WO2020073922A1 - 补虚损保健品组合物及其制备方法和其应用 - Google Patents
补虚损保健品组合物及其制备方法和其应用 Download PDFInfo
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Abstract
一种补虚损保健品组合物及其制备方法和其应用。按质量份数计，制备该组合物所需的原料包括：蒲公英5份～40份、鳞茎菜类10份～120份、香辛叶菜类10份～100份、水果8份～16份。该补虚损保健品组合物的制备方法包括如下步骤：将蒲公英、鳞茎菜类、香辛叶菜类等原料粉碎、混合，得到固体混合物；将固体混合物加纯化水浸提，过滤得到浸提汁；对浸提汁进行浓缩得到浓缩液；加乙醇对浓缩液进行沉淀除杂，得到精制液；对精制液进行包埋处理，得到提取液；将提取液冷冻干燥处理，得到补虚损保健品组合物的冻干粉。此方法制备得到的补虚损保健品组合物不含激素、无明显毒副作用且具有补虚损、补肾壮阳的功效。
Description
本申请要求于2018年10月10日提交香港特别行政区知识产权署，申请号为18112945.1，发明名称为“补虚损保健品组合物及其制备方法和其应用”的香港短期专利的优先权，其全部内容通过引用结合在本申请中。
本发明涉及保健品领域，特别是涉及一种补虚损保健品组合物及其制备方法和其应用。
随着人们生活节奏的不断加快，工作和生活压力不断增加，处于亚健康状态的人数也不断增加。尤其是男性，人到中年，常常出现体力不支、肝肾阴虚及肾阳虚等症状。这给患者带来极大的精神压力，甚至影响正常的家庭生活。
为此，患者常常需要寻求药物帮助。目前市场上销售的补肾壮阳类药物虽然种目繁多，但是大多数都含有性激素，或含有明显的副作用，久服会产生药物依赖，甚至危害身体健康。
发明内容
基于此，有必要提供一种无明显毒副作用且具有补虚损、补肾壮阳功效的补虚损保健品组合物。
此外，还提供一种补虚损保健品组合物的制备方法和其应用。
一种补虚损保健品组合物，按照质量份数计，制备所述补虚损保健品组合物的原料包括：
蒲公英5份～40份、鳞茎菜类10份～120份、香辛叶菜类10份～100份、水果8份～16份；
其中，所述鳞茎菜类选自葱、洋葱及蒜中至少一种，所述香辛叶菜 类选自韭菜、芹菜及芫荽中至少一种，所述水果选自葡萄、蓝莓、黑加仑、柠檬、橘子、橙子、荔枝、樱桃、龙眼肉、草莓、菠萝、椰子、火龙果、雪莲果，榴莲、诺丽果、五指果及西红柿中至少一种。
上述补虚损保健品组合物的原料均选自常见的蔬菜水果，不含性激素、无明显毒副作用；并且发明人通过临床试验证实由上述原料制备得到的补虚损保健品组合物具有补虚损、补肾壮阳的功效。
在其中一个实施例中，按照质量份数计，制备所述补虚损保健品组合物的原料还包括0份～6份的食用种子，所述食用种子选自枸杞子、余甘子、沙棘子、燕麦、苦荞麦、纳豆、桑椹子、核桃仁、芝麻、牡丹花子、百香果、杏仁、桃仁、红花子、紫苏子、南瓜子、苦瓜籽、松籽、辣木籽、玛卡籽、黄秋葵子、山楂、可可豆及咖啡豆中至少一种。
在其中一个实施例中，其特征在于，按照质量份数计，制备所述补虚损保健品组合物的原料还包括0份～6份的茶籽金花菌和0份～6份的松花粉。
在其中一个实施例中，按照质量份数计，制备所述补虚损保健品组合物的原料还包括0份～6份的香辛料，所述香辛料选自姜、肉桂、茴香、八角、胡椒、香果、花椒及丁香中至少一种。
上述任一实施例的补虚损保健品组合物在制备保健药物、保健饮料或巧克力中的应用。
在其中一个实施例中，上述补虚损保健品组合物的制备方法，包括如下步骤：将所述原料粉碎、混合，然后在纯化水中70℃～80℃下浸提处理，得到浸提汁。
在其中一个实施例中，在所述浸提处理的步骤之后还包括如下步骤：
将所述浸提汁浓缩至相对密度为1.18～1.20，得到浓缩液；
加入0.3％～6％的浓缩液体积的包埋剂进行包埋处理，得到提取液。
在其中一个实施例中，所述浓缩时的反渗透压为30kg/cm
2～150kg/cm
2，所述包埋剂为β-环糊精或多孔淀粉。
在其中一个实施例中，在所述浓缩处理的步骤之后，所述包埋处理 的步骤之前，还包括加入3倍浓缩液体积的乙醇溶液沉淀除杂得到精制液的步骤，所述乙醇溶液中乙醇的体积百分含量高于70％。
在其中一个实施例中，在所述包埋处理的步骤之后还包括在-70℃～-35℃的温度下，将所述提取液冷冻干燥制成冻干粉的步骤。
一个或多个实施例通过与之对应的附图中的图片进行示例性说明，这些示例性说明并不构成对实施例的限定。
图1是本申请一实施例提供的保健品的制备方法流程图。
为了便于理解本发明，下面将参照相关附图对本发明进行更全面的描述。附图中给出了本发明的较佳的实施例。但是，本发明可以以许多不同的形式来实现，并不限于本文所描述的实施例。相反地，提供这些实施例的目的是使对本发明的公开内容的理解更加透彻全面。
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本发明。
如图1所示，一实施方式的补虚损保健品组合物的制备方法，包括如下步骤：
步骤S110：按照质量份数计，将5份～40份的蒲公英、10份～120份的鳞茎菜类、10份～100份的香辛叶菜类、8份～16份的水果、0份～6份的食用种子、0份～6份的茶籽金花菌、0份～6份的松花粉及0份～6份的香辛料粉碎、混合，得到固体混合物。
其中，蒲公英是指菊科多年生草本植物蒲公英的整个全草。蒲公英，味甘、寒，无毒，归肝，肾经。中医经典记载其功用为清热解毒，利尿通淋。《纲目》记载：“乌须发，壮筋骨”；《医林纂要》记载：“补脾和胃，养阴凉血，舒筋固齿，通乳益精”，又有“泻火安土”之功；《本草 求真》则认为其“能入阳明胃，厥阴肝，凉血解热”；希雍曰“甘平之剂，能补肝肾”。
其中，鳞茎菜类选自葱、洋葱及蒜中至少一种。葱，味辛，气温，入肺、胃、肝三经，其功用发表，通阳，解毒。并能通关节，通阳气，发散风邪；又能达表和里。葱实则有温肾，明目，治阳痿之功。葱具有独特的香辣素，葱所含的苹果酸和磷酸糖能兴奋神经，改善促进血循环。大蒜是指百合科葱属中以鳞芽构成鳞的草本植物，性温，味辛辣，具有下气，除风，散痛，消毒气之功，大蒜中含有铁、镁、锗和硒，还含有17种氨基酸，以精氨酸含量最高，占氨基酸总量的20.4％。大蒜还含有大蒜素，是蒜氨酸经蒜氨酸酶的作用而形成的一种挥发性硫化物。据研究，大蒜有降血压，抗血小板聚集，抗动脉硬化和防癌等生理功效。大蒜中的植物杀菌素有较强杀菌作用。
需要说明的是，上述的葱、洋葱并不限于具体的品种，例如它还可以是汉葱、胡葱、茖葱、山葱、冬葱等；也不限于具体的食用部位，例如它可以是葱叶、葱白、葱花、葱籽等。同样地，上述的蒜也并不限于具体的品种，例如它可以是大蒜、黑蒜等；蒜也不限于具体的食用部位，例如它可以是蒜白、蒜苗、蒜薹等。
其中，香辛叶菜类选自韭菜、芹菜及芫荽中至少一种。韭菜，辛温，入肝、胃、肾经。《本草拾遗》记载：“温中，下气，补虚，调和脏腑”。《日华子本草》记载：“止泄精，暖腰膝”。《中药大辞典》记载：“温中，行气，散血，解毒”，“治阳虚肾冷，阳道不振，或腰膝冷痛，遗精梦泄”。韭菜中蛋白质、脂肪、碳水化合物含量较高，维生素含量丰富，并富含钙、磷、铁等矿物质，还含有挥发性精油和硫化物等成分，具有兴奋神经等作用，亦含生物碱、皂甙，可温补肝肾，固精壮阳。芹菜是指伞形科芹属中形成肥嫩叶柄的二年生草本植物。分为中国芹菜和西芹两种。芹菜有平肝清热的作用。芹菜含有维生素A、维生素B1、维生素B2、维生素C、钙、铁、磷等营养成分。芹菜含铁量较多，是补充缺铁的食疗佳品。芹菜含有芹菜苷，佛手苷内酯，挥发油及丁基苯酞等成分。芹菜中还含一种使平滑肌舒张的物质，有降压和健脑等作用。芫荽为伞形花 科芫荽属中食用叶和嫰茎的一年生草本植物。芫荽有发汗透疹，消食下气，醒脾和中的功用。芫荽含有钙、磷、铁、胡萝卜素、维生素C、硫胺素、核黄素，并含有芳香油类，如芳樟醇，异香豆酮A、B和香柑内酯等，是芳香物质的主要来源。
需要说明的是，上述的韭菜、芹菜及芫荽既不限于具体的品种，也不限于具体的食用部位等。
其中，水果选自葡萄、蓝莓、黑加仑、柠檬、橘子、橙子、荔枝、樱桃、龙眼肉、草莓、菠萝、椰子、火龙果、雪莲果，榴莲、诺丽果、五指果及西红柿中至少一种。葡萄，甘酸、平，入肺、脾、肾经。《中药大辞典》谓其：“补气血，强筋骨，利小便”。《本经》记载：“主筋骨湿痹，益气倍力，强志”。《滇南本草》记载：“大补气血，舒筋活络”。《随息居饮食谱》记载：“补气，滋肾液，益肝阴，强筋骨，止渴，安胎”。《陆川本草》记载：“滋养强壮，补血，强心利尿”。柠檬，《中药大辞典》记述：“生津，止渴，袪暑，安胎”。《食物考》记述：“孕妇宜食，能安胎”，《纲目拾遗》记述：“下气和胃”。柠檬能改善肌肉工作能力，防止疲劳和解除已有的疲劳。蓝莓果胶含量很高，富含维生素C，含有微量元素锰，并且是花青素含量丰富的水果，在40余种果蔬中的抗氧化能力排名第一。其所含的类黄素可防止脑细胞被自由基破坏。吃蓝莓可以预防癌症和减缓衰老，提高老年人的平衡性和协调性，尤其对于记忆力衰退和运动神经，更有予防效果。此外蓝莓有保护毛细血管，有益心脏健康，含有的多酚类物质，花青素等成分，可增强人体免疫力。研究指出蓝莓的有效成分花青素能通过血管内皮细胞来刺激一氧化氮的合成，从而改善男性勃起质量。黑加仑，又叫旱葡萄、紫梅、黑豆果等。果实富含花青素、酚类物质，含糖类，多种维生素和有机酸等，尤其维生素C含量极高，并含磷、镁、钾、钙，其中锌含量高。其种子中亚油酸含量高，有降压、降血脂和抗动脉硬化等作用，另一种r-亚麻酸，是人体不能合成的特有成分，可起到抗心血管疾病的作用。果实有补肾益气血的功用，其保健功效包括：予防痛风、贫血、水肿、关节炎、风湿、口腔咽喉疾患，对心脑血管，高血压等有很好的效果。黑加仑有较 高的药用价值，可增强人体免疫力，抗衰老。橘子有开胃理气等作用，含有钙、磷、铁、钾、胡萝卜素、维生素B1、维生素B2、维生素C等，橘子中所含多种有机酸、维生素可兴奋心脏，降低毛细血管的脆性对老年人及心血管病人具有保健意义。橙子可理气，消食开胃，化痰，富含多种有机酸、维生素，对人体新陈代谢以及心脏十分有益。此外，橘橙中所含的黄酮类物质能扩张冠状动脉，增加冠状动脉血流量，是维护心脏健康的重要物质。
需要说明的是，上述的各种水果均不限于其形态，例如它们可以是鲜果、干果或者果汁。
其中，所述食用种子选自枸杞子、余甘子、沙棘子、燕麦、苦荞麦、纳豆、桑椹子、核桃仁、芝麻、牡丹花子、百香果、杏仁、桃仁、红花子、紫苏子、南瓜子、苦瓜籽、松籽、辣木籽、玛卡籽、黄秋葵子、山楂、可可豆及咖啡豆中至少一种。
其中，香辛料选自姜、肉桂、茴香、八角、胡椒、香果、花椒及丁香中至少一种。
步骤S120：加入800ml的纯化水到上述固体混合物中，升温到70℃～80℃浸提1h～2h，过滤得到浸提汁。
步骤S130：将上述浸提汁在在反渗透压为30kg/cm
2～150kg/cm
2的压力下，浓缩至相对密度为1.18～1.20的浓缩液。
步骤S140：往上述浓缩液中加入3倍浓缩液体积的乙醇溶液沉淀除杂，得到精制液。
其中，乙醇溶液中乙醇的体积百分含量高于70％。
步骤S150：往上述精制液中加入0.3％～6％的浓缩液体积的包埋剂，搅拌混合进行包埋处理，得到提取液。
其中，包埋剂选自β-环糊精及多孔淀粉中至少一种。
步骤S160：将上述提取液在-70℃～-35℃时冷冻干燥，制成补虚损保健品组合物冻干粉。
步骤S170：按照质量份数计，往上述提取液或者冻干粉中添加0.01份～5份的甜味剂、0.01份～0.05份的食盐、0.3份～0.5份的碳酸氢 钠及0.1份～0.3份的调味剂制成液体饮料或者固体饮料。
其中，甜味剂选自食品加工领域常用的甜味剂，如葡萄糖、红糖、蜂蜜、白砂糖、冰糖、果糖、蛋白糖、甜菊糖、木糖醇、甜蜜素及安赛蜜中的至少一种。同样地，调味剂也选用常用的调味剂产品，在此不再赘述。
需要说明的是，步骤S110～S150制备得到的提取液用于制备液体饮料；其中步骤S140可以省略，省略后，步骤S150直接对步骤S130中的浓缩液进行包埋处理。步骤S160制备得到的冻干粉用于制备固体饮料，也就是说，如果不需要制备固体饮料，就没有步骤S160。步骤S170用于将步骤S150中的提取液制成保健品液体饮料，或者用于将步骤S160中的冻干粉制成保健品固态饮料。
按上述补虚损保健品组合物的制备方法，通过将上述的各种原料按上述比例粉碎、混合，然后按相应的步骤处理制备得到液态或者固态的补虚损保健品组合物。将上述补虚损保健品组合物添加适量的食品添加剂，采用食品加工工艺可以用于制作保健药物、保健饮料(保健醋、保健酒、酵素类等)或巧克力等产品。其中保健药物的剂型为口服液、胶囊、丸剂、片剂、蜜膏剂等常用剂型。
上述补虚损保健品组合物的制备方法制备得到的补虚损保健品组合物的制作原料全部取自蔬菜、水果或药食两用材料，不含激素且无明显的毒副作用。另外，经临床试验证明：上述补虚损保健品组合物还具有补虚损、补肾壮阳功效。
以下为实施例部分：
实施例1
本实施例的补虚损保健品组合物的制备过程如下：
(1)按照质量份数计，将25份蒲公英、35份葱、10份韭菜、8份葡萄与蓝莓和黑加仑的混合物、3份茶籽金花菌、3份松花粉、3份南瓜子与苦瓜籽和芝麻的混合物及3份姜粉碎、混合，得到固体混合物。
(2)加入800ml的纯化水到上述固体混合物中，升温到70℃浸提100min，过滤得到浸提汁。
(3)将上述浸提汁在反渗透压为30kg/cm
2的压力下，浓缩至相对密度为1.18的浓缩液。
(4)往上述浓缩液中加入3倍浓缩液体积的乙醇溶液(乙醇体积百分含量为70％)沉淀除杂，得到精制液。
(5)往上述精制液中加入0.3％的浓缩液体积的β-环糊精，搅拌混合进行包埋处理，得到提取液。
(6)按照质量份数计，往上述提取液中加入3份葡萄糖、0.01份食盐，升温到76.6℃杀菌2min，调配制备得到补虚损保健品组合物液体饮料。
实施例2
本实施例的补虚损保健品组合物的制备过程如下：
(1)按照质量份数计，将30份蒲公英、10份葱、10份韭菜、8份柠檬与橘子和橙子的混合物、3份茶籽金花菌、3份松花粉、3份枸杞子与余甘子和沙棘子的混合物及3份肉桂粉碎、混合，得到固体混合物。
(2)加入800ml的纯化水到上述固体混合物中，升温到70℃浸提100min，过滤得到浸提汁。
(3)将上述浸提汁在反渗透压为100kg/cm
2的压力下，浓缩至相对密度为1.20的浓缩液。
(4)往上述浓缩液中加入3倍浓缩液体积乙醇溶液(乙醇体积百分含量为75％)沉淀除杂，得到精制液。
(5)往上述精制液中加入0.6％的浓缩液体积的β-环糊精，搅拌混合进行包埋处理，得到提取液。
(6)将上述提取液在-70℃冷冻干燥，制成补虚损保健品组合物冻干粉。
(7)按照质量份数计，将5份红糖，在60℃下烘干12小时，粉碎后过60目筛，得到红糖处理物；将0.1份食盐在105℃烘干3小时，室温冷却后过16目筛，得到食盐处理物；在12℃将上述冻干粉、红糖处理物、食盐处理物及0.1份香精混合，得到补虚损保健品组合物固体饮料。
实施例3
本实施例的补虚损保健品组合物的制备过程如下：
(1)按照质量份数计，将20份蒲公英、10份葱、80份韭菜、14份荔枝与龙眼的混合物、6份松籽与辣木籽和玛卡籽的混合物及3份茴香粉碎、混合，得到固体混合物。
(2)加入800ml的纯化水到上述固体混合物中，升温到70℃浸提60min，过滤得到浸提汁。
(3)将上述浸提汁在反渗透压为150kg/cm
2的压力下，浓缩至相对密度为1.20的浓缩液。
(4)往上述浓缩液中加入3倍浓缩液体积的乙醇溶液(乙醇体积百分含量为75％)沉淀除杂，得到精制液。
(5)往上述精制液中加入1.5％的浓缩液体积的β-环糊精，搅拌混合进行包埋处理，得到提取液。
(6)按照质量份数计，往上述提取液中加入3份葡萄糖、0.01份食盐，升温到93℃杀菌，杀菌3min，调配制备得到补虚损保健品组合物液体饮料。
实施例4
本实施例的补虚损保健品组合物的制备过程如下：
(1)按照质量份数计，将30份蒲公英、30份葱、10份韭菜、11份樱桃与草莓和西红柿的混合物、6份茶籽金花菌及6份松花粉粉碎、混合，得到固体混合物。
(2)加入800ml的纯化水到上述固体混合物中，升温到75℃浸提120min，过滤得到浸提汁。
(3)将上述浸提汁在反渗透压为80kg/cm
2的压力下，浓缩至相对密度为1.20的浓缩液。
(4)往上述浓缩液中加入3倍体积的乙醇溶液(乙醇体积百分含量为96％)沉淀除杂，得到精制液。
(5)往上述精制液中加入1.5％的β-环糊精，搅拌混合进行包埋处理，得到提取液。
(6)将上述提取液在-50℃冷冻干燥，制成补虚损保健品组合物冻干粉。
(7)按照质量份数计，将4份白砂糖，在60℃下烘干12小时，粉碎后过60目筛，得到白砂糖处理物；将0.05份食盐在105℃烘干3小时，室温冷却后过16目筛，得到食盐处理物；在12℃将上述冻干粉、白砂糖处理物、食盐处理物、0.5份碳酸氢钠及0.3份调味剂混合，得到补虚损保健品组合物固体饮料。
实施例5
本实施例的补虚损保健品组合物的制备过程如下：
(1)按照质量份数计，将40份蒲公英、120份葱子、10份韭黄、16份菠萝与椰子和火龙果的混合物、3份红花子与紫苏子和黄秋葵子的混合物及3份胡椒粉碎、混合，得到固体混合物。
(2)加入800ml的纯化水到上述固体混合物中，升温到75℃浸提90min，过滤得到浸提汁。
(3)将上述浸提汁在反渗透压为100kg/cm
2的压力下，浓缩至相对密度为1.20的浓缩液。
(4)往上述浓缩液中加入3倍浓缩液体积的乙醇溶液(乙醇体积百分含量为75％)沉淀除杂，得到精制液。
(5)往上述精制液中加入3％的浓缩液体积的β-环糊精，搅拌混合进行包埋处理，得到提取液。
(6)将上述提取液在-50℃冷冻干燥，制成补虚损保健品组合物冻干粉。
(7)按照质量份数计，将3份冰糖，在60℃下烘干12小时，粉碎后过60目筛，得到冰糖处理物；将0.2份食盐在105℃烘干3小时，室温冷却后过16目筛，得到食盐处理物；在12℃将上述冻干粉、冰糖处理物、食盐处理物、0.5份碳酸氢钠及0.3份调味剂混合，得到补虚损保健品组合物固体饮料。
实施例6
本实施例的补虚损保健品组合物的制备过程如下：
(1)按照质量份数计，将40份蒲公英、10份葱白、100份韭菜籽、9份雪莲果与榴莲的混合物、3份燕麦与苦荞麦和牡丹花子的混合物及6份香果粉碎、混合，得到固体混合物。
(2)加入800ml的纯化水到上述固体混合物中，升温到75℃浸提90min，过滤得到浸提汁。
(3)将上述浸提汁在反渗透压为100kg/cm
2的压力下，浓缩至相对密度为1.20的浓缩液。
(4)往上述浓缩液中加入3倍浓缩液体积的乙醇溶液(乙醇体积百分含量为80％)沉淀除杂，得到精制液。
(5)往上述精制液中加入1.5％的浓缩液体积的多孔淀粉，搅拌混合进行包埋处理，得到提取液。
(6)将上述提取液在-60℃冷冻干燥，制成补虚损保健品组合物冻干粉。
(7)按照质量份数计，将3份红糖，在60℃下烘干12小时，粉碎后过60目筛，得到红糖处理物；将0.3份食盐在105℃烘干3小时，室温冷却后过16目筛，得到食盐处理物；在12℃将上述冻干粉、红糖处理物、食盐处理物、0.5份碳酸氢钠及0.2份调味剂混合，得到补虚损保健品组合物固体饮料。
实施例7
本实施例的补虚损保健品组合物的制备过程如下：
(1)按照质量份数计，将10份蒲公英、15份洋葱、25份芹菜、8份诺丽果、6份茶籽金花菌、6份松花粉、6份桑椹子与百香果和山楂的混合物及3份花椒粉碎、混合，得到固体混合物。
(2)加入800ml的纯化水到上述固体混合物中，升温到80℃浸提120min，过滤得到浸提汁。
(3)将上述浸提汁在反渗透压为100kg/cm
2的压力下，浓缩至相对密度为1.20的浓缩液。
(4)往上述浓缩液中加入3倍的浓缩液体积的乙醇溶液(乙醇体积百分含量为85％)沉淀除杂，得到精制液。
(5)往上述精制液中加入5％的浓缩液体积的多孔淀粉，搅拌混合进行包埋处理，得到提取液。
(6)将上述提取液在-35℃冷冻干燥，制成补虚损保健品组合物冻干粉。
(7)按照质量份数计，将4份果糖，在60℃下烘干12小时，粉碎后过60目筛，得到果糖处理物；将0.15份食盐在105℃烘干3小时，室温冷却后过16目筛，得到食盐处理物；在12℃将上述冻干粉、果糖处理物、食盐处理物、0.3份碳酸氢钠及0.3份调味剂混合，得到补虚损保健品组合物固体饮料。
实施例8
本实施例的补虚损保健品组合物的制备过程如下：
(1)按照质量份数计，将5份蒲公英、10份蒜、30份韭白、6份五指果、6份茶籽金花菌、6份松花粉及3份核桃仁与杏仁和桃仁的混合物及6份丁香粉碎、混合，得到固体混合物。
(2)加入800ml的纯化水到上述固体混合物中，升温到80℃浸提60min，过滤得到浸提汁。
(3)将上述浸提汁在反渗透压为100kg/cm
2的压力下，浓缩至相对密度为1.20的浓缩液。
(4)往上述浓缩液中加入3倍浓缩液体积的乙醇溶液(乙醇体积百分含量为96％)沉淀除杂，得到精制液。
(5)往上述精制液中加入5％的浓缩液体积的多孔淀粉，搅拌混合进行包埋处理，得到提取液。
(6)将上述提取液在-35℃冷冻干燥，制成补虚损保健品组合物冻干粉。
(7)按照质量份数计，将0.05份蛋白糖，在60℃下烘干12小时，粉碎后过60目筛，得到蛋白糖处理物；将0.05份食盐在105℃下烘干3小时，室温冷却后过16目筛，得到食盐处理物；在12℃下将上述冻干粉、蛋白糖处理物、食盐处理物、0.4份碳酸氢钠及0.2份调味剂混合，得到补虚损保健品组合物固体饮料。
实施例9
本实施例的补虚损保健品组合物的制备过程如下：
(1)按照质量份数计，将5份蒲公英、25份汉葱、10份芫荽、8份榴莲、6份茶籽金花菌、6份松花粉、3份纳豆与可可豆和咖啡豆的混合物及2份八角粉碎、混合，得到固体混合物。
(2)加入800ml的纯化水到上述固体混合物中，升温到80℃浸提60min，过滤得到浸提汁。
(3)将上述浸提汁在反渗透压为100kg/cm
2的压力下，浓缩至相对密度为1.20的浓缩液。
(4)往上述浓缩液中加入3倍浓缩液体积的乙醇溶液(乙醇体积百分含量为75％)沉淀除杂，得到精制液。
(5)往上述精制液中加入6％的浓缩液体积的多孔淀粉，搅拌混合进行包埋处理，得到提取液。
(6)将上述提取液在-35℃冷冻干燥，制成补虚损保健品组合物冻干粉。
(7)按照质量份数计，将0.01份甜菊糖，在60℃下烘干12小时，粉碎后过60目筛，得到甜菊糖处理物；将0.02份食盐在105℃烘干3小时，室温冷却后过16目筛，得到食盐处理物；在12℃将上述冻干粉、甜菊糖处理物、食盐处理物、0.3份碳酸氢钠及0.3份调味剂混合，得到补虚损保健品组合物固体饮料。
测试部分：
将实施例和中药参茸三鞭粉剂、喜得康粉剂进行如下临床试验：
1.实验对象资料
所有观察对象为临床确诊为肾虚的亚健康人群共36例，均为男性，年龄最小21岁，最大66岁，平均年龄44岁。
将亚健康人群分为三组，每组12人，分别命名为组1～3，利用SPSS统计软件对3个组年龄，中医症状记分比较，P>0.05，差异无统计学意义，说明这3组具有可比性。
2.实验对象的选择标准
2.1病例纳入标准
(1)临床确诊的亚健康人群；
(2)年龄18～75周岁；
(3)签署知情同意书。
2.2病例排除标准
(1)有过敏史者；
(2)伴有肝、肾、造血系统及心、脑血管等原发性疾病以及精神病患者；
(3)肝功能异常者；
(4)有其他脏器病变者。
3.实验方法
组1的亚健康人群分别服用由实施例1制备的本发明的组合物得到的固体粉剂，组2和组3分别服用由对比1、对比2制备的中药参茸三鞭粉剂及喜得康粉剂，一次15g，一天两次，检查并记录实验者的身体反应。
4.中医证候疗效评定标准
将肾虚精亏、气血两虚、失眠、健忘、腰腿酸软、眩晕耳鸣等症状分为无、轻、重三个等级，对应的分值为0、2、4分，服用20天后对观察者进行评分。
疗效指数(n)＝[(治疗前分值-治疗后分值)÷治疗前分值]×100％
显效：证候中上述症状大部分消失，有效率n≥70％；
有效：证候中上述症状基本消失，有效率30％n≤n<70％；
无效：证候中上述症状有一定改善，有效率n<30％；
有效率＝[显效例数+有效例数/总例数]×100％。
5.实验结果
表1临床试验结果
| 组别 | 显效/人 | 有效/人 | 无效/人 | 有效率％ |
| 1 | 7 | 4 | 1 | 91.66 |
| 2 | 5 | 5 | 2 | 83.33 |
| 3 | 8 | 2 | 2 | 83.33 |
从表1的结果可知，本发明制备的补虚损保健品组合物对肾虚所致的虚损的亚健康状态具有良好的补虚损，补肾壮阳的功效，有效率达91.66％。
6.病例反馈
病例1：周某，男，60岁，近一年来体弱多病，体质虚弱，全身不适，易疲乏，稍干点活儿就累，出现心慌，腿无力，时伴有耳鸣，服用本组合物液体饮料6瓶，感觉精神见好，疲劳减轻，身体较舒服。服用一个疗程共20天，体质改善，所见症状恢复，精神饱满，精力旺盛，体力恢复正常。
病例2：张某，男，24岁，与女友相识半年，性生活不如意，勃起疲软，伴有早泄症状，恋爱前有手淫史，服用本组合物粉剂，一个疗程，性功能恢复，与女友性生活持续约40分钟，性要求强烈。
病例3：朱某，男，29岁，性欲减退，夜尿频多，伴疲乏无力，服本组合物粉剂，服1瓶后即有性冲动，连喝5～6瓶，勃起坚挺，夜尿明显减少，且思考能力明显提升，一星期都如此，运动反应比以前灵敏、快捷，夜间工作不感到疲倦，尤其性生活旺盛，房事后无疲劳感。
综上，上述补虚损保健品组合物至少具有以下有益效果：
(1)制备上述补虚损保健品组合物所需的原料为日常生活中常用的蔬菜、水果以及食用种子等，故上述补虚损保健品组合物不含性激素，且无明显的毒副作用；
(2)上述补虚损保健品组合物经临床试验证实具有良好的补虚损，补肾壮阳的效果。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。
Claims (10)
- 一种补虚损保健品组合物，其特征在于，按照质量份数计，制备所述补虚损保健品组合物的原料包括：蒲公英5份～40份、鳞茎菜类10份～120份、香辛叶菜类10份～100份、水果8份～16份；其中，所述鳞茎菜类选自葱、洋葱及蒜中至少一种，所述香辛叶菜类选自韭菜、芹菜及芫荽中至少一种，所述水果选自葡萄、蓝莓、黑加仑、柠檬、橘子、橙子、荔枝、樱桃、龙眼肉、草莓、菠萝、椰子、火龙果、雪莲果，榴莲、诺丽果、五指果及西红柿中至少一种。
- 根据权利要求1所述的补虚损保健品组合物，其特征在于，按照质量份数计，制备所述补虚损保健品组合物的原料还包括0份～6份的食用种子，所述食用种子选自枸杞子、余甘子、沙棘子、燕麦、苦荞麦、纳豆、桑椹子、核桃仁、芝麻、牡丹花子、百香果、杏仁、桃仁、红花子、紫苏子、南瓜子、苦瓜籽、松籽、辣木籽、玛卡籽、黄秋葵子、山楂、可可豆及咖啡豆中至少一种。
- 根据权利要求1所述的补虚损保健品组合物，其特征在于，按照质量份数计，制备所述补虚损保健品组合物的原料还包括0份～6份的茶籽金花菌和0份～6份的松花粉。
- 根据权利要求1所述的补虚损保健品组合物，其特征在于，按照质量份数计，制备所述补虚损保健品组合物的原料还包括0份～6份的香辛料，所述香辛料选自姜、肉桂、茴香、八角、胡椒、香果、花椒及丁香中至少一种。
- 根据权利要求1～4任一项所述的补虚损保健品组合物在制备保健药物、保健饮料或巧克力中的应用。
- 权利要求1～4任一项所述的补虚损保健品组合物的制备方法，其特征在于，包括如下步骤：将所述原料粉碎、混合，然后在纯化水中70℃～80℃下浸提处理，得到浸提汁。
- 根据权利要求6所述的补虚损保健品组合物的制备方法，其特征 在于，在所述浸提处理的步骤之后还包括如下步骤：将所述浸提汁浓缩至相对密度为1.18～1.20，得到浓缩液；加入0.3％～6％的浓缩液体积的包埋剂进行包埋处理，得到提取液。
- 根据权利要求7所述的补虚损保健品组合物的制备方法，其特征在于，所述浓缩时的反渗透压为30kg/cm 2～150kg/cm 2，所述包埋剂为β-环糊精或多孔淀粉。
- 根据权利要求7所述的补虚损保健品组合物的制备方法，其特征在于，在所述浓缩处理的步骤之后，所述包埋处理的步骤之前，还包括加入3倍浓缩液体积的乙醇溶液沉淀除杂得到精制液的步骤，所述乙醇溶液中乙醇的体积百分含量高于70％。
- 根据权利要求7所述的补虚损保健品组合物的制备方法，其特征在于，在所述包埋处理的步骤之后还包括在-70℃～-35℃的温度下，将所述提取液冷冻干燥制成冻干粉的步骤。
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| JP7199518B2 (ja) | 2023-01-05 |
| EP3864969A1 (en) | 2021-08-18 |
| KR20210057122A (ko) | 2021-05-20 |
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