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 : 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: Nowadays people are restricting their use of chemical drugs as much as possible, creating a growing need for a systematic study of the use of herbal, animal and mineral medicines at a new level through traditional and innovative methods. Based on the study of traditional national technologies, it is important to study and apply in practice the drugs and pharmaceutical ingredients that contain the most modern scientific achievements including cardiovascular drugs, obtained from ancient rare scriptures. Research materials and methods: Data collected from the Clinical Department of Stress-Related Mental Disorders of the National Center for Mental Health was the primary source for this study. Secondary sources included statistics on the hospital’s website, internal reports of the organization, research related to health services, and legal documents. Research method: Serum cortisol levels were determined with a STATFAX-2100 ELISA (450 nm) according to the manufacturer’s specific methodology (www.melsin.com, Human Cortisol, ELISA KIT- CAT. NO:EKHU-0704).
The amount of cortisol in human serum was calculated as a linear quantitative assay by diluting 7.5 ug/L-90 ug/L in a standard working solution. Conclusion “Srog ‘dzin-5” has a clinical effect of reducing serum cortisol by an average of 27.3%. The statistic (p<0.01) is likely to increase this percentage depending on the time taken. Clinical observations have shown that “Srog ‘dzin-5” has pharmacological action against stress, depression and mental illness.

Introduction: Amenorrhea has still been listed as one of common diseases among women in Mongolia. Some traditional prescription for amenorrhea, used commonly in Mongolian traditional medicine, needs more attention to dig out its scientific proof of therapeutic effect on pathogenesis of some diseases. Therefore, we aimed to research Shimshin-6 traditional prescription to develop a granule formulation for amenorrhea and other female reproductive diseases, and study its qualitative and quantitative characteristics. Material and method: In this study, Shimshin-6 traditional prescription was randomly collected from 5 pharmaceutical manufacturers named as “Х-1, Х-2, Х-3, Х-4 and Х-5”. The collected prescriptions were granulated and optimized by a wet-granulation method. Then, granule spill weight and flow quality were detected in obtained granule formulation. Result: 20 types of granule formulation from Shimshin-6 were obtained by using 8% and 10% of gelatin, 6% and 8% of polyvinylpyrrolidone as a binder in these formulations. As a result, the suitable binder in this formulation was detected 6% of polyvinylpyrrolidone after researching the granule spill weight and flow rate. For the granule formulations of X-1, X-2 and X-5 prescriptions, the polyvinylpyrrolidone was chosen as the suitable binder due to the result from granule spill weight of the formulation. As for the X-3 and X-4 prescriptions, gelatin was the suitable binder in these formulations. After studying the flow quality of newly obtained granule formulations from “Х- 1, Х-2, Х-3, Х-4 and Х-5”, the most suitable binder was polyvinylpyrrolidone. Conclusion Altogether, these results showed that the most suitable binder for granulating Shimshin-6 traditional medicine was 6% of polyvinylpyrrolidone due to the results from granule spill weight and flow rate.

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 Mongolian people have been using traditional medicine for hundreds of years. However, there is a need to produce traditional medicinal dosage forms such as capsules, tablets, decoctions easier to drink, store and transport, and to standardize not only finished product, but the raw materials used for traditional medicines in line with the current drug production, drug quality and safety requirements. Therefore, in this study, we aim to standardize five ingredients of a traditional powder medicine, which have been widely used for colds and flu in Mongolian, Chinese and Tibetan traditional medicine practice, and to convert the powder drug into tablet form using qualified raw materials. Materials and Methods: The study to convert multi-ingredient traditional powder into tablet was carried out at the Experimental production pharmaceutical technology unit and Pharmaceutical chemistry Laboratory of the Drug research institute, Monos Group, and the Quality control laboratory of medicine of Monos Pharm LLC. Result All raw materials were standardized and wet granulation method was used to prepare granules for the tableting with qualified raw materials. 4 different models of the tablet form was prepared and investigated. It was determined that model X-2 fully meets the general requirements for the tablet form.

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: Rhodiola rosea L. (R.rosea) is a popular plant in traditional medicine of the Nordic countries, Eastern Europe, and Asia. R.rosea plants are successfully cultivated in Mongolia. The Botanical Garden of Medicinal Plants under the “Monos” Group started to cultivate R. rosea since May 2015. Objective: The aim of this research was to study the salidroside contents of R.rosea collected from Zavkhan and Khuvsgul province, Mongolia, and cultivated in the Botanical Garden of Medicinal Plants, Drug research Institute, Monos group. Material and Methods: The underground parts of wild roseroot plants were collected from April to May 2020 from Jargalant soum, Khuvsgul province, and Nomrog soum, Zavkhan province, 3-years and 4-years-old cultivated R.rosea gathered from the Botanical Garden of Medicinal Plants in April 2020. For comparison, 4-year-old Rhodiola grenulata (R. grenulata) was ordered from Shanxi Zhendong Genuine Medicinal Materials Development Co., Ltd, China, and used for the study. The quantity of the salidroside constituents of the underground parts were compared and the sourcing of roseroot raw material was evaluated. Chemical analysis of roots and rhizome of R. Rosea namely the appearance, identification, moisture, organic impurities, mineral impurities, residue on ignition, water-soluble extractives, fresh weight of roots, and salidroside content were determined according to the National Pharmacopoeia of Mongolia (NPhM) 2011. Microbiological analysis was performed in accordance with the requirements of grade 3b specified in Annex 1 of the Order No. A / 219 of the Minister of Health dated May 30, 2017 to determine the degree of microbiological purity in medicinal products of roots and rhizome raw materials. Result: The content of salidroside, the main biologically active substance of R.rosea plant, was 1.57% in samples collected from Zavkhan province, 1.45% in samples collected from Khuvsgul province, 1.7% in samples grown in China and 0.25% for 3-years-old samples and 1.89% for 4-years-old samples grown in the Botanical Garden of Medicinal Plants, Monos group, Mongolia. In addition, these raw materials meet the general requirements for plant raw materials and microbiological parameters. Conclusion Samples of underground parts of R.rosea cultivated for 4 years in the Botanical Garden of Medicinal Plants have the highest content (1.89%) of the salidrosde. Therefore, it is suggested that the roots and rhizomes of R.rosea planted in the future can be standardized and used as a raw materials for medicines.

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.