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Comparative Analysis of Domestic and International Drugs Microbiological Testing Methods

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DOI: 10.23977/medcm.2020.020101 | Downloads: 12 | Views: 1846


Kunjie Wu 1, Ruiyin Yang 1, Xiaodong Yang 1


1 Xi`an Institute for Food and Drug Control, Key Laboratory of National Medical Products Administration

Corresponding Author

Xiaodong Yang


Under the background of the new era, The United State puts forward higher requirements for the pharmaceutical industry. As one of the important indexes to evaluate the safety of drugs, the microbiological test of drugs is used to detect whether a drug is contaminated by microorganisms during the development, production and storage of the drug. The accuracy of test and measurement results is not only affected by the laboratory quality control and the expertise of the testing personnel, but also by the testing technology. Based on the comparative analysis of domestic and international drug microbiological testing methods, this study believes that in the past decades, Chinese drug microbiological testing technology has made certain breakthroughs, but compared with other developed countries, Chinese microbiological testing technology is at the initial stage, there are problems such as immature technology. In addition, Chinese microbiological testing laboratories are short of funds, relatively backward testing hardware and facilities, lack of professional testing talents, and many operations are not carried out as required. This study has certain theoretical and practical significance, which enriches the content of Chinese drug microbiological testing technology, and plays a guiding role in the innovation of Chinese drug microbiological testing method in practice.


Drug Microorganism, Comparative Analysis, Microbiological Detection


Kunjie Wu, Ruiyin Yang and Xiaodong Yang, Comparative Analysis of Domestic and International Drugs Microbiological Testing Methods. MEDS Chinese Medicine (2020) Vol. 2: 1-6. DOI:


[1] F. Pérez-García, Ruiz-Serrano M J, P. López Roa, et al. Diagnostic performance of Anyplex II MTB/MDR/XDR for detection of resistance to first and second line drugs in Mycobacterium tuberculosis [J]. Journal of Microbiological Methods, 2017, 139 (1): 74-78.
[2] Klotoe B J, Barbara M M, Magdinier G H, et al. TB-EFI, a novel 18-Plex microbead-based method for prediction of second-line drugs and ethambutol resistance in Mycobacterium tuberculosis complex. [J]. Journal of Microbiological Methods, 2018, 152 (1): 10-17.
[3] Wolny-Koladka K , Malinowski M , Pieklik A , et al. Microbiological air contamination in university premises and the evaluation of drug resistance of staphylococci occurring in the form of a bioaerosol [J]. Indoor and built environment, 2019, 28 (2): 235-246.
[4] Balamuruganvelu S , Geethavani B , Reddy S V , et al. Incidence microbiological profile and drug resistance pattern of uropathogens causing asymptomatic bacteriuria among below poverty line diabetic male patients [J]. African Journal of Clinical & Experimental Microbiology, 2017, 18 (3): 145.
[5] Harish Chandra, Archana Yadav, Rajendra Prasad. Assessment of microbiological quality of raw medicinal plants used for the preparation of Ayurvedic drugs [J]. Medicinal Plants - International Journal of Phytomedicines and Related Industries, 2017, 9 (4): 296.
[6] Meenakshisundaram C, Rani J U, Rao U A, et al. Hypothetical Estimate of Drug-Burden on a Diabetic Foot Ulcer Patient and its Relevance to Microbiological Analysis [J]. International Journal of Current Microbiology and Applied ences, 2017, 6 (6): 1139-1153.
[7] Talukdar A, Hodiwala A B, Sharma R. A Microbiological Study of Acinetobacter baumannii with Special Reference to Multi-Drug Resistance [J]. International Journal of Current Microbiology and Applied Sciences, 2018, 7 (2): 1176-1186.
[8] Kanlidere Z, Karatuna O, Kocagöz, Tanil. Rapid detection of beta-lactamase production including carbapenemase by thin layer chromatography [J]. Journal of Microbiological Methods, 2019, 156 (1): 15-19.
[9] Malik T, Naim A, Saeed A. Molecular Detection of TEM, SHV and CTX-M Genes Among Gram-negative Klebsiella Isolates [J]. Current Drug Delivery, 2017, 15 (3): 417-423.
[10] Randjelovic G, Otasevic S, Mladenovic-Antic S, et al. Streptococcus pyogenes as the cause of vulvovaginitis and balanitis in children [J]. Pediatrics International, 2017, 59 (4): 432-437.

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