CN106581136A - 用于治疗喉炎的药物组合物 - Google Patents
用于治疗喉炎的药物组合物 Download PDFInfo
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- CN106581136A CN106581136A CN201611133103.0A CN201611133103A CN106581136A CN 106581136 A CN106581136 A CN 106581136A CN 201611133103 A CN201611133103 A CN 201611133103A CN 106581136 A CN106581136 A CN 106581136A
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Classifications
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- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
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- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
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- A—HUMAN NECESSITIES
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- A61K2236/30—Extraction of the material
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- A—HUMAN NECESSITIES
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- A61K2236/50—Methods involving additional extraction steps
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/55—Liquid-liquid separation; Phase separation
Landscapes
- Health & Medical Sciences (AREA)
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Abstract
本发明公开了一种治疗喉炎的药物组合物及其制备方法,本发明药物组合物是以榼藤子、万年藓、光甘草宁、桑橙酮、青阳参苷元为原料药,配比而成,可按常规制剂工艺制成各种剂型,治疗喉炎疗效显著。
Description
技术领域
本发明属于中药技术领域,尤其涉及一种治疗喉炎的药物组合物及其制备方法。
背景技术
急性喉炎是指咽部粘膜急性弥漫性炎症。以犬吠样咳嗽、声嘶、喉鸣,吸气性呼吸困难为临床特征。冬春季节多发,常见于 1-3岁幼儿。常见病毒为副流感病毒,嗜血性流感病毒和腺病毒; 常见的病原菌为金黄色葡萄球菌,肺炎球菌和链球菌等。糖皮质激素以其强大的抗炎、抗过敏、减少微血管渗漏和粘膜水肿等多项作用,广泛的应用于喉炎的治疗,布地奈德雾化混悬液是一种吸入型不含卤素的糖皮质激素,水溶性较高,减少了全身性副作用,增加了局部抗炎活性,是喉炎治疗的常用药。目前抗生素配合糖皮质激素吸入雾化治疗是急性喉炎的主要治疗方法,但随着医学的发展,抗生素的耐药性及毒副作用越来越得到大家的重视,中医药在加强合理用药,减少抗生素使用中,发挥着越来越重要的作用。
榼藤子:本品为豆科植物榼藤Entada phaseoloides(L.)Merr.的成熟种子。冬季采种子,去皮,煮熟或炒熟,晒干。【性味】甘、凉;有毒。【功能与主治】清肝热,强壮补肾,催吐。用于心脏病,肝热病,肾病,中毒症之热症、白脉病。【性状】本品为扁圆形,直径4~15cm,厚10~18mm。表面棕褐色,具光泽,少数两面中央微凹,被棕黄色粉状物,除去后可见细密的网状纹理。种脐长椭圆形,种皮极坚硬。破开厚1~2mm,种仁乳白色,子叶两片,甚大,约厚5~7mm,子叶中央常有空腔,近种脐处有细小的胚。气微,味淡,嚼之有豆腥味。榼藤子收载于卫生部颁藏药标准(第一册),标准编号:WS3-BC-0116-95。
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。
桑橙酮(Macluraxanthone):CAS号5848-14-6,分子式C23H22O6,分子量394.42。【药理作用】驱杀虫 。【成分来源】藤黄科植物巴西瑞地亚木,桑科桑橙茎皮。
青阳参苷元(Qingyangshengenin):CAS号84745-94-8,分子式C28H36O8,分子量500.58。【生物活性】抗炎、跌打损伤,抗惊厥。【成分来源】萝藦科鹅绒藤属植物断节参。
光甘草宁(Glabranin):CAS号41983-91-9,分子式C20H20O4,分子量324.38。【药理作用】有雌激素活性,未成熟大鼠口服能增加子宫重量, 但对卵巢重量影响小。【用途】性激素,作用于子宫。【成分来源】伞形科植物裸禾蕨 Platytaenia absinthifolia 根,豆科植物光甘草 Glycyrrhiza glabra L.。
3个原料药化学结构:
青阳参苷元(Qingyangshengenin)
桑橙酮(Macluraxanthone) 光甘草宁(Glabranin)。
发明内容
本发明的目的是克服背景技术的不足,提供一种有效治疗喉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:
制成该治疗喉炎的药物组合物的原料药的组成和重量份为:
榼藤子481-487重量份 万年藓264-268重量份 光甘草宁42-48重量份 桑橙酮34-36重量份 青阳参苷元8-10重量份。
优选的用于治疗喉炎的药物组合物,是由如下重量份的原料药组成:
榼藤子484重量份 万年藓266重量份 光甘草宁45重量份 桑橙酮35重量份 青阳参苷元9重量份。
一种治疗喉炎的药物组合物,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。
一种治疗喉炎的药物组合物,其特征在于药物组合物与化学药或中药组成的治疗喉炎药物。
一种治疗喉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榼藤子481-487重量份 万年藓264-268重量份 光甘草宁42-48重量份 桑橙酮34-36重量份 青阳参苷元8-10重量份;
制备方法:
(1)按原料药配比取榼藤子、万年藓、光甘草宁、桑橙酮、青阳参苷元,混匀,用重量百分比浓度40%乙醇作为溶剂,36℃温浸提取,提取次数为7次,每次提取时间为30小时,每次溶剂用量为原料药总重量的57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1.13,滤过,药液通过HPD750大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度16%乙醇溶液洗脱HPD750大孔吸附树脂柱,收集重量百分比浓度16%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56%乙醇作为溶剂,加热回流提取16次,每次提取时间为0.6小时,每次溶剂用量为药渣A重量的39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1.16,滤过,药液通过XAD-5大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度79%乙醇溶液洗脱XAD-5大孔吸附树脂柱,收集重量百分比浓度79%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。
优选的一种治疗喉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:榼藤子484重量份 万年藓266重量份 光甘草宁45重量份桑橙酮35重量份 青阳参苷元9重量份;
制备方法:
(1)按原料药配比取榼藤子、万年藓、光甘草宁、桑橙酮、青阳参苷元,混匀,用重量百分比浓度40%乙醇作为溶剂,36℃温浸提取,提取次数为7次,每次提取时间为30小时,每次溶剂用量为原料药总重量的57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1.13,滤过,药液通过HPD750大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度16%乙醇溶液洗脱HPD750大孔吸附树脂柱,收集重量百分比浓度16%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56%乙醇作为溶剂,加热回流提取16次,每次提取时间为0.6小时,每次溶剂用量为药渣A重量的39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1.16,滤过,药液通过XAD-5大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度79%乙醇溶液洗脱XAD-5大孔吸附树脂柱,收集重量百分比浓度79%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。
一种治疗喉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。
一种治疗喉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治疗喉炎药物。
药物组合物治疗喉炎疗效显著。
具体实施方式
实施例1:治疗喉炎的药物组合物及其制备方法
治疗喉炎的药物组合物的原料药的组成和重量份为:榼藤子484g 万年藓266g 光甘草宁45g 桑橙酮35g 青阳参苷元9g;
制备方法:
(1)按原料药配比取榼藤子、万年藓、光甘草宁、桑橙酮、青阳参苷元,混匀,用重量百分比浓度40%乙醇作为溶剂,36℃温浸提取,提取次数为7次,每次提取时间为30小时,每次溶剂用量为原料药总重量的57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1.13,滤过,药液通过HPD750大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度16%乙醇溶液洗脱HPD750大孔吸附树脂柱,收集重量百分比浓度16%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56%乙醇作为溶剂,加热回流提取16次,每次提取时间为0.6小时,每次溶剂用量为药渣A重量的39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1.16,滤过,药液通过XAD-5大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度79%乙醇溶液洗脱XAD-5大孔吸附树脂柱,收集重量百分比浓度79%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:治疗喉炎的药物组合物及其制备方法
治疗喉炎的药物组合物的原料药的组成和重量份为:榼藤子481g 万年藓268g 光甘草宁42g 桑橙酮36g 青阳参苷元8g;
制备方法:
(1)按原料药配比取榼藤子、万年藓、光甘草宁、桑橙酮、青阳参苷元,混匀,用重量百分比浓度40%乙醇作为溶剂,36℃温浸提取,提取次数为7次,每次提取时间为30小时,每次溶剂用量为原料药总重量的57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1.13,滤过,药液通过HPD750大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度16%乙醇溶液洗脱HPD750大孔吸附树脂柱,收集重量百分比浓度16%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56%乙醇作为溶剂,加热回流提取16次,每次提取时间为0.6小时,每次溶剂用量为药渣A重量的39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1.16,滤过,药液通过XAD-5大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度79%乙醇溶液洗脱XAD-5大孔吸附树脂柱,收集重量百分比浓度79%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:治疗喉炎的药物组合物及其制备方法
治疗喉炎的药物组合物的原料药的组成和重量份为:榼藤子487g 万年藓264g 光甘草宁48g 桑橙酮34g 青阳参苷元10g;
制备方法:
(1)按原料药配比取榼藤子、万年藓、光甘草宁、桑橙酮、青阳参苷元,混匀,用重量百分比浓度40%乙醇作为溶剂,36℃温浸提取,提取次数为7次,每次提取时间为30小时,每次溶剂用量为原料药总重量的57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1.13,滤过,药液通过HPD750大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度16%乙醇溶液洗脱HPD750大孔吸附树脂柱,收集重量百分比浓度16%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56%乙醇作为溶剂,加热回流提取16次,每次提取时间为0.6小时,每次溶剂用量为药渣A重量的39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1.16,滤过,药液通过XAD-5大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度79%乙醇溶液洗脱XAD-5大孔吸附树脂柱,收集重量百分比浓度79%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428g,加入淀粉150g,混匀,制粒,干燥,加微晶纤维素154g,硬脂酸镁10g,混匀,压制成3200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370g,加入淀粉490g,混匀,制粒,干燥,整粒,加入适量硬脂酸镁,混匀,装胶囊2200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 210g水浴(80℃)加热煮熔,加入实施例3药物组合物7g,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-7℃,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57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。
实施例7:治疗喉炎的药物组合物
治疗喉炎的药物组合物的原料药的组成和重量份为:
光甘草宁130重量份 桑橙酮2重量份 青阳参苷元40重量份。
实施例8:治疗喉炎的药物组合物
治疗喉炎的药物组合物的原料药的组成和重量份为:
光甘草宁20重量份 桑橙酮120重量份 青阳参苷元2重量份。
实施例9:治疗喉炎的药物组合物
治疗喉炎的药物组合物的原料药的组成和重量份为:
光甘草宁30重量份 桑橙酮120重量份 青阳参苷元3重量份。
实验例1:治疗喉炎的试验研究
1 临床资料
共治疗观察 32 例,均为本市医院儿科就诊的小儿急性感染性喉炎患者,均符合小儿急性感染性喉炎诊断标准,并参考急性喉炎喉梗阻的诊断标准,选择合并-度喉梗阻者为研究对象。年龄 6 月-5岁,男16例,女 16例,平均 2 岁 3个月。所有患儿就诊时均有声音嘶哑、犬吠样咳嗽、喉鸣,部分伴有发热。按就诊先后顺序分为对照组及治疗组各 16例,两组患者性别、年龄、病程及病情等方面比较,差异均无统计学意义( P>0.05) ,具有可比性。
2 治疗方法
两组均给予常规对症治疗基础上,对照组采用德国百瑞公司生产的空气压缩泵雾化吸入布地奈德混悬液液氧驱雾化吸入,布地奈德混悬液 0.5mL/次,每天 2 次,疗程 3 天;治疗组加用药物组合物 (1.5g/日),每天 2 次口服。两组疗程均 3 天,观察患儿症状体征消失情况。
3 治疗结果
3.1 疗效标准
显效: 喉梗阻症状缓解,声音嘶哑、吸气喉鸣消失或基本消失、犬吠样咳嗽消失或转为单咳;
有效: 喉梗阻症状有所缓解,声音嘶哑较治疗前减轻、吸气喉鸣、犬吠样咳嗽好转;
无效: 以上症状无减轻。
3.2 结果
结果见表1及表2。
表 1 两组临床疗效比较(例)
组别 | 例数 | 显效 | 有效 | 无效 | 总有效率(%) |
治疗组 | 16 | 9 | 6 | 1 | 93.75* |
对照组 | 16 | 4 | 6 | 6 | 62.50 |
与对照组比较,* P<0.05。
表 2 两组症状消失天数比较(x±s,d)
组别 | 例数 | 声嘶 | 咳嗽 | 喉鸣 |
治疗组 | 16 | 2.36±1.03* | 3.01±1.07** | 2.01±1.01 |
对照组 | 16 | 3.01±1.17 | 4.25±1.29 | 2.43±1.22 |
与对照组比较,* P<0.05; **P<0.01。
Claims (8)
1.一种治疗喉炎的药物组合物,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:
榼藤子481-487重量份 万年藓264-268重量份 光甘草宁42-48重量份 桑橙酮34-36重量份 青阳参苷元8-10重量份。
2.根据权利要求1所述一种治疗喉炎的药物组合物,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:
榼藤子484重量份 万年藓266重量份 光甘草宁45重量份 桑橙酮35重量份 青阳参苷元9重量份。
3.根据权利要求1所述一种治疗喉炎的药物组合物,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所述一种治疗喉炎的药物组合物,其特征在于药物组合物与化学药或中药组成的治疗喉炎药物。
5.一种治疗喉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:榼藤子481-487重量份 万年藓264-268重量份 光甘草宁42-48重量份 桑橙酮34-36重量份 青阳参苷元8-10重量份;
制备方法:
(1)按原料药配比取榼藤子、万年藓、光甘草宁、桑橙酮、青阳参苷元,混匀,用重量百分比浓度40%乙醇作为溶剂,36℃温浸提取,提取次数为7次,每次提取时间为30小时,每次溶剂用量为原料药总重量的57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1.13,滤过,药液通过HPD750大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度16%乙醇溶液洗脱HPD750大孔吸附树脂柱,收集重量百分比浓度16%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56%乙醇作为溶剂,加热回流提取16次,每次提取时间为0.6小时,每次溶剂用量为药渣A重量的39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1.16,滤过,药液通过XAD-5大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度79%乙醇溶液洗脱XAD-5大孔吸附树脂柱,收集重量百分比浓度79%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所述一种治疗喉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:榼藤子484重量份 万年藓266重量份 光甘草宁45重量份桑橙酮35重量份 青阳参苷元9重量份;
制备方法:
(1)按原料药配比取榼藤子、万年藓、光甘草宁、桑橙酮、青阳参苷元,混匀,用重量百分比浓度40%乙醇作为溶剂,36℃温浸提取,提取次数为7次,每次提取时间为30小时,每次溶剂用量为原料药总重量的57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1.13,滤过,药液通过HPD750大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度16%乙醇溶液洗脱HPD750大孔吸附树脂柱,收集重量百分比浓度16%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56%乙醇作为溶剂,加热回流提取16次,每次提取时间为0.6小时,每次溶剂用量为药渣A重量的39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1.16,滤过,药液通过XAD-5大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度79%乙醇溶液洗脱XAD-5大孔吸附树脂柱,收集重量百分比浓度79%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所述一种治疗喉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所述一种治疗喉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治疗喉炎药物。
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