Objective  To establish the microbial limit test method and analyze the microbial pollution for vitamin C Yinqiao series preparations in the national drug sampling and inspection, and provide reference for regulation.

Methods  According to the requirements of Chinese Pharmacopoeia (2020 edition), the examination methods about microbial limit were studied, and the counting results and detected bacteria were analyzed.

Results  Test solutions of 1 ∶ 50 and 1 ∶ 10 were used in the microbial tests on the total number of aerobic bacteria, mold and yeast in vitamin C Yinqiao tablets and vitamin C Yinqiao capsules (hard capsules). Test solution of 1 ∶ 10 was used in the counting test in soft capsules, while the microbial tests on the total number of aerobic bacteria, mold and yeast were conducted in granules using 1 ∶ 20 and 1 ∶ 10 test solutions, respectively. Escherichia coli could be tested by conventional methods. All 212 batches of samples fitted to the quality requirements. Most of the contaminative microorganisms tested from the samples were genus Bacillus, while 3 strains of bacteria of Bacillus cereus group detected from a certain enterprise had high homology, and 1 strain of genus Brucella was detected from another enterprise.

Conclusion  The established microbial limit test method has high accurate, which can be used for quality control of this series of products. The overall microbiological test results of this series of products are good. However, it’s necessary for enterprises to promptly identify and assess the quality risks in the production process to fully ensure the drug safety.

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