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.

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.

Introduction: Carthamus tinctorius L. widely accepted as Safflower or false saffron, belongs to the Compositae or Asteraceae family. Hydroxysafflor yellow A is the main active chemical compound present in florets of Carthamus tinctorius L. A joint research team of the “Tsombo Pharm” Co., LTD and the Drug research Institute is conducting an experiment to produce a solution of “Carthamus tinctorius” injection prepared by Carthamus tinctorius L. Goal : The aim of this study was to develop the validation method of hydroxysafflor yellow A in “Carthamus tinctorius” injection. Material and Methods : As a test sample “Carthamus tinctorius” injection was produced by “Tsombo pharma” Co., LTD. The standard Hydroxysafflor yellow A was supplied from Sigma-Aldrich Co., Ltd. The reagent were high-performance liquid chromatography grade acetonitrile, phosphoric 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: A Shimpack С18 column was used with methanol:acetonitrile:0.7% phosphoric acid as the mobile phase under the condition of gradient elution. The hydroxysafflor yellow A were analyzed by using a timed wavelength measure according to their maximum absorption wavelength. Accuracy and precision were assessed by analyzing five sets of samples, independently prepared at low (50%) middle (100%) and high (150%) concentrations. The intraday and interday precisions of the investigated compound were less than 1.59 % and the average recoveries ranged from 81.9% to 101.5%.
There were good linear correlations between the concentrations of the hydroxysafflor yellow A and its chromatographic peak areas (R2 = 0.998), the proposed method was successfully applied to determine the hydroxysafflor yellow A in “Carthamus tinctorius” injection. Conclusions The results indicated that the proposed method is simple, stable, and accurate and could be readily utilized as a quality control method for manufacturing process of “Carthamus tinctorius” injection.

Introduction : The roots of Sophora Flavescentis is one of the key ingredient in Norbu 7 traditional medicine, the bioactive compound being quinolizidine alkaloids, matrine and oxymatrine. A high performance liquid chromatography (HPLC) method was used to determine matrine, oxymatrine simultaneously in the traditional medicine. The HPLC method was tested and validated for selective determination of matrine and oxymatrine in the Norbu 7 granule. The proposed method was validated for linearity, precision (system precision, method precision, intermediate or inter- day precision) and accuracy, stability in analytical solution, system suitability and ruggedness. Goal: The goal of this study was to develop validated determination method of alkaloid in Norbu 7 granule for quality control. Material and Method: HPLC analysis was performed on Chromecore amino bonded silica gel as the stationary phase (250 mm : 4.6 mm i.d., 5µm) using mixture of acetonitrile, dehydrated ethanol and 3% phosphoric acid (80:10:10) as the mobile phase, 220 nm as the UV light detection.
The research methodology was approved by Research Ethic Review Committee of Mongolian University of Pharmaceutical Science on 16th of November, 2020. Results: The calibration curve of oxymatrine showed good linearity (R2=0.9955) within the established range of 8 – 64 µg/ml. The limit of detection (LOD) and quantification (LOQ) were 10.13 µg/ml and 30.71 µg/ ml respectively. Good results were achieved with repeatability (%RSD < 2.0) and recovery (93.08 – 104.32%). Conclusion The method was found to be selective, accurate, reproducible and the other components did not interfere with determinations. It was successfully used to analyze the granule traditional medicine with 7 different plant formulation and additives. The HPLC method can be used to evaluate and control quality, stability of Norbu 7 granules.

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.