CN113491687A - 一种解毒药物组合物及其用途 - Google Patents
一种解毒药物组合物及其用途 Download PDFInfo
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- CN113491687A CN113491687A CN202010252075.4A CN202010252075A CN113491687A CN 113491687 A CN113491687 A CN 113491687A CN 202010252075 A CN202010252075 A CN 202010252075A CN 113491687 A CN113491687 A CN 113491687A
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- poisoning
- levocarnitine
- antidote
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- detoxification
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Abstract
本发明公开了一种解毒药物，该解毒药物由左卡尼汀、左卡尼汀衍生物、左卡尼汀药用盐及代谢调节药物、催吐剂、氧化剂、吸附剂、保护剂、泻药、有机磷类中毒解毒药物、金属类中毒解毒药物、氰化物中毒解毒药物、高铁血红蛋白血症解毒药物、中枢神经抑制剂解毒药物、胆碱酯酶复活剂、一氧化碳中毒解毒药物、有机氟中毒解毒药物、酒精中毒解毒药物、细菌性中毒解毒药物、真菌性中毒解毒药物、动植物源性中毒解毒药物中的一种或几种组成，具有促进毒物清除，保护组织器官功能的作用。
Description
技术领域
本发明涉及药物领域，具体地说，涉及一种解毒药物及包含该解毒药物的组合物在制备防治中毒药物中的用途。
背景技术
外界某化学物质进入人体后，与人体组织发生反应，引起人体发生暂时或持久性损害的过程称为中毒。生活中的中毒有意外中毒、他杀中毒（投毒）、自杀中毒、滥用药物导致的中毒以及环境污染导致的中毒。在临床上可以分为急性中毒（毒物进入体内后24小时内发病）、慢性中毒（毒物进入体内后2个月后发病）、亚急性中毒（介于急性和亚急性中毒之间）。其中急性中毒起病突然，病情发展快，引起人体各个器官功能受损，从而影响患者的预后，严重者甚至因此丧失生命，必须尽快甄别并采取紧急救治措施。
常见的中毒如敌敌畏、对硫磷等有机磷类中毒；铅汞镉等金属、类金属中毒；如氰化钾、乙腈等氰化物中毒；亚硝酸盐中毒引起的高铁血红蛋白血症；如一氧化碳、甲烷等有毒气体中毒；如氟乙酸胺、氟醋酸钠等有机氟中毒；以及酒精性中毒、细菌真菌性食物中毒及误食有毒食物或被有毒动植物所伤引起的中毒。
中毒常见的治疗措施有脱离有毒现场，吸氧、催吐、洗胃、清泻等，根据毒物的种类，中毒发生的时间，毒物进入人体的途径，发生毒性反应的症状等，采取相应的药物对症治疗，尽快解毒，维持患者的生命体征，并迅速转院，进行进一步治疗。目前常见的治疗方案中只关注去除毒物和解毒，缺乏对机体重要器官的保护，临床上许多患者，甚至包括那些得到及时救治的患者，由于在治疗方案中未考虑对组织器官的保护，患者往往预后不佳。
发明内容
发明目的：本发明第一目的是提供一种解毒药物，第二目的是提供一种包含所述解毒药物的解毒药物组合物，第三目的是提供一种解毒药物或解毒药物组合物在制备防治中毒药物中的应用。
技术方案
本发明的解毒药物，包含左卡尼汀、左卡尼汀衍生物、左卡尼汀药用盐中的一种或多种，所述左卡尼汀衍生物包含甲酰左卡尼汀、乙酰左卡尼汀、丙酰左卡尼汀；所述的左卡尼汀可药用盐包含盐酸盐、溴氢酸盐、碘氢酸盐、硫酸盐、硝酸盐、磷酸盐、乙酸盐、马来酸盐、富马酸盐、枸缘酸盐、柠檬酸盐、草酸盐、琥珀酸盐、酒石酸盐、苹果酸盐、扁桃酸盐、三氟乙酸盐、泛酸盐、甲磺酸盐、对甲苯磺酸盐。
左卡尼汀是哺乳动物能量代谢中必需的体内天然物质，其主要功能是促进脂类代谢。它既能将长链脂肪酸带进线粒体基质，并促进其氧化分解，为细胞提供能量，又能将线粒体内产生的短链脂肪酸输出。补充左卡尼汀可缓解因体内肉碱缺乏引起的脂肪代谢紊乱、骨骼肌和心肌等组织的功能障碍。临床用于防治左卡尼汀缺乏症，适用于继发性肉碱缺乏产生的一系列并发症状，临床表现如心肌病、骨骼肌病、心律失常、高脂血症，以及低血压和透析中肌痉挛等。此外，左卡尼汀对机体脑、心脏、肝脏、肾脏等重要组织的缺血缺氧损伤具有显著的保护作用，在心脑血管疾病治疗领域具有广泛的应用，且不良反应少，安全性高，临床有大量用于治疗慢性肾衰竭、心肌炎、心力衰竭、心绞痛、心肌梗死、抗疲劳、提高运动耐力、抗氧化、抗癌等应用报道。
金属离子、氰化物、一氧化碳、有机磷、有机氟、神经抑制剂等常见的中毒，最终均会导致组织细胞能量代谢障碍，发生损伤和凋亡，而左卡尼汀或其衍生物或其可药用盐不但能够直接促进脂肪酸代谢，还能简介促进葡萄糖代谢，增加ATP供应，还能对因为能量代谢障碍为导致的细胞损伤有保护作用。因此，左卡尼汀或其衍生物或其可药用盐能够用于解毒，或与现有的任一款解毒剂形成组合物，相互协同，共同发挥解毒作用，和保护机体组织细胞作用。
本发明的解毒药物组合物，包括本发明的解毒药物，及代谢调节药物、催吐剂、氧化剂、吸附剂、保护剂、泻药、有机磷类中毒解毒药物、金属类中毒解毒药物、氰化物中毒解毒药物、中枢神经抑制剂解毒药物、胆碱酯酶复活剂、一氧化碳中毒解毒药物、有机氟中毒解毒药物、酒精中毒解毒药物、细菌性中毒解毒药物、真菌性中毒解毒药物、动植物源性中毒解毒药物中的一种或几种。
所述的代谢调节药物，是对葡萄糖、脂肪酸、嘌呤、蛋白质、水盐等机体物质、能量代谢具有促进或抑制作用的药物，包括曲美他嗪、盐酸曲美他嗪、长春西汀、肌酐葡萄糖、辅酶A、能量合剂、果糖二磷酸钠。在中毒治疗以及预后康复发过程中，代谢调节药物能够调节机体物质和能量代表，增加机体组织细胞的能量供应，保护细胞功能。
所述的催吐剂，是一种能够引起呕吐的药物，包括阿扑吗啡、硫酸铜；所述氧化剂，包括高氯酸盐、高锰酸盐、重铬酸盐，过氧化钠。在中毒治疗过程中，使用催吐药物能够将胃肠道残留的毒性物质呕吐出来，减少吸收，减轻中毒。
所述的吸附剂，是一种能够吸附固定活性成分的固体物质，包括活性炭、分子筛。在中毒治疗和康复的过程中，使用吸附剂物能够吸附胃肠道残留的毒性物质，减少吸收，减轻中毒。
所述的保护剂，是一种能够保护胃肠道粘膜的药物，包括植物油、牛奶、豆浆、米汤。在中毒治疗和康复的过程中，使用保护剂物能够保护胃肠道粘膜免受毒性物质和治疗药物的刺激损害，保护胃肠道。
所述的泻药，是一种能够引起腹泻的药物，包括硫酸镁、硫酸钠；所述有机磷类中毒解毒药物，包括碘解磷定，氯解磷定。在中毒治疗过程中，使用泻药能够将胃肠道残留的毒性物质排泄出去，减少吸收，减轻中毒。
所述的金属类中毒解毒药物，是一种能够对金属、类金属中毒有特别针对性作用的药物，包括谷胱甘肽、依地酸钙钠、二巯丁二钠、二巯丙磺钠、巯乙胺。在金属、类金属中毒治疗过程中，使用金属类中毒解毒药物能够和金属离子、类金属离子络合，形成低毒、无毒的几乎不解离的、可溶性金属络合物，从尿液中排出体外。
所述的氰化物中毒解毒药物，是一种能够对氰化物中毒有特别针对性作用的药物，包括亚硝酸钠、亚甲蓝、硫代硫酸钠。在氰化物中毒治疗过程中，使用氰化物中毒解毒药物能够迅速恢复细胞色素氧化酶的活性和加速氰化物转变为无毒或低毒的物质排出体外。
所述的中枢神经抑制剂解毒药物，是一种能够对镇静催眠药、全身麻醉药、镇痛药等中枢神经抑制剂中毒有特别针对性作用的药物，包括氟马西尼、纳洛酮、烯丙吗啡。在中枢神经抑制剂中毒治疗过程中，使用中枢神经抑制剂解毒药物能够迅速解除中枢神经的抑制状态。
所述的胆碱酯酶复活剂，是一类能使失活的胆碱酯酶恢复活性从而使胆碱酯酶水解的药物，包括阿托品、东茛菪碱、盐酸戊乙奎醚。
所述的一氧化碳中毒解毒药物，是一类能够对一氧化碳中毒有特别针对性的药物，包括细胞色素C。一氧化碳中毒解毒药物能够竞争性的与血红蛋白结合，维持血红蛋白的携氧能力，或促进脑组织的能量代谢，维持生命活动。
所述的有机氟中毒解毒药物，是一类能够对有机氟中毒有特别针对性的药物，包括乙酰胺。有机氟中毒解毒药物能够在体内与有机氟毒性物质争夺酰胺酶，使得氟乙酰胺不能转化为具有细胞毒性的氟乙酸，阻断了氟乙酰胺对三羧酸循环的影响。
所述的酒精中毒解毒药物，是一种对长期过量饮酒导致的中枢神经系统严重中毒有特别针对性作用的药物，包括美他多辛、纳洛酮、纳美芬。
所述的细菌性中毒解毒药物，是一种对细菌和/或其毒素所引起的中毒性疾病有特别针对性作用的药物，包括抗生素及抗毒血清。
所述的真菌性中毒解毒药物，是一种对真菌和/或其毒素所引起的中毒性疾病有特别针对性作用的药物，包括抗真菌药物。
所述的动植物源性中毒解毒药物，是一种对动植物源性感染、咬伤所引起的中毒性疾病有特别针对性作用的药物，包括抗毒血清。
本发明的解毒药物或解毒药物组合物在制备防治中毒药物中的用途。
所述的中毒是包括有机磷、金属、类金属、氰化物、有机氟、一氧化碳、中枢神经抑制剂、胆碱酯酶抑制剂、酒精、亚硝酸盐、硝酸盐、非那西汀、普鲁卡因、苯胺、细菌、真菌、动植物导致的中毒。
所述的药物以口服给药形式、注射给药形式或局部给药形式给药。所述的口服给药形式包括片剂、颗粒剂、胶囊剂、口服溶液剂、糖浆剂、吸入剂、喷剂；所述的注射给药形式包括冻干粉针剂、注射用混悬剂、注射用乳剂、溶液注射剂；所述局部给药形式包括气雾剂、软膏剂、洗剂、栓剂、贴剂、搽剂、滴眼剂、阴道泡腾片。
所述的药物组合物中各药物组分的用量均参照这些组分已经上市的单方制剂产品的药品使用说明书中记载的用量，也可通过有限的科学试验筛选出优选的各药物组分的重量比范围或特定的比例。
具体实施方式
下面的实施例可以帮助本领域的技术人员更全面的理解本发明，但不以任何方式限制本发明。
实施例1：对急性有机磷（敌敌畏）中毒大鼠的治疗作用
对非致死量敌敌畏作用的影响:健康大鼠72只, 雌雄各半, 按性别和体重随机分为6组, 每组12只，分别为正常对照组、染毒组（30mg/kg敌敌畏）、染毒（30mg/kg敌敌畏）+左卡尼汀600mg/kg灌胃治疗组、染毒（30mg/kg敌敌畏）+左卡尼汀600mg/kg腹腔注射治疗组、染毒（30mg/kg敌敌畏）+氯解磷定30mg/kg注射治疗组、染毒（30mg/kg敌敌畏）+左卡尼汀600mg/kg注射+氯解磷定30mg/kg注射治疗组。除正常组外，动物禁食24 h后, 一次性灌胃给予敌敌畏30 mg/kg染毒, 灌胃容积为1 ml/100 g。染毒5 min后开始给予相应的药物治疗，染毒未治疗组给予生理盐水。24小时内观察动物状态及第24小时的存活情况。根据DeBleecker评分标准进行肌束震颤评分，无肌束震颤为0 分；口周肌肉出现而其他肌肉偶见肌束震颤为1 分；腹肌、后肢肌多处出现肌束震颤为2 分；腹肌、后肢肌频繁出现多发性肌束震颤为3 分。24小时后戊巴比妥40mg/kg麻醉，腹主动脉取血测定全血胆碱酯酶活性以及血清SOD、MDA。
结果显示：
1.左卡尼汀及氯解磷定能减轻大鼠敌敌畏中毒症状，提高大鼠存活率，其中左卡尼汀与氯解磷定联用效果最佳。
表1 各组大鼠中毒症状及存活情况（n=12）
| 组别 | 翘尾 | 流涎 | 存活 |
| 正常对照组 | 0 | 0 | 12 |
| 染毒组 | 12 | 12 | 6 |
| 左卡尼汀口服组 | 5 | 4 | 8 |
| 左卡尼汀注射组 | 4 | 4 | 9 |
| 氯解磷定组 | 4 | 3 | 9 |
| 左卡尼汀+氯解磷定组 | 2 | 2 | 10 |
2.左卡尼汀能显著减轻敌敌畏中毒大鼠的肌束震颤强度，延长翻正反射消失时间。
表2 各组大鼠肌束中毒症状比较
| 组别 | 肌颤强度/分 | 翻正反射消失时间/min |
| 正常对照组 | 0 | 0 |
| 染毒组 | 3.00±0.00 | 3.98±1.34 |
| 左卡尼汀口服组 | 2.22±0.54* | 13.21±2.25* |
| 左卡尼汀注射组 | 2.13±0.64* | 15.81±5.56* |
| 氯解磷定组 | 1.88±0.67* | 16.61±5.23* |
| 左卡尼汀+氯解磷定组 | 1.67±0.53* | 32.11±9.28* |
注：与染毒组比较，*P＜0.05。
3.左卡尼汀能显著提高敌敌畏中毒大鼠AchE、SOD活性及MDA含量。
表3 各组大鼠血液指标
| 组别 | AchE（U/L） | SOD(U/mL) | MDA(nmol/L) |
| 正常对照组 | 236.78±34.22 | 47.68±10.34 | 2.99±0.74 |
| 染毒组 | 177.84±30.00 | 30.79±7.14 | 4.14±0.81 |
| 左卡尼汀口服组 | 184.17±27.18 | 44.07±7.38* | 4.05±0.97 |
| 左卡尼汀注射组 | 208.54±43.53* | 45.04±11.66* | 3.83±0.70* |
| 氯解磷定组 | 214.31±26.58* | 45.12±7.53* | 3.61±0.67* |
| 左卡尼汀+氯解磷定组 | 232.08±23.97* | 47.97±8.59* | 3.00±0.52* |
注：与染毒组比较，*P＜0.05。
实施例2：对金属（铅）中毒小鼠的治疗作用
出生一周的健康清洁级昆明种雄性小鼠72只，小鼠体重10±2克，小鼠适应性喂饲1周后，随机分为6组，醋酸铅模型组、依地酸二钠钙组（75mg/kg，i.m）、左卡尼汀灌胃100mg/kg、200mg/kg、400mg/kg组，依地酸二钠钙+左卡尼汀400mg/kg组，每组12只。正常对照组小鼠灌胃去离子水0.4ml，其余各组灌胃含醋酸铅的去离子水（铅离子含量2mg/L）0.4ml，干预组分别灌胃醋酸铅溶液隔4小时后再给予相应的药物干预。连续治疗14天，最后一次干预后24小时，眼眶取血，肝素钠抗凝，加4:1（体积分数）浓硝酸／高氯酸溶液混匀，加热消化。断颈处死，迅速分离右侧股骨，去除其外周脂肪及结缔组织，烤干后准确称取0.5000g，以4:1（体积分数）浓硝酸／高氯酸溶液加热消化，溶液变为澄清透明后，取下冷却定溶。采用火焰原子吸收分光光度仪测定全血及股骨重金属元素铅含量。
结果显示：左卡尼汀干预能显著降低血液中和骨骼中的铅含量，提示左卡尼汀具有促进排铅的作用，与依地酸二钠钙联用效果最佳。
表4 左卡尼汀对血液及骨骼中铅含量的影响
| 组别 | 全血（μg/ml） | 骨骼（μg/g） |
| 醋酸铅模型组 | 5.12±1.02 | 50.57±10.23 |
| 依地酸二钠钙组 | 3.17±1.56* | 14.78±3.66* |
| 左卡尼汀低剂量组 | 4.75±2.12* | 20.01±4.54* |
| 左卡尼汀中剂量组 | 3.22±2.55* | 15.72±4.17* |
| 左卡尼汀高剂量组 | 3.01±1.58* | 14.11±2.96* |
| 依地酸二钠钙+左卡尼汀组 | 1.96±0.79* | 12.10±3.25* |
注：与模型组比较，*P＜0.01。
实施例3：对急性一氧化碳中毒大鼠的治疗作用
急性一氧化碳中毒模型建立及药物干预：雄性SD大鼠60只，体质量220~250 g，分为正常对照组，急性CO中毒组，左卡尼汀 600mg/kg组，左卡尼汀600mg/kg+曲美他嗪6mg/kg组，其中正常对照组12只，其余各组16只。按文献报道方法，将大鼠置于染毒箱内，持续吸入浓度为2 000 ppm的CO 35 min，随后持续吸入浓度为3 000 ppm的CO 25 min后出箱；正常对照组大鼠在染毒箱内持续吸入空气1 h。染毒结束后立即采用改良的Rodkey FL微量定量法检测血液碳氧血红蛋白浓度（COHb%），当COHb%> 40%时视为模型建立成功。治疗组大鼠于染毒结束后1 h灌胃给予相应的药物，每日2 次，连续7 d。
Morris 水迷宫实验：每组中各取6只大鼠用于Morris水迷宫实验，于染毒后第2~7天进行。染毒后第2天，各组大鼠于水迷宫内无站台游泳60 s以熟悉水环境。染毒后第3~6天行隐蔽站台试验。站台位于第3象限中心。单次试验时限为60 s，每天每只大鼠试验4次，分别以该大鼠4次试验逃避潜伏期和平均游泳速度的平均值作为当日的成绩。染毒后第7天行空间探索试验，记录大鼠60 s内在第3象限游泳时间和平均游泳速度。
其余大鼠于染毒后第8天麻醉，冰浴中分离海马和皮质，称重后加入冰生理盐水制备10%脑组织匀浆液，4 ℃ 12 000 r/min 离心30 min，取上清液，严格按照说明书要求检测MDA、大鼠8-OHdG水平。
实验结果：剔除染毒过程中死亡的及COHb%＜ 40%的大鼠，各组大鼠保留12只正式实验。结果显示：染毒后即刻，急性CO中毒组与治疗组大鼠血液COHb%比较，差异无统计学意义。Morris水迷宫实验连续每天各组大鼠平均游泳速度比较差异无统计学意义，各组大鼠逃避潜伏期均随试验次数的增加而缩短，染毒后第3~5天各组大鼠逃避潜伏期无统计学差异，但染毒后第6天，急性CO中毒组与正常对照组或治疗组大鼠相比，逃避潜伏期明显延长。脑组织氧化应激指标MDA、大鼠8-OHdG水平检测结果显示，治疗组可显著降低海马及皮质MDA和8-OHdG水平。提示左卡尼汀单用或与曲美他嗪联用可改善急性CO中毒模型大鼠学习与记忆功能，调节抗氧化应激，降低脑组织MDA、8-OHdG水平，发挥对急性CO中毒大鼠脑损伤的神经保护作用。
表5 对CO中毒大鼠第7天Morris水迷宫逃避潜伏期的影响
| 组别 | 第7天逃避潜伏期 |
| 正常对照组 | 7.82±2.15 |
| 急性CO中毒组 | 22.27±1.98 |
| 左卡尼汀 600mg/kg组 | 18.53±2.01* |
| 左卡尼汀600mg/kg+曲美他嗪6mg/kg组 | 13.47±1.55* |
注：与模型组比较，*P＜0.05。
表6 对CO中毒大鼠海马及皮质组织MDA、8-OHdG水平的影响
注：与模型组比较，*P＜0.05。
实施例4：左卡尼汀对慢性氟中毒大鼠的影响
将30 只大鼠随机分为正常对照组、模型对照组、左卡尼汀组，每组大鼠10 只。正常组大鼠给予去离子水自由饮用；模型组、左卡尼汀组大鼠给予100 mg/L NaF 溶液自由饮用，连续饮用12 周。左卡尼汀组给予左卡尼汀600 mg/kg灌胃，正常组和模型组给予等体积生理盐水。喂饲3个月后，检查氟斑牙患病率。大鼠处死前采集尿液。断头处死动物，取血清，用氟离子选择电极法测定血清氟、尿氟含量。
结果显示：
1.各组氟斑牙患病率有显著性差异，但因中毒时间过短，各组均无重度氟斑牙病例出现。
表7 各组氟斑牙患病情况
| 组别 | 正常 | 可疑 | 轻微 |
| 正常对照组 | 10 | 0 | 0 |
| 模型对照组 | 0 | 5 | 5 |
| 左卡尼汀组 | 3 | 5 | 2 |
2.左卡尼汀可显著降低各组大鼠血氟含量，促进氟排泄.
表8 各组大鼠血氟、尿氟含量
| 组别 | 血氟（mg/L） | 尿氟（mg/L） |
| 正常对照组 | 0.12±0.01 | 0.97±0.06 |
| 模型对照组 | 0.40±0.23 | 13.32±4.15 |
| 左卡尼汀组 | 0.26±0.11* | 25.50±11.15* |
注：与模型组比较，*P＜0.01
实施例5：对急性亚硝酸钠中毒的预防作用
亚硝酸钠是一种有毒化学品，摄入过量时可与血液中的血红蛋白(Hb) 结合而转化为高铁血红蛋白(MetHb)，使血细胞失去携氧能力，导致组织缺氧。同时，它作为一种强氧化剂，进入人体内时可产生NO，与阴离子结合后生成有毒物质，引起脂质过氧化，进而生成一系列自由基，可侵犯神经系统，产生神经毒性。
昆明小鼠，随机分为正常组，模型组，左卡尼汀低、中、高剂量(100、200、400 mg /kg) 组，每组12 只，每天灌胃给药1 次(20 mL /kg)，连续14 d，正常组、模型组给予等体积生理盐水。末次给药1 h 后，除正常组外其余各组腹腔注射中毒剂量(100 mg /kg) 的亚硝酸钠，1 h 后眼眶取血，全血加到肝素抗凝管中，封口后轻轻颠倒混匀，MetHb 测试盒测定Hb 含有量。
结果显示：左卡尼汀可抑制高铁血红蛋白的形成。
表9 对亚硝酸钠中毒小鼠模型的血红蛋白的影响
| 组别 | MetHb（g/L） | Hb（g/L） |
| 正常组 | 2.04±0.57 | 165.3±34.25 |
| 模型组 | 52.84±10.11 | 103.4±32.15 |
| 左卡尼汀低剂量组 | 47.50±16.59* | 121.3±31.6* |
| 左卡尼汀中剂量组 | 23.95±9.87* | 137.6±47.5* |
| 左卡尼汀高剂量组 | 16.62±10.89* | 151.0±51.2* |
注：与模型组比较，*P＜0.05。
实施例6：左卡尼汀对氰化物中毒的解毒作用
氰化物毒性作用是其解离出的氰基(CN-)对线粒体呼吸链的终末酶———细胞色素氧化酶aa3 的抑制, 使细胞生物氧化过程受阻, 中枢神经系统是其主要的靶器官。
SD大鼠50只，随机分为正常对照组，模型对照组，左卡尼汀200,400,600mg/kg组，每组10只。正常对照组和模型对照组正常对照组腹腔注射生理盐水，左卡尼汀组给予相应剂量的左卡尼汀，灌胃给药，给药容积10ml/kg，连续给药7天。末次给药后1小时，正常对照组腹腔注射1ml/kg生理盐水，其他各组腹腔注射3.5mg/kg氰化钠染毒，染毒5min后，断头处死大鼠，冰浴中分离大脑皮质，称重后加入冰生理盐水制备10%脑组织匀浆液，4 ℃ 12 000r/min 离心30 min，取上清液，严格按照说明书要求测定SOD 、GSH-Px 、XOD 、Na+-KATPase 的活力和ROS 的含量。
结果显示：左卡尼汀能显著提高氰化钠染毒大鼠皮质SOD 、GSH-Px 活力，提高Na+-K+ATP酶活性，维持细胞内离子浓度，保障细胞内能量的产生和利用，减少ROS的产生，提高机体抗氧化能力。
表10 对氰化钠中毒大鼠脑皮质生化指标的影响
注：与模型组比较，*P＜0.05；**P＜0.01。
实施例7：乙酰左卡尼汀抗菌作用
1、实验材料
菌株：金黄色葡萄球菌、大肠埃希氏菌、痢疾志贺氏菌、肺炎克雷伯氏菌，由中国科学院微生物研究所提供；乙型溶血性链球菌、流感嗜血杆菌购自中国医学细菌保藏中心；
营养肉汤：购自上海康朗生物科技有限公司；
2、实验方法
采用试管法培养金黄色葡萄球菌、乙型溶血性链球菌、大肠埃希氏菌、痢疾志贺氏菌、流感嗜血杆菌、肺炎克雷伯氏菌，取18h培养的各菌株营养肉汤培养物，用营养肉汤作10-5稀释用于实验。灭菌试管21支，每管加入营养肉汤液体培养1mL，取乙酰左卡尼汀溶液（20mg/mL，生理盐水溶解）作为供试品1号，吸取供试品1号1mL加入第1管中混匀后取1mL至第2管，依次稀释至第10管，第10管吸出1mL弃去，阿莫西林溶液（20mg/mL，生理盐水溶解）作为供试品2号，吸取供试品2号1mL加入第11管中混匀后取1mL至第12管，依次稀释至第20管，第20管吸出1mL弃去，混合溶液（每毫升含乙酰左卡尼汀20mg+阿莫西林20mg）作为供试品3号，吸取供试品2号1mL加入第21管中混匀后取1mL至第22管，依次稀释至第30管，第31管不加药液作为对照。每管加入菌液（10-5稀释）0.1mL，37℃培养20h，取出观察各管有无菌生长，完全抑制细菌生长所含的最小药物浓度即为药物的最低抑菌浓度MIC。
3、结果处理及分析
体外抑菌活性试验结果见表11。
表11体外抑菌活性结果
上述实验结果显示，单用乙酰左卡尼汀和阿莫西林均有抗菌作用，但乙酰左卡尼汀和阿莫西林合用的抗菌效果优于乙酰左卡尼汀、阿莫西林单用。
实施例8：左卡尼汀注射液
处方：左卡尼汀 1000g
依地酸二钠 0.5g
盐酸 适量
注射用水 加至1000ml
工艺：在制备容器中，加处方量80%的注射用水，加左卡尼汀溶解后，加入预备配置好的依地酸二钠和盐酸溶液，搅拌均匀，调节药液PH6.0~6.2，注射用水至全量，再加入0.1%活性炭脱色，用垂熔玻璃滤器与膜滤器过滤，并在氮气气流下灌封，最后于100℃流通蒸汽15min灭菌。
实施例9：复方（左卡尼汀+阿扑吗啡）片
处方：左卡尼汀 1000g
阿扑吗啡 15g
乳糖 1400g
淀粉 600g
10%淀粉浆 210g
干淀粉 20g
硬脂酸镁 适量
制成5000片
工艺：将左卡尼汀、阿扑吗啡过80目筛，与淀粉、乳糖混匀，加淀粉浆制成软材，用14目筛制粒后，置70℃~80℃干燥后于12目筛整粒，加入干淀粉及硬脂酸镁混匀后，压片，即得。
实施例10：复方（左卡尼汀+亚甲蓝）输液
处方：左卡尼汀 300g
亚甲蓝 10g
依地酸二钠 5g
盐酸 200g
注射用水 加至10000ml
工艺：取约8000ml热注射用水，按处方量投入左卡尼汀、亚甲蓝，搅拌使全溶，加抗氧剂，并用10%盐酸调PH至6.0左右，加注射用水适量，在加入0.15%活性炭脱色，过滤至澄明，灌封于100ml输液瓶内，充氮气，加塞，轧盖，于100℃灭菌30min即可。
实施例11： 复方（左卡尼汀+盐酸曲美他嗪）片
处方：左卡尼汀 1000g
盐酸曲美他嗪 5g
乳糖 200g
淀粉 100g
10%淀粉浆 100g
干淀粉 20g
硬脂酸镁 15g
制成2000片
工艺：将左卡尼汀、盐酸曲美他嗪过80目筛，与淀粉、乳糖混匀，加淀粉浆制成软材，用14目筛制粒后，置70℃~80℃干燥后于12目筛整粒，加入干淀粉及硬脂酸镁混匀后，压片，即得。
实施例12：复方（左卡尼汀+长春西汀+纳洛酮）片
处方：左卡尼汀 500g
长春西汀 5g
盐酸纳洛酮 1g
乳糖 150g
微晶纤维素 50g
10%淀粉浆 50g
交联聚维酮 20 g
硬脂酸镁 适量
制成1000片
工艺：将左卡尼汀、盐酸纳洛酮和盐酸曲美他嗪过80目筛，与微晶纤维素、乳糖混匀，加淀粉浆制成软材，用14目筛制粒后，置70℃~80℃干燥后于12目筛整粒，加入交联聚维酮及硬脂酸镁混匀后，压片，即得。
实施例13：复方（左卡尼汀+植物油+阿托品）胶丸
处方：左卡尼汀 3000克
硫酸阿托品 10克
明胶 1000克
甘油 60克
水 1200克
精炼食用植物油 适量
工艺：取左卡尼汀和阿托品，加精炼食用植物油溶解，作为药液待用；另取甘油与水加热至70℃，加入明胶，搅拌溶化，保温2小时，过滤，加入滴丸机滴制，以液体石蜡为冷却液，收集冷凝的胶丸，用纱布拭去黏附的冷却液，在室温下吹冷风3小时，放于25℃下烘4小时，再经石油醚洗涤两次（每次5min），除去胶丸外层液体石蜡，再用95%乙醇洗涤石油醚，最后在35℃烘干约2小时，筛选，质检，包装，即得。
Claims (8)
1.一种解毒药物，其特征在于，包含左卡尼汀、左卡尼汀衍生物、左卡尼汀药用盐中的一种或多种。
2.根据权利要求1所述的解毒药物，其特征在于，所述左卡尼汀衍生物包含甲酰左卡尼汀、乙酰左卡尼汀、丙酰左卡尼汀、丁酰左卡尼汀；所述的左卡尼汀可药用盐包含盐酸盐、溴氢酸盐、碘氢酸盐、硫酸盐、硝酸盐、磷酸盐、乙酸盐、马来酸盐、富马酸盐、枸缘酸盐、柠檬酸盐、草酸盐、琥珀酸盐、酒石酸盐、苹果酸盐、扁桃酸盐、三氟乙酸盐、泛酸盐、甲磺酸盐、对甲苯磺酸盐。
3.一种解毒药物组合物，其特征在于，所述解毒药物组合物包括权利要求1—2任一项中的解毒药物，及代谢调节药物、催吐剂、氧化剂、吸附剂、保护剂、泻药、有机磷类中毒解毒药物、金属类中毒解毒药物、氰化物中毒解毒药物、高铁血红蛋白血症解毒药物、中枢神经抑制剂解毒药物、胆碱酯酶复活剂、一氧化碳中毒解毒药物、有机氟中毒解毒药物、酒精中毒解毒药物、细菌性中毒解毒药物、真菌性中毒解毒药物、动植物源性中毒解毒药物中的一种或几种。
4.根据权利要求3所述的解毒药物组合物，其特征在于，所述代谢调节药物包括曲美他嗪、盐酸曲美他嗪、长春西汀、肌酐葡萄糖、辅酶A、能量合剂、果糖二磷酸钠；所述的催吐剂，包括阿扑吗啡、硫酸铜；所述氧化剂，包括高氯酸盐、高锰酸盐、重铬酸盐，过氧化钠；所述的吸附剂，包括活性炭、分子筛；所述保护剂，包括植物油、牛奶、豆浆、米汤；所述泻药，包括硫酸镁、硫酸钠；所述有机磷类中毒解毒药物，包括碘解磷定，氯解磷定；所述的金属类中毒解毒药物，包括谷胱甘肽、依地酸钙钠、二巯丁二钠、二巯丙磺钠、巯乙胺；所述氰化物中毒解毒药物，包括亚硝酸钠、亚甲蓝、硫代硫酸钠；所述中枢神经抑制剂解毒药物，包括氟马西尼、纳洛酮、烯丙吗啡；所述胆碱酯酶复活剂，包括阿托品、东茛菪碱、盐酸戊乙奎醚；所述一氧化碳中毒解毒药物，包括细胞色素C；有机氟中毒解毒药物，包括乙酰胺；酒精中毒解毒药物，包括美他多辛、纳洛酮、纳美芬；所述的细菌性中毒解毒药物，包括抗生素及抗毒血清；所述的真菌性中毒解毒药物，包括抗真菌药物；所述的动植物源性中毒解毒药物，包括抗毒血清。
5.权利要求1-2任一项所述的解毒药物或权利要求3-4任一项所述的解毒药物组合物在制备防治中毒药物中的用途。
6.根据权利要求5的用途，其特征在于，所述的中毒是包括有机磷、金属、氰化物、有机氟、一氧化碳、中枢神经抑制剂、胆碱酯酶抑制剂、酒精、亚硝酸盐、硝酸盐、非那西汀、普鲁卡因、苯胺、细菌、真菌、动植物导致的中毒。
7.根据权利要求5的用途，其特征在于，所述的药物以口服给药形式、注射给药形式或局部给药形式给药。
8.所述的口服给药形式包括片剂、颗粒剂、胶囊剂、口服溶液剂、糖浆剂、吸入剂、喷剂；所述的注射给药形式包括冻干粉针剂、注射用混悬剂、注射用乳剂、溶液注射剂；所述局部给药形式包括气雾剂、软膏剂、洗剂、栓剂、贴剂、搽剂、滴眼剂、阴道泡腾片。
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