CN106039000A - 一种可以降低全麻后寒战发病率药物的制备方法 - Google Patents
一种可以降低全麻后寒战发病率药物的制备方法 Download PDFInfo
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Abstract
本发明公开了一种可以降低全麻后寒战发病率药物的制备方法,以解决特发性全麻后寒战的预防问题。其特征在于:将对对参、独花兰、皂角刺、升麻、穿山甲、清香桂、肿节风、枳茹、九节菖蒲、杜蘅、柳叶藓、丝瓜络混合加水煎煮,30分钟后取滤液,药渣加水继续煎煮20分钟后取滤液,两次滤液合并,即得。临床实验证明:本发明预防特发性全麻后寒战具有疗效好和安全性较高的特点,值得临床应用、推广。
Description
技术领域
本发明是发明专利申请《一种神经外科全麻术前干预药物》(2014101709354)的分案申请。涉及中药领域,具体涉及一种可以降低全麻后寒战发病率药物的制备方法。
背景技术
神经外科手术,尤其是涉及开颅手术的患者,由于麻醉、创伤、高颅压、气管导管刺激、外界因素的影响,其术后并发症较其他外科手术要高得多。如特发性全麻后寒战(postanesthesia shivering,PS)的发生率,既往文献报道,普通外科手术为5%~38%,而开颅手术则为13%~65%。所谓特发性全麻后寒战,也称“硫喷妥钠样强直”,属于麻醉并发症。生理状态下的寒战是机体对低体温的代偿反应,通过骨骼肌快速节律性收缩而产热。而颅脑外科手术后的发生机制则与术后大脑体温调节中枢功能紊乱有关,且同时伴有麻醉状态下的交感神经功能阻滞,热量再分布调节失常。
目前,对于PS的治疗为针对性的对症治疗,多采用吗啡受体兴奋剂哌替啶,或者中枢呼吸兴奋药物多沙普仑。但寒战出现的同时即会伴发机体代谢率显著升高导致的心肺负荷增加;甚至心肌缺血;同时还会损害血小板功能,凝血级联反应抑制,失血量显著增加,输血量增多。因此如何在术前进行有效干预,减少PS的发生率,且不会引发其他的术后并发症,是神经外科开颅手术的研究新课题。
发明内容
本发明的技术任务是针对以上现有技术的不足,提供一种疗效肯定且副作用小的神经外科全麻术前干预药物。
本发明解决其技术问题的技术方案是:一种可以降低全麻后寒战发病率药物的制备方法,其特征在于:将对对参10~30份、独花兰6~12份、皂角刺3~10份、升麻6~12份、穿山甲3~10份、清香桂6~12份、肿节风6~12份、枳茹6~12份、九节菖蒲6~12份、杜蘅1~5份、柳叶藓3~10份、丝瓜络10~25份混合加水煎煮,30分钟后取滤液,药渣加水继续煎煮20分钟后取滤液,两次滤液合并,即得。
本发明中药是由下述最佳重量份配比的原料制备而成的:对对参20份、独花兰10份、皂角刺6份、升麻10份、穿山甲6份、清香桂10份、肿节风10份、枳茹10份、九节菖蒲10份、杜蘅2份、柳叶藓6份、丝瓜络20份。
其中所述的:对对参,为兰科植物长距鸟足兰Satyrium nepalense D. Don的块茎。性味平;甘。归肾;心经。功可壮腰益肾。
独花兰,为兰科独花兰Changuienia amoena Chien,以全草、根入药。功可清热、凉血,解毒。
皂角刺,为豆科植物皂荚Gleditsia sinensis Lam.的干燥棘刺。性味辛,温。归肝、胃经。功可消肿托毒,排脓,杀虫。
升麻,为毛茛科植物大三叶升麻Cimicifuga heracleifolia Kom. 、兴安升麻Cimicifuga dahurica (Turcz.)Maxim . 或升麻Cimicifuga foetida L. 的干燥根茎。性味辛、微甘,微寒。归肺、脾、胃、大肠经。功可发表透疹,清热解毒,升举阳气。
穿山甲,为鲮鲤科动物穿山甲Manis pentadactyla Linnaeus的鳞甲。性味咸,微寒。归肝、胃经。功可通经下乳,消肿排脓,搜风通络。
清香桂,为黄杨科野扇花属植物清香桂Sarcococca ruscifolia Stapf根。性味苦,平。功可理气止痛,祛风活络。
肿节风,为金粟兰科植物草珊瑚Sarcandra glabra (Thunb.)Nakai的干燥全株。苦、辛、平。归心、肝经。功可清热凉血,活血消斑,祛风通络。
枳茹,为芸香科植物枸橘Poncirus tuifoliata (L.)Raf.的树皮屑或果皮屑。性味辛;温。归肝;肾经。功可息风止痉;化痰通络。
九节菖蒲,为毛茛科银莲花属植物阿尔泰银莲花Anemone altaica Mey.,以根状茎入药。性味辛,温。功可芳香开窍,化痰,安神。
杜蘅,为马兜铃科植物杜衡Asarum forbesii Maxim.的根茎及根或全草。性味辛;温。归肺;肝;肾;膀胱经。功可疏风散寒;消痰利水;活血止痛。
柳叶藓,为柳叶藓科植物柳叶藓Amblystegium serpens(Hedw.)B.S.G.的植物体。性味涩;平。功可收敛止血。
丝瓜络,为葫芦科植物丝瓜Luffa cylindrica (L.)Roem.的干燥成熟果实的维管束。甘,平。归肺、胃、肝经。功可通络,活血,祛风。
组方原理:特发性全麻后寒战(PS)与其他寒战不同,不但不伴有继发高热,同时还表现为中心体温下降。风寒病症中,寒战发热的原因是寒邪客于肌表卫分,而PS为麻醉药物导致生理状态的阴阳内外不能交通,具体表现为元阳内伏于少阴,阳气被阻,卫气不与荣分相和,营卫之气不能透达肌表所致。风寒病症用解表散寒药物发散寒邪以除寒战,但如果是PS使用辛温解表药物,则太阴元阳不足,当藏反泄,或变生他症。故其预防,应以交通内外、散结通络、固本清热并进。
与现有技术相比较,本发明具有以下特点:
1、组方独特:方中取对对参、皂角刺为君,所述的对对参、皂角刺配合,针对PS而言,对对参温曛少阴元阳,皂角刺循肝经辛温托散;对对参与其他的培补药物不同,其阴阳平和,性味平甘,无衍生内火之虞,但对对参的特点是守而不走,临床多用于壮腰益肾,但配合皂角刺托举阳气,元阳之气方可行走于少阴经络。对对参、皂角刺1:3比例水煎液灌胃,可以提高大鼠血前列腺素E l水平,并呈量-效线性关系趋势,而单一对对参和单一皂角刺水煎液对于血前列腺素E l水平的影响与空白对照组比较无统计学意义。
2、方中取独花兰、升麻、穿山甲、清香桂、肿节风为臣:独花兰、肿节风有清解之功,可以有效地防止阳气过于涣散所带来的热盛,升麻、清香桂升举阳气,辅助皂角刺托举阳气;穿山甲搜风通络,增加行走功效。其中,清香桂善走头目九窍,其气轻轻上浮,故而尤其适用于神经外科开颅手术术前干预使用。
3、佐助药物少而精,枳茹息风通络;九节菖蒲开窍安神;杜蘅辛温走散,且有活血止痛之功效,适合于术后缓解疼痛;丝瓜络通络活血。
4、神经外科开颅手术中的一部分为脑出血病患,为了防止组方中的药物过于辛散,所以加用柳叶藓佐制,柳叶藓涩平,有收敛之效,又不会滞涩营卫气机。
5、本发明药物原料用量是经发明人进行大量摸索总结得出的,各原料用量为在下述重量份范围都具有较好的疗效。
具体实施方式
以下结合实际情况,对本发明的具体实施方式作详细说明。
实施例1,原料药重量配比:对对参20份、独花兰10份、皂角刺6份、升麻10份、穿山甲6份、清香桂10份、肿节风10份、枳茹10份、九节菖蒲10份、杜蘅2份、柳叶藓6份、丝瓜络20份。
实施例1的制备方法是:将对对参、独花兰、皂角刺、升麻、穿山甲、清香桂、肿节风、枳茹、九节菖蒲、杜蘅、柳叶藓、丝瓜络混合加水煎煮,30分钟后取滤液,药渣加水继续煎煮20分钟后取滤液,两次滤液合并,分成两份早晚服用。
实施例2,原料药重量配比:对对参10份、独花兰6份、皂角刺3份、升麻6份、穿山甲3份、清香桂6份、肿节风6份、枳茹6份、九节菖蒲6份、杜蘅1份、柳叶藓3份、丝瓜络10份。
实施例3,原料药重量配比:对对参20份、独花兰10份、皂角刺6份、升麻10份、穿山甲6份、清香桂10份、肿节风10份、枳茹10份、九节菖蒲10份、杜蘅2份、柳叶藓6份、丝瓜络20份。
实施例4,原料药重量配比:对对参30份、独花兰12份、皂角刺10份、升麻12份、穿山甲10份、清香桂12份、肿节风12份、枳茹12份、九节菖蒲12份、杜蘅5份、柳叶藓10份、丝瓜络25份。
实施例2~4的中药可按下列方法制备而成:
(1)将肿节风、独花兰、九节菖蒲、枳茹、清香桂、杜蘅粗粉分别以水蒸气蒸馏提取挥发油,并收集挥发油后混合备用,药渣备用;
(2)对对参、皂角刺、升麻、柳叶藓、穿山甲、丝瓜络和步骤1中所得药渣混匀加4倍水量,加水煎煮2次,每次1小时,合并煎液,静置;然后往煎液中加入3~4倍药液的95%的乙醇,静置15分钟,然后以3000rpm/min离心20分钟,取离心液,浓缩,喷雾干燥,得出初料;
(3)将步骤1中所得挥发油喷入步骤2所得初料中混匀,粉碎,过60目筛,装胶囊而成。
可以设定每粒胶囊为0.5g。
上述药物的有效组合,互相协调,交通内外、散结通络、固本清热,有效达到预防PS之目的,且副作用较少。上述结果为临床资料充分证明,有关资料如下。
1 对象与方法。
1.1 对象 。
1.1.1 病例选择: 2013年2月~2014年2月收治的99例神经外科全麻下颅脑手术患者,且术前3日内未使用昂丹司琼、曲马朵、可乐定等治疗寒战的药物。手术原因包括:幕上肿瘤26例,后颅窝肿瘤11例,脑室肿瘤3例,脑血管病6例,垂体瘤19例,颅咽管瘤2例,癫痫手术3例,其他手术如脑积水、颅骨修补等29例。年龄在7~71岁之间,平均年龄44.5±10.3岁,其中:年龄< 14岁17例,年龄> 60岁11例;男性患者47例,女性患者52例。
1.1.2 分组:患者随机分为对照组32例、汤剂组34例和胶囊组33例。三组患者治疗前在性别、年龄、病情、麻醉方式上比较,差异无统计学意义(P>0.05),具有可比性。
1.2 方法。
1.2.1干预方法:对照组常规术前术后给药,通过皮肤进行保温。汤剂组和胶囊组,在对照组的基础上,从术前三天开始,分别以本发明实施例1中所得汤剂、以本发明实施例3中所得胶囊口服,2次/d,合计三天。
1.2.2统计学分析:SPSS 13.0进行统计学分析。计数资料用χ2检验。
2 结果。
2.1 术后5小时内三组PS发生率分别为:对照组28.13%(9/32),汤剂组8.82%(3/34),胶囊组9.09%(3/33)。汤剂组和胶囊组寒战发生率明显低于对照组(χ2=4.12,P<0.05;χ2=3.91,P<0.05)。
2.2 三组患者其他麻醉后恢复室(PACU)并发症比较:见下表,
例数 | 心血管相关并发症 | 消化系并发症 | 精神系并发症 | 呼吸系并发症 | 苏醒延迟 | |
对照组 | 32 | 10 | 4 | 7 | 1 | 1 |
汤剂组 | 34 | 9 | 5 | 7 | 1 | 1 |
胶囊组 | 33 | 11 | 4 | 6 | 0 | 1 |
对照组、汤剂组、胶囊组在心血管相关并发症、消化系并发症、精神系并发症、呼吸系并发症、苏醒延迟方面差异无统计学意义。
2.3不良反应发生率比较:汤剂组、胶囊组并未出现明显药物相关不良反应。
3.结论。
本研究结果显示,服用本发明的汤剂组和胶囊组PS发生率明显低于对照组,且不会造成其他的PACU并发症,说明本发明在预防神经外科术后PS方面拥有不良反应较轻、安全性较高的优点。
Claims (1)
1.一种可以降低全麻后寒战发病率药物的制备方法,其特征在于:其特征在于:将对对参10~30份、独花兰6~12份、皂角刺3~10份、升麻6~12份、穿山甲3~10份、清香桂6~12份、肿节风6~12份、枳茹6~12份、九节菖蒲6~12份、杜蘅1~5份、柳叶藓3~10份、丝瓜络10~25份混合加水煎煮,30分钟后取滤液,药渣加水继续煎煮20分钟后取滤液,两次滤液合并,即得。
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