Quality of Non-Sterile Herbal Pharmaceutical Products – Detection of Fungi

  • Manuela-Claudia Curticapean George Emil Palade University of Medicine, Pharmacy, Sciences, and Technology of Targu Mures, Faculty of Pharmacy, Cell Biology and Microbiology Department, Gh. Marinescu Street, no.38, Targu Mures, 540139, Romania
Keywords: identification of fungi, non-sterile herbal pharmaceutical products, quality control, qPCR

Abstract

The aim of this paper was to use real-time quantitative PCR (qPCR) to perform microbiological purity tests, aiming to identify the presence/absence of fungal DNA and its quantification from non-sterile pharmaceuticals, with different manufacturers and various compositions. For identification a potential presence of fungi in non-sterile drug samples, fungal DNA has been isolated, amplified and quantified under real-time qPCR conditions. qPCR analysis of non-sterile pharmaceutical samples showed the presence of fungi in all investigated non-sterile herbal drugs. The highest amount of fungal DNA was recorded for S2 sample (0.0767 ng) and the lowest fungal DNA quantities have been registered for S1 sample (0.000032 ng). qPCR-based methods provided an earlier and more sensitive detection, identification, and quantification of fungal contamination compared to standard methods.

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Published
2021-04-20
Section
Articles