CN114246910A - 一种治疗痛风的中药组合物及其用途 - Google Patents
一种治疗痛风的中药组合物及其用途 Download PDFInfo
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- CN114246910A CN114246910A CN202010999345.8A CN202010999345A CN114246910A CN 114246910 A CN114246910 A CN 114246910A CN 202010999345 A CN202010999345 A CN 202010999345A CN 114246910 A CN114246910 A CN 114246910A
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- Medicines Containing Plant Substances (AREA)
Abstract
本发明公开了一种中药组合物在制备治疗痛风药物中的用途,属于中药领域。本发明所述的中药组合物主要由金银花、白花蛇舌草、玄参、山慈菇、地黄、白芍、当归、甘草、蜈蚣、青风藤、鹿衔草制备而成。本发明所述的中药组合物经动物学实验证实,能够显著改善大鼠痛风性关节炎的足肿胀,降低痛风大鼠血清和关节滑膜组织中炎症因子的水平,改善由于痛风模型造成的肝肾损伤,表现出显著的抗痛风作用。
Description
技术领域
本发明涉及一种中药组合物的新用途,具体涉及一种中药组合物在制备治疗痛风药物中的用途,属于中药领域。
背景技术
痛风是一种常见且复杂的关节炎类型,最常发病的关节是第一跖骨(大脚趾),此外还有手部关节、膝盖、肘部等。其症状为关节疼痛、水肿、红肿和炎症,发病急,持续几天或几周不等。造成痛风的本质原因是体内尿酸水平升高,尿酸盐在关节和肾脏部位沉积,从而腐蚀骨质,导致关节变形。
痛风是一种单钠尿酸盐(MSU)沉积所致的晶体相关性关节病,与嘌呤代谢紊乱及(或)尿酸排泄减少所致的高尿酸血症直接相关,属代谢性风湿病范畴。痛风可并发肾脏病变,严重者可出现关节破坏、肾功能损害,常伴发高脂血症、高血压病、糖尿病、动脉硬化及冠心病等。
作为一种慢性晶体性关节炎——痛风,高尿酸血症是痛风发生的基础。遗传因素影响痛风和高尿酸血症发生和发展的全过程,单基因遗传病可能影响尿酸代谢通路上的关键酶,SNP则可导致尿酸转运蛋白的差异以及炎症反应的程度。高尿酸血症和尿中尿酸过饱和,使尿酸盐沉积到肾小管管腔或间质中,导致急性炎性反应。
痛风可伴发肥胖症、高血压病、糖尿病、高血脂、脂代谢紊乱等多种代谢性疾病。其中,肥胖是痛风的主要危险因素之一,肥胖不仅增加痛风发生的风险,而且肥胖患者痛风发病年龄较早。肥胖可导致胰岛素抵抗,通过多种途径最终导致肾脏尿酸排泄减少。肥胖还会引起游离脂肪酸增加,通过影响黄嘌呤氧化酶等的活性增加尿酸的合成。
痛风在民间被称为“富贵病”,随着现代生活水平的提高和饮食习惯、结构的变化,该病的发病率越来越高,且趋于年轻化。中医治疗痛风依据中医学整体观念、辨证论治原则,在全面分析病因、病机的基础上,“坚持急则治其标、缓则治其本”,全方面辨证,分期、分型或分期分型相结合,并在传统诊疗基础上结合现代医学施治,体现了中医药诊疗特色。
痛风属中医学“痹证”“痛风”“历节”范畴。《素问·痹论》曰:“风寒湿三气杂至,合而为痹也”,其认为痹证多是由风、寒、湿、热等外邪侵袭人体肌肉、骨、关节,闭阻经络,气血运行不畅所致,亦或气血亏虚致受外邪侵袭所致。《金匮要略·中风历节病脉证并治》言:“寸口脉沉而弱,沉即主骨,弱即主筋,沉即为肾,弱即为肝,汗出入水中,如水伤心,历节黄汗出,故曰历节。”提示历节病机乃肝肾不足,水湿侵袭所致,“少阴脉浮而弱,弱则血不足,浮则为风,风血相搏,即疼痛如掣”提示其病机乃由阴血不足,外感风邪所致;“盛人脉涩小,短气自汗出,历节疼不可屈伸,此乃饮酒汗出当风所致”表明其病机亦有气虚饮酒,汗出当风所致。
中国发明专利CN1256134C公开了一种新的治疗活动期类风湿病的药物组合物,该药物组合物包括金银花、青风藤、白花蛇舌草、玄参、地黄、山慈姑、鹿衔草、白芍、当归、甘草、蜈蚣,依托该专利生产的“金藤清痹颗粒”为鲁南厚普制药有限公司的独家产品,临床上用于治疗活动期风湿及类风湿性关节炎,治疗效果显著,获得广大患者的一致好评。
发明内容
本发明是在中国发明专利CN1256134C的基础上,对专利中涉及的中药组合物所做的进一步的开发,具体的涉及所述中药组合物在制备治疗痛风药物中的用途,该中药组合物可治疗各种原因引起的痛风,治疗有效率高。
本发明主要目的为公开了一种中药组合物在制备治疗痛风药物中的用途,所述的中药组合物主要由金银花、白花蛇舌草、玄参、山慈菇、地黄、白芍、当归、甘草、蜈蚣、青风藤、鹿衔草组成。
具体的,上述中药组合物主要由以下原料组成:
7.如权利要求6所述的用途,其特征在于,所述中药组合物由以下原料组成:
优选的,所述中药组合物由以下原料组成:
本发明所述的痛风可以是原发性痛风或继发性痛风。
优选的,上述继发性痛风是指由疾病或药物所引起的痛风。
优选的,上述疾病可以是肾功能损伤、肾功能损伤酸中毒、细胞增殖中的任意一种或多种。
上述痛风按照中医辩证可以是湿热蕴结证、瘀热阻滞证、痰浊阻滞证或肝肾阴虚证。
本发明还提供了一种由上述中药组合物制备而成的制剂;所述的制剂可以是为颗粒剂、胶囊剂、丸剂、片剂、口服液、糖浆剂、合剂中的一种或多种;
优选的,所述剂型为颗粒剂。
本发明还提供了上述制剂的制备方法,主要包括以下步骤:
A、蜈蚣、部分当归粉碎,过筛,备用;
B、金银花水提醇沉法提取,提取液浓缩,干燥,粉碎,得金银花提取物备用;
C、青风藤、白花蛇舌草混合,乙醇回流提取,得药液I;
D、白芍、玄参、生地、山慈菇、鹿衔草、甘草、剩余当归,水提醇沉法提取,得药液II;
E、将步骤C所得药液I与步骤D所得药液II合并,浓缩至稠膏,干燥,粉碎过筛,得提取物备用;
F、将步骤A中所得蜈蚣粉和当归粉、步骤B所得金银花提取物、步骤E所得提取物混合均匀,按照常规制备工艺制成制剂。
具体的,上述制剂的制备方法包括以下步骤:
A、取处方量蜈蚣粉碎,过100目筛,灭菌,得蜈蚣粉备用;取1/2处方量当归粉碎,过100目筛,灭菌,得当归粉备用;
B、取处方量金银花加水,加热至沸,保温热浸,提取两次,滤过,滤液合并并浓缩至相对密度为1.15-1.20(50℃)的清膏,放冷,加乙醇使含醇量达70%,静置24小时,取上清液回收乙醇并浓缩至相对密度为1.25-1.30(50℃)的稠膏,真空干燥,粉碎过100目筛,得金银花提取物细粉备用;
C、取处方量青风藤、白花蛇舌草混合,以70%乙醇回流提取2次,滤过,滤液合并,回收乙醇,得药液I;
D、取处方量白芍、玄参、生地、山慈菇、鹿衔草、甘草、1/2处方量当归,加水煎煮2次,滤过,滤液合并,浓缩至相对密度为1.15-1.20(50℃)的清膏,放冷,加醇使含醇量达60%,静置24小时,取上清液回收乙醇,得药液II;
E、将步骤C所得药液I与步骤D所得药液II合并,浓缩至相对密度为1.25-1.30(50℃)的稠膏,真空干燥,粉碎后过100目筛,得提取物细粉备用;
F、取步骤A中所得蜈蚣粉和当归粉、步骤B所得金银花提取物细粉、步骤E所得提取物细粉混合均匀,按照常规制备工艺制成制剂。
本发明的目的还在于提供由上述中药组合物按照所述制备方法制备而成的金藤清痹颗粒在制备治疗痛风药物中的用途。
药理实验表明,本发明中药组合物能够显著改善大鼠痛风性关节炎的足肿胀,降低痛风大鼠血清与关节滑膜组织中UA、IL-1β、IL-6、TNF-α、XOD、BUN、Cr、Cys-c、ALT水平以及大鼠关节滑膜组织中UA、IL-1β、IL-6和TNF-α含量,抑制尿酸形成,对肝肾起保护作用,表现出显著的抗痛风作用。
具体实施例
一、具体实施方式
实施例1:颗粒剂制备
处方为:
制备方法为:
A、取处方量蜈蚣粉碎,过100目筛,灭菌,得蜈蚣粉备用;取1/2处方量当归粉碎,过100目筛,灭菌,得当归粉备用;
B、取处方量金银花加水,加热至沸,保温热浸,提取两次,滤过,滤液合并并浓缩至相对密度为1.15-1.20(50℃)的清膏,放冷,加乙醇使含醇量达70%,静置24小时,取上清液回收乙醇并浓缩至相对密度为1.25-1.30(50℃)的稠膏,真空干燥,粉碎过100目筛,得金银花提取物细粉备用;
C、取处方量青风藤、白花蛇舌草混合,以70%乙醇回流提取2次,滤过,滤液合并,回收乙醇,得药液I;
D、取处方量白芍、玄参、生地、山慈菇、鹿衔草、甘草、1/2处方量当归,加水煎煮2次,滤过,滤液合并,浓缩至相对密度为1.15-1.20(50℃)的清膏,放冷,加醇使含醇量达60%,静置24小时,取上清液回收乙醇,得药液II;
E、将步骤C所得药液I与步骤D所得药液II合并,浓缩至相对密度为1.25-1.30(50℃)的稠膏,真空干燥,粉碎后过100目筛,得提取物细粉备用;
F、取步骤A中所得蜈蚣粉和当归粉、步骤B所得金银花提取物细粉、步骤E所得提取物细粉混合均匀,按照常规制备工艺制成颗粒剂。
实施例2:颗粒剂制备
处方为:
制备方法:同实施例1。
实施例3:胶囊剂制备
处方为:
制备方法:同实施例1。
实施例4:片剂制备
处方为:
制备方法为:同实施例1。
实施例5:丸剂制备
处方为:
制备方法为:同实施例1所述制备方法。
对比实施例1
取青风藤药材粉末1kg,加10倍量80%乙醇为溶剂,加热回流提取,提取3次,每次2h,提取液过滤,减压浓缩,干燥,得提取物粉末。
二、药效学实验
本发明所述的中药组合物在治疗痛风中的用途,源于现有金藤清痹颗粒产品临床使用反馈。
以下仅以部分具有代表性的配方产品对氧嗪酸钾腹腔注射联合关节腔注射尿酸钠致大鼠痛风模型的治疗作用为例说明本发明中药组合物对痛风疾病的治疗效果,对于本发明中提到的其他配方及其他类型或原因所引起的痛风,发明人亦进行了相关的研究。研究结果表明,可以达到与以下动物实验类似、相同或更优的效果。
1.动物
健康SD大鼠,体重180-220g,许可证号:SYXK(鲁)2018 0008,由鲁南制药集团股份有限公司提供。大鼠实验前适应性喂养5-7d。
2.药物、给药剂量
2.1药物
实施例1所得颗粒剂、实施例2所得颗粒剂、对比实施例1所得提取物粉末
秋水仙碱片(国药准字H22020491)
2.2给药剂量
实施例1颗粒剂:1.35g/kg(低剂量)、2.7g/kg(中剂量)、5.4g/kg(高剂量);
实施例2颗粒剂:2.7g/kg
对比实施例1:3.5g/kg生药;
秋水仙碱片:0.54mg/kg。
3.造模、分组及给药
取大鼠80只,随机分为空白组、模型组、秋水仙碱片组、实施例1(高、中、低)三个剂量组、实施例2组、对比实施例1组。实验期间,上午除空白组外,模型组与各给药组腹腔注射氧嗪酸钾溶液(0.3g/kg),下午各给药组大鼠每天给予相应的药物,空白组、模型组给予生理盐水。连续14天。在第12天给药1h后,除空白组外,各组大鼠选取右侧关节进行造模,找到髌骨外侧缘与股骨外侧踝之间的髌骨关节间隙,注入0.2ml尿酸钠溶液,诱导急性关节炎模型,空白组大鼠对应位置注入相同体积的生理盐水。
4.检测指标
4.1踝关节肿胀度
急性关节炎模型造模24、48h后,用绕线法测关节周径,重复3次,取平均值。
4.2血清中IL-1β、IL-6、TNF-α、UA、XOD、BUN、Cr、Cys-c、ALT含量
在第14天造模4h后,大鼠眼眶取血,离心,取血清,ELISA法测定血清中IL-1β、IL-6、TNF-α、UA、XOD、BUN、Cr、Cys-c以及ALT含量。
4.3足踝关节滑膜组织中IL-1β、IL-6、TNF-α、UA含量
取大鼠右后足踝关节滑膜组织,ELISA法测定关节滑膜组织中IL-1β、IL-6、TNF-α、UA含量。
4.4统计学统计
数据处理采用SPSS 22.0统计软件,计量资料以均数±标准差表示,组间比较采用t检验,以P<0.05为差异有统计学意义。
5结果与结论
5.1本发明中药组合物对大鼠关节肿胀的影响
与空白组相比,模型组与低剂量组在造模24、48h后关节肿胀均有显著作用(P<0.05或P<0.01);与模型组相比,阳性组、青风藤总生物碱组在造模48h后,关节肿胀度极其显著下降(P<0.01)。
注:与空白组比较,&P<0.05,*P<0.01;
与模型组比较,¥P<0.05,△P<0.01
与秋水仙碱片组比较,@P<0.05,#P<0.01。
5.2本发明中药组合物对大鼠血清生化指标的影响
模型组大鼠血清中UA、IL-1β、IL-6以及TNF-α浓度均显著高于空白组(P<0.01);与模型组比较,各给药组大鼠经治疗,血清中UA、IL-1β、IL-6以及TNF-α浓度显著降低(P<0.05或P<0.01),说明本发明中药组合物不仅能够降低痛风模型大鼠的尿酸值,还能够抑制炎症因子的生成。
模型组大鼠血清中ALT、Cys-c、BUN、XOD以及Cr含量均高于空白组,具有极其显著性差异(P<0.01),说明痛风模型可使大鼠的肝脏与肾脏均有不同程度的损伤。与模型组相比较,各给药组大鼠经治疗,血清中ALT、Cys-c、BUN、XOD以及Cr含量显著降低(P<0.05或P<0.01),且呈剂量依赖性。说明本发明中药组合物通过降低这些血生化指标,对肝脏和肾脏起到一定的保护作用。
注:与空白组比较,&P<0.05,*P<0.01;
与模型组比较,¥P<0.05,△P<0.01
与秋水仙碱片组比较,@P<0.05,#P<0.01。
注:与空白组比较,&P<0.05,*P<0.01;
与模型组比较,¥P<0.05,△P<0.01
与秋水仙碱片组比较,@P<0.05,#P<0.01。
5.3本发明中药组合物对大鼠关节滑膜组织生化指标的影响
模型组大鼠关节滑膜组织中UA、IL-1β、IL-6以及TNF-α浓度均显著高于空白组(P<0.01);
与模型组比较,各给药组大鼠经治疗,关节滑膜组织中UA、IL-1β、IL-6以及TNF-α浓度显著降低(P<0.05或P<0.01)。上述结果表明,本发明中药组合物可减轻尿酸钠导致大鼠急性痛风引发的机体炎症反应。
注:与空白组比较,&P<0.05,*P<0.01;
与模型组比较,¥P<0.05,△P<0.01
与秋水仙碱片组比较,@P<0.05,#P<0.01。
综上,本发明中药组合物能够显著改善大鼠痛风性关节炎的足肿胀,降低痛风大鼠血清与关节滑膜组织中UA、IL-1β、IL-6、TNF-α、XOD、BUN、Cr、Cys-c、ALT水平以及大鼠关节滑膜组织中UA、IL-1β、IL-6和TNF-α含量,抑制尿酸形成,对肝肾起保护作用,表现出显著的抗痛风作用。
Claims (10)
1.一种主要由金银花、白花蛇舌草、玄参、山慈菇、地黄、白芍、当归、甘草、蜈蚣、青风藤、鹿衔草组成的中药组合物在制备治疗痛风药物中的用途。
2.如权利要求1所述的用途,其特征在于,所述的痛风可以是原发性痛风或继发性痛风。
3.如权利要求2所述的用途,其特征在于,所述的继发性痛风是指由疾病或药物所引起的痛风。
4.如权利要求3所述的用途,其特征在于,所述的疾病可以是肾功能损伤、肾功能损伤酸中毒、细胞增殖中的任意一种或多种。
5.如权利要求1所述的用途,其特征在于,所述的痛风按照中医辩证是指湿热蕴结证、瘀热阻滞证、痰浊阻滞证或肝肾阴虚证。
8.一种主要由权利要求1-7任一项所述的中药组合物制备而成的制剂;优选的,所述制剂可以为颗粒剂、胶囊剂、丸剂、片剂、软膏剂中的一种或多种;进一步优选的,所述剂型为颗粒剂。
9.如权利要求8所述的制剂的制备方法,其特征在于,所述制备方法主要包括以下步骤:
A、蜈蚣、部分当归粉碎,过筛,备用;
B、金银花水提醇沉法提取,提取液浓缩,干燥,粉碎,得金银花提取物备用;
C、青风藤、白花蛇舌草混合,乙醇回流提取,得药液I;
D、白芍、玄参、生地、山慈菇、鹿衔草、甘草、剩余当归,水提醇沉法提取,得药液II;
E、将步骤C所得药液I与步骤D所得药液II合并,浓缩至稠膏,干燥,粉碎,得提取物备用;
F、将步骤A中所得蜈蚣粉和当归粉、步骤B所得金银花提取物、步骤E所得提取物混合均匀,按照常规制备工艺制成制剂。
10.金藤清痹颗粒在制备治疗痛风药物中的用途。
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