CN104367765A - 一种用于治疗抑郁症的中药组合物及其制备方法和应用 - Google Patents
一种用于治疗抑郁症的中药组合物及其制备方法和应用 Download PDFInfo
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Abstract
本发明提供了一种治疗抑郁症的中药组合物,它由如下原料制备得到:小叶桑根、水葫芦七、大人血七、桃金娘花等,本发明能治疗抑郁症。
Description
技术领域
本发明涉及中药制剂技术领域,具体涉及一种用于治疗抑郁症的中药组合物及其制备方法和应用。
背景技术
抑郁症是危害人类身心健康的常见病、多发病,以显著而持久的心境低落为主,并有相应的思维和行为改变,是一种常见的情感性精神障碍。由于抑郁症的发病年龄绝大多数处于工作年龄段,部分严重的抑郁症可自杀而死。也就是说,抑郁症既可以影响人们的工作,又可危及病人的生命。目前此类疾病多以西药治疗为主,但此类药物在治疗中多为对症施治,顾此失彼,往往有较大的毒副作用,不少病人不能耐受,尤其是一些需长期服药的患者。为此,急要开发出更多安全有效的治疗抑郁症的药物满足临床治疗的需要。
发明内容
为了解决上述问题,本发明的目的在于提供一种可治疗抑郁症疾病的中药制剂。为了达到这个目的,采用如下技术方案:
技术方案:一种用于治疗抑郁症的中药组合物,它所含的活性成分由下列重量份原料药提取制备而成:小叶桑根16份、水葫芦七12份、大人血七15份、桃金娘花6份、苣荬菜8份、金刚口摆10份、菜子七6份、山菠萝根20份、肾炎草12份、紫绿草14份、大脖子药12份、和筋草6份、铁马鞭8份、对节叶16份、窿缘桉叶12份、桦菌芝14份、忽布筋骨草13份、土荆皮10份、狗狗秧8份、跌打老7份、荚蒾子16份。
所述用于治疗抑郁症的中药组合物,剂型是药学上可接受的颗粒剂、片剂、胶囊剂。
所述用于治疗抑郁症的中药组合物,制备步骤为:取上述中药,加药材10倍重量的水,浸泡0.5h,煎煮1小时,过滤,药渣再加入药材8倍重量的水,煎煮1小时,药液滤出,合并两次煎煮液,减压浓缩至60℃相对密度为1.05,加乙醇使含醇量的体积百分比达75%,搅拌,静置,过滤,滤液减压浓缩至65℃时相对密度为1.25,并回收乙醇,得浓缩液,将浓缩液喷雾干燥,喷雾干燥条件为:进风温度为100℃,出风温度为90℃,物料温度为70℃,雾化压力为0.2兆帕,喷雾速度为10ml/s,添加辅料制成胶囊剂、片剂、颗粒剂。
所述用于治疗抑郁症的中药组合物在制备治疗抑郁症药物中的应用。
本发明中小叶桑根为桑科植物鸡桑的根。水葫芦七为菊科植物水葫芦七的根。大人血七为罂粟科植物人血草的带根全草。桃金娘花为桃金娘科植物桃金娘的花。苣荬菜为菊科植物苣荬菜的全草。荚蒾子为忍冬科植物荚蒾的果实。菜子七为十字花科植物白花碎米荠的根。山菠萝根为百合科植物荞麦叶大百合的鳞茎。肾炎草为菊科植物倒卵叶兔耳风的全草。紫绿草为荨麻科植物粗齿冷水花的全草。大脖子药为苦苣苔科植物歪冠苦苣苔的根。和筋草为石竹科植物日本狗筋蔓的全草。铁马鞭为豆科植物铁马鞭的全草。对节叶为爵床科植物对节叶的叶。窿缘桉叶为桃金娘科植物窿缘桉的叶。桦菌芝为多孔菌种植物木蹄的菌体。忽布筋骨草为唇形科植物白苞筋骨草的全草。土荆皮为松科植物金钱松的树皮。狗狗秧为旋花科植物日本天剑的全草。跌打老为樟科植物轮叶木姜子的根。金刚口摆为海桐科植物狭叶海桐的全草。
有益效果:本发明治疗抑郁症效果明显。本发明能积极有效地防治抑郁症的发生与发展,这对于提高广大群众的生存与生活质量、保护广大群众的健康,进而提高劳动生产力,具有重要意义和较高的实用价值。由于本病发病率高,预计一经市场推广应用,必将产生良好的社会效益和经济效益。
具体实施方式
以下通过实施例形式,对本发明的上述内容再作进一步的详细说明,但不应将此理解为本发明上述主题的范围仅限于以下的实例,凡基于本发明上述内容所实现的技术均属于本发明的范围。
1、颗粒剂实施例的制备:取小叶桑根16g、水葫芦七12g、大人血七15g、桃金娘花6g、苣荬菜8g、金刚口摆10g、菜子七6g、山菠萝根20g、肾炎草12g、紫绿草14g、大脖子药12g、和筋草6g、铁马鞭8g、对节叶16g、窿缘桉叶12g、桦菌芝14g、忽布筋骨草13g、土荆皮10g、狗狗秧8g、跌打老7g、荚蒾子16g,加药材10倍重量的水,浸泡0.5h,煎煮1小时,过滤,药渣再加入药材8倍重量的水,煎煮1小时,药液滤出,合并两次煎煮液,减压浓缩至60℃相对密度为1.05,加乙醇使含醇量的体积百分比达75%,搅拌,静置,过滤,滤液减压浓缩至65℃时相对密度为1.25,并回收乙醇,得浓缩液,将浓缩液喷雾干燥,喷雾干燥条件为:进风温度为100℃,出风温度为90℃,物料温度为70℃,雾化压力为0.2兆帕,喷雾速度为10ml/s,添加淀粉,制粒,制成颗粒剂。
2、片剂实施例的制备:取小叶桑根16g、水葫芦七12g、大人血七15g、桃金娘花6g、苣荬菜8g、金刚口摆10g、菜子七6g、山菠萝根20g、肾炎草12g、紫绿草14g、大脖子药12g、和筋草6g、铁马鞭8g、对节叶16g、窿缘桉叶12g、桦菌芝14g、忽布筋骨草13g、土荆皮10g、狗狗秧8g、跌打老7g、荚蒾子16g,加药材10倍重量的水,浸泡0.5h,煎煮1小时,过滤,药渣再加入药材8倍重量的水,煎煮1小时,药液滤出,合并两次煎煮液,减压浓缩至60℃相对密度为1.05,加乙醇使含醇量的体积百分比达75%,搅拌,静置,过滤,滤液减压浓缩至65℃时相对密度为1.25,并回收乙醇,得浓缩液,将浓缩液喷雾干燥,喷雾干燥条件为:进风温度为100℃,出风温度为90℃,物料温度为70℃,雾化压力为0.2兆帕,喷雾速度为10ml/s,添加糊精,制粒,压片,制成片剂。
3、胶囊剂实施例的制备:取小叶桑根16g、水葫芦七12g、大人血七15g、桃金娘花6g、苣荬菜8g、金刚口摆10g、菜子七6g、山菠萝根20g、肾炎草12g、紫绿草14g、大脖子药12g、和筋草6g、铁马鞭8g、对节叶16g、窿缘桉叶12g、桦菌芝14g、忽布筋骨草13g、土荆皮10g、狗狗秧8g、跌打老7g、荚蒾子16g,加药材10倍重量的水,浸泡0.5h,煎煮1小时,过滤,药渣再加入药材8倍重量的水,煎煮1小时,药液滤出,合并两次煎煮液,减压浓缩至60℃相对密度为1.05,加乙醇使含醇量的体积百分比达75%,搅拌,静置,过滤,滤液减压浓缩至65℃时相对密度为1.25,并回收乙醇,得浓缩液,将浓缩液喷雾干燥,喷雾干燥条件为:进风温度为100℃,出风温度为90℃,物料温度为70℃,雾化压力为0.2兆帕,喷雾速度为10ml/s,添加淀粉,制粒,灌装,制成胶囊剂。
4、本发明中药组合物抗抑郁药效学研究
4.1实验目的:观察本发明组合物对动物利血平抑郁模型的影响
4.1.1实验材料
4.1.1.1动物:健康ICR小鼠,♀♂,体重18-22g,由南京中医药大学实验动物中心提供,生产许可证:SCXK(苏)2002-0053。
4.1.1.2药品与试剂:本发明中药组合物颗粒剂,按上述颗粒剂实施例的制备方法制备,利血平注射液上海医科大学红旗制药厂提供,批号:121106,阳性药盐酸氟西汀片常州四药制药有限公司,批号:130405。
4.1.1.3给药剂量:按照小鼠体重计,小剂量、中剂量和大剂量分别为10g生药量/kg、20g生药量/kg和40g生药量/kg。氟西汀15.6mg/kg,相当于人用量的6倍,即浓度为0.78mg/ml;利血平2mg/kg即浓度为0.2mg/ml,以0.1ml/10g尾静脉注射。
4.1.2实验方法与结果
取健康ICR小鼠120只,♀♂各半,随机分6组,每组20只。即①正常对照组(0.1ml/10g),②模型组(0.1ml/10g),③阳性药氟西汀组(15.6mg/kg),④本发明大剂量(40g生药量/kg),⑤本发明组合物中剂量(20g生药量/kg),⑥本发明组合物小剂量(10g生药量/kg),给药6天,于第6天上午,除正常组外,其余各组尾静脉注射2mg/kg利血平,同时灌胃给药。1h后将动物放于支架上观察15S,比较动物关闭眼帘一半的动物数;然后,将动物放于直径7.5cm圆形白纸的中央观察15S或更长时间,比较呆在圈内动物数;结果进行λ2检验;4h后测量动物肛温。结果见下表,并进行T检验比较。
观察指标:1、眼帘下垂2、运动不能3、动物体温
表1:本发明对利血平引起动物抑郁模型的影响(n=20)
注:关闭眼帘一半的动物数和运动不能动物数,结果进行λ2检验;动物肛温,结果进行T检验。与正常对照组相比,△P<0.05,△△P<0.01;与模型组相比*P<0.05,**P<0.01
实验结果表明:本发明组合物对利血平引起动物抑郁模型的眼帘下垂、运动不能和动物体温与模型组相比,有显著差异。表明本发明中药组合物对利血平引起动物抑郁模型眼帘下垂、运动不能和动物体温下降有明显抑制作用。
4.2实验目的:观察本发明组合物对小鼠悬尾实验的影响
实验材料同上。
取健康ICR小鼠120只,♂,随机分6组,每组20只。即①正常对照组(0.1ml/10g),②模型组(0.1ml/10g),③氟西汀组(15.6mg/kg),④本发明中药组合物大剂量(40g生药量/kg),⑤本发明中药组合物中剂量(20g生药量/kg),⑥本发明中药组合物小剂量(10g生药量/kg)。给药3天,实验前禁食不禁水12h,于第3天上午,除正常组外,其余各组尾静脉注射2mg/kg利血平,同时给药1h后,将小鼠尾部2cm处用胶布粘于高5cm处,让小鼠先适应1min后开始记录时间,记录6min中小鼠不动的时间。结果见下表,并进行T检验比较。
表2:本发明中药组合物对小鼠悬尾实验的影响(n=20)
组别 | 悬尾不动时间(s) |
正常组 | 113.65±46.73 |
模型组 | 223.76±68.25△△ |
阳性药组 | 153.39±56.87* |
本发明小剂量 | 124.46±73.26* |
本发明中剂量 | 118.92±38.49* |
本发明大剂量 | 102.53±36.75* |
注:与正常对照组相比,△△P<0.01;与模型组相比*P<0.05,**P<0.01
实验结果表明:本发明组合物对小鼠悬尾实验的悬尾不动时间与模型组相比,有显著差异;表明本发明组合物对小鼠悬尾实验的悬尾不动时间有明显对抗作用。
4.3实验目的:观察本发明组合物对小鼠强迫游泳实验的影响
实验材料同上。
取健康ICR小鼠120只,♂,随机分6组,每组20只。即①正常对照组(0.1ml/10g),②模型组(0.1ml/10g),③氟西汀组(15.6mg/kg),④本发明中药组合物大剂量(40g生药量/kg),⑤本发明中药组合物中剂量(20g生药量/kg),⑥本发明中药组合物小剂量(10g生药量/kg)。给药3天,实验前禁食不禁水12h,于第3天上午,除正常组外,其余各组尾静脉注射2mg/kg利血平,同时给药1h后,将小鼠放入深10cm的水槽中,让小鼠先适应1min后(水温保持在20-24℃),开始记录时间,记录15min中小鼠游泳不动的时间。结果见下表,并进行T检验比较。
表3:本发明中药组合物对小鼠强迫游泳实验的影响(n=20)
组别 | 游泳不动时间(s) |
正常组 | 207.38±96.31 |
模型组 | 714.42±118.65△△ |
阳性药组 | 437.78±112.42* |
本发明小剂量 | 426.52±133.74* |
本发明中剂量 | 368.57±118.65* |
本发明大剂量 | 292.84±98.73* |
注:与正常对照组相比,△△P<0.01;与模型组相比*P<0.05,**P<0.01
实验结果表明:本发明中药组合物对小鼠游泳实验的游泳不动时间与模型组相比,有显著差异;表明本发明中药组合物对小鼠游泳实验的游泳不动时间有明显对抗作用。
综上所述,本发明中药组合物具有很好的抗抑郁作用,可用于制备治疗抑郁症的药物。
Claims (4)
1.一种用于治疗抑郁症的中药组合物,其特征在于,它所含的活性成分由下列重量份原料药提取制备而成:小叶桑根16份、水葫芦七12份、大人血七15份、桃金娘花6份、苣荬菜8份、金刚口摆10份、菜子七6份、山菠萝根20份、肾炎草12份、紫绿草14份、大脖子药12份、和筋草6份、铁马鞭8份、对节叶16份、窿缘桉叶12份、桦菌芝14份、忽布筋骨草13份、土荆皮10份、狗狗秧8份、跌打老7份、荚蒾子16份。
2.如权利要求1所述用于治疗抑郁症的中药组合物,其特征在于,剂型是药学上可接受的颗粒剂、片剂、胶囊剂。
3.如权利要求1所述用于治疗抑郁症的中药组合物,其特征在于,制备步骤为:取上述中药,加药材10倍重量的水,浸泡0.5h,煎煮1小时,过滤,药渣再加入药材8倍重量的水,煎煮1小时,药液滤出,合并两次煎煮液,减压浓缩至60℃相对密度为1.05,加乙醇使含醇量的体积百分比达75%,搅拌,静置,过滤,滤液减压浓缩至65℃时相对密度为1.25,并回收乙醇,得浓缩液,将浓缩液喷雾干燥,喷雾干燥条件为:进风温度为100℃,出风温度为90℃,物料温度为70℃,雾化压力为0.2兆帕,喷雾速度为10ml/s,添加辅料制成胶囊剂、片剂、颗粒剂。
4.根据权利要求1所述用于治疗抑郁症的中药组合物在治疗抑郁症药物中的应用。
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