CN104257873A - 一种中药麻醉剂及其制备方法 - Google Patents
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Abstract
本发明涉及一种中药麻醉剂及其制备方法,由洋金花、冰片、薄荷、杜仲、青黛、金银花、白芷、当归、甘草、花椒、海州常山制成,剂型为注射剂,本发明目的在于提供一种新的中药麻醉剂,具有麻醉效果好,麻醉过程温和及副作用小的优点。
Description
技术领域
本发明属于医药领域,具体涉及一种中药麻醉剂及其制备方法。
背景技术
在临床手术中,麻醉是施行手术时或进行诊断性检查操作时为消除疼痛、保障病人安全、创造良好的手术条件而采取的各种方法。病人在进行手术或诊断性检查操作时,会感到疼痛,需要用麻醉药或其他方式使之暂时失去知觉。手术或检查操作还可引起精神紧张和反射性不良反应,如胃肠道手术可引起恶心、呕吐。长时间的不舒适的体位(如俯卧位),可增加病人的不适和痛苦,因此应使病人在舒适、安静的环境中,在对不良刺激无反应,暂时失去知觉的情况下接受手术。
目前,普遍采用注射普鲁卡因或传导阻断的方法进行麻醉或者通过贴膜进行表面麻醉。现有的麻醉方式操作比较繁琐,同时还具有麻醉风险。因此,市场上急需一种麻醉用中药制剂以更好的实施局部麻醉。
发明内容
本发明的发明目的是提供一种新的中药麻醉剂及其制备方法,主要针对小范围的、局部的麻醉,具有麻醉效果温和,麻醉效果好,副作用小等优点,解除患者疾苦,创造良好的社会和经济效益。
本发明的药物组合物原料按重量配比是:洋金花150份、冰片100份、薄荷150份、杜仲120份、青黛100份、金银花100份、白芷120份、当归120份、甘草100份、花椒100份、海州常山100份。
以上药物组合物的制备方法为:上述十一味药材粉碎成粗颗粒,用60%乙醇浸提3次,每次2小时,滤过,合并滤液,减压浓缩至相对密度1.05~1.15,测定温度为60℃,加乙醇使含醇量达50~80%,静置48小时,滤过,减压回收乙醇,调节pH为3~5,高速离心,上清液用无机膜滤过,滤液用超滤膜过滤,滤液再用纳滤膜过滤,得浓缩液,定容,加注射用氯化钠调至等渗,调节pH为5.5~7,冷藏48小时,微孔滤膜滤过,补加注射用水,灌封成小容量注射剂,灭菌,即得。
洋金花:现代药学研究证明,洋金花含多种莨菪烷类生物碱,其中以东莨菪碱(scopolamine)的含量较高,约占总生物碱的85%,东莨菪碱为M-胆碱受体阻断剂,对中枢神经系统有抑制作用。
冰片:现代药学研究证明,局部应用冰片对感觉神经有较微刺激,有一定的止痛及温和的防腐作用。
薄荷:现代药学研究证明,薄荷中含有薄荷醇、薄荷油,均对中枢有抑制作用。
杜仲:现代药学研究证明,杜仲对神经中枢有镇静作用,能增强细胞的免疫功能,促进皮质醇分泌和血浆中cAMP和cGMP代谢。
青黛:清热解毒、凉血消斑。现代药学研究证明,青黛主含靛蓝,具有抑菌作用。
金银花:现代药学研究证明,金银花具有抗菌、抗内毒素等作用。
白芷:祛风解表、散寒止痛、除湿通窍、消肿排脓。现代药学研究证明,白芷具有良好的解热、镇痛、抗炎、抗菌作用。
当归:补血活血,调经止痛、润燥滑肠。现代药学证明,当归具有抗缺氧作用,调节机体免疫功能,具有抗癌作用、补血活血作用,抑菌作用。还具有有镇静、催眠、镇痛、麻醉、一致中枢神经系统等作用。
甘草:补脾益气、清热解毒、祛痰止咳、缓急止痛、调和诸药。现代药学研究证明,甘草具有抗炎、抗变态反应、抗过敏的作用,甘草黄酮、甘草浸膏及甘草次酸均有明显的镇咳作用。
花椒:温中止痛、除湿止泻、杀虫止痒。现代药学研究证明,花椒有麻醉效果。除此之外,辣椒性温,能经过发汗下降体温,并减轻肌肉痛苦,因而具有较强的解热镇痛效果,美国研讨发现,辣椒素能削减传达痛感的神经递质,使人对痛苦的感受削弱,并且花椒里富含的挥发油对6种以上的细菌、11种以上的真菌都具有较好的抑菌、灭菌效果。
海州常山:现代药学研究证明,海州常山具有镇静、镇痛、抗炎等作用。
为了表明本发明药物的麻醉作用,本发明进行了以下的药理实验。
1.材料与方法
主要试剂及仪器:枸橼酸舒芬太尼注射液,本发明实施例1中的注射液,转动杆(转杆直径为3cm,转速5r/min,自制),平衡杆(宽1cm,距地面高80cm,自制)。
动物选择及分组:成年SD大鼠,体重190~230g,由第三军医大学实验动物中心提供,实验前对大鼠进行转杆操作能力训练,在转杆上保持2min以上不下落为合格。符合人选标准大鼠60只。采用随机数字表法分为药物组和对照组,每组30只,药物组给予本发明实施例注射液10ml/kg,对照组一次性腹腔给予舒芬太尼100ug/kg。
给药后,对麻醉深度进行评分。通过翻正反射消失和麻醉深度评价麻醉效果。麻醉深度评分:参照Antunes等人(Antunes L M,Roughan J V,Flecknell PA.Evaluation of auditory evoked potentials to predict depth of anaesthesia duringfentanyl/flunanisone-midazolam anaesthesia in rat[J].Veterinary Anaesthesia andAnalgesia,2001,28(4):196-203.)的方法分别在给药后10min、30min、50min对大鼠的麻醉深度进行评分,得分越低表示麻醉程度越深。
统计学处理:采用SPSS 16.0统计学软件进行分析,计量资料以均数±标准差表示,组内比较采用t检验,组间比较采用单因素方差分析,P<0.05为差异有显著性统计学意义。
2.结果
麻醉深度评分见表1
表1麻醉深度评分(n=30)
注:*与对照组比较,P<0.05,有显著性差异
从以上结果可以看出,药物组和对照组比较,两组之间差异有显著性,治疗组的麻醉效果优于对照组。
在临床上,共进行试验1267例,均有麻醉效果,且1184例苏醒后无注射部位疼痛,头晕,恶心,耳鸣等症状,52例患者有轻微的头晕恶心,23例患者有苏醒时间较长症状,11例患者有耳鸣症状,18例患者具有注射部位红肿症状;综合效果来看,副作用较少,适于临床推广。
本发明组方中的麻醉剂,采用纯中药提取制成,其麻醉过程温和,麻醉时间持久,麻醉后苏醒时间短,副作用小,利于临床大量推广。
具体实施例
实施例1洋金花150g、冰片100g、薄荷150g、杜仲120g、青黛100g、金银花100g、白芷120g、当归120g、甘草100g、花椒100g、海州常山100g
制备方法:以上述十一味药材粉碎成粗颗粒,用60%乙醇浸提3次,每次2小时,滤过,合并滤液,减压浓缩至相对密度1.05~1.15,测定温度为60℃,加乙醇使含醇量达50~80%,静置48小时,滤过,减压回收乙醇,调节pH为3~5,高速离心,上清液用无机膜滤过,滤液用超滤膜过滤,滤液再用纳滤膜过滤,得浓缩液,定容至1000ml,加注射用氯化钠调至等渗,调节pH为5.5~7,冷藏48小时,微孔滤膜滤过,补加注射用水至1000ml,灌封成小容量注射剂,10ml/支,灭菌,即得。
Claims (4)
1.一种中药麻醉剂,其特征在于按照重量份计,制成该药物组合物有效组分的原料为:洋金花、冰片、薄荷、杜仲、青黛、金银花、白芷、当归、甘草、花椒、海州常山。
2.如权利要求1所述的一种中药麻醉剂,其特征在于制成该药物组合物有效组分的原料为:洋金花150份、冰片100份、薄荷150份、杜仲120份、青黛100份、金银花100份、白芷120份、当归120份、甘草100份、花椒100份、海州常山100份。
3.如权利要求1或2所述的一种中药麻醉剂,其特征在于制备方法为:将所述十一味药材粉碎成粗颗粒,用60%乙醇浸提3次,每次2小时,滤过,合并滤液,减压浓缩至相对密度1.05~1.15,测定温度为60℃,加乙醇使含醇量达50~80%,静置48小时,滤过,减压回收乙醇,调节pH为3~5,高速离心,上清液用无机膜滤过,滤液用超滤膜过滤,滤液再用纳滤膜过滤,得浓缩液,定容,加注射用氯化钠调至等渗,调节pH为5.5~7,冷藏48小时,微孔滤膜滤过,补加注射用水,灌封成小容量注射剂,灭菌。
4.如权利要求3所述的一种中药麻醉剂,其特征在于制备方法为:取洋金花150g、冰片100g、薄荷150g、杜仲120g、青黛100g、金银花100g、白芷120g、当归120g、甘草100g、花椒100g、海州常山100g,将以上十一味药材粉碎成粗颗粒,用60%乙醇浸提3次,每次2小时,滤过,合并滤液,减压浓缩至相对密度1.05~1.15,测定温度为60℃,加乙醇使含醇量达50~80%,静置48小时,滤过,减压回收乙醇,调节pH为3~5,高速离心,上清液用无机膜滤过,滤液用超滤膜过滤,滤液再用纳滤膜过滤,得浓缩液,定容至1000ml,加注射用氯化钠调至等渗,调节pH为5.5~7,冷藏48小时,微孔滤膜滤过,补加注射用水至1000ml,灌封成小容量注射剂,10ml/支,灭菌。
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