CN105853796A - 一种医治习惯性流产的药物组合物 - Google Patents
一种医治习惯性流产的药物组合物 Download PDFInfo
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Abstract
本发明涉及一种医治习惯性流产的药物组合物,其由下述重量配比的原料药制备而成,覆盆子20份、杜仲15份、女贞子15份、蒲公英12份、甘草15份、桑寄生20份、枸杞子20份、荆芥10份、大蓟10份、侧柏叶10份、没药10份、乳香10份、丹参15份、肉苁蓉15份、巴戟天10份、茯苓10份、竹茹20份、黄芪20份、香附20份、乌药20份、赤芍10份、连翘10份、鱼腥草10份、黄柏10份、牡丹皮10份、山药10份、益母草12份、艾叶20份、党参20份。经临床验证,本发明的药物对于习惯性流产疗效显著,具有广阔的应用前景。
Description
技术领域
本发明涉及中药药物技术领域,特别是一种医治习惯性流产的药物组合物。
背景技术
习惯性流产是指自然流产连续发生3次或更多,每次发生的时间,可在同一妊娠月份,也有时间长短不同者。其临床表现与一般流产相同,根据发生的时间,可分为早期流产及晚期流产两类,早期流产发生在妊娠12周以前,与遗传、母体内分泌失调及免疫等因素有关,发生在妊娠12周以后为晚期流产,与子宫畸形,宫颈发育不良,血型不合,母患疾病等有关。因习惯性流产病因较为复杂,治疗较难。
习惯性流产的危害:1、容易造成感染:多次出现可因扩张太过为细菌侵入行方便之门,轻者会导致子宫内膜炎或输卵管炎。就算孕卵着床也会因子宫内膜频繁吸刮而受到损伤进而影响胎盘的种植和使胎盘血液循环出现障碍,导致缺氧而生长迟缓,使早产儿以及新生儿死亡率上升;2、容易形成自然流产:多次人工流产有造成自然流产的危险。因多次流产给女性的神经内分泌和生殖机能带来很大的影响,特别是对未产妇可增加妊娠早期、中期的自然流产率。还增加宫外孕、前置胎盘和产后出血的发病率;3、容易损伤子宫内膜:多次人工流产易损害子宫内膜,因吸刮时最易损伤子宫内膜基底层组织,因此致使子宫穿孔的也有很多。在子宫内膜与功能层基底层组织之间的正常组织被破坏以后,子宫内膜很容易向基底层或肌层组织内生长,产生子宫肌腺症或腺肌瘤,致使不孕、腹痛等症。
西医认为,习惯性流产的发生与遗传因素、外界有毒物质影响、母体的疾病、免疫因素造成的排斥及母儿血型不合等有关。目前常见的治疗药物有镇静药、激素类药物、维生素类药物。其中较为常见的化学药有催眠镇静药如安定、雌激素如黄体酮、维生素E,但长期应用产生很大的不良反应。如早期妊娠时持续用镇静药,存在有可引起小儿唇裂的危险,孕妇长期服用大量的镇静药,会影响小儿的智力发育。妊娠期前3个月的妇女如果应用雌激素有可能使胎儿异化 ;妊娠3个月后服用雌激素,可使胎儿生殖器暂时性增大。大量的维生素E可使激素代谢紊乱,如经闭或月经过多,乳房增大肿胀,还可使血中胆固醇和甘油三酯升高,免疫功能减退等。
中医认为,习惯性流产又名滑胎、胎漏,大多因脾肾双亏而致病,有腰痛、小腹累坠累痛、脉沉弱而无力、舌质淡或有齿痕、苔薄等症状。随着经济社会发展,一些处于生育阶段的妇女由于生活压力大、生活不规律、饮食不科学、情志失调等原因极易造成劳倦内伤,引起脾肾双虚。肾气亏损,不能固胎;脾气虚弱,不能载胎,从而最终引起习惯性流产。其为“血气不足,故不能养胎所以致胎数堕”。肾气不足包括两个方面,一是父母的精气,若不足则阴阳虽能结合成形,但是胎元不固,或有畸形,终致流产,甚或频坠;二是母体虚弱,肾气不足。脾胃虚弱主要导致气血的不足,气虚不能载胎,血虚不能养胎,故而流产。脾肾双亏,血气不足,是习惯性流产的主要病因。因此,中医治疗习惯性流产重在辨证。由于习惯性流产多因气血虚弱、肾虚、血热及外伤,导致内分泌不足、气血循环不佳流产。所以在治疗上必须以补气、固肾、养血、清热、活血等疗法处方用药。在中医来看,本症有虚有实。虚证是肾虚、气血虚弱,无法充养于胚胎;实证为血热、瘀血等病因损伤胎儿所致。依中医理论,虚证宜补肾、益气养血;实证宜滋阴降火、化瘀。
现有技术中药处方缺乏辩证,治疗周期长,对症性不强,疗效不明显,甚至还会给患者带来副作用,增加患者痛苦,从天然药物中寻找有效、安全的药物,已成为普遍需要解决的问题。
发明内容
本发明的目的在于克服现有技术对治疗习惯性流产的不足,提供一种医治习惯性流产的药物组合物,该药物组合物不仅具有益气养血,补肾安胎的功能,还具有温肾健脾和疏调气血的效果,用于治疗习惯性流产具有见效快,疗效好,无毒副作用的优点,并且开发成方便服用的成品制剂后,普遍适用性好,疗效依然显著,生产工艺简单,易于推广应用。为实现上述目的,本发明采用的技术方案如下:
一种医治习惯性流产的药物组合物,其由下述重量配比的原料药制备而成:
覆盆子20份、杜仲15份、女贞子15份、蒲公英12份、甘草15份、
桑寄生20份、枸杞子20份、荆芥10份、大蓟10份、侧柏叶10份、
没药10份、乳香10份、丹参15份、肉苁蓉15份、巴戟天10份、
茯苓10份、竹茹20份、黄芪20份、香附20份、乌药20份、
赤芍10份、连翘10份、鱼腥草10份、黄柏10份、牡丹皮10份、
山药10份、益母草12份、艾叶20份、党参20份。
优选地,所述中药制剂,其制备方法包括如下步骤:
1)称取各原料药,备用;
2)取甘草、香附、山药粉碎过100目筛获得复合物A;
3)取覆盆子、女贞子、蒲公英、荆芥、大蓟、侧柏叶、肉苁蓉、赤芍、鱼腥草、牡丹皮、艾叶加冷水漫过药面,浸泡30分钟,再加水至没过药面约4厘米,进行第一次煎煮,武火煎煮,沸后用文火煎煮1小时,过滤收集滤液和滤渣;往滤渣中添加水,以没过滤渣为准,第二次煎煮,武火煮沸,然后文火煎煮0.5小时,过滤收集滤液和滤渣,合并两次滤液,冷却后,浓缩成密度为1.2g/ml的浸膏;80℃烘干后,粉碎成粉末,即为复合物B;
4)取剩余成分加的68-75%(体积比)乙醇浸泡1.5小时,然后提取两次,每次1小时,合并提取液,滤过,浓缩成相对密度为1.2g/ml的浸膏,干燥后粉碎,得复合物C;
5) 将复合物A、复合物B、复合物C混合搅拌均匀,制备药物制剂。
本发明中药制剂组方依据祖国医学对治疗习惯性流产的辨证认知,遵循中药的配伍理论,为了制成方便易用且疗效稳定的制剂,强化了药材的使用量,诸药配合,相辅相成,协同作用,在治疗习惯性流产方面有十分显著的疗效。本发明中药制剂不仅具有益气养血,补肾安胎的功能,还具有温肾健脾和疏调气血的疗效,用于治疗习惯性流产见效快,疗效好,无毒副作用,并且开发成方便服用的成品制剂后,普遍适用性好,疗效依然显著,生产工艺简单,易于推广应用。
具体实施方式
实施例1
一种医治习惯性流产的药物组合物,其由下述重量配比的原料药制备而成:
覆盆子20份、杜仲15份、女贞子15份、蒲公英12份、甘草15份、
桑寄生20份、枸杞子20份、荆芥10份、大蓟10份、侧柏叶10份、
没药10份、乳香10份、丹参15份、肉苁蓉15份、巴戟天10份、
茯苓10份、竹茹20份、黄芪20份、香附20份、乌药20份、
赤芍10份、连翘10份、鱼腥草10份、黄柏10份、牡丹皮10份、
山药10份、益母草12份、艾叶20份、党参20份。
所述中药制剂的制备方法包括如下步骤:
1)称取各原料药,备用;
2)取甘草、香附、山药粉碎过100目筛获得复合物A;
3)取覆盆子、女贞子、蒲公英、荆芥、大蓟、侧柏叶、肉苁蓉、赤芍、鱼腥草、牡丹皮、艾叶加冷水漫过药面,浸泡30分钟,再加水至没过药面约4厘米,进行第一次煎煮,武火煎煮,沸后用文火煎煮1小时,过滤收集滤液和滤渣;往滤渣中添加水,以没过滤渣为准,第二次煎煮,武火煮沸,然后文火煎煮0.5小时,过滤收集滤液和滤渣,合并两次滤液,冷却后,浓缩成密度为1.2g/ml的浸膏;80℃烘干后,粉碎成粉末,即为复合物B;
4)取剩余成分加的75%(体积比)乙醇浸泡1.5小时,然后提取两次,每次1小时,合并提取液,滤过,浓缩成相对密度为1.2g/ml的浸膏,干燥后粉碎,得复合物C;
5) 将复合物A、复合物B、复合物C混合搅拌均匀,灭菌消毒制得胶囊剂产品,每次口服0.1g,一日三次。
一个月为一个疗程,连续服用2-3个疗程。
实施例3
急性毒性试验
受试药物:本发明实施例1所制造的胶囊剂,验动物:普通级NIH小鼠10只,体重16g±5g,雌雄各半,雌性小鼠均无孕。 小鼠灌胃实施例1中药制剂制备的混悬液,给药后小鼠出现轻微活动减少,1小时左右恢复正常,给药后连续观察7天,无一动物死亡,其全身状况、饮食、摄水、小便和体重增长均正常,试验结果表明该药急性毒性极低,临床用药安全。
动物长期毒性试验
试验动物:普通级SD大鼠20只,体重220g±15g,雌雄各半,雌性大鼠均无孕,均分成2组,每组10只。
将本发明实施例1所得中药胶囊剂制备混悬液备用。灌喂大鼠,另外一组作为对照组,灌胃等容积生理盐水;上述各试验组连续灌胃60天。
观察动物全身毒性反应及严重程度,处死后按操作规程检查各部位,并进行血液学,ALT、BUN及心、肝、脾、肺、肾、胃等主要脏器的病理学检查;经过长期喂食,3组大鼠均未出现毒性反应,发育良好,肉眼外观及主要脏器未见异常,外周血象及血清ALT、BUN与对照组比较无病理性改变,病理报告心、肝、脾、肺、肾、胃等均未有意义的改变,因此,认为经病理证实,该中药胶囊剂对动物无慢性毒性表现。
实施例3
临床资料
从近几年来入院就诊先兆流产病例中选择62例,年龄25-38岁,平均年龄分别为31.7岁随机分成三组,实施例1组31人,对照组31人,各组选用的病例中病史、病情、年龄、性别尽量相当。
记录患者服药后的身体状况,未孕者记录例假情况,治疗过程中受孕者记录患者孕期反应情况、孕妇相关激素检查。治疗结束1年后回访所有患者,统计孕产情况。
试验评价标准
治愈:患者习惯性流产相关症状完全消失,顺利度过习惯性流产期,并生下健康婴儿。
显效:习惯性流产相关症状部分消失,身体状况好转,但仍需进一步治疗。
无效:习惯性流产相关症状没有任何改善,甚至更加严重。
治疗方法:
对照组:服用保胎灵胶囊,每天3次,每次3粒;一个月为一个疗程,连续治疗3个疗程;
实施例1组:服用本发明实施例1制备的中药制剂,每次口服0.1g,一日三次。
所有病例试验完毕后,对结果进行统计分析计算,如表1所示。
表1
组别 | 例次 | 治愈 | 显效 | 无效 | 总有效率 |
实施例1组 | 31 | 25 | 5 | 1 | 96.8% |
对照组 | 31 | 15 | 6 | 10 | 67.7% |
实施例4
典型病例
林某,35岁。患者自述结婚5年,孕三次,均于3月大小时流产,2015年做的试管婴儿,于胚胎植入后2个月,住院保胎。诊断为:习惯性流产。给予本发明实施例1制备的药物组合物制备1个疗程,B 超检查提示胎儿发育正常,后孩子足月顺利生产,期间无不良反应。
本发明采用的上述各中药互作配伍,能发挥其协同治病作用,所用中药原料各成分之间具有药效相互交织相互促进和协调效能,本申请药物制剂成本低廉,疗效显著,具有广阔的应用前景。
Claims (3)
1.一种医治习惯性流产的药物组合物,其由下述重量配比的原料药制备而成:
覆盆子20份、杜仲15份、女贞子15份、蒲公英12份、甘草15份、
桑寄生20份、枸杞子20份、荆芥10份、大蓟10份、侧柏叶10份、
没药10份、乳香10份、丹参15份、肉苁蓉15份、巴戟天10份、
茯苓10份、竹茹20份、黄芪20份、香附20份、乌药20份、
赤芍10份、连翘10份、鱼腥草10份、黄柏10份、牡丹皮10份、
山药10份、益母草12份、艾叶20份、党参20份。
2.根据权利要求1所述的药物组合物,其特征在于,所述药物组合物的制备方法包括如下步骤:
1)称取各原料药,备用;
2)取甘草、香附、山药,混合,粉碎过100目筛获得复合物A;
3)取覆盆子、女贞子、蒲公英、荆芥、大蓟、侧柏叶、肉苁蓉、赤芍、鱼腥草、牡丹皮、艾叶,混合,加冷水漫过药面,浸泡30分钟,再加水至没过药面约4厘米,进行第一次煎煮,武火煎煮,沸后用文火煎煮1小时,过滤收集滤液和滤渣;往滤渣中添加水,以没过滤渣为准,第二次煎煮,武火煮沸,然后文火煎煮0.5小时,过滤收集滤液和滤渣,合并两次滤液,冷却后,浓缩成密度为1.2g/ml的浸膏;80℃烘干后,粉碎成粉末,即为复合物B;
4)取剩余原料药,混合,加的75%乙醇浸泡1.5小时,然后提取两次,每次1小时,合并提取液,滤过,浓缩成相对密度为1.2g/ml的浸膏,干燥后粉碎,得复合物C;
5)将复合物A、复合物B、复合物C混合搅拌均匀,即得。
3.权利要求1-2所述药物组合物的药物用途。
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