CN112891382A - 乙酰氨基葡萄糖微生态制剂及其在制备应激性胃溃疡治疗药物或保健食品中的应用 - Google Patents
乙酰氨基葡萄糖微生态制剂及其在制备应激性胃溃疡治疗药物或保健食品中的应用 Download PDFInfo
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Abstract
本发明涉及医药和保健品领域,具体是一种含乙酰氨基葡萄糖的微生态制剂,及其在制备提高机体抗应激能力和治疗应激性胃溃疡的药物或保健食品中的应用。乙酰氨基葡萄糖作为一种微生态制剂组合物组分,与益生菌配合,对防治应激性胃溃疡起到了新的有益的效果,在人群试用中效果显著。
Description
技术领域
本发明涉及医药和保健品技术领域,具体地说,是一种含乙酰氨基葡萄糖的微生态制剂,及所述的微生物制剂在制备应激性胃溃疡治疗药物或保健食品中的应用。
背景技术
应激反应(stress),也称为狩猎式反应,当机体受到各种强烈刺激(如创伤、手术、寒冷、缺氧、饥饿、疼痛及精神紧张和焦虑不安等),机体就会出现以交感神经兴奋,儿茶酚胺分泌增多和垂体-肾上腺皮质分泌增多为主的一系列神经内分泌反应,以适应强烈的刺激,提高机体适应能力。适当强度的应激反应对人有积极意义,可提高身体的抵抗和适应能力,但如果应激反应过于强烈、持久,那么无论这种反应是生理性的,还是心理性的,都是有害的。
应激性胃溃疡是指机体在应激状态下发生的以炎症糜烂、浅表性溃疡及胃肠道出血为特征的急性胃黏膜病变。其可以是机体在外伤、感染、休克等应激状态引起,也可以由强烈情绪变化引起,且情绪应激以及精神因素是胃溃疡产生的重要因素。我们理解,在复杂多变的生活压力、社会心理压力、以及动态的对机体的应激源的存在,以及老年人变差的机体抵抗力遇到季节、气候的变化所带来的机体应激反应损伤,以及本身有基础疾病,而外来的刺激源却未可预期,这对本身患有心脑血管疾病等基础疾病的患者来说,要求对可能超出自身承受能力的应激反应损伤有所防备,在知识储备上,或在干预手段上可谓困难重重。在这种情况下,既能跟上人们生活、工作、身体健康状况动态,又能防治应激性胃溃疡、多种环境应激源造成的应激反应损伤等等,是一个崭新的课题。
有研究显示增加菌群多样性,促使紊乱的肠道菌群水平回调,能有效改善应激性胃溃疡引发的胃黏膜损伤。也有使用酪酸梭菌对水浸应激性胃溃疡的预防治疗及机制探讨。
因此,需要一种大众既能易于接受又能有效提高机体应激能力的用于应激性胃溃疡的治疗药物或保健食品。
发明内容
本发明的目的在于提供一种含乙酰氨基葡萄糖的微生态制剂,及所述的微生物制剂在制备应激性胃溃疡治疗药物或保健食品中的应用。
本发明的第一方面,提供一种含乙酰氨基葡萄糖的微生态制剂,包括乙酰氨基葡萄糖或其药学上可接受的盐,和益生菌组合物;其中乙酰氨基葡萄糖的含量为0.1~32wt%,益生菌组合物的含量为40-60wt%;所述益生菌组合物由嗜酸乳杆菌、鼠李糖乳杆菌、保加利亚乳杆菌、青春双岐杆菌、婴儿双岐杆菌按如下重量比组成:(0.01~1):(0.01~1):(0.01~1):(0.01~1):(0.01~1)。
进一步的,所述的微生态制剂还可以包含常规药用赋形剂、载体或稀释剂。
进一步的,所述的微生态制剂中乙酰氨基葡萄糖的含量为10~32wt%。
更进一步的,所述的微生态制剂中乙酰氨基葡萄糖的含量为20wt%。
进一步的,所述的乙酰氨基葡萄糖药学上可接受的盐选自乙酰氨基葡萄糖的盐酸盐、磷酸盐、硫酸盐、柠檬酸盐、草酸盐、马来酸盐。
进一步的,所述的益生菌组合物中嗜酸乳杆菌、鼠李糖乳杆菌、保加利亚乳杆菌、青春双岐杆菌、婴儿双岐杆菌的重量比为0.5:0.5:0.5:1:1。
更进一步的,所述的微生态制剂中,以所述微生态制剂总量为基准计,所述微生态制剂中益生菌活菌数量为:嗜酸乳杆菌LA85:1.5×109cfu/g,鼠李糖乳杆菌LRa05:1.5×109cfu/g,保加利亚乳杆菌LB42:1.5×109cfu/g、青春双歧杆菌BAC30:3×109cfu/g,婴儿双歧杆菌BI45:3×109cfu/g。以上菌株均为市售产品。
进一步的,所述的微生态制剂为胶囊剂、散剂或片剂。
本发明的第二方面,提供一种如上所述的含乙酰氨基葡萄糖的微生态制剂在制备应激性胃溃疡治疗药物或保健食品中的应用。
更进一步的,所述的应用为,在制备保护胃黏膜的药物或保健食品中的应用。
本发明优点在于:
本发明提供一种含乙酰氨基葡萄糖的微生态制剂,及其在制备提高机体抗应激能力和治疗应激性胃溃疡的药物或保健食品中的应用,乙酰氨基葡萄糖作为一种微生态制剂组合物组分,与益生菌配合,对防治应激性胃溃疡起到了新的有益的效果,在人群试用中效果显著。
具体实施方式
下面结合实施例对本发明提供的具体实施方式作详细说明。
实施例1:含乙酰氨基葡萄糖的微生态制剂对大鼠应激性胃溃疡的预防实验研究
一、材料与方法
1.药品试剂
乙酰氨基葡萄糖,市售;甲氰咪胍,市售;福尔马林、多聚甲醛、苏木素、伊红等均为分析醇,市售,常规配置。益生菌组合物配方为:以益生菌的总量为基准计,益生菌中嗜酸乳杆菌LA85、鼠李糖乳杆菌LRa05、保加利亚乳杆菌LB42、青春双岐杆菌BAC30、婴儿双岐杆菌BI45的重量份数比例为0.5:0.5:0.5:1:1;且以微生态制剂总量为基准计,嗜酸乳杆菌LA85:1.5×109cfu/g,鼠李糖乳杆菌LRa05:1.5×109cfu/g,保加利亚乳杆菌LB42:1.5×109cfu/g,青春双歧杆菌BAC30:3×109cfu/g,婴儿双歧杆菌BI45:3×109cfu/g。以上菌株均为市售产品。
2.仪器设备
多功能显微镜;数码相机。
3.动物分组
Wistar大鼠,体重200g±20g,常规饲养。
取大鼠80只,雌雄各半,随机分成8组:正常对照组;应激性胃溃疡模型对照组;含高、中、低剂量乙酰氨基葡萄糖微生态制剂应激性胃溃疡预防实验组;甲氰米胍应激性胃溃疡预防阳性对照组;乙酰氨基葡萄糖高剂量预防组;益生菌预防组;每组10只。
4.给药方法
含乙酰氨基葡萄糖微生态制剂应激性胃溃疡预防实验组(乙酰氨基葡萄糖+益生菌)分别为高剂量组;中剂量组;低剂量组;正常对照组给等量的生理盐水;甲氰咪胍阳性对照组;应激性胃溃疡模型对照组给等量的生理盐水;乙酰氨基葡萄糖高剂量预防组;益生菌预防组。所有药物均提前8小时口服灌胃。
乙酰氨基葡萄糖微生态制剂,其中乙酰氨基葡萄糖含量:(高剂量组剂量为320mg/kg,中剂量组剂量为160mg/kg,低剂量组剂量为30mg/kg。灌胃液用生理盐水配制,其中乙酰氨基葡萄糖高剂量浓度为100mg/mL,中剂量浓度为50mg/mL,低剂量浓度为30mg/mL);且同时灌胃益生菌组合物:予以1×109cfu/kg灌胃。乙酰氨基葡萄糖高剂量组剂量320mg/kg,生理盐水配制,浓度为100mg/mL。益生菌组以1×109cfu/kg剂量灌胃。
正常对照组和应激性胃溃疡模型对照组均灌胃等体积的生理盐水;甲氰咪胍阳性对照组剂量为50mg/kg,生理盐水稀释,浓度为1%。
5.水浸法应激性胃溃疡动物模型
大鼠禁食24小时,经乙醚麻醉后,将其四肢绑扎固定于鼠板。待其清醒后垂直浸于20℃~22℃的水浴中,浸入深度为胸骨水平。24小时后取出,将动物处死,即剖检。先将幽门用线结扎,然后用注射器抽1%的福尔马林溶液10毫升,自食管注入胃内,拔出针头结扎贲门。在两结扎线的两端切断食管及十二指肠,摘下全胃,再将胃浸泡在1%福尔马林溶液中10分钟。沿胃大弯剪开胃,用自来水轻轻冲洗去胃内容物,将胃平展在玻璃板上,备检。
6.观察方法
直接观察每组动物的胃粘膜的变化及溃疡情况,石蜡包埋,病理切片,HE染色,光镜下观察其损伤情况。
7.溃疡指数(UI)及溃疡抑制率的计算
根据Guth标准计算胃黏膜溃疡指数(ulcel index,UI)及溃疡抑制率。将在福尔马林中固定好的胃组织取出,沿胃大弯剪开,在冰盒里展平,使用测微尺,按溃疡或糜烂长度计算(mm),进行UI评估:斑点状糜烂计1分,糜烂长度﹤1mm为2分,大于1mm不足2mm为3分,大于2mm不足3mm为4分,>3mm者为5分;糜烂宽度>1mm时则分值加倍。全胃得分之总和则为该大鼠的溃疡指数。溃疡抑制率(%)=(模型组溃疡平均指数-给药组溃疡平均指数)/模型组溃疡平均指数×100%。
8.统计方法
采用SPSS19.0统计软件进行结果统计分析。
二、结果
1、含乙酰氨基葡萄糖的微生态制剂对大鼠胃粘膜的保护作用
正常大鼠的胃组织完整,胃粘膜光滑、粘膜层无充血、发红、无溃疡面和出血点,表面无糜烂、水肿等情况。应激性胃溃疡模型对照组大鼠的胃粘膜有许多溃疡,形状各异,有圆型、不规则形或线形,溃疡面有的较大,且深入粘膜下层和肌肉层。含高、中、低剂量乙酰氨基葡萄糖的微生态制剂组,预防应激性胃溃疡效果大致相当,大鼠胃黏膜的损伤程度较低,只有一些浅表性溃疡点和短的窄的线形损伤,明显好于应激性胃溃疡模型对照组,说明乙酰氨基葡萄糖的微生态制剂对应激性胃溃疡有明显的保护作用。甲氰咪胍阳性对照组大鼠的胃黏膜情况与乙酰氨基葡萄糖微生态制剂近似。
2、溃疡指数与溃疡抑制率计算结果
组别 | 只/组 | 溃疡指数(分) | 溃疡抑制率(%) |
正常对照组 | 10 | 0.50±0.30 | — |
模型对照组 | 10 | 29.50±3.83<sup>##</sup> | — |
甲氰米胍阳性对照组 | 10 | 16.25±3.34<sup>**</sup> | 44.91 |
乙酰氨基葡萄糖(高剂量)+益生菌 | 10 | 15.93±2.52<sup>**</sup> | 46.00 |
乙酰氨基葡萄糖(中剂量)+益生菌 | 10 | 14.25±3.12<sup>**</sup> | 51.69 |
乙酰氨基葡萄糖(低剂量)+益生菌 | 10 | 16.50±2.82<sup>**</sup> | 44.08 |
乙酰氨基葡萄糖(高剂量) | 10 | 18.12±3.23<sup>**</sup> | 40.97 |
益生菌 | 10 | 19.56±3.57<sup>**</sup> | 38.08 |
注:与正常对照组比,##P<0.01;与模型对照组比较,**P<0.01
以上已对本发明创造的较佳实施例进行了具体说明,但本发明创造并不限于所述实施例,熟悉本领域的技术人员在不违背本发明创造精神的前提下还可做出种种的等同的变型或替换,这些等同的变型或替换均包含在本申请权利要求所限定的范围内。
Claims (10)
1.一种含乙酰氨基葡萄糖的微生态制剂在制备应激性胃溃疡治疗药物或保健食品中的应用,其特征在于,所述的微生态制剂包括乙酰氨基葡萄糖或其药学上可接受的盐,和益生菌组合物;其中乙酰氨基葡萄糖的含量为0.1~32wt%,益生菌组合物的含量为40-60wt%;所述益生菌组合物由嗜酸乳杆菌、鼠李糖乳杆菌、保加利亚乳杆菌、青春双岐杆菌、婴儿双岐杆菌按如下重量比组成:(0.01~1):(0.01~1):(0.01~1):(0.01~1):(0.01~1)。
2.根据权利要求1所述的应用,其特征在于,所述的应用为在制备保护胃黏膜的药物或保健食品中的应用。
3.根据权利要求1所述的应用,其特征在于,所述的乙酰氨基葡萄糖药学上可接受的盐选自乙酰氨基葡萄糖的盐酸盐、磷酸盐、硫酸盐、柠檬酸盐、草酸盐、马来酸盐。
4.根据权利要求1所述的应用,其特征在于,所述的益生菌组合物中嗜酸乳杆菌、鼠李糖乳杆菌、保加利亚乳杆菌、青春双岐杆菌、婴儿双岐杆菌的重量比为0.5:0.5:0.5:1:1。
5.根据权利要求1所述的应用,其特征在于,所述的微生态制剂中,以所述微生态制剂总量为基准计,所述微生态制剂中益生菌活菌数量为:嗜酸乳杆菌LA85:1.5×109cfu/g,鼠李糖乳杆菌LRa05:1.5×109cfu/g,保加利亚乳杆菌LB42:1.5×109cfu/g、青春双歧杆菌BAC30:3×109cfu/g,婴儿双歧杆菌BI45:3×109cfu/g。
6.一种含乙酰氨基葡萄糖的微生态制剂,其特征在于,所述的微生态制剂包括乙酰氨基葡萄糖或其药学上可接受的盐,和益生菌组合物;其中乙酰氨基葡萄糖的含量为0.1~32wt%,益生菌组合物的含量为40-60wt%;所述益生菌组合物由嗜酸乳杆菌、鼠李糖乳杆菌、保加利亚乳杆菌、青春双岐杆菌、婴儿双岐杆菌按如下重量比组成:(0.01~1):(0.01~1):(0.01~1):(0.01~1):(0.01~1)。
7.根据权利要求6所述的微生态制剂,其特征在于,所述的乙酰氨基葡萄糖药学上可接受的盐选自乙酰氨基葡萄糖的盐酸盐、磷酸盐、硫酸盐、柠檬酸盐、草酸盐、马来酸盐。
8.根据权利要求6所述的微生态制剂,其特征在于,所述的益生菌组合物中嗜酸乳杆菌、鼠李糖乳杆菌、保加利亚乳杆菌、青春双岐杆菌、婴儿双岐杆菌的重量比为0.5:0.5:0.5:1:1。
9.根据权利要求6所述的微生态制剂,其特征在于,所述的微生态制剂中,以所述微生态制剂总量为基准计,所述微生态制剂中益生菌活菌数量为,嗜酸乳杆菌LA85:1.5×109cfu/g,鼠李糖乳杆菌LRa05:1.5×109cfu/g,保加利亚乳杆菌LB42:1.5×109cfu/g、青春双歧杆菌BAC30:3×109cfu/g,婴儿双歧杆菌BI45:3×109cfu/g。
10.根据权利要求6所述的微生态制剂,其特征在于,所述的微生态制剂为胶囊剂、散剂或片剂。
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