Evaluation of the Antimicrobial System of Levocetirizine Dihydrochloride Oral Solution

OBJECTIVE To evaluate the antimicrobial effectiveness and use of antimicrobial agent of Levocetirizine oral solution, which was included in the national evalutive sampling and testing program in 2021, and analyze the control level of its antimicrobial system to microbial contamination.

METHODS According to the method of aciclovir eye drops in Part II of the 2020 edition of Chinese Pharmacopoeia, the samples produced by 8 manufacturers were screened for the types of antimicrobial agent. Determine the content of samples produced by 6 manufacturers added with antimicrobial agent according to the method provided by the manufacturers. According to General Rule 1121 of PartⅣ of the 2020 edition of the Chinese Pharmacopoeia, evaluate whether the antimicrobial effectiveness of the sample meets the requirements of the pharmacopoeia.

RESULTS The types and dosage of antimicrobial agent in all samples produced by 8 manufacturers were consistent with the prescription. The results of the antimicrobial effectiveness test showed that the samples produced by the 6 manufacturers that added antimicrobial agent all met the requirements of the pharmacopoeia. Among the samples produced by the 2 manufacturers that don't add antimicrobial agent, one met the requirements and one did not.

CONCLUSION The tested Levocetirizine oral solution don't add or abuse antimicrobial agent in violation of regulations, but there is doubt whether the antimicrobial system is the best prescription. It is suggested that the manufacturer should carry out evaluation based on the concept of risk assessment in combination with the characteristics of excipients, water activity, etc. to optimize the prescription design, and establish a more reasonable antimicrobial system.