CN106334155A - 一种治疗动甲状腺肿大的中药组合物及其制备方法 - Google Patents

一种治疗动甲状腺肿大的中药组合物及其制备方法 Download PDF

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CN106334155A
CN106334155A CN201610879439.5A CN201610879439A CN106334155A CN 106334155 A CN106334155 A CN 106334155A CN 201610879439 A CN201610879439 A CN 201610879439A CN 106334155 A CN106334155 A CN 106334155A
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parts
root
tuber
chinese medicine
radix
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不公告发明人
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Qingdao You Cheng New And High Technology Co Ltd
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Qingdao You Cheng New And High Technology Co Ltd
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Abstract

本发明涉及中医药领域,尤其涉及一种治疗动甲状腺肿大的中药组合物。由桃金娘、昆布、海藻、川穹、大青叶、八月札、当归、三七、白术、半夏、鸡爪草、茯苓、鱼腥草、蝉蜕、玄参、蜈蚣、红枣、半夏、柴胡、桔梗、乳香、狼毒、虎杖、决明子、益母草、陈皮、郁金、香附、厚朴、天门冬、三棱、白芷等组成。本发明纯属中草药,有软坚散结、活血化瘀、疏肝解郁、理气化痰的作用,能从根本上整体调理治疗,更有针对性的治疗甲状腺肿,达到恢复健康的目的,具有安全可靠,疗效确切,无毒副作用。

Description

一种治疗动甲状腺肿大的中药组合物及其制备方法
技术领域
[0001] 本发明属于中药学技术领域,具体涉及一种治疗动甲状腺肿大的中药组合物及其 制备方法。
背景技术
[0002] 甲状腺是人体最大的内分泌腺体,位于甲状软骨下紧贴在气管第三,四软骨环前 面,由两侧叶和峡部组成,平均重量成大约20_25g,女性略大略重。甲状腺后面有甲状旁腺4 枚及喉返神经。血液供应有上下左右四条动脉,所以甲状腺血供较丰富,腺体受颈交感神经 节的交感神经和迷走神经支配,甲状腺的主要功能是合成甲状腺激素,调节机体代谢。
[0003] 单纯性甲状腺肿是甲状腺功能正常的甲状腺肿,是以缺碘、致甲状腺肿物质或相 关酶缺陷等原因所致的代偿性甲状腺肿大,不伴有明显的甲状腺功能亢进或减退,故又称 非毒性甲状腺肿,其特点是散发于非地方性甲状腺肿流行区,且不伴有肿瘤和炎症,病程初 期甲状腺多为弥漫性肿大,以后可发展为多结节性肿大。
[0004] 目前,甲状腺肿的治疗主要通过补碘、服用甲状腺片、应用甲状腺激素,多年的临 床实践证明,这些治疗方法治标不治本,治疗效果差,复发率高。单纯性甲状腺肿大症属中 医"癭病"范畴,由于情志内伤、饮食及水土失宜,以致气、痰、瘀三者壅结颈前而成本病,属 本虚标实,虚实夹杂之症。肝、脾、胃亏损为本,气、痰、瘀互相交结为标。治疗以疏肝理气,健 脾化痰、活血消癭为基本治法。
发明内容
[0005] 为了克服现有技术中的不足,本发明提供一种治疗动甲状腺肿大的中药组合物, 具有显著疗效。
[0006] 为了解决上述技术问题,本发明采用的技术方案如下:治疗代甲状腺肿大的中药 组合物是由以下重量份数配比的各原料组分制成:
[0007] 治疗代甲状腺肿大的中药组合物,由以下重量份数的各组分组成:桃金娘1-6份、 昆布2-13份、海藻1-7份、川穹2-17份、大青叶3-18份、八月札1-10份、当归3-14份、三七5-18 份、白术2-7份、半夏3-11份、鸡爪草1-6份、茯苓3-10份、鱼腥草2-3份、蝉蜕2-16份、玄参 0.02-3份、蜈蚣0.05-2份、红枣5-20份、半夏1-13份、柴胡2-10份、桔梗3-11份、乳香1-6份、 狼毒1-14份、虎杖2-7份、决明子3-18份、益母草3-20份、陈皮1-11份、郁金2-13份、香附1-10 份、厚朴1-18份、天门冬1-15份、三棱2-7份、白芷1-6份、薄荷2-7份、浮萍3-18份、栀子2-10 份、谷精草1-6份、黄连1-13份、山慈菇2-3份、牡丹皮2-16份、桃仁3-11份、木香5-18份、赤芍 3-11份、白薇1-6份、郁李仁1-11份、泽漆1-18份、绿萼梅3-10份、鸡矢藤1-18份、金银花5-15 份、蒲公英3-18份、紫花地丁 3-11份。
[0008] 进一步而言,优选的各组份重量份数配比为:
[0009] 桃金娘1-6份、昆布2-10份、海藻1-7份、川穹2-10份、大青叶3-10份、八月札1-10 份、当归3-10份、三七5-10份、白术2-7份、半夏3-10份、鸡爪草1-6份、茯苓3-10份、鱼腥草2- 3份、蝉蜕2-10份、玄参0.02-3份、蜈蚣0.05-2份、红枣5-10份、半夏1-13份、柴胡2-10份、桔 梗3-10份、乳香1-6份、狼毒1-10份、虎杖2-7份、决明子3-18份、益母草3-20份、陈皮1-10份、 郁金2-10份、香附1-10份、厚朴1-10份、天门冬1-10份、三棱2-7份、白芷1-6份、薄荷2-7份、 浮萍3-10份、栀子2-10份、谷精草1-6份、黄连1-10份、山慈菇2-3份、牡丹皮2-10份、桃仁3-10份、木香5-10份、赤芍3-10份、白薇1-6份、郁李仁1-10份、泽漆1-10份、绿萼梅3-10份、鸡 矢藤1-10份、金银花5-10份、蒲公英3-10份、紫花地丁3-7份。
[0010] 进一步而言,更为优选的各组份重量份数配比为: _ 1] 桃金娘1份、昆布2份、海藻1份、川穹2份、大青叶3份、八月札3份、当归3份、三七5 份、白术2份、半夏3份、鸡爪草2份、茯苓3份、鱼腥草3份、蝉蜕3份、玄参0.02份、蜈蚣0.05份、 红枣5份、半夏3份、柴胡3份、桔梗3份、乳香4份、狼毒1份、虎杖2份、决明子5份、益母草6份、 陈皮1份、郁金2份、香附1份、厚朴1份、天门冬2份、三棱3份、白芷2份、薄荷3份、浮萍3份、栀 子2份、谷精草1份、黄连2份、山慈菇3份、牡丹皮2份、桃仁3份、木香5份、赤芍3份、白薇2份、 郁李仁2份、泽漆3份、绿萼梅4份、鸡矢藤2份、金银花5份、蒲公英3份、紫花地丁 4份。
[0012] 进一步而言,更为优选的各组份重量份数配比为:
[0013] 桃金娘3份、昆布3份、海藻1份、川穹2份、大青叶5份、八月札3份、当归4份、三七5 份、白术4份、半夏6份、鸡爪草1份、茯苓3份、鱼腥草2份、蝉蜕5份、玄参0.05份、蜈蚣0.05份、 红枣5份、半夏3份、柴胡2份、桔梗3份、乳香3份、狼毒1份、虎杖2份、决明子5份、益母草6份、 陈皮1份、郁金2份、香附1份、厚朴1份、天门冬2份、三棱3份、白芷2份、薄荷3份、浮萍3份、栀 子2份、谷精草1份、黄连2份、山慈菇3份、牡丹皮2份、桃仁3份、木香5份、赤芍3份、白薇2份、 郁李仁2份、泽漆3份、绿萼梅4份、鸡矢藤2份、金银花5份、蒲公英3份、紫花地丁 4份。
[0014] 本发明药物可以按照本领域的常规工艺制备成任何药剂学上可接受的丹剂、散 剂、注射剂、硬膏剂、糖浆剂、口服液、口含剂、颗粒剂、糖衣片剂、薄膜衣片剂、胶囊剂。
[0015] 另外,本发明还提供了上述治疗代甲状腺肿大的中药组合物的制备方法,包括以 下步骤:包括以下步骤:将上述原料药炮制后,干燥后,采用60%~95% (wt%)乙醇萃取药 物中的活性成分,萃取1-2次,每次萃取时间为20min,每次萃取采用乙醇的质量为原药物总 重量的8倍,每次萃取的温度为80°C ;收取上述乙醇得到的药汁,采用袋装或小瓶分装,灭菌 处理后低温保存。
[0016] 本发明的其它优选剂型还可按如下制备方法制成:包括以下步骤:将上述原料药 炮制后,干经清洗、低温干燥后再经乙醇萃取后溶于注射水中,超声、搅拌使其完全溶解,加 入注射用活性炭,在55°C水浴中保持40min,微孔过滤膜过滤,在用截留分子量为5万的超滤 膜超滤,得到滤液,进行加压蒸馏,真空干燥,得到药物粉末,加入药物辅料,得到相应的剂 型药物。
[0017] 本发明还包括所述中药组合物在制备抗动甲状腺肿大的药物中的应用。
[0018] 本发明还提供上述药物组合物以及药学可接受的载体或赋形剂。
[0019] 本发明纯属中草药,有软坚散结、活血化瘀、疏肝解郁、理气化痰的作用,能从根本 上整体调理治疗,更有针对性的治疗甲状腺肿,达到恢复健康的目的,具有安全可靠,疗效 确切,无毒副作用。本发明利用中药相互间的协同或抵抗作用,提高了治疗效果,减少了不 良反应,标本兼治。本发明药物具有配伍严谨,药性平和,疗效显著的特点,标本兼治,便于 在临床上大面积推广应用。
具体实施方式
[0020] 本申请请求保护的核心与关键是中药组合物的配伍,不在于剂型,凡是采用本中 药组合物制成的任何剂型,均属于本发明请求保护的范围。其包含的原料组分是:桃金娘、 昆布、海藻、川穹、大青叶、八月札、当归、三七、白术、半夏、鸡爪草、茯苳、鱼腥草、蝴銳、玄 参、蜈蚣、红枣、半夏、柴胡、桔梗、乳香、狼毒、虎杖、决明子、益母草、陈皮、郁金、香附、厚朴、 天门冬、三棱、白芷、薄荷、浮萍、栀子、谷精草、黄连、山慈菇、牡丹皮、桃仁、木香、赤芍、白 薇、郁李仁、泽漆、绿萼梅、鸡矢藤、金银花、蒲公英、紫花地丁。
[0021] 其中,每一中药组分的主要成分及功效分别介绍如下:
[0022] 桃金娘:性味:味甘;涩;性平。归经:归肝;脾经,归肺经。功能主治:养血止血;涩肠 固精。主血虚体弱;吐血;鼻衄;劳伤咳血;便血;崩漏;遗精;带下;痢疾;脱肛;烫伤;外伤出 血。
[0023] 昆布:性味:咸,寒。归经:归肝、胃、肾经。功能主治:软坚散结,消痰,利水。用于癭 瘤,瘰疬,睾丸肿痛,痰饮水肿。
[0024] 海藻:性味:苦、咸,寒。归经:归肝、胃、肾经。功能主治:软坚散结,消痰,利水。用于 癭瘤,瘰疬、睾丸肿痛,痰饮水肿。
[0025] 川穹:性味:辛,温。归经:归肝、胆、心包经。功能主治:活血行气,祛风止痛。用于月 经不调,经闭痛经,症瘕腹痛,胸胁刺痛,跌扑肿痛,头痛,风湿痹痛。
[0026] 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。
[0027] Λ月札:性味:昧微苦,性平。归肝、胃、膀胱经。归经:肝;胃经。功能主治:疏肝和 胃,活血止痛,软坚散结,利小便。主肝胃气滞,脘腹、胁助胀痛,饮食不消,下痢便泄,疝气疼 痛,腰痛,经闭痛经,癭瘤瘰疬,恶性肿瘤。
[0028] 当归:性味:甘、辛,温。归经:归肝、心、脾经。功能主治:补血活血,调经止痛,润肠 通便。用于血虚萎黄,眩晕心悸,月经不调,经闭痛经,虚寒腹痛,肠燥便秘,风湿痹痛,跌扑 损伤,痈疽疮疡。酒当归活血通经。用于经闭痛经,风湿痹痛,跌扑损伤。
[0029] 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,胸腹刺痛,跌扑肿痛。
[0030]白术:性味:苦、甘,温。归经:归脾、胃经。功能主治: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。
[0031] 半夏:性味:辛,温,有毒。①《本经》:〃辛,平。〃②《别录》:〃生微寒,熟温,有毒。〃③ 《药性论》:〃有大毒。〃④《日华子本草》:〃味辛。〃⑤(医学启源》:〃《主治秘要》云,性温,味辛 苦。归经:入脾、胃经。功能主治:燥湿化痰,降逆止呕,消痞散结。治湿痰冷饮,呕吐,反胃,咳 喘痰多,胸膈胀满,痰厥头痛,头晕不眠。外消痈肿。用于痰多咳喘、痰饮眩悸、内痰眩晕、呕 吐反胃、胸脘痞闷、梅核气症;生用外治痈肿痰核。姜半夏多用于降逆止呕。
[0032] 鸡爪草:性味:甘;辛;温。归经:肺;肝;脾经。功能主治:解表散寒;祛风除湿;消结。 主外感风寒;风湿麻木;瘰疬。
[0033] 茯苳:性味:甘淡,平。①《本草图经》:〃味甘,性凉,无毒。〃②《滇南本草》:〃性平,味 苦微涩。〃③《纲目》:〃甘淡,平,无毒。〃归经:入肝、胃经。①《纲目》:〃为阳明本药。〃②《本草 通玄》:〃入胃、肝二经。〃③《本草再新》:〃入肝、脾二经。〃功能主治:解毒,除湿,利关节。治梅 毒,淋池,筋骨挛痛,脚气,疔疮,痈肿,瘰疬。
[0034] 鱼腥草:性味:辛,微寒。归经:归肺经。功能主治:清热解毒,消痈排脓,利尿通淋。 用于肺痈吐脓,痰热喘咳,热痢,热淋,痈肿疮毒。
[0035] _銳:性味:甘,寒。归经:归肺、肝经。功能主治:散风除热,利咽,透疹,退翳,解痉。 用于风热感冒,咽痛,音哑,麻疹不透,风疹瘙痒,目赤翳障,惊风抽搐,破伤风。
[0036] 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。
[0037] 蜈蚁:性味:辛,温;有毒。归经:归肝经。功效:息风镇痉,功毒散结,通络止痛。用于 小儿惊风,抽搐痉挛,中风口歪,半身不遂,破伤风,风湿顽痹,疮疡,瘰疬,毒蛇咬伤。
[0038] 红率:性温、味甘,具益气补血、健脾和胃、袪风功效,对治疗过敏性紫癜、贫血、高 血压、急慢性肝炎和肝硬化患者的血清转氨酶增高,以及预防输血反应等均有理想效果;大 枣含有三萜类化合物及环磷酸腺苷,有较强的抑癌、抗过敏作用;枣中含有抗疲劳作用的物 质,能增强人的耐力;枣还具有减轻毒性物质对肝脏损害的功效;枣中的黄酮类化合物,有 镇静降血压的作用。
[0039] 半夏:半夏:性味:辛,温,有毒。功能主治:燥湿化痰,降逆止呕,消痞散结。治湿痰 冷饮,呕吐,反胃,咳喘痰多,胸膈胀满,痰厥头痛,头晕不眠。外消痈肿。用于痰多咳喘、痰饮 眩悸、内痰眩晕、呕吐反胃、胸脘痞闷、梅核气症;生用外治痈肿痰核。姜半夏多用于降逆止 呕。
[0040] 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。
[0041] 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。
[0042] 乳香:性味:辛苦,温。①《别录》:〃微温。〃②《日华子本草》:〃味辛,热,微毒。〃③李 杲:〃味苦辛,热。〃归经:入心、肝、脾经。①朱震亨:〃入手少阴经。〃②《本草经疏》:〃入足太 阴、手少阴,兼入足厥阴经。〃功能主治:调气活血,定痛,追毒。治气血凝滞、心腹疼痛,痈疮 肿毒,跌打损伤,痛经,产后瘀血刺痛。①《别录》:〃疗风水毒肿,去恶气。〃〃疗风瘾疹痒毒。〃 ②《本草拾遗》:〃疗耳聋,中风口噤,妇人血气,能发酒,理风冷,止大肠泄擗,疗诸疮令内 消。〃③《日华子本草》:〃止霍乱,心腹痛。煎膏止痛长肉。〃④《证类本草》:〃治不眠。〃⑤《珍珠 囊》:〃定诸经之痛。〃⑥《纲目》:〃消痈疽诸毒,托里护心,活血定痛,伸筋,治妇人难产,折 伤。〃⑦《本草从新》:〃治癫狂,止泄痢。〃
[0043] 狼毒:性味:辛、苦,平。有毒。功能主治:散结,逐水,止痛,杀虫。用于水气肿胀,淋 巴结结核;外用治疥、癣,杀蝇、蛆。
[0044] 虎杖:性味:微苦,微寒。归经:归肝、胆、肺经。功能主治:祛风利湿,散瘀定痛,止咳 化痰。用于关节痹痛,湿热黄疸,经闭,症瘕,水火烫伤,跌扑损伤,痈肿疮毒,咳嗽痰多。
[0045] 决明子:性味:甘、苦、咸,微寒。归经:归肝、大肠经。功能主治:清热明目,润肠通 便。用于目赤涩痛,羞明多泪,头痛眩晕,目暗不明,大便秘结。
[0046] 益母草:性味:苦、辛,微寒。归经:归肝、心包经。功能主治:活血调经,利尿消肿。用 于月经不调,痛经,经闭,恶露不尽,水肿尿少;急性肾炎水肿。
[0047] 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。
[0048] 郁金:性味:辛、苦,寒。归经:归肝、心、肺经。功能主治:行气化瘀,清心、解郁,利胆 退黄。用于经闭痛经,胸腹胀痛、刺痛,热病神昏,癫痫发狂,黄疸尿赤。
[0049] 香附:性味:辛、微苦、微甘,平。归经:归肝、脾、三焦经。功能主治:行气解郁,调经 止痛。用于肝郁气滞,胸、胁、脘腹胀痛,消化不良,胸脘痞闷,寒疝腹痛,乳房胀痛,月经不 调,经闭痛经。
[0050] 厚朴:性味:苦、辛,温。归经:归脾、胃、肺、大肠经。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。
[0051] 天门冬:性味:甘苦,寒。①《本经》:〃味苦,平。〃②《别录》:〃甘,大寒,无毒。〃③《滇 南本草》:〃性寒,味甘微苦。〃归经:入肺、肾经。①《汤液本草》:〃入手太阴、足少阴经。〃②《本 草经解》:〃入手太阴肺经、手少阴心经。〃功能主治:滋阴,润燥,清肺,降火。治阴虚发热,咳 嗽吐血,肺痿,肺痈,咽喉肿痛,消渴,便秘。
[0052] 三棱:性味:辛、苦,平。归经:归肝、脾经。功能主治:破血行气,消积止痛。用于症瘕 痞块,瘀血经闭,食积胀痛。
[0053] 白:性味:辛,温。归经:归胃、大肠、肺经。功能主治:散风除湿,通穷止痛,消肿排 脓。用于感冒头痛,眉棱骨痛,鼻塞,鼻渊,牙痛,白带,疮疡肿痛。
[0054] 薄荷:性味:辛,凉。归经:归肺、肝经。功能主治:宣散风热。清头目,透疹。用于风热 感冒,风温初起,头痛,目赤,喉痹,□疮,风疹,麻疹,胸胁胀闷。
[0055] 浮萍:性味:味辛;性寒。归经:肺;膀胱经。功能主治:发汗解表;透疹止痒;利水消 月中;清热解毒。主风热表证;麻疹不透;隐疹瘙痒;水肿;癃闭;疮癣;丹毒;烫伤。
[0056] 栀子:性味:苦,寒。归经:归心、肺、三焦经。功能主治:果实:泻火除烦,清热利尿, 凉血解毒。用于热病心烦,黄疸尿赤,血淋涩痛,血热吐衄,目赤肿痛,火毒疮疡;外治扭挫伤 痛。根:泻火解毒,清热利湿,凉血散瘀。用于传染性肝炎,跌打损伤,风火牙痛。
[0057] 谷精草:性味:辛、甘,平。归经:归肝、肺经。功能主治:疏散风热,明目,退翳。用于 风热目赤,肿痛羞明,眼生翳膜,风热头痛。
[0058] 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。
[0059] 山慈菇:性味:甘、微辛,凉。归经:归肝、脾经。功能主治:清热解毒,化痰散结。用于 痈肿疔毒,瘰疬痰核,淋巴结结核,蛇虫咬伤。
[0060] 牡丹皮:性味:苦、辛,微寒。归经:归心、肝、肾经。功能主治:清热凉血,活血化瘀。 用于温毒发斑,吐血衄血,夜热早凉,无汗骨蒸,经闭痛经,痈肿疮毒,跌扑伤痛。
[0061] 桃仁:性味:苦甘,平。①《本经》:〃味苦,平。〃②《别录》:〃甘,无毒。〃③《千金•食 治》:〃味苦甘辛,平,无毒。〃归经:入心、肝、大肠经。功能主治:破血行瘀,润燥滑肠。治经闭, 症瘕,热病蓄血,风痹,疟疾,跌打损伤,瘀血肿痛,血燥便秘。
[0062] 赤芍:性味:苦,微寒。归经:归肝经。功能主治:清热凉血,散瘀止痛。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。
[0063] 白薇:性味:苦咸,寒。归经:入肺、胃、肾经。功能主治:清热凉血,利尿通淋,解毒疗 疮。用于温邪伤营发热,阴虚发热,骨蒸劳热,产后血虚发热,热淋,血淋,痈疽肿毒。刀伤。
[0064] 郁李仁:性味:辛、苦、甘,平。归经:归脾、大肠、小肠经。功能主治:润燥滑肠,下气, 利水。用于津枯肠燥,食积气滞,腹胀便秘,水肿,脚气,小便不利。
[0065] 泽漆:性味:辛、苦,微寒;有毒。归经:归肺、小肠、大肠经。功能主治:利水消肿,化 痰散结,杀虫。用于水肿,肝硬化腹水,细菌性痢疾;外用治淋巴结结核,结核性痿管,神经性 皮炎。并可灭蛆、孑孓。
[0066] 绿萼梅:功能主治:疏肝解郁,开胃升津。用于胸闷不舒、胃纳不佳及梅核气。
[0067] 鸡矢藤:性味:甘酸,平。①《岭南采药录》:〃味辛苦,平。〃②《上海常用中草药》:〃甘 酸,平。〃功能主治:祛风活血,止痛解毒,消食导滞,除湿消肿。治风湿疼痛,腹泻痢疾,肮腹 疼痛,气虚浮肿,头昏食少,肝脾肿大,瘰疬,肠痈,无名肿毒,跌打损伤。
[0068] 金银花:性味:甘,寒。归经:归肺、心、胃经。功能主治:清热解毒,凉散风热。用于痈 肿疔疮,喉痹,丹毒,热毒血痢,风热感冒,温病发热。
[0069] 蒲公英:性味:苦、甘,寒。归经:归肝、胃经。功能主治: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。
[0070] 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。
[0071] 下面结合具体实施例对本发明做进一步阐述。
[0072] 实施例1
[0073] 本发明有效成分的原料组成及重量份数为:桃金娘3份、昆布3份、海藻1份、川穹2 份、大青叶5份、八月札3份、当归4份、三七5份、白术4份、半夏6份、鸡爪草1份、茯苓3份、鱼腥 草2份、蝉蜕5份、玄参0.05份、蜈蚣0.05份、红枣5份、半夏3份、柴胡2份、桔梗3份、乳香3份、 狼毒1份、虎杖2份、决明子5份、益母草6份、陈皮1份、郁金2份、香附1份、厚朴1份、天门冬2 份、三棱3份、白JE2份、薄荷3份、浮萍3份、栀子2份、谷精草1份、黄连2份、山慈燕3份、牡丹皮 2份、桃仁3份、木香5份、赤芍3份、白薇2份、郁李仁2份、泽漆3份、绿萼梅4份、鸡矢藤2份、金 银花5份、蒲公英3份、紫花地丁 4份。
[0074] 上述药物制备包括以下步骤:将上述原料药炮制后,干燥后,采用65 (wt%)乙醇萃 取药物中的活性成分,萃取2次,每次萃取时间为20min,每次萃取采用乙醇的质量为原药物 总重量的8倍,每次萃取的温度为80°C;收取上述乙醇得到的药汁,采用袋装或小瓶分装,灭 菌处理后低温保存。
[0075] 实施例2
[0076] 本发明有效成分的原料组成及重量份数为:桃金娘1份、昆布2份、海藻1份、川穹2 份、大青叶3份、八月札3份、当归3份、三七5份、白术2份、半夏3份、鸡爪草2份、茯苓3份、鱼腥 草3份、蝉蜕3份、玄参0.02份、蜈蚣0.05份、红枣5份、半夏3份、柴胡3份、桔梗3份、乳香4份、 狼毒1份、虎杖2份、决明子5份、益母草6份、陈皮1份、郁金2份、香附1份、厚朴1份、天门冬2 份、三棱3份、白J£2份、薄荷3份、浮萍3份、栀子2份、谷精草1份、黄连2份、山慈燕3份、牡丹皮 2份、桃仁3份、木香5份、赤芍3份、白薇2份、郁李仁2份、泽漆3份、绿萼梅4份、鸡矢藤2份、金 银花5份、蒲公英3份、紫花地丁 4份。
[0077] 上述药物制备包括以下步骤:将上述原料药炮制后,干燥后,采用70 (wt%)乙醇萃 取药物中的活性成分,萃取2次,每次萃取时间为30min,每次萃取采用乙醇的质量为原药物 总重量的6倍,每次萃取的温度为80°C;收取上述乙醇得到的药汁,采用袋装或小瓶分装,灭 菌处理后低温保存。
[0078] 实施例3
[0079] 本发明有效成分的原料组成及重量份数为:桃金娘1份、昆布2份、海藻1份、川穹2 份、大青叶3份、八月札3份、当归3份、三七5份、白术2份、半夏3份、鸡爪草2份、茯苓3份、鱼腥 草3份、蝉蜕3份、玄参0.02份、蜈蚣0.05份、红枣5份、半夏3份、柴胡3份、桔梗3份、乳香4份、 狼毒1份、虎杖2份、决明子5份、益母草6份、陈皮1份、郁金2份、香附1份、厚朴1份、天门冬2 份、三棱3份、白JE2份、薄荷3份、浮萍3份、栀子2份、谷精草1份、黄连2份、山慈燕3份、牡丹皮 2份、桃仁3份、木香5份、赤芍3份、白薇2份、郁李仁2份、泽漆3份、绿萼梅4份、鸡矢藤2份、金 银花5份、蒲公英3份、紫花地丁 4份。
[0080] 将上述原料药炮制后,干经清洗、低温干燥后再经乙醇萃取后溶于注射水中,超 声、搅拌使其完全溶解,加入注射用活性炭,在55°c水浴中保持40min,微孔过滤膜过滤,在 用截留分子量为5万的超滤膜超滤,得到滤液,进行加压蒸馏,真空干燥,得到药物粉末,加 入胶囊辅料,得到相应的胶囊剂。
[0081] 动物试验:
[0082] 1.急性毒性试验:选取体重为20-25克的小鼠40只,分为4组,每组10只;各组药量 按等比级数排列,一次给药,观察3天,试验期间记录小鼠死亡数,雌、雄性小鼠:(LD50)为 236g/kgBW〉21.5g/kgBW,说明本发明产品属于无毒级;
[0083] 2.遗传毒性试验(Ames试验,骨髓细胞微核试验,小鼠精子畸形试验):试验结果均 为阴性,未见遗传毒性作用;
[0084] 3.大鼠30天的喂养试验:选取体重为35-40克大鼠30只,雌雄不拘,分为3组,每组 10只,其中两组给药剂量分别为0.3克和0.6克,另外一组不给任何药,给药期间对血常规、 血生化指标、脏器系数及体重、增重、进食量、食物利用等各项指标进行检测,均未见不良影 响;30天后,对病理组织学观察,肝、脾、肾、胃、十二指肠、睾丸、卵巢均未见有意义的病理改 变。本试验中大鼠每天的用量约为成人每天用量的100倍左右,以上给药对主要脏器官的病 理检查,均未见不良影响,所以说本药临床用量是安全的。
[0085] 临床试验
[0086] 1、本发明中药于2008年至2015年临床观察动甲状腺肿大123例患者,其中男性34 例,女性89例,随机分为对照组与受试组。
[0087] 2、治疗方法:治疗组口服本发明按照具体实施例1制得的药物,每日3次,疗程4周。 对照组口服巯咪唑片(商品名:Thyrozol),进口注册号:H20120404,生产厂家:Merck Serono GmbH,Germany,按照其说明书服用,疗程4周。
[0088] 3、疗效评定标准:
[0089] 参照中药新药临床研究指导原则(试行)中有关标准,显效:患者临床症状消失,甲 状腺功能恢复正常;有效:临床症状减轻,甲状腺功能较疗前有所恢复但未达到正常标准; 无效:经治疗3个月症状及甲状腺功能检查无改善。实验室指标:游离三碘甲状腺原氨酸 (FT3)、血清游离甲状腺素(FT 4)、促甲状腺激素(TSH)、血常规等治疗前后各一次。再者,CRP、 血沉治疗0、2、4周各查一次。
[0090] 4、治疗结果。
[0091] 表1.两组治疗效果的比较
Figure CN106334155AD00111
[0093] 表2.两组治疗血沉变化的比较(mm/h) ( ^ ±、)
Figure CN106334155AD00112
[0095] 注:与本组治疗前比较*P<0.01
[0096] 两组治疗前无明显差异。实验组治疗后血沉均有显著下降,治疗后各周两组较治 疗前相比,均有显著下降,P<〇.01。两组间比较无统计学差异,P>〇.05。
[0097] 表3.两组治疗CRP变化的比较(mg/1) (X土 S)
Figure CN106334155AD00113
[0099] 注:与本组治疗前比较*P<0.01
[0100] 两组治疗后各周CRP较治疗前均有显著下降,但是实验组下降尤为显著,P<0.01。 治疗后两组相比无统计学差异,P>〇. 05。
[0101] 表4.安全性指标及甲状腺功能比较
Figure CN106334155AD00121
[0104] 两组治疗后实验组安全性指标均正常,甲状腺功能正常恢复无明显差异。
[0105] 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 (9)

1. 一种治疗动甲状腺肿大的中药组合物,其特征在于,由以下各组分组成:桃金娘1-6 份、昆布2-13份、海藻1-7份、川穹2-17份、大青叶3-18份、八月札1-10份、当归3-14份、三七 5-18份、白术2-7份、半夏3-11份、鸡爪草1-6份、茯苓3-10份、鱼腥草2-3份、蝉蜕2-16份、玄 参0.02-3份、蜈蚣0.05-2份、红枣5-20份、半夏1-13份、柴胡2-10份、桔梗3-11份、乳香1-6 份、狼毒1-14份、虎杖2-7份、决明子3-18份、益母草3-20份、陈皮1-11份、郁金2-13份、香附 1- 10份、厚朴1-18份、天门冬1-15份、三棱2-7份、白芷1-6份、薄荷2-7份、浮萍3-18份、栀子 2- 10份、谷精草1-6份、黄连1-13份、山慈菇2-3份、牡丹皮2-16份、桃仁3-11份、木香5-18份、 赤芍3-11份、白薇1-6份、郁李仁1-11份、泽漆1-18份、绿萼梅3-10份、鸡矢藤1-18份、金银花 5-15份、蒲公英3-18份、紫花地丁 3-11份。
2. 根据权利要求1所述的一种治疗动甲状腺肿大的中药组合物,其特征在于:由以下重 量份数的各组分组成: 桃金娘1-6份、昆布2-10份、海藻1-7份、川穹2-10份、大青叶3-10份、八月札1-10份、当 归3-10份、三七5-10份、白术2-7份、半夏3-10份、鸡爪草1-6份、茯苓3-10份、鱼腥草2-3份、 蝉蜕2-10份、玄参0.02-3份、蜈蚣0.05-2份、红枣5-10份、半夏1-13份、柴胡2-10份、桔梗3-10份、乳香1-6份、狼毒1-10份、虎杖2-7份、决明子3-18份、益母草3-20份、陈皮1-10份、郁金 2- 10份、香附1-10份、厚朴1-10份、天门冬1-10份、三棱2-7份、白芷1-6份、薄荷2-7份、浮萍 3- 10份、栀子2-10份、谷精草1-6份、黄连1-10份、山慈菇2-3份、牡丹皮2-10份、桃仁3-10份、 木香5-10份、赤芍3-10份、白薇1-6份、郁李仁1-10份、泽漆1-10份、绿萼梅3-10份、鸡矢藤1-10份、金银花5-10份、蒲公英3-10份、紫花地丁3-7份。
3. 根据权利要求2所述的一种治疗动甲状腺肿大的中药组合物,其特征在于:由以下重 量份数的各组分组成: 桃金娘1份、昆布2份、海藻1份、川穹2份、大青叶3份、八月札3份、当归3份、三七5份、白 术2份、半夏3份、鸡爪草2份、茯苓3份、鱼腥草3份、蝉蜕3份、玄参0.02份、蜈蚣0.05份、红枣5 份、半夏3份、柴胡3份、桔梗3份、乳香4份、狼毒1份、虎杖2份、决明子5份、益母草6份、陈皮1 份、郁金2份、香附1份、厚朴1份、天门冬2份、三棱3份、白芷2份、薄荷3份、浮萍3份、栀子2份、 谷精草1份、黄连2份、山慈菇3份、牡丹皮2份、桃仁3份、木香5份、赤芍3份、白薇2份、郁李仁2 份、泽漆3份、绿萼梅4份、鸡矢藤2份、金银花5份、蒲公英3份、紫花地丁 4份。
4. 根据权利要求1至3所述的一种治疗动甲状腺肿大的中药组合物,其特征在于:由以 下重量份数的各组分组成: 桃金娘3份、昆布3份、海藻1份、川穹2份、大青叶5份、八月札3份、当归4份、三七5份、白 术4份、半夏6份、鸡爪草1份、茯苓3份、鱼腥草2份、蝉蜕5份、玄参0.05份、蜈蚣0.05份、红枣5 份、半夏3份、柴胡2份、桔梗3份、乳香3份、狼毒1份、虎杖2份、决明子5份、益母草6份、陈皮1 份、郁金2份、香附1份、厚朴1份、天门冬2份、三棱3份、白芷2份、薄荷3份、浮萍3份、栀子2份、 谷精草1份、黄连2份、山慈菇3份、牡丹皮2份、桃仁3份、木香5份、赤芍3份、白薇2份、郁李仁2 份、泽漆3份、绿萼梅4份、鸡矢藤2份、金银花5份、蒲公英3份、紫花地丁 4份。
5. 根据权利要求1至4所述的一种治疗动甲状腺肿大的中药组合物,其特征在于:所述 中药制剂的剂型为:丹剂、散剂、注射剂、硬膏剂、糖浆剂、口服液、口含剂、颗粒剂、糖衣片 剂、薄膜衣片剂、胶囊剂。
6. 根据权利要求1至5所述的一种治疗动甲状腺肿大的中药组合物的制备方法,其特征 在于:包括以下步骤:将上述原料药炮制后,干燥后,采用60%~95% (wt%)乙醇萃取药物 中的活性成分,萃取1-2次,每次萃取时间为20min,每次萃取采用乙醇的质量为原药物总重 量的8倍,每次萃取的温度为80°C;收取上述乙醇得到的药汁,采用袋装或小瓶分装,灭菌处 理后低温保存。
7. 根据权利要求5所述的一种治疗动甲状腺肿大的中药组合物的制备方法,其特征在 于:包括以下步骤:将上述原料药炮制后,干经清洗、低温干燥后再经乙醇萃取后溶于注射 水中,超声、搅拌使其完全溶解,加入注射用活性炭,在55°C水浴中保持40min,微孔过滤膜 过滤,在用截留分子量为5万的超滤膜超滤,得到滤液,进行加压蒸馏,真空干燥,得到药物 粉末,加入药物辅料,得到相应的剂型药物。
8. 权利要求1至7的中药组合物在制备抗动甲状腺肿大的药物中的应用。
9. 一种药物组合物,其中包括权利要求1至4的中药组合物以及药学可接受的载体或赋 形剂。
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