CN104474513A - 一种治疗子宫内膜异位症的药剂 - Google Patents

一种治疗子宫内膜异位症的药剂 Download PDF

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CN104474513A
CN104474513A CN201410727494.3A CN201410727494A CN104474513A CN 104474513 A CN104474513 A CN 104474513A CN 201410727494 A CN201410727494 A CN 201410727494A CN 104474513 A CN104474513 A CN 104474513A
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范旭升
范军丽
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Abstract

本发明涉及一种治疗子宫内膜异位症的药剂，它由下列重量份的物质制成：双色龙胆200-500份、五香草300-400份、樱桃叶200-300份、见风消200-300份、莱菔子100-300份、苍术200-500份、干姜200-300份、荆芥穗200-300份、绿茶100-300份、忍冬藤100-300份、牛白藤200-300份、双肾子300-500份、地肤子200-300份、益母草200-300份、葛根300-500份、书带蕨200-500份、薄荷200-300份、白冷草200-300份、白藓皮200-300份、白乳菇100-300份、苦参200-500份、桑叶200-300份、当归藤200-500份、回心草300-500份、麦瓶草200-300份和甘草100-300份。本发明所述的药剂互相影响，协同作用，疗效确切，成本低廉，无毒副作用。

Description

一种治疗子宫内膜异位症的药剂
技术领域
本发明涉及医药领域，具体来说涉及一种治疗子宫内膜异位症的药剂。
背景技术
内异症是雌激素依赖性疾病，只要卵巢分泌雌激素，病情就随着每次月经的来潮而逐渐加重，甚至形成严重粘连，影响生活质量。
发明内容
本发明的目的是提供一种治疗子宫内膜异位症的药剂。
为了实现本发明的目的，本发明提供一种治疗子宫内膜异位症的药剂，它由中药材制成的。
优选地，本发明所述的治疗子宫内膜异位症的药剂由下列重量份的物质制成：双色龙胆200-500份、五香草300-400份、樱桃叶200-300份、见风消200-300份、莱菔子100-300份、苍术200-500份、干姜200-300份、荆芥穗200-300份、绿茶100-300份、忍冬藤100-300份、牛白藤200-300份、双肾子300-500份、地肤子200-300份、益母草200-300份、葛根300-500份、书带蕨200-500份、薄荷200-300份、白冷草200-300份、白藓皮200-300份、白乳菇100-300份、苦参200-500份、桑叶200-300份、当归藤200-500份、回心草300-500份、麦瓶草200-300份和甘草100-300份。
优选地，本发明所述的治疗子宫内膜异位症的药剂由下列重量份的物质制成：双色龙胆300份、五香草350份、樱桃叶230份、见风消280份、莱菔子200份、苍术300份、干姜210份、荆芥穗230份、绿茶200份、忍冬藤200份、牛白藤260份、双肾子330份、地肤子220份、益母草250份、葛根320份、书带蕨300份、薄荷210份、白冷草270份、白藓皮250份、白乳菇200份、苦参300份、桑叶240份、当归藤300份、回心草320份、麦瓶草260份和甘草200份。
优选地，所述药剂可以是片剂、分散片、胶囊剂、软胶囊剂、汤剂或散剂。
本发明还提供组合物在制备治疗子宫内膜异位症的药物中的用途，所述组合物由下列重量份的物质制成：双色龙胆200-500份、五香草300-400份、樱桃叶200-300份、见风消200-300份、莱菔子100-300份、苍术200-500份、干姜200-300份、荆芥穗200-300份、绿茶100-300份、忍冬藤100-300份、牛白藤200-300份、双肾子300-500份、地肤子200-300份、益母草200-300份、葛根300-500份、书带蕨200-500份、薄荷200-300份、白冷草200-300份、白藓皮200-300份、白乳菇100-300份、苦参200-500份、桑叶200-300份、当归藤200-500份、回心草300-500份、麦瓶草200-300份和甘草100-300份。
优选地，所述组合物由下列重量份的物质制成：双色龙胆300份、五香草350份、樱桃叶230份、见风消280份、莱菔子200份、苍术300份、干姜210份、荆芥穗230份、绿茶200份、忍冬藤200份、牛白藤260份、双肾子330份、地肤子220份、益母草250份、葛根320份、书带蕨300份、薄荷210份、白冷草270份、白藓皮250份、白乳菇200份、苦参300份、桑叶240份、当归藤300份、回心草320份、麦瓶草260份和甘草200份。
优选地，所述药物可以是片剂、分散片、胶囊剂、软胶囊剂、汤剂或散剂。
在本发明的组合物中，双色龙胆、五香草能扩张周围血管，改善子宫微循环，为君药；樱桃叶、见风消、莱菔子、苍术、干姜、荆芥穗能够调节免疫和神经系统等多方而功能，改善血液流变性，为臣药；绿茶、忍冬藤、牛白藤、双肾子、地肤子、益母草、葛根、书带蕨、薄荷、白冷草、白藓皮、白乳菇、苦参、桑叶、当归藤、回心草、麦瓶草具有抗凝、促纤溶、抗血栓等作用，能消散局部疲血、水肿、溶解纤维组织，缩小包块，为佐药；甘草调和诸药，为使药。
本发明所述的药剂互相影响，协同作用，治疗子宫内膜异位症能够取得更加理想的治疗效果，值得被推广和应用到临床治疗中去。
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。
实施例本发明的散剂
称取双色龙胆300克、五香草350克、樱桃叶230克、见风消280克、莱菔子200克、苍术300克、干姜210克、荆芥穗230克、绿茶200克、忍冬藤200克、牛白藤260克、双肾子330克、地肤子220克、益母草250克、葛根320克、书带蕨300克、薄荷210克、白冷草270克、白藓皮250克、白乳菇200克、苦参300克、桑叶240克、当归藤300克、回心草320克、麦瓶草260克和甘草200克，粉碎，过40目筛，加入水10升，在回流的条件下加热5小时，冷却至室温，过滤，使滤液蒸干至恒重，得到粉末，加入糖粉250克，混合均匀，分装，得到本发明的散剂。
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；将实施例中制备的散剂加入水，使得浓度为826g生药/ml，灌胃，灌胃容积为5ml/kg(即单次给药剂量为41.3g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药物LD50>41.3g生药/kg，每日最大给药量为82.6g生药/kg/日。本发明的药物临床用药量为6.13g生药/日/人，成人体重以60kg计，平均用药剂量为0.102g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810倍。因此本发明内服的药剂急性毒性低，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。将实施例中制备的散剂加入水制成溶液来进行测试。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，大鼠各脏器均无明显改变。说明本发明内服的药剂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
收集的子宫内膜异位症60例均为已婚患者，年龄28-43岁；病程3.5-5.5年；痛经56例，其中有性交痛28例，非经期下腹痛18例。合并巧克力囊肿36例、子宫后穹窿触痛性结节50例、不孕22例、月经不调52例。中医辨证有下腹痛、痛有定处、舌质紫黠或瘀斑，脉涩或结代等瘀血征象。
诊断标准
①根据郎景和《子宫内膜异位症诊断与治疗规范》诊断包括“疼痛-痛经，非经期腹痛，性交痛，不孕，盆腔检查，影像学检查及血清CA125检测”；②腹腔镜检查；③特殊部位根据症状进行相应检查。
使用实施例中制备的散剂来进行治疗，每日三次，每日的临床用药量为6.13g生药/日/人，连续治疗5个月。
疗效判断标准
根据张玉珍《中医妇科学》标准评定疗效。治愈：症状全部消失，盆腔包块及局部体征基本消失，从症状体征消失后不育患者在1年内妊娠或生育；显效：症状消失，盆腔包块缩小1/2以上，从症状消失起1年无复发，虽局部体征存在但不育患者能生育；有效：症状显著减轻，盆腔包块缩小1/3以上，主要症状消失1年无复发；无效：主要症状无变化或恶化局部病变无变化或有加重趋势。
结果
经过治疗，在60例患者中，治愈35例，显效13例，有效12例，总有效率为100％。并且在治疗过程中并未发现明显的不良反应。
典型案例
张某某，女，34岁，公务员，患有子宫内膜异位症，每到经期疼痛难忍。使用实施例中制备的散剂来进行治疗，每日三次，每日的临床用药量为6.13g生药/日/人，连续治疗5个月。症状全部消失，盆腔包块及局部体征基本消失，从症状体征消失后不育患者在半年后妊娠。

Claims (7)

1.一种治疗子宫内膜异位症的药剂，其特征在于，它由中药材制成的。
2.根据权利要求1所述的治疗子宫内膜异位症的药剂，其特征在于，它由下列重量份的物质制成：双色龙胆200-500份、五香草300-400份、樱桃叶200-300份、见风消200-300份、莱菔子100-300份、苍术200-500份、干姜200-300份、荆芥穗200-300份、绿茶100-300份、忍冬藤100-300份、牛白藤200-300份、双肾子300-500份、地肤子200-300份、益母草200-300份、葛根300-500份、书带蕨200-500份、薄荷200-300份、白冷草200-300份、白藓皮200-300份、白乳菇100-300份、苦参200-500份、桑叶200-300份、当归藤200-500份、回心草300-500份、麦瓶草200-300份和甘草100-300份。
3.根据权利要求2所述的治疗子宫内膜异位症的药剂，其特征在于，它由下列重量份的物质制成：双色龙胆300份、五香草350份、樱桃叶230份、见风消280份、莱菔子200份、苍术300份、干姜210份、荆芥穗230份、绿茶200份、忍冬藤200份、牛白藤260份、双肾子330份、地肤子220份、益母草250份、葛根320份、书带蕨300份、薄荷210份、白冷草270份、白藓皮250份、白乳菇200份、苦参300份、桑叶240份、当归藤300份、回心草320份、麦瓶草260份和甘草200份。
4.根据权利要求2或3所述的治疗子宫内膜异位症的药剂，其特征在于，所述药剂可以是片剂、分散片、胶囊剂、软胶囊剂、汤剂或散剂。
5.组合物在制备治疗子宫内膜异位症的药物中的用途，其特征在于，所述组合物由下列重量份的物质制成：双色龙胆200-500份、五香草300-400份、樱桃叶200-300份、见风消200-300份、莱菔子100-300份、苍术200-500份、干姜200-300份、荆芥穗200-300份、绿茶100-300份、忍冬藤100-300份、牛白藤200-300份、双肾子300-500份、地肤子200-300份、益母草200-300份、葛根300-500份、书带蕨200-500份、薄荷200-300份、白冷草200-300份、白藓皮200-300份、白乳菇100-300份、苦参200-500份、桑叶200-300份、当归藤200-500份、回心草300-500份、麦瓶草200-300份和甘草100-300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物质制成：双色龙胆300份、五香草350份、樱桃叶230份、见风消280份、莱菔子200份、苍术300份、干姜210份、荆芥穗230份、绿茶200份、忍冬藤200份、牛白藤260份、双肾子330份、地肤子220份、益母草250份、葛根320份、书带蕨300份、薄荷210份、白冷草270份、白藓皮250份、白乳菇200份、苦参300份、桑叶240份、当归藤300份、回心草320份、麦瓶草260份和甘草200份。
7.根据权利要求5或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、汤剂或散剂。
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