CN103877105B - 一种抗乳腺增生的药物组合物及其应用 - Google Patents
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Abstract
本发明公开了一种抗乳腺增生的药物组合物及其应用，该组合物由活性成分和辅料制备而成，所述的活性成分包括野蔷薇苷或/和其衍生物。本发明具有较强的抗乳腺增生的生物活性，并且不会产生耐药性。
Description
技术领域
本发明属于医药技术领域，具体而言，尤其涉及一种抗乳腺增生的药物组合物及其应用。
背景技术
乳腺增生是指乳腺上皮和纤维组织增生，乳腺组织导管和乳小叶在结构上的退行性病变及进行性结缔组织的生长。其主要的临床表现为：（1）乳房疼痛。常为胀痛或刺痛，可累及一侧或两侧乳房，以一侧偏重多见，疼痛严重者不可触碰，甚至影响日常生活及工作。疼痛以乳房肿块处为主，亦可向患侧腋窝、胸胁或肩背部放射；有些则表现为乳头疼痛或痒。乳房疼痛常于月经前数天出现或加重，行经后疼痛明显减轻或消失；疼痛亦可随情绪变化而波动。这种与月经周期及情绪变化有关的疼痛是乳腺增生病临床表现的主要特点。（2）乳房肿块。肿块可发于单侧或双侧乳房内，单个或多个，好发于乳房外上象限，亦可见于其他象限。肿块形状有片块状、结节状、条索状、颗粒状等，其中以片块状为多见。肿块边界不明显，质地中等或稍硬韧，活动好，与周围组织无粘连，常有触痛。肿块大小不一，小者如粟粒般大，大者可逾3-4cm。乳房肿块也有随月经周期而变化的特点，月经前肿块增大变硬，月经来潮后肿块缩小变软。
乳腺增生症是女性临床上常见的乳房疾病，其发病高峰多为3O-40岁。目前多认为该病是由于乳腺生理性增生与复旧不全而形成的乳腺正常结构紊乱，是一种良性乳腺病，从正常(轻度乳痛和微小囊肿)到失常(中度乳痛和临床囊肿)再到疾病(重度乳痛和巨大囊肿)有一个逐渐变化的过程，与内分泌功能失调和精神因素有关。女性处于事业和家庭双重压力下，心情忧虑、紧张压抑、生活不规律等均能引起性激素水平紊乱，孕酮与雌激素比例失调，刺激乳腺组织增生，若激素刺激反应比较敏感，疼痛的症状就相对明显。由于对乳腺增生发生的机理和病因尚无确切了解，目前治疗上基本为对症治疗。症状较明显，病变范围较广泛的病人，可以胸罩托起乳房；口服中药小金丹或消遥散，或5%碘化钾均可缓解症状。近年来类似的药物产品较多，如乳块消、乳癖消、天冬素片、平消片、囊癖灵、三苯氧胺等等，治疗效果不一。此外，尚有激素疗法，有人采用雄激素治疗本病，藉以抑制雌激素效应，软化结节，减轻症状；但这种治疗有可能加剧人体激素间失衡，不宜常规应用。仅在症状严重，影响正常工作和生活时，才考虑采用。
野蔷薇苷是从蔷薇科植物中提取分离出的一种甾醇苷类化合物，国内外对其生物活性研究较少。CN102499932A公开了一种野蔷薇苷在制备抗缺氧药物中的应用，其通过整体及细胞水平缺氧模型，观察野蔷薇苷的抗缺氧作用，结果表明野蔷薇苷可显著提高窒息性缺氧小鼠的存活时间，对内皮细胞缺氧损伤亦具有显著的保护作用。CN102532243A公开了一种同时制备野蔷薇苷和蔷薇苷化合物的方法，该方法为：将金樱根的根茎，粉碎，用提取溶剂提取后，将提取液减压浓缩，进行溶剂萃取或上大孔树脂吸附，并依次用水、30％、40-90％乙醇洗脱，收集40-90％乙醇洗脱物，回收溶剂，再将萃取物或洗脱物经过柱层析分离，或将提取液浓缩至干后，直接经过柱层析分离；将含有野蔷薇苷和蔷薇苷的馏分再次经过硅胶柱层析分离，收集含有野蔷薇苷和蔷薇苷的馏分，得野蔷薇苷和蔷薇苷粗晶，再加入重结晶试剂反复重结晶即得。
通过检索国内外文献，目前尚没有发现野蔷薇苷具有抗乳腺增生的生物活性的文献报道。
发明内容
本发明的目的在于通过对天然药物进行研究，提供一种植物源性的抗乳腺增生的药物。该治疗药物以野蔷薇苷为活性成分，可用于患者乳腺增生症患者的治疗。
本发明的目的是这样实现的：
一种抗乳腺增生的药物组合物，由活性成分和辅料制备而成，所述的活性成分包括野蔷薇苷或/和其衍生物。
需要说明的是，野蔷薇苷的衍生物是指以在其基础上经过结构修饰的化合物，比如野蔷薇苷经水解后的野蔷薇苷元。
优选地，如上所述抗乳腺增生的药物组合物，其中所述的活性成分由野蔷薇苷组成。
进一步优选地，如上所述抗乳腺增生的药物组合物，其中所述的药物组合物为口服制剂，所述的口服制剂包括片剂、胶囊剂、颗粒剂。
本发明通过动物试验研究证明，灌服野蔷薇苷4周后，乳腺增生模型大鼠的乳房直径及乳头高度相比模型对照组明显减小，这表明野蔷薇苷能够减轻乳腺增生大鼠的症状，可用于患者乳腺增生症患者的治疗。因此，本发明还提供一种制药用途，即：野蔷薇苷在制备抗乳腺增生的药物中的应用。
与现有技术相比，本发明涉及的含有野蔷薇苷的药物组合物具有如下突出的优势：
（1）具有较强的抗乳腺增生的生物活性，并且不会产生耐药性；
（2）为治疗乳腺增生症提供了新的候选药物，可以单独作为防治乳腺增生症的药物使用，具有非常重要的临床意义。
具体实施方式
下面通过动物试验例进一步说明野蔷薇苷具有较强的抗乳腺增生的生物活性。
Wistar大鼠30只，雌性未孕，体质量180-220g，按体质量随机分为如下三组，即空白对照组，模型对照组，野蔷薇苷干预组。试验开始后，正常对照组大鼠腹腔注射生理盐水0.2mL／只，每日1次，连续30d，其他两组按如下方法制造乳腺增生模型大鼠：大鼠腹腔注射苯甲酸雌二醇注射液0.5mg/kg，每日1次，连续25d，随后腹腔注射黄体酮注射液4mg/kg，每天1次，连续5d。于造模完成第二天，干预组给予野蔷薇苷15mg/（kg?d）灌胃，正常对照组和模型对照组大鼠给予等体积纯水灌胃。各组均每日1次灌胃相应受试物，10mL/kg，共灌胃4周。于实验开始和结束时用游标卡尺测量第二对乳房直径和乳头高度。
外观肉眼观察造模第3周大鼠开始出现竖毛、皮毛欠光泽、脱毛、倦怠、反应迟钝、易激怒等症状，并且持续加重一直到实验结束。与此同时造模大鼠乳房直径及乳头高度出现不同程度的增大。灌服野蔷薇苷4周后，给药组大鼠上述症状明显得到改善，野蔷薇苷组大鼠的乳房直径及乳头高度明显减小，这表明野蔷薇苷能够减轻乳腺增生大鼠的症状，具体试验结果见表1、表2。
表l给药前后乳腺增生模型大鼠乳房直径的变化
与空白对照组比较，★ P＜0.05，★★ P＜0.01；
与模型对照组比较，▼ P＜0.05，▼▼ P＜0.01。
表2给药前后乳腺增生模型大鼠乳头高度的变化
与空白对照组比较，★ P＜0.05，★★ P＜0.01；
与模型对照组比较，▼ P＜0.05，▼▼ P＜0.01。
Claims (3)
1.野蔷薇苷在制备抗乳腺增生的药物中的应用。
2.根据权利要求1所述野蔷薇苷在制备抗乳腺增生的药物中的应用，其特征在于：所述药物由活性成分和辅料制备而成，所述的活性成分由野蔷薇苷组成。
3.根据权利要求2所述野蔷薇苷在制备抗乳腺增生的药物中的应用，其特征在于：所述的药物为口服制剂，所述的口服制剂为片剂、胶囊剂或颗粒剂。
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