CN115192680A - 一种治疗流感的药物制备方法及其功效 - Google Patents
一种治疗流感的药物制备方法及其功效 Download PDFInfo
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Abstract
本发明涉及一种治疗流感的药物。具体的说是一种治疗流感的纯中药组成、还涉及到制备方法。本发明治疗流感的药物,由以下组分制备而成,均以重量份计:金银花7.5~30份,蒲公英15~25份,槟榔50~75份,厚朴25~50份,草果15~30份,知母25~30份,芍药25~50份,黄芩25~50份,甘草12~30份,柴胡0~30份,青蒿0~30份组成。本发明的药物为纯中药制成,与含有化学成分的药品不同,服用后不瞌睡,降温效果好,且对人体的副作用较小。
Description
技术领域
本发明主要涉及医药、健康保健技术领域,具体是一种治疗流感的纯中药药物组成,还涉及到具体制备方法,还进一步涉及到功效试验和安全性试验。
背景技术
流行性感冒是由流感病毒引起的一种急性呼吸道传染病。其临床特点为起病急,全身症状明显,如高热、头痛、全身酸痛、四肢软弱无力等,而呼吸道症状主要表现为咳嗽,痰多,呼吸困难。流行性感冒主要通过飞沫传播,传染性强,轻症患者病程短,常呈自限性,重症患者需进行药物治疗,一般可治愈。
流感的传染性非常强,它是由流感病毒引起的急性呼吸道传染病。流感病毒有A型、B型和C型3种,由于这种病毒变异非常迅速,而人们对流感病毒变异所产生的新种系往往缺乏免疫力,所以流感不但容易引起暴发性流行,也可能会是灾难性的。一般来说,流行性感冒的症状多半表现在呼吸道***上,大部份人都能在两天至一星期内自行痊愈,但是对于长者及患有慢性疾病的患者来说,如心脏病、慢性呼吸道疾病患者,则易因细菌感染而导致支气管炎、肺炎及脑膜炎等并发症的发生,甚至导致死亡。目前的治疗方法主要是采用西医治疗,但是很多治疗感冒的药物属于抗生药物,并且还含有扑尔敏等导致人嗜睡的成份,不能满足大众的需求。
目前,治疗感冒发烧的药物很多,但是,许多中西药品绝大部分含有马来酸氯苯那敏(扑尔敏),虽然降温效果不错,但嗜睡、瞌睡的副作用较大,影响工作、学习、作业安全。
发明内容
本发明的目的在于克服上述缺陷,提供了一种安全、有效地治疗流感的药物。
本发明的另一目的是提供治疗流感的药物的制备方法。
本发明目的在于提供一种治疗流感的药物组成。其特征在于,由下述的按重量分数计的各原料药:金银花7.5~30份,蒲公英15~25份,槟榔50~75份,厚朴25~50份,草果15~30份,知母25~30份,芍药25~50份,黄芩25~50份,甘草12~30份,柴胡0~30份,青蒿0~30份组成。
一种治疗流感的药物组成、制备方法及其功效。其特征在于,由下述的按重量分数计的各原料药:金银花15份,蒲公英10份,槟榔30份,厚朴25份,草果12份,知母25份,芍药25份,黄芩25份,甘草8份,柴胡10份,与适量食品或药学可接受的辅料组成。
一种治疗流感的药物组成、制备方法及其功效。其特征在于,由下述的按重量分数计的各原料药:金银花10份,蒲公英10份,槟榔30份,厚朴25份,草果15份,知母25份,芍药25份,黄芩25份,甘草10份,与适量食品或药学可接受的辅料组成。
一种治疗流感的药物组成、制备方法及其功效,其特征在于,由下述的按重量分数计的各原料药:金银花15份,蒲公英10份,青蒿10份,柴胡10份,槟榔35份,厚朴30份,草果125份,知母25份,芍药25份,黄芩25份,甘草10份,与适量食品或药学可接受的辅料组成。
本发明目的还在于组方合理。
方用
金银花又名忍冬(学名:Lonicerajaponica)。“金银花”一名出自《本草纲目》,由于忍冬花初开为白色,后转为黄色,因此得名金银花。药材金银花为忍冬科忍冬属植物忍冬及同属植物干燥花蕾或带初开的花。金银花性寒,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。其对于头昏头晕、口干作渴、多汗烦闷、肠炎、菌痢、麻疹、肺炎、乙脑、流脑、急性乳腺炎、败血症、阑尾炎、皮肤感染、痈疽疔疮、丹毒、腮腺炎、化脓性扁桃体炎等病症均有一定疗效。现代药理研究表明:金银花水煎剂(1:20)在人胚肾原单层上皮细胞组织培养上,对流感病毒、孤儿病毒、疱疹病毒有抑制作用。在本发明中,金银花具有清热解毒、透邪外出、和胃止呕作用,可用以邪热壅阻,胃气不和,发热烦躁,胸膈痞闷,口渴干呕,舌红苔燥,脉象滑数。
蒲公英本品为菊科植物蒲公英Taraxacum mongolicum Hand.-Mazz.、碱地蒲公英Taraxacum sinicum Kitag.或同属数种植物的干燥全草。春至秋季花初开时采挖,除去杂质,洗净,晒干。归肝、胃经。性味苦、甘,寒。清热解毒,消肿散结,利尿通淋。用于疔疮肿毒,乳痈,瘰疠,目赤,咽痛,肺痈,肠痈,湿热黄疸,热淋涩痛。蒲公英与金银花,同是消痈化疡之物,蒲公英只入阳明、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。本发明中,蒲公英清热解毒,利尿,缓泻。
槟榔为棕榈科植物槟榔的种子。归胃、大肠经。性味苦、辛,温。杀虫消积,降气,行水,截疟。用于绦虫、蛔虫、姜片虫病,虫积腹痛,积滞泻痢,里急后重,水肿脚气,疟疾。《日华子本草》:"除一切风,下一切气,通关节,利九窍,补五劳七伤,健脾调中,除烦,破癥结,下五膈气。"《本草汇言》:" 槟榔,主治诸气,祛瘴气、破滞气、开郁气、下痰气、去积气、解蛊气、消谷气、逐水气、散脚气、杀虫气、通上气、宽中气、泄下气之药也。现代药理研究表明,煎剂和水浸剂对流感病毒甲型某些株有一定的抑制作用,推测抗病毒作用可能与其中所含鞣质有关。本发明中:槟榔可辛散湿邪,化痰破结,使邪速溃。
厚朴为木兰科植物厚朴或凹叶厚朴的树皮或根皮。归脾、胃、肺、大肠经。性味苦、辛,温。功能主治燥湿消痰,下气除满。用于湿滞伤中,脘痞吐泻,食积气滞,腹胀便秘,痰饮喘咳。芳香化浊,理气祛湿;
草果为姜科植物草果Amomum tsao-ko Crevost et Lemaire的干燥成熟果实。归脾、胃经。性味辛、温。功能主治燥湿温中,除痰截疟。用于寒湿内阻,脘腹胀痛,痞满呕吐,疟疾寒热。《本草正义》:"草果,辛温燥烈,善除寒湿而温燥中宫,故为脾胃寒湿主药。""按岚瘴皆雾露阴湿之邪,最伤清阳之气,故辟瘴多用温燥芳香,以胜阴霾湿浊之蕴祟。草果之治瘴疟,意亦犹是。然凡是疟疾,多湿痰蒙蔽为患,故寒热往来,纠缠不巳,治宜开泄为先。草果善涤湿痰,而振脾阳,更以知母辅之,酌量其分量,在本发明中,辛香化浊,辟秽止呕,宣透伏邪
知母为百合科植物知母Anemarrhena asphodeloides Bunge.的干燥根茎。归肺、胃、肾经。性味苦、甘,寒。清热泻火,生津润燥。用于外感热病,高热烦渴,肺热燥咳,骨蒸潮热,内热消渴,肠燥便秘。用于温热病、高热烦燥、口渴、脉洪大等肺胃实热之症及肺热喘咳、痰黄而稠。知母苦寒,上能清肺热,中能清胃火,故适用于肺胃有实热的病症。用于阴虚发热、虚劳咳嗽及消渴等症。知母能泻肺火而滋肾,故不仅能清实热,且可清虚热。知母性味苦寒而不燥,上能清肺,中能凉胃,下能泻肾火。配以黄芩,则泻肺火;知母既能清实热,又可退虚热,但它滋阴生津的功效较弱,用于阴虚内热、肺虚燥咳及消渴等症,须与滋阴药配伍,始能发挥它的作用。在本发明中,清热滋阴,并可防诸辛燥药之耗散阴津。
黄芩为唇形科植物黄芩Scutellariabaicalensis Georgi的干燥根。归肺、胆、脾、大肠、小肠经。性味苦,寒。清热燥湿,泻火解毒,止血,安胎。用于湿温、暑温胸闷呕恶,湿热痞满,泻痢,黄疸,肺热咳嗽,高热烦渴,血热吐衄,痈肿疮毒,胎动不安。《本经疏证》:仲景用黄芩有三耦焉,气分热结者,与柴胡为耦(小柴胡汤、大柴胡汤、柴胡桂枝干姜汤、柴胡桂枝汤):血分热结者,与芍药为耦(桂枝柴胡汤、黄芩汤、大柴胡汤、黄连阿胶汤、鳖甲煎丸、大黄虫丸、奔汤、王不留行散、当归散);湿热阻中者,与黄连为耦(半夏泻心汤、甘草泻心汤、生姜泻心汤、葛根黄芩黄连汤、于姜黄芩黄连人参汤)。以柴胡能开气分之结,不能泄气分之热,芍药能开血分之结,不能清迫血之热,黄连能治湿生之热,不能治热主之湿。譬之解斗,但去其斗者,未平其致斗之怒,斗终未已也。故黄芩协柴胡,能清气分之热,协芍药,能泄迫血之热,协黄连,能解热生之湿也。
白芍为毛茛科植物芍药Paeonia lactifloraPall.的干燥根。归肝、脾经。性味苦、酸,微寒。平肝止痛,养血调经,敛阴止汗。用于头痛眩晕,胁痛,腹痛,四肢挛痛,血虚萎黄,***,自汗,盗汗。
甘草为豆科植物甘草Glycyrrhiza uralensis Fisch.、胀果甘草GlycyrrhizainflataBat.或光果甘草Glycyrrhiza glabra L.的干燥根。归心、肺、脾、胃经。性味甘,平。补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。用于脾胃虚弱,倦怠乏力,心悸气短,咳嗽痰多,脘腹、四肢挛急疼痛,痈肿疮毒,缓解药物毒性、烈性。生用为使者,既能清热解毒,
柴胡为伞形科植物柴胡Bupleurum chinense DC.或狭叶柴胡BupleurumscorzonerifoliumWilld.的干燥根。归肝、胆经。性味苦,微寒。和解表里,疏肝,升阳。用于感冒发热,寒热往来,胸胁胀痛,***,子官脱垂,脱肛。解热镇痛作用:《纲目》:劳有五劳,病在五脏。若劳在肝、胆、心及包络有热,或少阳经寒热者,则柴胡乃手足厥阴、少阳必用之药;劳在脾胃有热,或阳气下陷,则柴胡乃引清气退热必用之药;惟劳有肺肾者不用可尔。然东垣李氏言诸有热者宜加之,无热则不加。又言诸经之疟,皆以柴胡为君;十二经疮疽,须用柴胡以散结聚。则有肺疟肾疟、十二经之疮有热者,皆可用之矣。但要用者精思病原,加减佐使可也。
青蒿为菊科植物黄花蒿Artemisia annua L.的干燥地上部分。归肝、胆经。性味苦、辛,寒。清热解暑,除蒸,截疟。用于暑邪发热,阴虚发热,夜热早凉,骨蒸劳热,疟疾寒热,湿热黄疸。《本草新编》:"青蒿,专解骨蒸劳热,尤能泄暑热之火,泄火热而不耗气血,用之以佐气血之药,大建奇功,可君可臣,而又可佐可使,无不宜也。但必须多用,因其体既轻,而性兼补阴,少用转不得力。又青蒿之退阴火,退骨中之火也,然不独退骨中之火,即肌肤之火,未尝不共泻之也,故阴虚而又感邪者,最宜用耳。又青蒿最宜沙参、地骨皮共享,则泻阴火更捷,青蒿能引骨中之火,行于肌表,而沙参、地骨皮只能凉骨中之火,而不能外泄也。"《重庆堂随笔》:"青蒿,专解湿热,而气芳香,故为湿温疫疠要药。
“疫者感天地之疠气,……邪从口鼻而入,则其所客,内不在脏腑,外不在经络,舍于伏膂之内,去表不远,附近于胃,乃表里之分界,是为半表半里,即所谓‘横连膜原’者也。”疫邪入膜原半表半里,邪正相争,故见憎寒壮热;温疫热毒内侵入里,导致呕恶、头痛、烦躁、苔白厚如积粉等一派秽浊之候。此时邪不在表,忌用发汗;热中有湿,不能单纯清热;湿中有热,又忌片面燥湿。当以开达膜原,辟秽化浊为法。方用金银花清热解毒、透邪外出、和胃止呕。蒲公英清热解毒,利尿,缓泻。槟榔辛散湿邪,化痰破结,使邪速溃,共为君药。厚朴芳香化浊,理气祛湿;草果辛香化浊,辟秽止呕,宣透伏邪,共为臣药。以上三药气味辛烈,可直达膜原,逐邪外出。凡温热疫毒之邪,最易化火伤阴,故用白芍、知母清热滋阴,并可防诸辛燥药之耗散阴津;黄芩苦寒,清热燥湿,共为佐药。配以甘草生用为使者,既能清热解毒,又可调和诸药。全方合用,共奏开达膜原,辟秽化浊,清热解毒之功,可使秽浊得化,热毒得清,阴津得复,则邪气溃散,速离膜原,故以“达原饮”名之。
本发明所述本发明目的在于提供一种治疗流感的药物,其制备方法,包括以下步骤:
(1)提取:分别加6~10倍量的水煎煮2~3次,每次1~2小时,滤过,浓缩。
(2)浓缩:双效浓缩装置,减压浓缩。
(3)干燥:喷雾干燥。
(4)成型:可以加食品或药学可以接受的辅料或者食品添加剂,经制粒、干燥、总混、制备成颗粒剂、胶囊剂、片剂、缓释片、分散片或散剂。
上述的辅料或食品添加剂,可以是药物或食品可以接受的玉米淀粉、麦芽糊精、羧甲淀粉钠、微晶纤维素、羟基纤维素钠等。
上述所说的制粒,是指全部原料、辅料或添加剂混合均匀,加入粘合剂,搅拌,制成软材,经颗粒机制成颗粒,干燥。
上述所说的粘合剂,可以是药学或者食品可以接受的不同质量比例的乙醇、淀粉浆、羧甲淀粉钠胶浆、纤维素溶液、聚乙烯吡咯烷酮乙醇溶液。
上述所说的制粒,也可以干法制粒。
上述所说的制粒,也可以不制粒,直接粉末分装、灌装胶囊或直接压片。
本发明的最大有益效果是:
本发明的药物为纯中药制成,不含任何化学成分,具有明显的解热降温效果,服用后不瞌睡,不影响学生上课听讲,完成作业。不影响驾驶人员正常驾驶操作。不影响高空作业人员的正常工作。且对人体无副作用。
本发明在于有明确的有效性
本发明的有效性在于对角叉菜胶致大鼠足跖肿胀有明显的影响
方法:50只雄性大鼠,分为模型对照组、阳性对照组(醋酸***, 2.0mg/kg)、本品供试品低(1.75g/kg)、中(3.50g/kg)、高(7.00g/kg)剂量组,10只/性别/组。每天灌胃给药1次,连续7天,给药体积1.0ml/100g。末次给药后1.5h于大鼠左后足跖皮下注入1%角叉菜胶0.1ml/只致炎,用足趾容积测量仪分别在致炎前、致炎后1、2、3h测量各组足跖容积,计算出足跖肿胀值 (致炎后容积与致炎前容积之差)。
结果:
组别 | 剂量 | 动物数(只) | 致炎后1h | 致炎后2h | 致炎后3h |
模型对照 | — | 10 | 0.410±0.100 | 0.414±0.126 | 0.444±0.102 |
阳性对照 | 2.0mg/kg | 10 | 0.115±0.044<sup>**</sup> | 0.007±0.087<sup>**</sup> | 0.107±0.091<sup>**</sup> |
低剂量 | 1.75g/kg | 10 | 0.343±0.109 | 0.387±0.069 | 0.371±0.102 |
中剂量 | 3.50g/kg | 10 | 0.367±0.083 | 0.329±0.079<sup>*</sup> | 0.366±0.091 |
高剂量 | 7.00g/kg | 10 | 0.267±0.097<sup>**</sup> | 0.322±0.094<sup>*</sup> | 0.353±0.107<sup>*</sup> |
结论:在本实验统计下,在3.50~7.00g/kg剂量下对角叉菜胶引起的大鼠足跖肿胀具有明显的消炎作用。
本发明的有效性还在于对小鼠有明显的镇痛作用(扭体法)
50只SPF级ICR小鼠,雌雄各半,按体重随机为模型对照组、阳性对照组 (阿司匹林,0.2g/kg)、供试品低剂量(3.50g/kg)、中剂量(7.00g/kg)和高剂量(14.00g/kg)组。每天灌胃给药1次,连续7天,给药体积0.2ml/10g。末次给药后1.5小时,腹腔注射0.6%的冰醋酸0.2ml/20g,腹腔注射0.6%的冰醋酸后即刻记录各组小鼠15分钟内的扭体次数。
表扭体次数结果表
组别 | 剂量(g/kg) | 动物数(只) | 扭体次数(次) |
模型对照 | — | 10 | 26.5±14.05 |
阳性对照 | 0.2 | 10 | 10.0±7.26<sup>**</sup> |
低剂量 | 3.50 | 10 | 23.3±13.05 |
中剂量 | 7.00 | 10 | 16.8±7.91<sup>**</sup> |
高剂量 | 14.00 | 10 | 16.6±8.09<sup>**</sup> |
注:**P﹤0.01,与模型对照组比较。
结论在7.00~14.00 g生药/kg之间,对0.6%的冰醋酸引起的腹痛(扭体反应)有一定的镇痛作用。
本发明的有效性还在于对小鼠有明显的镇痛作用(热板法)
50只SPF级ICR小鼠,雌性,按体重随机为模型对照组、阳性对照组(吲哚美辛,5mg/kg)、供试品低剂量(3.50 g/kg)、中剂量(7.00 g/kg)和高剂量 (14.00 g/kg)组。每天灌胃给药1次,连续7天,给药体积0.2ml/10g。末次给药90分钟后,將小鼠放入热板仪中,分别测定各组小鼠痛阈值。
表 痛阈值结构记录表
组别 | 剂量 | 动物数(只) | 痛阈值(s) |
模型对照 | — | 10 | 18.91±2.95 |
阳性对照 | 5mg/kg | 10 | 28.24±5.92<sup>**</sup> |
低剂量 | 3.50g/kg | 10 | 21.28±2.99 |
中剂量 | 7.00g/kg | 10 | 24.80±1.68<sup>**</sup> |
高剂量 | 14.00g/kg | 10 | 26.86±3.94<sup>**</sup> |
注:**P﹤0.01,与模型对照组比较。
结论:供试品在7.00~14.00 g生药/kg之间,对热板(55℃)致小鼠引起的疼痛具有一定的镇痛作用。
本发明的有效性还在于对内毒素(脂多糖)所致发热家兔模型体温有明显的影响
选体温在38.0~39.5℃范围内且每天波动不超过0.4℃的家兔30只,以试验当日测得的体温正常值按体温正常值均衡原则分为5组,分别为模型对照组、对乙酰氨基酚阳性对照组(0.2g/kg)、供试品低(1.05g生药/kg)、中(2.10g 生药/kg)、高(4.20g生药/kg)剂量组,每组6只,雌雄各半。灌胃给药1次,给药体积3ml/kg。于给药30分钟后,家兔耳缘静脉注射脂多糖(0.2ug/kg)造模,给药后每隔1小时测量1次体温,共测5次,测量致热后不同时间的体温变化。
结果:对脂多糖所致兔发热的影响(X±SD,n=6)
注:与模型对照组比较,*P<0.05,**P<0.01
结论:供试品在2.10~4.20g生药/kg之间,对内毒素(脂多糖)所致发热家兔有一定的降温趋势。
本发明的有效性还在于对酵母致大鼠发热有明显的影响
方法:检疫合格的大鼠,于试验前2天,每天测基础体温2次,选取体温在37.0~39.0℃范围内的正常大鼠50只,雌雄各半,按体温顺序排列,依拉丁方分组法分为模型对照组、阳性药对照组(对乙酰氨基酚0.166g/kg)、供试品低(1.75g/kg)、中(3.50g/kg)、高(7.00g/kg)剂量组,5只/组/性别。给药前5h大鼠皮下注射20%酵母悬液造模。给药后0h、1h、2h、3h、4h和5h各测 1次体温。
结果:
对酵母致大鼠发热的影响(℃,X±S,n=10)
注:统计学显著性比较,*:P<0.01
结论:在1.75~7.0g生药/kg剂量范围内,对酵母菌所致发热大鼠有一定的降温趋势。
本发明好在于明确的安全性
本发明的安全性在于大鼠灌胃单次给药毒性极低(最大给药量法)
采用最大给药量法进行单次给药毒性试验。取SPF级SD大鼠40只,雌雄各半、按体重分为2组,溶媒对照组、供试品组,每组20只。24h两次灌胃给药,给药体积为20ml/kg,药后观察动物的毒性反应情况,连续观察14 d。于给药时、药后第1、3、5、7、9、14d称重。中途死亡动物及存活观察结束后将所有的大鼠进行解剖,观察各脏器的位置、形态、大小、颜色、质地,有无分泌物(或渗出物)、瘀血、出血、水肿、坏死等变化。
结论:给药后大鼠出现活动减少、排便黑色、尿液深黄色等症状,症状在2~3天后消失。大体解剖肉眼观察未见明显的病理学改变,给药组存活动物2~3 天后均恢复正常,体重增长良好。未能引起明显的急性毒性反应。
本发明的安全性进一步在于大鼠灌胃给药4周重复给药未见严重的毒性反应
分组给药取检疫合格的大鼠120只,雌雄各半,分为4组,分别为溶媒对照组(蒸馏水)、供试品低(6.45g生药/kg)、中(19.35g生药/kg)、高(64.50g生药/kg)剂量组,15只/性别/组,每天灌胃给药1次,连续给药28 天,停药恢复28天。
检测指标及频率每天进行一般体征观察,每周1次体重和摄食量测定,于给药期末(10只/性别/组)和恢复期末(5只/性别/组)分别进行剖检,进行血液学、血液生化学、尿常规等检测,对主要脏器进行称重、计算脏器系数,进行组织病理学检查。
结论
在本试验条件下,SD大鼠灌胃给予供试品28天及恢复28天结果显示:
1摄食量的变化给药期间,雌鼠中、高剂量组,雄鼠高剂量组动物均出现摄食量减低,说明供试品对动物摄食量有一定影响。但恢复期未见明显影响,说明摄食量的变化具有可逆性。
2一般体征变化高剂量组(64.50g生药/kg)动物给药后出现自主活动减少。停药48h后恢复正常,说明该体征变化具有可逆性。
3未观察到临床不良反应剂量(NOAEL)和毒性剂量
中剂量组、高剂量组动物给药后出现摄食量的显著降低,同时高剂量组动物出现活动减少,而低剂量组动物给药后未见明显异常。因此,大鼠的NOAEL ≤6.45g生药/kg,毒性剂量≥19.35g生药/kg。
综上所述,在本试验条件下,灌胃给药对SD大鼠的NOAEL≤6.45g生药/kg,该剂量为大鼠等效剂量的3.1倍,临床剂量的18.4倍。毒性剂量≥19.35 g生药/kg,该剂量相当于大鼠等效剂量的9.2倍,临床剂量的55.3倍。
具体实施方式
以下实施例对本发明做进一步的说明。
实施例1
加6倍量水,提取2次,每次30min,黄芩苷提取量不得低于241.7366mg;
实施例2
加6倍量水,提取3次,每次60min,黄芩苷提取量不得低于269mg;
实施例3
加6倍量水,提取4次,每次90min,黄芩苷提取量不得低于305mg;
实施例4
加7倍量水,提取2次,每次90min,黄芩苷提取量不得低于214mg;
实施例5
加7倍量水,提取3次,每次30min,黄芩苷提取量不得低于118mg;
实施例6
加7倍量水,提取4次,每次60min,黄芩苷提取量不得低于85mg;
实施例7
加8倍量水,提取2次,每次60min,黄芩苷提取量不得低于228mg;
实施例8
加8倍量水,提取3次,每次90min,黄芩苷提取量不得低于303mg;
实施例9
加8倍量水,提取4次,每次30min,黄芩苷提取量不得低于277mg;
工艺验证试验
按处方投料,分别加6倍量的水煎煮3次,每次1.5小时,滤过,浓缩,干燥,称重。共5批,黄芩苷提取量为284±0.30mg。
具有很好的稳定性以上述工艺提取成浸膏,按照药品生产工艺制成胶囊剂,常温放置下,共18个月,性状、崩解时限、水分、含量均未见明显改变。
实际应用,取得明显效果。
Claims (4)
1.一种治疗流感的药物,其特征在于,由下述的按重量分数计的各原料药:金银花7.5~30份,蒲公英15~25份,槟榔50~75份,厚朴25~50份,草果15~30份,知母25~30份,芍药25~50份,黄芩25~50份,甘草12~30份,柴胡0~30份,青蒿0~30份组成。
2.一种治疗流感的药物,其特征在于,由下述的按重量分数计的各原料药:金银花15份,蒲公英10份,槟榔30份,厚朴25份,草果12份,知母25份,芍药25份,黄芩25份,甘草8份,柴胡10份,与适量食品或药学可接受的辅料组成。
3.一种治疗流感的药物,其特征在于,由下述的按重量分数计的各原料药:金银花10份,蒲公英10份,槟榔30份,厚朴25份,草果15份,知母25份,芍药25份,黄芩25份,甘草10份,与适量食品或药学可接受的辅料组成。
4.一种治疗流感的药物,其特征在于,由下述的按重量分数计的各原料药:金银花15份,蒲公英10份,青蒿10份,柴胡10份,槟榔35份,厚朴30份,草果125份,知母25份,芍药25份,黄芩25份,甘草10份,与适量食品或药学可接受的辅料组成。
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