CN104435149A - 一种含有海风藤的治疗痛风的中药组合物 - Google Patents
一种含有海风藤的治疗痛风的中药组合物 Download PDFInfo
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- CN104435149A CN104435149A CN201410638229.8A CN201410638229A CN104435149A CN 104435149 A CN104435149 A CN 104435149A CN 201410638229 A CN201410638229 A CN 201410638229A CN 104435149 A CN104435149 A CN 104435149A
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Abstract
本发明涉及一种中药组合物，具体涉及一种治疗痛风的中药组合物，属于医药技术领域。本发明的治疗痛风的中药组合物为由以下重量配比的药用原料制成的药剂：大黄15～20份、通草12～15份、土元2～5份、海风藤10～12份。本发明治疗痛风的中药组合物，4味药用原料按配比组合后，具有协同增效功能，经临床研究表明，本发明药物用于治疗痛风疗效好，且未发现明显的副作用及不良反应。
Description
技术领域
本发明涉及一种中中药组合物，具体涉及一种治疗痛风的中药组合物，属于医药技术领域。
背景技术
痛风又称高尿酸血症，发病率高、治愈难、反复发作，属于嘌呤代谢障碍引起的代谢性疾病。痛风多发生于中老年人、肥胖者和脑力劳动者，其临床特点为高尿酸血症及由此引起的痛风性急性关节炎反复发作，痛风石沉积、痛风石性慢性关节炎和关节畸形等，以关节红肿、热痛、反复发作、关节活动不灵活为主要临床表现。常累及肾脏引起慢性间质性肾炎和尿酸肾结石形成。根据血中尿酸增高原因可分为原发性和继发性两大类。原发性痛风的病因是由于先天性嘌呤代谢紊乱所致，属遗传性。继发性痛风的病因，可由肾脏病、白血病、药物、食物等多种原因引起，好发于男性及绝经期女性。
目前用于治疗痛风的西药主要有：秋水仙碱、保泰松或羟基保泰松、消炎痛、布洛芬(ibvprofen，异丁苯丙酸)、炎痛喜康(piroxicanum)、萘普生(naproxen消痛灵)、ACTH及强的松等。但上述药物大多只能稳定病情，不能根治痛风；还会引起严重的副作用造成肝肾功能的损害；即使近期治疗有效也不能控制病情复发，而且可产生耐药性和抵抗性，甚至会出现白细胞减少、心脏功能受损、肝肾功能受损、刺激肠胃系统、再生障碍性贫血、导致糖尿病等合并症。
中医学上，痛风属于“痹证”范畴，《血证论》：“痛风、身体不仁、四肢疼痛、今名痛风、古曰痹证”。越来越多的专家认为，从中医的整体观念出发，用中医药整体辨证施治，不失为治疗痛风疾病的又一条佳径；不但中药本身的毒副作用小，而且可降低西药服用量，克服长期单纯服用西药所带来的巨大毒副作用。
发明内容
本发明的目的在于克服现有技术中所存在西药副作用大、治疗不彻底的上述不足，通过申请人建立的中药药效筛选平台，经过反复多次研究，提供一种治疗痛风的中药组合物，该中药组合物治疗痛风疗效好、见效快，且对患者身体副作用小。
为了实现上述发明目的，本发明提供了以下技术方案：
一种治疗痛风的中药组合物，它是由以下重量配比的药用原料制备而成：大黄15～20份、通草12～15份、土元2～5份、海风藤10～12份。所述各种药用原料均为符合国家或地方标准规定的中药材，其中海风藤为膜翅目蚁科Polyrhachis vicina Roger的干燥全虫体。
优选的，上述药用原料配比中，大黄所占重量比例为16～18份。更优选的，大黄所占重量比例为18份。
优选的，上述药用原料配比中，通草所占重量比例为13～14份。更优选的，通草所占重量比例为14份。
优选的，上述药用原料配比中，土元所占重量比例为3～5份。更优选的，土元所占重量比例为4份。
优选的，上述药用原料配比中，海风藤所占重量比例为6～12份。更优选的海风藤所占重量比例为12份。
本发明的治疗痛风的中药组合物，可以按照中药学上常规的提取方法提取药用原料的活性组分，再加上药学上可接受的载体或/和辅料，如淀粉、糊精、微晶纤维、可压性淀粉、硬脂酸镁、微粉硅胶、蔗糖、羧甲基淀粉钠、羟丙基甲基纤维素、植物油、卵磷脂、聚乙二醇、丙二醇、尼泊金乙酯等，制成药剂学上适宜的剂型，如颗粒剂、片剂、硬胶囊、口服液、软胶囊、滴丸、水泛丸等。
本发明中药组合物的提取方法可以采用但不限于以下方法：
(1)按配方比例取各药用原料，向药用原料中加入药用原料体积8～10倍的60～80％乙醇，或水，回流提取2～3次，提取时间分别为1～2h，收集合并提取液，并将提取液浓缩成浸膏，干燥，得到本发明中药组合物的药用原料的提取物。
(2)将上述提取物制成药剂学上可接受的各种药物剂型。
根据制备各种剂型药物的需要，本发明药物在制备过程中还可加入适当的药用辅料如填充剂、崩解剂、粘合剂、润滑剂、防腐剂等。
与现有技术相比，本发明的有益效果：本发明治疗痛风的中药组合物，是发明人基于祖国医学对痛风的发病机理的认识和利用申请人创制的中药复方药效筛选平台，根据自己多年临床经验，先从众多中药中确定一系列治疗痛风有效的中药，再经临床反复验证，而筛选出来的，其中大黄具有具有攻积滞、清湿热、泻火、凉血、祛瘀、解毒等功效；通草湿利水；通乳。主淋症涩痛；小便不利；水肿；黄疸；湿温病；小便短赤；产后乳少；经闭；带下。用于湿温尿赤，淋病涩痛，水肿尿少，乳汁不下；土元(Eupolyphagasinensis Walker)破瘀血，续筋骨。用于筋骨折伤，瘀血经闭，症瘕痞块；海风藤祛风湿，通经络，止痹痛。用于风寒湿痹，肢节疼痛，筋脉拘挛，屈伸不利。4味药用原料按所述配比组合具有协同增效功能，经临床研究试验，本发明的中药组合物用于治疗痛风疗程短、见效快，给药4天后，即可见效，且疗效显著，患者服药期间未出现明显不良反应。
具体实施方式
下面结合试验例及具体实施方式对本发明作进一步的详细描述，但不应将此理解为本发明上述主题的范围仅限于以下的实施例，凡基于本发明内容所实现的技术均属于本发明的范围。
本发明的实施例和对比例中所用乙醇均为乙醇的水溶液，乙醇的百分含量，如无特殊说明，均为体积百分含量。
实施例1
本实施例的治疗痛风的中药组合物，是由以下重量配比的药用原料制备而成：大黄15g、通草12g、土元4g、海风藤10g。
上述药用原料的提取方法：按配方比例取药用原料，向药用原料中加水回流提取两次2次，2次的用水体积均为药用原料体积的10倍，2次回流提取时间依次为2h、1h。每次回流完后，过滤并收集滤液，合并2次滤液，得到本实施例药用原料的提取液。将合并后的提取液浓缩至相对密度1.15(80℃)，得实施例1的提取物。
向上述提取物中加入提取物重量2倍重量的可溶性淀粉，制粒，干燥，分装成袋，得到颗粒剂。
实施例2
本实施例的治疗痛风的中药组合物，是由以下重量配比的药用原料制备而成：大黄18g、通草14g、土元4g、海风藤12g。
上述药用原料的提取方法：
按配方比例取药用原料，向药用原料中加入80％乙醇，回流提取3次，3次所用80％乙醇的体积均为药用原料体积的10倍，3次回流提取时间依次为2h、1h和1h，每次回流完后，过滤并收集滤液，合并3次滤液，除去滤液中的乙醇得到实施例2药用原料的提取液。
实施例3
本实施例的治疗痛风的中药组合物，是由以下重量配比的药用原料制备而成：大黄20g、通草15g、土元5g、海风藤12g。
上述药用原料的提取方法：
(1)按配方比例取大黄药材，向大黄中加入水回流提取三次，三次回流所用水的体积均为大黄体积的8倍，三次的提取时间分别为2.0h、1.5h和1.5h，每次回流后，过滤并收集滤液，合并3次滤液得大黄提取液，将大黄提取液浓缩至相对密度为2.48(80℃)；然后向浓缩后的大黄提取液中，加等体积水稀释，然后静置沉淀24h，过滤并收集上层清液，将上层清夜浓缩成稀浸膏，然后干燥至恒重，得到大黄提取物。
(2)按配方比例取通草药材，向通草中加入60％乙醇回流提取3次，3次回流所用60％乙醇的体积均为通草体积的6倍；3次回流提取的时间均为2h；每次回流提取后，过滤并收集滤液，合并3次滤液，将滤液浓缩至相对密度为2.51(80℃)；然后用乙酸乙酯分3次萃取通草提取物,每次萃取加入等体积的乙酸乙酯；合并3次萃取的乙酸乙酯层，回收乙酸乙酯和乙醇后，得通草提取液，干燥通草提取液至恒重,得通草提取物。
(3)按配方比例取土元药材，向土元中85％乙醇，回流提取3h，所述85％乙醇的体积为土元体积的10倍，收集提取液，离心除去提取液中的沉淀，干燥上清液至恒重，得到土元提取物。
(4)按配方比例取海风藤粉碎，过80目筛，即得。
(5)将上述(1)至(4)得到的各物料混合均匀，得实施例3药用原料的提取物。
实施例4
本实施例的治疗痛风的中药组合物，是由以下重量配比的药用原料制备而成：大黄12g、通草15g、土元3g、海风藤12g。
本实施例的药用原料按实施例3的提取方法提取药用原料的活性组分后，得到实施例4药用原料的提取物。
实施例5
本实施例的治疗痛风的中药组合物，是由以下重量配比的药用原料制备而成：大黄12g、通草13g、土元2g、海风藤11g。
本实施例的药用原料按实施例3的提取方法提取药用原料的活性组分后，得到实施例5药用原料的提取物。
实施例6
本实施例的治疗痛风的中药组合物，是由以下重量配比的药用原料制备而成：大黄16g、通草14g、土元3g、海风藤11g。
上述药用原料的提取方法：按配方比例取药用原料，将所述药用原料混和在一起，向所述药用原料中加入水煎煮提取2次，两次煎煮的用水体积分别为药用原料体积的10倍和8倍，两次的煎煮时间分别为2h和1.5h,每次煎煮后过滤并收集滤液，将2次滤液混合均匀，得本实施例药用原料的提取物。
对比例1
本对比例的治疗痛风的中药组合物，是由以下重量配比的药用原料制备而成：大黄18g、通草14g、土元4g。
上述药用原料的提取方法：按配方比例取药用原料，向药用原料中加入80％乙醇，回流提取3次，3次所用80％乙醇的体积均为药用原料体积的10倍，3次回流提取时间依次为2h，1h和1h；每次回流完后，过滤并收集滤液；将3次收集的滤液合并，除去滤液中的乙醇后，得对比例1药用原料的提取液。
对比例2
本实施例的治疗痛风的中药组合物，是由以下重量配比的药用原料制备而成：大黄18g、通草14g、海风藤12g。。
上述药用原料的提取方法：按配方比例取药用原料，向药用原料中加入80％乙醇，回流提取3次，3次所用80％乙醇的体积均为药用原料体积的10倍，3次回流提取时间依次为2h，1h和1h；每次回流完后，过滤并收集滤液；将3次收集的滤液合并，并混合均匀，除去滤液中的乙醇后，得对比例2药用原料的提取液。
药效学和毒性试验：
为了证实本发明药物的疗效和安全性，发明人进行了药效学和毒性试验考察。所采用的研究方法及试验结果如下：
1、试验材料
(1)药物及试剂：
根据实施例2制备的实施例2药用原料提取液；
根据对比例1制备的对比例1药用原料提取液；
根据对比例2制备的对比例2药用原料提取液；
秋水仙碱：为云南植物药业有限公司产品。
(2)动物：昆明种小鼠、SD大鼠，由四川抗菌素研究所实验动物中心提供。
2、试验方法与结果
(1)对高尿酸血症小鼠血尿酸水平的影响
取昆明种小鼠60只，雌雄皆用，体重18～22g，随机分为六组，每组10只，第一组为生理盐水组，第二组为本发明药物实验组(20g生药材/kg)，第三组为阳性对照组，第四组为对照组1，第五组为对照组2，第六组为模型组。
对第一组按8g/kg的剂量灌服生理盐水，第二组按20g生药材/kg的剂量灌服本发明实施例2制备的中药组合物，第三组按0.1mg/kg的药剂剂量灌服秋水仙碱，第四组按20g生药材/kg的剂量灌服对比例1制备的中药组合物，第五组按20g生药材/kg的剂量灌服对比例2制备的中药组合物，第六组不作任何处理，每日1次，连续4d。
末次给药1h后，除生理盐水组外，其余各组，即第二组到第六组，动物腹腔注射次黄嘌呤1mg/kg，造成小鼠高血尿酸，生理盐水组按1mg/kg注射生理盐水。注射后0.5h，对各组动物摘眼球取血，将取得的血液在3000r/min的转速条件下离心15min后，取血清测血尿酸值。表1为各实验组和对照组经处理后，血尿酸测量值的统计结果。
表1
注：与模型组比较:**P<0.01；与对照组1比较:▲▲P<0.01；与对照组2比较:◆◆P<0.01。
表1中,本发明药物实验组测得血尿酸值为151±16umol/l：相对模型组测得的血尿酸值，P<0.01，具有显著性差异；与生理盐水组的血尿酸值132±24umol/l及阳性对照组的血尿酸值159±15umol/l接近；本发明治疗痛风的中药组合物治疗痛风具有很好的疗效。
表1中,对照组1和对照组2测得血尿酸值分别为269±34umol/l和285±39umol/l，相对本发明药物实验组测得血尿酸值为151±16umol/l明显升高，为生理盐水组的血尿酸值132±24umol/l的2倍左右，对比例1和对比例2制得的中药组合物，治疗痛风疗效差；本发明药物实验组的血尿酸测量值较对照组1和对照组2的血尿酸测量值显著降低；本发明药物实验组的血尿酸测量值与对照组1的血尿酸测量值比较，P＜0.01，具有显著性差异；本发明药物实验组的血尿酸测量值与对照组2的血尿酸测量值比较，P＜0.01，具有显著性差异。由此得知，4种药用原料按所述重量配比组合后，具有协同增效功能，能显著提高中药组合物的疗效，缺少任意组分，中药组合物的疗效均显著下降。
综上所述，本发明治疗痛风的中药组合物，治疗痛风的疗程短，见效快，给药4天即可见效；疗效显著，给药4天后，注射次黄嘌呤后，本发明药物实验组的血尿酸测量值均不会发生显著升高现象；4种药用原料按所述重量配比组合后，具有协同增效功能，能显著提高中药组合物的疗效，缺少任意组分，或任意组分超出所述重量配比范围，其疗效均显著下降，如对照组1和对照组2，注射次黄嘌呤后，测得血尿酸值相对本发明药物实验组的血尿酸测量显著提高。
Claims (8)
1.一种含有海风藤的治疗痛风的中药组合物，其特征在于：它是由以下重量配比的药用原料制备而成：大黄15～20份、通草12～15份、土元2～5份、海风藤10～12份。
2.根据权利要求1所述的治疗痛风的中药组合物，其特征在于：大黄所占重量比例为16～18份。
3.根据权利要求2所述的治疗痛风的中药组合物，其特征在于：大黄所占重量比例为18份。
4.根据权利要求1所述的治疗痛风的中药组合物，其特征在于：通草所占重量比例为13～14份。
5.根据权利要求4所述的治疗痛风的中药组合物，其特征在于：通草所占重量比例为14份。
6.根据权利要求1所述的治疗痛风的中药组合物，其特征在于：土元所占重量比例为3～5份。
7.根据权利要求6所述的治疗痛风的中药组合物，其特征在于：土元所占重量比例为4份。
8.根据权利要求1所述的治疗痛风的中药组合物，其特征在于：海风藤所占重量比例为12份。
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