CN110237182A - 一种缓解体力疲劳的组合物、制备方法和用途 - Google Patents
一种缓解体力疲劳的组合物、制备方法和用途 Download PDFInfo
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- CN110237182A CN110237182A CN201910680338.9A CN201910680338A CN110237182A CN 110237182 A CN110237182 A CN 110237182A CN 201910680338 A CN201910680338 A CN 201910680338A CN 110237182 A CN110237182 A CN 110237182A
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- Medicines Containing Plant Substances (AREA)
Abstract
本发明属于一种医药技术领域,具体是涉及到一种缓解体力疲劳的组合物、制备方法和用途,包括如下原料组分,人参超微粉10~25%、中药材水提物超微干粉60~80%、二氧化硅1~5%、微晶纤维素5~10%、硬脂酸镁0.1~0.5%;所述中药材水提物超微干粉包括黄精5~8份、淫羊藿2~4份、枸杞子2~4份、女贞子2~4份、菟丝子1~2份、丹参2~4份、金樱子2~4份、大枣2~3份;本发明药物制造成本低廉,见效快,可有效的缓解体力疲劳。
Description
技术领域
本发明属于一种医药技术领域,具体是涉及到一种缓解体力疲劳的组合物、制备方法和用途。
背景技术
随着社会的发展,科技的进步,工作、生活节凑的加快,工作压力与精神压力的逐渐增加,疲劳已成为成年人的一个普遍现象,也成为一个全球性现象。因此研发具有强身健体、缓解体力疲劳的保健产品,是社会的需求、时代的需求,具有重要的经济社会意义。
现代中医认为,疲劳为一个病名,有其病因病机,是临床上常见病、多发病,是必须重视的新病种,归于亚健康范畴,涉及五脏六腑,主要以脾、肝、肾为主。疲劳为元气耗伤之虚证与心理变化或不畅双重因素所致,治疗上不仅要补虚扶正,也应祛疲安神。一方面,补虚固元,滋养机体,虚得补,正则旺,疲劳自除;另一方面,调畅心志,舒心畅意,神得安,心则宁,疲劳可消。
已有研究表明,虫草、当归、肉苁蓉、唐古特青兰、云芝糖肽通过改善心、脑、骨骼肌的缺血、缺氧缓解体力疲劳;银杏黄酮、银杏内酯、构杞多糖、红景天、锁阳、刺五加、马先蒿、乌饭树等通过改善肝脏代谢和酶的活性、抗氧化清除自由基和乳酸缓解体力疲劳;人参皂苷、虫草等通过提高人体激素水平缓解体力疲劳;灵芝、白蚁等通过增加机体的营养物质缓解体力疲劳。
目前市面上缓解体力疲劳的产品良莠不齐,大多围绕虫草、肉苁蓉、灵芝、锁阳、人参等名贵药材,尤其是野生珍稀药材,破坏了药材的自然资源;或大多围绕肉苁蓉、锁阳、人参、玛咖、淫羊藿、巴戟天、刺五加等提高人体激素作用的药材。
已发表的专利也有上百个,如CN 107875216 A公开了一种具有缓解体力疲劳功效的组合物及其制备方法,由人参、黄芪、淫羊藿和巴戟天的混合水提物600~700份、微晶纤维素200~400份、淀粉100~260份、糊精50~150份、蔗糖30~50份和硬脂酸镁5~10份组成,其中最重要的抗疲劳成份人参皂苷在水提过程将大量损失,且人参、淫羊藿、巴戟天均有提高人体激素的作用,三者用量过大,可能引起人体激素失调。CN 103504299 B公开了一种缓解体力疲劳的保健食品,由玛咖粉4~80份、人参粉2~60份、牛磺酸0.6~30份、淫羊藿提取物0.6~30份、山茱萸提取物0.6~30份、巴戟天提取物0.6~30份、二氧化硅0.5~15份、硬脂酸镁0.2~10份组成,玛咖、人参、淫羊藿、巴戟天等均有提高人体激素的作用,用量过大,可能引起人体激素失调。CN108095078 A公开了一种增强免疫力缓解疲劳用组合物及其制备方法,该组合物由西洋参20~40份、黄芪30~60份、黄精30~60份、麦冬20~50份为原料,水提,制成固体颗粒产品、固体粉末饮品或液体饮料,其中最重要的抗疲劳成份人参与人参皂苷在水提过程将大量损失。
增强免疫力的中草药有很多种,比如人参、西洋参、黄芪、麦冬、山药、白芍、党参、当归、冬虫夏草、石斛、鹿茸、地黄等许多中草药,这些药物或多或少都具有增强免疫力的功效,但是想要达到较好的抗疲劳效果,一般需要使用到一些较为昂贵的中草药,比如野生人参、冬虫夏草、石斛,造成成本高昂,难以推广,且药物有效成分较为单一,起效时间较长,一般仅仅作为保健品使用。
发明内容
本发明要解决的技术问题是提供一种缓解体力疲劳的组合物、制备方法和用途,本发明药物制造成本低廉,见效快,可有效的缓解体力疲劳。
本发明的内容包括如下原料组分,人参超微粉10~25%、中药材水提物超微干粉60~80%、二氧化硅1~5%、微晶纤维素5~10%、硬脂酸镁0.1~0.5%;所述中药材水提物超微干粉包括黄精5~8份、淫羊藿2~4份、枸杞子2~4份、女贞子2~4份、菟丝子1~2份、丹参2~4份、金樱子2~4份、大枣2~3份。
优选的,包括如下原料组分,人参超微粉20%、中药材水提物超微干粉70%、二氧化硅3%、微晶纤维素6.6%、硬脂酸镁0.4%。
优选的,所述中药材水提物超微干粉包括黄精6份、淫羊藿3份、枸杞子3份、女贞子3份、菟丝子2份、丹参3份、金樱子3份、大枣2份。
本发明提供一种缓解体力疲劳的组合物的制备方法,包括如下步骤:
1、药材前处理:取人参药材,清洗、除杂、烘干、灭菌、超微粉碎,得人参超微粉;取黄精药材,清洗、除杂、切块;取淫羊藿、枸杞子、女贞子、菟丝子、金樱子和大枣药材除杂;取丹参药材,清洗、除杂、切段;
2、药材提取、浓缩与干燥:将处理后的黄精、淫羊藿、枸杞子、女贞子、菟丝子、丹参、金樱子和大枣的混合物在80℃,真空水提至少2次,第1次料液比为1:(10~15),提取时间1~2h,第2次料液比1:(5~10),提取时间0.5~1h;100目筛过滤,合并2次滤液;-0.03~-0.06Mpa、60~90℃减压浓缩成相对密度为1.2~1.3的浸膏;进行真空带式干燥,参数为:-95KPa~-100KPa、加料泵频率7~9Hz、传动频率15~17Hz、涂料频率7~9Hz、输料角度40°、一区温度100~105℃、二区温度80~85℃、冷却区温度25~30℃;
3、超微粉碎:将上述干燥后的提取物干膏于超微粉碎机超微粉碎,粉碎温度-15℃,得到水提物超微干粉;
4、干法制粒:指步骤1所制备的人参超微粉与步骤3所制备的水提物超微干粉于混合机混均,添加二氧化硅、微晶纤维素、硬脂酸镁,混合10~15min,混合均匀;于干法制粒机干法制粒,制粒压力5Mpa,垂直转速18转/min,水平转速48转/min,压辊转速13转/min,整粒转速120转/min,得到缓解体力疲劳的组合物;
优选的,包括如下步骤:将缓解体力疲劳的组合物进行胶囊填充,抛光,得到复方胶囊。
本发明还提供一种缓解体力疲劳的组合物在制备缓解体力疲劳药物方面的用途。
本发明的人参,甘,微苦,微温,归脾、肺、心、肾经;具大补元气、复脉固脱、补脾益肺、生津养血、安神益智功效。
淫羊藿,辛、甘,温,归肝、肾经,具补肾阳、强筋骨、袪风湿功效。枸杞子,甘,平,归肝、肾经,具滋补肝肾,益精明目功效,用于虚劳精亏、腰膝酸育等。
枸杞子,甘,平,归肝、肾经,具滋补肝肾,益精明目功效,用于虚劳精亏、腰膝酸软等。
女贞子,甘、苦,凉,归肝、肾经,具滋补肝肾,明目乌发作用。
菟丝子,辛,甘,闰,归肝、肾、脾经,具补益肝肾、固精缩尿、安胎、明目、止泻作用。
金樱子,酸、甘、涩,平,归肾、膀胱、大肠经,具固精缩尿、固崩止带、涩肠止泻功效。
丹参,苦,微寒,归心、肝经,具活血袪瘀、通经止痛、清心除烦、凉血消痈功效。黄精,甘,平,归脾、肺、肾经;具补气养阴、健脾润肺益肾功效,用于脾胃气虚、体倦乏力、精血不足、腰膝酸软等。
大枣,甘、温,归脾、胃、心经,具补中益气、养血安神之功效。
本发明的有益效果是,本发明配伍、配比科学合理,按传统中药理论结合现代临床医学理论配伍,以人参为君药,补虚固元;以黄精、淫羊藿、枸杞子、女贞子、菟丝子为臣药,滋补肝肾,生津造血,滋养机体;以金樱子、丹参为佐药,通过补气、活血、固精,调节精气血;以大枣为使药,调和诸药。以高效抗疲劳成分人参皂苷为主成份,以具有抗疲劳作用的淫羊藿多糖、枸杞子多糖、女贞子多糖、菟丝子多糖、金樱子多糖、丹参多糖、黄精多糖为辅助成分。
本发明配伍、用量科学合理,本发明所用药材均为人工栽培的大宗药材,所涉及工艺为简单生产工艺,成本低,易于实施、转化。即解决了部份野生珍稀药材的资源保护问题,又避免了过度使用提高人体激素水平药材的副作用问题,还解决了产业化成本问题。
本发明采用-15℃低温超微粉碎,最大程度的保留了人参药材中的皂苷成分,且超微粉极易被人体吸收,又大大提高人参皂苷及营养成份的生物利用度,保证了产品缓解体力疲劳的作用。另外,本发明处方中含有大量粗多糖,疗效好,但生产实施存在困难,药液粘稠,干燥存在困难,喷雾干燥容易堵喷头、粘壁,损耗大,如果采用抽真空干燥,时间长,本发明采用带式干燥,时间短,耗能小,温度相对较低,有效成分损失小。带式干燥收料后,采用-15℃低温超微粉碎,解决浸膏粉碎难题,同时,超微粉极易被人体吸收,又大大提高水提物中多糖及营养的生物利用度,进一步提供了产品缓解体力疲劳的作用。制粒采用干法制粒,区别于湿法制粒,直接制粒,不用再次干燥,减少损耗,减少工序及生产周期。
附图说明
图1为本发明的干颗粒的形貌图。
图2为本发明的胶囊的形貌图。
具体实施方式
实施例1
本实施例的一种缓解体力疲劳的组合物,其原料配比为:人参超微粉10%、黄精等8味药水提物微粉干粉80%、二氧化硅4%、微晶纤维素5.8%、硬脂酸镁0.2%。黄精等8味药水提物微粉干粉为黄精6份、淫羊藿3份、枸杞子3份、女贞子3份、菟丝子2份、丹参3份、金樱子3份、大枣2份的混合物的水提产物。
制备方法为:
①药材前处理:取人参药材,清洗、除杂、烘干、灭菌、超微粉碎,得人参超微粉;取黄精药材,清洗、除杂、切块;取淫羊藿、枸杞子、女贞子、菟丝子、金樱子和大枣药材除杂;取丹参药材,清洗、除杂、切段;
②取处理后的黄精等8味药的混合物80℃、真空水提2次,第1次料液比1:10,提取时间1.5h,第2次料液比1:8,提取时间1h;100目筛过滤,合并2次滤液,-0.03~-0.06Mpa、60~90℃减压浓缩成相对密度为1.3(60℃)的浸膏,-99KPa、加料泵频率8Hz、传动频率16Hz、涂料频率8Hz、输料角度40°、一区温度105℃、二区温度85℃、冷却区温度25~30℃带式干燥。
③取黄精等8味药水提物干膏于超微粉碎机超微粉碎,粉碎温度-15℃,得到超微干粉;
④按比例取人参粉、黄精等8味药水提物干粉、二氧化硅、微晶纤维素、硬脂酸镁于混合机混合10~15min,混合均匀;于干法制粒机干法制粒,制粒压力5Mpa,垂直转速18转/min,水平转速48转/min,压辊转速13转/min,整粒转速120转/min,得到缓解体力疲劳的组合物;
⑤胶囊填充,取干颗粒进行胶囊自动填充、抛光。
本实施例组合物,成人每日2次,每次2粒,空腹服用。
实施例2
本实施例的一种缓解体力疲劳的组合物,其原料配比为:人参超微粉15%、黄精等8味药水提物超微干粉75%、二氧化硅2%、微晶纤维7.5%、硬脂酸镁0.5%。黄精等8味药水提物超微干粉为黄精5份、淫羊藿2份、枸杞子4份、女贞子3份、菟丝子1份、丹参2份、金樱子4份、大枣2份的混合物的水提产物。
制备:同实施例1。
本实施例组合物,成人每日2次,每次2粒,空腹服用。
实施例3
本实施例一种缓解体力疲劳的组合物,其原料配比为:人参超微粉20%、黄精等8味药水提物超微干粉70%、二氧化硅3%、微晶纤维6.6%、硬脂酸镁0.4%。黄精等8味药水提物超微干粉为黄精6份、淫羊藿3份、枸杞子3份、女贞子3份、菟丝子2份、丹参3份、金樱子3份、大枣2份的混合物的水提产物。
制备:同实施例1。本实施例组合物,成人每日2次,每次2粒,空腹服用。
实施例4
本实施例一种缓解体力疲劳的组合物,其原料配比为:人参超微粉25%、黄精等8味药水提物超微干粉65%、二氧化硅3%、微晶纤维6.8%、硬脂酸镁0.2%。黄精等8味药水提物超微干粉为黄精6份、淫羊藿3份、枸杞子3份、女贞子3份、菟丝子2份、丹参3份、金樱子3份、大枣2份的混合物的水提产物。
制备:同实施例1。本实施例组合物,成人每日2次,每次2粒,空腹服用。
对比例1
一种缓解体力疲劳的组合物,其原料配比为:西参粉20%、中药水提物干粉70%、二氧化硅3%、微晶纤维素6.6%、硬脂酸镁0.4%。中药水提物干粉为黄精6份、淫羊藿3份、枸杞子3份、黄芪3份、丹参3份、巴戟天3份、冬虫夏草2份的混合物的水提产物。
制备方法为:
①取西洋参药材,清洗、除杂、烘干、粗粉,过80目筛,灭菌;取黄精药材,清洗、除杂、切块;取淫羊藿、枸杞子、黄芪、巴戟天、冬虫夏草药材除杂;取丹参药材,清洗、除杂、切段。
②取处理后的黄精、淫羊藿、枸杞子、黄芪、丹参、巴戟天和冬虫夏草的混合物80℃、真空水提2次,第1次料液比1:10,提取时间1.5h,第2次料液比1:8,提取时间1h;合并2次滤液,减压浓缩成相对密度为1.1(60℃)的浸膏,低温带式干燥。
③取上述中药水提物干粉干膏低温粉碎。
④按比例取西洋参粉、中药水提物干粉、二氧化硅、微晶纤维素、硬脂酸镁混合均匀,干法制粒。
⑤胶囊填充,取干颗粒进行胶囊自动填充、抛光。
本实施例组合物,成人每日2次,每次2粒,空腹服用。
实验例1
为了证明本发明公开的组合物具有较好的缓解体力疲劳作用,本发明以实施例3制得的组合物进行了如下的抗疲劳试验:
以昆明种小鼠为实验对象,选用18~22g的健康小鼠20只,雌雄各10只,分为五组,每组两只雌两只雄:
第1组为空白组;
第2组为每天喂服一次实施例3,1次1粒,连续喂养30天;
第3组为每天喂服两次实施例3,1次2粒,连续喂养30天;
第4组为每天喂服两次实施例3,1次3粒,连续喂养30天;
第5组为每天喂服两次实施例3,1次4粒,连续喂养30天。
①负重游泳试验
未次给药后30min,同时将五组小鼠投入到25℃的温水中,鼠尾根部捆上体重5%的石块,记录小鼠坚持的时间,结果如表1所示。
表1 不同剂量小鼠的平均负重游泳时间表
第1组 | 第2组 | 第3组 | 第4组 | 第5组 | |
平均负重游泳时间(s) | 252 | 340 | 720 | 760 | 790 |
②跑步试验
未次给药后30min,同时将五组小鼠置于转动鼠笼中,记录小鼠跑动时间及休息次数,结果见表2所示。
表2 不同剂量小鼠的跑步试验数据表
第1组 | 第2组 | 第3组 | 第4组 | 第5组 | |
平均跑步时间(min) | 39 | 63 | 112 | 122 | 135 |
平均休息次数 | 3 | 3 | 2 | 2 | 2 |
由表1和表2可以看出,第1-5组的小鼠,耐力和体力都是逐渐增加的,说明本发明所制备的组合物具有较好的缓解体力疲劳的作用。综合考虑第3-5组的增幅与成本,选择第3组为服用剂量。
实验例2
为了证明本发明公开的组合物在缓解体力疲劳作用方面见效快,本发明以实施例3制得的组合物和对比例1的组合物进行了如下的抗疲劳试验:
以昆明种小鼠为实验对象,选用18~22g的健康小鼠40只,雌雄各20只,分为二组,每组十只雌十只雄:
第6组为喂服一次实施例3药物,1次4粒;
第7组为喂服一次对比例1药物,1次4粒。
①负重游泳试验
给药后30min、1h、3h、5h、10h、1天和2天,同时将2组小鼠投入到25℃的温水中,鼠尾根部捆上体重5%的石块,记录小鼠坚持的时间,结果如表3所示。
表3 小鼠的平均负重游泳时间表
0.5h | 1h | 3h | 5h | 10h | 1天 | 2天 | |
第六组平均负重游泳时间(s) | 234 | 325 | 334 | 327 | 305 | 215 | 206 |
第七组平均负重游泳时间(s) | 221 | 310 | 322 | 325 | 297 | 211 | 202 |
②跑步试验
给药后30min,同时将二组小鼠置于转动鼠笼中,记录小鼠跑动时间及休息次数,结果见表4所示。
表4 不同剂量小鼠的跑步试验数据表
第6组 | 第7组 | |
平均跑步时间(min) | 65 | 43 |
平均休息次数 | 3 | 3 |
由表3和表4可以看出,第6组的小鼠,在给药后半小时后的耐力和体力都明显优于第7组的小鼠,其高峰时期的峰值数据都差不多,所能影响的时间也差不多,证明本发明药物和对比例1的药物具有相当的长期疗效,但是本发明的药物的见效速度更快。
Claims (6)
1.一种缓解体力疲劳的组合物,其特征是,包括如下原料组分,人参超微粉10~25%、中药材水提物超微干粉60~80%、二氧化硅1~5%、微晶纤维素5~10%、硬脂酸镁0.1~0.5%;所述中药材水提物超微干粉包括黄精5~8份、淫羊藿2~4份、枸杞子2~4份、女贞子2~4份、菟丝子1~2份、丹参2~4份、金樱子2~4份、大枣2~3份。
2.如权利要求1所述的缓解体力疲劳的组合物,其特征是,包括如下原料组分,人参超微粉20%、中药材水提物超微干粉70%、二氧化硅3%、微晶纤维素6.6%、硬脂酸镁0.4%。
3.如权利要求1或2所述的缓解体力疲劳的组合物,其特征是,所述中药材水提物超微干粉包括黄精6份、淫羊藿3份、枸杞子3份、女贞子3份、菟丝子2份、丹参3份、金樱子3份、大枣2份。
4.一种如权利要求1、2或3所述的缓解体力疲劳的组合物的制备方法,其特征是,包括如下步骤:
①药材前处理:取人参药材,清洗、除杂、烘干、灭菌、超微粉碎,得人参超微粉;取黄精药材,清洗、除杂、切块;取淫羊藿、枸杞子、女贞子、菟丝子、金樱子和大枣药材除杂;取丹参药材,清洗、除杂、切段;
②药材提取、浓缩与干燥:将处理后的黄精、淫羊藿、枸杞子、女贞子、菟丝子、丹参、金樱子和大枣的混合物在80℃,真空水提至少2次,第1次料液比为1:(10~15),提取时间1~2h,第2次料液比1:(5~10),提取时间0.5~1h;100目筛过滤,合并2次滤液;-0.03~-0.06Mpa、60~90℃减压浓缩成相对密度为1.20~1.30的浸膏;进行真空带式干燥,参数为:-95KPa~-100KPa、加料泵频率7~9Hz、传动频率15~17Hz、涂料频率7~9Hz、输料角度40°、一区温度100~105℃、二区温度80~85℃、冷却区温度25~30℃;
③超微粉碎:将上述干燥后的提取物干膏于超微粉碎机超微粉碎,粉碎温度-15℃,得到超微干粉;
④干法制粒:指步骤1所制备的人参超微粉与步骤3所制备的水提物超微干粉于混合机混均,添加二氧化硅、微晶纤维素、硬脂酸镁,混合10~15min,混合均匀;于干法制粒机干法制粒,制粒压力5Mpa,垂直转速16~20转/min,水平转速45~50转/min,压辊转速12~15转/min,整粒转速110~130转/min,得到缓解体力疲劳的组合物。
5.如权利要求4所述的制备方法,其特征是,包括如下步骤:将缓解体力疲劳的组合物进行胶囊填充,抛光,得到复方胶囊。
6.一种如权利要求1-3任一项所述的缓解体力疲劳的组合物在制备缓解体力疲劳药物方面的用途。
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