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目的 :为确保临床用药的安全 ,对中药牙周缓释剂黄甲棒进行毒理学检测。方法 :按新药的有关要求作如下实验 :①IRC小鼠最大耐受量 (MTD)试验。②IRC小鼠致死量 (LD5 0 )测定。③Wistar大鼠慢性毒理学试验。④Wistar大鼠口腔粘膜毒性及刺激试验。⑤豚鼠皮肤过敏试验。结果 :动物对该药物有很大耐受性 ,MTD =5 .3g/kg体重 ,ipLD5 0 =(192 .7± 2 9.3)mg/kg体重 (P =0 .95 ) ,对动物 15项血液学及其生化指标 ,13个重要脏器均无明显影响 ,对皮肤和口腔粘膜无刺激和致敏作用。结论 :该制剂临床应用是安全的
Purpose : To ensure the safety of clinical medications, toxicology testing was conducted on the traditional Chinese medicine periodontal sustained-release agent Huangjiabang. Methods: According to the relevant requirements of the new drug for the following experiments: 1 IRC mouse maximum tolerated dose (MTD) test. 2 IRC mouse lethal dose (LD50) determination. 3 Wistar rat chronic toxicology test. 4 Oral mucosal toxicity and irritation test in Wistar rats. 5 Guinea pig skin allergy test. RESULTS: Animals were highly tolerant to the drug, with an MTD of 5.3 g/kg body weight, ipLD50 (192.7+29.3) mg/kg body weight (P=0.95), and 15 animals. The study and its biochemical indicators showed no significant effect on 13 important organs and no irritation and sensitization on the skin and oral mucosa. Conclusion : The clinical application of the preparation is safe