CN114010736B - 中药组合物在制备改善非酒精性脂肪肝引起的焦虑抑郁失眠的药物中的应用 - Google Patents
中药组合物在制备改善非酒精性脂肪肝引起的焦虑抑郁失眠的药物中的应用 Download PDFInfo
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Abstract
本发明涉及一种调摄焦虑抑郁失眠症的中药组合物及其制备方法。受职业和工作环境特殊性的影响,多数飞行官兵易出现焦虑、抑郁、失眠等情志问题,没有特效的针对性治疗方法。本发明基于“肝-脑-肠轴”理论,为调摄焦虑抑郁失眠症提供了药食同源的药物,包含玉竹、桑葚、黄精、薏仁、酸枣仁、枳椇子、栀子,能有效改善肝细胞炎症状态,抑制肝损伤模型的肝组织细胞凋亡,通过保肝护肝,舒肝整肠,调节肝的不良状态来改善人们的焦虑抑郁失眠症状,维护身体健康。
Description
技术领域
本发明涉及一种药物组合物,具体涉及一种调摄焦虑抑郁失眠症的中药组合物及其制备方法。
背景技术
据调查显示,美国军队军人失眠率达22.7%,我军飞行员失眠率达18.1%,因睡眠不足、疲劳征象所引发的飞行事故约占事故总数的10%以上。飞行人员作为特殊人群,由于职业和工作环境的特殊性,如飞行训练强度高,体力消耗大,飞行前及飞行中长时间处于精神高度紧张、机体高负荷状态,同时长期受加速度、低气压、缺氧、辐射、振动和噪声等因素的影响,多数官兵易出现焦虑、抑郁、失眠等情志问题。
中医辨证认为,肝主情志,藏魂。肝乃六郁之首,喜、怒、忧、思、悲、恐、惊,对情志变化影响大。百病皆生于气,若肝气亢奋,肝疏泄失调时,可见失眠、多梦等证。Toshiaki研究显示“肝-脑-肠轴”(Brain-gut-liver axis),即中枢神经系统与外周肠功能、肝脏功能之间的相互作用。肝脏迷走神经感觉传入负责间接感知肠道微环境,并将感觉输入中转到脑干的束缚核,并最终传递到迷走副交感神经和肠道神经元,为此精神不畅加之神经内分泌失调,极易导致出现肠腑病、脂肪肝、不寐症等疾病。
因此基于“肝-脑-肠轴”(Brain-gut-liver axis)理论,具有除烦安神、健脾整肠、补益肝肾等作用的中药制剂占有举足轻重的地位。中国专利CN112057542A公开发布了一种治疗失眠、焦虑、抑郁和更年期综合征的中药组合物及其制备方法,此中药组合物主要由山萸肉、五味子、酸枣仁、白芍、地黄、莲子心、牡丹皮等组成;中国专利CN108159155A公布了一种治疗焦虑失眠的中药组方,组方包括柴胡、生白芍、木香、当归、炒栀子、酸枣仁、白术、黄芩等;中国专利CN106110089A公开发布了一种治疗焦虑、失眠的中药组合物及其制备方法,该复方主要由生枣仁、茯神、远志、佛手、丹皮、杏仁、柏子仁等组成。然而,是药三分毒,现有的多数缓郁病,改善睡眠的中药方剂具有一定毒副作用,且药效作用靶位单一,且不可长期使用。显然,寻找无毒无害、服用简便的舒肝整肠,解郁,改善睡眠的“药食合一”产品,对特殊环境中官兵的健康维护有前瞻性意义。
发明内容
本发明的目的是提供一种调摄焦虑抑郁失眠症的中药组合物及其制备方法,该药物可用于调肝缓郁、改善睡眠,无毒无害,“药食合一”,服用简便。
为了达到上述目的,本发明所采用的技术方案为:
调摄焦虑抑郁失眠症的中药组合物,其特征在于:
所述中药组合物包含以下重量份的组分:
玉竹5-15份;
桑葚10-20份;
黄精10-20份;
薏仁25-35份;
酸枣仁10-20份;
枳椇子10-20份;
栀子10-14份。
所述中药组合物包含以下重量份的组分:
玉竹10份;
桑葚15份;
黄精15份;
薏仁30份;
酸枣仁15份;
枳椇子15份;
栀子12份。
所述中药组合物的剂型为颗粒剂或膏剂。
如所述的调摄焦虑抑郁失眠症的中药组合物的制备方法,其特征在于:
所述中药组合物颗粒剂的制备方法包括以下步骤:
第一步:提取玉竹、桑葚、黄精、薏仁、酸枣仁、枳椇子和栀子的复方水提物,制成粗粉。
第二步:将辅料和第二步获得的粗粉混合,加入酒精制成软材,制粒干燥过筛,获得颗粒剂。
所述第一步具体为:
将玉竹、桑葚、黄精、薏仁、酸枣仁、枳椇子、栀子剪碎后浸泡3h,加水煎煮两次,每次1.5h,合并药液,醇沉后过滤,浓缩至清膏,常压干燥,得到复方水提物,制成粗粉。
所述第二步中,软材的制备过程具体为:
以药辅质量比1:1.5的比例,将辅料与粗粉混合,加入浓度为85%的酒精制成软材。
所述第二步中,辅料为糊精:乳糖的混合物,质量混合比为4:1。
所述第二步中,制粒干燥过筛的过程具体为:
将软材通过12目筛网进行制粒,后进行干燥;将干燥好的颗粒经一号筛筛除粗大颗粒,经五号筛筛除细粉,获得颗粒剂。
如所述的调摄焦虑抑郁失眠症的中药组合物的制备方法,其特征在于:
所述中药组合物膏剂的制备方法包括以下步骤:
第一步:将玉竹、桑葚、黄精、薏仁、酸枣仁、枳椇子、栀子饮片放入陶瓷缸中,加水没过饮片3cm,浸泡8h;
第二步:将充分浸泡的药材放入锅中,加水煎煮3次,每次1.5h;煎煮完成后充分挤压药渣,过滤后合并药液;
第三步:将药液置锅中加热,煮沸后用文火浓缩;在浓缩过程中充分搅拌,不断撇去浮沫,直至药液浓缩至稠厚状成清膏;
第四步:将清膏继续搅拌浓缩,同时加入炼蜜,不停搅拌,使之均匀混合,直到成膏;蜜含量为30%。
与现有技术相比,本发明的有益效果如下:
本发明优选药食同源的中药材,纯天然、安全无毒,可长期服用。玉竹为君药,具有养阴润燥,生津止渴,清肝明目的作用;黄精补气养阴润肺,健脾益肾;桑椹、黄精、薏仁三药合用能健脾益气,兼以补益肝肾,为臣药;酸枣仁、枳椇子、栀子等共起养心安神,清肝除烦的作用,为佐使药。
本发明的复方补益肝肾,健脾益气,除烦安神;适应症为烦躁不安,纳少乏力,失眠多梦等肝肾不足,心脾两虚之证。经实验证明,能有效改善肝细胞炎症状态,抑制肝损伤模型的肝组织细胞凋亡,通过保肝护肝,舒肝整肠,调节肝的不良状态来改善人们的焦虑抑郁失眠症状,维护身体健康。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本发明的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他实施例的附图。
图1是降低药物性肝损伤小鼠模型谷草转氨酶(AST)和谷丙转氨酶(ALT)活性、以及升高超氧化物歧化酶(SOD)的对比示意图。
图2是降低肝损伤小鼠Caspase-3、Caspase-9蛋白表达水平的对比示意图。
图3是中央静脉附近肝细胞坏死程度减轻且炎症细胞浸润程度减轻的对比示意图。
具体实施方式
为了便于理解本发明,下面将参照相关附图对本发明进行更全面的描述。附图中给出了本发明的较佳实施方式。但是,本发明可以以许多不同的形式来实现,并不限于本文所描述的实施方式。相反地,提供这些实施方式的目的是使对本发明的公开内容理解的更加透彻全面。
本发明提供了一种调摄焦虑抑郁失眠症的中药组合物,所述中药组合物包含以下重量份的组分:
玉竹5-15份;
桑葚10-20份;
黄精10-20份;
薏仁25-35份;
酸枣仁10-20份;
枳椇子10-20份;
栀子10-14份。
桑葚为桑科植物桑(Morus alba L.)的干燥果穗;玉竹为百合科植物玉竹(Polygonatum odoratum(Mill.)Druce)的干燥根茎;黄精为为百合科植物滇黄精(Polygonatum kingianum Coll.et Hemsl)的干燥根茎;薏仁为禾本科植物薏米(Coixlacryma-jobi L.var.ma-yuen(Roman.)Stapf)的干燥成熟种仁;酸枣仁为鼠李科植物酸枣(Ziziphus jujuba Mill.var.spinosa(Bunge)Hu ex H.F.Chou)的干燥成熟种子;枳椇子为鼠李科植物枳椇(Hovenia dulcis Thunb.)的干燥成熟种子;栀子为茜草科植物栀子(Gardenia jasminoides Ellis)的干燥成熟果实。
实施例1:所述中药组合物包含以下重量份的组分:
玉竹10份;
桑葚15份;
黄精15份;
薏仁30份;
酸枣仁15份;
枳椇子15份;
栀子12份。
实施例2:所述中药组合物包含以下重量份的组分:
玉竹5份;
桑葚20份;
黄精10份;
薏仁35份;
酸枣仁10份;
枳椇子20份;
栀子10份。
实施例3:所述中药组合物包含以下重量份的组分:
玉竹15份;
桑葚10份;
黄精20份;
薏仁25份;
酸枣仁20份;
枳椇子10份;
栀子14份。
所述中药组合物的剂型为颗粒剂或膏剂,优选颗粒剂。
所述颗粒剂为玉竹颗粒,制备方法包括以下步骤:
第一步:将玉竹、桑葚、黄精、薏仁、酸枣仁、枳椇子、栀子剪碎后浸泡3h,加水煎煮两次,每次1.5h,合并药液,醇沉后过滤,浓缩至清膏,常压干燥,得到复方水提物,制成粗粉。
第二步:以药辅质量比1:1.5的比例,将辅料与粗粉混合,加入浓度为85%的酒精制成软材。将软材通过12目筛网进行制粒,后进行干燥;将干燥好的颗粒经一号筛筛除粗大颗粒,经五号筛筛除细粉,获得颗粒剂。辅料为糊精:乳糖的混合物,质量混合比为4:1。
所述膏剂为桑玉膏,制备方法包括以下步骤:
第一步:将玉竹、桑葚、黄精、薏仁、酸枣仁、枳椇子、栀子饮片放入陶瓷缸中,加水没过饮片3cm,浸泡8h;
第二步:将充分浸泡的药材放入锅中,加水煎煮3次,每次1.5h;煎煮完成后充分挤压药渣,过滤后合并药液;
第三步:将药液置锅中加热,煮沸后用文火浓缩;在浓缩过程中充分搅拌,不断撇去浮沫,直至药液浓缩至稠厚状成清膏;
第四步:将清膏继续搅拌浓缩,同时加入炼蜜,不停搅拌,使之均匀混合,直到成膏;蜜含量为30%。
本发明基于经典名方《洪氏集验方》和现代中医新理论,依据《药食同源食品目录》2021版、《保健食品注册与备案管理办法》(2020年修订版)优选药食同源的中药材,研发纯天然、安全无毒、可长期服用,具有益脾养肝,疏肝行气,改善睡眠等功效的食品-桑玉颗粒(组方:玉竹,桑葚,黄精,薏仁,酸枣仁,枳椇子,栀子),通过保肝护肝,舒肝整肠,调节肝的不良状态来改善人们的焦虑抑郁失眠症状,维护身体健康。
本发明中药组合物中的各个组分,相辅相成,组成合理的配伍,不仅发挥了每个组分的经典功效,更发挥了组分间的协同作用。玉竹为君药,具有养阴润燥,生津止渴,清肝明目的作用;古代医家普遍认为黄精具有补气养阴润肺、健脾益肾的功效,是传统的养生保健佳品。《名医别录》中有对于黄精性、味、功效的记载,书中认为黄精“味甘、平,无毒,主补中益气,除风湿,安五脏,久服轻身、延年、不饥”,而《神农本草经疏》中对于黄精的功效有更深入的解读:“味厚气薄土位乎中,脾治中焦……故仙经累赘其能服饵驻颜,久而弥盛矣。桑椹、黄精、薏仁3药合用健脾益气,兼以补益肝肾,为臣药;酸枣仁、枳椇子、栀子等共起养心安神,清肝除烦的作用,为佐使药。此复方主要补益肝肾,健脾益气,除烦安神。适应症:烦躁不安,纳少乏力,失眠多梦等肝肾不足,心脾两虚之证。经实验表明,本发明能有效改善肝细胞炎症状态,抑制肝损伤模型的肝组织细胞凋亡,通过保肝护肝,舒肝整肠,调节肝的不良状态来改善人们的焦虑抑郁失眠症状,维护身体健康。
药理实验:
(1)建立免疫性肝损伤小鼠模型
将雄性SPF级ICR小鼠,体重18-22g,饲养于12h:12h昼夜循环交替动物室,室温20-24℃,湿度45-55度,自由饮食饮水,适应性生长7天后随机分为5组,分别为空白组(CON)、模型组(MOD)、治疗组(3剂量,低剂量组:MOD+L;中剂量组:MOD+M;高剂量组:MOD+H)。造模第一天,模型组和治疗各剂量组小鼠经尾静脉注射BCG 2.5mg/0.25ml/只致敏,正常组小鼠经尾静脉注射等量的生理盐水,3h后,治疗组用桑玉颗粒灌胃,正常组、模型组灌胃等量生理盐水,连续给药15d,末次给药后进食不进水,最后一次给药8h后,除正常组外,各组经尾静脉注射LPS7.5μg/0.2ml/只,诱导小鼠肝损伤。小鼠经尾注射LPS 16h后,眼眶取血后立断颈椎处死,剖腹取肝脏、脾脏,用4℃生理盐水冲洗,滤纸吸干,称重,按式计算肝脏、脾脏指数。小鼠取血后,分离血清备测;摘取肝脏后,肝脏右叶组织用4℃的生理盐水漂洗,除去血液与结缔组织、滤纸拭干,以1:9(w/v)的生理盐水制成肝匀浆。按试剂盒说明书方法分别测定血清中ALT、AST,肝组织中MDA、GSH、NO、蛋白质含量及SOD、GSH-Px酶活力。摘取的肝脏左叶组织用10%中性福尔马林固定,制作病理切片,HE染色,于光镜下观察肝组织切片的组织病理学变化。
(2)建立药物性肝损伤小鼠模型
将雄性SPF级KM小鼠,体重18-22g,饲养于12h:12h昼夜循环交替动物室,室温20-24℃,湿度45-55度,自由饮食饮水,适应性生长7天后随机分为5组,分别为空白组(CON)、模型组(MOD)、治疗组(3剂量,低剂量组:MOD+L;中剂量组:MOD+M;高剂量组:MOD+H)。禁食不禁水饲养12h,空白组给予等体积生理盐水,其他各组腹腔注射等体积对乙酰氨基酚(265mg·kg-1)建立急性肝损伤模型,测定ALT和AST含量,与正常组相比,升高则判定造模成功。造模成功后对各组小鼠进行治疗性给药,空白组与模型组给予同体积生理盐水,治疗组给予同体积相应浓度桑玉颗粒药物,每天2次,连续给药4d,末次给药后,禁食不禁水6h后摘取眼球取血,颈椎脱臼处死小鼠,迅速解剖分离肝脏,用生理盐水洗净后用滤纸吸干残余液体,称定质量计算脏器系数。将取得的血以3500r·min-1离心10min分离血清,检测血清中ALT、AST和ALP活性,使用ELISA法检测血清中THF-α、IL-6、IL-1β水平含量;取部分新鲜肝脏匀浆,离心得肝脏匀浆上清液,检测脂质过氧化物(LPO)、一氧化氮(NO)、一氧化氮合酶(NOS)、过氧化氢酶(CAT)、丙二醛(MDA)、谷胱甘肽过氧化物酶(GSH-PX)、微量还原性谷胱甘肽(GSH)、超氧化物歧化酶(SOD)、Na+K+-ATP酶、Mg2+-ATP酶、Ca2+-ATP酶活性以及总蛋白含量采用免疫;组织化学法检测Bax、Bcl-2蛋白的表达;采用Western blot检测Caspase-3、Caspase-9蛋白表达水平。用10%甲醛溶液固定左下叶肝脏组织,24h后采用石蜡包埋、切片、HE染色,在光学显微镜下观察肝脏组织病理学变化。
(3)建立非酒精性脂肪肝小鼠模型
SPF级雄性C57BL/6J小鼠,2-8周龄,体重(20±2)g,饲养于12h:12h昼夜循环交替动物室,室温20-24℃,湿度45-55度,自由饮食饮水,适应性生长7天后随机将小鼠分为5组,分别为空白组(CON)、模型组(MOD)、治疗组(3剂量,低剂量组:MOD+L;中剂量组:MOD+M;高剂量组:MOD+H)。空白组灌胃PBS,模型组灌胃等剂量肠内营养液(配方为10%蔗糖、10%猪油、3%鸡蛋黄、2%胆固醇、胆酸钠、0.5%丙硫氧嘧啶),灌胃开始后每周称量小鼠体重。第1周按0.01mL/g进行灌胃,第2周0.02mL/g,第3周起恢复正常剂量0.03mL/g,每天灌胃2次,持续16周。在第12、14、16周分别处死3只小鼠检测是否达到NAFLD脂变程度,期间所有小鼠均自由饮食。造模成功后开始对各组小鼠进行治疗性给药,空白组与模型组给予同体积生理盐水,治疗组给予同体积相应浓度药物,每天灌胃2次,连续4d。末次给药后禁食不禁水12h,进行眼球取血后断颈处死小鼠,完整分离肝脏和脾脏,用生理盐水洗净血水,滤纸擦干后称重,计算脏器系数并测定肝脏脂质,表1为桑玉颗粒对小鼠肝质量和肝指数的影响。
接着,对小鼠睡眠时间和睡眠潜伏期进行测定,结果如表2。
将采集的血液进行离心分离血清,检测甘油三酯(TG)、总胆固醇(TC)、谷丙转氨酶(ALT)、谷草转氨酶(AST)、高密度脂蛋白(HDL-C)和低密度脂蛋白(LDL-C)的含量,ELISA法测定肿瘤坏死因子-α(TNF-α)和白细胞介素-6(IL-6)的含量。
实验结果:
(1)与模型组相比,桑玉颗粒可以降低药物性肝损伤小鼠模型的谷草转氨酶(AST)和谷丙转氨酶(ALT)活性,升高超氧化物歧化酶(SOD)活性,改善肝细胞炎症状态(图1)。
(2)与模型组相比,桑玉颗粒可以降低肝损伤小鼠的Caspase-3、Caspase-9蛋白表达水平,说明桑玉颗粒能抑制肝损伤小鼠的肝组织细胞凋亡(图2)。
(3)肝组织病理切片显示,空白对照组小鼠肝小叶正常,肝细胞形态正常且肝细胞排列整齐致密,肝细胞索呈放射状排列在中央静脉周围;肝损伤小鼠模型组肝组织结构破坏,肝小叶结构不清晰,中央静脉附近有大量的肝细胞变性、肿胀坏死,且中央静脉附近有大量的炎性细胞浸润,部分肝细胞有明显的点状和灶状坏死;桑玉颗粒治疗组中央静脉附近肝细胞坏死程度减轻且炎症细胞浸润程度减轻(图3)。
以上应用了具体个例对本发明进行阐述,只是用于帮助理解本发明,并不用以限制本发明。对于本发明所属技术领域的技术人员,依据本发明的思想,还可以做出若干简单推演、变形或替换。
Claims (9)
1.中药组合物在制备改善非酒精性脂肪肝引起的焦虑抑郁失眠的药物中的应用,其特征在于:
所述中药组合物由以下重量份的组分制成:
玉竹 5-15份;
桑葚10-20份;
黄精10-20份;
薏仁25-35份;
酸枣仁10-20份;
枳椇子10-20份;
栀子10-14份。
2.根据权利要求1所述的应用,其特征在于:
所述中药组合物由以下重量份的组分制成:
玉竹 10份;
桑葚15份;
黄精15份;
薏仁30份;
酸枣仁15份;
枳椇子15份;
栀子12份。
3.根据权利要求1所述的应用,其特征在于:
所述中药组合物的剂型为颗粒剂或膏剂。
4.根据权利要求3所述的应用,其特征在于:
所述中药组合物颗粒剂的制备方法包括以下步骤:
第一步:提取玉竹、桑葚、黄精、薏仁、酸枣仁、枳椇子和栀子的复方水提物,制成粗粉;
第二步:将辅料和第一步获得的粗粉混合,加入酒精制成软材,制粒干燥过筛,获得颗粒剂。
5.根据权利要求4所述的应用,其特征在于:
所述第一步具体为:
将玉竹、桑葚、黄精、薏仁、酸枣仁、枳椇子、栀子剪碎后浸泡3h,加水煎煮两次,每次1.5h,合并药液,醇沉后过滤,浓缩至清膏,常压干燥,得到复方水提物,制成粗粉。
6.根据权利要求5所述的应用,其特征在于:
所述第二步中,软材的制备过程具体为:
以药辅质量比1:1.5的比例,将辅料与粗粉混合,加入浓度为85%的酒精制成软材。
7.根据权利要求6所述的应用,其特征在于:
所述第二步中,辅料为糊精和乳糖的混合物,质量混合比为4:1。
8.根据权利要求7所述的应用,其特征在于:
所述第二步中,制粒干燥过筛的过程具体为:
将软材通过12目筛网进行制粒,后进行干燥;将干燥好的颗粒经一号筛筛除粗大颗粒,经五号筛筛除细粉,获得颗粒剂。
9.根据权利要求3所述的应用,其特征在于:
所述中药组合物膏剂的制备方法包括以下步骤:
第一步:将玉竹、桑葚、黄精、薏仁、酸枣仁、枳椇子、栀子饮片放入陶瓷缸中,加水没过饮片3cm,浸泡8h;
第二步:将充分浸泡的药材放入锅中,加水煎煮3次,每次1.5h;煎煮完成后充分挤压药渣,过滤后合并药液;
第三步:将药液置锅中加热,煮沸后用文火浓缩;在浓缩过程中充分搅拌,不断撇去浮沫,直至药液浓缩至稠厚状成清膏;
第四步:将清膏继续搅拌浓缩,同时加入炼蜜,不停搅拌,使之均匀混合,直到成膏;蜜含量为30%。
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