CN109498671A - 一种防治糖尿病肾病的天然产物组合物及应用 - Google Patents
一种防治糖尿病肾病的天然产物组合物及应用 Download PDFInfo
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- CN109498671A CN109498671A CN201811614327.2A CN201811614327A CN109498671A CN 109498671 A CN109498671 A CN 109498671A CN 201811614327 A CN201811614327 A CN 201811614327A CN 109498671 A CN109498671 A CN 109498671A
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Abstract
本发明公开了一种防治糖尿病肾病的天然产物组合物及应用,该天然药物组合物由由以下重量份的原料天然产物制成:南烛叶醇提取物10‑30份,火龙果皮醇提取物10‑30份,蚕沙水提取物20‑40份,分子量为2000‑15000、酯化度为8%‑28%的改性果胶粉20‑70份。本发明用于防治糖尿病肾病的天然产物组合物的各组分通过抗氧化、降血糖、改善肾小球和肾小管的纤维化等作用,达到防治糖尿病肾病的目的。各组分原料来源广泛,成本低廉,能够有效防治I型和II型糖尿病肾病进程。该组合物口服安全性高,疗效确切,是一种具有广阔市场前景的防治糖尿病肾病的天然产物组合物原料。
Description
技术领域
本发明涉及天然产物组合物技术领域,尤其涉及一种防治糖尿病肾病的天然产物组合物及其制备方法和应用。
背景技术
糖尿病发病率逐年递增,危害程度仅次于恶性肿瘤,是现代人类健康的第二大杀手,在三大并发症中,致死、致残率最高的并发症是糖尿病肾病。糖尿病肾病是I型及II型糖尿病患者发生慢性肾功能衰竭的主要原因,也是引发糖尿病患者死亡率高的重要原因。因此,开发防治糖尿病肾病的食品和药品具有广阔的市场前景,具有良好的社会效益和经济效益。糖尿病肾病的基本病理改变为肾小球系膜细胞增殖,肾小球基底膜增厚,细胞外基质增多和结节性或弥漫性肾小球硬化,肾小管间质损害。后期为肾小球、肾小管间质的纤维化,最终导致蛋白尿和肾功能衰竭。普遍认为长期高血糖是糖尿病肾病发病的关键因素,细胞因子和炎症介质糖尿病发病的重要因素,如胰岛素样生长因子和血小板来源因子参与肾小球血流动力学改变,转化生长因子TGF-β参与细胞肥大过程,肿瘤坏死因子TNF-α和IGF-1共同影响胰岛素信号传递。目前开发的防治糖尿病肾病的药物主要从降血糖、降血压、降血脂、血液透析、改善血液流变学等方面入手。目前用于防治糖尿病肾病的天然产物包括姜黄素、丹参、红花、葛根、黄芩、甘草、金樱子、金蝉花、黄芪等。目前用于防治糖尿病肾病的中药或天然产物组合物的专利有:金蝉花、生地、淮山药、枸杞子为主要组方的组合物(CN201810174368.8);头花蓼提取物、当归提取物、车前子提取物、仙茅提取物为主要组方的组合物(CN201810316958.X);黄芪提取物(CN108498566A);鱼藤酮提取物(CN108524492A);猫蕊花糖苷(CN108451961A)等等。
然而,研发更多原料来源广、成本低廉、原料质量易控制、防治作用效果显著、安全性高的天然产物组合物仍然十分必要。
发明内容
本发明的目的是针对现有天然产物原料来源有限的不足,提供一种防治糖尿病肾病的天然产物组合物及应用。
本发明的目的是通过以下技术方案来实现的:一种防治糖尿病肾病的天然产物组合物,它由以下重量份的原料天然产物组成:南烛叶醇提物10-30份、火龙果皮醇提取物10-30份、蚕沙水提取物20-40份、改性果胶粉20-70份。
进一步地,它优选由以下重量份的原料成分制成:南烛叶醇提物12-20g、火龙果皮醇提物15-28g、蚕沙水提物20-35g、改性果胶粉25-65g。
进一步地,所述的天然产物组合物可制备成膏剂、颗粒剂、片剂、胶囊剂等口服制剂。
进一步地,所述南烛叶醇提物通过以下方法制备得到:3天内采摘的新鲜南烛叶或-20℃冻存的新鲜南烛叶用经盐酸调整pH值在3-6的体积浓度为70-75%的乙醇溶液,在75℃加热条件下回流提取2-4h,将所得提取物冻干后粉碎。
进一步地,所述火龙果皮醇提物通过以下方法制备得到:火龙果皮粉碎后在70-80℃加热条件下,用体积浓度为70-80%的乙醇溶液回流提取2-3h,将所得提取物冻干后粉碎。
进一步地,所述蚕沙水提物通过以下方法制备得到:蚕沙经蒸馏水在80-95℃加热条件下浸提3-4h,将所得提取物冻干后粉碎;所述蚕沙原料为二眠、三眠、四眠蚕的粪便。
进一步地,所述改性果胶粉为来源于柑橘、胡萝卜、地瓜、甜菜、土豆等原料的分子量在2000-15000、酯化度为8%-28%的改性果胶。
本发明还提供了一种上述的天然产物组合物在制备防治糖尿病肾病的食品、药品中的应用。
本发明的有益效果在于:
1、本发明以特定分子量和酯化度的改性果胶作为主要成分,改性果胶具有良好的调节血糖、改善微血管病变的作用,能够防止高血糖或微血管病变引起的肾脏功能衰退。辅以蚕沙水提物的降血糖作用,南烛叶水提物的抗氧化、抗炎作用,火龙果皮提取物的抗肾小球、肾小管的纤维化作用,适用于防治I型和II型糖尿病引起的肾病,经动物试验结果显示,能够有效防止糖尿病模型的肾纤维化和肾功能减退。
2、原料来源广泛易得,原料标准化易控制,安全性高,食用药用均可。
3、可利用范围广,可以用于添加到日常方便食品中,也可以做成片剂、胶囊剂或膏剂服用。
附图说明
图1是天然产物组合物干预后对II型糖尿病大鼠模型体重的影响示意图;
图2是天然产物组合物干预后对II型糖尿病大鼠血糖的影响示意图;
图3是天然产物组合物干预后对II型糖尿病大鼠糖化血红蛋白的影响示意图;
图4是天然产物组合物干预后对II型糖尿病大鼠尿蛋白的影响示意图;
图5是天然产物组合物后对II型糖尿病大鼠肾脏病理变化的影响示意图;其中,(a)为正常大鼠肾脏,(b)为II型糖尿病大鼠肾脏,(c)为实施例干预后的II型糖尿病大鼠肾脏;
图6是本发明天然产物组合物的制备工艺流程图。
具体实施方式
下面结合附图对本发明提供的具体实施方式作详细说明。
实施例1
本发明的工艺流程如图6所示。各天然产物份配比为:南烛叶醇提物15g、火龙果皮醇提物20g、改性果胶粉45g、蚕沙水提物20g。
(1)南烛叶醇提物制备:采摘3天内的新鲜南烛叶,-20℃冷冻12小时,粉碎机粉碎,经盐酸调pH值为4的70%乙醇溶液75℃加热条件下回流提取3h,提取液冻干后粉碎过60目筛。
(2)火龙果皮醇提物制备:火龙果皮粉碎打浆,75%的酒精78℃加热回流提取3h,提取液冻干后粉碎过60目筛。
(3)蚕沙水提物的制备:三眠蚕粪便,用蒸馏水95℃加热浸提4h,将所得提取物冻干粉碎。
(4)改性果胶制备:胡萝卜来源的果胶经碱解后,控制产品的分子量15000,酯化度28%。所得产品过60目筛。
(5)混合成要求的制剂:按照配比将上述粉剂混合即得所需产品。
实施例2
各天然产物份配比为:南烛叶醇提物12g、火龙果皮醇提物18g、改性果胶粉50g、蚕沙水提物20g。
(1)南烛叶醇提物制备:-20℃冷冻的新鲜南烛叶,粉碎机粉碎,经盐酸调pH值为3的75%乙醇溶液75℃加热条件下回流提取4h,提取液冻干后粉碎过60目筛。
(2)火龙果皮醇提物制备:火龙果皮粉碎打浆,80%的酒精75℃加热回流提取2h,提取液冻干后粉碎过60目筛。
(3)蚕沙水提物的制备:四眠蚕粪便,用蒸馏水90℃加热浸提3h,将所得提取物冻干粉碎。
(4)改性果胶制备:向日葵盘来源的果胶经碱解后,控制产品的分子量12000,酯化度25%。所得产品过60目筛。
(5)混合成要求的制剂:按照配比将上述粉剂混合即得所需产品。
实施例3
各天然产物份配比为:南烛叶醇提物16g、火龙果皮醇提物16g、改性果胶粉43g、蚕沙水提物25g。
(1)南烛叶醇提物制备:新鲜南烛叶,-20℃冷冻12h,粉碎机粉碎,经盐酸调pH值为5的70%乙醇溶液75℃加热条件下回流提取3h,提取液冻干后粉碎过60目筛。
(2)火龙果皮醇提物制备:火龙果皮粉碎打浆,70%的酒精78℃加热回流提取3h,提取液冻干后粉碎过60目筛。
(3)蚕沙水提物的制备:二眠蚕粪便,用蒸馏水95℃加热浸提2h,将所得提取物冻干粉碎。
(4)改性果胶制备:向日葵盘来源的果胶经碱解后,控制产品的分子量5000,酯化度8%。所得产品过60目筛。
(5)压片制剂:按照配比将上述粉剂混合后压片即可得产品。
实施例4
各天然产物份配比为:南烛叶醇提物15g、火龙果皮醇提物20g、改性果胶粉35g、蚕沙水提物20g。
(1)南烛叶醇提物制备:新鲜南烛叶,-20℃冷冻12h,粉碎机粉碎,经盐酸调pH值为4的75%乙醇溶液75℃加热条件下回流提取4h,提取液冻干后粉碎过60目筛。
(2)火龙果皮醇提物制备:火龙果皮粉碎打浆,70%的酒精80℃加热回流提取2h,提取液冻干后粉碎过60目筛。
(3)蚕沙水提物的制备:二眠蚕粪便,用蒸馏水85℃加热浸提4h,将所得提取物冻干粉碎。
(4)改性果胶制备:向日葵盘来源的果胶经碱解后,控制产品的分子量8000,酯化度13%。所得产品过60目筛。
(5)压片制剂:按照配比将上述粉剂混合后压片即可得产品。
实施例5
各天然产物份配比为:南烛叶醇提物18g、火龙果皮醇提物22g、改性果胶粉25g、蚕沙水提物35g。
(1)南烛叶醇提物制备:新鲜南烛叶,-20℃冷冻12h,粉碎机粉碎,经盐酸调pH值为4.5的70%乙醇溶液75℃加热条件下回流提取3h,提取液冻干后粉碎过60目筛。
(2)火龙果皮醇提物制备:火龙果皮粉碎打浆,70%的酒精75℃加热回流提取3h,提取液冻干后粉碎过60目筛。
(3)蚕沙水提物的制备:三眠蚕粪便,用蒸馏水90℃加热浸提3h,将所得提取物冻干粉碎。
(4)改性果胶制备:向日葵盘来源的果胶经碱解后,控制产品的分子量10000,酯化度18%。所得产品过60目筛。
(5)胶囊制剂:按照配比将上述粉剂混合后灌胶囊即可得产品。
实施例6
各天然产物份配比为:南烛叶醇提物15g、火龙果皮醇提物20g、改性果胶粉40g、蚕沙水提物25g。
(1)南烛叶醇提物制备:新鲜南烛叶,-20℃冷冻12h,粉碎机粉碎,经盐酸调pH值为3的75%乙醇溶液75℃加热条件下回流提取4h,提取液冻干后粉碎过60目筛。
(2)火龙果皮醇提物制备:火龙果皮粉碎打浆,70%的酒精75℃加热回流提取2h,提取液冻干后粉碎过60目筛。
(3)蚕沙水提物的制备:三眠蚕粪便,用蒸馏水95℃加热浸提3h,将所得提取物冻干粉碎。
(4)改性果胶制备:向日葵盘来源的果胶经碱解后,控制产品的分子量12000,酯化度20%。所得产品过60目筛。
(5)胶囊制剂:按照配比将上述粉剂混合后灌胶囊即可得产品。
实施例7
各天然产物份配比为:南烛叶醇提物14g、火龙果皮醇提物16g、改性果胶粉50g、蚕沙水提物20g。
(1)南烛叶醇提物制备:冷冻新鲜南烛叶,粉碎机粉碎,经盐酸调pH值为3.5的70%乙醇溶液75℃加热条件下回流提取3h,提取液冻干后粉碎过60目筛。
(2)火龙果皮醇提物制备:火龙果皮粉碎打浆,78%的酒精75℃加热回流提取3h,提取液冻干后粉碎过60目筛。
(3)蚕沙水提物的制备:三眠蚕粪便,用蒸馏水90℃加热浸提3h,将所得提取物冻干粉碎。
(4)改性果胶制备:向日葵盘来源的果胶经碱解后,控制产品的分子量18000,酯化度25%。所得产品过60目筛。
(5)颗粒制剂:按照配比将上述粉剂混合后制颗粒即可得产品。
实施例8
各天然产物份配比为:南烛叶醇提物16g、火龙果皮醇提物15g、改性果胶粉40g、蚕沙水提物29g。
(1)南烛叶醇提物制备:冷冻新鲜南烛叶,粉碎机粉碎,经盐酸调pH值为4的70%乙醇溶液75℃加热条件下回流提取2h,提取液冻干后粉碎过60目筛。
(2)火龙果皮醇提物制备:火龙果皮粉碎打浆,70%的酒精75℃加热回流提取2h,提取液冻干后粉碎过60目筛。
(3)蚕沙水提物的制备:三眠蚕粪便,用蒸馏水90℃加热浸提4h,将所得提取物冻干粉碎。
(4)改性果胶制备:向日葵盘来源的果胶经碱解后,控制产品的分子量15000,酯化度23%。所得产品过60目筛。
(5)颗粒制剂:按照配比将上述粉剂混合后制颗粒即可得产品。
实施例9
各天然产物份配比为:南烛叶醇提物15g、火龙果皮醇提物15g、改性果胶粉45g、蚕沙水提物25g。
(1)南烛叶醇提物制备:冷冻新鲜南烛叶,粉碎机粉碎,经盐酸调pH值为3的70%乙醇溶液75℃加热条件下回流提取3h,提取液冻干后粉碎过60目筛。
(2)火龙果皮醇提物制备:火龙果皮粉碎打浆,70%的酒精75℃加热回流提取3h,提取液冻干后粉碎过60目筛。
(3)蚕沙水提物的制备:四眠蚕粪便,用蒸馏水95℃加热浸提2h,将所得提取物冻干粉碎。
(4)改性果胶制备:向日葵盘来源的果胶经碱解后,控制产品的分子量18000,酯化度25%。所得产品过60目筛。
(5)膏剂制剂:按照配比将上述粉剂混合后每10g组合物100ml水沸水熬制60min即可得产品。
实施例10
各天然产物份配比为:南烛叶醇提物20g、火龙果皮醇提物20g、改性果胶粉40g、蚕沙水提物20g。
(1)南烛叶醇提物制备:冷冻新鲜南烛叶,粉碎机粉碎,经盐酸调pH值为4的70%乙醇溶液75℃加热条件下回流提取4h,提取液冻干后粉碎过60目筛。
(2)火龙果皮醇提物制备:火龙果皮粉碎打浆,70%的酒精75℃加热回流提取2h,提取液冻干后粉碎过60目筛。
(3)蚕沙水提物的制备:二眠蚕粪便,用蒸馏水90℃加热浸提3h,将所得提取物冻干粉碎。
(4)改性果胶制备:向日葵盘来源的果胶经碱解后,控制产品的分子量15000,酯化度18%。所得产品过60目筛。
(5)膏剂制剂:按照配比将上述粉剂混合后每10g组合物100ml水沸水熬制60min即可得产品。
实施例11:天然产物防治糖尿病肾病的动物试验
取SPF级体重为200±20g的雄性SD大鼠100只,饲喂高脂饲料1个月后,禁食不禁水16h,用0.1mmol·L-1柠檬酸缓冲液(pH=4.2),将STZ配成2%的溶液,按50mg·kg-1STZ的剂量尾静脉注射,1周后测定血糖值和体重,选取血糖值>20mmol·L-1、体重450±50g大鼠32只用于试验,分为4组,每组8只,各组分别给予相应的干预措施,每日2次,连续干预8周,每周测定一次体重和空腹血糖值,每2周空腹尾静脉取血,分离血清测定BUN、Scr,每两周测定一次尿蛋白含量,每4周测定大鼠糖化血红蛋白含量。实验8周后处死大鼠取肾组织,进行HE染色和PAS观察病理变化。另选择相应体重的大鼠作为正常对照组,给予蒸馏水干预。高脂饲料配方:10%猪油,10%白糖,10%蛋黄粉,0.25%胆固醇,69.75%(基础饲料),由动物中心人员自行配置。分析比较不同干预措施对II型糖尿病模型体重、空腹血糖、糖化血红蛋白和肾脏组织的影响。
结果发现实施例天然产物组合物比单一组方或其他对照组方有更好的降血糖及保护肾脏的效果。
对体重的影响结果如图1所示,实施例组能够有效缓解II型糖尿病大鼠模型的体重降低现象。
对空腹血糖的影响结果如图2所示,实施例组能够起到持续降低II型糖尿病大鼠血糖的作用。随着时间的延长,降血糖效果逐渐增加。
对糖化血红蛋白的影响结果如图3所示,实施例组能够起到持续降低II型糖尿病大鼠糖化血红蛋白的作用。
对糖尿病大鼠血清BUN的影响效果如表1所示,实施例组在干预六周后开始能够显著降低血清BUN,有效改善II型糖尿病大鼠的肾功能损伤。
表1:天然产物组合物干预后对II型糖尿病大鼠血清BUN的效果
结果以表示,n=8。与模型对照组比:*p<0.05,**p<0.01
对糖尿病大鼠尿蛋白的影响效果如图4所示,实施例组在干预四周后开始能够显著降低尿蛋白含量,说明实施例组能有效改善II型糖尿病大鼠的肾功能损伤。
对糖尿病大鼠肾脏病理变化的影响如图5所示,实施例组能够降低肾小球基底膜部分增生,有少量PAS阳性物质染成红色。
该动物试验结果显示,本发明能够有效防止糖尿病模型的肾纤维化和肾功能减退。
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员,在不脱离本发明方法的前提下,还可以做出若干改进和补充,这些改进和补充也应视为本发明的保护范围。
Claims (8)
1.一种防治糖尿病肾病的天然产物组合物,其特征在于,它由以下重量份的原料天然产物组成:南烛叶醇提物10-30份、火龙果皮醇提取物10-30份、蚕沙水提取物20-40份、改性果胶粉20-70份。
2.根据权利要求1所述的天然产物组合物,其特征在于,它可以优选由以下重量份的原料成分制成:南烛叶醇提物12-20g、火龙果皮醇提物15-28g、蚕沙水提物20-35g、改性果胶粉25-65g。
3.根据权利要求1所述的天然产物组合物,其特征在于,所述的天然产物组合物可制备成膏剂、颗粒剂、片剂、胶囊剂等口服制剂。
4.根据权利要求1所述的天然产物组合物,其特征在于,所述南烛叶醇提物通过以下方法制备得到:3天内采摘的新鲜南烛叶或-20℃冻存的新鲜南烛叶用经盐酸调整pH值在3-6的体积浓度为70-75%的乙醇溶液,在75℃加热条件下回流提取约2-4h,将所得提取物冻干后粉碎。
5.根据权利要求1所述的天然产物组合物,其特征在于,所述火龙果皮醇提物通过以下方法制备得到:火龙果皮粉碎后在70-80℃加热条件下,用体积浓度为70-80%的乙醇溶液回流提取约2-3h,将所得提取物冻干后粉碎。
6.根据权利要求1所述的天然产物组合物,其特征在于,所述蚕沙水提物通过以下方法制备得到:蚕沙经蒸馏水在80-95℃加热条件下浸提约3-4h,将所得提取物冻干后粉碎;所述蚕沙原料为二眠、三眠、四眠蚕的粪便。
7.根据权利要求1所述的天然产物组合物,其特征在于,所述改性果胶粉为来源于柑橘、胡萝卜、地瓜、甜菜、土豆等原料的分子量在2000-15000、酯化度为8%-28%的改性果胶。
8.一种权利要求1所述的天然产物组合物在制备防治糖尿病肾病的食品、药品中的应用。
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