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.

Introduction: Helianthus tuberosus L. is main source of inuline in pharmaceutical and food industry. Pharmacological studies of the plant have showed some important therapeutic properties such as anti-diabetic, anti-osteoporosis, anti-cancer and strengthening cardiovascular system, immune system. Material and method: Helianthus tuberosus L., which has been cultivated in Botanical Garden of Medicinal Plants of Drug Research Institute, Monos Group, was used as a research raw material. The aerial and below ground parts of the plants were harvested in September 2020. The content of inulin, the main active ingredient in the plant, was determined by spectrophotometry. Raw materials of the plant were processed in several ways and prepared for further use as a pharmaceutical raw material. Result: Inulin content in Sample 1 was 34.5 ± 0.76%, Sample 2 was 70.31 ± 1.25%, Sample 3 was 78.43 ± 0.44% and Sample 4 was 75.36 ± 1.42%. The inulin content and yield were the highest in samples prepared by heat and cold cutting methods. Conclusion According to the results of appearance, yield, inulin content and moisture contents during the different processings of plant materials, it can be considered that the most suitable method for preparing Helianthus tuberosus L. as a pharmaceutical raw material is the cutting followed by freeze-drying.

Introduction: Rhodiola rosea L. (R.rosea) is a popular plant in traditional medicine of the Nordic countries, Eastern Europe, and Asia. R.rosea plants are successfully cultivated in Mongolia. The Botanical Garden of Medicinal Plants under the “Monos” Group started to cultivate R. rosea since May 2015. Objective: The aim of this research was to study the salidroside contents of R.rosea collected from Zavkhan and Khuvsgul province, Mongolia, and cultivated in the Botanical Garden of Medicinal Plants, Drug research Institute, Monos group. Material and Methods: The underground parts of wild roseroot plants were collected from April to May 2020 from Jargalant soum, Khuvsgul province, and Nomrog soum, Zavkhan province, 3-years and 4-years-old cultivated R.rosea gathered from the Botanical Garden of Medicinal Plants in April 2020. For comparison, 4-year-old Rhodiola grenulata (R. grenulata) was ordered from Shanxi Zhendong Genuine Medicinal Materials Development Co., Ltd, China, and used for the study. The quantity of the salidroside constituents of the underground parts were compared and the sourcing of roseroot raw material was evaluated. Chemical analysis of roots and rhizome of R. Rosea namely the appearance, identification, moisture, organic impurities, mineral impurities, residue on ignition, water-soluble extractives, fresh weight of roots, and salidroside content were determined according to the National Pharmacopoeia of Mongolia (NPhM) 2011. Microbiological analysis was performed in accordance with the requirements of grade 3b specified in Annex 1 of the Order No. A / 219 of the Minister of Health dated May 30, 2017 to determine the degree of microbiological purity in medicinal products of roots and rhizome raw materials. Result: The content of salidroside, the main biologically active substance of R.rosea plant, was 1.57% in samples collected from Zavkhan province, 1.45% in samples collected from Khuvsgul province, 1.7% in samples grown in China and 0.25% for 3-years-old samples and 1.89% for 4-years-old samples grown in the Botanical Garden of Medicinal Plants, Monos group, Mongolia. In addition, these raw materials meet the general requirements for plant raw materials and microbiological parameters. Conclusion Samples of underground parts of R.rosea cultivated for 4 years in the Botanical Garden of Medicinal Plants have the highest content (1.89%) of the salidrosde. Therefore, it is suggested that the roots and rhizomes of R.rosea planted in the future can be standardized and used as a raw materials for medicines.

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 Caryopteris mongolica 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.

Introduction: Scutellaria baicalensis Georgi, which is used in traditional medicine, has the ability to remove blood-drying heat. Chiazospermum erectum Bernh. has the ability to relieve typhoid fever and poison fever. Carthamus tinctorius L. has antiseptic, analgesic and anti-toxic properties. Saussurea amara L. has bactericidal, anti-infective, and anti-inflammatory properties. Researchers found that the Hepaclin-4 recipe has antioxidant, membrane-strengthening, liver-protective, necrosis-preventing, detoxification, and peroxidation product accumulation-reducing properties. Therefore, extracting the granular medicine form from the concentrated extract containing the Hepaclin-4 formulation is the basis of our research work. Goal: To obtain the granular medicine form from the concentrated extract containing ingredients of the Hepaclin-4 recipe. Materials and Methods: The research was carried out with the support of the Institute of Pharmaceutical Research and the University of Pharmaceutical Sciences. The raw materials for the Hepaclin-4 formula were extracted by remaceration with water, 40% ethanol, and 70% ethanol (1:10 ratio). Six types of granules were extracted from the concentrated extract using several excipients by the wet granulation method, and the pouring weight and flowability were determined. Results: The quality index of the concentrated extract of the Hepaclin-4 recipe complies with the standards outlined in the 11th Pharmacopoeia of the National Pharmacopoeia of Mongolia. In qualitative analysis of total flavonoid, spots were detected at the same level as standard quercetin (Rf=0.88) and rutin (Rf=0.4), indicating the presence of flavonoids. According to the results of the above research, lactose was found to be the suitable filler for extracting granules, and starch at 8% was identified as the appropriate binding agent from the concentrated extract of the Hepaclin-4 formula. Conclusion It was found suitable to select 8% lactose as a filler and starch as a binding agent from the concentrated extract of the Hepaclin-4 formula and obtain a granule drug form using the wet granulation method.