CN106063860A - 一种芦荟中药组合物 - Google Patents
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Abstract
本发明公开了一种治疗骨关节炎的中药组合物及其制备方法，属中药领域；以中药芦荟、马尾黄、一品红和云苔草为原料制成活性组分，与常用药物制剂辅料制成口服或外用制剂，该中药组合物对骨关节炎具有确定的治疗作用。
Description
技术领域
本发明涉及一种中药组合物，具体涉及一种治疗骨关节炎的中药组合物制剂及其制备方法，属于中药技术领域。
技术背景
骨关节炎(Osteoarthritis，OA)又称骨关节病、增生性关节炎、老年性关节炎、退化性关节炎、肥大性关节炎等，是最常见的慢性退行性关节病损，以缓慢发展的关节疼痛、僵硬、肥大伴活动受限等为主要特点，是一种慢性关节疾病，其主要改变是关节软骨退行性病及继发性骨质增生。人群发病率约为2～6％，是导致50岁以上人群功能残疾、造成经济损失和影响社会发展的主要疾病之一；根据发病原因分为原发性骨关节病和继发性骨关节病，在我国以继发性骨关节病较多见，即因某种已知原因导致软骨破坏或关节结构改变，日后因关节面磨擦或压力不平衡等因素而造成退行性变者称为继发性骨关节病，临床症状表现为关节疼痛、活动受限和关节畸形等症状，该疾患以手远端和近端指间关节，膝、肘、肩及脊柱关节易受累，而腕、踝关节较少发。初起为钝痛，随着病情进展有逐渐加重。疼痛的特点为劳累后加重，休息后好转；关节静止不动较久或在清晨感到疼痛，稍活动后疼痛减轻。
骨关节炎的治疗主要为中西药物和非药物治疗，其中非药物治疗为患者健康教育、自我训练、关节活动度训练、肌力训练、助行工具的使用、膝内翻的楔行鞋垫、职业治疗及关节保护、日常生活的辅助设施等；西药治疗包括：透明质酸钠关节腔内注射，口服氨基葡萄糖，口服或外用非甾体镇痛抗炎药。当内科保守治疗无效，而日常活动进行性受限时，考虑关节镜清理、截骨术和关节置换手术等外科治疗。
骨性关节炎属中医学“骨痹”、“膝痹”范畴，中医学认为风、寒、湿、热邪是关节炎发生发展的外部条件，而诸虚内存，正气不足是其发病内在原因；在此病因病机指导下，无论内服和外用中药大多以扶正祛邪为治则组方用药。中国专利公开号CN103191212A公开了“治疗骨关节炎的外用中药散剂及其制备方法”，该发明由威灵仙、寻骨风、鸡血藤、五加皮、骨碎补、元胡组成，用米醋浸泡后外用。中国发明专利公开号CN102302616A公开“治疗膝骨性关节炎巴布剂及其制备方法”，其药用成分由三七、独一味、祖师麻、冰片组成。中国专利公开号CN103006946公开了“治疗骨关节炎和类风湿关节炎”的中药组合物及其制备方法，该发明由中药桑寄生、独活、海马、枸杞子、人参、白芍、秦艽、杜仲、续断、狗脊、牛膝、木瓜、千年健、茯苓、当归、厚朴、肉桂、小茴香、川芎、荆芥和甘草组成，该组合物以滋补温阳类中药为主。中国专利公开号CN103006884A公开了“一种治疗骨关节炎的中药组合物 及其制备方法”，该发明由独活、杜仲、桑寄生、川牛膝、细辛、秦艽、熟地黄、茯苓、肉桂、防风、川芎、党参、甘草、当归、赤芍、没药、苍术和黄柏组成，该组合物以祛湿止痛，补益肝肾中药为主。上述内服和外用中药组合物主要为补肾祛湿，活血止痛的中药组方。
本发明是从中药材中科学筛选及剂量配比得到的中药组合物，各药材协同作用，起到清热消肿，疏筋止痛作用，从而改善患者关节肿胀疼痛症状；与西药相比，具有毒副作用小，适于长期服用的优点，适于患有骨关节炎的人群服用。
发明内容
本发明的目的是提供一种中药组合物，在中医药理论指导下，通过各药材的合理配比，协同作用，起到治疗骨关节炎作用。本发明另外一个目的是提供该中药组合物的制备方法。
本发明所述的治疗骨关节炎的中药组合物，选择芦荟、马尾黄、一品红、云苔草为原料，其中芦荟Aloe vera L.为百合科植物库拉索芦荟的叶汁经浓缩的干燥品，苦，寒。归肝、胃、大肠经，具有清肝热功效；马尾黄为毛茛科植物多叶唐松草的根茎及根，苦，寒，具有清热燥湿功效；一品红大戟科猩猩草Euphorbia heterophylla L.全草，苦、涩，寒，具有清热消肿功效；云苔草Primula efarinosa Pax，为报春花科植物无粉报春的全草，苦、平，具有清热解毒功效。上述中药材合理配伍，共同体现清热消肿作用。
制备本发明药物活性组分的原料用量为：芦荟5-25份、马尾黄5-25份、一品红5-15份、云苔草5-15份；优选为芦荟15份、马尾黄12份、一品红9份、云苔草9份。
本发明中药组合物可采用中药制剂常规方法制备成常规口服制剂。
芦荟15份、马尾黄12份、一品红9份和云苔草9份，按上述重量配比的马尾黄、一品红和云苔草混合，加3倍量水浸泡2小时，加热煎煮2小时，过滤，药渣再加1倍量水加热煎煮1小时，过滤，合并两次滤液，静置1小时，倒出上清液；上清液浓缩至60℃时相对密度1.05浸膏，真空干燥，粉碎干燥固形物，过筛后得细粉；该制备细粉与芦荟粉混匀，过筛，得细粉。该细粉可加入制备不同固体剂型需要的辅料，如润滑剂、粘合剂等，制备成常规中药内服如片剂、胶囊剂、颗粒剂，外用如散剂、贴剂、膏剂等。
以下结合实施例对本发明作进一步的阐述
实施例1 本发明的胶囊剂制备
1.按下述重量配比称取各原料药：芦荟50份、马尾黄50份、一品红50份、云苔草50份备用；
2.上述重量马尾黄、一品红和云苔草加3倍量水浸泡2小时，加热煎煮2小时，过滤，药渣再加1倍量水加热煎煮1小时，过滤，合并两次滤液，静置1小时，倒出上清液；上清液浓缩至60℃时相对密度1.05浸膏，真空干燥，粉碎干燥固形物，过筛后得细粉；
3，上述2制备细粉与芦荟粉50份混匀，过筛，得细粉；加入辅料后混匀，装入明胶硬胶囊。
实施例2 本发明的片剂制备
1.按下述重量配比称取各原料药：芦荟250份、马尾黄250份、一品红150份、云苔草150份备用；
2.上述重量马尾黄250份、一品红150份、云苔草150份加5倍量水浸泡2小时，加热煎煮2小时，过滤，药渣再加3倍量水加热煎煮1小时，过滤，合并两次滤液，静置1小时，倒出上清液；上清液浓缩至60℃时相对密度1.10浸膏，真空干燥，粉碎干燥固形物，过筛后得细粉；
3.上述2制备细粉与芦荟粉250份混匀，过筛，得细粉；加入辅料后制成颗粒，干燥，压片。
实施例3 本发明的颗粒剂制备
1.按下述重量配比称取各原料药：芦荟150份、马尾黄120份、一品红90份和云苔草90份备用；
2.上述重量马尾黄120份、一品红90份、云苔草90份加5倍量水浸泡2小时，加热煎煮2小时，过滤，药渣再加3倍量水加热煎煮1小时，过滤，合并两次滤液，静置1小时，倒出上清液；上清液浓缩至60℃时相对密度1.10浸膏，真空干燥，粉碎干燥固形物，过筛后得细粉；
3.上述2制备细粉与芦荟粉150份混匀，过筛，得细粉，加入辅料制成颗粒剂。
实施例4 本发明的散剂制备
1.按下述重量配比称取各原料药：芦荟150份、马尾黄120份、一品红90份和云苔草90份备用；
2.上述重量马尾黄120份、一品红90份、云苔草90份加5倍量水浸泡2小时，加热煎煮2小时，过滤，药渣再加3倍量水加热煎煮1小时，过滤，合并两次滤液，静置1小时，倒出上清液；上清液浓缩至60℃时相对密度1.10浸膏，真空干燥，粉碎干燥固形物，研细均匀，过筛后得细粉；
3.上述1备用的芦荟粉150份研细均匀，过筛后得细粉；
4.上述2和3制备的细粉，加入辅料混匀，制成散剂。
实验例1 本发明中药组合物对大鼠佐剂性关节炎的抑制作用
1.实验动物
SPF级SD实验大鼠50只，雌雄各半，体重200±10g，常规分笼喂养。
2.动物分组
上述实验动物随机分组为5组，包括空白组、可的松组(阳性对照组)、本发明组合物受试组(高、中、低剂量)，每组10只。
3.实验方法
以Freund完全佐剂对大鼠足致炎，从致炎前2天开始给药，给药方法为：将本发明中药组合物受试物原液稀释到相应浓度(20.0g/kg、10.0g/kg和5.0g/kg)分别灌胃给药，空白对照组灌胃生理盐水，阳性对照组用醋酸氢化可的松25mg/kg皮下注射，隔天1次；致炎后第21天给药各组停药。采用容积法测量大鼠致炎足后不同时问点的体积，按下述公式计算肿胀度，结果见表1。
4.实验结果
各组受试组动物在致炎后的3h、7d、14d、21d的不同时间点，大鼠足肿胀度与空白组比较均具有显著性差异(P＜0.05)；在致炎后3h、7d、14d、21d各时间点中，7d足肿胀度各组达到最高点，14d和21d后逐渐呈下降趋势，一方面与各组药物作用有关，另一方面也说明本实验动物模型制备成功。在3h、7d、14d、21d各时间点中各受试物不同剂量组呈现确定的量效正相关趋势。由此提示：本发明中药组合物具有改善大鼠佐剂性关节炎病变的作用。
表1 本发明中药组合物对大鼠佐剂性关节炎的影响(N＝10，X±SD)
*代表与空白组比较P＜0.05 。
Claims (4)
1.一种治疗骨关节炎的中药组合物，其特征在于它的活性组分是由下列重量份的原料药制成：芦荟5-25份、马尾黄5-25份、一品红5-15份、云苔草5-15份。
2.根据权利要求1的中药组合物，其中各原料药的用量为：芦荟15份、马尾黄12份、一品红9份、云苔草9份。
3.根据权利要求1或2所述中药组合物的制备方法，包括如下步骤：
1)称取各原料药芦荟、马尾黄、一品红和云苔草备用；
2)按上述重量配比的马尾黄、一品红和云苔草混合，加3-5倍量水浸泡2小时，加热煎煮2小时，过滤，药渣再加1-3倍量水加热煎煮1小时，过滤，合并两次滤液，静置1小时，倒出上清液；上清液浓缩至60℃时相对密度1.05-1.10浸膏，真空干燥；粉碎干燥固形物，过筛后得细粉；
3)上述2)制备的细粉与1)备用的芦荟细粉混匀，过筛，即该中药组合物的活性组分。
4.根据权利要求3所述的制备方法，将步骤3)得的活性组分与药物制剂常用辅料混合，制备成固体制剂。
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1208584A (zh) * | 1998-08-28 | 1999-02-24 | 史秀生 | 芦荟茶 |
| CN105250397A (zh) * | 2015-09-22 | 2016-01-20 | 广州国宇医药科技有限公司 | 一种螺旋藻中药组合物 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1208584A (zh) * | 1998-08-28 | 1999-02-24 | 史秀生 | 芦荟茶 |
| CN105250397A (zh) * | 2015-09-22 | 2016-01-20 | 广州国宇医药科技有限公司 | 一种螺旋藻中药组合物 |
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| Title |
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| 娄俊东等: "张鸣鹤治疗骨关节炎经验浅析", 《社区医学杂志》 * |
| 时宵宵: "《邹平中药志》", 31 January 2015, 中医古籍出版社 * |
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