CN113679796A - 用于治疗痛风的药物及其制备方法 - Google Patents
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Abstract
本发明提供一种用于治疗痛风的药物,由以下重量份的组份组成:土茯苓10‑30份,威灵仙10‑30份,黄芪10‑30份,秦皮5‑15份,炒苍术5‑15份,防风5‑15份,银杏叶5‑15份,卷柏5‑15份,鸡血藤5‑15份,猫须草5‑15份。本发明还提供了用于治疗痛风的药物的制备方法,将药物有效成分提取出来制成浸膏粉加入特定的辅料制成的片剂,具有崩解时间短,抗湿性强等特点,而且本发明的用于治疗痛风的药物在治疗痛风性关节炎具有显著的疗效。
Description
技术领域
本发明涉及中药制剂技术领域,尤其涉及一种用于治疗痛风的药物及其制备方法。
背景技术
痛风是由于人体内嘌呤代谢紊乱导致尿酸过多、单钠尿酸盐MSU沉积在关节或关节周围所致的炎症性关节疾病,痛风的发生受种族、年龄、性别、地区分布、环境因素、生活方式、疾病、职业和饮食等影响,在临床上会出现急性痛风性关节炎、高尿酸血症、痛风石沉积、痛风性肾病、肾炎等症状。
现代医学根据痛风病因不同,痛风可分为原发性痛风和继发性痛风两大类。原发性痛风指在排除其他疾病的基础上,因为先天性嘌呤代谢紊乱或尿酸排泄障碍所引起的痛风。在临床上,原发性痛风分为四期,即无症状期、急性关节炎期、痛风石及慢性关节炎期与慢性痛风性肾病期。继发性痛风指继发于肾脏疾病或某些药物所致的尿酸排泄减少、骨髓增生性疾病及肿瘤化疗所致的尿酸生成增多等而引起的痛风。
痛风在治疗上,西医多采用抑制血尿酸形成和促进血尿酸排泄及解热、消炎、止痛等对症治疗,临床疗效好,但明显的不良反应限制了其广泛应用。后来人们逐渐认识化学药物的长期使用,其毒副作用、不良反应、复发率高等问题显著。长期以来祖国医药学在痛风治疗方面积累了丰富的经验,中医更强调整体的治疗,标本兼治预防为主,中药以不良反应少而著称。中医学指出痛风属风湿热痹之证,表现为湿热内蕴、气血不通、热邪瘀阻。很多中药具有祛湿除痹、利水消肿、行气活血、散瘀止痛的功效,能够用来治疗痛风。研究证明中药的化学成分复杂,具有多靶点的治疗效果,从中药中筛选出治疗痛风的中药具有重要意义。
片剂系指药物与适宜的辅料混匀压制而成的圆片状或异形片状的固体制,与胶囊剂、针剂并称为药物三大剂型。片剂的特点:1)相较于针剂,片剂药物方便运输,便于携带。2)片剂药物的生产自动化程度相比于其他剂型较高,因此其生产成本低。3)片剂药物有较好的化学稳定性,在包衣膜的保护下,受存储环境的影响小,不易发生变质。4)片剂外观一般光洁美好,其外表包衣可以遮盖药物本身的气味。5)片剂吞服比散剂方便,比液体药则可省用量具,药师在调配片剂处方时不用称量,方便省时。因此,片剂具有许多其他类型药物所不具备的优势。
CN 112023012 A公开了一种治疗痛风的中药,由芦荟叶、白蒺藜、艾叶、玄明粉、水蛭、生大黄等29味原材料制成,其原料成分太多且治疗痛风性关节炎时的总有效率只有97%。
CN 112641908 A公开了一种治疗痛风性关节炎的组合物及其制备方法,该方法中药物的有效成分的提取为将大黄和刘寄奴进行醇提、其余成分进行水提的方式分别收集清膏,然后将得到两种清膏混合、干燥、粉碎,加入辅料制成口服剂型,在治疗痛风性关节炎的临床实验中最佳总有效率为98%。
发明内容
有鉴于现有技术的上述缺陷,本发明所要解决的技术问题是提供一种治疗痛风性关节炎效果更好的药物。
为实现上述目的,本发明提供了一种用于治疗痛风的药物的制备方法,由该方法制备得到的药物在治疗痛风性关节炎中疗效显著,而且该药物的崩解时间短、抗湿性强。
为了实现上述发明目的,本发明采用了如下的技术方案:
一种用于治疗痛风的药物,包括下面所述原材料:土茯苓、威灵仙、黄芪、秦皮、炒苍术、防风、银杏叶、卷柏、鸡血藤、猫须草。
一种用于治疗痛风的药物,包括下述重量份的原料:土茯苓10-30份,威灵仙10-30份,黄芪10-30份,秦皮5-15份,炒苍术5-15份,防风5-15份,银杏叶5-15份,卷柏5-15份,鸡血藤5-15份,猫须草5-15份。
本发明还公开了一种用于治疗痛风的药物,所述药物的剂型为片剂,其制备方法如下:
S1按照配方称取各原料干燥、粉碎、过筛得中药材混合物;
S2将步骤S1得到的中药材混合物用体积百分比浓度为60-80%的乙醇水溶液回流提取,乙醇水溶液的重量为所述中药材混合物重量的8-12倍,提取2-3次,每次0.5-2小时,将提取完毕的混合液过滤,分离滤液和滤渣,滤液浓缩至60~80℃时测定相对密度为1.20-1.30的浸膏,得提取浸膏A,药渣备用;
S3将步骤S2得到的药渣,加水加热至90~110℃,水的重量为药渣重量的5-10倍,提取2-3次,每次0.5-2小时,将提取完毕的混合物过滤,分离滤液和滤渣,滤液浓缩至60~80℃时测定相对密度为1.20-1.30的浸膏,得提取浸膏B;
S4、将提取浸膏A和提取浸膏B合并,得总提取浸膏,60-80℃真空干燥,研磨得浸膏粉,所述浸膏粉水含量为2~3%;
S5、按照如下重量百分比称取各组分:2~3%粘合剂,60~85%填充剂,2~3%附加剂,余量为浸膏粉,混合均匀后,进行干法制粒,干燥,压片即得用于治疗痛风的药物。
所述步骤5)中粘合剂为聚乙烯吡咯烷酮、聚醋酸乙烯酯、明胶中的一种或两种及两种以上的混合;优选的粘合剂为聚乙烯吡咯烷酮。
所述步骤5)中填充剂为微晶纤维素、异麦芽酮糖、微粉硅胶中至少一种。进一步优选的,所述步骤5)中填充剂由微晶纤维素、异麦芽酮糖、微粉硅胶的质量百分数为,40~60%微晶纤维素、10~30%异麦芽酮糖、10~30%微粉硅胶。
所述步骤5)中附加剂为马铃薯淀粉或改性淀粉;
所述改性淀粉的制备方法为:将5~20g马铃薯淀粉加入到50-100mL水中;80-90℃下加热搅拌至淀粉完全糊化;冷却至20-30℃,出现凝胶;将凝胶置于0-10℃的水中10-12小时;取出凝胶浸入60-80wt%乙醇水溶液中,浸泡时间为24-48小时;取出凝胶置于40-60℃下干燥6-8小时、研磨得到改性淀粉。
对本发明所用的组份说明如下:
土茯苓,为百合科植物光叶菝葜Smilax glabra Roxb.的干燥根茎,味甘、淡,性平。有解毒,除湿,通利关节之功效,主要用于梅毒及汞中毒所致的肢体拘挛,筋骨疼痛;湿热淋浊,带下,痈肿,瘰疬,疥癣。
威灵仙,为毛茛科植物威灵仙Clematis chinensis Osbeck、棉团铁线莲Clematishexapetala Pall.或东北铁线莲Clematis manshurica Rupr.的干燥根和根茎,性辛、咸,温。归膀胱经。具有祛风湿,通经络的效果。用于风湿痹痛,肢体麻木,筋脉拘挛,屈伸不利。
黄芪,为豆科植物蒙古黄芪Astragalus membranaceus(Fisch.)Bge.var.mongholicus(Bge.)Hsiao或膜荚黄芪Astragalus membranaceus(Fisch.)Bge.的干燥根。性甘,微温。归肺、脾经。具有补气升阳,固表止汗,利水消肿,生津养血,行滞通痹,托毒排脓,敛疮生肌等功效。用于气虚乏力,食少便溏,中气下陷,久泻脱肛,便血崩漏,表虚自汗,气虚水肿,内热消渴,血虚萎黄,半身不遂,痹痛麻木,痈疽难溃,久溃不敛。
秦皮,中药名。为木犀科植物苦枥白蜡树、白蜡树、尖叶白蜡树或宿柱白蜡树的干燥枝皮或干皮。味苦、涩,性寒。主治:清热燥湿、收涩止痢,止带,明目。用于热毒泻痢、赤白带下、目赤肿痛、目生翳障。
炒苍术,又名麸炒苍术,辛、苦,温。归脾、胃、肝经。燥湿健脾,祛风散寒,明目。用于脘腹胀满,泄泻,水肿,风湿痹痛,风寒感冒,夜盲。
防风,为伞形科植物防风Saposhnikovia divaricate(Turcz.)Schischk.的干燥根,味辛、甘,性微温。具有祛风解表,胜湿止痛,止痉的功效。用于感冒头痛,风湿痹痛,风疹瘙痒,破伤风。
银杏叶,为银杏棵植物银杏Ginkgo biloba L.的干燥根。性甘、苦、涩,平。归心、肺经。活血化瘀,通络止痛,敛肺平喘,化浊降脂。用于瘀血阻络,胸痹心痛,中风偏瘫,肺虚咳喘,高脂血症。
卷柏,为卷柏科植物卷柏Selaginella tamariscina(Beauv.)Spring或垫状卷柏Selaginella pulvinata(Hook,etGrev.)Maxim.的干燥全草。性辛,平。归肝、心经。活血通经。用于经闭痛经,癥瘕痞块,跌扑损伤。卷柏炭化瘀止血。用于吐血,崩漏,便血,脱肛。
鸡血藤,为豆科植物密花豆Spatholobus suberectus Dunn的干燥藤茎。性苦、甘,温。归肝、肾经。活血补血,调经止痛,舒筋活络。用于月经不调,痛经,经闭,风湿痹痛,麻木瘫痪,血虚萎黄。
猫须草(clerodendranthus spicatus Thunb)其傣名为雅糯渺,又名肾茶,是唇形科肾茶属植物,是一种珍贵的药用保健植物,含有肌醇、硫酸钙、黄酮类、挥发油、戊糖、皂甙、戊糖、葡萄糖醛酸以及多种有机酸的钙盐、钾盐,性甘淡,味苦凉,具有清热祛湿、排石利水的功效。可用于治疗急性肾炎、膀胱炎、黄疸、尿路结石、风湿性关节炎等多种肾系疾病。
中医学者认为痰浊、瘀血影响肝、脾肾等脏器从而引起高尿酸血症的发作。《内经》曰“风寒湿三气杂至,合而为弊也”,说明弊病与外邪侵袭有关,而且气血虚的患者感受风邪也容易出现急性痛风性关节炎发作。高尿酸血症多以体虚为本,感受湿邪、风邪、瘀血之邪,堆积于体内,形成湿浊、痰湿,瘀血等标实之证;痛风的发生内外因皆有,痰湿体质、体型偏胖、喜食肥甘厚腻、饮酒过多者伤及脾胃,湿浊内生,长期痹阻体内发为此病,若痰浊留于关节,日久则发为痛风。
本发明基于祖国医学对痛风发病机理的认识及治疗原则,参考现代药理的研究成就,结合现代有关研究资料和长期临床实践,认为与脾、肾之间有密不可分的关系。本发明筛选出湿泻浊、通络止痛、活血清热药方,土茯苓、威灵仙、炒苍术、防风可以泄浊、通利关节,健脾除湿,黄芪补中益气,鸡血藤补血活血,猫须草调益脾肾,各味药方合理配伍,起到治疗痛风的效果。
本发明适应症状:用于湿热浊毒、脾湿下注、寒热相搏、引起的关节红肿热痛、痛风等。
本发明的有益效果:(1)本发明通过各组分的合理配伍,制备得到的用于治疗痛风药物在治疗痛风性关节炎的临床实验中总有效率达到100%;(2)本发明选择特定的辅料,制得的片剂具有崩解时间短、抗吸湿性强等特点。
具体实施方式
结合一下具体实施例,对本发明作进一步的详细说明。实施发明的过程、条件、实验方法等,除以下专门提及的内容之外,均为本领域的普通知识和公知常识,本发明没有特别限制内容。
聚乙烯吡咯烷酮,含量为99%,食品级。
微晶纤维素,购买于江苏奥福生物科技有限公司,有效物质含量为99%,型号为食品级。
异麦芽酮糖,购买于河南宣丰生物科技有限公司,含量为99%,级别为食品级。
微粉硅胶,购买于赣州洛华医药有限公司,密度为2.2g/cm3,熔点为1723℃,折射率为1.6。
马铃薯淀粉,购买于苏州蛟骐环保科技有限公司,含量≥98%,密度为2.5g/cm3,型号为JQ-019。
实施例1
用于治疗痛风的药物的制备方法,包括如下步骤:
S1称取20g土茯苓、20g威灵仙、20g黄芪、10g秦皮、10g炒苍术、10g防风、10g银杏叶、10g卷柏、10g鸡血藤、10g猫须草干燥、粉碎、过10目筛混合均匀得中药材混合物;
S2将步骤S1得到的中药材混合物用体积百分比浓度为75%的乙醇水溶液加热至75℃提取,乙醇水溶液的重量为所述中药材混合物重量的10倍,提取2次,每次1小时,将提取完毕的混合物过滤,分离滤液和滤渣,滤液浓缩至80℃时测定相对密度为1.25的浸膏,得提取浸膏A,药渣备用;
S3将步骤S2得到的药渣,加水提取加热至90℃提取,水的重量为药渣重量的10倍,提取2次,每次1小时,将提取完毕的混合物过滤,分离滤液和滤渣,滤液浓缩至80℃时测定相对密度为1.25的浸膏,得提取浸膏B;
S4、将提取浸膏A和提取浸膏B合并,得总提取浸膏,60℃真空干燥24小时,研磨得浸膏粉;所述浸膏粉的水含量为2%;
S5、按照如下重量百分比称取各组分:2%聚乙烯吡咯烷酮、60%填充剂、2%马铃薯淀粉,余量为浸膏粉,混合均匀后,进行干法制粒,37℃干燥,压片,控制每片重量为0.5g,即得用于治疗痛风的药物;所述填充剂质量百分数为70%微晶纤维素、30%异麦芽酮糖组成。
实施例2
用于治疗痛风的药物的制备方法,包括如下步骤:
S1称取20g土茯苓、20g威灵仙、20g黄芪、10g秦皮、10g炒苍术、10g防风、10g银杏叶、10g卷柏、10g鸡血藤、10g猫须草干燥、粉碎、过10目筛混合均匀得中药材混合物;
S2将步骤S1得到的中药材混合物用体积百分比浓度为75%的乙醇水溶液加热至75℃提取,乙醇水溶液的重量为所述中药材混合物重量的10倍,提取2次,每次1小时,将提取完毕的混合物过滤,分离滤液和滤渣,滤液浓缩至80℃时测定相对密度为1.25的浸膏,得提取浸膏A,药渣备用;
S3将步骤S2得到的药渣,加水提取加热至90℃提取,水的重量为药渣重量的10倍,提取2次,每次1小时,将提取完毕的混合物过滤,分离滤液和滤渣,滤液浓缩至80℃时测定相对密度为1.25的浸膏,得提取浸膏B;
S4、将提取浸膏A和提取浸膏B合并,得总提取浸膏,60℃真空干燥24小时,研磨得浸膏粉;所述浸膏粉的水含量为2%;
S5、按照如下重量百分比称取各组分:2%聚乙烯吡咯烷酮,60%填充剂、2%马铃薯淀粉,余量为浸膏粉,混合均匀后,进行干法制粒,37℃干燥,压片,控制每片重量为0.5g,即得用于治疗痛风的药物;所述填充剂为质量百分数为30%异麦芽酮糖、70%微粉硅胶组成。
实施例3
用于治疗痛风的药物的制备方法,包括如下步骤:
S1称取20g土茯苓、20g威灵仙、20g黄芪、10g秦皮、10g炒苍术、10g防风、10g银杏叶、10g卷柏、10g鸡血藤、10g猫须草干燥、粉碎、过10目筛混合均匀得中药材混合物;
S2将步骤S1得到的中药材混合物用体积百分比浓度为75%的乙醇水溶液加热至75℃提取,乙醇水溶液的重量为所述中药材混合物重量的10倍,提取2次,每次1小时,将提取完毕的混合物过滤,分离滤液和滤渣,滤液浓缩至80℃时测定相对密度为1.25的浸膏,得提取浸膏A,药渣备用;
S3将步骤S2得到的药渣,加水提取加热至90℃提取,水的重量为药渣重量的10倍,提取2次,每次1小时,将提取完毕的混合物过滤,分离滤液和滤渣,滤液浓缩至80℃时测定相对密度为1.25的浸膏,得提取浸膏B;
S4、将提取浸膏A和提取浸膏B合并,得总提取浸膏,60℃真空干燥24小时,研磨得浸膏粉;所述浸膏粉的水含量为2%。
S5、按照如下重量百分比称取各组分:2%聚乙烯吡咯烷酮,60%填充剂、2%马铃薯淀粉,余量为浸膏粉,混合均匀后,进行干法制粒,37℃干燥,压片,控制每片重量为0.5g,即得用于治疗痛风的药物;所述填充剂为质量百分数为50%微晶纤维素、50%微粉硅胶组成。
实施例4
用于治疗痛风的药物的制备方法,包括如下步骤:
S1称取20g土茯苓、20g威灵仙、20g黄芪、10g秦皮、10g炒苍术、10g防风、10g银杏叶、10g卷柏、10g鸡血藤、10g猫须草干燥、粉碎、过10目筛混合均匀得中药材混合物;
S2将步骤S1得到的中药材混合物用体积百分比浓度为75%的乙醇水溶液加热至75℃提取,乙醇水溶液的重量为所述中药材混合物重量的10倍,提取2次,每次1小时,将提取完毕的混合物过滤,分离滤液和滤渣,滤液浓缩至80℃时测定相对密度为1.25的浸膏,得提取浸膏A,药渣备用;
S3将步骤S2得到的药渣,加水提取加热至90℃提取,水的重量为药渣重量的10倍,提取2次,每次1小时,将提取完毕的混合物过滤,分离滤液和滤渣,滤液浓缩至80℃时测定相对密度为1.25的浸膏,得提取浸膏B;
S4、将提取浸膏A和提取浸膏B合并,得总提取浸膏,60℃真空干燥24小时,研磨得浸膏粉;所述浸膏粉的水含量为2%。
S5、按照如下重量百分比称取各组分:2%聚乙烯吡咯烷酮,60%填充剂、2%马铃薯淀粉,余量为浸膏粉,混合均匀后,进行干法制粒,37℃干燥,压片,控制每片重量为0.5g,即得用于治疗痛风的药物;所述填充剂由质量百分数为60%微晶纤维素、20%异麦芽酮糖、20%微粉硅胶组成。
实施例5
用于治疗痛风的药物的制备方法,包括如下步骤:
S1称取20g土茯苓、20g威灵仙、20g黄芪、10g秦皮、10g炒苍术、10g防风、10g银杏叶、10g卷柏、10g鸡血藤、10g猫须草干燥、粉碎、过10目筛混合均匀得中药材混合物;
S2将步骤S1得到的中药材混合物用体积百分比浓度为75%的乙醇水溶液加热至75℃提取,乙醇水溶液的重量为所述中药材混合物重量的10倍,提取2次,每次1小时,将提取完毕的混合物过滤,分离滤液和滤渣,滤液浓缩至80℃时测定相对密度为1.25的浸膏,得提取浸膏A,药渣备用;
S3将步骤S2得到的药渣,加水提取加热至90℃提取,水的重量为药渣重量的10倍,提取2次,每次1小时,将提取完毕的混合物过滤,分离滤液和滤渣,滤液浓缩至80℃时测定相对密度为1.25的浸膏,得提取浸膏B;
S4、将提取浸膏A和提取浸膏B合并,得总提取浸膏,60℃真空干燥24小时,研磨得浸膏粉;所述浸膏粉的水含量为2%;
S5、按照如下重量百分比称取各组分:2%聚乙烯吡咯烷酮、60%填充剂、2%改性淀粉,余量为浸膏粉,混合均匀后,进行干法制粒,37℃干燥,压片,控制每片重量为0.5g,得到用于治疗痛风的药物;所述填充剂由质量百分数为60%微晶纤维素、20%异麦芽酮糖、20%微粉硅胶组成。
所述改性淀粉的制备方法为:将10g马铃薯淀粉加入到100mL水中;90℃下加热搅拌至淀粉完全糊化;冷却至30℃,出现凝胶;将凝胶置于8℃的水中12小时;取出凝胶浸入75wt%乙醇水溶液中,浸泡时间为48小时;取出凝胶置于50℃下干燥6小时、研磨得到改性淀粉。
测试例1
本发明用于治疗痛风的药物,一日3次,一次2克,用温开水冲服。
为了表明研究本发明的药物对痛风的治疗效果,采用实施例5制得的药物用于治疗2018年至今100例重庆同康骨科医院门诊痛风患者。
中医诊断痛风的标准为:病人患有高尿酸血症,常于午夜关节剧烈疼痛,足趾关节皮肤发红、局部肿胀、灼热、疼痛,昼轻夜重,烦渴汗出,关节腔有积液,反复发作后,可伴有关节周围及耳廓、耳轮和趾、指骨间出现痛风石沉淀。如果出现如上症状,即可确诊。
在确诊观察的对象中,男性75例,女性25例,无其它严重疾病,年龄为30岁-70岁,平均年龄45.3岁。服用实施例5制得的中药组合物,一日3次,一次2克,用温开水冲服,连续服用30天。开展临床实验期间,停服其它药物和保健营养品,忌酒及高嘌呤食物,治疗结束后随访3个月。
疗效判定:
临床痊愈:体质增强,身体有劲,关节的红、肿、热、痛消失;局部无明显异常,活动自如,血尿酸值降至正常范围。
好转:体质增强,身体有劲,关节红、肿、热、痛减轻,血尿酸值下降,但未达到正常范围。
未愈:关节红、肿、热、痛症改善不明显,活动受限,血尿酸值不下降。
结果:治愈者68例,好转者32例,总有效率达100%。本发明为纯中药治疗,无毒副作用和不良反应,适合痛风患者长期治疗。
典型病例:
患者王先生,男,年龄56岁,有痛风史8年,查血尿酸为538umol/L;左足拇趾关节红肿疼痛,活动障碍,服用实施例5中药组合物,一日3次,一次2克,用温开水冲服,服用30天后,左足拇趾关节红肿疼痛消失,血尿酸为450umol/L,继续服用15天后,血尿酸为436umol/L,左足拇趾关节活动自如,且无不良反应,随诊,至今没有复发。
测试例2
崩解时间测试:按照《中华人民共和国药典》2015年版,第四部,通则0921项下,对实施例1-5中药物片剂进行崩解时限检测法(吊篮式)检测。每管各一片,加挡板,启动崩解仪进行检测,记录每片片剂的崩解时间,取平均值即得。所有中药片剂均应在1小时内全部崩解。测试结果见表1。
表1:实施例1-5所制药物的崩解时间
片重 | 崩解时间 | |
实施例1 | 0.5g/片 | 250s |
实施例2 | 0.5g/片 | 300s |
实施例3 | 0.5g/片 | 120s |
实施例4 | 0.5g/片 | 20s |
实施例5 | 0.5g/片 | 15s |
抗吸湿性能测试:将实施例1-5制得的片剂放置于37℃,相对湿度为75%的条件下,测试7天和14天后的吸湿度(吸湿增重的百分比),测试结果见表2:
表2:实施例1-5所制药物的吸湿度
7天吸湿度(%) | 14天吸湿度(%) | |
实施例1 | 1.6 | 2.5 |
实施例2 | 2.0 | 3.0 |
实施例3 | 1.8 | 2.7 |
实施例4 | 1.2 | 1.9 |
实施例5 | 1.0 | 1.6 |
中药浸膏粉成分复杂,含有大量水溶性和亲水性成分,吸收和结合水分的能力很强,在机械缠绕、立体效应、静电引力、游离液体、固体桥等作用下浸膏粉易聚集、黏结,导致流动性降低,甚至板结成块,不仅给中药制剂制备过程带来较大的困难,也是影响中药制剂稳定性的主要因素。从表2数据可知,实施例5制得的药物抗吸湿性能优于其他实施例所制得的药物,取得了显著的进步。
Claims (7)
1.一种用于治疗痛风的药物,其特征在于,由下述组分组成:土茯苓、威灵仙、黄芪、秦皮、炒苍术、防风、银杏叶、卷柏、鸡血藤、猫须草。
2.如权利要求1所述的用于治疗痛风的药物,其特征在于,由下述重量份的组份组成:土茯苓10-30份,威灵仙10-30份,黄芪10-30份,秦皮5-15份,炒苍术5-15份,防风5-15份,银杏叶5-15份,卷柏5-15份,鸡血藤5-15份,猫须草5-15份。
3.如权利要求1~2任一项所述的用于治疗痛风的药物的制备方法,其特征在于,包括以下步骤:
S1按照配方称取各原料干燥、粉碎、过筛得中药材混合物;
S2将步骤S1得到的中药材混合物用体积百分比浓度为60-80%的乙醇水溶液回流提取,乙醇水溶液的重量为所述中药材混合物重量的8-12倍,提取2-3次,每次0.5-2小时,将提取完毕的混合液过滤,分离滤液和滤渣,滤液浓缩至60~80℃时测定相对密度为1.20-1.30的浸膏,得提取浸膏A,药渣备用;
S3将步骤S2得到的药渣,加水加热至90~110℃,水的重量为药渣重量的5-10倍,提取2-3次,每次0.5-2小时,将提取完毕的混合物过滤,分离滤液和滤渣,滤液浓缩至60~80℃时测定相对密度为1.20-1.30的浸膏,得提取浸膏B;
S4、将提取浸膏A和提取浸膏B合并,得总提取浸膏,60-80℃真空干燥,研磨过筛得浸膏粉,所述浸膏粉水含量为2~3%;
S5、按照如下重量百分比称取各组分:2~3%粘合剂,60~85%填充剂,2~3%附加剂,余量为浸膏粉,混合均匀后,进行湿法制粒,干燥,过筛,压片即得用于治疗痛风的药物。
4.如权利要求3所述的用于治疗痛风的药物的制备方法,其特征在于,步骤S5中粘合剂为聚乙烯吡咯烷酮、聚醋酸乙烯酯、明胶中的一种或两种及两种以上的混合。
5.如权利要求3所述的用于治疗痛风的药物的制备方法,其特征在于,步骤S5中填充剂为微晶纤维素、异麦芽酮糖、微粉硅胶中至少一种。
6.如权利要求3所述的用于治疗痛风的药物的制备方法,其特征在于,所述步骤S5中附加剂为马铃薯淀粉或改性淀粉。
7.如权利要求6所述的用于治疗痛风的药物的制备方法,其特征在于,所述改性淀粉的制备方法为:将5~20g马铃薯淀粉加入到50-100mL水中;80-90℃下加热搅拌至淀粉完全糊化;冷却至20-30℃,出现凝胶;将凝胶置于0-10℃的水中10-12小时;取出凝胶浸入60-80wt%乙醇水溶液中,浸泡时间为24-48小时;取出凝胶置于40-60℃下干燥6-8小时、研磨得到改性淀粉。
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