ABSTRACT
Introduction@#The main goal of the modern national drug manufacturer is to develop highly biological active, low-side effects and no toxicity pharmaceutical products that can replace synthetic drugs with natural animal, plant and mineral raw materials. We conducted this study in aim to develop the standard of pharmacopoeia of root of <i>Caryopteris mongolica</i> which an antibacterial activity plant that grows in Mongolia. The study included experiments to determine the appearance of the plant, to determine its anatomical structure, to determine the quantitative analysis of pharmacognosy and to determine the microbiological analysis.@*Method@#We defined the appearance of plant by sensory method, anatomical structure of plant by light microscopy method. And we experimented the quantitative analysis of pharmacognosy and microbiological analysis of plant according to the methodology specified in the general requirements for medicinal plant raw material of the National Pharmacopoeia of Mongolia.@*Conclusion@#As a result of the study, the appearance of plant was brown, woody thick, has many branched roots, odorless and bitter. The quantitative analysis of pharmacognosy of plant met the general requirements for medicinal plant raw material. For microbiological analysis, plant met the all requirements.
ABSTRACT
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.