CN105943668A - 一种治疗血热伤胎型习惯性流产的中药及其制备方法 - Google Patents
一种治疗血热伤胎型习惯性流产的中药及其制备方法 Download PDFInfo
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Abstract
本发明提供了一种治疗血热伤胎型习惯性流产的中药及其制备方法,中药中包括以下原料药材:寒莓根、鹅肠草、无名异、丝瓜根、辣蓼草、阴香皮、澄茄子、木麻黄、山沉香、小芸木、羊耳菊、吹风散、小叶榕、睡菜、篱天剑和蒲桃壳。本发明的有益效果:本发明的中药能够结合常规西药治疗血热伤胎型习惯性流产,使用方便,针对性强,有效提高治愈率,无毒副作用和不良反应,制备工艺简单。
Description
技术领域
本发明涉及中医药工程技术领域,尤其涉及一种治疗血热伤胎型习惯性流产的中药及其制备方法。
背景技术
习惯性流产又称反复流产,是指自然流产连续发生3次或以上者,每次流产往往发生在同一妊娠月份。近年国际上常用复发性自然流产取代,早期流产的原因常为黄体功能不全、甲状腺功能低下、染色体异常、晚期流产最常见的原因为宫颈口松弛、子宫畸形、子宫肌瘤等。习惯性流产的临床表现与一般流产相同,也是经历先兆流产、难免流产、不全或完全流产几个阶段。早期仅可表现为阴道少许出血,或有轻微下腹隐疼,出血时间可持续数天或数周,血量较少。一旦阴道出血增多,腹疼加重,检查宫颈口已有扩张,甚至可见胎囊堵塞颈口时,流产已不可避免。如妊娠物全部排出,称为完全流产;仅部分妊娠物排出,尚有部分残留在子宫腔内时,称为不全流产,需立即清宫处理。习惯性流产发生以后,夫妻双方都应去正规医院或计生服务站接受检查,找出导致“流产”的原因,对症治疗。
习惯性流产属于中医学“滑胎”的范畴。明代《景岳全书·妇人规》提出“屡见小产,堕胎者,多在三个月及五月、七月之间,而下次之堕必如期复然”的滑胎现象。祖国医学认为:肾为先天之本,肾藏精、肝藏血、脾主运化、肝肾为冲任之本,肝肾不足,则冲任不固,就会胎失所系,导致胎漏,脾为后天之本,生化之源,脾胃虚弱则化源不足,胎失所养,脾肾相资为用,故补肾兼补脾,气血不足也会胎失所养。肝失调达,抑郁化热也会损失胎无,而致胎动不安及胎漏。本病的形成与房劳多产、过食辛辣、跌扑损伤、禀赋虚弱、饮食不节等因素致肾虚、冲任不固,胎失所系,以及脾虚气血生化不足,胎失所养;跌扑损伤,直伤冲任、胎元等因素关系密切。
发明内容
本发明所要解决的技术问题在于,利用我国传统的中医理论,提供一种疗效确切且无毒性作用的治疗血热伤胎型习惯性流产的中药及其制备方法。
为了解决上述技术问题,本发明提供了一种治疗血热伤胎型习惯性流产的中药,所述中药包括以下原料药材:寒莓根、鹅肠草、无名异、丝瓜根、辣蓼草、阴香皮、澄茄子、木麻黄、山沉香、小芸木、羊耳菊、吹风散、小叶榕、睡菜、篱天剑和蒲桃壳。
所述中药中的各种原料药材的重量份数比可以优选为:寒莓根25~35份、鹅肠草10~20份、无名异15~25份、丝瓜根20~30份、辣蓼草5~15份、阴香皮10~20份、澄茄子25~35份、木麻黄8~18份、山沉香25~35份、小芸木15~25份、羊耳菊18~28份、吹风散10~20份、小叶榕5~15份、睡菜20~30份、篱天剑12~22份和蒲桃壳10~20份。
所述中药中的各种原料药材的重量份数比还可以进一步优选为:寒莓根25~30份、鹅肠草15~20份、无名异17~22份、丝瓜根23~28份、辣蓼草8~13份、阴香皮13~18份、澄茄子27~32份、木麻黄10~15份、山沉香28~33份、小芸木18~23份、羊耳菊20~25份、吹风散12~17份、小叶榕8~14份、睡菜22~27份、篱天剑15~20份和蒲桃壳13~18份。
所述中药中的各种原料药材的重量份数比也可以进一步优选为:寒莓根28份、鹅肠草16份、无名异21份、丝瓜根24份、辣蓼草12份、阴香皮14份、澄茄子31份、木麻黄10份、山沉香32份、小芸木18份、羊耳菊24份、吹风散13份、小叶榕14份、睡菜22份、篱天剑18份和蒲桃壳14份。
所述中药中的各种原料药材的重量份数比也可以进一步优选为:寒莓根26份、鹅肠草18份、无名异19份、丝瓜根26份、辣蓼草9份、阴香皮17份、澄茄子28份、木麻黄15份、山沉香29份、小芸木22份、羊耳菊20份、吹风散16份、小叶榕10份、睡菜26份、篱天剑16份和蒲桃壳18份。
当所述中药的剂型为散剂时,其制备方法包括以下步骤:
第一步,将所述原料药材按比例混合,粉碎成粉末;
第二步,将第一步获得粉末加入冷水中浸泡6小时~12小时,以文火煎煮,煎煮时间为3小时~5小时,将煎煮液过滤,获得第一滤液,所加入的水的质量是第一步获得的粉末质量的2~4倍;
第三步,将第二步过滤获得的滤渣再次加入冷水中,以文火煎煮2小时~4小时,过滤获得第二滤液,所加入的水的质量是第二步获得的粉末质量的2~4倍;
第四步,将第二步获得的第一滤液和第三步获得的第二滤液混合,减压浓缩除去水,干燥,粉碎成粉末,粒度为80~120目;
第五步,在所述第四步获得的粉末中,加入淀粉,所述淀粉在所述散剂中的重量百分比为15%~30%,将混匀后的物质用小袋或包装盒分装,每5~10克为一袋或一盒分装。
当所述中药的剂型为氯化钠注射液时,其制备方法包括以下步骤:
第一步,将所述原料药材按比例混合,放入超微粉碎机中粉碎成0.1~10μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料,所述混合粉料的得粉率至少为95%;
第二步,在第一步获得的混合粉料中加入相对于所述混合粉料的质量3~5倍的醇浓度为85%~95%的乙醇,搅拌溶解获得乙醇溶液,将乙醇溶液在5℃~10℃的条件下静置24~36小时,采用渗漉法以每分钟1~2ml的速度缓缓渗漉,收集渗漉液,浓缩并干燥,并在此放入超微粉碎机中粉碎40~60分钟,获得0.1~10μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料,所述混合粉料的得粉率至少为95%;
第三步,取第二步获得的混合粉料1~3g,加入氯化钠90~110g,加1000ml注射用水,搅拌使其溶解;加注射用水至10000ml;用0.22~0.24μm微孔滤膜过滤;分装灌封,每瓶250ml,灭菌即可。
本发明的有益效果:本发明的中药能够结合常规西药治疗血热伤胎型习惯性流产,使用方便,针对性强,有效提高治愈率,无毒副作用和不良反应,制备工艺简单。
具体实施方式
本发明提供了一种治疗血热伤胎型习惯性流产的中药,中药中包括以下原料药材:寒莓根、鹅肠草、无名异、丝瓜根、辣蓼草、阴香皮、澄茄子、木麻黄、山沉香、小芸木、羊耳菊、吹风散、小叶榕、睡菜、篱天剑和蒲桃壳。
各种原料药材的药理如下:
寒莓根:【来源】药材基源:为蔷薇科植物寒莓的根。【性味】苦;酸;寒。【归经】肝;肾经。【功能主治】清热解毒;活血止痛。主湿热黄疸;产后发热;小儿高热;月经不调;白带过多;胃痛叶酸;痔疮肿痛;肛门漏管。【摘录】《中华本草》
鹅肠草:【别名】抽筋草、伸筋藤、伸筋草、壮筋丹、鸡卵菜、鹅儿肠、白头娘草、鸡娘草。【来源】药材基源:为石竹科植物牛繁缕的全草。【性味】甘;酸;性平。【归经】肝;胃经。【功能主治】清热解毒;散瘀消肿。主肺热喘咳;痢疾;痈疽;痔疮;牙痛;月经不调;小儿疳积。【摘录】《中华本草》
无名异:【别名】土子、干子、秃子、铁砂。【来源】药材基源:为氧化物类矿物软锰矿的矿石。【性味】甘;平;咸;寒;无毒。【归经】肾;肝经。【功能主治】去瘀止血;消肿止痛;生肌敛疮。主跌打损伤;金疮出血;痈肿疮疡;水火烫伤。【摘录】《中华本草》《中药大辞典》
丝瓜根:【来源】药材基源:为葫芦和植物丝瓜或奥丝瓜的根。【性味】味甘;微苦;性寒。【功能主治】活血通络;清热解毒。主偏头痛;腰痛;痹证;乳腺炎;鼻炎;鼻窦炎;喉风肿痛;肠风下血;痔漏。【摘录】《中华本草》
辣蓼草:【别名】辣蓼、酸模叶蓼、旱苗蓼、苦蓼大马蓼、白辣蓼。【来源】药材基源:为蓼科植物柳叶蓼的全草。【性味】辛;性温。【功能主治】解毒;健脾;化湿;活血;截疟。主疮疡肿痛;暑湿腹泻;肠炎痢疾;小儿疳积;跌打伤疼;疟疾。【摘录】《中华本草》
阴香皮:【别名】广东桂皮、小桂皮、山肉桂、山玉桂。【来源】药材基源:为樟科植物阴香的树皮。【性味】辛;微甘;性温。【归经】脾经。【功能主治】温中止痛;祛风散寒;解毒消肿;止血。主治寒性胃痛;腹痛泄泻;食欲不振;风寒湿痹;腰腿疼痛;跌打损伤;创伤出血;疮疖肿毒。【摘录】《中华本草》《中药大辞典》
澄茄子:【别名】山胡椒、味辣子、山苍子、木姜子、木香子、野胡椒、臭樟子。【来源】药材基源:为樟科植物山鸡椒的果实。【性味】辛;微苦;温。【归经】脾;胃;肾经。【功能主治】温中止痛;行气活血;平喘;利尿。主脘腹冷痛;食积气胀;反胃呕吐;中暑吐泻;泄泻痢疾;寒疝腹痛;哮喘;寒湿水臌;小便不利;小便浑浊;疮疡肿毒;牙痛;寒湿痹痛;跌打损伤。【摘录】《中华本草》
木麻黄:【别名】木贼叶木麻黄、木贼麻黄。【来源】药材基源:为木麻黄科植物木麻黄的幼嫩枝叶或树皮。【性味】微苦;辛;性温。【归经】肺;大肠;小肠经。【功能主治】宣肺止咳,行气止痛,温中止泻,利湿。主感冒发热;咳嗽;疝气;腹痛;泄泻;痢疾;小便不利;脚气肿毒。【摘录】《中华本草》
山沉香:【别名】羽叶丁香。【来源】木犀科山沉香,以根入药。【性味】辛,微温。【功能主治】降气,温中,暖胃。主治胃腹胀痛,寒喘。外用治皮肤擦伤,烧烟熏治子宫脱垂、脱肛。【摘录】《全国中草药汇编》
小芸木:【别名】鸡屎木、山萸皮、癞蛤蟆跌打、野黄皮、野茶辣、小黄皮、半边风。【来源】药材基源:为芸香科植物小芸木的根、树皮或叶。【性味】味苦、辛;性温。【归经】胃;膀胱;肺经。【功能主治】疏风解表;温中行气;散瘀消肿。主流感;感冒咳嗽;胃痛;风湿痹痛;跌打肿痛;骨折。【摘录】《中华本草》
羊耳菊:【别名】白牛胆、大力王、毛柴胡[湖南]、叶下白、山白芷[广东、福建]、冲天白、小茅香、大茅香、牛耳风、羊耳风、白面风、白背风、绵毛旋覆花、天鹅绒、毛舌头、毛山肖。【来源】为菊科旋覆花属植物羊耳菊,以根或全草入药。夏、秋采割全草,春、秋挖根,洗净鲜用或晒干。【性味】辛、微苦,温。【功能主治】散寒解表,祛风消肿,行气止痛。用于风寒感冒,咳嗽,神经性头痛,胃痛,风湿腰腿痛,跌打肿痛,月经不调,白带,血吸虫病。【摘录】《全国中草药汇编》
吹风散:【别名】入地射香、水灯盏、细风藤。【来源】药材基源:为五味子科植物冷饭藤的藤或根。【性味】甘;性温。【归经】肺;胃;脾;肠;肾经。【功能主治】祛风除湿;行气止痛。主感冒;风湿痹痛;心胃气痛;痛经;跌打损伤。【摘录】《中华本草》
小叶榕:【来源】药材基源:为桑科植物小叶榕的根。【性味】微苦;性平。【功能主治】祛风除湿;行气活血。主风湿痹痛;胃痛;阴挺;跌打损伤。【摘录】《中华本草》
睡菜:【别名】绰菜、瞑菜、醉草、锡打、水胡豆。【来源】药材基源:为龙胆科植物睡菜的全草或叶。【性味】甘;微苦;性寒。【归经】心;脾经。【功能主治】健脾消食;养心安神;清热利尿。主胃炎;消化不良;心悸失眠;湿热黄疸;胆囊炎;水肿;小便不利或赤热涩痛。【摘录】《中华本草》
篱天剑:【别名】打碗花、面根藤。【来源】旋花科打碗花属植物篱打碗花,以根入药。秋季采集,晒干。【性味】甘,寒。【功能主治】清热利湿,理气健脾。用于急性结膜炎,咽喉炎,白带,疝气。【摘录】《全国中草药汇编》
蒲桃壳:【来源】药材基源:为挑金娘科植物蒲挑的干燥果皮。【性味】味甘;微酸;性温。【归经】归脾;肺经。【功能主治】暖胃健脾;温肺止咳;破血消肿。主胃寒呃逆;脾虚泄泻;久痢;肺虚寒嗽;疽瘤。【摘录】《中华本草》
所述中药中的各种原料药材的重量份数比可以优选为:寒莓根25~35份、鹅肠草10~20份、无名异15~25份、丝瓜根20~30份、辣蓼草5~15份、阴香皮10~20份、澄茄子25~35份、木麻黄8~18份、山沉香25~35份、小芸木15~25份、羊耳菊18~28份、吹风散10~20份、小叶榕5~15份、睡菜20~30份、篱天剑12~22份和蒲桃壳10~20份。
所述中药中的各种原料药材的重量份数比还可以进一步优选为:寒莓根25~30份、鹅肠草15~20份、无名异17~22份、丝瓜根23~28份、辣蓼草8~13份、阴香皮13~18份、澄茄子27~32份、木麻黄10~15份、山沉香28~33份、小芸木18~23份、羊耳菊20~25份、吹风散12~17份、小叶榕8~14份、睡菜22~27份、篱天剑15~20份和蒲桃壳13~18份。
所述中药中的各种原料药材的重量份数比也可以进一步优选为:寒莓根28份、鹅肠草16份、无名异21份、丝瓜根24份、辣蓼草12份、阴香皮14份、澄茄子31份、木麻黄10份、山沉香32份、小芸木18份、羊耳菊24份、吹风散13份、小叶榕14份、睡菜22份、篱天剑18份和蒲桃壳14份。
所述中药中的各种原料药材的重量份数比也可以进一步优选为:寒莓根26份、鹅肠草18份、无名异19份、丝瓜根26份、辣蓼草9份、阴香皮17份、澄茄子28份、木麻黄15份、山沉香29份、小芸木22份、羊耳菊20份、吹风散16份、小叶榕10份、睡菜26份、篱天剑16份和蒲桃壳18份。
当所述中药的剂型为散剂时,其制备方法包括以下步骤:
第一步,将所述原料药材按比例混合,粉碎成粉末;
第二步,将第一步获得粉末加入冷水中浸泡6小时~12小时,以文火煎煮,煎煮时间为3小时~5小时,将煎煮液过滤,获得第一滤液,所加入的水的质量是第一步获得的粉末质量的2~4倍;
第三步,将第二步过滤获得的滤渣再次加入冷水中,以文火煎煮2小时~4小时,过滤获得第二滤液,所加入的水的质量是第二步获得的粉末质量的2~4倍;
第四步,将第二步获得的第一滤液和第三步获得的第二滤液混合,减压浓缩除去水,干燥,粉碎成粉末,粒度为80~120目;
第五步,在所述第四步获得的粉末中,加入淀粉,所述淀粉在所述散剂中的重量百分比为15%~30%,将混匀后的物质用小袋或包装盒分装,每5~10克为一袋或一盒分装。
当所述中药的剂型为氯化钠注射液,其包括以下步骤:
第一步,将所述原料药材按比例混合,放入超微粉碎机中粉碎成0.1~10μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料,所述混合粉料的得粉率至少为95%;
第二步,在第一步获得的混合粉料中加入相对于所述混合粉料的质量3~5倍的醇浓度为85%~95%的乙醇,搅拌溶解获得乙醇溶液,将乙醇溶液在5℃~10℃的条件下静置24~36小时,采用渗漉法以每分钟1~2ml的速度缓缓渗漉,收集渗漉液,浓缩并干燥,并在此放入超微粉碎机中粉碎40~60分钟,获得0.1~10μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料,所述混合粉料的得粉率至少为95%;
第三步,取第二步获得的混合粉料1~3g,加入氯化钠90~110g,加1000ml注射用水,搅拌使其溶解;加注射用水至10000ml;用0.22~0.24μm微孔滤膜过滤;分装灌封,每瓶250ml,灭菌即可。
以下采用实施例来详细说明本发明的实施方式,借此对本发明如何应用技术手段来解决技术问题,并达成技术效果的实现过程能充分理解并据以实施。
实施例1:散剂
取寒莓根260g、鹅肠草180g、无名异190g、丝瓜根260g、辣蓼草90g、阴香皮170g、澄茄子280g、木麻黄150g、山沉香290g、小芸木220g、羊耳菊200g、吹风散160g、小叶榕100g、睡菜260g、篱天剑160g和蒲桃壳180g。
其制备方法包括以下步骤:
第一步,将所述原料药材按比例混合,粉碎成粉末;
第二步,将第一步获得粉末加入冷水中浸泡8小时,以文火煎煮,煎煮时间为4小时,将煎煮液过滤,获得第一滤液,所加入的水的质量是第一步获得的粉末质量的4倍;
第三步,将第二步过滤获得的滤渣再次加入冷水中,以文火煎煮4小时,过滤获得第二滤液,所加入的水的质量是第二步获得的粉末质量的3倍;
第四步,将第二步获得的第一滤液和第三步获得的第二滤液混合,减压浓缩除去水,干燥,粉碎成粉末,粒度为100目;
第五步,在所述第四步获得的粉末中,加入淀粉,所述淀粉在所述散剂中的重量百分比为26%,将混匀后的物质用小袋分装,每10克为一袋分装。
实施例2:氯化钠注射液
取寒莓根280g、鹅肠草160g、无名异210g、丝瓜根240g、辣蓼草120g、阴香皮140g、澄茄子310g、木麻黄100g、山沉香320g、小芸木180g、羊耳菊240g、吹风散130g、小叶榕140g、睡菜220g、篱天剑180g和蒲桃壳140g。
其制备方法包括以下步骤:
第一步,将所述原料药材按比例混合,放入超微粉碎机中粉碎成3μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料,所述混合粉料的得粉率至少为95%;
第二步,在第一步获得的混合粉料中加入相对于所述混合粉料的质量4倍的醇浓度为90%的乙醇,搅拌溶解获得乙醇溶液,将乙醇溶液在6℃的条件下静置30小时,采用渗漉法以每分钟2ml的速度缓缓渗漉,收集渗漉液,浓缩并干燥,并在此放入超微粉碎机中粉碎50分钟,获得0.5μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料,所述混合粉料的得粉率至少为95%;
第三步,取第二步获得的混合粉料2g,加入氯化钠100g,加1000ml注射用水,搅拌使其溶解;加注射用水至10000ml;用0.23μm微孔滤膜过滤;分装灌封,每瓶250ml,灭菌即可。
毒性实验:
急性毒性实验:应用小鼠60只,雌雄各半,体重20-34g,进行急性毒性试验。小鼠随机分为两组,即对照组和给药组,实验前禁食12小时,将本发明的实施例1制备的中药散剂溶解在水中,(浓度为8.49g生药/ml,最高浓度)灌胃,灌胃容积为5ml/kg(即单次给药剂量为42.45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。小鼠口服灌胃本发明的散剂LD50>42.45生药/kg,每日最大给药量为84.9生药/kg/日。本发明的中药临床用药量为7.9g生药/日/人,成人体重以60KG计,平均用药剂量为0.132g生药/kg/日。按体重计:小鼠(平均体重以27g计)口服灌胃本发明的中药的耐受量为临床用量的643倍。因此本发明的中药急性毒性极低,临床用药安全。
长期毒性实验:本发明中药实施例1散剂对三组小鼠(每组20只)按12.59、25.37和41.53g生药/kg连续用药15周(1.0ml/100g体重,每天2次)及停药3周后,结果表明:本发明中药对小鼠的毛发、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15周及停药3周后,小鼠各脏器均无明显改变。说明本发明中药对小鼠长期用药后毒性小,停药后也没有异样反应,应用安全。
临床资料:
病例选择:所有入选的120例病例均来源于本院的血热伤胎型习惯性流产患者,治疗组与对照组各60例。治疗组60例中,年龄27-42岁;流产次数3-6次。对照组60例中,年龄25-39岁;流产次数3-5次。治疗组与对照组在年龄、流产次数和临床症状上比较无显著性差异,具有可比性。
诊断标准:
西医诊断标准:1、自然流产连续发生3次或以上。2、每次流产多发生在同一妊娠月份,其临床经过与一般流产相同。3、屡孕屡堕,男方检查正常。4、染色体检查,排除遗传因素所致。5、妇科检查子宫无畸形。
中医辨证分型标准:血热伤胎型:孕后胎动欲坠,小腹胀痛或阴道下血,伴五心烦热,心烦不安,口干咽燥,失眠多梦,小便短黄,大便干结。舌质红,苔黄,脉滑数
治疗方法:
对照组:采用西医常规治疗。肌注促绒毛膜激素针1000u,隔日1次,10d后改为隔2d肌注1000u至停经3个月;口服维生素E胶丸100mg,2次/d;黄体功能不足者,可肌注黄体酮20mg,隔日一次;治疗3个月。
治疗组:在对照组治疗基础上,同时口服本发明中药实施例1散剂,每次20g,每天3次;治疗3个月。
疗效判断标准:1、治愈:妊娠足月分娩或妊娠超过28周;2、无效:妊娠不足28周自然终止。
治疗结果:两组分别治疗3个月后,统计结果参见表1。
表1两组分别治疗3个月后临床疗效比较(单位:例)
组别 | 例数 | 治愈 | 无效 | 总有效率 |
治疗组 | 60 | 55 | 5 | 55(91.7%) |
对照组 | 60 | 47 | 13 | 47(78.3%) |
从表1可以看出,治疗组采用本发明的中药,配合西医治疗血热伤胎型习惯性流产,相对于对照组,在治疗效果上,具有显著的改进。
不良反应:两组治疗期间,均未发现肝肾功能损害或其他明显不良反应。
具体病例:高某,女,38岁,婚后曾怀孕3次,均于三个月左右出现阴道流血,治疗无效流产,与一般流产相同;再次怀孕,至本院求诊,中医症见:孕后胎动欲坠,阴道下血,伴五心烦热,心烦不安,口干咽燥,失眠多梦,小便短黄,大便干结;舌质红,苔黄,脉滑数;结合其他临床检查,确诊并分型为血热伤胎型习惯性流产。给予肌注促绒毛膜激素针、口服维生素和口服本发明中药实施例1散剂;治疗3月后,身体各项检查均恢复正常,妊娠继续。孕40周顺产1名女婴,发育良好,治愈。
所有上述的首要实施这一知识产权,并没有设定限制其他形式的实施这种新产品或新方法。本领域技术人员将利用这一重要信息,上述内容修改,以实现类似的执行情况。但是,所有修改或改造基于本发明新产品属于保留的权利。
以上所述,仅是本发明的较佳实施例而已,并非是对本发明作其它形式的限制,任何熟悉本专业的技术人员可能利用上述揭示的技术内容加以变更或改型为等同变化的等效实施例。但是凡是未脱离本发明技术方案内容,依据本发明的技术实质对以上实施例所作的任何简单修改、等同变化与改型,仍属于本发明技术方案的保护范围。
Claims (9)
1.一种治疗血热伤胎型习惯性流产的中药,其特征在于,所述中药包括以下原料药材:寒莓根、鹅肠草、无名异、丝瓜根、辣蓼草、阴香皮、澄茄子、木麻黄、山沉香、小芸木、羊耳菊、吹风散、小叶榕、睡菜、篱天剑和蒲桃壳。
2.如权利要求1所述的中药,其特征在于,所述原料药材的重量份数比为:寒莓根25~35份、鹅肠草10~20份、无名异15~25份、丝瓜根20~30份、辣蓼草5~15份、阴香皮10~20份、澄茄子25~35份、木麻黄8~18份、山沉香25~35份、小芸木15~25份、羊耳菊18~28份、吹风散10~20份、小叶榕5~15份、睡菜20~30份、篱天剑12~22份和蒲桃壳10~20份。
3.如权利要求1或2所述的中药,其特征在于,所述原料药材的重量份数比为:寒莓根25~30份、鹅肠草15~20份、无名异17~22份、丝瓜根23~28份、辣蓼草8~13份、阴香皮13~18份、澄茄子27~32份、木麻黄10~15份、山沉香28~33份、小芸木18~23份、羊耳菊20~25份、吹风散12~17份、小叶榕8~14份、睡菜22~27份、篱天剑15~20份和蒲桃壳13~18份。
4.如权利要求1至3所述的中药,其特征在于,所述原料药材的重量份数比为:寒莓根28份、鹅肠草16份、无名异21份、丝瓜根24份、辣蓼草12份、阴香皮14份、澄茄子31份、木麻黄10份、山沉香32份、小芸木18份、羊耳菊24份、吹风散13份、小叶榕14份、睡菜22份、篱天剑18份和蒲桃壳14份。
5.如权利要求1至4所述的中药,其特征在于,所述原料药材的重量份数比为:寒莓根26份、鹅肠草18份、无名异19份、丝瓜根26份、辣蓼草9份、阴香皮17份、澄茄子28份、木麻黄15份、山沉香29份、小芸木22份、羊耳菊20份、吹风散16份、小叶榕10份、睡菜26份、篱天剑16份和蒲桃壳18份。
6.如权利要求1至5所述的中药,其特征在于,所述中药的剂型为散剂,其制备方法包括以下步骤:
第一步,将所述原料药材按比例混合,粉碎成粉末;
第二步,将第一步获得粉末加入冷水中浸泡6小时~12小时,以文火煎煮,煎煮时间为3小时~5小时,将煎煮液过滤,获得第一滤液,所加入的水的质量是第一步获得的粉末质量的2~4倍;
第三步,将第二步过滤获得的滤渣再次加入冷水中,以文火煎煮2小时~4小时,过滤获得第二滤液,所加入的水的质量是第二步获得的粉末质量的2~4倍;
第四步,将第二步获得的第一滤液和第三步获得的第二滤液混合,减压浓缩除去水,干燥,粉碎成粉末,粒度为80~120目;
第五步,在所述第四步获得的粉末中,加入淀粉,所述淀粉在所述散剂中的重量百分比为15%~30%,将混匀后的物质用小袋或包装盒分装,每5~10克为一袋或一盒分装。
7.如权利要求1至5所述的中药,其特征在于,所述中药的剂型为氯化钠注射液,其制备方法包括以下步骤:
第一步,将所述原料药材按比例混合,放入超微粉碎机中粉碎成0.1~10μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料,所述混合粉料的得粉率至少为95%;
第二步,在第一步获得的混合粉料中加入相对于所述混合粉料的质量3~5倍的醇浓度为85%~95%的乙醇,搅拌溶解获得乙醇溶液,将乙醇溶液在5℃~10℃的条件下静置24~36小时,采用渗漉法以每分钟1~2ml的速度缓缓渗漉,收集渗漉液,浓缩并干燥,并在此放入超微粉碎机中粉碎40~60分钟,获得0.1~10μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料,所述混合粉料的得粉率至少为95%;
第三步,取第二步获得的混合粉料1~3g,加入氯化钠90~110g,加1000ml注射用水,搅拌使其溶解;加注射用水至10000ml;用0.22~0.24μm微孔滤膜过滤;分装灌封,每瓶250ml,灭菌即可。
8.一种权利要求1至5所述的中药的制备方法,其特征在于,所述中药的剂型为散剂,其制备方法包括以下步骤:
第一步,将所述原料药材按比例混合,粉碎成粉末;
第二步,将第一步获得粉末加入冷水中浸泡6小时~12小时,以文火煎煮,煎煮时间为3小时~5小时,将煎煮液过滤,获得第一滤液,所加入的水的质量是第一步获得的粉末质量的2~4倍;
第三步,将第二步过滤获得的滤渣再次加入冷水中,以文火煎煮2小时~4小时,过滤获得第二滤液,所加入的水的质量是第二步获得的粉末质量的2~4倍;
第四步,将第二步获得的第一滤液和第三步获得的第二滤液混合,减压浓缩除去水,干燥,粉碎成粉末,粒度为80~120目;
第五步,在所述第四步获得的粉末中,加入淀粉,所述淀粉在所述散剂中的重量百分比为15%~30%,将混匀后的物质用小袋或包装盒分装,每5~10克为一袋或一盒分装。
9.一种权利要求1至5所述的中药的制备方法,其特征在于,所述中药的剂型为氯化钠注射液,其制备方法包括以下步骤:
第一步,将所述原料药材按比例混合,放入超微粉碎机中粉碎成0.1~10μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料,所述混合粉料的得粉率至少为95%;
第二步,在第一步获得的混合粉料中加入相对于所述混合粉料的质量3~5倍的醇浓度为85%~95%的乙醇,搅拌溶解获得乙醇溶液,将乙醇溶液在5℃~10℃的条件下静置24~36小时,采用渗漉法以每分钟1~2ml的速度缓缓渗漉,收集渗漉液,浓缩并干燥,并在此放入超微粉碎机中粉碎40~60分钟,获得0.1~10μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料,所述混合粉料的得粉率至少为95%;
第三步,取第二步获得的混合粉料1~3g,加入氯化钠90~110g,加1000ml注射用水,搅拌使其溶解;加注射用水至10000ml;用0.22~0.24μm微孔滤膜过滤;分装灌封,每瓶250ml,灭菌即可。
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