ABSTRACT
OBJECTIVE: To analyze the microbial contamination and investigate the bacteriostatic efficacy of compound balloonflowers and ephedrine syrup(Ⅱ). METHODS: The compound balloonflowers and ephedrine syrup(Ⅱ) was analyzed for the bacteriostatic efficacy, content of bacteriostatic agent and C18 column was adopted with gradient elution. The mobile phase consisted of 0.02 mol•L-1 ammonium acetate solution and methanol. The detective wavelength was set at 255 nm. The contaminating bacteria detected in the samples were identified by VITEK2 Campact, MALDI-TOF-MS and 16S rRNA sequencing, and homology analysis was conducted for the contaminating bacteria in the samples from the same enterprise. RESULTS: The bacteriostatic efficacy of the products of one enterprise did not meet the requirements of Chinese Pharmacopoeia(2015 edition). There were excessive and uneven contamination of microorganisms in the samples. The dosages of bacteriostatic agents in some enterprises did not conform to the standard requirements. CONCLUSION: Production enterprises should strictly control the dosages of bacteriostatic agents and the stability of the production process, and strengthen the monitoring of the sterilization effect of the whole production process to improve product quality.
ABSTRACT
The matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) is one of the first choice techniques for clinical microbiological identification owing to its fast,accuracy,low cost and easy to be operated.The accuracy of identification of MALDI-TOF MS relies on good instrument status,appropriate pre-trement,standardized operation and the rules of interpretation.Any errors in this process will directly influence the accuracy of identification.Therefore,strict internal quality control for the microbiological identification by MALDI-TOF MS is very important.Based on six years of research and clinical application experience,our laboratory establishes a relatively complete internal quality control system for the microbiological identification by MALDI-TOF MS,including all aspects of hardware,software and manual operation,the parameter settings,maintenance and calibration of the instrument,the preparation of strains and reagents,spectra acquisition and the interpretation and analysis of results,Which can make abnormal results be quickly traced and timely handled.