CN102920808A - 一种治疗动脉硬化、冠心病的中药制剂及其制备方法 - Google Patents
一种治疗动脉硬化、冠心病的中药制剂及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗动脉硬化、冠心病的中药制剂及其制备方法。它是由如下重量配比的原料药制备而成的制剂:雪胆2~30,山楂10~100。本发明还提供了该药物制剂的制备方法。本发明将具有清热解毒、健胃止痛作用的雪胆,与健胃、通结气主要用于能消食积,补脾的山楂进行配伍,对动脉硬化、冠心病等疾病有良好的治疗作用,为临床用药提供了一种新的选择。
Description
技术领域
本发明涉及中药制剂,具体涉及一种治疗动脉硬化、冠心病的中药制剂及其制备方法。
背景技术
冠状动脉粥样硬化导致冠心病、脑缺血,具有心脑血管病发病率高、致残率高、复发率高、病死率高和并发症多等特点。该病尤其多发生在40岁以后,男性多于女性,脑力劳动者较多。据资料报导,在美国约2.5%的人口患有此病,男性美国人65岁以前患此病的约占1/5。近年来,随着人们生活水平的提高,加上人口结构老龄化,该病的发病率和病死率呈快速上升趋势,发病年龄呈年轻化趋势。据报道,我国每年患此病约死亡110万人,1988年至1997年10年上升25%。因此开发治疗该病的药物渐成研究的热点。
目前,西医治疗和预防动脉硬化、冠心病的药物主要有调脂药物如他汀类、胆酸整合剂和胆固醇吸收抑制剂、贝特类和烟酸类等,抗血小板药物如阿司匹林、噻吩并吡啶类衍生物氯吡格雷、噻氯匹定,抗凝药物如普通肝素和低分子质量肝素、直接凝血酶抑制剂水蛭素、阿加曲班和比伐卢啶等,还有血管紧张素转换酶抑制剂雷米普利、培哚普利、β-受体阻滞剂、钙离子拮抗剂及硝酸酯类药物、醛固酮受体拮抗剂依普利酮、钾离子通道开放剂尼可地尔等。以上各类药物虽有一定疗效,但有明显的副作用。如血管扩张引起的头痛、低血压反射性心动过速、口干、腹胀或便秘等,除此之外,还有众多的使用配伍禁忌,极不安全,如气管炎、哮喘、低血压、心动过缓等都需慎用。
除了药物治疗外,经皮冠脉介入和冠脉旁路移植术等手术治疗技术也取得了巨大进步。但药物治疗仍是动脉硬化、冠心病治疗的基础。因为即使成功介入和手术治疗后的患者仍需坚持药物治疗。这说明药物治疗现在和今后将一直是动脉硬化、冠心病治疗的主导,并强调以预防为主。
现代临床及药理研究表明,动脉硬化、冠心病发病机制与多层次,多因素的全身病变有密不可分的联系,而中医学整体辨证的方药治疗正是多层次、多靶点的整体综合调理,且无明显毒性。这种立足整体,着眼局部,进行综合调节的治疗原则符合动脉硬化、冠心病的发病机制,是中医药治疗动脉硬化、冠心病的巨大优势所在,亦是西药单纯局部治疗所不能比拟的。
因此,近年来,在西方国家已得到公认,人民对使用西药治疗动脉硬化、冠心病,尤其是老年期慢性疾病多有担心,转而开始对传统疗法产生兴趣。目前,还未见将中药雪胆和山楂配伍后治疗动脉硬化、冠心病的研究。
发明内容
本发明的目的是提供一种治疗效果好,疗效确切,副作用小的用于治疗动脉硬化、冠心病的药物制剂。
本发明还提供一种治疗动脉硬化、冠心病的药物制剂之制备方法。
实现上述目的,本发明采用如下技术方案:一种治疗动脉硬化、冠心病的中药制剂,其特征在于,它是由如下重量份的原料药制备而成:雪胆2~30,山楂10~100。
所述中药制剂是任何一种药剂学上所说的剂型。
一种治疗动脉硬化、冠心病的中药制剂之制备方法,其特征在于,包括如下步骤:
1)将雪胆和山楂分别粉碎成24~40目粉末,备用;
2)称取步骤1)得到的所述粗粉,按配方混合均匀;其中雪胆2~30,山楂10~100;
3)在步骤2)混合物中加3~8倍量的乙醇,浸泡30~50分钟;再加5~8倍量的乙醇,回流提取30~90分钟;乙醇提取液,滤过;
然后,将药渣加乙醇提取2~4次,乙醇用量均为药材的5~10倍量,时间30~90分钟,乙醇提取液滤过;其中,乙醇的浓度为40%~90%;
4)再合并上述乙醇提取液,回收乙醇;60℃~65℃条件下,真空浓缩至比重为1.3~1.4,得药物浸膏;其中,真空度0.08Mpa;
5)将步骤4)得到的药物浸膏经真空干燥得到雪胆和山楂的中药干浸膏制剂,其中,真空度0.08Mpa,温度50℃~70℃;
6)再将步骤5)得到的干浸膏粉碎,过60~80目筛即获得本制剂。
相比现有技术,本发明具有如下有益效果:
本发明将具有清热解毒、健胃止痛作用的雪胆与健胃、通结气主要用于能消食积,补脾的山楂采用特定的配比配伍使用后,发挥了协同增效作用,其药效显著优于同等剂量下的雪胆和山楂单味药材,能够增加心肌营养性血流量、降低耗氧量及降脂抗炎等,对动脉硬化、冠心病等疾病有良好的治疗作用,为临床用药提供了一种新的选择。
具体实施方式
下面通过具体实施例对本发明作进一步详细说明,并通过试验例来证明本发明的有益效果。
一、药物配方如下表所示:
原料配方 | 实施例1 | 实施例2 | 实施例3 | 实施例4 | 实施例5 |
雪胆 | 3 | 5 | 15 | 30 | 2 |
山楂 | 12 | 35 | 70 | 100 | 10 |
合计 | 15 | 40 | 85 | 130 | 12 |
二、用于治疗动脉硬化和冠心病药物制剂的制备方法:
按上述配方将雪胆2~30g与山楂10~100g混合,加40%~90%乙醇3~8倍量,浸泡30~50分钟,然后加5~8倍量的40%~90%乙醇,回流提取30~90分钟,乙醇提取液,滤过;药渣再加相同溶媒提取2~4次,用量均为药材的5~10倍量,时间30~90分钟,乙醇提取液滤过。合并乙醇提取液,回收乙醇,真空浓缩(真空度0.06Mpa,温度65℃左右)至比重为1.3~1.4(60℃左右),得药物浸膏。药物浸膏真空干燥(真空度0.08Mpa,温度50℃~70℃)得干浸膏,干浸膏粉碎,过60~80目筛。药物浸膏也可采用喷雾干燥方式干燥得到干浸膏粉,得到雪胆、山楂的中药制剂。
药物浸膏也可采用喷雾干燥方式进行干燥,当采用喷雾干燥时,在真空浓缩步骤,药物浸膏比重应控制在1.1~1.2(60℃左右),即得到雪胆、山楂的中药制剂。
三、用于治疗动脉硬化和冠心病药物制剂的(含雪胆和山楂)的剂型:
(一)将实施例1~5任一种配方制备得到的制剂,加入玉米油、豆油或者其他油类和其他适宜辅料,搅拌均匀,以明胶为主要囊皮材料,按药剂学常规制备方法,制成软胶囊剂。
(二)将实施例1~5任一种配方制备得到的制剂,加入二氧化硅、乳糖、糊精、淀粉、微晶纤维素、羧甲基淀粉等药剂学上可接受的辅料,搅拌均匀,湿法制粒,干燥、粉碎、过筛,装入胶囊,即得本发明药物的胶囊剂。
(三)将实施例1~5任一种配方制备得到的制剂,加入乳糖、糊精、微晶纤维素、低取代羟纤维素等可接受的辅料,混匀,制粒,低温干燥(或者采用干法制粒),得到颗粒剂。
(四)将实施例1~5任一种配方制备得到的制剂,加入淀粉、乳糖、糖粉、微晶纤维素、羧甲基淀粉、滑石粉、硬脂酸镁等药剂学上可接受的辅料,混匀,制粒,低温干燥(或者采用干法制粒),过筛,压片,得到片剂。
(五)将实施例1~5任一种配方制备得到的制剂,加入乳糖、糊精、淀粉、糖粉、微晶纤维素、羧甲基淀粉等药剂学上可接受的辅料,混匀,制软材,制丸,干燥,得到丸剂。
(六)将实施例1~5任一种配方制备得到的制剂,加入聚乙二醇(如聚乙二醇4000、聚乙二醇6000或者其混合物)、硬脂酸聚烃氧(40)酯、明胶、硬脂酸等药剂学上可接受的辅料,混匀,滴制,得到滴丸剂。
以下仅以上述实施例1作试验,通过试验例来验证本发明的功效。其中,给药剂量均以生药量计。
、对小鼠常压耐缺氧的影响:
取18-22g小鼠50只随机分为5组,每组10只,按表1灌胃给药,每日一次,连续5天,对照组给予同等体积的蒸馏水。末次给药后1小时,置于盛有钠石灰的广口瓶中,加盖密闭,记录小鼠存活时间。结果见表1。
表1 对小鼠常压耐缺氧的影响( ±s)
注:与对照组比较 *<0.05,**P<0.01。
由表1可见:雪胆与山楂配伍能显著延长常压缺氧状态下小鼠的存活时间。提示雪胆与山楂配伍能够降低小鼠的耗氧量,从而保障心、脑等重要器官的正常运行。
、对氯仿致小鼠心律失常的影响:
取18-22g小鼠50只随机分为5组,每组10只,按表2灌胃给药,每日一次,连续5天,对照组给予同等体积的蒸馏水。每只小鼠末次给药后1h放入含有2ml氯仿的棉球(每换1鼠加氯仿0.5ml)的倒置500ml烧杯内,至呼吸停止立即取出剖开胸腔,肉眼检查是否发生心室颤动,记录发生心室颤动的动物数。结果见表2。
注:与对照组比较 **P<0.01。
由表2可见: 雪胆与山楂配伍能明显减少氯仿诱发产生心律失常的小鼠数量,同时单用雪胆和山楂也有一定的对抗作用,但没有统计学差异。
、对肾上腺素+冰水所致大鼠血液流变学的影响:
将大鼠随机分为6组,每组10只,按表3灌胃给药,每日一次,连续7天,对照组给予同等体积的蒸馏水。末次给药后1小时,除正常对照组外,其余各组均按0.08ml/100g皮下注射0.1%的肾上腺素,2h后将动物置于4℃冰水中浸泡5分钟,于首次注射后4小时再次给予同剂量的肾上腺素,禁食不禁水18小时。次日股动脉取血4ml注入肝素抗凝试管中,测定全血粘度,再将血离心,测定血浆粘度,并计算出聚集指数、刚性指数、变形指数。结果见表3。
注:与模型组比较 *<0.05,**P<0.01。
(续表3)
注:与模型组比较 *<0.05。
由表3可见:雪胆与山楂配伍能降低血瘀模型大鼠的高切和低切全血粘度、血浆粘度、红细胞压积;雪胆能降低血浆粘度;山楂能降低大鼠的高切全血粘度、血浆粘度、红细胞压积。提示雪胆与山楂配伍对血瘀模型大鼠有一定的活血化瘀作用,并且比单用雪胆和山楂效果更强。
3.4 对垂体后叶素致大鼠心肌缺血的影响
将大鼠随机分为6组,每组10只,按表4灌胃给药,每日一次,连续7天,对照组给予同等体积的蒸馏水。于末次给药后1h,用20%乌拉坦0.5ml/100g麻醉,背位固定,用BL-410生物机能实验系统记录药前心电图,舌下静脉照射0.75 U/kg垂体后叶素,记录10秒、30秒、45秒、1分、3分、5分的大鼠心电图,分别测量S-T段、T波的电压,计算与给药前心电图的差值。末次测量心电图后取血检测乳酸脱氢酶(LDH)、肌酸激酶(CK)、超氧化物歧化酶(SOD)、丙二醛(MDA)。结果见表4~7。
注:与模型组比较 *<0.05。
注:与模型组比较 *<0.05。
由表4和表5可见:雪胆与山楂配伍能明显降低垂体后叶素引起的心肌缺血大鼠10、30、45秒ST段和T波升高;雪胆能降低30、45秒ST段和T波升高。提示雪胆与山楂配伍能有效缓解垂体后叶素引起的大鼠心肌缺血,并且比单用雪胆和山楂效果更强。
表6 对垂体后叶素致心肌缺血大鼠血清LDH、CK的影响
注:与模型组比较 *<0.05,**P<0.01。
由表6可见:雪胆与山楂配伍、单用雪胆和山楂均能明显降低垂体后叶素引起心肌缺血大鼠的乳酸脱氢酶(LDH)升高;雪胆与山楂配伍还能明显降低垂体后叶素引起心肌缺血大鼠的肌酸激酶(CK)升高。
表7 对垂体后叶素致心肌缺血大鼠血清SOD、MDA的影响
注:与模型组比较 *<0.05,**P<0.01。
由表7可见:雪胆与山楂配伍、单用雪胆和山楂均能明显升高垂体后叶素引起心肌缺血大鼠的超氧化物歧化酶(SOD)活性;雪胆与山楂配伍还能能明显降低垂体后叶素引起心肌缺血大鼠的丙二醛(MDA)含量。
3.5 对大鼠高脂血症的影响
大鼠适应环境5天,喂饲普通饲料,第六天尾静脉取血测TC、TG。根据TC、TG结果分为6组。除正常对照组外,其余各组在给药同时喂饲脂肪乳1ml/100g,每日一次,连续14天。末次给药后1小时,取尾静脉血测TC、TG、HDL-C、LDL-C。第15天开始停服脂肪乳,继续给药,每日一次,连续14天。末次给药后1小时,股动脉放血测TC、TG、HDL-C、LDL-C,同时取肝脏组织,按检测试剂盒说明书测肝组织中的TC、TG,比较结果。结果见表8:
表8 对大鼠血脂血症的影响
给药二周
给药四周
注:与模型组比较 *<0.05,**P<0.01。
由表8可见:与正常对照组相比,模型组及各给药组的TC、TG、LDL-C水平明显升高。与模型组比较,雪胆与山楂配伍在给药后1、2、4周能明显降低高脂模型的大鼠血清中脂质TC和TG的含量,并且在给药后4周能明显降低高脂模型的大鼠肝脂质TC含量;单用雪胆和山楂对高脂模型大鼠的血清中脂质升高有一定的降低作用趋势。提示雪胆与山楂配伍对高脂模型大鼠的血清中脂质升高有明显降低作用,并且比单用雪胆和山楂效果更强。
综上所述,本发明能够增加心肌营养性血流量、降低耗氧量及降脂抗炎等,对动脉硬化、冠心病等疾病有良好的治疗作用;另外通过试验得知:雪胆和山楂组方后的药理效应明显增强,复方优于单方,为临床用药提供了一种新的选择。
其他实施例的动物实验具有相当的效果,在此不重复。
最后需要说明的是,以上实施例仅用以说明本发明的技术方案而非限制技术方案,尽管申请人参照较佳的实施例对本发明进行了详细说明,本领域的普通技术人员应当理解,那些对本发明的技术方案进行修改或者等同替换,而不脱离本技术方案的宗旨和范围,均应涵盖在本发明的权利要求范围当中。
Claims (5)
1.一种治疗动脉硬化、冠心病的中药制剂,其特征在于,它的药用成份是由如下重量份的原料药制成:雪胆2~30,山楂10~100。
2.根据权利要求1所述治疗动脉硬化、冠心病的中药制剂,其特征在于,所述原料药的重量配比为:雪胆2~20,山楂10~50。
3.根据权利要求1所述治疗动脉硬化、冠心病的中药制剂,其特征在于,所述中药制剂是任何一种药剂学上所说的剂型。
4.根据权利要求1所述治疗动脉硬化、冠心病的中药制剂,其特征在于,所述中药制剂是软胶囊剂、滴丸剂、胶囊剂、颗粒剂、片剂或丸剂口服剂型。
5.一种治疗动脉硬化、冠心病的中药制剂之制备方法,其特征在于,包括如下步骤:
1)将雪胆和山楂分别粉碎成24~40目粉末,备用;
2)称取步骤1)得到的所述粗粉,按配方混合均匀;其中雪胆2~30,山楂10~100;
3)在步骤2)混合物中加3~8倍量的乙醇,浸泡30~50分钟;再加5~8倍量的乙醇,回流提取30~90分钟;乙醇提取液,滤过;
然后,将药渣加乙醇提取2~4次,乙醇用量均为药材的5~10倍量,时间30~90分钟,乙醇提取液滤过;其中,乙醇的浓度为40%~90%;
4)再合并上述乙醇提取液,回收乙醇;60℃~65℃条件下,真空浓缩至比重为1.3~1.4,得药物浸膏;其中,真空度0.08Mpa;
5)将步骤4)得到的药物浸膏经真空干燥得到雪胆和山楂的中药干浸膏制剂,其中,真空度0.08Mpa,温度50℃~70℃;
6)再将步骤5)得到的干浸膏粉碎,过60~80目筛即获得本制剂。
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RU2071782C1 (ru) * | 1994-09-28 | 1997-01-20 | Юрий Аркадьевич Богдарин | Лекарственный препарат "кардиотрон", обладающий антиаритмическим действием |
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