| gjzh195820 |
2009-04-07 10:57 |
我准备写论文，摘要写好了，大家看翻译的怎么样，指点一下
【摘要】目的 艾迪滴丸是根据《部颁标准》20册WS3-B-3809-98“艾迪注射液”的处方，改变工艺，将注射剂改变成滴丸制剂。并通过实验观察动物反复给予受试药物后，对机体产生的毒性反应及其严重程度，提供无毒性反应剂量及临床上主要监测指标，为制定人用剂量提供参考。方法艾迪滴丸六个月长期毒性试验，共分四个组，大剂量组、中剂量组、小剂量组、空白对照组。均采用灌胃给药，大剂量7.875g/kg.bw，为临床用量的70倍，中剂量3.9375g/kg.bw，为临床用量的35倍；小剂量1.9688g/kg.bw，为临床用量的17.5倍。观测项目包括一般性观察和全面检测。检测内容有血液学检查、血液生化学检查以及脏器重量和病理组织学检查。结果一般观察，大鼠毛色光洁，行为活动、腺体分泌、呼吸、粪便性状均正常，大鼠体重增长差值和大鼠饲料摄入量，各剂量组虽有个别时间与对照组比较有显著性，但因无剂量关系，且同一剂量有时高于对照组，有时低于对照组，故无生物学意义，因此，本品对大鼠体重食量及状态无明显影响。全面观察，在给药剂量范围内，本品对血液学、血液生化学无毒理学指标无毒理学影响。结论 因此，艾迪滴丸在正常的临床剂量下没有明显毒性反应，是安全的。
【主题词】艾迪滴丸；长期毒性；一般性观察；全面检测；药理
The Studies on the Long-term Toxicity Experiment of the AiDi Dropping Pills
GUAN Jing-zhi, PAN Hui，QU Yun-zhi
(1 Department of pharmacy, Inner Mongolia College, Hohhot 010059 China,2 BEIJING CHIA TAI GREEN CONTINENT PHARMACEUTICAL CO,LTD)
ABSTRACT Objective AiDi injection was transformed to AiDi dropping pills by changing technology, which was based on the twentieth volume WS3-B-3809-98 about the prescriptionof AiDi injection from the Ministry Standard. We observed the toxic reaction and the serious extent by repeatedly administering animals, to find atoxic reaction dose and main clinical monitoring index, formulating reference dose for human. Methods: Six months long-term toxicity experiment of AiDi dropping pills was divided into four groups: large-dose, moderate-dose, low-dose and controlled-dose. All the groupswere given intragastric administration. Large-dose group(7.875g/kg.bw),moderate-dose group(3.9375g/kg.bw)and low-dose group(1.9688g/kg.bw) were 70,35 and 17.5 times of clinical dose respectively. Results: In the general observation, we found that color pattern, behavior, gland secretion, respiration and stool of rats were normal. the Difference of the increase of weight and feed intake in rats， although there was significant difference between various dosage groups and control group with compared，because there was no does relationship，so the result is no biological significance.
，so AiDi dropping pills had no remarkable effect on weight, appetite and state of rats. In the comprehensive inspection, at the range of given-dose, the AiDi dropping pills had no toxic effect on hematology and blood bichemics. Conclusion: At the range of the normal clinical dose, AiDi dropping pills was safe because of no remarkable toxic reaction.
Key Words AiDi Dropping Pills; Long-term Toxicity; General Observation;Comprehensive Inspection; Pharmacological
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