CN104306579B - 一种治疗阴虚血瘀型糖尿病视网膜病变的中药及其制备方法与应用 - Google Patents
一种治疗阴虚血瘀型糖尿病视网膜病变的中药及其制备方法与应用 Download PDFInfo
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Abstract
本发明公开了一种治疗阴虚血瘀型糖尿病视网膜病变的中药,其特征在于,按下列重量份配比的原料药提取制备而成:枸杞子8‑12份、制何首乌8‑12份、三七8‑12份、炒蒲黄10‑20份、丹参10‑20份、红花8‑12份、赤芍8‑12份、山楂15‑25份,采用醇提和水提的方法制备成口服液、片剂、胶囊或颗粒剂,具有滋肾平肝,活血化瘀,治疗阴虚血瘀型糖尿病视网膜病变之功效。
Description
技术领域
本发明属于中药组合物技术领域,更具体的说,涉及一种治疗阴虚血瘀型糖尿病视网膜病变的中药配方药物及其制备方法与应用。
背景技术
糖尿病视网膜病变是糖尿病主要慢性微血管并发症之一,表现为视网膜毛细血管微血管瘤形成,血管扩张,管壁渗漏造成视网膜水肿、渗出、出血进而发生毛细血管和小动脉闭塞,视网膜缺血,视网膜新生血管生长等所引起的一系列临床症状。中医学认为其病机常以阴虚火旺为始,虚火灼伤目络而致血溢络外,病程日久,穷必及肾,肝肾同源,最终导致肝肾亏虚。临床常表现为不同程度的视力减退、视物变形、眼前黑影飘动及视野缺损等症状。目前使用的化药均有一定的毒副作用,而中药治疗历史已经很久,由于中药独有的用药安全性和治疗效果好而受到患者的欢迎,目前市场紧缺疗效确切的中药治疗糖尿病视网膜病变,特别是治疗阴虚血瘀型糖尿病视网膜病变。
发明内容
鉴于现有技术的不足,本发明的目在于提供一种疗效显著,副作用小的治疗阴虚血瘀型糖尿病视网膜病变的中药制剂及其制备方法与应用.
本发明的目的是这样实现的:
一种治疗阴虚血瘀型糖尿病视网膜病变的中药,按下列重量份配比的原料药提取制备而成:枸杞子8-12份、制何首乌8-12份、三七8-12份、炒蒲黄10-20份、丹参10-20份、红花8-12份、赤芍8-12份、山楂15-25份。
所述治疗阴虚血瘀型糖尿病视网膜病变的中药,按下列重量份配比的原料药提取制备而成:枸杞子10份、制何首乌10份、三七10份、炒蒲黄15份、丹参15份、红花10份、赤芍10份、山楂20份。
所述治疗阴虚血瘀型糖尿病视网膜病变的中药,制备方法包括如下步骤:
a.按上述重量份数取制何首乌、三七、炒蒲黄、丹参、赤芍经乙醇回流提取,滤过,回收乙醇,浓缩得醇提浓缩液;
b.将上述步骤a醇提后的药渣与枸杞子、红花、山楂三味合并,加水煎煮,滤过,浓缩,冷却,加乙醇醇沉得水提醇沉浓缩液,将水提醇沉浓缩液与步骤a的醇提浓缩液合并制成干浸膏粉;
c.取步骤b的干浸膏粉,添加辅料制成口服液、片剂、胶囊或颗粒剂。
所述治疗阴虚血瘀型糖尿病视网膜病变的中药,所述辅料为糊精、乳糖、淀粉、蔗糖、葡萄糖、微晶纤维素、甘露糖、甲基纤维素、羟丙基纤维素、羧甲基纤维素和甜菊苷的一种或几种。
所述治疗阴虚血瘀型糖尿病视网膜病变的中药,步骤a乙醇回流所加乙醇量是药材总重量的10倍量,分3次乙醇回流提取,加乙醇量分别为药材总重量的4倍量、3倍量和3倍量,乙醇浓度以体积比计为60%,每次回流1.5小时,合并提取液,滤过,滤液减压回收乙醇,浓缩至无醇味,得醇提浓缩液。
所述治疗阴虚血瘀型糖尿病视网膜病变的中药,步骤b中加水量是药材总重量的15倍量,分3次煎煮,加水量分别为药材总重量的7倍量、4倍量和4倍量,每次浸泡0.5小时,煎煮1.5小时,合并三次水煎液,滤过,将滤液浓缩至60℃时相对密度为1g/ml,冷却,加乙醇至含醇量体积比达50%,搅匀,放置48小时后离心,弃去沉淀,回收乙醇,与步骤a醇提浓缩液合并,浓缩后在70℃条件下进行真空干燥,粉碎得到干浸膏粉。
所述治疗阴虚血瘀型糖尿病视网膜病变的中药,步骤c中辅料为乳糖,干浸膏粉与乳糖的重量比为2:1,以90%乙醇湿法制颗粒,湿颗粒在50℃干燥,即得颗粒剂。
所述治疗阴虚血瘀型糖尿病视网膜病变的中药在制备治疗阴虚血瘀型糖尿病视网膜病变中药中的应用。
有益效果:
1、糖尿病性视网膜病变是糖尿病主要慢性微血管并发症之一,属中医学消渴目病范畴,其病机常以阴虚火旺为始,虚火灼伤目络而致血溢络外,病程日久,穷必及肾,肝肾同源,故肝肾亏虚在本病变的发生发展中起着关键作用。本发明中枸杞子、何首乌(制)滋补肝肾、益精明目,共为君药;三七、炒蒲黄化瘀止血,是为臣药;佐以丹参、红花、赤芍,入肝经,清热凉血、散瘀止痛;以生山楂为使药,行气散瘀。众药合用,具有滋肾平肝,活血化瘀之功效。
2、本发明处方设计合理,配伍严谨,经长期的临床验证,疗效确切。
3、本发明组成为中药材,均为药典品种,无毒副作用,价格便宜。
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。
1、制备实施例
实施例1:称取枸杞子250份、制何首乌250份、三七250份、炒蒲黄375份、丹参375份、红花250份、赤芍250份、山楂500份,以上八味中制何首乌、三七、炒蒲黄、丹参、赤芍用乙醇回流,加乙醇量是药材总重量的10倍量,分3次乙醇回流提取,加乙醇量分别为药材总重量的4倍量、3倍量和3倍量,乙醇浓度以体积比计为60%,每次回流1.5小时,合并提取液,滤过,滤液减压回收乙醇,浓缩至无醇味,得醇提浓缩液。醇提所得药渣与上述枸杞子、红花、山楂进行水提,加水量是药材总重量的15倍量,分3次煎煮,加水量分别为药材总重量的7倍量、4倍量和4倍量,每次浸泡0.5小时,煎煮1.5小时,合并三次水煎液,滤过,将滤液浓缩至60℃时相对密度为1g/ml,冷却,加乙醇至含醇量体积比达50%,搅匀,放置48小时后离心,弃去沉淀,回收乙醇,与步骤a醇提浓缩液合并,浓缩后在70℃条件下进行真空干燥,粉碎得到干浸膏粉,加乳糖湿法制粒,干浸膏粉与乳糖的重量比为2:1,以90%乙醇湿法制颗粒,湿颗粒在50℃干燥,即得颗粒剂1000克。
实施例2:称取枸杞子80份、制何首乌120份、三七80份、炒蒲黄200份、丹参100份、红花120份、赤芍80份、山楂250份,以上八味中制何首乌、三七、炒蒲黄、丹参、赤芍用乙醇回流,加乙醇量是药材总重量的10倍量,分3次乙醇回流提取,加乙醇量分别为药材总重量的4倍量、3倍量和3倍量,乙醇浓度以体积比计为60%,每次回流1.5小时,合并提取液,滤过,滤液减压回收乙醇,浓缩至无醇味,得醇提浓缩液。醇提所得药渣与上述枸杞子、红花、山楂进行水提,加水量是药材总重量的15倍量,分3次煎煮,加水量分别为药材总重量的7倍量、4倍量和4倍量,每次浸泡0.5小时,煎煮1.5小时,合并三次水煎液,滤过,将滤液浓缩至60℃时相对密度为1g/ml,冷却,加乙醇至含醇量体积比达50%,搅匀,放置48小时后离心,弃去沉淀,回收乙醇,与步骤a醇提浓缩液合并,浓缩后在70℃条件下进行真空干燥,粉碎得到干浸膏粉,加淀粉,制粒,压片,得片剂。
实施例3:称取枸杞子120份、制何首乌80份、三七120份、炒蒲黄100份、丹参200份、红花80份、赤芍120份、山楂150份,以上八味中制何首乌、三七、炒蒲黄、丹参、赤芍用乙醇回流,加乙醇量是药材总重量的10倍量,分3次乙醇回流提取,加乙醇量分别为药材总重量的4倍量、3倍量和3倍量,乙醇浓度以体积比为60%,每次回流1.5小时,合并提取液,滤过,滤液减压回收乙醇,浓缩至无醇味,得醇提浓缩液。醇提所得药渣与上述枸杞子、红花、山楂进行水提,加水量是药材总重量的15倍量,分3次煎煮,加水量分别为药材总重量的7倍量、4倍量和4倍量,每次浸泡0.5小时,煎煮1.5小时,合并三次水煎液,滤过,将滤液浓缩至60℃时相对密度为1g/ml,冷却,加乙醇至含醇量体积比达50%,搅匀,放置48小时后离心,弃去沉淀,回收乙醇,与步骤a醇提浓缩液合并,浓缩后在70℃条件下进行真空干燥,粉碎得到干浸膏粉,加淀粉,制粒,灌装,得胶囊剂。
实施例4:称取枸杞子100份、制何首乌100份、三七100份、炒蒲黄150份、丹参150份、红花100份、赤芍100份、山楂200份,以上八味中制何首乌、三七、炒蒲黄、丹参、赤芍用乙醇回流,加乙醇量是药材总重量的10倍量,分3次乙醇回流提取,加乙醇量分别为药材总重量的4倍量、3倍量和3倍量,乙醇浓度以体积比为60%,每次回流1.5小时,合并提取液,滤过,滤液减压回收乙醇,浓缩至无醇味,浓缩得醇提浓缩液。醇提所得药渣与上述枸杞子、红花、山楂进行水提,加水量是药材总重量的15倍量,分3次煎煮,加水量分别为药材总重量的7倍量、4倍量和4倍量,每次浸泡0.5小时,煎煮1.5小时,合并三次水煎液,滤过,将滤液浓缩至60℃时相对密度为1g/ml,冷却,加乙醇至含醇量体积比达50%,搅匀,放置48小时后离心,弃去沉淀,回收乙醇,与步骤a醇提浓缩液合并,浓缩后灌装,得口服液。
上述中药中枸杞子为茄科植物宁夏枸杞Lycium barbarum L.的干燥成熟果实;何首乌(制)为蓼科植物何首乌Polygonum multiflorum Thunb.的干燥块根;三七为五加科植物三七Panax notoginseng(Burk.)F.H.Chen的干燥根和根茎;蒲黄(炒)为香蒲科植物水烛香蒲Typha angustifolia L.、东方香蒲Typha orientalis Presl或同属植物的干燥花粉;丹参为唇形科植物丹参Salvia miltiorrhiza Bge.的干燥根和根茎;红花为菊科植物红花Carthamus tinctorius L.的干燥花;赤芍为毛茛科植物芍药Paeonia lactiflora Pall.或川赤芍Paeonia veitchii Lynch的干燥根;山楂为蔷薇科植物山里红Crataeguspinnatifida Bge.var.major N.E.Br.或山楂Crataegus pinnatifida Bge.的干燥成熟果实。
2、效果实施例
2.1病例选择:所有病例均来自2013年4月至2013年12月南京市中医院眼科门诊及内分泌科提供的符合纳入标准的病人,共35例68眼,治疗组19例36眼,对照组16例32眼。观察组服用本发明实施例1所得颗粒剂,每次1袋,每袋10克,一日三次,对照组服用羟苯磺酸钙分散片,批号为20121210,江苏万高药业有限公司生产,一次0.5g(2片),一日3次。疗程:2组均观察12周。
2.2诊断标准
2.2.1西医诊断标准
参照我国眼底病学组制定的《糖尿病视网膜病变分期标准》:I期:有微动脉瘤或并有小出血点。II期:有黄白色“硬性渗出”或并有出血斑。III期:有白色“软性渗出”或并有出血斑。IV期:眼底有新生血管或并有玻璃体积血。V期:眼底有新生血管和纤维增生。VI期:眼底有新生血管和纤维增生,并发视网膜脱离。I-III期为单纯型,IV-VI期增生型。
2.2.2中医证型诊断标准
参照《中药新药临床研究指导原则》中肝肾阴虚和血行瘀滞证候分类标准制订,肝肾阴虚兼有血瘀型:主症见双眼视力下降或视物模糊;眼底出血及渗出、增殖征象,腰膝酸软乏力,头晕耳鸣;次症见五心烦热;口干咽燥。舌质暗红或有瘀斑,苔薄白;脉细数或细涩。
2.2.3中医症状分级量化标准
中医症状分级量化标准参照国家食品药品监督管理局2002年颁布的《中药新药临床研究指导原则》.根据症状不同程度按轻、中、重评分,无此症状则记0分。
糖尿病视网膜病变症状分级量化表
记分:表格中带*症状无记0分,轻记2分,中记4分,重记6分,其余症状无记0分,轻记1分,中记2分,重记3分,舌脉具体措述,不记分。
2.2.4测定
两组在治疗前后测定血液中空腹血糖(FBG)、糖化血红蛋白(Hba1c)、胆固醇(TG)、甘油三酯(HDL)、高密度脂蛋白(LDL)、低密度脂蛋白(TG),并进行比较。
2.3疗效判断标准
参照国家中医药管理局颁布的《中医病证诊断及疗效标准》及《中药新药临床研究指导原则》制定。
显效:临床症状明显改善,眼底出血或渗出大部分吸收,吸收面积达1/2以上,视力提高2行以上(含2行)。
有效:临床症状均有好转,眼底出血或渗出部分吸收,吸收面积达1/3以上;视力提高1行(0.1以下视力每增加().02相当于1行;由光感到眼前手动、或由手动到眼前指数相当于l行)。
无效:临床症状无明显改善,眼底出血或渗出无变化。视力无提高或减退。
恶化:临床症状更加严重,眼底出血或渗出增加。视力减退。
根据积分法判定证候疗效方法:有效率疗效指数=[(治疗前积分—治疗后积分)÷治疗前积分]×100%。评定标准:疗效指数有效率95%以上为痊愈;疗效指数有效率70%以上为显效;疗效指数有效率30%以上为有效;疗效指数有效率<30%无效。
两组治疗前后矫正视力比较
注:与对照组比较,*P<0.05
两组治疗前后眼底改变情况
注:与对照组比较,*P<0.05。
两组治疗前后中医证候积分比较
注:①P>0.05,②③P<0.01,④P<0.05。
两组治疗前后中医证候疗效比较
注:与对照组比较,*P<0.05。
两组治疗前后FBG、Hba1c比较
注:*P>0.05。
两组治疗前后TG、CHO、HDL、LDL比较
注:*P>0.05,△P<0.05。
2.4结论:临床研究显示本发明可以改善非增殖性糖尿病视网膜病变患者的临床症状、眼底病变、提高视力,除此之外还有一定的调节血脂之功效。该药通过提高组织对缺氧的耐受、抑制血小板聚集、降低血粘度等,改善视网膜微循环,增加眼底血供,从而改善眼底局部缺血缺氧状态,实现提高患者视力及改善临床症状的治疗目的。
以下结合实例对本发明作进一步的描述,实施例仅用于对本发明进行说明,并不构成对权利要求范围的限制,本领域技术人员可以想到的其他替代手段,均在本发明权利要求范围内。
Claims (8)
1.一种治疗阴虚血瘀型糖尿病视网膜病变的中药,其特征在于,按下列重量份配比的原料药提取制备而成:枸杞子8-12份、制何首乌8-12份、三七8-12份、炒蒲黄10-20份、丹参10-20份、红花8-12份、赤芍8-12份、山楂15-25份,制备方法包括如下步骤:
a.按上述重量份数取制何首乌、三七、炒蒲黄、丹参、赤芍经乙醇回流提取,滤过,回收乙醇,浓缩得醇提浓缩液;
b.将上述步骤a醇提后的药渣与枸杞子、红花、山楂三味合并,加水煎煮,滤过,浓缩,冷却,加乙醇醇沉得水提醇沉浓缩液,将水提醇沉浓缩液与步骤a的醇提浓缩液合并制成干浸膏粉;
c.取步骤b的干浸膏粉,添加辅料制成口服液、片剂、胶囊或颗粒剂。
2.根据权利要求1所述治疗阴虚血瘀型糖尿病视网膜病变的中药,其特征在于,按下列重量份配比的原料药提取制备而成:枸杞子10份、制何首乌10份、三七10份、炒蒲黄15份、丹参15份、红花10份、赤芍10份、山楂20份。
3.根据权利要求1所述治疗阴虚血瘀型糖尿病视网膜病变的中药,其特征在于,所述辅料为糊精、乳糖、淀粉、蔗糖、葡萄糖、微晶纤维素、甘露糖、甲基纤维素、羟丙基纤维素、羧甲基纤维素和甜菊苷的一种或几种。
4.根据权利要求1所述治疗阴虚血瘀型糖尿病视网膜病变的中药,其特征在于,步骤a乙醇回流所加乙醇量是药材总重量的10倍量,分3次乙醇回流提取,加乙醇量分别为药材总重量的4倍量、3倍量和3倍量,乙醇浓度以体积比计为60%,每次回流1.5小时,合并提取液,滤过,滤液减压回收乙醇,浓缩至无醇味,得醇提浓缩液。
5.根据权利要求1所述治疗阴虚血瘀型糖尿病视网膜病变的中药,其特征在于,步骤b中加水量是药材总重量的15倍量,分3次煎煮,加水量分别为药材总重量的7倍量、4倍量和4倍量,每次浸泡0.5小时,煎煮1.5小时,合并三次水煎液,滤过,将滤液浓缩至60℃时相对密度为1g/ml,冷却,加乙醇至含醇量体积比达50%,搅匀,放置48小时后离心,弃去沉淀,回收乙醇,与步骤a醇提浓缩液合并,浓缩后在70℃条件下进行真空干燥,粉碎得到干浸膏粉。
6.根据权利要求1所述治疗阴虚血瘀型糖尿病视网膜病变的中药,其特征在于,步骤c中辅料为乳糖,干浸膏粉与乳糖的重量比为2:1,以90%乙醇湿法制颗粒,湿颗粒在50℃干燥,即得颗粒剂。
7.根据权利要求1所述治疗阴虚血瘀型糖尿病视网膜病变的中药在制备治疗阴虚血瘀型糖尿病视网膜病变中药中的应用。
8.根据权利要求1所述治疗阴虚血瘀型糖尿病视网膜病变的中药在制备调节血脂药物中的应用。
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