CN106728139A - 一种用于咽炎的药物组合物 - Google Patents
一种用于咽炎的药物组合物 Download PDFInfo
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Classifications
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
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- A61K35/57—Birds; Materials from birds, e.g. eggs, feathers, egg white, egg yolk or endothelium corneum gigeriae galli
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- A61K2236/30—Extraction of the material
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- A—HUMAN NECESSITIES
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Abstract
本发明公开了一种咽炎的药物组合物及其制备方法,本发明药物组合物是以虾须草、万年藓、藜芦托素、鹅蛋壳、一柱香为原料药,配比而成,可按常规制剂工艺制成各种剂型,咽炎疗效显著。
Description
技术领域
本发明属于中药技术领域,尤其涉及一种咽炎的药物组合物及其制备方法。
背景技术
慢性单纯性咽炎(simplechronicpharyngitis)为咽粘膜的慢性炎症,为临床常见病、多发病,中医学家认为慢性咽炎是气滞痰阻、互结咽喉所致。多因急性咽炎反复发作或治疗不彻底,以及邻近器官病灶刺激如鼻窦炎、扁桃体炎,鼻咽炎、气管炎等引起。烟酒过度,粉尘及有害气体刺激亦为常见病因。此病常为上呼吸道性炎症的一部分,并与某些全身性病症如贫血,糖尿病、便秘、心脏病,肾炎、肝硬化等引起局部末梢循环障碍有关。慢性单纯性咽炎发作时咽部可有各种不同的感觉,如异物感,干燥,灼热,微痛等,咽分泌物增多,粘稠,故常有清嗓动作,吐白色粘痰,严重者可引起刺激性咳嗽及恶心,呕吐。咽部检查见粘膜弥漫充血,血管扩张,色暗红,附有少量粘稠分泌物,悬雍垂肿胀或松弛延长。
鹅蛋壳:本品为为鸭科雁属动物家鹅Anser cygnoides domestica Brisson.的卵壳。食用鹅蛋时,收集蛋壳,洗净,晒干或烘干。【性味】甘;淡;平。【归经】肺经。【功能主治】拔毒排脓;理气止痛。主痈疽脓成难溃;疝气;难产。【性状】多呈现碎片状,外表面白色稍粗糙,易破裂;内表面光滑,质脆易碎。气微,味淡。收载于中药大辞典。
虾须草:本品为菊科虾须草属植物虾须草Sheareria nana S. Moore的全草。夏、秋季采收,镁用或晒干。【性味】 味苦;性平。【功能主治】 清热解毒;利水消肿。主疮疡肿毒;水肿;风热头痛。【原植物形态】 一年生草本。茎直立,高30~40厘米,中部以下分枝。叶互生,稀疏,线形,长1~3厘米,宽2~3毫米,先端尖,基部狭,全缘,无柄。头状花序小,顶生;花少数;总苞钟形,苞片2层,外层苞片广卵形,内层苞片稍大;舌状花3~4朵,白色,雌性;管状花2~3朵,两性。瘦果长椭圆形。花期8~9月。收载于中药大辞典。
万年藓:本品为万年藓科万年藓属植物万年藓Climacium dendroides(Hedw.)Web.et Mohr[Leskea dendroides Hedw.]的植物体。春、夏季采收,洗净,晒干。【性味】 苦;寒。【功能主治】 清热除湿;舒筋活络。主风湿劳伤;筋骨疼痛。【化学成份】 含β-谷甾醇(β-sitosterol),豆甾醇(stigmasterol),麦角甾醇(ergosterol),菜油甾醇(campesterol),环鸦片甾烯醇(cyclolaudenol),31-去甲环鸦片甾烯醇(31-norcyclolaudenol),以及金属元素铁、锰、锌、铜等。【原植物形态】 植物体粗大呈树形,地下茎匍匐横生,具假根及膜质鳞状小叶。地上茎直立,多分枝,高达15-20cm,分枝密布绿色鳞毛。茎上部的叶及分枝基部的叶片呈宽卵状三角形或卵状披针形,基部略下延。中肋单一,达于叶尖前终止,叶片上部细胞狭菱形,叶角部细胞圆形,无色半透明。分枝上部的叶片较小,狭长披针形,叶缘锯齿达于中部。雌雄异株。蒴柄细长,长2-4cm,红色;孢蒴直立,长柱形,多出;蒴盖高圆雌形;蒴帽兜形,包盖全孢蒴。收载于中药大辞典。
一柱香:为茜草科假耳草属植物一柱香Anotis ingrata (wall.) Hook. F.[Neanotis yngrata(Wall.ex Hook .f,)W.H.Lewis]的全草。夏、秋季收采全草,除尽泥土、杂物,晒干备用。【性味】味辛;性凉。【归经】心;肝经。【功能主治】清肝泻火。主无名肿毒;目赤红肿;毒蛇咬伤。【原植物形态】 多年生草木,高达1m。茎不分枝或有少数分枝,直立或下部卧地。叶对生;叶柄短;托叶下部近三角形,连合,着生于两叶柄之间,边缘具细绒毛;叶片薄纸质,卵圆形或长卵圆形至卵状披针形,长4-9cm,宽约1.8cm,先端渐尖,基部楔形,全缘,两面均被短柔毛。二歧聚伞花序顶生,总花梗和分枝均有狭翅状棱角;花白色,无梗或有短梗;花萼4裂,裂片三角状披针形,花冠长约5mm,冠管稍宽,内生柔毛;雄蕊4,花药露出花冠外;子房下位,2室,柱头2裂。蒴果近球形,稍侧扁,宽约2mm。种子小而多数,平凸,有小疣点。花期6-7月,果期7-8月。收载于中药大辞典。
藜芦托素(Veratrosine):CAS号475-00-3,分子式C33H49NO7,分子量571.74。【生物活性】抗高血压。【成分来源】绿藜芦 Veratrum viride,毛叶藜芦 Veratrumgrandiflorum。
1个原料药化学结构:
藜芦托素(Veratrosine)。
发明内容
本发明的目的是克服背景技术的不足,提供一种有效咽炎的药物组合物及其制备方法。
本发明是采用如下技术方案实现的:
制成该咽炎的药物组合物的原料药的组成和重量份为:
虾须草120-160重量份 万年藓80-100重量份 藜芦托素20-30重量份 鹅蛋壳60-80重量份 一柱香40-70重量份。
优选的用于咽炎的药物组合物,是由如下重量份的原料药组成:
虾须草140重量份 万年藓90重量份 藜芦托素25重量份 鹅蛋壳70重量份 一柱香50重量份。
一种咽炎的药物组合物,其特征在于药物组合物可以采用制剂学的常规方法制备成片剂或胶囊剂或滴丸。
一种咽炎的药物组合物,其特征在于药物组合物与化学药或中药组成的咽炎药物。
一种咽炎的药物组合物的制备方法,其特征在于按如下步骤制备:
原料药的组成和重量份为:虾须草120-160重量份 万年藓80-100重量份 藜芦托素20-30重量份 鹅蛋壳60-80重量份 一柱香40-70重量份;
制备方法:
(1)按原料药配比取虾须草、万年藓、藜芦托素、鹅蛋壳、一柱香,混匀,用重量百分比浓度34%乙醇作为溶剂,在29℃温浸提取,提取次数为10次,每次提取时间为43小时,每次溶剂用量为原料药总重量的70倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.14,滤过,药液通过CD180大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度24%乙醇溶液洗脱CD180大孔吸附树脂柱,收集重量百分比浓度24%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度47%乙醇作为溶剂,加热回流提取17次,每次提取时间为0.7小时,每次溶剂用量为药渣A重量的20倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.05,滤过,药液通过LKS01大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度76%乙醇溶液洗脱LKS01大孔吸附树脂柱,收集重量百分比浓度76%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
优选的一种咽炎的药物组合物的制备方法,其特征在于按如下步骤制备:
原料药的组成和重量份为:虾须草140重量份 万年藓90重量份 藜芦托素25重量份 鹅蛋壳70重量份 一柱香50重量份;
制备方法:
(1)按原料药配比取虾须草、万年藓、藜芦托素、鹅蛋壳、一柱香,混匀,用重量百分比浓度34%乙醇作为溶剂,在29℃温浸提取,提取次数为10次,每次提取时间为43小时,每次溶剂用量为原料药总重量的70倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.14,滤过,药液通过CD180大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度24%乙醇溶液洗脱CD180大孔吸附树脂柱,收集重量百分比浓度24%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度47%乙醇作为溶剂,加热回流提取17次,每次提取时间为0.7小时,每次溶剂用量为药渣A重量的20倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.05,滤过,药液通过LKS01大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度76%乙醇溶液洗脱LKS01大孔吸附树脂柱,收集重量百分比浓度76%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
一种咽炎的药物组合物的制备方法,其特征在于药物组合物可以采用制剂学的常规方法制备成片剂或胶囊剂或滴丸。
一种咽炎的药物组合物的制备方法,其特征在于药物组合物与化学药或中药组成咽炎药物。
药物组合物咽炎疗效显著。
具体实施方式
实施例1:咽炎的药物组合物及其制备方法
咽炎的药物组合物的原料药的组成和重量份为:虾须草140g 万年藓90g 藜芦托素25g鹅蛋壳70g 一柱香50g;
制备方法:
(1)按原料药配比取虾须草、万年藓、藜芦托素、鹅蛋壳、一柱香,混匀,用重量百分比浓度34%乙醇作为溶剂,在29℃温浸提取,提取次数为10次,每次提取时间为43小时,每次溶剂用量为原料药总重量的70倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.14,滤过,药液通过CD180大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度24%乙醇溶液洗脱CD180大孔吸附树脂柱,收集重量百分比浓度24%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度47%乙醇作为溶剂,加热回流提取17次,每次提取时间为0.7小时,每次溶剂用量为药渣A重量的20倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.05,滤过,药液通过LKS01大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度76%乙醇溶液洗脱LKS01大孔吸附树脂柱,收集重量百分比浓度76%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
实施例2:咽炎的药物组合物及其制备方法
咽炎的药物组合物的原料药的组成和重量份为:虾须草160g 万年藓80g 藜芦托素30g鹅蛋壳60g 一柱香70g;
制备方法:
(1)按原料药配比取虾须草、万年藓、藜芦托素、鹅蛋壳、一柱香,混匀,用重量百分比浓度34%乙醇作为溶剂,在29℃温浸提取,提取次数为10次,每次提取时间为43小时,每次溶剂用量为原料药总重量的70倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.14,滤过,药液通过CD180大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度24%乙醇溶液洗脱CD180大孔吸附树脂柱,收集重量百分比浓度24%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度47%乙醇作为溶剂,加热回流提取17次,每次提取时间为0.7小时,每次溶剂用量为药渣A重量的20倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.05,滤过,药液通过LKS01大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度76%乙醇溶液洗脱LKS01大孔吸附树脂柱,收集重量百分比浓度76%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
实施例3:咽炎的药物组合物及其制备方法
咽炎的药物组合物的原料药的组成和重量份为:虾须草120g 万年藓100g 藜芦托素20g 鹅蛋壳80g 一柱香40g;
制备方法:
(1)按原料药配比取虾须草、万年藓、藜芦托素、鹅蛋壳、一柱香,混匀,用重量百分比浓度34%乙醇作为溶剂,在29℃温浸提取,提取次数为10次,每次提取时间为43小时,每次溶剂用量为原料药总重量的70倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.14,滤过,药液通过CD180大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度24%乙醇溶液洗脱CD180大孔吸附树脂柱,收集重量百分比浓度24%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度47%乙醇作为溶剂,加热回流提取17次,每次提取时间为0.7小时,每次溶剂用量为药渣A重量的20倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.05,滤过,药液通过LKS01大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度76%乙醇溶液洗脱LKS01大孔吸附树脂柱,收集重量百分比浓度76%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
实施例4:片剂的制备
取实施例1药物组合物550g,加入淀粉1050g,混匀,制粒,干燥,加微晶纤维素530g,硬脂酸镁0.5g,混匀,压制成5000片, 即得药物组合物片剂。
实施例5:胶囊的制备
取实施例2药物组合物2090g,加入淀粉2520g,混匀,制粒,干燥,整粒,加入适量硬脂酸镁,混匀,装胶囊10000粒,即得药物组合物胶囊。
实施例6:滴丸的制备
称取聚乙二醇 6000 1680g水浴(80℃)加热煮熔,加入实施例3药物组合物110g,充分搅拌均匀,以液体石蜡为冷却剂,置玻璃管(4*80cm)中,冷却温度为6℃,滴口内外径为7.0/2.0(mm/mm),滴口距液面为2.5cm,滴速以每分59滴为最佳条件,用棉布吸干滴丸表面的冷凝剂,即得药物组合物滴丸。
实验例1:咽炎的试验研究
1 资料和方法
1.1 一般资料
38例门诊病人,男性19例,女性19例,年龄最大58岁,最小9岁,病程<1年者21例,1-3年者10例,>3年以上者7例。
1.2 诊断标准
首诊时自觉咽部不适、微痛、干痒、异物感、灼热感,常有“吭喀”动作。检查见咽反射敏感,口腔黏膜微暗红,血管扩张,亦有见咽后壁黏膜干燥,萎缩。症候分析:虚火上升,阴虚津少,肺失肃降,肺气上逆。
1.3 分组及治疗方法
38例病人分为对照组和试验组。试验组19例,口服药物组合物(实施例1药物组合物)每次1.5g,1日3次,7 d为1个疗程。对照组19例口含复方草珊瑚含片,每2-3 h 1片,7 d为1个疗程。最长治疗8个疗程,随访时间为2年。服药期间不使用抗生素及各种口含片,忌辛辣食物,保持心情舒畅。
1.4 疗效判定
疗效判定分为下列4种情况。
痊愈:用药1个疗程内症状减轻,8个疗程内临床症状及体征消失,2年内无复发。
显效:用药2个疗程内症状减轻,8个疗程内临床症状和体征消失。1年内无复发。若偶感冒,则咽部不适感时间不超过10 d。
有效:用药2个疗程症状减轻,8个疗程内临床症状和部分体征消失。
无效:用药2个疗程后症状稍有减轻或不减轻,体征无明显改善。
痊愈+显效+有效计为总有效。
1.5 统计学处理
两组治疗效果采用配对t检验进行处理。
2 结 果
2.1 疗效
经过最长8个疗程的治疗,随访2年,结果见表1。
表1 2组治疗慢性咽炎的疗效比较
组别 | n | 痊愈 | 显效 | 有效 | 无效 | 总有效率(%) |
复方草珊瑚含片 | 19 | 7 | 6 | 5 | 1 | 94.74 |
药物组合物 | 19 | 3 | 5 | 6 | 5 | 73.68 |
结果表明,药物组合物疗效优于复方草珊瑚含片。
2.2 不良反应
两组病人在治疗及随访期间均未见明显的药品不良反应发生,说明两种药物治疗慢性咽炎是安全的。
Claims (8)
1.一种咽炎的药物组合物,其特征在于制成该药物组合物的原料药的组成和重量份为:
虾须草120-160重量份 万年藓80-100重量份 藜芦托素20-30重量份 鹅蛋壳60-80重量份 一柱香40-70重量份。
2.根据权利要求1所述一种咽炎的药物组合物,其特征在于制成该药物组合物的原料药的组成和重量份为:
虾须草140重量份 万年藓90重量份 藜芦托素25重量份 鹅蛋壳70重量份 一柱香50重量份。
3.根据权利要求1所述一种咽炎的药物组合物,其特征在于药物组合物可以采用制剂学的常规方法制备成片剂或胶囊剂或滴丸。
4.根据权利要求1所述一种咽炎的药物组合物,其特征在于药物组合物与化学药或中药组成的咽炎药物。
5.一种咽炎的药物组合物的制备方法,其特征在于按如下步骤制备:
原料药的组成和重量份为:虾须草120-160重量份 万年藓80-100重量份 藜芦托素20-30重量份 鹅蛋壳60-80重量份 一柱香40-70重量份;
制备方法:
(1)按原料药配比取虾须草、万年藓、藜芦托素、鹅蛋壳、一柱香,混匀,用重量百分比浓度34%乙醇作为溶剂,在29℃温浸提取,提取次数为10次,每次提取时间为43小时,每次溶剂用量为原料药总重量的70倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.14,滤过,药液通过CD180大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度24%乙醇溶液洗脱CD180大孔吸附树脂柱,收集重量百分比浓度24%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度47%乙醇作为溶剂,加热回流提取17次,每次提取时间为0.7小时,每次溶剂用量为药渣A重量的20倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.05,滤过,药液通过LKS01大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度76%乙醇溶液洗脱LKS01大孔吸附树脂柱,收集重量百分比浓度76%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
6.根据权利要求5所述一种咽炎的药物组合物的制备方法,其特征在于按如下步骤制备:
原料药的组成和重量份为:虾须草140重量份 万年藓90重量份 藜芦托素25重量份 鹅蛋壳70重量份 一柱香50重量份;
制备方法:
(1)按原料药配比取虾须草、万年藓、藜芦托素、鹅蛋壳、一柱香,混匀,用重量百分比浓度34%乙醇作为溶剂,在29℃温浸提取,提取次数为10次,每次提取时间为43小时,每次溶剂用量为原料药总重量的70倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.14,滤过,药液通过CD180大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度24%乙醇溶液洗脱CD180大孔吸附树脂柱,收集重量百分比浓度24%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度47%乙醇作为溶剂,加热回流提取17次,每次提取时间为0.7小时,每次溶剂用量为药渣A重量的20倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.05,滤过,药液通过LKS01大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度76%乙醇溶液洗脱LKS01大孔吸附树脂柱,收集重量百分比浓度76%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
7.根据权利要求5所述一种咽炎的药物组合物的制备方法,其特征在于药物组合物可以采用制剂学的常规方法制备成片剂或胶囊剂或滴丸。
8.根据权利要求5所述一种咽炎的药物组合物的制备方法,其特征在于药物组合物与化学药或中药组成咽炎药物。
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