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: A joint research team of the Drug Research Institute аndMonos pharm Co.ltd is conducting an experiment to produce of “Darmon” tablets.Idridoids are one of the predominant biological active compound in “Darmon” tablets and will be an important indicator of the quality of the drug. Objectives: This is the first report on the determination of iridoids by spectrophotometric method in “Darmon” tablets. Methods: The amount of total iridoids of “Darmon” tablets was confirmed by spectrophotometry and the absorbance was measured at 238 nm. Geniposide (98%, Xilong Scientific Co., Ltd) was used as the standard substance. Results: The developed spectrophotometric method showed good linearity (R²=0.9989), high precision (RSD<2%) and a good recovery (96.01-104.48%). All the validation parameters of the spectrophotometric method were found to be within the permissible limits according to the ICH guidelines. Conclusions The method was robust, accurate and reliable for the quality control of “Darmon” tablets.

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: Astragalus is the largest member of the Fabaceae family of about 3,000 species on all continents except Australia, and the Astragalus mongholicus Bunge and the Astragalus membranaceus (Fisch.) Bge are studied and widely used. Astragalus contains polysaccharides, saponins, flavonoids, amino acids and trace elements, so it has a variety of pharmacological effects and is active in supporting the immune system and protecting the liver, heart and kidneys. Objectives: A joint research team of the “Tsombo Pharm” Co., LTD and the Drug research Institute is conducting an experiment to produce an injectable solution from Astragalus mongholicus Bunge. The aim is to expand these previous studies to determine the main parameters of the “Монгол хунчир” injection drug technology. Methods: The quality of the injection was assessed by the following parameters. These include: appearance, color of the injection solution, mechanical mixture sensing method, solution filling volume method, solution environment potentiometry method, solution clarity comparison method, insoluble particle size microscopy method, heavy metal mixture atomic absorption spectroscopy method and calicosine-7-o-β-d-glycoside content was determined by HPLC. Results: According to the results of the study, the injectable drug was weak yellow, clear, free of mechanical impurities and heavy metal content, filling 2 ± 0.001 ml, pH 6.5, insoluble particle size greater than 10 μm, 3 particles per 1 ml, small particles larger than 25 μm were present in 1 ml. Calicosin-7-o-β-d-glycosides were identified in the “Монгол хунчир” injection as having the same standard and sample peak times, with the standard substance being detected at 9.003 minutes and the sample solution at 9.016 minutes (Picture 1, 2). In addition, the injection sample contained 0.0477 ± 0.0021 mg / g of calicosin-7-o-β-d-glycoside, and 0.0451-0.0551 mg / g was considered appropriate for further standardization. Conclusions The “Монгол хунчир” injection meets the general requirements for injection in accordance with the Mongolian National Pharmacopeia 2011. This shows that the technological parameters developed by our research team are appropriate.

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.