CN105726980A - 一种麻醉科治疗疾病疼痛的药物及其用途 - Google Patents
一种麻醉科治疗疾病疼痛的药物及其用途 Download PDFInfo
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Abstract
本发明属于中药技术领域，具体涉及一种麻醉科治疗疾病疼痛的药物物及其用途。所述药物组合物包括如下组份：百脚虫，牛膝，藏红花，断肠草，穿山甲，白芍，蜈蚣。本发明为纯中药组合物，组方合理，辨证给药，对于麻醉科治疗疾病疼痛有较好的疗效。
Description
技术领域
本发明属于医药技术领域，具体涉及一种麻醉科治疗疾病疼痛的药物及其用途。
背景技术
硬膜外麻醉是临床上常用的麻醉方法，它广泛应用于腹部、下肢手术的麻醉。膜外麻醉后的腰背疼痛是一种比较特殊的术后疼痛，其发生率通常可高44％，约11.5％的硬膜外麻醉后腰背痛将长期不能缓解，严重者有“腰断感”。给患者造成重大的身心创伤并严重影响患者的术后生活质量。硬膜外麻醉后的腰背疼痛病机未明，现认为主要与以下有关：穿刺损伤，即穿刺时穿刺针经过皮肤、皮下组织、肌肉和韧带，引起局部无菌性炎症和反射性肌肉痉挛，从而产生术后腰痛，另一方面，局部炎症引起效应感受器敏感度增加，痛阈降低，导致疼痛增强。
中药治疗具有辩证施治，多靶点作用、多途径起效、复发率低、不良反应发生率低的特点，可以起到提高患者生活质量的目的。结合现代中医药发展理论，从提高药物疗效、降低副作用和复发率的角度出发，经过对中药进行筛选提取和/或配伍制得的中药制剂，具有化学合成药不能比拟的优势，因此研制疗效更为确切的治疗硬膜外麻醉后腰背疼痛的中药制剂很有必要。
发明内容
本发明提供了一种麻醉科治疗疾病疼痛的药物，克服了以往单纯西医或中医治疗的不足，毒副作用小。
所述药物组合物由以下原料药制得：百脚虫，金蚕，藏红花，断肠草，穿山甲，白芍，蜈蚣。为解决其技术问题所采用的技术方案是所述麻醉科治疗疾病疼痛的药物，由下列重量份配比的原料药物组成：百脚虫15-20g，金蚕10-16g，藏红花5-10g，断肠草7-11g，穿山甲5-15g，白芍6-12g，蜈蚣4-8g。
优选的是，所述药物组合物由下列重量份配比的药物制得：百脚虫16-18g，金蚕12-14g，藏红花6-9g，断肠草8-10g，穿山甲8-12g，白芍8-10g，蜈蚣5-7g。
本发明最优选技术方案是，所述本发明药物组合物，由以下重量份的原料药制得：百脚虫17g，金蚕13g，藏红花8g，断肠草9g，穿山甲10g，白芍9g，蜈蚣6g。
本发明还提供了所述药物组合物的制备方法，具体包括如下步骤：将上述重量份的原料药分别粉碎后，混合均匀，加药材总重量的5倍量的水，浸泡2h后煎煮两次，每次2h，滤过，滤液合并后浓缩至稠膏，干燥后粉碎即可。
本领域技术人员可以在制得的本发明药物活性成分基础上直接入药使用或加入药剂学上可接受的辅料按常规工艺制备成所需制剂。优选的是，本发明药物组合物按照常规制备工艺制备成软膏剂。
用途。在临床观察过程中，治疗组1例病例，是好转后退出，以好转统计疗效，其余均完成临床观察。治疗组疗效结果如下：临床痊愈22例(44％)，好转16例(32％)，显效11例(22％)，无效1例(2％)，总有效率98％，治疗效果优于对照组。治疗组治疗过程中生命体征平稳且无过敏等严重不良反应，治疗结束后对治疗组50例患者的实验室指标血常规、大便常规、小便常规、心电图等进行统计学处理，未见明显异常。结果表明本方的临床运用是安全有效的，值得进一步研究并推广应用。进一步地，本发明所述药物组合物，各中药组份的功能效果及方解如下：所述百脚虫，咸，寒；有小毒。归肝经。破瘀血，续筋骨。用于筋骨折伤，瘀血经闭，癥瘕痞块。金蚕，苦、酸，平。归肝、肾经。补肝肾，强筋骨，逐瘀通经，引血下行。用于腰膝酸痛，筋骨无力，经闭癥瘕，肝阳眩晕。藏红花，辛，温。归心、肝经。活血通经，散瘀止痛。用于经闭，痛经，恶露不行，癥瘕痞块，跌扑损伤，疮疡肿痛。断肠草，苦、辛，微温。归肝、脾经。活血化瘀，行水消肿。用于月经不调，经闭，痛经，产后瘀血腹痛，水肿。蝎，辛，平；有毒。归肝经。息风镇痉，攻毒散结，通络止痛。用于小儿惊风，抽搐痉挛，中风口歪，半身不遂，破伤风，风湿顽痹，偏正头痛，疮疡，瘰疬。白芍，苦、酸，微寒。归肝、脾经。平肝止痛，养血调经，敛阴止汗。用于头痛眩晕，胁痛，腹痛，四肢挛痛，血虚萎黄，月经不调，自汗，盗汗。蜈蚣，辛，温；有毒。归肝经。息风镇痉，功毒散结，通络止痛。用于小儿惊风，抽搐痉挛，中风口歪，半身不遂，破伤风，风湿顽痹，疮疡，瘰疬，毒蛇咬伤。本发明组方中百脚虫，金蚕，补肝肾，强筋骨，逐瘀通经，引血下行；藏红花，白芍，活血通经，散瘀止痛；断肠草，活血化瘀，行水消肿；穿山甲，蜈蚣，息风镇痉，攻毒散结，通络止痛。诸药合用，可补肝肾，强筋骨，活血化瘀，通经止痛，攻毒散结，对硬膜外麻醉后腰背疼痛症状有显著改善。经临床应用验证，其疗效确切，药性平和，未出现明显毒副作用及不良反应，安全系数高。
具体实施方式
以下通过具体实施例进一步描述本发明，但是本发明不仅仅限于以下具体实施例。在本发明的范围内或者在不脱离本发明的内容、精神和范围内，对本发明进行的变更、组合或替换，对于本领域的技术人员来说是显而易见的，且包含在本发明的范围之内。实施例1软膏剂按以下重量份称取本发明各原料：百脚虫17g，金蚕13g，藏红花8g，断肠草9g，穿山甲10g，白芍9g，蜈蚣6g。制备工艺如下：将上述重量份的原料药分别粉碎后，混合均匀，加药材总重量的5倍量的水，浸泡2h后煎煮两次，每次2h，滤过，滤液合并后浓缩至清膏；取石蜡、单硬脂酸甘油酯、白凡士林、液状石蜡、丙二醇、司盘80和对羟基苯甲酸乙酯于水浴上加热熔化并保持80℃，搅拌下缓慢加入80℃的纯化水，边加边搅拌至冷凝，即软膏基质；取清膏溶于适量的纯化水中，加入到基质中，搅拌均匀，即得软膏剂。使用本发明药物组合物治疗硬膜外麻醉后腰背疼痛时，使用所制备的软膏剂，每支50g，含生药量25g，每日3-4次均匀涂敷患处。
实施例2按以下重量份称取本发明各原料：百脚虫16g，金蚕12g，藏红花6g，断肠草8g，穿山甲8g，白芍8g，蜈蚣5g。制备工艺同实施例1。
实施例3按以下重量份称取本发明各原料：百脚虫18g，金蚕14g，藏红花9g，断肠草10g，穿山甲12g，白芍10g，蜈蚣7g。制备工艺同实施例1。
实施例4按以下重量份称取本发明各原料：百脚虫15g，金蚕10g，藏红花5g，断肠草7g，穿山甲5g，白芍6g，蜈蚣4g。制备工艺同实施例1。
实施例5按以下重量份称取本发明各原料：百脚虫20g，金蚕16g，藏红花10g，断肠草11g，穿山甲15g，白芍12g，蜈蚣8g。制备工艺同实施例1。
实施例6按以下重量份称取本发明各原料：百脚虫10g，金蚕8g，藏红花15g，断肠草15g，白芍5g。制备工艺同实施例1。
实施例7本发明药物组合物治疗硬膜外麻醉后腰背疼痛的临床观察1、病例资料：选择医院病房骨科、普外科、泌尿外科等各种经硬膜外麻醉后1周内出现腰背部疼痛住院治疗的符合硬膜外麻醉后腰背疼痛患者共150例，经本专科检查及B超、X线等检查未发现腹腔内脏器、脊柱等器质性病变的患者。采用平行对照法，平均分为治疗组和对照a、b组各50例。其中治疗组男性34例，女性16例；年龄22～55岁，平均(36.3±1.54)岁，骨科16例、普外科22例、泌尿外科12例；对照a组男性30例，女性20例；年龄21～56岁，平均(35.1±1.44)岁，骨科15例、普外科20例、泌尿外科15例；对照b组男性32例，女性18例；年龄20～55岁，平均(36.7±1.56)岁，骨科16例、普外科20例、泌尿外科14例。三组患者性别、年龄、病程等一般资料无显著性差异，具有可比性。2、排除标准：(1)同时合并其他系统严重疾病的患者，因为其他系统严重的疾病更需优先医治，否则会危及生命。(2)排除对本研究所用药物过敏的患者；(3)伴有严重心、肝、肾功能不全及存在严重感染的患者；(4)有严重精神、智力障碍的患者。3、剔除标准：(1)纳入后发现伴有排除标准疾病者；(2)未按试验方案规定用药的病例；(3)服药过程资料记录不全，无法判定疗效者。4、脱落与终止标准：(1)观察中病人自行退出、失访者；(2)受试者发生并发症或特殊生理变化等不宜继续接受试验者；(3)试验中发生严重不良反应者，应及时终止临床试验。脱落与终止的病例应详细记录原因，并将其最后一次的主要疗效检测结果转接为最终结果进行统计。5、治疗方法：对照a组：给予曲马多止痛治疗，0.1g肌注，1次/d，连续治疗4周。治疗组：给予用实施例1制备的软膏剂，每支50g，含生药量25g，每日3-4次均匀涂敷患处。对照b组：给予用实施例6制备的软膏剂，每支50g，含生药量25g，每日3-4次均匀涂敷患处。两周一疗程，治疗两个疗程后，进行近期疗效评价。7、疗效判定标准：参照《中药新药临床研究指导原则》制定有关标准。治愈：腰背部疼痛症状消失，食欲好，二便正常，VAS0分；好转：腰背部疼痛症状明显缓解，食欲好，二便正常，VAS1-3分；显效：腰背部疼痛症状缓解，食欲好，二便正常，VAS4-6分；无效：治疗后腰背部疼痛症状未明显改变，VAS7-10分。两组治疗后疼痛轻重程度视觉模拟评分(visualsnaloguescale)：0分，无痛；1-3分，轻度疼痛；4-6分，中度疼痛；7-10分，重度疼痛。7、临床疗效比较在临床观察过程中，治疗组脱落1例病例，对照a组脱落2例病例，对照b组脱落1例病例，该4例患者均是好转后退出，以好转统计疗效，其余均完成临床观察。治疗组疗效结果如下：临床痊愈22例(44％)，好转16例(32％)，显效11例(22％)，无效1例(2％)，总有效率98％；对照a组临床痊愈12例(24％)，好转13例(26％)，显效13例(26％)，无效12例(24％)，总有效率76％；对照b组临床痊愈11例(22％)，好转13例(26％)，显效11例(22％)，无效15例(30％)，总有效率70％。三组间总有效率比较，治疗组与对照a、b组有显著性差异，治疗组治疗效果优于对照组，对照a、b组无显著性差异，没有治疗效果。
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 (3)
1.一种麻醉科治疗疾病疼痛的药物，其特征在于，其由以下重量份的原料药制得：百脚虫15-20g，金蚕10-16g，藏红花5-10g，断肠草7-11g，穿山甲5-15g，白芍6-12g，蚯蚓4-8g。
2.如权利要求1所述的麻醉科治疗疾病疼痛的药物，其特征在于，其由以下重量份的原料药制得：地鳖虫16-18g，金蚕12-14g，藏红花6-9g，断肠草8-10g，穿山甲8-12g，白芍8-10g，蜈蚣5-7g。
3.如权利要求2所述的麻醉科治疗疾病疼痛的药物，其特征在于，其由以下重量份的原料药制得：地鳖虫17g，金蚕13g，藏红花8g，断肠草9g，穿山甲10g，白芍9g，蜈蚣6g。
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