Study on the Antimicrobial and Antimicrobial Effectiveness of Jianer Xiaoshi Oral Liquids

OBJECTIVE To investigate the employment state of antimicrobial in 220 batchs of Jianer Xiaoshi oral liquids from 35 enterprises and to explore the effect on antimicrobial effectiveness of antimicrobial variety, concentration, shelf-life, pH and other factors. METHODS Acid estimation apparatus was used to detect the the pH of 220 batchs of Jianer Xiaoshi oral liquids from nationwide. The method of HPLC-UV was applied with mobile phase of acetonitrile-0.02 mol·L^-1 ammonium acetate(5∶95); detection wavelength of 254 nm; flow rate of 1.0 ml·min^-1. And to carry out the determin of antimicrobial effectiveness, according to the requirements described in guiding principle in subdivision appendix ⅩⅧD of Chinese Pharmacopeia (2010 Edition) and the examination methods of antimicrobial effectiveness in tetrodivision general information 1121 of Chinese Pharmacopeia (2015 Edition). RESULTS The pH were all among 3.5~4.7 of 220 batchs of Jianer Xiaoshi oral liquids from 35 selected enterprises. There were 91.43%(32/35) enterprises reached quality standards in antimicrobial variety, however, 2.86%(1/35) enterprises had changed their antimicrobial variety, 5.71%(2/35) enterprises had added other antimicrobial. The content of potassium sorbate was 0.6-0.7 mg·mL^-1 in Jianer Xiaoshi oral liquids from 17.14%(6/35) enterprises, while it was 0.5-0.6, <0.3 and >0.7 mg·mL^-1 from 42.86%(15/35), 8.57%(3/35) and 14.28%(5/35) enterprises, respectively. Additionally, the content of potassium sorbate was 0 mg·mL^-1 and >2.3 mg·mL^-1 from 2.86%(1/35) and 2.86%(1/35) enterprises. Antimicrobial concentration and pH had greater influence on antimicrobial effectiveness than shelf-life. CONCLUSION The violation of variety and content of antimicrobial result in quality risk of Jianer xiaoshi oral liquids. With the same pH, more antimicrobial, stronger antimicrobial effectiveness; with the same content antimicrobial, lower pH, stronger antimicrobial effectiveness. moreover, the dependence on pH more than on given antimicrobial content to antimicrobial effectiveness.