CN110038015B - 蒲公英甾醇在制备治疗尼古丁中毒的药物中的应用 - Google Patents
蒲公英甾醇在制备治疗尼古丁中毒的药物中的应用 Download PDFInfo
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Abstract
本发明属于医药领域，具体涉及蒲公英甾醇在制备治疗尼古丁中毒的药物中的应用。所述的蒲公英甾醇制备的治疗尼古丁中毒的药物，包括以下组份：蒲公英甾醇10份、可压性淀粉15份、微晶纤维素10份、糊精15份、蔗糖10份、甘露糖醇10份、薄荷醇10份、乳糖15‑20份、硬脂酸镁0‑5份。采用植物提取，提取的物质纯度高，无毒副作用。药效显著、持续时间长本发明制备的片剂可有效治疗尼古丁中毒，可以改善尼古丁对人体许多器官的刺激损害。制备的片剂由植物中提取，价格低。
Description
技术领域
本发明属于医药领域，具体涉及蒲公英甾醇在制备治疗尼古丁中毒的药物中的应用。
背景技术
据报道，目前全国每天约有2000余人死于因吸烟引发的疾病，预计到2050年死亡人口将增至8000人。在出生率下降、老龄化加剧、人口红利逐渐消失的今天控烟已刻不容缓。在中国，尽管许多城市业已出台公共场所禁止吸烟，但是由于历史原因及社会风气的影响，吸烟早已成为一种风尚。禁烟非但不会一蹴而就，而且烟民还有年轻化和女性化的趋势。因而研发一种能够降解尼古丁毒性的药物以成为当务之急。
尼古丁又称烟碱，是一种无色透明的油状挥发性液体，具有刺激的烟臭味。尼古丁是主要的成瘾源。吸入纸烟烟雾中的尼古丁只需7.5秒就可以到达大脑，使吸烟者感到一种轻柔愉快的感觉，它可使中枢神经系统先兴奋后抑制。尼古丁在血浆中的半衰期为30分钟，当尼古丁低于稳定水平时，吸烟者会感到烦躁、不适、恶心、头痛并渴望吸一支烟以补充尼古丁。一支香烟中尼古丁含量随烟叶质量和加工工艺而不尽相同，一般每支含1.5-3毫克。吸烟时，约25%的尼古丁被燃烧破坏，5%残留烟头内，50%扩散到空间，真正被人体吸收的尼古丁只有20%，所以有的人一天吸一盒香烟也未出现中毒现象。但尼古丁对人体许多器官的刺激损害作用却与日增加。
现有用于治疗尼古丁中毒的急救措施主要有洗胃、灌肠并结合注射纳洛酮和阿托品等药物。纳洛酮口服无效，需注射给药，并且药效持续时间短，作用消失需重复给药。蒲公英甾醇在医药领域应用广泛，据研究报道蒲公英甾醇具有抗菌、消炎等作用，但并没有报道研究其在治疗尼古丁中毒上的应用。
发明内容
针对尼古丁中毒的特性及现阶段治疗尼古丁中毒存在的问题，本发明通过研究发现蒲公英甾醇可以有效治疗尼古丁中毒，再结合现状，提出了一种治疗尼古丁中毒的药物，同时还提供了制备这种药物的方法。
蒲公英甾醇在制备治疗尼古丁中毒的药物中的应用。
一种采用蒲公英甾醇制备的治疗尼古丁中毒的药物，包括以下组份：蒲公英甾醇10份、可压性淀粉15份、微晶纤维素10份、糊精15份、蔗糖10份、甘露糖醇10份、薄荷醇10份、乳糖15-20份、硬脂酸镁0-5份。
上述蒲公英甾醇的制备方法，包括以下步骤：
1、新鲜苣荬菜剪成小段；滤纸收集苣荬菜乳汁；
2、将滤纸冷冻干燥后得乳汁粉末；
3、将乳汁粉末用90%的乙醇浸提，得膏状浸提物A；
4、将A用石油醚萃取，减压蒸馏得萃取物B；
5、将B用50:1石油醚--丙酮溶液洗脱，得洗脱物C；
6、将C用硅胶色谱分离，再用10:1的石油醚--乙酸乙酯得洗脱物D；干燥。
治疗尼古丁中毒药物的制备方法，包括以下步骤：
（1）按配方称取组份；
（2）过筛，并充分混合均匀；
（3）粉末直接压片法，压片制成片剂。
步骤（3）所述的片剂即可吞服也可含服。
本发明的有益效果
1、无副作用
本申请的药物，采用植物提取，提取的物质纯度高，无毒副作用。
2、药效显著、持续时间长
本发明制备的片剂可有效治疗尼古丁中毒，可以改善尼古丁对人体许多器官的刺激损害。
3、成本低
本发明制备的片剂由植物中提取，价格低。
具体实施方式
实施例1
蒲公英甾醇提取工艺
1 夏日清晨，采摘经过专家鉴定的新鲜苣荬菜植株，用剪刀将其剪成小段；
2 用清洁的分析滤纸吸收苣荬菜乳汁；
3. 将饱吸苣荬菜乳汁的分析滤纸放入真空冷冻干燥机，冷冻干燥后得乳汁粉末；
4. 将苣荬菜乳汁粉末用90%的乙醇溶液浸提过夜，得膏状浸提物A；
5. 将A用石油醚萃取，减压蒸馏得萃取物B;
6. 将B用50:1石油醚--丙酮溶液洗脱，得洗脱物C；
7. 将C用硅胶色谱分离，再用10:1的石油醚--乙酸乙酯得洗脱物D;干燥。
8. 最后将D用高效液相色谱仪进行分析鉴定，证明D为蒲公英甾醇，其纯度为98%。
实施例2
昆明种小鼠260只，雌雄各半。一级，体重(18±2)g，购于山东大学生命科学学院。
1.小鼠尼古丁致死剂量选择
80只小鼠雌雄各半，随机分成4组，每组20只。尼古丁溶于生理盐水。因为每只小鼠质量不超过20g，为了把注射液的体积控制在1ml以内，所以我们设置的尼古丁溶液浓度分别为500μg/ml、1000μg/ml和1500μg/ml。第一组、第二组和第三组每只小鼠皮下分别注射剂量为25μg/g、50μg/g和75μg/g的尼古丁，对照组每只小鼠注射1ml生理盐水。计算每组小鼠出现尼古丁中毒症状的平均时间及标准差（
±s ,n =20）并记录每组小鼠的死亡数量。
不同剂量的尼古丁溶液注射到小鼠体内以后，小鼠出现中毒症状的时间不等，中毒表现也不尽相同。当尼古丁剂量从25μg/g、50μg/g增加到75μg/g时，小鼠出现中毒症状的时间逐渐缩短，每组平均时间从(20±5) s到(11±4) s最终缩短到(5±3) s（如表1所示）。小鼠的死亡数量也随着尼古丁剂量增大而增加，从2只、11只逐步增加到18只。兼顾小鼠中毒症状和死亡数量，本试验选择剂量为75 mg/kg尼古丁作为小鼠的致死剂量持续下一步试验。
实施例3
2.蒲公英甾醇抗尼古丁试验
120只小鼠雌雄各半，随机分成6组，每组20只。蒲公英甾醇溶于生理盐水，其浓度分别为500μg /ml、400μg/ml、300μg/ml、200μg /ml、100μg/ml。首先第一组、第二组、第三组、第四组和第五组、每只小鼠分别注射剂量为25μg/g、20μg/g 、15μg/g、10μg/g和5μg/g的蒲公英甾醇，对照组注射1ml生理盐水，然后再给第一组、第二组、第三组、第四组、第五组及对照组，每只小鼠皮下分别注射剂量为75μg/g的尼古丁。计算每组小鼠出尼古丁现中毒症状的平均时间及标准差（
±s ,n =20）并记录每组小鼠的死亡数量。
表2蒲公英甾醇抗尼古丁实验统计表(
±s ,n =20)
当剂量为75μg/g尼古丁注入体内含有不同剂量蒲公英甾醇的小鼠体内以后，小鼠产生的中毒症状与实施例1实验的中毒症状类似。不同的是尼古丁溶液注入小鼠体内以后，小鼠出现中毒症状时间比实施例1实验小鼠出现中毒症状时间明显滞后(如表2所示)。随着蒲公英甾醇剂量增加：从0μg/g（对照）、5μg/g、10μg/g、15μg/g、20μg/g逐步增大到25μg/g，小鼠出现中毒症状时间从(4±2) s、(8±2) s、(15±4) s、(32±5) s、(33±3) s逐渐延迟到(46±6) s。同时小鼠的死亡数量也随着蒲公英甾醇浓度的增加而逐渐减少，从18只、17只、15只、7只、6只逐步减少到2只。本试验得到的结论是，蒲公英甾醇能够降低尼古丁的毒性，在推迟尼古丁中毒症状产生时间的同时，还能降低小鼠的死亡数量。
实施例4
3.抗尼古丁药物的疗效试验
表3抗尼古丁药物疗效实验统计表(n =20)
| 组别 | 尼古丁 | 抗尼古丁药物 | 小鼠数（只） | 死亡数（只） | 死亡率 |
| 第一组 | 75μg/g | 500μg/ml | 20 | 3 | 15% |
| 第二组 | 75μg/g | 500μg/ml | 20 | 2 | 10% |
| 对照组 | 75μg/g | 生理盐水 | 20 | 18 | 90% |
60只小鼠雌雄各半，随机分成6组，每组20只。抗尼古丁药物溶于生理盐水，其有效成分浓度为500μg/ml。首先三组小鼠分别注射75μg/g致死剂量的尼古丁，然后第一组、第二组小鼠分别灌注1ml有效成分浓度为500μg/ml的抗尼古丁药物，对照组灌注1ml生理盐水。观查记录每组小鼠的死亡数量并计算其死亡率(如表3)所示。分析结果（如表4）显示，在α=0.01时，查表可得F0.01(2.57)=4.93,由于计算值（36）大于该值（4.93），可以推断在三组处理中，与对照组相比较第一组、第二组至少有一组处理达到极显著水平。结论，本发明所研制的抗尼古丁药物在降解尼古丁毒性方面具有显著疗效。
表4方差分析表
| 变异来源 | 平方和 | 自由度 | 均方 | F |
| 处理 | 8.03 | 2 | 4.01 | 36<sup>**</sup> |
| 误差 | 6.15 | 57 | 0.11 | |
| 总变异 | 14.18 | 59 |
Claims (1)
1.蒲公英甾醇作为唯一活性成分在制备治疗尼古丁中毒的药物中的应用。
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| CN1331978A (zh) * | 2000-06-22 | 2002-01-23 | 中国科学院植物研究所 | 苦苣菜属植物在制备抗烟毒药物中的应用 |
| CN101810625A (zh) * | 2010-04-09 | 2010-08-25 | 上海新康制药厂 | 蒲公英甾醇的应用 |
| CN103272196A (zh) * | 2013-05-21 | 2013-09-04 | 李秋暑 | 解毒的药物组合物和药物制剂及其制备方法 |
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| CN1331978A (zh) * | 2000-06-22 | 2002-01-23 | 中国科学院植物研究所 | 苦苣菜属植物在制备抗烟毒药物中的应用 |
| CN101810625A (zh) * | 2010-04-09 | 2010-08-25 | 上海新康制药厂 | 蒲公英甾醇的应用 |
| CN103272196A (zh) * | 2013-05-21 | 2013-09-04 | 李秋暑 | 解毒的药物组合物和药物制剂及其制备方法 |
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