CN106110204A - 一种提高免疫力的蒲公英口服液及其制备方法 - Google Patents
一种提高免疫力的蒲公英口服液及其制备方法 Download PDFInfo
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Abstract
本发明提供一种提高免疫力的蒲公英口服液,包括:蒲公英10~50份,茵陈10~20份,夏枯草10~20份,菊花10~20份,白芍10~20份,白术10~20份,垂盆草10~20份,莪术10~20份,五味子10~20份,金樱子10~20份,地骨皮10~20份,丹参10~20份,墨旱莲10~20份,制首乌10~20份,菟丝子10~20份,栀子10~20份,熟地10~20份,穿心莲10~20份,绞股蓝10~20份,黄精10~20份。本发明是一种具有抗菌、抗病毒的中药保健品,没有难以下咽的中药味,使人易于接受,可以长期服用,能改善亚健康人群易感冒、眼睛酸涩、睡眠质量不高,脾虚乏力;食少口干的症状。
Description
技术领域
本发明涉及含有来源于植物、动物或矿物原料的医用保健品,特别涉及一种提高免疫力的蒲公英口服液及其制备方法。
背景技术
人体免疫是人体对外界的病原微生物等的防御机能,或者说是防御系统,在正常情况下,它能够保证人体不受外界病原微生物的侵害。通常说的人体免疫力就是指人体的免疫系统抵御外来病原微生物等侵害的能力。在人体免疫力正常的情况下,人体自身能够抵御相当多的病菌的侵害,避免对人体造成损伤。免疫力在人体生命机制中发挥重要的作用,而人体的营养、劳累、心情、环境、疾病、用药、辐射等导致自身的免疫力下降。数百万年来,人类在生活一个既适合生存又充满危险的环境,人类得以存续,也获得了非凡的免疫力。所以说免疫力是生物进化过程的产物。
免疫力低下的身体易于被感染或患癌症;免疫力超常也会产生对身体有害的结果,如引发过敏反应、自身免疫疾病等。各种原因使免疫系统不能正常发挥保护作用,在此情况下,极易招致细菌、病毒、真菌等感染,因此免疫力低下最直接的表现就是容易生病。因经常患病,加重了机体的消耗,所以一般有体质虚弱、营养不良、精神萎靡、疲乏无力、食欲降低、睡眠障碍等表现,生病、打针吃药便成了家常便饭。每次生病都要很长时间才能恢复,而且常常反复发作。长此以往会导致身体和智力发育不良,还易诱发重大疾病。深层原因是免疫力低下或免疫力不健全。当人体免疫功能失调,或者免疫系统不健全时,下列问题就会反复发作:--感冒反复发作、扁桃体炎反复发作、哮喘反复发作、支气管炎反复发作、肺炎反复发作、腹泻反复发作……所以千万不可小视。
免疫力是指机体抵抗外来侵袭,维护体内环境稳定性的能力。空气中充满了各种各样的微生物:细菌、病毒、支原体、衣原体、真菌等等。在人体免疫力低下的情况下,它们都可以成为感早班的病原体。虽然人体对不同的病原体会产生相应的抗体,以抵御再次感染,但抗体具有专一性和时限性,比如链球菌抗体只能在较短时期内保护机体不受链球菌的再次侵犯,也并不能抵御其他病毒的感染。免疫力低下的人根本无法抵御感冒病毒的侵袭,这才是易感人群频繁感冒的真正原因。
生蒲公英富含维生素A、维生素C及钾,也含有铁、钙、维生素B2、维生素B1、镁、维生素B6、叶酸及铜。具体的元素含量主要是水分,每60克生蒲公英叶含水分86%,蛋白质1.6克,碳水化合物5.3克,热量约有108.8千焦。蒲公英植物体中含有蒲公英醇、蒲公英素、胆碱、有机酸、菊糖等多种健康营养成分。性味甘,微苦,寒。归肝、胃经。有利尿、缓泻、退黄疸、利胆等功效。治热毒、痈肿、疮疡、内痈、目赤肿痛、湿热、黄疸、小便淋沥涩痛、疔疮肿毒,乳痈,瘰疬,牙痛,目赤,咽痛,肺痈,肠痈,湿热黄疸,热淋涩痛。治急性乳腺炎,淋巴腺炎,瘰疬,疔毒疮肿,急性结膜炎,感冒发热,急性扁桃体炎,急性支气管炎,胃炎,肝炎,胆囊炎,尿路感染等。蒲公英可生吃、炒食、做汤,是药食兼用的植物。
蒲公英提高免疫力,利尿散结。治急性乳腺炎,淋巴腺炎,瘰疬,疔毒疮肿,急性结膜炎,感冒发热,急性扁桃体炎,急性支气管炎,胃炎,肝炎,胆囊炎,尿路感染。《唐本草》:主妇人乳痈肿。《本草图经》:敷疮,又治恶刺及狐尿刺。《本草衍义补遗》:化热毒,消恶肿结核,解食毒,散滞气。《滇南本草》:敷诸疮肿毒,疥癞癣疮;祛风,消诸疮毒,散瘰疬结核;止小便血,治五淋癃闭,利膀胱。《纲目》:乌须发,壮筋骨。《本草经疏》:蒲公英味甘平,其性无毒。当是入肝入胃,解热凉血之要药。乳痈属肝经,妇人经行后,肝经主事,故主妇人乳痈肿乳毒,并宜生暖之良。《本草述》:蒲公英,甘而微余苦,是甘平而兼有微寒者也。希雍有曰:甘平之剂点朗肝肾。′昧此一语,则知其入胃而兼入肝肾矣,不然,安能凉血、乌须发,以合于冲任之血脏乎?即是思之,则东垣所谓肾经必用者,尤当推而广之,不当止以前所主治尽之也。《本草新编》:蒲公英,至贱而有大功,借世人不知用之。阳明之火,每至燎原,用白虎汤以泻火,未免太伤胃气。盖胃中之火盛,由于胃中士衰也,泻火而土愈衰矣。故用白虎汤以泻胃火,乃一时之极宜,而不可恃之为经久也。蒲公英亦泻胃火之药,但其气甚平,既能泻火,又不损土,可以长服久服而无碍。凡系阳明之火起者,俱可大剂服之,火退而胃气自生。但其泻火之力甚微,必须多用,一两,少亦五、六钱,始可散邪辅正耳。或问,蒲公英泻火,止泻阳明之火,不识各经之火,亦可尽消之乎?曰,火之最烈者,无过阳明之焰,阳明之火降,而各经余火无不尽消。蒲公英虽非各经之药,而各经之火,见蒲公英而尽伏,即谓蒲公英能消各经之火,亦无不可也。或问,蒲公英与金银花,同是消痈化疡之物,二物毕竟孰胜?夫蒲公英止入阳明、太阴二经,而金银花则无经不入,蒲公英不可与金银花同于功用也。然金银花得蒲公英而其功更大。
蒲公英全草含蒲公英甾醇、胆碱、菊糖、果胶等。根中含蒲公英醇、蒲公英赛醇、Ψ-葡公英甾醇、蒲公英甾醇、β-香树脂醇、豆甾醇、β-谷甾醇、胆碱、有机酸、果糖、蔗糖、葡萄糖、葡萄糖甙以及树脂、橡胶等。叶含叶黄素、蝴蝶梅黄素、叶绿醌、维生素C(50~70毫克/100克)和维生素D(5~9毫克/100克)。
花中含山金车二醇、叶黄素和毛莨黄素。花粉中含β-谷甾醇、5z-豆甾-7-烯-3β-醇、叶酸和维生素C。绿色花萼中含叶绿醌。花茎中含β-谷甾醇和β-香树脂醇。又该品含考迈斯托醇、核黄素1.43微克/克和胡萝卜素7.7~8.8毫克%。
(1)抗菌作用:该品注射液试管内对金黄色葡萄球菌耐药菌株、溶血性链球菌有较强的杀菌作用。对肺炎双球菌、脑膜炎球菌、白喉杆菌、绿脓杆菌、痢疾杆菌、伤寒杆菌等及卡他球菌也有一定杀菌作用。本品醇提液1:400能抑制结核菌,但煎剂1:100无效。其1:80的水煎剂能延缓ECHO11病毒细胞病变,醇提物(31mg/kg)能杀死钩端螺旋体,对某些真菌亦有抑制作用。对幽门弯曲杆菌有良好的杀灭作用。
(2)通乳:该品叶有疏通乳脉管之阻塞,促进泌乳的作用。
(3)抗肿瘤作用:药用蒲公英中提取的多糖(Tof-CFr),以40、2、600mg/kg ip给于接种MM46肿瘤细胞的C3H小鼠,前期给药未见作用,但11~20天和2~20天的后期隔日给药则有效。对肿瘤细胞的迟延型过敏反应(T-DHR),在ddy-Ehrlich(同种肿瘤)系和C3H-MM46(同系肿瘤)系中,Tof-CFr后期给药其足跖反应与对照组相比均明显上升。在ADMC系中,Tof-CFr与已知能活化巨噬细胞的糖原相比,具有更强的激活能力
(4)利胆作用:国外研究,该品有利胆作用,临床上治疗慢性胆囊痉挛及结石症有效。此外本品尚有利尿健胃,轻泻等作用。
是药三分毒,中药保健品一定要控制好剂量,使其毒性降到最低。本发明大大改进中药提取技术,使得中药的有毒成分降到最低,可以使人体吸收,大大提高其利用率。控制剂量;加强“量效关系”和“量毒关系”研究;运用现代技术,体内外方法结合评价。
发明内容
本发明所要解决的技术问题在于,本发明所要解决的技术问题在于,现代人的免疫力正变得越来越脆弱,环境污染,作息不规律、生活节奏快、吃的不健康,不知节欲,造成各种疾病的发病率都在不断上升。尤其所谓的办公室一族,更是免疫力低下的高发人群。大部分人都是亚健康状态,在透支原本就不健康的身体。大部分人的症状为失眠多梦、易感冒、眼睛酸涩、脾虚乏力;食少口干;消渴;肾亏腰膝酸软;阳痿遗精;耳鸣目暗;须发早白;体虚赢瘦;风癞癣疾。怎样找到安全有效的活性物质保健品,能大大提高免疫力,增强体质一直是人们期待解决问题的关键。本发明大大改进中药提取技术,使得中药的有毒成分降到最低,可以使人体吸收,大大提高其利用率。
为解决上述技术问题,本发明提供一种提高免疫力的蒲公英口服液,其所述口服液可以包括以下重量份数的原料药:蒲公英10~50份,茵陈10~20份,夏枯草10~20份,菊花10~20份,白芍10~20份,白术10~20份,垂盆草10~20份,莪术10~20份,五味子10~20份,金樱子10~20份,地骨皮10~20份,丹参10~20份,墨旱莲10~20份,制首乌10~20份,菟丝子10~20份,栀子10~20份,熟地10~20份,穿心莲10~20份,绞股蓝10~20份,黄精10~20份。
所述提高免疫力的蒲公英口服液,其所述口服液中各种原料药的重量份数也可以为:蒲公英10~30份,茵陈10~15份,夏枯草10~15份,菊花10~15份,白芍10~15份,白术10~15份,垂盆草10~15份,莪术10~15份,五味子10~15份,金樱子10~15份,地骨皮10~20份,丹参10~20份,墨旱莲10~20份,制首乌10~20份,菟丝子10~20份,栀子10~20份,熟地10~20份,穿心莲10~20份,绞股蓝10~20份,黄精10~20份。
所述提高免疫力的蒲公英口服液,其所述口服液中各种原料药的重量份数还可以为:蒲公英10~40份,茵陈10~20份,夏枯草10~20份,菊花10~20份,白芍10~20份,白术10~20份,垂盆草10~20份,莪术10~20份,五味子10~20份,金樱子10~20份,地骨皮10~15份,丹参10~15份,墨旱莲10~15份,制首乌10~15份,菟丝子10~15份,栀子10~15份,熟地10~15份,穿心莲10~15份,绞股蓝10~15份,黄精10~15份。
为解决上述技术问题,本发明还提供一种提高免疫力的蒲公英口服液的制备方法,其所述口服液的制备步骤包括:
a.蒲公英的萃取,作为组分1;
b.将所述其余原料药放入乙醇中加热回流提取2次,作为组分2;
c.将上述两种提取液组分1和组分2合并,浓缩后加蜂蜜或糊精调和,消毒杀菌后制备成口服液装瓶。
所述步骤a中,可以在采摘蒲公英后切碎,将其浸泡置于有盖不锈钢桶内,加70%乙醇液,质量为粗颗粒的0.8-1倍,搅拌均匀,湿润密闭放置1小时以上,使充分膨胀;将渗漉筒底部滤板用纱布袋包裹铺平后再将湿润膨胀后的药物样品拌松弄散,然后用不锈钢勺盛粉,均匀的装入渗漉筒,装10-12厘米厚,用T型棒压匀,再按上述操作,一层一层的装入,适当加压,药粉填装不得超过渗漉筒的2/3高处;药粉面上盖不锈钢孔板压牢,打开渗漉筒下面的放料阀,并放一容器,然后缓缓加入70%乙醇液;待排出药粉粉粒之间的空气,并有乙醇流出约20L左右,关闭放料阀,盖上漉筒、浸渍24小时,然后开放料阀进行渗漉,控制渗漉速度一般为1000g药材每分钟流出2~3ml,滤液放入贮液缸内,并将排空时的乙醇液倒入贮液缸;将渗滤液合并静置,静置备用,作为组分1。
所述步骤b中,可以将所述其余原料泡入占其质量10倍量乙醇中,加热提取2次,每次1-2小时,取上清液,合并提取液,100-120目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.06的浸膏,加热浓缩至膏状,静置备用,成组分2。
所述步骤c中,可以将组分1和组分2合并后,置入双效真空浓缩器中,浓缩至90℃时相对密度为1.36的浓缩液,置0~5℃低温冷藏24小时;将冷藏液加0.3%的助滤剂硅藻土,过滤,滤液再置入双效真空浓缩器中,浓缩至每1ml含0.1g生药量;浓缩后的膏剂加蜂蜜或糊精调和,紫外线消毒杀菌后装瓶。
为解决上述技术问题,本发明也提供一种提高免疫力的蒲公英口服液的制备方法,其制备步骤还可以为:
a.将蒲公英加乙醇提取,作为组分1;
b.将蒲公英提取后残渣与所述其余原料药一起加水浸泡、提取2次作为组分2;
c.将组分1、组分2混合浓缩后加蜂蜜调和,紫外线消毒杀菌后装瓶。
所述步骤a中,可以将采摘好的蒲公英洗净,晾晒后放入提取罐加占其质量5-10倍量乙醇,加热提取2次,每次1-2小时,取上清液,合并提取液,100-120目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.06的浸膏,作为组分1;所述步骤b中,将提取的蒲公英渣滓与所述其余原料一起放入占其质量5-10倍量水中,浸泡1-2小时,加热提取2次,每次1-2小时,取上清液,合并提取液,100-120目滤过,将2次提取液合并静置,减压并浓缩至药液浓度为0.6g生药/mL,抽滤后,滤液的相对密度约为20℃时1.08;减压至0.03-0.08MPa,温度保持在60-80℃,浓缩至相对密度为1.20,温度至60℃-70℃的浸膏,作为组分2。
所述步骤c中,可以将组分1与组分2混合后放入减压浓缩罐内,减压回收乙醇,浓缩至药液浓度为0.1g生药/mL,抽滤至滤液的相对密度为20℃时1.06;上述滤液经体积为10L的大孔吸附树脂柱吸附后,用10倍树脂柱体积的去离子水或蒸馏水洗脱,再用5倍树脂柱体积的95%乙醇洗脱,收集乙醇洗脱液,去除溶剂,再调和蜂蜜,紫外线消毒杀菌后装瓶。
医学鉴定,蒲公英可以提高免疫力,降糖降脂,具有减肥作用,清理肠胃,排毒养颜,滋肝润肺,本发明是一种具有抗菌、抗病毒作用的中药保健品,尤其对感冒、咽炎等上呼吸道感染具有明显的治疗作用。具有清热解毒、消炎止痛、抗流感病毒的功效,是预防和治疗流行性感冒、咽喉炎、热毒诸症、急性胃肠炎最理想的天然药物。没有难闻难以下咽的中药味,使人易于接受,可以长期服用,能较好的改善亚健康人群易感冒、眼睛酸涩、睡眠质量不高,脾虚乏力;食少口干;消渴;肾亏腰膝酸软;阳痿遗精;耳鸣目暗;须发早白;体虚赢瘦;风癞癣疾的症状,能较好的达到提高免疫力的功效。
具体实施方式
人体免疫是人体对外界的病原微生物等的防御机能,或者说是防御系统,在正常情况下,它能够保证人体不受外界病原微生物的侵害。通常说的人体免疫力就是指人体的免疫系统抵御外来病原微生物等侵害的能力。在人体免疫力正常的情况下,人体自身能够抵御相当多的病菌的侵害,避免对人体造成损伤。免疫力在人体生命机制中发挥重要的作用,而人体的营养、劳累、心情、环境、疾病、用药、辐射等导致自身的免疫力下降。越来越多研究表明,中药对人体免疫力的调节越来越发挥重要作用。
蒲公英提高免疫力,利尿散结。治急性乳腺炎,淋巴腺炎,瘰疬,疔毒疮肿,急性结膜炎,感冒发热,急性扁桃体炎,急性支气管炎,胃炎,肝炎,胆囊炎,尿路感染。《唐本草》:主妇人乳痈肿。《本草图经》:敷疮,又治恶刺及狐尿刺。《本草衍义补遗》:化热毒,消恶肿结核,解食毒,散滞气。《滇南本草》:敷诸疮肿毒,疥癞癣疮;祛风,消诸疮毒,散瘰疬结核;止小便血,治五淋癃闭,利膀胱。《纲目》:乌须发,壮筋骨。《本草经疏》:蒲公英昧甘平,其性无毒。当是入肝入胃,解热凉血之要药。乳痈属肝经,妇人经行后,肝经主事,故主妇人乳痈肿乳毒,并宜生暖之良。《本草述》:蒲公英,甘而微余苦,是甘平而兼有微寒者也。希雍有曰:甘平之剂点朗肝肾。′昧此一语,则知其入胃而兼入肝肾矣,不然,安能凉血、乌须发,以合于冲任之血脏乎?即是思之,则东垣所谓肾经必用者,尤当推而广之,不当止以前所主治尽之也。《本草新编》:蒲公英,至贱而有大功,借世人不知用之。阳明之火,每至燎原,用白虎汤以泻火,未免太伤胃气。盖胃中之火盛,由于胃中士衰也,泻火而土愈衰矣。故用自虎汤以泻胃火,乃一时之极宜,而不可恃之为经久也。蒲公英亦泻胃火之药,但其气甚平,既能泻火,又不损土,可以长服久服而无碍。凡系阳明之火起者,俱可大剂服之,火退而胃气自生。但其泻火之力甚微,必须多用,一两,少亦五、六钱,始可散邪辅正耳。或问,蒲公英泻火,止泻阳明之火,不识各经之火,亦可尽消之乎?曰,火之最烈者,无过阳明之焰,阳明之火降,而各经余火无不尽消。蒲公英虽非各经之药,而各经之火,见蒲公英而尽伏,即谓蒲公英能消各经之火,亦无不可也。或问,蒲公英与金银花,同是消痈化疡之物,二物毕竟孰胜?夫蒲公英止入阳明、太阴二经,而金银花则无经不入,蒲公英不可与金银花同于功用也。然金银花得蒲公英而其功更大。
蒲公英全草含蒲公英甾醇、胆碱、菊糖、果胶等。根中含蒲公英醇、蒲公英赛醇、ψ-葡公英甾醇、蒲公英甾醇、β-香树脂醇、豆甾醇、β-谷甾醇、胆碱、有机酸、果糖、蔗糖、葡萄糖、葡萄糖甙以及树脂、橡胶等。叶含叶黄素、蝴蝶梅黄素、叶绿醌、维生素C(50~70毫克/100克)和维生素D(5~9毫克/100克)。
夏枯草有清火明目之功效,能治目赤肿痛、头痛等。本品煎剂、水浸出液、乙醇-水浸出液及乙醇浸出液均可明显降低实验动物血压,茎、叶、穗及全草均有降压作用,但穗的作用较明显;本品水煎醇沉液小鼠腹腔注射,有明显的抗炎作用;本品煎剂在体外对痢疾杆菌、伤寒杆菌、霍乱弧菌、大肠杆菌、变形杆菌、葡萄球菌及人型结核杆菌均有一定的抑制作用。夏枯草配伍当归、白芍夏枯草清肝散淤;当归、白芍养血补血.三者伍用有解肝郁、养肝血之功效用于治疗肝郁血虚所致诸症.夏枯草配伍菊花夏枯草清肝火、平肝阳;菊花清热凉肝.二者合用有清肝、凉肝、平肝之功用于治疗肝火上炎、肝经风热引起目赤肿痛;或肝阳上亢导致之头痛、眩晕。
白芍苦,微寒。归肝经。主治功效:清热凉血;活血祛瘀。主温毒发斑;吐血衄血;肠风下血;目赤肿痛;痈肿疮疡;闭经;痛经;崩带淋浊;瘀滞胁痛;疝瘕积聚;跌扑损伤。用于温毒发斑,吐血衄血,目赤肿痛,肝郁胁痛,经闭痛经,症瘕腹痛,跌扑损伤,痈肿疮疡。《本经》:主邪气腹痛,除血痹,破坚积,寒热疝瘕,止痛,利小便,益气。《别录》:通顺血脉,缓中,散恶血,逐贼血,去水气,利膀胱大小肠,消痈肿,时行寒热,中恶腹痛,腰痛。《药性论》:治肺邪气,腹中疞痛,血气积聚,通宣脏腑拥气,治邪痛败血,主时疾骨热,强五脏,补肾气,治心腹坚胀,妇人血闭不通,消瘀血,能蚀脓。
墨旱莲菊科,一年生草本植物。直立,具匍匐茎;叶对生,披针形;头状花序,腋生或顶生,花白色;瘦果黑色。全国广布种。常见于田梗,沟溪边湿地。全草药用,能收敛、止血、补肝肾之功效。滋补肝肾、凉血止血,可治各种吐血,肠出血等症。捣汁涂眉发,能促进毛发生长,内服有乌发、黑发功效。《唐本草》说,墨旱莲“主血痢,针灸疮发,洪血不可止者敬之”《日华子本草》中也说,墨旱莲可以“排脓,止血,通小肠,敷一切疮并蚕瘑”。
中药何首乌有生首乌与制首乌之分,直接切片入药为生首乌,用黑豆煮汁拌蒸后晒干入药为制首乌。二者的功用有所不同:生首乌功能解毒、消痈、润肠通便,常用于治疗瘰疬疮痈、风疹瘙痒、肠燥便秘;制首乌功能补肝肾、益精血、乌须发、强筋骨,用于血虚萎黄、眩晕耳鸣、须发早白、腰膝酸软、肢体麻木、崩漏带下、久疟体虚等。本发明所采用的制首乌是补肾益肾的佳品。
栀子苦寒,能血分而清邪热,宽肠通便,防癌,栀子花含有纤维素,能预防痔疮的发作和直肠癌瘤的发生。栀子花根、叶、果实均可入药,有泻火除烦,消炎祛热、清热利尿,外用解毒之功效。栀子花、果实、叶和根可入药,一般泡茶或煎汤服。栀子含栀子甙、去羟栀子甙、鸡屎藤次甙甲酯及少量山栀甙,有清热利尿、外用解毒、黄疸、血淋痛涩、目红肿痛、火毒疮、降血压等功效。其中栀子果入药,主治热病高烧,心烦不眠,实火牙痛,口舌生疮,鼻规,吐血,眼结膜炎,疮疡肿毒,黄疸型传染性肝炎,蚕豆病,尿血;外用治外伤出血、扭挫伤。根入药主治传染性肝炎,跌打损伤,风火牙痛。《本草纲目》称其“悦颜色,《千金翼》面膏用之。”《滇南本草》称其“泻肺火,止肺热咳嗽,止鼻衄血,消痰。”性味归经:性寒,味甘苦;入肺、肝经。功效主治:清肺止咳,外用止血。主治肺热咳嗽,鼻,咯痰,肿毒等病症。主要成分:栀子花含有三萜成分,栀子花酸A、B和子酸。含挥发油,包括乙酸苄酯、乙酸芳樟酯,另含色素甙、木蜜醇等。另外,还含有碳水化合物、蛋白质、粗纤维及多种维生素。
金樱子,中药名。为蔷薇科植物金樱子Rosa laevigata Michx.的干燥成熟果实。分布于陕西、安徽、江西、江苏、浙江、湖北、湖南、广东、广西、台湾、福建、四川、云南、贵州等地。具有固精缩尿,固崩止带,涩肠止泻之功效。常用于遗精滑精,遗尿尿频,崩漏带下,久泻久痢。
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。唐等《新修本草》载“五味皮肉甘酸,核中辛苦,都有成味”,故有五味子之名。五味子分为南、北二种。古医书称它荎蕏、玄及、会及,最早列于神农本草经上品中药,能滋补强壮之力,药用价值极高,有强身健体之效,与琼珍灵芝合用治疗失眠。
茵陈清热利湿;退黄。主治:黄疸、小便不利、湿疮瘙痒、传染性黄疸型肝炎。等.药理学研究有利胆,保护肝功能,解热,抗炎,降血脂,降压,扩冠等作用.茵陈与青蒿,二者均气味芳香,能解湿热,故湿热黄疸,湿温,暑温之证,均可应用。但茵陈主入脾胃,为退黄主药;青蒿主入肝,胆,功专解骨蒸劳热,尤能泄暑温之火,为骨蒸劳热,疟疾寒热及暑温壮热所常用。
菊花的功效与作用:味微辛、甘、苦,性微寒。能疏散风热,清肝明目,平肝阳,解毒。用于感冒风热,发热头昏;肝经有热;目赤多泪,或肝肾阴虚,眼目昏花;肝阳上亢,眩晕头痛;疮疡肿痛。现代又用于冠心病、高血压病。降血压:菊花具有降血压、消除癌细胞、扩张冠状动脉和抑菌的作用,长期饮用能增加人体钙质、调节心肌功能、降低胆固醇,适合中老年人和预防流行性结膜炎时饮用。
地骨皮清热,凉血。治虚劳潮热盗汗,肺热咳喘,吐血,衄血,血淋,消渴,高血压,痈肿,恶疮。《本经》:″主五内邪气,热中消渴,周痹。″《别录》:″主风湿,下胸胁气,客热头痛,补内伤大劳嘘吸,坚筋,强阴,利大小肠,耐寒暑。″
白术,拉丁学名Atractylodes macrocephala。别名桴蓟,于术,冬白术,淅术,杨桴,吴术,片术、苍术等,属于菊科、苍术属多年生草本植物。喜凉爽气候,以根茎入药,具有多项药用功能。主要分布于四川、云南、贵州等山区湿地。白术具有健脾益气,燥湿利水,止汗,安胎的功效,用于脾虚食少,腹胀泄泻,痰饮眩悸,水肿,自汗,胎动不安。《医学启源》记载:“除湿益燥,和中益气,温中,去脾胃中湿,除胃热,强脾胃,进饮食,安胎。”
菟丝子中药菟丝子为双子叶植物药旋花科植物菟丝子、南方菟丝子、金灯藤等的种子,能补肾益精、养肝明目、固胎止泄之功效。滋补肝肾、固精缩尿,安胎,明目,止泻。用于阳痿遗精、尿有余沥、遗尿尿频、腰膝酸软、目昏耳鸣、肾虚胎漏、胎动不安、脾肾胎漏、胎动不安、脾肾虚泻;外治白癜风。将原药筛去泥屑,拣去杂质,晒干
熟地为玄参科植物地黄(学名:Rehmannia glutinosa)的块根,又名熟地黄或伏地,经加工炮制而成。通常以酒、砂仁、陈皮为辅料经反复蒸晒,至内外色黑油润,质地柔软粘腻。切片用,或炒炭用。熟地又名熟地黄或伏地,属玄参科植物,是一种上好中药材,具有补血滋阴功效,可用于血虚萎黄,眩晕,心悸失眠,月经不调,崩漏等症,亦可用于肾阴不足的潮热骨蒸、盗汗、遗精、消渴等症,是虚证类非处方药药品六味地黄丸主要成分之一。
绞股蓝主要有效成份是绞股蓝皂甙、绞股蓝糖甙(多糖)、水溶性氨基酸、黄酮类、多种维生素、微量元素、矿物质等。药材基源:为葫芦科植物绞股蓝的全草。性味:味苦;微甘;性凉。归经:归肺;脾;肾经。功效:益气健脾,化痰止咳,清热解毒。功效分类:补虚药;化痰药;清热药。主治:体虚乏力;虚劳失精;白细胞减少症;高脂血症;病毒性肝炎;慢性胃肠炎;慢性气管炎。
黄精(学名:Polygonatum sibiricum),又名:鸡头黄精、黄鸡菜、笔管菜、爪子参、老虎姜、鸡爪参。为黄精属植物,根茎横走,圆柱状,结节膨大。叶轮生,无柄。药用植物,具有补脾,润肺生津的作用。壮筋骨,益精髓,变白发:黄精、苍术各四斤,枸杞根、柏叶各五斤,天门冬三斤。煮汁一石,同曲十斤,糯米一石,如常酿酒钦。(《纲目》)补精气:枸杞子(冬采者佳)、黄精等分。为细末,二味招和,捣成块,捏作饼子,干复捣为末,炼蜜为丸,如梧桐子大。每服五十丸,空心温水送下。(《奇效良方》枸杞丸)。
垂盆草,中药名。为景天科植物垂盆草的干燥全草。甘、淡,凉。有利湿退黄,清热解毒之功效。常用于湿热黄疸,小便不利,痈肿疮疡。归肝、胆、小肠经。功效利湿退黄,清热解毒。主治用于湿热黄疸,小便不利,痈肿疮疡。
穿心莲(学名:Andrographis paniculata(Burm.f.)Nees),又名春莲秋柳,一见喜,榄核莲、苦胆草、金香草、金耳钩、印度草,苦草等。一年生草本植物,长4~8厘米,宽1~2.5厘米。药用植物,有清热解毒、消炎、消肿止痛作用。穿心莲水煎剂在体外能提高外周血白细胞吞噬金黄色葡萄球菌的能力。有报道口服穿心莲能使肿瘤病人及其它病人或健康人对旧结核菌素所致皮肤延缓型超敏反应增强。穿心莲甲素注射液也可增强吞噬细胞功能。3H--胸腺嘧啶核苷渗入淋巴细胞的体外试验表明,穿心莲水溶性衍生物注射液对PHA促进3H--胸腺嘧啶渗入有抑制作用。用穿心莲内酯合成的脱水穿心莲内酯琥珀酸半酯(DAS)对2,4--三硝基氯苯所致小鼠迟发型超敏反应也有抑制作用。穿心莲内酯有明显抑制静脉血中碳末廓清率的作用。穿心莲制剂一新得平(内含酯和酮)可提高小鼠血清溶菌酶水平。
本发明具体实施方式
具体实施例1:
采摘新鲜蒲公英5000g,洗净晾晒后将其浸泡乙醇中1-2小时,加热提取2次,每次1-2小时,取上清液,合并提取液,100-120目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.06的浸膏,加热浓缩至膏状,静置备用,成组分1。
将其余原料药茵陈1000g,夏枯草1000g,菊花1000g,白芍1000g,白术1000g,垂盆草1000g,莪术1000g,五味子1000g,金樱子1000g,地骨皮1000g,丹参1000g,墨旱莲1000g,制首乌1000g,菟丝子1000g,栀子1000g,熟地1000g,穿心莲1000g,绞股蓝1000g,黄精1000g,放入10倍量乙醇中,浸泡1-2小时,加热提取2次,每次1-2小时,合并提取液,静置后取上清液,然后放入减压浓缩罐内,减压回收乙醇,浓缩至药液浓度为0.6g生药/mL,抽滤至滤液的相对密度为80℃时1.06的浸膏,成为组分2。
将组分1和组分2合并后置入双效真空浓缩器中,浓缩至90℃时相对密度为1.36的浓缩液,置0~5℃低温冷藏24小时;将冷藏液加0.3%的助滤剂硅藻土,过滤,滤液再置入双效真空浓缩器中,浓缩至每1ml含0.1g生药量;浓缩后的膏剂加糊精调和,紫外线消毒杀菌后装瓶。
具体实施例2:
采摘新鲜蒲公英,洗净晾晒,共5000g,将其浸泡置于有盖不锈钢桶内,加70%乙醇液,质量为粗颗粒的0.8-1倍,搅拌均匀,湿润密闭放置1小时以上,使充分膨胀;将渗漉筒底部滤板用纱布袋包裹铺平后再将湿润膨胀后的药物样品拌松弄散,然后用不锈钢勺盛粉,均匀的装入渗漉筒,装10-12厘米厚,用T型棒压匀,再按上述操作,一层一层的装入,适当加压,药粉填装不得超过渗漉筒的2/3高处;药粉面上盖不锈钢孔板压牢,打开渗漉筒下面的放料阀,并放一容器,然后缓缓加入70%乙醇液;待排出药粉粉粒之间的空气,并有乙醇流出约20L左右,关闭放料阀,盖上漉筒、浸渍24小时,然后开放料阀进行渗漉,控制渗漉速度一般为1000g药材每分钟流出2~3ml,滤液放入贮液缸内,并将排空时的乙醇液倒入贮液缸;将渗滤液合并静置,静置备用,作为组分1。
将茵陈1200g,夏枯草1200g,菊花1100g,白芍1200g,白术1200g,垂盆草1100g,莪术1100g,五味子1200g,金樱子1200g,地骨皮1200g,丹参1100g,墨旱莲1100g,制首乌1200g,菟丝子1200g,栀子1200g,熟地1200g,穿心莲1200g,绞股蓝1200g,黄精1200g,将其余原料药的药放入10倍量乙醇中,浸泡1-2小时,加热提取2次,每次1-2小时,合并提取液,静置后取上清液,然后放入减压浓缩罐内,减压回收乙醇,浓缩至药液浓度为0.6g生药/mL,抽滤至滤液的相对密度为20℃时1.06的浸膏,成为组分2。
将组分1和组分2合并后置入双效真空浓缩器中,浓缩至90℃时相对密度为1.35的浓缩液,置0~5℃低温冷藏24小时;将冷藏液加0.3%的助滤剂硅藻土,过滤,滤液再置入双效真空浓缩器中,浓缩至每1ml含0.1g生药量;浓缩后的膏剂加糊精调和,紫外线消毒杀菌后装瓶。
具体实施例3:采摘新鲜蒲公英,洗净晾晒,共4500g后,放入提取罐加热提取2次,每次1-2小时,取上清液,合并提取液,100-120目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.06的浸膏,作为组分1,将所述其余原料茵陈1200g,夏枯草1200g,菊花1100g,白芍1200g,白术1200g,垂盆草1100g,莪术1100g,五味子1200g,金樱子1200g,地骨皮1200g,丹参1100g,墨旱莲1100g,制首乌1200g,菟丝子1200g,栀子1200g,熟地1200g,穿心莲1200g,绞股蓝1200g,黄精1200g,放入5-10倍量水中,浸泡1-2小时,加热提取2次,每次1-2小时,取上清液,合并提取液,100-120目滤过,将2次提取液合并静置,减压回收乙醇,并浓缩至药液浓度为0.6g生药/mL,抽滤后,滤液的相对密度约为20℃时1.08;减压至0.03-0.08MPa,温度保持在60-80℃,浓缩至相对密度为1.20,温度至60℃-70℃的浸膏,作为组分2。将组分1组分2混合置入双效真空浓缩器中,浓缩至90℃时相对密度为1.05的浓缩液,置0~5℃低温冷藏24小时;将冷藏液加0.3%的助滤剂硅藻土,过滤,滤液再置入双效真空浓缩器中,浓缩至每1ml含0.1g生药量;浓缩后的膏剂,紫外线消毒杀菌后装瓶。
具体实施例4:采摘新鲜蒲公英,洗净晾晒,共4500g后,泡入10倍量乙醇中,加热提取2次,每次1-2小时,取上清液,合并提取液,100-120目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.06的浸膏,加热浓缩至膏状,静置备用,成组分1。将茵陈1200g,夏枯草1200g,菊花1100g,白芍1200g,白术1200g,垂盆草1100g,莪术1100g,五味子1200g,金樱子1200g,地骨皮1200g,丹参1100g,墨旱莲1100g,制首乌1200g,菟丝子1200g,栀子1200g,熟地1200g,穿心莲1200g,绞股蓝1200g,黄精1200g,将所述原料药放入粉碎机粉碎后,将颗粒物放入乙醇中加热回流提取2次,每次1~2小时,将2次提取液合并静置;将上述乙醇提取过的药渣加10倍量水加热回流提取2次,每次1~2小时,将2次提取液合并静置,将上述两种提取液合并,作为组分2;合并组分1组分2减压浓缩相对密度为80℃时1.36的滤液,回收乙醇,调入蜂胶,紫外线杀菌后装瓶。
药理学毒性试验
一、皮肤刺激实验
1、实验方法
将豚鼠背部脊柱两侧将脱毛剂均匀涂上,使去毛范围约20平方厘米。洗净脱毛剂归笼观察24小时,每组豚鼠分别涂本发明4、8和12g,分别含生药92mg、184mg和368mg,另一组涂溶媒0.8ml每日二次,连续一周,实验结束后,将豚鼠处死,心,肝,肾及脱毛皮肤做病理检验。
2、结果
上述三组用药豚鼠躯干脱毛区,未见局部皮肤有水肿、充血、红斑、出血点及溃疡。用药组豚鼠毛发色泽、摄食、四肢活动等对照组无明显差异,病理组织学检查,给药组心、肝、肾及脱毛皮与对照字比较也无明显差异。
结果提示,本发明无局部刺激作用,也未见全身毒性表现。表明本发明制剂使用安全。
二、动物急性毒性试验研究:
本发明经预试验,不能测出LD 50,故测定最大给药量。采用直肠给药途径,测得小鼠的一日最大给药量为62.7g/kg(以药粉计),约为拟临床人用量的1567.5倍(人以60kg计),大鼠的一日最大给药量62.7g/kg(以药粉计),约为拟临床人用量的1567.5倍。实验动物均连续观察一周,其外观体征、精神状态、饮食、饮水、粪便等均未见明显异常。实验结束时,动物均健康存活,体重增加。
三、动物长期毒性试验研究:
本试验设本发明药物高、中、低剂量组和基质对照组、空白对照组,采用直肠给药途径给予大鼠,给药剂量分别为3.2、2.4和1.6g/kg(以药粉计),相当于拟临床病人用量[0.04g(药粉)/kg]的80、60和40倍,连续给药2个月,在给药过程中,各给药组及基质组大鼠的体重、饮食量、外观体征、行为活动、精神状态、毛色、粪便性状与空白对照组比较,无明显差异(P>0.05),动物体重增长值和主要脏器系数与空白对照组比较差异不显著(P>0.05),血液学和血液生化指标检查结果给药组个别指标与空白对照组比较差异显著(P<0.05),但恢复期结束后有差异的血液学和血液生化指标均已恢复正常,其他指标与空白对照比较差异不显著(P>0.05),给药期和恢复期组织学检查高剂量组动物主要脏器与空白对照组比较未见明显差异,未见迟缓性毒性出现。
药效学实验:
用现代免疫学理论和技术,研究中药对增强与调节机体免疫功能的作用,这对阐明有关中医理论的物质基础有着十分重要的意义。本发明由蒲公英、制首乌、垂盆草等数种天然药物经科学配伍而成。已有的研究发现,蒲公英可调整机体各系统脏器的功能,对免疫细胞和免疫分子均有调节作用。本实验旨在进一步探讨本发明对免疫力低下小鼠免疫调节作用的分子免疫学机制。
1材料与方法
1.1仪器与试剂:本发明蒲公英保健口服液由本院提供(按实施例2方法制备);注射用环磷酰胺由上海华联制药有限公司提供。细胞因子检测试剂盒均购于美国R&D公司。流式细胞仪,2000FCA,美国BD公司生产。
1.2动物昆明系雄性小鼠30只,5-7周,体重为25±2g,由山东大学实验动物有限责任公司提供。
1.3方法
1.3.1动物模型建立与分组将昆明系雄性小鼠随机分为3组:空白对照组、模型组和药物组,每组10只。空白对照组:实验进程中正常饲养不作任何处理;模型组:腹腔内注射100mg/kg环磷酰胺造成免疫力低下模型,1次/d,连续3天;药物组:腹腔内注射100mg/kg环磷酰胺造成免疫力低下模型,1次/d,连续3天,并在造模第一天在小鼠左胫前肌涂抹给药,0.1mL/只,一周后加强免疫1次,剂量同第一次。4d后采集样本。
1.3.2小鼠免疫器官指数的测定小鼠称量体重后,颈椎脱臼处死小鼠,取胸腺、脾脏称其湿重,计算胸腺指数和脾指数:胸腺指数=胸腺重×1000/体重脾指数=脾重×1000/体重1.3.3小鼠血清IgG,IgM水平的测定按试剂盒说明书方法,测定小鼠血清中IgG,IgM含量。
1.3.4小鼠脾组织T淋巴细胞及其亚群CD4+,CD8+及CD4+/CD8+的测定无菌取脾,置于盛有适量无Hank’s液平皿中,用镊子轻轻将脾磨碎,制成单个胞悬液,经200目筛网过滤,将细胞悬浮于1mL的完全培养液中,调整细胞浓度1×109L-1,用微量移液器小心地将100μL充分混匀的脾细胞悬液加到进样管的底部,加20μL单克隆抗体,低速振荡混匀3S,室温避光孵育30min,于The medicine studyPREP破碎红细胞后,上流式细胞仪检测T细胞亚群含量。
1.3.5小鼠血清IFN-Y、IL-10水平的测定按试剂盒说明书方法,测定血清中IFN-Y、IL-10的水平。
1.2统计学处理所有数值均以x±s表示,运用SPSS13.0统计软件进行数据分析,组间比较采用t检验。以P<0.05作为统计显著性差异标准。
2结果
2.1对免疫力低下小鼠免疫器官的影响由表1得出,与正常对照组相比,模型组脾脏和胸腺指数显著降低,差异有统计学意义,P<0.01。与模型组比较,药物组小鼠脾脏指数明显增加,具有统计学意义,P<0.01,胸腺指数也有所增加,但差异不显著。
表1本发明对免疫力低下小鼠免疫器官重量的的影响(n=10,mean±s)
组别 | 脾脏指数(mg/g) | 胸腺指数(mg/g) |
正常对照组 | 6.06±1.04 | 3.23±1.01 |
模型组 | 2.91±0.89△Δ | 1.45±0.75ΔΔ |
本发明组 | 5.28±0.42** | 1.85±0.86 |
与正常对照组比:Δ:P<0.05,ΔΔ:P<0.01;与模型组比:*:P<0.05,**:P<0.01
2.2对免疫力低下小鼠脾组织T淋巴亚群的影响由表2看出,与正常对照组相比,模型组小鼠脾脏CD4+细胞亚群百分比下降,CD8+细胞亚群百分比上升,具有显著差异,P<0.05,CD4+/CD8+比值明显降低,具有极显著性差异,P<0.01。而药物组能明显抵消环磷酰胺破坏免疫力的作用,具有显著性差异,P<0.05。
表2金刚天盾液对免疫力低下小鼠体液T细胞亚群的的影响(n=10,mean±SD)
与正常对照组比:ΔP<0.05,△ΔP<0.05;与比模型组:*P<0.05,**P<0.05。
胸腺、脾脏为机体的重要淋巴器官。胸腺是T细胞发育,分化,成熟的场地,其结构及功能与机体状态紧密相关。胸腺指数的降低以及胸腺萎缩,都是小鼠以细胞免疫为主的免疫抑制的表现。脾脏是体内最大的外周免疫器官,脾脏的免疫细胞以B淋巴细胞为主,而B淋巴细胞是参与体液免疫的主要细胞,因此脾脏与机体体液免疫的关系密切。胸腺指数和脾指数直观的反应了免疫机体功能的强弱。本实验表明,本发明对环磷酰胺所致免疫力低下小鼠脾脏的发育有促进作用,对胸腺的发育也有一定的促进作用。T淋巴细胞按其功能可分为CD4+和CD8+两个亚群。CD4+T淋巴细胞在机体的免疫反应中处于非常重要的中心地位,它通过分泌多种淋巴因子激活其他T、B细胞亚群及参与免疫反应的其他细胞,使其增殖和分化,并协调免疫细胞间的相互作用,发挥机体免疫系统的功能。CD4+/CD8+的比值上升,提示免疫应答的正调节占优势,而比值下降,提示免疫功能低下。对外周血中T淋巴细胞亚群的测定,表明本发明能够使环磷酰胺所致免疫力低下小鼠CD4+T淋巴细胞的百分含量升高,使CD4+/CD8+的比值上升,提示本发明对T淋巴细胞免疫系统起正调节作用。IgG、IgM水平则反映了体液免疫能力。本研究表明本发明促进免疫力低下小鼠IgG、IgM分泌增加。说明本发明不但促进了机体细胞免疫功能的增强,同时对体液免疫也有促进作用。
具体实施例:李某,男,46岁,于2015年1月初诊。自述是项目经理,经常出差、应酬多,压力大,抽烟喝酒。最近感觉经常感冒,且失眠多梦,易燥,免疫力低下。性功能低下,不能正常勃起。血项,B超未见器质性病变。人到中年,各种压力以及环境污染使免疫系统不能正常发挥保护作用,在此情况下,极易招致细菌、病毒、真菌等感染,因此免疫力低下最直接的表现就是容易生病。因经常患病,加重了机体的消耗,所以一般有体质虚弱、营养不良、精神萎靡、疲乏无力、性欲低下、夜尿频多、食欲降低、睡眠障碍等表现,生病、打针吃药便成了家常便饭。每次生病都要很长时间才能恢复,而且常常反复发作因常年服药,对药物产生抵触情绪,建议用养生保健品代替服用中药。
方用:蒲公英15g,茵陈12g,夏枯草13g,菊花11g,白芍11g,白术12g,垂盆草13g,莪术12g,五味子12g,金樱子13g,地骨皮12g,丹参12g,墨旱莲13g,制首乌12g,菟丝子12g,栀子12g,熟地13g,穿心莲12g,绞股蓝12g,黄精12g。制成口服液,每日3瓶,服用10天后,患者自觉诸症改善,食欲大增、睡眠障碍减低,精神萎靡改善、疲乏无力改善、晨勃现象增多,夜尿几乎没有。继续服用2个月,睡眠好,精神状态大好,并且性生活和谐。继续每天使用,诸症皆消,精力旺盛。
Claims (10)
1.一种提高免疫力的蒲公英口服液,其特征在于,所述口服液包括以下重量份数的原料药:蒲公英10~50份,茵陈10~20份,夏枯草10~20份,菊花10~20份,白芍10~20份,白术10~20份,垂盆草10~20份,莪术10~20份,五味子10~20份,金樱子10~20份,地骨皮10~20份,丹参10~20份,墨旱莲10~20份,制首乌10~20份,菟丝子10~20份,栀子10~20份,熟地10~20份,穿心莲10~20份,绞股蓝10~20份,黄精10~20份。
2.根据权利要求1所述提高免疫力的蒲公英口服液,其特征在于,所述口服液还包括以下重量份数的原料药:蒲公英10~30份,茵陈10~15份,夏枯草10~15份,菊花10~15份,白芍10~15份,白术10~15份,垂盆草10~15份,莪术10~15份,五味子10~15份,金樱子10~15份,地骨皮10~20份,丹参10~20份,墨旱莲10~20份,制首乌10~20份,菟丝子10~20份,栀子10~20份,熟地10~20份,穿心莲10~20份,绞股蓝10~20份,黄精10~20份。
3.根据权利要求1所述提高免疫力的蒲公英口服液,其特征在于,所述口服液也包括以下重量份数的原料药:蒲公英10~40份,茵陈10~20份,夏枯草10~20份,菊花10~20份,白芍10~20份,白术10~20份,垂盆草10~20份,莪术10~20份,五味子10~20份,金樱子10~20份,地骨皮10~15份,丹参10~15份,墨旱莲10~15份,制首乌10~15份,菟丝子10~15份,栀子10~15份,熟地10~15份,穿心莲10~15份,绞股蓝10~15份,黄精10~15份。
4.一种如权利要求1~3中任一项所述提高免疫力的蒲公英口服液的制备方法,其特征在于,所述口服液的制备步骤包括:
a.蒲公英的萃取,作为组分1;
b.将所述其余原料药放入乙醇中加热回流提取2次,作为组分2;
c.将上述两种提取液组分1和组分2合并,浓缩后加蜂蜜或糊精调和,消毒杀菌后制备成口服液装瓶。
5.根据权利要求4所述提高免疫力的蒲公英口服液的制备方法,其特征在于,所述步骤a中,采摘蒲公英后切碎,将其浸泡置于有盖不锈钢桶内,加70%乙醇液,质量为粗颗粒的0.8-1倍,搅拌均匀,湿润密闭放置1小时以上,使充分膨胀;将渗漉筒底部滤板用纱布袋包裹铺平后再将湿润膨胀后的药物样品拌松弄散,然后用不锈钢勺盛粉,均匀的装入渗漉筒,装10-12厘米厚,用T型棒压匀,再按上述操作,一层一层的装入,适当加压,药粉填装不得超过渗漉筒的2/3高处;药粉面上盖不锈钢孔板压牢,打开渗漉筒下面的放料阀,并放一容器,然后缓缓加入70%乙醇液;待排出药粉粉粒之间的空气,并有乙醇流出约20L左右,关闭放料阀,盖上漉筒、浸渍24小时,然后开放料阀进行渗漉,控制渗漉速度一般为1000g药材每分钟流出2~3ml,滤液放入贮液缸内,并将排空时的乙醇液倒入贮液缸;将渗滤液合并静置,静置备用,作为组分1。
6.根据权利要求4所述提高免疫力的蒲公英口服液的制备方法,其特征在于,所述步骤b中,将所述其余原料泡入占其质量10倍量乙醇中,加热提取2次,每次1-2小时,取上清液,合并提取液,100-120目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.06的浸膏,加热浓缩至膏状,静置备用,成组分2。
7.根据权利要求4所述提高免疫力的蒲公英口服液的制备方法,其特征在于,所述步骤c中,将组分1和组分2合并后,置入双效真空浓缩器中,浓缩至90℃时相对密度为1.36的浓缩液,置0~5℃低温冷藏24小时;将冷藏液加0.3%的助滤剂硅藻土,过滤,滤液再置入双效真空浓缩器中,浓缩至每1ml含0.1g生药量;浓缩后的膏剂加蜂蜜或糊精调和,紫外线消毒杀菌后装瓶。
8.一种如权利要求1~3中任一项所述提高免疫力的蒲公英口服液的制备方法,其特征在于,制备步骤还可以为:
a.将蒲公英加乙醇提取,作为组分1;
b.将蒲公英提取后残渣与所述其余原料药一起加水浸泡、提取2次作为组分2;
c.将组分1、组分2混合浓缩后加蜂蜜调和,紫外线消毒杀菌后装瓶。
9.根据权利要求8所述提高免疫力的蒲公英口服液的制备方法,其特征在于,所述步骤a中,将采摘好的蒲公英洗净,晾晒后放入提取罐加占其质量5-10倍量乙醇,加热提取2次,每次1-2小时,取上清液,合并提取液,100-120目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.06的浸膏,作为组分1;所述步骤b中,将提取的蒲公英渣滓与所述其余原料一起放入占其质量5-10倍量水中,浸泡1-2小时,加热提取2次,每次1-2小时,取上清液,合并提取液,100-120目滤过,将2次提取液合并静置,减压并浓缩至药液浓度为0.6g生药/mL,抽滤后,滤液的相对密度约为20℃时1.08;减压至0.03-0.08MPa,温度保持在60-80℃,浓缩至相对密度为1.20,温度至60℃-70℃的浸膏,作为组分2。
10.根据权利要求8所述提高免疫力的蒲公英口服液的制备方法,其特征在于,所述步骤c中,将组分1与组分2混合后放入减压浓缩罐内,减压回收乙醇,浓缩至药液浓度为0.1g生药/mL,抽滤至滤液的相对密度为20℃时1.06;上述滤液经体积为10L的大孔吸附树脂柱吸附后,用10倍树脂柱体积的去离子水或蒸馏水洗脱,再用5倍树脂柱体积的95%乙醇洗脱,收集乙醇洗脱液,去除溶剂,再调和蜂蜜,紫外线消毒杀菌后装瓶。
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