目的研究丹参滴注液是否具有肝毒性,为药品的安全性评价提供参考依据。方法对人张氏肝细胞加样培养,然后收集24、36、48 h细胞上清液,分别进行丙氨酸氨基转移酶(ALT)、天门冬酸氨基转移酶(AST)、乳酸脱氢酶(LDH)检测,将所得的各种酶活力与中国药典规定的酶活力范围进行比较,若在范围之内表示无毒性或毒性较小;若超过范围,则表示毒性较大。结果 3种细胞株的ALT、AST、LDH检测结果均在中国药典规定的安全范围之内。结论临床用量50倍以内的丹参滴注液的肝毒性较小,而导致不良反应的具体因素有待后期实验进一步研究。
Objective To study the toxicity of Danshen Dripping Solution on human liver cells,Chang liver,in order to provide reference for drug′s safety evaluation.Methods Chang liver cells were performed the sampling culture and the supernatant was collected at 24,36,48 h in order to detect ALT,AST and LDH.The various detected enzyme activities were compared with the enzyme activity ranges fomulated by the Chinese Pharmacopoeia.If the detected results were within the range,there was no toxicity or less toxicity,if the detected results exceeded the range,the greater toxicity was indicated.Results The detection results of 3 kinds of cell lines all were within the safe range fomulated by the pharmacopoeia.Conclusion Danshen Dripping Solution within 50 times amount of clinical dosage has little toxicity.But the concrete factors leading to adverse reactions need to be further studied in the later experiments.