CN110063977A - 一种党参、沙棘复合冲剂及其应用 - Google Patents
一种党参、沙棘复合冲剂及其应用 Download PDFInfo
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Abstract
本发明公开了一种党参、沙棘复合冲剂,其有效成分由党参成分和沙棘成分组成,所述党参成分和沙棘成分的质量份比为1:2~5。本发明的党参、沙棘复合冲剂具有修复胃溃疡、保护胃粘膜的功效,其中党参成分具有抗胃溃疡的作用,配以沙棘成分实现对修复胃溃疡、保护胃粘膜的增强作用同时可降低长期服用党参成分所产生的长时间精神兴奋、烦躁、失眠方面的副作用。
Description
技术领域
本发明涉及医学中药领域,具体涉及一种含党参、沙棘的复合冲剂及其在修复胃溃疡、保护胃粘膜中的应用。
背景技术
党参系桔梗科植物,党参属植物,与人参类似,但分枝较少,仅根上端1~3cm部分有环纹,质稍软,断面裂隙少,味微酸。党参其药用作用味甘,性平,入脾,肺二经,具有补中益气,生津和胃之功。党参含多糖、酚类、甾醇、挥发油、黄芩素葡萄糖甙、皂甙及微量生物碱,这些是党参作为补益药的物质基础;还含有铁,铜,钴等微量元素,对血液的形成有重要影响,锌还有促进生长发育和提高性功能,钾、钠、钙、镁等元素对调节神经,肌肉的功能和酶代谢,以及维持水电解质平衡,保持人体环境有重要作用,虽然党参较人参作用弱,但基本具人参的功能,故党参代替人参应用于一般性虚证是有科学根据的。党参在中药里面具有举足轻重的作用,其作为药材主剂或辅剂出现在很多的配方中以实现很多症状的治疗或辅助治疗,但是党参同时具有提神的作用,在应用于中医脾胃病等调理历时较长的疾病时需长期服用党参的情况下,患者容易出现精神兴奋、失眠以及烦躁等症状。
沙棘是一种药食同源的植物,它的根、花、叶、果、籽均可入药,特别是沙棘果实含有人体不能合成的、人的身心健康不可少的多种维生素、享有“世界植物之奇”、维生素宝库之称。沙棘果中还富含类胡萝卜素、多种氨基酸、亚油酸、蛋白质、维生素E、维生素A、5-羟色胺、磷脂、黄酮、多种微量元素等营养成分,其中黄酮和酚类有多达36种,黄酮具有增强免疫、有降减血浆胆固醇、减少血管壁中胆固醇含量的作用,能防治高血脂症和动脉粥样硬化症,并有促进伤口愈合的作用,5-羟色胺作为神经递质,主要分布于松果体和下丘脑,可参与痛觉、睡眠和体温等生理功能的调节。对调节神经系统及睡眠的调节作用最为显著。目前沙棘的药用主要是用于降低胆固醇、缓解心绞痛发作、还有防治冠状动脉粥样硬化性心脏病的作用。
发明内容
本发明的目的是提供一种含党参同时配以沙棘成分的复合冲剂及其在修复胃溃疡、保护胃粘膜中的应用,实现修复胃溃疡、保护胃粘膜的作用。
本发明解决上述技术问题采用的技术方案为:
一种党参、沙棘复合冲剂,其有效成分由党参成分和沙棘成分组成,所述党参成分和沙棘成分的质量份比为1:2~5。
进一步地,所述沙棘成分为由新鲜沙棘果榨取果汁后,果汁采用真空负压低温浓缩、喷雾干燥技术加糊精喷雾干燥后得到的沙棘干燥粉,每克沙棘干燥粉含原果汁2克的有效成分,所述的有效成分为纯沙棘果汁中的有效固形物。
进一步地,所述的党参成分为将中药党参加纯水,经提取、真空负压低温浓缩、喷雾干燥技术加糊精喷雾干燥后得到的党参干燥粉,每克党参干燥粉含党参饮片2克的有效成分,所述的有效成分为中药党参饮片水提有效固形物。
进一步地,将所述的党参干燥粉与沙棘干燥粉按1:2~5比例进行配比均匀混合,添加少量辅料进行造粒、干燥、包装得到本发明的复合冲剂,将得到的复合冲剂按每袋6g包装。还可以将所述的党参干燥粉与沙棘干燥粉按1:2~5比例进行配比均匀混合,选择性的添加少量辅料后制成为片剂、颗粒剂、蜜丸剂等剂型。
进一步地,所述的辅料为糊精和甜味剂,所述的甜味剂为赤藓糖醇,所述的辅料在复合冲剂、颗粒剂中的质量占比为5%,所述的辅料在片剂中的质量占比为0~2%,所述的辅料在蜜丸剂中的质量占比为10~20%。
所述的一种党参、沙棘复合冲剂在修复胃溃疡、保护胃粘膜中的应用。
根据党参的归经源流、历代本草沿革及方剂配伍应用发现党参为补中益气之要药,代替部分方剂的人参,且广泛应用于中医脾胃病。现代研究也表明,中药党参主脾胃虚弱、食少便溏、四肢乏力、气微两亏等症,同时具有调节胃肠动力、纠正病态的胃肠运动功能紊乱、抗消化性溃疡等作用,可见党参的治疗范围相当广泛,且对人没有明显的毒副作用,是一种理想的药食两用的中药材。在治疗胃溃疡等疾病时,由于胃病调理历时较长,需要长期服用药物,而党参同时具有提神的作用,长期服用时患者容易出现精神兴奋、失眠以及烦躁等症状,在出现烦躁等情绪不稳定症状时往往会影响胃病的治疗甚至是加重胃病的症状如出现嗳气等症状,不利于胃病的调理。
沙棘中医认为味酸、涩,性温。功效消食化滞、止咳祛痰、活血散瘀。可用于消化不良、食积腹痛、咳嗽痰多、瘀血经闭、跌扑瘀肿。沙棘在用于调理脾胃虚寒和治疗慢性胃炎中也有应用,但是通常是作为辅助药物与多种乃至数十种药物联用。沙棘目前的主要应用还是用于降低胆固醇、缓解心绞痛发作、还有防治冠状动脉粥样硬化性心脏病的研究报道较多,但未见沙棘果对胃溃疡的治疗及胃黏膜保护的报道。
本发明的党参、沙棘复合冲剂具有修复胃溃疡、保护胃粘膜的功效,其中党参成分具有抗胃溃疡的作用,配以沙棘成分实现对修复胃溃疡、保护胃粘膜的增强作用同时可降低因长期服用党参成分所产生的出现精神兴奋、烦躁以及失眠等症状的副作用。
具体实施方式
下面结合具体实施例对本发明做进一步的说明。
实施例1:一种党参/沙棘复合剂,其有效成分由党参成分和沙棘成分组成,所述党参成分和沙棘成分的质量份比为1:3;将所述的党参成分和沙棘成分按照质量份比备取好以后混合均匀,添加辅料糊精和甜味剂赤藓糖醇后进行造粒、干燥后制备为本发明的复合冲剂。
实施例2:一种党参/沙棘复合冲剂,其有效成分由党参成分和沙棘成分组成,所述党参成分和沙棘成分的质量份比为1:4;将所述的党参成分和沙棘成分按照质量份比备取好以后混合均匀,添加辅料糊精和甜味剂后进行造粒、干燥后制备为本发明的复合冲剂。
实施例3:一种党参/沙棘复合冲剂,其有效成分由党参成分和沙棘成分组成,所述党参成分和沙棘成分的质量份比为1:2;将所述的党参成分和沙棘成分按照质量份比备取好以后混合均匀,添加辅料糊精和甜味剂后进行造粒、干燥后制备为本发明的复合冲剂。
实施例4:一种党参/沙棘复合冲剂,其有效成分由党参成分和沙棘成分组成,所述党参成分和沙棘成分的质量份比为1:5;将所述的党参成分和沙棘成分按照质量份比备取好以后混合均匀,添加质量占比5%的辅料糊精和甜味剂后进行造粒、干燥后制备为本发明的复合冲剂。
对比例1:有效成分为党参成分,将所述的党参成分与质量占比5%的辅料糊精和甜味剂混合后进行造粒、干燥后制备为复合冲剂。
对比例2:有效成分为沙棘成分,将所述的沙棘成分与质量占比5%的辅料糊精和甜味剂混合后进行造粒、干燥后制备为复合冲剂。
进一步地,所述沙棘成分为由新鲜沙棘果榨取果汁后,果汁采用真空负压低温浓缩、喷雾干燥技术加糊精喷雾干燥后得到的沙棘干燥粉,每克沙棘干燥粉含原果汁2克的有效成分。
进一步地,所述的党参成分为将中药党参加纯水,经提取、真空负压低温浓缩、喷雾干燥技术加糊精喷雾干燥后得到的党参干燥粉,每克党参干燥粉含党参饮片2克的有效成分。
上述实施例中所述的一种党参、沙棘复合冲剂在修复胃溃疡/保护胃粘膜中的应用,用法用量,每次6g,一日两次,四周为一个疗程。
急性毒性研究:
取健康大鼠和小鼠分别单次经口灌胃给予实施例1制备的党参/沙棘复合冲剂,灌胃等效剂量为临床拟用量的100倍。给药后小鼠出现轻微活动减少,1小时左右恢复正常,给药后连续观察7天,无一动物死亡,其全身状况、摄水、饮食、小便和体重增长均正常,未出现明显的急性毒性反应,小鼠未出现明显的急性毒性反应;给药后大鼠表现与小鼠相似。提示该药剂急性毒性非常低,临床用药安全。
药理学研究一:
取体重180±20g健康大鼠70只,雌雄各半,按性别、体重随机分为7组,第一组为本发明实施例1的药物组、第二组为本发明实施例2的药物组、第三组为本发明实施例3的药物组、第四组为本发明实施例4的药物组、第五组为对比例1药物组、第六组为对比例2药物组,第七组为蒸馏水对照组。每日灌胃2次,连续给药28d。于末次给药后各组动物禁食不禁水24h,各组大鼠均灌胃无水乙醇1.0ml只,1h后处死,剖腹结扎幽门和贲门。取胃并向胃内注射生理盐水10ml,置于10%甲醛液中固定、10min后,沿胃大弯切开,用生理盐水冲去胃内残留物,观察并评定溃疡指数。评定方法为:胃腺出现条索状损伤的长度大于1mm的,测量长度,每mm计1分,其宽度大于1mm者计分加倍,长度与宽度均小于1mm,计分0.5分,将计分相加即为该鼠的溃疡指数。
结果表明党参成分和沙棘成分均对对大鼠无水乙醇型急性胃粘膜损伤有一定的保护作用,党参成分与沙棘成分结合后的制剂对大鼠无水乙醇型急性胃粘膜损伤有明显的保护作用
药理学研究二:
取体重范围在30±5g的健康小鼠70只,雌雄各半,按性别、体重随机分为7组,第一组为本发明实施例1的药物组、第二组为本发明实施例2的药物组、第三组为本发明实施例3的药物组、第四组为本发明实施例4的药物组、第五组为对比例1药物组、第六组为对比例2药物组,第七组为蒸馏水对照组。小鼠正常饮食条件下每日灌服2次实施例1的药物、实施例2的药物、实施例3的药物、实施例4的药物、对比例1药物、对比例2药物、蒸馏水,每次灌服0.25克,每日灌服2次,连续给药10d后,在第11天第一次灌服结束后准确记录灌服结束时间、翻正反射消失时间、反正反射恢复时间及观察所见。
组 | 例数 | 翻正反射消失时间(s) | 睡眠时间(min) |
第一组 | 10 | 181±15 | 121.2±3.5 |
第二组 | 10 | 183±16 | 117.5±4.0 |
第三组 | 10 | 198±17 | 111.5±7.2 |
第四组 | 10 | 169±18 | 132.3±5.6 |
第五组 | 10 | 266±16 | 73.5±8.3 |
第六组 | 10 | 133±19 | 152.75±5.5 |
第七组 | 10 | 184±20 | 118.6±7.0 |
小鼠灌服发明的党参成分与沙棘成分结合后的制剂时,能明显降低小鼠自发活动数,副交感神经作用增强,并可明显对抗长期服用党参所致的神经性兴奋眠,具有明显的中枢神经抑制效应,延长小鼠睡眠时间,并与不食用药物时表现较为相似。
应当注意的是,本发明的上述实施方案都仅为对本发明的说明而不能限制发明,权利要求书指出了本发明的保护范围,而上述实施方式的说明并未指出本发明的范围,因此,在与本发明的权利要求书相当的含义和范围内的任何变化,都应认为是包括在权利要求书的范围内。
Claims (6)
1.一种党参、沙棘复合冲剂,其特征在于:有效成分由党参成分和沙棘成分组成,所述党参成分和沙棘成分的质量份比为1:2~5。
2.根据权利要求1所述的一种党参、沙棘复合冲剂,其特征在于:所述沙棘成分为新鲜沙棘果榨取果汁后,果汁采用真空负压低温浓缩、喷雾干燥技术加糊精喷雾干燥后得到的沙棘干燥粉,每克沙棘干燥粉含原果汁2克的有效成分。
3.根据权利要求1所述的一种党参、沙棘复合冲剂,其特征在于:所述的党参成分为将中药党参饮片加纯水,经提取、真空负压低温浓缩、喷雾干燥技术加糊精喷雾干燥后得到的党参干燥粉,每克党参干燥粉含党参饮片2克的有效成分。
4.根据权利要求1-3任一项所述的一种党参、沙棘复合冲剂,其特征在于:所述的党参成分与沙棘成分按1:2~5比例进行配比混合,添加少量辅料进行造粒、干燥得到复合冲剂。
5.根据权利要求1-3任一项所述的一种党参、沙棘复合冲剂,其特征在于:将所述的党参成分和沙棘成分按1:2~5比例进行配比混合后添加辅料制成为片剂、颗粒剂或蜜丸剂。
6.一种如权利要求1-5任一项所述的党参、沙棘复合冲剂在修复胃溃疡、保护胃粘膜中的应用。
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