养阴生肌散急性毒性及全身过敏性实验研究

摘要

目的：对养阴生肌散进行安全性试验，为临床安全用药提供依据。方法：将养阴生肌散按1∶0.7配成混悬液，0.02 mL/g灌胃，观察小鼠的急性毒性反应；运用养阴生肌散对豚鼠进行致敏和攻击，观察豚鼠有无全身过敏反应发生。结果：养阴生肌散LD50未能测出，按照毒理学评价标准，LD50＞1000 mg/kg，属无毒性物质，本实验剂量增加到12000 mg/kg仍未出现毒性反应，表明养阴生肌散对小鼠安全无毒；对豚鼠全身过敏反应呈弱阳性。结论：养阴生肌散急性毒性及全身过敏性安全指标基本符合规定要求。%Objective:To provide evidence for clinical use of YangYin ShengJi powder through the safety test-ing. Methods:YangYin ShengJi powder was prepared into suspension in the ratio of 1 to 0.7, and it was applied to the mice through intragastric administration in the concentration of 0.02mL/g, acute toxicity experments of the mice were performed;guinea pigs were sensitized and attacked by YangYin ShengJi powder, systemic allergic experiment of guinea pigs were observed. Results:LD50 of YangYin ShengJi powder couldn't be tested, according to the stan-dards of toxicological evaluation, the drug was nontoxic, and there was still no toxicity when the dosage in the ex-periment was increased to 12 000 mg/kg, which presented that it was safe to the mice;the results of systemic allergic experiments were weakly positive. Conclusion:Acute toxicity testing and systemic allergic experiments of YangYin-ShengJi powder basically conform to specified requirements.