CN105998339A - 一种药物在制备抗血栓药物中的应用 - Google Patents
一种药物在制备抗血栓药物中的应用 Download PDFInfo
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Abstract
本发明公开了一种药物在制备抗血栓药物中的应用,该药物由如下重量份的原料药制成:黄芪100‑150重量份,党参80‑120重量份,丹参60‑100重量份,葛根60‑100重量份,淫羊藿60‑100重量份,山楂60‑100重量份,地黄40‑80重量份,当归40‑80重量份,黄连40‑80重量份,醋延胡索40‑80重量份,灵芝40‑80重量份,人参20‑30重量份,炙甘草20‑30重量份。本发明中抗血栓的药物治疗效果好,制备大鼠颈动脉用于大鼠体内溶解血栓试验,经过较短时间,与阴性对照和阳性对照相比,本发明的药物具有抗血栓的作用,并且抗血栓效果显著。
Description
技术领域
本发明涉及一种药物的新用途,具体地,本发明涉及一种药物在制备抗血栓药物中的应用,属于中药应用领域。
背景技术
血栓形成是在生理或病理情况下,凝血系统在不同程度上被激活,循环血液中有形成分在血液中形成栓子,造成血管腔部分或完全堵塞。与之相应的临床事件有急性心肌梗死、缺血性脑卒中、肺栓塞和弥散性血管内凝血。
血液在多种危险因素(如血管壁损伤、血液流变学改变、血液成分的变化等)的作用下,体内全身凝血系统或局部凝血系统的凝血与抗凝平衡失调,导致动脉血栓、静脉血栓、心房血栓或微血管血栓的形成,这种失衡若发生在动脉系统(如脑动脉、冠状动脉),其主要由血小板通过纤维蛋白原相互交联形成血小板血栓的头部,进而凝血酶参与,最终纤维蛋白网络血液有形成分形成动脉血栓的尾部—红色血栓,失衡若发生在静脉系统、左右心房,则主要形成红色血栓。不同部位的血栓,组成成分不同,其形成的分子机制亦不同。
血栓的治疗主要有中、西医两种治疗方法,西医治疗主要有扩张血管剂、降压药和抗血小板凝聚剂等药物,这些药物疗效显著,但比较容易引起出血并发症,造成皮肤、血液等系统的不良反应。中医毒副作用小,但是抗血栓时间长,很容易使患者放弃治疗。因此需要继续探索开发新的溶解血栓药物。
本发明是在CN 101953935专利的基础上进行的改进发明,本发明引用的专利文件记载的内容。上述专利未公开该药物在治疗血栓疾病中的应用。
发明内容
本发明的目的是提供一种药物在制备抗血栓药物中的应用,所述药物由如下重量份的原料药制成:
黄芪100-150重量份,党参80-120重量份,丹参60-100重量份,葛根60-100重量份,淫羊藿60-100重量份,山楂60-100重量份,地黄40-80重量份,当归40-80重量份,黄连40-80重量份,醋延胡索40-80重量份,灵芝40-80重量份,人参20-30重量份,炙甘草20-30重量份。
优选的,该药物由如下重量份的原料药制成:
或,
或,
或,
或,
取上述原料药,加入常规辅料,按照常规工艺,制成临床可接受的片剂、颗粒剂、丸剂、胶囊剂、滴丸、软胶囊剂、缓释剂、口服液体制剂或冻干粉针剂。
本发明药物的制备方法包括如下步骤:
取原料药中的人参、黄连、醋延胡索、山楂与一半量的黄芪,粉碎成细粉,其余八味原料药与剩余黄芪加水煎煮1-3次,每次1-3小时,合并煎液,滤过,滤液浓缩至90-95℃时相对密度为1.05~1.15,放冷,加一倍量乙醇使沉淀,取上清液,回收乙醇,并浓缩至90-95℃时相对密度为1.15~1.25的清膏,与上述药粉混合,制成片剂、颗粒剂、丸剂、胶囊剂、滴丸、软胶囊剂、缓释剂、口服液体制剂或冻干粉针剂。
本发明药物的制备方法优选包括如下步骤:
取原料药中的人参、黄连、醋延胡索、山楂与一半量的黄芪,粉碎成细粉,其余八味原料药与剩余黄芪加水煎煮2次,第一次2小时,第二次1.5小时,合并煎液,滤过,滤液浓缩至90℃时相对密度为1.06~1.12,放冷,加一倍量乙醇使沉淀,取上清液,回收乙醇,并浓缩至90℃时相对密度为1.20~1.22的清膏,与上述药粉混合,制成片剂、颗粒剂、丸剂、胶囊剂、滴丸、软胶囊剂、缓释剂、口服液体制剂或冻干粉针剂。
本发明药物制剂中滴丸的制备方法包括如下步骤:
取原料药,用8-12重量倍的水浸40-80分钟,煮沸1-3小时,取出药液,药渣再加6-10重量倍的水煎煮70-110分种,合并二次药液,滤过;药液通过已处理好的JD-1(WLD)大孔吸附树脂柱,树脂用量为原料药重量的1-3倍,控制吸附流速2-4ml/min,吸附完毕,用水冲洗树脂柱至流出液澄清后,用树脂重量2-4倍的60-90%乙醇洗脱,收集洗脱液,后用1-2体积倍水冲洗,合并洗脱液,回收乙醇,浓缩至相对密度为1.05-1.20,喷雾干燥,得提取物喷雾干燥药粉,加入常规辅料制备得滴丸。
本发明药物制剂中滴丸的制备方法优选包括如下步骤:
取原料药,用10重量倍的水浸60分钟,煮沸2小时,取出药液,药渣再加8重量倍的水煎煮90分钟,合并二次药液,滤过;药液通过已处理好的JD-1(WLD)大孔吸附树脂柱,树脂用量为原料药重量的1.5倍,控制吸附流速2-4ml/min,吸附完毕,用水冲洗树脂柱至流出液澄清后,用树脂重量3倍的70%乙醇洗脱,收集洗脱液,后用1.5体积倍水冲洗,合并洗脱液,回收乙醇,浓缩至相对密度为1.08-1.15,喷雾干燥,得提取物喷雾干燥药粉,加入常规辅料制备得滴丸。
其中,上述制备方法中喷雾干燥的条件控制为:进料速度为35-40ml/min,雾化速度:25000-35000rpm,进风温度:130-160℃,出风温度:70-80℃。
其中,上述制备方法中喷雾干燥的条件控制优选为:进料速度为37ml/min,雾化速度:30000rpm,进风温度:145~147℃,出风温度:71~76℃。
其中,上述制备方法中得提取物后,滴丸的制备方法还可以为:
称取聚乙二醇-4000,于60-90℃下水浴至彻底溶胀,加入上述提取物喷雾干燥药粉,加入质量比例为药粉∶聚乙二醇-4000=1∶2-6,于80-90℃下保温搅拌均匀,使药粉完全溶解分散在聚乙二醇-4000中;移入滴丸机中,保持滴距和滴温,调整滴制参数为:油浴温度:80-90℃,药液温度:75-85℃,滴盘温度:85-90℃,制冷温度:10-15℃,管口温度:35-40℃,滴头口径为:3mm/5mm,滴速:1滴/1秒-1滴/7秒;调节开关使液滴适速滴入冷凝剂二甲基硅油或液体石蜡中,药滴经过冷凝收缩成滴丸,收集滴丸,以转速1000-4000转/分离心脱油,再进入筛选干燥机进行筛选干燥,即得本发明药物滴丸。
其中,上述制备方法中得提取物后,滴丸的制备方法还可以优选为:
称取聚乙二醇-4000,于80-85℃下水浴至彻底溶胀,加入上述提取物喷雾干燥药粉,加入质量比例为药粉∶聚乙二醇-4000=1∶4,于85℃下保温搅拌均匀,使药粉完全溶解分散在聚乙二醇-4000中;移入滴丸机中,保持滴距和滴温,调整滴制参数为:油浴温度:85℃,药液温度:80℃,滴盘温度:87℃,制冷温度:12℃,管口温度:37℃,滴头口径为:3mm/5mm,滴速:1滴/2秒-1滴/5秒;调节开关使液滴适速滴入冷凝剂二甲基硅油或液体石蜡中,药滴经过冷凝收缩成滴丸,收集滴丸,以转速1500-3000转/分离心脱油,再进入筛选干燥机进行筛选干燥,即得本发明药物滴丸。
所述血栓包括动脉血栓、静脉血栓、心房室血栓、微血管血栓。
本发明的有益效果是:药效学试验研究发现本发明中抗血栓的药物治疗效果好,制备大鼠颈动脉用于大鼠体内溶解血栓试验,经过较短时间,与阴性对照和阳性对照的药物相比,本发明的药物具有抗血栓的作用,并且抗血栓效果显著。
具体实施方式
实施例1
用于抗血栓的药物片剂由如下重量份的原料药制成:
所述药物片剂的制备方法,包括以下步骤:取原料药中的人参、黄连、醋延胡索、山楂与一半量的黄芪,粉碎成细粉,其余八味原料药与剩余黄芪加水煎煮2次,第一次2小时,第二次1.5小时,合并煎液,滤过,滤液浓缩至90℃时相对密度为1.06~1.12,放冷,加一倍量乙醇使沉淀,取上清液,回收乙醇,并浓缩至90℃时相对密度为1.20~1.22的清膏,与上述药粉混合,制成颗粒,干燥,压制成1000片(小片),包糖衣或薄膜衣片,或压制成500片(大片),包薄膜衣,即得。小片每片重0.3g,每日服用3次,一次4~6片;大片每片重0.6g,每日服用3次,一次2~3片。
药效学试验研究发现,本实施例的药物具有明显的抗血栓作用,血栓为动脉血栓和/或静脉血栓和/或心房室血栓和/或微血管血栓。
实施例2
用于抗血栓的药物胶囊剂由如下g的原料药制成:
所述药物胶囊剂的制备方法,包括以下步骤:取原料药中的人参、黄连、醋延胡索、山楂与一半量的黄芪,粉碎成细粉,其余八味原料药与剩余黄芪加水煎煮2次,第一次2小时,第二次1.5小时,合并煎液,滤过,滤液浓缩至90℃时相对密度为1.06~1.12,放冷,加一倍量乙醇使沉淀,取上清液,回收乙醇,并浓缩至90℃时相对密度为1.20~1.22的清膏,与上述药粉混合,制成胶囊剂。
药效学试验研究发现,本实施例的药物具有明显的抗血栓作用,血栓为动脉血栓和/或静脉血栓和/或心房室血栓和/或微血管血栓。
实施例3
用于抗血栓的药物颗粒剂由如下重量份的原料药制成:
所述药物颗粒剂的制备方法,包括以下步骤:取原料药中的人参、黄连、醋延胡索、山楂与一半量的黄芪,粉碎成细粉,其余八味原料药与剩余黄芪加水煎煮2次,第一次2小时,第二次1.5小时,合并煎液,滤过,滤液浓缩至90℃时相对密度为1.06~1.12,放冷,加一倍量乙醇使沉淀,取上清液,回收乙醇,并浓缩至90℃时相对密度为1.20~1.22的清膏,与上述药粉混合,制成颗粒剂。
药效学试验研究发现,本实施例的药物具有明显的抗血栓作用。
实施例4
用于抗血栓的药物丸剂由如下原料药制成:
所述药物丸剂的制备方法,包括以下步骤:取上述原料药,加入常规辅料,按照常规工艺制成丸剂。
实施例5
用于抗血栓的药物口服液由如下的原料药制成:
所述药物口服液的制备方法,包括以下步骤:取上述原料药,加入常规辅料,按照常规工艺制成口服液。药效学试验研究发现,本实施例的药物具有明显的抗血栓作用。
实施例6
用于抗血栓的药物注射剂由如下原料药制成:
所述药物注射剂的制备方法,包括以下步骤:取上述原料药,加入常规辅料,按照常规工艺制成注射剂。药效学试验研究发现,本实施例的药物具有明显的抗血栓作用。
实施例7
用于抗血栓的药物滴丸由如下的原料药制成:
所述药物滴丸的制备方法,包括以下步骤:
取原料药,用10重量倍的水浸60分钟,煮沸2小时,取出药液,药渣再加8重量倍的水煎煮90分钟,合并二次药液,滤过;药液通过已处理好的JD-1(WLD)大孔吸附树脂柱,树脂用量为原料药重量的1.5倍,控制吸附流速2-4ml/min,吸附完毕,用水冲洗树脂柱至流出液澄清后,用树脂重量3倍的70%乙醇洗脱,收集洗脱液,后用1.5体积倍水冲洗,合并洗脱液,回收乙醇,浓缩至相对密度为1.08-1.15,喷雾干燥,得提取物喷雾干燥药粉,加入常规辅料制备得滴丸,丸重49-52mg/粒,口服,一次10粒,一日3次。药效学试验研究发现,本实施例的药物具有明显的抗血栓作用,血栓为动脉血栓和/或静脉血栓和/或心房室血栓和/或微血管血栓。。
本发明人根据大量的实验,意外发现:本发明的药物的各个原料的结合以及配比关系对抗血栓作用具有至关重要的影响,配比关系决定了抗血栓作用的有无及效果是否显著。
实验例1
为阐明本发明药物抗血栓的作用,用按上述实施例1方法制备得到的片剂(以下称本发明药物)进行下列实验以证明其疗效,但不能对本发明的范围构成任何限制。
1实验材料
SD大鼠若干只,体重220—230g。
2实验方法
2.1大鼠分组与给药
将大鼠随机分为8组,每组10只。CMC-Na水溶液组:按3ml/kg剂量灌胃CMC-Na水溶液,此为阴性对照组。本发明药物低剂量组:将本发明药物研磨成粉悬浮在0.7%的CMC-Na水溶液中,制成悬浮液,按486mg/kg剂量灌胃低剂量组悬浮液。本发明药物高剂量组:将本发明药物研磨成粉悬浮在0.7%的CMC-Na水溶液中,制成悬浮液,按972mg/kg剂量灌胃高剂量组悬浮液。阿司匹林组:将阿司匹林悬浮在0.7%的CMC-Na水溶液中,制成悬浮液,按9mg/kg剂量灌胃阿司匹林粉悬浮液。此为阳性对照组。
注:本发明药物的低剂量用成人口服一次6片,每日3次,共18片,5.4g/70kg乘以系数6.3换算得来。高剂量为低剂量的2倍。
2.2手术
各组大鼠按1200mg/kg剂量腹腔注射乌拉坦溶液进行麻醉,45分钟后开进行手术。麻醉大鼠仰卧位固定,分离右颈总动脉,于近心端夹动脉夹,近心端和远心端分别穿入手术线,将远心端的手术线于皮毛用止血钳夹紧,准备在远心端插管。插管为硅烷化过的聚乙烯胶管,分三段,中段为聚乙烯胶管,长60.0mm,内径3.5mm;两端为相同的聚乙烯管,管长100.0mm,内径1.0mm,外径2.0mm该管的一端拉成尖管(用于插入大鼠颈动脉或静脉),外径为1.0mm。将编好号的干净青霉素小瓶中分别装入6cm长的黑色手术线,称重;然后取出丝线,按照编号放入准备好的插管的中段较粗的插管中。
打开大鼠右侧动脉夹,用注射器通过尖管端将管中注满肝素生理盐水溶液(50IU·kg-1),然后将插管的动脉端插入大鼠右侧颈总动脉,将计算量的肝素缓缓注入大鼠体内。
夹闭右侧颈动脉夹,将插管的静脉端插入分离好的大鼠左侧颈静脉,打开动脉夹,使血液开始循环。并同时开始计时。此过程中插管中央的粗管中的丝线上会因为血液循环而产生血栓。
2.3检测方法
计时15min后,剪断动静脉插管,停止循环,用眼科镊小心取出丝线,在滤纸上轻轻蘸掉血滴,放入事先称重好的青霉素小瓶中,精确称重并记录。计算出血栓的湿重。统计各组的血栓湿重并做t检验。
3结果
实验中称得血栓的湿重结果见表1。
表1本发明药物在大鼠血栓模型上的抗血栓活性
注:与CMC-Na水溶液相比*P<0.05,**P<0.01;与阿司匹林组相比ΔP<0.05,ΔΔP<0.01
4结论
两种剂量的本发明药物都具有抗血栓活性。高剂量本发明药物的疗效明显比低剂量本发明药物的疗效好。
Claims (12)
1.一种药物在制备抗血栓药物中的应用,其特征是,所述药物由如下重量份的原料药制成:
黄芪100-150重量份,党参80-120重量份,丹参60-100重量份,葛根60-100重量份,淫羊藿60-100重量份,山楂60-100重量份,地黄40-80重量份,当归40-80重量份,黄连40-80重量份,醋延胡索40-80重量份,灵芝40-80重量份,人参20-30重量份,炙甘草20-30重量份。
2.如权利要求1所述的应用,其特征是:所述血栓为动脉血栓和/或静脉血栓和/或心房室血栓和/或微血管血栓。
3.如权利要求1或2所述的应用,其特征是,所述药物由如下重量份的原料药制成:
4.如权利要求1或2所述的应用,其特征是,所述药物由如下重量份的原料药制成:
5.如权利要求1或2所述的应用,其特征是,所述药物由如下重量份的原料药制成:
6.如权利要求1或2所述的应用,其特征是,所述药物由如下重量份的原料药制成:
7.如权利要求1或2中任一项所述的应用,其特征是,所述药物的制备方法包括以下步骤:取原料药中的人参、黄连、醋延胡索、山楂与一半量的黄芪,粉碎成细粉,其余八味原料药与剩余黄芪加水煎煮1-3次,每次1-3小时,合并煎液,滤过,滤液浓缩至90-95℃时相对密度为1.05~1.15,放冷,加一倍量乙醇使沉淀,取上清液,回收乙醇,并浓缩至90-95℃时相对密度为1.15~1.25的清膏,与上述药粉混合,制成片剂、颗粒剂、丸剂、胶囊剂、滴丸、软胶囊剂、缓释剂、口服液体制剂或冻干粉针剂。
8.如权利要求7所述的应用,其特征是,所述药物的制备方法包括以下步骤:取原料药中的人参、黄连、醋延胡索、山楂与一半量的黄芪,粉碎成细粉,其余八味原料药与剩余黄芪加水煎煮2次,第一次2小时,第二次1.5小时,合并煎液,滤过,滤液浓缩至90℃时相对密度为1.06~1.12,放冷,加一倍量乙醇使沉淀,取上清液,回收乙醇,并浓缩至90℃时相对密度为1.20~1.22的清膏,与上述药粉混合,制成片剂、颗粒剂、丸剂、胶囊剂、滴丸、软胶囊剂、缓释剂、口服液体制剂或冻干粉针剂。
9.如权利要求1或2所述的应用,其特征是,所述药物的滴丸制剂的制备方法包括如下步骤:
取原料药,用10重量倍的水浸60分钟,煮沸2小时,取出药液,药渣再加8重量倍的水煎煮90分钟,合并二次药液,滤过;药液通过已处理好的JD-1大孔吸附树脂柱,树脂用量为原料药重量的1.5倍,控制吸附流速2-4ml/min,吸附完毕,用水冲洗树脂柱至流出液澄清后,用树脂重量3倍的70%乙醇洗脱,收集洗脱液,后用1.5体积倍水冲洗,合并洗脱液,回收乙醇,浓缩至相对密度为1.08-1.15,喷雾干燥,得提取物喷雾干燥药粉,加入常规辅料制备得滴丸。
10.如权利要求9所述的应用,其特征是,所述喷雾干燥的条件为:进料速度为
37ml/min,雾化速度:30000rpm,进风温度:145~147℃,出风温度:71~76℃。
11.如权利要求9所述的应用,其特征是,在得提取物物喷雾干燥药粉后,按如下方法制备成滴丸:
称取聚乙二醇-4000,于60—90℃下水浴至彻底溶胀,加入上述提取物喷雾干燥药粉,加入比例为药粉:聚乙二醇-4000=1:2—6,于80—90℃下保温搅拌均匀,使药粉完全溶解分散在聚乙二醇-4000中;移入滴丸机中,保持滴距和滴温,调整滴制参数为:油浴温度:80—90℃,药液温度:75—85℃,滴盘温度:85—90℃,制冷温度:10—15℃,管口温度:35—40℃,滴头口径为:3mm/5mm,滴速:1滴/1秒-1滴/7秒;调节开关使液滴适速滴入冷凝剂二甲基硅油或液体石蜡中,药滴经过冷凝收缩成滴丸,收集滴丸,以转速1000-4000转/分离心脱油,再进入筛选干燥机进行筛选干燥,即得本发明药物滴丸。
12.如权利要求11所述的应用,其特征是,在得提取物物喷雾干燥药粉后,按如下方法制备成滴丸:
称取聚乙二醇-4000,于80-85℃下水浴至彻底溶胀,加入上述提取物喷雾干燥药粉,加入比例为药粉:聚乙二醇-4000=1:4,于85℃下保温搅拌均匀,使药粉完全溶解分散在聚乙二醇-4000中;移入滴丸机中,保持滴距和滴温,调整滴制参数为:油浴温度:85℃,药液温度:80℃,滴盘温度:87℃,制冷温度:12℃,管口温度:37℃,滴头口径为:3mm/5mm,滴速:1滴/2秒-1滴/5秒;调节开关使液滴适速滴入冷凝剂二甲基硅油或液体石蜡中,药滴经过冷凝收缩成滴丸,收集滴丸,以转速1500-3000转/分离心脱油,再进入筛选干燥机进行筛选干燥,即得本发明药物滴丸。
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