CN106309705A - 一种降糖降脂的黄连地黄组合物及其检测方法 - Google Patents
一种降糖降脂的黄连地黄组合物及其检测方法 Download PDFInfo
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Classifications
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
- A61K36/718—Coptis (goldthread)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/80—Scrophulariaceae (Figwort family)
- A61K36/804—Rehmannia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
Abstract
本发明提供一种降糖、或、降脂的黄连地黄组合物,生地黄和黄连的质量比是:1∶1‑8∶1。
Description
技术领域
本发明涉及一种降糖降脂的黄连地黄组合物及其检测方法,属于中药领域。
背景技术
黄连《神农本草经》:“味苦,寒。主治热气,目痛,眦伤,泣出,明目,肠澼,腹痛,下痢,妇人阴中肿痛。久服令人不忘”。《名医别录》:“微寒,无毒。主治五藏冷热,久下泄澼、脓血,止消渴、大惊,除水,利骨,调胃,厚肠,益胆,治口疮”。《本草拾遗》:“主羸瘦气急”。《药性论》:“恶白僵蚕,忌猪肉,恶冷水。杀小儿疳虫,点赤眼昏痛,镇肝,去热毒”。现代药理研究黄连药理作用有抗溃疡、抑制胃酸分泌、保护胃粘膜、抗炎镇痛、抑菌。广泛用于湿热痞满,呕吐,泻痢,黄疸,高热神昏,心火亢盛,心烦不寐,血热吐衄,目赤吞酸,牙痛,消渴,痈肿疔疮;外治湿疹,湿疮,耳道流脓。
黄连为毛茛科植物黄连Coptischinensis Franch.、三角叶黄连CoptisdeltoideaC.Y.Cheng et Hsiao.或云连Coptis teeta wall.的干燥根茎,味苦性寒,主要含有小檗碱等生物碱类成分,黄连及其主要成分小檗碱治疗糖尿病及其并发症、血脂异常等的药理活性。但是,给大鼠连续灌胃较大剂量的黄连水煎剂10天后,对大鼠胃肠激素胃动素、胃泌素等均有明显影响,可导致胃粘膜PGE2水平下降、氧自由基体系代谢活跃,胃黏膜脂质过氧化产物堆积,进而导致大鼠胃肠功能紊乱甚至死亡;临床应用时也常有黄连及小檗碱制剂的不良反应报道。可见,黄连或小檗碱虽然药效作用明显,但,单独用药安全剂量范围窄,安全性不佳,在临床前研究和临床使用中均存在一定的风险,就有必要进行中药复方配伍来提高黄连临床使用的安全性。
黄连地黄的复方组合始载于孙思邈《备急千金药方》之黄连丸,该方用黄连一斤,生地黄一斤,为末,绞生地取汁,渍黄连,出,晒之燥,复纳之。但是,由于“绞生地取汁”的具体用量不清楚,“渍黄连,出,晒之燥,复纳之”的具体工艺不清楚,由于本领域技术人员不能通过常规的用量选择、工艺优选来加以确定,不能简单通过常规方法来提高黄连临床使用的安全性,黄连地黄的组合药物依然处于空白状态,无法开发出临床上使用方便、安全有效的药物制剂。
发明内容
本发明的目的是提供一种降糖、或、降脂的黄连地黄组合物,以及该黄连地黄组合物的制备方法和检测方法。
本发明的目的是提供一种降糖、或、降脂的黄连地黄组合物,生地黄和黄连的质量比是:1∶1-8∶1。
本发明的目的是提供一种降糖、或、降脂的黄连地黄组合物,生地黄和黄连的质量比是:2∶1-6∶1。
一种降糖、或、降脂的黄连地黄组合物,将生地黄和黄连混合,粉碎,过100目筛,制成散剂。
一种降糖、或、降脂的黄连地黄组合物,将生地黄和黄连混合,用5-15倍量的水煎煮1-3次,每次1-3小时,合并提取液,制成汤剂。
一种降糖、或、降脂的黄连地黄组合物,将生地黄和黄连混合,用5-15倍量的水煎煮1-3次,每次1-3小时,合并提取液,加入矫味剂适量,制成口服液。
一种降糖、或、降脂的黄连地黄组合物,将生地黄和黄连混合,用5-15倍量的水煎煮1-3次,每次1-6小时,合并提取液,适量浓缩后,浸膏真空干燥;按照浸膏10-40g,乳糖200-500g,微粉硅胶10-30g,羧甲基淀粉钠10-40g,可溶性淀粉50-200g,硬脂酸镁1-3g,混合均匀,制成片剂。
一种降糖、或、降脂的黄连地黄组合物,取黄连适量,洗净,粉碎并过筛,得黄连粉末;取新鲜的生地黄适量,洗净,加水1-10倍量浸泡1-6小时,混合打浆,过滤;用适量黄连粉末吸收适量生地黄汁;在35-40摄氏度加热1-6小时,真空干燥,既得。
一种降糖、或、降脂的黄连地黄组合物,取黄连适量,洗净,粉碎并过筛,得黄连粉末;取新鲜的生地黄适量,洗净,加水1-10倍量浸泡1-6小时,混合打浆,过滤,得生地黄汁;用适量黄连粉末吸收适量生地黄汁;在35-40摄氏度加热1-6小时,真空干燥,既得。
一种降糖、或、降脂的黄连地黄组合物,取黄连适量,洗净,粉碎并过筛,得黄连粉末;取新鲜的生地黄适量,洗净,加水1-10倍量浸泡1-6小时,混合打浆,过滤,得生地黄汁;用适量黄连粉末吸收适量生地黄汁;在35-40摄氏度加热1-6小时,真空干燥,压片,既得。
一种降糖、或、降脂的黄连地黄组合物,取黄连适量,洗净,粉碎并过筛,得黄连粉末;取新鲜的生地黄适量,洗净,加水1-10倍量浸泡1-6小时,混合打浆,过滤,得生地黄汁;用适量黄连粉末吸收适量生地黄汁;在35-40摄氏度加热1-6小时,真空干燥,按照干燥物10-40g,乳糖200-500g,微粉硅胶10-30g,羧甲基淀粉钠10-40g,可溶性淀粉50-200g,硬脂酸镁1-3g,混合均匀,制成片剂。
一种降糖、或、降脂的黄连地黄组合物,取黄连适量,洗净,粉碎并过筛,得黄连粉末;取新鲜的生地黄适量,洗净,粉碎,加水1-10倍量浸泡1-3小时,混合打浆,过滤,得生地黄汁;用适量黄连粉末吸收适量生地黄汁;在35-40摄氏度加热1-6小时,真空干燥,既得。
一种降糖、或、降脂的黄连地黄组合物,取黄连适量,洗净,粉碎并过筛,得黄连粉末;取新鲜的生地黄适量,洗净,粉碎,加水1-10倍量浸泡1-3小时,混合打浆,过滤,得生地黄汁;用适量黄连粉末吸收适量生地黄汁;在35-40摄氏度加热1-6小时,真空干燥,压片,既得。
一种降糖、或、降脂的黄连地黄组合物,取黄连适量,洗净,粉碎并过筛,得黄连粉末;取新鲜的生地黄适量,洗净,粉碎,加水1-10倍量浸泡1-3小时,混合打浆,过滤,得生地黄汁;用适量黄连粉末吸收适量生地黄汁;在35-40摄氏度加热1-6小时,真空干燥,按照干燥物10-40g,乳糖200-500g,微粉硅胶10-30g,羧甲基淀粉钠10-40g,可溶性淀粉50-200g,硬脂酸镁1-3g,混合均匀,制成片剂。
一种降糖、或、降脂的黄连地黄组合物可单一或与药学上可接受的药物载体用于制备预防或治疗代谢综合征的药物或保健品制剂。
所述的药物制剂形式可以是任何可药用的剂型,这些剂型包括:汤剂、散剂、颗粒剂、胶囊剂、丸剂、片剂、或口服液等。
本发明利用原发性高血压大鼠、高脂饲料结合链脲佐菌素诱导的II型糖尿病大鼠、果糖饲料诱导的代谢综合征大鼠、db/db小鼠、四氧嘧啶诱导的I型糖尿病小鼠、高脂饲料诱导的代谢综合征小鼠进行体内药效实验。
结果表明:本发明优选了组分用量、优选了工艺,提供的中药组合物可明显降低模型动物血清甘油三酯、胆固醇、低密度脂蛋白等水平,改善血糖和葡萄糖、胰岛素耐量,抑制高脂饮食造成的高血脂、高血糖,显示出良好的降糖降脂的药用价值。
本发明的技术方案如下:
一种黄连地黄组合物的检测方法,包括如下鉴别方法中的一种或几种:
A.黄连鉴别
取黄连地黄组合物细粉2-10g,加入乙酸乙酯10-50ml,超声提取0.5-2小时,滤过,作为供试品溶液;
取黄连药材适量,加乙酸乙酯制成每1ml含1-10mg药材的溶液,,超声提取0.5-2小时,滤过,作为对照品溶液;
分别吸取上述溶液各1-5μl,点于同一硅胶G薄层板上,以体积份数比为(3-5)∶(0.5-2)异丙醇-冰醋酸为展开剂,展开,取出,晾干,喷以重量体积比2%三氯化铁乙醇溶液,在105℃加热至斑点显色清晰;供试品色谱中,在与对照品色谱相应的位置上,显相同或类似颜色的斑点;
B.地黄鉴别
取黄连地黄组合物细粉2-10g,加入乙醇10-50ml,超声提取0.5-2小时,滤过,作为供试品溶液;
取地黄药材适量,加乙醇制成每1ml含1-10mg药材的溶液,超声提取0.5-2小时,滤过,作为对照品溶液;
分别吸取上述溶液各2-10μl,点于同一硅胶G薄层板上,以体积份数比为(1-9)∶(0.5-2)甲酸乙酯-甲酸为展开剂,展开,取出,晾干,喷以重量体积比5%的香草醛硫酸溶液,105℃加热至斑点清晰;供试品色谱中,在与对照品色谱相应的位置上,显相同或类似颜色的斑点;
本发明的鉴定方法,专属性强,进一步确保了产品质量安全、均一、有效、质量可控。
具体实施方式
下面结合实施例对本发明做进一步详细、完整的说明。
实施例1
将新鲜的生地黄、和黄连以质量比1g∶1g混合,粉碎,过100目筛,真空干燥,制成散剂。
实施例2
将新鲜的生地黄、和黄连以质量比3g∶1g混合,粉碎,过100目筛,真空干燥,制成散剂。
实施例3
将新鲜的生地黄、和黄连以质量比1g∶1g混合,粉碎,过100目筛,用10g水煎煮1次,每次3小时,合并提取液,适量浓缩后,浸膏真空干燥。
实施例4
将新鲜的生地黄、和黄连以质量比1g∶1g混合,粉碎,过100目筛,用10g水在35摄氏度浸泡1次,每次3小时,合并提取液,适量浓缩后,浸膏真空干燥。
实施例5
将新鲜的生地黄、和黄连以质量比1g∶1g混合,粉碎,过100目筛,用10g水在40摄氏度浸泡1次,每次3小时,合并提取液,适量浓缩后,浸膏真空干燥。
实施例6
将黄连1g,粉碎,过100目筛;
将新鲜的生地黄1g,粉碎,过100目筛,用10g水在35摄氏度浸泡1次,每次3小时,合并生地黄汁;
将黄连粉与生地黄汁混合,在35摄氏度浸泡1次,每次3小时,得到混合物;
混合物适量浓缩后,浸膏真空干燥。
实施例7
将黄连1g,粉碎,过100目筛;
将新鲜的生地黄1g,粉碎,过100目筛,用10g水在35摄氏度浸泡1次,每次3小时,合并生地黄汁;
将黄连粉与生地黄汁混合,在35摄氏度浸泡1次,每次3小时,得到混合物;
混合物适量浓缩后,浸膏真空干燥。
实施例8
将新鲜的生地黄和黄连以质量比1g∶1g混合,粉碎,过100目筛,用10g水煎煮1次,每次3小时,合并提取液,适量浓缩后,浸膏真空干燥;按照浸膏2g,乳糖40g,微粉硅胶2g,羧甲基淀粉钠2g,可溶性淀粉10g,硬脂酸镁0.2g,混合均匀,制成片剂。
实施例9
将新鲜的生地黄和黄连以质量比1g∶1g混合,粉碎,过100目筛,用10g水在35摄氏度浸泡1次,每次3小时,合并提取液,适量浓缩后,浸膏真空干燥;按照浸膏2g,乳糖40g,微粉硅胶2g,羧甲基淀粉钠2g,可溶性淀粉10g,硬脂酸镁0.2g,混合均匀,制成片剂。
实施例10
将生地黄和黄连以质量比1g∶1g混合,粉碎,过100目筛,用10g水在40摄氏度浸泡1次,每次3小时,合并提取液,适量浓缩后,浸膏真空干燥;按照浸膏2g,乳糖40g,微粉硅胶2g,羧甲基淀粉钠2g,可溶性淀粉10g,硬脂酸镁0.2g,混合均匀,制成片剂。
实施例11
将黄连1g,粉碎,过100目筛;
将新鲜的生地黄1g,粉碎,过100目筛,用10g水在35摄氏度浸泡1次,每次3小时,合并生地黄汁;
将黄连粉与生地黄汁混合,在35摄氏度浸泡1次,每次3小时,得到混合物;
混合物适量浓缩后,浸膏真空干燥;
按照浸膏2g,乳糖40g,微粉硅胶2g,羧甲基淀粉钠2g,可溶性淀粉10g,硬脂酸镁0.2g,混合均匀,制成片剂。
实施例12
将黄连1g,粉碎,过100目筛;
将新鲜的生地黄1g,粉碎,过100目筛,用10g水在35摄氏度浸泡1次,每次3小时,合并生地黄汁;
将黄连粉与生地黄汁混合,在35摄氏度浸泡1次,每次3小时,得到混合物;
混合物适量浓缩后,浸膏真空干燥;
按照浸膏2g,乳糖40g,微粉硅胶2g,羧甲基淀粉钠2g,可溶性淀粉10g,硬脂酸镁0.2g,混合均匀,制成片剂。
实施例13
选用(200±20)g健康雄性wistar大鼠,随机分为正常组和高脂组(88%普通饲料+10%猪油+2%胆固醇),饲喂4周后,高脂组腹腔注射链脲佐菌素35mg/kg,五天后剪尾测随机血糖,筛选血糖值超过16.7mmol/L的大鼠进入实验,并分为模型组、单用黄连组(生药用5倍量水煎煮30分钟,过滤,既得)、单用生地黄组(生药用5倍量水煎煮30分钟,过滤,既得)、给药组1-7。连续给药2周,
正常组:生理盐水;
模型组:生理盐水;
单用黄连组:每天口服灌胃8g生药/kg,1次,
单用生地黄组:每天口服灌胃8g生药/kg,1次,
给药组1-7分别给予实施例1-7的产品,给药组1-7每天口服灌胃8g生药/kg,1次,
给药结束后,测定各组大鼠血空腹血糖值。实验数据进行方差分析,结果以x±s表示。
给药结束后测定大鼠空腹血糖、血清甘油三酯和总胆固醇水平。实验数据进行方差分析,结果以x±s表示。
注:#P<0.05,##P<0.01,与正常组相比;*P<0.05,**P<0.01,***P<0.001,与模型组相比。
同时,与模型组相比,中药组合物有显著的降低体重、血压和血清甘油三酯的作用,同时对空腹血糖和血清总胆固醇也具有一定的调节作用,说明中药组合物具有良好的治疗代谢综合征的作用。
给药2周后,取其粪便。比较菌群种属水平的组成差异。
模型组相对于正常组:
拟杆菌属、脱硫弧菌属、异常球菌属的丰度显著增长;
吉氏副拟杆菌等的丰度显著增长;
螺杆菌属的丰度增加;
Alistipes、Anaerotruncus、颤杆菌属的丰度明显降低。
单用黄连组、单用生地黄组:
拟杆菌属、脱硫弧菌属、异常球菌螺杆菌属,丰度明显降低;
吉氏副拟杆菌丰度,降低;
颤杆菌属的丰度显著增加;
Alistipes的丰度显著增加;
给药组1-7组:水平恢复正常组
拟杆菌属、异常球菌属丰度降低;
螺杆菌属、Alistipes、Anaerotruncus、颤杆菌属、脱硫弧菌属、吉氏副拟杆菌的丰度水平恢复正常组。
表明该中药组合物可在提高安全性的同时增强药效,能调节肠道菌群,具有很大的药物开发潜力和临床应用价值。
实施例14
一种黄连地黄组合物的检测方法,包括如下鉴别方法中的一种或几种:
A.黄连鉴别
取实施例2的黄连地黄组合物细粉2g,加入乙酸乙酯10ml,超声提取0.5小时,滤过,作为供试品溶液;
取黄连药材适量,加乙酸乙酯制成每1ml含1mg药材的溶液,超声提取0.5小时,滤过,作为对照品溶液;
分别吸取上述溶液各1μl,点于同一硅胶G薄层板上,以体积份数比为3∶0.5异丙醇-冰醋酸为展开剂,展开,取出,晾干,喷以重量体积比2%三氯化铁乙醇溶液,在105℃加热至斑点显色清晰;供试品色谱中,在与对照品色谱相应的位置上,显相同或类似颜色的斑点;
B.地黄鉴别
取实施例2的黄连地黄组合物细粉2g,加入乙醇10ml,超声提取0.5小时,滤过,作为供试品溶液;
取地黄药材适量,加乙醇制成每1ml含1mg药材的溶液,超声提取0.5小时,滤过,作为对照品溶液;
分别吸取上述溶液各2μl,点于同一硅胶G薄层板上,以体积份数比为3∶0.5甲酸乙酯-甲酸为展开剂,展开,取出,晾干,喷以重量体积比5%的香草醛硫酸溶液,105℃加热至斑点清晰;供试品色谱中,在与对照品色谱相应的位置上,显相同或类似颜色的斑点;
本发明的鉴定方法,专属性强,进一步确保了产品质量安全、均一、有效、质量可控。
本发明的地黄和黄连组合物具有降糖降脂的新用途。同时由于地黄具有药食同源的特性,与黄连合用可起到减毒增效的作用。
Claims (6)
1.一种降糖、或、降脂的黄连地黄组合物,其特征在于:生地黄和黄连的质量比是:1∶1-8∶1。
2.根据权利要求1的一种降糖、或、降脂的黄连地黄组合物,其特征在于:将生地黄和黄连混合,粉碎,过100目筛,制成散剂。
3.根据权利要求1的一种降糖、或、降脂的黄连地黄组合物,其特征在于:将生地黄和黄连混合,用5-15倍量的水煎煮1-4次,每次1-3小时,合并提取液,制成汤剂。
4.根据权利要求1的一种降糖、或、降脂的黄连地黄组合物,其特征在于:将生地黄和黄连混合,用5-15倍量的水煎煮1-4次,每次1-3小时,合并提取液,制成片剂。
5.根据权利要求1的一种降糖、或、降脂的黄连地黄组合物,其特征在于:将生地黄和黄连混合,用5-15倍量的水煎煮1-4次,每次1-3小时,合并提取液,适量浓缩后,浸膏真空干燥;按照浸膏10-40g,乳糖200-500g,微粉硅胶10-30g,羧甲基淀粉钠10-40g,可溶性淀粉50-200g,硬脂酸镁1-4g,混合均匀,制成片剂。
6.根据权利要求1的一种降糖、或、降脂的黄连地黄组合物,其特征在于:取黄连,洗净,粉碎并过筛,得黄连粉末;取新鲜的生地黄,洗净,加水1-10倍量浸泡1-6小时,混合打浆,过滤,得生地黄汁;用适量黄连粉末吸收适量生地黄汁;在35-40摄氏度加热1-6小时,真空干燥,既得。
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