CN104491594A - 一种治疗卵巢早衰的药物组合物 - Google Patents
一种治疗卵巢早衰的药物组合物 Download PDFInfo
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Abstract
本发明涉及一种治疗卵巢早衰的药物组合物，它由下列重量份的中药材制成：尖山橙30-80份、光叶山黄麻50-100份、花酸苔20-60份、吊兰50-100份、苦瓜30-70份、红直当药20-80份、白芍50-100份、旱田草20-70份、王不留行20-50份、麦芽50-100份、地黄50-90份、芸香草50-100份、合欢皮50-100份、黄连20-50份、苣荬菜50-100份、天麻10-50份、过坛龙50-100份、芡实50-100份、扶芳藤50-90份和甘草50-90份。本发明所述的药物组合物互相影响，协同作用，治疗卵巢早衰效果显著，值得临床推广。
Description
技术领域
本发明涉及医药领域，具体来说涉及一种治疗卵巢早衰的药物组合物。
背景技术
卵巢早衰(简称POF)指妇女在40岁以前出现闭经或月经稀少、不孕和围绝经症候群，伴有低雌激素和高促性腺激素为特征的一种妇科疑难病。中医称“血枯经闭”、“经水早断”。近10年来本病发生有显著升高和年轻化趋势，严重影响患者的身心健康和生活质量，给患者及家庭带来极大痛苦，成为当今生殖医学和生殖健康研究的热点和难点之一。
发明内容
本发明的目的是提供一种治疗卵巢早衰的药物组合物。
为了实现本发明的目的，本发明提供一种治疗卵巢早衰的药物组合物，它由中药材制成。
优选地，本发明所述的治疗卵巢早衰的药物组合物由下列重量份的中药材制成：尖山橙30-80份、光叶山黄麻50-100份、花酸苔20-60份、吊兰50-100份、苦瓜30-70份、红直当药20-80份、白芍50-100份、旱田草20-70份、王不留行20-50份、麦芽50-100份、地黄50-90份、芸香草50-100份、合欢皮50-100份、黄连20-50份、苣荬菜50-100份、天麻10-50份、过坛龙50-100份、芡实50-100份、扶芳藤50-90份和甘草50-90份。
优选地，本发明所述的治疗卵巢早衰的药物组合物由下列重量份的中药材制成：尖山橙50份、光叶山黄麻70份、花酸苔50份、吊兰80份、苦瓜50份、红直当药50份、白芍70份、旱田草50份、王不留行40份、麦芽80份、地黄60份、芸香草60份、合欢皮60份、黄连40份、苣荬菜70份、天麻30份、过坛龙80份、芡实60份、扶芳藤60份和甘草60份。
优选地，所述药物组合物可以是片剂、分散片、胶囊剂、软胶囊剂或汤剂。
本发明还提供组合物在制备治疗卵巢早衰的药物中的用途，所述组合物由下列重量份的中药材制成：尖山橙30-80份、光叶山黄麻50-100份、花酸苔20-60份、吊兰50-100份、苦瓜30-70份、红直当药20-80份、白芍50-100份、旱田草20-70份、王不留行20-50份、麦芽50-100份、地黄50-90份、芸香草50-100份、合欢皮50-100份、黄连20-50份、苣荬菜50-100份、天麻10-50份、过坛龙50-100份、芡实50-100份、扶芳藤50-90份和甘草50-90份。
优选地，所述组合物由下列重量份的中药材制成：尖山橙50份、光叶山黄麻70份、花酸苔50份、吊兰80份、苦瓜50份、红直当药50份、白芍70份、旱田草50份、王不留行40份、麦芽80份、地黄60份、芸香草60份、合欢皮60份、黄连40份、苣荬菜70份、天麻30份、过坛龙80份、芡实60份、扶芳藤60份和甘草60份。
优选地，所述药物可以是片剂、分散片、胶囊剂、软胶囊剂或汤剂。
在本发明的组合物中，尖山橙、光叶山黄麻为君药；花酸苔、吊兰、苦瓜、红直当药、白芍为臣药；旱田草、王不留行、麦芽、地黄、芸香草、合欢皮、黄连、苣荬菜、天麻、过坛龙、芡实、扶芳藤为佐药；甘草调和诸药，为使药。
本发明所述的药物组合物互相影响，协同作用，相辅相成，共奏君臣佐使之功，治疗卵巢早衰效果显著，值得临床推广。
具体实施方式
下面通过实施例进一步说明本发明。应该理解的是，本发明的实施例是用于说明本发明而不是对本发明的限制。根据本发明的实质对本发明进行的简单改进都属于本发明要求保护的范围。除非另有说明，否则本发明中的百分数是重量百分数。
实施例 本发明的汤剂
称取尖山橙50克、光叶山黄麻70克、花酸苔50克、吊兰80克、苦瓜50克、红直当药50克、白芍70克、旱田草50克、王不留行40克、麦芽80克、地黄60克、芸香草60克、合欢皮60克、黄连40克、苣荬菜70克、天麻30克、过坛龙80克、芡实60克、扶芳藤60克和甘草60克，粉碎，过20目筛，加入6000毫升水，在装有冷凝管的烧瓶中加热回流3小时，冷却至室温，过滤，向滤液中加入无水乙醇至醇含量为80体积％，室温封闭的条件下放置12小时，过滤，将滤液中的乙醇回收完全后得到本发明所述的汤剂。
毒性试验
急性毒性试验：应用NIH小鼠60只，SPF级，雌雄各半，体重17～24g，进行急性毒性试验。小鼠随机分为两组，每组30只，即对照组和给药组，实验前禁食12小时；调整实施例中制备的汤剂，使得浓度为6.35g生药/ml，灌胃，灌胃容积为5ml/kg(即单次给予药物组合物量为31.75g生药/kg)，对照组给予等量生理盐水，一天给药2次，给药间隔时间6小时，给药后连续观察14天，并记录小鼠的毒性反应及死亡数。实验结果表明：与对照组比较，给药后小鼠未见明显差异，实验连续观察14天，小鼠全身状况、饮食、饮水、体重增长均正常。选择处死给药组小鼠，显微镜下检查：心、肝、肺、胃内及胸腺等重要脏器，未见异常改变。小鼠口服灌胃本发明的汤剂LD50＞31.75g生药/kg，每日最大给药量为63.5g生药/kg/日。本发明的药物临床用药量为6.61g生药/日/人，成人体重以60kg计，平均用药物组合物量为0.110g生药/kg/日。按体重计：小鼠(平均体重以21g计)口服灌胃本发明的中药的耐受量为临床用量的577倍。因此本发明内服的药物组合物急性毒性低，临床用药安全。
长期毒性试验：应用SD大鼠，体重200g±10g，雌雄各半。使用实施例中制备的汤剂来进行测试。配制高、中、低三个剂量组，分别为临床用药量的300、150、75倍，用含2重量％阿拉伯树胶的生理盐水1∶1混合。采用灌胃给药方式，连续用药16周(1.0ml/100g体重，每天2次)及停药4周后，结果表明：本发明药物对大鼠的毛发、行为、大小便、体重、脏器重量、血象、肝肾功能、血糖、血脂等指标均无明显影响，脏器肉眼没有发现异样变化和组织学检查结果表明，用药16周及停药4周后，大鼠各个脏器均无明显改变。说明本发明内服的药物组合物对大鼠长期用药后毒性小，停药后也没有异样反应，应用安全。
实验例
一般资料
选取我院收治的卵巢早衰患者54例，符合卵巢早衰诊断标准，即年龄在40岁以下，闭经3-12个月，E2＜73.2pmol/L，FSH＞40IU/L，LH＞30IU/L，PRL正常，B超检查子宫略小于正常或内膜薄或卵巢偏小，无明显卵泡，近3个月内未接受中西药治疗者。54例患者中，年龄最小25岁，最大37岁，平均(31.5±4.5)岁；病程最短0.3年，最长3年，平均(1.45±1.49)年；54例中未婚2例，已婚52例，其中未孕4例，已孕48例中孕产1次13例，2次11例，3次及以上24例，最多1例孕产10次。临床症状：闭经38例，月经稀少或先后不定16例，潮热汗出43例，白带少阴道干40例，腰痛脱发20例，心烦失眠16例，大便干结或溏12例，怕冷10例。血激素：E2＜25pmol/L28例，E2＜73.2pmol/L 26例；FSH＜100IU/L 41例，FSH＞100IU/L13例。B超：子宫小于正常30例，内膜偏薄33例，卵巢未探及或无明显卵泡24例。
使用实施例中制备的汤剂来进行治疗，每日2次，本发明的药物临床用药量为6.61g生药/日/人。连续治疗6个月。
统计学处理
对数据进行片方检验，应用SPSS 13.0软件处理。P＜0.05说明疗效差异显著，有统计学意义。
疗效评价标准
参照《中医病证诊断疗效标准》有关闭经的疗效标准评定。痊愈：治疗后月经连续行经3次以上，期量基本正常，临床症状消失，临床检查卵巢功能基本恢复正常；显效：治疗后月经来潮3次以上，周期接近正常(40天以内)，临床症状明显改善；卵巢功能有改善者或尚未改善；有效：治疗后月经来潮1-2次，周期或前或后、量少，临床症状有所改善；卵巢功能有改善者或尚未改善；无效：连续治疗后，月经未见来潮，临床症状及卵巢功能均无改善。
结果
经过治疗，痊愈28例，显效12例，有效10例，无效4例，总有效率为92.6％。
治疗前后血清性激素的比较见下表
Claims (7)
1.一种治疗卵巢早衰的药物组合物，其特征在于，它由中药材制成。
2.根据权利要求1所述的治疗卵巢早衰的药物组合物，其特征在于，它由下列重量份的中药材制成：尖山橙30-80份、光叶山黄麻50-100份、花酸苔20-60份、吊兰50-100份、苦瓜30-70份、红直当药20-80份、白芍50-100份、旱田草20-70份、王不留行20-50份、麦芽50-100份、地黄50-90份、芸香草50-100份、合欢皮50-100份、黄连20-50份、苣荬菜50-100份、天麻10-50份、过坛龙50-100份、芡实50-100份、扶芳藤50-90份和甘草50-90份。
3.根据权利要求2所述的治疗卵巢早衰的药物组合物，其特征在于，它由下列重量份的中药材制成：尖山橙50份、光叶山黄麻70份、花酸苔50份、吊兰80份、苦瓜50份、红直当药50份、白芍70份、旱田草50份、王不留行40份、麦芽80份、地黄60份、芸香草60份、合欢皮60份、黄连40份、苣荬菜70份、天麻30份、过坛龙80份、芡实60份、扶芳藤60份和甘草60份。
4.根据权利要求3所述的治疗卵巢早衰的药物组合物，其特征在于，所述药物组合物可以是片剂、分散片、胶囊剂、软胶囊剂或汤剂。
5.组合物在制备治疗卵巢早衰的药物中的用途，其特征在于，所述组合物由下列重量份的中药材制成：尖山橙30-80份、光叶山黄麻50-100份、花酸苔20-60份、吊兰50-100份、苦瓜30-70份、红直当药20-80份、白芍50-100份、旱田草20-70份、王不留行20-50份、麦芽50-100份、地黄50-90份、芸香草50-100份、合欢皮50-100份、黄连20-50份、苣荬菜50-100份、天麻10-50份、过坛龙50-100份、芡实50-100份、扶芳藤50-90份和甘草50-90份。
6.根据权利要求5所述的用途，其特征在于，所述组合物由下列重量份的中药材制成：尖山橙50份、光叶山黄麻70份、花酸苔50份、吊兰80份、苦瓜50份、红直当药50份、白芍70份、旱田草50份、王不留行40份、麦芽80份、地黄60份、芸香草60份、合欢皮60份、黄连40份、苣荬菜70份、天麻30份、过坛龙80份、芡实60份、扶芳藤60份和甘草60份。
7.根据权利要求6所述的用途，其特征在于，所述药物可以是片剂、分散片、胶囊剂、软胶囊剂或汤剂。
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