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.

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.

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.

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.