CN105641507A - 一种用于焦虑症日常调理的药物组合物及其制备方法 - Google Patents
一种用于焦虑症日常调理的药物组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开的是一种用于焦虑症日常调理的药物组合物及其制备方法,所述的组合物是中药成分和西药成分组成的,中药主要由以下原料组成:白残花、乳源木莲果、刺苞南蛇藤果、高粱、扁担杆、密纹薄芝、槭叶草、贵州远志、打碗花、建兰花、娑罗子、厚叶川木香、酸枣仁提取物、淡竹叶提取物;西药主要成分为:L-酪氨酸、氟甲硝基安定、维生素C、维生素B1,本发明配伍合理,采用中西医结合理论,中药从机理调节,西药快速缓解症状,具有宁心安神、疏肝理气、健脾解郁、调理气血的功效,对焦虑症辅助治疗的有很好的疗效。
Description
技术领域
本发明涉及药物护理领域,具体是涉及一种用于焦虑症日常调理的药物组合物及其制备方法。
背景技术
随着生活节奏的加快,激烈的职场竞争,复杂的人际关系,超负荷的脑力和体力劳动等等因素导致人们情绪的各种变化,使得精神疾病成为危害人类健康的一大因素,其中,焦虑症越来越普遍,尤其是在中青年群体中,甚至很多青少年也受此病的煎熬,并且由此病导致的多种身体疾病也不少见,严重影响着现代人的身心健康。焦虑症是常见的神经类疾病,以情绪焦虑为主要特征,表现为情绪焦躁、恐惧不安、神经衰弱、肌肉紧张,心慌、疲惫、甚至引发恶心、便秘、晕厥、尿频尿急等症状。焦虑症分为慢性焦虑即广泛性焦虑和急性焦虑,慢性焦虑表现为广泛而持久的焦虑,持续时间较长,患者多会表现出长期的不安,紧张,害怕等情绪,注意力无法集中,严重者甚至会出现呼吸困难、胃部不适、头晕、恶心等功能性障碍症状,且很难治愈,需长期慢慢调理。急性焦虑表现为突发惊恐状,心脏剧烈跳动,肢体僵硬,甚者可致精神崩溃,从而做出危及生病的事情,这些情况完全不受本人控制,但急性发作一般持续时间短,及时治疗就能得到缓解。目前对于焦虑症的治疗分为心理治疗和药物治疗,心理治疗是通过安抚患者情绪,寻求发病原因,从而排除患者的心理障碍,达到减轻痛苦的目的,但此法因人而异,也不能保证会完全奏效,还需配合药物治疗,才能达到快速缓解的效果。现有的药物疗法西医主要以一些安定类药物为主,控制住患者的情绪,虽见效快但副作用大,只能暂时缓解;中药疗法提倡调理为主,疏肝健脾,宁心安神,虽可对症治疗,但疗效太慢,故需要研制一种疗效快并且能将治疗和调理相结合的药物,以缓解焦虑症患者发作时的痛苦。
发明内容
本发明解决的技术问题是提供一种用于焦虑症日常调理的药物组合物及其制备方法。
为解决上述技术问题,本发明所采用的技术方案是:
一种用于焦虑症日常调理的药物组合物,主要是由中药成分和西药成分组成的,按重量组份计,所述的中药成分由以下原料组成:白残花74-102份、乳源木莲果70-98份、刺苞南蛇藤果65-92份、高粱61-87份、扁担杆57-81份、密纹薄芝51-71份、槭叶草42-66份、贵州远志35-63份、打碗花28-56份、建兰花23-45份、娑罗子18-32份、厚叶川木香12-26份、酸枣仁提取物7-13份、淡竹叶提取物5-10份;所述西药成分包括以下组份:L-酪氨酸0.06-0.12份、维生素C0.05-0.09份、氟甲硝基安定0.04-0.09份、维生素B10.02-0.08份。
进一步地,一种用于焦虑症日常调理的药物组合物,主要是由中药成分和西药成分组成的,按重量组份计,所述的中药成分由以下原料组成:白残花88份、乳源木莲果84份、刺苞南蛇藤果78.5份、高粱74份、扁担杆69份、密纹薄芝61份、槭叶草54份、贵州远志49份、打碗花42份、建兰花34份、娑罗子25份、厚叶川木香19份、酸枣仁提取物10份、淡竹叶提取物7.5份;所述西药成分包括以下组份:L-酪氨酸0.09份、维生素C0.07份、氟甲硝基安定0.065份、维生素B10.05份。
进一步地,所述的酸枣仁提取物为酸枣仁总皂苷,其提取方法为:取除杂干燥后的酸枣仁,用粉碎机粉碎,得到的粗粉加11倍量的石油乙醚脱脂,除去酸枣仁中的脂肪油,设置脱脂温度为72-86℃,脱脂时间为3.5h,回收石油乙醚,将脱脂后的酸枣仁置于烘干箱中烘干,设置烘干温度为69-75℃,使其水分含量低于7%即可,再用质量浓度为73%的乙醇以1:25的料液比进行超声提取55-65min,所得提取液回收乙醇后,用微孔滤膜法过滤,所得滤液加入8倍量的水饱和正丁醇萃取4次,每次30min,合并正丁醇萃取液,浓缩并经真空干燥,所得粉末过160目筛,得到酸枣仁总皂苷。酸枣仁总皂苷有养肝、宁心、安神的功效,对焦虑症有很好的缓解作用。
进一步地,所述的淡竹叶提取物为淡竹叶总黄酮,其提取方法为:取淡竹叶的干燥根茎,用烘干箱低温烘干,设置烘干温度为49-53℃,使水分含量低于4%,粉碎成粗粉,所得粗粉加9倍量的石油乙醚脱脂,设置脱脂温度为58-64℃,脱脂时间为4h,回收石油乙醚后继续低温烘干,使其水分含量低于8%即可,按1:35的料液比加入质量浓度为76%的乙醇溶液浸提3次,浸提时间分别为8h,5.5h,5h,设置浸提温度为83-85℃,减压回收乙醇后,用大孔树脂柱过滤,滤液减压浓缩用喷雾干燥塔喷雾干燥,过150目筛,得到淡竹叶总黄酮。淡竹叶总黄酮具有清热除烦、抗衰老、抗疲劳和增强免疫力的功效。
一种用于焦虑症日常调理的药物组合物的制备方法,包括以下步骤:
(1)取除杂干燥后的酸枣仁,用粉碎机粉碎成粗粉,过30-50目筛,得到的粗粉加11倍量的石油乙醚脱脂,除去酸枣仁中的脂肪油,设置脱脂温度为72-86℃,脱脂时间为3.5h,回收石油乙醚,将脱脂后的酸枣仁置于烘干箱中烘干,设置烘干温度为69-75℃,使其水分含量低于7%即可,再用质量浓度为73%的乙醇以1:25的料液比进行超声提取55-65min,所得提取液回收乙醇后,用微孔滤膜法过滤,所得滤液加入8倍量的水饱和正丁醇萃取4次,每次30min,合并正丁醇萃取液,浓缩并经真空干燥,所得粉末过160目筛,得到酸枣仁提取物酸枣仁总皂苷,备用,酸枣仁总皂苷有养肝、宁心、安神的功效,对焦虑症有很好的缓解作用;
(2)取淡竹叶的干燥根茎,用烘干箱低温烘干,设置烘干温度为49-53℃,使水分含量低于4%,粉碎成20-30目的粗粉,所得粗粉加9倍量的石油乙醚脱脂,设置脱脂温度为58-64℃,脱脂时间为4h,回收石油乙醚后继续低温烘干,使其水分含量低于8%即可,按1:35的料液比加入质量浓度为76%的乙醇溶液浸提3次,浸提时间分别为8h,5.5h,5h,设置浸提温度为83-85℃,减压回收乙醇后,用大孔树脂柱过滤,滤液减压浓缩用喷雾干燥塔喷雾干燥,过150目筛,得到淡竹叶提取物淡竹叶总黄酮,备用,淡竹叶总黄酮具有清热除烦、抗衰老、抗疲劳和增强免疫力的功效;
(3)按照所述重量配比称取白残花、乳源木莲果、刺苞南蛇藤果、密纹薄芝、建兰花,加5倍量的纯净水浸泡4h,再加入10-12倍量的纯净水,武火煮沸20min,改文火煎煮5h,过滤得到滤液Ⅰ,再向过滤后的药渣中加入6-9倍量的纯净水,武火煮沸,改文火煎煮3h,过滤得到滤液Ⅱ,将滤液Ⅰ和滤液Ⅱ混合,给混合液中加入5-6倍量的质量浓度为73%的乙醇溶液,静置13-17h,取上清液减压回收乙醇后浓缩成浸膏,真空干燥,过140-170目筛,灭菌备用;
(4)按照所述重量配比称高粱、扁担杆、槭叶草、贵州远志、打碗花、娑罗子、厚叶川木香干品,清洗干净后用烘干机烘干12-16min,烘干温度为57-67℃,再将其用粉粹机粉碎成粗粉,过20-50目筛,将粗粉和质量浓度为73-89%的乙醇溶液按1:13的料液比混合,加入超声波提取器中进行超声提取,设置提取温度为45-53℃,提取时间为1-1.8h,得到的提取液用微孔滤膜过滤,减压回收乙醇,浓缩得到浸膏,喷雾干燥,过130-150目筛,灭菌备用,超声提取是依据超声的空化效应、热效应和机械作用实现的,可快速地释放、溶解药物,与传统提取方法相比,缩短了提取时间,且使有效成分的含量也得以提高;
(5)按照所述重量配比称步骤(1)和(2)制得的酸枣仁提取物和淡竹叶提取物,与步骤(3)和(4)制得的浸膏粉混合均匀得到混合粉,所得混合粉中再加入L-酪氨酸、维生素C、氟甲硝基安定、维生素B1,放于搅拌机里以260r/min的转速搅拌20-28min,使其充分混合,灭菌,即得所述药物组合物。
进一步地,将所述药物组合物制成颗粒剂,颗粒剂避免了传统中药煎煮的麻烦,方便服用。
进一步地,一种用于焦虑症日常调理的药物组合物的颗粒剂的制备方法包括以下步骤:
(1)取除杂干燥后的酸枣仁,用粉碎机粉碎成粗粉,过30-50目筛,得到的粗粉加11倍量的石油乙醚脱脂,除去酸枣仁中的脂肪油,设置脱脂温度为72-86℃,脱脂时间为3.5h,回收石油乙醚,将脱脂后的酸枣仁置于烘干箱中烘干,设置烘干温度为69-75℃,使其水分含量低于7%即可,再用质量浓度为73%的乙醇以1:25的料液比进行超声提取55-65min,所得提取液回收乙醇后,用微孔滤膜法过滤,所得滤液加入8倍量的水饱和正丁醇萃取4次,每次30min,合并正丁醇萃取液,浓缩并经真空干燥,所得粉末过160目筛,得到酸枣仁提取物酸枣仁总皂苷,备用,酸枣仁总皂苷有养肝、宁心、安神的功效,对焦虑症有很好的缓解作用;
(2)取淡竹叶的干燥根茎,用烘干箱低温烘干,设置烘干温度为49-53℃,使水分含量低于4%,粉碎成20-30目的粗粉,所得粗粉加9倍量的石油乙醚脱脂,设置脱脂温度为58-64℃,脱脂时间为4h,回收石油乙醚后继续低温烘干,使其水分含量低于8%即可,按1:35的料液比加入质量浓度为76%的乙醇溶液浸提3次,浸提时间分别为8h,5.5h,5h,设置浸提温度为83-85℃,减压回收乙醇后,用大孔树脂柱过滤,滤液减压浓缩用喷雾干燥塔喷雾干燥,过150目筛,得到淡竹叶提取物淡竹叶总黄酮,备用,淡竹叶总黄酮具有清热除烦、抗衰老、抗疲劳和增强免疫力的功效;
(3)按照所述重量配比称取白残花、乳源木莲果、刺苞南蛇藤果、密纹薄芝、建兰花,加5倍量的纯净水浸泡4h,再加入10-12倍量的纯净水,武火煮沸20min,改文火煎煮5h,过滤得到滤液Ⅰ,再向过滤后的药渣中加入6-9倍量的纯净水,武火煮沸,改文火煎煮3h,过滤得到滤液Ⅱ,将滤液Ⅰ和滤液Ⅱ混合,给混合液中加入5-6倍量的质量浓度为73%的乙醇溶液,静置13-17h,取上清液减压回收乙醇后浓缩成浸膏,真空干燥,过140-170目筛,灭菌备用;
(4)按照所述重量配比称高粱、扁担杆、槭叶草、贵州远志、打碗花、娑罗子、厚叶川木香干品,清洗干净后用烘干机烘干12-16min,烘干温度为57-67℃,再将其用粉粹机粉碎成粗粉,过20-50目筛,将粗粉和质量浓度为73-89%的乙醇溶液按1:13的料液比混合,加入超声波提取器中进行超声提取,设置提取温度为45-53℃,提取时间为1-1.8h,得到的提取液用微孔滤膜过滤,减压回收乙醇,浓缩得到浸膏,喷雾干燥,过130-150目筛,灭菌备用,超声提取是依据超声的空化效应、热效应和机械作用实现的,可快速地释放、溶解药物,与传统提取方法相比,缩短了提取时间,且使有效成分的含量也得以提高;
(5)按照所述重量配比称步骤(1)和(2)制得的酸枣仁提取物和淡竹叶提取物,与步骤(3)和(4)制得的浸膏粉混合均匀得到混合粉,所得混合粉中再加入L-酪氨酸、维生素C、氟甲硝基安定、维生素B1,放于搅拌机里以260r/min的转速搅拌20-28min,使其充分混合,灭菌,即得所述药物组合物。
(6)向步骤(5)制得的药物组合物中加入淀粉浆5-13份、低取代-羟丙基纤维素4-11份、微粉硅胶3-9份、甘油2-7份,混合均匀,用制粒装置通过加热干燥,搓圆制粒,再进行灭菌包装等工艺流程制成颗粒剂;淀粉浆:取11%的浓度,以冲浆法制成,可作粘合剂;低取代-羟丙基纤维素有良好的吸水速度和吸水量,可作崩解剂;微粉硅胶作润滑剂,可改善颗粒的流动性;甘油可作甜味剂,改善中药的苦味。
本发明所选药物的药理活性为:
白残花,功能主治:清暑热,化湿浊,顺气和胃。主治暑热胸闷,口渴,呕吐,不思饮食,口疮口糜。
乳源木莲果,功能主治:疏肝理气;通便止咳。主肝胃气痛;胁肋胀痛;老年便秘;咳嗽。
刺苞南蛇藤果,功能主治:宁心安神;活络止痛;解毒消肿。主心悸失眠;筋骨疼痛;腰腿麻木;牙痛;疮疡肿毒。
高粱,功能主治:健脾止泻;化痰安神。主脾虚泄泻;霍乱;消化不良;痰湿咳嗽;失眠多梦。
扁担杆,功能主治:健脾益气,固精止带,祛风除湿。用于小儿疳积,脾虚久泻,遗精,红崩,白带,子宫脱垂,脱肛,风湿关节痛。
密纹薄芝,功能主治:宁心安神;解毒保肝。主神经衰弱;心悸;失眠;急性肝炎;慢性肝炎。
槭叶草,功能主治:宁心安神。主心慌;心悸。
贵州远志,功能主治:止咳化痰;宁心安神。主咳嗽多痰;失眠。
打碗花,功能主治:健脾益气,利尿,调经,止带;用于脾虚消化不良,月经不调,白带,乳汁稀少。
建兰花,功能主治:理气,宽中,明目。治久咳,胸闷,腹泻,青盲内障。
娑罗子,功能主治:理气宽中,和胃止痛。用于胸腹胀闷,胃脘疼痛。
厚叶川木香,功能主治:疏肝理气,健胃止痛。用于慢性胃肠炎、消化不良、支气管炎。
酸枣仁提取物:酸枣仁总皂苷有养肝、宁心、安神的功效,对焦虑症有很好的缓解作用。
淡竹叶提取物:淡竹叶总黄酮具有清热除烦、抗衰老、抗疲劳和增强免疫力的功效。
L-酪氨酸:是氨基酸的一种,是从含有蛋白质物质的水溶液中提取而得,可以对人体补充营养,增强免疫力。
维生素C:可以调节人体新陈代谢,提高免疫力,提高机体应急能力,辅助L-酪氨酸发挥更好的作用。
氟甲硝基安定:有催眠、遗忘、镇静、抗焦虑、肌肉松弛和抗惊厥作用,可快速缓解焦虑症的症状,减轻病人痛苦。
维生素B1:可帮助人体进行能量代谢,维持机体正常所需,改善精神状况,维持精神组织、肌肉等的正常活动,改善焦虑症状。
与现有技术相比,本发明的有益效果是:针对焦虑症的日常护理,选用中西结合的疗法,采用先进的提取设备提炼而成,配伍合理,有效成分含量高,西药快速缓解症状,中药从内调理,也可缓解西药的副作用,调节新陈代谢,提高免疫能力,从而使患者达到良好的精神状态。本发明具有宁心安神、疏肝理气、健脾解郁、调理气血的功效,对焦虑症的日常调理有很好的疗效。
具体实施方式
下面结合具体的实施方式来对本发明的技术方案做进一步的限定,但要求保护的范围不仅局限于所作的描述。
实施例1:
一种用于焦虑症日常调理的药物组合物,是由中药成分和西药成分组成的,按重量组份计,所述的中药成分由以下原料组成:白残花74份、乳源木莲果70份、刺苞南蛇藤果65份、高粱61份、扁担杆57份、密纹薄芝51份、槭叶草42份、贵州远志35份、打碗花28份、建兰花23份、娑罗子18份、厚叶川木香12份、酸枣仁提取物7份、淡竹叶提取物5份;所述西药成分包括以下组份:L-酪氨酸0.06份、维生素C0.05份、氟甲硝基安定0.04份、维生素B10.02份。
一种用于焦虑症日常调理的药物组合物的制备方法,包括以下步骤:
(1)取除杂干燥后的酸枣仁,用粉碎机粉碎成粗粉,过30目筛,得到的粗粉加11倍量的石油乙醚脱脂,除去酸枣仁中的脂肪油,设置脱脂温度为72℃,脱脂时间为3.5h,回收石油乙醚,将脱脂后的酸枣仁置于烘干箱中烘干,设置烘干温度为69℃,使其水分含量低于7%即可,再用质量浓度为73%的乙醇以1:25的料液比进行超声提取55min,所得提取液回收乙醇后,用微孔滤膜法过滤,所得滤液加入8倍量的水饱和正丁醇萃取4次,每次30min,合并正丁醇萃取液,浓缩并经真空干燥,所得粉末过160目筛,得到酸枣仁提取物酸枣仁总皂苷,备用,酸枣仁总皂苷有养肝、宁心、安神的功效,对焦虑症有很好的缓解作用;
(2)取淡竹叶的干燥根茎,用烘干箱低温烘干,设置烘干温度为49℃,使水分含量低于4%,粉碎成20目的粗粉,所得粗粉加9倍量的石油乙醚脱脂,设置脱脂温度为58℃,脱脂时间为4h,回收石油乙醚后继续低温烘干,使其水分含量低于8%即可,按1:35的料液比加入质量浓度为76%的乙醇溶液浸提3次,浸提时间分别为8h,5.5h,5h,设置浸提温度为83℃,减压回收乙醇后,用大孔树脂柱过滤,滤液减压浓缩用喷雾干燥塔喷雾干燥,过150目筛,得到淡竹叶提取物淡竹叶总黄酮,备用,淡竹叶总黄酮具有清热除烦、抗衰老、抗疲劳和增强免疫力的功效;
(3)按照所述重量配比称取白残花、乳源木莲果、刺苞南蛇藤果、密纹薄芝、建兰花,加5倍量的纯净水浸泡4h,再加入10倍量的纯净水,武火煮沸20min,改文火煎煮5h,过滤得到滤液Ⅰ,再向过滤后的药渣中加入6倍量的纯净水,武火煮沸,改文火煎煮3h,过滤得到滤液Ⅱ,将滤液Ⅰ和滤液Ⅱ混合,给混合液中加入5倍量的质量浓度为73%的乙醇溶液,静置13h,取上清液减压回收乙醇后浓缩成浸膏,真空干燥,过140目筛,灭菌备用;
(4)按照所述重量配比称高粱、扁担杆、槭叶草、贵州远志、打碗花、娑罗子、厚叶川木香干品,清洗干净后用烘干机烘干12min,烘干温度为57℃,再将其用粉粹机粉碎成粗粉,过20目筛,将粗粉和质量浓度为73%的乙醇溶液按1:13的料液比混合,加入超声波提取器中进行超声提取,设置提取温度为45℃,提取时间为1h,得到的提取液用微孔滤膜过滤,减压回收乙醇,浓缩得到浸膏,喷雾干燥,过130目筛,灭菌备用,超声提取是依据超声的空化效应、热效应和机械作用实现的,可快速地释放、溶解药物,与传统提取方法相比,缩短了提取时间,且使有效成分的含量也得以提高;
(5)按照所述重量配比称步骤(1)和(2)制得的酸枣仁提取物和淡竹叶提取物,与步骤(3)和(4)制得的浸膏粉混合均匀得到混合粉,所得混合粉中再加入L-酪氨酸、维生素C、氟甲硝基安定、维生素B1,放于搅拌机里以260r/min的转速搅拌20min,使其充分混合,灭菌,即得所述药物组合物。
(6)向步骤(5)制得的药物组合物中加入淀粉浆5份、低取代-羟丙基纤维素4份、微粉硅胶3份、甘油2份,混合均匀,用制粒装置通过加热干燥,搓圆制粒,再进行灭菌包装等工艺流程制成颗粒剂。
其中,L-酪氨酸:是氨基酸的一种,是从含有蛋白质物质的水溶液中提取而得,可以对人体补充营养,增强免疫力;维生素C:可以调节人体新陈代谢,提高免疫力,提高机体应急能力,辅助L-酪氨酸发挥更好的作用;氟甲硝基安定:有催眠、遗忘、镇静、抗焦虑、肌肉松弛和抗惊厥作用,可快速缓解焦虑症的症状,减轻病人痛苦;维生素B1:可帮助人体进行能量代谢,维持机体正常所需,改善精神状况,维持精神组织、肌肉等的正常活动,改善焦虑症状;淀粉浆:取11%的浓度,以冲浆法制成,可作粘合剂;低取代-羟丙基纤维素有良好的吸水速度和吸水量,可作崩解剂;微粉硅胶作润滑剂,可改善颗粒的流动性;甘油可作甜味剂,改善中药的苦味。
实施例2:
一种用于焦虑症日常调理的药物组合物,是由中药成分和西药成分组成的,按重量组份计,所述的中药成分由以下原料组成:白残花88份、乳源木莲果84份、刺苞南蛇藤果78.5份、高粱74份、扁担杆69份、密纹薄芝61份、槭叶草54份、贵州远志49份、打碗花42份、建兰花34份、娑罗子25份、厚叶川木香19份、酸枣仁提取物10份、淡竹叶提取物7.5份;所述西药成分包括以下组份:L-酪氨酸0.09份、维生素C0.07份、氟甲硝基安定0.065份、维生素B10.05份。
一种用于焦虑症日常调理的药物组合物的制备方法,包括以下步骤:
(1)取除杂干燥后的酸枣仁,用粉碎机粉碎成粗粉,过40目筛,得到的粗粉加11倍量的石油乙醚脱脂,除去酸枣仁中的脂肪油,设置脱脂温度为79℃,脱脂时间为3.5h,回收石油乙醚,将脱脂后的酸枣仁置于烘干箱中烘干,设置烘干温度为72℃,使其水分含量低于7%即可,再用质量浓度为73%的乙醇以1:25的料液比进行超声提取60min,所得提取液回收乙醇后,用微孔滤膜法过滤,所得滤液加入8倍量的水饱和正丁醇萃取4次,每次30min,合并正丁醇萃取液,浓缩并经真空干燥,所得粉末过160目筛,得到酸枣仁提取物酸枣仁总皂苷,备用,酸枣仁总皂苷有养肝、宁心、安神的功效,对焦虑症有很好的缓解作用;
(2)取淡竹叶的干燥根茎,用烘干箱低温烘干,设置烘干温度为51℃,使水分含量低于4%,粉碎成25目的粗粉,所得粗粉加9倍量的石油乙醚脱脂,设置脱脂温度为61℃,脱脂时间为4h,回收石油乙醚后继续低温烘干,使其水分含量低于8%即可,按1:35的料液比加入质量浓度为76%的乙醇溶液浸提3次,浸提时间分别为8h,5.5h,5h,设置浸提温度为84℃,减压回收乙醇后,用大孔树脂柱过滤,滤液减压浓缩用喷雾干燥塔喷雾干燥,过150目筛,得到淡竹叶提取物淡竹叶总黄酮,备用,淡竹叶总黄酮具有清热除烦、抗衰老、抗疲劳和增强免疫力的功效;
(3)按照所述重量配比称取白残花、乳源木莲果、刺苞南蛇藤果、密纹薄芝、建兰花,加5倍量的纯净水浸泡4h,再加入11倍量的纯净水,武火煮沸20min,改文火煎煮5h,过滤得到滤液Ⅰ,再向过滤后的药渣中加入7.5倍量的纯净水,武火煮沸,改文火煎煮3h,过滤得到滤液Ⅱ,将滤液Ⅰ和滤液Ⅱ混合,给混合液中加入5.5倍量的质量浓度为73%的乙醇溶液,静置15h,取上清液减压回收乙醇后浓缩成浸膏,真空干燥,过160目筛,灭菌备用;
(4)按照所述重量配比称高粱、扁担杆、槭叶草、贵州远志、打碗花、娑罗子、厚叶川木香干品,清洗干净后用烘干机烘干14min,烘干温度为62℃,再将其用粉粹机粉碎成粗粉,过35目筛,将粗粉和质量浓度为81%的乙醇溶液按1:13的料液比混合,加入超声波提取器中进行超声提取,设置提取温度为49℃,提取时间为1.4h,得到的提取液用微孔滤膜过滤,减压回收乙醇,浓缩得到浸膏,喷雾干燥,过140目筛,灭菌备用,超声提取是依据超声的空化效应、热效应和机械作用实现的,可快速地释放、溶解药物,与传统提取方法相比,缩短了提取时间,且使有效成分的含量也得以提高;
(5)按照所述重量配比称步骤(1)和(2)制得的酸枣仁提取物和淡竹叶提取物,与步骤(3)和(4)制得的浸膏粉混合均匀得到混合粉,所得混合粉中再加入L-酪氨酸、维生素C、氟甲硝基安定、维生素B1,放于搅拌机里以260r/min的转速搅拌24min,使其充分混合,灭菌,即得所述药物组合物。
(6)向步骤(5)制得的药物组合物中加入淀粉浆9份、低取代-羟丙基纤维素7.5份、微粉硅胶6份、甘油4.5份,混合均匀,用制粒装置通过加热干燥,搓圆制粒,再进行灭菌包装等工艺流程制成颗粒剂。
其中,L-酪氨酸:是氨基酸的一种,是从含有蛋白质物质的水溶液中提取而得,可以对人体补充营养,增强免疫力;维生素C:可以调节人体新陈代谢,提高免疫力,提高机体应急能力,辅助L-酪氨酸发挥更好的作用;氟甲硝基安定:有催眠、遗忘、镇静、抗焦虑、肌肉松弛和抗惊厥作用,可快速缓解焦虑症的症状,减轻病人痛苦;维生素B1:可帮助人体进行能量代谢,维持机体正常所需,改善精神状况,维持精神组织、肌肉等的正常活动,改善焦虑症状;淀粉浆:取11%的浓度,以冲浆法制成,可作粘合剂;低取代-羟丙基纤维素有良好的吸水速度和吸水量,可作崩解剂;微粉硅胶作润滑剂,可改善颗粒的流动性;甘油可作甜味剂,改善中药的苦味。
实施例3:
一种用于焦虑症日常调理的药物组合物,是由中药成分和西药成分组成的,按重量组份计,所述的中药成分由以下原料组成:白残花102份、乳源木莲果98份、刺苞南蛇藤果92份、高粱87份、扁担杆81份、密纹薄芝71份、槭叶草66份、贵州远志63份、打碗花56份、建兰花45份、娑罗子32份、厚叶川木香26份、酸枣仁提取物13份、淡竹叶提取物10份;所述西药成分包括以下组份:L-酪氨酸0.12份、维生素C0.09份、氟甲硝基安定0.09份、维生素B10.08份。
一种用于焦虑症日常调理的药物组合物的制备方法,包括以下步骤:
(1)取除杂干燥后的酸枣仁,用粉碎机粉碎成粗粉,过50目筛,得到的粗粉加11倍量的石油乙醚脱脂,除去酸枣仁中的脂肪油,设置脱脂温度为86℃,脱脂时间为3.5h,回收石油乙醚,将脱脂后的酸枣仁置于烘干箱中烘干,设置烘干温度为75℃,使其水分含量低于7%即可,再用质量浓度为73%的乙醇以1:25的料液比进行超声提取65min,所得提取液回收乙醇后,用微孔滤膜法过滤,所得滤液加入8倍量的水饱和正丁醇萃取4次,每次30min,合并正丁醇萃取液,浓缩并经真空干燥,所得粉末过160目筛,得到酸枣仁提取物酸枣仁总皂苷,备用,酸枣仁总皂苷有养肝、宁心、安神的功效,对焦虑症有很好的缓解作用;
(2)取淡竹叶的干燥根茎,用烘干箱低温烘干,设置烘干温度为53℃,使水分含量低于4%,粉碎成30目的粗粉,所得粗粉加9倍量的石油乙醚脱脂,设置脱脂温度为64℃,脱脂时间为4h,回收石油乙醚后继续低温烘干,使其水分含量低于8%即可,按1:35的料液比加入质量浓度为76%的乙醇溶液浸提3次,浸提时间分别为8h,5.5h,5h,设置浸提温度为85℃,减压回收乙醇后,用大孔树脂柱过滤,滤液减压浓缩用喷雾干燥塔喷雾干燥,过150目筛,得到淡竹叶提取物淡竹叶总黄酮,备用,淡竹叶总黄酮具有清热除烦、抗衰老、抗疲劳和增强免疫力的功效;
(3)按照所述重量配比称取白残花、乳源木莲果、刺苞南蛇藤果、密纹薄芝、建兰花,加5倍量的纯净水浸泡4h,再加入12倍量的纯净水,武火煮沸20min,改文火煎煮5h,过滤得到滤液Ⅰ,再向过滤后的药渣中加入9倍量的纯净水,武火煮沸,改文火煎煮3h,过滤得到滤液Ⅱ,将滤液Ⅰ和滤液Ⅱ混合,给混合液中加入6倍量的质量浓度为73%的乙醇溶液,静置17h,取上清液减压回收乙醇后浓缩成浸膏,真空干燥,过170目筛,灭菌备用;
(4)按照所述重量配比称高粱、扁担杆、槭叶草、贵州远志、打碗花、娑罗子、厚叶川木香干品,清洗干净后用烘干机烘干16min,烘干温度为67℃,再将其用粉粹机粉碎成粗粉,过50目筛,将粗粉和质量浓度为89%的乙醇溶液按1:13的料液比混合,加入超声波提取器中进行超声提取,设置提取温度为53℃,提取时间为1.8h,得到的提取液用微孔滤膜过滤,减压回收乙醇,浓缩得到浸膏,喷雾干燥,过150目筛,灭菌备用,超声提取是依据超声的空化效应、热效应和机械作用实现的,可快速地释放、溶解药物,与传统提取方法相比,缩短了提取时间,且使有效成分的含量也得以提高;
(5)按照所述重量配比称步骤(1)和(2)制得的酸枣仁提取物和淡竹叶提取物,与步骤(3)和(4)制得的浸膏粉混合均匀得到混合粉,所得混合粉中再加入L-酪氨酸、维生素C、氟甲硝基安定、维生素B1,放于搅拌机里以260r/min的转速搅拌28min,使其充分混合,灭菌,即得所述药物组合物。
(6)向步骤(5)制得的药物组合物中加入淀粉浆13份、低取代-羟丙基纤维素11份、微粉硅胶9份、甘油7份,混合均匀,用制粒装置通过加热干燥,搓圆制粒,再进行灭菌包装等工艺流程制成颗粒剂。
其中,L-酪氨酸:是氨基酸的一种,是从含有蛋白质物质的水溶液中提取而得,可以对人体补充营养,增强免疫力;维生素C:可以调节人体新陈代谢,提高免疫力,提高机体应急能力,辅助L-酪氨酸发挥更好的作用;氟甲硝基安定:有催眠、遗忘、镇静、抗焦虑、肌肉松弛和抗惊厥作用,可快速缓解焦虑症的症状,减轻病人痛苦;维生素B1:可帮助人体进行能量代谢,维持机体正常所需,改善精神状况,维持精神组织、肌肉等的正常活动,改善焦虑症状;淀粉浆:取11%的浓度,以冲浆法制成,可作粘合剂;低取代-羟丙基纤维素有良好的吸水速度和吸水量,可作崩解剂;微粉硅胶作润滑剂,可改善颗粒的流动性;甘油可作甜味剂,改善中药的苦味。
临床试验:
1.临床病例选择
1.1选择标准:选取出现焦虑症症状的患者,如坐卧不安、心烦少眠、多梦易惊并伴有恶心、心悸、易疲累等症。
1.2选择并分组:发明人共收集120例口臭患者,随机分为三组,每组40人。
2.试验方法:分别给三组患者使用本发明实施例1、实施例2和实施例3制备的颗粒剂,每日两次,每次一袋。10天一个疗程,连用3个疗程。
3.疗效标准与治疗结果:
3.1疗效标准
(1)疗效显著:患者情绪平稳,恢复正常生活状态;
(2)有效:症状有明显改善,但还需进一步观察;
(3)无效:症状无改善,或有加重趋势。
3.2治疗统计结果
表1—三组疗效比较
4.结论:临床试验过程中,接受本发明药物治疗的患者未发现有任何不良反应,由表1数据可见,本发明药物对口臭调理的总有效率达95%以上,是口臭调理的安全有效药物,且见效快,无任何副作用,具有很好的临床意义。
5.临床个体病例:
病例1:康某某,女,31岁,生产完第一个孩子后患有产后忧郁症,调理后好转,但近几年总是失眠多梦,并时常会莫名烦躁,工作时坐立不安,整个人的精神状态很差,就诊后确诊为焦虑症,服药调理但一直效果不佳,使用本发明实施例1制备的颗粒剂一个疗程,情绪得到缓解,睡眠质量得到改善,三个疗程后精神状态明显好转,晚上也能睡得着觉,遇事也不那么急躁,五个月后随访,未见复发。
病例2:王某,男,17岁,高中生,之前由于家庭变故使其受到很大刺激,加之高中课程压力大,学习成绩有所下滑,导致他越来越自卑,内向,渐渐地与同学疏远,并常有精神紧张不安,浑身酸痛,恶心头晕,考试注意力不集中等症状,使用本发明实施例2制备的颗粒剂一个疗程,症状缓解,坚持服用三个疗程后,恶心头痛,浑身酸痛等症消失,精神状态也慢慢调整,并通过学校老师进行心理辅导,五个月后随访,未见复发。
病例3:卫某,女,36岁,由于婚姻的破裂导致其患上焦虑症,脾气暴躁,一个人生活使其变得固执倔强,与人相处多疑,常会坐立不安,身体难受,服用的治疗焦虑症的西药,症状有所缓解,但副作用大,使用本发明实施例3制备的颗粒剂两个疗程,情绪得到控制,使用三个疗程后,身体上的症状消失,精神状态明显好转,建议其多去参加集体活动,增加与人的交往,使生活变得丰富起来,五个月后随访,未见复发。
最后应说明的是:以上实施例仅用以说明本发明的技术方案,而非对其限制;尽管参照前述实施例对本发明进行了详细的说明,本领域的普通技术人员应当理解:其依然可以对前述实施例所记载的技术方案进行修改,或者对其中部分技术特征进行等同替换;而这些修改或者替换,并不使相应技术方案的本质脱离本发明实施例技术方案的精神和范围。
Claims (7)
1.一种用于焦虑症日常调理的药物组合物,其特征在于所述的组合物是中药成分和西药成分组成的,按重量组份计,所述的中药成分由以下原料组成:白残花74-102份、乳源木莲果70-98份、刺苞南蛇藤果65-92份、高粱61-87份、扁担杆57-81份、密纹薄芝51-71份、槭叶草42-66份、贵州远志35-63份、打碗花28-56份、建兰花23-45份、娑罗子18-32份、厚叶川木香12-26份、酸枣仁提取物7-13份、淡竹叶提取物5-10份;所述西药成分包括以下组份:L-酪氨酸0.06-0.12份、维生素C0.05-0.09份、氟甲硝基安定0.04-0.09份、维生素B10.02-0.08份。
2.根据权利要求1所述的一种用于焦虑症日常调理的药物组合物,其特征在于所述的组合物是中药成分和西药成分组成的,按重量组份计,所述的中药成分由以下原料组成:白残花88份、乳源木莲果84份、刺苞南蛇藤果78.5份、高粱74份、扁担杆69份、密纹薄芝61份、槭叶草54份、贵州远志49份、打碗花42份、建兰花34份、娑罗子25份、厚叶川木香19份、酸枣仁提取物10份、淡竹叶提取物7.5份;所述西药成分包括以下组份:L-酪氨酸0.09份、维生素C0.07份、氟甲硝基安定0.065份、维生素B10.05份。
3.根据权利要求1或2任意一项所述的一种用于焦虑症日常调理的药物组合物,其特征在于,所述酸枣仁提取物为酸枣仁总皂苷,其提取方法为:取除杂干燥后的酸枣仁,用粉碎机粉碎,得到的粗粉进行脱脂处理,除去酸枣仁中的脂肪油,将脱脂后的酸枣仁置于烘干箱中烘干,设置烘干温度为69-75℃,使其水分含量低于7%即可,再用质量浓度为73%的乙醇以1:25的料液比进行超声提取55-65min,所得提取液回收乙醇后,用微孔滤膜法过滤,所得滤液加入8倍量的水饱和正丁醇萃取4次,每次30min,合并正丁醇萃取液,浓缩并经真空干燥,所得粉末过160目筛,得到酸枣仁总皂苷。
4.根据权利要求1或2任意一项所述的一种用于焦虑症日常调理的药物组合物,其特征于,所述的淡竹叶提取物为淡竹叶总黄酮,其提取方法为:取淡竹叶的干燥根茎,用烘干箱低温烘干,设置烘干温度为49-53℃,使水分含量低于4%,粉碎成粗粉,所得粗粉进行脱脂处理,再低温烘干使其水分含量低于8%即可,按1:35的料液比加入质量浓度为76%的乙醇溶液浸提3次,浸提时间分别为8h,5.5h,5h,设置浸提温度为83-85℃,减压回收乙醇后,用大孔树脂柱过滤,滤液减压浓缩用喷雾干燥塔喷雾干燥,过150目筛,得到淡竹叶总黄酮。
5.根据权利要求1至4任意一项所述的一种用于焦虑症日常调理的药物组合物的制备方法,其特征在于,包括以下步骤:
(1)取除杂干燥后的酸枣仁,用粉碎机粉碎,得到的粗粉进行脱脂处理,除去酸枣仁中的脂肪油,将脱脂后的酸枣仁置于烘干箱中烘干,设置烘干温度为69-75℃,使其水分含量低于7%即可,再用质量浓度为73%的乙醇以1:25的料液比进行超声提取55-65min,所得提取液回收乙醇后,用微孔滤膜法过滤,所得滤液加入8倍量的水饱和正丁醇萃取4次,每次30min,合并正丁醇萃取液,浓缩并经真空干燥,所得粉末过160目筛,得到酸枣仁总皂苷,备用;
(2)取淡竹叶的干燥根茎,用烘干箱低温烘干,设置烘干温度为49-53℃,使水分含量低于4%,粉碎成粗粉,所得粗粉进行脱脂处理,再低温烘干使其水分含量低于8%即可,按1:35的料液比加入质量浓度为76%的乙醇溶液浸提3次,浸提时间分别为8h,5.5h,5h,设置浸提温度为83-85℃,减压回收乙醇后,用大孔树脂柱过滤,滤液减压浓缩用喷雾干燥塔喷雾干燥,过150目筛,得到淡竹叶总黄酮,备用;
(3)按照所述重量配比称取白残花、乳源木莲果、刺苞南蛇藤果、密纹薄芝、建兰花,加5倍量的纯净水浸泡4h,再加入10-12倍量的纯净水,武火煮沸20min,改文火煎煮5h,过滤得到滤液Ⅰ,再向过滤后的药渣中加入6-9倍量的纯净水,武火煮沸,改文火煎煮3h,过滤得到滤液Ⅱ,将滤液Ⅰ和滤液Ⅱ混合,给混合液中加入5-6倍量的质量浓度为73%的乙醇溶液,静置13-17h,取上清液减压回收乙醇后浓缩成浸膏,真空干燥得浸膏粉,过140-170目筛,灭菌备用;
(4)按照所述重量配比称取高粱、扁担杆、槭叶草、贵州远志、打碗花、娑罗子、厚叶川木香干品,清洗干净后用烘干机烘干12-16min,烘干温度为57-67℃,再将其用粉粹机粉碎成粗粉,过20-50目筛,将粗粉和质量浓度为73-89%的乙醇溶液按1:13的料液比混合,加入超声波提取器中进行超声提取,设置提取温度为45-53℃,提取时间为1-1.8h,得到的提取液用微孔滤膜过滤,减压回收乙醇,浓缩得到浸膏,喷雾干燥得浸膏粉,过130-150目筛,灭菌备用;
(5)按照所述重量配比称步骤(1)和(2)制得的酸枣仁提取物和淡竹叶提取物,与步骤(3)和(4)制得的浸膏粉混合均匀得到混合粉,所得混合粉中再加入L-酪氨酸、维生素C、氟甲硝基安定、维生素B1,放于搅拌机里以260r/min的转速搅拌20-28min,使其充分混合,灭菌,即得所述药物组合物。
6.根据权利要求5所述的一种用于焦虑症日常调理的药物组合物的制备方法,其特征在于,将所述药物组合物制成颗粒剂。
7.根据权利要求6所述的一种用于焦虑症日常调理的药物组合物的制备方法,其特征在于所述的颗粒剂的制备方法包括以下步骤:
(1)取除杂干燥后的酸枣仁,用粉碎机粉碎,得到的粗粉进行脱脂处理,除去酸枣仁中的脂肪油,将脱脂后的酸枣仁置于烘干箱中烘干,设置烘干温度为69-75℃,使其水分含量低于7%即可,再用质量浓度为73%的乙醇以1:25的料液比进行超声提取55-65min,所得提取液回收乙醇后,用微孔滤膜法过滤,所得滤液加入8倍量的水饱和正丁醇萃取4次,每次30min,合并正丁醇萃取液,浓缩并经真空干燥,所得粉末过160目筛,得到酸枣仁总皂苷,备用;
(2)取淡竹叶的干燥根茎,用烘干箱低温烘干,设置烘干温度为49-53℃,使水分含量低于4%,粉碎成粗粉,所得粗粉进行脱脂处理,再低温烘干使其水分含量低于8%即可,按1:35的料液比加入质量浓度为76%的乙醇溶液浸提3次,浸提时间分别为8h,5.5h,5h,设置浸提温度为83-85℃,减压回收乙醇后,用大孔树脂柱过滤,滤液减压浓缩用喷雾干燥塔喷雾干燥,过150目筛,得到淡竹叶总黄酮,备用;
(3)按照所述重量配比称取白残花、乳源木莲果、刺苞南蛇藤果、密纹薄芝、建兰花,加5倍量的纯净水浸泡4h,再加入10-12倍量的纯净水,武火煮沸20min,改文火煎煮5h,过滤得到滤液Ⅰ,再向过滤后的药渣中加入6-9倍量的纯净水,武火煮沸,改文火煎煮3h,过滤得到滤液Ⅱ,将滤液Ⅰ和滤液Ⅱ混合,给混合液中加入5-6倍量的质量浓度为73%的乙醇溶液,静置13-17h,取上清液减压回收乙醇后浓缩成浸膏,真空干燥,过140-170目筛,灭菌备用;
(4)按照所述重量配比称高粱、扁担杆、槭叶草、贵州远志、打碗花、娑罗子、厚叶川木香干品,清洗干净后用烘干机烘干12-16min,烘干温度为57-67℃,再将其用粉粹机粉碎成粗粉,过20-50目筛,将粗粉和质量浓度为73-89%的乙醇溶液按1:13的料液比混合,加入超声波提取器中进行超声提取,设置提取温度为45-53℃,提取时间为1-1.8h,得到的提取液用微孔滤膜过滤,减压回收乙醇,浓缩得到浸膏,喷雾干燥,过130-150目筛,灭菌备用;
(5)按照所述重量配比称取步骤(1)和(2)制得的酸枣仁提取物和淡竹叶提取物,与步骤(3)和(4)制得的浸膏粉混合均匀得到混合粉,所得混合粉中再加入L-酪氨酸、维生素C、氟甲硝基安定、维生素B1,放于搅拌机里以260r/min的转速搅拌20-28min,使其充分混合,灭菌,即得所述药物组合物。
(6)向步骤(5)制得的药物组合物中加入淀粉浆5-13份、低取代-羟丙基纤维素4-11份、微粉硅胶3-9份、甘油2-7份,混合均匀,用制粒装置通过加热干燥,搓圆制粒,再进行灭菌包装等工艺流程制成颗粒剂。
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