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目的考察家兔单次股四头肌肌内注射丹参酮ⅡA磺酸钠(60 mg)后,给药局部肌肉组织是否出现扩张、红肿、充血、水肿、瘀斑、变性、坏死等局部肌肉刺激性反应,综合判断供试品肌内注射的安全性,并且为该药物的安全性评价提供参考。方法以等量等渗的氯化钠溶液为阴性对照药进行自身性对照,设结束期和恢复期两组,进行一般症状肉眼观察和组织病理学检查。结果家兔单次股四头肌肌内给药后一般症状观察均无异常表现;剖检肉眼观察结果评分符合标准;剖检镜下观察结果显示恢复期观察时间内,局部的肌肉刺激反应具有完全可逆性。结论丹参酮ⅡA磺酸钠注射液对家兔股四头肌无明显刺激性。
Objective To investigate whether intramuscular injection of tanshinone Ⅱ A sulfonate (60 mg) into the quadriceps muscle of a rabbit shows local muscle irritation such as dilation, redness, congestion, edema, ecchymosis, degeneration and necrosis Reaction, comprehensive judgment of the safety of the test intramuscular injection, and provide a reference for the safety evaluation of the drug. Methods The same amount of isotonic sodium chloride solution as negative control drug for their own control, set the end of the recovery period and the two groups, the general symptoms of macroscopic and histopathological examination. Results All rabbits showed no abnormal symptoms after intramuscular administration of quadriceps; the results of macroscopic observation were consistent with the standard; the results of dissection microscopy showed that within the observation period of convalescence, the local muscle stimulation reaction had Completely reversible. Conclusion Sodium tanshinone Ⅱ A sulfonate injection has no obvious irritation on quadriceps femoris.