1. The results of detection of Herpes Simplex virus (1+2) IgM by ELISA
Mungulun S ; Khulan J ; Tsatsral S ; Ochirkhuyag B
Health Laboratory 2016;5(1):31-33
World population relatively common viral diseasespread among the population are one of the mosttroubling health problems. Viral diseases includingherpes virus infections, herpes infections occurin many forms, including clinical herpes simplexinfections in the world are one of the common diseasesspread. HSV-1 and HSV-2 are transmitted by contactwith an infected area of the skin during reactivationsof the virus. Herpes simplex virus (HSV)-2 isperiodically shed in the human genital tract, most oftenasymptomatically, and most sexual transmissionsoccur during asymptomatic shedding. There have been many diagnostic techniques for HSV infections, including new viral detection methods and serological tests. We detection of herpes simlex virus by ELISA. Of 341 patient involved 43% (148) male, 57% (193) female. For all served patient 65.6% (224) were dominated by 20-40 years old. There were symptoms are herpes simplex virus infection in 23.4% (80) was 40% (32) male and 60% (48)female.
2.Detection of human rhinoviruses in patients with acute respiratory infections in 2008-2012 in Mongolia
Tsatsral S ; Maitsetseg CH ; Nymadawaa P
Mongolian Medical Sciences 2013;165(3):16-20
Background: Human rhinoviruses (HRVs) consist of approximately 150 types that cause a wide range of clinical outcomes, including asymptomatic infections, common cold, sinusitis, bronchiolitis, asthma and pneumonia. Rhinovirus illnesses are common inall age groups, they occur throughout the year and they are present world-wide. The prevalence of this virus has not been studied so far in Mongolia. Method: Nasopharyngeal swabs were collected between November 2008 to December 2012 from 2218 persons with acute respiratory tract infections. HRVs in the clinical samples were detected by multiplex real-time PCR with the commercial kit “Respiratory pathogen 21, FTD”, Fast Track Diagnostics, Luxembourg). We have used three sets of primers to detect and sequence all HRV positive samples with.Results: HRVs were detected in 257(23.4%) patients. These patients were ranged in age from 0 month to 63 years old, HRVs detected from all ages. Co-infections with other respiratory viruses were detected in 59(23%) of the HRV positive patients. HRV was detected whole year around and the peak seasonal prevalence was in early fall. We have genotyped 34(14.2%) HRV positive samples randomly selected from 240 samples. Out of 34 tested for genotyping rhinoviruses, 22(65%) tested positive for HRV-A, 9(26%) for HRV-C, only 3(9%) for HRV-B.
3.Results of the assessment study of GMP implementation level among local pharmaceutical manufacturers
Tsatsral I ; Patrick HOET ; Purevsuren S ; Tsendeekhuu D
Mongolian Medical Sciences 2014;169(3):62-72
IntroductionCurrently there are 31 pharmaceutical manufacturers in Mongolia. The first standard on Goodmanufacturing practice was adopted in 2005 and during these 9 years the Good manufacturing practicestandard was upgraded twice in 2011 and 2014, and the latest version reached to WHO GMP guidelinelevel.Purpose of the studyAccording to the Law of Medicine and medical devices of Mongolia, all pharmaceutical manufacturersshould comply with the Good manufacturing practice standard MNS 5524:2014. The study was aimedto asses GMP implementation level among local pharmaceutical manufacturers and to define mostlyobserved deficiencies in three categories as “critical”, “major” and “minor”.Materials and MethodAll stable operating pharmaceutical manufacturers were asked to be involved in this study accordingto the Helsinki declaration and 11 of them were involved. Direct observation method was used for thisstudy. WHO guideline on Good manufacturing practice: Main principles and on Sterile products wasused as the criteria of the assessment.ResultsAll deficiencies observed during the study were classified into three groups as critical, major and minorand the frequency was defined.Conclusions:The critical deficiencies are related mainly with the design and general layout of the premises and heatingventilation and air conditioning system. It requires investment and proper planning from the manufacturers.The major deficiencies are mainly related to documentation, qualification and validation.The minor deficiencies are with regard of documentation system, technical requirements of equipmentand storage area condition and its management.For taking corrective actions of major and minor deficiencies do not require investment, but it requirestime, training, implementation, monitoring and continuous improvement from the manufacturer.
4.Results of ongoing stability studies of medicines
Tsatsral I ; Purevsuren S ; Tsendeekhuu D ; Uransolongo L ; Tsetsegmaa N
Mongolian Medical Sciences 2015;174(4):36-40
Introduction. The safety and effi cacy of fi nished pharmaceutical products depend on its stabilityattribute. Stability requirements were included for fi rst time in Good manufacturing practice standardMNS 5524:2014. The pharmaceutical manufacturer is responsible to conduct stability studies and tosubmit the report as part of marketing authorization documentation.Purpose of the study. The purpose of this study is to conduct ongoing stability study of the mostlyproduced domestic medicine to monitor the product over its shelf-life.Materials and Methods. As a material used 2 locally produced Paracetamol (Acetaminophen INN) 500mg tablets (local manufacturer (LM) 1 with batch number 271110, LM 2 with batch number 441110). Asa method we used shelf-life specifi cation: Mongolian national standard of Paracetamol 500 mg tablets,MNS 4358:2007. Testing frequency was at 0 time (when tablets were produced) and at 12, 24 and 36months (study was covered the shelf-life).Results. In frame of this study we defi ned the most produced product as Paracetamol (AcetaminophenINN) 500 mg tablets. From the LICEMED- medicines registration record we found 8 tablets, containingAcetaminophen in 500 mg. Two of them were produced locally. These two products were involved inongoing stability study. Testing results showed that no any stability issues over the defi ned shelf life.Discussion. The shelf life was defi ned as 36 months, initially by manufacturers before productsregistered. After a marketing authorization has been granted, the stability of the fi nished pharmaceuticalproducts should be monitored according to a continuous appropriate program that should be permittedthe detection of any stability issue associated with the formulation in the container closure system inwhich it is marketed.Conclusions. After 36 months, testing results were in acceptable limits, selected products wereremaining their quality over the shelf-life.