CN106390021A - 一种防治子宫肌瘤和卵巢囊肿的药物组合物、其制备方法及剂型和应用 - Google Patents
一种防治子宫肌瘤和卵巢囊肿的药物组合物、其制备方法及剂型和应用 Download PDFInfo
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- CN106390021A CN106390021A CN201610903900.6A CN201610903900A CN106390021A CN 106390021 A CN106390021 A CN 106390021A CN 201610903900 A CN201610903900 A CN 201610903900A CN 106390021 A CN106390021 A CN 106390021A
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Abstract
本发明一种防治子宫肌瘤和卵巢囊肿的药物组合物、其制备方法及剂型和应用,属于中医药技术领域。所述药物组合物由下列重量份的原料药制备而成:桃仁150份、大黄100份、桂枝100份、夏枯草150份、牡蛎150份、炙山甲150份、炙鳖甲150份、牡丹皮150份、皂角刺150份、浙贝母150份、三棱300份、莪术300份、西洋参300份、冬虫夏草100份、淫羊藿150份、茯苓150份、铁丝威灵仙150份、甘草100份。本发明具有工艺简单、质量均匀稳定;能有效防治子宫肌瘤和卵巢囊肿;具有活血化淤,消征散结;对子宫肌瘤,卵巢囊肿,月经不调,色暗红,量多且有血块,少腹胀痛等症有较好的治疗效果的有益效果。
Description
技术领域
本发明属于中医药技术领域,具体涉及一种防治子宫肌瘤和卵巢囊肿的药物组合物、其制备方法及剂型和应用。
背景技术
子宫肌瘤是女性生殖系统中最常见的良性肿瘤,据世界统计,35岁以上妇女每5人就有一个患子宫肌瘤,发病率20%左右,尤其41-50岁左右的妇女,发病率可达50%,临床上根据肌瘤所在部位,可分为子宫肌瘤和子宫颈肌瘤,以前者相对多见。月经过多或不规则子宫出血是子宫肌瘤的最主要表现。月经过多的临床表现与肌瘤的大小、数量、部位直接相关。除此之外,部分子宫肌瘤还伴有下腹疼痛,肿瘤压迫直肠可见便秘,压迫膀胱见尿频、排尿困难、尿褚留,过多出血可见贫血,另外还可有白带增多、不孕、流产和早产,目前子宫肌瘤的病因尚不明确,多数人认为子宫肌瘤与雌激素分泌过多和长期刺激有关。西医治疗子宫肌瘤要以手术为主。
卵巢囊肿是妇科常见良性病变,包括卵巢、卵泡囊肿,卵巢黄体囊肿,卵巢黄素囊肿及良性浆液性囊腺瘤,良性卵巢内膜样肿物,卵巢子宫内膜异位囊肿(巧克力囊肿)等。以上病变目前西医仍以手术切除为主。卵巢囊肿属中医“血瘕病”范畴,也可归于痛经、月经不调、不孕病的范畴。其临床症状与子宫肌瘤有诸多形似之处,如月经量多,下腹疼痛,腰痛,舌质暗红有瘀斑,脉弦或弦细等。
现在临床使用的防治子宫肌瘤和卵巢囊肿的方法,西医主要以手术为主;中成药物虽然较多,但并没有针对乳腺癌患者口服他莫昔芬后导致的子宫肌瘤和卵巢囊肿的中成药。
发明内容
针对上述现有情况,本发明提供了一种疗效好、毒副作用低的防治子宫肌瘤和卵巢囊肿的中药制剂。
本发明的第一个目的在于公开了一种防治子宫肌瘤和卵巢囊肿的药物组合物。
本发明的第二个目的在于公开了上述药物组合物的剂型。
本发明的第三个目的在于公开了上述药物组合物及其剂型的应用。
本发明的第四个目的在于公开了上述药物组合物的制备方法。
本发明的技术方案如下:
一种防治子宫肌瘤和卵巢囊肿的药物组合物,其中,所述药物组合物由下列重量份的原料药制备而成:桃仁150份、大黄100份、桂枝100份、夏枯草150份、牡蛎150g、炙山甲150份、炙鳖甲150份、牡丹皮150份、皂角刺150份、浙贝母150份、三棱300份、莪术300份、西洋参300份、冬虫夏草100份、淫羊藿150份、茯苓150份、铁丝威灵仙150份、甘草100份。
上述技术方案所述的一种防治子宫肌瘤和卵巢囊肿的药物组合物,其中,所述药物组合物由下列重量份的原料药制备而成:桃仁150g、大黄100g、桂枝100g、夏枯草150g、牡蛎150g、炙山甲150g、炙鳖甲150g、牡丹皮150g、皂角刺150g、浙贝母150g、三棱300g、莪术300g、西洋参300g、冬虫夏草100g、淫羊藿150g、茯苓150g、铁丝威灵仙150g、甘草100g。
一种防治子宫肌瘤和卵巢囊肿的药物组合物,其特征在于,所述药物组合物由上述技术方案中所述重量份的原料药按照下述方法制备而成:
(1)、将冬虫夏草粉碎成细粉;
(2)、三棱、莪术提取挥发油,挥发油另器收集;其中,三棱、莪术提取挥发油的具体步骤为:将三棱、莪术研成粗粉,用4倍水浸泡湿润后,浸泡0.5h,然后加热至沸腾,保持微沸状态提取9h,经冷凝后收集馏出液,即得三棱莪术挥发油;
(3)、步骤(2)中的药渣与桃仁、大黄、桂枝、夏枯草、牡蛎、炙山甲、炙鳖甲、牡丹皮、皂角刺、浙贝母、西洋参、淫羊藿、茯苓、铁丝威灵仙和甘草,加水煎煮2次,第1次3小时,第2次2小时,合并煎液,滤过,得滤液;
(4)、步骤(3)的滤液与步骤(2)的水溶液合并,浓缩至2100ml,加乙醇使含醇量达65%,静置24h,滤过,滤液收回乙醇并浓缩至稠膏状,干燥,粉碎成细粉;
(5)、步骤(4)所得细粉中加入步骤(1)中的冬虫夏草细粉、步骤(2)中的三棱莪术挥发油,混匀,即得。
上述技术方案所述的药物组合物在制备防治子宫肌瘤和卵巢囊肿药物中的应用。
上述技术方案所述的药物组合物制备的剂型,其中,它由上述技术方案所述药物组合物和药学上可接受的载体组成;所述剂型为胶囊剂。
上述技术方案所述的剂型,其中,所述载体为淀粉。
上述技术方案所述的剂型在制备防治子宫肌瘤和卵巢囊肿药物中的应用。
一种防治子宫肌瘤和卵巢囊肿的药物组合物的制备方法,其中,所述制备方法包括下述步骤:
(1)、称取下列重量份的原料药:桃仁150份、大黄100份、桂枝100份、夏枯草150份、牡蛎150g、炙山甲150份、炙鳖甲150份、牡丹皮150份、皂角刺150份、浙贝母150份、三棱300份、莪术300份、西洋参300份、冬虫夏草100份、淫羊藿150份、茯苓150份、铁丝威灵仙150份、甘草100份;
(2)、将冬虫夏草粉碎成细粉;
(3)、三棱、莪术提取挥发油,挥发油另器收集;其中,三棱、莪术提取挥发油的具体步骤为:将三棱、莪术研成粗粉,用4倍水浸泡湿润后,浸泡0.5h,然后加热至沸腾,保持微沸状态提取9h,经冷凝后收集馏出液,即得三棱莪术挥发油;
(4)、步骤(2)中的药渣与桃仁、大黄、桂枝、夏枯草、牡蛎、炙山甲、炙鳖甲、牡丹皮、皂角刺、浙贝母、西洋参、淫羊藿、茯苓、铁丝威灵仙、甘草,加水煎煮二次,第一次3小时,第二次2小时,合并煎液,滤过,得滤液;
(5)、步骤(3)的滤液与步骤(2)的水溶液合并,浓缩至2100ml,加乙醇使含醇量达65%,静置24h,滤过,滤液收回乙醇并浓缩至稠膏状,干燥,粉碎成细粉;
(6)、步骤(4)所得细粉中加入步骤(1)中的冬虫夏草细粉、步骤(2)中的三棱莪术挥发油,混匀,即得。
本发明胶囊剂的服用方法为:服用方法:每次3粒,每日3-4次。
本发明具有以下有益效果:
1、本发明制备工艺简单,药品质量均匀稳定;
2、本发明药物组合物能有效防治子宫肌瘤和卵巢囊肿,无明显毒副作用,经济、方便。
3、本发明药物组合物具有活血化淤,消征散结;对子宫肌瘤,卵巢囊肿,月经不调,色暗红,量多且有血块,少腹胀痛等症有较好的治疗效果。
具体实施方式:
为使本发明的技术方案便于理解,以下结合具体实施例来说明本发明一种防治子宫肌瘤和卵巢囊肿的药物组合物的制备方法。
实施例1:一种防治子宫肌瘤和卵巢囊肿的药物组合物:
(1)、称取下列重量份的原料药:桃仁150g、大黄100g、桂枝100g、夏枯草150g、牡蛎150g、炙山甲150g、炙鳖甲150g、牡丹皮150g、皂角刺150g、浙贝母150g、三棱300g、莪术300g、西洋参300g、冬虫夏草100g、淫羊藿150g、茯苓150g、铁丝威灵仙150g、甘草100g;
(2)、将冬虫夏草粉碎成细粉;细粉为胶囊剂中粉末的规格,不易过粗;
(3)、三棱、莪术提取挥发油,挥发油另器收集;其中,三棱、莪术提取挥发油的具体步骤为:将三棱、莪术研成粗粉,用4倍水浸泡湿润后,浸泡0.5h,然后加热至沸腾,保持微沸状态提取9h,经冷凝后收集馏出液,即得三棱莪术挥发油;
(4)、步骤(2)中的药渣与桃仁、大黄、桂枝、夏枯草、牡蛎、炙山甲、炙鳖甲、牡丹皮、皂角刺、浙贝母、西洋参、淫羊藿、茯苓、铁丝威灵仙、甘草,加水煎煮二次,第一次3小时,第二次2小时,合并煎液,滤过,得滤液;
(5)、步骤(3)的滤液与步骤(2)的水溶液合并,浓缩至2100ml,加乙醇使含醇量达65%,静置24h,滤过,滤液收回乙醇并浓缩至稠膏状,干燥,粉碎成细粉;
(6)、步骤(4)所得细粉中加入步骤(1)中的冬虫夏草细粉、步骤(2)中的三棱莪术挥发油,混匀,即得。
实施例2:“妇瘤消胶囊”的制备:
按照实施例1的步骤制得一种防治子宫肌瘤和卵巢囊肿的药物组合物,加入药学上可接受的赋形剂淀粉,混匀后,装胶囊,制成1000粒,即得“妇瘤消胶囊”(防治子宫肌瘤和卵巢囊肿的胶囊剂)。
以下通过本发明实施例2制备所得的胶囊剂(以下称“妇瘤消胶囊”)的药效学实验来说明本发明药物组合物及其胶囊剂所具有的有益效果:
实验例1:急性毒性试验:
雌雄小鼠20只,禁食不禁水12h。将胶囊剂以最大给药容积最高给药浓度1次灌胃,连续观察7d,纪录期间小鼠死亡数和一般情况。结果给药小鼠物1例死亡,也未出现明显中毒现象。可知该胶囊剂毒性较小,半数致死量不能测出。
最大耐受量的测定:雌雄小鼠40只随机分为两组,禁食不禁水12h。一组将胶囊剂配制成最大浓度的液体,以最大容量灌服。每天灌胃2次后进行常规饲养。另一组给予等体积的生理盐水,连续观察7天,详细记录动物每天反应及体重变化和死亡情况。
实验结果:以最大浓度和最大剂量给药2次的那一组小鼠,在灌胃后部分小鼠出现自主活动减少、静卧不动、闭目、反应迟钝等反应,但无竖毛、懒动、抽搐、翻倒等异常情况,连续观察7d,小鼠无出现死亡情况,体重增长。试验结束时,将动物全部处死,观察心、肝、脾、肺、肾等组织脏器,均未见明显毒副作用,可见妇瘤消胶囊对小鼠无明显的毒副作用。
实验例2:治疗子宫肌瘤:
子宫肌瘤是女性生殖系统中最常见的良性肿瘤,“妇瘤消胶囊”治疗子宫肌瘤取得了较好的疗效。
共观察病例56例,56例病人的临床表现如表1所示,肿块大小如表2所示;本组病例最大年龄53岁,最小年龄32岁,平均44.57岁。本组选择的56例子宫肌瘤病人,根据临床表现和舌脉象临床中医辨证均为痰瘀互结型。
治疗方法:口服“妇瘤消胶囊”,每粒0.4g,每次3粒,每日3次,连用一个月为一疗程。
疗效评定标准:
CR[完全缓解]:症状消失并维持二月以上,病灶消失并维持二个月以上。
PR[显效]:症状减少2/3,并维持二个月以上,病灶缩小50%以上并维持二个月以上。
MR[有效]:症状减少1/3,并维持二个月以上,病灶缩小25%以上并维持二个月以上。
PD[无效]:症状加重或无变化,病灶增大或缩小25%以下。
结果见表3和表4,该药有较为理想的改善症状和消瘤作用,其中月经改善77.27%,疼痛减轻68.18%,便秘改善81.82%,白带改善77.78%,腰痛改善73.33%,经疗后B超检查,病灶消失及缩小50%以上者19例,占33.93%,无效20例,占35.71%,使部分病人免除手术之苦,也是子宫肌瘤病人可供选择的治疗方法,该药在观察中未发现不良反应,安全可靠。
表1 临床表现
表3 症状改善情况(疗前疗后对比)
表4 疗前后肿块大小变化(B超检查)
实验例3:治疗卵巢囊肿:
卵巢囊肿是妇科常见良性病变,中医辨证多为痰瘀互结,治疗多采用活血化瘀,消痰散结为主。卵巢囊肿属中医“血瘕病”范畴,也可归于痛经、月经不调、不孕病的范畴。其临床症状与子宫肌瘤有诸多形似之处,如月经量多,下腹疼痛,腰痛,舌质暗红有瘀斑,脉弦或弦细等。中医辨证多为痰瘀互结,治疗多采用活血化瘀,消痰散结为主。
“妇瘤消胶囊”在治疗子宫肌瘤的基础上,用该药观察治疗44例各种类型卵巢囊肿患者,44例病人的临床表现如表5所示,肿块大小如表6所示;本组病例最大年龄52岁,最小年龄31岁,平均41.71岁。根据临床表现和舌脉象临床中医辨证均为痰瘀互结型。
治疗方法同实验例2,疗效评定标准同实验例2。
结果见表7和表8,其中月经改善81.14%,疼痛改善76%,贫血改善78.57%,腰痛改善76.47%,白带改善90.48%。疗前疗后B超检查,病灶缩小50%以上14例,占31.82%,无效19例,占43.18%。该药有较为理想的改善临床症状和消瘤的作用,该药可使部分病人改善症状,免除手术之苦,是卵巢囊肿,特别是巧克力囊肿可供选择的治疗方法之一,该药物无严重不良反应,安全可靠。
表5 临床表现
表6 肿块大小
表7 症状改善情况(疗前疗后对比)
表8 疗前后肿块大小变化(B超检查)
以上所述,仅为本发明的较佳实施例,并非对本发明作任何形式上和实质上的限制,凡熟悉本专业的技术人员,在不脱离本发明技术方案范围内,当可利用以上所揭示的技术内容,而作出的些许更动、修饰与演变的等同变化,均为本发明的等效实施例;同时,凡依据本发明的实质技术对以上实施例所作的任何等同变化的更动、修饰与演变,均仍属于本发明的技术方案的范围内。
Claims (8)
1.一种防治子宫肌瘤和卵巢囊肿的药物组合物,其特征在于,所述药物组合物由下列重量份的原料药制备而成:桃仁150份、大黄100份、桂枝100份、夏枯草150份、牡蛎150份、炙山甲150份、炙鳖甲150份、牡丹皮150份、皂角刺150份、浙贝母150份、三棱300份、莪术300份、西洋参300份、冬虫夏草100份、淫羊藿150份、茯苓150份、铁丝威灵仙150份、甘草100份。
2.根据权利要求1所述的一种防治子宫肌瘤和卵巢囊肿的药物组合物,其特征在于:所述药物组合物由下列重量份的原料药制备而成:桃仁150g、大黄100g、桂枝100g、夏枯草150g、牡蛎150g、炙山甲150g、炙鳖甲150g、牡丹皮150g、皂角刺150g、浙贝母150g、三棱300g、莪术300g、西洋参300g、冬虫夏草100g、淫羊藿150g、茯苓150g、铁丝威灵仙150g、甘草100g。
3.一种防治子宫肌瘤和卵巢囊肿的药物组合物,其特征在于,所述药物组合物由权利要求1或2中所述重量份的原料药按照下述方法制备而成:
(1)、将冬虫夏草粉碎成细粉;
(2)、三棱、莪术提取挥发油,挥发油另器收集;其中,三棱、莪术提取挥发油的具体步骤为:将三棱、莪术研成粗粉,用4倍水浸泡湿润后,浸泡0.5h,然后加热至沸腾,保持微沸状态提取9h,经冷凝后收集馏出液,即得三棱莪术挥发油;
(3)、步骤(2)中的药渣与桃仁、大黄、桂枝、夏枯草、牡蛎、炙山甲、炙鳖甲、牡丹皮、皂角刺、浙贝母、西洋参、淫羊藿、茯苓、铁丝威灵仙和甘草,加水煎煮2次,第1次3小时,第2次2小时,合并煎液,滤过,得滤液;
(4)、步骤(3)的滤液与步骤(2)的水溶液合并,浓缩至2100ml,加乙醇使含醇量达65%,静置24h,滤过,滤液收回乙醇并浓缩至稠膏状,干燥,粉碎成细粉;
(5)、步骤(4)所得细粉中加入步骤(1)中的冬虫夏草细粉、步骤(2)中的三棱莪术挥发油,混匀,即得。
4.权利要求1~3中任一权利要求所述的药物组合物在制备防治子宫肌瘤和卵巢囊肿药物中的应用。
5.权利要求1~3中任一权利要求所述的药物组合物制备的剂型,其特征在于:它由权利要求1或2所述药物组合物和药学上可接受的载体组成;所述剂型为胶囊剂。
6.根据权利要求5所述的剂型,其特征在于:所述载体为淀粉。
7.权利要求5所述的剂型在制备防治子宫肌瘤和卵巢囊肿药物中的应用。
8.一种防治子宫肌瘤和卵巢囊肿的药物组合物的制备方法,其特征在于,所述制备方法包括下述步骤:
(1)、称取下列重量份的原料药:桃仁150份、大黄100份、桂枝100份、夏枯草150份、牡蛎150g、炙山甲150份、炙鳖甲150份、牡丹皮150份、皂角刺150份、浙贝母150份、三棱300份、莪术300份、西洋参300份、冬虫夏草100份、淫羊藿150份、茯苓150份、铁丝威灵仙150份、甘草100份;
(2)、将冬虫夏草粉碎成细粉;
(3)、三棱、莪术提取挥发油,挥发油另器收集;其中,三棱、莪术提取挥发油的具体步骤为:将三棱、莪术研成粗粉,用4倍水浸泡湿润后,浸泡0.5h,然后加热至沸腾,保持微沸状态提取9h,经冷凝后收集馏出液,即得三棱莪术挥发油;
(4)、步骤(2)中的药渣与桃仁、大黄、桂枝、夏枯草、牡蛎、炙山甲、炙鳖甲、牡丹皮、皂角刺、浙贝母、西洋参、淫羊藿、茯苓、铁丝威灵仙、甘草,加水煎煮二次,第一次3小时,第二次2小时,合并煎液,滤过,得滤液;
(5)、步骤(3)的滤液与步骤(2)的水溶液合并,浓缩至2100ml,加乙醇使含醇量达65%,静置24h,滤过,滤液收回乙醇并浓缩至稠膏状,干燥,粉碎成细粉;
(6)、步骤(4)所得细粉中加入步骤(1)中的冬虫夏草细粉、步骤(2)中的三棱莪术挥发油,混匀,即得。
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