CN107837290A - 一种中药制剂添加剂 - Google Patents
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Abstract
本发明公开了一种中药制剂添加剂,由鹿茸、西洋参多糖、西洋参皂苷混合而成,且鹿茸、西洋参多糖、西洋参皂苷的质量比为2.6∶1.8∶1。本发明改变了西洋参块或提取物入药的传统形式,以西洋参总多糖、总皂苷两个有效部位入药,优选三者配伍方法获得更好的药理效果,实现功效最大化,为保健食品或临床使用制剂开发提供基础。
Description
技术领域
本发明涉及中药制剂领域,具体涉及一种中药制剂添加剂。
背景技术
西洋参与鹿茸的配伍使用,传统功效明确,可达到协同作用。经查询国家食品药品监督管理局数据库,二者配伍应用的保健食品达20余种。各种产品鹿茸-西洋参处方剂量不明确且差别较大。同时未明确处方的缓解体力疲劳及调节免疫功效成分,并且缺乏对标志性成分的质量控制。因此目前该类保健食品虽然数量多,但存在功效成分不明确、缺乏配方的筛选过程,无明确的量-效关系,质量可控性较差等问题。
从化学组分角度讲,每味中药就是多种化学成分的天然配比,而当将化学组分拆分后再按照不同比例组合时,就可能获得更好的药效作用。既可以提高疗效、易控质量,也大大减少了服药量,充分体现中药配伍的优势。
发明内容
本发明的目的是提供一种中药制剂添加剂,优化了处方中西洋参多糖与皂苷的比例,提高了鹿茸、西洋参的药材利用度,实现制剂开发质量可控。
为实现上述目的,本发明采取的技术方案为:
一种中药制剂添加剂,由鹿茸、西洋参多糖、西洋参皂苷混合而成,且鹿茸、西洋参多糖、西洋参皂苷的质量比为2.6∶1.8∶1。
优选地,由以下重量的组分构成:
鹿茸293mg、西洋参多糖201mg、西洋参皂苷111mg。
其中,所述的西洋参多糖、西洋参皂苷是由西洋参药材块根经水提醇沉后,分离沉淀与醇液所得。
本发明具有以下有益效果:
改变西洋参块或提取物入药的传统形式,以西洋参总多糖、总皂苷两个有效部位入药,优选三者配伍方法获得更好的药理效果,实现功效最大化,为保健食品或临床使用制剂开发提供基础。
具体实施方式
为了使本发明的目的及优点更加清楚明白,以下结合实施例对本发明进行进一步详细说明。应当理解,此处所描述的具体实施例仅仅用以解释本发明,并不用于限定本发明。
实施例
实验动物及分组
取健康昆明种小鼠70只,雌雄各半,体重18~22g,随机分成7组,每组 10只,分别为空白对照组(蒸馏水组),阳性对照组(鹿茸洋参片)0.13g /(kg·d),配伍组5组。
给药方法
小鼠给药前禁食不禁12h,饲养饲养于标准环境内,室温(22±2)℃。实验组小鼠按照0.2ml/10g的剂量灌胃给药,每天1次,连续给药14天,对照组给予相同剂量的蒸馏水,阳性对照组给予相同剂量的鹿茸洋参片水溶液。实验第14天测定小鼠负重游泳时间及运动后即刻的血清尿素氮(BUN)、肝糖原的含量;运动前、运动后即刻及运动后休息20min的血乳酸(LD)含量。试验期间小鼠自由饮水和摄食。
配伍组剂量的选择
根据鹿茸洋参片原方剂量比(鹿茸-西洋参1∶3)、两味药的临床保健食品用量,折算得到新处方中鹿茸、西洋参多糖、西洋参皂苷的基础配比为20∶5∶4,将三者视为3个考察因素,按照基本配比每个因素分别增(减)含量的30%,分为5个水平,见表1。根据均匀设计法,按U5(53)重新拟合成5个不同药物配比的处方,见表2。
表1 鹿茸、西洋参多糖与西洋参皂苷配伍均匀设计剂量表
表2 U5(53)均匀设计表
将人体临床服用量换算为小鼠服用量,例如,70Kg的成人给药量为1g生药,根据人与小鼠换算系数,小鼠给药量为1g/70Kg*12=0.17g/Kg。根据处方设计剂量水平,设称药量为Xmg,则小鼠给药量为12X/70mg/Kg,小鼠灌胃体积为0.2mL/10g,故配置溶液浓度为6X/700mg/mL。
根据6X/700mg/mL的溶液浓度,称定三种药品适量分别置于5个烧杯中,加入少许CMC-Na溶液助溶,加蒸馏水至刻度,使用电动搅拌器搅拌至上述细粉完全溶解,即得。
蒽酮试剂:精密吸取132mL蒸馏水,缓慢加入400mL浓硫酸,边加边搅拌散热.等到加完而且冷却到室温后加入2.4g蒽酮,摇匀,即得。
实验方法
小鼠负重游泳游泳时间
第14天给30min后进行游泳负重试验。置小鼠于水深为30cm,尾根部负小鼠体质量5%的橡皮泥球,水温为(10±2)℃,水深25cm的水池中进行低温游泳试验。用秒表记录小鼠出现自然沉降时间作为小鼠负重游泳时间 (min)。
血清尿素氮(BUN)、血乳酸(LD)的测定
对负重游泳力竭后的小鼠进行摘眼球取血,置于肝素钠处理过的离心管内,离心(3500r·min-1)8min,分离血清,利用相应的试剂盒检测LD、 BUN活力。
肝糖原的含量测定
对负重游泳力竭后的小鼠脱进行颈椎处死,取肝脏及股四头肌,置于冰培养皿上,经生理盐水漂洗后用滤纸吸干,精确称取肝脏200mg,肌肉500mg,加入5%的三氯乙酸4ml,匀浆1min后,3000r·min-1离心15min,取1mL 上清液移入另一试管内,加入95%乙醇4mL,混匀,加塞室温竖直放置过夜,沉淀完全后,3000r·min-1离心15min,倒掉上清液,倒立放置10min,用 2mL蒸馏水溶解肝糖原,振荡混匀。同法配置空白液与对照品溶液。再分别加入10mL蒽酮试剂,混匀,放冷后沸水浴15min,放冷,于620nm处测定吸光度。
分析数据处理与结果判定
不同分组组间整体比较采用单因素方差分析法;组间多重比较采用SNK 法;对负重游泳时间、体重变化率、BUN、LD和肝糖原五个抗疲劳指标采用因子分析法以筛选最优处方。采用SAS 9.3统计软件完成。
根据《保健食品检验与评价技术规范》(2003年),1项以上(含1项) 运动试验和2项以上(含2项)生化指标为阳性,即可以判断该受试物具有抗疲劳作用。
实验结果
表3 各组别小鼠负重游泳时间、体重变化率%、BUN(mg/L)、LD(mg/L)、肝糖原(mg/kg)数据记录表
不同配伍组对小鼠负重游泳时间和体重变化率的影响
表4 配伍组对小鼠负重游泳时间和体重变化率的影响
注:与空白对照比较,P*<0.05;与阳性对照比较,P#<0.05
由表4可知,与空白对照组相比,五个配伍组均能显著增加小鼠负重游泳时间和小鼠体重,说明三者合用具有协同作用。与阳性对照组相比,处方I、 II、III能显著增加小鼠负重游泳时间;处方II能显著增加小鼠体重。
不同配伍组对BUN、LD、肝糖原水平的作用影响
表5 配伍组对BUN、LD、肝糖原的影响
注:与空白对照比较,P*<0.05;与阳性对照比较,P#<0.05
由表5可知,与空白对照组相比,处方II、III、IV、V能显著降低小鼠 BUN水平;与阳性对照组相比处方I有差异,但为负相关,不能说明处方I有作用,而其它处方组均有BUN降低的趋势。与空白对照组相比,处方II、V组小鼠LD水平显著减低;与阳性对照组相比处方II有显著差异。在肝糖原水平影响方面,处方II与阳性对照相比有显著。
因子分析法优选最佳配比
因子分析是考察多个变量间相关性的一种多元统计方法。研究通过少数几个主分量来解释多个变量间的内部结构。即从原始变量中导出少数几个主分量,使它们尽可能多地保留原始变量的信息,且彼此间互不相关,属于多元分析中处理降维的一种统计方法。
对抗疲劳功效所设定的五个指标做因子分析。如表6。
表6 对抗疲劳五个指标的因子分析解释的总方差
提取方法:主成分分析
由表6可知,提取特征值大于1的成分,共一个成分大于1,即成分1。结果如表7。
表7 成份矩阵a
(注:提取方法主成分分析法。-代表负相关,比较绝对值。)
由表7所示,表示抗疲劳各变量中所含原始信息能被提取的公因子所表示的程度,对保存的共因子分析结果如表8。
表8 公因子得分在组间的比较
由表8可知,对保存的成分因子分析结果显示,因子得分越高,效果越好。
对不同组各因子的得分比较结果如9表。
表9 公因子得分在组间的多重比较(SNK法)
由表9可知,空白对照组分为一类子集;处方I、III聚集在一类子集;处方IV、阳性对照、处方V聚集在一类子集中;处方II为一类子集。同类子集差异均无显著性。由各处方均值显示:处方II>处方V>处方IV>处方III>处方>I。且处方II与其他处方差异均有统计学意义,可以认为处方II在抗疲劳上的效果最好。
现代研究药理表明,西洋参水煎液、西洋参粗根多糖或多糖、茎叶皂苷都能够能增加小鼠体重、胸腺重量、脾重、抗体滴度、淋巴细胞转化率;现代研究药理表明,西洋参水煎液能增强小鼠耐高温的能力;水提液或总皂苷能延长小鼠负重游泳的时间,降低运动后小鼠血乳酸、血清尿素氮及肝糖原消耗量;超微粉和常规粉能延长常压耐缺氧时间,提高运动疲劳小鼠血清肝糖原,降低血清尿素氮;西洋参20%醇提物制成粉剂能抑制低温环境小鼠体温的下降,明显延明显延长小鼠负重游泳时间和常压耐缺氧时间;西洋参归肾经,用于增强免疫、抗肿瘤、抗炎、抗病毒、抗诱变,符合“肾藏精”“肾精抵御外邪”的中医理论。鹿茸归肾经,传统功效明确。两者合用有“药有个性之专长,方有合群之妙用”之精妙,符合基础中医药理论。
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以作出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (3)
1.一种中药制剂添加剂,其特征在于,由鹿茸、西洋参多糖、西洋参皂苷混合而成,且鹿茸、西洋参多糖、西洋参皂苷的质量比为2.6∶1.8∶1。
2.如权利要求1一种中药制剂添加剂,其特征在于,由以下重量的组分构成:
鹿茸293mg、西洋参多糖201mg、西洋参皂苷111mg。
3.如权利要求1一种中药制剂添加剂,其特征在于,所述的西洋参多糖、西洋参皂苷是由西洋参药材块根经水提醇沉后,分离沉淀与醇液所得。
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