CN106620475B - 一种防治糖尿病认知障碍的中药组合物及制备方法 - Google Patents
一种防治糖尿病认知障碍的中药组合物及制备方法 Download PDFInfo
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Abstract
本发明涉及一种防治糖尿病认知障碍的中药组合物及其制备方法,原料药组成为:黄芪20‑26份、制何首乌8‑11份、盐益智仁8‑11份、淫羊藿8‑11份、雄蚕蛾4‑7份、熟地8‑10份、丹参13‑17份、制远志2‑5份、黄连1‑3份。制备方法包括以下步骤:(1)将盐益智仁蒸馏提取挥发油;(2)将制何首乌、黄连用乙醇回流提取;(3)将雄蚕蛾、丹参用乙醇回流提取;(4)将黄芪、淫羊藿、熟地、制远志原料药及步骤(2)药渣,煎煮;(5)水液合并浓缩,加入醇提浓缩液,再次浓缩得稠膏;(6)加入可溶性淀粉,制成颗粒,干燥,喷入盐益智仁挥发油,混匀,密闭放置。经药理实验证明,本发明组方合理,功效显著,疗效确切,具有明显的降血糖和改善2型糖尿病导致的认知障碍的作用。
Description
技术领域
本发明涉及一种防治糖尿病认知障碍的中药组合物及其制备方法和应用。属于中药技术及中医治疗领域。
背景技术
糖尿病是一种以高血糖为特征的代谢紊乱综合征,发病率正逐年攀升。2013年国际糖尿病联盟研究统计,全球糖尿病在20~79岁成人中患病率为8.3%,患者人数达3.82亿;中国糖尿病患病人数为9840万,患病率居全球首位。随着糖尿病发病人数逐年增多,其导致的认知障碍成为备受关注的问题。认知障碍指与学习记忆以及思维判断有关的大脑高级智能加工过程出现异常,从而引起严重学习、记忆障碍,同时伴有失语或失用或失认或失行等改变的病理过程。
医学专家认为糖尿病患者发生认知障碍的风险是同龄非糖尿病患者的3倍,亦为诱发阿尔茨海默病的重要独立危险因素。这不仅影响患者生活质量,还给患者家庭和社会带来沉重负担,已成为全球面临的严重社会问题。
糖尿病认知功能障碍属获得性认知行为缺陷为特征的糖尿病慢性并发症,对糖尿病认知功能障碍的防治是当今医学界面临的重要课题。西医主要治疗方法是在控制血糖基础上,辅以改善脑细胞功能的药物。目前临床使用的药物包括乙酰胆碱酯酶抑制剂多奈哌齐、二氢麦角碱、吡拉西坦等改善学习记忆的药物,以及依那普利、尼莫地平等改善脑血管药物;部分药物如蛋白或多肽类等,受血脑屏障的限制,目前仅处于动物实验研究阶段,尚未用于临床。总体看来西医现有药物对改善糖尿病认知功能障碍的临床症状和提高生活质量依然有限。因此发挥中医药特色优势,对防治糖尿病认知功能障碍有着重要价值和意义。
糖尿病认知功能障碍属中医“健忘”、“呆证”、“文痴”等的范畴,为糖尿病慢性并发症。一般认为本病的主要病机为消渴日久导致肾精亏损,脑髓失养,出现“脑髓渐空”,导致智能下降。辨证多为髓海不足、心脾两虚、肾虚血瘀、痰浊阻窍,论治以补肾益精、充养髓海,补养心脾,补肾活血,燥湿祛痰等;中药复方治疗具有多渠道、多靶点作用优势,但多在试验探讨阶段,尚未见药物面市。
发明内容
本发明的目的是提供一种防治糖尿病认知障碍的中药组合物,该组合物具有很好的健脾益肾,养血活血,填精益智功效,适用于糖尿病认知障碍患者,中医辨证属脾肾亏损,精血亏虚,瘀血阻络,脑髓失养者。
制备方法
本发明是通过以下技术方案实现的:
本发明涉及一种治疗糖尿病的中药组合物,原料药组成:黄芪20~26重量份、制何首乌8~11重量份、盐益智仁8~11重量份、淫羊藿8~11重量份、雄蚕蛾4~7重量份、熟地8~10重量份、丹参13~17重量份、制远志2~5重量份、黄连1~3重量份。
上述的中药组合物,优选配方为,原料药组成:黄芪24重量份、制何首乌10重量份、盐益智仁10重量份、淫羊藿10重量份、雄蚕蛾6重量份、熟地9重量份、丹参15重量份、制远志3重量份、黄连2重量份。
上述的中药组合物,优选的,所述制何首乌是将何首乌饮片破碎为0.5厘米的小块,所述盐益智仁是将益智仁饮片破碎至露白,所述制远志是将远志饮片破碎为0.5厘米的小段。
上述中药组合物,优选剂型为颗粒剂。
上述中药组合物的制备方法,包括以下步骤:
(1)将盐益智仁蒸馏提取挥发油,蒸馏后的水液收集;
(2)将制何首乌、黄连用乙醇回流提取,得浓缩液及药渣;
(3)将雄蚕蛾、丹参用乙醇回流提取,得浓缩液;
(4)将黄芪、淫羊藿、熟地、制远志原料药及步骤(2)药渣,加水浸泡,煎煮两次,滤过,合并滤液得水煎液;
(5)将步骤(4)所得的水煎液与步骤(1)水液合并,浓缩,加入步骤(2)(3)的醇提浓缩液,再次浓缩得稠膏。
(6)将步骤(5)所得的稠膏,加入可溶性淀粉,制成颗粒,干燥,喷入盐益智仁挥发油,混匀,密闭放置。
上述的制备方法,优选的,步骤(1)中蒸馏提取时间为5h。
上述的制备方法,优选的,步骤(2)乙醇溶液的体积百分比浓度为60%,回流提取3次,3次加入的乙醇溶液质量分别为制何首乌、黄连质量和的4、3、3倍,每次2小时。
上述的制备方法,优选的,步骤(3)乙醇溶液的体积百分比浓度为50%,回流提取3次,3次加入的乙醇溶液质量分别为雄蚕蛾、丹参质量和的5、3、3倍,每次70分钟。
上述的制备方法,优选的,步骤(5)第一次煎煮加入黄芪、淫羊藿、熟地、制远志原料药与步骤(2)药渣质量和的8倍量水,浸泡1小时,煎煮160分钟,第二次煎煮加入6倍量水,煎煮160分钟。
上述的制备方法,优选的,步骤(5)第一次浓缩至相对密度为1.18~1.22,第二次浓缩至相对密度为1.30~1.33。
发明人经过大量的研究和试验,得出了本发明组成的配方,通过各原料的配伍协同作用,有着很好的功效,各原料性味归经及功效如下:
黄芪, 性味甘,微温。归肺、脾经。具有补气升阳,固表止汗,利水消肿,生津养血,行滞通痹,托毒排脓,敛疮生肌功效。用于气虚乏力,食少便溏,中气下陷,久泻脱肛,便血崩漏,表虚自汗,气虚水肿,内热消渴,血虚萎黄,半身不遂,痹痛麻木,痈疽难溃,久溃不敛。
制何首乌, 性味苦、甘、涩,微温。归肝、心、肾经。具有补肝肾,益精血,乌须发,强筋骨,化浊降脂功效。用于血虚萎黄,眩晕耳鸣,须发早白,腰膝酸软,肢体麻木,崩漏带下,高脂血症。
黄芪、制何首乌配伍,脾肾双补,黄芪重在补脾气,首乌重在补肾精,二药合用,双补脾肾,益气养血,以养脑髓。
盐益智仁, 性味辛,温。归脾、肾经。具有暖肾固精缩尿,温脾止泻摄唾功效。用于肾虚遗尿,小便频数,遗精白浊,脾寒泄泻,腹中冷痛,口多唾涎。
淫羊藿, 性味辛、甘,温。归肝、肾经。具有补肾阳,强筋骨,祛风湿功效。用于肾阳虚衰,阳痿遗精,筋骨痿软,风湿痹痛,麻木拘挛。
雄蚕蛾, 性味咸、温。具有补益肝肾,壮阳涩精,止血生肌功效。用于阳痿、遗精、血浊、尿血。
熟地, 性昧甘,微温。归肝、肾经。具有补血滋明,益精填髓功效。用于血虚萎黄,心悸怔忡,月经不调,崩漏下血,肝肾阴虛,腰膝酸软,骨蒸潮热,盗汗遗精,内热消渴,眩晕,耳鸣,须发早白。
丹参, 性味苦,微寒。归心、肝经。具有活血祛瘀,通经止痛,清心除烦,凉血消痈功效。用于胸痹心痛,脘腹胁痛,癥瘕积聚,热痹疼痛,心烦不眠,月经不调,痛经经闭,疮瘍肿痛。
制远志, 性味苦、辛,温。归心、肾、肺经。具有安神益智,交通心肾,祛痰,消肿功效。用于心肾不交引起的失眠多梦、健忘惊悸、神志恍惚,咳痰不爽,疮疡肿毒,乳房肿痛。
黄连, 性味苦,寒。归心、脾、胃、肝、胆、大肠经。具有清热燥湿,泻火解毒功效。用于湿热痞满,呕吐吞酸,泻痢,黄疸,高热神昏,心火亢盛,心烦不寐,心悸不宁,血热吐魈,目赤,牙痛,消渴,痈肿疔疮。
本发明人通过长期对本病的临床研究认为,糖尿病认知障碍症的发生中医主要责之于脾肾。脾为后天之本,肾为先天之本。脾之健运,化生精微,须借助于肾阳的推动,故有“脾阳根于肾阳”之说。肾中精气亦有赖于水谷精微的培育和补养,才能不断充盈和成熟。因此脾与肾在生理上是后天与先天的关系,它们是相互资助,相互促进。在生理上亦相互影响,互为因果。人至中年脾肾逐渐亏虚,脾肾亏虚,代谢紊乱,易发消渴病,消渴病日久导致脾肾更虚,脾虚失运,气血生化乏源,不能滋养肾精,肾精亏损,脑髓失养,出现“脑髓渐空”,导致智能下降而发呆证。正如《素问•五脏生成》说:“肾为先天之根,封藏之本,藏精生髓。髓乃肾精所化。”《医学心悟》说:“肾主智,肾虚则智不足,善忘其前言。” 消渴日久,肾气虚损,气不生精,肾精匮乏,髓海失充,元神失养。或者肾气日衰,温煦推动无力,水液精津不能蒸腾气化,则脑髓空虚,神机失用。故本病的主要病机为肾精亏虚、脑髓失养;辨证为脾肾亏损,精血亏虚,瘀血阻络,脑髓失养;治宜健脾益肾、养血活血、填精益智。经多年反复临床验证,组成纯中药复方,研制成本发明的“芪智消渴颗粒”,用于糖尿病认知障碍症的防治,安全有效。
功效:健脾益肾,养血活血,填精益智。
主治:适用于糖尿病认知障碍患者。
适应症:糖尿病认知障碍者,中医辨证属脾肾亏损,精血亏虚,瘀血阻络,脑髓失养。
本发明的有益成果是:
经药理实验证明, 本发明组方合理,效果显著,疗效确切,具有明显的降血糖和改善2型糖尿病导致的认知障碍的作用。
本发明生产工艺简单、生产成本低,同时本颗粒剂具有快速溶解吸收,口感好,特别适合该类病症的患者,该剂型不易结块,具有长期保存的优势。
附图说明
图1 为芪智消渴颗粒对2型糖尿病小鼠乙醇致记忆再现障碍模型记忆潜伏期的时效关系。
图2为芪智消渴颗粒对2型糖尿病小鼠乙醇致记忆再现障碍模型错误次数的时效关系。
图3 为芪智消渴颗粒对乙醇所致小鼠记忆再现障碍模型记忆潜伏期的时效关系。
图4为芪智消渴颗粒对乙醇所致小鼠记忆再现障碍模型错误次数的时效关系。
具体实施方式
实施例
1、辅料质量标准
可溶性淀粉(Soluble Starch):本品系淀粉通过酶或酸水解等方法加工,改善其在水中溶解度而制得。本品为白色或类白色粉末。其质量应符合《中国药典》2015年版四部第494页可溶性淀粉项下有关的各项规定。
2、药物的前处理
(一)制何首乌:将市售饮片破碎为0.5厘米的小块,备用。
(二)盐益智仁:将市售饮片适度破碎至露白,备用。
(三)制远志:将市售饮片破碎为0.5厘米的小段,备用。
3、配方和制备方法
(1)按处方比例分别称取黄芪144g、何首乌60g、益智仁60g、淫羊藿60g、雄蚕蛾36g、熟地54g、丹参90g、远志18g、黄连12g。将何首乌破碎为0.5厘米的小块得制何首乌。将益智仁破碎至露白得盐益智仁。将远志破碎为0.5厘米的小段得制远志。
(2)将盐益智仁加水600mL,浸泡1小时,蒸馏提取挥发油5小时,蒸馏后的水液收集。
(3)将制何首乌、黄连加入体积百分比浓度为60%乙醇溶液,90℃以下加热回流提取3次,3次加入的乙醇溶液的质量分别为:288g、216g、216g,每次2小时,滤过,滤液90℃以下回收乙醇,得浓缩液及药渣。
(4)将雄蚕蛾、丹参加入体积百分比浓度为50%乙醇溶液,90℃以下加热回流,流提取3次,3次加入的乙醇溶液的质量分别为:630g、378g、378g,每次70分钟,滤过,滤液90℃以下回收乙醇,得浓缩液。
(5)将黄芪、淫羊藿、熟地、制远志原料药及步骤(2)药渣,加入8倍量水,浸泡1小时,煎煮160分钟,滤过,药渣再加入6倍量水,煎煮160分钟,滤过,合并滤液得水煎液。
(6)将步骤(5)的水煎液与步骤(2)蒸馏后的水液合并,浓缩至相对密度为1.18~1.22(60℃),加入步骤(3)(4)醇提浓缩液,再次浓缩至相对密度为1.30~1.33(60℃)得稠膏。
(7)取步骤(6)所得的稠膏,加入790g可溶性淀粉,制成颗粒,干燥,喷入盐益智仁挥发油,混匀,密闭放置24小时,即得治疗糖尿病的中药颗粒。
4、用法与用量
用法用量:温开水冲服。一次10克(10g),一日3次;或遵医嘱。
规格:10g/袋
贮藏:密封。
测试例 药效学实验
1 实验材料
1.1 实验动物 昆明小鼠,SPF级,体质量18-22g,雌雄各半,济南朋悦实验动物繁育有限公司提供,许可证号:SCXK(鲁)20140007,编号:No.37009200002699。
1.2 药物与试剂 实施例提供的中药颗粒(芪智消渴颗粒),山东省中医药研究院制剂室提供;健脑丸,批号:141010,青岛国风药业股份有限公司。
1.3 主要试剂 链脲佐菌素(STZ),货号:S0130,柠檬酸三钠二水、柠檬酸一水,均购于美国 sigma 公司;高糖高脂饲料,由北京科澳协力饲料有限公司提供,许可证号:SCXK(京)2014-0010;无水乙醇(AR),天津市富宇精细化工有限公司;怡成虹吸式血糖试条,北京怡成生物电子技术有限公司生产。
1.4 仪器 YLS-3T型跳台记录仪,山东医学科学院设备供应维修站;PL303电子天平,梅特勒 - 托利多仪器( 上海) 有限公司;JPS -5 型手持式快速全血葡萄糖测试仪,北京怡成生物电子技术有限公司。
2 方法与结果
2.1 动物分组与给药
小鼠按体质量随机分为空白对照组、模型对照组、阳性对照组、芪智消渴颗粒低、中、高剂量组。阳性对照组灌胃给予健脑丸4.39g/kg,芪智消渴颗粒低、中、高剂量组分别灌胃给予芪智消渴颗粒4.5g/kg、18g/kg、36g/kg,空白对照组和模型对照组灌胃给予等体积蒸馏水,每日灌胃给药一次,连续给药16w。
2.2 诱发构建2型糖尿病小鼠模型
各组动物预防性给药2w后,采用高糖高脂饲料结合STZ 诱发建立小鼠2型糖尿病模型,除空白对照组喂养普通饲料外,其余各组小鼠喂养高糖高脂饲料,高糖高脂饲料共喂养14 w。在高糖高脂饲料喂养第4w(28d)时,各组小鼠禁食不禁水16 h,次日空白对照组腹腔注射柠檬酸缓冲液,其余各组小鼠腹腔注射1% STZ 溶液100 mg/kg,该试验操作流程需要在冰浴上进行,并确保注射过程在 15 min 内完成。
2.3 芪智消渴颗粒对2型糖尿病小鼠空腹血糖的影响
分别于给药第7w、8w、10w、12w时(即造模后1w、2w、4w、6w),禁食不禁水12 h,尾静脉取血,采用怡成虹吸式血糖试条测量小鼠空腹血糖。实验结果见表1。
*P<0.05,**P<0.01,***P<0.001 与空白对照组比较
△P<0.05,△△P<0.01 与模型对照组比较
高糖高脂饲料联合STZ注射制造2型糖尿病模型,在给药第7w、8w、10w、12w时(即造模后1w、2w、4w、6w)检测小鼠空腹血糖。由表1结果显示,模型对照组小鼠空腹血糖均显著升高,与空白对照组比较具有显著性差异;与模型对照组相比芪智消渴颗粒在给药7w、8w、10w、12w时(即造模后1w、2w、4w、6w)具有明显的降血糖作用。
2.4 芪智消渴颗粒对2型糖尿病模型小鼠乙醇致记忆再现障碍行为学的影响
制造小鼠2型糖尿病模型,分别在给药第11w和14w时,模型对照组和各给药组小鼠在给药1h后,跳台训练5min;训练后24h,测试前20min按10ml/kg灌胃40%乙醇,空白对照组灌胃给予等体积蒸馏水,进行跳台测试,记录5min内各鼠第一次跳下平台的潜伏期和5min的错误次数。实验结果见表2、表3。
*P<0.05 与空白对照组比较
△P<0.05 与模型对照组比较
表2结果显示:与空白对照组比较,模型对照组小鼠记忆再现错误次数明显增多,记忆潜伏期具有缩短趋势;与模型对照组比较,芪智消渴颗粒高剂量组小鼠记忆再现潜伏期明显延长,错误次数明显减少。实验结果说明芪智消渴颗粒对2型糖尿病模型小鼠乙醇所致记忆再现障碍具有一定的改善作用。
*P<0.05 与空白对照组比较
△P<0.05,△△P<0.01 与模型对照组比较
表3结果显示:与空白对照组比较,模型对照组小鼠记忆再现潜伏期明显缩短,错误次数具有增多的趋势;与模型对照组相比,芪智消渴颗粒中、高剂量组小鼠记忆再现潜伏期明显延长,错误次数明显减少。实验结果说明芪智消渴颗粒对乙醇所致记忆再现障碍具有一定的改善作用。
2.5 芪智消渴颗粒对乙醇所致小鼠记忆再现障碍行为学的影响
小鼠按体质量随机分为空白对照组、模型对照组、阳性对照组、芪智消渴颗粒低、中、高剂量组。阳性对照组灌胃给予健脑丸4.39g/kg,芪智消渴颗粒低、中、高剂量组分别灌胃给予芪智消渴颗粒4.5g/kg、18g/kg、36g/kg;空白对照组和模型对照组灌胃给予等体积蒸馏水。在给药第4w、8w、11w、14w时,试验日各组小鼠灌胃给药1h后进行跳台实验。测试前20min按10ml/kg灌胃40%乙醇,空白对照组灌胃给予等体积蒸馏水,进行跳台测试,记录5min内各鼠第一次跳下平台的记忆潜伏期和5min的错误次数。实验结果见表4-表7。
**P<0.01,***P<0.001 与空白对照组比较
***P<0.001 与空白对照组比较
△P<0.05,△△P<0.01 与模型对照组比较
由表5结果说明,与空白对照组比较,模型对照组小鼠记忆再现潜伏期明显缩短,错误次数明显增多,说明造模成功。与模型对照组比较,给药8w芪智消渴颗粒高剂量组小鼠记忆再现潜伏期明显延长,错误次数明显减少。实验结果说明芪智消渴颗粒对乙醇所致记忆再现障碍具有一定的改善作用。
**P<0.01 与空白对照组比较
由表6结果说明,与空白对照组比较,模型对照组小鼠记忆再现潜伏期明显缩短,错误次数明显增多,说明造模成功。与模型对照组比较,给药11w芪智消渴颗粒高剂量组小鼠记忆再现潜伏期及错误次数虽未见统计学差异,但具有一定的作用趋势。
*P<0.05,***P<0.001 与空白对照组比较
△P<0.05,△△P<0.01,△△△P<0.001 与模型对照组比较
由表7结果说明,与空白对照组比较,模型对照组小鼠记忆再现记忆潜伏期明显缩短,错误次数明显增多,说明造模成功。与模型对照组比较,给药14w芪智消渴颗粒高剂量组小鼠记忆再现潜伏期明显延长,错误次数明显减少;中剂量组小鼠错误次数明显减少。实验结果说明芪智消渴颗粒对乙醇所致记忆再现障碍具有一定的改善作用。
3 小结
综述以上试验结果说明:
1、芪智消渴颗粒对构建2型糖尿病模型小鼠有明显的降血糖作用。
2、芪智消渴颗粒能改善复合法致2型糖尿病认知障碍小鼠模型的学习记忆,该作用强度与用药剂量-时间-效应呈明显正相关。试验结果说明:芪智消渴颗粒具有提高2型糖尿病合并认知障碍小鼠学习与记忆能力。
3、芪智消渴颗粒具有明显改善乙醇所致小鼠记忆再现障碍的作用,该作用与剂量-时间-效应呈正相关。试验结果说明:芪智消渴颗粒对小鼠学习记忆再现有一定促进作用。
Claims (5)
1.一种防治糖尿病认知障碍的中药组合物,其特征在于,原料药组成:黄芪20~26重量份、制何首乌8~11重量份、盐益智仁8~11重量份、淫羊藿8~11重量份、雄蚕蛾4~7重量份、熟地8~10重量份、丹参13~17重量份、制远志2~5重量份、黄连1~3重量份。
2.根据权利要求1所述的中药组合物,其特征在于,原料药组成:黄芪24重量份、制何首乌10重量份、盐益智仁10重量份、淫羊藿10重量份、雄蚕蛾6重量份、熟地9重量份、丹参15重量份、制远志3重量份、黄连2重量份。
3.根据权利要求1或2所述的中药组合物,其特征在于,所述制何首乌是将何首乌饮片破碎为0.5厘米的小块,所述盐益智仁是将益智仁饮片破碎至露白,所述制远志是将远志饮片破碎为0.5厘米的小段。
4.根据权利要求3所述的中药组合物,其特征在于,剂型为颗粒剂。
5.一种如权利要求4所述中药组合物的制备方法,其特征在于,包括以下步骤:
(1)将盐益智仁蒸馏提取挥发油,蒸馏后的水液收集;所述步骤中,蒸馏提取时间为5h;
(2)将制何首乌、黄连用乙醇回流提取,得浓缩液及药渣;所述步骤中,乙醇溶液的体积百分比浓度为 60%,回流提取3次,3次加入的乙醇溶液质量分别为制何首乌、黄连质量和的4、3、3倍,每次2 小时;
(3)将雄蚕蛾、丹参用乙醇回流提取,得浓缩液;所述步骤中,乙醇溶液的体积百分比浓度为50%,回流提取3次,3次加入的乙醇溶液质量分别为雄蚕蛾、丹参质量和的5、3、3 倍,每次70分钟;
(4)将黄芪、淫羊藿、熟地、制远志原料药及步骤(2)药渣,加水浸泡,煎煮两次,滤过,合并滤液得水煎液;
(5)将步骤(4)所得的水煎液与步骤(1)水液合并,浓缩,加入步骤(2)(3)的醇提浓缩液,再次浓缩得稠膏;所述步骤中,第一次煎煮加入黄芪、淫羊藿、熟地、制远志原料药与步骤(2)药渣质量和的8倍量水,浸泡1小时,煎煮160分钟,第二次煎煮加入6倍量水,煎煮160分钟; 所述步骤中,第一次浓缩至相对密度为1.18 ~1.22,第二次浓缩至相对密度为1.30~1.33;
(6)将步骤(5)所得的稠膏,加入可溶性淀粉,制成颗粒,干燥,喷入盐益智仁挥发油,混匀,密闭放置。
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