CN114028509A - 一种疏肝健脾活血的药食同源组合物及其制备方法 - Google Patents
一种疏肝健脾活血的药食同源组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种疏肝健脾活血的药食同源组合物,由以下质量份数的原料制成:枳椇子0.5~8份,葛根0.5~8份,佛手0.5~5份,牡蛎1.5~15份,广藿香0.5~5份,茯苓1~10份,薏苡仁1.5~15份,赤小豆0.5~8份,橘皮0.2~3份,白扁豆0.5~8份,山药1.5~15份,山楂1.5~15份,当归0.5~5份;本发明还公开了该组合物的制备方法:一、原料粉碎后微氧化;二、高温高压破壁;三、常压分散后提取;四、蒸发浓缩;五、氧化降解、均质、研磨和制剂成形。本发明的组合物采用药食同源的中药材,快速有效地解酒,具有保肝护肝的效果;本发明的制备方法提高了有效成分的提取率,适合规模化生产和推广。
Description
技术领域
本发明属于中药技术领域,具体涉及一种疏肝健脾活血的药食同源组合物及其制备方法。
背景技术
随着现代生活节奏加快,不良生活方式显著增多,亚健康人群比重增加。据调查研究显示亚健康的现患率为46%,特别是慢性病群体大幅攀升,严重影响国民身体素质且耗费大量的医疗资源。“上医治未病”完全顺应了亚健康人群的健康管理,因此开发药食同源组合物很有必要。
目前,市面上的保肝护肝等保健产品琳琅满目,但都存在功效单一、疗效不佳,甚至添加了激素等可能损害机体的配料。药酒是常见的活血保健品,但对于胃溃疡等病人不可服用。长期或者过量服用药酒,都会对身体造成一定危害。
葛根为豆科植物野葛的根,入脾,解燥,生津止渴,解酒毒。现代药理研究表明葛根粉中的大豆甙可以分解乙醇,有显著的抗脂质过氧化作用,这可能是葛根抗酒精性肝损伤作用的药理机制之一。
枳椇子为鼠李科枳椇属植物北枳椇、枳椇和毛果枳的成熟种子。味甘,性平,入胃经,解酒毒,止除烦渴,止呕。现代药理研究表明枳椇子可以维持并提高乙醛脱氢酶的活性,而乙醛脱氢酶促进肝脏代谢酒精,减少酒精对人体的伤害。故素有“千杯不醉枳椇子”的美称。
发明内容
本发明所要解决的技术问题在于针对上述现有技术的不足,提供一种疏肝健脾活血的药食同源组合物。该组合物采用枳椇子等十余味药食同源的中药材为原料,制得的药食同源组合物不仅能快速有效地解酒,具有保肝护肝的效果,而且还能达到疏肝理气、健脾祛湿和活血化瘀的整体性的五行平衡,还具有显著降脂减脂,解腻消食等诸多保健功效。
为解决上述技术问题,本发明采用的技术方案为:一种疏肝健脾活血的药食同源组合物,其特征在于,由以下质量份数的原料制成:枳椇子0.5~8份,葛根0.5~8份,佛手0.5~5份,牡蛎1.5~15份,广藿香0.5~5份,茯苓1~10份,薏苡仁1.5~15份,赤小豆0.5~8份,橘皮0.2~3份,白扁豆0.5~8份,山药1.5~15份,山楂1.5~15份,当归0.5~5份。
中医理论认为,肝属木,心属火,脾属土,肺属金,肾属水。当人体五脏相对平衡时,才能维持身体健康。本发明秉承传统中医药精髓之药食同源原理,严格按照中医君臣佐使组方原则及养生原理,选用枳椇子等十余味药食同源的中药材为原料,根据药物禁忌,谨慎科学地合理搭配,以枳椇子、葛根为主要原料,升清降浊,健运脾胃,在其基础上,通过佛手、牡蛎、广藿香的配伍疏肝解郁,通过茯苓、薏苡仁达到溺水渗湿、健脾止泻之功效,以赤小豆、橘皮、白扁豆、山药、山楂、当归健脾祛湿,功效显著,制得的药食同源组合物不仅能快速有效地解酒,具有保肝护肝的效果,而且还能达到疏肝理气、健脾祛湿和活血化瘀的整体性的五行平衡,还具有著的降脂减脂,解腻消食等诸多保健功效。同时,本发明的保健品采用的原料均为药食同源植物,对人体无不良反应,取材广泛,安全有效,可长期服用。
上述的一种疏肝健脾活血的药食同源组合物,其特征在于,由以下质量份数的原料制成:枳椇子1.5份,葛根1.5份,佛手1份,牡蛎3份,广藿香1份,茯苓2份,薏苡仁3份,赤小豆1.5份,橘皮0.5份,白扁豆1.5份,山药3份,山楂3份,当归1份。
上述的一种疏肝健脾活血的药食同源组合物,其特征在于,由以下质量份数的原料制成:枳椇子3份,葛根3份,佛手2份,牡蛎8份,广藿香2份,茯苓5份,薏苡仁5份,赤小豆3份,橘皮2份,白扁豆5份,山药3份,山楂3份,当归2份。
上述的一种疏肝健脾活血的药食同源组合物,其特征在于,由以下质量份数的原料制成:枳椇子6份,葛根6份,佛手1份,牡蛎10份,广藿香3份,茯苓8份,薏苡仁2份,赤小豆3份,橘皮3份,白扁豆7份,山药5份,山楂3份,当归5份。
另外,本发明还公开了一种制备上述的疏肝健脾活血的药食同源组合物的方法,其特征在于,该方法包括以下步骤:
步骤一、将各质量份数的原料经水力碎浆机粉碎均匀,然后使用微纳米气泡曝气机进行微氧化;所述微氧化的时间为10min~60min;
步骤二、将步骤一中经微氧化后的各原料通过螺旋输送机送到搓揉机中揉搓挤压进行高温高压破壁,得到破壁原料;所述揉搓挤压的温度为120℃~200℃,压力为0.4MPa~1.2MPa,揉搓机的螺杆转速为400r/min~1200r/min;
步骤三、将步骤二中得到的破壁原料经常压分散后送入双辊洗涤机进行提取,得到原料提取液;
步骤四、将步骤三中得到的原料提取液进行蒸发浓缩,得到原料提取浓缩液;
步骤五、将步骤四中得到的原料提取浓缩液送入反应釜中进行氧化降解,得到小分子原料提取浓缩液,然后依次转入均质釜中搅拌均质、送入研磨机中研磨,得到提取原液,再将提取原液进行制剂成形,得到疏肝健脾活血的药食同源组合物。
相较于传统植物萃取方法采用捣碎、加温、化学置换等手段,导致植物本体被破坏且化学置换后产生的废渣污染严重、处置成本高的状况,本发明将各原料粉碎均匀后采用微纳米气泡曝气机进行微氧化,以充分快速消除原料中的不良残留与污染,提高好氧微生物乳杆菌菌种的特异性,促进原料中有益菌的快速生成,抑制厌氧菌的生长;然后进行揉搓挤压以实现高温高压破壁,充分破坏原料的细胞结构,有利于提高后续提取过程中提取溶剂的渗透速度,进而提高各原料中有效成分的提取率,得到的破壁原料经常压分散后进行提取,得到的原料提取液经蒸发浓缩进行氧化降解得到小分子原料提取浓缩液,使得有效成分进一步降解为小分子化合物,便于人体吸收,再依次经均质、研磨得到提取原液,经制剂成形得到疏肝健脾活血的药食同源组合物,显著提高了中药原料的利用度,且制备工艺简单易行,无需添加任何化学试剂或者减损有效成分,还剥离了原有中药原料的农药残留和重金属污染,适合规模化生产和推广,为工业化生产提供了可行性途径。
上述的方法,其特征在于,步骤一中所述微氧化的时间为30min。通常控制氧化的时间为20min~60min,优选30min,既通过充分氧化消除了农药残留和污染,又有效保证了好氧微生物的特异性。
上述的方法,其特征在于,步骤二中所述揉搓挤压的温度为100℃~180℃,压力为0.1MPa~1.0MPa,揉搓机的螺杆转速为200r/min~1200r/min。更优选地,揉搓挤压的温度为120℃~140℃,压力为0.3MPa~0.5MPa,揉搓机的螺杆转速为600r/min~1000r/min。
上述的方法,其特征在于,步骤四中所述原料提取浓缩液的质量浓度为10%~40%。更优选地,原料提取浓缩液的质量浓度为20%~30%。
上述的方法,其特征在于,步骤五中所述制剂成形的形式为颗粒剂、片剂、胶囊、咀嚼片或口服液。本发明的药食同源组合物的剂型形式多样,覆盖了常见的剂型形式,应用范围广,实用价值高。
上述的方法,其特征在于,步骤五中所述提取原液作为原料添加于功能性饮料、糖果类或饼干糕点类中。本发明的药食同源保健品采用的原料均为药食同源植物,对人体无不良反应,可应用于食品领域中,进一步扩大了本发明的应用范围。
本发明与现有技术相比具有以下优点:
1、本发明采用枳椇子等十余味药食同源的中药材为原料,根据药物禁忌,谨慎科学地合理搭配,制得的药食同源组合物不仅能快速有效地解酒,具有保肝护肝的效果,而且还能达到疏肝理气、健脾祛湿和活血化瘀的整体性的五行平衡,还具有显著降脂减脂,解腻消食等诸多保健功效。
2、本发明的保健品采用的原料均为药食同源植物,对人体无不良反应,取材广泛,安全有效,可长期服用。
3、本发明的制备方法采用物理机械揉搓挤压工艺,充分破坏中药原料的细胞结构,提高了有效成分的提取率,同时采用微氧化工艺充分剥离了中药原料中的农药残留和重金属污染,适合规模化生产和推广,为工业化生产提供了可行性途径。
4、本发明的制备方法将原料提取液经蒸发浓缩进行氧化降解得到小分子原料提取浓缩液,使得有效成分进一步降解为小分子化合物,便于人体吸收,显著提高了中药原料的利用度,且制备工艺简单易行。
5、本发明的药食同源组合物均为药食同源植物,对人体无不良反应,且剂型形式多样,应用领域广,实用价值高。
下面通过实施例对本发明的技术方案作进一步的详细描述。
具体实施方式
实施例1
本实施例疏肝健脾活血的药食同源组合物由以下质量份数的原料制成:枳椇子1.5份,葛根1.5份,佛手1份,牡蛎3份,广藿香1份,茯苓2份,薏苡仁3份,赤小豆1.5份,橘皮0.5份,白扁豆1.5份,山药3份,山楂3份,当归1份。
本实施例疏肝健脾活血的药食同源组合物的制备方法包括以下步骤:
步骤一、称取各质量份数的原料,通过水力碎浆机粉碎均匀,然后采用纳米微爆气进行微氧化30min;
步骤二、将步骤一中经微氧化后的各原料通过螺旋输送机送到搓揉机中揉搓挤压,进行高温高压破壁,得到破壁原料;所述揉搓挤压的温度为140℃~160℃,压力为0.6MPa~1.0MPa,揉搓机的螺杆转速为600r/min~1000r/min;
步骤三、将步骤二中得到的破壁原料经常压分散后送入双辊洗涤机进行提取,得到原料提取液;
步骤四、将步骤三中得到的原料提取液通过蒸发浓缩系统(MVR)进行蒸发浓缩,得到质量浓度20%的原料提取浓缩液;
步骤五、将步骤四中得到的原料提取浓缩液送入反应釜中加热至100℃~120℃进行氧化降解,得到小分子原料提取浓缩液,然后依次转入均质釜中搅拌均质、送入研磨机中研磨,得到提取原液,再将提取原液进行制剂成形,得到疏肝健脾活血的药食同源组合物。
实施例2
本实施例疏肝健脾活血的药食同源组合物由以下质量份数的原料制成:枳椇子0.5份,葛根0.5份,佛手0.5份,牡蛎1.5份,广藿香0.5份,茯苓1份,薏苡仁1.5份,赤小豆0.5份,橘皮0.2份,白扁豆0.5份,山药1.5份,山楂1.5份,当归0.5份。
本实施例疏肝健脾活血的药食同源组合物的制备方法包括以下步骤:
步骤一、称取各质量份数的原料,通过水力碎浆机粉碎均匀,然后采用纳米微爆气进行微氧化10min;
步骤二、将步骤一中经微氧化后的各原料通过螺旋输送机送到搓揉机中揉搓挤压,进行高温高压破壁,得到破壁原料;所述揉搓挤压的温度为120℃~140℃,压力为0.4MPa~0.8MPa,揉搓机的螺杆转速为400r/min~800r/min;
步骤三、将步骤二中得到的破壁原料经常压分散后送入双辊洗涤机进行提取,得到原料提取液;
步骤四、将步骤三中得到的原料提取液通过蒸发浓缩系统(MVR)进行蒸发浓缩,得到质量浓度20%的原料提取浓缩液;
步骤五、将步骤四中得到的原料提取浓缩液送入反应釜中加热至100℃~120℃进行氧化降解,得到小分子原料提取浓缩液,然后依次转入均质釜中搅拌均质、送入研磨机中研磨,得到提取原液,再将提取原液进行制剂成形,得到疏肝健脾活血的药食同源组合物。
实施例3
本实施例疏肝健脾活血的药食同源组合物由以下质量份数的原料制成:枳椇子3份,葛根3份,佛手0.5份,牡蛎5份,广藿香1.5份,茯苓4份,薏苡仁5份,赤小豆1.5份,橘皮1.5份,白扁豆3.5份,山药2.5份,山楂1.5份,当归2.5份。
本实施例疏肝健脾活血的药食同源组合物的制备方法包括以下步骤:
步骤一、称取各质量份数的原料,通过水力碎浆机粉碎均匀,然后采用纳米微爆气进行微氧化40min;
步骤二、将步骤一中经微氧化后的各原料通过螺旋输送机送到搓揉机中揉搓挤压,进行高温高压破壁,得到破壁原料;所述揉搓挤压的温度为160℃~180℃,压力为0.8MPa~1.2MPa,揉搓机的螺杆转速为800r/min~1200r/min;
步骤三、将步骤二中得到的破壁原料经常压分散后送入双辊洗涤机进行提取,得到原料提取液;
步骤四、将步骤三中得到的原料提取液通过蒸发浓缩系统(MVR)进行蒸发浓缩,得到质量浓度20%的原料提取浓缩液;
步骤五、将步骤四中得到的原料提取浓缩液送入反应釜中加热至100℃~120℃进行氧化降解,得到小分子原料提取浓缩液,然后依次转入均质釜中搅拌均质、送入研磨机中研磨,得到提取原液,再将提取原液进行制剂成形,得到疏肝健脾活血的药食同源组合物。
实施例4
本实施例疏肝健脾活血的药食同源组合物由以下质量份数的原料制成:枳椇子8份,葛根8份,佛手5份,牡蛎15份,广藿香5份,茯苓10份,薏苡仁15份,赤小豆8份,橘皮3份,白扁豆8份,山药15份,山楂15份,当归5份。
本实施例疏肝健脾活血的药食同源组合物的制备方法包括以下步骤:
步骤一、称取各质量份数的原料,通过水力碎浆机粉碎均匀,然后采用纳米微爆气进行微氧化60min;
步骤二、将步骤一中经微氧化后的各原料通过螺旋输送机送到搓揉机中揉搓挤压,进行高温高压破壁,得到破壁原料;所述揉搓挤压的温度为180℃~200℃,压力为1.0MPa~1.2MPa,揉搓机的螺杆转速为1000r/min~1200r/min;
步骤三、将步骤二中得到的破壁原料经常压分散后送入双辊洗涤机进行提取,得到原料提取液;
步骤四、将步骤三中得到的原料提取液通过蒸发浓缩系统(MVR)进行蒸发浓缩,得到质量浓度20%的原料提取浓缩液;
步骤五、将步骤四中得到的原料提取浓缩液送入反应釜中加热至100℃~120℃进行氧化降解,得到小分子原料提取浓缩液,然后依次转入均质釜中搅拌均质、送入研磨机中研磨,得到提取原液,再将提取原液进行制剂成形,得到疏肝健脾活血的药食同源组合物。
本发明实施例1~实施例4步骤五中制剂成形的形式为颗粒剂、片剂、胶囊、咀嚼片或口服液;所述提取原液作为原料添加于功能性饮料、糖果类或饼干糕点类中。
实施例5
本实施例与实施例1的不同之处在于:疏肝健脾活血的药食同源组合物由以下质量份数的原料制成:枳椇子3份,葛根3份,佛手2份,牡蛎8份,广藿香2份,茯苓5份,薏苡仁5份,赤小豆3份,橘皮2份,白扁豆5份,山药3份,山楂3份,当归2份。
实施例6
本实施例与实施例1的不同之处在于:疏肝健脾活血的药食同源组合物由以下质量份数的原料制成:枳椇子6份,葛根6份,佛手1份,牡蛎10份,广藿香3份,茯苓8份,薏苡仁2份,赤小豆3份,橘皮3份,白扁豆7份,山药5份,山楂3份,当归5份。
对本发明实施例1~实施例3的药食同源组合物进行药效研究实验和临床实验。
一、药效研究实验
1实验材料
1.1实验动物
小鼠选用体重为25g±2g的健康清洁级小白鼠,实验前自由进食和饮水饲养一周,待小鼠适应环境后,选择状态良好的小鼠进行实验。
1.2实验药物
本发明实施例1~实施例3的药食同源组合物。
1.3实验试剂
乙醇检测试剂盒;乙醇脱氢酶(ADH)试剂盒;生理盐水;白酒;碳末;XZC-A型压痛仪,山东省医学科学院设备站;灌胃器;标准测量尺。
1.4实验方法
1.4.1药食同源组合物对急性酒精中毒小鼠的翻正反应实验
将选择的实验小鼠按雌雄随机分为空白对照组、实验组1、实验组2和实验组3(对应本发明实施例1~实施例3的药食同源组合物),共计4组,每组10只。各组小鼠禁食12h后,按照给药量3mL/kg灌喂药食同源组合物,对照组为相同体积的生理盐水即质量浓度0.9%氯化钠注射液;30min后,各组小鼠均按照10mL/kg灌胃西凤酒(53℃),以小鼠翻正反射消失作为醉酒指标,记录各组小鼠翻正反射消失时间和恢复时间,计算醉酒潜伏期和醉酒维持时间,结果见表1。
表1
组别 | 醉酒潜伏期(min) | 醒酒时间(min) |
实验组1 | 63.2±5.5** | 318.5±14.3** |
实验组2 | 45.4±2.1* | 389.7±16.3* |
实验组3 | 55.2±3.2** | 359.6±15.7** |
空白对照组 | 13.5±4.4 | 480.3±18.5 |
注:与空白对照组比较,*P<0.05,**P<0.01
从表1可知,与空白对照组比较,各实验组的小鼠醉酒潜伏时间显著增加,醒酒时间显著缩短,其中,实验组1和实验组3的效果要好于实验组2,说明本发明的药食同源组合物能够延缓醉酒和缩短醒酒时间,具有解酒效果。
1.4.2药食同源组合物对小鼠全血中乙醇浓度和乙醇脱氢酶(ADH)活性的影响
将选择的实验小鼠按雌雄随机分为空白对照组、实验组1、实验组2和实验组3(对应本发明实施例1~实施例3的药食同源组合物),共计4组,每组10只。各组小鼠禁食12h后,按照给药量3mL/kg灌喂药食同源组合物,对照组为相同体积的生理盐水即质量浓度0.9%氯化钠注射液;30min后,各组小鼠均按照10mL/kg灌胃西凤酒(53℃),灌酒3h后眼眶取血,剖取肝脏,收集的全血在3000r/min离心10min,取上清液置-20℃冰箱保存,采用乙醇检测试剂盒检测血清乙醇浓度;将剖取的肝脏在3000r/min匀浆离心15min,取上清液,采用乙醇脱氢酶(ADH)试剂盒检测肝脏ADH活性,结果见表2。
表2
组别 | 乙醇浓度(mg/ml) | ADH(U/ml) |
实验组1 | 4.859±0.228 | 16.69±1.28** |
实验组2 | 5.378±0.234* | 14.78±1.49 |
实验组3 | 5.134±0.178* | 15.32±2.11 |
空白对照组 | 6.871±0.335** | 12.46±1.89 |
注:与空白对照组比较,*P<0.05,**P<0.01
从表2可知,各实验组的小鼠全血中乙醇浓度显著低于空白对照组,且乙醇脱氢酶(ADH)活性显著高于空白对照组,其中,实验组1达到显著水平,说明本发明的药食同源组合物能够增强小鼠肝脏ADH活性,降低小鼠血清乙醇浓度,从而达到解酒的效果。
1.4.3药食同源组合物对胃肠道蠕动功能的影响
将选择的实验小鼠按雌雄随机分为空白对照组、实验组1、实验组2和实验组3(对应本发明实施例1~实施例3的药食同源组合物),共计4组,每组10只。各组小鼠禁食12h后,按照给药量3mL/kg灌喂药食同源组合物,对照组为相同体积的生理盐水即质量浓度0.9%氯化钠注射液;30min后给每只小鼠灌胃0.15mL稀释调匀好的碳末,10min后将小鼠脱颈处死,剖腹将肠道展开,使用标准测量尺进行碳墨在肠道中推进距离(胃幽门部开始到碳末在肠管儿中推进末段)的测量,结果见表3。
表3
注:与空白对照组比较,*P<0.05,**P<0.01
从从表3可知,各实验组小鼠肠道碳末推进距离均明显长于空白对照组,其中,实验组1和实验组3达到显著水平,说明本发明的药食同源组合物具有较明显的促进胃肠蠕动的作用。
1.4.4药食同源组合物对小鼠肝郁血瘀模型的血浆纤维蛋白原的影响
将选择的实验小鼠按雌雄随机分为空白对照组、实验组1、实验组2和实验组3(对应本发明实施例1~实施例3的药食同源组合物),共计4组,每组10只。各组小鼠进行适应性饲养2日后,除空白对照组外,对各小鼠进行肝郁模型的造模。本法采用外界刺激结合药物刺薇多种方法进行造模,对实验小鼠进行轮流交替刺激法进行随机的造模,包括夹尾激怒、悬尾、昼夜颠倒、皮下注射盐酸肾上腺素、鼠笼倾斜刺激、禁食禁水、冰水游泳、超声刺激等多种刺激连续进行15日;第16日起,按照给药量3mL/kg灌喂药食同源组合物,对照组为相同体积的生理盐水即质量浓度0.9%氯化钠注射液,连续7日;灌胃给药结束前一晚对各组小鼠禁食不禁水,并于最后一日进行灌胃给药30min后,采用20%乌拉坦对小鼠腹腔注射进行麻醉后,用含有肝素钠的采血管对小鼠进行腹主动脉取血,采集5mL血液,震荡摇匀,防止血凝。将所采集的血液样本,用血液流变仪测定血浆纤维蛋白原,结果见表4。
表4
注:与空白对照组比较,*P<0.05,**P<0.01
从表4可以看出,各实验组的小鼠血浆纤维蛋白原均明显低于空白对照组,且都达到显著水平,说明本发明的药食同源组合物具有较明显的活血化瘀作用。
二、临床实验
2.1一般资料
随机选取2018年6月至2019年4月期间在我院就诊的患者40例,其中男性33例,女性7例,年龄35-65岁,平均年龄40岁;患者均符合“肝癖”(湿热蕴结型)的中医诊断辨症标准,排除不符合《酒精性肝病诊疗指南》,合并有心脑血管、造血系统、肝、肾等严重危及生命的原发病及精神病患者,正在接受其它治疗,可影响本研究的效果判定者,准备妊娠、妊娠期及哺乳期妇女。
2.2中医诊断标准
根据其病因、病理及临床特征,可将其归属于“肝癖”、“酒癖”、“酒疸”、“胁痛”、“积聚”等范畴。目前辩证分型仍缺乏指南,总结历代文献及现代诸多临床研究发现,多数医家认为酒为湿热有毒之物,因此湿热蕴结为发病过程中的主要病因病机被广泛认可。本次临床观察为“湿热蕴结型”患者,证型诊断标准如下,主症:①右胁肋胀痛;②舌质红,苔黄腻。次症:①口粘或口干口苦;②胸腕痞满;③周身困重;④食少纳呆;⑤脉濡数或滑数。上述症候确定,主症必备,加次症2项以上即可诊断。
2.3治疗方法
予以本发明药食同源组合物治疗,观察组每次1支(25mL),每日两次,直接饮用,疗程为4周,同时患者需戒酒及清淡饮食。对照组服用葵花护肝片,一次4片,一日3次,疗程为4周,同时患者需戒酒及清淡饮食。
2.4症状观察指标
参照《中药新药临床研究指导原则》,观察患者治疗前后的症状变化并予积分,具体如下:0级:没有症状,积0分;I级:症状轻微,不影响日常生活,积1分;U级:症状中等,部分影响日常生活,积2分;m级:症状严重,影响到日常生活,难以坚持工作,积3分。
2.5总疗效判定标准
参照《中药新药临床研究指导原则》与文献的有关标准拟总疗效判定标准,具体如下:痊愈:自觉症状完全消失,血脂检查属正常范围,肝功能正常;显效:自觉症状消失,血脂下降接近正常范围,肝功能正常有效:自觉症状基本消失,其他指标有不同程度好转;无效:自觉症状与有关实验室指标检查无明显改善,临床症候疗效比较见表5。
表5
注:痊愈率=痊愈例数/总案例数×100%;显效率=(显效例数+有效例数)/总案例数×100%;无效率=无效例数/总案例数×100%。
从表5可知,观察组患者治疗的有效率是100%,对照组患者治疗的总有效率为95%,观察组患者治疗的有效率高于对照组患者,说明本发明的药食同源组合物提高了患者的临床疗效。
以上所述,仅是本发明的较佳实施例,并非对本发明作任何限制。凡是根据发明技术实质对以上实施例所作的任何简单修改、变更以及等效变化,均仍属于本发明技术方案的保护范围内。
Claims (10)
1.一种疏肝健脾活血的药食同源组合物,其特征在于,由以下质量份数的原料制成:枳椇子0.5~8份,葛根0.5~8份,佛手0.5~5份,牡蛎1.5~15份,广藿香0.5~5份,茯苓1~10份,薏苡仁1.5~15份,赤小豆0.5~8份,橘皮0.2~3份,白扁豆0.5~8份,山药1.5~15份,山楂1.5~15份,当归0.5~5份。
2.根据权利要求1所述的一种疏肝健脾活血的药食同源组合物,其特征在于,由以下质量份数的原料制成:枳椇子1.5份,葛根1.5份,佛手1份,牡蛎3份,广藿香1份,茯苓2份,薏苡仁3份,赤小豆1.5份,橘皮0.5份,白扁豆1.5份,山药3份,山楂3份,当归1份。
3.根据权利要求1所述的一种疏肝健脾活血的药食同源组合物,其特征在于,由以下质量份数的原料制成:枳椇子3份,葛根3份,佛手2份,牡蛎8份,广藿香2份,茯苓5份,薏苡仁5份,赤小豆3份,橘皮2份,白扁豆5份,山药3份,山楂3份,当归2份。
4.根据权利要求1所述的一种疏肝健脾活血的药食同源组合物,其特征在于,由以下质量份数的原料制成:枳椇子6份,葛根6份,佛手1份,牡蛎10份,广藿香3份,茯苓8份,薏苡仁2份,赤小豆3份,橘皮3份,白扁豆7份,山药5份,山楂3份,当归5份。
5.一种制备如权利要求1~权利要求4中任一权利要求所述的疏肝健脾活血的药食同源组合物的方法,其特征在于,该方法包括以下步骤:
步骤一、将各质量份数的原料经水力碎浆机粉碎均匀,然后使用微纳米气泡曝气机进行微氧化;所述微氧化的时间为10min~60min;
步骤二、将步骤一中经微氧化后的各原料通过螺旋输送机送到搓揉机中揉搓挤压进行高温高压破壁,得到破壁原料;所述揉搓挤压的温度为120℃~200℃,压力为0.4MPa~1.2MPa,揉搓机的螺杆转速为400r/min~1200r/min;
步骤三、将步骤二中得到的破壁原料经常压分散后送入双辊洗涤机进行提取,得到原料提取液;
步骤四、将步骤三中得到的原料提取液进行蒸发浓缩,得到原料提取浓缩液;
步骤五、将步骤四中得到的原料提取浓缩液送入反应釜中进行氧化降解,得到小分子原料提取浓缩液,然后依次转入均质釜中搅拌均质、送入研磨机中研磨,得到提取原液,再将提取原液进行制剂成形,得到疏肝健脾活血的药食同源组合物。
6.根据权利要求5所述的方法,其特征在于,步骤一中所述微氧化的时间为30min。
7.根据权利要求5所述的方法,其特征在于,步骤二中所述揉搓挤压的温度为100℃~180℃,压力为0.1MPa~1.0MPa,揉搓机的螺杆转速为200r/min~1200r/min。
8.根据权利要求5所述的方法,其特征在于,步骤四中所述原料提取浓缩液的质量浓度为10%~40%。
9.根据权利要求5所述的方法,其特征在于,步骤五中所述制剂成形的形式为颗粒剂、片剂、胶囊、咀嚼片或口服液。
10.根据权利要求5所述的方法,其特征在于,步骤五中所述提取原液作为原料添加于功能性饮料、糖果类或饼干糕点类中。
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