CN109010609A - 一种含金线莲苷的金线莲提取物的制备方法及提取物之应用 - Google Patents
一种含金线莲苷的金线莲提取物的制备方法及提取物之应用 Download PDFInfo
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- CN109010609A CN109010609A CN201811161400.5A CN201811161400A CN109010609A CN 109010609 A CN109010609 A CN 109010609A CN 201811161400 A CN201811161400 A CN 201811161400A CN 109010609 A CN109010609 A CN 109010609A
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- Prior art keywords
- terminal bud
- roxburgh anoectochilus
- anoectochilus terminal
- anoectochilus
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
本发明提供了一种含金线莲苷的金线莲提取物的制备方法,所述的金线莲提取物包括金线莲提取液、金线莲稠膏、金线莲干膏、金线莲干膏粉,该制备方法包括药材醇提、水提、减压浓缩、干燥,粉碎等工序。本发明方法能使有效成分金线莲苷的转移率较传统水提工艺提高50%以上,显著提高了名贵药材金线莲的利用率,工艺可操作性好,重复性好,设备要求低,适用于工业化生产。本发明方法制备的金线莲提取物能用于制备保健食品,成品服用携带方便,质量稳定,对化学性肝损伤辅助保护作用、辅助降血脂、辅助降血糖功效显著。
Description
技术领域
本发明属于医药技术领域,涉及植物药提取物及提取方法,具体涉及金线莲提取物的制备方法及其提取物之应用。
背景技术
金线莲为兰科开唇兰属植物花叶开唇兰(Anoectochilus roxburghii(Wall.)Lindl.)的多年生草本植物,全草药用。本品系闽台等省的民间珍稀名贵草药,素有“药王”美称,其性平味甘;具有清热凉血、祛风利湿等功效,民间常被用于肝炎、肾炎、肺炎及小儿急惊风等症。现代药理学研究表明:本品具有保肝、抗HBV、降血脂、降血糖、抗炎、抗氧化、抗骨质疏松等药理活性。
金线莲苷为金线莲的主要活性成分,含量为12%以上(高达18%),具有保肝护肝、降血糖、降血脂和改善骨质疏松的作用。金线莲多糖具有抗氧化、降血糖、降血脂、提高免疫力等作用,含量为6%以上(高达10.2%)。
金线莲传统的服用方法为泡茶、煨汤、煎煮等方式,近年来人们对金线莲的加工技术进行了改进,CN102697748B号专利公开了一种金线莲含片及其制备方法,该方法将干燥后的金线莲粉碎过筛后直接入药,并未对有效成分进行提取,生物利用度较低;CN105106653A(一种金线莲颗粒的制备方法)、CN105288190A(一种金线莲浸膏片及其制备方法)、CN107822134A(金线莲含片及制作工艺)及CN107929543A号专利(一种金线莲浓缩粉及其制作方法)中金线莲提取方法采用热水或水蒸汽进行浸提,金线莲苷溶于水和乙醇,但由于内酯环结构和苷类结构的影响,在水环境下易分解,造成金线莲苷利用率降低。
发明内容
本发明的任务是提供一种含金线莲苷的金线莲提取物的制备方法,所述的金线莲提取物包括金线莲提取液、金线莲稠膏、金线莲干膏、金线莲干膏粉等。
本发明的另一个任务是提供含金线莲苷的金线莲提取物的应用。
本发明的又一个任务是提供一种含金线莲苷的颗粒剂、片剂的制备方法。
实现本发明的具体方案是:
本发明提供的含金线莲苷的金线莲提取液的制备方法,包括以下步骤:
(1)提取:将切成段的金线莲药材置于提取罐中,加浓度为50%~95%(v/v)乙醇回流提取1~2小时,乙醇与金线莲药材的用量比(v/w)为12~20:1;滤过,收集滤液,滤渣加水煎煮提取1~2次,每次1~2小时,滤过,水与金线莲药材的用量比(v/w)为10~15:1;
(2)将乙醇回流提取滤液与水煎煮提取滤液合并,得到含金线莲苷的金线莲提取液。
本发明提供的含金线莲苷的金线莲稠膏的制备方法,包括以下步骤:
(1)提取:将切成段的金线莲药材置于提取罐中,加浓度为50%~95%(v/v)乙醇回流提取1~2小时,乙醇与金线莲药材的用量比(v/w)为12~20:1;滤过,收集滤液,滤渣加水煎煮提取2次,每次1~2小时,滤过,水与金线莲药材的用量比(v/w)为10~15:1;
(2)将乙醇回流提取滤液与第一次水煎煮提取滤液合并,得到合并的金线莲提取液;将第2次水煎煮提取滤液单独收集,得到第2次水煎煮金线莲提取液;
(3)浓缩:将步骤(1)得到的合并的金线莲提取液和第2次水煎煮金线莲提取液分别进行减压加热浓缩,回收乙醇,滤液浓缩至50℃条件下相对密度为1.25-1.30的稠膏,然后合并稠膏。
本发明提供的含金线莲苷的金线莲干膏的制备方法,其特征在于,按照权利要求2所述的方法制备含金线莲苷的金线莲提取液稠膏,然后将合并后的稠膏于55~65℃下减压干燥得干膏。
本发明提供的含金线莲苷的金线莲干膏粉的制备方法,其特征在于,按照权利要求3所述的方法制备含金线莲苷的金线莲提取液干膏,然后将得到的干膏粉碎,过80目筛,得干膏粉。
本发明提供的含金线莲苷的颗粒剂的制备方法,包括以下步骤:
步骤一、辅料前处理:将填充剂80℃干燥2~6h,过100目筛,按处方量称取,备用;
步骤二、制软材:将填充剂置入制粒机中,加入按照权利要求4所述方法制备的含金线莲苷的金线莲干膏粉,充分混匀后,喷入润湿剂,充分混匀,过14~24目筛制粒;所述填充剂重量与金线莲干膏粉重量(按生药材计)之比为3:5-2:1;所述的填充剂可以为乳糖、蔗糖、甘露醇、山梨醇或麦芽糖醇;所述的润湿剂为80%-90%乙醇;
步骤三、干燥整粒:干燥,过10目筛除去粗颗粒,过50目筛除去细粉,得到初制颗粒剂;所述的干燥为采用沸腾干燥或干燥箱干燥,温度为40~60℃,干燥至颗粒水份为2.0%~5.0%。
步骤四、总混:将润滑剂加入步骤三得到的初制颗粒剂中,充分混匀,即制得含金线莲苷的颗粒剂。所述的润滑剂可以是硬脂酸镁、滑石粉、聚乙二醇或二氧化硅。在该步骤四中,还可同时加入甜味剂和/或芳香剂,所述的甜味剂可以是阿司巴甜、甜菊甙或三氯蔗糖;所述的芳香剂可以选用天然水果香精。
本发明提供的含金线莲苷的片剂的制备方法,包括以下步骤:
(a)辅料前处理:将填充剂80℃干燥2~6h,过100目筛,按处方量称取,备用;
(b)制粒:将填充剂、按照权利要求4所述方法制备的含金线莲苷的金线莲干膏粉置入制粒机中,充分混匀后,喷入润湿剂,干燥,过20~30目筛整粒;
(c)总混:将润滑剂加入干颗粒中,充分混匀;
(d)压片:按标示片重压片,压力控制为7~12kgf;
(e)包衣:包薄膜衣,包衣增重至2%~4%。
所述的填充剂为乳糖、蔗糖、甘露醇、山梨醇、麦芽糖醇、淀粉、麦芽糊精、糊精或微晶纤维素;润湿剂为80%-90%乙醇;润滑剂为硬脂酸镁、滑石粉、聚乙二醇或二氧化硅。按金线莲生药材计的金线莲干膏粉用量和填充剂的用量为:以重量计,金线莲干膏粉(按生药材计)10份~20重量份,填充剂6份~12重量份。制粒方法采用一步制粒机制粒或高效湿法制粒。
本发明提供了一种含金线莲苷的金线莲提取物的制备方法,所述的金线莲提取物包括金线莲提取液、金线莲稠膏、金线莲干膏、金线莲干膏粉,该制备方法包括药材醇提、水提、减压浓缩、干燥,粉碎等工序。本发明方法能使有效成分金线莲苷的转移率较传统水提工艺提高50%以上,显著提高了名贵药材金线莲的利用率,工艺可操作性好,重复性好,设备要求低,适用于工业化生产。本发明所采用醇提后水提的方法有效成分金线莲苷、多糖的转移率最佳,金线莲苷转移率可达70%以上。按本发明方法制备的含金线莲苷的片剂和颗粒剂,通过对急性酒精性肝损伤保护作用的评价,发现能明显降低小鼠急性酒精性肝损伤肝匀浆中MDA、TG,明显增加肝匀浆中GSH,减轻急性酒精性肝损伤小鼠肝组织病理改变,可以作为化学性肝损伤的辅助保护作用的保健食品和药品应用。本发明方法制备含金线莲苷的金线莲提取物用于制备保健食品,可以克服现有金线莲制剂中有效成分金线莲苷的转移率低的问题,剂型选择可以为颗粒剂或片剂,剂量准确,服用携带方便,质量稳定。本发明方法制备得到的含金线莲苷的金线莲提取液、含金线莲苷的金线莲稠膏、含金线莲苷的金线莲干膏、含金线莲苷的金线莲干膏粉可用于制备保健品和药物,本发明方法制备的金线莲提取物能用于制备保健食品,成品服用携带方便,质量稳定,对化学性肝损伤辅助保护作用、辅助降血脂、辅助降血糖功效显著。
附图说明
图1:急性酒精性肝损伤模型肝脏切片(油红O染色),其中:
图1(A)为正常组;
图1(B)为模型组;
图1(C)为阳性药组;
图1(D)为含金线莲苷的片;
图1(E)为含金线莲苷的颗粒。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白,以下结合附图及实施例,对本发明进行进一步详细说明。应当理解,此处所描述的具体实施例仅仅用以解释本发明,并不用于限定本发明。此外,下面所描述的本发明各个实施方式中所涉及到的技术特征只要彼此之间未构成冲突就可以相互组合。
实施例1:金线莲干膏粉的制备方法及转移率
A、取金线莲净制后,加12倍50%乙醇回流提取1.5h,收集滤液,滤渣加10倍水煎煮提取2次,每次1.5h,同法滤过。第一次第二次滤液合并,第三次滤液单独收集。将金线莲提取液减压加热浓缩,回收乙醇,滤液浓缩至相对密度1.25(50℃)的稠膏,合并。55℃下减压干燥,得干膏。粉碎,过80目筛,得干膏粉。
B、取金线莲净制后,加15倍70%乙醇回流提取1小时,收集滤液,滤渣加12倍水煎煮提取2次,每次1h,同法滤过。第一次第二次滤液合并,第三次滤液单独收集。将金线莲提取液减压加热浓缩,回收乙醇,滤液浓缩至相对密度1.30(50℃)的稠膏,合并。60℃下减压干燥,得干膏。粉碎,过80目筛,得干膏粉。
C、取金线莲净制后,加20倍95%乙醇回流提取2h,收集滤液,滤渣加水煎煮提取2次,水量为15倍,每次2h,同法滤过。第一次第二次滤液合并,第三次滤液单独收集。将金线莲提取液减压加热浓缩,回收乙醇,滤液浓缩至相对密度1.28(50℃)的稠膏,合并。干燥:65℃下减压干燥,得干膏。粉碎,过80目筛,得干膏粉。
D、取金线莲净制后,加15倍水回流提取1h,收集滤液,滤渣加12倍水煎煮提取2次,每次1h,同法滤过。第一次第二次滤液合并,第三次滤液单独收集。将金线莲提取液减压加热浓缩,回收乙醇,滤液浓缩至相对密度1.30(50℃)的稠膏,合并。60℃下减压干燥,得干膏。粉碎,过80目筛,得干膏粉。转移率的影响如表1所示。
表1(醇提+水提)对转移率的影响
注:[1][2]转移率=[干膏粉含量(g/kg)×干膏粉总量(kg)]×100%/[生药材含量(%)×生药材用量(g))
转移率提高率=(现方法转移率-原方法转移率)×100%/原方法转移率
实施例2:含金线莲苷的颗粒剂制备
一种含金线莲苷的保健食品,剂型为颗粒剂,由下列重量比的成分组成:
所述的填充剂,如用于对化学性肝损伤或辅助降血脂,可用乳糖、蔗糖、甘露醇、山梨醇、麦芽糖醇,如用于辅助降血糖,可用甘露醇、山梨醇、麦芽糖醇。润湿剂为80%-90%乙醇。润滑剂可为硬脂酸镁、滑石粉、聚乙二醇、二氧化硅;甜味剂可为阿司巴甜、甜菊甙、三氯蔗糖;芳香剂为天然水果香精。
制备方法:将填充剂80℃干燥4h,过100目筛,按处方量称取,备用;将填充剂置于制粒机中,加入金线莲干膏粉,充分混匀后,喷入润湿剂,充分混匀,过14~24目筛制粒;干燥,温度控制为(50±5)℃,颗粒水份应为2.0%~5.0%,过10目筛除去粗颗粒,过50目筛除去细粉;将润滑剂、甜味剂、芳香剂加入颗粒剂中,充分混匀,装袋,即得。
应用:用于化学性肝损伤,高血脂、高血糖等疾病的预防和辅助作用。
实施例3:含金线莲苷的片剂制备
一种含金线莲苷的保健食品,剂型为片剂,由下列重量比的成分组成:
所述的填充剂,如用于对化学性肝损伤或辅助降血脂,可为乳糖、蔗糖、甘露醇、山梨醇、麦芽糖醇、淀粉、麦芽糊精、糊精、微晶纤维素,如用于辅助降血糖,可用甘露醇、山梨醇、麦芽糖醇、淀粉、麦芽糊精。润湿剂为80%-90%乙醇;润滑剂可为硬脂酸镁、滑石粉、聚乙二醇、二氧化硅等。
制备方法:将填充剂80℃干燥2~6h,过100目筛,按处方量称取,备用;制粒:将填充剂、金线莲干膏粉置入制粒机中,充分混匀后,喷入润湿剂,干燥,温度控制为(50±5)℃,过20~30目筛整粒,颗粒水份控制在2%~5%;将润滑剂加入干颗粒中,充分混匀;按标示片重压片,压力控制为7~12kgf;包薄膜衣,包衣增重至2%~4%,包装,即得。
应用:用于化学性肝损伤,高血脂、高血糖等疾病的预防和辅助作用。
实施例4:
按本发明方法制备的含金线莲苷的片剂和颗粒剂按照《保健食品检验与评价技术规范》(2003年版),进行了急性酒精性肝损伤模型进行评价:
(1)照丙二醛(MDA)测定试剂盒、还原型谷胱甘肽(GSH)、甘油三酯(TG)测定试剂盒中小鼠肝组织的测定方法进行测定,结果见表2。
表2肝匀浆检测结果表
注:*表示与模型组比较有显著差异,0.01﹤P﹤0.05,**表示与模型组比较有极显著差异,P﹤0.01。
(2)肝脏病理组织学变化及结果判定:
从肝左叶中部横切面取材,冰冻切片,油红O染色,在光学显微镜下观察肝细胞损伤程度,结果如图1。图1为急性酒精性肝损伤模型肝脏切片(油红O染色),其中:
图A:正常组;
图B:模型组;
图C:阳性药组;
图D:含金线莲苷的片;
图E:含金线莲苷的颗粒。
结果表明,肝损伤模型组肝匀浆中MDA、TG升高,还原型GSH活性降低,脂肪变性明显,与空白对照组存在显著性差异,说明本次实验建模成功。实验结果显示,阳性药、片剂组、颗粒剂组能明显降低小鼠急性酒精性肝损伤的血清TG,肝匀浆中MDA、TG,明显增加肝匀浆中GSH,减轻急性酒精性肝损伤小鼠肝组织病理改变,说明本品对小鼠急性酒精性肝损伤具有保护作用。
实验结论:金线莲提取时,我们采用醇取后水提方法,活性成分金线莲苷的转移率较传统水提工艺提高了50%,显著提高了名贵药材金线莲的利用率。含金线莲苷的片剂和颗粒剂通过对急性酒精性肝损伤保护作用的评价,发现本品能通过消除细胞内氧自由基,抑制肝细胞膜脂质过氧化,抑制脂肪在肝细胞内沉积,稳定细胞膜,从而减轻肝组织病理改变,起到肝保护作用,可以作为化学性肝损伤的辅助保护作用的保健食品进行开发应用。
本领域的技术人员容易理解,以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等,均应包含在本发明的保护范围之内。
Claims (13)
1.一种含金线莲苷的金线莲提取液的制备方法,包括以下步骤:
(1)提取:将切成段的金线莲药材置于提取罐中,加浓度为50%~95%(v/v)乙醇回流提取1~2小时,乙醇与金线莲药材的用量比(v/w)为12~20:1;滤过,收集滤液,滤渣加水煎煮提取1~2次,每次1~2小时,滤过,水与金线莲药材的用量比(v/w)为10~15:1;
(2)将乙醇回流提取滤液与水煎煮提取滤液合并,得到含金线莲苷的金线莲提取液。
2.一种含金线莲苷的金线莲稠膏的制备方法,其特征在于,
(1)提取:将切成段的金线莲药材置于提取罐中,加浓度为50%~95%(v/v)乙醇回流提取1~2小时,乙醇与金线莲药材的用量比(v/w)为12~20:1;滤过,收集滤液,滤渣加水煎煮提取2次,每次1~2小时,滤过,水与金线莲药材的用量比(v/w)为10~5:1;
(2)将乙醇回流提取滤液与第一次水煎煮提取滤液合并,得到合并的金线莲提取液;将第2次水煎煮提取滤液单独收集,得到第2次水煎煮金线莲提取液;
(3)浓缩:将步骤(1)得到的合并的金线莲提取液和第2次水煎煮金线莲提取液分别进行减压加热浓缩,回收乙醇,滤液浓缩至50℃条件下相对密度为1.25-1.30的稠膏,然后合并稠膏。
3.一种含金线莲苷的金线莲干膏的制备方法,其特征在于,按照权利要求2所述的方法制备含金线莲苷的金线莲提取液稠膏,然后将合并后的稠膏于55~65℃下减压干燥得干膏。
4.一种含金线莲苷的金线莲干膏粉的制备方法,其特征在于,按照权利要求3所述的方法制备含金线莲苷的金线莲提取液干膏,然后将得到的干膏粉碎,过80目筛,得干膏粉。
5.一种含金线莲苷的颗粒剂的制备方法,包括以下步骤:
步骤一、辅料前处理:将填充剂80℃干燥2~6h,过100目筛,按处方量称取,备用;
步骤二、制软材:将填充剂置入制粒机中,加入按照权利要求4所述方法制备的含金线莲苷的金线莲干膏粉,充分混匀后,喷入润湿剂,充分混匀,过14~24目筛制粒。
步骤三、干燥整粒:干燥,过10目筛除去粗颗粒,过50目筛除去细粉,得到初制颗粒剂;
步骤四、总混:将润滑剂加入步骤三得到的初制颗粒剂中,充分混匀,即制得含金线莲苷的颗粒剂。
6.根据权利要求5所述的含金线莲苷的颗粒剂的制备方法,其特征在于:所述填充剂重量与金线莲干膏粉重量(按生药材计)之比为3:5-2:1。
7.根据权利要求5所述的含金线莲苷的颗粒剂的制备方法,其特征在于:所述的填充剂为乳糖、蔗糖、甘露醇、山梨醇或麦芽糖醇;所述的润湿剂为80%-90%乙醇;润滑剂为硬脂酸镁、滑石粉、聚乙二醇或二氧化硅。
8.根据权利要求5所述的含金线莲苷的颗粒剂的制备方法,其特征在于:所述干燥为采用沸腾干燥或干燥箱干燥,温度为40~60℃,干燥至颗粒水份为2.0%~5.0%。
9.一种含金线莲苷的片剂的制备方法,包括以下步骤:
(a)辅料前处理:将填充剂80℃干燥2~6h,过100目筛,按处方量称取,备用;
(b)制粒:将填充剂、按照权利要求4所述方法制备的含金线莲苷的金线莲干膏粉置入制粒机中,充分混匀后,喷入润湿剂,干燥,过20~30目筛整粒;
(c)总混:将润滑剂加入干颗粒中,充分混匀;
(d)压片:按标示片重压片,压力控制为7~12kgf;
(e)包衣:包薄膜衣,包衣增重至2%~4%。
10.根据权利要求9所述的含金线莲苷的片剂的制备方法,其特征在于:所述的填充剂为乳糖、蔗糖、甘露醇、山梨醇、麦芽糖醇、淀粉、麦芽糊精、糊精或微晶纤维素;所述的润湿剂为80%-90%乙醇;所述的润滑剂为硬脂酸镁、滑石粉、聚乙二醇或二氧化硅。
11.根据权利要求9所述的含金线莲苷的片剂的制备方法,其特征在于:以重量计,金线莲干膏粉(按生药材计)10份~20重量份,填充剂6份~12重量份。
12.一种含金线莲苷的药物制剂,含有以下所述的含金线莲苷的金线莲提取物中的一种:
a.按照权利要求1所述方法制备的含金线莲苷的金线莲提取液;
b.按照权利要求2所述方法制备的含金线莲苷的金线莲稠膏;
c.按照权利要求3所述方法制备的含金线莲苷的金线莲干膏;
d.按照权利要求4所述方法制备的含金线莲苷的金线莲干膏粉。
13.权利要求12中任意一项所述方法制备的产物或权利要求12所述的药物制剂在制备用于预防和/或治疗肝损伤、高血脂或高血糖的保健食品或药物中的应用。
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