OBJECTIVE:To study the feasibility of 10 kinds of culture media used in pharmaceutical microbial limit test stated in Chinese Pharmacopoeia(2010 edition)autoclaving at 121 ℃ for 15 min. METHODS:The performance(color,pH,sterility,the growth-promoting activity,antibacterial ability,indication)of 10 kinds of culture media including Modified Martin Broth medium were tested after autoclaving at 121 ℃ for 15 min or in the parameters from the product instructions according to GB4789.28-2013 and the requirements for quality control of culture media in Chinese Pharmacopoeia(2010 edition). The quality of the media were compared after autoclaved by different parameters. RESULTS:The quality of the media which were autoclaved at 121 ℃ for 15 min were equivalent with the media which were autoclaved by the parameters from the product instructions,and their quality met the requirements for quality control of media in Chinese Pharmacopoeia(2010 edition). CONCLUSIONS:The sterilization parame-ters of 10 kinds of media in Chinese Pharmacopoeia (2010 edition) can be adjusted to be autoclaved at 121 ℃ for 15 min,the quality of the media remain stable after autoclaving.

Objective To establish the drug use evaluation(DUE)criteria of recombinant human prourokinase(rhPro-UK),and to provide reference for the rational clinical application of rhPro-UK.Methods Based on the drug instructions of rhPro-UK,DUE standard rules were established by referring to relevant guidelines,expert consensus,authoritative literature and expert consultation.The medical records of hospitalized patients treated with rhPro-UK from January 2019 to May 2022 in Xilin Gol League Central Hospital were evaluated by retrospective investigation.The effectiveness of rhPro-UK was evaluated based on clinical outcome,and its safety was evaluated based on the incidence and severity of adverse reactions.Results A total of 230 cases were included,and 4 cases fully met the evaluation criteria(medication indication,medication process,medication results),accounting for 1.74％.There were 226 patients(98.26％)with irrational drug use,mainly manifested in two aspects of drug indication and drug process(administration mode and dosage).Treatment was effective in 221 patients,with an overall effective rate of 96.09％;139 patients experienced adverse reactions,with an incidence rate of 60.43％.Conclusion The clinical use of rhPro-UK in our hospital is irrational in the indication of medication and the process of medication,and the establishment of the DUE standard rules of rhPro-UK can provide a reference to standardize the clinical application of rhPro-UK and promote its rational use.