LI Yanan, LI Tiantian, SHA Miao, et al. Establishment of Microbial Limit Test for Capsule Preparations and Analysis of Test Results. [J]. 20(2):228-231(2020)
LI Yanan, LI Tiantian, SHA Miao, et al. Establishment of Microbial Limit Test for Capsule Preparations and Analysis of Test Results. [J]. 20(2):228-231(2020) DOI: 10.14009/j.issn.1672-2124.2020.02.027.
Establishment of Microbial Limit Test for Capsule Preparations and Analysis of Test Results
OBJECTIVE: To probe into the microbial limit test for three kinds of capsule preparations( Huangshen Yisheng capsules
Qufengning capsules and Songteringling capsules). METHODS: According to General Principles1105
1106 of Chinese Pharmacopoeia: Volume Ⅳ( 2015 Edition)
the suitability of the total number of aerobic bacteria
mold and yeast and control bacteria was examined. RESULTS: Three kinds of hospital capsule preparations were tested for the total number of aerobic bacteria by the 1 ∶ 100 test solution plate method. The recoveries of Pseudomonas aeruginosa
Staphylococcus aureus and Bacillus subtilis were 0. The culture medium dilution method could not eliminate the bacteriostasis of the test product to the control bacteria. The results showed that when the concentration of capsule shell was diluted to 1 ∶ 200
the bacteriostasis of capsule shell was not eliminated
and the recoveries of Pseudomonas aeruginosa
Staphylococcus aureus and Bacillus subtilis were 0. After removing the capsule shells
the content of the drug can be determined by the 1 ∶20 test liquid plate method for the total number of aerobic bacteria
the total number of mold and yeast determination
and direct inoculation method was used for control bacteria inspection. CONCLUSIONS: Capsule shells can significantly inhibit the growth of microorganisms
it is recommended to pay attention to the quality and safety of capsule shells.