CN104491474B - 一种辅助降血糖的中药组合物及其制备方法 - Google Patents
一种辅助降血糖的中药组合物及其制备方法 Download PDFInfo
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- CN104491474B CN104491474B CN201410833146.4A CN201410833146A CN104491474B CN 104491474 B CN104491474 B CN 104491474B CN 201410833146 A CN201410833146 A CN 201410833146A CN 104491474 B CN104491474 B CN 104491474B
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Abstract
本发明公开了一种辅助降血糖的中药组合物及其制备方法。该中药组合物是由铁皮石斛、白术、罗汉果、马齿苋、余甘子、菊苣为原料制备而成的。动物药效学结果显示:在糖耐量试验以及降低空腹血糖试验中,服用本发明的小鼠的空腹血糖值降低,糖耐量试验各时点血糖曲线下面积降低,同时对小鼠的体重无明显影响。因此,本发明具有辅助降血糖功能,适于高血糖人群长期食用以辅助控制血糖。
Description
技术领域
本发明涉及医药卫生领域,具体涉及一种辅助降血糖的中药组合物及其制备方法。
背景技术
糖尿病是由多种原因引起的糖、脂肪、蛋白质代谢紊乱,以血糖增高和糖尿为特点,进而导致多系统、多脏器损害的综合征。随着生活水平的提高和生活方式的改变,高血糖和糖尿病患者人数与日俱增,已成为继恶性肿瘤、心血管疾病的第三大疾病,严重威胁着人类的健康。
近些年研究发现,很多药食同源中药降糖作用温和持久,作用机理具有多效应、多靶点、多功能的综合作用特点,在糖尿病人和高血糖人群血糖和并发症辅助控制方面具有功效确切,长期食用安全的明显优势。目前,市场上辅助降血糖的产品有辅助降血糖胶囊、辅助降血糖片、辅助降血糖袋泡茶、辅助降血糖软胶囊等保健品。这些产品多是以动植物的提取物或者辅以营养素添加剂组成。这些产品中并没有进一步详细规定该产品适用人群。因此,需要开发一种能长期使用、安全,并且能同时可起到清咽保肝、提升免疫力等辅助作用以减轻糖尿病的相关并发症,适用于血糖偏高尤其为伴有咽喉部明显不适的人群使用的产品。
发明内容
本发明的目的是提供一种辅助降血糖的中药组合物;
本发明的另一目的是提供一种辅助降血糖的中药组合物的制备方法。
本发明的目的是通过下列的技术方案实现的:
本发明所述的辅助降血糖的中药组合物,是由以下重量份的原料制备而成的:铁皮石斛6-12份、白术6-12份、罗汉果9-15份、马齿苋9-15份、余甘子3-9份、菊苣9-18份。
优选地,是由以下重量份的原料制备而成的:
铁皮石斛10份、白术7份、罗汉果12份、马齿苋10份、余甘子9份、菊苣15份。
以下是本发明的药材来源:
铁皮石斛:本品为兰科植物铁皮石斛Dendrobium officinale Kimura et Migo的干燥茎。【性味与归经】甘、微寒。归胃肾经。【功能与主治】益胃生津,滋阴清热。用于热病津伤,口干烦渴,胃阴不足,食少干呕,病后虚热不退,阴虚火旺,骨蒸劳热,目暗不明,筋骨痿软。现代药理研究表明铁皮石斛多糖具有抑制胰岛细胞凋亡和坏死、保护胰岛细胞而起到预防、治疗糖尿病的作用。
白术:本品为菊科植物白术Atractylodes macrocephala Koidz.的干燥根茎。冬季下部叶枯黄、上部叶变脆时采挖,除去泥沙,烘干或晒干,再除去根须。【性味与归经】苦、甘、温。归脾、胃经。【功能与主治】健脾益气,燥湿利水,止汗,安胎。用于脾虚食少,腹胀泻泄,痰饮眩悸,水肿,自汗,胎动不安。
罗汉果:本品为葫芦科植物罗汉果Siraitia grosvenorii(Swingle)C.Jeffreyex A.M.Lu er Z.Y.Zhang的干燥果实,秋季果实由嫩绿色变深绿色时采收,晾数天后,低温干燥。【性味与归经】甘、凉。归肺、大肠经。【功能与主治】清热润肺,利咽开音,滑肠通便。用于肺热燥咳,咽痛失音,肠燥便秘。
马齿苋:本品为马齿苋科植物马齿苋Portulaca oleracea L.的干燥地上部分。夏秋二季采收,除去残根和杂质,洗净,略蒸或烫后晒干。【性味与归经】酸、寒。归肝、大肠经。【功能与主治】清热解毒,凉血止血,止痢。用于热毒血痢,痈肿疔疮,湿疹,丹毒,蛇虫咬伤,便血,痔血,崩漏下血。
余甘子:本品为藏族习用药材。为大戟科植物余甘子Phyllanthus emblica L.的干燥成熟果实。冬季至次春果实成熟时采收,除去杂质,干燥。【性味与归经】甘、酸、涩、凉。归肺、胃经。【功能与主治】清热凉血,消食健胃,生津止渴。用于血热血瘀,消化不良,腹胀,咳嗽,喉痛,口干。
菊苣:本品为维吾尔族习用药材。为菊科植物毛菊苣Cichorium glandulosumBoiss.et Huet或菊苣Cichorium intybus L.的干燥地上部分或根。夏、秋二季采割地上部分或秋末挖根,除去泥沙和杂质,晒干。【性味与归经】微苦、咸、凉【功能与主治】清肝利胆,健胃消食,利尿消肿。用于湿热黄疸,胃痛食少,水肿尿少。
本发明的另一方面是提供了本发明中铁皮石斛超微细粉的制备方法,具体为:铁皮石斛经冷冻干燥后制备成为超微细粉。
优选地,铁皮石斛超微细粉的制备方法为:将新鲜的铁皮石斛洗净,用酒精消毒后,于-60℃~-0℃下冷冻干燥,用超微气流粉碎成超微粉。
优选地,铁皮石斛超微细粉的制备方法为:将新鲜的铁皮石斛洗净,用75%酒精消毒,于-60~-0℃下冷冻干燥30-50小时,干燥后用超微气流粉碎成超微粉。
本发明的另一方面是提供了本发明中白术、罗汉果、马齿苋、余甘子、菊苣五味中药活性成分的制备方法,该方法是采用水提或20-80%体积百分浓度的乙醇提取。具体的制备方法如下:
方案一:取白术、罗汉果、马齿苋、余甘子、菊苣,加水提取2-3次,每次加水量相当于药材总重量的6-12倍,每次提取时间为1-3小时,合并提取液,浓缩,静置24h~48h,离心,上清液浓缩至60-80℃时相对密度为1.10-1.20的清膏,干燥、粉碎,即得。
方案二:取白术、罗汉果、马齿苋、余甘子、菊苣,加水提取2-3次,每次加水量相当于药材总重量的6-12倍,每次提取时间为1-3小时,合并提取液,滤过,滤液浓缩至60-80℃时相对密度为1.05-1.10的清膏,加入乙醇,使含醇量为40-80%,冷藏12-24小时,滤过,取滤液,干燥,粉碎,即得。
方案三:取白术、罗汉果、马齿苋、余甘子、菊苣,用40-80%乙醇回流提取2-3次,每次乙醇用量为药材总量的6-10倍,提取时间为1-3小时,合并提取液,过滤,浓缩,加入提取液体积1-3倍的纯化水,冷藏12-24h,过滤,滤液浓缩成流浸膏,干燥,粉碎,即得。
本发明的另一方面还提供了一种辅助降血糖的中药组合物的活性成分制备方法,具体为:白术、罗汉果、马齿苋、余甘子、菊苣提取活性成分后与铁皮石斛超微粉混合而成。
优选地:取方案一至三中任一项所得白术、罗汉果、马齿苋、余甘子、菊苣五味中药活性成分,加入铁皮石斛超微粉混合均匀,即得。
本发明所述的辅助降血糖的中药组合物,可以与医药学上可接受的载体配合,制成各种常用制剂,如片剂、颗粒剂、胶囊剂、咀嚼片、丸剂等。
本发明的药学上可接受的载体包括但不限于以下:
稀释剂:淀粉、糖粉、乳糖、糊精、微晶纤维素、无机盐、糖醇类等。
润湿剂与粘合剂:纯化水、乙醇、明胶、聚乙二醇、纤维素衍生物等。
崩解剂:淀粉、羧甲基淀粉钠、纤维素衍生物、交联聚维酮等。
润滑剂:硬脂酸镁、微粉硅胶、滑石粉、聚乙二醇等。
助溶剂:水、乙醇、甘油、丙二醇、液状石蜡、植物油等。
矫味剂:蔗糖、单糖、芳香剂等。
防腐剂:苯甲酸、山梨酸、甲酯、乙酯、丙酯等。
方法1:颗粒剂
取方案一至三所得的活性成分,加入铁皮石斛超微粉混合均匀,加入颗粒剂常用辅料,按常规生产方法制备得本发明颗粒剂。
上述颗粒剂常用辅料包括稀释剂、润湿剂、粘合剂之一或全部。
方法2:片剂
取方案一至三所得的活性成分,加入铁皮石斛超微粉,混合均匀,加入片剂常用辅料,按常规生产方法制备得本发明片剂。
上述片剂常用辅料包括稀释剂、润湿剂、粘合剂、崩解剂、润滑剂之一或全部。
方法3:胶囊剂
取方案一至三所得的活性成分,加入铁皮石斛超微粉,混合均匀,加入胶囊剂常用辅料,按常规生产方法制备得本发明胶囊剂。
上述胶囊剂常用辅料包括稀释剂、润湿剂、粘合剂、润滑剂之一或全部。
方法4:咀嚼片
取方案一至三所得的活性成分,加入铁皮石斛超微粉,混合均匀,加入咀嚼片常用辅料,按常规生产方法制备得本发明咀嚼片。
上述咀嚼片常用辅料包括稀释剂、润湿剂、粘合剂、润滑剂之一或全部。
方法5:丸剂
取方案一至三所得的活性成分,加入铁皮石斛超微粉,混合均匀,加入丸剂常用辅料,按常规生产方法制备得本发明丸剂。
上述丸剂常用辅料包括稀释剂、润湿剂、粘合剂、润滑剂之一或全部。
方解:糖尿病在中医上属于多种因素引起的一种消渴病。根据中医基础理论下消渴之病机,主要是阴虚为本,燥热为标。其病位在肺、胃、肾三脏,在不同时期各有偏重,肺主气,为水之上源,敷布津液于全身,肺受燥热所伤,不能正常敷布津液,则津液而直趋下行,随小便排出,故小便频多;肺不敷布津液则口渴多饮,糖无以固摄而随尿漏泄,水谷精微无以濡养肌夫,可见消瘦症状。故临床可见口干、多饮、多尿等症,结合舌脉,大多数消渴病患者可辨为阴虚燥热证。本发明中主要治以清热润肺、益胃生津、益气健脾。本发明中以铁皮石斛为君,铁皮石斛益胃生津、滋阴清热;臣以白术、罗汉果养阴增液,健脾益气,清热润肺;佐以马齿苋、余甘子、菊苣以增强生津止渴、清热解毒作用;诸药共用,可达清热、润燥、养阴、健脾、益胃、生津止渴作用,从而减弱消渴病的多种症状,并且具有清咽功能。因此,本方特别适用于血糖偏高尤其为伴有咽喉部明显不适的人群。
本发明的配方中的铁皮石斛、白术是属于《可用于保健食品的物品》名单中的中药材,其余四味均为《既是食品又是药品的物品》名单中的中药材,全文药材均是安全性高、药性温和,可长期服用。
本发明提供的一种辅助降血糖的中药组合物具有以下优点:
1、本发明具有清热润肺、益胃生津、益气健脾作用,能够起到较好的起到辅助降血糖作用。在降空腹血糖实验,给予本发明样品30d的小鼠,第30d血糖值均低于模型对照组,各实施例组血糖下降百分率均大于模型对照组,且血糖下降百分率与模型对照组的差异具有显著性(P<O.05),表明该样品具有降低高血糖模型小鼠的空腹血糖的作用。
2、在糖耐量实验中,给与本发明的各剂量组各时间点的血糖曲线下面积均低于模型对照组,且高、中剂量组的血糖曲线下面积与模型对照组的差异具有显著性(分别P<0.01和P<0.05),表明该样品具有降低高血糖小鼠糖耐量试验各时点血糖曲线下面积的作用。
3、另外给予本发明的正常小鼠的血糖值与试验前比较无显著性差异(P>0.05),与空白对照组比较亦无显著性差异(P>0.05),表明该样品对正常小鼠的空腹血糖没有明显影响。
4、本发明组合物配方合理创新,生产成本低、工艺简单。
具体实施方式
下面通过实施例进一步说明本发明。应该理解的是,本发明的实施例是用于说明本发明而不是对本发明的限制。根据本发明的实质对本发明进行的简单改进都属于本发明要求保护的范围。
实施例1
取铁皮石斛10kg、白术8kg、罗汉果13kg、马齿苋11kg、余甘子7kg、菊苣9kg。将新鲜的铁皮石斛洗净,喷75%酒精消毒,置于-60℃下冷冻干燥50小时,干燥后置于超微气流粉碎机中粉碎,过筛,得到超微粉。另取白术、罗汉果、马齿苋、余甘子、菊苣,加水提取2次,每次加水量相当于药材总重量的12倍,每次提取时间为3小时,合并提取液,滤过,滤液静置24h,离心,上清液浓缩至60℃时相对密度为1.20的清膏,干燥、粉碎,得干膏粉。将干膏粉与铁皮石斛超微粉混合均匀,加入辅料淀粉、蔗糖粉、滑石粉、硬脂酸镁,制得颗粒剂。
实施例2
铁皮石斛超微粉12kg、白术12kg、罗汉果15kg、马齿苋15kg、余甘子9kg、菊苣18kg。将新鲜的铁皮石斛洗净,喷75%酒精消毒,置于-0℃下冷冻干燥30小时,干燥后置于超微气流粉碎机中粉碎,过筛,得超微粉。另取白术、罗汉果、马齿苋、余甘子、菊苣,加水提取3次,每次加水量分别相当于药材总重量的12倍、10倍、6倍,每次提取时间分别为3小时、2小时、1小时,合并提取液,滤过,滤液浓缩至80℃时相对密度为1.05的清膏,加入乙醇,使含醇量为40%,冷藏24小时,滤过,收取沉淀,干燥,粉碎过300目,即干膏粉,加入铁皮石斛超微粉混合均匀,再加入辅料微晶纤维素、羟丙基纤维素、羧甲基淀粉钠、滑石粉、硬脂酸镁制成片剂。
实施例3
铁皮石斛6kg、白术6kg、罗汉果9kg、马齿苋9kg、余甘子3kg、菊苣9kg。将新鲜的铁皮石斛洗净,喷75%酒精消毒,置于-40℃下冷冻干燥50小时,干燥后,置于超微气流粉碎机中粉碎,过筛,得超微粉。另取白术、罗汉果、马齿苋、余甘子、菊苣,加水提取2次,每次加水量相当于药材总重量的12倍,每次提取时间为1小时,合并提取液,滤过,滤液浓缩至60℃时相对密度为1.20的清膏,加入乙醇,使含醇量为50%,冷藏12小时,滤过,收取沉淀,干燥,粉碎过300目,即得干膏粉,加入铁皮石斛超微粉混合均匀,再加入辅料微晶纤维素、羟丙基纤维素、滑石粉、硬脂酸镁制成胶囊剂。
实施例4
铁皮石斛6kg、白术12kg、罗汉果15kg、马齿苋15kg、余甘子9kg、菊苣9kg。将新鲜的铁皮石斛洗净,喷75%酒精消毒,置于-30℃下冷冻干燥40小时,干燥后,置于超微气流粉碎机中粉碎,过筛,得超微粉。另取白术、罗汉果、马齿苋、余甘子、菊苣,用40%乙醇回流提取3次,每次乙醇用量分别为药材总量10倍、8倍、6倍,提取时间分别为3小时、2小时、1小时,合并提取液,过滤,浓缩,加入提取液体积1倍的纯化水,冷藏24h,过滤,滤液浓缩成流浸膏,干燥,粉碎,即得,得干浸膏,加入铁皮石斛超微粉混合均匀,再加入辅料木糖醇、甘露醇、硬脂酸镁制成咀嚼片。
实施例5
铁皮石斛10kg、白术6kg、罗汉果9kg、马齿苋15kg、余甘子3kg、菊苣18kg。将新鲜的铁皮石斛洗净,喷75%酒精消毒,置于-20℃下冷冻干燥30个小时,干燥后,置于超微气流粉碎机中粉碎,过筛,得超微粉。另取白术、罗汉果、马齿苋、余甘子、菊苣,用80%乙醇回流提取2次,每次乙醇用量分别为药材总量10倍,提取时间为3小时,合并提取液,过滤,浓缩,加入提取液体积3倍的纯化水,冷藏12h,过滤,滤液浓缩成流浸膏,干燥,粉碎,即得,得干浸膏,加入铁皮石斛超微粉混合均匀,再加入辅料蜂蜜、蜂蜡制成丸剂。
实施例6
取铁皮石斛10kg、白术8kg、罗汉果13kg、马齿苋11kg、余甘子7kg、菊苣9kg。将新鲜的铁皮石斛洗净,喷75%酒精消毒,置于-60℃下冷冻干燥50小时,干燥后置于超微气流粉碎机中粉碎,过筛,得到超微粉。另取白术、罗汉果、马齿苋、余甘子、菊苣,加水提取2次,每次加水量相当于药材总重量的12倍、10倍、6倍,每次提取时间分别为为3小时、2小时、1小时,合并提取液,浓缩,静置24h,离心,上清液浓缩至60℃时相对密度为1.20的清膏,干燥、粉碎,得干膏粉。将干膏粉与铁皮石斛超微粉混合均匀,加入辅料淀粉、蔗糖粉、滑石粉、硬脂酸镁,制得颗粒剂。
实施例7
称取铁皮石斛10kg、白术8kg、罗汉果13kg、马齿苋11kg、余甘子7kg、菊苣9kg。将全部原料洗净,粉碎,过筛,即得粉剂。
药效学试验:
1实验材料
1.1动物
健康SPF级昆明种成年雄性小鼠256只,体重26±2g,购买自广西医科大学实验动物中心(生产许可证号:SCXK桂2009-0002)。
1.2受试样品与试剂
本发明实施例1-6、血糖试纸
2实验分组及给药方法
分别为空白组、模型组、治疗组。
空白组和模型组:给予纯水;
治疗组:分别给予实施例1-6制备的药品,给药量按药材生药量3.87g/kg计,每天灌胃1次。
给药方法:每天灌胃1次,连续30d。
3实验方法
3.1造模
小鼠禁食24h后给予四氧嘧啶(120mg/kg BW)1次腹腔注射造模。5d后禁食4h,眼内眦取血测血糖,若血糖值为lO~25mmol/L,则可认为造高血糖模型成功。选取186只小鼠进行造模,结果其中造模成功147只。选用造模成功的小鼠140只纳入试验,将小鼠分为2批,第一批70只进行降低空腹血糖试验,第二批70只进行糖耐量试验。
3.2降低空腹血糖试验:第一批高血糖模型动物,按禁食4h血糖水平进行分层随机分成7组,每组10只。治疗组给予实施例1-6样品溶液,模型对照组给纯水,连续30d,采血测空腹血糖值(禁食同试验前),比较各组动物空腹血糖值及血糖下降百分率。血糖下降百分率=(实验前血糖值-实验后血糖值)/实验前血糖值×100%。
在模型成立条件下,如治疗组空腹血糖实测值比模型对照组降低或血糖下降百分率有统计学意义,可判定该项试验结果为阳性。
3.3正常动物:选健康成年动物70只,按禁食4h血糖水平分组,随机分成空白对照组和受试治疗组,每组10只。其余操作同3.2。
3.4糖耐量试验:第二批高血糖模型小鼠70只,按禁食4h血糖水平进行分层随机分成7组,每组10只,灌胃方式同3.2。第31天将小鼠禁食4h,治疗组给予实施例1-6样品溶液,模型对照组给予等体积纯水。15min后,各组经口灌胃给予葡萄糖(2.0g/kg BW)溶液。测定给葡萄糖后0、0.5、2h血糖值,观察模型对照组与受试治疗组给葡萄糖后各时间点血糖曲线下面积的变化。
血糖曲线下面积=0.25×(Oh血糖值+4×0.5h血糖值+3×2h血糖值)
在模型成立条件下,如治疗组在给葡萄糖后0、0.5、2h血糖曲线下面积比模型对照组低并有统计学意义,即可判定该项试验结果为阳性。
3.5试验数据处理采用SPSS1l.0统计软件进行方差分析统计处理。
3.6结果判定在模型成立条件下,空腹血糖和糖耐量二项指标中有一项指标阳性,且对正常动物空腹血糖无影响,即可判定该受试样品辅助降血糖功能动物实验结果阳性。
4实验结果:样品对高血糖模型小鼠血糖的影响结果见表1、表2、表3。
表1高血糖模型小鼠的空腹血糖结果
注:与模型对照组比较,*P<0.05,#P<0.05
从表1可见,造模后4h禁食后血糖值>10mmol/L,造模成功。经口给予本发明实施例1-6样品30d的小鼠,第30d血糖值均低于模型对照组,各实施例组血糖下降百分率均大于模型对照组,且血糖下降百分率与模型对照组的差异具有显著性(P<O.05),表明该样品具有降低高血糖模型小鼠的空腹血糖的作用。
表2高血糖模型小鼠糖耐量实验结果
注:与模型对照组比较,*P<0.05
从表2结果可知,经口给予高血糖模型小鼠实施1-6的样品30d后,实施例各组各时间点的血糖曲线下面积均低于模型对照组,且血糖曲线下面积与模型对照组的差异具有显著性(P<O.05),表明实施例1-6的样品具有降低高血糖小鼠糖耐量试验各时点血糖曲线下面积的作用。
表3正常小鼠空腹血糖结果
注:与空白对照组比较,△P>0.05,实验前后比较,P>0.05
表3结果显示,经口给予正常小鼠实施例1-6样品30d,小鼠的血糖值与试验前比较无显著性差异(P>0.05),与空白对照组比较亦无显著性差异(P>0.05),表明该样品对正常小鼠的空腹血糖没有明显影响。
结论:本研究表明,本发明能降低小鼠的空腹血糖值,降低小鼠的糖耐量试验各时点血糖曲线下面积,对小鼠的体重无明显影响;实施例1-6的样品给正常小鼠连续灌胃30d,对小鼠的空腹血糖值和体重无明显影响。因此,该产品安全无毒,具有辅助降血糖功能,适于高血糖人群长期食用以辅助控制血糖。
虽然,上文中已经用一般性说明、具体实施方式及试验,对本发明作了详尽的描述,但在本发明基础上,可以对之作一些修改或改进,这对本领域技术人员而言是显而易见的。因此,在不偏离本发明精神的基础上所做的这些修改或改进,均属于本发明要求保护的范围。
Claims (9)
1.一种辅助降血糖的中药组合物,其特征在于它是由如下重量份的原料制备而成的:铁皮石斛10份、白术7份、罗汉果12份、马齿苋 10份、余甘子9份、菊苣15份。
2.如权利要求1所述的中药组合物,其特征在于铁皮石斛经冷冻干燥后制备成为超微细粉。
3.如权利要求2所述的中药组合物,其特征在于将新鲜的铁皮石斛洗净,用酒精消毒后,于-60℃~-0℃下冷冻干燥,用超微气流粉碎成超微粉。
4.如权利要求2所述的组合物,其特征在于将新鲜的铁皮石斛洗净,用75%酒精消毒,于-60~-0℃下冷冻干燥30-50h,干燥后用超微气流粉碎成超微粉。
5.如权利要求2所述的中药组合物,其特征在于白术、罗汉果、马齿苋、余甘子、菊苣的活性成分是采用水提或20-80%体积百分浓度的乙醇提取制备而成的。
6.如权利要求5所述的中药组合物,其特征在于白术、罗汉果、马齿苋、余甘子、菊苣的活性成分是通过以下方法制备而成的:取白术、罗汉果、马齿苋、余甘子、菊苣,加水提取2-3次,每次加水量相当于药材总重量的6-12倍,每 次提取时间为1-3小时,合并提取液,浓缩,静置24h~48h,离心,上清液浓缩 至60-80℃时相对密度为1.10-1.20的清膏,干燥、粉碎,即得。
7.如权利要求5所述的中药组合物,其特征在于白术、罗汉果、马齿苋、余甘子、菊苣的活性成分是通过以下方法制备而成的:取白术、罗汉果、马齿苋、余甘子、菊苣,加水提取2-3次,每次加水量相当于药材总重量的6-12倍,每次提取时间为1-3小时,合并提取液,滤过,滤液浓缩至60-80℃时相对密度为 1.05-1.10的清膏,加入乙醇,使含醇量为40-80%,冷藏12-24小时,滤过,取滤液,干燥,粉碎,即得。
8.如权利要求5所述的中药组合物,其特征在于白术、罗汉果、马齿苋、余甘子、菊苣的活性成分是通过以下方法制备而成的:取白术、罗汉果、马齿苋、余甘子、菊苣,用40-80%乙醇回流提取2-3次,每次乙醇用量为药材总量的6-10倍,提取时间为1-3小时,合并提取液,过滤,浓缩,加入提取液体积1-3倍的纯化水,冷藏12-24h,过滤,滤液浓缩成流浸膏,干燥,粉碎,即得。
9.一种辅助降血糖的中药组合物,由权利要求2所述的辅助降血糖的中药组合物与医药行业上可接受的载体配合制备而成。
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Non-Patent Citations (1)
Title |
---|
单味降糖中草药与消渴病辨证用药;孙永宁等;《现代中医药》(第06期);13-14 * |
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