Introduction: Inula helenium L. is a medicinal plant widely used in traditional Mongolian and Tibetan medicine. Its roots and rhizomes contain active compounds, including sesquiterpene lactones (alantolactone and isoalantolactone), inulin, flavonoids, and essential oils, with anti-inflammatory, antimicrobial, and immunomodulatory properties. This study evaluates the quality of Inula helenium L. roots and quantifies their key active compounds in accordance with pharmacopoeial standards. Methods: The roots of Inula helenium L. cultivated in the Medicinal Plant Botanical Garden of Monos Group were used as raw material. Physicochemical parameters, including moisture, total ash, acid-insoluble ash, and extractive values, were determined according to pharmacopoeial methods. Qualitative analysis was carried out using color reactions for polysaccharides and thin-layer chromatography for the identification of sesquiterpene lactones. Quantitative analysis was performed using spectrophotometry for total polysaccharides and high-performance liquid chromatography (HPLC) for the determination of alantolactone and isoalantolactone. Conclusion The physicochemical parameters of Inula helenium L. root were standardized, with total inulin content determined as 47.13±0.45%, alantolactone as 1.41±0.02%, and isoalantolactone as 1.33±0.02%. Analytical methods for inulin, alantolactone, and isoalantolactone were validated according to ICH Q2(R2) guidelines, confirming the possibility of updating the MNS standard or developing a manufacturer’s pharmacopoeial monograph based on these validated methods.

Introduction: Ursodeoxycholic acid (UDCA) is used to treat liver and biliary disorders, including neonatal jaundice. In neonatal practice, UDCA administered orally (10–30 mg/kg/day, divided doses) shortens phototherapy duration and reduces serum total bilirubin. A suspension dosage form may mask bitter taste, improve dissolution and bioavailability, and is not currently registered in Mongolia. To develop and evaluate suspension formulations of UDCA and to identify an optimal composition and manufacturing technology. Methods: UDCA drug substance was characterized according to the European Pharmacopoeia (EP 11.0). Five suspension formulations (A1–A5) were prepared using wet-milling (size-reduction) technology and appropriate excipients. Physical, chemical and microbiological quality attributes of the suspensions were assessed per the United States Pharmacopeia (USP 2021) and microbiological methods of the Pharmacopoeia of the Russian Federation (GOST 2018). Assays were performed by validated chromatographic methods; measurements were performed in triplicate (n=3).
The UDCA raw material met pharmacopeial specifications and was suitable for use. All five formulations were uniform and free of agglomerates by visual inspection. Formulation A5 met USP acceptance criteria for pH (4.5 ± 0.02), sedimentation volume (0.91 ± 0.20 mL), density (1.14 ± 0.005 g/cm3), viscosity (1583.5 ± 0.38 mPa·s), fill volume (150 ± 0 mL) and active substance content (96.6 ± 0.05%), and complied with microbiological limits. Other formulations failed one or more quality attributes (notably pH, assay or sedimentation). Conclusion The UDCA raw material complied with pharmacopeial quality standards. Among tested variants, formulation A5 satisfied critical quality attributes for a stable suspension and was identified as the optimal formulation with respect to composition and manufacturing process.

Introduction: Doxylamine succinate has an anticholinergic effect and is an antihistaminic active compound. Drugs containing this active compound relieve the symptoms of allergies, allergic rhinitis, and the common cold and treat short-term insomnia.
In Mongolia’s National Drug Registration list, five doxylamine succinate-based tablets are cataloged, and imported from France, Turkey, Slovenia, India, and South Korea. Doxylamine succinate tablets have not yet been introduced into production within domestic industries. Therefore, we have developed tablets featuring novel technology and standardization. Purpose: This study aims to investigate the research on technology and standardization of doxylamine succinate tablets and assess the viability of their introduction into domestic manufacturing. Methods: For the technological study, the main raw material was purchased from Apollo Healthcare Ltd. in China, and tablets of 5 versions were obtained by wet granulation compression method. Carr’s index and Hausner’s ratio of the granules were calculated according to the British pharmacopeia.
For the standardization study, we purchased standards from Sigmaaldrich® and determined physical, and chemical parameters by Mongolian National Pharmacopoeia (MNP) and United States Pharmacopoeia (USP). Results: Version 2’s Carr’s index was 8.15%, and Hausner’s ratio was 1.09, indicating that the tablet’s compressibility and flowability of granules are excellent. Moreover, version 3’s Carr’s index was 10.70%, and Hausner’s ratio was 1.12, which indicates the tablet’s compressibility and flowability of granules are good.
Both versions above met the requirements as appearance, friability, breaking force, weight variation limits, dissolution, and assay according to USP and MNP. Despite that, only version 3 conformed to disintegration for requirements outlined in the MNP. Conclusion The assay determination method has been validated following ICH guidelines and the quality attributes of the tablet have been specified. Based on the results obtained, version 3 of the experimental tablets is deemed feasible for introduction into production.

The Jerusalem Artichoke (JA) (Helianthus tuberosus L.) is an annual plant native to North America and widely distributed in Europe and Central Asia. The tuber of JA contains 80% water, 15% polysaccharide (Inulin etc.), 2% protein, and a small amount of starch and fat. Inulin is a polysaccharide that is widely used as a prebiotic, fat substitute, and sugar substitute. This substance has high biological activity and is contained in large quantities.
The purpose of this study was to standardize the quality and safety of dried tubers of JA. Standardization includes parameters such as microscopic analysis, identification, quantification, validation of methods following the guidelines issued by ICH guidelines, and quality, including safety analysis (appearance, moisture, mechanical impurities, heavy metals, microbiological purity).
The content of inulin was 64.17±1.25%. The mean relative standard deviation of method validation (RMS%) was 1.27%, 1.18%, 1.22%, and the relative mean standard deviation (RMS) of method precision was 1.94%. The specific absorbance was 307 nm. The correlation coefficient R2=0.9998 was obtained for the reference curve of the standard substance. The detection limit of the method was 2.64 μg/ml, and the detection limit was 7.99 μg/ml.
The method mentioned above has been confirmed to be suitable for the quantitative determination of inulin in the tuber of JA. Moreover, Microbiological purity and heavy metal requirements are met.

Background: The high-performance liquid chromatography (HPLC) method was developed to select salidroside in tablet formulation dietary supplements, raw material containing other components. Further, the proposed method was validated for linearity, precision (system precision, method precision, intermediate or inter-day precision), and accuracy, stability in analytical solution, syst em suitability, and ruggedness. The developed method exhibited the best results in terms of the validation above parameters. The other components and additives did not interfere with their determinations. The method was found to be selective, simple, economical, accurate, reproducible, rapid, and reliable for routine estimation purposes of salidroside in golden root dry extract. The goal of this study was to develop the validation method of salidroside in the dietary supplement. Material and Methods: The Rhodiola rosae L. dry extract was supplied Arshin Co.ltd in People’s Republic of China. The standard salidroside was supplied from Sigma Aldrich Co Ltd. We used solvents for HPLC grade (methanol, acetonitrile). Chromatographic conditions: A gradient HPLC (Shimadzu CBM20AD) with serial dual plunger pump; analytical column: Shimadzu GIST С18 150 x 4.6 mm, particle size 5 μm; flow rate: 1 ml/min; column temperature: 400C, detection: UV 275 nm. Chromatographic procedure: 20 μl of the mixed standard preparation and assay (sample) preparation were separately injected into the chromatography, the chromatograms were recorded, and the responses for the major peaks were measured. The run time was approximately 15 minutes. Results The calibration curves for the salidroside were made by plotting the peak area versus the concentration for each analyte using regression analysis. Each calibration curve was obtained using six levels of concentrations in the range of 100-800 µg/mL. The linear correlation coefficient (r2=1) for all calibration curves was higher than 1 for all analytes. The LOD and LOQ for salidroside were golden root dry extract in 8.788 µg/mL and 26.61 µg/mL, respectively. Accuracy and precision were assessed by analyzing five samples independently prepared at low, middle, and high concentrations. The RSD values of repeatability and intermediate precision were below 1.12%, 1.19 and 1.79%. The accuracy remains between 91 to 109%. The resulting accuracy data were satisfactory for the quantitative analysis of salidroside in golden root dry extract. This article presents a simple, accurate, reproducible, and thoroughly validated HPLC-based method for qualitative and quantitative analysis of salidroside, as part of the quality assessment of golden root dry extract.

Purpose: Colorectal cancer (CRC) is the most frequent cancer with limited therapeutic achievements. Recently, adoptive cellular immunotherapy has been developed as an antitumor therapy. However, its efficacy has not been tested in CRC. This study investigated the ability of an immune cell cocktail of dendritic cells (DCs), T cells, and natural killer (NK) cells to overcome immunological hurdles and improve the therapeutic efficacy of cell therapy for CRC. Methods: CRC lysate-pulsed monocyte-derived DCs (Mo-DCs), CRC antigen-specifically expanded T cells (CTL), and in vitro-expanded NK cells were cultured from patient peripheral blood mononuclear cells (PBMC). The ability of the combined immune cells to kill autologous tumor cells was investigated by co-culturing the combined immune cells with patient-derived tumor cells. Results: The Mo-DCs produced expressed T cell co-stimulating molecules like CD80, CD86, human leukocyte antigen (HLA)-DR and HLA-ABC, at high levels and were capable of activating naive T cells. The expanded T cells were predominantly CD8 T cells with high levels of CD8 effector memory cells and low levels of regulatory T cells. The NK cells expressed high levels of activating receptors and were capable of killing other cancer cell lines (K562 and HT29). The immune cell cocktail demonstrated a higher ability to kill autologous tumor cells than single types. An in vivo preclinical study confirmed the safety of the combined immune cell adaptive therapy showing no therapy-related death or general toxicity symptoms. Conclusion The results suggested that combined immune cell adaptive therapy could overcome the limited efficacy of cell immunotherapy.

Introduction: Over 800,000 people in the world contract HCC each year and approximately 700,000 die from the disease. HCC is the 6th most common cancer in the world. HCC is the 3rd leading cause of cancer deaths in the world. 2/3 of liver cancer deaths are caused by hepatitis. In the U.S, HCV infection is the more common cause of HCC, while in Asia and Africa, HBV is more common. Mongolia ranks first in the world in mortality from liver cancer, indicating the need for early detection and treatment of cirrhosis. Sysmex Corporation has introduced for HISCL series analyser, a new cirrhosis marker M2BPGi of non-invasive, blood-testing. In 2016, the test was introduced at Medipas Hospital in Orkhon province. It is possible to study the advantages and significance of the marker for use in clinical practice. Materials and methods: From a total of 385 patients who underwent M2BPGi marker testing in 2016-2017Medipas hospital laboratory, data from a total of 283 patients tested for hepatitis B and C virus and M2BRGi markers were selected. A comparison of age, sex, and test parameters of a total of HCVab and HBsAg positive 172 patients tested for Total bilirubin, GPT, GOT, GGT, AFP and M2BPGi. HCV Ab, HBsAg, AFP, M2BPGi markers were analyzed by SysmexHISCL-5000 fully automated immunological analyzer, Liver function tests were performed with a fully automatic biochemical analyzer JEOL Biomajesty BM6010/C. Results: Of the M2BPGi marker tested 283 patients 94 (33%) were infected with the C virus, 78 (28%) were with the B virus,11 (4%) were co-infected with B and C viruses, 100 (35%) no any viral infection. Of the 172 patients diagnosed with hepatitis B and C virus infection, 97 (56%) were male, 75 (44%) were female. In terms of age, 72% of the population is over 45 years old.
Of the 172 patients, 115 (67%) had M2BPGi marker abnormal or > 1.0 COI. Of the M2BPGi marker abnormal patients, 47 (41%) were infected with the B virus and 68 (59%) with the C virus. In terms of age, 27.7% of hepatitis B patients and 10.3% of hepatitis C patients were under 45 years of age, 72.3% of hepatitis B patients and 89.7% of hepatitis C virus patients were over 45 years of age.
Hepatitis B and C viruses are slightly more common in men than in women. The majority of patients infected with the hepatitis virus over the age of 45. The majority of patients with hepatitis virus have abnormal liver function. Increased M2BPGi markers in people under the age of 45 with hepatitis B virus infection are relatively higher for hepatitis B virus infection than for C virus infection. Conclusions The M2BPGi marker was abnormal in 67% of hepatitis virus infected patients. It has been observed that the probability of an increase in M2BPGi marker is slightly higher in hepatitis C virus infection than in hepatitis B virus infection.

Introduction: Coronavirus infection 2019 (Ковид-19) is an infection caused by a novel virus and induces severe ARDS. КОВИД-19 pandemic has rapidly spreaded in 221 countries, 245,373,039 cases and 4,979,421 mortalities have been reported. Pulmonary and renal thrombotic angiopathy occur in patients with complications of ARDS, sepsis, and multi-organ failure. Elevated D-dimer in КОВИД-19 patients has been reported firstly by doctors in Wuhan, China. In addition, many studies have revealed that elevated D-dimer has been associated with the severity of the diseases, an increased rate of poor prognosis. Objective: We aim to determine D-dimer in КОВИД-19 patients, and patient condition a decrease of D-dimer level after administration of anticoagulant therapy. Case report: We introduce a rare case of КОВИД-19. Laboratory test results and the effect of anticoagulant therapy have been evaluated during the infection. 85 aged women were admitted with a diagnosis other than КОВИД-19. PCR for SARS-Cov-2 was negative on the previous day of admission, and Sars-Cov-2 Ag rapid test was also negative on the admission day. However, the D-dimer test result was much higher with 7120 ng/мл and X-ray and CT revealed a similar pattern to the КОВИД-19 patient. Then anti-Sars-Cov-2 test was positive with 4,08 COI. Based on laboratory test results of D-dimer, LDH, CRP, and CT pattern the patient was diagnosed with post-КОВИД-19 pneumonia, and anticoagulant therapy was initiated additionally to prevent hypercoagulation induced by КОВИД-19. D-dimer test taken before administration of anticoagulant therapy increased more to 10910 ng/мл. 3 days later D-dimer level decreased to 8180ng/мл and the patient’s condition was improved. Conclusion The evaluation of D-dimer of the patients with КОВИД-19 is highly significant. Anticoagulant therapy might be necessary for КОВИД-19 patients with high D-dimer level in serum. Further studies are needed to assess the long-term outcome of the illness and mortality.

Background: Sulfated polysaccharides have specific antiviral activities, which biological mechanism is assumed to the electrostatic interaction between (+)-charged virus surface glycoproteins and (-)-charged sulfate groups. Objective: For the elucidation of the mechanism, several oligopeptides referenced by the sequence of Human Immunodeficiency Virus glycoprotein 120 (HIV gp120) and hemagglutinin (HA) of influenza A and B were synthesized by a peptide synthesizer and the interaction with structurally distinct sulfated polysaccharides such as curdlan sulfate and dextran sulfate was analyzed by SPR. Method: In this study, six oligopeptides were synthesized from the sequence of the V3 loop, C-terminus, and CD4 binding domain in the HIV gp120. Oligopeptide A from the V3 loop comprises 20 amino acids with seven positively charged lysine and arginine in the sequence. The basic amino acids were relatively dispersed along the sequence compared with that of oligopeptide B. Likewise, oligopeptide B from the C–terminus comprises seven lysine and arginine, also oligopeptide of Influenza A/Yamagata HA and Influenza A/Brisbane HA comprises 23 amino acids with eight positively charged lysine and arginine in the sequence. Oligopeptide C from the CD4 binding domain and Influenza B /Hong Kong from the HA comprises one lysine and next to the biotin. The biotinylated peptides were synthesized by a microwave assisted solid phase peptide synthesizer using Fmoc protected amino acids. The peptides were purified by RP-HPLC and identified the structure by using MALDI TOF MS. Result: Peptides A and B from HIV gp120 were found to have interacted strongly with dextran and curdlan sulfates, however, the peptide C without positively charged amino acids showed no interaction. These results suggest that the interaction was due to the electrostatic interaction between negatively charged sulfate groups and positively charged amino groups of the peptides. The results of influenza HAs, influenza A (Yamagata and Brisbane) and B (Hong Kong) viruses, are also presented. Conclusion Curdlan and dextran sulfates were found to increase the interaction with increasing the molecular weights and degree of sulfation (DS), which were found to be important factors for the antiviral activity of sulfated polysaccharides. Based on the above, suggesting the antivirus mechanism of sulfated polysaccharides to be the electrostatic interaction of negatively charged sulfated polysaccharides and virus surface glycoprotein at the positively charged amino acid regions.

Introduction: Calycosin-7-O-β-D-glucoside is a glycosyloxyisoflavone that is calycosin substituted by a beta-D-glucopyranosyl residue at position at 7 via a glycosidic linkage. calycosin-7-O-β-D-glucoside, a calycosin derivative compound derived from Astragali Radix, has protective effect against ischemia/ reperfusion injury as well as bacterial endotoxin-induced vascular cell injury. A joint research team of the “Tsombo Pharm” Co., LTD and the Drug research Institute is conducting an experiment to produce a solution of “Astragalus mongholicus” injection prepared by Astragalus mongholicus bunge. Goal : The aim of this study was to develop the validation method of Calycosin-7-O-β-D-glucoside in “Astragalus mongholicus” injection. Material and Methods: As a test sample “Astragalus mongholicus” injection was produced by “Tsombo pharma” Co., LTD. The starndard Calycosin-7-O-β-D-glucoside was supplied from Xilong Scientific Co., Ltd. The reagent were high-performance liquid chromatography (HPLC) grade acetonitrile, formic acid, methanol and purified water. Shimadzu HPLC (CMB-20 A, UV detector Shimadzu SPD-20A was used as the analytical instrument and the analysis conditions were as follows Table 1. Results: The calibration curves for Calycosin-7-O-β-D-glucoside were made by plotting the peak area versus the concentration for each analyte using regression analysis. Each calibration curve was obtained using six levels of concentrations in the range 12.5-100µg/ml. The linear correlation coefficient (R2) for all calibration curves was higher than 0.9981 for all analytes. The limit of detection and limit of quantitation for Calycosin-7-O-β-D-glucoside were in 10.37 µg/ml and 31.45 µg/ml. Accuracy and precision were assessed by analyzing five sets of samples, independently prepared at low (50%) middle (100%) and high (150%) concentrations. The RSD values of both repeatability and intermediate precision were below 0.68% and 0.618% the accuracy remaining between 95.55 to 101.71%. The resulting accuracy data were satisfactory for the quantitative analysis of Calycosin-7-O-β-D-glucoside in “Astragalus mongholicus” injection. Conclusions Finally, this method can be employed conveniently, reliably and successfully for the estimation of Calycosin-7-O-β-D-glucoside for routine quality contral and stability studies in “Astragalus mongholicus” injection.