CN101500654B - 用于慢性退行性炎性病症治疗的组合物 - Google Patents

用于慢性退行性炎性病症治疗的组合物 Download PDF

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CN101500654B
CN101500654B CN2007800293227A CN200780029322A CN101500654B CN 101500654 B CN101500654 B CN 101500654B CN 2007800293227 A CN2007800293227 A CN 2007800293227A CN 200780029322 A CN200780029322 A CN 200780029322A CN 101500654 B CN101500654 B CN 101500654B
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E·邦巴尔代利
P·莫拉佐尼
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Abstract

包含下述的组合物：水杨醇或其衍生物或者包含10％至50％的水杨醇的柳属物种(Salix spp)提取物；基本纯的穿心莲内酯或包含5％至30％的穿心莲内酯的富含穿心莲内酯的穿心莲(Andrographis paniculata)提取物；任选地N-乙酰基-葡糖胺和/或-葡糖醛酸或葡糖醛酸内酯。

Description

用于慢性退行性炎性病症治疗的组合物
发明领域
本发明涉及包含下述的组合的制剂：镇痛药/抗炎剂、免疫调度剂以及任选地软骨重构剂(cartilage-reconstructing agent)，所述制剂用于治疗退行性炎性病症如类风湿性关节炎，以及更普遍而言地，关节炎病症。
通过多种作用机制作用的这些物质的组合减少了疼痛并且阻止了关节损伤的进展。
技术背景
类风湿性关节炎是一种慢性退行性疾病，它对很大一部分老年人造成影响，并给患者带来严重问题。类风湿性关节炎和关节炎病症的发病机理首先归因于免疫系统，接着归因于炎性病症，所述的炎性病症侵蚀关节内表面，引起变形性损伤，这种损伤是不可逆转的并且是疼痛的。
柳属的不同物种的树皮和枝条提取物已经使用了很长时间用于治疗关节的风湿性形式和痛风。但是，当通过水杨酸乙酰化合成乙酰基水杨酸的19世纪末，基本上弃用了柳属提取物，所述水杨酸是通过在柳属中存在的化合物氧化获得的。然而，乙酰基水杨酸和柳属提取物在作用机制和对骨关节的活性方面具有显著的不同。提取物作用于酶COX2，而乙酰基水杨酸主要作用于COX1，其对胃肠道和血液凝固有众所周知的副作用，这严重限制了其长期使用，而所述长期使用反而是在此类慢性退行性病理如关节病和类风湿性关节炎的情形中所需要的。例如，根据在本文引用作为参考的专利申请MI2005A001349，制备富含水杨醇的柳属提取物。
已经报道了穿心莲(Andrographis paniculata)具有多种药理活性。这些包括对免疫系统的刺激和炎症的减少。众所周知穿心莲提取物或者其主要成分穿心莲内酯抑制促炎细胞因子的合成。向内皮(endohelid)细胞培养物添加穿心莲内酯(与肿瘤坏死因子(TNF)一起)影响了内皮单核细胞粘附的TNF-诱导的增强的浓度依赖的降低，所述内皮单核细胞粘附是炎性过程的一部分。
穿心莲提取物中的主要活性成分是穿心莲内酯，其是苦的二萜内酯(diterpenoid lactone)。该提取物还含有其它二萜内酯、二萜糖苷(diterpene glucoside)、二萜二聚体和类黄酮。
可以通过将穿心莲的地上部分浸入一种或多种适当的溶剂(例如乙醇、甲醇和丙酮)中；将液体与固体剩余物分离并且浓缩该液体来制备用于本发明的提取物。由此获得的提取物可以被进一步加工。例如，通过已知方法可以移除杂质、改变成分的比例。
发明内容
本发明涉及包含活性成分的组合的组合物，所述活性成分能够诱导特别重要的治疗效果，而且甚至在长期治疗后也没有严重的副作用。
本发明的药物制剂包含：
-纯的水杨醇或其衍生物或者包含10％至50％的水杨醇的柳属物种(Salix spp)提取物；
-基本纯的穿心莲内酯或包含5％至30％的穿心莲内酯的富含穿心莲内酯的穿心莲提取物；
-以及任选地N-乙酰基-葡糖胺和/或
-葡糖醛酸或葡糖醛酸内酯。
本发明的制剂优选包含：
-含有25％(重量)水杨醇的柳属物种提取物；
-含有15％(重量)的穿心莲内酯的穿心莲提取物以及任选地N-乙酰基-葡糖胺和/或葡糖醛酸或葡糖醛酸内酯。
柳属提取物和穿心莲提取物优选分别在制剂中以2∶1的重量比例存在。
制剂通常将包含40至500mg的柳属提取物、20至250mg的穿心莲提取物，以及任选地各为10至500mg的葡糖胺和葡糖醛酸或葡糖醛酸内酯。
本制剂可以是软或硬明胶胶囊剂、片剂的形式或其它适于口服施用的形式。优选含有月见草(Enothera biennis)油作为载体的胶囊剂。
N-乙酰基-葡糖胺、葡糖醛酸或葡糖醛酸内酯被认为是结缔组织的结构单元，它们使本发明的制剂的疗效性质得到完善，因为它们促进关节中蛋白聚糖的重合成，这是一种重要的修复过程，它与前文提到的因素一起使症状改善。
本发明的组合物可以以单次或重复日常给药的形式长期施用，直到康复或缓解症状。
下述实施例进一步解释本发明。
实施例1-制备穿心莲提取物
在静止的渗滤器中在65℃用3.2升70％的乙醇覆盖1000g穿心莲地上部分(生物量)3小时。然后回收滤出液并且在相同的条件下(但是每次提取使用2.6升的溶剂)再次对生物量进行5次提取，从而获得大约15.2升的滤出液。过滤合并的滤出液并且通过旋转蒸发器在60℃在减少的压力下浓缩所述滤出液。将提取物在60℃在减少的压力下干燥一夜。该提取物具有总的干燥剩余物90.9g，产量vs初始材料是10.1w/w。穿心莲内酯HPLC含量是22.38％。
实施例II——制备纤维素胶囊
每个胶囊包含：
Salix rubra提取物(水杨醇中25％)  200mg
包含15％穿心莲内酯的穿心莲提取物 100mg
N-乙酰基-葡糖胺                  100mg
葡糖醛酸内酯                     100mg
月见草油                   适量至700mg
当施用于患有类风湿性关节炎病症的患者时，实施例I的制剂在减轻疼痛、提高受累肢体的灵活性、关节的活组织检验和感觉舒适方面显示出稳定的临床效果。
实施例III-制备胶囊
每个胶囊包含：
Salix rubra提取物(水杨醇中25％)    200mg
穿心莲提取物(包含15％的穿心莲内酯) 100mg
双醋瑞因(Diacerhein)               100mg
N-乙酰基-葡糖胺                    100mg
葡糖醛酸内酯                       100mg
月见草油                     适量至700mg
当施用于患有类风湿性关节炎或关节炎病症的患者时，实施例I的制剂在减轻疼痛、提高受累肢体的灵活性、关节的活组织检验和感觉舒适方面显示出稳定的临床效果。

Claims (6)

1.用于治疗类风湿性关节炎或关节炎的组合物，其包含：
-水杨醇或者包含10％至50％的水杨醇的柳属物种(Salix spp)提取物；
-穿心莲内酯或包含5％至30％的穿心莲内酯的富含穿心莲内酯的穿心莲(Andrographis paniculata)提取物；
-N-乙酰基-葡糖胺和/或
-葡糖醛酸或葡糖醛酸内酯；
其中柳属提取物的量在40至500mg之间、穿心莲提取物的量在20至250mg之间，葡糖胺和葡糖醛酸或葡糖醛酸内酯的量各在10至500mg之间，水杨醇的量在4至250mg之间，以及穿心莲内酯的量在1至75mg之间。
2.根据权利要求1的组合物，其包含
-含有25％(重量)水杨醇的柳属物种提取物；
-含有15％(重量)的穿心莲内酯的穿心莲提取物，以及N-乙酰基-葡糖胺和/或葡糖醛酸或葡糖醛酸内酯。
3.根据权利要求2的组合物，其中柳属提取物和穿心莲提取物的重量比分别为2∶1。
4.根据权利要求1至3中任一项的组合物，其为软或硬明胶胶囊剂、片剂的形式或其它适于口服施用的形式。
5.根据权利要求4的组合物，其为含有月见草(Enothera biennis)油作为载体的胶囊剂的形式。
6.水杨醇或柳属物种提取物以及穿心莲内酯或富含穿心莲内酯的穿心莲提取物的组合在制备用于治疗类风湿性关节炎的组合物中的用途。
CN2007800293227A 2006-08-08 2007-07-27 用于慢性退行性炎性病症治疗的组合物 Expired - Fee Related CN101500654B (zh)

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CN102809625B (zh) * 2012-08-23 2015-02-04 神威药业集团有限公司 一种穿心莲内酯有关物质的测定方法
JP6270362B2 (ja) * 2013-07-17 2018-01-31 日本水産株式会社 関節痛改善剤
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CN105640938A (zh) * 2016-01-21 2016-06-08 广西医科大学 穿心莲内酯在治疗骨关节退行性病变药物中的应用

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