CN115282194A - 一种用于清热除湿、杀虫止痒的中药组合物的制备方法 - Google Patents
一种用于清热除湿、杀虫止痒的中药组合物的制备方法 Download PDFInfo
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Abstract
本发明涉及一种用于清热除湿、杀虫止痒的中药组合物的制备方法,该中药组合物是由熊胆粉、苍术、艾叶、黄连、土荆皮、雄黄、丁香叶、儿茶、煅白矾共九味中药制备而成;该药具有清热除湿、杀虫止痒的功效;主要用于妇女湿热下注型带下,症见阴痒灼痛、带下量多、味臭、呈泡沫状、豆渣样或色黄如脓,舌苔黄腻,脉数等,用于霉菌性、滴虫性、非特异性阴道炎见上述症状者。本发明中药组合物的临床药效学试验效果显著提高,生物利用度高,且无任何毒副作用。
Description
技术领域
本发明涉及一种用于清热除湿、杀虫止痒的中药组合物的制备方法,属于制药技术领域。
技术背景
妇女湿热下注型带下是一种常见的妇科病,主要表现为霉菌性、滴虫性、非特异性阴道炎,主要症状为:阴痒灼痛、带下量多、味臭、呈泡沫状、豆渣样或色黄如脓,舌苔黄腻,脉数等。目前治疗妇女湿热下注型带下的中成药洗剂很多,但大多治疗效果不够理想。现有技术专利检索:1、中国专利公报2005年7月6日公开了名称为“一种治疗妇科炎症的中药外用洗剂”公开号CN1634357A的专利申请,组成此发明原料药的配比为:熊胆粉0.2%-0.25%、苦参32%-35%、蛇床子20%-24%、黄连16%-18%、土荆皮10%-12%、雄黄0.5%-0.8%、丁香叶10%-12%、儿茶0.8%-1.0%、白矾(煅)0.8%-1.0%。2、中国专利公报2016年12月21日公开了名称为“一种治疗阴道炎的外用药物及其制备方法”公开号CN106236866A的专利申请,组成此发明原料药的配比为:熊胆粉16g、苦参2400g、蛇床子1600g、黄连1200g、雄黄48g、儿茶64g、土荆皮800g、白矾(煅)64g、丁香叶800g。3、中国专利公报1994年11月16日公开了名称为“复方清带散的制备方法”公开号CN1094964A的专利申请,组成此发明原料药的配比为:蛇床子200kg、黄连150kg、苦参200kg、土荆皮100kg、丁香叶100kg、枯白矾10kg、儿茶膏8kg、雄黄6kg、熊胆2kg。在实际应用过程中我们发现用以上这种组方配比制成的中成药的效果不够理想;在近十年的时间里,我们在此组方的基础上,通过大量的实验摸索,对我公司产品“复方清带灌注液”的处方进行二次开发,意外的发现将“苦参”改成“苍术”、“蛇床子”改成“艾叶”,并对处方用量进行筛选,并对工艺进行调整,对“苍术、艾叶、丁香叶”进行水提取。发现本发明中药配方制成的中成药,其临床药效学实验效果显著提高,且无任何毒副作用;我们按常规工艺制成妇科外用灌注液。
发明内容
本发明的目的在于:提供疗效更为显著的一种用于清热除湿、杀虫止痒的中药组合物的制备方法。其特点是,本发明中药组合物各原料药的用量配比为:
现有技术专利检索:1、中国专利公报2005年7月6日公开了名称为“一种治疗妇科炎症的中药外用洗剂”公开号CN1634357A的专利申请,组成此发明原料药的配比为:熊胆粉0.2%-0.25%、苦参32%-35%、蛇床子20%-24%、黄连16%-18%、土荆皮10%-12%、雄黄0.5%-0.8%、丁香叶10%-12%、儿茶0.8%-1.0%、白矾(煅)0.8%-1.0%。2、中国专利公报2016年12月21日公开了名称为“一种治疗阴道炎的外用药物及其制备方法”公开号CN106236866A的专利申请,组成此发明原料药的配比为:熊胆粉16g、苦参2400g、蛇床子1600g、黄连1200g、雄黄48g、儿茶64g、土荆皮800g、白矾(煅)64g、丁香叶800g。3、中国专利公报1994年11月16日公开了名称为“复方清带散的制备方法”公开号CN1094964A的专利申请,组成此发明原料药的配比为:蛇床子200kg、黄连150kg、苦参200kg、土荆皮100kg、丁香叶100kg、枯白矾10kg、儿茶膏8kg、雄黄6kg、熊胆2kg。在实际应用过程中我们发现用以上现有技术1、2、3这几种组方配比制成的中成药的效果不够理想;在近十年的时间里,我们在此组方的基础上,通过大量的实验摸索,对我公司产品“复方清带灌注液”的处方进行二次开发,意外的发现将“苦参”改成“苍术”、“蛇床子”改成“艾叶”,并对处方用量进行筛选,并对工艺进行调整,对“苍术、艾叶、丁香叶”进行水提取。发现本发明中药配方制成的中成药,其临床药效学实验效果显著提高,且无任何毒副作用;我们按常规工艺制成妇科外用灌注液。
1、本发明妇科灌注液的制备方法如下:
组方配比:
制备方法:
以上熊胆粉、苍术、艾叶、黄连、土荆皮、雄黄、丁香叶、儿茶、煅白矾共九味,雄黄粉碎成极细粉,熊胆粉、儿茶、白矾三味粉碎成最细粉;丁香叶、苍术、艾叶加水10倍量煎煮二次,每次1小时,合并煎液,滤过,滤液浓缩至80℃时测得相对密度为1.20~1.24的清膏;土荆皮酌予碎断,加5倍量75%乙醇,40℃温浸二次,每次48小时,合并浸渍液,滤过,滤液回收乙醇并浓缩至80℃时测得相对密度为1.20~1.24的清膏;取黄连,酌予碎断,加8倍量的0.5%硫酸溶液煎煮两次,每次2小时,合并煎液,滤过,滤液加石灰乳调pH至9~10,静置过夜,取上清液,浓缩至80℃时测得相对密度为1.20~1.24的清膏;将上述细粉及清膏混合,加水稀释,搅匀,加入羧甲基纤维素钠,搅匀,即得灌注液。
本发明妇科灌注液具有清热除湿、杀虫止痒的功效;主要用于妇女湿热下注型带下,症见阴痒灼痛、带下量多、味臭、呈泡沫状、豆渣样或色黄如脓,舌苔黄腻,脉数等,用于霉菌性、滴虫性、非特异性阴道炎见上述症状者。
主要药效学试验
实验药物的制备:
1、试验用药物的制备:
本发明妇科灌注液组:按照本发明说明书实施例1的方法制得灌注液。
a组为:按照对比文件1公开号为CN1634357A的专利申请说明书实施例1的方法制得的外用洗剂。
b组为:按照对比文件1公开号为CN1634357A的专利申请说明书实施例2的方法制得的外用洗剂。
c组为:按照对比文件1公开号为CN1634357A的专利申请说明书实施例3的方法制得的外用洗剂。
d组为:按照对比文件2公开号为CN106236866A的专利申请说明书实施例1的方法制得的外用洗剂。
e组为:按照对比文件2公开号为CN106236866A的专利申请说明书实施例3的方法制得的外用洗剂。
f组为:按照对比文件3公开号为CN1094964A的专利申请说明书中本发明实施例的方法制得的外用洗剂。
实验目的:通过对本发明妇科灌注液组和a组、b组、c组、d组、e组、f组的抗炎、镇痛、止痒和提高机体免疫力等药理实验研究,将本发明妇科灌注液组与a组、b组、c组、d组、e组、f组进行对比,观察其药理作用的强弱。
试验方法:本发明妇科灌注液组和a组、b组、c组、d组、e组、f组对二甲苯所致小鼠耳廓肿胀的影响;对小鼠腹腔毛细血管渗透性的影响;对醋酸所致小鼠扭体反应的影响;对磷酸组织胺引起豚鼠致痒反应的影响;对小鼠细胞免疫功能的影响。
一、对二甲苯所致小鼠耳廓肿胀的影响
实验材料
1、动物:昆明种雌性小鼠,体重25~29g。
2、药物:本发明妇科灌注液组和a组、b组、c组、d组、e组、f组。药物在实验前按含生药材为14%的浓度配制。
实验方法
昆明种雌性小鼠80只,体重25~29g,随机分成8组,每组10只。用100%二甲苯0.02ml/只涂于左耳内外两面,右耳不作任何处理,0.5h后在涂抹二甲苯的部位涂抹药物,对照组涂抹等量的生理盐水;本发明妇科灌注液组和a组、b组、c组、d组、e组、f组分别涂抹给药均为2.8g生药/kg。给药4h后将小鼠颈椎脱臼致死,沿耳廓基线剪下两耳,用直径6mm打孔器分别在左右两耳相同部位打下圆耳片,用分析天平称重,每鼠左耳片重量减去右耳片重量即为肿胀度。实验结果:见表1
与对照组相比**P<0.01;*P<0.05;与本发明妇科灌注液组比△P<0.05。
结果表明:本发明妇科灌注液组和a组、b组、c组、d组、e组、f组对二甲苯所致小鼠耳廓肿胀具有显著的抑制作用,a组、b组、c组、d组、e组、f组与对照组相比较有显著性差异(P<0.05);本发明妇科灌注液组与对照组相比有极显著性差异(P<0.01);本发明妇科灌注液组与a组、b组、c组、d组、e组、f组相比较有显著性差异(P<0.05)。可见,本发明妇科灌注液组比a组、b组、c组、d组、e组、f组的抗炎作用强。
二、对小鼠腹腔毛细血管渗透性的影响
实验材料
1、动物:昆明种雌性小鼠,体重25~29g。
2、药物:本发明妇科灌注液组和a组、b组、c组、d组、e组、f组。药物在实验前按含生药材为14%的浓度配制。
实验方法
昆明种雌性小鼠80只,体重25~29g,随机分成8组,每组10只。实验各组小鼠皮下注射给药,对照组注射等量的生理盐水;本发明妇科灌注液组和a组、b组、c组、d组、e组、f组分别注射给药均为2.8g生药/kg,给药1h后,各组小鼠尾静脉注射0.5%伊文思蓝生理盐水溶液0.1ml/10g体重,随即腹腔注射0.6%的冰醋酸生理盐水0.2ml/只,20min后处死小鼠,剪开腹部皮肤肌肉,用5ml生理盐水分数次洗涤腹腔,吸管吸出洗涤液,合并后加人生理盐水至5ml,3000r/min离心15分钟,离心后取上清液于721分光光度计下591nm比色,测定吸收度的值。实验结果:见表2
与对照组相比**P<0.01;*P<0.05;与本发明妇科灌注液组比△P<0.05。
结果表明:本发明妇科灌注液组和a组、b组、c组、d组、e组、f组均能明显减轻小鼠腹腔毛细血管的渗透性,a组、b组、c组、d组、e组、f组与对照组相比较有显著性差异(P<0.05);本发明妇科灌注液组与对照组相比有极显著性差异(P<0.01);本发明妇科灌注液组与a组、b组、c组、d组、e组、f组相比较有显著性差异(P<0.05)。可见,本发明妇科灌注液组比a组、b组、c组、d组、e组、f组对水肿炎症渗出的抑制作用强。
三、对醋酸所致小鼠扭体反应的影响
实验材料
1、动物:昆明种雌性小鼠,体重25~29g。
2、药物:本发明妇科灌注液组和a组、b组、c组、d组、e组、f组。药物在实验前按含生药材为14%的浓度配制。
实验方法
昆明雌性小鼠80只,体重25~29g,随机分成8组,每组10只。实验各组小鼠皮下注射给药,对照组注射等量的生理盐水;本发明妇科灌注液组和a组、b组、c组、d组、e组、f组分别注射给药均为2.8g生药/kg,小鼠按0.2ml/10g体积注射,给药1h后,每鼠均腹腔注射0.6%醋酸0.2ml/只,记录20min内小鼠扭体次数。实验结果:见表3
与对照组相比**P<0.01;*P<0.05;与本发明妇科灌注液组比△P<0.05。
结果表明:本发明妇科灌注液组和a组、b组、c组、d组、e组、f组对醋酸所致小鼠扭体具有明显的抑制作用,a组、b组、c组、d组、e组、f组与对照组相比较有显著性差异(P<0.05);本发明妇科灌注液组与对照组相比有极显著性差异(P<0.01);本发明妇科灌注液组与a组、b组、c组、d组、e组、f组相比较有显著性差异(P<0.05)。可见,本发明妇科灌注液组比a组、b组、c组、d组、e组、f组的镇痛作用强。
四、对磷酸组织胺引起豚鼠致痒反应的影响
实验材料
1、动物:雌性豚鼠,体重260~300g。
2、药物:本发明妇科灌注液组和a组、b组、c组、d组、e组、f组。药物在实验前按含生药材为14%的浓度配制。
实验方法
健康雌性豚鼠80只,体重260~300g,随机分成8组,每组10只。对照组涂抹等量的生理盐水;本发明妇科灌注液组和a组、b组、c组、d组、e组、f组分别涂抹给药均为1.1g生药/kg。实验前1日给各组豚鼠右后足背剃毛,各组按剂量涂药1次。实验当天,以粗砂纸擦伤右后足背剃毛处,面积约1cm2,局部再按剂量涂药1次,涂药后10min,开始在创面处滴0.01%磷酸组织胺0.05ml/只,此后每隔3min依0.02%、0.03%、0.04%……递增浓度,每次均为0.05ml/只。直至出现豚鼠回头舔擦伤处,以引起豚鼠出现回头舔擦伤处所给予的磷酸组织胺总量为致痒阈,求各组平均值。实验结果:见表4
与对照组相比**P<0.01;*P<0.05;与本发明妇科灌注液组比△P<0.05。
结果表明:本发明妇科灌注液组和a组、b组、c组、d组、e组、f组能明显提高磷酸组织胺引起豚鼠瘙痒的致痒阈,a组、b组、c组、d组、e组、f组与对照组相比较有显著性差异(P<0.05);本发明妇科灌注液组与对照组相比有极显著性差异(P<0.01);本发明妇科灌注液组与a组、b组、c组、d组、e组、f组相比较有显著性差异(P<0.05)。可见,本发明妇科灌注液组比a组、b组、c组、d组、e组、f组的止痒作用强。
五、对小鼠细胞免疫功能的影响
实验材料
1、动物:昆明种雌性小鼠,体重25~29g。
2、药物:本发明妇科灌注液组和a组、b组、c组、d组、e组、f组。药物在实验前按含生药材为14%的浓度配制。
实验方法
昆明种雌性小鼠80只,体重25~29g,随机分成8组,每组10只。每鼠每天肌肉注射植物血凝素10mg/kg,共注射3d,同时实验各组小鼠每日皮下注射给药,对照组注射等量的生理盐水;本发明妇科灌注液组和a组、b组、c组、d组、e组、f组分别注射给药均为2.8g生药/kg,小鼠按0.2ml/10g体积注射,共8d,第8d剪尾,取血推片,瑞氏染色,油镜下计数200个淋巴细胞中淋巴母细胞的数量,计算所占百分率。实验结果:见表5
与对照组相比**P<0.01;*P<0.05;与本发明妇科灌注液组比△P<0.05。
结果表明:本发明妇科灌注液组和a组、b组、c组、d组、e组、f组均可使小鼠对植物血凝素刺激淋巴细胞转化反应增强,淋巴母细胞的百分率增大,a组、b组、c组、d组、e组、f组与对照组相比较有显著性差异(P<0.05);本发明妇科灌注液组与对照组相比有极显著性差异(P<0.01);本发明妇科灌注液组与a组、b组、c组、d组、e组、f组相比较有显著性差异(P<0.05)。可见,本发明妇科灌注液组比a组、b组、c组、d组、e组、f组的提高细胞免疫功能强。
实验结果:本发明妇科灌注液组和a组、b组、c组、d组、e组、f组能明显抑制二甲苯所致小鼠耳廓肿胀;能明显减轻小鼠腹腔毛细血管的渗透性;对醋酸所致小鼠扭体具有明显的抑制作用;能明显提高磷酸组织胺引起豚鼠瘙痒的致痒阈;可使小鼠对植物血凝素刺激淋巴细胞转化反应增强,提高细胞免疫功能。
结论:本发明妇科灌注液组比a组、b组、c组、d组、e组、f组的抗炎、镇痛、止痒和提高机体免疫力等药理作用强,因此,本发明妇科灌注液组比a组、b组、c组、d组、e组、f组临床用于清热除湿、杀虫止痒的治疗效果好。
具体实施方式
实施例1:本发明妇科灌注液的制备:
组方配比:
制备方法:
以上熊胆粉、苍术、艾叶、黄连、土荆皮、雄黄、丁香叶、儿茶、煅白矾共九味,雄黄粉碎成极细粉,熊胆粉、儿茶、白矾三味粉碎成最细粉;丁香叶、苍术、艾叶加水10倍量煎煮二次,每次1小时,合并煎液,滤过,滤液浓缩至80℃时测得相对密度为1.20~1.24的清膏;土荆皮酌予碎断,加5倍量75%乙醇,40℃温浸二次,每次48小时,合并浸渍液,滤过,滤液回收乙醇并浓缩至80℃时测得相对密度为1.20~1.24的清膏;取黄连,酌予碎断,加8倍量的0.5%硫酸溶液煎煮两次,每次2小时,合并煎液,滤过,滤液加石灰乳调pH至9~10,静置过夜,取上清液,浓缩至80℃时测得相对密度为1.20~1.24的清膏;将上述细粉及清膏混合,加水稀释,搅匀,加入羧甲基纤维素钠,搅匀,即得灌注液。
Claims (2)
1.一种用于清热除湿、杀虫止痒的中药组合物的制备方法,其特征在于所述中药组合物的配方组成为:
制备方法为:
以上熊胆粉、苍术、艾叶、黄连、土荆皮、雄黄、丁香叶、儿茶、煅白矾共九味,雄黄粉碎成极细粉,熊胆粉、儿茶、白矾三味粉碎成最细粉;丁香叶、苍术、艾叶加水10倍量煎煮二次,每次1小时,合并煎液,滤过,滤液浓缩至80℃时测得相对密度为1.20~1.24的清膏;土荆皮酌予碎断,加5倍量75%乙醇,40℃温浸二次,每次48小时,合并浸渍液,滤过,滤液回收乙醇并浓缩至80℃时测得相对密度为1.20~1.24的清膏;取黄连,酌予碎断,加8倍量的0.5%硫酸溶液煎煮两次,每次2小时,合并煎液,滤过,滤液加石灰乳调pH至9~10,静置过夜,取上清液,浓缩至80℃时测得相对密度为1.20~1.24的清膏;将上述细粉及清膏混合,加水稀释,搅匀,加入羧甲基纤维素钠,搅匀,即得灌注液。
2.根据权利要求1所述中药组合物,其特征在于所述中药组合物的剂型为:外用灌注液。
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