Analysis of Microbial Contamination and Investigation on Bacteriostatic Efficacy of Compound Balloonflowers and Ephedrine Syrup(Ⅱ) / 中国药学杂志

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.