CN104547489A - 一种中药组合物在制备治疗粉碎性骨折药物中的用途 - Google Patents
一种中药组合物在制备治疗粉碎性骨折药物中的用途 Download PDFInfo
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- CN104547489A CN104547489A CN201410847212.3A CN201410847212A CN104547489A CN 104547489 A CN104547489 A CN 104547489A CN 201410847212 A CN201410847212 A CN 201410847212A CN 104547489 A CN104547489 A CN 104547489A
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Abstract
本发明属于中药领域,具体涉及一种中药组合物在制备治疗粉碎性骨折药物中的用途。该中药组合物的主要原料药材有黄芪、白术、人参、怀山药、熟地、五味子、白芍、川芎、香附、川贝母、陈皮、桂枝、当归、茯苓、牡丹皮、枸杞子、大枣、泽泻、甘草19味中药材组成。该中药组合物在治疗粉碎性骨折方面具有效果好、标本兼治、侧重活血化瘀、散瘀止痛等技术优势,并且其制剂工艺简便易行、制剂药效稳定、适用范围广、无任何毒副作用、易于推广应用。
Description
技术领域
本发明属于中药领域,具体涉及一种中药组合物在制备治疗粉碎性骨折药物中的用途。
背景技术
骨折是指骨结构的连续性完全或部分断裂,是外伤、跌打等外界力而引起的骨伤、折断、粉碎性所致的一种病症。骨折分为完全骨折和不完全骨折,而粉碎性骨折属于完全性骨折,指骨质碎裂成三块以上,又称为t或y型骨折开放性骨折是指骨折处皮肤或粘膜破裂,骨折端与外界相通。
粉碎性骨折的主要临床表现为:骨折部有局限性疼痛和压痛,出现肿胀和瘀斑,肢体功能部位或完全丧失,有时还会出现肢体异常活动症状即正常情况下肢体不能活动的部位,骨折后出现不正常的活动;有时还会出现肢体畸形症状即骨折段移位可使患肢外形发生改变,主要表现为缩短,骨擦音或骨擦感症状;有时骨折处会出现大量内出血,血肿吸收时,体温略有升高,容易出现感染的问题,从而产生休克症状;有时也会因广泛的软组织损伤、大量出血、剧烈疼痛或并发内脏损伤等而引起休克的症状。粉碎性骨折不仅给患者带来巨大的疼痛,还给患者的生活带来了极大的不便。
目前,粉碎性骨折一般是采用西药治疗,治疗粉碎性骨折的药物有舒筋活血片、骨折挫伤胶囊、复方氯唑沙宗胶囊、独一味胶囊和三七片等等舒筋活络,接骨止痛的药物,消肿散瘀,消炎止痛的药物,这些药物都是对症下药,临时控制疼痛,无法从根本上解决骨折给患者带来的痛苦,而且治疗效果难以持续,需要患者长期用药,患者会对药物产生依赖性,副作用较大,对患者的健康存在较大的危害。因此,研究发开出一种治疗粉碎性骨折效果持续,副作用小的药物是当前亟需解决的问题。
发明内容
本发明要解决的技术问题是提供一种中药组合物在制备治疗粉碎性骨折药物中的用途,公开一种治疗治疗粉碎性骨折的中药组合物,并且该中药组合物可以利用现代制药技术制成方便易用的成品制剂。
为解决该技术问题,发明人根据自身多年的行医经验,在总结古人治疗治疗粉碎性骨折的经验的基础上,结合现代工业制药技术特点,重新配伍组方,经临床实践反复印证和调整,终于发明了一个对治疗粉碎性骨折有显著治疗效果的全新的中药组方和其制备工艺。该中药组方为(以重量份计):
黄芪12-32份、白术10-20份、人参10-22份、怀山药13-19份、熟地4-12份、五味子6-16份、白芍6-18份、川芎12-26份、香附9-18份、川贝母5-15份、陈皮4-14份、桂枝6-13份、当归10-24份、茯苓8-22份、牡丹皮4-12份、枸杞子6-18份、大枣8-16份、泽泻3-9份、甘草8-18份。
从上述中药组方范围中优选出1个治疗治疗粉碎性骨折效果最佳的中药组方:该中药组方为(以重量份计):黄芪20份、白术16份、人参15份、怀山药16份、熟地6份、五味子8份、白芍10份、川芎18份、香附12份、川贝母10份、陈皮8份、桂枝9份、当归14份、茯苓15份、牡丹皮8份、枸杞子10份、大枣12份、泽泻6份、甘草10份。
将上述中药组方做成成品制剂的制备工艺为以下步骤:
(1)、按中药组方分别称取黄芪、白术、人参、怀山药、熟地、五味子、白芍、川芎、香附、川贝母、陈皮、桂枝、当归、茯苓、牡丹皮、枸杞子、大枣、泽泻、甘草等各味药材,分别粉碎,备用;
(2)、将所有药材加入初始药材10倍重量的纯化水,浸泡18小时,回流煎煮3小时,过滤,再加入初始重量7倍重量的纯化水,回流煎煮1小时,过滤并保留滤渣,合并滤液,浓缩至60℃相对密度为1.25的浓缩液备用;
(3)、将步骤(2)的滤渣加6倍重量的浓度80%的乙醇,回流提取2次,每次5小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至60℃相对密度为1.20的浓缩液备用;
(4)、将步骤(2)和(3)所得的浓缩液合并,继续浓缩至60℃相对密度为1.33的中药浸膏,备用;
(5)、将步骤(4)的中药浸膏添加适当的辅料,利用现代通用的中药制剂技术制成临床需要的成品制剂,如胶囊剂、颗粒剂、片剂、丸剂、散剂或糖浆剂等剂型。
本发明中药组合物所用中药材的来源、性味、归经及功效:
黄芪:本品为豆科植物蒙古黄芪或膜荚黄芪的干燥根。味甘,性温;归肺、脾经;补气固表,利尿托毒,排脓,敛疮生肌,活血化瘀。
白术:本品为菊科植物白术的干燥根茎。味苦、甘,性温;归脾、胃经;健脾益气,燥湿利水,止汗,安胎。
人参:本品为五加科植物人参的干燥根。味甘、微苦,性平;归脾、肺、心经;大补元气,复脉固脱,补脾益肺,生津,安神。
怀山药:本品为薯蓣科植物薯蓣的干燥根茎。味甘,性平;归脾、肺、肾经;补脾养胃,生津益肺,补肾涩精。
熟地:本品为生地黄的炮制加工品。味甘,性微温;归肝、肾经;滋阴补血,益精填髓。
五味子:本品为木兰科植物五味子或华中五味子的干燥成熟果实。味酸、甘,性温;归肺,心、肾经;收敛固涩,益气生津,补肾宁心。
白芍:本品为毛茛科植物芍药的干燥根。味苦、酸,性微寒;归肝、脾经;平肝止痛,养血调经,敛阴止汗,散瘀止痛。
川芎:本品为伞形科植物川芎的干燥根茎。味辛,性温;归肝、胆、心包经;活血行气,祛风止痛。
香附:本品为莎草科植物莎草的干燥根茎。味辛、微苦、微甘,性平;归肝、脾、三焦经;行气解郁,调经止痛。
川贝母:本品为百合科植物川贝母、暗紫贝母、甘肃贝母或梭砂贝母的干燥鳞茎。味苦、甘,性微寒;归肺、心经;清热润肺,化痰止咳。
陈皮:为芸香科植物橘及其栽培变种的成熟果皮。味苦、辛,性温;归肺、脾经;理气健脾,燥湿化痰。
桂枝:本品为樟科植物肉桂的干燥嫩枝。味辛、甘,性温;归心、肺、膀胱经;发汗解肌,温通经脉,助阳化气,平冲降气。
当归:本品为伞形科植物当归的干燥根。味甘、辛,性温;归肝、心、脾经;补血活血,调经止痛,润肠通便。
茯苓:本品为多孔菌科真菌茯苓的干燥菌核。味甘、淡,性平;归心、脾、肾经;渗湿利水、健脾和胃、宁心安神。
牡丹皮:本品为毛茛科植物牡丹的干燥根皮。味苦、辛,性微寒;归心、肝、肾经;清热凉血,活血化瘀。
枸杞子:本品为茄科植物宁夏枸杞的干燥成熟果实。味甘,性平;归肝、肾经;滋补肝肾,益精明目。
大枣:本品为鼠李科枣属植物枣的干燥成熟果实。味甘,性温;归脾、胃经;补中益气,养血安神。
泽泻:本品为泽泻科植物泽泻的干燥块茎。味甘,性寒;归肾、膀胱经;利小便,清湿热。
甘草:本品为豆科植物甘草、胀果甘草或光果甘草的干燥根。味甘,性平;归心、肺、脾、胃经;补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。
本发明中药组方的组方分析:
本发明中药组方是以黄芪、白术、人参、怀山药、熟地为君药,补气固表、健脾益气、活血化瘀、散瘀止痛、滋阴补血;以五味子、陈皮、桂枝、当归、大枣为臣药,益气生津、理气健脾、温通经脉、补血活血、止痛祛瘀;以白芍、茯苓、川贝母、牡丹皮为佐药,补血活血、渗湿利水、清热润肺、活血化瘀;以川芎、香附、枸杞子、泽泻为使药,活血行气、行气解郁、清热利尿;以甘草调和诸药性,使诸药协同配合,相辅相成,共同达到补气固表、活血化瘀、散瘀止痛、理气健脾、养血调经等功效,对粉碎性骨折等症有十分显著的治疗效果。
与现有技术相比,本发明中药组合物在治疗粉碎性骨折方面具有效果好、标本兼治、侧重活血化瘀、散瘀止痛等技术优势,并且其制剂工艺简便易行、制剂药效稳定、适用范围广、无任何毒副作用、易于推广应用。
具体实施方式
实施例1、本发明中药组合物胶囊剂的制备
(1)、按中药组方分别称取黄芪12kg、白术10kg、人参10kg、怀山药13kg、熟地4kg、五味子6kg、白芍6kg、川芎12kg、香附9kg、川贝母15kg、陈皮14kg、桂枝13kg、当归24kg、茯苓22kg、牡丹皮12kg、枸杞子18kg、大枣16kg、泽泻9kg、甘草18kg,分别粉碎,备用;
(2)、将所有药材加入初始药材10倍重量的纯化水,浸泡18小时,回流煎煮3小时,过滤,再加入初始重量7倍重量的纯化水,回流煎煮1小时,过滤并保留滤渣,合并滤液,浓缩至60℃相对密度为1.25的浓缩液备用;
(3)、将步骤(2)的滤渣加6倍重量的浓度80%的乙醇,回流提取2次,每次5小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至60℃相对密度为1.20的浓缩液备用;
(4)、将步骤(2)和(3)所得的浓缩液合并,继续浓缩至60℃相对密度为1.33的中药浸膏,备用;
(5)、将步骤(4)的中药浸膏添加适当的辅料,制备成胶囊剂。
实施例2、本发明中药组合物胶囊剂的制备
(1)、按中药组方分别称取黄芪20kg、白术16kg、人参15kg、怀山药16kg、熟地6kg、五味子8kg、白芍10kg、川芎18kg、香附12kg、川贝母10kg、陈皮8kg、桂枝9kg、当归14kg、茯苓15kg、牡丹皮8kg、枸杞子10kg、大枣12kg、泽泻6kg、甘草10kg,分别粉碎,备用;
(2)、将所有药材加入初始药材10倍重量的纯化水,浸泡18小时,回流煎煮3小时,过滤,再加入初始重量7倍重量的纯化水,回流煎煮1小时,过滤并保留滤渣,合并滤液,浓缩至60℃相对密度为1.25的浓缩液备用;
(3)、将步骤(2)的滤渣加6倍重量的浓度80%的乙醇,回流提取2次,每次5小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至60℃相对密度为1.20的浓缩液备用;
(4)、将步骤(2)和(3)所得的浓缩液合并,继续浓缩至60℃相对密度为1.33的中药浸膏,备用;
(5)、将步骤(4)的中药浸膏添加适当的辅料,制备成胶囊剂。
实施例3、本发明中药组合物片剂的制备
(1)、按中药组方分别称取黄芪32kg、白术20kg、人参22kg、怀山药19kg、熟地12kg、五味子16kg、白芍18kg、川芎26kg、香附18kg、川贝母5kg、陈皮4kg、桂枝6kg、当归10kg、茯苓8kg、牡丹皮4kg、枸杞子6kg、大枣8kg、泽泻3kg、甘草8kg,分别粉碎,备用;
(2)、将所有药材加入初始药材10倍重量的纯化水,浸泡18小时,回流煎煮3小时,过滤,再加入初始重量7倍重量的纯化水,回流煎煮1小时,过滤并保留滤渣,合并滤液,浓缩至60℃相对密度为1.25的浓缩液备用;
(3)、将步骤(2)的滤渣加6倍重量的浓度80%的乙醇,回流提取2次,每次5小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至60℃相对密度为1.20的浓缩液备用;
(4)、将步骤(2)和(3)所得的浓缩液合并,继续浓缩至60℃相对密度为1.33的中药浸膏,备用;
(5)、将步骤(4)的中药浸膏添加适当的辅料,制备成片剂。
实施例4、本发明中药组合物散剂的制备
(1)、按中药组方分别称取黄芪28kg、白术16kg、人参15kg、怀山药14kg、熟地6kg、五味子8kg、白芍16kg、川芎18kg、香附10kg、川贝母12kg、陈皮6kg、桂枝8kg、当归10kg、茯苓8kg、牡丹皮6kg、枸杞子6kg、大枣10kg、泽泻3kg、甘草10kg,分别粉碎,备用;
(2)、将所有药材加入初始药材10倍重量的纯化水,浸泡18小时,回流煎煮3小时,过滤,再加入初始重量7倍重量的纯化水,回流煎煮1小时,过滤并保留滤渣,合并滤液,浓缩至60℃相对密度为1.25的浓缩液备用;
(3)、将步骤(2)的滤渣加6倍重量的浓度80%的乙醇,回流提取2次,每次5小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至60℃相对密度为1.20的浓缩液备用;
(4)、将步骤(2)和(3)所得的浓缩液合并,继续浓缩至60℃相对密度为1.33的中药浸膏,备用;
(5)、将步骤(4)的中药浸膏添加适当的辅料,制备成散剂。
实施例5、本发明中药组合物颗粒剂的制备
(1)、按中药组方分别称取黄芪22kg、白术12kg、人参10kg、怀山药13kg、熟地8kg、五味子10kg、白芍6kg、川芎14kg、香附11kg、川贝母13kg、陈皮8kg、桂枝6kg、当归15kg、茯苓10kg、牡丹皮4kg、枸杞子6kg、大枣14kg、泽泻5kg、甘草18kg,分别粉碎,备用;
(2)、将所有药材加入初始药材10倍重量的纯化水,浸泡18小时,回流煎煮3小时,过滤,再加入初始重量7倍重量的纯化水,回流煎煮1小时,过滤并保留滤渣,合并滤液,浓缩至60℃相对密度为1.25的浓缩液备用;
(3)、将步骤(2)的滤渣加6倍重量的浓度80%的乙醇,回流提取2次,每次5小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至60℃相对密度为1.20的浓缩液备用;
(4)、将步骤(2)和(3)所得的浓缩液合并,继续浓缩至60℃相对密度为1.33的中药浸膏,备用;
(5)、将步骤(4)的中药浸膏添加适当的辅料,制备成颗粒剂。
实施例6、 本发明中药组合物对家兔骨折模型的影响
1、试验材料
1.1、试验动物:大白兔,雄性,2.2-2.4kg,由山东大学新药安评中心提供。
1.2、仪器:日立7020全自动生化分析仪,日本Hitachi公司。骨密度测定仪(Piximus bone densito-meter,美国LUNAR公司)
1.3、试验药物:独一味胶囊,0.3g*50粒/瓶;
本发明实施例2制备的中药组合物胶囊剂。
2、试验方法
2.1、动物分组:取白兔55只,随机分为5组,每组11只,分别为模型组、独一味阳性组、低剂量组、中剂量组和高剂量组;各组给药量如下所示:
模型组:灌胃给予相同体积的蒸馏水;
独一味阳性组:灌胃给予独一味胶囊0.2g/kg.d;
低剂量组:灌胃给予本发明实施例2制备胶囊 0.1g/kg.d;
中剂量组:灌胃给予本发明实施例2制备胶囊 0.2g/kg.d;
高剂量组:灌胃给予本发明实施例2制备胶囊 0.5g/kg.d;
2.2、动物模型的制备:家兔适应性饲养一周后,家兔用3%戊巴比妥钠溶液按照1ml/kg剂量静脉麻醉后,两侧前肢剪毛,75%酒精消毒,在无菌条件下用医用手术牙科钻在两侧桡骨中上段1/3交界处横钻成宽约为3mm,深入骨髓腔形成骨损伤,缝合皮肤,手术后次日开始灌胃给药,连续给药,给药后第14、28天取各组家兔中的7只,测定各项指标。
2.3、骨密度测定:分别于给药后第14、28天截取两侧桡骨,其长度包括损伤及上下各正常段骨质,用美国LUNAR公司Piximus bone densito-meter测定仪测定骨密度,观察骨折愈合情况。
3、试验结果
试验结果表明(具体见表1):连续给予本发明的中药组合物14天后,独一味组和本发明中药组合物低中高三个剂量组的骨密度增加,与模型组相比具有显著性差异(p<0.05)。给药28天后,独一味组与模型组相比具有极显著性差异(p<0.01),本发明中药组合物低剂量组、中剂量组和高剂量组与模型组相比有显著性差异(p<0.05),并且28天的骨密度比14天的骨密度增大,结果表明本发明的中药组合物具有加快骨矿沉积速率,提高骨密度,促进骨折部位愈合的功能。
表 1 本发明中药组合物对家兔骨折模型骨密度的影响
组别 | 动物数 | 骨密度(g/cm3,14d) | 骨密度(g/cm3,28d) |
模型组 | 11 | 0.186±0.032 | 0.246±0.056 |
独一味组 | 11 | 0.280±0.046▲▲ | 0.378±0.038▲▲ |
低剂量组 | 11 | 0.236±0.058▲ | 0.264±0.044 |
中剂量组 | 11 | 0.248±0.050▲ | 0.320±0.054▲ss |
高剂量组 | 11 | 0.274±0.052▲▲ | 0.350±0.052▲ |
▲P<0.05,▲▲P<0.01;
实施例7、本发明中药组合物对粉碎性骨折患者的临床疗效试验
1.试验对象资料:
选取120例粉碎性骨折临床志愿者,其中男76例,女44例,年龄20~90岁,平均40岁,将120名患者分为治疗组和对照组,每组60人。
2、试验药物
试验药物为本发明实施例2制备的胶囊剂,独一味胶囊。
3、试验方法
治疗组口服本发明实施例2制备的胶囊剂,5g/次,每日3次,1个月一个疗程。对照组服用独一味胶囊(甘肃独一味生物制药有限责任公司,0.3g*50粒/瓶),每日3次,每次3粒,1个月一个疗程。治疗结束后回访所有患者,统计粉碎性骨折患者的情况。
4、试验评价标准
所有患者均经过X线检查、CT检查和MRI检查确诊,并结合患者症状确诊。
5、临床症状
粉碎性骨折患者的临床症状有:骨折处疼痛,骨折处畸形,行动出现骨擦音,骨折处出现创伤性炎症、水肿和出血等症状。
6、疗效标准
(1)治愈:无粉碎性骨折的临床症状,X线显示有大量骨痂形成,无需固定治疗。
(2)显效:粉碎性骨折临床症状基本消失,X线显示有骨痂形成,仍需固定治疗。
(3)有效:粉碎性骨折临床症状部分消失,X线显示有少量骨痂形成,仍需进一步治疗。
(4)无效:粉碎性骨折临床症状没有任何改善。
7、治疗效果
表2 本发明实施例2胶囊剂治疗粉碎性骨折效果表
组别 | 病例数 | 治愈(率) | 显效(率) | 有效(率) | 无效(率) | 总有效率 |
治疗组 | 60 | 25(41.7%) | 18(30%) | 11(18.3%) | 6(10%) | 90% |
对照组 | 60 | 24(40%) | 20(33.3%) | 9(15%) | 7(11.7%) | 88.3% |
8、试验结论
本发明实施例2制备胶囊剂的治疗组的治愈率为41.7%,总有效率为90%,对照组的治愈率为40%,总有效率为88.3%,证明本发明的中药组合物治疗粉碎性骨折效果显著,无毒副作用,有利于该中药组合物大规模的推广和应用。
Claims (4)
1.一种中药组合物在制备治疗粉碎性骨折药物中的用途,其特征在于,所述中药组合物的中药组方为:
黄芪12-32份、白术10-20份、人参10-22份、怀山药13-19份、熟地4-12份、五味子6-16份、白芍6-18份、川芎12-26份、香附9-18份、川贝母5-15份、陈皮4-14份、桂枝6-13份、当归10-24份、茯苓8-22份、牡丹皮4-12份、枸杞子6-18份、大枣8-16份、泽泻3-9份、甘草8-18份。
2.根据权利要求1所述的用途,其特征在于,所述中药组合物的中药组方为:
黄芪20份、白术16份、人参15份、怀山药16份、熟地6份、五味子8份、白芍10份、川芎18份、香附12份、川贝母10份、陈皮8份、桂枝9份、当归14份、茯苓15份、牡丹皮8份、枸杞子10份、大枣12份、泽泻6份、甘草10份。
3.根据权利要求1或2所述的用途,其特征在于,所述中药组合物的制备工艺为以下步骤:
步骤(1)、按中药组方分别称取黄芪、白术、人参、怀山药、熟地、五味子、白芍、川芎、香附、川贝母、陈皮、桂枝、当归、茯苓、牡丹皮、枸杞子、大枣、泽泻、甘草等各味药材,分别粉碎,备用;
步骤(2)、将所有药材加入初始药材10倍重量的纯化水,浸泡18小时,回流煎煮3小时,过滤,再加入初始重量7倍重量的纯化水,回流煎煮1小时,过滤并保留滤渣,合并滤液,浓缩至60℃相对密度为1.25的浓缩液备用;
步骤(3)、将步骤(2)的滤渣加6倍重量的浓度80%的乙醇,回流提取2次,每次5小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至60℃相对密度为1.20的浓缩液备用;
步骤(4)、将步骤(2)和(3)所得的浓缩液合并,继续浓缩至60℃相对密度为1.33的中药浸膏,备用;
步骤(5)、将步骤(4)的中药浸膏添加适当的辅料,利用现代通用的中药制剂技术制成临床需要的成品制剂。
4.根据权利要求1-3任一所述的用途,其特征在于,所述中药组合物制成胶囊剂、颗粒剂、片剂、丸剂、散剂或糖浆剂。
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