CN106334157A - 一种外用骨质疏松药物 - Google Patents
一种外用骨质疏松药物 Download PDFInfo
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Abstract
本发明涉及一种外用骨质疏松药物，所述的药物由以下原料药制成：淫羊藿、续断、丹参、知母、补骨脂、生地黄、赤芍、三棱、莪术、川芎、牡蛎(煅)。本发明还提供该药物的应用。其优点表现在：本发明的中药组合物功能主治：补肾壮骨、活血通络、强筋壮骨，禁忌：孕妇，可用于治疗骨质疏松症。本发明的中药组合物通过透药机给药，疗效显著。
Description
技术领域
本发明涉及中药技术领域，具体地说，是一种外用骨质疏松药物。
背景技术
骨质疏松症(osteoporosis，OP)是一种以骨量减少、骨组织微结构破坏、骨骼脆性增加及易发生骨折为特征的全身性代谢性骨骼疾病。骨质疏松症可分为原发性骨质疏松症和继发性骨质疏松症。随着社会老龄化现象的加重，骨质疏松症发生率逐渐增加。骨质疏松症患者由于钙质丢失，骨脆性增加，骨强度降低，轻度外力作用下即可发生骨折。
临床上通常采用药物治疗骨质疏松症，仙灵骨葆胶囊是在苗药验方的基础上研制而成的纯中药制剂，主要成分为淫羊藿、续断、补骨脂、地黄、丹参、知母，具有滋肝补肾、活血通络、强筋壮骨的功效。
经皮给药系统或称透皮给药系统由于不经过胃肠系统的吸收，不经过肝脏首过效应，备受青睐、发展迅速。
中国专利文献CN200510067849.1公开了仙灵骨葆的配方：淫羊藿12-20份，续断2-8份，丹参1-5份，知母1-5份，补骨脂1-5份，地黄1-5份。中国专利申请CN97107552.2、CN200410046192.6、CN200510041699.7、200610065646.3、CN200810176798.X、CN201110317157.3等公开了不同的仙灵骨葆的提取物的制备方法。但是关于本发明的一种外用骨质疏松药物目前还未见报道。
发明内容
本发明的目的是针对现有技术中的不足，提供一种外用骨质疏松药物。
本发明的再一的目的是，提供一种外用骨质疏松药物的用途。
为实现上述目的，本发明采取的技术方案是：一种治疗骨质疏松的中药组合物，所述的中药组合物由以下重量份的原料药制成：淫羊藿130～170份、续断15～25份、丹参13～17份、知母13～17份、补骨脂13～17份、生地黄13～17份、赤芍8～12份、三棱8～12份、莪术8～12份、川芎8～12份、煅牡蛎8～12份。
所述的中药组合物由以下重量份的原料药制成：淫羊藿140～160份、续断18～22份、丹参14～16份、知母14～16份、补骨脂14～16份、生地黄14～16份、赤芍9～11份、三棱9～11份、莪术9～11份、川芎9～11份、煅牡蛎9～11份。
所述的中药组合物由以下重量份的原料药制成：淫羊藿150份、续断20份、丹参15份、知母15份、补骨脂15份、生地黄15份、赤芍10份、三棱10份、莪术10份、川芎10份、煅牡蛎10份。
所述的中药组合物为外用药物。
所述的中药组合物通过透药机给药。
为实现上述第二个目的，本发明采取的技术方案是：所述的中药组合物在制备治疗骨质疏松的药物中的应用。
所述的骨质疏松为原发性骨质疏松或继发性骨质疏松。
本发明优点在于：
1、本发明的中药组合物功能主治：补肾壮骨、活血通络、强筋壮骨，禁忌：孕妇，可用于治疗骨质疏松症。
2、本发明的中药组合物通过透药机给药，疗效显著。
具体实施方式
下面结合实施例对本发明提供的具体实施方式作详细说明。
本发明的治疗骨质疏松的中药(外用)
成分：淫羊藿、续断、丹参、知母、补骨脂、生地黄、赤芍、三棱、莪术、川芎、牡蛎(煅)
功能主治：补肾壮骨、活血通络、强筋壮骨
禁忌：孕妇
实施例1
淫羊藿150份、续断20份、丹参15份、知母15份、补骨脂15份、生地黄15份、赤芍10份、三棱10份、莪术10份、川芎10份、牡蛎(煅)10份
实施例2
淫羊藿140份、续断22份、丹参14份、知母16份、补骨脂14份、生地黄16份、赤芍9份、三棱11份、莪术9份、川芎11份、煅牡蛎9份
实施例3
淫羊藿160份、续断18份、丹参16份、知母14份、补骨脂16份、生地黄14份、赤芍11份、三棱9份、莪术11份、川芎9份、煅牡蛎11份
实施例4
淫羊藿130份、续断25份、丹参13份、知母7份、补骨脂13份、生地黄17份、赤芍8份、三棱12份、莪术8份、川芎12份、煅牡蛎8份
实施例5
淫羊藿170份、续断15份、丹参17份、知母13份、补骨脂17份、生地黄13份、赤芍12份、三棱8份、莪术12份、川芎8份、煅牡蛎12份
实施例6
一、资料与方法
1、一般资料
200例骨质疏松患者全部来自于上海市普陀区人民医院，随机分为4组，对照组一、对照组二、对照组三、实验组各50例。4组患者的年龄、性别、病程等一般资料比较差异无统计学意义(P＞0.05)，具有可比性。
2、病例选择
纳入标准：参照中华中医学骨伤科分会骨质疏松诊断标准拟定；以双能X线吸收测量法测得汉族人峰值骨密度(BMD)(M±SD)为正常参考值；骨密度>M-1.0SD为骨量正常，M-2.0SD≤骨密度≤M-1.0SD，为骨量减少；骨密度<M-2.0SD为疏松。
排除标准：妊娠期和哺乳期妇女，合并房颤，合并心功能异常、肝肾功能异常和肺功能异常，合并甲亢、骨髓瘤等影响钙离子代谢的慢性疾病，合并造血系统疾病，合并精神性疾病，合并类风湿性关节炎，对本研究药物过敏者。
3、治疗方法
对照组一：仙灵骨葆胶囊，每次3粒，每日2次，口服。
对照组二：中医定向透药治疗仪外用治疗，将淫羊藿150份、续断20份、丹参15份、知母15份、补骨脂15份、生地黄15份研磨成粉末，取20g装入药疗包内包裹妥当，放入温热黄酒内浸透控干备用。药疗包敷于病灶部位，将电极保湿片(中医定向透药治疗仪配套设备)紧密贴压在药疗包上，用纱布绷带包扎稳固，连通中医定向透药治疗仪的电极，保持38℃～45℃治疗温度，持续治疗25分钟，每日1次。
对照组三：实施例1的中药组合物研磨成粉末后常规方法外敷，每日1次。
治疗组：中医定向透药治疗仪外用治疗，将实施例1的中药组合物研磨成粉末，取20g装入药疗包内包裹妥当，放入温热黄酒内浸透控干备用。药疗包敷于病灶部位，将电极保湿片(中医定向透药治疗仪配套设备)紧密贴压在药疗包上，用纱布绷带包扎稳固，连通中医定向透药治疗仪的电极，保持38℃～45℃治疗温度，持续治疗25分钟，每日1次。
4组患者均进行健康教育，给予富含钙、低盐和适量优质蛋白质的均衡膳食，适当进行户外活动和日照，避免嗜烟酗酒，慎用影响骨代谢药物，加强自身保护，防止跌倒和损伤，并对患者进行基础治疗和对症治疗。基础治疗：患者除膳食补充钙和维生素D外，还要补充碳酸钙、葡萄糖酸钙、枸橼酸钙等钙剂和维生素D，每日钙和维生素D总摄入量分别为800～1200mg及400～1200U。对症治疗：对于有疼痛患者给予适量非甾体抗炎药(阿司匹林肠溶片或吲哚美辛肠溶片)，发生骨折患者给予降钙素制剂，骨畸形患者应局部固定或采用其他矫形措施。
疗程：4组均3个月1个疗程，治疗1个疗程。
4、观察指标
1)疼痛程度评分：治疗前后对4组患者进行疼痛程度评分，采用视觉模拟评分法(VAS)评分。
2)骨密度检测：治疗前后采用双能X线骨矿含量测定仪测定腰椎前后位骨密度(BMD)。
3)疗效评定标准：
治愈：临床症状消失，血清钙、磷等指标正常，骨密度测定基本正常。
显效：临床症状消失或明显好转，血钙、磷等指标有改善，骨密度明显提高。
有效：临床症状有好转，血清钙、磷等指标有改善，骨密度测定有改善或未见加重。
无效：临床症状无好转，血清钙、磷等指标无改善，BMD无改善或反而加重。
二、结果
1、4组患者疼痛缓解情况比较
4组患者疼痛均有不同程度的缓解，治疗组的疼痛缓解情况优于对照组，4组患者治疗前后疼痛的VAS评分比较见表1。
表1 4组患者疼痛缓解情况比较
2、4组患者治疗前后BMD值测定
4组患者BMD值均有不同程度的改善，治疗组的骨密度改善情况优于对照组，4组患者治疗前后BMD值(g/cm2)比较见表2。
表2 4组患者BMD值比较
3、4组患者疗效比较
治疗组具有较高的有效率，具体结果见表3。
表3 4组患者疗效比较
以上所述仅是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员，在不脱离本发明方法的前提下，还可以做出若干改进和补充，这些改进和补充也应视为本发明的保护范围。
Claims (7)
1.一种治疗骨质疏松的中药组合物，其特征在于，所述的中药组合物由以下重量份的原料药制成：淫羊藿130～170份、续断15～25份、丹参13～17份、知母13～17份、补骨脂13～17份、生地黄13～17份、赤芍8～12份、三棱8～12份、莪术8～12份、川芎8～12份、煅牡蛎8～12份。
2.根据权利要求1所述的中药组合物，其特征在于，所述的中药组合物由以下重量份的原料药制成：淫羊藿140～160份、续断18～22份、丹参14～16份、知母14～16份、补骨脂14～16份、生地黄14～16份、赤芍9～11份、三棱9～11份、莪术9～11份、川芎9～11份、煅牡蛎9～11份。
3.根据权利要求1所述的中药组合物，其特征在于，所述的中药组合物由以下重量份的原料药制成：淫羊藿150份、续断20份、丹参15份、知母15份、补骨脂15份、生地黄15份、赤芍10份、三棱10份、莪术10份、川芎10份、煅牡蛎10份。
4.根据权利要求1所述的中药组合物，其特征在于，所述的中药组合物为外用药物。
5.根据权利要求4所述的中药组合物，其特征在于，所述的中药组合物通过透药机给药。
6.根据权利要求1-5任一所述的中药组合物在制备治疗骨质疏松的药物中的应用。
7.根据权利要求6所述的应用，其特征在于，所述的骨质疏松为原发性骨质疏松或继发性骨质疏松。
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