CN105497439A - 一种治疗妇产科术后低热症的药物组合物 - Google Patents
一种治疗妇产科术后低热症的药物组合物 Download PDFInfo
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Abstract
一种治疗妇产科术后低热症的药物组合物,所述药物组合物的原料药由牡丹皮、东白薇、升麻、地骨皮、鸡血藤、大青叶、青蒿、重楼、益母草、葛根、甘草、白芍、白术、马齿苋、金银花、山楂、益母草、桂枝、苦参、当归、枳实、白花蛇舌草、山药、煅牡蛎、秦艽、乌梅、五味子、川芎、厚朴、大枣组成。诸药合用,用药适宜,配伍精简,主次分明,标本兼治,可有效治疗妇产科术后低热症,能够大大缩短患者的康复时间,有效改善和优化患者的身体素质和生活质量,在临床试验上已经取得优异的治疗效果。
Description
技术领域
本发明属于医药技术领域,涉及一种中药组合物,具体涉及一种治疗妇产科术后低热症的药物组合物。
背景技术
妇产科术后低热症属于非常普遍的临床妇产科疾病,其临床症状主要包括咳嗽、心悸、食欲不振、乏力、头晕等,主要诱发原因为结核、风湿等等炎性反应以及人体长期处于巨大压力下导致体温神经中枢受损等。多方面的原因会导致持续低烧,患者的心情也和该疾病的发病有密切联系。目前西药治疗多采用静脉注射抗生素,成本高,且副作大。
发明内容
本发明的目的是提供一种配制简便、成本低、疗效显著、无副作用的治疗妇产科术后低热症的药物组合物。
本发明的上述目的是通过下述技术方案来实现的:
一种治疗妇产科术后低热症的药物组合物,所述药物组合物的原料药由牡丹皮、东白薇、升麻、地骨皮、鸡血藤、大青叶、青蒿、重楼、益母草、葛根、甘草、白芍、白术、马齿苋、金银花、山楂、益母草、桂枝、苦参、当归、枳实、白花蛇舌草、山药、煅牡蛎、秦艽、乌梅、五味子、川芎、厚朴、大枣组成。
进一步地,制成所述药物组合物的原料药组成及重量份数为:甘草12-20份,白花蛇舌草10-16份,苦参3-8份,牡丹皮5-12份,升麻12-17份,东白薇7-12份,桂枝4-9份,山楂15-20份,厚朴10-15份,金银花8-12份,益母草2-5份,青蒿3-7份,鸡血藤11-14份,重楼9-15份,地骨皮3-6份,马齿苋8-13份,煅牡蛎3-5份,益母草1-3份,当归5-10份,葛根5-10份,乌梅13-16份,大青叶3-10份,枳实8-13份,山药3-5份,白芍1-3份,川芎5-10份,大枣3-6份,白术8-13份,秦艽3-5份,五味子4-8份。
进一步地,制成所述药物组合物的原料药组成及重量份数为:甘草12份,白花蛇舌草16份,苦参3份,牡丹皮12份,升麻12份,东白薇10份,桂枝9份,山楂15份,厚朴15份,金银花8份,益母草5份,青蒿3份,鸡血藤14份,重楼9份,地骨皮6份,马齿苋8份,煅牡蛎5份,益母草1份,当归10份,葛根5份,乌梅16份,大青叶10份,枳实8份,山药5份,白芍1份,川芎10份,大枣6份,白术8份,秦艽3份,五味子4份。
进一步地,制成所述药物组合物的原料药组成及重量份数为:甘草20份,白花蛇舌草10份,苦参8份,牡丹皮5份,升麻17份,东白薇12份,桂枝4份,山楂20份,厚朴10份,金银花12份,益母草2份,青蒿7份,鸡血藤11份,重楼15份,地骨皮3份,马齿苋13份,煅牡蛎3份,益母草3份,当归5份,葛根10份,乌梅13份,大青叶3份,枳实13份,山药3份,白芍3份,川芎5份,大枣4份,白术10份,秦艽4份,五味子5份。
进一步地,制成所述药物组合物的原料药组成及重量份数为:甘草13份,白花蛇舌草11份,苦参4份,牡丹皮6份,升麻13份,东白薇7份,桂枝5份,山楂18份,厚朴11份,金银花9份,益母草4份,青蒿6份,鸡血藤12份,重楼13份,地骨皮4份,马齿苋9份,煅牡蛎4份,益母草2份,当归6份,葛根6份,乌梅14份,大青叶5份,枳实10份,山药4份,白芍2份,川芎6份,大枣5份,白术12份,秦艽3份,五味子6份。
进一步地,制成所述药物组合物的原料药组成及重量份数为:甘草17份,白花蛇舌草15份,苦参7份,牡丹皮11份,升麻16份,东白薇8份,桂枝8份,山楂16份,厚朴14份,金银花11份,益母草3份,青蒿5份,鸡血藤13份,重楼14份,地骨皮5份,马齿苋12份,煅牡蛎3份,益母草1份,当归10份,葛根9份,乌梅13份,大青叶7份,枳实11份,山药3份,白芍1份,川芎10份,大枣4份,白术11份,秦艽4份,五味子7份。
进一步地,制成所述药物组合物的原料药组成及重量份数为:甘草15份,白花蛇舌草12份,苦参5份,牡丹皮9份,升麻15份,东白薇9份,桂枝7份,山楂19份,厚朴13份,金银花10份,益母草4份,青蒿4份,鸡血藤11份,重楼11份,地骨皮5份,马齿苋10份,煅牡蛎5份,益母草3份,当归8份,葛根8份,乌梅14份,大青叶9份,枳实12份,山药5份,白芍3份,川芎8份,大枣6份,白术9份,秦艽5份,五味子7份。
进一步地,制成所述药物组合物的原料药组成及重量份数为:甘草19份,白花蛇舌草14份,苦参6份,牡丹皮7份,升麻14份,东白薇9份,桂枝6份,山楂17份,厚朴13份,金银花10份,益母草4份,青蒿4份,鸡血藤11份,重楼11份,地骨皮5份,马齿苋10份,煅牡蛎5份,益母草3份,当归8份,葛根8份,乌梅14份,大青叶4份,枳实9份,山药5份,白芍3份,川芎8份,大枣3份,白术8份,秦艽5份,五味子8份。
进一步地,所述药物组合物采用下列制备步骤:
(1)取权利要求3-8任一所述药物组合物中重量组分的各药材,第一次煎煮加药材总重量的10-15倍的水煎煮提取,煎煮1-2小时:第二次加入8-12倍量的水,煎煮1-1.2h,滤出药液待用;第三次加入8-12倍量的水,煎煮0.8-1.2h,滤出药液待用;合并三次煎液,过滤,收集滤液,浓缩至50-60℃时相对密度为1.10-1.30的清膏;
(2)将步骤(1)制得的清膏放置至室温后,加乙醇使含乙醇量至重量百分比60-75%,静置24-48小时,取上清液;上清液回收乙醇,减压浓缩至50-60℃时相对密度为1.20-1.30的清膏,随后在3000r/min的转速下离心;在60℃-80℃喷雾干燥,得干浸膏;
(3)将步骤(2)制得的干浸膏放入超微粉碎机中粉碎1-2小时,过筛,得到100-200目的超微细粉,加入适量蔗糖、糊精混合,以乙醇为润湿剂,制粒,干燥,整粒,可制得颗粒剂;或者将步骤(2)制得的干浸膏干燥后放入超微粉碎机中粉碎1-2小时,过筛,得到100-200目的超微细粉,制成散剂;或者将步骤(2)制得的干浸膏放入超微粉碎机中粉碎1-2小时,过筛,得到100-200目的超微细粉,加入适量微粉硅胶、α-半乳糖混合,以乙醇为润湿剂,制粒,干燥,整粒,装胶囊,制得胶囊剂;或者将步骤(2)制得的干浸膏放入超微粉碎机中粉碎1-2小时,过筛,得到100-200目的超微细粉,加入适量蔗糖、糊精混合,以乙醇为润湿剂,制粒,干燥,整粒,压片,制得片剂;或者向上述步骤(2)得到的离心后的浓缩液中加入适量蔗糖、香精混合,灭菌,灌装,制得药液剂。
本发明还涉及一种所述药物组合物在治疗妇产科术后低热症药物中的应用。
本发明所提供的治疗妇产科术后低热症的药物组合物,其以常见的中草药为原料,充分发挥各组分的药性:
牡丹皮,咸,微寒。归肝、肾经。功能主治:滋阴潜阳,软坚散结,退热除蒸。用于阴虚发热,劳热骨蒸,虚风内动,经闭,癓瘕,久疟疟母。
东白薇:味辛、苦,微寒。归肝、胃、大肠经。清热解毒,消痈排脓,祛瘀止痛。用于肠痈,肺痈高热,咳吐脓血,热毒疮疔,胸腹疼痛,产后腹痛,痛经。
升麻,辛、微甘,微寒。归肺、脾、胃、大肠经。功能主治:发表透疹,清热解毒,升举阳气。用于风热头痛,齿痛,口疮,咽喉肿痛,麻疹不透,阳毒发斑;脱肛,子宫脱垂。
地骨皮,甘,凉。归肺、大肠经。功能主治:清热润肺,滑肠通便。用于肺火燥咳,咽痛失音,肠燥便秘。
鸡血藤:味苦、甘,性温。归肝、肾经。补血,活血,通络。用于月经不调,血虚萎黄,麻木瘫痪,风湿痹痛。
大青叶,苦、辛,寒。归肝、胆经。功能主治:清热解暑,除蒸,截疟。用于暑邪发热,阴虚发热,夜热早凉,骨蒸劳热,疟疾寒热,湿热黄疸。
青蒿,味苦,气平、微寒,无毒。入肺、胃、脾、心四经。消热痰最利,止久嗽宜用,心中逆气多愁郁者可解,并治伤寒结胸之症,疗人面疮能效。
重楼性苦微寒,归肝经,功能清热解毒,消肿止痛,苦参性苦,寒,归心、肝、胃、大肠、膀胱经,具有清热燥湿,杀虫,利尿之功。
益母草:味苦,性寒,归心、肺、大肠、膀胱经,具有清热解毒,凉血,消肿,燥湿的功效,主治感冒发热,咽喉肿痛,口舌生疮,顿咳劳嗽,泄泻痢疾,热淋涩痛,痈肿疮疡,毒蛇咬伤等证。
葛根,味甘、辛,性凉。入脾、胃经。具有升阳解肌,透疹止泻,除烦止温的功效。用于伤寒、温热头痛项强,烦热消渴,泄泻,痢疾,癍疹不透,高血压,心绞痛,耳聋。临床上用来治疗高血压病颈项强痛、冠心病心绞痛,而且还具有降血糖作用。
甘草,性味:甘、平,具有补脾益气、清热解毒、祛痰止咳、缓急止痛、调和诸药的功效,用于治疗食少、脾胃虚弱、腹痛便溏、倦怠乏力、心悸气短、咳嗽痰多、脘腹、四肢挛急疼痛、痈肿疮毒、缓解药物毒性和烈性。
白芍为我国著名的传统常用中药材,应用历史悠久,芍药始载于东汉《神农本草经》,列为中品,记有“主邪气,白芍腹痛,除血痹,破坚积,寒热疝瘕,止痛,利小便,益气”。养血柔肝,缓中止痛,敛阴收汗。治胸腹胁肋疼痛,泻痢腹痛,自汗盗汗,阴虚发热,月经不调,崩漏,带下等症。
白术,甘、苦,凉。归心、肝经。凉血止血,散瘀解毒消痈。血热出血证。本品性属寒凉,善清血分之热而凉血止血,无论吐咯衄血,便血崩漏等出血由于血热妄行所致者皆可选用。兼能利尿通淋,故尤善治尿血、血淋,可单味应用,也可配伍生地、滑石、山栀、淡竹叶等。热毒痈肿。本品能清热解毒,散瘀消肿,用治热毒疮疡初起肿痛之证。
马齿苋,酸,寒。清热利湿,凉血解毒。用于细菌性痢疾,急性胃肠炎,急性阑尾炎,乳腺炎,痔疮出血,白带;外用治疔疮肿毒,湿疹、带状疱疹。《本草纲目》:“散血消肿,利肠滑胎,解毒通淋,治产后虚汗。”
金银花:忍冬科植物忍冬LonicerajaponicaThunb.、红腺忍冬LonicerahypoglaucaMiq.、山银花LoniceraconfusaDC.或毛花柱忍冬LoniceradasystylaRehd.的干燥花蕾或带初开的花。性甘寒气芳香,甘寒清热而不伤胃,芳香透达又可祛邪。金银花既能宣散风热,还善清解血毒,用于各种热性病,如身热、发疹、发斑、热毒疮痈、咽喉肿痛等证,均效果显著。
山楂为蔷薇料植物山楂或野山楂的果实,其酸、甘,微温,入脾、胃、肝经,具有消食积,散瘀血,利尿,止泻的功效。人体服用山楂后,能够增加胃中酶类的活性,促进食物消化,行气散瘀,利于消肉积。
益母草:味辛甘,气微温,无毒。入心、肝、膀胱经。活血,祛瘀,调经,消水。治月经不调,胎漏难产,胞衣不下,产后血晕,瘀血腹痛,崩中漏下,尿血,泻血,痈肿疮疡。
桂枝味辛甘,性温,是里寒常用的内温药,具有补元阳、通腑降浊、通血脉、暖脾胃之功效,常与补肝肾药、补气血药配伍,治疗肾阳不足、命门火衰、肢冷脉微,与其它温里药配伍治疗脘腹冷痛、寒痹腰痛,具有明显的镇痛和抗癌防癌的作用。
苦参:苦,寒。归心、肝、胃、大肠、膀胱经。清热燥湿,杀虫,利尿。用于热痢,便血,黄疸尿闭,赤白带下,阴肿阴痒,湿疹,湿疮,皮肤瘙痒,疥癣麻风;外治滴虫性阴道炎。
当归:甘、辛、温。归肝、心、脾经。补血;活血;调经止痛;润燥滑肠。主血虚诸证;月经不调;经闭;痛经;症瘕结聚;崩漏;虚寒腹痛;痿痹;肌肤麻木;肠燥便难;赤痢后重;痈疽疮疡;跌扑损伤。
枳实:温;苦、辛、酸;归脾、胃经。破气消积,化痰散痞。用于积滞内停,痞满胀痛,泻痢后重,大便不通,痰滞气阻胸痹,结胸;胃下垂,脱肛,子宫脱垂。
白花蛇舌草:味苦、甘,性寒,入心,肝,脾,大肠经,具有清热解毒,利水渗湿的作用,用于肺热喘咳,咽喉肿痛,肠痈,疖肿疮疡,毒蛇咬伤,热淋涩痛,水肿,痢疾,肠炎,湿热黄疸,癌肿等证,常利用白花蛇舌草抗癌治癌,其具有一定的抗辐射作用。
山药:味甘,性平、无毒,归脾、肺、肾经,主要有效成分薯蓣皂甙是一种多糖,对四氧嘧啶所致的大鼠胰岛B细胞损伤有保护作用,对禁食大鼠和兔有降血糖作用,能控制四氧嘧啶等引起的高血糖。
煅牡蛎,咸,微寒。归肝、胆、肾经。重镇安神,潜阳补阴,软坚散结。用于惊悸失眠,眩晕耳鸣,瘰疬痰核,症瘕痞块。煅牡蛎收敛固涩。用于自汗盗汗,遗精崩带,胃痛吞酸。
秦艽,苦辛,平。入肝、胃、胆经。功能主治:祛风除湿,和血舒筋,清热利尿。治风湿痹痛,筋骨拘挛,黄疸,便血,骨蒸潮热,小儿疳热,小便不利。
乌梅:药性酸,涩,平。归肝、脾、肺、大肠经;功效:敛肺止咳,涩肠止泻,安蛔止痛,生津止渴。
五味子性温;味酸、甘,归肺、心、肾经。功能主治:收敛固涩,益气生津,补肾宁心。用于津伤口渴,短气脉虚,内热消渴,心悸失眠。现代研究,含有丰富的有机酸、维生素、类黄酮、植物固醇及有强效复原作用的木酚素,它也是兼具精、气、神三大补益的少数药材之一。
川芎,性味辛,温。入肝、胆经。主治行气开郁,法风燥湿,活血止痛。治风冷头痛旋晕,胁痛腹疼,寒痹筋挛,经闭,难产,产后瘀阻块痛,痈疽疮疡。用于月经不调,经闭痛经,瘕腹痛,胸胁刺痛,跌扑肿痛,头痛,风湿痹痛。
厚朴:苦、辛,温。归脾、胃、肺、大肠经。功效与主治:燥湿消痰,下气除满。用于湿滞伤中,脘痞吐泻,食积气滞,腹胀便秘,痰饮喘咳。
大枣:甘,温。归脾、胃经。功效与主治:补中益气,养血安神。用于牌虚食少.乏力便溏,妇人脏躁。
在本发明的药物组合物中,牡丹皮滋阴潜阳,软坚散结,退热除蒸,升麻发表透疹,清热解毒,升举阳气,大青叶清热解暑,除蒸,截疟,葛根升阳解肌,透疹止泻,除烦止温,白芍养血柔肝,缓中止痛,敛阴收汗,桂枝补元阳、通腑降浊、通血脉、暖脾胃,煅牡蛎重镇安神,潜阳补阴,软坚散结,牡丹皮、升麻、大青叶、葛根、白芍、桂枝、煅牡蛎为君药;金银花宣散风热,清解血毒,东白薇清热解毒,消痈排脓,祛瘀止痛,青蒿消热痰,重楼清热解毒,消肿止痛,益母草清热解毒,凉血,消肿,燥湿,白术凉血止血,散瘀解毒消痈,马齿苋清热利湿,凉血解毒,苦参清热燥湿,杀虫,利尿,白花蛇舌草清热解毒,利水渗湿,秦艽祛风除湿,和血舒筋,清热利尿,金银花、东白薇、青蒿、重楼、益母草、白术、马齿苋、苦参、白花蛇舌草、秦艽为臣药;地骨皮清热润肺,滑肠通便,鸡血藤补血,活血,通络,山楂消食积,散瘀血,利尿,止泻,益母草活血,祛瘀,调经,消水,当归补血、活血、调经止痛、润燥滑肠,枳实破气消积,化痰散痞,山药健脾补肾,乌梅敛肺止咳,涩肠止泻,安蛔止痛,生津止渴,五味子收敛固涩,益气生津,补肾宁心,川芎行气开郁,法风燥湿,活血止痛,厚朴燥湿消痰,下气除满,大枣补中益气,养血安神,地骨皮、鸡血藤、山楂、益母草、当归、枳实、山药、乌梅、五味子、川芎、厚朴、大枣为佐药;甘草具有补脾益气、清热解毒、祛痰止咳、缓急止痛、调和诸药的功效,为使药。诸药合用,用药适宜,配伍精简,主次分明,标本兼治,可有效治疗妇产科术后低热症,能够大大缩短患者的康复时间,有效改善和优化患者的身体素质和生活质量,在临床试验上已经取得优异的治疗效果。
具体实施方式
为使本发明实施例的目的、技术方案和优点更加清楚,下面将结合实施例对本发明的技术方案进行清楚、完整地描述。显然,所描述的实施例是本发明的一部分,而不是全部的实施例。基于所描述的本发明的实施例,本领域普通技术人员在无需创造性劳动的前提下所获得的所有其他实施例,都属于本发明保护的范围。除非另有说明,本发明中的乙醇量的百分数是体积百分数,v/v表示溶液的体积比。
实施例1:
本发明的一种治疗妇产科术后低热症的药物组合物,取下列中药原料药:甘草12克,白花蛇舌草16克,苦参3克,牡丹皮12克,升麻12克,东白薇10克,桂枝9克,山楂15克,厚朴15克,金银花8克,益母草5克,青蒿3克,鸡血藤14克,重楼9克,地骨皮6克,马齿苋8克,煅牡蛎5克,益母草1克,当归10克,葛根5克,乌梅16克,大青叶10克,枳实8克,山药5克,白芍1克,川芎10克,大枣6克,白术8克,秦艽3克,五味子4克。
所述中药组合物的制备方法为:
(1)取所述中药组合物中重量组分的各药材,第一次煎煮加药材总重量的10-15倍的水煎煮提取,煎煮1小时:第二次加入8倍量的水,煎煮1h,滤出药液待用;第三次加入8-12倍量的水,煎煮1.2h,滤出药液待用;合并三次煎液,过滤,收集滤液,浓缩至50-60℃时相对密度为1.30的清膏;
(2)将步骤(1)制得的清膏放置至室温后,加乙醇使含乙醇量至重量百分比60-75%,静置24小时,取上清液;上清液回收乙醇,减压浓缩至60℃时相对密度为1.20-1.30的清膏,随后在3000r/min的转速下离心;在60℃-80℃喷雾干燥,得干浸膏;
(3)将步骤(2)制得的干浸膏放入超微粉碎机中粉碎1-2小时,过筛,得到100-200目的超微细粉,加入适量蔗糖、糊精混合,以乙醇为润湿剂,制粒,干燥,整粒,可制得颗粒剂。
实施例2:
本发明的一种治疗妇产科术后低热症的药物组合物,取下列中药原料药:甘草20克,白花蛇舌草10克,苦参8克,牡丹皮5克,升麻17克,东白薇12克,桂枝4克,山楂20克,厚朴10克,金银花12克,益母草2克,青蒿7克,鸡血藤11克,重楼15克,地骨皮3克,马齿苋13克,煅牡蛎3克,益母草3克,当归5克,葛根10克,乌梅13克,大青叶3克,枳实13克,山药3克,白芍3克,川芎5克,大枣4克,白术10克,秦艽4克,五味子5克。
其中,所述中药组合物的制备方法为:
(1)取所述中药组合物中重量组分的各药材,第一次煎煮加药材总重量的10-15倍的水煎煮提取,煎煮1-2小时:第二次加入12倍量的水,煎煮1.2h,滤出药液待用;第三次加入8-12倍量的水,煎煮0.8-1.2h,滤出药液待用;合并三次煎液,过滤,收集滤液,浓缩至50-60℃时相对密度为1.10的清膏;
(2)将步骤(1)制得的清膏放置至室温后,加乙醇使含乙醇量至重量百分比60-75%,静置24-48小时,取上清液;上清液回收乙醇,减压浓缩至50-60℃时相对密度为1.20-1.30的清膏,随后在3000r/min的转速下离心;在60℃-80℃喷雾干燥,得干浸膏;
(3)将步骤(2)制得的干浸膏干燥后放入超微粉碎机中粉碎1-2小时,过筛,得到100-200目的超微细粉,制成散剂。
实施例3:
本发明的一种治疗妇产科术后低热症的药物组合物,取下列中药原料药:甘草13克,白花蛇舌草11克,苦参4克,牡丹皮6克,升麻13克,东白薇7克,桂枝5克,山楂18克,厚朴11克,金银花9克,益母草4克,青蒿6克,鸡血藤12克,重楼13克,地骨皮4克,马齿苋9克,煅牡蛎4克,益母草2克,当归6克,葛根6克,乌梅14克,大青叶5克,枳实10克,山药4克,白芍2克,川芎6克,大枣5克,白术12克,秦艽3克,五味子6克。
其中,所述中药组合物的制备方法为:
(1)取所述中药组合物中重量组分的各药材,第一次煎煮加药材总重量的10-15倍的水煎煮提取,煎煮1-2小时:第二次加入8-12倍量的水,煎煮1-1.2h,滤出药液待用;第三次加入8-12倍量的水,煎煮0.8h,滤出药液待用;合并三次煎液,过滤,收集滤液,浓缩至50-60℃时相对密度为1.15的清膏;
(2)将步骤(1)制得的清膏放置至室温后,加乙醇使含乙醇量至重量百分比60-75%,静置48小时,取上清液;上清液回收乙醇,减压浓缩至50-60℃时相对密度为1.20-1.30的清膏,随后在3000r/min的转速下离心;在60℃-80℃喷雾干燥,得干浸膏;
(3)将步骤(2)制得的干浸膏放入超微粉碎机中粉碎1-2小时,过筛,得到100-200目的超微细粉,加入适量微粉硅胶、α-半乳糖混合,以乙醇为润湿剂,制粒,干燥,整粒,装胶囊,制得胶囊剂。
实施例4:
本发明的一种治疗妇产科术后低热症的药物组合物,取下列中药原料药:甘草17克,白花蛇舌草15克,苦参7克,牡丹皮11克,升麻16克,东白薇8克,桂枝8克,山楂16克,厚朴14克,金银花11克,益母草3克,青蒿5克,鸡血藤13克,重楼14克,地骨皮5克,马齿苋12克,煅牡蛎3克,益母草1克,当归10克,葛根9克,乌梅13克,大青叶7克,枳实11克,山药3克,白芍1克,川芎10克,大枣4克,白术11克,秦艽4克,五味子7克。
其中,所述中药组合物的制备方法为:
(1)取所述中药组合物中重量组分的各药材,第一次煎煮加药材总重量的15倍的水煎煮提取,煎煮1-2小时:第二次加入8-12倍量的水,煎煮1-1.2h,滤出药液待用;第三次加入8-12倍量的水,煎煮0.8-1.2h,滤出药液待用;合并三次煎液,过滤,收集滤液,浓缩至50-60℃时相对密度为1.10-1.30的清膏;
(2)将步骤(1)制得的清膏放置至室温后,加乙醇使含乙醇量至重量百分比60-75%,静置24-48小时,取上清液;上清液回收乙醇,减压浓缩至50-60℃时相对密度为1.20-1.30的清膏,随后在3000r/min的转速下离心;在60℃-80℃喷雾干燥,得干浸膏;
(3)将步骤(2)制得的干浸膏放入超微粉碎机中粉碎1-2小时,过筛,得到100-200目的超微细粉,加入适量蔗糖、糊精混合,以乙醇为润湿剂,制粒,干燥,整粒,压片,制得片剂。
实施例5:
本发明的一种治疗妇产科术后低热症的药物组合物,取下列中药原料药:甘草15克,白花蛇舌草12克,苦参5克,牡丹皮9克,升麻15克,东白薇9克,桂枝7克,山楂19克,厚朴13克,金银花10克,益母草4克,青蒿4克,鸡血藤11克,重楼11克,地骨皮5克,马齿苋10克,煅牡蛎5克,益母草3克,当归8克,葛根8克,乌梅14克,大青叶9克,枳实12克,山药5克,白芍3克,川芎8克,大枣6克,白术9克,秦艽5克,五味子7克。
其中,所述中药组合物的制备方法为:
(1)取所述中药组合物中重量组分的各药材,第一次煎煮加药材总重量的10-15倍的水煎煮提取,煎煮1.5小时:第二次加入8倍量的水,煎煮1-1.2h,滤出药液待用;第三次加入8-12倍量的水,煎煮0.8-1.2h,滤出药液待用;合并三次煎液,过滤,收集滤液,浓缩至50-60℃时相对密度为1.10-1.30的清膏;
(2)将步骤(1)制得的清膏放置至室温后,加乙醇使含乙醇量至重量百分比75%,静置24-48小时,取上清液;上清液回收乙醇,减压浓缩至50-60℃时相对密度为1.20-1.30的清膏,随后在3000r/min的转速下离心;
(3)向上述步骤(2)得到的离心后的浓缩液中加入适量蔗糖、香精混合,灭菌,灌装,制得药液剂。
实施例6:
本发明的一种治疗妇产科术后低热症的药物组合物,取下列中药原料药:甘草19克,白花蛇舌草14克,苦参6克,牡丹皮7克,升麻14克,东白薇9克,桂枝6克,山楂17克,厚朴13克,金银花10克,益母草4克,青蒿4克,鸡血藤11克,重楼11克,地骨皮5克,马齿苋10克,煅牡蛎5克,益母草3克,当归8克,葛根8克,乌梅14克,大青叶4克,枳实9克,山药5克,白芍3克,川芎8克,大枣3克,白术8克,秦艽5克,五味子8克。
其中,所述中药组合物的制备方法为:
(1)取所述中药组合物中重量组分的各药材,第一次煎煮加药材总重量的10-15倍的水煎煮提取,煎煮1.2小时:第二次加入8-12倍量的水,煎煮1-1.2h,滤出药液待用;第三次加入8-12倍量的水,煎煮0.8-1.2h,滤出药液待用;合并三次煎液,过滤,收集滤液,浓缩至50-60℃时相对密度为1.10-1.30的清膏;
(2)将步骤(1)制得的清膏放置至室温后,加乙醇使含乙醇量至重量百分比60-75%,静置24-48小时,取上清液;上清液回收乙醇,减压浓缩至50-60℃时相对密度为1.20-1.30的清膏,随后在3000r/min的转速下离心;
(3)向上述步骤(2)得到的离心后的浓缩液中加入适量蔗糖、香精混合,灭菌,灌装,制得药液剂。
急性毒性试验:
取小鼠40只,体重22-24克,按体重随机分为2组,治疗组和对照组:治疗组服用本发明实施例6制备的药液剂,禁食12小时后按0.42ml/10g体重灌胃给药,药量0.395g/ml,对照组服用蒸馏水,一日三次,给药后观察14天,小鼠无一死亡,主要脏器未见异常,亦未见其它明显异常,第14天处死并剖检部分小鼠,肉眼观察主要脏器未见异常。
六个月长期毒性试验:给药期间每周称体重一次,每日称食量,无死亡或濒死动物,结果小鼠毛色光洁,行为活动、腺体分泌、呼吸、粪便性状均正常。病理检查提示,对各种脏器无明显药物所致病理改变。
临床论证:
为了验证本发明药物组合物的效果,2013年1月-2014年9月,门诊处随机抽取妇产科术后低热症患者180例,患者年龄范围为21-42岁,平均年龄为33.5±2.2岁,病程为10-30天。治疗前,患者表现为面容憔悴、舌质淡黄、脉细弱,而且伴有胸闷、食欲缺乏等典型症状。患者体温范围:83例37.2~37.8℃,67例37.9~38.2℃,30例38.3~38.7℃。将180例患者随机分为治疗组和对照组,2组性别、年龄、病程等比较,差异均无显著性意义(P>0.05),具有可比性。
治疗方法:
治疗组服用本发明实施例1制备的颗粒剂,口服一次10mg,一日两次。
对照组静脉滴注加入抗生素的氧化钠液,每天2次;根据患者体温变化(高于38℃)调节复方氨基比林使用情况。
两组均以20天为一个疗程,然后3天后进行第二个疗程,总疗程为40天时间。
疗效标准:
疗效标准参考《中医病证诊断疗效标准》拟定。
基本治愈:患者经治疗后,体温正常,伴随症状消失;
显效:患者经治疗后,体温正常,伴随症状基本消失;
有效:患者经治疗后,体温基本恢复正常,伴随症状基本消失;
无效:患者经治疗后,体温无变化,伴随症状未消失。
效果评价:经过两个疗程之后,对两组患者观察,记录其体温、脉搏、舌质等内容。显效率=基本治愈率+显效率。
数据处理:所有数据均使用SPSS17.0数据分析软件进行统计学处理,差异性比较采用t检验,计量资料用(x±s)表示,记数资料比较用χ2检验,以P<0.05为差异有显著性。
疗效结果:
表1两组患者有效率对比分析
组别 | 例数 | 基本治愈 | 显效 | 有效 | 无效 | 总有效 |
治疗组 | 90 | 27(30%) | 54(60%) | 6(6.7%) | 3(3.3%) | 87(96.7%) |
对照组 | 90 | 24(26.7%) | 27(30%) | 11(12.2%) | 28(31.1%) | 62(68.9%) |
表1结果显示:本发明实施例1制备的颗粒剂总有效率为96.7%,对照组总有效率68.9%,结果表明,本发明技术方案制备的中药组合物在治疗妇产科术后低热症疾病方面的临床疗效显著,并优于常规的静脉滴注加入抗生素的氧化钠液,适于规模化临床应用。
典型病例:
病例1
赵某,女,41岁,系青岛市崂山区人,于2014年3月16日就诊。患者因月经量增多1年有余,来我院行全子宫加左侧附件切除术。术后低热绵绵,且伴恶寒,自汗,动辄汗多,体倦乏力,头晕眼花,心悸,气短懒言,纳差,舌淡苔薄,脉细弱。给予本发明实施例3的胶囊剂予以治疗,每天两次,每次两粒,20天一个疗程,一个疗程后热势渐退,两个疗程后则体温降至正常,且诸症悉消。
病例2
钱某,女,35岁,青岛即墨人,于2014年5月1日就诊。患者因子宫全切除术及双侧输卵管破视成形术、粘连分离术、肠管修补术后,发热不退(体温38~38.5e)已逾数日,伴恶寒,汗多,纳呆食少,口干且苦,大便溏而不爽,日行2次,舌质偏暗,苔薄黄腻,脉濡滑。给予本发明实施例5的药汤剂予以治疗,每天两次,20天一个疗程,2个疗程后,体温下降至37.5~37.8e,汗出减少并渐止,恶寒亦减,继服1个疗程后诸症皆消,体温正常。
病例3
孙某,女,29岁,青岛市市南区人,于2014年11月23日就诊。患者因宫外孕待排而行腹腔镜手术。术后3天,患者出现发热,予抗生素治疗后,热势仍未缓解。术后第7天,体温38e,同时感腹痛,左侧为甚,左侧腹部切口下可触及约2.5cm3.5cm的硬块,伴纳呆不香,二便正常,舌质偏暗,苔黄腻,脉弦涩。给予本发明实施例2的散剂予以治疗,每天两次,每次两包,20天一个疗程,1个疗程后,热即退去,体温正常,腹痛及腹部硬结亦告消失。
最后应说明的是:以上实施例仅用以说明本发明的技术方案,而非对其限制;尽管参照前述实施例对本发明进行了详细的说明,本领域的普通技术人员应当理解:其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分技术特征进行等同替换;而这些修改或者替换,并不使相应技术方案的本质脱离本发明各实施例技术方案的范围。
Claims (10)
1.一种治疗妇产科术后低热症的药物组合物,其特征在于:所述药物组合物的原料药由牡丹皮、东白薇、升麻、地骨皮、鸡血藤、大青叶、青蒿、重楼、益母草、葛根、甘草、白芍、白术、马齿苋、金银花、山楂、益母草、桂枝、苦参、当归、枳实、白花蛇舌草、山药、煅牡蛎、秦艽、乌梅、五味子、川芎、厚朴、大枣组成。
2.根据权利要求1所述的治疗妇产科术后低热症的药物组合物,其特征在于:制成所述药物组合物的原料药组成及重量份数为:甘草12-20份,白花蛇舌草10-16份,苦参3-8份,牡丹皮5-12份,升麻12-17份,东白薇7-12份,桂枝4-9份,山楂15-20份,厚朴10-15份,金银花8-12份,益母草2-5份,青蒿3-7份,鸡血藤11-14份,重楼9-15份,地骨皮3-6份,马齿苋8-13份,煅牡蛎3-5份,益母草1-3份,当归5-10份,葛根5-10份,乌梅13-16份,大青叶3-10份,枳实8-13份,山药3-5份,白芍1-3份,川芎5-10份,大枣3-6份,白术8-13份,秦艽3-5份,五味子4-8份。
3.根据权利要求1所述的治疗妇产科术后低热症的药物组合物,其特征在于:制成所述药物组合物的原料药组成及重量份数为:甘草12份,白花蛇舌草16份,苦参3份,牡丹皮12份,升麻12份,东白薇10份,桂枝9份,山楂15份,厚朴15份,金银花8份,益母草5份,青蒿3份,鸡血藤14份,重楼9份,地骨皮6份,马齿苋8份,煅牡蛎5份,益母草1份,当归10份,葛根5份,乌梅16份,大青叶10份,枳实8份,山药5份,白芍1份,川芎10份,大枣6份,白术8份,秦艽3份,五味子4份。
4.根据权利要求1所述的治疗妇产科术后低热症的药物组合物,其特征在于:制成所述药物组合物的原料药组成及重量份数为:甘草20份,白花蛇舌草10份,苦参8份,牡丹皮5份,升麻17份,东白薇12份,桂枝4份,山楂20份,厚朴10份,金银花12份,益母草2份,青蒿7份,鸡血藤11份,重楼15份,地骨皮3份,马齿苋13份,煅牡蛎3份,益母草3份,当归5份,葛根10份,乌梅13份,大青叶3份,枳实13份,山药3份,白芍3份,川芎5份,大枣4份,白术10份,秦艽4份,五味子5份。
5.根据权利要求1所述的治疗妇产科术后低热症的药物组合物,其特征在于:制成所述药物组合物的原料药组成及重量份数为:甘草13份,白花蛇舌草11份,苦参4份,牡丹皮6份,升麻13份,东白薇7份,桂枝5份,山楂18份,厚朴11份,金银花9份,益母草4份,青蒿6份,鸡血藤12份,重楼13份,地骨皮4份,马齿苋9份,煅牡蛎4份,益母草2份,当归6份,葛根6份,乌梅14份,大青叶5份,枳实10份,山药4份,白芍2份,川芎6份,大枣5份,白术12份,秦艽3份,五味子6份。
6.根据权利要求1所述的治疗妇产科术后低热症的药物组合物,其特征在于:制成所述药物组合物的原料药组成及重量份数为:甘草17份,白花蛇舌草15份,苦参7份,牡丹皮11份,升麻16份,东白薇8份,桂枝8份,山楂16份,厚朴14份,金银花11份,益母草3份,青蒿5份,鸡血藤13份,重楼14份,地骨皮5份,马齿苋12份,煅牡蛎3份,益母草1份,当归10份,葛根9份,乌梅13份,大青叶7份,枳实11份,山药3份,白芍1份,川芎10份,大枣4份,白术11份,秦艽4份,五味子7份。
7.根据权利要求1所述的治疗妇产科术后低热症的药物组合物,其特征在于:制成所述药物组合物的原料药组成及重量份数为:甘草15份,白花蛇舌草12份,苦参5份,牡丹皮9份,升麻15份,东白薇9份,桂枝7份,山楂19份,厚朴13份,金银花10份,益母草4份,青蒿4份,鸡血藤11份,重楼11份,地骨皮5份,马齿苋10份,煅牡蛎5份,益母草3份,当归8份,葛根8份,乌梅14份,大青叶9份,枳实12份,山药5份,白芍3份,川芎8份,大枣6份,白术9份,秦艽5份,五味子7份。
8.根据权利要求1所述的治疗妇产科术后低热症的药物组合物,其特征在于:制成所述药物组合物的原料药组成及重量份数为:甘草19份,白花蛇舌草14份,苦参6份,牡丹皮7份,升麻14份,东白薇9份,桂枝6份,山楂17份,厚朴13份,金银花10份,益母草4份,青蒿4份,鸡血藤11份,重楼11份,地骨皮5份,马齿苋10份,煅牡蛎5份,益母草3份,当归8份,葛根8份,乌梅14份,大青叶4份,枳实9份,山药5份,白芍3份,川芎8份,大枣3份,白术8份,秦艽5份,五味子8份。
9.根据权利要求3-8任一所述的治疗妇产科术后低热症的药物组合物,其特征在于,所述药物组合物采用下列制备步骤:
(1)取权利要求3-8任一所述药物组合物中重量组分的各药材,第一次煎煮加药材总重量的10-15倍的水煎煮提取,煎煮1-2小时:第二次加入8-12倍量的水,煎煮1-1.2h,滤出药液待用;第三次加入8-12倍量的水,煎煮0.8-1.2h,滤出药液待用;合并三次煎液,过滤,收集滤液,浓缩至50-60℃时相对密度为1.10-1.30的清膏;
(2)将步骤(1)制得的清膏放置至室温后,加乙醇使含乙醇量至重量百分比60-75%,静置24-48小时,取上清液;上清液回收乙醇,减压浓缩至50-60℃时相对密度为1.20-1.30的清膏,随后在3000r/min的转速下离心;在60℃-80℃喷雾干燥,得干浸膏;
(3)将步骤(2)制得的干浸膏放入超微粉碎机中粉碎1-2小时,过筛,得到100-200目的超微细粉,加入适量蔗糖、糊精混合,以乙醇为润湿剂,制粒,干燥,整粒,可制得颗粒剂;或者将步骤(2)制得的干浸膏干燥后放入超微粉碎机中粉碎1-2小时,过筛,得到100-200目的超微细粉,制成散剂;或者将步骤(2)制得的干浸膏放入超微粉碎机中粉碎1-2小时,过筛,得到100-200目的超微细粉,加入适量微粉硅胶、α-半乳糖混合,以乙醇为润湿剂,制粒,干燥,整粒,装胶囊,制得胶囊剂;或者将步骤(2)制得的干浸膏放入超微粉碎机中粉碎1-2小时,过筛,得到100-200目的超微细粉,加入适量蔗糖、糊精混合,以乙醇为润湿剂,制粒,干燥,整粒,压片,制得片剂;或者向上述步骤(2)得到的离心后的浓缩液中加入适量蔗糖、香精混合,灭菌,灌装,制得药液剂。
10.如权利要求1-9任一所述的治疗妇产科术后低热症的药物组合物在治疗妇产科术后低热症药物中的应用。
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CN106110096A (zh) * | 2016-08-23 | 2016-11-16 | 杜娟 | 一种治疗妇产科术后低热症的药物组合物 |
CN107496772A (zh) * | 2017-10-09 | 2017-12-22 | 宿淑平 | 一种治疗妇产科术后低热症的药物组合物 |
CN108498737A (zh) * | 2018-06-06 | 2018-09-07 | 青岛市妇女儿童医院(青岛市妇幼保健院、青岛市残疾儿童医疗康复中心、青岛市新生儿疾病筛查中心) | 用于治疗妇产科术后低热症的中药组合物、制备方法和治疗装置 |
CN108671073A (zh) * | 2018-07-13 | 2018-10-19 | 贾方平 | 一种用于妇产科术后的中药及其制备方法 |
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