Background: By supporting the production of domestic substitutes for essential medicines listed in Mongolia’s national drug policy, pharmaceutical companies are enabled to ensure product quality assurance, conduct safety monitoring and research, and carry out quality control and certification of medicines. Therefore, ongoing quality assessment is essential to ensure that domestically manufactured medicines meet established standards before they can replace imported alternatives. This study seeks to assess whether the quality parameters of both locally produced and imported 500 mg Chloramphenicol capsules available in the Mongolian pharmaceutical market conform to the requirements of the Mongolian National Pharmacopoeia. Aim: To compare and study the quality parameters of certain domestically manufactured and imported chloramphenicol capsule formulations in accordance with pharmacopoeial standards Materials and Methods: This study examined four types of 0.5 g Chloramphenicol capsules: three domestically produced (X1, X2, X4) and one imported (X3). The evaluation included tests for identification, average weight, weight variation, dissolution, disintegration, thin-layer chromatography (TLC), assay, high-performance liquid chromatography (HPLC), and microbiological analysis, following the standards outlined in the Mongolian National Pharmacopoeia 2011 (MNP 2011), United States Pharmacopeia 39 (USP 39), Japanese Pharmacopoeia 18 (JP 18), and Chinese Pharmacopoeia 2020 (ChP 2020). Statistical analysis was performed using SPSS version 22.0. Result: The purity analysis of samples X1, X2, X3, and X4 indicated that all met the applicable standards. Among them, X1 and X3 complied with pharmacopoeial requirements for identification, weight variation, dissolution, active ingredient assay, and thin-layer chromatography (TLC). In contrast, X4 failed the identification test and had a low active ingredient content, while both X2 and X4 exhibited inadequate dissolution, suggesting non-compliance with standard requirements. Furthermore, high-performance liquid chromatography (HPLC) analysis based on USP criteria revealed that neither X1 nor X3 met the specified limits. Conclusion Among the four Chloramphenicol capsule samples analyzed, only X1 and X3 met the pharmacopoeial standards. The non-compliance of X2 and X4 underscores the importance of continuous monitoring and quality assessment of domestically manufactured pharmaceuticals.

Background: Globally, 697.5 million people—9.1% of the world’s population—suffer from chronic kidney disease (CKD). In Mongolia, diseases of the kidney and urinary tract rank third in overall morbidity and are a leading cause of hospital admissions. Due to the asymptomatic and progressive nature of these diseases, early diagnosis of CKD has become a critical issue in recent years. One such early diagnostic marker is KIM-1 (Kidney Injury Molecule-1). KIM-1 is synthesized in the epithelial cells of the proximal tubule during renal injury and serves as a receptor for the phagocytosis of apoptotic cell debris. It is considered a promising biomarker for the early detection of kidney damage. Aim: To evaluate the relationship between KIM-1 (Kidney Injury Molecule-1) and clinical biochemical parameters in patients with chronic kidney disease. Materials and Methods: An analytical case-control study was conducted. A total of 54 participants were involved: a case group of 26 and a control group of 28. The case group included 26 patients with chronic kidney disease who were being treated at the Emergency and Internal Medicine departments of the First Central Hospital of Mongolia (FCHM). Serum KIM-1 protein levels were determined using an Enzyme-Linked Immunosorbent Assay (Human Kim-1 ELISA Kit, Cat: ELK2287). Statistical analysis was performed using SPSS-23.0, while text processing and data visualization were conducted using Microsoft Office. Result: KIM1 levels are positively correlated with creatinine, urea, uric acid, glucose, and potassium, and inversely correlated with calcium, total protein, and albumin, indicating a correlation with clinical biochemical parameters. The mean level of KIM-1 protein was 1379±208.3 pg/mL in the chronic kidney disease group and 91.19±22.09 pg/mL in the control group, showing a statistically significant difference between the two groups (p<0.0001). ROC analysis for KIM-1 (pg/mL) showed an Area Under the Curve (AUC) of 0.979 (95% CI: 0.951–1.000, p<0.001). The optimal diagnostic cut-off value was determined at KIM-1 236.17 pg/mL, where sensitivity reached 96.2% and specificity 92.9%, with the highest Youden index (0.89). Conclusion KIM1 levels were positively correlated with creatinine, urea, uric acid, glucose, and potassium, and inversely correlated with calcium, total protein, and albumin. KIM1 protein levels were significantly higher in patients with chronic kidney disease, suggesting that KIM1 is a highly sensitive and specific biomarker for the diagnosis of CKD.

Background: Spinal muscular atrophy (SMA) is a degenerative neuromuscular disease that causes progressive muscle weakness and atrophy due to the loss of the motor neurons. Approximately 95% of patients with SMA are homozygous for the deletion of SMN1 exon 7. With an incidence of 1/10.000 and a carrier frequency of 1/40 to 1/50, SMA is the most common genetic cause of death in infants. Purpose: To detect homozygous deletion of SMN1 exon 7 and to analyse the SMN1 copy number by molecular genetic analysis. Materials and Methods: In this study, 3 SMA patients with SMN1 gene homozygous deletion and 17 people of their relatives were included. Molecular genetic analysis was performed in the Central Scientific Research Laboratory of the Institute of Medical Sciences. DNA was extracted from peripheral blood, and its purity was assessed by spectrophotometer. Homozygous deletion of SMN1 gene was analyzed with allele-specific PCR, and the SMN1 gene copy number was evaluated by real-time PCR. Results: Among the five participants diagnosed with SMA by clinical symptom and electromyographic test, three cases were found to have homozygous deletion of exon 7 of the SMN1 gene, while two cases did not exhibit such mutation by the allele specific PCR analysis.
The mean age of study participants was 27.76±16.07 (ranging from 8 months to 52 years). Six of the 7 relatives of the first proband had 1 copy number of SMN1 (0.75±0.29) or were carriers of SMA, while one had 3 copy numbers (2.99) or no deletion of SMN1 gene. Additionally, 6 of the 7 individuals of the second proband had 1 copy number of the SMN1 gene (0.72±0.14), and 1 person had 2 copy numbers. All 3 relatives of the third proband had 1 copy number of SMN1 gene (0.96±0.37). Conclusion We consider that determination of SMN1 gene homozygous deletion and carrier testing can be performed by the PCR method locally. Further, it is necessary to implement the molecular genetic testing method into practice and to study the requirements and needs of early detection of SMA in the newborn screening program of Mongolia.

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.

Background: In 2021, 5981 of cancer new cases was registered in Mongolian population. Among those cases, liver cancer was commonly registered with a prevalence of 32.7%. Studies on anticancer agents with no-adverse effects and good-preventive efficacy against cancer have been attracted more attention from the researchers in the field of pharmaceutical sciences. Scutellaria baicalensis Georgi, Saussurrea amara.L, Chiazospermum erectum Berh, and Carthamus tinctorius.L are well recognized as effective agent against liver diseases. Using these raw materials, researchers have been invented a traditional prescription and named as Hepaclin-4. In this study, we aimed to investigate the qualitative study of raw materials and some biologically active sub- stances in the compounds. Purpose: To study the qualitative study of raw materials for Hepaclin-4 prescription Materials and methods: Some qualitative properties of raw materials for Hepaclin-4 prescription, including appearance, minerals, some organic compounds, total ash, water-soluble substances and fungi, were investigated according to Mongolian pharmacopeia and total flavonoid was detected by thin layer chromatography. Results: No changes were observed on the appearance of raw materials, and minerals and organic compounds weren’t detected in the prescription. No contamination with fungi and insects were identified. The moist in the raw materials were 5.9 to 8.1%, total ash was 4.7 to 13.3% and the water-soluble substances were detected 33.8 to 42.9%. Number of aerobic bacteria, fungi and E.coli, Salmonella species were detected in normal range, indicating that the prescription was matched with the requirement of pharmacopeia. According to the thin layer chromatography study of the raw materials, a yellow spot on the chromatogram were identified and same as quercetin (Rf=0.9-0.98) and rutin ((Rf=0.18-0.23)) as standard compounds, which indicated that the spot which indicated that the spot was flavonoids in the prescription. Conclusions These results showed that the appearance, moist, minerals, organic compound, water-soluble substances, ash and biologically active substances of the raw materials for Hepaclin-4 prescription was corresponded with the requirements of pharmacopeia, and flavonoid was detected in raw materials of Hepaclin-4.