CN106334114A - 一种治疗咽炎的中药及其制备方法 - Google Patents
一种治疗咽炎的中药及其制备方法 Download PDFInfo
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- CN106334114A CN106334114A CN201610879387.1A CN201610879387A CN106334114A CN 106334114 A CN106334114 A CN 106334114A CN 201610879387 A CN201610879387 A CN 201610879387A CN 106334114 A CN106334114 A CN 106334114A
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Abstract
本发明涉及中医药领域,尤其涉及一种治疗咽炎的中药。由穿山甲、射干、甘草、金银花、蒲公英、山豆根、玉竹、玄参、黄柏、薄荷、瓜蒌、桔梗、陈皮、板蓝根、大青叶、三七、贝母、麦冬、绞股蓝、红枣、红景天、紫花地丁、芦荟、车前草、胆南星、胖大海、益母草、柚子皮、荆芥、菟丝子、白茅根等组成。本发明相对于现有技术具有疗效好、成本低、局限性小、无不良反应等优点。本发明中药组合物生产工艺简单,用药安全,稳定可靠,疗效好,在治疗咽炎方面具有很好的功效。与同类药物比较,本发明药物具有配伍严谨,药性平和,疗效显著的特点,便于在临床上大面积推广应用。
Description
技术领域
本发明属于中药学技术领域,具体涉及一种治疗咽炎的中药及其制备方法。
背景技术
由于目前人们工作压力大生活节奏快和环境污染等原因,使得咽炎成为常见病。咽炎是咽部粘膜,粘膜下组织的炎症,常为上呼吸道感染的一部分。依据病程的长短和病理改变性质的不同,分为急性咽炎,慢性咽炎两大类。
其中,急性咽炎是咽粘膜,并波及粘膜下及淋巴组织的急性炎症,常继发于急性鼻炎或急性扁桃体发炎之后或为上呼吸道感染之一部分。亦常为全身疾病的局部表现或为急性传染病之前驱症状。其中,慢性咽炎主要为咽黏膜慢性炎症,弥漫性炎症常为上呼吸道慢性卡他性炎症的一部分,局限性炎症则多伴有咽淋巴样组织的炎症。慢性咽炎在临床上是一种常见病、多发病,在常规的药物治疗中,比较顽固,且反复发作,以中年人多见。
咽炎的临床症状主要表现在,急性咽喉炎的主要症状是起病急,初起时咽部干燥,灼热;继而疼痛,吞咽唾液时咽痛往往比进食时更为明显;可伴发热,头痛,食欲不振和四肢酸痛;侵及喉部,可伴声嘶和咳嗽。慢性咽喉炎的主要症状是咽部不适,干、痒、胀,分泌物多而灼痛,易干恶,有异物感,咯之不出,吞之不下。以上症状尤其会在说话稍多、食用刺激性食物后、疲劳或天气变化时加重。
中医治疗方法是否真能治好咽炎?在现代临床医学中,应用中药治疗咽炎是以中医辨证理论为基础,并且以滋阴增液、滋养肺肾、清热化痰、润喉利咽为主要治疗目的。在咽炎患者的临床治疗中,中药治疗方法逐步展现了强大的发展潜力。但中药因存在煎药食用的瓶颈,难以融入现代人生活,很多人还是多以西药为主,由于咽炎患者在西药治疗过程中,各类抗菌素的滥用,极易导致患者的脾胃受到严重损伤。而脾为后天之本,气血生化之源,若脾虚生化不足,则咽喉失养,出现咽痛、咽干不适等症状,影响着人们的身体健康,现虽有多种治疗咽炎中西药物,但由于种种原因,其使用并不尽人意,因此,研制治疗咽炎的新药物势在必行。
发明内容
为了克服现有技术中的不足,本发明提供一种治疗咽炎的中药。
为了解决上述技术问题,本发明采用的技术方案如下:一种治疗咽炎的中药,由以下重量份数的各组分组成:
穿山甲1-20份、射干1-20份、甘草1-20份、金银花1-20份、蒲公英1-20份、山豆根1-20份、玉竹1-20份、玄参1-20份、黄柏1-20份、薄荷1-20份、瓜蒌1-20份、桔梗1-20份、陈皮1-20份、板蓝根1-20份、大青叶1-20份、三七1-20份、贝母1-20份、麦冬1-20份、绞股蓝1-20份、红枣1-20份、红景天1-20份、紫花地丁1-20份、芦荟1-20份、车前草1-20份、胆南星1-20份、胖大海1-20份、益母草1-20份、柚子皮1-20份、荆芥1-20份、菟丝子1-20份、白茅根1-20份、黄连1-20份、枸杞子1-20份、桑枝1-20份、白头翁1-20份、枇杷叶1-20份、柴胡1-20份、野菊花1-20份、苦杏仁1-20份、茯苓1-20份、黄芩1-20份。
所述治疗咽炎的中药,其所述中药制剂中各种原料药的重量份数可以优选为:
穿山甲1-15份、射干1-15份、甘草1-15份、金银花1-15份、蒲公英1-15份、山豆根1-15份、玉竹1-15份、玄参1-15份、黄柏1-15份、薄荷1-15份、瓜蒌1-15份、桔梗1-15份、陈皮1-15份、板蓝根1-15份、大青叶1-15份、三七1-15份、贝母1-15份、麦冬1-15份、绞股蓝1-15份、红枣1-15份、红景天1-15份、紫花地丁1-15份、芦荟1-15份、车前草1-15份、胆南星1-15份、胖大海1-15份、益母草1-15份、柚子皮1-15份、荆芥1-15份、菟丝子1-15份、白茅根1-15份、黄连1-15份、枸杞子1-15份、桑枝1-15份、白头翁1-15份、枇杷叶1-15份、柴胡1-15份、野菊花1-15份、苦杏仁1-15份、茯苓1-15份、黄芩1-15份。
所述治疗咽炎的中药,其所述中药制剂中各种原料药的重量份数还可以优选为:
穿山甲1-10份、射干1-10份、甘草1-10份、金银花1-10份、蒲公英1-10份、山豆根1-10份、玉竹1-10份、玄参1-10份、黄柏1-10份、薄荷1-10份、瓜蒌1-10份、桔梗1-10份、陈皮1-10份、板蓝根1-10份、大青叶1-10份、三七1-10份、贝母1-10份、麦冬1-10份、绞股蓝1-10份、红枣1-10份、红景天1-10份、紫花地丁1-10份、芦荟1-10份、车前草1-10份、胆南星1-10份、胖大海1-10份、益母草1-10份、柚子皮1-10份、荆芥1-10份、菟丝子1-10份、白茅根1-10份、黄连1-10份、枸杞子1-10份、桑枝1-10份、白头翁1-10份、枇杷叶1-10份、柴胡1-10份、野菊花1-10份、苦杏仁1-10份、茯苓1-10份、黄芩1-10份。
所述治疗咽炎的中药,所述中药制剂的剂型为:片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、硬胶囊剂、软胶囊剂、口服液、口含剂、颗粒剂、冲剂、蜜丸剂、散剂、丹剂、溶液剂、注射剂、栓剂、硬膏剂或糖浆剂。
为解决上述技术问题,本发明还提供治疗咽炎的中药的制备方法,所述胶囊制备包括以下步骤:
a.将所述原料药放入粉碎机粉碎后过筛,
b.将过筛后剩下的颗粒物放入乙醇中加热回流提取2次;
c.再取上述乙醇提取后的药渣,加水加热回流提取2次;
d.将上述两种提取液合并,减压回收乙醇并喷雾干燥,得药粉;将过筛后得到的原料细粉与乙醇提炼药粉混合装入胶囊。
所述步骤a中,将所述原料药放入粉碎机粉碎后过100目细筛,使能通过100目筛的细粉量在达到50%,收集通过100目筛的原料细粉备用。
所述步骤b中,将过筛后剩下的颗粒物放入乙醇中加热回流提取2次,每次1~3小时,将2次提取液合并静置;所述步骤c中,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1~3小时,将2次提取液合并静置。
所述步骤d中将上述两种提取液合并,减压浓缩相对密度为70℃时1.08的滤液,回收乙醇,将所得滤液调整比重到1.06,通入喷雾干燥机进行喷雾干燥,过喷雾干燥机喷头的压缩空气压力为4kg/m2,干燥室热气流温度是60℃,得原料药粉;将过筛后得到的原料细粉与乙醇提炼药粉混合装入胶囊。
为解决上述技术问题,本发明还提供治疗咽炎的中药的制备方法,所述中药制剂的剂型为口服液剂,其制备步骤包括:
a、取原料药放入水中浸泡,热提取2次,成浸膏状,为组分1;
b、药渣乙醇提取1次,浓缩过滤为浸膏状,为组分2;
c、将上述两种浸膏浓缩成糊状,浓缩液用CO60灭菌,辐照剂量8k,加入糊精,然后真空冷冻密封即得。
为解决上述技术问题,本发明还提供治疗咽炎的中药的制备方法,所述内服药物的剂型为丸剂,其制备步骤包括:
a.将所述原料药混合,切碎,过120目筛,得细药粉备用;
b.将未过筛的粗粉浸泡乙醇中提取2次;
c.再取上述步骤提取后的药渣,加水加热回流提取2次;
d.将上述两种提取液合并,减压回收乙醇成浸膏,与a步骤得到细药粉合并加入蜂蜜搓成丸剂。
本发明相对于现有技术具有疗效好、成本低、局限性小、无不良反应等优点。本发明中药组合物生产工艺简单,用药安全,稳定可靠,疗效好,在治疗咽炎方面具有很好的功效。与同类药物比较,本发明药物具有配伍严谨,药性平和,疗效显著的特点,便于在临床上大面积推广应用。
具体实施方式
中医认为咽炎的病变在于咽喉,但其病理形成与肺、肝、胃、肾有密切关系。因此咽炎不可急于求成而用一些消炎类的西药。慢性咽炎病因病机常为脏腑虚损,耗伤阴分,虚火上炎于咽喉而致,或因风热喉痹反复发作,余邪滞留,或粉尘,浊气刺激,嗜好烟酒辛辣,劳伤过度等引起,肺阴虚则津液不足,咽喉失于濡养,兼之虚火循经上炎;肾阴虚,肾之经脉上络于肺,肾阴虚每致肺也阴虚,虚火上炎,遂至喉痹。另外,虚火上蒸,烁津成痰,加之脉络痹阻,气机不利,致气滞痰凝,痰火郁结。
本发明中:穿山甲:称炮山甲:捕杀取下鳞片后洗净晒干,投入加热之砂中,翻炒至发泡,边缘向内卷曲,表面呈黄色取出。也可醋的功效与作用炙用,称醋山甲,将炮山甲趁热投入醋中稍浸,捞出干燥即成。炮后厚而坚硬之质变酥脆,易于粉碎及煎出有效成分;醋炙一可矫臭,二可增强活血止痛作用。性味归经:咸,微寒。归肝、胃经。功效:活血消痈排脓,搜风活络,通经下乳。主治痈疽,疮疡肿毒,风寒湿痹,瘀血闭经,症瘕积聚,乳汁不通。
射干:性味:苦,寒。归经:归肺经。功能主治:清热解毒,消痰,利咽。用于热毒痰火郁结,咽喉肿痛,痰涎壅盛,咳嗽气喘。
甘草:性味:甘,平。①《本经》:"味甘,平。"②《别录》:"无毒。"③《本草衍义》:"微凉。"④《珍珠囊》:"生甘,平;炙甘,温。"归经:入脾、胃、肺经。①《汤液本草》:"入足厥阴、太阴、少阴经。"②《雷公炮制药性解》:"入心、脾二经。"③《本草通玄》:"入脾、胃。"④《本草经 解》:"入手太阴肺经、足太阴脾经。"功能主治:和中缓急,润肺,解毒,调和诸药。炙用,治脾胃虚弱,食少,腹痛便溏,劳倦发热,肺痿咳嗽,心悸,惊痫;生用,治咽喉肿痛,消化性溃疡,痈疽疮疡,解药毒及食物中毒。
金银花:性味:甘,寒。①《滇南本草》:"性寒,味苦。"②《本草正》:"味甘,气平,其性微寒。"归经:入肺、胃经。①《雷公炮制药性解》:"入肺经。"②《得配本草》:"入足阳明、太阴经。"功能主治:清热,解毒。治温病发热,热毒血痢,痈疡,肿毒,瘰疬,痔漏。
蒲公英:性味:苦甘,寒。①《唐本草》:"味甘,平,无毒。"②李杲:"微苦,寒。"③《本草述》:"甘,平微寒。"④广州部队《常用中草药手册》:"苦甘,寒。"归经:入肝、胃经。①李杲:"足少阴经。"②《本草衍义补遗》:"入阳明、太阴经。"功能主治:清热解毒,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。
山豆根:味苦,气寒,无毒。入肺经。止咽喉肿痛要药,亦治蛇伤虫咬。然只能治肺经之火邪,止咽痛实神。故治实火之邪则可,治虚火之邪则不可也。
玉竹:性味:甘,微寒。归经:归肺、胃经。功能主治:养阴润燥,生津止渴。用于肺胃阴伤,燥热咳嗽,咽干口渴,内热消渴。
玄参:性味:甘、苦、咸,微寒。归经:归肺、胃、肾经。功能主治:凉血滋阴,泻火解毒。用于热病伤阴,舌绛烦渴,温毒发斑,津伤便秘,骨蒸劳嗽,目赤,咽痛,瘰疠,白喉,痈肿疮毒。
黄柏:性味:苦,寒。归经:归肾、膀胱经。功能主治:清热燥湿,泻火除蒸,解毒疗疮。用于湿热泻痢,黄疸,带下,热淋,脚气,痿{辟},骨蒸劳热,盗汗,遗精,疮疡肿毒,湿疹瘙痒。盐黄柏滋阴降火。用于阴虚火旺,盗汗骨蒸。
薄荷:性味:辛,凉。①《医学启源》:"《主治秘要》云,性凉,辛。"②《医林纂要》:"辛,寒。"归经:入肺、肝经。①《汤液本草》:"手大阴、厥阴经药。"②《纲目》:"入手少、太阴,足厥阴。"③《本草新编》:"入肺与包络二经,亦能入肝、胆。"功能主治:疏风,散热,辟秽,解毒。治外感风热,头痛,目赤,咽喉肿痛,食滞气胀,口疮,牙痛,疮疥,瘾疹。
瓜蒌:性味:甘、微苦、寒。归经:归肺、胃、大肠经。功能主治:清热涤痰,宽胸散结,润燥滑肠。用于肺热咳嗽,痰浊黄稠,胸痹心痛,结胸痞满,乳痈,肺痈,肠痈肿痛,大便秘结。
桔梗:性味:苦、辛,平。归经:归肺经。功能主治:宣肺,利咽,祛痰,排脓。用于咳嗽痰多,胸闷不畅,咽痛,音哑,肺痈吐脓,疮疡脓成不溃。
陈皮:具理气降逆、调中开胃、燥湿化痰之功。主治脾胃气滞湿阻、胸膈满闷、脘腹胀痛、不思饮食、呕吐秽逆、二便不利、肺气阻滞、咳嗽痰多,亦治乳痈初起。经多年研究,现已知陈皮具有许多药理作用。
板蓝根:性味:苦,寒。归经:归心、胃经。功能主治:清热解毒,凉血利咽。用于温毒发斑,舌绛紫暗,痄腮,喉痹,烂喉丹痧,大头瘟疫,丹毒,痈肿。
大青叶:性味:苦,寒。归经:归心、胃经。功能主治:清热解毒,凉血消斑。用于温邪入营,高热神昏,发斑发疹,黄疸,热痢,痄腮,喉痹,丹毒,痈肿。
三七:性味:甘、微苦,温。归经:归肝、胃经。功能主治:散瘀止血,消肿定痛。用于咯血,吐血,衄血,便血,崩漏,外伤出血,胸腹剌痛,跌扑肿痛。
贝母:性味:苦,寒。归经:归肺、心经。功能主治:清热散结,化痰止咳,用于风热犯肺,痰火咳嗽,肺痈,乳痈,瘰疬,疮毒。
麦冬:味甘、微苦,性微寒,归胃、肺、心经,有养阴润肺、益胃生津、清心除烦的功效,用于肺燥干咳、阴虚痨嗽、喉痹咽痛、津伤口渴、内热消渴、心烦失眠、肠燥便秘等症。
绞股蓝:性味:味苦;微甘;性凉。归经:归肺;脾;肾经。功能主治:清热;补虚;解毒。主体虚乏力;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。
大枣:性味:甘,温。归经:归脾、胃经。功能主治:果(大枣):补中益气,养血安神。用于脾虚食少,乏力便溏,妇人脏躁。树皮:消炎,止血,止泻。用于气管炎,肠炎,痢疾,崩漏;外用治外伤出血。根:行气,活血,调经。用于月经不调,红崩,白带。
红景天:性味:性寒,味甘涩。功能主治:活血止血,清肺止咳。治咳血,咯血,肺炎咳嗽,妇女白带。外用治跌打损伤,汤火伤。
紫花地丁:性味:苦、辛,寒。归经:归心、肝经。功能主治:清热解毒,凉血消肿。用于疔疮肿毒,痈疽发背,丹毒,毒蛇咬伤。
芦荟:性味:苦,寒。归经:归肝、胃、大肠经。功能主治:清肝热,通便。用于便秘,小儿疳积,惊风;外治湿癣。
车前草:性味甘、寒。能清热利尿、清肝明目、祛痰止咳、渗湿止泻。适用于湿热内郁之水肿;泌尿系感染时出现的尿频、尿急、尿痛;暑热泄泻、菌痢;肝热所致的目赤肿痛,怕光流泪,视物昏花。
胆南星:性味:苦、微辛,凉。归经:归肺、肝、脾经。功能主治:清热化痰,息风定惊。用于痰热咳嗽,咯痰黄稠,中风痰迷,癫狂惊痫。
胖大海:性味:甘,寒。归经:归肺、大肠经。功能主治:清热润肺,利咽解毒,润肠通便。用于肺热声哑,干咳无痰,咽喉干痛,热结便闭,头痛目赤。
益母草:性味:味辛;苦;性微进。归经:归肝;肾;心包经。功能主治:活血调经;利尿消肿;清热解毒。主月经不调;经闭;胎漏难产;胞衣不上;产后血晕;瘀血腹痛;跌打损伤;小便不利;水肿;头号肿疮疡。
柚子皮:性味:辛;苦;甘;温。归经:脾;肾;膀胱经。功能主治:宽中理气;消食;化痰;止咳平喘。主气郁胸闷;脘腹冷痛;食积;泻痢;咳喘;疝气。
荆芥:性味:辛,微温。归经:归肺、肝经。功能主治:解表散风,透疹。用于感冒,头痛,麻疹,风疹,疮疡初起。炒炭治便血,崩漏,产后血晕。、
菟丝子: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。
白茅根:性味:甘,寒。归经:归肺、胃、膀胱经。功能主治:凉血止血,清热利尿。用于血热吐血,衄血,尿血,热病烦渴,黄疸,水肿,热淋涩痛;急性肾炎水肿。、
黄连:性味:苦,寒。归经:归心、脾、胃、肝、胆、大肠经。功能主治:清热燥湿,泻火解毒。用于湿热痞满,呕吐吞酸,泻痢,黄疸,高热神昏,心火亢盛,心烦不寐,血热吐衄,目赤,牙痛,消渴,痈肿疔疮;外治湿疹,湿疮,耳道流脓。酒黄连善清上焦火热。用于目赤,口疮。姜黄连清胃和胃止呕。用于寒热互结,湿热中阻,痞满呕吐。萸黄连舒肝和胃止呕。用于肝胃不和,呕吐吞酸。
枸杞子:味甘,性平。入肝、肾经。滋肾,润肺,补肝,明目。治肝肾阴亏,腰膝酸软,头晕,目眩,目昏多泪,虚劳咳嗽,消渴,遗精。
桑枝:性味:微苦,平。归经:归肝经。功能主治:祛风湿,利关节。用于肩臂、关节酸痛麻木。
白头翁:性味:苦,寒。归经:归胃、大肠经。功能主治:清热解毒,凉血止痢。用于热毒血痢,阴痒带下,阿米巴痢。
枇杷叶:性味:苦,微寒。归经:归肺、胃经。功能主治:清肺止咳,降逆止呕。用于肺热咳嗽,气逆喘急,胃热呕逆,烦热口渴。
柴胡:性味:苦,微寒。归经:归肝、胆经。功能主治:和解表里,疏肝,升阳。用于感冒发热,寒热往来,胸胁胀痛,月经不调,子官脱垂,脱肛。
野菊花:性味:苦辛,凉。①《本草汇言》:"味苦辛,气凉,有小毒。"②《四川中药志》:"性微寒,味甘苦,无毒。"归经:《本草求真》:"入肺、肝。"功能主治:疏风清热,消肿解毒。治风热感冒,肺炎、白喉,胃肠炎:高血压,疔,痈,口疮,丹毒,湿疹,天泡疮。
茯苓:性味:甘、淡,平。归经:归心、肺、脾、肾经。功能主治:利水渗湿,健脾宁心。用于水肿尿少,痰饮眩悸,脾虚食少,便溏泄泻,心神不安,惊悸失眠。
黄芩:性味:苦,寒。归经:归肺、胆、脾、大肠、小肠经。功能主治: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。
下面结合具体实施例对本发明做进一步阐述。
实施例1
a、将穿山甲1份、射干1份、甘草1份、金银花4份、蒲公英4份、山豆根1份、玉竹4份、玄参1份、黄柏1份、薄荷4份、瓜蒌1份、桔梗1份、陈皮4份、板蓝根4份、大青叶1份、三七4份、贝母1份、麦冬1份、绞股蓝1份、红枣4份、红景天1份、紫花地丁1份、芦荟4份、车前草1份、胆南星1份、胖大海4份、益母草4份、柚子皮4份、荆芥1份、菟丝子4份、白茅根1份、黄连4份、枸杞子4份、桑枝1份、白头翁1份、枇杷叶4份、柴胡4份、野菊花4份、苦杏仁4份、茯苓1份、黄芩1份原料药放入粉碎机粉碎后过100目细筛,使能通过100目筛的细粉量在达到50%,收集通过100目筛的原料细粉备用。
b.将过筛后剩下的颗粒物放入乙醇中加热回流提取2次,每次1~3小时,将2次提取液合并静置;
c.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1~3小时,将2次提取液合并静置;
d.将上述两种提取液合并,减压浓缩相对密度为70℃时1.08的滤液,回收乙醇,将所得滤液调整比重到1.06,通入喷雾干燥机进行喷雾干燥,过喷雾干燥机喷头的压缩空气压力为4kg/m2,干燥室热气流温度是60℃,得原料药粉;将过筛后得到的原料细粉与乙醇提炼药粉混合装入胶囊。
实施例2
a、将穿山甲1份、射干1份、甘草1份、金银花4份、蒲公英4份、山豆根1份、玉竹4份、玄参1份、黄柏1份、薄荷4份、瓜蒌1份、桔梗1份、陈皮4份、板蓝根4份、大青叶1份、三七4份、贝母1份、麦冬1份、绞股蓝1份、红枣4份、红景天1份、紫花地丁1份、芦荟4份、车前草1份、胆南星1份、胖大海4份、益母草4份、柚子皮4份、荆芥1份、菟丝子4份、白茅根1份、黄连4份、枸杞子4份、桑枝1份、白头翁1份、枇杷叶4份、柴胡4份、野菊花4份、苦杏仁4份、茯苓1份、黄芩1份原料药放入粉碎机粉碎后过100目细筛,使能通过100目筛的细粉量在达到50%,收集通过100目筛的原料细粉备用。
b.将上述未过筛的粗粉加入5-10倍量的乙醇中浸泡1-2小时,加热提取2次,每次1-2小时,去上清液,合并提取液,100-180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1.10的浸膏,加热浓缩,静置备用。
c.将乙醇提取过的药渣放入10倍量水中,加热回流提取2次,每次提取时间为1~2小时,100-120目滤过,再用孔径在1000um,截留分子量在300KDalton的耐高温高截留率卷式纳滤膜,分离出滤液中的大颗粒物质和上清液,上清液浓缩,浓缩为60℃下相对密度为1.14的稠膏,加热浓缩,静置备用。
d.将上述两种提取液合并,减压回收乙醇成浸膏,与a步骤得到细药粉合并加入蜂蜜搓成丸剂。
实施例3
a、将穿山甲1份、射干1份、甘草1份、金银花4份、蒲公英4份、山豆根1份、玉竹4份、玄参1份、黄柏1份、薄荷4份、瓜蒌1份、桔梗1份、陈皮4份、板蓝根4份、大青叶1份、三七4份、贝母1份、麦冬1份、绞股蓝1份、红枣4份、红景天1份、紫花地丁1份、芦荟4份、车前草1份、胆南星1份、胖大海4份、益母草4份、柚子皮4份、荆芥1份、菟丝子4份、白茅根1份、黄连4份、枸杞子4份、桑枝1份、白头翁1份、枇杷叶4份、柴胡4份、野菊花4份、苦杏仁4份、茯苓1份、黄芩1份原料药放放入乙醇中浸泡,热提取2次,成膏状,为组分1;
b、药渣水提取2次,浓缩过滤为膏状,为组分2;
c、将上述两种组分膏状浓缩成糊状,浓缩液用CO 60灭菌,辐照剂量8k,加入糊精,然后真空罐装密封即得,使用时直接饮用。
本发明药物组合物的动物毒性试验
1、应用小鼠进行急性毒性实验表明:小鼠口服灌胃本发明的中药制剂口服液,在488.8g生药/kg剂量下,给药后小鼠出现轻微活动减少,1小时左右恢复正常,给药后连续观察7天,无一动物死亡,其全身状况、饮食、摄水、小便和体重增长均正常,实验结果表明:小鼠口服灌胃本发明的中药制剂口服液的最大给药量为488.8g生药/kg/d(LD50>488.8g生药/kg)。本发明的中药制剂每日临床用药总量为0.1g生药/kg/d;按体重计,小鼠灌胃本发明的中药制剂的耐受量为临床病人的4888倍。提示该药急性毒性低,临床用药安全。
2、选用SD大鼠,给予不同浓度(18.0、6.0、2.0g生药/kg)的本发明的中药制剂丸剂,每天灌胃一次,连续90天,末次给药后24小时各组活杀1/2动物(雌雄各半),其余1/2动物继续观察2周后活杀。试验期间观察动物的外观、一般行为、摄食量、体重变化,给药后90天和停药2周进行血液学(RBC、HB、网织红细胞、PLT、CT、WBC及分类)和血液生化(AST、ALT、ALP、Glu、BUN、Crea、TP、T.BIL、ALB、CHOL)、尿液生化、脏器系数、病理组织学等指标检查。试验结果表明:本发明的中药制剂在高、中、低剂量组动物一般状态良好,外观体征、行为活动、进食量和体重增长均无异常变化;三个剂量组及对照组血液学检查、血液生化学、尿液生化检查均在正常范围,组间无显著差异;各组主要脏器组织病理学检查未见明显异常。上述指标停药2周后也未见改变。本试验用药剂量分别为临床用药剂量的180、60、20倍,根据试验结果本发明的中药制剂在高、中、低三个剂量(18.0、6.0、2.0g生药/kg)连续90天给药对大鼠无明显影响,无明确的毒性靶器官和敏感指标,恢复期观察也未见延迟性毒性反应,提示本发明的中药制剂临床应用的剂量安全性较高。
3、选用SD大鼠,给予不同浓度(18.0、6.0、2.0g生药/kg)的本发明的中药制剂胶囊剂,每天灌胃一次,连续90天,末次给药后24小时各组活杀1/2动物(雌雄各半),其余1/2动物继续观察2周后活杀。试验期间观察动物的外观、一般行为、摄食量、体重变化,给药后90天和停药2周进行血液学(RBC、HB、网织红细胞、PLT、CT、WBC及分类)和血液生化(AST、ALT、ALP、Glu、BUN、Crea、TP、T.BIL、ALB、CHOL)、尿液生化、脏器系数、病理组织学等指标检查。试验结果表明:本发明的中药制剂在高、中、低剂量组动物一般状态良好,外观体征、行为活动、进食量和体重增长均无异常变化;三个剂量组及对照组血液学检查、血液生化学、尿液生化检查均在正常范围,组间无显著差异;各组主要脏器组织病理学检查未见明显异常。上述指标停药2周后也未见改变。本试验用药剂量分别为临床用药剂量的180、60、20倍,根据试验结果本发明的中药制剂在高、中、低三个剂量(18.0、6.0、2.0g生药/kg)连续90天给药对大鼠无明显影响,无明确的毒性靶器官和敏感指标,恢复期观察也未见延迟性毒性反应,提示本发明的中药制剂临床应用的剂量安全性较高。
药理学实验说明:
下面结合临床实验数据说明本发明的有益效果:
1、一般资料
申请人于2013年10月~2016年12月间共收集100例咽炎患者,其中男60例,女40例。随机分为:治疗组60例,对照组40例。两组性别、年龄等资料无显著性差异,具有可比性。
2、试验方法
2.1治疗方法
对照组服用氨酚曲麻片,按其说明书服用,疗程10天。
治疗组口服本发明按照具体实施例1制得的胶囊,每日2次。疗程10天。
2.2观察项目:实验前后,对咳嗽,体温,血液生化指标化验记录。X光透视比对记录。
3、疗效标准与治疗结果
3.1疗效标准
痊愈:临床症状全部消失,试验室检查正常,半年内未见复发。好转:临床症状减轻,实验室检查改善或正常。无效:临床症状、实验室检查无明显好转或加重。
3.2治疗统计结果见表1。
表1两组疗效比较
可见,本发明制得的药物能够安全有效治疗咽炎。
以上所述,仅是本发明的最佳实施例而已,并非对本发明作任何形式上的限制,任何熟悉本领域的技术人员,在不脱离本发明技术方案范围情况下,利用上述揭示的方法内容对本发明技术方案做出许多可能的变动和修饰,均属于权利要求书保护的范围。
Claims (10)
1.一种治疗咽炎的中药,其特征在于:由以下重量份数的各组分组成:
穿山甲1-20份、射干1-20份、甘草1-20份、金银花1-20份、蒲公英1-20份、山豆根1-20份、玉竹1-20份、玄参1-20份、黄柏1-20份、薄荷1-20份、瓜蒌1-20份、桔梗1-20份、陈皮1-20份、板蓝根1-20份、大青叶1-20份、三七1-20份、贝母1-20份、麦冬1-20份、绞股蓝1-20份、红枣1-20份、红景天1-20份、紫花地丁1-20份、芦荟1-20份、车前草1-20份、胆南星1-20份、胖大海1-20份、益母草1-20份、柚子皮1-20份、荆芥1-20份、菟丝子1-20份、白茅根1-20份、黄连1-20份、枸杞子1-20份、桑枝1-20份、白头翁1-20份、枇杷叶1-20份、柴胡1-20份、野菊花1-20份、苦杏仁1-20份、茯苓1-20份、黄芩1-20份。
2.根据权利要求1所述的一种治疗咽炎的中药,其特征在于:由以下重量份数的各组分组成:
穿山甲1-15份、射干1-15份、甘草1-15份、金银花1-15份、蒲公英1-15份、山豆根1-15份、玉竹1-15份、玄参1-15份、黄柏1-15份、薄荷1-15份、瓜蒌1-15份、桔梗1-15份、陈皮1-15份、板蓝根1-15份、大青叶1-15份、三七1-15份、贝母1-15份、麦冬1-15份、绞股蓝1-15份、红枣1-15份、红景天1-15份、紫花地丁1-15份、芦荟1-15份、车前草1-15份、胆南星1-15份、胖大海1-15份、益母草1-15份、柚子皮1-15份、荆芥1-15份、菟丝子1-15份、白茅根1-15份、黄连1-15份、枸杞子1-15份、桑枝1-15份、白头翁1-15份、枇杷叶1-15份、柴胡1-15份、野菊花1-15份、苦杏仁1-15份、茯苓1-15份、黄芩1-15份。
3.根据权利要求1至2所述的一种治疗咽炎的中药,其特征在于:由以下重量份数的各组分组成:
穿山甲1-10份、射干1-10份、甘草1-10份、金银花1-10份、蒲公英1-10份、山豆根1-10份、玉竹1-10份、玄参1-10份、黄柏1-10份、薄荷1-10份、瓜蒌1-10份、桔梗1-10份、陈皮1-10份、板蓝根1-10份、大青叶1-10份、三七1-10份、贝母1-10份、麦冬1-10份、绞股蓝1-10份、红枣1-10份、红景天1-10份、紫花地丁1-10份、芦荟1-10份、车前草1-10份、胆南星1-10份、胖大海1-10份、益母草1-10份、柚子皮1-10份、荆芥1-10份、菟丝子1-10份、白茅根1-10份、黄连1-10份、枸杞子1-10份、桑枝1-10份、白头翁1-10份、枇杷叶1-10份、柴胡1-10份、野菊花1-10份、苦杏仁1-10份、茯苓1-10份、黄芩1-10份。
4.根据权利要求1至3所述的一种治疗咽炎的中药,其特征在于:所述中药制剂的剂型为:片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、硬胶囊剂、软胶囊剂、口服液、口含剂、颗粒剂、冲剂、蜜丸剂、散剂、丹剂、溶液剂、注射剂、栓剂、硬膏剂或糖浆剂。
5.根据权利要求1至4所述的一种治疗咽炎的中药的制备方法,其特征在于:所述胶囊制备的包括以下步骤:
a.将所述原料药放入粉碎机粉碎后过筛,
b.将过筛后剩下的颗粒物放入乙醇中加热回流提取2次;
c.再取上述乙醇提取后的药渣,加水加热回流提取2次;
d.将上述两种提取液合并,减压回收乙醇并喷雾干燥,得药粉;将过筛后得到的原料细粉与乙醇提炼药粉混合装入胶囊。。
6.根据权利要求5所述的一种治疗咽炎的中药的制备方法,其特征在于:所述步骤的a中,将所述原料药放入粉碎机粉碎后过100目细筛,使能通过100目筛的细粉量在达到50%,收集通过100目筛的原料细粉备用。
7.根据权利要求5所述的一种预防和治疗乳腺增生的中药组合物的制备方法,其特征在于:所述步骤b中,将过筛后剩下的颗粒物放入乙醇中加热回流提取2次,每次1~3小时,将2次提取液合并静置;所述步骤c中,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1~3小时,将2次提取液合并静置。。
8.根据权利要求5所述的治疗咽炎的中药的制备方法,其特征在于:所述步骤d中将上述两种提取液合并,减压浓缩相对密度为70℃时1.08的滤液,回收乙醇,将所得滤液调整比重到1.06,通入喷雾干燥机进行喷雾干燥,过喷雾干燥机喷头的压缩空气压力为4kg/m2,干燥室热气流温度是60℃,得原料药粉;将过筛后得到的原料细粉与乙醇提炼药粉混合装入胶囊。
9.一种如权利要求1至4所述的治疗咽炎的中药的制备方法,其特征在于,所述中药制剂的剂型为口服液剂,其制备步骤包括:
a、取原料药放入水中浸泡,热提取2次,成浸膏状,为组分1;
b、药渣乙醇提取1次,浓缩过滤为浸膏状,为组分2;
c、将上述两种浸膏浓缩成糊状,浓缩液用CO60灭菌,辐照剂量8k,加入糊精,然后真空冷冻密封即得。
10.一种如权利要求1至9所述的治疗咽炎的中药的制备方法,其特征在于,所述内服药物的剂型为丸剂,其制备步骤包括:
a.将所述原料药混合,切碎,过120目筛,得细药粉备用;
b.将未过筛的粗粉浸泡乙醇中提取2次;
c.再取上述步骤提取后的药渣,加水加热回流提取2次;
d.将上述两种提取液合并,减压回收乙醇成浸膏,与a步骤得到细药粉合并加入蜂蜜搓成丸剂。
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