牛皮癣等病症。当归热水提取物对慢性风湿性病实验动物模型在其佐剂关节炎急性发作时有明显的抑制作用。
临床应用
1.治疗慢性气管炎
以5%当归液注入膻中、肺俞、定喘、孔最等穴。每次
每穴注入0.5-1毫升。针刺入(深约1.5厘米左右)后,用摇动针管及轻度提插的手法,使针下产生酸胀感觉,然后缓缓注入药液。治疗50岁以上的患者93例,结果痊愈5例,显著好转26例,好转52例,无效10例,总有效率为89.3%。
2.治疗肌肉、关节疼痛及神经痛
采用当归液穴位注射,治疗腰肌劳损、肌肉风湿、四肢关节捩伤、关节炎,及各种神经痛(坐骨神经痛、胁间神经痛、枕神经痛等),有较好效果。据1000例各种原因引起的肌肉、关节、神经、血管组织病症的治疗结果,有效率达89.1%,其中治愈者381例,好转510例。又据50例枕神经痛的观察,经1-15次治疗后,33例获愈,其余亦均有不同程度的好转。绝大部分病例于首次注射后1-3分钟即基本止痛或明显减轻,止痛效果可维持2-8小时,再注射时仍有效。实践证明,当归穴位注射,不仅止痛效果显著,而且具有松弛肌肉,降低软组织的炎症性反应,及改善末梢神经和血管功能等作用。用法:用5-10%当归液循经取穴或痛点、敏感点,或腱鞘内注射。每次选择1-4点,每点注入1-5毫升。针刺入肌层,出现酸、胀针感,回抽无血后,推入药液。一般无副作用,但于腱鞘内注射时,则在注射后数小时出现局部肿胀,疼痛剧烈,影响功能活动,无需特殊处理,在1-3日内即可消退,并显出治疗效果。凡因结核、肿瘤引起的腰背痛或四肢关节痛,局部外伤,化脓性病灶以及皮肤病患者,急性损伤局部瘀血、肿胀严重者皆不宜用。孕妇慎用。
3.治疗慢性盆腔炎
用当归组织液行穴位注射。治疗5例,经1-2疗程,患者症状及体征显著改善或消失,腹痛减轻,月经正常,均在治疗后6个月内再次受孕。取穴及用法:穴位分两组,第一组维胞(双)、三阴交(左)、足三里(右);第二组关元透中极、三阴交(右)、足三里(左)。两组穴位交替注射,每日或隔日1次,或每周2次,每次一组。每穴注射药液2-6毫升,6-10次为一疗程。注药前先捻转针头,使其得气,再注入药液。月经期停止治疗。注射后局部酸胀感向下放射。有3例于注药后自觉心跳、发冷,持续5分钟即自行消失,不需处理。
4.治疗月经病
将当归20克,红花10克分别浸于50%酒精50毫升中,48小时后过滤,混匀,加酒精至100毫升。每日3次饭后服,每次3毫升,经期停服。用于治疗月经不调、痛经、子宫发育不全等病54例,服药60-600毫升不等,除7例无进步外,其余均有效果。复查的11例痛经患者中有7例妊娠;16例子宫发育不全患者中有8例妊娠(大多与性激素合并治疗);月经异常的26例中有6例妊娠。
5.治疗高血压病
用20%复方当归注射液(当归、红花、川芎等量)2毫升加入10%葡萄糖液2毫升内,或75%复方当归注射液1毫升加10%葡萄糖液3毫升,于两侧曲池及足三里交替注射,每穴2毫升,10次为一疗程。一般用4个疗程。第一疗程每日1次,第二疗程隔日1次,第三疗程每周2次,第四疗程隔日1次。注射时采用5号针头,刺入穴位后,待患者有酸麻胀感时,再缓缓注入药液。初步观察7例,用药后均有不同程度的血压下降,其中收缩压下降16-56毫米汞柱,舒张压下降2-30毫米汞柱;头晕、耳鸣、眼花、
失眠等症状也有改善或消失,个别病例还显示出心率减慢的作用。
6.治疗带状疱疹
将当归研粉,依年龄大小每服0.5或1克,4-6小时1次。治疗儿童带状疱疹54例,服药后1天止痛的22例;2天止痛的32例。带状疱疹一般在服药后第3天有部分枯萎,未再发生新疹,第4天结痂。又有用0.5克当归浸膏片内服,每次2-4片,4小时1次,治疗成人患者23例,亦取得相似效果。
7.治疗鼻炎
用5%当归液于迎香(双)、印堂穴行穴位注射,每穴0.3-0.5毫升。每天1次,5天1疗程。一般一个疗程即可见效,通常作2个疗程。药液注入后,局部有轻度疼痛及酸麻感,无其它不良反应。治疗慢性单纯性、肥厚性、过敏性鼻炎和副鼻窦炎等共120例,治愈73例(60.8%),有效45例(37.5%),无效2例(1.7%)。实践证明,当归液穴位注射具有消炎消肿、止痛、抗过敏、止血及调节鼻腔植物神经功能等作用,对消除鼻因性头痛有特效。病程越短,疗效越好。
白术:味苦,甘,性温。归脾、胃经。味苦。温主风寒湿痹死肌,痉疸,止汗,除热,消食,作煎饵。久服轻身延年,不饥。《长沙药解》:味甘、微苦,入足阳明胃、足太阴脾经。补中燥湿,止渴生津,最益脾精,大养胃气,降浊阴而进饮食,善止呕吐,升清阳而消水谷,能医泄利。健脾益气,燥湿利水,止汗,安胎。用于脾虚食少,腹胀泄泻,痰饮眩悸,水肿,自汗,胎动不安。土白术健脾,和胃,安胎。用于脾虚食少,泄泻便溏,胎动不安。具有明显而持久的利尿作用。白术不仅增加水的排泄,也促进电解质特别是钠的排出,并且钠的排泄还胜于水的排泄。它也不影响垂体后叶激素的抗利尿作用,因此白术增加水的排泄可能主要不是影响水的主动性重吸收,而是续发于电解质重吸收的减少,既有汞撒利样排泄氯、钠的作用;又有增高尿中二氧化碳容量、pH值以及增加钾排泄,减少铵排泄的醋唑磺胺样的特点。实验表明白术尚具降血糖作用,防止四氯化碳引起的肝糖元减少作用。白术挥发油中之中性油对食管癌细胞有明显抑制作用。白术挥发油50~100mg/kg腹腔注射对艾氏腹水癌有显着抑制作用。白术对MethA肿瘤的中如活性比对照组明显增加,并显着增强MethA肿瘤的迟发性超敏反应,还促进植物血细胞凝集素-P和脂多糖诱导的幼若化反应。对胃肠平滑肌的作用:过去报道,白术对胃肠道功能(如胃酸的胃液分泌,推进性肠蠕动等)无影响,亦无抗溃疡、抗炎和镇痛作用,不影响正常体温,对中枢神经系统无明显抑制作用,后者被认为可以作为与苍术相区别的依据。白术能增强兔离体小肠自发性收缩活动,使其收缩幅度加大,白术油抑制肠管的自发运动。白术能明显促进小肠蛋白质的合成。白术提取物50mg和200mg/kg灌胃给药,对动物水浸束缚应激性溃疡,有显着抑制效果。水浸液在试管内对絮状表皮癣菌、星形奴卡氏菌有抑制作用。煎剂对脑膜炎球菌亦有抑制作用。近报道白术煎剂和四君子汤对伤寒杆菌、甲型副伤寒杆菌、福氏痢疾杆菌、大肠杆菌、绿脓杆菌等均有不同程度的抑菌作用,而无杀菌作用。白术能促进小鼠骨髓红系造血祖细胞(CFU-E)的生长。对于用化学疗法或放射疗法引起的白血球下降,有使其升高的作用。明显促进小鼠小肠蛋白质的合成。白术对呼吸有短暂的兴奋作用,另外白术对家兔、肠鼠、大鼠和小鼠的子宫平滑肌有明显抑制作用,白术煎剂对小鼠因四氧化碳引起的肝损伤有保护作用。白术乙酸乙酯提取物,大白鼠十二指肠给药,可明显增加胆汁分泌。少量挥发油有镇静作用。
黄芪:甘,微温。归肺、脾、肝、肾经。黄芪是百姓经常食用的纯天然品,民间流传着“常喝黄芪汤,防病保健康”的俗语,意思是说经常用黄芪煎汤或泡水代茶饮,具有良好的防病保健作用。黄芪和人参均属补气良药,人参偏重于大补元气,回阳救逆,常用于虚脱、休克等急症。而黄芪则以补虚为主,常用于体衰日久、言语低弱、脉细无力者。现代医学研究表明,黄芪有增强机体免疫功能、保肝、利尿、抗衰老、抗应激、降压和较广泛的抗菌作用。能消除实验性肾炎蛋白尿,增强心肌收缩力,调节血糖含量。黄芪不仅能扩张冠状动脉,改善心肌供血,提高免疫功能,而且能够延缓细胞衰老的进程。黄芪食用方便,可煎汤,煎膏,浸酒,入菜肴等。现代药理研究发现黄芪有效成分主要有:皂苷类、黄酮类、氨基酸类、多糖类、硒、硅、锌、钴、铜、钼等多种微量元素、还包括香豆素、生物碱、蛋白质、维生素、叶酸、苦味酸、胆碱、香菜碱、亚油酸、β-谷甾醇等多种化学成分。黄芪可以提高人体免疫力且具有双向调节作用:人体免疫功能过低时可以使其恢复,过高时又可以使其抑制,使机体病理状态恢复到生理平衡状态。黄芪能促进病毒诱生和自身诱生干扰素的能力, 其抗病毒作用广谱,对水疱性口腔炎病毒、辛德毕斯病毒、流感病毒、柯萨奇病毒均有明显的对抗作用。黄芪具有显著的抗氧化活性,能抑制自由基的产生和清除体内过剩的自由基,保护细胞免受自由基产生的过度氧化作用的影响,进而延长细胞寿命。黄芪是中医治疗糖尿病的常用药,在常用的中医治疗糖尿病的处方中黄芪使用频率最高。黄芪多糖可通过改善肝脏的内质网应激来减轻内质网损伤,增加糖原合成酶活性,增加胰岛素信号蛋白合成量和活性,从而发挥抗糖尿病作用。黄芪具有促进胰岛B细胞分泌胰岛素的作用,适用于2型糖尿病的治疗。黄芪可双向调节免疫功能,促进蛋白质合成,减少蛋白质漏出,通过扩张血管、降低血压增加肾血流量,降低血小板黏附率,改善微循环,调节肾小球滤过膜,减少蛋白尿渗出,减轻或延缓糖尿病性肾病的进展。黄芪皂苷是黄芪正性肌力作用的主要活性成分,不但对正常和心功能受抑制大鼠左室表现正性肌力作用,且对收缩和舒张功能均有改善作用,而不增加心肌耗氧量。黄芪对血压具双向调节作用,黄芪能利尿降压,降低肺动脉压及右心室的前负荷,扩张周围血管,改善微循环,降低动脉压,同时还对冠状动脉有直接扩张作用。可能机制是血管平滑肌细胞诱导一氧化氮合成酶(NOS)的生成,增加NO的生成,继而激活血管内皮细胞一氧化氮-鸟苷酸环化酶途径,引起血管扩张。黄芪能抑制血管平滑肌细胞的增殖,减少成纤维细胞的胶原合成,改善受损的血管内皮细胞功能。黄芪有增强心肌细胞抗病毒能力的作用,除与药物诱导心肌细胞产生干扰素及促诱生干扰素的作用外,也与药物促进细胞代谢有关。早期使用黄芪对急性柯萨奇病毒B3所致的病毒性心肌炎有一定的防治作用。黄芪对感染病毒心肌的保护作用与其具有钙拮抗有关。早期使用药物既可改善感染细胞的钙平衡,减轻钙对细胞的继发损伤,又可抑制感染细胞的病毒核酸复制,减轻病毒对心肌的直接损伤。黄芪对造血功能有保护和促进作用,对血细胞数下降也有明显的回升作用。黄芪通过抑制磷酸二酯酶活性,增加血小板cAMP含量,发挥抑制血小板聚集作用。
研究发现,肿瘤化疗前应用注射用黄芪多糖,可达以下功效:(1)有效提高外周血白细胞计数,使外周血白细胞总数化疗时高于对照组,使患者能安全度过化疗期;(2)保护骨髓,减少化疗药物对造血细胞损伤及抑制作用,减少及减轻骨髓抑制的发生;(3)随着疗程的增加,保护骨髓的作用越来越明显;(4)提高外周血白细胞计数温和且持久。用芪枣冲剂治疗白细胞减少症,总有效率达80%。黄芪有降低血液黏稠度的作用,对治疗和预防心血管疾病有良好的作用。肾脏疾病黄芪治疗慢性肾衰竭所致贫血,与肾促红细胞生成素分泌减少或尿毒症患者血浆中一些毒性物质干扰红细胞生成及体内代谢产物潴留影响红细胞寿命等因素有关黄芪对肾衰竭有阻抑作用,对缺血性的肾脏有保护作用。因其具有抗氧化、清除自由基、促进细胞代谢、利尿消肿、减少尿白蛋白排泄、促肝脏合成白蛋白、降脂、调节免疫、降血压等作用故可以保护肾脏细胞免受损害。大量的实验研究表明黄芪具有抗癌作用。黄芪有对抗毒素B1诱发癌变的作用,可增强环磷酰胺(CTX)的抗癌活性,并促进因CTX所致机体造血功能及免疫功能的恢复。黄芪多糖能增强网状内皮系统的吞噬功能促进抗体形成,促进T淋巴细胞转化,增强NK细胞的细胞毒活性,从而增强机体免疫力。黄芪注射液配合化疗可减轻化疗药物对机体各种功能细胞的杀伤作用,提高肿瘤患者细胞的免疫功能。黄芪中富含的皂苷、多糖、异黄酮类化合物、多种氨基酸及硒元素等能降低顺铂等化疗药物的肾毒性。黄芪富含硒,硒能抑制癌细胞的氧化磷酸化,刺激免疫球蛋白及抗体的产生,增强SOD的活性,并对各种金属如镉、汞等化学致癌物有拮抗作用。黄芪可扩张脑血管增加脑血流量,尤其是改善脑微循环,降低血液黏稠度、降低血小板聚集力,增强红细胞变形能力,清除自由基抗氧化,增强脑细胞耐缺氧能力,调节机体免疫功能。调节血压和利尿降低脑水肿等,使脑细胞得到保护,并增强了受损脑细胞的修复功能。黄芪常与党参合用。黄芪专于气分而达肌表,党参益气生血长于止泻,一表一里,相互为用,其扶正补气之功更加显著,临床上常用来治疗各种气虚之证。据报道,黄芪与四物汤合用可治疗治疗周围白细胞数过低,症见面色萎黄,四肢倦怠,气短乏力,食欲不振,舌淡苔白,脉沉弱无力等,可使白细胞总数恢复至正常,症状消失或者改善。配伍山药可用于降低血糖,促进尿糖转阴。因为黄芪补气升阳实腠理,山药补脾养肺固肾精。二者一阴一阳,相互促进,相互转化,益气生津,健脾补肾,敛脾精,止漏浊,达到治标固本的作用。
慢性肾小球肾炎患者多表现为表虚,易感冒,从而加重病情,用玉屏风散补气固表,可预防感冒,减少复发。对艾滋病的中药治剂也大都应用该药而收到明显效果。肿瘤患者中医药治疗中使用黄芪后,症状显著好转,可延长存活时间。由此可见,黄芪的确是一味防衰抗老,济弱扶倾的很有前途的中药。
干姜:归脾、胃、肾、心、肺经。用于脘腹冷痛,呕吐泄泻,肢冷脉微,寒饮喘咳。干姜,能引血药入血分、气药入气分。又能去恶养新,有阳生阴长之意,故血虚者用之。凡人吐血、衄血、下血,有阴无阳者,亦宜用之,乃热因热用,从治之法也。《本草经疏》:炮姜,辛可散邪理结,温可除寒通气,故主胸满咳逆上气,温中出汗,逐风湿痹,下痢因于寒冷,止腹痛。其言止血者,盖血虚则发热,热则血妄行,干姜炒黑,能引诸补血药入阴分,血得补则阴生而热退,血不妄行矣。治肠僻,亦其义也。《本经》:主胸满咳逆上气,温中,止血,出汗,逐风湿痹,肠僻下痢,生者尤良。
白术:味苦,甘,性温。归脾、胃经。味苦。温主风寒湿痹死肌,痉疸,止汗,除热,消食,作煎饵。久服轻身延年,不饥。《长沙药解》:味甘、微苦,入足阳明胃、足太阴脾经。补中燥湿,止渴生津,最益脾精,大养胃气,降浊阴而进饮食,善止呕吐,升清阳而消水谷,能医泄利。健脾益气,燥湿利水,止汗,安胎。用于脾虚食少,腹胀泄泻,痰饮眩悸,水肿,自汗,胎动不安。土白术健脾,和胃,安胎。用于脾虚食少,泄泻便溏,胎动不安。具有明显而持久的利尿作用。白术不仅增加水的排泄,也促进电解质特别是钠的排出,并且钠的排泄还胜于水的排泄。它也不影响垂体后叶激素的抗利尿作用,因此白术增加水的排泄可能主要不是影响水的主动性重吸收,而是续发于电解质重吸收的减少,既有汞撒利样排泄氯、钠的作用;又有增高尿中二氧化碳容量、pH值以及增加钾排泄,减少铵排泄的醋唑磺胺样的特点。实验表明白术尚具降血糖作用,防止四氯化碳引起的肝糖元减少作用。白术挥发油中之中性油对食管癌细胞有明显抑制作用。白术挥发油50~100mg/kg腹腔注射对艾氏腹水癌有显着抑制作用。白术对MethA肿瘤的中如活性比对照组明显增加,并显着增强MethA肿瘤的迟发性超敏反应,还促进植物血细胞凝集素-P和脂多糖诱导的幼若化反应。对胃肠平滑肌的作用:过去报道,白术对胃肠道功能(如胃酸的胃液分泌,推进性肠蠕动等)无影响,亦无抗溃疡、抗炎和镇痛作用,不影响正常体温,对中枢神经系统无明显抑制作用,后者被认为可以作为与苍术相区别的依据。白术能增强兔离体小肠自发性收缩活动,使其收缩幅度加大,白术油抑制肠管的自发运动。白术能明显促进小肠蛋白质的合成。白术提取物50mg和200mg/kg灌胃给药,对动物水浸束缚应激性溃疡,有显着抑制效果。水浸液在试管内对絮状表皮癣菌、星形奴卡氏菌有抑制作用。煎剂对脑膜炎球菌亦有抑制作用。近报道白术煎剂和四君子汤对伤寒杆菌、甲型副伤寒杆菌、福氏痢疾杆菌、大肠杆菌、绿脓杆菌等均有不同程度的抑菌作用,而无杀菌作用。白术能促进小鼠骨髓红系造血祖细胞(CFU-E)的生长。对于用化学疗法或放射疗法引起的白血球下降,有使其升高的作用。明显促进小鼠小肠蛋白质的合成。白术对呼吸有短暂的兴奋作用,另外白术对家兔、肠鼠、大鼠和小鼠的子宫平滑肌有明显抑制作用,白术煎剂对小鼠因四氧化碳引起的肝损伤有保护作用。白术乙酸乙酯提取物,大白鼠十二指肠给药,可明显增加胆汁分泌。少量挥发油有镇静作用。
胎盘:母体孕育胎儿时候,胎盘是负责母体和胎儿血液和养分交换的组织,能够产生非常多活性物质。据《本草纲目》记载:胎盘,母体腹中的胎儿的包衣,“性味甘温,具有益气补虚,温中暖下,调补肾虚、羸瘦之功效……”。科学家经过大量实验证实,胎盘还具有养血安神、丰肌泽肤、延年益寿等功效,是大补元气的滋补强壮药。人胎盘又称紫河车,其神奇功效越来越被人们了解并接受。猪牛羊等动物都是国人畜牧食品、生物医药之一,草食动物胎盘较人胎盘更为洁净,是养阴补血的药食佳品。动物胎盘的营养组成与人类胎盘基本一致,营养结构是自然界中最接近人类胎盘的组织,其合理的自然结构特别丰富的营养成分,其中含有丰富的蛋白质、17种氨基酸、14种微量元素、磷脂、脂多糖、维生素,还有与免疫功能和机体正常运转相关的多种活性多肽,其营养成分天然搭配的比例最接近人体的需求。另一重要原因是,动物胎盘不会感染人类肝炎等病毒,不会与人类产生交叉感染。可能带有这种病毒其他动物胎盘(包括人胎盘)则应尽量避免,在大批量生产中,只要有一只胎盘带有病毒,产品的危害是可想而知的,而使用动物胎盘,相对要安全得多。
本发明采用动物胎盘,突破了人生物安全问题、伦理问题、资源受限等诸多现实问题。将胎盘经特殊的酶切工艺制成胎盘短肽则大大增强了胎盘的提升机体免疫能力、自身修复能力功效。
白芷:白芷色白味辛,归肺,脾,胃经。白芷气温无毒,其香气烈,亦芳草也,上行头目,下抵肠胃,中达肢体,遍通肌肤以至毛窍,而利泄邪气。白芷气温力厚,通窍行表,性温气厚,行手阳明,芳香上达,入手太阴肺经,为阳明主药风热者辛以散之,湿热者温以除之。解砒毒,蛇伤,鼻衄、刀箭金疮。亦可作香料。白芷的芳香气能矫胎盘不良味,改善口感,利于服用,增加依从性,其独特的药理作用增加了处方提升患者免疫和机体修复功能的效果。甘草,根和根状茎供药用,是一种补益中草药,气微,味甜而特殊,能调和某些药物的烈性。如调味承气汤用本品缓和大黄、芒硝的泻下作用及其对胃肠道的刺激;甘草所含的次酸能阻断致癌物诱发肿瘤生长的作用。
金银花:金银花又名忍冬,尚有“银花”、“双花”、“二花”、“二宝花”、“双宝花”等美名。性寒,味甘,入肺、心、胃经,具有清热解毒、抗炎、补虚疗风的功效,主治胀满下疾、温病发热,热毒痈疡和肿瘤等症。
金银花对畜禽的多种至病的病菌、病毒有抑制作用。金银花自古被誉为清热解毒的良药。它性甘寒气芳香,甘寒清热而不伤胃,芳香透达又可祛邪。金银花既能宣散风热,还善清解血毒,用于各种热性病等症,均效果显著。
金银花自古以来就以它的药用价值广泛而著名。其功效主要是清热解毒,主治温病发热、热毒血痢、痈疽疔毒等。现代研究证明,金银花含有绿原酸、木犀草素苷等药理活性成分,对溶血性链球菌、金黄葡萄球菌等多种致病菌及上呼吸道感染致病病毒等有较强的抑制力,另外还可增强免疫力、抗早孕、护肝、抗肿瘤、消炎、解热、止血(凝血)、抑制肠道吸收胆固醇等,其临床用途非常广泛,可与其它药物配伍用于治疗呼吸道感染、菌痢、急性泌尿系统感染、高血压等40余种病症。
金银花含有的绿原酸虽具有致敏原作用,可引起变态反应,但口服无此反应,因绿原酸可为小肠分泌物转化为无致敏活性的物质。研究表明金银花具有如下作用。
1、抗病原微生物作用:体外实验表明,花和藤对多种致病菌如金黄色葡萄球菌、溶血性链球菌、大肠杆菌、痢疾杆菌、霍乱弧菌、伤寒杆菌、副伤寒杆菌等均有一定抑制作用,对肺炎球菌、脑膜炎双球菌、绿脓杆菌、结核杆菌亦有效。水浸剂比煎剂作用强,叶煎剂比花煎剂作用强。若和连翘合用,抗菌范围还可互补;与青霉素合用,能加强青霉素对耐药金黄色葡萄球菌的抗菌作用,这可能是在抑制细菌体内蛋白质合成上有协同的作用。
2、抗炎和解热作用:腹腔注射金银花提取液0.25g/kg,能抑制大鼠角叉菜胶性脚肿。另有报道金银花注射液30~40g/kg能减轻蛋清性脚肿程度。腹腔注射金银花提取液8g/kg,2次/天,连续6天,对大鼠巴豆油性肉芽囊,也有明显抗渗出和抗增生的作用。早期报道金银花具有明显的解热作用,但用霍乱菌苗、马铃薯杆菌、枯草浸液等给家兔耳静脉注射,致热,未证实金银花煎剂5g/kg灌胃有退热作用,认为这可能和使用的金银花制剂、剂量或家兔的耐受性不同有关。
3、加强免疫机能作用:金银花煎剂稀释至1:1280的浓度,仍能促进白细胞的吞噬功能。小鼠腹腔注射金银花注射液,也有明显促进炎性细胞吞噬功能的作用。
4、中枢兴奋作用:经电休克、转笼等多种实验方法证明口服绿原酸后,可引起大鼠、小鼠等动物中枢神经系统兴奋,其作用强度为咖啡因的1/6,二者合用无相加及增强作用。
5、降血脂作用:大鼠灌胃金银花2.5g/kg能减少肠内胆固醇吸收,降低血浆中胆固醇含量。体外实验也发现金银花可和胆固醇相结合,但四妙勇安汤(金银花、玄参、当归、甘草)治疗家兔实验性动脉粥样硬化。未观察到有降血脂和主动脉壁胆固醇含量的作用。
6、抗内毒素:用鲎试验法测定内毒素含量,300%金银花(忍冬)注射液以1:2~1:64稀释,体外试验无论用凹片法或试管法,均明显降低试液中的内毒素含量,其中1:2~1:8的稀释管与阴性对照管一样呈液态,阳性对照呈凝胶状。金银花(忍冬)蒸馏液6g/kg静脉注射,对绿脓杆菌内毒互2.8mg/kg静脉注射引起的兔体温下降及白细胞数下降有对抗作用,金银花(忍冬)蒸馏液7.5g/kg或注射液2.5g/kg腹腔注射,对绿脓杆菌内毒素65mg/kg腹腔注射的小鼠有保护作用,减少小鼠死亡率。
7、其它作用:曾有体外筛选实验报告金银花的水及酒浸液对肉瘤180及艾氏腹水癌有明显的细胞毒作用。金银花提取物口服对大鼠实验性胃溃疡有轻度预防效果。口服大剂量绿原酸能增加胃肠蠕动,促进胃液及胆汁分泌。绿原酸及其分解产物对大鼠离体子宫有兴奋作用。此外,绿原酸还能轻微增强肾上腺素及其去甲肾上腺素对猫和大鼠的升压作用,但对猫的瞬膜反应无影响。
甘草:别名:国老、甜草、乌拉尔甘草、甜根子。豆科、甘草属多年生草本,根与根状茎粗壮,根和根状茎供药用,是一种补益中草药。气微,味甜而特殊。清热解毒、祛痰止咳、脘腹等。在临床上甘草主要用于心气虚,心悸怔忡,脉结代,以及脾胃气虚,倦怠乏力等;痈疽疮疡、咽喉肿痛等。可单用,内服或外敷,或配伍应用。痈疽疮疡,常与金银花、连翘等同用,共奏清热解毒之功,如仙方活命饮。咽喉肿痛,常与桔梗同用,如桔梗汤。若农药、食物中毒,常配绿豆或与防风水煎服;气喘咳嗽。可单用,亦可配伍其他药物应用。如治湿痰咳嗽的二陈汤;治寒痰咳喘的苓甘五味姜辛汤;治燥痰咳嗽的桑杏汤;治热毒而致肺痈咳唾腥臭脓痰的桔梗汤;治咳唾涎沫的甘草干姜汤等。另风热咳嗽、风寒咳嗽、热痰咳嗽亦常配伍应用;胃痛、腹痛及腓肠肌挛急疼痛等,能显著增强治挛急疼痛的疗效;调和某些药物的烈性。如调味承气汤用本品缓和大黄、芒硝的泻下作用及其对胃肠道的刺激。另外,在许多处方中也常用本品调和诸药;甘草有类似肾上腺皮质激素样作用。对组胺引起的胃酸分泌过多有抑制作用;并有抗酸和缓解胃肠平滑肌痉挛作用;甘草黄酮、甘草浸膏及甘草次酸均有明显的镇咳作用;祛痰作用也较显著,其作用强度为甘草酸>甘草黄酮>甘草浸膏;抗炎,抗过敏作用,能保护发炎的咽喉和气管粘膜。甘草浸膏和甘草酸对某些毒物有类似葡萄糖醛酸的解毒作用;治疗随更年期而来的症状.因为甘草里含有甘草素,是一种类似激素的化合物,它有助于平衡女性体内的激素含量;甘草所含的次酸能阻断致癌物诱发肿瘤生长的作用。
甘草含有多种化学成分,主要成分有甘草酸、甘草甙等。甘草的化学组成极为复杂,目前为止从甘草中分离出的化合物有甘草甜素、甘草次酸、甘草甙、异甘草甙、新甘草甙、新异甘草甙、甘草素、异甘草素以及甘草西定、甘草醇、异甘草醇、7-甲基香豆精、伞形花内酯等数十种化合物,但这些成分和数量通常会随甘草的种类、种植区域、采收时间等因素的不同而异。大量的研究表明,甘草甜素和黄酮类物质是甘草中最重要的生理活性物质,主要存在于甘草根表皮以内的部分。
本发明采用甘草能调和某些药物的烈性。如调味承气汤用本品缓和大黄、芒硝的泻下作用及其对胃肠道的刺激;金银花增强机体免疫,增强机体抗病毒功能;姜具有的温中和胃,缓和诸腥臭味药材的不良腥味对人体的不良刺激等作用。所以本发明用甘草、金银花、姜,调和胎盘强烈的腥臭味对人的味觉、及胃肠的不良刺激,同时经体外的特殊处理,及服用后通过增强机体的免疫功能等一系列的生理生化过程,减少胎盘等其他药材中对人体不利的毒副作用,增加本制剂的疗效和用药的安全性。
胡萝卜:营养丰富的家常蔬菜,素有“小人参”之称。胡萝卜富含糖类、脂肪、胡萝卜素、维生素A、维生素B1、维生素B2、花青素、钙、铁等营养成分,其具有的温中和胃,缓和诸腥臭味药材的不良腥味对人体的不良刺激等作用。
本发明的有益效果为:
肺部疾病,主要包括肺纤维化、间质性、阻塞性肺病及肺癌等;所述呼吸系统疾病除前述肺部疾病外尚有鼻咽癌、喉癌等疾患。如果说肺癌除小细胞肺癌外,非小细胞肺癌尚有抗癌药、鼻咽癌、喉癌也算有抗癌药可用的话,而肺纤维化、间质性、阻塞性肺病则是无药可医,无药可治,是至今仍围绕医药学领域专家学者,緾缚医患双方的一大难题,为解决诸如此类前述难题,本发明就是应运而生。本发明不但通过中医中药气血、经络理论及相关理论调理病患者的气机,为患者赢得修复机体的时机,还通过胎盘短肽,在提升患者的免疫能力和自身修复能力,这也契合了当前新型冠状病毒肺炎中医中药治疗的理念,不但如此,本发明在提升患者的免疫能力与机体自身修复能力的同时,同时提供给患者各种营养要素、合理的营养,进而帮助患者最终战胜病魔,使患者健康得以恢复,获得高质量的生活。
本发明通过提升患者的免疫和自身修复能力,使疾病和各种治疗手段对患者造成的损害,及疾病本身获得疗愈。而且本发明提供的用于肺纤维化、间质性、阻塞性肺病及肺癌等呼吸系统疾病的生物医药及医用全营养食品,组方合理、疗效好,在服药期间对患者无限制性要求,不影响患者的正常工作与生活。
具体实施方式
实施例1:用于肺及等呼吸系统疾病的生物医药的制备
按以下重量份配比称取各原料备用:
太子参7份,冬虫夏草(或其人工培养品)5份,藿香叶19份,当归11份,杏仁10份 ,山药19份,泽泻25份,山茱萸16份,黄芪21份,甘草23份,金银花25份,姜29份,白术13份,胡萝卜39份,白芷13份,芦根29份,百合19份,胎盘15份。
(1)提油 取金银花、霍香叶、姜、白芷、当归、泽泻放入容器内,加水6倍重量,浸泡40~70分钟,水蒸气蒸馏2.5~3.5h,得到油水混合物,再对油水混合物进行分离,分离得到挥发油;以10倍重量β-环糊精包合挥发油,在60±5℃包合2小时,得到包合物;对蒸馏后的剩余物料进行液固分离,得到药渣和药液;
(2)提脂 将步骤(1)的药渣与杏仁、山茱萸、另包的拣净的胎盘用乙醇回流提取2次,第一次加10倍重量的浓度为60%-85%乙醇,回流提取1.5-2.5小时,过滤后的药渣再加8倍重量的浓度为60%-85%乙醇,回流提取1.5-2.5小时,合并两次提取液,并在负压状态下回收乙醇,直至提取液无醇味得到含脂溶性物质的液体;对回流后的剩余物料在负压状态下回收残留乙醇,直至无醇味,进行液固分离,得到药渣和药液;
(3)煎提 取太子参、黄芪,甘草,白术,胡萝卜,芦根,百合,另包的拣净的山药放入容器内,与步骤(2)的药渣、另包的拣净的胎盘混合,加水浸泡后,煎煮2次,每次各40~70分钟,第一次加8倍重量水浸泡,第二次加6倍重量水,煎煮前均浸泡40~70分钟,合并两次煎煮、过滤后的药液,以及步骤(1)得到的全部药液,浓缩至相对密度为1.10~1.15后进行低温干燥,收集干燥物备用;
(4)酶切 分取步骤(3)的另包的拣净的胎盘煎煮包,将冬虫夏草或其人工培养品及煎煮后的胎盘,分别充分干燥,经6000-100000转/小时超高速粉碎机将其微粉化;将微粉化后的冬虫夏草或其人工培养品、胎盘微粉,分别浆液化,将浆液化后的胎盘、冬虫夏草或其人工培养品微粉分别酶切,分取酶切获得的分子量≤3000Da的胎盘、冬虫夏草或其人工培养品短肽备用;上述酶切的酶可选自生物医药级食品级复合酶、食品用中性蛋白酶 FDG-2209、食品级中性蛋白酶(高活力浓缩型)FDG-2230、酸性蛋白酶APRL型FDY-2205、酸性蛋白酶APRS型FDG-2237、食品用碱性蛋白酶 FDG-2202、食品级碱性蛋白酶(高活力浓缩型)FDG-2227、碱性蛋白酶FDG-4001 、内切型蛋白酶FDY-2220、内切酶DNaseⅠ、内切酶DNaseⅡ、内切酶BamHI、内切酶phi29及其适宜的一种、两种或两种以上酶混合物;上述酶切的温度为0-69℃,湿度为30-99%,光照强度为0-300Lx,离心搅拌机转速为9-75r/s;酶切时,超声振荡、搅拌或射流等适宜措施行酶切,为提高品质可加适量的磷脂,使分子量≤3000Da的短肽包裹在磷脂脂质体中,方便获得分子量≤3000Da的短肽及短肽脂质体,可大地提升产品品质,使短肽获得更大的生物效应。
(5)取步骤(3)浓缩液干燥物及上述步骤获得的分子量≤3000Da的胎盘、冬虫夏草或其人工培养品短肽混合,再加入步骤(1)的包合物、步骤(2)的含脂溶性物质的液体、步骤(3)另包的拣净去皮的山药的干燥粉碎物,混合均匀后脱水(干燥)使其微粉化,获得含水量≤5%的干燥微粉物。将此干燥微粉物制成固体饮料、或制成粉剂、或微粉剂、或颗粒剂、或散剂、或溶液剂、或混悬剂、或凝胶剂、或片剂、或胶囊剂等各种适宜的应用形式;上述干燥为冷冻干燥、或干燥塔内喷雾干燥,所述冷冻干燥温度则在-10℃以下至-45℃;喷雾干燥,干燥塔内的烘干压力为100~150Pa,干燥塔的进口温度为180±5℃,出口温度为80±5℃。
实施例2
按以下重量份配比称取各原料备用;
太子参15份,冬虫夏草(或其人工培养品)7份,藿香叶29份,当归11份、杏仁13份 ,山药19份,泽泻25份,山茱萸16份,黄芪19份、甘草21份,金银花29份,姜6份、白术8份、胡萝卜29份,白芷9份,芦根21份,百合29份,胎盘13份;
制备方法同实施例1。
实施例3:用于肺及呼吸系统疾病的生物医药的制备
按以下重量份配比称取各原料备用:
太子参29份,冬虫夏草(或其人工培养品)9份、藿香叶27份,当归19份,杏仁15份 ,山药29份,泽泻33份,山茱萸17份,黄芪40份、甘草33份,金银花29份,姜12份、白术18份、胡萝卜39份,白芷29份,芦根35份,百合15,胎盘19份。
其余操作同实施例1。
实施例4:用于肺及呼吸系统疾病的全营养医用食品的制备
按以下重量份配比称取各原料备用:
太子参19份、冬虫夏草(或其人工培养品)7份、藿香叶29份,当归21份,杏仁19份 ,山药39份,泽泻37份,山茱萸13份,黄芪36份、甘草40份,金银花42份,干姜7份、白术9份、胡萝卜29份,白芷19份,胎盘9份,麦芽糊精30份,膳食纤维15份,中链甘油三酯30份,微量元素10份,水溶性维生素15份,脂溶性维生素3份,适宜的调味剂19份。
(1)提油 取金银花、霍香叶、姜、白芷、当归、泽泻放入容器内,加水6倍重量,浸泡40~70分钟,水蒸气蒸馏2.5~3.5h,得到油水混合物,再对油水混合物进行分离,分离得到挥发油;以10倍重量β-环糊精包合挥发油,在60±5℃包合2小时,得到包合物;对蒸馏后的剩余物料进行液固分离,得到药渣和药液;
(2)提脂 将步骤(1)的药渣与杏仁、山茱萸、另包的拣净的胎盘用乙醇回流提取2次,第一次加10倍重量的浓度为60%-85%乙醇,回流提取1.5-2.5小时,过滤后的药渣再加8倍重量的浓度为60%-85%乙醇,回流提取1.5-2.5小时,合并两次提取液,并在负压状态下回收乙醇,直至提取液无醇味得到含脂溶性物质的液体;对回流后的剩余物料在负压状态下回收残留乙醇,直至无醇味,进行液固分离,得到药渣和药液;
(3)煎提 取太子参、黄芪,甘草,白术,胡萝卜,芦根,百合,另包的拣净的山药放入容器内,与步骤(2)的药渣、另包的拣净的胎盘混合,加水浸泡后,煎煮2次,每次各40~70分钟,第一次加8倍重量水浸泡,第二次加6倍重量水,煎煮前均浸泡40~70分钟,合并两次煎煮、过滤后的药液,以及步骤(1)得到的全部药液,浓缩至相对密度为1.10~1.15后进行低温干燥,收集干燥物备用;
(4)酶切 分取步骤(3)的另包的拣净的胎盘煎煮包,将冬虫夏草或其人工培养品及煎煮后的胎盘,分别充分干燥,经6000-100000转/小时超高速粉碎机将其微粉化;将微粉化后的冬虫夏草或其人工培养品、胎盘微粉,分别浆液化,将浆液化后的胎盘、冬虫夏草或其人工培养品微粉分别酶切,分取酶切获得的分子量≤3000Da的胎盘、冬虫夏草或其人工培养品短肽备用;上述酶切的酶可选自生物医药级食品级复合酶、食品用中性蛋白酶 FDG-2209、食品级中性蛋白酶(高活力浓缩型)FDG-2230、酸性蛋白酶APRL型FDY-2205、酸性蛋白酶APRS型FDG-2237、食品用碱性蛋白酶 FDG-2202、食品级碱性蛋白酶(高活力浓缩型)FDG-2227、碱性蛋白酶FDG-4001 、内切型蛋白酶FDY-2220、内切酶DNaseⅠ、内切酶DNaseⅡ、内切酶BamHI、内切酶phi29及其适宜的一种、两种或两种以上酶混合物;上述酶切的温度为0-69℃,湿度为39-99%,光照强度为0-300Lx,离心机转速为9-75r/s;酶切时,适量的磷脂,超声振荡、搅拌或射流等适宜措施行酶切,使分子量≤3000Da的短肽包裹在磷脂脂质体中,方便获得分子量≤3000Da的短肽及短肽脂质体,使短肽发挥更大的生物效应。
(5)取步骤(3)浓缩液干燥物及上述步骤获得的分子量≤3000Da的胎盘、冬虫夏草或其人工培养品短肽混合,再加入步骤(1)的包合物、步骤(2)的含脂溶性物质的液体、肺病型全营养组件(麦芽糊精、膳食纤维、中链甘油三酯、微量元素、水溶性维生素、脂溶性维生素、适宜的调味剂),步骤(3)另包的拣净去皮的山药后干燥粉碎粉,混合均匀后干燥使其微粉化,获得含水量≤5%的干燥微粉物。将此干燥微粉物制成固体饮料、或制成粉剂、或微粉剂、或颗粒剂、或散剂、或溶液剂、或混悬剂、或凝胶剂、或片剂、或胶囊剂等各种适宜的应用形式。上述干燥可为冷冻干燥,或干燥塔内喷雾干燥,冷冻干燥温度则在-10℃以下至-45℃;喷雾干燥,干燥塔内的烘干压力为100~150Pa,干燥塔的进口温度为180±5℃,出口温度为80±5℃。
实施例5:用于肺及呼吸系统疾病的全营养医用食品的制备
按以下重量份配比称取各原料备用:
太子参1份、冬虫夏草(或其人工培养品)7份、藿香叶13份、当归7份,杏仁5份 ,山药19份,泽泻15份,山茱萸5份,黄芪12份、甘草15份,金银花16份,干姜1份、白术3份、胡萝卜19份,白芷0.9份,胎盘1.5份,肺病型全营养组件包括麦芽糊精0.9份,膳食纤维0.5份,中链甘油三酯0.01份,微量元素0.1份,水溶性维生素0.1份,脂溶性维生素0.1份,适宜的调味剂0.9份;
其余操作同实施例4。
实施例6:用于肺及呼吸系统疾病的全营养医用食品的制备
按以下重量份配比称取各原料备用:
太子参30份、冬虫夏草(或其人工培养品)7份、藿香叶19份、当归15份,杏仁17份 ,山药29份,泽泻25份,山茱萸16份,黄芪40份、甘草40份,金银花42份,干姜10份、白术12份、胡萝卜29份,白芷19份,胎盘19份,肺病型全营养组件包括麦芽糊精49份,膳食纤维30份,中链甘油三酯55份,微量元素19份,水溶性维生素27份,脂溶性维生素5份,适宜的调味剂15份;
其余操作同实施例4。
疗效对比分析
以下临床试验本发明的中成药或医用食品治疗自体免疫性与免疫相关性疾病,与传统的治疗方法的疗效、及人胎盘组方疗效对比分析:
一、对肺纤维化的疗愈作用
肺纤维化传统的治疗方法为给予吸氧、激素,抗生素,对自体免疫性与免疫相关性疾病具有一定的缓解作用,是临床上常用于肺纤维化处置的方法之一,因此,选用常规治疗手段作为对照组。在基础治疗上增加服用人胎盘组方作为治疗A组。在基础治疗上增加服用本发明组方作为治疗B组。在“双盲”的条件下对临床主要症状、肺功能、肺纤维化等血清、CT影像学等指标进行观察对比、分析。
1.对象与方法
1.1对象。观察对象225例,均为肝纤维化患者,其中男120例,女105例;年龄45—79岁,平均年龄为55岁。
1.2分组:225例随机分成对照组75例,其中男40例,女35例,年龄45-78岁。治疗A组75例,其中男40例,女35例,年龄46-79岁。治疗B组75例,其中男40例,女35例,年龄45-78岁。三组性别、年龄分布及病情基本一致,三组均接受基础治疗,包括⑴控制性氧气治疗(控制性吸氧);⑵盐酸氨溴索注射液静滴⑶口服乙酰半胱氨酸⑷必要时使用抗生素⑸对症基础治疗;
治疗A组:在基础治疗的基础上,增加服用人胎盘制剂处方组成(金银花20-50份,胎盘10-30份,甘草10-50份,姜0.5-50份,以上重量份原料提取有效物质、粉碎混合后,制成胶囊)。
治疗B组:在基础治疗的基础上,增加服用本发明的制剂,每天3次,每次医用用特殊食品(短肽型)营养制剂粉末10-29克(或胶囊每次3-6粒,每粒胶囊0.5克);治疗A组:在基础治疗的基础上,增加服用人胎盘制剂,每天3次,每次3-6粒(每粒胶囊装药粉0.5克)(或医用食品营养制剂粉末10-30克)。对症治疗一致,疗程3个月,随访半年。
1.3观察项目。(1)症状:咳嗽、喘息(气喘)、胸闷、肺部Velcro啰音、面色气短、痰多(2)肺功能;(3)动脉血气分析:(4)血清免疫指标:血清前白蛋白(PA)、白蛋白(ALB)含量、白蛋白球蛋白比值(A/G);(5)胸部HRCT等
2. 疗效比较:
2.1治疗前后症状变化:三组患者治疗后主要症状(咳嗽、咳痰、气喘、胸闷、肺Velcro啰音 徒步气喘、口渴、纳差)均获得明显改善,结果见(表1)。
表1治疗前后症状变化(例数)
结果表明,在综合主要症状(咳嗽、咳痰、气喘、胸闷、肺Velcro啰音 徒步气喘、口渴、纳差)等方面三组治疗前后均获得改善,且治疗B组显著地优于对照组(P<0.05),与治疗A组接近;治疗B组疗效优于治疗A组。
2.2治疗前后肺功能变化:
表2 治疗前后肺功能变化情况比较表
治疗前三组患者肺总量 (TLC)、肺活量(VC)占预计值百分比(%)、一氧化碳弥散量(DLCO)占预计值百分比(%)无显著差异(P>0.05),具可比性。三组肺功能相关指标治疗后均有不同程度改善,治疗A、B组治疗前后有显著性差异(P<0.05),对照组治疗前后差异无显著性(P>0.05)。在肺功能改善方面治疗B组显著地优于对照组(P<0.05);治疗B组疗效优于治疗A组。
2.3三组患者治疗前后动脉血氧、二氧化碳分压变化情况
表3.三组治疗前后动脉血氧、二氧化碳分压比较(mmHg)比较表
治疗前三组患者动脉血氧、二氧化碳分压均无显著性差异(P>0.05),具可比性。治疗后三组患者动脉血氧、二氧化碳分压均获不同程度的改善,治疗组治疗前后变化具显著性差异,治疗B组显著地优于对照组,具统计学意义(P<0.05);治疗B组疗效优于治疗A组。
2.4治疗前后血清前白蛋白(PA)、白蛋白(ALB)含量、白球比(A/G)情况
表4.三组治疗前后血清前白蛋白(PA)、白蛋白(ALB)含量、白球比(A/G)情况对比表
三组治疗前,患者血清前白蛋白(PA)、白蛋白(ALB)、白蛋白球蛋白比值(A/G)对比差异无统计学意义,治疗后,上述指标值均明显改善,且治疗B组明显优于对照组,组间对比,差异均有统计学意义(P<0.05)。尤其值得一提的是,A/G的改善,提示该发明的制剂对改机体免疫机能,提高机体自身修复能力具有特别重要的意义。治疗B组疗效优于治疗A组。
2.5治疗前后三组患者胸部HRCT变化情况
2.5.1.HRCT显示肺间质纤维化:病变以胸膜下,基底部分分布为主的网格影、蜂窝、伴或不伴牵张性支气管扩张。
2.5.2.肺纤维化病变范围评分
采用4分法对肺纤维化病变范围评分(x±s,分),根据网格和蜂窝病变占整个肺脏的范围:⑴0分:未受累;⑵1分:病变范围≤25%;⑶2分:病变范围≥26%,≤50%(26%~50%);⑷3分:病变范围51%~75%(≥51%病变范围≤75%);⑸4分:病变范围76%~100%(76%≥病变范围≤100%);
HRCT影像学显示,治疗前三组患者治疗前在牵张性支扩(例)、网格影(例)、蜂窝(例)、纵隔淋巴结肿大(例)和肺纤维化评分(x±s,分)等方面均无统计学显著性差异(P>0.05),具可比性;治疗后三组患者上述考核指标方面具统计学显著性差异(P<0.05)
表5.三组患者治疗前后胸部HRCT影像学相关指标对比表
2.5.3.治疗前后三组患者胸部HRCT情况比较
表6.治疗前后三组患者疗效比较表
肺间质纤维化在影像学上不同的病程、不同时期有不同的表现:肺泡炎期表现为病理变化尚可逆的磨玻璃影;肺纤维化期表现为网织结构;而肺纤维化后期影像学表现为蜂窝状可伴有少量磨玻璃影、网织结构。胸部HRCT可发现初期病变,如出现在胸膜下,较早发现肺内出现不规则的线条状网格样改变,常伴有囊性小气腔形成,其相互连接可形成胸膜下线,是诊断早期肺间质纤维化的重要手段之一。
研究结果示:对照组治疗后有0例患者胸部HRCT病灶影大部吸收或消失;10例患者胸部HRCT好转,32例稳定,33例加重,总有效率56.0%。治疗A组治疗后有14例患者胸部HRCT病灶影大部吸收或消失;27例患者胸部HRCT好转,32例稳定,2例加重,总有效率97.3%。治疗B组治疗后有15例患者胸部HRCT病灶影大部吸收或消失;30例患者胸部HRCT好转,29例处于稳定状态,1例较治疗前疑似有进展,有效率98.7%。治疗B组在统计学意义和临床意义上均显著优于治疗A组(P<0.05)。
Claims (10)
1.一种用于肺及呼吸系统疾病的生物医药,其特征在于,由以下重量份原料,部分经粉碎、部分经提取有效物质及酶切后,制成临床上所能接受的剂型:太子参1~30份,冬虫夏草或其人工培养品0.5~29份,藿香叶1~49份,当归2~45份,杏仁4~54份,山药6~45份,泽泻7~42份,山茱萸8~46份,黄芪2~40份,甘草10-50份,金银花9-50份,姜1~29份,白术3~33份,胡萝卜1-39份,白芷1-39份,芦根1-30份,百合1-39份,胎盘0.5-55份。
2.制备如权利要求1所述的一种用于肺及呼吸系统疾病的生物医药的方法,其特征在于,制备步骤如下:
(1)提油 取金银花、霍香叶、姜、白芷、当归、泽泻放入容器内,加水4~8倍重量,浸泡40~70分钟,水蒸气蒸馏2.5~3.5h,得到油水混合物,再对油水混合物进行分离,分离得到挥发油;以8~12倍重量β-环糊精包合挥发油,在60±5℃包合2小时,得到包合物;对蒸馏后的剩余物料进行液固分离,得到药渣和药液;
(2)提脂 将步骤(1)的药渣与杏仁、山茱萸、另包的拣净的胎盘用乙醇回流提取2次,第一次加10倍重量的浓度为60%-85%乙醇,回流提取1.5-2.5小时,过滤后的药渣再加8倍重量的浓度为60%-85%乙醇,回流提取1.5-2.5小时,合并两次提取液,并在负压状态下回收乙醇,直至提取液无醇味得到含脂溶性物质的液体;对回流后的剩余物料在负压状态下回收残留乙醇,直至无醇味,进行液固分离,得到药渣和药液;
(3)煎提 取太子参、黄芪,甘草,白术,胡萝卜,芦根,百合,另包的拣净的山药放入容器内,与步骤(2)的药渣、另包的拣净的胎盘混合,加水浸泡后,煎煮2次,每次各40~70分钟,第一次加8倍重量水浸泡,第二次加6倍重量水,煎煮前均浸泡40~70分钟,合并两次煎煮、过滤后的药液以及步骤(1)得到的药液,将混合后的药液浓缩至相对密度为1.10~1.15后进行低温干燥,收集干燥物备用;
(4)酶切 分取步骤(3)的另包的拣净的胎盘煎煮包,将冬虫夏草或其人工培养品及煎煮后的胎盘,分别充分干燥,经6000-100000转/小时超高速粉碎机将其微粉化;将微粉化后的冬虫夏草或其人工培养品、胎盘微粉,分别浆液化,将浆液化后的胎盘、冬虫夏草或其人工培养品微粉分别酶切,分取酶切获得的分子量≤3000Da的胎盘、冬虫夏草或其人工培养品短肽备用;
(5)取步骤(3)浓缩液干燥物及上述步骤获得的分子量≤3000Da的胎盘、冬虫夏草或其人工培养品短肽混合,再加入步骤(1)的包合物、步骤(2)的含脂溶性物质的液体、步骤(3)另包的拣净去皮的山药的干燥粉碎物,混合均匀后干燥使其微粉化,获得含水量≤5%的干燥微粉物;将此干燥微粉物制成制成临床上所能接受的剂型。
3.根据权利要求2所述的一种用于肺及呼吸系统疾病的生物医药的制备方法,其特征在于:步骤(4)中所述酶切所用的酶,为食品级复合酶、食品用中性蛋白酶 FDG-2209、食品级高活力浓缩型中性蛋白酶FDG-2230、酸性蛋白酶APRL型FDY-2205、酸性蛋白酶APRS型FDG-2237、食品用碱性蛋白酶 FDG-2202、食品级高活力浓缩型碱性蛋白酶FDG-2227、碱性蛋白酶FDG-4001 、内切型蛋白酶FDY-2220、内切酶DNaseⅠ、内切酶DNaseⅡ、内切酶BamHI、内切酶phi29中的一种或两种以上混合。
4.根据权利要求2所述的一种用于肺及呼吸系统疾病的生物医药的制备方法,其特征在于:步骤(3)所述浓缩的温度为75~80℃;所述干燥的温度为75~80℃;步骤(4)所述酶切的温度为0-69℃,湿度为30-99%,光照强度为0-300Lx,离心搅拌机转速为9-75r/s;步骤(5)所述的干燥为冷冻干燥、或干燥塔内喷雾干燥,所述冷冻干燥温度则在-10℃以下至-45℃;喷雾干燥,干燥塔内的烘干压力为100~150Pa,干燥塔的进口温度为180±5℃,出口温度为80±5℃。
5.根据权利要求2所述的一种用于肺及呼吸系统疾病的生物医药的制备方法,其特征在于:步骤(3)所述混合后的药液如混浊,则进行醇沉后再浓缩;步骤(4)所述酶切过程中,加入磷脂,并加以超声振荡、搅拌或射流作用,获得分子量≤3000Da的短肽脂质体。
6.一种用于肺及呼吸系统疾病的医用全营养食品,其特征在于,由以下重量份原料,部分经粉碎、部分经提取有效物质及酶切后,制成临床上所能接受的剂型:太子参1~30份,冬虫夏草或其人工培养品0.5~29份,藿香叶1~49份,当归2~45份,杏仁4~54份 ,山药6~45份,泽泻7~42份,山茱萸8~46份,黄芪2~40份,甘草10-50份,金银花9-50份,姜1~29份,白术3~33份,胡萝卜1-39份,白芷1-39份,芦根1-30份,百合1-39份,胎盘0.5-55份,由麦芽糊精0.9-49份,膳食纤维0.5-30份,中链甘油三酯0.01-55份,微量元素0.1-19份,水溶性维生素0.1-27份,脂溶性维生素0.1-5份,适宜的调味剂0.1-37份组成的肺病型全营养组件。
7.制备如权利要求6所述的一种用于肺及呼吸系统疾病的医用全营养食品的方法,其特征在于,制备步骤如下:
(1)提油 取金银花、霍香叶、姜、白芷、当归、泽泻放入容器内,加水4~8倍重量,浸泡40~70分钟,水蒸气蒸馏2.5~3.5h,得到油水混合物,再对油水混合物进行分离,分离得到挥发油;以8~12倍重量β-环糊精包合挥发油,在60±5℃包合2小时,得到包合物;对蒸馏后的剩余物料进行液固分离,得到药渣和药液;
(2)提脂 将步骤(1)的药渣与杏仁、山茱萸、另包的拣净的胎盘用乙醇回流提取2次,第一次加10倍重量的浓度为60%-85%乙醇,回流提取1.5-2.5小时,过滤后的药渣再加8倍重量的浓度为60%-85%乙醇,回流提取1.5-2.5小时,合并两次提取液,并在负压状态下回收乙醇,直至提取液无醇味得到含脂溶性物质的液体;对回流后的剩余物料在负压状态下回收残留乙醇,直至无醇味,进行液固分离,得到药渣和药液;
(3)煎提 取太子参、黄芪,甘草,白术,胡萝卜,芦根,百合,另包的拣净的山药放入容器内,与步骤(2)的药渣、另包的拣净的胎盘混合,加水浸泡后,煎煮2次,每次各40~70分钟,第一次加8倍重量水浸泡,第二次加6倍重量水,煎煮前均浸泡40~70分钟,合并两次煎煮、过滤后的药液以及步骤(1)得到的药液,将混合后的药液浓缩至相对密度为1.10~1.15后进行低温干燥,收集干燥物备用;
(4)酶切 分取步骤(3)的另包的拣净的胎盘煎煮包,将冬虫夏草或其人工培养品及煎煮后的胎盘,分别充分干燥,经6000-100000转/小时超高速粉碎机将其微粉化;将微粉化后的冬虫夏草或其人工培养品、胎盘微粉,分别浆液化,将浆液化后的胎盘、冬虫夏草或其人工培养品微粉分别酶切,分取酶切获得的分子量≤3000Da的胎盘、冬虫夏草或其人工培养品短肽备用;
(5)取步骤(3)浓缩液干燥物及上述步骤获得的分子量≤3000Da的胎盘、冬虫夏草或其人工培养品短肽混合,再加入步骤(1)的包合物、步骤(2)的含脂溶性物质的液体、步骤(3)另包的拣净去皮的山药的干燥粉碎物以及肺病型全营养组件,混合均匀后干燥使其微粉化,获得含水量≤5%的干燥微粉物;将此干燥微粉物制成临床上所能接受的剂型。
8.根据权利要求7所述的一种用于肺及呼吸系统疾病的医用全营养食品的制备方法,其特征在于:步骤(4)中所述酶切所用的酶,为食品级复合酶、食品用中性蛋白酶 FDG-2209、食品级高活力浓缩型中性蛋白酶FDG-2230、酸性蛋白酶APRL型FDY-2205、酸性蛋白酶APRS型FDG-2237、食品用碱性蛋白酶 FDG-2202、食品级高活力浓缩型碱性蛋白酶FDG-2227、碱性蛋白酶FDG-4001 、内切型蛋白酶FDY-2220、内切酶DNaseⅠ、内切酶DNaseⅡ、内切酶BamHI、内切酶phi29一种或两种以上混合。
9.根据权利要求7所述的一种用于肺及呼吸系统疾病的生物医药的制备方法,其特征在于:步骤(3)所述浓缩的温度为75~80℃;所述干燥的温度为75~80℃;步骤(4)所述酶切的温度为0-69℃,湿度为30-99%,光照强度为0-300Lx,离心搅拌机转速为9-75r/s;步骤(5)所述的干燥为冷冻干燥、或干燥塔内喷雾干燥,所述冷冻干燥温度则在-10℃以下至-45℃;喷雾干燥,干燥塔内的烘干压力为100~150Pa,干燥塔的进口温度为180±5℃,出口温度为80±5℃。
10.根据权利要求7所述的一种用于肺及呼吸系统疾病的医用全营养食品的制备方法,其特征在于:步骤(3)所述混合后的药液如混浊,则进行醇沉后再浓缩;步骤(4)所述酶切过程中,加入磷脂,并加以超声振荡、搅拌或射流作用,获得分子量≤3000Da的短肽脂质体。
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