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目的:进行调胃健脾丸的最大给药量实验,为其用药安全性提供理论依据。方法:SPF级昆明小鼠40只,雌雄各半,随机分为两组,实验组予以最大浓度的调胃健脾丸混悬液灌胃,24h内3次,灌胃容积为每次0.4m L/10g,对照组灌胃等容量的蒸馏水,连续14d。观察并记录小鼠的体质量、摄食量、外观、行为、分泌物、排泄物、死亡情况及中毒反应等。结果:14d内无动物死亡,未见毒性反应,肉眼观察心、肝、脾、胃、肺、肾、大肠、小肠等组织脏器的外观、形态、质地、颜色等无异常变化。调胃健脾丸的最大给药量为69.36g(生药)/kg,为成人临床每天用药量的231.2倍。结论:调胃健脾丸的安全性较好。
OBJECTIVE: To experiment on the maximal dosage of Tiaowei Jianpi Pills, which provides a theoretical basis for its drug safety. Methods: Forty SPF Kunming mice were randomly divided into two groups. The experimental group was given the maximal concentration of Tiaweijianpi Pill suspension, three times in 24h, and the gastric volume was 0.4m L / 10g, control group, intragastric administration of distilled water, continuous 14d. Observe and record the body weight, food intake, appearance, behavior, secretions, excrement, death and poisoning reaction in mice. RESULTS: No animals died within 14 days and no toxic reaction was observed. No abnormal changes of appearance, morphology, texture and color of heart, liver, spleen, stomach, lung, kidney, large intestine and small intestine were observed macroscopically. Tiawei Jianpi pills maximum dose of 69.36g (crude drug) / kg, 231.2 times the daily dose of adult clinical. Conclusion: Tiaowei Jianpi pill is safe.