CN106138960B - 药物组合物及其用途 - Google Patents
药物组合物及其用途 Download PDFInfo
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- CN106138960B CN106138960B CN201610522369.8A CN201610522369A CN106138960B CN 106138960 B CN106138960 B CN 106138960B CN 201610522369 A CN201610522369 A CN 201610522369A CN 106138960 B CN106138960 B CN 106138960B
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Abstract
本发明公开了药物组合物及其用途。其中，该药物组合物是由以下重量份数的原料药制成的：川断8‑12重量份、炒杜仲8‑12重量份、川牛膝16‑24重量份、补骨脂8‑12重量份、土元5‑7重量份、砂仁5‑7重量份、细辛2‑4重量份、桂枝13‑17重量份、威灵仙8‑12重量份、生龙骨16‑24重量份、生牡蛎16‑24重量份、珍珠母8‑12重量份、忍冬藤16‑24重量份、青风藤13‑17重量份、透骨草8‑12重量份、乳香5‑7重量份、末药5‑7重量份、山萸肉13‑17重量份、泽泻8‑12重量份和蜈蚣1‑3条。该药物组合物不但可以治疗骨质疏松，而且可以改善患者乏力、疼痛、行走困难等症状，患者骨折的发生率明显降低。同时，相对于现有的治疗骨质疏松的药物，毒副作用明显下降。
Description
技术领域
本发明涉及医药领域，具体地，涉及药物组合物及其用途，更具体地，涉及药物组合物和药物组合物在制备药物中的用途，该药物用于治疗骨质疏松。
背景技术
骨质疏松症(Osteoporosis，OP)是一种以骨量低下、骨微结构破坏，骨脆性增加，易发生骨折为特征的全身性骨病。第三次美国健康及营养调查数据显示，超过990万美国人患骨质疏松症，约有4310万美国人患骨量减少。每2位白人女性中就有1位一生中发生过骨质疏松性骨折，男性为每5人中有1位患骨质疏松性骨折。随着人类寿命延长和老龄化社会的到来，骨质疏松症已成为全球健康问题，中国也不例外。据北京等地区影像学的流行病学调查显示，50岁以上妇女脊柱骨折的患病率为15％，相当于每7位50岁以上妇女中就有1位发生过脊柱骨折。骨质疏松性骨折会导致病残率和死亡率的增加。如发生髋部骨折后1年内死亡率超过未发生髋部骨折的8.4％～36％。虽然椎体骨折的死亡率较低，但也会给患者带来疼痛、残疾、畸形等负担。治疗骨质疏松性骨折需要投入巨大的人力和财力，造成沉重的家庭、社会和经济负担。然而尽早预防可以避免骨质疏松性骨折，即使发生过骨折，当采取治疗后也可以有效降低再次骨折的风险。因此，提高对骨质疏松症的认识，尤其做到早期诊断、及时预测骨折风险并采取规范的防治措施十分重要。目前对于骨质疏松的治疗相当有限，效果也不甚理想。
发明内容
本发明旨在至少解决现有技术中存在的技术问题之一。为此，本发明的一个目的在于提出一种药物组合物，该药物组合物不但可以治疗骨质疏松，而且可以改善患者乏力、疼痛、行走困难症状，患者骨折的发生率明显降低，并且，该药物组合物的毒副作用小。
需要说明的是，本发明是基于发明人的下列工作而完成的：
目前市场上批准入市的治疗骨质疏松的药物主要包括双膦酸盐类药物、降钙素、雌激素、雷洛昔芬、结合雌激素/巴多昔芬、特立帕肽和狄诺塞麦等，这些药物不但价格昂贵，而且治疗效果也并不特别理想，副作用也比较大。基于目前质量骨质疏松药物的缺陷，发明人针对骨质疏松患者共同的病因入手进行治疗，即骨质疏松病人普遍存在肾脏导致的肾阴虚、气虚或者肾阳性，甚至是混合性肾虚，同时伴有脾虚的症状。发明人针对上述病因，采用下述药物组合物进行治疗，该药物组合物是由以下重量份数的原料药制成的：川断10g、炒杜仲10g、川牛膝20g、补骨脂10g、土元6g、砂仁6g、细辛3g、桂枝15g、威灵仙10g、生龙骨20g、生牡蛎20g珍珠母10g、忍冬藤20g、青风藤15g、透骨草10g、乳香6g、没药6g、山萸肉15g、泽泻10g和蜈蚣2条。该药物组合物对病人进行肾阴阳双补，阴中求阳，阳得阴生而生化无穷，同时健脾促进并促进钙的吸收与生骨。发明人发现该药不但可以治疗骨质疏松，而且可以改善患者乏力、疼痛、行走困难等症状，患者骨折的发生率明显降低。同时，相对于现有的治疗骨质疏松的药物，毒副作用明显下降。
因而，根据本发明的一个方面，本发明提供了一种药物组合物。根据本发明的实施例，所述药物组合物是由以下重量份数的原料药制成的：川断8-12重量份、炒杜仲8-12重量份、川牛膝16-24重量份、补骨脂8-12重量份、土元5-7重量份、砂仁5-7重量份、细辛2-4重量份、桂枝13-17重量份、威灵仙8-12重量份、生龙骨16-24重量份、生牡蛎16-24重量份、珍珠母8-12重量份、忍冬藤16-24重量份、青风藤13-17重量份、透骨草8-12重量份、乳香5-7重量份、没药5-7重量份、山萸肉13-17重量份、泽泻8-12重量份和蜈蚣1-3条。
发明人惊奇地发现，该药物组合物针对骨质疏松病人普遍存在肾脏导致的肾阴虚、气虚或者肾阳性，甚至是混合性肾虚，同时伴有脾虚的症状进行治疗，肾阴阳双补，阴中求阳，阳得阴生而生化无穷，同时健脾促进并促进钙的吸收与生骨。进而，该药物组合物不但可以治疗骨质疏松，而且可以改善患者乏力、疼痛、行走困难等症状，患者骨折的发生率明显降低。同时，相对于现有的治疗骨质疏松的药物，毒副作用明显下降。
另外，根据本发明上述实施例的药物组合物，还可以具有如下附加的技术特征：
根据本发明的实施例，所述药物组合物是由以下重量份数的原料药制成的：川断10重量份、炒杜仲10重量份、川牛膝20重量份、补骨脂10重量份、土元6重量份、砂仁6重量份、细辛3重量份、桂枝15重量份、威灵仙10重量份、生龙骨20重量份、生牡蛎20重量份、珍珠母10重量份、忍冬藤20重量份、青风藤15重量份、透骨草10重量份、乳香6重量份、没药6重量份、山萸肉15重量份、泽泻10重量份和蜈蚣2条。
根据本发明的实施例，该药物组合物可以进一步包括：全蝎2-4重量份。
根据本发明的实施例，该药物组合物可以进一步包括：独活8-12重量份。
根据本发明的实施例，该药物组合物可以进一步包括：狗脊8-12重量份。
根据本发明的实施例，该药物组合物可以进一步包括：炒白术13-17重量份。
根据本发明的实施例，该药物组合物可以进一步包括：双花13-17重量份。
根据本发明的实施例，该药物组合物可以进一步包括：花粉8-12重量份和黄芪13-17重量份。
根据本发明的实施例，该药物组合物可以进一步包括：枣仁16-24重量份。
根据本发明的实施例，该药物组合物可以进一步包括：知母13-17重量份和枸杞子13-17重量份。
根据本发明的另一方面，本发明提供了前述的药物组合物制备药物中的用途，所述药物用于治疗骨质疏松。
根据本发明实施例的药物，针对骨质疏松病人普遍存在肾脏导致的肾阴虚、气虚或者肾阳性，甚至是混合性肾虚，同时伴有脾虚的症状进行治疗，肾阴阳双补，阴中求阳，阳得阴生而生化无穷，同时健脾促进并促进钙的吸收与生骨。进而，该药物不但可以治疗骨质疏松，而且可以改善患者乏力、疼痛、行走困难等症状，患者骨折的发生率明显降低。同时，相对于现有的治疗骨质疏松的药物，毒副作用明显下降。
本发明的附加方面和优点将在下面的描述中部分给出，部分将从下面的描述中变得明显，或通过本发明的实践了解到。
具体实施方式
下面详细描述本发明的实施例。下面描述的实施例是示例性的，仅用于解释本发明，而不能理解为对本发明的限制。实施例中未注明具体技术或条件的，按照本领域内的文献所描述的技术或条件或者按照产品说明书进行。所用试剂或仪器未注明生产厂商者，均为可以通过市购获得的常规产品。
根据本发明的一个方面，本发明提供了一种药物组合物。根据本发明的实施例，所述药物组合物是由以下重量份数的原料药制成的：川断8-12重量份、炒杜仲8-12重量份、川牛膝16-24重量份、补骨脂8-12重量份、土元5-7重量份、砂仁5-7重量份、细辛2-4重量份、桂枝13-17重量份、威灵仙8-12重量份、生龙骨16-24重量份、生牡蛎16-24重量份、珍珠母8-12重量份、忍冬藤16-24重量份、青风藤13-17重量份、透骨草8-12重量份、乳香5-7重量份、没药5-7重量份、山萸肉13-17重量份、泽泻8-12重量份和蜈蚣1-3条。
该药物组合物针对骨质疏松病人普遍存在肾脏导致的肾阴虚、气虚或者肾阳性，甚至是混合性肾虚，同时伴有脾虚的症状进行治疗。该药物组合物能够有效通过调节提高肾阴阳的平衡与功能从而调节机体代谢，刺激骨形成；提高骨密度，增加骨矿含量；抑制破骨细胞的吸收活动，加快骨再建活动，使整体骨量和骨的质量得到恢复。通过健脾增加食物中钙的吸收，增加血清骨钙素促进骨小梁成熟、成骨细胞增加，并能丰富髓腔内细胞，促进软骨细胞成熟。同时，通过脾肾双补促、通络活血的方法进纤维组织形成、外骨痂形成，加快骨痂组织的代谢活动，使外伤性骨质疏松得到尽快的恢复。通过活血止痛、清热解毒，疏风通络能明显减轻骨质疏松患者的疼痛。从而，该药物组合物肾阴阳双补，阴中求阳，阳得阴生而生化无穷，同时健脾促进并促进钙的吸收与生骨。进而，该药物组合物不但可以治疗骨质疏松，而且可以改善患者乏力、疼痛、行走困难等症状，患者骨折的发生率明显降低。同时，相对于现有的治疗骨质疏松的药物，毒副作用明显下降。
根据本发明的具体实施例，该药物组合物是由以下重量份数的原料药制成的：川断10重量份、炒杜仲10重量份、川牛膝20重量份、补骨脂10重量份、土元6重量份、砂仁6重量份、细辛3重量份、桂枝15重量份、威灵仙10重量份、生龙骨20重量份、生牡蛎20重量份、珍珠母10重量份、忍冬藤20重量份、青风藤15重量份、透骨草10重量份、乳香6重量份、没药6重量份、山萸肉15重量份、泽泻10重量份和蜈蚣2条。由此，治疗骨质疏松的效果更佳，而且可以明显改善患者乏力、疼痛、行走困难等症状，患者骨折的发生率也明显降低。同时，毒副作用小。
根据本发明的实施例，该药物组合物可以进一步包括：全蝎2-4重量份，全蝎用于息风镇痉，通络止痛。与药物组合物中的蜈蚣同用能加强蜈蚣的熄风、镇痉、止痛、散结之功效，由此，通过加入全蝎，不仅能有效治疗骨质疏松，还能有效地缓解缺钙引起的抽搐和抽筋等问题。
根据本发明的实施例，该药物组合物可以进一步包括：独活8-12重量份。由此，利用独活作为引经药，引药入肾，特别是腰以下，增强川断、牛膝、补骨脂等补肾药的补肾力量，而且独活本身具有祛风除湿、痛痹止痛的作用，使药物组合物的止痛效果显著提高，并促进骨骼的重建。
根据本发明的实施例，该药物组合物可以进一步包括：狗脊8-12重量份。狗脊具有祛风湿，补肝肾，强腰膝的功效，配伍药物组合物中的炒杜仲、川牛膝、山萸肉和补骨脂等，可增强补益肝肾虚损，治疗腰膝酸软，下肢无力等症，故狗脊的使用使药物组合物的补肾功效进一步提高。
根据本发明的实施例，该药物组合物可以进一步包括：炒白术13-17重量份。本发明实施例的药物组合物对部分患者的胃肠道可以有刺激作用，白术具有健脾益气，燥湿利水的功效，可以有效地用于调节胃肠道功能，缓解药物组合物对胃肠道的副作用，同时还能增加其他药物吸收的功效。
根据本发明的实施例，该药物组合物可以进一步包括：双花13-17重量份。双花具有清热解毒的功效，添加双花，可以祛虚火，整个组方偏于温热，加入该药起到反佐之意，长期使用该药疗效更佳，副作用更少。
根据本发明的实施例，该药物组合物可以进一步包括：花粉8-12重量份和黄芪13-17重量份。发明人将花粉和黄芪与本发明实施例的药物组合物联用，邪之所凑，其气必虚，骨质疏松是一个长期的过程，其气也必虚，加入黄芪具有补气固表、利水退肿，花粉清热生津可以有效缓解患者口渴乏力的症状。
根据本发明的实施例，该药物组合物可以进一步包括：枣仁16-24重量份。枣仁具有镇静催眠的作用，骨质疏松患者很多晚上骨骼隐痛不适，影响睡眠，通过加入枣仁使患者的睡眠质量明显提高。
根据本发明的实施例，该药物组合物可以进一步包括：知母13-17重量份和枸杞子13-17重量份。知母和枸杞子均为滋肾阴、祛肾火，可以有效地缓解患者五心烦热的症状，配伍桂枝、细辛、威灵仙和川断，可以阴中求阳，阳得阴助而生化无穷，使药物的疗效更佳。
根据本发明的另一方面，本发明提供了前述的药物组合物制备药物中的用途，所述药物用于治疗骨质疏松。
根据本发明实施例的药物，针对骨质疏松病人普遍存在肾脏导致的肾阴虚、气虚或者肾阳性，甚至是混合性肾虚，同时伴有脾虚的症状进行治疗，肾阴阳双补，阴中求阳，阳得阴生而生化无穷，同时健脾促进并促进钙的吸收与生骨。进而，该药物不但可以治疗骨质疏松，而且可以改善患者乏力、疼痛、行走困难等症状，患者骨折的发生率明显降低。同时，相对于现有的治疗骨质疏松的药物，毒副作用明显下降。
根据本发明的实施例，药物的剂型可以选自汤剂、片剂、颗粒剂、糖浆剂、胶囊和口服液之一。
本发明中药组合物的剂型采用常规的制备方法制备，例如，范碧亭《中药药剂学》(上海科学出版社1997年12月第1版)记载的制备工艺，制成药剂学可接受的常规剂型。
本发明的应用中，药物的剂型选自汤剂、片剂、颗粒剂、糖浆剂、胶囊和口服液之一，为使上述剂型能够实现，需在制备这些剂型时加入药学可接受的辅料，例如：填充剂、崩解剂、润滑剂、助悬剂、粘合剂、甜味剂、矫味剂、防腐剂、基质等。填充剂包括：淀粉、预胶化淀粉、乳糖、甘露醇、甲壳素、微晶纤维素、蔗糖等；崩解剂包括：淀粉、预胶化淀粉、微晶纤维素、羧甲基淀粉钠、交联聚乙烯吡咯烷酮、低取代羟丙纤维素、交联羧甲基纤维素钠等；润滑剂包括：硬脂酸镁、十二烷基硫酸钠、滑石粉、二氧化硅等；助悬剂包括：聚乙烯吡咯烷酮、微晶纤维素、蔗糖、琼脂、羟丙基甲基纤维素等；粘合剂包括，淀粉浆、聚乙烯吡咯烷酮、羟丙基甲基纤维素等；甜味剂包括：糖精钠、阿斯帕坦、蔗糖、甜蜜素、甘草次酸等；矫味剂包括：甜味剂及各种香精；防腐剂包括：尼泊金类、苯甲酸、苯甲酸钠、山梨酸及其盐类、苯扎溴铵、醋酸氯乙定、桉叶油等；基质包括：PEG6000，PEG4000，虫蜡等。为使上述剂型能够实现中药药剂学，需在制备这些剂型时加入药学可接受的其它辅料(范碧亭《中药药剂学》，上海科学出版社1997年12月第1版中各剂型记载的辅料)。
下面参考具体实施例，对本发明进行说明，需要说明的是，这些实施例仅仅是说明性的，而不能理解为对本发明的限制。
实施例1
原料药组成：川断10g、炒杜仲10g、川牛膝20g、补骨脂10g、土元6g、砂仁6g、细辛3g、桂枝15g、威灵仙10g、生龙骨20g、生牡蛎20g珍珠母10g、忍冬藤20g、青风藤15g、透骨草10g、乳香6g、没药6g、山萸肉15g、泽泻10g和蜈蚣2条
制备方法：将上述原料药加600毫升水煎煮，武火煎煮至沸，继续文火煎煮20分钟，滤过，取汁200毫升。再加水500毫升，重复煎煮一次文火20分钟，滤过，取汁200毫升，合并两次煎煮的药汁，混匀，共计400毫升，即得汤剂，分早晚两次温服。
实施例2
1994年WHO建议根据BMD或BMC(骨矿含量)值对骨质疏松症进行分级诊断：正常为BMD或BMC在正常成人骨密度平均值的1个标准差(SD)之内；骨质减少为BMD或BMC较正常成人骨密度平均值降低1～2.5个标准差；骨质疏松症为BMD或BMC较正常成人骨密度平均值降低2.5个标准差以上；严重骨质疏松症为BMD或BMC较正常成人骨密度平均值降低2.5个标准差以上并伴有1个或1个以上的脆性骨折。该诊断标准中BMD或BMC可在中轴骨或外周骨骼测定。
选择T值在<2.5范围内的病患30名，并将30名骨质疏松病人随机分成对照1组与骨易健两组，每组15人，然后再从绝经期后骨质疏松的患者中随机选取15名患者为对照2组，实验组使用骨易健方(即实施例1煎煮得到的汤剂)早晚两次服用，对照组1组使用阿仑膦酸钠每周1次，1次1片70mg，对照1组使用巴多昔芬20mg，一天一次，其中，对照2组巴多昔芬组为绝经期后骨质疏松组，使用2、4、6个月分别检测骨密度值同时进行观察乏力、疼痛、行走困难、骨折的变化，记录不良反应发生的症状与频率。其中，骨密度值如下所示：
| 0个月 | 2个月 | 4个月 | 6个月 | |
| 实验组 | -2.58±0.46 | -2.33±0.52 | -2.16±0.67 | 1.97±0.42 |
| 对照1组 | -2.64±0.55 | -2.52±0.62 | -2.39±0.49 | -2.29±0.53 |
| 对照2组 | -2.57±0.58 | -2.43±0.49 | -2.32±0.56 | -2.26±0.47 |
结果表明，三组经过治疗后，骨质疏松情况均得到改善，但实验组采用本发明的药物组合物-骨易健方的改善效果更佳明显，并且对乏力和疼痛的症状也明显缓解，而对照组的阿仑膦酸钠和巴多昔芬对乏力和疼痛无明显改善，同时，三组药物均能有效改善行走困难的症状，对照两组在治疗期间均能减少骨折的发生，但骨易健组治疗期间均无骨折再发生。由此，本发明的药物组合物不但可以治疗骨质疏松，而且可以改善患者乏力、疼痛、行走困难等症状，患者骨折的发生率明显降低。同时，相对于现有的治疗骨质疏松的药物，毒副作用明显下降。
在本说明书的描述中，参考术语“一个实施例”、“一些实施例”、“示例”、“具体示例”、或“一些示例”等的描述意指结合该实施例或示例描述的具体特征、结构、材料或者特点包含于本发明的至少一个实施例或示例中。在本说明书中，对上述术语的示意性表述不一定指的是相同的实施例或示例。而且，描述的具体特征、结构、材料或者特点可以在任何的一个或多个实施例或示例中以合适的方式结合。
尽管已经示出和描述了本发明的实施例，本领域的普通技术人员可以理解：在不脱离本发明的原理和宗旨的情况下可以对这些实施例进行多种变化、修改、替换和变型，本发明的范围由权利要求及其等同物限定。
Claims (12)
1.一种药物组合物，其特征在于，所述药物组合物是由以下重量份数的原料药制成的：
川断8-12重量份、炒杜仲8-12重量份、川牛膝16-24重量份、补骨脂8-12重量份、土元5-7重量份、砂仁5-7重量份、细辛2-4重量份、桂枝13-17重量份、威灵仙8-12重量份、生龙骨16-24重量份、生牡蛎16-24重量份、珍珠母8-12重量份、忍冬藤16-24重量份、青风藤13-17重量份、透骨草8-12重量份、乳香5-7重量份、没药5-7重量份、山萸肉13-17重量份、泽泻8-12重量份和蜈蚣1-3条。
2.根据权利要求1所述的药物组合物，其特征在于，所述药物组合物是由以下重量份数的原料药制成的：
川断10重量份、炒杜仲10重量份、川牛膝20重量份、补骨脂10重量份、土元6重量份、砂仁6重量份、细辛3重量份、桂枝15重量份、威灵仙10重量份、生龙骨20重量份、生牡蛎20重量份、珍珠母10重量份、忍冬藤20重量份、青风藤15重量份、透骨草10重量份、乳香6重量份、没药6重量份、山萸肉15重量份、泽泻10重量份和蜈蚣2条。
3.根据权利要求1所述的药物组合物，其特征在于，进一步包括：
全蝎2-4重量份。
4.根据权利要求1所述的药物组合物，其特征在于，进一步包括：
独活8-12重量份。
5.根据权利要求1所述的药物组合物，其特征在于，进一步包括：
狗脊8-12重量份。
6.根据权利要求1所述的药物组合物，其特征在于，进一步包括：
炒白术13-17重量份。
7.根据权利要求1所述的药物组合物，其特征在于，进一步包括：
双花13-17重量份。
8.根据权利要求1所述的药物组合物，其特征在于，进一步包括：
花粉8-12重量份和黄芪13-17重量份。
9.根据权利要求1所述的药物组合物，其特征在于，进一步包括：
枣仁16-24重量份。
10.根据权利要求1所述的药物组合物，其特征在于，进一步包括：
知母13-17重量份和枸杞子13-17重量份。
11.权利要求1-10任一项所述的药物组合物制备药物中的用途，所述药物用于治疗骨质疏松。
12.根据权利要求11所述的用途，其特征在于，所述药物的剂型选自汤剂、片剂、颗粒剂、糖浆剂、胶囊和口服液之一。
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