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Introduction@#<i>Astragalus</i> is the largest member of the <i>Fabaceae</i> family of about 3,000 species on all continents except Australia, and the <i>Astragalus mongholicus</i> Bunge and the <i>Astragalus membranaceus</i> (Fisch.) Bge are studied and widely used. <i>Astragalus</i> 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 <i>Astragalus mongholicus</i> 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.
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Introduction@#<i>Helianthus tuberosus</i> 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@#<i>Helianthus tuberosus</i> 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 <i>Helianthus tuberosus</i> L. as a pharmaceutical raw material is the cutting followed by freeze-drying.
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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 (R<sup>2</sup>=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.
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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. </br> 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.
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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. </br> 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%. </br> 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.
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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.
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Introduction@#Pyridoxine hydrochloride is least expensive supplement named as a vitamin 6<sup>1</sup>. Pyridoxal kinase is the enzyme that produces pyridoxal phosphate which known as pyridoxine hydrochloride that occurs in the human body. Diabetes, age and neurodegenerative diseases complications can be reduced by pyridoxine hydrochloride<sup>2 3</sup>. Quantification of pyridoxine hydrochloride in neurorubin as an injection form was developed by high performance liquid chromatography (HPLC) method. Further, 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 roughness. The developed method exhibited the best results in terms of the aforesaid validation parameters. The method was found to be selective, simple, economical, accurate, reproducible, rapid and reliable for routine estimation purpose of pyridoxine hydrochloride in injection.@*Goal@#The aim of this study was to develop the validation method of pyridoxine hydrochloride in injection. @*Material and Methods@#</br>I) Test Article. As a test article neurorubin injection was produced by Tsombo Farm LLC. The standard pyridoxine hydrochloride was supplied from Sigma Aldrich Co. </br>II) Reagents and Equipment. The reagents were HPLC grade acetonitrile methanol, and purified water. Balance, and micropipette used as equipment. Shimadzu HPLC (LC20AD) was used as the analytical instrument and the analysis conditions were as follows (Table 1). @*Results@#The calibration curves for pyridoxine hydrochloride 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 12.5-100 pg/mL. The linear correlation coefficient (R<sup>2</sup>) for all calibration curves was higher than 0.995 for all analytes. The LOD and LOQ for pyridoxine hydrochloride were in 15.29 pg/mL and 46.33 pg/mL, respectively.</br> Accuracy and precision were assessed by analyzing five sets of samples, independently prepared at low, middle and high concentrations. The RSD values of both repeatability and intermediate precision were below 1.669 % and 1.678 % the accuracy remaining between 95.25 to 102.775 %. The resulting accuracy data were satisfactory for the quantitative analysis of pyridoxine hydrochloride in neurorubin injection.</br> The results of summarized in table 2, 3, 4. This article presents a simple, accurate, reproducible, and thoroughly validated HPLC-based method for qualitative and quantitative analysis of pyridoxine hydrochloride, as part of the quality assessment of products containing in injection.
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Background@#The high performance liquid chromatography (HPLC) method was developed for selective determination of dihydromyricetin in capsule formulation dietary supplement 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, system suitability and ruggedness. The developed method exhibited the best results in terms of the aforesaid validation parameters. The other components and additives did not interfere in their determinations. The method was found to be selective, simple, economical, accurate, reproducible, rapid and reliable for routine estimation purpose of dihydromyricetin in dietary supplement capsule.@*Goal @#The goal of this study was to develop the validation method of dihydromyricetin in the dietary supplement.@*Material and Methods @#The hangover preparation was produced by Technological section of Drug Research Institute. The standard dihydromyricetin was supplied from Sigma Aldrich Co. We used solvents for HPLC grade (methanol, acetonitrile). Chromatographic conditions: A gradient HPLC (Shimadzu LC20AD) with serial dual plunger pump; analytical column: Supelco inertsil С18 250 × 4.6 mm, particle size 5 μm; flow rate: 1 ml/min; column temperature: 350C, detection: UV 365 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 10 minutes.@*Results @#The calibration curves for dihydromyricetin 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 28-224 µg/mL. The linear correlation coefficient (r2 ) for all calibration curves was higher than 0.999 for all analytes. The LOD and LOQ for dihydromyricetin were in 11.29 µg/mL and 34.21 µg/mL, respectively. Accuracy and precision were assessed by analyzing five sets of samples, independently prepared at low, middle and high concentrations. The RSD values of both repeatability and intermediate precision were below 0.261% and 0.262%. The accuracy remaining between 101.65 to 104.7%. The resulting accuracy data were satisfactory for the quantitative analysis of dihydromyricetin in anti-hangover preparation. The results of summarized in Table 1, 2, 3. This article presents a simple, accurate, reproducible, and thoroughly validated HPLC-based method for qualitative and quantitative analysis of dihydromyricetin, as part of the quality assessment of products containing anti-hangover preparation.
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AbstractIntroduction: In recent years, researchers have paid attention to the biological active products fromraw materials of animal origin. Lyophilized bovine bile and bovine liver hydrolyze and varieties ofplants have been used for increase secretion of bile in traditional systems of medicine of variouscountries. We investigated that beneficial effects of new product particularly its treatment liverdamage, improve regeneration process of damaged liver cell, effects on bile secretion, bile bilirubin,and bile cholesterol and plasma cholesterol levels. Moreover, we investigate physical, chemicalcapacity and drafted a MNS document.Goal: To complete pharmacological, technological and standardization study of Sillichol biologicalactive product.Material and MethodsSeveral biochemical methods were used for determination of chemical compounds in liverhydrolysate and lyophilized bile. The product was formed in combined powder form by dried stirringmethod and it was capsuled by NJP-1200 capsule machine. Litchfield-Wilcoxon’s method was usedto study the acute toxicity effect. The median lethal dose (LD50) value was calculated using themethod of Pearson and toxicity level of was determined according to classification of Sidorov K.K(1973). Human equivalent dose (effective dose) was calculated with according to FDA guidancefor drug-dose conversion. Acute hepatitis – Carbon tetrachloride (CCl4) induced liver damage inrats (Skakun et al, 1984); Bile secretion effect was determined by method of Rozuet Jousse, 1980.All value expressed as mean S.E obtained from n number of experiments. The Student’s t-testfor unpaired observation between control and experimental samples was carried out for statisticalevaluation of a difference; p values of 0.05 or less were considered as statistically significant.ResultsTotal nitrogen, amino nitrogen, fat, ash and solution index were measured in liver hydrolysate.The results were accepted standard requirements of MNS 6484:2014. Bovine bile was dried byLabconco freezone L12 freeze drier in Drug Research Institute. The product named Sillichol wasformed combined powder form and capsuled №0 capsule. From the result of preclinical study, ourinvestigational new product is included in practically non-toxic class according to toxicity classificationby Sidorov (1750 mg/kg). Sillichol biological active product was increase bile level which is producedin liver cells and decreased bile cholesterol levels by 2.3-8.0% in the test group compared with thecontrol and reference groups.Conclusion: The biological active product was improving regeneration process of liver cells,normalize cell structure, effect to the anti-inflammatory in damaged liver cells.
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Introduction. Monos Group, Drug Research Institute is starting to investigate of Ellipin preparationfrom the mid-1990s, Ellipin has anti cancer activity in liver and several studies were investigated withscientists from Japan and China. Especially Hayashi K., Khurelbaatar L and Ambaga M were determinedanti-cancer action of the preparation and they were explained of mechanism of action, which apoptosisis seduced by influence of unsaturated fatty acids in tumor cells. However, changes of fatty acidscomposition at production stage were did not study yet. Therefore, we studied that composition of fattyacids in different term of production stage and compared of Ellipin dense substance.Materials and Methods. Samples of study were collected from production stage of “Ellipin” series130304, which was tacked in 48th hour, 120th hour of production. Each sample was dried at freezedryer “Labconco freezone12L” in Drug Research Institute. Total lipids of sample were extracted withchloroform: methanol (2: 1 v/v) according to Folch et al. Fatty acid methyl esters were analyzed usingAgilent Packard Gas Chromatograph (GC) (Model HP-6890 Agilent Packard) with mass-spectrumdetector (Model HP MSD 5973N) of Buryat State University, in Ulan-Ude.Results. Ellipin preparation is derived from bovine liver, and which is based on homogenization of bovineliver for isotonic. In this process, unsaturated fatty acids were extracted in organic solution. We studiedchanges which saturated and unsaturated fatty acids of bovine liver in process of homogenization andconsist of each fatty acid contents of end product. Results have shown that unsaturated fatty acidswere decreased by 0.4-44% till 120th hour of homogenization process. While, there were decreasedby 4-12% in the end product, although, ω-6 fatty acids were increased by 13.1-38.4%. Moreover, 25saturated fatty acids and 12 unsaturated fatty acids were detected in the Ellipin dense substance (endproduct). Hence, 67.5% of total fatty acid was saturated fatty acids, 32.5% was unsaturated fatty acidsin the Ellipin dense substance. Resent results and results of previous studies indicated that Ellipindense substance may contains saturated fatty acids on in average 50.34%, unsaturated fatty acids onin average 49,32%, respectively.Conclusion. Proportion of saturated and unsaturated fatty acids in Ellipin production was about 2:1.Saturated fatty acids and unsaturated fatty acids were found 25 and 12, respectively. Saturated fattyacids were gradually decreased and unsaturated fatty acids were slowly increased in production period,which from 48th hour of production-conveyer till end product. Moreover, content of ω-3-6-9 fatty acidswas consist 83,9-87,5% of total unsaturated fatty acid.
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IntroductionOur country imported drugs that are contain androgen and testosterone with high selling cost. Therefore,we have to made new body potential and strength biologically activity product which have natural, lowcost and high effective.GoalThe main purpose of study was to determine chemical composition of dried testicle powder and maincompounds of Tribulus terrestris, Astragalus mongolicus.Material and MethodsThe bovine testicle used in this research was purchased from “Makh Market” Co.Ltd in 2013. T.terrestriswas collected from Gurvansaikhan, Dundgobi province July 20, 2014 and A. mongolicus was collectedfrom Botanical garden of Medicinal Plant of Drug Research Institute in September, 2014. Testicles wereremoved from skin and other parts than cut in a mechanical cutting machine. It was freeze dried at -500Cby Labconco freezone12 freeze drier. 500 g of the finely powdered T. terrestris was extracted three timeswith 5000 ml 70% ethanol for 72 hours. All extracts were combined and evaporated by vacuum rotary till2500 ml. 50 g of the powdered A. mongolicus was extracted three times with 500 ml of distilled water for72 hours. Extract was heated until 800C for 24 hours. Extract were collected and evaporated by vacuumrotary till 200 ml. Protodioscin was determined by high performance liquid chromatography (HPLC) wasachieved by using reversed-phase (RP-18) column, ultraviolet detector (UV) and water, acetonitrilegradient as mobile phase, polysaccharide was determined spectrophotometric method, protein wasanalyzed by Kjeldahl method, moisture was measured by Moisture balance 6KD-50K instrument, totalfat was analyzed by Soxhlet apparatus.ResultThe analyses of testicle powder showed 69.8% protein, 8.0% ashes, 5.42% moisture, 15.6% total fatcontent and protodioscin content 1.12% in T.terrestris extract. In A.mongolicus water extract the 7.26%polysaccharide content was found. We were determined to chemical composition of bovine testiclepowder and results were agreed with MNS 5775:2007. More over, high content of polysaccharide andprotodioscin were found T.terrestris and A.mongolicus. Therefore, those raw materials can use forpotential and strength biological activity product.