CN112022929A - 一种治疗糖尿病周围神经病变的中药组合物及其制备方法 - Google Patents
一种治疗糖尿病周围神经病变的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明属于中药领域,具体涉及一种治疗糖尿病周围神经病变的中药组合物。本发明所提供的中药组合物,由包含如下所述的中药原料制成:黄芪50‑150重量份,生地黄50‑150重量份,当归25‑75重量份,葛根25‑75重量份,玄参25‑75重量份,川芎15‑50重量份,丹参25‑75重量份,红花15‑50重量份,牛膝25‑75重量份,金银花25‑75重量份,鸡血藤25‑75重量份,甘草15‑50重量份。本发明还提供了制备上述中药组合物的方法,可将中药组合物制成片剂、丸剂、胶囊剂或颗粒剂。
Description
技术领域
本发明属于中药领域,具体涉及一种治疗糖尿病周围神经病变的中药组合物及其制备方法。
背景技术
糖尿病周围神经病变(Diabetic Peripheral Neuropathies,简称DPN)是指在排除其他原因的情况下,糖尿病患者出现周围神经功能障碍相关的症状和/或体征。其临床表现较为复杂,多为感觉及自主神经受累,伴相对较轻的运动神经元受累,并以远端对称性肢体疼痛、麻木和感觉减退为主要特征,亦有痛觉过敏者,昼轻夜重。我国住院糖尿病患者中DPN的发生率约为60%,且随着神经系统检测手段的不断提高,DPN的检出率呈现逐年上升的趋势。DPN已成为糖尿病最常见的慢性并发症和主要致残因素之一。
DPN的病因与发病机制迄今尚未完全阐明,普遍认为其发生与机体代谢紊乱所致的氧化应激自由基增多、血管性缺血缺氧、神经生长因子缺乏等密切相关,且与自身免疫紊乱、维生素缺乏、遗传及环境等因素亦有较大关系。本病的西医治疗,多在严格控制血糖的基础上对因治疗,以纠正代谢紊乱(如依帕司他)为主,辅以神经营养(如甲钴胺、B族维生素、神经生长因子)、改善微循环(如前列腺素E、尼莫地平、阿司匹林)、拮抗氧化应激(如α-硫辛酸、依达拉奉)等综合治疗措施。上述化学药物的干预和治疗措施针对DPN的不同发病机理均能起到一定的治疗效果,但对于病程较长、病情复杂的者,疗效常不甚理想,加之部分化药价格昂贵,临床应用也受到一定限制。因此,急需研制出能够治疗DPN的中药药物。
糖尿病属于中医学上“消渴”范畴,而DPN在中医学中虽无确切病名,但从其临床症状及体征表现而言,多数学者将其归属于中医“消渴”合并“痹症”、“痿证”范畴,亦有将其归属“血痹”、“脉痹”者。金元时期,李杲在《兰室秘藏》较为详细记载了消渴病人后期可见“上下齿皆麻,舌根强硬,肿疼,四肢痿弱,前阴如冰”;明代《普济方》亦云“肾消口干,眼涩阴痿,手足烦疼”;清代《王旭高医案》则曰“消渴日久,但见手足麻木,肢凉如冰”。以上诸家对消渴病证的描述与DPN的现代临床表现大致相符,可见本病因消渴病日久致气阴两虚,气虚血滞,气滞血瘀,络脉失养,且久病入络,病久致瘀,亦致脉络失养。DPN的病机表现出气阴两虚、瘀血阻络的本虚标实特点,其虚实夹杂的病机如不能及时得到纠正,各病机间势必将相互影响,互为因果,导致病变程度不断加重。因此,基于中医学对DPN的病因病机认识,治疗上遵循“治病必求其本”的思想,从“虚者补之,实者泻之”、“通则不痛,痛则不通”、“以通为补,以通为用”治则出发,形成益气养阴、活血通络、祛瘀清热的组方立意,达到补中寓泻、标本兼治、固本善后的整体疗效。
发明内容
本发明技术目的之一在于提供一种治疗糖尿病周围神经病变的中药组合物。
所述中药组合物由含有黄芪、生地黄、当归、葛根、玄参、川芎、丹参、红花、牛膝、金银花、鸡血藤和甘草的中药原料制备而成,所述中药组合物具有益气养阴、活血通络、祛瘀清热的功效,用于治疗糖尿病周围神经病变,中医辨证属气阴两虚、瘀热互结证,症见肢体麻木,肢凉刺痛,或灼热疼痛,下肢为主,入夜加剧,口干多饮,伴有尿频量多,神疲乏力,形体消瘦,腰膝酸软,自汗盗汗,五心烦热,舌质暗淡或暗红,苔少而干,脉细涩或细数。
本发明的技术目的是通过以下技术方案实现的:
一种治疗糖尿病周围神经病变的中药组合物,该组合物是由包含如下所述的中药原料制成:
上述中药组合物优选为:
上述中药组合物优选为:
上述中药组合物优选为:
针对糖尿病周围神经病变“气阴两虚”的中医学核心病机,方中重用黄芪、生地黄,二者共为君药。其中,黄芪甘而微温,能补气升阳、益卫固表、行滞通痹、养血生津、利水消肿,有“补药之长”、“补气诸药之最”之称;生地黄味甘性寒,能清热凉血、养阴生津,《神农本草经疏》称其“乃补肾家之要药,益阴血之上品”、“为至阴之药,正补肾水真阴而益血”。黄芪、生地黄配伍应用,黄芪补气,生地黄养阴,共奏益气养阴之功。
方中当归、葛根、玄参、川芎、丹参、红花6种原料药材,既辅助君药以增强益气养阴作用,又针对病变的“气滞血瘀”兼证而发挥行气活血、散瘀通络作用,共为臣药。其中,当归甘辛性温,主补血活血、调经止痛,《本草正》曰:“当归,其味甘而重,故专能补血,其气轻而辛,故又能行血,补中有动,行中有补,诚血中之气药,亦血中之圣药也”;川芎味辛性温,能活血行气、祛风止痛,《本草发明》称其“能助血流行,血中之气药也。”当归、川芎配伍,当归养血之中兼具活血之功,川芎行气活血之中兼有补血之能,二者合用,润燥相济,可补而不壅滞,通而不伤正,使养血活血、行气散瘀之力增强。因有形之血生于无形之气,气旺则血生,故当归配伍黄芪,可使益气生血作用增强,达到气血双补。
葛根甘辛性凉,能解肌退热、生津止渴、通络止痛,《神农本草经》载其主“消渴”、“诸痹”,《本草经解》则曰:“诸痹皆起于气血不流通,葛根辛甘和散,气血活,诸痹自愈也。”葛根、生地黄均具甘凉滋润之性,配伍用于治疗阴虚内热口渴能协同增效,相辅相成;同时二者又可相反相成,生地黄通过葛根的“散”可以起到“通补”的作用,做到补中有散,补而不滞。因津血同源,皆属于阴。当归养血以生阴津,葛根清热生津止渴,二药相伍,热清则津不伤,血充则津自生。
玄参甘苦咸而性微寒,能清热凉血、滋阴降火、解毒散结,《本草纲目》载其“滋阴降火,解斑毒,利咽喉,通小便血滞”。生地黄、玄参皆为清热凉血之佳品,也是养阴生津之良药,二药伍用,玄参助生地黄以养阴清热,使滋阴作用增强。
丹参味苦微寒,功擅活血祛瘀、痛经止痛,兼能清心除烦、凉血消痈,“为调理血分之首药”,《景岳全书》称其“养血活血,生新血,行宿血,……,此心脾肝肾血分之药,所以亦能养阴定志,益气解烦”;红花味辛性温,功专活血通经、祛瘀止痛,“乃行血之要药”,《药品化义》曰:“红花,善通利经脉,为血中气药,能泻而又能补。”丹参、红花皆归心、肝经,二者相须为用,寒温相济以活血祛瘀,既不温躁,亦无动血之痹,养血清热又无寒凉凝滞之虞。
方中金银花、鸡血藤,既协助臣药以加强活血通络作用,又针对病变“阴虚夹热”、“瘀热互结”的虚热兼证而发挥清热凉血作用,故同属佐药。其中,金银花味甘性寒,功擅清热解毒、凉散风热,《重订石室秘录》云:“金银花败毒而又不伤气,去火而又能补阴。”鸡血藤苦甘性温,苦而不燥,温而不烈,能补血活血、舒筋活络,《饮片新参》载其“去瘀血,生新血,流利经脉。治暑痧、风血痹症”。丹参、鸡血藤皆色赤入血分,二者伍用,养血活血凉血之效尤著,且温通气血、通络蠲痹亦得到加强。
方中牛膝、甘草,或为引经药,或为调和药,故均为使药。其中,牛膝苦甘酸平,能活血通经、引血下行,《景岳全书》称其“走十二经络,助一身元气。……,其性下走如奔,故能通经闭,破血癥,引诸药下降”;《医学衷中参西录》云:“牛膝,……,原为补益之品,而善引气血下注,是以用药欲其下行者,恒以之为引经。”甘草味甘性平,能益气补中、清热解毒、缓急止痛、调和药性,《本草正》赞其“得中和之性,有调补之功,故毒药得之解其毒,刚药得之和其性,表药得之助其外,下药得之缓其速。……,随气药入气,随血药入血,无往不可,故称国老”。
以上黄芪等12种原料药材,基于糖尿病周围神经病变患者多表现为气阴两虚、瘀热互结之本虚标实、虚实夹杂的特点,依据中药方剂学“君臣佐使”和“药对”配伍理论进行组方,诸药相合,共奏益气养阴、活血通络、祛瘀清热之功,主治糖尿病周围神经病变,中医辨证属气阴两虚、瘀热互结者,每获良效。
本发明的另一个目的是提供一种含有上述中药组合物的中药口服固体制剂及其制备方法,所述中药口服固体制剂为片剂、丸剂、胶囊剂或颗粒剂。
所述中药口服固体制剂的制备方法包括以下步骤:
1)取黄芪、生地黄、当归、葛根、玄参、川芎、丹参、红花、牛膝、金银花、鸡血藤和甘草12种原料药材,其中黄芪、生地黄、当归、葛根、玄参、川芎、鸡血藤切片,备用;丹参、牛膝、甘草切段,备用;红花、金银花净选,备用;
2)取步骤1)所得当归片、川芎片混匀,蒸馏提取挥发油,所得挥发油加入环糊精,制成环糊精包合物,备用;蒸馏后的水溶液另器贮存,备用;蒸馏后所得药渣Ⅰ,备用;
3)取步骤1)中所得葛根片、丹参段、红花混匀,乙醇回流提取,提取液滤过,减压回收乙醇并浓缩成浸膏Ⅰ,备用;提取后所得药渣Ⅱ,备用;
4)将步骤2)中所得药渣Ⅰ、步骤3)中所得药渣Ⅱ与步骤1)中剩余黄芪片、生地黄片、玄参片、鸡血藤片、牛膝段、甘草段、金银花7味药材饮片混匀,加水煎煮,煎煮液备用;
5)将步骤4)中所得煎煮液及步骤2)中所得蒸馏后的水溶液合并,滤过,滤液浓缩成清膏,加入乙醇,调整含醇量,搅匀,冷沉,滤过,滤液减压回收乙醇并浓缩成浸膏Ⅱ,备用;
6)将步骤3)所得浸膏Ⅰ和步骤5)所得浸膏Ⅱ合并,混匀,得浸膏Ⅲ,备用;
7)将步骤6)所得浸膏Ⅲ和步骤2)中所得环糊精包合物混合,加入常规辅料,制成片剂、丸剂、胶囊剂或颗粒剂。
优选的,上述中药口服固体制剂的制备方法的操作步骤中:
步骤3)的具体操作为:
取上述步骤1)中所得葛根片、丹参段、红花混匀,用60%-80%乙醇回流提取2次,每次2小时,滤过,滤液合并,减压回收乙醇并浓缩成50-70℃时相对密度为1.15-1.35的浸膏Ⅰ,备用;提取后所得药渣Ⅱ,备用;
步骤4)的具体操作为:
将步骤2)中所得药渣Ⅰ、步骤3)中所得药渣Ⅱ与步骤1)中剩余黄芪片、生地黄片、玄参片、鸡血藤片、牛膝段、甘草段、金银花7味药材饮片混匀,加水煎煮2次,每次1-2小时,合并两次煎液,备用;
步骤5)的具体操作为:
将步骤4)中所得煎煮液及步骤2)中所得蒸馏后的水溶液合并滤过,滤液浓缩成50-70℃时相对密度为1.10-1.20的清膏,加入95%乙醇使含醇量达50%-80%,搅匀,冷沉12-48小时,滤过,滤液减压回收乙醇并浓缩成浸膏Ⅱ,备用;
进一步优选的,上述具体操作中:
步骤3)中所述药材用75%乙醇加热回流提取2次,每次2小时。
步骤4)所述药渣Ⅰ、药渣Ⅱ与其余黄芪等7味药材饮片加水煎煮2次,每次1.5小时。
步骤5)所述清膏加入95%乙醇使含醇量达60%。
优选地,上述中药口服固体制剂的制备方法的操作步骤中,步骤2)中所加入的环糊精为β-环糊精、羟丙基-β-环糊精或γ-环糊精中的一种或多种。
发明人对本发明技术方案进行了药效学试验研究和临床研究,用以证明本发明中药组合物对糖尿病周围神经病变(DPN)的治疗作用。药效学试验及临床研究所选取的样品为本发明技术方案所得的具有代表性的样品,其它配方及制备方法所得样品涉及的实验及结果,不再一一穷举。以下是主要研究结果。
实验例1对糖尿病周围神经病变模型大鼠的血清丙二醛(MDA)、超氧化物歧化酶(SOD)和谷胱甘肽过氧化物酶(GSH-Px)水平的影响
1材料
1.1实验动物
SPF级雄性SD大鼠,体重(200±20)g,由济南朋悦实验动物繁育有限公司提供,实验动物许可证号:SCXK(鲁)2014007。实验前在清洁级动物实验室适应性喂养1周,室温20-25℃,相对湿度50%-60%,室内12h明暗自动切换,自由摄食、饮水。
1.2仪器、试剂及药品
仪器:UV-2401PC型紫外-可见分光光度计,日本Shimadzu公司;DRHH-S6型数显恒温水浴锅,上海双捷实验设备有限公司;H1650-W台式微量高速离心机,长沙湘仪离心机仪器有限公司;QL-901型旋涡混匀器,海门市其林贝尔仪器制造有限公司;稳豪型血糖仪及血糖试纸,上海强生医疗器材有限公司;BL-420F型生物信号采集处理系统,成都泰盟科技有限公司;
试剂:链脲佐菌素(STZ)购自美国Sigma公司;丙二醛(MDA)、超氧化物歧化酶(SOD)、谷胱甘肽过氧化物酶(GSH-Px)测定试剂盒购自南京建成生物工程研究所;
药品:受试药物为根据实施例7项下配方及制法所制得的胶囊剂样品;阳性对照药为甲钴胺胶囊(规格:0.5mg/粒,批号:13070102),扬子江药业集团南京海陵药业有限公司。
2方法
2.1分组和造模
造模:雄性SD大鼠适应性喂养1周后,改用高脂高糖饲料喂养4周后,将STZ用0.1mmol/L无菌柠檬酸钠缓冲液(pH4.5,4℃)配制成1%的溶液,按50mg/kg予腹腔注射,72h后取尾静脉血检测空腹血糖,大鼠血糖值≥16.7mmol/L,且连续3d血糖值稳定,即判定糖尿病大鼠(简称“DM大鼠”)造模成功;将DM大鼠俯卧位固定,充分暴露其腰背部及双下肢,将冷冻好的干冰袋(规格:400ml,12×20cm)沿大鼠坐骨神经解剖位置,分别放置于腰骶部及双侧下肢进行冷敷,30min/次,1次/d,连续放置两周后,改为隔天冷敷1次,于第12周末检测大鼠坐骨神经动作电位传导速度变化,出现坐骨神经功能减退,则判定糖尿病周围神经病变大鼠(“DPN大鼠”)造模成功。
同时,正常组大鼠一直常规饲料喂养,同期腹腔注射等量0.1mmol/L无菌柠檬酸钠缓冲液(pH4.5,4℃)。
分组:选取正常组大鼠10只,作为正常对照组;
选取造模成功的大鼠,随机分为5组,即模型对照组、甲钴胺阳性对照组、试验低剂量组、试验中剂量组和试验高剂量组,每组10只。
2.2给药DPN大鼠造模完成后1周,将受试药物的内容物和甲钴胺胶囊的内容物分别配制成混悬液,开始灌胃给药,1次/d,连续给药8周。其中,正常对照组和模型对照组给予等体积生理盐水;试验高剂量组1.12g/kg(按体表面积算,相当于临床8倍剂量)、中剂量组0.56g/kg和低剂量组0.28g/kg;甲钴胺阳性对照组0.173mg/kg。
2.3观察指标检测末次灌胃给药并禁食、禁水12小时后,经内眦于眶后静脉丛采血,分装不同试管内,3000r/min离心10min分离血清,4℃保存,严格按丙二醛(MDA)、超氧化物歧化酶(SOD)和谷胱甘肽过氧化物酶(GSH-Px)测定试剂盒说明书要求,分别测定血清中MDA、SOD含量和GSH-Px的活力水平。
3结果
与正常对照组相比,模型对照组大鼠的血清MDA水平明显升高,血清SOD、GSH-Px水平明显降低。与模型对照组比较,试验低、中、高剂量组及甲钴胺阳性对照组能降低DPN模型大鼠血清MDA和提高血清SOD水平,差异有统计学意义(P<0.05或P<0.01);试验中、高剂量组及甲钴胺阳性对照组能升高DPN模型大鼠血清GSH-Px的活力水平,差异有统计学意义(P<0.05或P<0.01)。结果见表1。
注:与正常对照组比较:#P<0.05;与模型对照组比较:*P<0.05或**P<0.01。
实验例2治疗糖尿病周围神经病变(DPN)的临床疗效观察
1资料与方法
1.1一般资料选取2017年1月至2018年4月期间临沂市中医医院内分泌科门诊就诊的DPN患者,经中医辨证属气阴两虚、瘀热互结者,共56例。糖尿病诊断参照中华医学会《中国Ⅱ型糖尿病防治指南(2013年版)》;DPN符合中国医师协会《糖尿病周围神经病变临床诊疗规范》中的诊断标准;DPN中医辨证分型及诊断标准参照卫生部《中药新药临床研究指导原则》(中国医药科技出版社,2002)中消渴病的诊断及分型标准,证候表现:肢体麻木,肢凉刺痛,或灼热疼痛,下肢为主,入夜加剧,口干多饮,伴有尿频量多,神疲乏力,形体消瘦,腰膝酸软,自汗盗汗,五心烦热,舌质暗淡或暗红,苔少而干,脉细涩或细数,中医辨证属气阴两虚、瘀热互结证。
纳入标准:①符合糖尿病诊断标准;②符合DPN诊断标准;③符合中医消渴病诊断标准及中医气阴两虚、瘀热互结证的辨证标准;④中医证候积分6分以上;⑤病程≥1年;⑥年龄25-75岁;⑦原治疗糖尿病及DPN的中药及中成药均停药4周;⑧所有患者均知情同意。
排除标准:①妊娠及哺乳期妇女;②近3个月内有糖尿病酮症酸中毒等急性并发症;③合并心、肝、肾等严重原发性疾病;④合并高血压及脑血管意外;⑤其他疾病如脑梗死、格林-巴利综合征、颈腰椎病变等或代谢毒物损害神经引起的周围神经病变;⑥年龄<25岁或>75岁;⑦不能配合治疗的患者;⑧治疗过程中发生意外事件而不能坚持治疗者。
采用随机数字表法将56例DPN患者分为观察组与对照组两组,各28例。其中观察组男18例、女10例,年龄32-75岁,平均年龄(63.5±6.0)岁,病程1-6年,平均病程(2.4±1.2)年;对照组男17例、女11例,年龄30-75岁,平均年龄(62.8±5.7)岁,病程1-8年,平均病程(2.6±1.3)年。两组患者在男女构成比例、年龄、病程等一般资料比较差异均无统计学意义(P>0.05),具有可比性。
1.2方法观察组口服实施例07制备的胶囊剂样品,每次3粒,每日3次;对照组口服甲钴胺(规格:0.5mg/粒,扬子江药业集团南京海陵药业有限公司),每次1粒,每日3次。两组患者均以4周为1个疗程,连续治疗2个疗程。
1.3疗效判定标准参照《中药新药临床研究指导原则》,采用尼莫地平法“(治疗前积分﹣治疗后积分)÷治疗前积分”×100%,对中医证候疗效进行疗效评定。显效:患者用药后其临床症状和体征明显好转,证候积分减少超过70%以上;有效:用药后患者中医临床症状以及体征较前略有改善,证候积分减少超过30%;无效:用药后患者临床症状及体征无改变甚至恶化,证候积分减少低于30%。
2试验结果
两组患者中医证候临床疗效比较结果比较见表2。两组数据经chi-square test检验(卡方检验),其中P>0.05,表明观察组样品与对照组甲钴胺胶囊相比,二者疗效相当,且观察组治愈率、总有效率均高于对照组。
表2两组患者治疗后中医临床疗效比较(n,%)
具体实施方式
以下结合实施例,具体描述本发明中药组合物及其制备方法。
实施例1片剂的制备
1)取黄芪、生地黄、当归、葛根、玄参、川芎、丹参、红花、牛膝、金银花、鸡血藤和甘草12种原料药材,其中黄芪、生地黄、当归、葛根、玄参、川芎、鸡血藤切片,备用;丹参、牛膝、甘草切段,备用;红花、金银花净选,备用;
2)取步骤1)中当归片0.25kg、川芎片0.5kg混匀,蒸馏提取挥发油,所得挥发油加入β-环糊精,制成β-环糊精包合物,备用;蒸馏后的水溶液另器贮存,备用;蒸馏后所得药渣Ⅰ,备用;
3)取步骤1)中葛根片0.75kg、丹参段0.25kg、红花0.15kg混匀,用75%乙醇回流提取2次,每次2小时,滤过,滤液合并,减压回收乙醇并浓缩成50-70℃时相对密度为1.2的浸膏Ⅰ,备用;所得药渣Ⅱ备用;
4)取步骤1)中黄芪片0.5kg、生地黄片0.5kg、玄参片0.75kg、牛膝段0.25kg、金银花0.75kg、鸡血藤片0.75kg、甘草段0.5kg共7味药材饮片,与步骤2)所得药渣Ⅰ、步骤3)所得药渣Ⅱ混匀,加水煎煮2次,每次2.0小时,合并两次煎煮液,备用;
5)将步骤4中所得煎煮液与步骤2)中所得蒸馏后的水溶液合并,滤过,滤液浓缩成50-70℃时相对密度为1.12的清膏,加入95%乙醇使含醇量达60%,搅匀,冷沉12小时,滤过,滤液减压回收乙醇并浓缩成浸膏Ⅱ;
6)将步骤3)所得浸膏Ⅰ、步骤5)中所得浸膏Ⅱ合并,混匀,得浸膏Ⅲ,备用;
7)将步骤6)所得浸膏Ⅲ、步骤2)中所得β-环糊精包合物混合,加入配方量的微晶纤维素、羧甲基淀粉钠(重量比8:3),混匀,制成粗颗粒,干燥,粉碎,过筛,制颗粒,低温干燥,整粒,加入0.2%硬脂酸镁和0.1%的滑石粉,混匀,压制成1000片,包薄膜衣,即得。
实施例2胶囊剂的制备
1)取黄芪、生地黄、当归、葛根、玄参、川芎、丹参、红花、牛膝、金银花、鸡血藤和甘草12种原料药材,其中黄芪、生地黄、当归、葛根、玄参、川芎、鸡血藤切片,备用;丹参、牛膝、甘草切段,备用;红花、金银花净选,备用;
2)取步骤1)中当归片0.4kg、川芎片0.4kg混匀,蒸馏提取挥发油,所得挥发油加入β-环糊精,制成β-环糊精包合物,备用;蒸馏后的水溶液另器贮存,备用;蒸馏后所得药渣Ⅰ,备用;
3)取步骤1)中葛根片0.6kg、丹参段0.4kg、红花0.2kg混匀,用60%乙醇回流提取2次,每次2小时,滤过,滤液合并,减压回收乙醇并浓缩成50-70℃时相对密度为1.35的浸膏Ⅰ,备用;提取后所得药渣Ⅱ,备用;
4)取步骤1)中黄芪片0.8kg、生地黄片0.8kg、玄参片0.6kg、牛膝段0.4kg、金银花0.6kg、鸡血藤片0.6kg、甘草段0.4kg共7味药材饮片与步骤2)中所得药渣Ⅰ、步骤3)中所得药渣Ⅱ混匀,加水煎煮2次,每次1.0小时,合并两次煎煮液,备用;
5)将步骤4)所得煎煮液与步骤2)中所得蒸馏后的水溶液合并,滤过,滤液浓缩成50-70℃时相对密度为1.18的清膏,加入95%乙醇使含醇量达80%,搅匀,冷沉48小时,滤过,滤液减压回收乙醇并浓缩成浸膏Ⅱ,备用;
6)将步骤3)所得浸膏Ⅰ、步骤5)所得浸膏Ⅱ合并,混匀,得浸膏Ⅲ,备用;
7)取步骤6)所得浸膏Ⅲ、步骤2)所得β-环糊精包合物混合,加入配方量的淀粉、微粉硅胶(重量比4:1),混匀,制粒,干燥,整粒,灌装,磨光机中抛光,剔除破损胶囊,即得。
实施例3丸剂的制备
1)取黄芪、生地黄、当归、葛根、玄参、川芎、丹参、红花、牛膝、金银花、鸡血藤和甘草12种原料药材,其中黄芪、生地黄、当归、葛根、玄参、川芎、鸡血藤切片,备用;丹参、牛膝、甘草切段,备用;红花、金银花净选,备用;
2)取步骤1)中当归片0.43kg、川芎片0.29kg混匀,蒸馏提取挥发油,所得挥发油加入羟丙基-β-环糊精包合物,制成羟丙基-β-环糊精包合物,备用;蒸馏后的水溶液另器贮存,备用;蒸馏后所得药渣Ⅰ,备用;
3)取步骤1)中葛根片0.43kg、丹参段0.43kg、红花0.29kg混匀,用70%乙醇回流提取2次,每次2小时,滤过,滤液合并,减压回收乙醇并浓缩成50-70℃时相对密度为1.25的浸膏Ⅰ,备用;提取后所得药渣Ⅱ,备用;
4)取步骤1)中黄芪片1.07kg、生地黄片1.07kg、玄参片0.55kg、牛膝段0.43kg、金银花0.43kg、鸡血藤片0.43kg、甘草段0.29kg共7味药材饮片与步骤2)中所得药渣Ⅰ、步骤3)中所得药渣Ⅱ混匀,加水煎煮2次,每次1.5小时,合并两次煎煮液,备用;
5)将步骤3)所得煎煮液、步骤2)所得蒸馏后的水溶液合并,滤过,滤液浓缩成50-70℃时相对密度为1.20的清膏,加入95%乙醇使含醇量达70%,搅匀,冷沉36小时,滤过,滤液减压回收乙醇并浓缩成浸膏Ⅱ,备用;
6)将步骤3)所得浸膏Ⅰ、步骤5)所得浸膏Ⅱ合并,混匀,得浸膏Ⅲ,备用;
7)取步骤6)所得浸膏Ⅲ、步骤2)所得羟丙基-β-环糊精包合物混合,加入配方量的淀粉、糊精(重量比3:1),混匀,70℃以下干燥,粉碎成细粉,加入2.5%低取代羟丙基纤维素,混匀,用水泛制成丸1000粒,70℃以下干燥,打光,包衣,即得。
实施例4颗粒剂的制备
1)取黄芪、生地黄、当归、葛根、玄参、川芎、丹参、红花、牛膝、金银花、鸡血藤和甘草12种原料药材,其中黄芪、生地黄、当归、葛根、玄参、川芎、鸡血藤切片,备用;丹参、牛膝、甘草切段,备用;红花、金银花净选,备用;
2)取步骤1)中当归片0.75kg、川芎片0.5kg混匀,蒸馏提取挥发油,挥发油加入γ-环糊精,制成γ-环糊精包合物,备用;蒸馏后的水溶液另器贮存,备用;蒸馏后所得药渣Ⅰ,备用;
3)取步骤1)中葛根片0.25kg、丹参段0.75kg、红花0.5kg混匀,用65%乙醇回流提取2次,每次2小时,滤过,滤液合并,减压回收乙醇并浓缩成50-70℃时相对密度为1.2的浸膏Ⅰ,备用;提取后所得药渣Ⅱ,备用;
4)取步骤1)中黄芪片1.5kg、生地黄片1.5kg、玄参片0.15kg、牛膝段0.75kg、金银花0.25kg、鸡血藤片0.25kg、甘草段0.15kg共7味药材饮片与步骤2)所得药渣Ⅰ、步骤3)所得药渣Ⅱ混匀,加水煎煮2次,每次2.0小时,合并两次煎煮液,备用;
5)将步骤4)所得煎煮液、步骤2)所得蒸馏后的水溶液合并,滤过,滤液浓缩成50-70℃时相对密度为1.13的清膏,加入95%乙醇使含醇量达70%,搅匀,冷沉24小时,滤过,滤液减压回收乙醇并浓缩成浸膏Ⅱ,备用;
6)将步骤3)所得浸膏Ⅰ、步骤5)所得浸膏Ⅱ合并,混匀,得浸膏Ⅲ,备用;
7)取步骤6)所得浸膏Ⅲ、步骤2)所得γ-环糊精包合物混合,加入配方量的蔗糖粉、羟丙基淀粉、甘露醇(重量比5:2:3),混匀,制成颗粒,干燥,整粒,制成1000g,即得。
实施例5片剂的制备
1)取黄芪、生地黄、当归、葛根、玄参、川芎、丹参、红花、牛膝、金银花、鸡血藤和甘草12种原料药材,其中黄芪、生地黄、当归、葛根、玄参、川芎、鸡血藤切片,备用;丹参、牛膝、甘草切段,备用;红花、金银花净选,备用;
2)取步骤1)中当归片0.3kg、川芎片0.45kg混匀,蒸馏提取挥发油,挥发油加入γ-环糊精,制成γ-环糊精包合物,备用;蒸馏后的水溶液另器贮存,备用;蒸馏后所得药渣Ⅰ,备用;
3)取步骤1)中葛根片0.7kg、丹参段0.35kg、红花0.2kg混匀,用80%乙醇回流提取2次,每次2小时,滤过,滤液合并,减压回收乙醇并浓缩成50-70℃时相对密度为1.15的浸膏Ⅰ,备用;提取后所得药渣Ⅱ,备用;
4)取步骤4)中黄芪片0.6kg、生地黄片0.7kg、玄参片0.7kg、牛膝段0.35kg、金银花0.7kg、鸡血藤片0.7kg、甘草段0.45kg共7味药材饮片与步骤2)所得药渣Ⅰ、步骤3)所得药渣Ⅱ混匀,加水煎煮2次,每次1.5小时,合并两次煎煮液,备用;
5)将步骤4)所得煎煮液、步骤2)所得蒸馏后的水溶液合并,滤过,滤液浓缩成50-70℃时相对密度为1.15的清膏,加入95%乙醇使含醇量达50%,搅匀,冷沉36小时,滤过,滤液减压回收乙醇并浓缩成浸膏Ⅱ,备用;
6)将步骤3)所得浸膏Ⅰ、步骤5)所得浸膏Ⅱ合并,混匀,得浸膏Ⅲ,备用;
7)取步骤6)所得浸膏Ⅲ、步骤2)所得γ-环糊精包合物混合,加入配方量的淀粉、糊精和蔗糖(重量比5:1:1),混匀,制成粗颗粒,干燥,粉碎,过筛,制颗粒,低温干燥,整粒,加入0.5%硬脂酸镁,混匀,压制成1000片,包薄膜衣,即得。
实施例6颗粒剂的制备
1)取黄芪、生地黄、当归、葛根、玄参、川芎、丹参、红花、牛膝、金银花、鸡血藤和甘草12种原料药材,其中黄芪、生地黄、当归、葛根、玄参、川芎、鸡血藤切片,备用;丹参、牛膝、甘草切段,备用;红花、金银花净选,备用;
2)取步骤1)中当归片0.6kg、川芎片0.2kg混匀,蒸馏提取挥发油,挥发油加入β-环糊精,制成β-环糊精包合物,备用;蒸馏后的水溶液另器贮存,备用;蒸馏后所得药渣Ⅰ,备用;
3)取步骤1)中葛根片0.4kg、丹参段0.6kg、红花0.4kg混匀,用75%乙醇回流提取2次,每次2小时,滤过,滤液合并,减压回收乙醇并浓缩成50-70℃时相对密度为1.25的浸膏Ⅰ,备用;提取后所得药渣Ⅱ,备用;
4)取步骤1)中黄芪片1.2kg、生地黄片1.2kg、玄参片0.4kg、牛膝段0.6kg、金银花0.4kg、鸡血藤片0.4kg、甘草段0.2kg共7味药材饮片与步骤2)所得药渣Ⅰ、步骤3)所得药渣Ⅱ混匀,加水煎煮2次,每次2.0小时,合并两次煎煮液,备用;
5)将步骤4所得煎煮液、步骤2)所得蒸馏后的水溶液合并,滤过,滤液浓缩成50-70℃时相对密度为1.16的清膏,加入95%乙醇使含醇量达80%,搅匀,冷沉12小时,滤过,滤液减压回收乙醇并浓缩成浸膏Ⅱ,备用;
6)将步骤3)所得浸膏Ⅰ、步骤5)所得浸膏Ⅱ合并,混匀,得浸膏Ⅲ,备用;
7)取步骤6)所得浸膏Ⅲ、步骤2)所得β-环糊精包合物混合,加入配方量的蔗糖粉、糊精(重量比3:2),混匀,制成颗粒,干燥,整粒,制成1000g,即得。
实施例7胶囊剂的制备
1)取黄芪、生地黄、当归、葛根、玄参、川芎、丹参、红花、牛膝、金银花、鸡血藤和甘草12种原料药材,其中黄芪、生地黄、当归、葛根、玄参、川芎、鸡血藤切片,备用;丹参、牛膝、甘草切段,备用;红花、金银花净选,备用;
2)取步骤1),其中当归片0.5kg、川芎片0.3kg混匀,蒸馏提取挥发油,所得挥发油加入羟丙基-β-环糊精,制成羟丙基-β-环糊精包合物,备用;蒸馏后的水溶液另器贮存,备用;蒸馏后所得药渣Ⅰ,备用;
3)取步骤1)中葛根片0.5kg、丹参段0.5kg、红花0.3kg混匀,用75%乙醇回流提取2次,每次2小时,滤过,滤液合并,减压回收乙醇并浓缩成50-70℃时相对密度为1.20的浸膏Ⅰ,备用;提取后所得药渣Ⅱ,备用;
4)取步骤1)中黄芪1.0kg、生地黄1.0kg、玄参0.5kg、牛膝0.5kg、金银花0.5kg、鸡血藤0.5kg、甘草0.3kg共7味药材饮片与步骤2)中所得药渣Ⅰ、步骤3)中所得药渣Ⅱ混匀,加水煎煮2次,每次1.5小时,合并两次煎煮液,备用;
5)将步骤4)所得煎煮液、步骤2)所得蒸馏后的水溶液合并,滤过,滤液浓缩成50-70℃时相对密度为1.15的清膏,加入95%乙醇使含醇量达60%,搅匀,冷沉48小时,滤过,滤液减压回收乙醇并浓缩成浸膏Ⅱ,备用;
6)将步骤3)所得浸膏Ⅰ、步骤5)所得浸膏Ⅱ合并,混匀,得浸膏Ⅲ,备用;
7)取步骤6)所得浸膏Ⅲ、步骤2)所得羟丙基-β-环糊精包合物混合,加入配方量的淀粉、微粉硅胶、低取代羟丙基纤维素(重量比3:1:1),混匀,制粒,干燥,整粒,灌装,磨光机中抛光,剔除破损胶囊,即得。
实施例8丸剂的制备
1)取黄芪、生地黄、当归、葛根、玄参、川芎、丹参、红花、牛膝、金银花、鸡血藤和甘草12种原料药材,其中黄芪、生地黄、当归、葛根、玄参、川芎、鸡血藤切片,备用;丹参、牛膝、甘草切段,备用;红花、金银花净选,备用;
2)取步骤1)中当归片0.55kg、川芎片0.30kg混匀,蒸馏提取挥发油,所得挥发油加入γ-环糊精,制成γ-环糊精包合物,备用;蒸馏后的水溶液另器贮存,备用;蒸馏后所得药渣Ⅰ,备用;
3)取步骤1)葛根片0.45kg、丹参段0.55kg、红花0.35kg混匀,用80%乙醇回流提取2次,每次2小时,滤过,滤液合并,减压回收乙醇并浓缩成50-70℃时相对密度为1.35的浸膏Ⅰ,备用;提取后所得药渣Ⅱ,备用;
4)取步骤1)中黄芪片1.1kg、生地黄片1.15kg、玄参片0.45kg、牛膝段0.55kg、金银花0.45kg、鸡血藤片0.45kg、甘草段0.30kg共7味药材饮片与步骤2)所得药渣Ⅰ、步骤3)所得药渣Ⅱ混匀,加水煎煮2次,每次1.0小时,合并两次煎煮液,备用;
5)将步骤4)所得煎煮液、步骤2)所得蒸馏后的水溶液合并,滤过,滤液浓缩成50-70℃时相对密度为1.20的清膏,加入95%乙醇使含醇量达70%,搅匀,冷沉36小时,滤过,滤液减压回收乙醇并浓缩成浸膏Ⅱ,备用;
6)将步骤3)所得浸膏Ⅰ、步骤5)所得浸膏Ⅱ合并,混匀,得浸膏Ⅲ,备用;
7)取步骤6)所得浸膏Ⅲ、步骤2)中所得γ-环糊精包合物混合,加入配方量的淀粉,混匀,70℃以下干燥,粉碎成细粉,加入配方量的2.5%低取代羟丙基纤维素,混匀,用水泛制成丸1000粒,70℃以下干燥,打光,包衣,即得。
实施例9颗粒剂的制备
1)取黄芪、生地黄、当归、葛根、玄参、川芎、丹参、红花、牛膝、金银花、鸡血藤和甘草12种原料药材,其中黄芪、生地黄、当归、葛根、玄参、川芎、鸡血藤切片,备用;丹参、牛膝、甘草切段,备用;红花、金银花净选,备用;
2)取步骤1),其中当归片0.5kg、川芎片0.3kg混匀,蒸馏提取挥发油,所得挥发油加入羟丙基-β-环糊精,制成羟丙基-β-环糊精包合物,备用;蒸馏后的水溶液另器贮存,备用;蒸馏后所得药渣Ⅰ,备用;
3)取步骤1)中葛根片0.5kg、丹参段0.55kg、红花0.3kg混匀,用70%乙醇回流提取2次,每次2小时,滤过,滤液合并,减压回收乙醇并浓缩成50-70℃时相对密度为1.15的浸膏Ⅰ,备用;提取后所得药渣Ⅱ备用,备用;
4)取步骤1)中黄芪片1.0kg、生地黄片0.7kg、玄参片0.5kg、牛膝段0.5kg、金银花0.5kg、鸡血藤片0.5kg、甘草段0.3kg共7味药材饮片与步骤2)所得药渣Ⅰ、步骤3)所得药渣Ⅱ混匀,加水煎煮2次,每次1.5小时,合并两次煎煮液,备用;
5)将步骤4)中所得煎煮液、步骤2)中所得蒸馏后的水溶液合并,滤过,滤液浓缩成50-70℃时相对密度为1.18的清膏,加入95%乙醇使含醇量达70%,搅匀,冷沉48小时,滤过,滤液减压回收乙醇并浓缩成浸膏Ⅱ,备用;
6)将步骤3)所得浸膏Ⅰ、步骤5)所得浸膏Ⅱ合并,混匀,得浸膏Ⅲ,备用;
7)取步骤6)所得浸膏Ⅲ、步骤2)所得羟丙基-β-环糊精包合物混合,加入配方量的蔗糖粉、羟丙基淀粉、甘露醇(重量比2:2:1),混匀,制成颗粒,干燥,整粒,制成1000g,即得。
实施例10胶囊剂的制备
1)取黄芪、生地黄、当归、葛根、玄参、川芎、丹参、红花、牛膝、金银花、鸡血藤和甘草12种原料药材,其中黄芪、生地黄、当归、葛根、玄参、川芎、鸡血藤切片,备用;丹参、牛膝、甘草切段,备用;红花、金银花净选,备用;
2)取步骤1)中当归片0.65kg、川芎片0.2kg混匀,蒸馏提取挥发油,所得挥发油加入β-环糊精,制成β-环糊精包合物,备用;蒸馏后的水溶液另器贮存,备用;蒸馏后所得药渣Ⅰ,备用;
3)取步骤1)中葛根片0.3kg、丹参段0.65kg、红花0.45kg混匀,用60%乙醇回流提取2次,每次2小时,滤过,滤液合并,减压回收乙醇并浓缩成50-70℃时相对密度为1.25的浸膏Ⅰ,备用;提取后所得药渣Ⅱ,备用;
4)取步骤1)中黄芪片1.3kg、生地黄片1.3kg、玄参片0.35kg、牛膝段0.65kg、金银花0.3kg、鸡血藤片0.3kg、甘草片0.15kg共7味药材饮片与步骤2)所得药渣Ⅰ、步骤3)所得药渣Ⅱ混匀,加水煎煮2次,每次2.0小时,合并两次煎煮液,备用;
5)将步骤4)所得煎煮液、步骤2)所得上述蒸馏后的水溶液合并,滤过,滤液浓缩成50-70℃时相对密度为1.10的清膏,加入95%乙醇使含醇量达50%,搅匀,冷沉12小时,滤过,滤液减压回收乙醇并浓缩成浸膏Ⅱ,备用;
6)将步骤3)所得浸膏Ⅰ、步骤5)所得浸膏Ⅱ合并,混匀,得浸膏Ⅲ,备用;
7)取步骤6)所得浸膏Ⅲ、步骤2)所得β-环糊精包合物混合,加入配方量的淀粉、微晶纤维素(重量比9:1),混匀,制粒,干燥,整粒,灌装,磨光机中抛光,剔除破损胶囊,即得。
实施例11片剂的制备
1)取黄芪、生地黄、当归、葛根、玄参、川芎、丹参、红花、牛膝、金银花、鸡血藤和甘草12种原料药材,其中黄芪、生地黄、当归、葛根、玄参、川芎、鸡血藤切片,备用;丹参、牛膝、甘草切段,备用;红花、金银花净选,备用;
2)取步骤1)中当归片0.4kg、川芎片0.3kg混匀,蒸馏提取挥发油,所得挥发油加入羟丙基-β-环糊精,制成羟丙基-β-环糊精包合物,备用;蒸馏后的水溶液另器贮存,备用;蒸馏后所得药渣Ⅰ,备用;
3)取步骤1)中葛根片0.45kg、丹参段0.55kg、红花0.25kg混匀,用80%乙醇回流提取2次,每次2小时,滤过,滤液合并,减压回收乙醇并浓缩成50-70℃时相对密度为1.30的浸膏Ⅰ,备用;提取后所得药渣Ⅱ,备用;
4)取步骤1)中黄芪片0.95kg、生地黄片0.85kg、玄参片0.65kg、牛膝段0.55kg、金银花0.6kg、鸡血藤片0.6kg、甘草段0.35kg共7味药材饮片与步骤2)所得药渣Ⅰ、步骤3)所得药渣Ⅱ混匀,加水煎煮2次,每次2小时,合并两次煎煮液,备用;
5)将步骤4)所得煎煮液、步骤2)所得蒸馏后的水溶液合并,滤过,滤液浓缩成50-70℃时相对密度为1.17的清膏,加入95%乙醇使含醇量达60%,搅匀,冷沉36小时,滤过,滤液减压回收乙醇并浓缩成浸膏Ⅱ,备用;
6)将步骤3)所得浸膏Ⅰ、步骤5)所得浸膏Ⅱ合并,混匀,得浸膏Ⅲ,备用;
7)取步骤6)所得浸膏Ⅲ、步骤2)所得羟丙基-β-环糊精包合物混合,加入配方量的微晶纤维、羟丙基纤维(重量比5:3),混匀,制成粗颗粒,干燥,粉碎,过筛,制颗粒,低温干燥,整粒,加入0.5%硬脂酸镁,混匀,压制成1000片,包薄膜衣,即得。
实施例12丸剂的制备
1)取黄芪、生地黄、当归、葛根、玄参、川芎、丹参、红花、牛膝、金银花、鸡血藤和甘草12种原料药材,其中黄芪、生地黄、当归、葛根、玄参、川芎、鸡血藤切片,备用;丹参、牛膝、甘草切段,备用;红花、金银花净选,备用;
2)取步骤1)中当归片0.55kg、川芎片0.35kg混匀,蒸馏提取挥发油,所得挥发油加入γ-环糊精,制成γ-环糊精包合物,备用;蒸馏后的水溶液另器贮存,备用;蒸馏后所得药渣Ⅰ,备用;
3)取步骤1)中葛根片0.55kg、丹参段0.5kg、红花0.3kg混匀,用75%乙醇回流提取2次,每次2小时,滤过,滤液合并,减压回收乙醇并浓缩成50-70℃时相对密度为1.20的浸膏Ⅰ,备用;提取后所得药渣Ⅱ,备用;
4)取步骤1)中黄芪片0.9kg、生地黄片1.0kg、玄参片0.60kg、牛膝段0.45kg、金银花0.5kg、鸡血藤片0.55kg、甘草段0.35kg共7味药材饮片与步骤2)所得药渣Ⅰ、步骤3)所得药渣Ⅱ混匀,加水煎煮2次,每次1.5小时,合并两次煎煮液,备用;
5)将步骤4)所得煎煮液、步骤2)所得蒸馏后的水溶液合并,滤过,滤液浓缩成50-70℃时相对密度为1.14的清膏,加入95%乙醇使含醇量达80%,搅匀,冷沉24小时,滤过,滤液减压回收乙醇并浓缩成浸膏Ⅱ,备用;
6)将步骤3)所得浸膏Ⅰ、步骤5)所得浸膏Ⅱ合并,混匀,得浸膏Ⅲ,备用;
7)取步骤6)所得浸膏Ⅲ、步骤2)所得γ-环糊精包合物混合,入配方量的蔗糖粉、糊精(重量比5:1),混匀,70℃以下干燥,粉碎成细粉,加入2.5%低取代羟丙基纤维素,混匀,用水泛制成丸1000粒,70℃以下干燥,打光,包衣,即得。
Claims (10)
1.一种治疗糖尿病周围神经病变的中药组合物,其特征在于,该组合物是由包含黄芪、生地黄、当归、葛根、玄参、川芎、丹参、红花、牛膝、金银花、鸡血藤、甘草的中药原料制成。
5.一种中药口服固体制剂,其特征在于,含有如权利要求1-4中任一项所述的中药组合物;优选的,所述中药口服固体制剂为片剂、丸剂、胶囊剂或颗粒剂。
6.一种权利要求5所述的中药口服固体制剂的制备方法,其特征在于,包括以下步骤:
1)取黄芪、生地黄、当归、葛根、玄参、川芎、丹参、红花、牛膝、金银花、鸡血藤和甘草12种原料药材,其中黄芪、生地黄、当归、葛根、玄参、川芎、鸡血藤切片,备用;丹参、牛膝、甘草切段,备用;红花、金银花净选,备用;
2)取步骤1)所得当归片、川芎片混匀,蒸馏提取挥发油,所得挥发油加入环糊精,制成环糊精包合物,备用;蒸馏后的水溶液另器贮存,备用;蒸馏后所得药渣Ⅰ,备用;
3)取步骤1)中所得葛根片、丹参段、红花混匀,乙醇回流提取,提取液滤过,减压回收乙醇并浓缩成浸膏Ⅰ,备用;提取后所得药渣Ⅱ,备用;
4)将步骤2)中所得药渣Ⅰ、步骤3)中所得药渣Ⅱ与步骤1)中剩余黄芪片、生地黄片、玄参片、鸡血藤片、牛膝段、甘草段、金银花7味药材饮片混匀,加水煎煮,煎煮液备用;
5)将步骤4)中所得煎煮液及步骤2)中所得蒸馏后的水溶液合并,滤过,滤液浓缩成清膏,加入乙醇,调整含醇量,搅匀,冷沉,滤过,滤液减压回收乙醇并浓缩成浸膏Ⅱ,备用;
6)将步骤3)所得浸膏Ⅰ和步骤5)所得浸膏Ⅱ合并,混匀,得浸膏Ⅲ,备用;
7)将步骤6)所得浸膏Ⅲ和步骤2)中所得环糊精包合物混合,加入常规辅料,制成片剂、丸剂、胶囊剂或颗粒剂。
7.根据权利要求6所述的制备方法,其特征在于,步骤3)的具体操作为:取步骤1)中所得葛根片、丹参段、红花混匀,用60%-80%乙醇回流提取2次,每次2小时,提取液滤过,滤液合并,减压回收乙醇并浓缩成50-70℃时相对密度为1.15-1.35的浸膏Ⅰ,备用;提取后所得药渣Ⅱ备用。
8.根据权利要求6所述的制备方法,其特征在于,步骤4)的具体操作为:将步骤2)中所得药渣Ⅰ、步骤3)中所得药渣Ⅱ与步骤1)中剩余黄芪片、生地黄片、玄参片、鸡血藤片、牛膝段、甘草段、金银花7味药材饮片混匀,加水煎煮2次,合并两次煎煮液,备用。
9.根据权利要求6所述的制备方法,其特征在于,步骤5)的具体操作为:将步骤4)中所得煎煮液及步骤2)中所得蒸馏后的水溶液合并,滤过,滤液浓缩成50-70℃时相对密度为1.10-1.20的清膏,加入95%乙醇使含醇量达50%-80%,搅匀,冷沉12-48小时,滤过,滤液减压回收乙醇并浓缩成浸膏Ⅱ,备用。
10.根据权利要求6所述的制备方法,其特征在于,步骤2)中所加入的环糊精为β-环糊精、羟丙基-β-环糊精或γ-环糊精中的一种或多种。
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