CN101584750B - 一种无花果复方制剂 - Google Patents
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Abstract
本发明公开了一种无花果复方制剂,包括无花果提取物、壳聚糖,以及药学上可接受的辅料或赋形剂,其中,无花果提取物和壳聚糖的重量比为(1∶4)~(9∶1)。所述复方制剂为片剂、胶囊剂、丸剂、口服液中的任一种口服制剂。本发明以无花果提取物和壳聚糖配伍,配合以现代的药物制剂技术,制成复方用以腹泻及便秘的治疗。本发明将无花果的有效成分提取出来,与服用整颗无花果相比,摒弃了无花果中其它无治疗作用的成分,不但效果好,且不会有副作用。本发明具有成本低、效果好等优点。
Description
技术领域
本发明涉及一种无花果复方制剂。
背景技术
随着经济社会的发展和人们生活方式的改变,便秘、腹泻已经成为困扰现代人的常见疾病之一,尤其对于老年人和广大爱美的女性。而对于腹泻,目前基本的治疗方法为抗菌消炎,而大量抗生素的使用所引起的细菌耐药性以及肠道菌丛的紊乱引起的二次感染现象十分严重。对于便秘,既没有引起人们的足够重视,其治疗方法主要是致泻药物,其潜在的危害非常大。在这种情况下,就急需一种天然的,有效的,无毒副作用的保健产品。
无花果Fucys carucak,又名映日果、奶浆果、蜜果(江西)、树地瓜(四川),属桑科榕属植物。无花果的聚花果,落叶灌木,原产亚热带,在我国各地庭院均有栽培。近年来作为经济农作物,已开始大面积推广。无花果含有丰富的糖类、有机酸(柠檬酸、苹果酸)、氨基酸、维生素、果胶以及蛋白酶、微量元素等。
无花果历来被人们视为保健珍品。近年来,现代医学发现无花果具有较显著的抗癌防癌功效引起了全球的关注。研究证实,无花果显著的抗癌防癌作用是内含有效成分协同作用的结果。在国外无花果提取液已用于肿瘤病人的临床治疗,在治愈癌症和延长生命方面是令人瞩目的。但是关于无花果对于肠炎、痢疾、便秘等方面的疗效研究在国内外尚属空白。我国传统医学认为无花果性味甘、平,入脾、大肠,有解毒之功效。主治肠炎、痢疾、消化不良、食欲不振、便秘、黄疸、咽喉痛肿、痔疮肿痛等病症,有显著的效果。无花果的果实中含有大量的果胶和维生素,果实吸水膨胀后,能吸附多种化学物质。因此食用无花果能使肠道的各种有害的物质被吸附,然后排出体外,净化肠道,促进有益菌类的繁殖。
壳聚糖是由甲壳素脱掉大部分乙酰基形成的高分子多糖胺,其作用类似甲壳素,同时可以通过带正电荷的氨基吸附大量带负电荷的脂肪微滴,吸附体内有害物质并排出体外,起到润肠通变作用。
发明内容
针对上述现有技术,针对便秘、腹泻等疾病治疗的现状和不足,为充分发挥无花果在治疗便秘、腹泻中的优势,本发明提供了一种对胃肠具有双向调节作用的无花果复方制剂。
本发明是通过以下技术方案实现的:
一种无花果复方制剂,包括无花果提取物、壳聚糖,以及药学上可接受的辅料或赋形剂,其中,无花果提取物和壳聚糖的重量比为(1∶4)~(9∶1),药学上可接受的辅料或赋形剂无用量限制。
所述无花果提取物是通过以下方法制备的:取无花果鲜果或者干果,粉碎后,用水提取法(水提取法是公知的常规技术)提取无花果的有效成分,经过过滤、浓缩、离心处理后,再浓缩至相对密度1.1~1.3,最后喷雾干燥,成干浸膏粉,即为无花果提取物。
所述复方制剂为片剂、胶囊剂、丸剂、口服液中的任一种口服制剂。
所述复方制剂优选以下组分组成:60g无花果提取物,30g壳聚糖,淀粉10g,4g羟甲基淀粉钠。制备时,将各组分混匀,干压制成颗粒,填充至胶囊,或者加入适量滑石粉压片即可。
本发明所述的复方及其应用是依据无花果复方对便秘动物模型、腹泻动物模型的实验研究结果,是一种对胃肠具有双向调节作用的复方制剂,即:本复方主要用于便秘,也可以用于菌群失调等原因导致的腹泻。研究结果表明:无花果复方既可以有效缩短便秘小鼠的首次排便时间,增加排便数量,又可以延长腹泻小鼠的首次排便时间,减少排便次数,对便秘和腹泻具有良好的双向调节作用而无任何毒副作用。
本发明以无花果提取物和壳聚糖配伍,配合以现代的药物制剂技术,制成复方用以腹泻及便秘的治疗。本发明将无花果的有效成分提取出来,与服用整颗无花果相比,摒弃了无花果中其它无治疗作用的成分,不但效果好,且不会有副作用。本发明具有成本低、效果好等优点。
具体实施方式
下面结合实施例和试验对本发明作进一步的说明:
实施例1:无花果浸膏干粉的制备:
取无花果鲜果1000g,粉碎后,加5倍水提取3小时,提取后,提取液经过过滤、浓缩、离心处理后,再真空浓缩至相对密度1.2左右,最后喷雾干燥,得浸膏干粉112g。
实施例2:无花果复方胶囊的制备:
取无花果干浸膏粉60g,壳聚糖30g,淀粉10g混匀,加入4%羧甲基淀粉钠,混匀,干压制成颗粒,填充至胶囊,即得。
试验1:无花果复方胶囊对小鼠便秘模型的作用
取昆明种小鼠50只. 随机分为5组,每组10只,即空白对照、模型对照及无花果复方高、中、低剂量组(2g/kg、1g/kg、0.5g/kg),连续灌胃7d后进行指标测定,测定前禁食20h(期间自由饮水),模型组和3个剂量组灌胃给予复方地芬诺酯(10mg/kg),空白对照组给蒸馏水。0.5h后,3个剂量组给予含相应受试物墨汁,空白组和模型组给予墨汁灌胃。正常饮水进食。从给墨汁开始,记录每只动物首粒排出黑便时间。6h内排黑便粒数及重量。实验结果如表1所示:
表1无花果复方对复方地芬诺酯小鼠便秘模型排便的影响(x±s,n=10)
注:与模型对照组比较,*:P<0.05;**:P<0.01。
由表中数据可以看出无花果复方给药组,尤其是高剂量组能明显缩短首粒黑便排出时间,增加排便粒数和排便重量,能有效缓解复方地芬诺酯对小鼠便秘的影响,表明无花果复方具有治疗便秘的作用。
试验2:无花果复方胶囊对小鼠腹泻模型的作用
取小鼠50只,随机分5组,每组10只,雌雄各半。即:空白对照组,腹泻模型组(灌胃100%大黄煎液0.3ml/10g),无花果复方胶囊高、中、低剂量组(2g/kg、1g/kg、0.5g/kg),空白对照组灌胃生理盐水,腹泻模型组灌胃100%大黄煎液,1次/d,连续7d。另外3组小鼠在灌胃大黄煎液1h后(1次/d)以上述所示剂量分别给无花果复方胶囊混悬液2次/日,连续7d。于最末一次给药后将各组小鼠置滤纸上观察记录4h内小鼠排便次数、形状、颜色等情况。实验结果如表2所示:
表2无花果复方对大黄煎液致小鼠腹泻模型排便的影响(x±s,n=10)
注:与模型对照组比较,*:P<0.05;**:P<0.01。
由表中数据可以看出无花果复方给药组,尤其是高剂量给药组能明显减少小鼠排便次数,改善小鼠排便形状,改善小鼠排便颜色,表明无花果复方对大黄煎液致小鼠腹泻模型具有治疗作用。
Claims (2)
1.一种无花果复方制剂,其特征在于:由以下组分组成:60g无花果提取物,30g壳聚糖,10g淀粉,4g羧甲基淀粉钠;所述无花果提取物是通过以下方法制备的:取无花果鲜果或者干果,粉碎后,用水提取法提取无花果的有效成分,经过过滤、浓缩、离心处理后,再浓缩至相对密度1.1~1.3,最后喷雾干燥,成干浸膏粉,即为无花果提取物。
2.根据权利要求1所述的一种无花果复方制剂,其特征在于:所述复方制剂为片剂或胶囊剂。
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