CN104435893B - 抗痛风、抗炎、活血化瘀、镇痛的中药组合物 - Google Patents

抗痛风、抗炎、活血化瘀、镇痛的中药组合物 Download PDF

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CN104435893B
CN104435893B CN201410754719.4A CN201410754719A CN104435893B CN 104435893 B CN104435893 B CN 104435893B CN 201410754719 A CN201410754719 A CN 201410754719A CN 104435893 B CN104435893 B CN 104435893B
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赵玉
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Abstract

本发明为抗痛风、抗炎、活血化瘀、镇痛的中药组合物，解决治疗痛风病的中药方剂不能消除病因，抗痛风作用、抗炎作用较差的问题。它是由如下重量份的原料制成：防己1111—1667，骨碎补1999—2999，皂角刺1666—2499，川牛膝1666—2499，没药1666—2499，鹿衔草1666—2499，金银花2665—3998，板蓝根3332—4998，苍术1999—2999，关黄柏1111—1667，薏苡仁2221—3332，天竺黄1999—2999，胆南星999—1499。

Description

抗痛风、抗炎、活血化瘀、镇痛的中药组合物
技术领域：
本发明与治疗痛风病的中药组合物有关。
背景技术：
临床常用治疗痛风病的中药方剂身痛逐瘀汤配方为：秦艽9g、香附6g、羌活9g、川芎9g、没药6g、地龙9g、炒五灵脂6g、桃仁9g、红花9g、牛膝9g、当归9g、甘草6g。该方只注意於驱风、除湿、活血止痛，对通络化顽痰、通痹效果不明显，再者痛风与风湿病因无直接关系，而该方又易伤胃津、损脾阳，而该方的没药、灵脂活血止痛力显不足，川芎、红花、桃仁又易伤津耗液引邪深入。
发明内容：
本发明的目的是提供一种以清热解毒、通瘀化痰、除三焦湿毒、化脉络顽痰、通痹止痛以利关节，抗痛风、抗炎、活血化瘀、镇痛的中药组合物。
本发明是这样实现的：
本发明是以如下重量份的原料制成：
防己 1111—1667，
骨碎补 1999—2999，
皂角刺 1666—2499，
没药 1666—2499，
川牛膝 1666—2499，
鹿衔草 1666—2499，
金银花 2665—3998，
板蓝根 3332—4998，
苍术 1999—2999，
关黄柏 1111—1667，
薏苡仁 2221—3332，
天竺黄 1999—2999，
胆南星 999—1499。
苍术、关黄柏、川牛膝低浓度乙醇回流提取3次，每次30分钟，滤过，滤液回收乙醇，另存,备用，防己、皂角刺、骨碎补、没药、鹿衔草、金银花、板蓝根、薏苡仁、天竺黄、胆南星共煎两次，每次1小时，滤过，滤液备用，合并两次滤液及上述药液，浓缩成浸膏，将浸膏干燥，收集干浸膏粉末，加入糊精、阿斯巴甜和甜菊糖苷，混合，粉碎，加乙醇过12目筛，干燥，制成颗粒剂。
目前在医药领域尚无治疗痛风病的中成药，本发明为首创的以清热解毒、通瘀化痰、除三焦湿毒、化脉络顽痰、通痹止痛以利关节为治疗痛风病的中药组方制成颗粒冲剂。目前暂无市售治疗痛风病的任何中成药。
本发明与临床常用治疗痛风病的中药方剂身痛逐瘀汤有如下区别：
（1）处方组成不同：
本发明处方：金银花、板兰根、苍术、黄柏、苡仁、天竺黄、胆南星、汉防杞、皂刺、骨碎补、川牛膝、鹿衔草、没药十三味中药组成。
（2）身疼逐瘀汤处方：秦艽、香附、羌活、川芎、没药、地龙、炒五灵脂、桃仁、红花、牛膝、当归、甘草十二味药材组成的汤剂。
本发明与身痛逐瘀汤配方只两味药牛膝、没药相同，余药异之。历史沿用都是治疗痛痹的方剂。
（3）药物组成分析：
①本发明处方中金银花、板兰根、黄柏清热解毒，除三焦毒热为主。身疼逐瘀汤没有瘀、痰为热、毒久蕴而成，故本发明优於消病因为主。
②本发明处方中：苍术、苡仁、天竺黄、胆南星、除三焦湿热，化脉络顽痰，优於身疼逐瘀汤的灵脂、红花、地龙、秦艽。
③本发明处方中：汉防杞、骨碎补、鹿衔草除六经湿热，利关节水湿，优於身疼逐瘀汤中的牛膝、川芎、香附的功能。
④本发明中皂刺、川牛膝、没药的通络、通痹、止痛功能优强於身疼逐瘀汤中的羌活、地龙、当归。
⑤本发明中的君药金银花、板兰根以清热解毒见长，以解除阻碍脉络循环中痰、瘀的形成起到关键作用。痛风的主要病因应属中医的风、痰、火、毒为主因。历来各医学文献未有准确的病因认识和西医对痛风的病因<酶>代谢紊乱的中西医理论的汇通，所以目前对痛风的治疗方法缺失或不准确。凡治疗痛风病首先选用中药治疗必须将西医学<痛风>病的病因病机与中医理论相汇通、结合方能有效的应用中医方法和中药的方药治疗其根本原因，本发明将西医学<痛风>病的病因病机与中医理论相汇通、结合，以银花、板兰根清热解毒，胆南星、天竺黄化顽痰，皂角刺通络，没药止痛为特色的治疗方法，彻底根除痛风的痛因以达全愈。
本发明从以下三方面体现其特色：
（1）没有辛燥、大苦、大寒的药品伤津耗气，对肝、脾、肾功能没有明显的毒付作用。
（2）理论上突破了（痛风）病对中医病名的汇通为痛痹，病因为痰、瘀、火毒、病机为脉络瘀阻。
（3）用药以清、疏、通为大法，无收敛、重浊、辛发之品，从而避免了伤脾胃损肺肾之阴精，阳气血之害。无敛邪留寇之虑。
从以上分析是以表现本发明的理、法、方、药的精确组合和中医以痛风病的有效汇通以达到临床应用的重大意义和独具特色的优势。
两方功效比较：
本发明为清热解毒、通瘀化痰，尤以通络除顽痰为宗旨以达通痹止痛利关节的作用。
两方均为治疗痛痹的方法，但本发明重在清热解火毒，通络以除痰的病因机制，身疼逐瘀汤重大以驱风和血治痛，在病因、病机上与痛风的西医病名有明显差异。
本发明与身痛逐瘀汤方的适应证均为治疗血瘀痰阻、湿热火毒、痛痹，其病症均为痹证病史较长，反复发作，指趾关节红肿，痛热、疼痛剧烈、日轻夜重、兼有口渴、发热、小便赤热、大便干结、舌尖红、苔厚腻等特点的治疗，但身疼逐瘀汤以活血、驱风、止疼为主，本发明以清热解毒、活血通络、澄本清源为主的特色理、法、方药为主的治疗方法。
本发明经动物急性毒性试验，测定其LD50=109.1383g生药/kg，相当于人用量1.808g生药/kg的60倍。
本发明经长期毒性试验，大剂量36g生药/kg（相当于人用量1.808g生药/kg的19.9倍）；中剂量18 g生药/kg（相当于人用剂量1.808g生药/kg的10倍）；小剂量9 g生药/kg（相当于人用剂量1.808g生药/kg的5倍）连续给药6个月，除部分指标外，大部分指标与对照组比较无显著性差异；组织病理学检查结果未见明显的与受试药物有关的病理改变。
本发明经动物药效实验，结果说明：
①具有较好的抗痛风作用；
②有明显的抗炎作用；
③有一定的镇痛作用；
④有一定的活血化瘀作用。
本发明具功效，清热解毒、通瘀化痰、通痹止痛以利关节主治痛痹（慢性痛风）类风湿性关节炎，韧带粘连性肩周疾病。
颗粒剂中柚皮苷（C21H18O11）含量为1.0mg/g，苍术素（(Cl3H10O)含量为1.0mg/g。
临床试验拟定口服本发明的的实施例1或2或3或4制成的痛风颗粒剂，一次15g，一日3次。
根据《现代中医内科学.何绍奇主编》对痛风的诊断标准及《中西医结合内科学.崔玲主编》对痛风的诊断标准为依据，制定的诊治指南，确定的诊断标准，确定符合痛风患者，治疗组100例，对照组100例，以身痛逐瘀汤作为对照，疗程30天。结果显示：治疗组对抗炎、镇痛、活血化瘀、抗痛风的疗效优于对照组（P＜0.05）。100例中，治愈89例（89.0%）好转8例（8%）无效3例（3%）总有效率为97%。未发现明显不良反应，也未发现肝肾功能损害，服药安全。
临床治疗范围：痛风，中医病名痹证，分类为痛痹。应用剂型：颗粒剂每袋15克。服用方法：急性期（成人量）每次15g,一日3次，（饭后半小时温开水冲服）慢性期：每次15g,一日2次，（饭后半小时温开水冲服）.急慢性痛风病人需服三个疗程，每个疗程为30天，共90天为全程治疗。禁忌：服药期忌食海鲜产品、动物内脏、高脂类食品、啤酒、红酒、辛辣食品。
颗粒剂注意事项：低血压、低血糖、血小板减少症、严重心脑疾病、胃肠溃疡型病人慎服。与地平类降压药、阿斯匹林、呋噻类利尿药不可同服。合并高尿酸血症，每日晨口服10%碳酸氢钠水（苏打水）300ml，以辅助疗效。
具体实施方式：
实施例1：
本发明痛风颗粒制剂处方：
防己1111 g 骨碎补1999 皂角刺 1666g 没药1666g 川牛膝1666g 鹿衔草1666g金银花2665g 板蓝根3332g 苍术1999g 关黄柏1111g 薏苡仁2221g 天竺黄 1999g 胆南星999g。
制备工艺：
苍术、关黄柏、川牛膝低浓度乙醇回流提取3次，每次30分钟，滤过，滤液回收乙醇，另存,备用，防己、皂角刺、骨碎补、没药、鹿衔草、金银花、板蓝根、薏苡仁、天竺黄、胆南星共煎两次，每次1小时，滤过，滤液备用，合并两次滤液及上述药液，浓缩成浸膏，将浸膏干燥，收集干浸膏粉末，加入糊精、阿斯巴甜和甜菊素，混合，粉碎，加乙醇过12目筛，干燥，制成颗粒剂。
实施例2：
本发明痛风颗粒制剂处方：
防己1667g 骨碎补2999g皂角刺 2499g 没药2499g 川牛膝2499g鹿衔草2499g金银花 3998g 板蓝根4998g 苍术2999g 关黄柏1667g 薏苡仁3332g 天竺黄 2999g 胆南星1499g。
制备工艺与实施例1相同。
实施例3：
本发明痛风颗粒剂处方：
防己1200g 骨碎补2800g 皂角刺 2300g 没药1670g 川牛膝1800g鹿衔草1900g金银花 2670g 板蓝根3350g 苍术2100g 关黄柏1650g 薏苡仁3330g 天竺黄 2100g胆南星1000 g。
制备工艺与实施例1相同。
实施例4：
本发明痛风颗粒剂处方：
防己1500g 骨碎补2500g 皂角刺2000g 没药2000g 川牛膝2000g鹿衔草2000g 金银花 3500g 板蓝根3800g 苍术2500g 关黄柏1300g 薏苡仁2800g 天竺黄 2500g胆南星1200g。
制备工艺与实施例1相同。

Claims (2)

1.抗痛风、抗炎、活血化瘀、镇痛的中药组合物，其特征在于它是由如下重量份的原料制成：
防己 1111—1667
骨碎补 1999—2999
皂角刺 1666—2499
川牛膝 1666—2499
没药 1666—2499
鹿衔草 1666—2499
金银花 2665—3998
板蓝根 3332—4998
苍术 1999—2999
关黄柏 1111—1667
薏苡仁 2221—3332
天竺黄 1999—2999
胆南星 999—1499。
2.根据权利要求1所述的抗痛风、抗炎、活血化瘀、镇痛的中药组合物，它是用下述方法制成的颗粒剂：
苍术、关黄柏、川牛膝低浓度乙醇回流提取3次，每次30分钟，滤过，滤液回收乙醇，另存,备用，防己、皂角刺、骨碎补、没药、鹿衔草、金银花、板蓝根、薏苡仁、天竺黄、胆南星、共煎两次，每次1小时，滤过，滤液备用，合并两次滤液及上述药液，浓缩成浸膏，将浸膏干燥，收集干浸膏粉末，加入糊精、阿斯巴甜和甜菊糖苷，混合，粉碎，加乙醇过12目筛，干燥，制成颗粒剂。
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