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| 个人信息 |
| 姓 名： |
冯译员 [编号]:1579 |
性 别： |
女 |
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| 擅长专业： |
英语教学 |
出生年月： |
1985/6/1 |
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| 民 族： |
汉族 |
所在地区： |
四川 南充 |
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| 文化程度： |
硕士 |
所学专业： |
英语教学 |
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| 毕业时间： |
40725 |
毕业学校： |
西华师大 |
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| 第一外语： |
英语 |
等级水平： |
英语专业八级 |
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| 口译等级： |
中级 |
工作经历： |
1 年 |
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| 翻译库信息 |
| 可翻译语种： |
英语 |
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| 目前所在地： |
四川 南充 |
| 可提供服务类型： |
笔译、家教 |
| 每周可提供服务时间： |
每天 |
| 证书信息 |
| 证书名称： |
剑桥商务英语中级 |
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| 获证时间： |
2006/6/1 |
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| 获得分数： |
通过 |
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| 工作经历 |
| 工作时期： |
2009/2/1--2009/9/1 |
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| 公司名称： |
西华师大 |
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| 公司性质： |
其它 |
| 所属行业： |
教育/培训 |
| 所在部门： |
高职 |
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| 职位： |
教师 |
| 自我评价： |
自信，认真，负责。 |
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| 笔译案例信息 |
| 案例标题： |
喘可治注射液慢性毒性动物实验研究资料 |
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| 原文： |
摘 要
喘可治注射液为纯中药制剂，由淫羊藿(Epimedium ,icariin)等中药组成，具有温补肾阳、平喘止咳的功效，针对支气管哮喘中医辨证属肾虚挟痰患者所表现的喘息、肺部哮鸣音、咳嗽、咯痰、多汗、畏寒、腰酸肢软、面色苍白以及舌质淡、舌苔厚或滑、脉沉细等的异常均有较好疗效，临床上用于治疗成人及儿童支气管哮喘。
本试验喘可治注射液设低、中、高（1.76、3.51、7.02g生药/kg）3个剂量组及生理盐水对照组，连续静脉滴注给予Beagle犬9个月。观察给药后动物的行为活动、皮肤被毛、粪便性状等一般药物反应，并分别于给药3、6个月及给药结束、恢复期结束时进行血液学、血液生化学、心电图、粪尿等检测；3月、给药结束、恢复期结束时每组分别取4、4、2只动物（雌雄各半）进行骨髓检测并施以安乐死，进行系统尸检、病理组织学检查，主要结果如下：
一般状态：给药期间，前1个月，高剂量组部分动物出现呕吐及给药时流涎等症状，个别动物食欲下降；中剂量组个别动物出现呕吐及给药时流涎等症状。动物出现此类症状为不定期间隔出现，不具连续性，且在给药2个月后基本消失。低剂量组未见此类症状。各组动物皮毛光泽度良好，无竖毛、流量、抽搐及体重抑制等其他毒性症状反应。
血液学：WBC（白细胞）与GRA（粒细胞）均表现为给药3月及6月低剂量组及高剂量组高于对照组，其差异有统计学意义（p<0.05），但在正常值范围内，无生物学意义。给药结束及恢复期结束未见异常；PLT（血小板）与PCT（血小板比积）显示给药3月时，低、中、高三个剂量均低于对照组，给药6月时，高剂量低于对照组，给药结束时，中、高剂量低于对照组，其差异有统计学意义（p<0.05），但其值在正常范围之内，无生物学意义。其余指标3月及6月时各剂量组未见明显异常改变，偶见个别指标出现与生理盐水对照相比的升高或降低，虽然差异有统计学意义，但无生物学意义。
血生化、血凝、血电解质、心电图、粪尿、眼底、骨髓、脏器系数等检查均未见明显异常。
组织病理学检查结果显示，送检的Beagle犬各器官、组织均无明显的毒性损害。停药恢复1个月，亦未见延迟性毒性发生。
综上所述，在本实验室条件下，Beagle犬经静脉滴注给予喘可治注射液9个月，3、6、9月及恢复期结束时分别对动物进行血液学等相关检测，并与3、9个月及恢复期结束时每组解剖部分动物检查，结果显示，各检测指标均未见与药物相关的异常改变，即未观察到明显毒性反应。所设高剂量7.02g生药/kg为安全剂量。
1试验目的
按照《药品注册管理办法》对新药申报的相关要求，参照《中药、天然药物长期毒性研究技术指导原则》（2005.3），对珠海经济特区健心医药有限公司生产的喘可治注射液进行Beagle犬9个月经静脉滴注给药长期毒性试验，观察该药物可能引起毒性反应的性质、程度、量效和时效关系及可逆性；推测毒性靶器官或靶组织；为临床设计人用剂量安全范围和需重点监测的安全性指标提供参考。
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| 译文： |
Abstract
Antiasthmatic injection was the pure traditional Chinese medicine, which was made of Epimedium,etc. It had the efficacy of warming the kidney as well as curing cough and asthma. It also had good efficacy on the wheezing, pulmonary wheezing, cough, expectoration, sweating, chills, backache limb soft, pale, pale tough, thick fur or slippery, thin and abnormal pulse which were manifested by the patients who had the problems of sputum and kidney deficiency according to the diagnosis of bronchial asthma by the TCM. In clinical practice, it was used to cue the bronchial asthma in adults as well as children.
In this test, Antiasthmatic injection had three dose groups which consisted of low, medium and high doses (1.76, 3.51, 7.02g crude drug/kg), and normal saline control group. The Beagle dogs had continuous intravenous infusion for 9 months. As to the test, it observed the common drug reactions after having the drugs, such as the behaviors of the animals, skin coat, the traits of the feces, etc, and examined the hematology, blood biochemistry, electrocardiogram, feces, ect, after the delivery for 3 months, delivery for 6 months, the end of giving drugs and the recovery period respectively. It chose 4, 4 and 2 animals respectively (the male and female were equally divided) to have bone marrow, impose euthanasia, systematic autopsy and histopathological examination after the delivery for 3 months, the end of giving drugs and the recovery period. The major findings were as follows:
General Conditions: during the first month of having drugs, some animals in the high-dose groups had the symptoms of vomiting and salivation, and some of them lost their appetites; while some specific animals in the middle dose groups had the symptoms of vomiting and salivation. These symptoms occurred from time to time and discontinuously. Besides, the symptoms disappeared after 2 months. Low-dose groups had no such symptoms. The furs of the animals in each group were of good gloss. And the animals had no vertical hair, flow, cramps, and weight suppression, and other symptoms of toxic reaction.
Hematology: the WBC (white blood cells) and GRA (granulocyte) of the low-dose group and the high-dose group after having drugs of 3 months and 6 months were expressed to be much higher than the control group. The differences had statistical significance (p <0.05). However, the differences had no biological significance in the range of normal value. It was normal at the end of giving drugs and recovery. PLT (platelet) and PCT (platelet hematocrit) showed that the low, middle and high dose groups were all lower than the control group after having drugs for 3 months; the high-dose group was much lower than the control group after having drugs for 6 months; and at the end, the middle-dose group as well as the high-dose group were lower than the control group. The differences had statistical significance (p <0.05). However, the value was within the normal range, and had no biological significance. The study of the remaining indicators of each dose group showed no obvious abnormal changes in 3 and 6 months. It was occasionally seen that certain indicator increased or decreased compared with the normal saline. Through the difference had statistical significance, it had no biological significance.
The examinations of the blood biochemistry, blood clotting, blood electrolytes, electrocardiogram, feces and urine, retina, bone marrow, organ coefficient showed no obvious abnormalities.
Histopathological examination showed that all organs and tissues of the submitted Beagle dogs had no obvious toxic damages. It had no delayed toxicity after the withdrawal of drugs and recovery for 1 month.
In summary, the Beagle dogs could have Antiasthmatic injection for 9 months by the intravenous drips under the laboratory conditions. There would be some related hematological tests on the animals after 3, 6, and 9 months as well as at the end of the recovery respectively. Besides, there would be some tests on each anatomical part of the animals after 3, 9 months and at the end of the recovery. The results showed that the detections of targets had no drug-related abnormal change, which was to say there’s no observed significant toxicity. It considered the high dose of 7.02g crude drug / kg as a safe dose.
1. Purpose of the Experiment
According to the related requirements of the new drugs in the "Drug Registration Regulations," and in accordance with "Traditional Chinese medicine, natural medicine, long-term toxicity study of technical guidance principle" (2005.3), the Antiasthmatic injection produced by the Jian Xin Medicine Limited Company in Zhuhai Special Economic Zone was tested by the long-term toxicity tests by intravenous drips on Beagle dogs for 9 months. It observed the nature, extent, dose, time relationships and reversibility that might be led by the toxicity of the drugs; speculated the target organ toxicity or target tissue; and provided the references for the designer of the range of clinical dose and the safety index that should be checked intensively.
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