ABSTRACT
In this research,Microtox technology was used to evaluate the comprehensive toxicity of Shen-Fu injection,which was an exclusive product of the pharmaceutical company.Firstly,vibrio fischeri was used as test strain.The best test system and methodology were identified.Under the best test conditions,vibrio fischeri was firstly used in the luminescent bacteria comprehensive toxicity of the exclusive product Shen-Fu injection.The results showed that in the 2 mL reaction system,the best recovery liquid volume was 0.9 mL/ freeze-dried vial,50 μL bacterial suspensions/ sample,the detection time was 10 min after adding bacterial suspensions,the pH was 5-10,the luminous intensity was 800 000-12 000 000 for 10 rin.The RSD of replication experiment and intermediate precision test was ? and ?,respectively,which fitted to the requirements.There was no significant difference on EC50 values among 9 batches of tested Shen-Fu injection (41.07％,RSD ＜ 5％).It was concluded that there was significant concentration-effect relationship between Shen-Fu injection and the toxicity of vibrio fischeri.There was no significant difference on EC50 values among different batches.It indicated that there was small quality volatility among different batches of Shen-Fu injection.The control on product manufacturing was strong.