CN104547278A - 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 PDF

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CN104547278A
CN104547278A CN201510030968.3A CN201510030968A CN104547278A CN 104547278 A CN104547278 A CN 104547278A CN 201510030968 A CN201510030968 A CN 201510030968A CN 104547278 A CN104547278 A CN 104547278A
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周爱霞
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Abstract

本发明涉及一种治疗卵巢早衰的药物组合物，它包含蛇床子10-30份、石榴皮1-20份、红茶10-20份、杜仲10-30份和荷叶10-20份等。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，滋补肝肾，温养脾肾，疏肝健脾，调理气血，治疗卵巢早衰效果显著，值得临床推广。

Description

一种治疗卵巢早衰的药物组合物
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
卵巢早衰是妇科常见病、多发病，可由特发性自身免疫性染色体异常、遗传及卵巢破坏等多种原因所致。现代医学对该病的治疗主要采用雌激素替代疗法，但是该疗法容易出现持续性闭经和性器官萎缩，严重地影响了妇女的身心健康及生活质量。
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，它包含下列重量份的物质：蛇床子10-30份、石榴皮1-20份、红茶10-20份、杜仲10-30份和荷叶10-20份。
优选地，本发明所述的治疗卵巢早衰的药物组合物包含下列重量份的物质：蛇床子20份、石榴皮10份、红茶15份、杜仲20份和荷叶15份。
优选地，本发明所述的治疗卵巢早衰的药物组合物还包含下列重量份的物质：饿蚂蝗10-30份、秋枫木1-20份、狼尾草1-15份、高良姜1-20份、刘寄奴1-10份、香石藤5-20份、丹参1-15份、鬼毛针5-20份、乳香1-10份、老君须1-10份、三棱1-10份、金丝梅1-10份、栀子10-20份、钩藤1-15份、夜交藤1-10份、花椒10-20份、葛根10-20份、槐花1-15份和甘草10-20份。
优选地，本发明所述的治疗卵巢早衰的药物组合物还包含下列重量份的物质：饿蚂蝗20份、秋枫木10份、狼尾草10份、高良姜10份、刘寄奴8份、香石藤10份、丹参10份、鬼毛针10份、乳香8份、老君须9份、三棱6份、金丝梅5份、栀子15份、钩藤10份、夜交藤9份、花椒15份、葛根12份、槐花10份和甘草15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，所述组合物包含下列重量份的物质：蛇床子10-30份、石榴皮1-20份、红茶10-20份、杜仲10-30份和荷叶10-20份。
优选地，所述组合物包含下列重量份的物质：蛇床子20份、石榴皮10份、红茶15份、杜仲20份和荷叶15份。
优选地，所述组合物还包含下列重量份的物质：饿蚂蝗10-30份、秋枫木1-20份、狼尾草1-15份、高良姜1-20份、刘寄奴1-10份、香石藤5-20份、丹参1-15份、鬼毛针5-20份、乳香1-10份、老君须1-10份、三棱1-10份、金丝梅1-10份、栀子10-20份、钩藤1-15份、夜交藤1-10份、花椒10-20份、葛根10-20份、槐花1-15份和甘草10-20份。
优选地，所述组合物还包含下列重量份的物质：饿蚂蝗20份、秋枫木10份、狼尾草10份、高良姜10份、刘寄奴8份、香石藤10份、丹参10份、鬼毛针10份、乳香8份、老君须9份、三棱6份、金丝梅5份、栀子15份、钩藤10份、夜交藤9份、花椒15份、葛根12份、槐花10份和甘草15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，饿蚂蝗、秋枫木为君药；蛇床子、石榴皮、红茶、狼尾草、高良姜、刘寄奴为臣药；杜仲、荷叶、香石藤、丹参、鬼毛针、乳香、老君须、三棱、金丝梅、栀子、钩藤、夜交藤、花椒、葛根、槐花为佐药；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，滋补肝肾，温养脾肾，疏肝健脾，调理气血，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
称取蛇床子20克、石榴皮10克、红茶15克、杜仲20克、荷叶15克、饿蚂蝗20克、秋枫木10克、狼尾草10克、高良姜10克、刘寄奴8克、香石藤10克、丹参10克、鬼毛针10克、乳香8克、老君须9克、三棱6克、金丝梅5克、栀子15克、钩藤10克、夜交藤9克、花椒15克、葛根12克、槐花10克和甘草15克，加入5000毫升水，在装有冷凝管的烧瓶中加热回流2小时，然后过滤，得到滤液1和滤渣1；2)向滤渣1中加入2000毫升水，在装有冷凝管的烧瓶中加热1小时，过滤，得到滤液2和滤渣2；3)合并所述滤液1、滤液2，冷却至室温，即得。
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5.52g生药/ml，灌胃，灌胃容积为5ml/kg(即单次给予药物组合物量为27.6g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>27.6g生药/kg，每日最大给药量为55.2g生药/kg/日。本发明的药物临床用药量为6.31g生药/日/人，成人体重以60kg计，平均用药物组合物量为0.105g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526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
诊断标准
参照《中医病证诊断疗效标准》(国家中医药管理局.中医病证诊断疗效标准[S].南京:南京大学出版社，1994.)和《妇产科学》第6版(谢幸，丰有吉，等.妇产科学北京:人民卫生出版社，2003，339)有关闭经和卵巢早衰的诊断标准而拟订：(1)>40岁以前绝经，常为继发性闭经。(2)可伴有：潮红、烘热、出汗、情绪改变、失眠、记忆力减退、性欲低下、生殖器官萎缩等。舌质淡红或暗淡，或有裂纹，苔薄白或少苔，脉沉细弱或沉缓。(3)血雌二醇(E2)<30pg/ml，血促卵泡素(FSH)>40IU/L，或促黄体素(LH)>30IU/L。(4)B超示卵巢萎缩，无卵泡生长。(5)基础体温(BBT)单相，阴道脱落细胞学检查雌激素水平低下，可见底层细胞。(6)可伴有自身免疫性疾病的临床表现。
排除标准
排除卵巢不敏感综合征、高催乳素血症、多囊卵巢综合征。
选取符合上述标准的患者50例，年龄25-26岁。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6.31g生药/日/人。连续治疗90天。
疗效标准评定
参照《中医病证诊断疗效标准》有关闭经的疗效标准评定。治愈：临床症状消失(月经正常或BBT双相或妊娠)，B超检查及血清激素水平恢复正常；好转：临床症状明显改善，B超显示卵巢比治疗前增大，BBT双相，血清激素水平明显好转；无效：治疗前后临床症状、B超检查及血清激素无明显变化。
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说明差异显著，有统计学意义。
结果
经过治疗，50例患者中，治愈41例，好转9例。治疗前后血清FSH、LH、E2水平变化分别如下：在治疗前，FSH(IU/L)为71.5±8.3，LH(IU/L)为52.9±9.7，E2(pg/ml)为19.8±7.6，在治疗后，FSH(IU/L)为30.5±9.5，LH(IU/L)为22.9±7.4，E2(pg/ml)为61.2±6.8。在治疗前子宫的平均体积为23.7±11.0cm，在治疗后子宫的平均体积为24.6±12.3cm。经比较，前后子宫的平均体积无差异显著(P>0.05)。在治疗过程中也未发现明显的不良反应。

Claims (10)

1.一种治疗卵巢早衰的药物组合物，其特征在于，它包含下列重量份的物质：蛇床子10-30份、石榴皮1-20份、红茶10-20份、杜仲10-30份和荷叶10-20份。
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，它包含下列重量份的物质：蛇床子20份、石榴皮10份、红茶15份、杜仲20份和荷叶15份。
3.根据权利要求1或2所述的治疗卵巢早衰的药物组合物，其特征在于，它还包含下列重量份的物质：饿蚂蝗10-30份、秋枫木1-20份、狼尾草1-15份、高良姜1-20份、刘寄奴1-10份、香石藤5-20份、丹参1-15份、鬼毛针5-20份、乳香1-10份、老君须1-10份、三棱1-10份、金丝梅1-10份、栀子10-20份、钩藤1-15份、夜交藤1-10份、花椒10-20份、葛根10-20份、槐花1-15份和甘草10-20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，它还包含下列重量份的物质：饿蚂蝗20份、秋枫木10份、狼尾草10份、高良姜10份、刘寄奴8份、香石藤10份、丹参10份、鬼毛针10份、乳香8份、老君须9份、三棱6份、金丝梅5份、栀子15份、钩藤10份、夜交藤9份、花椒15份、葛根12份、槐花10份和甘草15份。
5.根据权利要求4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。
6.组合物在制备治疗卵巢早衰的药物中的用途，其特征在于，所述组合物包含下列重量份的物质：蛇床子10-30份、石榴皮1-20份、红茶10-20份、杜仲10-30份和荷叶10-20份。
7.根据权利要求6所述的用途，其特征在于，所述组合物包含下列重量份的物质：蛇床子20份、石榴皮10份、红茶15份、杜仲20份和荷叶15份。
8.根据权利要求6或7所述的用途，其特征在于，所述组合物还包含下列重量份的物质：饿蚂蝗10-30份、秋枫木1-20份、狼尾草1-15份、高良姜1-20份、刘寄奴1-10份、香石藤5-20份、丹参1-15份、鬼毛针5-20份、乳香1-10份、老君须1-10份、三棱1-10份、金丝梅1-10份、栀子10-20份、钩藤1-15份、夜交藤1-10份、花椒10-20份、葛根10-20份、槐花1-15份和甘草10-20份。
9.根据权利要求8所述的用途，其特征在于，所述组合物还包含下列重量份的物质：饿蚂蝗20份、秋枫木10份、狼尾草10份、高良姜10份、刘寄奴8份、香石藤10份、丹参10份、鬼毛针10份、乳香8份、老君须9份、三棱6份、金丝梅5份、栀子15份、钩藤10份、夜交藤9份、花椒15份、葛根12份、槐花10份和甘草15份。
10.根据权利要求9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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