加味二陈颗粒小鼠急性毒性实验研究

Experimental Study of Jiawei Erchen Granule on Acute Toxicity in Mice

摘要: 目的：研究加味二陈颗粒在小鼠体内的急性毒性。方法：处方药材水提取，减压浓缩，用淀粉和糊精为辅料制备加味二陈颗粒。以最大浓度和小鼠所能耐受的最大体积灌胃给予加味二陈颗粒，一日三次，给药1天，求算最大给药量及其相当于临床用量的倍数。连续观察14天，记录小鼠一般状况、体质量，测定血常规，检查主要脏器组织病理学。结果：制得加味二陈颗粒，每克相当于处方药材6.86 g。小鼠最大给药量折算成处方药材量为3.02 g/20 g，相当于临床成人使用剂量的147倍。14天内，小鼠的一般状况未见异常，体质量和血常规指标未受影响，重要脏器组织病理学未见改变。结论：尚未发现加味二陈颗粒小鼠急性毒性反应，因此其短期应用相对安全。

Abstract: Objective: To study the acute toxicity of Jiawei Erchen granule in mice. Methods: Crude drugs in prescription were extracted with water and concentrated under reduced pressure. Jiawei Erchen granule was made from the concentrate with starch and dextrin which served as excipients. The experimental mice were given Jiawei Erchen granule with the maximum concentration and the maximum volume that mice could tolerate, three times a day, gavage for one day. With continuous observation for 14 days, calculated maximal feasible dose and its multiple equivalent to the clinical dosage; recorded the general state and bodymass; measuredblood routine; examined histopathology of main organs. Results: Jiawei Erchen granulewas prepared, per gram of which equivalent to 6.86 g of crude drugs in prescription. Maximal feasible dose for micewas equivalent 3.02 g/20 g of crude drugs in prescription, which was 147, multiples the recommended clinical adult dose. During 14 days of continuous observation, themice had no abnormalities in appearance, diet, behavior, respiration, stool and urine; no affects in body mass and blood routine indexes; no pathological changes in heart, liver, spleen, lung, kidney and other important organs. Conclusions: Jiawei Erchen granule has not been found acute toxicity in mice, so its short-term application is relatively safe.