CN109432233A - 一种含有猴头菇提取物的抑反流护胃组合物及应用 - Google Patents
一种含有猴头菇提取物的抑反流护胃组合物及应用 Download PDFInfo
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- CN109432233A CN109432233A CN201811497515.1A CN201811497515A CN109432233A CN 109432233 A CN109432233 A CN 109432233A CN 201811497515 A CN201811497515 A CN 201811497515A CN 109432233 A CN109432233 A CN 109432233A
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- reflux
- suppression
- hericium erinaceus
- erinaceus extract
- alginate
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Abstract
本发明提供了一种含有猴头菇提取物的抑反流护胃组合物及应用,制备了一种含有猴头菇提取物的抑反流护胃组合物及乳液,具体成分包括海藻酸钠,黄原胶,茶油,氢氧化铝,碳酸氢钠,碳酸钙,猴头菇提取物和氢氧化钠。本发明制备的产品为一种更加安全、有效且具有药食两用价值的漂浮制剂,其在人胃内容物pH值时可形成比重低于人胃内容物的漂浮筏,当出现反流症状时,所形成的海藻酸盐筏优先被推动回流到食管中,粘附在食管表面,作为一种胃食管物理屏障保护粘膜不被胃酸、酶及食物侵蚀,从而缓解胃部灼热、烧心和反流症状,因此安全性更高,副作用更小,同时制备方法简单,成本低。
Description
技术领域
本发明涉及医用配制品技术领域,更具体的说是涉及一种含有猴头菇提取物的抑反流护胃组合物及应用。
背景技术
胃食管反流病(gastroesophageal reflux disease,GERD)是由胃内容物反流引起不适症状和(或)并发症的一种疾病,烧心和反流(反食、泛酸)是本病的特征性症状,主要发病机制是食管下括约肌的一过性松弛,从而导致胃内容物反流入食管。其中食管黏膜有组织病理学损伤改变者称为反流性食管炎(RE),具备GERD症状而无内镜下黏膜损害者称为非糜烂性胃食管反流病(NERD)。北京、上海两地的流行病学调查表明,食管反流症状发生率高达8.97%,GERD患病率为5.77%,RE发病率为1.92%,约50%-70%的GERD患者表现为NERD。随着国民经济的持续发展、人民生活水平的提高,饮食结构的改变,以及临床医师对GERD诊断水平的提高,GERD的发病率正逐年上升,且男女发病无明显差异。胃部灼热、烧心和反流严重降低了人们的生活水平,因而对GERD的治疗已成为消化学界研究的热点。GERD的治疗以改善症状、消除食管炎、降低反流损害性、增强抗反流防御机制为主要目的。只有情况严重或成为慢性病时才寻求专业帮助,普通人群遭受灼热、烧心和反流的,一般可通过自疗处理。如选择非处方药抗酸剂、H2受体拮抗剂和铋剂等来缓解或治疗胃灼热、烧心和反流。
传统的抗酸剂如碳酸氢钠、碳酸钙、氢氧化铝或三硅酸镁等起效迅速,一般几分钟就能使胃内pH提高到3.5以上,从而缓解烧心和反流的症状。但由于生理胃酸的持续分泌及胃排空的影响,其维持升高pH的能力有限,因此作用持续时间短。为提高疗效,人体需要反复给药才可持续缓解胃灼热等症状。这增加了用药频率,在实际生活中是不适用的。H2受体拮抗剂通过抑制胃酸分泌,预防和缓解烧心症状,但和抗酸剂相比需要经全身吸收才能发挥作用,因此具有一定的迟滞性,另外,H2受体拮抗剂对胃酸的抑制时间长达6h,这在一定程度上限制了其应用。含铋的产品一般适用于胃酸抑制过度的治疗,它既不中和胃酸,也不抑制胃酸分泌,而是在胃液pH条件下,在溃疡表面或溃疡基底肉芽组织形成一种坚固的氧化铋胶体沉淀,成为保护性薄膜,从而隔绝胃酸、酶及食物对溃疡黏膜的侵蚀作用,促进溃疡组织的修复和愈合,进而舒缓胃灼热,胃部不适和恶心的症状。但铋化合物会使舌头染色及粪便变暗,并且长期使用会造成神经毒性。
与传统的抗酸剂和H2受体拮抗剂不同,海藻酸盐漂浮物主要通过物理而非化学或药理手段起作用。这种独特的作用机制既提供了常规的抗酸剂起效快速的特点,又提供了更长的有效持续时间,如市售的Gaviscon。该治疗方式比化学和药理手段更安全,副作用更小。但是该组合物依赖于碳酸氢钠和碳酸钙产生的二氧化碳,它们在酸性条件下使海藻酸盐粘液发泡并降低粘液密度以使其漂浮在胃内容物上。该产品存在以下几个风险:1导致胃过度扩张,这对患有胃溃疡的患者存在胃穿孔风险;2组合物中使用碳酸氢钠和碳酸钙可能导致胃内容物的pH升高至正常值以上,这是治疗中所不希望发生的;3为使组合物有效,需要相对大量的碳酸氢钠,且该组合物给药是需长期进行的,考虑到和海藻酸钠连用,可能导致患者体内钠平衡紊乱。
因此需要发明一种更加安全且有效的漂浮制剂,使其在人胃内容物pH值时即可形成比重低于人胃内容物的漂浮物,用于缓解普通人群出现的胃灼热、烧心和反流的症状。该漂浮物不仅起效快,作用持续时间长,而且具有良好的生物粘附性和稳定性,因此具有更高的安全性和更小的副作用。同时,该漂浮物还具有一定的营养学价值,能够为人体提供所需能量。是一种药食两用的,安全、有效的创新型漂浮制剂。
发明内容
有鉴于此,本发明目的在于提供一种稳定性好,质量高,疗效好且不良反应小,可药食两用的含猴头菇提取物的抑反流护胃组合物及该组合物乳液。本发明制备的组合物及乳液与胃液接触后,能够形成密度低于胃内容物密度的筏漂浮于胃液之上,当出现反流症状时,所形成的海藻酸盐筏优先被推动回流到食管中,粘附在食管表面,作为一种胃食管物理屏障保护粘膜不被胃酸、酶及食物侵蚀,从而舒缓胃灼热,烧心和反流的症状。
为了实现上述目的,本发明采用如下技术方案:
本发明公开了一种含有猴头菇提取物的抑反流护胃组合物,包括以下重量份数的原料:
优选的,一种含有猴头菇提取物的抑反流护胃组合物,包括以下重量份数的原料:
优选的,海藻酸盐包括海藻酸钠、海藻酸钾或海藻酸钙中的一种或多种混合物。
优选的,所述黄原胶用刺槐豆胶替代。
本发明使用原理及有益效果为:
1、海藻酸盐作为一种安全,副作用小的生物骨架材料,包括海藻酸钠、海藻酸钾和海藻酸钙等其他有机衍生物。
2、黄原胶既作为生物粘附剂又作为有价值的悬浮剂,其效果优于Gaviscon产品中的卡波姆,因为卡波姆在海藻酸盐的存在下会失去生物粘附性。黄原胶作为生物粘附剂,能够使漂浮的筏更好的涂覆在反流性食管炎,胃炎,消化不良和/或与反流有关的食道疾病中的生物表面,从而发挥持续长久的保护作用。应当指出,本发明中,黄原胶还可用刺槐豆胶替代,但优选黄原胶。
3、茶油作为油相,具有凝固点低,不皂化物含量少,食用后易消化吸收,热稳定性好,不易氧化变质,安全无毒副作用的特点。茶油中的不饱和脂肪酸总含量高达90.48%,普遍高于其他食用油脂,其中亚油酸含量达到8%-10%,油酸含量为75%-86%,还含有必须脂肪酸亚麻酸,这些不饱和脂肪酸是合成人体内前列腺素所必须的,能够保证细胞的正常生理功能,降低血液中胆固醇和甘油三酯,降低血液粘稠度,改善血液微循环,从而起到预防和治疗高血压、冠心病等心血管疾病的作用。此外,茶油中还含有特殊的生理活性物质,如茶多酚和鞣质,可用于重金属解毒和抗辐射,阻止骨髓被放射性物质侵害,茶多酚还原性较强,可清楚氧自由基,增加血液含氧量,使人精力旺盛,皂苷能够调节免疫能力、抗疲劳、抗低温应激、抗脂质氧化、抗突变等功能。含有的锌元素能够促进维生素的吸收,参与核酸的合生,是人体必不可少的微量元素。含有的角鲨烯能够加速血液循环,消炎,修复皮外伤,烫伤等伤口细胞。总之,茶油含有多种功能性的成分,一方面具有清热化湿、解毒、消炎、镇痛、清胃润肠等作用,另一方面具有较强的抗氧化性能,使其能激活抗氧化酶SOD,清除自由基,保护免疫系统,进而促进胃肠道粘膜损伤的修复。其作为油乳液提供缓和剂的优点,用于缓和食道炎症组织及胃-食管交界组织。本发明中,茶油也可用沙棘油、橄榄油替代。
4、碳酸氢钠和碳酸钙作为助漂剂和胃酸中和剂,在中和胃酸同时产生二氧化碳促使海藻酸盐漂浮。因其用量较少,能够避免因过度膨胀存在的胃穿孔风险。钙离子一方面促进海藻酸盐交联,一方面也作为人体必须元素的来源。
5、氢氧化铝作为胃黏膜保护剂,在服用后,一方面,能够中和胃酸,保护胃黏膜免受胃酸侵蚀,另一方面,铝离子能够促进海藻酸盐的交联,缩短起漂时间。同时研究发现,氢氧化铝能够提供碱性条件从而提高海藻酸盐溶解度,而海藻酸盐又能够增强氢氧化铝的稳定性。
6、猴头菇不仅含有丰富的营养价值,能为人体提供能量,还拥有巨大的药用价值。猴头菇肉质鲜美,营养丰富,含有多种有益菌多糖和人体必需氨基酸及微量元素(如Fe、Cu、Zn和Se等)。其所含的营养物质中蛋白质含量高达28.35%,含有硫胺素、核黄素和胡萝卜素等维生素,且含有除甲硫氨酸之外的其他7种人体必需氨基酸。其含有的大量多糖和寡糖,对多种消化系统疾病如慢性胃炎、消化不良和胃溃疡都具有较好的疗效,同时还具有抗肿瘤、免疫调节、抗衰老、降血糖和保护神经等活性。是不可多得的具有药食两用价值的食材。应当指出,该组合物中猴头菇主要为其提取物。
由上述所述的含有猴头菇提取物的抑反流护胃组合物在制备含有猴头菇提取物的抑反流护胃组合物乳液中的应用。
一种含有猴头菇提取物的抑反流护胃组合物乳液的制备方法,包括以下步骤:
第一步:猴头菇提取物的制备:
(1)前处理:猴头菇清洗干净,切片,加入20-30倍量的去离子水,水温40-50℃,浸泡20-24h;
(2)提取:回流提取5-6h,滤除溶液,药材再加入10-15倍量的水回流提取4-5h,滤除溶液,药材再加入5-10倍量的水回流提取3-5h,弃去滤渣合并滤液;
(3)浓缩:将合并后的滤液减压浓缩,获取含水量30-40%浓缩物;
(4)醇沉:浓缩物边搅拌边加入4-8倍量95%乙醇,静置20-25h,去上清液,离心得浸膏;
(5)干燥:真空干燥,温度50-60℃,时间40-48h,得猴头菇提取物的干燥物;
(6)粉碎:干燥物过80目筛粉碎,备用。
第二步:称取上述所述含有猴头菇提取物的抑反流护胃组合物中的各原料备用;将称取的氢氧化钠与海藻酸盐溶于水中,然后加入氢氧化铝、碳酸氢钠、黄原胶、碳酸钙以及猴头菇提取物,得到混合溶液A;再将称取的茶油缓慢加入搅拌状态下的混合溶液A,经剪切机剪切,即得到抑反流护胃的海藻酸盐组合物乳液。
具体地说,氢氧化钠作为pH调节剂,用于调节溶液pH在8-9范围内,更优选pH范围为8.2-8.6。
本发明的含有猴头菇提取物的抑反流护胃组合物乳液,黏度在900~1000mPa.s。
本发明的含有猴头菇提取物的抑反流护胃组合物乳液,D50在0.1~10μm,更优在0.5~2μm。
本发明的含有猴头菇提取物的抑反流护胃组合物及乳液还可包含以下一种或多种化合物,如pH调节剂、矫味剂、粘合剂、抗氧化剂及着色剂等用于改善海藻酸盐组合物乳液的味道、稠度、颜色和储存期间稳定性的相关方面。
本发明的含有猴头菇提取物的抑反流护胃组合物及乳液还可与抗酸剂、H2受体拮抗剂、铋剂等联合使用而不会降低彼此药效。
上述制备的含有猴头菇提取物的抑反流护胃组合物及乳液可以应用于制备修复以及保护胃药物及保健品中。
本发明的有益效果包括以下几个方面:
1、本发明提供的海藻酸钠组合物乳液,主要通过物理手段即可达到缓解和治疗胃食管烧心、反流等症状,与化学和药理手段相比,该方法更加安全,副作用更小;
2、本发明提供的海藻酸盐组合物乳液,加入少量碳酸氢钠和碳酸钙即能达到成筏漂浮的目的,避免了大量使用碳酸氢钠和碳酸钙产气过多导致的胃过度扩张及对患有胃溃疡的患者造成胃穿孔的风险;
3、本发明提供的海藻酸盐组合物乳液,在缓解和治疗胃食管烧心、反流症状同时,还含有丰富的营养,能够为人体提供所需能量,是一种创新型的药食两用的组合物乳液;
4、本发明提供的海藻酸盐组合物乳液的制备方法,操作简单,条件温和,易于产业化生产。
具体实施方式
下面将结合本发明实施例,对本发明的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅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做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。
实施例1:
组分:(20ml每袋用量)
实施例2:
组分:(20ml每袋用量)
实施例3:
组分:(20ml每袋用量)
对照例1:
组分:(20ml每袋用量)
对照例2:
组分:(20ml每袋用量)
对照例3:
组分:(20ml每袋用量)
对照例4:
组分:(20ml每袋用量)
对照例5:
对照例6:
对照例7:
组分:(20ml每袋用量)
上述实施例和对照例制备方法如下所述:
第一步:猴头菇提取物的制备:
(1)前处理:猴头菇清洗干净,切片,加入20倍量的去离子水,水温40-50℃,浸泡24h;
(2)提取:回流提取6h,滤除溶液,药材再加入10倍量的水回流提取4h,滤除溶液,药材再加入5倍量的水回流提取3h,弃去滤渣合并滤液;
(3)浓缩:将合并后的滤液减压浓缩,获取含水量30-40%浓缩物;
(4)醇沉:浓缩物边搅拌边加入4倍量95%乙醇,静置24h,去上清液,离心得浸膏;
(5)干燥:真空干燥,温度50-60℃,时间48h,得猴头菇提取物的干燥物;
(6)粉碎:干燥物过80目筛粉碎,备用。
第二步:称取处方量的氢氧化钠溶于水中,溶解处方量的海藻酸钠,然后依次加入处方量的氢氧化铝、碳酸氢钠、黄原胶、碳酸钙和猴头菇提取物,得到混合溶液A;
第三步:将处方量的茶油缓慢加入搅拌状态下的混合溶液A,剪切机剪切10min(10000rpm)即得到海藻酸盐组合物乳剂。
一、海藻酸盐组合物乳剂粒径大小和稳定性的考察:
以实施例2的处方组成为依据,制备方法参照实施例和对照例制备方法,用激光粒度仪分别考察剪切1min、2min、3min、5min、8min、10min和15min时乳液的D50并分析粒径对样品稳定性的影响。分别于0h,2h,5h,10h,24h,5天,20天,1个月,3个月,9个月和12个月目视观察组合物乳液是否会产生沉淀,按照以下标准来评价,结果见表1。
◎:未产生沉淀
○:可观察到微量的沉淀产生
×:沉淀大量产生
表1不同剪切时间下D50对样品稳定性的影响
由表1结果分析可知,剪切时间越长,乳剂D50越小,样品稳定性越好。对比剪切10min和剪切15min,样品的粒径差别不大,且10min时样品稳定性也很好,考虑到大生产效率问题,将剪切时间定为10min。
二、海藻酸盐组合物乳剂稳定性测试:
在制造海藻酸盐组合物乳剂后,以25℃保存12个月,分别于0天,1个月,3个月,6个月和12个月目视观察组合物乳液是否会产生沉淀,按照以下标准来评价,结果见表2。
◎:未产生沉淀
○:可观察到微量的沉淀产生,但手动振摇能迅速分散
×:沉淀大量产生,即使手动振摇也不能重新分散
表2海藻酸盐组合物乳液的稳定性
由表2结果分析可知,黄原胶作为助悬剂,其用量直接影响组合物乳液的稳定性,不加黄原胶或黄原胶用量较低时,组合物乳液稳定性较差(对比实施例1和对照例1和2可知)。对照例3,对照例4,,对照例5和对照例6的结果可知,不加氢氧化铝,碳酸氢钠或碳酸钙,对乳液稳定性影响不大。由对照例7的结果分析可知,氢氧化钠用于调节溶液pH是必不可少的,其影响海藻酸盐的溶解性。
三、起漂时间和持续漂浮时间的考察:
体外实验观察海藻酸盐组合物乳液的漂浮性能。具体方法为:将人工胃液(不含酶)50mL作为漂浮介质,置于恒温振荡仪中,转速为100r/min,温度为(37±0.5)℃,取20ml海藻酸盐组合物乳剂加入人工胃液(不含酶)中,观察起漂时间并持续观察在2h、4h、10h及24h时漂浮物的沉降高度,并记录其沉降高度,结果见表3。
表3海藻酸盐组合物乳液起漂时间和持续漂浮时间
注:对照例7表示因海藻酸盐不溶沉淀,因此未考察组合物乳液起漂时间及持续漂浮时间。
由表3结果可知,实施例1、2和3的起漂时间迅速,1min内即可迅速起漂且持续漂浮时间长,说明组合物成筏迅速且作用时间持久。对比实施例2和对照例4可知,碳酸氢钙和碳酸钙作为助漂剂能够加速组合物乳液迅速起漂并能增强其持续漂浮时间,对比实施例2和对照例3可知,氢氧化铝因影响海藻酸盐的交联而影响其组合物乳液的起漂时间,由此可知,氢氧化铝在一定程度上影响组合物的起漂速度。对比实施例2和对照例5和6结果可知,单独使用碳酸氢钙或碳酸钙的助漂效果不如两者联合使用效果好。
四、生物粘附性考察:
实验条件为:将禁食供水饲养24h后的大鼠随机分为3组,处死后取胃,平铺于载物台上。分别取实施例和对照例的组合物乳液,均匀分散在胃黏膜表面,将其置于饱和氯化钠溶液的密闭容器中,保湿20min后取出,使载物台呈45°斜角放置。用人工胃液(不含酶)以20ml/min冲洗5min,求其相对滞留率,相对滞留率=冲洗后剩余物重量/未冲洗存在物重量*100%,结果见表4。
表4海藻酸盐组合物乳液的生物粘附性
注:对照例7表示因海藻酸盐沉淀,因此未考察组合物乳液的生物粘附性。
由表4结果可知,随着黄原胶用量的增加,其生物粘附性效果增强(具体参见实施例1、2和3结果),对比实施例2和対照例2可知,黄原胶生物粘附性效果优于卡波姆,对比实施例1和对照例1,实施例2和对照例3、4、5和6结果进一步显示,黄原胶用量影响生物粘附性大小。
本说明书中各个实施例采用递进的方式描述,每个实施例重点说明的都是与其他实施例的不同之处,各个实施例之间相同相似部分互相参见即可。对于实施例公开的装置而言,由于其与实施例公开的方法相对应,所以描述的比较简单,相关之处参见方法部分说明即可。
对所公开的实施例的上述说明,使本领域专业技术人员能够实现或使用本发明。对这些实施例的多种修改对本领域的专业技术人员来说将是显而易见的,本文中所定义的一般原理可以在不脱离本发明的精神或范围的情况下,在其它实施例中实现。因此,本发明将不会被限制于本文所示的这些实施例,而是要符合与本文所公开的原理和新颖特点相一致的最宽的范围。
Claims (10)
1.一种含有猴头菇提取物的抑反流护胃组合物,其特征在于,包括以下重量份数的原料:
2.根据权利要求1所述的一种含有猴头菇提取物的抑反流护胃组合物,其特征在于,包括以下重量份数的原料:
3.根据权利要求1或2所述的一种含有猴头菇提取物的抑反流护胃组合物,其特征在于,海藻酸盐包括海藻酸钠、海藻酸钾或海藻酸钙中的一种或多种混合物。
4.根据权利要求1或2所述的一种含有猴头菇提取物的抑反流护胃组合物,其特征在于,所述黄原胶用刺槐豆胶替代。
5.由权利要求1-4任一项所述的含有猴头菇提取物的抑反流护胃组合物在制备含有猴头菇提取物的抑反流护胃组合物乳液中的应用。
6.一种含有猴头菇提取物的抑反流护胃组合物乳液的制备方法,其特征在于,包括以下步骤:
1)称取如权利要求1-4所述含有猴头菇提取物的抑反流护胃组合物中的各原料备用;
2)将步骤1)中称取的氢氧化钠与海藻酸盐溶于水中,然后加入氢氧化铝、碳酸氢钠、黄原胶、碳酸钙以及猴头菇提取物,得到混合溶液A;
3)将步骤1)称取的茶油缓慢加入搅拌状态下的混合溶液A,经剪切机剪切,即得到抑反流护胃的海藻酸盐组合物乳液。
7.根据权利要求6所述的一种含有猴头菇提取物的抑反流护胃组合物乳液的制备方法,其特征在于,所述含有猴头菇提取物的抑反流护胃组合物乳液的pH为8~9。
8.根据权利要求6所述的一种含有猴头菇提取物的抑反流护胃组合物乳液的制备方法,其特征在于,所述含有猴头菇提取物的抑反流护胃组合物乳液的黏度在900~1000mPa.s。
9.根据权利要求6所述的一种含有猴头菇提取物的抑反流护胃组合物乳液的制备方法,其特征在于,所述含有猴头菇提取物的抑反流护胃组合物乳液的D50在1~10μm。
10.一种由权利要求6~9制备的含有猴头菇提取物的抑反流护胃组合物乳液在制备修复以及保护胃药物及保健品中的应用。
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