SPECIFIC CHARACTERISTICS OF ISOLATION OF SOME BACTERIAL SPECIES FROM MEDICATIONS

DOI: https://doi.org/None
Issue: 
3
Year: 
2015

O.V. Gunar, PhD; N.G. Sakhno, PhD; G.M. Bulgakova; I.A. Builova Research Center for Examination of Medical Products, Ministry of Health of Russia; 8 Petrovsky Boulevard, Moscow

The paper shows that certain bacterial species may be isolated and differentiated during their co-cultivation in the testing for the index «Microbiological purity» in the presence and absence of a drug. The trend in E. coli, S. aureus, and P. aeruginosa growth on a nonselective liquid medium has been studied. The strains tested are noted to be competitive for the nutrient substrates of a storage medium, which is due to the specific features of the growth of lag-phase bacterial cultures. The issues of the possibilities and validity of reducing a sample for microbiological examinations are considered. A number of pharmaceutical substances are used as an example to show that test sample mass exerts no impact on the probability of identifying certain species of contaminant microorganisms. In particular, E.coli can be isolated and measured from both 10 and 1 g of a medication with the same level of accuracy, as suggested by the results of appropriate processing of the findings. There is evidence that the sample mass can be reduced for analysis and simultaneous isolation of certain microbial species regulated by State Pharmacopoeia 12th Edition.

Keywords: 
medications
quality control
microbiological purity

References: 
  1. Gosudarstvennaya farmakopeya RF XII izdaniya. Chast` 1. M.: Medicina; 2007: 704.
  2. Shlegel` G. Obshhaya mikrobiologiya. Per. s nem. M.:Mir;1987: 567.
  3. V 2014 g. byudzhet rossiyskogo zdravoohraneniya umen`shitsya. Remedium, 2013; 10 (200): 4
  4. V Evrope ob``yavlena ocherednaya kampaniya po poisku metodov lecheniya redkih bolezney. Remedium, 2013; 12 (202): 4
  5. Shabrov R.V., Shadrin A.D. Zakon «Ob obrashhenii lekarstvennyh sredstv»: obzor i analiz izmeneniy. Remedium, 2013; 12 (202): 6–13.
  6. Mironov A.N., Vasil`ev A.N., Gavrishina E.V., Niyazov R.R. Vzaimozamenyaemost` lekarstvennyh preparatov: zarubezhnyy opyt, prepyatstviya i usloviya stanovleniya koncepcii v Rossii, rol` nauchnoy e`kspertizy. Remedium, 2013; 10 (200): 8–17.
  7. Obshhaya i sanitarnaya mikrobiologiya s tehnikoy mikrobiologicheskih issledovaniy. Pod red. A.S. Labinskoy, L.P. Blinkovoy, A.S. Eshhinoy. M.: Medicina; 2004: 576.
  8. Kolpakova S.D., Kolpakova G.A. Issledovanie osobennostey razvitiya muzeynyh i svezhevydelennyh iz organizma shtammov. Vestnik SamGU Estestvennonauchnaya seriya, 2005; 6 (40): 184–193.
  9. Evaluation, validation and implementation of new microbiological testing methods. Technical report No.33. PDA Journal of pharmaceutical science and technology. Supplement TR33., 2000; 54: 3: 39.
  10. Wu V.C. A review of microbial injury and recovery methods in foodyu Food microbiology, 2008; 735–744.
  11. European Pharmacopoeia. 8th ed. Strasburg; 2013.
  12. The United State Pharmacopeia. National Formulary (USP 36 – NF 31). The United State Pharmacopeial Convention, 2013.
  13. Clontz L. Microbial limit and bioburden tests : validation approaches and global requirements. 2nd ed. Lucia Clontz, CRC Press Taylor & Francis Group; 2009: 326.