Review & Monography

Research progress on applicability of microbial limit test for drugs*

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  • Yulin Center for Food and Drug Control, Yulin Engineering Technology Research Center for Quality Monitoring and Evaluation of Chinese Medicinal Materials(Including Spices), Yulin 537000, China

Received date: 2024-01-25

  Online published: 2024-10-16

Abstract

This article focuses on the key experimental operations in the study about the applicability of microbial limit testing methods for drugs, summarizing literature and experience from the preparation of test solution, design of methods for microbial counting and control bacteria inspection, operation of microbial recovery test, bacterial liquid concentration counting, and operational methods for controlling bacterial & fungal purity. Emphasis was placed on the preparation methods of water-soluble test samples with strong antibacterial effects, non-oil and fat test samples that were not easily soluble and dispersed, and the test solution for oil and fat test samples. Detailed introduction of the sequential experimental plan for methods of aerobic bacterial count, mold & yeast count, and control bacterial inspection were introduced. Four operational methods for adding bacteria about membrane filtration were explained, and the impact of different ways of adding bacteria on the results of the method was analyzed. Summarized three counting methods for bacterial & fungal concentrations. Detailed sharing of operational experience on controlling the purity of bacterial solution. Summarized the current status about research on the applicability of microbial limit testing methods of drugs. Four suggestions for the future development of research on the applicability of microbial limit testing methods for drugs have been proposed:(1) Unify the operation about bacteria adding method in membrane filtration,scientific and reasonable;(2)Strengthen supervision of pharmaceutical production enterprises and review of microbial limit testing methods for drugs;(3)Unify the microbial limit testing methods for the drugs of the national sampling plan,and gradually collect and bind into a book;(4)Strengthen the research on the applicability of microbial limit testing methods for excipients.

Cite this article

PANG Yun-juan, LIU Kang-lian, LIANG Xiao-ling, LAI Fu-xi, ZHOU De-hua, LI Xiang-chao, LI Qiang, FAN Wen-yan . Research progress on applicability of microbial limit test for drugs*[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44(8) : 1285 -1292 . DOI: 10.16155/j.0254-1793.2024-0060

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