CN115414405B - 一种中药组合物及其制剂和在治糖尿病肾病药物中的应用 - Google Patents
一种中药组合物及其制剂和在治糖尿病肾病药物中的应用 Download PDFInfo
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Abstract
本发明公开了一种中药组合物及其制剂和在治糖尿病肾病药物中的应用,该中药组合物包括以下重量份比例的原料:黄蜀葵花20‑60份、火把花根5‑30份、黄芪20‑60份、酒萸肉5‑20份、绞股蓝10‑30份、怀牛膝10‑30份。本发明所述的中药组合物针对DKD临床蛋白尿期具有缓解临床症状、减轻蛋白尿、保护肾功能和逆转DKD等作用,经临床证实治疗糖尿病肾病有较好的治疗效果。
Description
技术领域
本发明涉及一种中药组合物及其制剂和应用,具体涉及一种中药组合物及其制剂和在治糖尿病肾病药物中的应用。
背景技术
糖尿病肾病(DKD)是糖尿病致残致死主要微血管并发症之一,也是导致终末期肾脏病(ESRD)和心血管死亡的主要原因之一,在糖尿病患者中的发生率约为30-40%。根据2021年IDF全球糖尿病地图显示,中国糖尿病患者人数已达1.41亿,预测到2045年将增加至1.744亿,是世界成人糖尿病患者最多的国家,且仍有超过半数(51.7%)的成年糖尿病患者未被确诊,这导致DKD发病率也逐年增高,成为我国重大的社会经济负担。
DKD以蛋白尿和估计肾小球滤过率(eGFR)下降为主要临床特征,其早期症状较隐匿,待临床检测出蛋白尿时,大多已进入大量白蛋白尿期,此阶段DKD患者进展为终末期肾脏病(ESKD)的风险大约是其他肾脏疾病的14倍。然而现有的西医指南推荐的代谢控制策略(如:RASi、SGLT-2i等),仅能延缓部分早期DKD进展,一旦进展到临床蛋白尿期,上述措施临床疗效往往不佳,甚至在DKD中晚期有加速eGFR下降的风险。因此如何逆转DKD临床蛋白尿期仍然是该病的难点和瓶颈问题。
发明内容
发明目的:本发明的目的在于提供一种中药组合物及其在制备治糖尿病肾病药物中的应用。本发明还有一个目的是提供该中药组合物的制剂。
技术方案:本发明所述的中药组合物,包括以下重量份比例的原料:
黄蜀葵花20-60份、火把花根5-30份、黄芪20-60份、酒萸肉5-20份、绞股蓝10-30份、怀牛膝10-30份。
所述的中药组合物,包括以下重量份比例的原料:
黄蜀葵花25-35份、火把花根10-20份、黄芪25-35份、酒萸肉5-15份、绞股蓝10-20份、怀牛膝10-20份。
优选地,所述的中药组合物,包括以下重量份比例的原料:
黄蜀葵花27-32份、火把花根12-18份、黄芪28-32份、酒萸肉7-13份、绞股蓝12-18份、怀牛膝12-18份。
中药制剂,由所述的中药组合物经水煎煮过滤得到的煎煮液通过添加或不添加辅料制备而成。
所述的中药制剂,所述制剂的剂型为汤剂、口服液、膏剂、颗粒剂、胶囊剂。
所述的中药组合物在制备治疗糖尿病肾病药物中的应用。
所述的中药制剂在制备治疗糖尿病肾病药物中的应用。
本发明中的原料药详细情况如下:
黄蜀葵花为锦葵科秋葵属植物黄蜀葵或刚毛黄蜀葵的花,主产于我国的中南、西南及河北、浙江等地。其味甘、辛,性凉,归经为肾经,主要功效为清利湿热,和络化瘀。研究显示黄蜀葵花具有抑制免疫反应、减轻炎症反应、抗血小板聚集、改善肾纤维化保护肾小管上皮细胞等作用。
火把花根,为卫矛科雷公藤属植物昆明山海棠的根,分布于我国长江流域及西南地区,《中药学》记载昆明山海棠味苦、辛,性微温,有毒,归肝、脾、肾经,具有祛风除湿、活血止血、清热解毒等功效。临床研究表明火把花根是一种高效低毒的药物,具有抗炎、镇痛、免疫抑制等类似激素样作用及细胞毒药物的作用。现代药理研究表明火把花根具有调节免疫、改善微循环等作用。
黄芪味甘性微温,归脾肺经,最初记载于《神农本草经》,具有益气生津、升阳固表、养阴敛汗、利水消肿等功效。其补脾肺之气,以利生津止渴,兼可利水消肿,常用于糖尿病肾病治疗。现代药理研究表明黄芪具有调节糖脂代谢、调节免疫、改善氧化应激、抑制炎症反应、调节足细胞等作用。
酒萸肉为山茱萸用黄酒炮制而成,为临床常用中药之一,归肝肾经,具有温补肝肾、收涩固脱的功效。现代药理研究表明山茱萸有胰岛素样作用可以降血糖,同时具有免疫调节、抗氧化、抗肾纤维化等功效。
绞股蓝为葫芦科绞股蓝属多年生草质藤本植物,以全草供药食两用,素有“南方人参”的美誉。其味苦、微甘,性凉,归肺脾肾经,具有益气健脾、清热解毒之功效。药理学研究表明,绞股蓝具有降血糖、调血脂、抗炎、抗氧化和保护肝功能等多种作用。
怀牛膝系苋科牛膝的根,药性苦、甘、酸、平,归肝肾经,《本草经疏》言本品“走而能补,性善下行”,可引血、火、药下行,为临床常用的引经药,具有补肝肾、强筋骨、逐瘀通经、引血下行之功效。现代药理学研究认为,怀牛膝具有降血糖、降血脂、抗炎和提高免疫等作用。
本发明组方中,重用黄蜀葵花为君药,以清利湿热,和络化瘀,药理研究学显示黄葵具有抗氧化应激、抗炎、抗纤维化等作用。方取火把花根为臣药,助君药清热活络,研究表明火把花根可抑制炎症因子、调控NF-κB、TGF-β1等相关通路,起到抗炎、抗纤维化作用,与黄蜀葵花作用机制异曲同工,两者相使为用,共奏降低尿蛋白及改善肾损伤之效。佐以黄芪功善益气养阴、利水消肿,使补中有泄,祛邪而不伤正;酒萸肉温补肝肾,与黄芪共为佐药,两者配伍气阴双补,益气固涩之功增强。绞股蓝清热解毒、养肝健脾,同为佐药,既加强黄蜀葵花和火把花根清热之功效,又减轻火把花根肝损毒性,与黄芪同用,共奏补气健脾之效。怀牛膝苦酸梳利降泄、性善下行,作为使药,引诸药下行于肾。诸药合用,补泻同施,标本兼治,共奏益气养阴,清利和络之效。
有益效果:相对于现有技术,本发明所述的中药组合物由黄蜀葵花、火把花根、黄芪、酒萸肉、绞股蓝、怀牛膝组成,能够逆转糖尿病肾病临床蛋白尿期,根据临床经验结合现代药理组方,针对DKD临床蛋白尿期具有缓解临床症状、减轻蛋白尿、保护肾功能和逆转DKD等作用,经临床证实治疗糖尿病肾病有较好的治疗效果。
具体实施方式
下面通过具体实施例对本发明所述的技术方案给予进一步详细的说明。
实施例1
汤剂的制备
药物组成:黄蜀葵花30g、火把花根15g、黄芪30g、酒萸肉10g、绞股蓝15g、怀牛膝15g。
制备方法:称取上述重量份的原料,加500mL水煎煮,冷却后过滤弃去残渣即得。
实施例2
汤剂的制备
药物组成:黄蜀葵花20g、火把花根5g、黄芪20g、酒萸肉5g、绞股蓝10g、怀牛膝10g。
制备方法:称取上述重量份的原料,加500mL水煎煮,冷却后过滤弃去残渣即得。
实施例3
汤剂的制备
药物组成:黄蜀葵花60g、火把花根30g、黄芪60g、酒萸肉20g、绞股蓝30g、怀牛膝30g。
制备方法:称取上述重量份的原料,加500mL水煎煮,冷却后过滤弃去残渣即得。
实施例4
口服液的制备
药物组成:黄蜀葵花35g、火把花根20g、黄芪35g、酒萸肉15g、绞股蓝20g、怀牛膝20g。
制备方法:称取上述重量份的原料,加500mL水煎煮,冷却后过滤弃去残渣,加入羧甲基纤维素钠、蔗糖、山梨酸钾。
实施例5
昆葵膏的制备
药物组成:黄蜀葵花30g、火把花根15g、黄芪30g、酒萸肉10g、绞股蓝15g、怀牛膝15g。
制备方法:制备方法:称取上述重量份的原料,加500mL水煎煮,冷却后过滤弃去残渣,加蜂蜜100mL,并将溶液减压蒸发至膏状。
实施例6
昆葵颗粒剂的制备
药物组成:黄蜀葵花30g、火把花根15g、黄芪30g、酒萸肉10g、绞股蓝15g、怀牛膝15g。
制备方法:称取上述重量份的原料,加500mL水煎煮,冷却后过滤弃去残渣,加蜂蜜100mL,并将溶液减压蒸发至膏状,加入一定量的玉米淀粉、糊精、甘露醇,用40%乙醇润湿制成软材,挤压制粒并烘干。
实施例7
胶囊剂的制备
药物组成:黄蜀葵花30g、火把花根15g、黄芪30g、酒萸肉10g、绞股蓝15g、怀牛膝15g。
制备方法:将实施例6所得颗粒剂装胶囊,制得胶囊剂。
实施例8
本研究共纳入符合要求的DKD患者56人,临床试验中由于疫情影响,外地患者无法前来就诊或未配合相关血尿检验等原因,脱落15人,因疗程未达3月,剔除11人,最终共纳入DKD患者30例。服用实施例1的汤剂,每日两次。
(1)糖肾患者治疗前后尿蛋白指标变化:
表1.患者治疗前后尿蛋白指标变化[M(P25,P75)]
注:与治疗前相比,①P<0.01;②P<0.05
结果:患者治疗后UACR明显下降,差异有统计学意义(P<0.01);患者治疗后尿补体C3出现下降,差异有统计学意义(P<0.05)。
(2)尿蛋白定性的变化:
表2.患者治疗前后尿蛋白定性的变化[n(%)]
注:Fisher确切概率法:P<0.05
结果:患者治疗后尿蛋白阴性或弱阳性的比例增高,差异有统计学意义(P<0.05)。
(3)蛋白尿的疗效评价(参考中华中医药学会肾病分会2007年7月在《上海中医药杂志》上发表拟定的疗效评定标准):
近期缓解:UACR减少≥50%,或降至正常范围;显效:UACR减少≥30%,但不足50%;有效:UACR减少,但不足≥30%;无效:未达到上述有效标准者。总有效率=(近期缓解+显效+有效)/总例数×100%。
表3.降低蛋白尿有效率分析[n(%)]
结果:30位患者中近期缓解8例,显效8例,有效9例,无效5例,总有效率为83.33%。
(4)糖肾患者治疗前后肾功能指标变化:
表4.患者治疗前后肾功能指标变化/[M(P25,P75)]
注:与治疗前相比,①P<0.05;②P>0.05
结果:患者治疗后Scr下降,差异有统计学意义(P<0.05);患者治疗后eGFR有上升趋势,但未见明显统计学意义(P>0.05);患者治疗后BUN及CysC较治疗前有升高趋势,但未见明显统计学意义(P>0.05)。
(5)肾功能的疗效评价(参照《糖尿病肾脏病分期辩证规范与疗效评定方案及其研究(2017)》的疗效评定标准):
表5-1.肾功能综合疗效判定标准
①和②中具备1项,便可以判定。
总有效率=(显效+有效+稳定)/总例数×100%。
表5-2.提高肾功能有效率分析[n(%)]
结果:30位患者中显效8例,有效4例,稳定11例,无效7例,总有效率为76.67%。
(6)糖尿病肾病患者治疗前后临床症候疗效积分(参照《中药新药临床研究指导原则(2002)》中的标准):
临床症候疗效积分附表:
中医症状体征量化分级表
临床痊愈:中医临床症状、体征消失或基本消失,证候积分减少≥90%;显效:中医临床症状、体征明显改善,证候积分减少≥70%;有效:中医临床症状、体征均有好转,证候积分减少≥30%;无效:中医临床症状、体征均无明显改善,甚或加重,证候积分减少不足30%。
注:计算公式(尼莫地平法)为:[(治疗前积分-治疗后积分)/治疗前积分]×100%。具体评分标准见附表。
表6.临床症候疗效有效率分析[n(%)]
结果:30位患者中临床痊愈3例,显效6例,有效12例,无效9例,总有效率为70.0%。
(7)参考《中药新药临床研究指导原则(2002)》、《糖尿病肾脏病分期辩证规范与疗效评定方案及其研究(2017)》的糖尿病肾脏病疗效判定标准,对糖尿病肾病疾病疗效制定综合评价方案,分为显著逆转、部分逆转和好转和无效4个等级:
表7-1.糖尿病肾病综合疗效判定标准
①、②、③中具备1项,便可以判定。
总有效率=(显著逆转+部分逆转+好转)/总例数×100%。
表7-2.糖尿病肾病治疗前后有效率分析[n(%)]
结果:30位患者中显著逆转8例,部分逆转12例,好转8例,无效2例,总有效率为93.33%。
Claims (7)
1.一种用于治疗糖尿病肾病的中药组合物,其特征在于,原料按重量份比例为:
黄蜀葵花20-60份、火把花根5-30份、黄芪20-60份、酒萸肉5-20份、绞股蓝10-30份、怀牛膝10-30份。
2.根据权利要求1所述的用于治疗糖尿病肾病的中药组合物,其特征在于,原料按重量份比例为:
黄蜀葵花25-35份、火把花根10-20份、黄芪25-35份、酒萸肉5-15份、绞股蓝10-20份、怀牛膝10-20份。
3.一种用于治疗糖尿病肾病的中药制剂,其特征在于,由权利要求1-2任一项所述的中药组合物经水煎煮过滤得到的煎煮液通过添加或不添加辅料制备而成。
4.根据权利要求3所述的中药制剂,其特征在于,所述制剂的剂型为汤剂、口服液、膏剂、颗粒剂或胶囊剂。
5.如权利要求1-2任一项所述的中药组合物在制备治疗糖尿病肾病药物中的应用。
6.如权利要求3所述的中药制剂在制备治疗糖尿病肾病药物中的应用。
7.如权利要求1-2任一项所述的中药组合物或如权利要求3所述的中药制剂在制备治疗糖尿病肾病临床蛋白尿期药物中的应用。
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