CN104491667B - 一种制备用于骨折愈合的药物组合物的方法 - Google Patents

一种制备用于骨折愈合的药物组合物的方法 Download PDF

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CN104491667B
CN104491667B CN201410755434.2A CN201410755434A CN104491667B CN 104491667 B CN104491667 B CN 104491667B CN 201410755434 A CN201410755434 A CN 201410755434A CN 104491667 B CN104491667 B CN 104491667B
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吴锡进
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Abstract

本发明属于药物技术领域，公开了一种制备用于促进骨折愈合的药物组合物的方法，所述药物组合物由红花、伸筋草、六道木、牛膝、蒲公英、草果、川芎、桃仁、血竭、山慈菇、乌梅、续断、知母、枸杞子、桑椹、乳香、没药、大腹皮、丹参、鸡血藤、山楂、肉桂、巴戟天、昆布、合欢皮制备而得，其成本低廉，疗效显著，具有广阔的应用前景。

Description

一种制备用于骨折愈合的药物组合物的方法
技术领域
本发明涉及中医中药技术领域，特别是一种制备用于骨折愈合的药物组合物的方法。
背景技术
骨折是指骨结构的连续性完全或部分断裂。多见于儿童及老年人，中青年人也时有发生。病人常为—个部位骨折，少数为多发性骨折。经及时恰当处理，多数病人能恢复原来的功能，少数病人可遗留有不同程度的后遗症。其主要临床表现为：骨折部有局限性疼痛和压痛，局部肿胀和出现瘀斑，肢体功能部位或完全丧失，完全性骨折尚可出现肢体畸形及异常活动。随着居民生活水平的提高，生活节奏的加快，生活中各种劳损随着交通运输工具的发展，由高速度、高能量所致的损伤越来越多，交通运输导致的车祸、运动意外造成的运动伤逐年上升。据资料统计，骨伤科疾病发病率达13.3％，其中12.1％可能致残，我国每年仅骨折的医疗费高达200亿元人民币。如何使骨折、创伤早期康复，减少伤残率；如何防治骨性疾病，减少残废率，同时降低医疗费用，保护劳动力和维护人民健康，是中医药研究者的任务。
目前治疗骨折的方法主要采用手术治疗，及通过校正断裂骨头，用石膏等物固定，涂抹内服一些中西药物来彻底治愈，但是往往疗程长，费用高，容易留下后遗症。虽然治疗骨折的药物品种很多，但是由于效果不十分明显，治疗周期长，且收费高，给患者及家庭带来了诸多困难和痛苦。
中医中药在治疗外伤性骨折，扭伤肿痛病症方面有其独特的疗效，根据唯物辩证法的哲学思想和中医学中“天人合一，药食同源；辩证施治，标本兼治，内外同治；筋骨并重，动静结合；肝主筋、肾主骨，补肝肾，强筋骨；通经络、祛湿痹、舒筋脉、消肿痛、利关节；气滞则血瘀、气行则血行；不通则痛、通则不痛；中病即止”的重要理论。结合现代药物成分分析和掌握科学的治疗方法。重点加强对机体整合调节作用，降低血液粘稠度，促进血流，加强血中营养物质输送，改善微循环；提高机体抗氧化能力，免疫功能和调节性激素水平，以增加机体对钙的吸收和利用，促进骨细胞生成和增殖，有利于骨痂生长和抗折能力，促进骨折愈合。达到消肿止痛、筋骨强壮的治疗目的。
发明内容
本发明的目的是为了克服背景技术的不足，而提供的一种使用方便、价格低廉、骨折愈合快、治疗周期短的中药组合物配方及其制备方法。根据骨折损伤后, 整个愈合过程始终存在气血疲滞, 疲血不去新血不生, 新血不生则骨不能接,筋不能续的原则，通过对传统中药的研究，并结合辩证论证，多方收集众家之长，寻求最佳治疗方案，采用纯天然中药原料，结合传统中医技术精心配制成本发用于促进骨折愈合的药物组合物，其配制方法简单，效果显著。
为实现上述目的，本发明采用的技术方案如下：
一种制备用于骨折愈合的药物组合物的方法，所述组合物由下述原料制备而得：
红花、伸筋草、六道木、牛膝、蒲公英、草果、川芎、桃仁、血竭、山慈菇、乌梅、续断、知母、枸杞子、桑椹、乳香、没药、大腹皮、丹参、鸡血藤、山楂、肉桂、巴戟天、昆布、合欢皮。
优选地，用于骨折愈合的药物组合物，其由下述重量配比的原料制备而得：
红花40份、伸筋草35份、六道木35份、牛膝35份、蒲公英35份、
草果30份、川芎30份、桃仁28份、血竭28份、山慈菇25份、
乌梅25份、续断25份、知母20份、枸杞子20份、桑椹20份、
乳香15份、没药15份、大腹皮15份、丹参10份、鸡血藤10份、
山楂8份、肉桂8份、巴戟天7份、昆布5份、合欢皮5份。
本发明的药物组合物的制备方法为：取上述重量份数的原料药制备胶囊制剂，具体操作为：
1)称取各原料药，备用；
2）取六道木、牛膝、草果、川芎、桃仁、乌梅、续断、枸杞子、乳香、没药、肉桂、巴戟天、合欢皮混合均匀，加3倍重量的水武火煮沸，然后文火煎煮半小时，过滤收集滤液和滤渣；往滤渣中添加水，以没过滤渣为准，武火煮沸，然后文火煎煮半小时，过滤收集滤液；合并上述两次滤液，冷却后，浓缩成密度为1.2g/ml的浸膏；80℃烘干后，粉碎成粉末，即为复合物A；
3）取剩余成分加入相对于混合物5倍重量75%的乙醇，回流提取2次，每次1小时，提取液合并，浓缩至密度为1.2g/ml的清膏，80℃烘干，粉碎制备复合物B；
4) 将复合物A和复合物B混合搅拌均匀，灭菌消毒制得胶囊剂产品。
用法用量：一次0.5g，一日三次，30天为一个疗程。
本发明药物的组分均采用天然的中药原料，其配制简便，药源广泛，成本低廉，诸药合用，相得益彰，全方共奏活血化癖、行气止痛, 接骨续筋之效。
具体实施方式
实施例1
一种制备用于骨折愈合的药物组合物的方法，所述药物组合物由下述重量配比的原料制备而得：
红花40份、伸筋草35份、六道木35份、牛膝35份、蒲公英35份、
草果30份、川芎30份、桃仁28份、血竭28份、山慈菇25份、
乌梅25份、续断25份、知母20份、枸杞子20份、桑椹20份、
乳香15份、没药15份、大腹皮15份、丹参10份、鸡血藤10份、
山楂8份、肉桂8份、巴戟天7份、昆布5份、合欢皮5份。
上述药物组合物的制备方法为：取上述重量份数的原料药制备胶囊制剂，具体操作为：
1)称取各原料药，备用；
2）取六道木、牛膝、草果、川芎、桃仁、乌梅、续断、枸杞子、乳香、没药、肉桂、巴戟天、合欢皮混合均匀，加3倍重量的水武火煮沸，然后文火煎煮半小时，过滤收集滤液和滤渣；往滤渣中添加水，以没过滤渣为准，武火煮沸，然后文火煎煮半小时，过滤收集滤液；合并上述两次滤液，冷却后，浓缩成密度为1.2g/ml的浸膏；80℃烘干后，粉碎成粉末，即为复合物A；
3）取剩余成分加入相对于混合物5倍重量75%的乙醇，回流提取2次，每次1小时，提取液合并，浓缩至密度为1.2g/ml的清膏，80℃烘干，粉碎制备复合物B；
4) 将复合物A和复合物B混合搅拌均匀，灭菌消毒制得胶囊剂产品。
用法用量：一次0.5g，一日三次，30天为一个疗程。
实施例2
临床资料
从具有完整病例的骨折病人中选择122例，随机分成治疗组和对照组，每组各61例，治疗组和对照组所选用的病例中病史、病情、年龄、性别尽量相当；治疗组和对照组均为住院治疗。
治疗组61例，年龄18-62岁，平均年龄40岁。其中肱骨外科颈骨折9例，肱骨踝上骨折12例，尺桡骨骨折15例，股骨干骨折16例，胫脉骨骨折9例。
对照组61例，年龄20-60岁，平均年龄41岁。其中肱骨外科颈骨折10例，肱骨踝上骨折13例，尺桡骨骨折13例，股骨干骨折15例，胫脉骨骨折10例。
两组治疗前均未用过任何治疗骨折药物。以上病例多有外伤史，如高处跌伤、骑车碰伤、木头砸伤及汽车撞伤等。患者局部肿胀疼痛，功能性障碍，外观畸形，可触及骨擦音及假关节活动。
治疗组给予实施例1制备的药物组合物，一次0.5g，一日三次，30天为一个疗程；
对照组采用常规药物接骨续筋片，一次5片，一日三次，30天为一个疗程；
随时观察治疗效果，患部肿胀消退时间，每7日摄片一次，检查对位和骨痂生长情况及患肢功能恢复时间。
疗效评定标准
治愈：骨折对线对位满意，有连续性骨痂形成，断端无压痛，无冲击痛，功能恢复。好转：对位及对线尚可，或骨折对位不佳，但功能恢复尚好。未愈：骨折不愈合成局部明显畸形，功能障碍。
治疗结果如下表所示：
例数 治愈 好转 未愈 总有效率
治疗组 61 31 25 5 91.8%
对照组 61 18 26 17 72.1%
对照组与治疗组相比呈显著性差异。
实施例3
典型病例：
（1）夏某，女，51岁，从窗台上跌落，骨折，经X线片检查，发现左锁骨中外1/3处骨折，断端错位重叠，右外踝骨折，断端对位线可。诊断为：左锁骨骨折，右外踝骨折伴三角韧带损伤。住院经手术后给予实施例1制备的促进骨折愈合的药物组合物，一日3次，服用两周后，X线检查，左肱骨中段骨折部位无移位，有少量骨痂生长；服用三周后，X线检查，左肱骨中段骨折部位有明显骨痂生长，骨折线开始模糊；继续服用至两个疗程，X线检查，左肱骨中段骨折部位有大量骨痂生长，骨折线模糊并消失，符合骨折临床愈合标准，恢复正常工作和家务劳动。
（2）谭某，男，49岁，左尺、挠骨闭合性骨折，进行手法复位，小夹板固定，并给予实施例1制备的促进骨折愈合的药物组合物，一日3次，用药一周后肿痛消除，两周后 X线可见原始骨痂生成，一个疗程可见骨小梁通过骨折线。 X线检查，骨痂生长，骨折线模糊并消失。符合骨折临床愈合标准，下地负重行走，并逐渐恢复正常。
本发明采用的上述各中药互作配伍，能发挥其协同治病作用，所用中药原料各成分之间具有药效相互交织相互促进和协调效能，经临床验证，适用于人体全身各部位闭合性骨折及各部位粉碎性骨折，能够舒筋活络、祛瘀生新、止血止痛，本申请人近十年的医疗实践中，治愈的病例数目众多，均取得良好的效果，而且成本低廉，减轻患者的负担，应用前景良好。

Claims (1)

1.一种制备用于骨折愈合的药物组合物的方法，其特征在于，所述方法包括如下步骤：
步骤1) 按照重量份称取各原料药，备用；其中：
红花40份、伸筋草35份、六道木35份、牛膝35份、蒲公英35份、
草果30份、川芎30份、桃仁28份、血竭28份、山慈菇25份、
乌梅25份、续断25份、知母20份、枸杞子20份、桑椹20份、
乳香15份、没药15份、大腹皮15份、丹参10份、鸡血藤10份、
山楂8份、肉桂8份、巴戟天7份、昆布5份、合欢皮5份；
步骤2）取六道木、牛膝、草果、川芎、桃仁、乌梅、续断、枸杞子、乳香、没药、肉桂、巴戟天以及合欢皮，混合均匀，加3倍重量的水武火煮沸，然后文火煎煮半小时，过滤收集滤液和滤渣；往滤渣中添加水，以没过滤渣为准，武火煮沸，然后文火煎煮半小时，过滤收集滤液；合并上述两次滤液，冷却后，浓缩成密度为1.2g/ml的浸膏；80℃烘干后，粉碎成粉末，即为复合物A；
步骤3）取剩余原料药，混合，加入相对于混合物5倍重量75%的乙醇，回流提取2次，每次1小时，提取液合并，浓缩至密度为1.2g/ml的清膏，80℃烘干，粉碎制得复合物B；
步骤4) 将复合物A和复合物B混合搅拌均匀，灭菌消毒制得胶囊剂产品。
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