论文部分内容阅读
目的分析《中国药典》三部(2010版)及《越南药典》(2010版)方法测定破伤风抗毒素效价结果产生差异的原因。方法分别采用《中国药典》三部(2010版)及《越南药典》(2010版)规定的破伤风抗毒素效价检测方法(小鼠试验法),同步测定10批破伤风抗毒素供试品效价,比较结果差异;交换两种方法所用的稀释液,进行重复测定。结果两种方法测定结果差异有统计学意义(P<0.01),《中国药典》三部(2010版)方法测定结果比《越南药典》(2010版)方法高800~1 000 IU/ml;交换两种方法稀释液后,《中国药典》三部(2010版)方法供试组和对照组小鼠于注射48 h内全部死亡,《越南药典》(2010版)方法供试组和对照组小鼠于注射96 h后无发病症状,两种方法均不成立。结论《中国药典》三部(2010版)方法测定结果明显高于《越南药典》(2010版)方法,稀释液的不同是导致两种方法测定结果差异的原因之一。
Objective To analyze the causes of the differences in the titer of tetanus antitoxin between the three Chinese Pharmacopoeia (2010 edition) and the Vietnamese Pharmacopoeia (2010 edition). Methods The tetanus antitoxin titer (mouse test method) according to “Chinese Pharmacopoeia” (2010 edition) and “Vietnam Pharmacopoeia” (2010 edition) were respectively used to determine the titer of 10 batches of tetanus antitoxin , The difference between the results of comparison; swap the two diluents used in the method, repeat the determination. Results The results of the two methods were statistically significant (P <0.01). The results of the three Chinese Pharmacopoeia (2010 edition) methods were higher than those of the “Vietnam Pharmacopoeia” (2010 edition) by 800-1 000 IU / ml. After dilution of the two methods, all the mice in the “Chinese Pharmacopoeia” (2010 edition) test group and the control group all died within 48 h after injection. The “Vietnam Pharmacopoeia” (2010 version) test group and the control group were small Rats in the injection of 96 h after the onset of symptoms, two methods are not established. Conclusion The results of the three Chinese Pharmacopoeia (2010 edition) methods were significantly higher than those of the “Vietnam Pharmacopoeia” (2010 edition). The difference of the dilutions is one of the reasons for the difference between the two methods.