CN111543634A - 一种增加骨密度的中药保健食品及其制备方法 - Google Patents
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Abstract
本发明公开了一种增加骨密度的中药保健食品及其制备方法,其原料包括如下重量份数组成:碳酸钙20~35份、杜仲提取物5~15份、骨碎补提取物5~15份、补骨脂提取物3~10份、淫羊霍提取物3~10份。本发明提供的中药保健食品具有能够显著提高骨密度、缓解骨痛和改善尿频的功效,多组分合并用药在治疗骨质疏松和改善尿频方面疗效显著、确切,无副作用、治疗期间不引起食欲减退,临床用药安全可靠。
Description
技术领域
本发明属于中药保健品制剂领域,具体涉及一种增加骨密度的中药保健食品及其制备方法。
背景技术
随着中国老龄化社会的到来和人均寿命的延长,骨质疏松症及其合并症的发病率逐步上升,流行病学研究表明我国60-70岁中老年人中约1/3有骨质疏松症,80岁以上老年人半数以上患有骨质疏松症,骨折是骨质疏松的最终结局。骨折对老年人的健康和生活质量危害极大,10%-20%的患者于骨折后1年内死亡,大约一半的患者骨折愈合后生活不能自理,很难恢复至骨折前的体力活动水平。因此,严重威胁老年人健康的骨质疏松问题不容忽视,防治骨质疏松症、提高老年患者的生活质量已成为全世界越来越重视的课题。
研究表明老年性骨质疏松症与肾阳虚症关系密切。肾阳虚是指肾阳亏虚,功能衰退所表现的证候。“寒”是肾阳虚的主要表现特征,腰膝部位酸痛或疼痛,四肢冰冷,畏寒怕冷,体胖,浮肿(腰以下肿甚),按之凹陷不起,甚则腹部胀痛,心悸喘咳,大便久泻不止,五谷更泻,头晕目眩,精神萎靡,小便清长或夜尿多,舌淡胖苔白滑,脉沉迟无力或弱等等。女性表现为痛经,小腹寒冷,经血深乌有血块。男性表现为性功能下降,勃起开始有心无力,性欲减退。
结合骨质疏松的发生机制,其防治可以从补肾和补钙两个方面着手。目前市场上骨质疏松类产品不少,但绝大部分是以单纯补钙为主。中医保健理论认为中老年人多数肾精亏虚,脾胃运化不佳,淤血阻滞而容易使骨骼失养,脆性增加,导致骨质疏松而出现骨折。专利CN1994392公开了复方骨碎补胶囊片剂,只单纯从补肾角度治疗骨质疏松症,且中药材采用直接粉末入药,有效成分含量不高,药效上也没有进行论证。专利CN108095114A,公开了一种增加骨密度的中药保健食品及其制备方法,其中有多味补肾的中药,也有煅龙骨含钙的中药,既补肾也补钙,但是钙剂的量少,对于老年人每天服用的钙量达不到保健作用的要求。
发明内容
本发明在克服原有技术缺点的基础上,提供一种增加骨密度、缓解骨痛的中药保健食品及其制备方法,以碳酸钙、杜仲提取物、骨碎补提取物、补骨脂提取物和淫羊霍提取物为原料,通过赋形剂制成不同剂型;本发明是结合骨质疏松的发生机制,从补肾和补钙两个方面,具有促进成骨细胞增殖、增加骨密度,缓解骨痛,同时还具有非常好的改善尿频的保健功效,尤其适用于中老年人群。
本发明是通过以下技术方案实现的:
一方面,提供了一种增加骨密度的中药保健食品,包括如下重量份数的原料:碳酸钙20~35份、杜仲提取物5~15份、骨碎补提取物5~15份、补骨脂提取物3~10份、淫羊霍提取物3~10份;
进一步地,包括如下重量份数的原料:碳酸钙25~30份、杜仲提取物5~10份、骨碎补提取物5~10份、补骨脂提取物3~8份、淫羊霍提取物3~8份。
进一步地,杜仲提取物、骨碎补提取物、补骨脂提取物的制备方法,包括如下步骤:
所述杜仲提取物、骨碎补提取物、补骨脂提取物的制备方法,采用超临界萃取法,包括如下步骤:取盐炙杜仲、砂炒骨碎补、盐制补骨脂,粉碎,分别与85-95%乙醇夹带剂混合成悬浮物,泵入超临界萃取釜中,采用CO2为超临界溶剂,萃取温度为15~65℃,萃取压力为8~10MPa,萃取时间为4~12小时,得到的萃取物先经减压干燥,然后粉碎成细粉,得各中药提取物;
淫羊藿提取物的制备方法,包括如下步骤:羊脂炙淫羊藿粉碎,再分别采用60%~75%食用酒精回流提取两次,每次加6~10倍重量的食用酒精,每次提取1h~2h,然后滤过、浓缩、喷雾干燥、包装,得淫羊藿提取物。
杜仲提取物、骨碎补提取物、补骨脂提取物和淫羊霍提取物的水分≤5%。
进一步地,杜仲提取物、骨碎补提取物、补骨脂提取物制备时,离心的转速为17000rpm/min~19000rpm/min。
进一步地,淫羊霍提取物制备时,喷雾干燥的进口温度为180~200℃,出口温度为80~90℃。
本发明所用药材:
杜仲,功效成分为松脂醇二葡萄糖苷,主要成分为黄酮类物质、木脂素类物质、环烯醚萜类物质等。杜仲在本发明中的功效为:补肝肾、强筋骨,用于肝肾不足,腰膝酸痛,筋骨无力,头晕目眩。
骨碎补,主要成分为柚皮甙,骨碎补在本发明中的功效为:疗伤止痛、补肾强骨,用于跌扑闪挫,筋骨折伤,肾虚腰痛,筋骨痿软。
补骨脂,主要成分为补骨脂素、异补骨脂素、黄酮类、异黄酮类。补骨脂在本发明中的功效为:温肾助阳、温脾止泻,用于肾阳不足,阳痿遗精,遗尿尿频,腰膝冷痛,肾虚作喘,五更泄泻。
淫羊藿,主要成分为淫羊藿苷、黄酮类化合物、木脂素、生物碱、挥发油等。淫羊藿在本发明中的功效为:补肾阳、强筋骨,用于肾阳虚衰,阳痿遗精,筋骨痿软。
碳酸钙,功效成分为钙,用于补充钙剂,钙剂在绝经后骨质疏松治疗中是一线治疗药物的必需的辅助药物。
另一方面,提供了一种增加骨密度的中药保健食品的制备方法,包括以下步骤:
S1、按配方量称取杜仲提取物、骨碎补提取物、补骨脂提取物、淫羊霍提取物、碳酸钙过60目筛,置于混合机内;
S2、按配方量称取辅料过100目筛,置于混合机内,与步骤S1原料混合20~40min,制成总混料;
S3、将步骤S2中的总混料进行装囊、抛光、包装,得胶囊。
进一步地,步骤S2中的辅料为硬脂酸镁,加入的份数为0.3~0.6份。
进一步地,步骤S1以后还可以制备成片剂、丸剂、颗粒剂。
再一方面,所述中药保健食品适用于中老年人用于增加骨密度、缓解骨痛和改善尿频的保健作用。
有益效果:
1.本发明采用杜仲、骨碎补、补骨脂、淫羊藿、碳酸钙作为原药材,均为防治骨质疏松症的代表中药和钙剂。配方中,淫羊藿补肾阳、强筋骨,用于肾阳虚衰,阳痿遗精,筋骨痿软;杜仲补肝肾、强筋骨,用于肝肾不足,腰膝酸痛,筋骨无力,头晕目眩;补骨脂温肾助阳、温脾止泻,用于肾阳不足,阳痿遗精,遗尿尿频,腰膝冷痛,肾虚作喘,五更泄泻;骨碎补疗伤止痛、补肾强骨,用于跌扑闪挫,筋骨折伤,肾虚腰痛,筋骨痿软。以上中药材均能补命门之火,相伍为用,有温肾补阳、固精止遗之功效。
2.本发明根据中医治骨病的“清、调、补、修”的理论,科学高效全面治疗骨病,从根本上解决骨质疏松症的相关问题。“清”:清除骨缝间隙中的垃圾及骨关节坏死的细胞,防止肌肉骨骼老化,减轻骨关节间的摩擦力,消除滑膜炎症,避免骨刺的形成,促使新骨细胞的再次生长;“调”:本发明具有补肝肾、壮腰膝、强筋骨的功效,调节免疫、内分泌、中枢神经、循环等系统,改善气血、经络、关节劳损的受伤程度,维护骨细胞生活环境的稳定;“补”:补充骨关节所需的微量元素及对人体所需的氨基酸,全面均衡补充成骨细胞营养,提高血钙含量,增加骨密度,增强免疫细胞;“修”:通过清除体内垃圾,改善各大系统,提高血钙含量,增加骨密度,增强免疫细胞,促进骨病愈合,修复骨病受伤组织及细胞,从病源解决根本,使机体达到健康状态。
依据上述理论并形成了六步疗法:第一步:免疫调节,激活关节囊细胞活性;第二步:清除溶酶体,消除血管翳;第三步:清除骨关节重金属污染;第四步:清除骨关节毒素,调节关节液的酸碱平衡;第五步:增加性激素,保持青春活力;第六步:促进软骨的修复与再生,增加骨密度,缓解骨痛。
3.本发明经动物实验评价给药90天后,大鼠的股骨中心骨密度及远心端骨密度、骨钙含量显著提高;经过临床验证坚持服用了本发明制备的胶囊后,血钙含量明显提高,成骨细胞大量增殖,骨密度也明显增加,能有效缓解腰酸背痛,特别对中老年人中女性雌激素缺乏、男性性功能减退所致睾酮水平下降而引起的骨质疏松症有确切的保健康复作用。另外也发现本发明对中老年人的改善尿频,也具有非常好的疗效,有效率达80%以上。
4.本发明制备方法简单,采用全天然名贵中药材淫羊藿、杜仲、补骨脂、骨碎补,先进行炮制,以上中药材精细炮制后根据中药材有效成分的性质分别进行超临界CO2萃取或醇提,精准提取出脂溶性有效成分和水溶性有效成分,在提高药效的同时去除无效成分,之后再按照配方标准严格经过筛、混合、装囊、包装等主要工艺加工制成辅料占比不到1%,功效成分含量高,生物利用度高,稳定性好的胶囊剂,安全系数高且服用方便。
具体实施方式
下面结合实施例对本发明做进一步的描述,有必要在此指出的是以下实施例只是用于对本发明进行进一步的说明,不能理解为对本发明保护范围的限制,该领域的技术熟练人员根据上述发明内容所做出的一些非本质的改进和调整,仍属于本发明的保护范围。
实施例1
一种增加骨密度的中药保健食品,由如下重量份数的原料组成:
以胶囊1000粒计(规格:0.55g/粒)
一种增加骨密度的中药保健食品的制备方法
1)原药材的炮制:
淫羊藿的炮制:淫羊藿取羊脂油加热熔化,加入淫羊藿丝,用文火炒至均匀有光泽,取出,放凉。每100千克淫羊藿,用羊脂油20千克。
骨碎补的炮制:骨碎补取净骨碎补或片,照砂烫法用砂烫至鼓起并呈焦黄色,取出,筛去砂,冷却后撞去毛,筛去灰屑。
杜仲的炮制:先用食盐加适量开水溶化,取杜仲块或丝条,使与盐水充分拌透吸收,然后置锅内,用文火炒至微有焦斑为度,取出晾干。(每杜仲100斤,用食盐3斤)杜仲经炒制后,则杜仲胶被破坏,有效成分易于煎出。
补骨脂的炮制:取净补骨脂,加入盐水拌匀,润透,用文火炒至鼓起,颜色加深,有香气逸出时,取出放凉。补骨脂每100kg,用食盐2kg。
2)提取物的制备:
取盐炙杜仲、砂炒骨碎补、盐制补骨脂,粉碎,分别90%乙醇夹带剂混合成悬浮物,泵入超临界萃取釜中,采用CO2为超临界溶剂,萃取温度为50℃,萃取压力为8~10MPa,萃取时间为8小时,得到的萃取物先经减压干燥,然后粉碎成细粉,得各中药提取物。
淫羊藿提取物:粉碎、提取(60%食用酒精回流提取2次,第1次8倍量1.5h,第2次6倍量1h)、滤过、浓缩、喷雾干燥(进口温度180~200℃,出口温度80~90℃,含水率≤5%)、包装等主要工艺制成。粉碎、提取(60%食用酒精回流提取2次,第1次8倍量1.5h,第2次6倍量1h)、滤过、浓缩、喷雾干燥(进口温度180~200℃,出口温度80~90℃,含水率≤5%)、包装等主要工艺制成。
3)中药保健胶囊的制备:
S1、按配方量称取杜仲提取物、骨碎补提取物、补骨脂提取物、淫羊霍提取物、碳酸钙,过60目筛,硬脂酸镁过100目筛,至干燥洁净的二维运动混合机内,混合30min,制成总混料。
S2、总混:将杜仲提取物、骨碎补提取物、补骨脂提取物、淫羊霍提取物、碳酸钙及硬脂酸镁投入。
S3、装囊:将总混料和空心胶囊分别加入各自料斗中,操作全自动硬胶囊填充机进行胶囊填充,操作胶囊填充机时,随时注意胶囊填充量(0.55g/粒),调节填充量使填充出来的胶囊符合质量标准要求,及时剔出外观不合格的胶囊。
S4、抛光:将填充好的胶囊加入胶囊抛光机料斗中,操作胶囊抛光机进行胶囊抛光,及时剔出外观不合格的胶囊。
S6、包装:按本产品胶囊的包装规格30粒/瓶进行包装。
实施例2
一种增加骨密度的中药保健食品,由如下重量份数的原料组成:
以胶囊1000粒计(规格:0.55g/粒)
一种增加骨密度的中药保健食品的制备方法
1)原药材的炮制:
淫羊藿的炮制:淫羊藿取羊脂油加热熔化,加入淫羊藿丝,用文火炒至均匀有光泽,取出,放凉。每100千克淫羊藿,用羊脂油20千克。
骨碎补的炮制:骨碎补取净骨碎补或片,照砂烫法用砂烫至鼓起并呈焦黄色,取出,筛去砂,冷却后撞去毛,筛去灰屑。
杜仲的炮制:先用食盐加适量开水溶化,取杜仲块或丝条,使与盐水充分拌透吸收,然后置锅内,用文火炒至微有焦斑为度,取出晾干。(每杜仲100斤,用食盐3斤)杜仲经炒制后,则杜仲胶被破坏,有效成分易于煎出。
补骨脂的炮制:取净补骨脂,加入盐水拌匀,润透,用文火炒至鼓起,颜色加深,有香气逸出时,取出放凉。补骨脂每100kg,用食盐2kg。
2)提取物的制备:
取盐炙杜仲、砂炒骨碎补、盐制补骨脂,粉碎,分别与90%乙醇夹带剂混合成悬浮物,泵入超临界萃取釜中,采用CO2为超临界溶剂,萃取温度为40℃,萃取压力为8~10MPa,萃取时间为6小时,得到的萃取物先经减压干燥,然后粉碎成细粉,得各中药提取物。
淫羊藿提取物:粉碎、提取(60%食用酒精回流提取2次,第1次8倍量1.5h,第2次6倍量1h)、滤过、浓缩、喷雾干燥(进口温度180~200℃,出口温度80~90℃,含水率≤5%)、包装等主要工艺制成。粉碎、提取(60%食用酒精回流提取2次,第1次8倍量1.5h,第2次6倍量1h)、滤过、浓缩、喷雾干燥(进口温度180~200℃,出口温度80~90℃,含水率≤5%)、包装等主要工艺制成。
3)中药保健胶囊的制备:
S1、按配方量称取杜仲提取物、骨碎补提取物、补骨脂提取物、淫羊霍提取物、碳酸钙,过60目筛,硬脂酸镁过100目筛,至干燥洁净的二维运动混合机内,混合20min,制成总混料。
S2、总混:将杜仲提取物、骨碎补提取物、补骨脂提取物、淫羊霍提取物、碳酸钙及硬脂酸镁投入。
S3、装囊:将总混料和空心胶囊分别加入各自料斗中,操作全自动硬胶囊填充机进行胶囊填充,操作胶囊填充机时,随时注意胶囊填充量(0.55g/粒),调节填充量使填充出来的胶囊符合质量标准要求,及时剔出外观不合格的胶囊。
S4、抛光:将填充好的胶囊加入胶囊抛光机料斗中,操作胶囊抛光机进行胶囊抛光,及时剔出外观不合格的胶囊。
S6、包装:按本产品胶囊的包装规格30粒/瓶进行包装。
实施例3
一种增加骨密度的中药保健食品,由如下重量份数的原料组成:
以胶囊1000粒计(规格:0.55g/粒)
一种增加骨密度的中药保健食品的制备方法
1)原药材的炮制:
淫羊藿的炮制:淫羊藿取羊脂油加热熔化,加入淫羊藿丝,用文火炒至均匀有光泽,取出,放凉。每100千克淫羊藿,用羊脂油20千克。
骨碎补的炮制:骨碎补取净骨碎补或片,照砂烫法用砂烫至鼓起并呈焦黄色,取出,筛去砂,冷却后撞去毛,筛去灰屑。
杜仲的炮制:先用食盐加适量开水溶化,取杜仲块或丝条,使与盐水充分拌透吸收,然后置锅内,用文火炒至微有焦斑为度,取出晾干。(每杜仲100斤,用食盐3斤)杜仲经炒制后,则杜仲胶被破坏,有效成分易于煎出。
补骨脂的炮制:取净补骨脂,加入盐水拌匀,润透,用文火炒至鼓起,颜色加深,有香气逸出时,取出放凉。补骨脂每100kg,用食盐2kg。
2)提取物的制备:
取盐炙杜仲、砂炒骨碎补、盐制补骨脂,粉碎,分别与95%乙醇夹带剂混合成悬浮物,泵入超临界萃取釜中,采用CO2为超临界溶剂,萃取温度为50℃,萃取压力为8~10MPa,萃取时间为10小时,得到的萃取物先经减压干燥,然后粉碎成细粉,得各中药提取物。
淫羊藿提取物:粉碎、提取(60%食用酒精回流提取2次,第1次8倍量1.5h,第2次6倍量1h)、滤过、浓缩、喷雾干燥(进口温度180~200℃,出口温度80~90℃,含水率≤5%)、包装等主要工艺制成。粉碎、提取(60%食用酒精回流提取2次,第1次8倍量1.5h,第2次6倍量1h)、滤过、浓缩、喷雾干燥(进口温度180~200℃,出口温度80~90℃,含水率≤5%)、包装等主要工艺制成。
3)中药保健胶囊的制备:
S1、按配方量称取杜仲提取物、骨碎补提取物、补骨脂提取物、淫羊霍提取物、碳酸钙,过60目筛,硬脂酸镁过100目筛,至干燥洁净的二维运动混合机内,混合40min,制成总混料。
S2、总混:将杜仲提取物、骨碎补提取物、补骨脂提取物、淫羊霍提取物、碳酸钙及硬脂酸镁投入。
S3、装囊:将总混料和空心胶囊分别加入各自料斗中,操作全自动硬胶囊填充机进行胶囊填充,操作胶囊填充机时,随时注意胶囊填充量(0.55g/粒),调节填充量使填充出来的胶囊符合质量标准要求,及时剔出外观不合格的胶囊。
S4、抛光:将填充好的胶囊加入胶囊抛光机料斗中,操作胶囊抛光机进行胶囊抛光,及时剔出外观不合格的胶囊。
S6、包装:按本产品胶囊的包装规格30粒/瓶进行包装。
实施例4
除杜仲提取物、骨碎补提取物、补骨脂提取物的制备方法改用醇提,余同实施例1。
醇提过程具体为:取盐炙杜仲、砂炒骨碎补、盐制补骨脂,粉碎,再分别采用75%食用酒精回流提取两次,每次加8倍重量的食用酒精,每次提取1h,然后滤过、离心、浓缩、真空干燥、粉碎、过筛、包装,得提取物。
实施例5
(一)动物试验
1材料和方法
1.1样品
实施例1-3和对比例1制备的保健食品胶囊。人体口服推荐量为每日2次,每次2粒,成人体重按60kg计算,折合剂量0.0367g/kg·bw,样品钙含量约为20%。
1.2实验动物及环境
SPF级雌性SD大鼠90只,体重约300g,由长沙市开福区东创实验动物科技服务部提供,生产许可证号为SCXK(湘)2009-0012。实验条件为屏障环境,实验期间实验环境温度22℃~24℃,湿度52%~58%。实验动物使用许可证号为SYXK(湘)2005-0001。
1.3饲料配方(%):
低钙酪蛋白23.0,DL-蛋氨酸0.3,玉米淀粉32.0,蔗糖30.0,纤维5.0,玉米油5.0,混合矿物盐3.5,混合维生素1.0,二酒石酸胆碱0.2。
1.4主要仪器:
SD-1000C骨矿物质测量仪(核工业北京地质研究院仪器中心)。
1.5实验方法
1.5.1卵巢切除:大鼠以30mg/kg·bw的剂量腹腔注射戊巴比妥钠溶液,麻醉后进行双侧卵巢切除,术后肌肉注射2万单位的青霉素,连续3天。假手术组打开腹腔后仅切除0.5g左右的脂肪,保留双侧卵巢。大鼠卵巢切除后5天,进行阴道涂片检查,剔除卵巢切除不完全的大鼠。
1.5.2剂量组选择与受试物给予方式:
实验动物按体重随机分为七个组:假手术组、模型组(卵巢切除)、卵巢切除+高剂量碳酸钙对照组、卵巢切除+实施例1低剂量组、卵巢切除+实施例1中剂量组、卵巢切除+实施例1高剂量组、卵巢切除+对比例1中剂量组。据人体口服推荐量,设本发明中药保健食品胶囊低、中、高剂量分别为0.183g/kg·bw、0.367g/kg·bw、1.100g/kg·bw(分别相当于人体推荐剂量的5、10、30倍),样品配制时,低、中、高剂量分别取本发明中药保健食品胶囊内容物1.83g、3.678、11.00g加去离子水至100ml,假手术组和模型组给予等体积的去离子水,卵巢切除+高剂量碳酸钙对照组经口给予0.550g/kg·bw的碳酸钙(相当于样品高剂量组钙含量),分别给予受试动物灌胃,每天灌胃一次,灌胃体积为1.0ml/100g·bw。自试验开始,各组动物均单笼饲养,喂饲以上配方的饲料,灌胃给予各自的受试液,饮用去离子水,共90天。
1.5.3动物生长发育指标:每周称量体重。
1.5.4股骨骨密度测定:实验结束时,颈椎脱臼处死大鼠,剥离右股骨,烘烤至恒重,测量股骨中点处和远心端的骨密度(BMD)。
1.5.5骨钙含量的测定:称量股骨的总重量后,用化学法测定骨钙含量。
1.7结果判定
不以补钙为主的产品,模型组骨钙含量或骨密度显著低于假手术组,表明造成大鼠骨密度低于模型;卵巢切除+受试物组的骨钙含量或骨密度显著增加,且不低于相应剂量的CaCO3对照组,而其他指标(体重除外)不显著低于模型组,可判定该受试物具有增加骨密度功能作用。
2结果
2.1本发明中药保健食品胶囊对大鼠体重的影响,结果见表1。假手术组大鼠的末期体重及体重增重低于模型组,差异有显著性。
表1对大鼠体重的影响
续表1
*表示与假手术组比较P<0.05,#表示与模型组比较P<0.05
2.2本发明中药保健食品胶囊对大鼠股骨长度和骨密度的影响,结果见表2。假手术组、中、高剂量组大鼠股骨中心骨密度及远心端骨密度高于模型组,差异有显著性。
表2对大鼠股骨长度和骨密度的影响
*表示与假手术组比较P<0.05,#表示与模型组比较P<0.05。
2.3本发明中药保健食品胶囊对大鼠股骨重量和钙含量的影响,结果见表3。各组大鼠的股骨重量差异无显著性(P>0.05);假手术组、样品高剂量组骨钙含量高于模型组,差异有显著性(P<0.05)。
表3对大鼠股骨重量、骨钙含量的影响
*表示与假手术组比较P<0.05,#表示与模型组比较P<0.05。
3.小结
本实验室条件下,本发明中药保健食品胶囊给雌性去势SD大鼠灌胃90天,假手术组大鼠的末期体重及体重增重低于模型组,差异有显著性;假手术组大鼠股骨中心骨密度及远心端骨密度、骨钙含量显著高于模型组,表明大鼠骨密度低下模型造模成功;中剂量和高剂量组大鼠的股骨中心骨密度及远心端骨密度、骨钙含量显著高于模型组,结果显示该中药保健胶囊具有增加大鼠骨密度作用;与碳酸钙对照组对比,实施例所有剂量组在效果上均更优;与对比例1相比,在相同为中剂量给药的情况下,实施例效果更优,说明超临界CO2萃取法得到的提取物中,保留了更多易于增加骨密度的有效成分。
实施例6
考察本发明保健食品改善尿频的临床疗效,对本发明实施例1-3和对比例1制备的保健食品的疗效进行临床观察,每组20例。
1.病例选择
征集年龄40-70岁的尿频患者80例,随机分成4组,每组20人。
2.治疗用药
每天1粒,15天为一个疗程。
3.诊断标准
显效:用药3天内遗尿或尿频减轻,5天内明显减轻。
有效:用药5天内遗尿或尿频减轻,7天内明显减轻。
无效:用药7天内遗尿或尿频无明显减轻。
总有效率=(显效例数+有效例数)/总例数×100%。
4.测定结果,结果见表4
表4患者疗效结果
组别 | 人数 | 显效 | 有效 | 无效 | 总有效率 |
实施例1 | 20 | 1 | 16 | 3 | 80% |
实施例2 | 20 | 0 | 15 | 5 | 75% |
实施例3 | 20 | 1 | 16 | 3 | 80% |
对比例1 | 20 | 0 | 12 | 8 | 60% |
由上表4可知,本发明保健食品对尿频有显著的疗效,有效率均在75%以上,好于对比例1,即本发明杜仲提取物、骨碎补提取物、补骨脂提取物采用超临界CO2萃取法要好于醇提法,说明超临界CO2萃取法得到的提取物中,保留了更多易于改善尿频的有效成分。
实施例7
典型病例
1.李某,男,61岁,主诉:腰痛20余年,时轻时重,近一个月病情加重。腰痛难忍,并向双胯及下肢麻木疼痛,不能久站久坐及正常行走活动,腰腿怕冷明显,右腿明显,睡眠欠佳,饮食一般,小便基本正常,大便正常。曾服中西药及针灸治疗,当停止治疗时病情又复发。故来求治。舌质淡紫苔白,脉弦紧。腰椎X光片显示:腰椎生理曲度变直,椎间隙变窄。诊断为:腰椎骨质疏松症。
服用实施例1制备的中药保健品胶囊,一个疗程后症状减轻,继续服用一个疗程后症状部消失,停药观察至今已经一年多病情没有复发,为治愈。
2.任某,女,60岁,主诉:患者间断腰背疼痛,休息后缓解,左上肢尺骨及右上肢腕骨各骨折一次,由当地医院骨科处理,平时服用碳酸钙D3 1片/天,长期服用止痛药治疗(具体不详),一月前腰背痛加重;查骨密度L1-4椎体T值-2.8SD,BMD726mg/cm2,股骨颈T值-2.3SD,BMD725mg/cm2,实验检查:PTH90pg/mL,25OHD 12.8mmol/L,钙2.07mmol/L,骨钙素22.1ug/L,患者自述平日有肢体麻木,急躁易怒,咽干口燥,盗汗,膝软,舌红苔黄,脉细数。
服用实施例1制备的中药保健品胶囊,一个疗程后症状减轻,继续服用一个疗程后症状部消失,半年后复查,查骨密度L1-4椎体T值-2.6SD,BMD713mg/cm2,股骨颈T值-2.1SD,BMD710mg/cm2,实验检查:PTH65pg/mL,25OHD 30.8mmol/L,钙2.11mmol/L,骨钙素18.1ug/L,患者有腰背疼痛减轻,膝软、肢体麻木也有好转,偶有盗汗、咽干口燥,舌淡红苔薄黄,脉小数。停服阿尔法骨化醇,继续服碳酸钙D3和中药汤剂;随访一年,患者活动时腰背疼痛偶有疼痛。
3.林某,女,56岁,退休,主诉:间断双膝、双足痛5年,曾患慢性胰腺炎,慢性腹泻3年,无不良嗜好,生活习惯良好,绝经7年,有右踝骨骨折外伤史,因半月前双膝疼痛加重。患者自述平日有肢体麻木,急躁易怒,咽干口燥,盗汗,膝软,舌红苔黄,脉细数。平日食后腹胀,稍进油腻食物则腹泻,纳差,面色萎黄,少动懒言,腰膝酸软,舌淡胖,脉濡。
服用实施例1制备的中药保健品胶囊,一个疗程后症状减轻,继续服用一个疗程后症状部消失,半年后复查,患者双膝疼痛减轻,双足痛无,胃口变好,偶有腹泻。
Claims (9)
1.一种增加骨密度的中药保健食品,其特征在于,包括如下重量份数的原料:碳酸钙20~35份、杜仲提取物5~15份、骨碎补提取物5~15份、补骨脂提取物3~10份、淫羊霍提取物3~10份。
2.如权利要求1所述的一种增加骨密度的中药保健食品,其特征在于,包括如下重量份数原料:碳酸钙20~30份、杜仲提取物5~10份、骨碎补提取物5~10份、补骨脂提取物3~8份、淫羊霍提取物3~8份。
3.如权利要求1所述的一种增加骨密度的中药保健食品,其特征在于,
所述杜仲提取物、骨碎补提取物、补骨脂提取物的制备方法,采用超临界萃取法,包括如下步骤:取盐炙杜仲、砂炒骨碎补、盐制补骨脂,粉碎,分别与85-95%乙醇夹带剂混合成悬浮物,泵入超临界萃取釜中,采用CO2为超临界溶剂,萃取温度为15~65℃,萃取压力为8~10MPa,萃取时间为4~12小时,得到的萃取物先经减压干燥,然后粉碎成细粉,得各中药提取物;
所述淫羊藿提取物的制备方法,包括如下步骤:羊脂炙淫羊藿粉碎,再采用60%~75%食用酒精回流提取两次,每次加6~10倍重量的食用酒精,每次提取1h~2h,然后滤过、浓缩、喷雾干燥、包装,得淫羊藿提取物;
所述杜仲提取物、骨碎补提取物、补骨脂提取物和淫羊霍提取物的水分≤5%。
4.如权利要求3所述的一种增加骨密度的中药保健食品,其特征在于,所述杜仲提取物、骨碎补提取物、补骨脂提取物制备时,过滤离心转速为17000rpm/min~19000rpm/min。
5.如权利要求1所述的一种增加骨密度的中药保健食品,其特征在于,所述淫羊霍提取物制备时,喷雾干燥的进口温度为180℃~200℃,出口温度为80℃~90℃。
6.一种如权利要求1所述的增加骨密度的中药保健食品的制备方法,包括以下步骤:
S1、按配方量称取杜仲提取物、骨碎补提取物、补骨脂提取物、淫羊霍提取物、碳酸钙过60目筛,置于混合机内;
S2、按配方量称取辅料过100目筛,置于混合机内,与步骤S1原料混合20~40min,制成总混料;
S3、将步骤S2中的总混料进行装囊、抛光、包装,得胶囊。
7.如权利要求6所述的一种增加骨密度的中药保健食品的制备方法,其特征在于,所述步骤S2中的辅料为硬脂酸镁,加入的份数为0.3~0.6份。
8.如权利要求6所述的一种增加骨密度的中药保健食品的制备方法,其特征在于,所述步骤S1以后还可以制备成片剂、丸剂、颗粒剂。
9.如权利要求1-5任意一项所述的一种增加骨密度的中药保健食品,其特征在于,所述中药保健食品适用于中老年人用于增加骨密度、缓解骨痛和改善尿频的保健作用。
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