CN105687590A - 一种用于治疗骨折的药物制剂 - Google Patents

一种用于治疗骨折的药物制剂 Download PDF

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CN105687590A
CN105687590A CN201610121169.1A CN201610121169A CN105687590A CN 105687590 A CN105687590 A CN 105687590A CN 201610121169 A CN201610121169 A CN 201610121169A CN 105687590 A CN105687590 A CN 105687590A
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Abstract

本发明属于中药制剂领域，具体提供了一种治疗骨折的药物制剂，它由如下原料制备得到：碱地肤22份、矮茎朱砂根20份、密叶飞蓬18份、秃疮花15份、地皮消20份、血竭25份、地龙18份、补骨脂25份、甘草5份，本发明能治疗骨折。

Description

一种用于治疗骨折的药物制剂
技术领域
本发明涉及中药制剂技术领域，具体涉及一种用于治疗骨折的药物制剂及其制备方法和应用。
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。为此，急要开发出更多安全有效的治疗骨折的药物满足临床治疗的需要。
发明内容
为了解决上述问题，本发明的目的在于提供一种可治疗骨折疾病的中药制剂。为了达到这个目的，采用如下技术方案：
技术方案：一种用于治疗骨折的药物制剂，它所含的活性成分由下列重量份原料药提取制备而成：碱地肤22份、矮茎朱砂根20份、密叶飞蓬18份、秃疮花15份、地皮消20份、血竭25份、地龙18份、补骨脂25份、甘草5份。
所述用于治疗骨折的药物制剂，剂型是药学上可接受的颗粒剂、片剂、胶囊剂。
所述用于治疗骨折的药物制剂，制备步骤为：取上述中药，加药材10倍重量的水，浸泡0.5h，煎煮1小时，过滤，药渣再加入药材8倍重量的水，煎煮1小时，药液滤出，合并两次煎煮液，减压浓缩至60℃相对密度为1.05，加乙醇使含醇量的体积百分比达75％，搅拌，静置，过滤，滤液减压浓缩至65℃时相对密度为1.25，并回收乙醇，得浓缩液，将浓缩液喷雾干燥，喷雾干燥条件为：进风温度为100℃，出风温度为90℃，物料温度为70℃，雾化压力为0.2兆帕，喷雾速度为10ml/s，添加辅料制成胶囊剂、片剂、颗粒剂。
所述用于治疗骨折的药物制剂在制备治疗骨折药物中的应用。
碱地肤，为藜科地肤属下的一个变种。拉丁名为Kochiascoparia(L.)Schrad.var.sieversiana(Pall.)Ulbr.exAschers.etGraebn.，产东北，华北，西北。果实：清热利湿，祛风止痒。本发明以全草入药。
矮茎朱砂根为紫金牛科紫金牛属植物矮茎朱砂根ArdisiabrevicaulisDiels,以根入药。秋冬采挖，洗净晒干。清热利咽，活血消肿。用于咽喉肿痛，痈疮肿毒，蛇咬伤，风湿关节疼痛，跌打损伤。
密叶飞蓬，拉丁名为ErigeronmultifoliusHand.-Mazz，多年生草本，根状茎粗壮，径达10毫米，分枝或不分枝，具纤维状根，上端常发出莲座状叶丛。产于云南西北部(德钦、贡山)及西藏东南部(察瓦龙)。生于高山及亚高山草地或林缘，海拔2800-4100米。活血化瘀，健脾清积。用于小儿疳积，牙痛，瘫痪，咳嗽，疥疮，牙出血。本发明以全草入药。
秃疮花为罂粟科秃疮花属植物秃疮花Dicranostigmaleptopodum，通常为多年生草本，高25-80厘米，全体含淡黄色液汁，被短柔毛，稀无毛。主根圆柱形。茎多，绿色，具粉，上部具多数等高的分枝。清热解毒，消肿止痛，杀虫。用于扁桃体炎，牙痛，淋巴结结核；外用治头癣，体癣。本发明以全草入药。
地皮消为爵床科植物喜栎小苞爵床的全草，拉丁学名为Pararuelliadelauayana(Baill.)E.Hossain，清热解毒，散瘀消肿。治肺炎，扁桃体炎，腮腺炎，瘰疬，脓肿疮毒，骨折，创伤感染。其余中药为药典品种。
有益效果：中医认为骨折为外伤引起局部脉络受损，气血凝滞，阻塞经络而致。本发明碱地肤、矮茎朱砂根、密叶飞蓬、秃疮花、地皮消强筋健骨、滋养肝肾为君药，血竭、地龙、补骨脂活血化瘀为臣药，甘草为佐使药，全方相互配伍，治疗骨折效果明显。
具体实施方式
以下通过实施例形式，对本发明的上述内容再作进一步的详细说明，但不应将此理解为本发明上述主题的范围仅限于以下的实例，凡基于本发明上述内容所实现的技术均属于本发明的范围。
实施例1、颗粒剂实施例的制备：取碱地肤22g、矮茎朱砂根20g、密叶飞蓬18g、秃疮花15g、地皮消20g、血竭25g、地龙18g、补骨脂25g、甘草5g，加药材10倍重量的水，浸泡0.5h，煎煮1小时，过滤，药渣再加入药材8倍重量的水，煎煮1小时，药液滤出，合并两次煎煮液，减压浓缩至60℃相对密度为1.05，加乙醇使含醇量的体积百分比达75％，搅拌，静置，过滤，滤液减压浓缩至65℃时相对密度为1.25，并回收乙醇，得浓缩液，将浓缩液喷雾干燥，喷雾干燥条件为：进风温度为100℃，出风温度为90℃，物料温度为70℃，雾化压力为0.2兆帕，喷雾速度为10ml/s，添加淀粉50g，制粒，制成颗粒剂。
实施例2、片剂实施例的制备：取碱地肤22g、矮茎朱砂根20g、密叶飞蓬18g、秃疮花15g、地皮消20g、血竭25g、地龙18g、补骨脂25g、甘草5g，加药材10倍重量的水，浸泡0.5h，煎煮1小时，过滤，药渣再加入药材8倍重量的水，煎煮1小时，药液滤出，合并两次煎煮液，减压浓缩至60℃相对密度为1.05，加乙醇使含醇量的体积百分比达75％，搅拌，静置，过滤，滤液减压浓缩至65℃时相对密度为1.25，并回收乙醇，得浓缩液，将浓缩液喷雾干燥，喷雾干燥条件为：进风温度为100℃，出风温度为90℃，物料温度为70℃，雾化压力为0.2兆帕，喷雾速度为10ml/s，添加糊精50g，制粒，压片，制成片剂。
实施例3、胶囊剂实施例的制备：取碱地肤22g、矮茎朱砂根20g、密叶飞蓬18g、秃疮花15g、地皮消20g、血竭25g、地龙18g、补骨脂25g、甘草5g，加药材10倍重量的水，浸泡0.5h，煎煮1小时，过滤，药渣再加入药材8倍重量的水，煎煮1小时，药液滤出，合并两次煎煮液，减压浓缩至60℃相对密度为1.05，加乙醇使含醇量的体积百分比达75％，搅拌，静置，过滤，滤液减压浓缩至65℃时相对密度为1.25，并回收乙醇，得浓缩液，将浓缩液喷雾干燥，喷雾干燥条件为：进风温度为100℃，出风温度为90℃，物料温度为70℃，雾化压力为0.2兆帕，喷雾速度为10ml/s，添加淀粉50g，制粒，灌装，制成胶囊剂。
实施例4、本发明对实验动物的骨密度的影响的药效学研究
样品制备：按实施例1方法制备。珍壮肾骨胶囊，山东会仙药业集团有限公司，批号：20150411。维A酸片，山东良福制药有限公司，批号：140512
动物：Wistar大鼠，雄性，体重180-240g，上海斯莱克实验动物有限公司提供。
实验分组及骨折大鼠模型的建立：取正常Wistar大鼠30只随机分为5组，取其中6只为NS组；取其中6只作为模型组，单纯按维A酸70mg/kg灌胃两周；取其中6只作为珍壮肾骨胶囊对照组；剩余的12只大鼠作为本发明高低剂量组。作为珍牡肾骨胶囊对照组和本发明高、低剂量组按70mg/kg的剂量灌服维A酸的同时灌服相应的药物，灌服两周后停服维A酸继续给药两周测定各项指标。大鼠断头处死，取其股骨按组排列，使用X-线乳腺摄像机摄制光片，用黑白密度计于股骨的大转子、股骨头、股骨颈、转子间线上及转子间线下5部位定点测定并记录骨密度值。
本发明对大鼠骨密度的影响
注：与模型组比较，*P<0.05；**P<0.01
实验结果：本发明与模型组比较，具有显著性差异，说明本发明能提高骨密度，治疗骨折，而且效果优于珍壮肾骨胶囊，可用于制备治疗骨折药物中的应用。

Claims (4)

1.一种用于治疗骨折的药物制剂，其特征在于，它所含的活性成分由下列重量份原料药提取制备而成：碱地肤22份、矮茎朱砂根20份、密叶飞蓬18份、秃疮花15份、地皮消20份、血竭25份、地龙18份、补骨脂25份、甘草5份。
2.如权利要求1所述用于治疗骨折的药物制剂，其特征在于，剂型是药学上可接受的颗粒剂、片剂、胶囊剂。
3.如权利要求1所述用于治疗骨折的药物制剂，其特征在于，制备步骤为：取上述中药，加药材10倍重量的水，浸泡0.5h，煎煮1小时，过滤，药渣再加入药材8倍重量的水，煎煮1小时，药液滤出，合并两次煎煮液，减压浓缩至60℃相对密度为1.05，加乙醇使含醇量的体积百分比达75％，搅拌，静置，过滤，滤液减压浓缩至65℃时相对密度为1.25，并回收乙醇，得浓缩液，将浓缩液喷雾干燥，喷雾干燥条件为：进风温度为100℃，出风温度为90℃，物料温度为70℃，雾化压力为0.2兆帕，喷雾速度为10ml/s，添加辅料制成胶囊剂、片剂、颗粒剂。
4.根据权利要求1所述用于治疗骨折的药物制剂在治疗骨折药物中的应用。
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CN104800339A (zh) * 2015-05-18 2015-07-29 南京华宽信息咨询中心 一种用于治疗骨折的中药组合物
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CN107468829A (zh) * 2017-10-07 2017-12-15 南京正宽医药科技有限公司 一种用于治疗骨质疏松的外用软膏

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