CN107095903A - 一种具有解热功效的中药组合物、其口服液及制备方法 - Google Patents
一种具有解热功效的中药组合物、其口服液及制备方法 Download PDFInfo
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Abstract
本发明一种具有解热功效的中药组合物、其口服液及制备方法,属于医药制剂技术领域。所述中药组合物由下列重量份的原料药组成:金银花150份、蒲公英150份、板蓝根150份、金钱草150份、夏枯草150份和龙胆87.5份。所述口服液包括活性成分和药学上可接受的载体;所述活性成分由重量份为金银花150份、蒲公英150份、板蓝根150份、金钱草150份、夏枯草150份和龙胆87.5份的原料药制备得到。本发明具有以下优点:(1)中药组合物及其口服液能够提高机体免疫功能,有抗病毒、抗炎、抗菌等作用;(2)中药组合物及其颗粒剂能够清热解毒,利咽消肿的功能,适用于外感风热,毒热炽盛者。
Description
技术领域
本发明属于医药制剂技术领域,具体涉及一种具有解热功效的中药组合物、其口服液及制备方法技术领域。
背景技术
热毒炽盛是因外感热毒之邪,或饮食不节,恣食膏粱厚味,致热毒炽盛,燔灼营血,或导致气滞血瘀,阻隔经络的一类病证。其临床表现主要为发热,微恶风寒,鼻塞流涕,咽喉肿痛,吞咽困难,局部淋巴结肿痛,或见红丝发热,微恶风寒,鼻塞流涕,咽喉肿痛,吞咽困难,局部淋巴结肿痛,或见红丝等。目前针对该病,一般的化药治疗方法主要是对症治疗,缓解症状为主,加以必要的抗生素和抗病毒药,这一过程中,一方面抗生素与抗病毒药的使用易导致病菌的抗药性增强,另一方面,这一过程中的药物副作用明显,容易导致本就免疫力低下的患者产生新的病症。
发明内容
针对上述问题,本发明提供了一种中药制剂,有明显的解热药理作用,针对热毒炽盛有良好的抗毒消炎的效果,并且相比化学药品,毒副作用相对更低,有一定提高机体免疫功能的作用。
本发明的目的在于公开了一种具有解热功效的中药组合物。
本发明的第二个目的在于公开了一种具有解热功效的口服液。
本发明的第三个目的在于公开了一种具有解热功效的口服液的制备方法。
本发明的目的是通过以下技术方案实现的:
一种具有解热功效的中药组合物,其中,所述中药组合物由下列重量份的原料药组成:金银花150份、蒲公英150份、板蓝根150份、金钱草150份、夏枯草150份和龙胆87.5份。
上述技术方案所述的一种具有解热功效的中药组合物,其中,所述中药组合物由下列原料药组成:金银花150g、蒲公英150g、板蓝根150g、金钱草150g、夏枯草150g和龙胆87.5g。
一种具有解热功效的口服液,其中,所述口服液包括活性成分和药学上可接受的载体;所述活性成分由重量份为金银花150份、蒲公英150份、板蓝根150份、金钱草150份、夏枯草150份和龙胆87.5份的原料药通过下述方法制备得到:取原料药混合后,加水煎煮二次,第一次加10倍水,煎煮2.0小时;第二次加8倍水,煎煮1.5小时,合并煎液,滤过,即得活性成分。
上述技术方案所述的一种具有解热功效的口服液,其中,所述药学上可接受的载体为红糖、苯甲酸钠和蒸馏水。
上述技术方案所述的一种具有解热功效的口服液,其中,所述原料药的重量为金银花150g、蒲公英150g、板蓝根150g、金钱草150g、夏枯草150g和龙胆87.5g。
一种具有解热功效的口服液的制备方法,包括下述步骤:
(1)、称取原料药金银花150g、蒲公英150g、板蓝根150g、金钱草150g、夏枯草150g和龙胆87.5g;
(2)、将步骤(1)中称取的原料药混合后加水煎煮二次,第一次加10倍水,煎煮2.0小时;第二次加8倍水,煎煮1.5小时,合并煎液,滤过;
(3)、步骤(2)所得滤液进行浓缩、静置和滤过后,加入红糖156g,苯甲酸钠4g,加蒸馏水调整液体总量至1000ml,搅匀,即得具有解热功效的口服液。
本发明的中药组合物中:
金银花:为忍冬科植物忍冬Lonicera japonica Thμnb.的干燥花蕾或带初开的花。夏初花开放前采收,干燥。本品应符合中国药典2010年版一部第205页金银花项下之有关规定。
蒲公英:为菊科植物蒲公英Taraxacμm mongolicμm Hand.-Mazz.、碱地蒲公英Taraxacμm sinicμm 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。本品应符合中国药典2010年版一部第331页蒲公英项下之有关规定。
板蓝根:为十字花科植物菘蓝Isatis indigotica Fort.的干燥根。秋季采挖,除去泥沙,晒干。本品应符合中国药典2010年版一部第191页板蓝根项下之有关规定。
金钱草:为报春花科植物过路黄Lysimachia christinae Hance的干燥全草。夏、秋二季采收,除去杂质,晒干。本品应符合中国药典2010年版一部第204页金钱草项下之有关规定。
夏枯草:为唇形科植物夏枯草Prμnella vμlgaris L.的干燥果穗。夏季果穗呈棕红色时采收,除去杂质,晒干。本品应符合中国药典2010年版一部第263页夏枯草项下之有关规定。
龙胆:为龙胆科植物条叶龙胆Gentiana manshμrica Kitag.、龙胆Gentianascabra Bge.、三花龙胆Gentiana triflora pall.或滇龙胆Gentiana rigescens Franch.的干燥根及根茎。春、秋二季采挖,洗净,干燥。本品应符合中国药典2010年版一部第89页龙胆项下之有关规定。
本发明具有以下有益效果:
1、本发明的中药组合物及其口服液能够提高机体免疫功能,有抗病毒、抗炎、抗菌等作用。
2、本发明的中药组合物及其颗粒剂能够清热解毒,利咽消肿的功能,适用于外感风热,毒热炽盛者。
具体实施方式:
为使本发明的技术方案便于理解,以下结合具体实施例对本发明一种具有解热功效的中药组合物、其口服液及制备方法作进一步的说明。
实施例1:一种具有解热功效的中药组合物:
称取原料药金银花150g、蒲公英150g、板蓝根150g、金钱草150g、夏枯草150g和龙胆87.5g,混合即得中药组合物。
实施例2:一种具有解热功效的口服液:
(1)、称取原料药金银花150g、蒲公英150g、板蓝根150g、金钱草150g、夏枯草150g和龙胆87.5g;
(2)、将步骤(1)中称取的原料药混合后加水煎煮二次,第一次加10倍水,煎煮2.0小时;第二次加8倍水,煎煮1.5小时,合并煎液,滤过;
(3)、步骤(2)所得滤液进行浓缩、静置和滤过后,加入红糖156g,苯甲酸钠4g,加蒸馏水调整液体总量至1000ml,搅匀,即得具有解热功效的口服液。
以下通过具体实验例来说明本发明一种具有解热功效的中药组合物、其口服液(以下称复方双花合剂)所具有的清热解毒,泻肝利胆,凉血散结的功效。
实验例1:
一、材料
1、药物及试剂:
(1)具有解热功效的口服液(以下称复方双花合剂):由实施例2的方法制备;
(2)赋形剂(90%酒精∶氟里昂=7∶3);
(3)复方氨基比林注射液;
(4)三联菌苗;
(5)醋酸地塞米松片。
2、动物:选择健康成年雄性昆明种小鼠50只,体质量18~22g;新西兰种系大耳白兔28只。
二、方法:
1、灌胃测肛温:取健康家兔(白色)28只,标记称重,置入兔固定盒内固定。分别测肛温2次,以均值作为正常体温。然后自耳缘静脉注射三联菌苗1.5ml/kg,待体温比正常体温升高超过0.6~1.1℃时,随机分为复方双花合剂高剂量组(8ml/kg)、复方双花合剂中剂量组(4ml/kg)、复方双花合剂低剂量组(2ml/kg)、复方氨基比林注射液组和生理盐水(NS)对照组共5组,除复方氨基比林注射液组肌注给药外,其余组均为灌胃给药,对照组给予等量NS,于给药后每1小时测体温1次。共测8次。计算各组动物在给药后不同时间内的体温与发热体温的平均温差,以差值进行比较。
2、巴豆油致小鼠耳廓肿胀法:小鼠50只,雄性,体重18-22g。随机分为5组,每组10只。复方双花合剂(8.00g/kg)组、复方双花合剂(1.55g/kg)组、对照组(蒸馏水)、赋形剂组和地塞米松组(阳性药对照组)。均为灌胃给药。2次/d,连续4d。末次给药后1小时,各鼠左耳用2%巴豆油0.05ml/耳,致炎,右耳作对照。4h后将小鼠处死,剪下两耳,用直径9mm打孔器分别在同一部位打下圆耳片,用分析天平称重,以左右耳片重量差值作为炎性肿胀程度,并计算肿胀抑制百分率。
3、体外抑菌试验的平皿二倍稀释法:将已稀释好的复方双花合剂(FFSH)2ml分别加入冷却至55℃的18ml灭菌培养基中混匀,制成含复方双花合剂质量浓度分别为200.00、100.00、50.00、25.00、12.50、6.25、3.12、1.56、0.78g/L的药物平板。取金黄色葡萄球菌等实验菌悬液(菌液浓度约105CFU/ml),分别接种于营养肉汤置37℃培养8h,取出用无菌生理盐水稀释成1/100菌液,然后接种1/100菌液于药物平板上,置37℃孵箱培养24h,取出观察和记录其最小抑菌浓度(MIC,以重量计算)。
三、结果:
1、复方双花合剂对发热家兔的解热作用观察:
结果显示,复方双花合剂灌胃给药后1h,可出现明显的解热作用,给药后1h体温变化与复方氨基比林比较即有显著性差异(P<0.05),给药后8h体温变化仍有显著性差异(P<0.01)。说明复方双花合剂灌胃给药具有与复方氨基比林肌注给药相同的解热作用。与复方氨基比林注射液相比,复方双花合剂的解热作用稳定持久,没有反跳现象。说明复方双花合剂是一个比较理想的解热中成药。结果见表1。
表1复方双花合剂(FFSH)对发热家兔体温的影响
注:组间比较采用t检验.与NS组比较,*P<0.05;**P<0.01,与复方氨基比林组比较;△P<0.05;△△P<O.01
2、复方双花合剂对巴豆油所致小鼠耳廓炎性肿胀的影响:
结果表明,复方双花合剂8g/kg对巴豆油所致小鼠耳廓炎性肿胀有明显的抑制作用。与赋形剂组、对照组比较都有显著性差异(P<0.05),结果见表2。
表2复方双花合剂(FFSH)对巴豆油所致小鼠耳廓炎性肿胀的影响
注:与赋形剂组比较:*P<0.05;与对照组比较:△P<0.05,△△P<0.01
3、复方双花合剂体外抑菌作用:
采用平皿二倍稀释法,从表3结果记录到的复方双花合剂对10种常见致病菌体外抑制的最小抑菌浓度(MIC)中表明,复方双花合剂对所试菌株均有不同程度的抑菌作用。
表3复方双花合剂对10种常见致病菌体外抑制作用
家兔解热实验结果表明,复方双花合剂灌胃给药具有与复方氨基比林注射液肌注给药类似的解热作用,说明复方双花合剂灌胃给药吸收好,药效学效果快。与复方氨基比林注射液相比,复方双花合剂的解热作用稳定持久,没有反跳现象,显示复方双花合剂是一个比较理想的解热中成药。
复方双花合剂8g/kg能明显抑制巴豆油所致小鼠耳廓炎性肿胀,对金黄色葡萄球菌、白色葡萄球菌、乙型和甲型溶血性链球菌等上呼吸道感染常见的致病菌均具有不同程度的抑菌作用。显示该药具有明显抗炎及体外抑菌作用。
以上所述,仅为本发明的较佳实施例,并非对本发明作任何形式上和实质上的限制,凡熟悉本专业的技术人员,在不脱离本发明技术方案范围内,当可利用以上所揭示的技术内容,而作出的些许更动、修饰与演变的等同变化,均为本发明的等效实施例;同时,凡依据本发明的实质技术对以上实施例所作的任何等同变化的更动、修饰与演变,均仍属于本发明的技术方案的范围内。
Claims (6)
1.一种具有解热功效的中药组合物,其特征在于,所述中药组合物由下列重量份的原料药组成:金银花150份、蒲公英150份、板蓝根150份、金钱草150份、夏枯草150份和龙胆87.5份。
2.根据权利要求1所述的一种具有解热功效的中药组合物,其特征在于,所述中药组合物由下列原料药组成:金银花150g、蒲公英150g、板蓝根150g、金钱草150g、夏枯草150g和龙胆87.5g。
3.一种具有解热功效的口服液,其特征在于,所述口服液包括活性成分和药学上可接受的载体;所述活性成分由重量份为金银花150份、蒲公英150份、板蓝根150份、金钱草150份、夏枯草150份和龙胆87.5份的原料药通过下述方法制备得到:取原料药混合后,加水煎煮二次,第一次加10倍水,煎煮2.0小时;第二次加8倍水,煎煮1.5小时,合并煎液,滤过,即得活性成分。
4.根据权利要求3所述的一种具有解热功效的口服液,其特征在于:所述药学上可接受的载体为红糖、苯甲酸钠和蒸馏水。
5.根据权利要求3所述的一种具有解热功效的口服液,其特征在于:所述原料药的重量为金银花150g、蒲公英150g、板蓝根150g、金钱草150g、夏枯草150g和龙胆87.5g。
6.一种具有解热功效的口服液的制备方法,包括下述步骤:
(1)、称取原料药金银花150g、蒲公英150g、板蓝根150g、金钱草150g、夏枯草150g和龙胆87.5g;
(2)、将步骤(1)中称取的原料药混合后加水煎煮二次,第一次加10倍水,煎煮2.0小时;第二次加8倍水,煎煮1.5小时,合并煎液,滤过;
(3)、步骤(2)所得滤液进行浓缩、静置和滤过后,加入红糖156g,苯甲酸钠4g,加蒸馏水调整液体总量至1000ml,搅匀,即得具有解热功效的口服液。
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