CN110301518A - 一种降尿酸压片糖果及其制备方法 - Google Patents
一种降尿酸压片糖果及其制备方法 Download PDFInfo
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- CN110301518A CN110301518A CN201910726713.9A CN201910726713A CN110301518A CN 110301518 A CN110301518 A CN 110301518A CN 201910726713 A CN201910726713 A CN 201910726713A CN 110301518 A CN110301518 A CN 110301518A
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- pressed candy
- trioxypurine
- nattokinase
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- A—HUMAN NECESSITIES
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- Medicines Containing Plant Substances (AREA)
Abstract
本发明提供了一种降尿酸压片糖果及其制备方法,压片糖果包括以下重量份原料:菊苣10~30份、显齿蛇葡萄15~35份、纳豆激酶5~15份、黄秋葵5~15份、向日葵5~15份、薏苡仁5~20份、茯苓5~15份、木糖醇5~15份、微晶纤维素2~5份、麦芽糊精10~20份、硬脂酸镁0.5~2份。本发明降尿酸压片糖果以中药提取物为主要成分,能明显降低血尿酸,其降低血尿酸值效果与常规西药相当,患者愈后良好,无不良反应;本发明压片糖果添加了纳豆激酶,具有溶解血栓,软化和增加血管弹性等作用;木糖醇作为甜味剂,可以改善中药压片糖果的适口性,且木糖醇能促进肝糖元合成,血糖不会上升;支撑压片糖果具有一定的硬度,不易破损,便于运输和携带,易于消费者接受。
Description
技术领域
本发明涉及药品、保健食品领域,具体涉及一种降尿酸压片糖果及其制备方法。
背景技术
随着人们生活水平的提高和饮食习惯的改变,近年来,我国高尿酸血症和痛风的发病率呈逐年攀升趋势。高尿酸血症是由于嘌呤代谢紊乱和/或尿酸排泄障碍而导致血尿酸超过正常值的一种疾病,临床上不表现任何症状。而当人体长期处于高尿酸血症的情况下,尿酸即以钠盐的形式沉淀在关节、软组织、软骨和肾脏中,引起人体器官和组织病变,导致痛风,引发严重的并发症,包括痛风性关节炎、痛风性肾脏病变、痛风性肾结石、痛风性心脏病、痛风性高血压病等,病人出现关节痛、肾绞痛或血尿等症状。因此,如何有效降低尿酸是高尿酸血症患者和痛风患者面临的主要问题。
目前治疗高尿酸血症和痛风的药物主要有非布索坦、别嘌醇、秋水仙碱、苯溴马隆、丙磺舒等。体内尿酸的生成与嘌呤代谢有关,在嘌呤代谢的最后步骤中,次黄嘌呤在黄嘌呤氧化还原酶(XOR)的作用下生成黄嘌呤,再进一步生成尿酸,非布索坦和别嘌醇是XOR的抑制剂,这两种药物通过高度选择性地作用于该氧化酶,减少体内尿酸合成,降低尿酸浓度,从而有效治疗通风疾病;秋水仙碱通过减低白细胞活动和吞噬作用及减少乳酸形成从而减少尿酸结晶的沉积,减轻炎性反应,而起止痛作用;苯溴马隆和丙磺舒通过抑制肾小管对尿酸盐的主动再吸收,增加尿酸盐的排泄而降低血中尿酸盐的浓度,缓解或防止尿酸盐结节的生成,减少关节的损伤,促进已形成的尿酸盐的溶解。虽然这些药物对于治疗痛风都具有较好的疗效,但在临床中都表现出一定的毒副作用。在这种情况下,使用不良反应较少的保健食品、中药或中西药配合使用治疗痛风,有一定的优势。
发明内容
本发明目的是为了弥补已有技术缺陷,提供一种降尿酸中药口服液及其制备方法,本发明中药口服液降尿酸效果好,无毒副作用,可单独使用或与其他治疗手段配合治疗痛风,解决了现有降尿酸药物普遍存在的毒副作用大的问题。
为实现上述目的,本发明通过以下方案予以实现:
本发明提供了一种降尿酸压片糖果,包括以下重量份原料:菊苣10~30份、显齿蛇葡萄15~35份、纳豆激酶5~15份、黄秋葵5~15份、向日葵5~15份、薏苡仁5~20份、茯苓5~15份、木糖醇5~15份、微晶纤维素2~5份、麦芽糊精10~20份、硬脂酸镁0.5~2份。
优选地,各原料重量份为:菊苣20份、显齿蛇葡萄25份、纳豆激酶10份、黄秋葵10份、向日葵10份、薏苡仁15份、茯苓10份、木糖醇10份、微晶纤维素4份、麦芽糊精15份、硬脂酸镁2份。
优选地,纳豆激酶为纳豆激酶冻干粉,纳豆激酶活性为2000~4000Fu/g。
本发明还提供了一种降尿酸压片糖果的制备方法,包括以下步骤:
S1、按照重量份数称取菊苣、显齿蛇葡萄、黄秋葵、向日葵、薏苡仁、茯苓,超声清洗后放入恒温干燥箱中干燥至水分质量百分比小于10%、将干燥后的中药使用超微粉碎设备粉碎,粒度控制80~100目,将粉碎后的中药粉末充分混合后得到混合中药粉末;
S2、向步骤S1制备的混合中药粉末中加入乙醇溶液回流提取3-5次,过滤并回收乙醇,将药液减压浓缩成浸膏;
S3、将纳豆激酶、木糖醇、微晶纤维素、麦芽糊精加入步骤S2制备的中药浸膏中,搅拌10~20min,混合均匀后使用制粒机制粒,湿颗粒恒温干燥,控制颗粒水分质量百分比小于6%,再将干颗粒用整粒机整粒;
S4、向步骤S3中制备的干颗粒中加入硬脂酸镁与,搅拌10~15min混合均匀,用压片机将中药颗粒压片,制得降尿酸压片糖果。
优选地,恒温干燥的温度为40~60℃。
优选地,乙醇溶液质量浓度为20~30%,加入的乙醇溶液质量为中药粉末质量的10~15倍。
优选地,中药浸膏相对密度为1.05~1.20g/cm³。
本发明的有益效果是:
本发明降尿酸压片糖果以药物菊苣和为显齿蛇葡萄基础,还适当加入了黄秋葵、向日葵、薏苡仁、茯苓,促进尿酸排泄,增加肾脏滤除尿酸的能力,互相配合,互助互长;本发明降尿酸压片糖果中添加了纳豆激酶,具有溶解血栓,降低血粘度,改善血液循环,软化和增加血管弹性等作用,与上述中药配合,提高了降尿酸药物的效果;降尿酸压片糖果中添加木糖醇作为甜味剂,木糖醇溶于水时吸热,故以固体形式食用时在口中会产生愉快的清凉感,可以改善中药压片糖果的适口性,且木糖醇能促进肝糖元合成,血糖不会上升,对肝病患者有改善肝功能和抗脂肪肝的作用;降尿酸压片糖果功效成分或者标志性成分较为稳定,具有一定的硬度,不易破损,便于运输和携带,易于消费者接受;本发明中药口服液经临床试验,患者自身治疗前后血尿酸值降低明显,说明本发明降尿酸压片糖果能明显降低血尿酸,其降低血尿酸值效果与常规西药相当,患者愈后良好,无不良反应。
具体实施方式
下面将结合本发明实施例,对本发明的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其它实施例,都属于本发明保护的范围。
实施例1
一种降尿酸压片糖果,包括以下重量份原料:菊苣15份、显齿蛇葡萄25份、纳豆激酶冻干粉5份、黄秋葵10份、向日葵10份、薏苡仁15份、茯苓10份、蔗糖10份、木糖醇10份、微晶纤维素2份、麦芽糊精15份、硬脂酸镁2份,纳豆激酶冻干粉酶活性为3500Fu/g。
上述降尿酸压片糖果的制备方法,包括以下步骤:
S1、按照重量份数称取菊苣、显齿蛇葡萄、黄秋葵、向日葵、薏苡仁、茯苓,超声清洗后放入60℃恒温干燥箱中干燥至水分质量百分比小于10%、将干燥后的中药使用超微粉碎设备粉碎,粒度控制100目,将粉碎后的中药粉末充分混合后得到混合中药粉末;
S2、向步骤S1制备的混合中药粉末中加入质量浓度为25%乙醇溶液回流提取5次,加入的乙醇溶液质量为中药粉末质量的12倍,过滤并回收乙醇,将药液减压浓缩成对密度为1.20g/cm³的浸膏;
S3、将纳豆激酶、木糖醇、微晶纤维素、麦芽糊精加入步骤S2制备的中药浸膏中,搅拌30min,混合均匀后使用制粒机制粒,湿颗粒恒温干燥,控制颗粒水分质量百分比小于6%,再将干颗粒用整粒机整粒;
S4、向步骤S3中制备的干颗粒中加入硬脂酸镁与,搅拌15min混合均匀,用压片机将中药颗粒压片,控制片重5±0.2g,制得降尿酸压片糖果。
实施例2
一种降尿酸压片糖果,包括以下重量份原料:菊苣20份、显齿蛇葡萄30份、纳豆激酶冻干粉10份、黄秋葵15份、向日葵10份、薏苡仁15份、茯苓10份、木糖醇5份、微晶纤维素2份、麦芽糊精10份、硬脂酸镁1份,纳豆激酶冻干粉酶活性为2500Fu/g。
上述降尿酸压片糖果的制备方法,包括以下步骤:
S1、按照重量份数称取菊苣、显齿蛇葡萄、黄秋葵、向日葵、薏苡仁、茯苓,超声清洗后放入55℃恒温干燥箱中干燥至水分质量百分比小于10%、将干燥后的中药使用超微粉碎设备粉碎,粒度控制100目,将粉碎后的中药粉末充分混合后得到混合中药粉末;
S2、向步骤S1制备的混合中药粉末中加入质量浓度为30%乙醇溶液回流提取4次,加入的乙醇溶液质量为中药粉末质量的12倍,过滤并回收乙醇,将药液减压浓缩成对密度为1.10g/cm³的浸膏;
S3、将纳豆激酶、木糖醇、微晶纤维素、麦芽糊精加入步骤S2制备的中药浸膏中,搅拌30min,混合均匀后使用制粒机制粒,湿颗粒恒温干燥,控制颗粒水分质量百分比小于6%,再将干颗粒用整粒机整粒;
S4、向步骤S3中制备的干颗粒中加入硬脂酸镁与,搅拌10min混合均匀,用压片机将中药颗粒压片,控制片重5±0.2g,制得降尿酸压片糖果。
实施例3
一种降尿酸压片糖果,包括以下重量份原料:菊苣25份、显齿蛇葡萄20份、纳豆激酶冻干粉10份、黄秋葵10份、向日葵5份、薏苡仁10份、茯苓5份、木糖醇15份、微晶纤维素5份、麦芽糊精15份、硬脂酸镁2份,纳豆激酶冻干粉酶活性为4000Fu/g。
上述降尿酸压片糖果的制备方法,包括以下步骤:
S1、按照重量份数称取菊苣、显齿蛇葡萄、黄秋葵、向日葵、薏苡仁、茯苓,超声清洗后放入50℃恒温干燥箱中干燥至水分质量百分比小于10%、将干燥后的中药使用超微粉碎设备粉碎,粒度控制95目,将粉碎后的中药粉末充分混合后得到混合中药粉末;
S2、向步骤S1制备的混合中药粉末中加入质量浓度为20%乙醇溶液回流提取3次,加入的乙醇溶液质量为中药粉末质量的15倍,过滤并回收乙醇,将药液减压浓缩成对密度为1.05g/cm³的浸膏;
S3、将纳豆激酶、木糖醇、微晶纤维素、麦芽糊精加入步骤S2制备的中药浸膏中,搅拌30min,混合均匀后使用制粒机制粒,湿颗粒恒温干燥,控制颗粒水分质量百分比小于6%,再将干颗粒用整粒机整粒;
S4、向步骤S3中制备的干颗粒中加入硬脂酸镁与,搅拌10min混合均匀,用压片机将中药颗粒压片,控制片重5±0.2g,制得降尿酸压片糖果。
实施例4
一种降尿酸压片糖果,包括以下重量份原料:菊苣20份、显齿蛇葡萄25份、纳豆激酶10份、黄秋葵10份、向日葵10份、薏苡仁15份、茯苓10份、木糖醇10份、微晶纤维素4份、麦芽糊精15份、硬脂酸镁2份,纳豆激酶冻干粉酶活性为3000Fu/g。
上述降尿酸压片糖果的制备方法,包括以下步骤:
S1、按照重量份数称取菊苣、显齿蛇葡萄、黄秋葵、向日葵、薏苡仁、茯苓,超声清洗后放入50℃恒温干燥箱中干燥至水分质量百分比小于10%、将干燥后的中药使用超微粉碎设备粉碎,粒度控制100目,将粉碎后的中药粉末充分混合后得到混合中药粉末;
S2、向步骤S1制备的混合中药粉末中加入质量浓度为30%乙醇溶液回流提取5次,加入的乙醇溶液质量为中药粉末质量的10倍,过滤并回收乙醇,将药液减压浓缩成对密度为1.12g/cm³的浸膏;
S3、将纳豆激酶、木糖醇、微晶纤维素、麦芽糊精加入步骤S2制备的中药浸膏中,搅拌28min,混合均匀后使用制粒机制粒,湿颗粒恒温干燥,控制颗粒水分质量百分比小于6%,再将干颗粒用整粒机整粒;
S4、向步骤S3中制备的干颗粒中加入硬脂酸镁与,搅拌15min混合均匀,用压片机将中药颗粒压片,控制片重5±0.2g,制得降尿酸压片糖果。
实施例5
一种降尿酸中药口服液,包括以下重量份原料:菊苣15份、显齿蛇葡萄30份、纳豆激酶冻干粉15份、黄秋葵10份、向日葵10份、薏苡仁15份、茯苓10份、木糖醇12份、微晶纤维素4份、麦芽糊精18份、硬脂酸镁1份,纳豆激酶冻干粉酶活性为2000Fu/g。
上述降尿酸压片糖果的制备方法,包括以下步骤:
S1、按照重量份数称取菊苣、显齿蛇葡萄、黄秋葵、向日葵、薏苡仁、茯苓,超声清洗后放入60℃恒温干燥箱中干燥至水分质量百分比小于10%、将干燥后的中药使用超微粉碎设备粉碎,粒度控制85目,将粉碎后的中药粉末充分混合后得到混合中药粉末;
S2、向步骤S1制备的混合中药粉末中加入质量浓度为30%乙醇溶液回流提取4次,加入的乙醇溶液质量为中药粉末质量的15倍,过滤并回收乙醇,将药液减压浓缩成对密度为1.05g/cm³的浸膏;
S3、将纳豆激酶、木糖醇、微晶纤维素、麦芽糊精加入步骤S2制备的中药浸膏中,搅拌20min,混合均匀后使用制粒机制粒,湿颗粒恒温干燥,控制颗粒水分质量百分比小于6%,再将干颗粒用整粒机整粒;
S4、向步骤S3中制备的干颗粒中加入硬脂酸镁与,搅拌10min混合均匀,用压片机将中药颗粒压片,控制片重5±0.2g,制得降尿酸压片糖果。
实施例6
一种降尿酸中药口服液,包括以下重量份原料:菊苣20份、显齿蛇葡萄25份、纳豆激酶冻干粉15份、黄秋葵15份、向日葵15份、薏苡仁20份、茯苓15份、木糖醇10份、微晶纤维素2份、麦芽糊精15份、硬脂酸镁2份,纳豆激酶冻干粉酶活性为4000Fu/g。
上述降尿酸压片糖果的制备方法,包括以下步骤:
S1、按照重量份数称取菊苣、显齿蛇葡萄、黄秋葵、向日葵、薏苡仁、茯苓,超声清洗后放入55℃恒温干燥箱中干燥至水分质量百分比小于10%、将干燥后的中药使用超微粉碎设备粉碎,粒度控制80目,将粉碎后的中药粉末充分混合后得到混合中药粉末;
S2、向步骤S1制备的混合中药粉末中加入质量浓度为25%乙醇溶液回流提取5次,加入的乙醇溶液质量为中药粉末质量的15倍,过滤并回收乙醇,将药液减压浓缩成对密度为1.20g/cm³的浸膏;
S3、将纳豆激酶、木糖醇、微晶纤维素、麦芽糊精加入步骤S2制备的中药浸膏中,搅拌20min,混合均匀后使用制粒机制粒,湿颗粒恒温干燥,控制颗粒水分质量百分比小于6%,再将干颗粒用整粒机整粒;
S4、向步骤S3中制备的干颗粒中加入硬脂酸镁与,搅拌15min混合均匀,用压片机将中药颗粒压片,控制片重5±0.2g,制得降尿酸压片糖果。
临床试验
1、病例选择
在5所医院门诊或病房选取确证痛风的患者140例,临床表现为:卒然发生拇趾、趾趾关节或足背红肿热痛,常于夜间突然发病,且体温低于38℃;血尿酸(UA)高于8.0mg/dl。男性74例,女性66例,平均年龄38.7±3.6岁。
2、治疗方案
将符合上述标准的140例痛风高尿酸患者按就诊顺序随机分为实验组1-6和对照组,每组20例。实验组1-6分别使用实施例1-6中制备的压片糖果辅助治疗,口服,一次2片,一日3次,疗程:用药4周。对照组使用别嘌呤醇片治疗,口服,每次0.1g,每日3次,疗程:用药4周。
3、治疗结果
(1)一般情况观察
试食组:基本无卒然发生拇趾、趾趾关节或足背红肿热痛现象,关节功能恢复良好,患者体质增强,无不良反应。
对照组:基本无卒然发生拇趾、趾趾关节或足背红肿热痛现象,关节功能恢复,但用药期间部分患者出现胃肠道反应、过敏等不良反应。
(2)检测数据比较
分别测定实验组1-6和对照组患者自身服药前后血尿酸值对照,详见下表:
表1 治疗前后血尿酸变化(mg/dl)
项目 | 治疗前血尿酸UA | 治疗后血尿酸UA |
实验组1 | 8.14±1.06 | 1.98±1.22 |
实验组2 | 8.30±1.28 | 2.14±0.87 |
实验组3 | 8.65±0.97 | 2.26±1.14 |
实验组4 | 8.54±1.43 | 1.78±1.08 |
实验组5 | 8.45±1.21 | 2.14±1.12 |
实验组6 | 8.18±1.15 | 1.96±1.03 |
对照组 | 8.37±1.04 | 2.47±0.96 |
4、结果分析
本发明实验组1-6中,患者自身治疗前后血尿酸值降低明显,说明本发明降尿酸压片糖果液能明显降低血尿酸,其降低血尿酸值效果与对照组相当,患者愈后良好,无不良反应。而对照组用药期间,部分患者出现不良反应。
在本说明书的描述中,参考术语“一个实施例”、“示例”、“具体示例”等的描述意指结合该实施例或示例描述的具体特征、结构、材料或者特点包含于本发明的至少一个实施例或示例中。在本说明书中,对上述术语的示意性表述不一定指的是相同的实施例或示例。而且,描述的具体特征、结构、材料或者特点可以在任何的一个或多个实施例或示例中以合适的方式结合。
以上公开的本发明优选实施例只是用于帮助阐述本发明。优选实施例并没有详尽叙述所有的细节,也不限制该发明的具体实施方式。显然,根据本说明书的内容,可作很多的修改和变化。本说明书选取并具体描述这些实施例,是为了更好地解释本发明的原理和实际应用,从而使所属技术领域技术人员能很好地理解和利用本发明。本发明仅受权利要求书及其全部范围和等效物的限制。
Claims (7)
1.一种降尿酸压片糖果,包括以下重量份原料:菊苣10~30份、显齿蛇葡萄15~35份、纳豆激酶5~15份、黄秋葵5~15份、向日葵5~15份、薏苡仁5~20份、茯苓5~15份、木糖醇5~15份、微晶纤维素2~5份、麦芽糊精10~20份、硬脂酸镁0.5~2份。
2.根据权利要求1所述的降尿酸压片糖果,其特征在于,所述各原料重量份为:菊苣20份、显齿蛇葡萄25份、纳豆激酶10份、黄秋葵10份、向日葵10份、薏苡仁15份、茯苓10份、木糖醇10份、微晶纤维素4份、麦芽糊精15份、硬脂酸镁2份。
3.根据权利要求1所述的降尿酸压片糖果,其特征在于,所述纳豆激酶为纳豆激酶冻干粉,纳豆激酶活性为2000~4000Fu/g。
4.根据权利要求1或2所述的降尿酸压片糖果的制备方法,其特征在于,包括以下步骤:
S1、按照重量份数称取菊苣、显齿蛇葡萄、黄秋葵、向日葵、薏苡仁、茯苓,超声清洗后放入恒温干燥箱中干燥至水分质量百分比小于10%、将干燥后的中药使用超微粉碎设备粉碎,粒度控制80~100目,将粉碎后的中药粉末充分混合后得到混合中药粉末;
S2、向步骤S1制备的混合中药粉末中加入乙醇溶液回流提取3-5次,过滤并回收乙醇,将药液减压浓缩成浸膏;
S3、将纳豆激酶、木糖醇、微晶纤维素、麦芽糊精加入步骤S2制备的中药浸膏中,搅拌10~20min,混合均匀后使用制粒机制粒,湿颗粒恒温干燥,控制颗粒水分质量百分比小于6%,再将干颗粒用整粒机整粒;
S4、向步骤S3中制备的干颗粒中加入硬脂酸镁与,搅拌10~15min混合均匀,用压片机将中药颗粒压片,制得降尿酸压片糖果。
5.根据权利要求4所述的降尿酸压片糖果的制备方法,其特征在于,所述恒温干燥的温度为40~60℃。
6.根据权利要求4所述的降尿酸压片糖果的制备方法,其特征在于,所述乙醇溶液质量浓度为20~30%,加入的乙醇溶液质量为中药粉末质量的10~15倍。
7.根据权利要求4所述的降尿酸压片糖果的制备方法,其特征在于,所述中药浸膏相对密度为1.05~1.20g/cm³。
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