CN104524315A - 一种治疗先兆流产的药物组合物 - Google Patents

一种治疗先兆流产的药物组合物 Download PDF

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CN104524315A
CN104524315A CN201510036838.0A CN201510036838A CN104524315A CN 104524315 A CN104524315 A CN 104524315A CN 201510036838 A CN201510036838 A CN 201510036838A CN 104524315 A CN104524315 A CN 104524315A
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李艳芹
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Abstract

本发明涉及一种治疗先兆流产的药物组合物，它包含下列重量份的物质制成：车前子1-20份、芦根10-30份和白茅根1-10份等。本发明所述的药物组合物互相影响，协同作用，治疗先兆流产效果显著，值得临床推广。

Description

一种治疗先兆流产的药物组合物
技术领域
本发明涉及医药领域，具体来说涉及一种治疗先兆流产的药物组合物。
背景技术
先兆流产是流产的早期，属妇科常见妊娠疾病，此病若不经休息和及时的治疗，流血严重则会发展为流产。从临床观察看，除少数有遗传、免疫等因素外，先兆流产的发病原因以母体内分泌疾病为多见。先兆流产属中医“胎动不安”、“胎漏”等范畴。其主要病因病机是冲任气血失调，胎元不固，不能摄血养胎。
发明内容
本发明的目的是提供一种治疗先兆流产的药物组合物。
为了实现本发明的目的，本发明提供一种治疗先兆流产的药物组合物，它包含下列重量份的物质：车前子1-20份、芦根10-30份和白茅根1-10份。
优选地，本发明所述的治疗先兆流产的药物组合物包含下列重量份的物质：车前子10份、芦根20份和白茅根8份。
优选地，本发明所述的治疗先兆流产的药物组合物还包含下列重量份的物质：酒瓶花10-20份、黄泥菜1-10份、浮萍10-20份、海菜20-30份、啤酒花1-10份、木瓜10-30份、铜罗汉1-20份、萹蓄10-20份、三七1-20份、蓝实1-10份、红花10-20份、紫河车5-10份、蓬子菜1-20份、干姜10-20份、阿胶10-30份、益母草10-20份、岗梅根1-10份、黄芪10-30份、肉苁蓉1-20份、禹余粮1-10份和甘草10-20份。
优选地，本发明所述的治疗先兆流产的药物组合物还包含下列重量份的物质：酒瓶花15份、黄泥菜8份、浮萍15份、海菜25份、啤酒花6份、木瓜20份、铜罗汉10份、萹蓄15份、三七10份、蓝实8份、红花12份、紫河车6份、蓬子菜10份、干姜15份、阿胶20份、益母草15份、岗梅根6份、黄芪20份、肉苁蓉10份、禹余粮5份和甘草12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先兆流产的药物中的用途，所述组合物包含下列重量份的物质：车前子1-20份、芦根10-30份和白茅根1-10份。
优选地，所述组合物包含下列重量份的物质：车前子10份、芦根20份和白茅根8份。
优选地，所述组合物还包含下列重量份的物质：酒瓶花10-20份、黄泥菜1-10份、浮萍10-20份、海菜20-30份、啤酒花1-10份、木瓜10-30份、铜罗汉1-20份、萹蓄10-20份、三七1-20份、蓝实1-10份、红花10-20份、紫河车5-10份、蓬子菜1-20份、干姜10-20份、阿胶10-30份、益母草10-20份、岗梅根1-10份、黄芪10-30份、肉苁蓉1-20份、禹余粮1-10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：酒瓶花15份、黄泥菜8份、浮萍15份、海菜25份、啤酒花6份、木瓜20份、铜罗汉10份、萹蓄15份、三七10份、蓝实8份、红花12份、紫河车6份、蓬子菜10份、干姜15份、阿胶20份、益母草15份、岗梅根6份、黄芪20份、肉苁蓉10份、禹余粮5份和甘草12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，酒瓶花、黄泥菜为君药；车前子、芦根、白茅根、浮萍、海菜、啤酒花为臣药；木瓜、铜罗汉、萹蓄、三七、蓝实、红花、紫河车、蓬子菜、干姜、阿胶、益母草、岗梅根、黄芪、肉苁蓉、禹余粮为佐药；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，补肾益精而养胎，镇静止痛，补脾益气，清热安胎，凉血止血，养阴清热，治疗先兆流产效果显著，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
称取车前子10克、芦根20克、白茅根8克、酒瓶花15克、黄泥菜8克、浮萍15克、海菜25克、啤酒花6克、木瓜20克、铜罗汉10克、萹蓄15克、三七10克、蓝实8克、红花12克、紫河车6克、蓬子菜10克、干姜15克、阿胶20克、益母草15克、岗梅根6克、黄芪20克、肉苁蓉10克、禹余粮5克和甘草12克，加入6500毫升水，在装有冷凝管的烧瓶中加热回流3小时，然后过滤，得到滤液1和滤渣1；2)向滤渣1中加入3500毫升水，在装有冷凝管的烧瓶中加热2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7.85g生药/ml，灌胃，灌胃容积为5ml/kg(即单次给予药物组合物量为39.25g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>39.25g生药/kg，每日最大给药量为78.5g生药/kg/日。本发明的药物临床用药量为6.52g生药/日/人，成人体重以60kg计，平均用药物组合物量为0.109g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720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
妊娠28周前出现阴道流血，伴或不伴下腹阵挛性疼痛，阴道流血多为暗红色或血性白带，无妊娠物排出，宫颈口末开，子宫大小与孕周相符。
选取2013年1月至2014年11月我院收治的符合上述标准的先兆流产患者50例，所有患者均行尿妊娠试验、B超及妇科检查并排除宫颈炎及附件炎等引起的阴道或宫颈出血、异位妊娠、葡萄胎、子宫肌瘤。年龄22-35岁，平均26.5岁，12周内妊娠36例，12-28周内妊娠14例。所有患者自然流产发生1次或连续2次以上，症状为阴道少量流血，轻微腹痛腰酸或下腹坠胀。
口服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6.52g生药/日/人。连续治疗5天。
疗效评价标准
根据先兆流产的相关标准(李立凯.保胎饮加减治疗先兆流产.陕西中医，2003,24(5):397.)拟定。治愈：经治疗后阴道流血停止，腹痛腰酸消失或减轻，B超提示官内活胎，胚胎持续性发育，子宫大小及停经月份相符，用药后止血；好转：治疗后疗程止血；无效：治疗后仍出血不止，B超提示胚胎停止发育、胎死宫内。
结果
经过治疗，50例患者中治愈41例，好转8例，总有效率为100％。

Claims (10)

1.一种治疗先兆流产的药物组合物，其特征在于，它包含下列重量份的物质：车前子1-20份、芦根10-30份和白茅根1-10份。
2.根据权利要求1所述的治疗先兆流产的药物组合物，其特征在于，它包含下列重量份的物质：车前子10份、芦根20份和白茅根8份。
3.根据权利要求1或2所述的治疗先兆流产的药物组合物，其特征在于，它还包含下列重量份的物质：酒瓶花10-20份、黄泥菜1-10份、浮萍10-20份、海菜20-30份、啤酒花1-10份、木瓜10-30份、铜罗汉1-20份、萹蓄10-20份、三七1-20份、蓝实1-10份、红花10-20份、紫河车5-10份、蓬子菜1-20份、干姜10-20份、阿胶10-30份、益母草10-20份、岗梅根1-10份、黄芪10-30份、肉苁蓉1-20份、禹余粮1-10份和甘草10-20份。
4.根据权利要求3所述的治疗先兆流产的药物组合物，其特征在于，它还包含下列重量份的物质：酒瓶花15份、黄泥菜8份、浮萍15份、海菜25份、啤酒花6份、木瓜20份、铜罗汉10份、萹蓄15份、三七10份、蓝实8份、红花12份、紫河车6份、蓬子菜10份、干姜15份、阿胶20份、益母草15份、岗梅根6份、黄芪20份、肉苁蓉10份、禹余粮5份和甘草12份。
5.根据权利要求4所述的治疗先兆流产的药物组合物，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.组合物在制备治疗先兆流产的药物中的用途，其特征在于，所述组合物包含下列重量份的物质：车前子1-20份、芦根10-30份和白茅根1-10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：车前子10份、芦根20份和白茅根8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：酒瓶花10-20份、黄泥菜1-10份、浮萍10-20份、海菜20-30份、啤酒花1-10份、木瓜10-30份、铜罗汉1-20份、萹蓄10-20份、三七1-20份、蓝实1-10份、红花10-20份、紫河车5-10份、蓬子菜1-20份、干姜10-20份、阿胶10-30份、益母草10-20份、岗梅根1-10份、黄芪10-30份、肉苁蓉1-20份、禹余粮1-10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：酒瓶花15份、黄泥菜8份、浮萍15份、海菜25份、啤酒花6份、木瓜20份、铜罗汉10份、萹蓄15份、三七10份、蓝实8份、红花12份、紫河车6份、蓬子菜10份、干姜15份、阿胶20份、益母草15份、岗梅根6份、黄芪20份、肉苁蓉10份、禹余粮5份和甘草12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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