CN108743885A - 一种治疗糖尿病大血管病变的中药及其制备方法 - Google Patents
一种治疗糖尿病大血管病变的中药及其制备方法 Download PDFInfo
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Abstract
本发明涉及中药技术领域,特别公开了一种治疗糖尿病大血管病变的中药及其制备方法。该治疗糖尿病大血管病变的中药,以黄芪、当归、黄连、鸡血藤、川芎、三七粉、甘草、丹参、木瓜、赤芍、桃仁、红花、地龙、绞股蓝、红景天、地锦草、桂枝、艾叶、三棱、莪术、桑寄生、乳香、没药、黄精、姜黄和威灵仙为原料,按照一定的重量配比混合制成。本发明原料药材均采用天然的中药原料,其配制简便,药源广泛,成本低廉,其配伍遵循中医的处方用药原则,诸药合用,相得益彰,且制剂服用量小,药物有效成分易于释放,吸收快,生物利用度高,使药效能够充分发挥。
Description
(一)技术领域
本发明涉及中药技术领域,特别涉及一种治疗糖尿病大血管病变的中药及其制备方法。
(二)背景技术
糖尿病的发病率正逐年增高,近20年糖尿病流行情况更为严重。2型糖尿病(T2DM)占糖尿病总病例的90%,已成为严重影响当今人类健康的疾病之一。其中T2DM血管并发症,尤其大血管并发症是主要致残、致死原因,其中约80%存在相关部位的动脉粥样硬化病变。近年观察还注意到,在新诊断的2型糖尿病患者中,50%以上伴有冠心病,实际上糖尿病和冠心病完全可以看做是兄弟姐妹病了。大量研究已经证明Nrf2通过抗氧化应激发挥对血管内皮细胞的保护作用。且研究证明可以把Nrf2、HO-1、SOD作为衡量糖尿病血管病变患者体内氧化应激水平的指标。
此类疾病早在《黄帝内经》时代便有提及。时至今日,经过千百年来的繁衍、洗礼和不断实践总结,中医已经积累了丰富的临床经验,继续为人类健康保驾护航。糖尿病大血管病变病机为气虚血瘀,故应该标本同治,既要补气又要活血,由此可知治疗糖尿病大血管病变益气同时,必须与活血化瘀同步进行,方能奏效。
(三)发明内容
本发明为了弥补现有技术的不足,提供了一种工艺简单、成本低廉、效果显著的治疗糖尿病大血管病变的中药及其制备方法。
本发明是通过如下技术方案实现的:
一种治疗糖尿病大血管病变的中药,由以下重量份数的原料混合制成:
黄芪20-40份、当归15-25份、黄连6-12份、鸡血藤20-40份、川芎8-12份、三七粉2-4份、甘草2-4份、丹参10-20份、木瓜20-40份、赤芍10-20份、桃仁8-12份、红花8-12份、地龙8-12份、绞股蓝20-40份、红景天20-40份、地锦草10-20份、桂枝10-20份、艾叶9-15份、三棱9-15份、莪术9-15份、桑寄生20-40份、乳香10-20份、没药10-20份、黄精10-20份、姜黄10-20份、威灵仙20-40份。
其优选的重量配比为:
黄芪30份、当归20份、黄连9份、鸡血藤30份、川芎10份、三七粉3份、甘草3份、丹参15份、木瓜30份、赤芍15份、桃仁10份、红花10份、地龙10份、绞股蓝30份、红景天30份、地锦草15份、桂枝15份、艾叶12份、三棱12份、莪术12份、桑寄生30份、乳香15份、没药15份、黄精15份、姜黄15份、威灵仙30份。
所述中药为胶囊剂。服用方式为口服,一日三次,饭前半小时服用,每次0.5g,一个月为一个疗程。
本发明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,按中医理论组方,采用纯天然中药原料,经***研究、科学配伍,应用黄芪当归,配伍其他药物来治疗气虚血瘀型糖尿病大血管病变,效果明显;再结合传统中医技术精心配制成本发明的降血糖的中药,对治疗糖尿病大血管病变有较佳的功效。
上述中药的制备方法,包括如下步骤:
(1)分别称取各原料药,备用;
(2)取丹参、赤芍、红花、地锦草、黄精混合均匀,加水煎煮两次,过滤收集滤液后合并两次滤液,冷却后浓缩成浸膏,再烘干后粉碎成粉末,得复合物A;
(3)取黄芪、当归、黄连、鸡血藤、川芎、三七粉、甘草、木瓜、桃仁、地龙、绞股蓝、红景天、桂枝、艾叶、三棱、莪术、桑寄生、乳香、没药、姜黄、威灵仙,加乙醇浸泡,提取两次,合并提取液,滤过、浓缩成浸膏,干燥后粉碎,得复合物B;
(4)将复合物A和复合物B混合均匀,灭菌消毒制得胶囊剂产品。
本发明的更有技术方案为:
步骤(2)中,两次煎煮中,第一次加三倍重量的水武火煮沸,然后文火煎煮1h,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30min,过滤收集滤液,合并两次滤液。
滤液冷却后浓缩成密度为1.1-1.2g/mL的浸膏,80℃下烘干后粉碎成粉末,得复合物A。
步骤(3)中,加质量浓度为70%的乙醇溶液浸泡0.5-1.5h,提取两次,合并提取液;浓缩后浸膏的相对密度为1.2。
本发明药物中,黄芪甘温升发,功擅补气,为“补药之长”;当归味辛、苦、甘、微温,具有补血活血、调经止痛的功效;川芎、三七粉、丹参、桃仁、赤芍、红花、地龙、地锦草、三棱、莪术等破血逐瘀,通络止痛;鸡血藤、桑寄生、木瓜等舒筋通络,通脉止痛;姜黄、绞股蓝、桂枝、艾叶温经散寒,活血止痛;红景天益气活血,乳香、没药行气止痛;黄精、威灵仙补肾健脾生津;全方共奏益气活血之效。
本发明的中药可采用一般方法将处方中的各味药材按比例进行配伍,按现有制剂工艺制成各种临床适用剂型,所用的各种药材均为市售的经过检验合格的中药材。
本发明原料药材均采用天然的中药原料,其配制简便,药源广泛,成本低廉,其配伍遵循中医的处方用药原则,诸药合用,相得益彰,且制剂服用量小,药物有效成分易于释放,吸收快,生物利用度高,使药效能够充分发挥,经临床应用验证,其疗效明显可靠,药性平和,毒副作用小,应用前景广阔。
服药期间忌食辛辣刺激及寒凉食物,忌烟忌酒,避免情志刺激,生活要有规律,适量锻炼。
本发明的有益效果在于:
(1)药剂由纯中药制成,各组分符合药典法相关规定,利用各味中药的配伍作用,不含化工成分,不含激素,无毒副作用,标本兼治,达到更好的治疗糖尿病大血管病变的作用;
(2)总有效率高,预后较好;
(3)工艺简单,降低了生产成本,减轻了患者的经济负担。
(四)具体实施方式
下面通过具体的实施例来详尽解释本发明,但是并不作为对本发明内容的限制。
实施例1:
一种治疗糖尿病大血管病变的中药复合物,其由下述原料制备而得:黄芪30g、当归20g、黄连9g、鸡血藤30g、川芎10g、三七粉3g、甘草3g、丹参15g、木瓜30g、赤芍15g、桃仁10g、红花10g、地龙10g、绞股蓝30g、红景天30g、地锦草15g、桂枝15g、艾叶12g、三棱12g、莪术12g、桑寄生30g、乳香15g、没药15g、黄精15g、姜黄15g、威灵仙30g。
上述治疗糖尿病大血管病变的中药复合物的制备方法为:取上述重量份的原料药( 配比单位:克)制备胶囊,具体操作为:
(1)称取各原料药,备用;
(2)取丹参、赤芍、红花、地锦草、黄精混合均匀,加3倍重量的水武火煮沸,然后文火煎煮1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30分钟,过滤收集滤液;合并上述两次滤液,冷却后,浓缩成密度为1.1-1.2g/ml 的浸膏;80℃烘干后,粉碎成粉末,即为复合物A ;
(3)取黄芪、当归、黄连、鸡血藤、川芎、三七粉、甘草、木瓜、桃仁、地龙、绞股蓝、红景天、桂枝、艾叶、三棱、莪术、桑寄生、乳香、没药、姜黄、威灵仙加70%乙醇浸泡0.5-1.5 小时,提取两次,每次1-2小时,合并提取液,滤过,浓缩成相对密度为1.2的浸膏,干燥后粉碎,得复合物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。
服用方式:口服,一日三次,饭前半小时服用,每次0.5g,一个月为一个疗程。
实施例2:
一种治疗糖尿病大血管病变的中药复合物,其由下述原料制备而得:黄芪50g、当归35g、黄连15g、鸡血藤50g、川芎16g、三七粉5g、甘草5g、丹参25g、木瓜50g、赤芍25g、桃仁16g、红花16g、地龙16g、绞股蓝50g、红景天50g、地锦草25g、桂枝25g、艾叶20g、三棱20g、莪术20g、桑寄生50g、乳香25g、没药25g、黄精25g、姜黄25g、威灵仙50g。
制备及服用方法如实施例1。
实施例3:
一种治疗糖尿病大血管病变的中药复合物,其由下述原料制备而得:黄芪40g、当归25g、黄连12g、鸡血藤40g、川芎12g、三七粉4g、甘草4g、丹参20g、木瓜40g、赤芍20g、桃仁12g、红花12g、地龙12g、绞股蓝40g、红景天40g、地锦草20g、桂枝20g、艾叶16g、三棱16g、莪术16g、桑寄生40g、乳香20g、没药20g、黄精20g、姜黄20g、威灵仙40g。
制备及服用方法如实施例1。
实施例4:动物学实验
试验流程:
随机选8周龄SPF级Wistar成年雄性大鼠90只,由山东中医药大学动物实验室提供,体重200±20g。自由进食及饮水,动物房温度控制在温度22-25℃,湿度55%,光照12/24h。适应性饲养1周,血糖、血脂均为正常范围内,测量体重。
随机分为空白组(n=10)和造模组(n=80)。空白组予标准大鼠饲料,造模组予高糖高脂饲料6周,检测空腹血糖(FBG)、甘油三酯(TG)、总胆固醇(TC)、低密度脂蛋白(LDL)、高密度脂蛋白(HDL)、Nrf2、抗氧化蛋白酶包括血红素氧合酶1(HO-1)、超氧化物歧化酶(SOD)。
造模组大鼠高糖高脂饲料喂养6周后禁食12h,予链脲佐菌素(于0℃溶于0.1mol/LpH=4.4的柠檬酸钠缓冲液,终浓度为10mg/mL,按40mg/kg一次性腹腔注射);空白组注射等剂量的缓冲液。72小时后尾静脉采血,连续三次随机血糖≥16.7mmol/L且血脂较高,Nrf2、HO-1、SOD等低于正常的、实验室检查大血管发现动脉粥样硬化者确定为糖尿病大血管病变大鼠。
选取造模成功的大鼠60只,随机分为3组,每组20只,即模型组:不施用任何药物、本发明实施例1药物组10mg/Kg、对照药物组:施用二甲双胍(10mg/kg),施用方式均为口服,每天早晚饭前半时服用。连续服用10周后检测;停药10 天后再次监测各项指标。
经检测:对照药物组和本发明药物组空腹血糖、血脂均有明显下降,血清Nrf2、血清HO-1、血清SOD均有明显上升,试验室检查动脉粥样硬化减轻,动脉狭窄减小。本发明药物明显好于对照药物组,停药十天后,本发明药物组基本没有出现明显反弹,具体参见下列表。
;
;
;
;
。
实施例5:临床病例
资料与方法:一般资料门诊2型糖尿病大血管病变属于气虚血瘀型患者共56 例,其中男30例,女26例,患者年龄50-80岁,空腹血糖(FPG)以及餐后2h血糖(2hPG)、血脂 均大幅升高。血清Nrf2、血清HO-1、血清SOD均有大幅降低、实验室检查发现有动脉狭窄、粥样硬化等病变。服用本发明实施例1制备的药物两个疗程后,检测上述生化指标。
治愈:FPG<6.1mmol/L,2h血糖(2hPG)<8.0mmol/L,5.23mmol/L<TC<5.69mmol/L,血清Nrf2、血清HO-1、血清SOD上升至正常水平,动脉硬化所在器官原有症状消失;
有效:空腹血糖(FPG)、餐后2h血糖(2hPG)、血脂有所改善,血清Nrf2、血清HO-1、血清SOD均上升但未达到正常水平,动脉硬化所在器官原有症状改善,动脉狭窄减小;
无效:空腹血糖(FPG)、餐后2h 血糖(2hPG)、血脂、血清Nrf2、血清HO-1、血清SOD 均无明显改变,动脉硬化所在器官原有症状无改善。
治疗效果:治愈8例,有效47例,无效1例,总有效率为98%。
实施例6:典型病例
王某某,女,63岁,面色淡白,乏力,气少懒言,口干,多饮,气短、自汗,心悸,动则加重,心烦,视物模糊。舌暗红,苔薄白少津,舌边有齿痕,脉沉细。空腹血糖10.8mmol/L,餐后2h血糖14.0mmol/L,TC11.2mmol/L,有冠心病5年,血清Nrf2为186U/L、血清HO-1为155U/L、血清SOD为182U/L,冠状动脉造影显示冠状动脉狭窄,诊断为2型糖尿病大血管病变。给予实施例1的中药复合物,服用3个疗程后,症状减轻,继续服用2个疗程巩固,空腹血糖小于7.0mmol/L、血脂正常。血清Nrf2、血清HO-1、血清SOD上升至正常水平。半年后追访,血糖及其他生化指标值基本正常。
李某,男,71 岁,2型糖尿病伴有大血管病变病史7年,现面色晦暗,乏力、口干多饮,头晕,头痛,气短、多汗,纳差,视物模糊,双下肢麻木,舌暗。舌边有齿痕,苔薄白,脉沉涩。空腹血糖11.4mmol/L,餐后2h血糖16.0mmol/L,TC10.2mmol/L,血清Nrf2为 176U/L、血清HO-1为147U/L、血清SOD为179U/L,CT检查脑血管狭窄硬化,现口服格列美脲1片,QD,二甲双胍0.5TID,立普妥1片QD。在原有药物基础上给予实施例1的中药复合物,服用2个疗程后,症状减轻,继续服用1个疗程巩固。之后多次随访,血糖、血脂稳定。血清Nrf2、血清HO-1、血清上升至正常水平。脑动脉狭窄改善。
Claims (8)
1.一种治疗糖尿病大血管病变的中药,其特征为,由以下重量份数的原料混合制成:黄芪20-40份、当归15-25份、黄连6-12份、鸡血藤20-40份、川芎8-12份、三七粉2-4份、甘草2-4份、丹参10-20份、木瓜20-40份、赤芍10-20份、桃仁8-12份、红花8-12份、地龙8-12份、绞股蓝20-40份、红景天20-40份、地锦草10-20份、桂枝10-20份、艾叶9-15份、三棱9-15份、莪术9-15份、桑寄生20-40份、乳香10-20份、没药10-20份、黄精10-20份、姜黄10-20份、威灵仙20-40份。
2.根据权利要求1所述的治疗糖尿病大血管病变的中药,其特征为,由以下重量份数的原料混合制成:黄芪30份、当归20份、黄连9份、鸡血藤30份、川芎10份、三七粉3份、甘草3份、丹参15份、木瓜30份、赤芍15份、桃仁10份、红花10份、地龙10份、绞股蓝30份、红景天30份、地锦草15份、桂枝15份、艾叶12份、三棱12份、莪术12份、桑寄生30份、乳香15份、没药15份、黄精15份、姜黄15份、威灵仙30份。
3.根据权利要求1或2所述的治疗糖尿病大血管病变的中药,其特征在于:所述中药为胶囊剂。
4.根据权利要求1所述的治疗糖尿病大血管病变的中药的制备方法,其特征为,包括如下步骤:(1)分别称取各原料药,备用;(2)取丹参、赤芍、红花、地锦草、黄精混合均匀,加水煎煮两次,过滤收集滤液后合并两次滤液,冷却后浓缩成浸膏,再烘干后粉碎成粉末,得复合物A;(3)取黄芪、当归、黄连、鸡血藤、川芎、三七粉、甘草、木瓜、桃仁、地龙、绞股蓝、红景天、桂枝、艾叶、三棱、莪术、桑寄生、乳香、没药、姜黄、威灵仙,加乙醇浸泡,提取两次,合并提取液,滤过、浓缩成浸膏,干燥后粉碎,得复合物B;(4)将复合物A和复合物B混合均匀,灭菌消毒制得胶囊剂产品。
5.根据权利要求4所述的治疗糖尿病大血管病变的中药的制备方法,其特征在于:步骤(2)中,两次煎煮中,第一次加三倍重量的水武火煮沸,然后文火煎煮1h,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30min,过滤收集滤液,合并两次滤液。
6.根据权利要求4所述的治疗糖尿病大血管病变的中药的制备方法,其特征在于:步骤(2)中,滤液冷却后浓缩成密度为1.1-1.2g/mL的浸膏,80℃下烘干后粉碎成粉末,得复合物A。
7.根据权利要求4所述的治疗糖尿病大血管病变的中药的制备方法,其特征在于:步骤(3)中,加质量浓度为70%的乙醇溶液浸泡0.5-1.5h,提取两次,合并提取液。
8.根据权利要求4所述的治疗糖尿病大血管病变的中药的制备方法,其特征在于:步骤(3)中,浸膏的相对密度为1.2。
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