CN112402485A - 植物提取物在抗产褥期精神综合症药物中的应用 - Google Patents
植物提取物在抗产褥期精神综合症药物中的应用 Download PDFInfo
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Abstract
本发明涉及栀子与迷迭香提取物在抗产褥期精神综合症药物中的应用。所述栀子与迷迭香提取物制备方法包括以下步骤:由迷迭香、栀子提取物按照4:(1‑9)比例组成,其中迷迭香与栀子晒干用中药粉碎机粉碎后过筛,采用料液比1g:(10‑20)ml,超声提取,60℃下水或50%乙醇提取40‑60分钟,浓缩得浸膏,残渣按料液比1g:(50‑10)ml同样条件下提取30分钟,浓缩得浸膏,合并两次浸膏,得栀子与迷迭香水提取物。本发明制备的提取物相比与抗抑郁的西药和抗狂躁的西药,具备良好的抗产褥期精神综合症作用,表明提取物具备较好的应用前景。
Description
技术领域
本发明涉及一种植物提取物在抗产褥期精神综合症药物中的应用。
背景技术
产褥期精神综合症是指女性于产褥期出现明显的焦虑、躁狂等精神及行为障碍,是影响妇女最严重的致残性疾病之一,通常在产后6周内发生,临床常见症状:悲伤、沮丧、哭泣、孤独、焦虑、恐惧、易怒等,精神紊乱、急性幻觉和妄想等,严重者甚至有自杀倾向或伤害婴儿的行为。不同于传统的躁狂症、抑郁症,产褥期精神综合症通常是多种精神障碍同时出现。目前治疗产褥期精神综合症方法为心理治疗和抗精神病药物治疗。临床常用抗精神病药物分为典型抗精神病药物如:氯丙嗪、氟哌啶醇等(前者作用效果强但心血管、肝毒性也强且用量大;后者心血管、肝毒性小但疗效也小);非典型抗精神病药物:氯氮平、利培酮、奥氮平等(存在锥体外系反应、过量中毒等)。
CN110679697A涉及迷迭香紧压茶及其制备方法,所述迷迭香紧压茶包括如下原料:迷迭香、油橄榄叶、葛根、刺五加、桑叶、荷叶、牛蒡根、巧玲花、柿叶、银杏、黄栀子叶、粽叶和沙棘。所述迷迭香紧压茶,迷迭香具有镇静安神、醒脑作用,对消化不良和胃痛均有一定疗效。所述迷迭香紧压茶具有镇静、利尿作用,也可用于治疗失眠、心悸、头痛、消化不良等多种疾病,还具有强壮心脏、促进代谢、促进末梢血管的血液循环等作用。还可以改善语言、视觉、听力方面的障碍,增强注意力,治疗风湿痛,强化肝脏功能,降低血糖,有助于动脉硬化的治疗,帮助麻痹的四肢恢复活动能力,具有很好的商业前景。
CN2019100554359A提供了一种用于治疗抑郁症的中药组合物,所述中药组合物由以下重量份的原料药制成:当归10-20份,白芍10-30份,柴胡9-15份,酒黄芩10-15份,栀子9-15份,豆豉10-30份,五味子10-15份,麦冬10-20份,绿百合10-15份,紫贝齿20-30份,酸枣仁20-30份,夜交藤20-30份,浮小麦20-30份,大枣6-10份,炙甘草6-10份。所述中药组合物用于治疗抑郁症,也与其它抗抑郁药物联合用于制备用于治疗抑郁症的组合药物的用途。
CN110664965A公开了一种用于治疗抑郁或焦虑引起的睡眠障碍的组合物及制备方法。用于治疗抑郁或焦虑引起的睡眠障碍的组合物,包括如下成分:醋柴胡、醋香附、合欢皮、夜交藤、牡丹皮、焦栀子、黄连肉桂、川芎、知母、郁金、远志、龙骨、炒枣仁、柏子仁和朱珀牛心。所述组合物可对由焦虑和抑郁产生的睡眠障碍起到良好的缓解,使患者从根本上解除该种问题,并且不会对人体产生副作用。
但鉴于产褥期精神综合症与单纯的焦虑和抑郁并不相同,现有技术也未曾提供植物提取物能够在治疗产褥期精神综合症的药物方面的应用。
发明内容
本发明的目的是公开一种植物提取物在抗产褥期精神综合症药物中的应用,所述植物提取物为迷迭香、栀子的混合提取物。
为实现上述目的,本发明采取以下技术方案:
植物提取物在抗产褥期精神综合症药物中的应用,所述植物提取物为迷迭香、栀子的混合提取物。
所述的产褥期精神综合症为女性在产褥期内出现明显的焦虑、躁狂、精神错乱、急性幻觉和妄想等精神及行为障碍。
优选的,所述植物提取物的制备方法包括以下步骤:
迷迭香、栀子按照4:(1-9)质量比组成,其中迷迭香与栀子晒干用中药粉碎机粉碎后过筛,采用料液比1g:(10-20)ml,超声提取,40-60℃下水或50%乙醇提取40-60分钟,浓缩得浸膏,残渣按料液比1g:(5-10)ml同样条件下提取30分钟,浓缩得浸膏,合并两次浸膏。
优选的,迷迭香、栀子提取物按照4:(3-7)比例组成。
优选的,迷迭香、栀子提取物按照4:5比例组成。
优选的,迷迭香与栀子晒干用中药粉碎机粉碎后过筛,采用料液比1g:15ml超声提取。
优选的,残渣按料液比1g:7ml同样条件下提取30分钟。
本发明还提供了所述的植物提取物与其他膳食或药学上可接受的成分构成组合物在抗产褥期精神综合症中的应用。
优选的,所述的膳食上可接受成分是与迷迭香、栀子提取物无搭配禁忌的食材。
优选的,所述植物提取物与其他膳食或药学上可接受的成分构成组合物制成口服剂型。
优选的,植物提取物与其他膳食可接受的成分构成组合物可以是乳制品,压缩干粮,烘制食品,软饮品,运动饮料,果汁,水饮品,茶,加奶饮料或汤的形式。
优选的,所述的药学上可接受的成分是药学上允许的任意一种或多种辅料。
优选地,所述植物提取物与其他药学上可接受的成分构成组合物可以是胶囊、片剂、丸剂、微囊制剂、注射剂、栓剂、喷雾剂、软膏剂、缓释制剂、控释制剂。
优选地,为使上述剂型能够实现,可以广泛使用本领域公知的各种载体。关于载体的例子是,例如稀释剂与吸收剂,如淀粉、糊精、硫酸钙、白陶土、微晶纤维素、硅酸铝等;湿润剂和粘合剂,如水、甘油、聚二乙醇、乙醇、丙醇、淀粉浆、糊精、糖浆、蜂蜜、葡萄糖溶液、阿拉伯胶浆、明胶浆、羧甲基纤维素钠、紫胶、甲基纤维素、磷酸钾、聚乙烯吡咯烷酮等;崩解剂,例如干燥淀粉、海藻酸盐、琼脂粉、褐藻淀粉、碳酸氢钠与枸橼酸、碳酸钙、聚氧乙烯山梨糖醇脂肪酸酯、十二烷基苯磺酸钠、甲基纤维素、乙基纤维素等;崩解抑制剂,例如蔗糖、三硬脂酸甘油酯、可可脂、氢化油等;促吸收剂,例如季铵盐、十二烷基苯磺酸钠等;润滑剂,例如滑石粉、二氧化硅、玉米淀粉、硬脂酸镁、硼酸、液体石蜡、聚乙二醇等;助悬剂,例如聚乙烯吡咯烷酮、微晶纤维素、蔗糖、琼脂、羟丙基甲基纤维素等;甜味剂,例如糖精钠、阿西帕坦、蔗糖、甜蜜素等;防腐剂,例如尼泊金类、苯甲酸、苯甲酸钠、山梨酸及其盐类、苯扎溴铵、醋酸氯乙定、桉叶油等;基质,例如PEG6000、PEG4000、虫蜡等。
优选的,所述植物提取物与其他药学上可接受的成分构成组合物的给药方式为注射、口服、胃肠外、吸入式喷雾或透皮给药。
以下对本发明做进一步的解释:
栀子主要成分环烯醚萜类化合物具备保肝、镇静、镇痛、抗氧化等药理活性,迷迭香是目前公认的具有高抗氧化作用的一种植物,其主要成分具有抗氧化、保护神经元细胞、安神醒脑等药理活性,使用特定比例、特定提取方法的栀子和迷迭香的混合提取物能增强抗焦虑、躁狂的疗效,可能与在此特定比例,特定提取条件下,提取出来的有效成分与现有技术中抗抑郁的主要成分不同有较大的关系,同时在此比例下,二者主要药理活性成分极有可能发挥了意想不到的协同效应。
与现有技术相比,本发明优点在于:
本发明首次证明栀子和迷迭香提取物具有治疗产褥期精神综合症的作用,能显著降低大鼠产褥期精神综合症焦虑、躁狂等行为障碍,与模型对照组比较有显著差异。
具体实施方式
为使本发明的目的、技术方案和有点更加清楚,下面将结合本发明实施例,对本发明实施例中的技术方案进行清楚、完整地描述,所描述的实施例是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
以下实施例所使用的实验动物雌性SD大鼠66只,购于湖南斯莱克景达实验动物有限公司,实验动物生产许可证号:SCXK(湘)2011-0003,在湖南省药物安全评价研究中心屏障环境饲养,实验动物使用许可证号:SYXK(湘)2015-0016。
实施例1
迷迭香、栀子提取物的制备
将迷迭香与栀子以不同比例组合,晒干用中药粉碎机粉碎后过60目筛,采用料液比1g:15ml,100W超声辅助,60℃,水提取40-60分钟,浓缩得浸膏,残渣按料液比1g:7ml同样条件下提取30分钟,浓缩得浸膏,合并两次浸膏,得迷迭香、栀子提取物。迷迭香与栀子的不同组合比例如下:
组合1:迷迭香提取物与栀子提取物按4:7比例组成
组合2:迷迭香提取物与栀子提取物按4:5比例组成
组合3:迷迭香提取物与栀子提取物按4:3比例组成
实施例2
抗产褥期精神综合症药物组合的效果验证
(1)母婴分离联合慢性不可预知性应激产褥期精神综合症模型建立
健康SD雌性大鼠66只,孕期16-17d,独笼适应性喂养待产。将生产当日记为D0,D1-D28每日上午09:00将母鼠拿出置于隔离笼内3h,正常予以饲料与水,隔离笼与母鼠原鼠笼共处一室,使母鼠能听到子鼠声音,嗅到子鼠气味,并予以慢性不可预知性应激,包括束缚2h、夹尾5min、频闪12h、强迫游泳10min、噪音30min、禁食12h、禁水12h、昼夜颠倒等。
表1.慢性不可预知性应激时间表
时间 | 应激方式 |
星期一 | 束缚2h |
星期二 | 禁食禁水12h |
星期三 | 昼夜颠倒+强迫游泳10min |
星期四 | 噪音30min+夹尾5min |
星期五 | 束缚2h |
星期六 | 强迫游泳10min+禁食24h |
星期日 | 噪音30min+禁水24h |
(2)分组与给药
造模前将大鼠按照旷场实验评分结果随机分为正常对照组、模型对照组、盐酸氟西汀组(抗抑郁西药阳性对照组)、丙戊酸钠组(抗狂躁西药阳性对照组)、栀子提取物组、迷迭香提取物组、药物组合1、2、3组和药物组合2组低、中、高剂量组,每组6只,正常对照组不进行造模,造模期间正常对照组和模型对照组每天灌胃给予相应药液,给药体积10ml/kg,末次给药结束后分别进行旷场实验检测、高架十字迷宫检测。
(3)剂量设置
设置药物组合物低、中、高剂量为50mg/kg、100mg/kg、150mg/kg。盐酸氟西汀片临床日用量20mg,根据动物与人临床剂量换算成大鼠剂量为:20mg*0.018/0.2kg=1.8mg/kg,采用临床等效剂量2倍,即3.6mg/kg作为大鼠给药剂量。丙戊酸钠片临床用量15mg/kg,根据动物与人临床剂量换算成大鼠剂量为:15mg/kg*60kg*0.018/0.2kg=81mg/kg,采用临床等效剂量2倍,即162mg/kg作为大鼠给药剂量。详见表2所示。
表2.实验分组与剂量设计
(4)统计学方法
采用SPSS16.0进行统计分析,统计学意义的水平设定为P<0.05,计量资料采用均数±标准差表示,用Leven’s test方法检验正态性和方差齐性,如果符合正态性和方差齐性(P>0.05),用单因素方差分析(ANOVA)和LSD test进行统计分析;如果符合正态性和方差齐性(P≤0.05),则用Kruskal-Wallis检验,如果Kruskal-Wallis检验有统计学意义(P≤0.05),则用Dunnett’s Test(非参数方法)进行比较分析,评价时考虑统计学差异和生物学意义。
(5)检测指标
1.旷场实验
末次给药结束后,将动物放入测试箱中,适应3min后开始检测,检测大鼠10min内自发活动,通过监视器观察记录10min内运动总路程。
2.高架十字迷宫
末次给药结束后,观察大鼠5min内的自发活动,将大鼠头朝一侧闭合臂放于迷宫的中央区,计时5min,开始观察并记录。每只大鼠测试结束后清理粪便,并用75%酒精擦拭仪器,消除上一只大鼠气味。观察指标:开放臂进入次数(open arm entry,OE),以大鼠前两爪均进入到臂内为准,两前爪从该臂中完全退出则认为该次进入活动完成,开放臂停留时间(open arm time,OT);闭合臂进入次数(close arm entry,CE),判定方法同开放臂;闭合臂停留时间(close arm time,CT);并计算开放臂进入次数百分比:OE%=OE/(OE+CE)×l00%;开放臂停留时间百分比:OT%=OT/(OT+CT)×100%。
(6)实验结果
1.不同药物组合对产褥期精神综合症大鼠自主活动、高架十字迷宫实验数据的影响
如表3所示,与正常对照组比较,模型对照组自主活动总路程显著上升,OE%、OT%显著降低(P<0.01);与模型对照组比较,盐酸氟西汀组(抗抑郁西药阳性对照组)总路程显著升高,其他各给药组自主活动总路程显著降低(P<0.05或P<0.01)。以上结果显示,对于产褥期精神综合症躁狂样大鼠抗狂躁药丙戊酸钠、药物组合物均能有效降低躁狂样行为,抗抑郁药盐酸氟西汀会加重产褥期精神综合症躁狂样大鼠的躁狂行为学。尤其是药物组合2组高剂量组的总路程甚至还低于丙戊酸钠组,可见其降低产褥期精神综合症躁狂样大鼠的躁狂行为学甚至优于抗狂躁西药对照组。
与正常对照组比较,模型对照组OE%、OT%显著降低(P<0.01);与模型对照组比较,丙戊酸钠组(抗狂躁西药阳性对照组)、药物组合2中、高剂量组OE%、OT%显著升高(P<0.01),药物组合物低剂量组OT%显著升高(P<0.05),盐酸氟西汀组(抗抑郁西药阳性对照组)OE%显著升高(P<0.05)。以上结果显示,盐酸氟西汀、丙戊酸钠、药物组合物和单独栀子和迷迭香提取物均能有效缓解产褥期精神综合症大鼠焦虑行为。
注:与正常对照组比较+P<0.05,++P<0.01;与模型对照组比较*P<0.05,**P<0.01。
行为学结果显示,栀子与迷迭香组合使用对缓解大鼠焦虑、躁狂等行为学效果优于单独栀子或迷迭香提取物的缓解效果,且药物组合2组效果优于其他组合。
药物组合物提取物均能显著降低产褥期精神综合症躁狂样大鼠运动量,抗抑郁西药盐酸氟西汀片对于产褥期精神综合症躁狂样大鼠会起到相反的作用,药物组合物中、高剂量能显著升高产褥期精神综合症大鼠高架十字迷宫实验OE%、OT%。虽然丙戊酸钠对躁狂、焦虑发作均有较好的疗效,但因其能透过胎盘屏障存在潜在的致畸风险,因此对于孕妇与哺乳期女性存在使用禁忌。综上所述,药物组合2组具有非常好的抗产褥期精神综合症躁狂、焦虑作用,同时可安全使用。
另外,本发明的提取物不限于实施例所述的水提取方法,50%的醇提取液能达到相同的效果。另外相似的溶剂的提取方法在调整剂量的时候也能达到类似的效果,也应视为在本发明的保护范围内。
Claims (10)
1.植物提取物在抗产褥期精神综合症药物中的应用,其特征在于,所述植物提取物为迷迭香和栀子的混合水提物或醇提物。
2.根据权利要求1所述的应用,其特征在于,所述产褥期精神综合症为女性在产褥期内出现明显的焦虑、躁狂、精神错乱、急性幻觉和妄想等精神及行为障碍。
3.根据权利要求1所述的应用,其特征在于,所述植物提取物的原料中,迷迭香、栀子按照4:(1-9)质量比组成。
4.根据权利要求3所述的应用,其特征在于,所述植物提取物的原料中,迷迭香、栀子提取物按照4:(3-7)质量比组成。
5.根据权利要求3所述的应用,其特征在于,所述植物提取物的原料中,迷迭香、栀子提取物按照4:5质量比组成。
6.根据权利要求1-5任一项所述的应用,其特征在于,所述植物提取物的制备方法包括以下步骤:
将固定比例的迷迭香与栀子晒干、粉碎后过筛,超声提取,40-60℃下用水或乙醇提取40-60分钟,浓缩得浸膏,残渣同样条件下提取30-50分钟,浓缩得浸膏,合并两次浸膏。
7.根据权利要求6所述的应用,其特征在于,迷迭香与栀子晒干、粉碎后过筛,采用料液比1g:15ml超声提取,提取所用的乙醇质量浓度为30%-50%,残渣按料液比1g:7ml提取30分钟。
8.如权利要求1所述应用中的植物提取物与膳食可接受的成分构成组合物在抗产褥期精神综合症中的应用;其特征在于,植物提取物与其他膳食可接受的成分构成组合物为乳制品,压缩干粮,烘制食品,软饮品,运动饮料,果汁,水饮品,茶,加奶饮料或汤。
9.根据权利要求8所述的应用,其特征在于,所述的膳食上可接受成分是与迷迭香和栀子无搭配禁忌的食材。
10.如权利要求1所述应用中的植物提取物与药学上可接受的成分构成组合物在抗产褥期精神综合症中的应用,其特征在于,植物提取物与其他药学上可接受的成分构成组合物为胶囊、冲剂、片剂、丸剂、微囊制剂、注射剂、栓剂、喷雾剂、软膏剂、缓释制剂、控释制剂。
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