CN117064938A - 无花果提取物在制备预防和治疗结石的药物中的应用 - Google Patents
无花果提取物在制备预防和治疗结石的药物中的应用 Download PDFInfo
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Abstract
本发明公开了无花果提取物在制备预防和治疗结石的药物中的应用。本发明通过药效及药理学作用实验发现：无花果乙醇提取物和水提取物能有效抑制草酸钙的形成，显著降低草酸钙结晶的密度数量，改变其结构，以起到抗结石的效果。以上结果表明无花果提取物有很强的抗结石效果。经实验研究证实：本发明包括有效量的无花果提取物作为活性成分的药物在预防和治疗结石时，有效抑制结石晶体的形成，其毒副作用小，效果持久，价格低廉。
Description
技术领域
本发明属于医药技术领域，具体涉及无花果提取物在制备预防和治疗结石的药物中的应用。
背景技术
结石严重危害着人类的生命与健康。结石(Calculi)是指人体或动物体内的导管腔中或腔性器官(如肾脏、输尿管、胆囊或膀胱等)的腔中形成的固体块状物。主要见于胆囊及膀胱、肾盂中，也可见于胆管、胰导管、涎腺导管等的腔中。含钙结石是泌尿系结石中最常见的结石类型。含钙结石可分为：单纯的草酸钙、草酸钙和磷酸钙、以及除草酸钙还有少量的尿酸。发病率比较高，约5-6％，并且近年来更是呈逐年上升的趋势。
无花果(Ficus carica Linn)是桑科榕属植物，主要生长于一些热带和温带的地方，属亚热带落叶小乔木。无花果已知有八百个品种，绝大部分都是常绿品种，只有长于温带地方的才是落叶品种。果实呈球根状，尾部有一小孔，花粉由黄蜂传播。无花果除鲜食、观赏外、还可药用。
无花果的根、茎、叶、果均可入药,其药用价值很早就受到人们的重视。果实性味甘平,无毒,叶子性味甘微辛平、微毒,具有滋养、健脾、开胃、清热、润肠、解毒、消肿、降血压等功效,主治咽喉肿痛、干咳不愈、食欲不振、消化不良、乳汁缺少、痔疮等疾病。研究发现无花果的提取液对癌细胞具有明显的抑制作用，能阻止癌细胞的蛋白质合成，而对正常细胞无伤害。因此，无花果被认为是抗癌食品。据江苏省肿瘤防治研究所作抗癌试验表明无花果治疗癌症效果达40-50％，已被医药部门批准作抗癌新药试用。此外，无花果含有大量的膳食纤维、果胶等成分，可驱除人体内的铅，降低胆固醇和血糖，对心、脑血管硬化及糖尿病具有治疗作用，还可降低肝脏中的醋质含量，对脂肪肝有一定的疗效。
发明内容
本发明的目的是针对现有技术的不足，提供无花果提取物在制备预防和/或治疗结石的药物中的应用。
本发明通过药效及药理学作用实验发现：无花果提取物能有效抑制草酸钙的形成，或促进草酸钙的降解。在草酸钙一水化合物结晶化实验中，加入无花果提取物可以有效抑制草酸钙晶体的形成。与对照组比较，加入无花果水提物或乙醇粗提物，草酸钙结晶化的密度显著下降，晶体总面积显著性下降；加入水粗提物，草酸钙结晶化的密度显著下降，晶体总面积显著性下降。上述的指标均有统计学显著差异，表明无花果提取物有很强的抗结石效果。经实验研究证实：本发明的预防和治疗结石的药物毒副作用小，效果持久，价格低廉。
因此，本发明的目的是提供无花果提取物在制备预防和/或治疗结石的药物中的应用。
所述的无花果提取物是无花果的水提物或醇提物，所述的无花果是无花果的根、茎、叶、果或全株。进一步优选是干燥的无花果的根、茎、叶、果或全株。所述的醇提物是乙醇提取物，进一步可以是75％的乙醇提取物。
该预防和/或治疗结石的药物还包括药学上可接受的载体；所述的药学上可接受的载体为常规药物赋形剂或辅剂。
优选，所述的结石可以是尿结石或肾结石。
优选，所述的药物含有0.1％-99.9％重量的无花果提取物。
优选，所述的药物的剂型为液体剂型或固体剂型。
优选，所述的液体剂型为注射剂、溶液剂、混悬剂、乳剂或气雾剂。
优选，所述的固体剂型为片剂、胶囊、丸剂、粉针剂、缓释制剂或微粒给药系统。
本发明的药物可根据本领域已知的方法制备。用于此目的时，如果需要，可将活性成分与一种或多种固体或液体药物赋形剂和/或辅剂结合，制成可作为人药使用的适当施用形式或剂量形式。
本发明的药物可以单位剂量形式给药，给药途径可为肠道或非肠道，如口服、肌肉、皮下、鼻腔、口腔粘膜、皮肤、腹膜或直肠等。
本发明的药物的给药途径可为注射给药。注射包括静脉注射、肌肉注射、皮下注射、皮内注射和穴位注射等。
给药剂型可以是液体剂型、固体剂型。如液体剂型可以是溶液类、胶体类、微粒剂型、乳剂剂型、混悬剂型。固体剂型可以是片剂、胶囊、滴丸、气雾剂、丸剂、粉剂、溶液剂、混悬剂、乳剂、颗粒剂、栓剂、冻干粉针剂等。
本发明的药物可以制成普通制剂、也可以是缓释制剂、控释制剂、靶向制剂及各种微粒给药系统。
为了将单位给药剂型制成片剂，可以广泛使用本领域公知的各种载体。关于载体的例子是，如稀释剂与吸收剂：淀粉、糊精、硫酸钙、乳糖、甘露醇、蔗糖、氯化钠、葡萄糖、尿素、碳酸钙、白陶土、微晶纤维素、硅酸铝等；湿润剂与粘合剂：水、甘油、聚乙二醇、乙醇、丙醇、淀粉浆、糊精、糖浆、蜂蜜、葡萄糖溶液、阿拉伯胶浆、明胶浆、羧甲基纤维素钠、紫胶、甲基纤维素、磷酸钾、聚乙烯吡咯烷酮等；崩解剂，例如干燥淀粉、海藻酸盐、琼脂粉、褐藻淀粉、碳酸氢钠与枸橼酸、碳酸钙、聚氧乙烯山梨糖醇脂肪酸酯、十二烷基磺酸钠、甲基纤维素、乙基纤维素等；崩解抑制剂，如蔗糖、三硬脂酸甘油酯、可可脂、氨化油等；吸收促进剂，例如季铵盐、十二烷基硫酸钠等；润滑剂，例如滑石粉、二氧化硅、玉米淀粉、硬脂酸盐、硼酸、液体石蜡、聚乙二醇等；还可以将片剂进一步制成包衣片，例如糖包衣片、薄膜包衣片、肠溶包衣片，或双层片和多层片。
为了给药单元制成丸剂，可以广泛使用本领域公知的各种载体。关于载体的例子是，例如稀释剂与吸收剂，如葡萄糖、乳糖、淀粉、可可脂、氢化植物油、聚乙烯吡咯烷酮、Gelucire、高岭土、滑石粉等；粘合剂，如阿拉伯胶、黄蓍胶、明胶、乙醇、蜂蜜、液糖、米糊或面糊等；崩解剂，如琼脂粉、干燥淀粉、海藻酸盐、十二烷基磺酸钠、甲基纤维素、乙基纤维素等。
为了将给药单元制成栓剂，可以广泛使用本领域公知的各种载体，例如聚乙二醇、卵磷脂、可可脂、高级醇、高级醇的酯、明胶、半合成甘油酯等。
为了将栓剂制成胶囊，将有效成分与上述的各种载体混合，并将由此得到的混合物置于硬的明胶胶囊或软胶囊中，也可将有效成分制成微囊剂，混悬于水性介质中形成混悬剂，亦可装入硬胶囊中或制成注射剂应用。
例如将本发明的药物制成注射用制剂，如溶液剂、混悬剂溶液剂、乳剂、冻干粉针剂，这种制剂可以是含水或非水的，可含一种和/或多种药效学上可接受的载体、稀释剂、粘合剂、润滑剂、防腐剂、表面活性剂或分散剂，如稀释剂可选自水、乙醇、聚乙二醇、1，3-丙二醇、乙氧基化的异硬脂醇、多氧化的异硬脂醇、聚氧乙烯山梨醇脂肪酸酯等。另外，为了制备等渗注射液，可以向注射用制剂中添加适量的氯化钠、葡萄糖或甘油，此外，还可以添加常规的助溶剂、缓冲剂、pH调节剂等。这些辅料是本领域常用的。
此外，如需要，也可以向药物制剂中添加着色剂、防腐剂、香料、矫味剂、甜味剂或其他材料。
本发明的药物的给药剂量可以考虑个体差异在一定范围内变化，例如所要预防或治疗疾病的性质和严重程度，患者或动物的性别、年龄、体重、性格及个体的反应，给药途径、给药次数等。
本发明的第二个目的是提供一种预防和/或治疗结石的药物，包括有效量的无花果提取物作为活性成分。
本发明通过药效及药理学作用实验发现无花果提取物有很强的抗结石效果，利用无花果提取物制备的预防和治疗结石的药物具有毒副作用小，效果持久，价格低廉的优点，具有广泛的应用前景。
附图说明
图1是乙醇提取物作用于草酸钙一水化合物结晶化实验显微镜拍摄图。
图2是草酸钙一水化合物结晶化实验中乙醇提取物对晶体生成抑制率统计图。
图3是乙醇提取物作用于草酸钙一水化合物结晶化实验结晶密度统计结果图。
图4是乙醇提取物作用于草酸钙一水化合物结晶化实验结晶大小统计结果图。
图5是乙醇提取物作用于草酸钙一水化合物结晶化实验结晶总面积统计结果图。
图6是水提取物作用于草酸钙一水化合物结晶化实验显微镜拍摄图。
图7是草酸钙一水化合物结晶化实验中水提取物对晶体生成抑制率统计图。
图8是水提取物作用于草酸钙一水化合物结晶化实验结晶密度统计结果图。
图9是水提取物作用于草酸钙一水化合物结晶化实验结晶大小统计结果图。
图10是水提取物作用于草酸钙一水化合物结晶化实验结晶总面积统计结果图。
具体实施方式
以下实施例是对本发明的进一步说明，而不是对本发明的限制。
下面将结合具体实施方式，详细介绍本发明的无花果提取物在预防和治疗结石方面的应用以及含有无花果提取物成分的预防和治疗结石的药物。本发明发现无花果提取物可以在治疗结石药物中得到应用。
实施例1：
一、无花果提取物的分离提纯
1、水提取方法具体如下：
自然晾干的无花果包含果实的枝叶及根，破碎后称取适量无花果，放入加热容器中，加入无花果5倍重量的双蒸水。加热水煮2小时，过滤；滤液留存，无花果再次加水，方法同前。如此连续提取2次，合并两次的滤液，减压浓缩得无花果水提物。提取物4℃保存。
2、乙醇提取方法具体如下：
自然晾干的无花果包含果实的枝叶及根，破碎后称取适量无花果，将干燥破碎的无花果用20倍量的体积分数75％乙醇水溶液浸泡48小时，期间超声20分钟，提取液倒出后，进行如上二次浸泡，合并滤液、减压浓缩得无花果醇提物，4℃保存。
二、药效及药理作用实验
1.草酸钙一水化合物结晶化实验方案如下：
Jihae Chung等于2016年在有关结石疾病的研究中提出应用了此实验；发现抗结石药可以有效抑制草酸钙结晶的密度及晶体结构。在草酸钙的结晶化过程中加入药物，可应用于抗结石药的研究。具体步骤是：加入5mL的氯化钠(300mM)溶液，然后加入0.7mL的氯化钙(10mM)溶液。将一片清洁的玻片(大约1.3×1.3cm2)置于玻璃瓶底部，以收集草酸钙晶体用于显微镜观察。然后将玻璃瓶放入60℃的孵箱中以确保溶液达到结晶化温度。然后逐滴加入0.7mL草酸钠(10mM)，同时以400r.p.m的速率连续震荡。为了探索抑制剂的作用，将适量的抑制剂在草酸钠之前加入溶液。终溶液中包括0.7mM氯化钙；0.7mM草酸钠；150mM氯化钠；xμg mL-1抑制剂(x＝0-100，x为0时候为对照)，加纯水至总体积为10mL。稳定状态下，60℃孵育。三天后，取出玻片，用超纯水轻轻冲洗，室温晾干，准备分析。
2.实验材料：实验所需试剂均为分析纯，采购于西格玛奥德里奇公司。
3.实验结果：图1-5所示即为无花果乙醇提取物对草酸钙一水化合物结晶形成的抑制作用。如图1及图2所示，乙醇提取物对晶体形成具有显著抑制作用，并成剂量依赖(p***<0.001)如图3所示，结晶的密度分析发现，乙醇提取物使结晶密度显著性下降(p***<0.001)，并呈剂量依赖；如图4所示，在结晶大小分析中发现，加入乙醇提取物(100μg/mL)后，结晶大小显著性增加(p***<0.001)，结晶结构发生明显变化；如图5所示，在结晶总面积分析中，加入乙醇提取物后，晶体总面积显著性下降(p***<0.001)。以上结果表明，无花果乙醇提取物可以降低草酸钙结晶的密度数量，改变其结构，以起到抗结石的效果。
图6-10所示即为无花果水提取物对草酸钙一水化合物结晶形成的抑制作用。如图6及图7所示，无花果水提取物对晶体形成具有显著抑制作用，并成剂量依赖(p***<0.001)；如图8所示，结晶的密度分析发现，加入水提取物，结晶密度显著性下降，并呈剂量依赖(p***<0.001)；如图9所示，在结晶体积大小分析中发现，加入水提取物后，晶体大小显著性增加(p*<0.05，p***<0.001)，结晶结构发生明显变化；如图10所示，在结晶总面积分析中，加入水提取物后，晶体总面积显著性下降(p*<0.05，p***<0.001)，并呈剂量依赖。以上结果表明，无花果水提取物可以降低草酸钙结晶的密度数量，改变其结构，以起到抗结石的效果。
以上实验表明，本发明包括有效量的无花果醇提取物或水提取物作为活性成分的药物在预防和治疗结石时，可以有效降低结石晶体的形成，其毒副作用小，效果持久，价格低廉。
以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。
Claims (10)
1.无花果提取物在制备预防和/或治疗结石的药物中的应用。
2.根据权利要求1所述的应用，其特征在于，所述的无花果提取物是无花果的水提物或醇提物等方法提取物。
3.根据权利要求2所述的应用，其特征在于，所述的无花果是无花果的根、茎、叶、果或全株；优选是新鲜或干燥的无花果的根、茎、叶、果或全株。
4.根据权利要求2所述的应用，其特征在于，所述的醇提物是乙醇等有机溶剂或其它方法提取物，优选是75％的乙醇提取物。
5.根据权利要求1、2、3或4所述的应用，其特征在于，所述的预防和/或治疗结石的药物含有0.1％-99.9％重量的无花果提取物。
6.根据权利要求1所述的应用，其特征在于，所述的药物的剂型为液体剂型或固体剂型。
7.根据权利要求6所述的应用，其特征在于，所述的液体剂型为注射剂、溶液剂、混悬剂、乳剂或气雾剂；所述的固体剂型为片剂、胶囊、丸剂、粉针剂、缓释制剂或微粒给药系统。
8.根据权利要求1所述的应用，其特征在于，所述的预防和/或治疗结石的药物还包括药学上可接受的载体。
9.根据权利要求1所述的应用，其特征在于，所述的结石是尿结石或肾结石等腔管结石。
10.一种预防和/或治疗结石的药物，其特征在于，包括有效量的无花果提取物作为活性成分。
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| 艾沙江・阿不都沙拉木，等: "无花果在阿图什维吾尔族民间的传统应用的调查研究", 植物分类与资源学报, vol. 37, no. 02, 28 February 2015 (2015-02-28), pages 214 - 220 * |
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