CN114848780B - 预防子宫内膜异位症术后复发的中药组合物及其制备方法 - Google Patents
预防子宫内膜异位症术后复发的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明涉及医药领域,具体的,涉及一种预防子宫内膜异位症术后复发的中药组合物及其制备方法。所述中药组合物按照重量份数计,包括莪术20‑30份、桃仁30‑40份、当归80‑90份、香附10‑20份、夏枯草1‑5份、怀牛膝3‑8份、酸枣仁1‑3份、女贞子5‑15份、石斛12‑18份、甘草5‑10份。本发明提供的组合物以活血化瘀为主要治疗目的,同时辅以疏肝、健脾、益肾、安神,从根本上提高机体的抵抗力,从而抵抗术后病灶的复发,降低子宫内膜异位症术后复发率,并且药物温和安全,无不良反应,适合临床推广使用。
Description
技术领域
本发明涉及医药领域,具体的,涉及一种预防子宫内膜异位症术后复发的中药组合物及其制备方法。
背景技术
子宫内膜异位症(endometriosis)是指有活性的内膜细胞种植在子宫内膜以外的位置而形成的一种女性常见妇科疾病。内膜细胞本该生长在子宫腔内,但由于子宫腔通过输卵管与盆腔相通,因此使得内膜细胞可经由输卵管进入盆腔异位生长。病变可以波及所有的盆腔组织和器官,以卵巢、子宫直肠陷凹、宫骶韧带等部位最常见,也可发生于腹腔、胸腔、四肢等处。
子宫内膜异位症主要表现为盆腔疼痛,可引起不孕、月经失调、盆腔包块等相关症状。若子宫内膜异位至鼻腔,可引起鼻腔反复出血;若异位至剖宫产手术切口,可引起切口部位出现包块;若异位至膀胱可引起经期尿频、尿急、尿痛,甚至血尿;若异位至肠腔,可导致经期排便疼痛、肠痉挛等。可见,子宫内膜异位对女性的正常生活带来诸多不便,应及时救治。目前,治疗子宫内膜异位症的常用手段是手术,如果是根治性手段会切除子宫,不适合未生育或年轻的患者;如果是保守或半保守手术,虽然可保留卵巢功能和生育功能,但其实质是细胞减灭术,对深部浸润型或无色素沉着的病变,术中无法摘除干净,残留的病灶在周期性激素影响下容易复发,给患者在心里和身体上带来很大的伤害。子宫内膜异位症术后复发率高达40%-50%,因此为降低术后复发率联合药物治疗是非常必要的。
研究报道,孕三烯酮及GnRH-a类药物能降低子宫内膜异位症的术后复发率,但均具有一定的副作用,包括,在用药期间出现闭经、肝功能异常、体重增加、痤疮、潮热、阴道干涩;停药后甚至会对卵巢功能造成永久性损害,引发卵巢早衰。在内分泌及免疫调节方面,中药相比西药具有显著的优势,副作用小,原料来源广泛,价格低廉,更适合广大患者长期治疗。因此,亟需开发一种预防子宫内膜异位术后复发的中药组合物,以期改善子宫内膜异位症术后复发率高的问题,降低副作用。
发明内容
基于上述现有技术的缺陷,本发明提供一种预防子宫内膜异位症术后复发的中药组合物,该组合物可以有效降低子宫内膜异位症术后复发的概率,减少患者的副反应,适合临床推广使用。
为此,本发明提供一种预防子宫内膜异位症术后复发的中药组合物,按照重量份数计,包括莪术20-30份、桃仁30-40份、当归80-90份、香附10-20份、夏枯草1-5份、怀牛膝3-8份、酸枣仁1-3份、女贞子5-15份、石斛12-18份、甘草5-10份。
优选的,所述预防子宫内膜异位症术后复发的中药组合物,按照重量份数计,包括莪术25份、桃仁35份、当归85份、香附15份、夏枯草3份、怀牛膝5份、酸枣仁2份、女贞子10份、石斛15份、甘草8份。
本发明进一步提供上述中药组合物的制备方法,包括以下步骤:
(1)莪术、桃仁、当归、香附、怀牛膝、女贞子用乙醇提取,固液分离,保留提取液;
(2)夏枯草用乙醇提取,固液分离后,分别保留提取液和药物残渣;
(3)夏枯草药物残渣、酸枣仁、石斛和甘草加水提取,固液分离后,与步骤(1)和步骤(2)的提取液合并、浓缩、干燥,即得。
优选的,所述步骤(1)中乙醇体积百分数为70-80%。
优选的,所述步骤(1)中莪术、桃仁、当归、香附、怀牛膝、女贞子的总质量与乙醇的体积比为1:8-10,所述质量与体积的比值关系为g/mL。
优选的,所述步骤(1)的提取温度为60-80℃,提取时间为20-30min。
优选的,所述步骤(2)中乙醇的体积百分数为40-50%。
优选的,所述步骤(2)中夏枯草质量与乙醇体积的比为1:10-15,所述质量与体积的比值关系为g/mL。
优选的,所述步骤(2)的提取方式为回流浸提,所述浸提时间为50-70min,所述提取次数为1-3次,所述提取温度为40-50℃。
优选的,所述步骤(3)中夏枯草药物残渣、酸枣仁、石斛和甘草的总质量与水的体积比为1:7-10,所述质量与体积的比值关系为g/mL。
优选的,所述步骤(3)提取方式为超声-回流浸提。
优选的,所述超声功率为300-350w,超声时间为40-60min。
优选的,所述浸提时间为90-180min,所述提取次数为1-3次,所述提取温度为70-80℃。
本发明进一步提供一种预防子宫内膜异位症术后复发的药物制剂,包括上述中药组合物或上述制备方法制备得到的中药组合物以及药学上可接受的辅料。
优选的,所述制剂选自颗粒剂、片剂、口服液、胶囊中的任意一种。
本发明的有益效果为:
1、本发明提供的预防子宫内膜异位症术后复发的中药组合物,按照重量份数计,包括莪术20-30份、桃仁30-40份、当归80-90份、香附10-20份、夏枯草1-5份、怀牛膝3-8份、酸枣仁1-3份、女贞子5-15份、石斛12-18份、甘草5-10份。上述组合物以活血化瘀为主要治疗目的,同时辅以疏肝、健脾、益肾、安神,从根本上提高机体的免疫力,从而抵抗术后病灶的复发,降低复发率。具体原理为:当归活血止痛,为君药;莪术、桃仁破血行气、活血祛瘀为臣药;香附、怀牛膝、石斛、夏枯草、女贞子、酸枣仁,疏肝解郁、通经补肾、益胃生津,安心养神,为佐药;甘草补脾益气、调和诸药,为使药;上述药材配伍合理,增强疗效,可有效预防子宫内膜异位症患者术后复发,无不良反应。
2、本发明在制备组合物时区别于传统的煎、煮等炮制方法,分别针对不同提取物中有效成分的特定采用不同的提取方法,能够获得更有针对性的活性成分,减少非必要的毒性物质,从而提高产品的疗效,减少毒副反应的发生。
3、本发明提供的组合物可与任意的药物辅料,采用常规的药物制剂制备方法获得相应的剂型,以提高药物的稳定性,运输和服用的便捷性。
具体实施方式
下面将结合本发明实施例,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例,都涉及本发明保护的范围。
实施例1
本实施例提供一种预防子宫内膜异位症术后复发的中药组合物,包括莪术25g、桃仁35g、当归85g、香附15g、夏枯草3g、怀牛膝5g、酸枣仁2g、女贞子10g、石斛15g、甘草8g。
上述组合物的制备方法,包括以下步骤:
(1)莪术、桃仁、当归、香附、怀牛膝、女贞子,加1600mL75%乙醇,于70℃浸提25min,然后于800r/min离心15min,保留上清液;
(2)夏枯草加45%乙醇36mL,加热至45℃,回流浸提2次,每次浸提60min,然后于800r/min离心15min,合并上清液,夏枯草残渣晾干,称重为2.3g;
(3)夏枯草药物残渣、酸枣仁、石斛和甘草加入220ml水,于330w功率下超声50min,加热至75℃,回流浸提2次,每次120min,然后于800r/min离心15min,上清液与步骤(1)和步骤(2)中上清液合并,于50℃旋转蒸发至原体积的1/10,置于真空干燥箱中,45℃干燥48h,即得所述预防子宫内膜异位症术后复发的中药组合物。
本实施例还提供一种预防子宫内膜异位症术后复发的中药片剂,包括上述中药组合物20g,微晶纤维素10g,30%乙醇20g,羧甲基纤维素钠1.5g和硬脂酸镁0.25g。
上述中药片剂的制备方法,包括以下步骤:中药组合物与微晶纤维素、30%乙醇混合均匀后进行湿法造粒,然后颗粒干燥后与羧甲基纤维素钠、硬脂酸镁混合均匀后压片即得。
实施例2
本实施例提供一种预防子宫内膜异位症术后复发的中药组合物,包括莪术20g、桃仁30g、当归90g、香附20g、夏枯草1g、怀牛膝3g、酸枣仁1g、女贞子5g、石斛18g、甘草5g。
上述组合物的制备方法,包括以下步骤:
(1)莪术、桃仁、当归、香附、怀牛膝、女贞子,加1650mL70%乙醇80℃浸提20min,然后于800r/min离心15min,保留上清液;
(2)夏枯草加40%乙醇15mL,加热至50℃,回流浸提1次,浸提70min,然后于800r/min离心15min,合并上清液,夏枯草残渣晾干,称重为0.3g;
(3)夏枯草药物残渣、酸枣仁、石斛和甘草加入240mL水,于350w功率下超声40min,加热至70℃,回流浸提3次,每次90min,然后于800r/min离心15min,上清液与步骤(1)和步骤(2)中上清液合并,于50℃旋转蒸发至原体积的1/10,置于真空干燥箱中,45℃干燥48h,即得所述预防子宫内膜异位症术后复发的中药组合物。
本实施例还提供一种预防子宫内膜异位症术后复发的中药颗粒,包括上述中药组合物20g,微晶纤维素10g和30%乙醇20g。
上述中药颗粒的制备方法,包括以下步骤:中药组合物与微晶纤维素、30%乙醇混合均匀后进行湿法造粒,干燥后即得。
实施例3
本实施例提供一种预防子宫内膜异位症术后复发的中药组合物,包括莪术30g、桃仁40g、当归80g、香附10g、夏枯草5g、怀牛膝8g、酸枣仁3g、女贞子15g、石斛12g、甘草10g。
上述组合物的制备方法,包括以下步骤:
(1)莪术、桃仁、当归、香附、怀牛膝、女贞子,加1500mL80%乙醇60℃浸提30min,然后于800r/min离心15min,保留上清液;
(2)夏枯草加50%乙醇50mL,加热至40℃,回流浸提3次,每次浸提50min,然后于800r/min离心15min,合并上清液,夏枯草残渣晾干,称重为3.5g;
(3)夏枯草药物残渣、酸枣仁、石斛和甘草加入200mL水,于300w功率下超声60min,加热至80℃,回流浸提1次,浸提180min,然后于800r/min离心15min,上清液与步骤(1)和步骤(2)中上清液合并,于50℃旋转蒸发至原体积的1/10,置于真空干燥箱中,45℃干燥48h,即得所述预防子宫内膜异位症术后复发的中药组合物。
本实施例还提供一种预防子宫内膜异位症术后复发的中药胶囊,包括上述中药组合物20g,微晶纤维素10g,30%乙醇20g和硬脂酸镁0.25g。
上述中药胶囊的制备方法,包括以下步骤:中药组合物与微晶纤维素、30%乙醇混合均匀后进行湿法造粒,然后颗粒干燥后与硬脂酸镁混合均匀后装入胶囊壳即得。
实施例4
本实施例提供一种预防子宫内膜异位症术后复发的中药组合物,其与实施例1相比区别仅在于制备过程中提取溶剂的改变,具体如下:
(1)莪术、桃仁、当归、香附、怀牛膝、女贞子,加1600mL水,于70℃浸提25min,然后于800r/min离心15min,保留上清液;
(2)夏枯草加45%乙醇36mL,加热至45℃,回流浸提2次,每次浸提60min,然后于800r/min离心15min,合并上清液,夏枯草残渣晾干,称重为7.8g;
(3)夏枯草药物残渣、酸枣仁、石斛和甘草加入220ml75%乙醇,于330w功率下超声50min,加热至75℃,回流浸提2次,每次120min,然后于800r/min离心15min,上清液与步骤(1)和步骤(2)中上清液合并,于50℃旋转蒸发至原体积的1/10,置于真空干燥箱中,45℃干燥48h,即得所述预防子宫内膜异位症术后复发的中药组合物。
实施例5
本实施例提供一种预防子宫内膜异位症术后复发的中药组合物,其与实施例1相比区别仅在于制备过程夏枯草直接采用水提取,具体如下:
(1)莪术、桃仁、当归、香附、怀牛膝、女贞子,加1600mL75%乙醇,于70℃浸提25min,然后于800r/min离心15min,保留上清液;
(2)夏枯草、酸枣仁、石斛和甘草加入220ml水,于330w功率下超声50min,加热至75℃,回流浸提2次,每次120min,然后于800r/min离心15min,上清液与步骤(1)和步骤(2)中上清液合并,于50℃旋转蒸发至原体积的1/10,置于真空干燥箱中,45℃干燥48h,即得所述预防子宫内膜异位症术后复发的中药组合物。
对比例1
本对比例提供一种预防子宫内膜异位症术后复发的中药组合物,其与实施例1相比,区别仅在于采用三棱代替莪术。
对比例2
本对比例提供一种预防子宫内膜异位症术后复发的中药组合物,其与实施例1相比,区别仅在于采用10g佛手和5g玫瑰花代替15g香附。
对比例3
本对比例提供一种预防子宫内膜异位症术后复发的中药组合物,其与实施例1相比,区别仅在于采用柏子仁代替酸枣仁。
对比例4
本对比例提供一种预防子宫内膜异位症术后复发的中药组合物,其与实施例1相比,区别仅在于采用枸杞子代替女贞子。
实验例1
观察实施例1-5,对比例1-4的中药组合物对NOD-SCID鼠子宫内膜异位症术后质量的影响。
(1)实验动物:雌性NOD-SCID鼠,6-8周龄,体重20-25g;
(2)建模:取妊娠40-50天、自行人工流产术的妇女的蜕膜组织,置于RPMI-1640培养液无菌瓶(RPMI-1640培养液中含有100U/ml青霉素和100U/ml链霉素);用4℃的无菌磷酸缓冲盐溶液PBS洗去血块和黏液,剪成1×2mm小块,备用;100mg/kg氯胺酮腹腔注射麻醉小鼠,腹部消毒备皮,并做一0.5cm长的小口,将标本种植于皮下,无菌丝线缝合,正常喂养;4周后从小鼠的腹部皮下取出种植物,10%福尔马林固定,乙醇逐级脱水,常规石蜡包埋,分别做HE染色,结果显示小鼠镜检到子宫内膜腺体和间质,说明建模成功;
(3)预防复发:小鼠的腹部皮下取出种植物后,随机分为9组,每组3只,分别灌胃实施例1-5,对比例1-4的中药组合物(加水配置为2mg/mL的溶液),每天两次,每次10mL/kg体重,连续服用1个月,随后观察小鼠的腹部皮下子宫内膜异位复发的情况及小鼠不良反应发生情况,并正常喂养至6个月后,观察小鼠的腹部皮下子宫内膜异位复发的情况,结果见表1。
表1小鼠术后子宫内膜异位复发情况及不良反应
上表数据可以看出,本发明提供的预防子宫内膜异位症术后复发的中药组合物能够有效防止术后子宫内膜异位症复发,并且无不良反应,说明本发明提供的组合物配伍合理,疗效明确显著,温和安全。实施例4和5在术后6个月时,在原移植部位均出现少量液体聚集,提示存在复发的风险,可能是由于制备方法的改变,使得中药中有效成分并未完全释放,药物疗效有所降低。对比例1-4均在术后出现不同程度的复发以及不良发应,反向证明本发明提供的中药组合物配伍合理,做到了相须相使、相畏相杀,相互配合又相互制约,是一个完整的整体,如果替换其中某一味药物,会使整体的疗效降低,甚至可能出现毒副作用。
实验例2
收集100例子宫内膜异位症术后患者,年龄18-45岁,随机分为5组,各组患者在年龄、BMI、生育情况等方面无显著性差异,均无严重药物过敏史、首次因子宫内膜异位症行开腹或腹腔镜手术、无心脑血管、肝、肾及造血系统等严重原发性疾病,无精神病史。
5组患者分别服用本发明实施例1-5的中药制剂,每天2次,每次片剂2片(0.5g/片)、颗粒1袋(1g/袋)、胶囊3粒(0.3g/粒),连续服用3个月,治疗结束后12个月随访,记录患者复发情况。
复发标准:①出现病变复发并加重;②盆腔阳性体征复发;③超声检查发现新的内异症病灶。以上情况出现任意一种即可认定为复发,结果见表2。
表2各组中药组合物临床应用情况
复发率(%) | |
实施例1 | 0 |
实施例2 | 5 |
实施例3 | 0 |
实施例4 | 15 |
实施例5 | 10 |
上表数据可以看出,本发明提供的中药组合物临床应用效果良好,能够有效减少子宫内膜异位症术后复发的情况。
以上仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (9)
1.一种预防子宫内膜异位症术后复发的中药组合物,其特征在于,由以下重量份的原料药材制成:莪术20-30份、桃仁30-40份、当归80-90份、香附10-20份、夏枯草1-5份、 怀牛膝3-8份、酸枣仁1-3份、女贞子5-15份、石斛12-18份、甘草5-10份。
2.根据权利要求1所述的预防子宫内膜异位症术后复发的中药组合物,其特征在于,由以下重量份的原料药材制成:莪术25份、桃仁35份、当归85份、香附15份、夏枯草3份、 怀牛膝5份、酸枣仁2份、女贞子10份、石斛15份、甘草8份。
3.一种权利要求1或2所述的中药组合物的制备方法,其特征在于,包括以下步骤:
(1)莪术、桃仁、当归、香附、怀牛膝、女贞子用乙醇提取,固液分离,保留提取液;
(2)夏枯草用乙醇提取,固液分离后,分别保留提取液和药物残渣;
(3)夏枯草药物残渣、酸枣仁、石斛和甘草加水提取,固液分离后,与步骤(1)和步骤(2)的提取液合并、浓缩、干燥,即得。
4.根据权利要求3所述的制备方法,其特征在于,所述步骤(1)中乙醇体积百分数为70-80%;和/或,步骤(2)中乙醇的体积百分数为40-50%。
5.根据权利要求3所述的制备方法,其特征在于,所述步骤(1)中莪术、桃仁、当归、香附、怀牛膝、女贞子的总质量与乙醇的体积比为1:8-10,所述质量与体积的比值关系为g/mL;
和/或,所述步骤(2)中夏枯草质量与乙醇体积的比为1:10-15,所述质量与体积的比值关系为g/mL;
和/或,所述步骤(3)中夏枯草药物残渣、酸枣仁、石斛和甘草的总质量与水的体积比为1:7-10,所述质量与体积的比值关系为g/mL。
6.根据权利要求3所述的制备方法,其特征在于,所述步骤(1)的提取温度为60-80℃,提取时间为20-30min。
7.根据权利要求3所述的制备方法,其特征在于,所述步骤(2)的提取方式为回流浸提,浸提时间为50-70min,提取次数为1-3次,提取温度为40-50℃。
8.根据权利要求3所述的制备方法,其特征在于,所述步骤(3)提取方式为超声-回流浸提;超声功率为300-350w,超声时间为40-60min;和/或,浸提时间为90-180min,提取次数为1-3次,提取温度为70-80℃。
9.一种预防子宫内膜异位症术后复发的药物制剂,其特征在于包括权利要求1或2所述中药组合物或权利要求3-8任一项所述制备方法制备得到的中药组合物,以及药学上可接受的辅料。
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