ABSTRACT
Introduction@#It is important to standardize a tincture prepared from the herb and root of <i>Paeonia anomala<i> L, which is widely used as a sedative in traditional medicine, based on the results of the studies its chemical composition, biological and pharmacological activities. Moreover, there is a need to carry out a quantitative stability testing in order to establish the ability to maintain quality under certain storage condition, shelf-life and to develop suitable packaging information.@*Materials and methods@#Standardization parameters of prepared <i>Paeonia anomala</i> tincture have been evaluated according to WHO guidelines for the determination of crude drug material, plant preparations and finished products technical parameters, along with the Mongolian National Pharmacopoeian (MNP) and Russian XIV Pharmacopoeian methods for tincture. The color of a tincture, dry residue, special density, alcohol content, and microbiological content were determined according to the methods described in MNP. A qualitative analysis of biological active constituents has been evaluated by thin-layer chromatography, the total phenolic compounds were determined by the reaction with Folin Chicalteu reagent and total monoterpene glycosides by the reaction with hydroxylamine in alkaline solution and ferric (III) chloride following spectrophotometric examination, respectively.</br> The stability testing study was performed according to the “General requirements for the stability testing study of drug-active compounds” MNS-6439-2014 using the real-time methods for the standardization parameters of the tincture.@*Conclusions@#The standardized parameters of tincture prepared from the herb and root of <i>Paeonia anomala</i> L. were approved by the National Reference Laboratory for Food Safety analysis. Consequently, the Mongolian pharmacopoeian article on <i>Paeonia anomala</i> tincture was officially permitted under the number ҮФӨ-0327-2017.</br> The stability study of tincture was carried out according to the MNS-6439-2014 by real-time tests for 24 months which provided that the changes in tincture quality were within the permitted limits. Consequently, it can conclude that the storage condition and shelf-time of <i>Paeonia anomala</i> tincture are 2 years under not above 25°С.
ABSTRACT
Abstract@#CHUN-7 a Mongolian traditional recipe consisting of 7 medicinal plants is described in the scripture named “༆༆ །།གཡུ་ཐོག་པའི་མཛད་པའི་རིམས སྲུང་ཁྱུ་ལྔ་རྒྱམ་ཏོན་གསལ་བ །།”. The ingredients including Caowu (Radix <i>Aconiti kusnezoffii</i>, CW) and <i>Glehniae Radix</i> (GR) have the effects of suppressing pneumonia, viral pneumonia, relieving pain, stimulating the immune system and reducing fever. The present study was aimed to determine acute and chronic toxicity properties of traditional drug. @*Materials and methods@#CHUN 7 traditional drug were prepared in the traditional medicine sector of the Drug research Institute of Monos group. All WISTAR rats were kept in the same feed, under 12 hours lighting and 12 hours darkness housing. The study of acute and chronic toxicity of CHUN-7 traditional drug was studied by using IP and oral administration were performed on ten WISTAR rats and continued for a total of 28 days with 102.9 mg / kg dose (calculated from human dose: 16.7 mg/kg) in accordance with the WHO General Guidelines for the Evaluation and Study of Traditional Medicine.@*Results@#The result showed no structural changes in the internal organs according to tissue morphology when we administrated CHUN-7 traditional drug.@*Conclusion@#This study showed CHUN-7 traditional drug has no toxic effects to internal organs including liver, kidney, stomach, lungs and heart. Therefore, CHUN-7 traditional drug has potential to use orally without any toxicology.
ABSTRACT
Abstract@#In pharmaceutical industry there are some possibilities of contamination and cross contamination because of improper cleaning of equipment, apparatus, processing area or the starting material, this can lead to severe hazards, therefore in pharmaceutical industry we could not afford any contamination as well as cross contamination. This can be minimized by proper cleaning of equipment, apparatus as well as the processing area. Prevention of cross contamination is one of the most significant conditions of Good Manufacturing Practices for drugs. This is especially topical for a multipurpose (shared) manufacture where several medicinal products, including drugs of different pharmacotherapeutic groups, are produced using the same facilities (manufacturing areas, workrooms, and equipment). The industry is able to achieve these key goals with the help of implementation of GMP. Therefore, a perfect cleaning method is required for avoiding the possibilities of contamination and cross contamination, for this a validated program is required, this program is known as cleaning validation. “Cleaning validation is documented evidence which assure that cleaning of equipment, piece of equipment or system will obtain pre-determined and acceptable limits”.
ABSTRACT
Introduction@#In pharmaceutical industry there are some possibilities of contamination and cross contamination because of improper cleaning of equipment, apparatus, processing area or the starting material, this can lead to severe hazards, therefore in pharmaceutical industry could not afford any contamination as well as cross contamination. This can be minimized by proper cleaning of equipment, apparatus as well as the processing area. The cleaning validation is a documented process that proves the effectiveness and quality prospective. Manufacturing of Diclofenac sodium (DICLOMON) retard tablets and utilizing common facility, where diclofenac sodium could be possible cross contaminant. The present study was carried out to validate the cleaning activity from both regulatory and quality prospective.@*Methods@#All chemicals and reagents used for cleaning validation were analytical grade and used LC-20AT Shimadzu HPLC. Traditional methods were used for microbiological analysis. The instruments in the common facility were cleaned with purified water after production of Diclofenac sodium retard tablets 100mg. Validation of cleaning activity was carried out by visual inspection, swab sampling for chemical residue and similarly swab sampling for Microbiological analysis.@*Conclusion@#The cleaning validation studies of Diclofenac sodium retard tablets 100mg was observed by visual inspection, swab sampling for chemical residue and similarly swab sampling for microbiological analysis. The result revealed that (1) There were no visual residues on the equipment (2) Chemical residues were below acceptance criteria (3) Total aerobic microbial count(TAMC) were below acceptance criteria (4) Total combined molds and yeast count was Nil and (5) Pathogens were absent Upon the compiled data, it was concluded that the train of equipment in tablet manufacturing block is completed, and the results were found to be satisfactory and there is no cross contamination of Diclofenac sodium to next product.
ABSTRACT
Introduction@#Nowadays, there is a growing trend to use natural medicines with low side effects, and research on medicinal raw materials used in traditional medicine has become more widespread. Therefore, it is important to obtain a suitable drug form from <i>Plantago Major</i> L and to conduct chemical and pharmaceutical technology research.@*Material and method@#The research was conducted in the pharmaceutical industry and technology laboratory. A granule formulation with several variants consisting of a concentrated extract and excipients was obtained. The sum of flavonoids of <i>Plantago Major</i> L extracts and Granular Dosage Forms was detected by thin-layer chromatography in a suitable solvent system prepared in the ratio of ethyl acetate, formic acid, glacial acetic acid, and water (100: 11:11:26). The total flavonoid content of the drug forms was determined by spectrophotometry.@*Result@#Technological researches were carried out with lactose and glucose fillers, gelatin 8%, polyvinyl chloride (PVP) 6%, starch 5% binders, talc 1%, magnesium stearate 1% sliding and lubricating agents and the wet granulation method was used to obtain granules in several variants and was determined by using parameters such as particle spill weight and flow quality. In this research, the flow rate of <i>Plantago Major</i> L grains with lactose as a filler and PVP as a binder was -2.8 ± 0.18 g / sec (p <0.001) and the spill weight was -0.54 ± 0.03 g /cm3 (p <0.001). Based on the results of the above research, lactose was added as a filler, PVP as a binder, 6% as a slide and lubricant, 3% as talc and 1% as magnesium stearate, and the granular drug technology was developed by wet granulation. Analysis of the total flavonoids by thin-layer chromatography revealed the same level of yellow-brown spots (Rf = 0.4) on the plate. The total flavonoid content of the granules from <i>Plantago Major</i> L was 3.8 ± 0.2% (p <0.002).@*Conclusion@#In this study, a simple and suitable drug formulation from <i>Plantago Major</i> L was successfully obtained and it was a basic research to make new drug formulations in further needs.
ABSTRACT
Introduction@#In Mongolia, there is opportunity to replace importing products by using raw materials based on the animal and minerals. Those products can be used for medical purposes.</br> In traditional medicine, yellow marrow has been widely used to treat burns and mechanical wounds, as well as frozen and open wounds. The purpose of this study was to determine the pharmacological action of “CIBO” ointment. We created a model of mechanical wound to evaluate the healing of wounds and its index after applying the ointment contains the above mentioned raw materials. @*Material and methods@#Four different groups of “CIBO” ointment was prepared in the technology sector of the Drug Research Institute. Mebo wound ointment was used for comparison as control. The study was con- ducted in the Pharmacology Sector of the Drug Research Institute on white rats of the WISTAR breed under one feeding regime and one condition (12h / 12h). Mechanical wound injury and exposure to open wounds in experimental rats and its size were measured on the 3<sup>rd</sup>, 7<sup>th</sup>, 14<sup>th</sup>, 21<sup>st</sup>, and 28<sup>th</sup> days of treatment. Wound healing, morphology, structure, size, and its index was quan- tified based on the defects. The ointment were applied once a day during the treatment period of 28 days to cover the wound.@*Result@#Mechanical wound showed that study treatment group healed 0-6.2% on the 3<sup>rd</sup> day, 21.4-35.7% on the 7<sup>th</sup> day, 50-60% on the 14<sup>th</sup> day, and 33.3-50% on the 21<sup>st</sup> day separately compared with the untreated group. On the 28<sup>th</sup> day, all the groups were decreased by 66.6%. The wound index was between from 0.002 to 0.0005 in the all experimental groups. Among experimented groups, the group consists of yellow marrow and Chinese white cinder was showed better performance than other groups.@*Conclusion@#The study group 4 (Yellow marrow + Chinese white cinder) has been showed to have a pharmacological action of rapid healing and regeneration of burn wounds caused by experimental rats. It has also been shown to have pharmacological action to regenerate skin tissue and suppress caused by mechanicals. Inclusion of Chinese white cinder in “CIBO” ointment promotes regener ation and healing of “CIBO” ointment.
ABSTRACT
Abstract@#Burn injury causes considerable incidence of disability, increase of hospitalization and rehabilitation. It is a crucial factor of morbidity and mortality, throughout the world, especially in the developing countries. Burn wound healing is a complex process including inflammation, granulation, and regeneration of the skin tissue. There are many animal and mineral derived agents applied for burn wounds treatment. For example, minerals and animal yellow marrow are applied as standard topical therapy in healing of burn wounds in the history. Specially, Mongolian camel’s (<i>Camelus Bactrianus</i>) yellow marrow and cinders have been used the healing effect standard topical antimicrobial for burn wounds for several centuries. The present study aimed to determine the healing effect of “CIBO” ointment with animal and mineral raw materials on third -degree burn wound in rats.@*Introduction@#In our study, we selected an ointment containing a combination of yellow marrow and cinder. In ancient times, Mongolians used camel yellow marrow to relieve joint pain, spread people who had been bedridden for a long time due to the disease, and to prevent caries, and to use it on open wounds. In traditional medicine, cinder has been used as a mineral raw material and has been used to treat frostbite and burns.@*Material and methods@#In the Vivar Department of the Pharmacology Sector of the Drug research institute, 18 Wistar white rats weighing 182-220 g fed in one environment for (12 hours a day/12 hour a night) were randomly selected and divided into the following groups. These are: negative control, Group 1 “Yellow marrow + Uvs black cinder”, Group 2 “Yellow marrow + Uvs brown red cinder”, Group 3 “Yellow marrow + Chinese red cinder”, Group 4 “Yellow marrow + Chinese white cinder”, Standard “Mebo” wound ointment. The wound area was prepared by scraping the hair 5 cm from the back of the test animal’s skull. The prepared area was sterilized with 70% ethanol and 10% iodine solution, resulting in a third-degree burn wound of 2.4 cm2. Wound experiential’s ointments were applied once daily for a total of 28 days, and wound healing was evaluated at 0, 3, 7, 14, 21, and 28 days after pathogenesis, with 16.1-pixel accuracy. Photo confirmed using a SONY brand camera.@*Result@#“CIBO” ointment contains four deferent cinders which are from collected from deferent area and that have been shown to good affect burn wounds, and is more compatible with yellow marrow than Group 4 (Yellow marrow+Chinese white cinder).</br> Wound healing variables of control group compared with group 4 (Yellow marrow + Chinese white cinder) increased by 11.1% on the 3th day, 4% on the 7th day, 44.8% on the 14th day, and 54.5% on the 21st day. On the 28th day, healing and regeneration were accelerated by 50%. @*Conclusion@#The group 4 (Yellow marrow + Chinese white cinder) has been shown to have a pharmacological action of rapid healing and regeneration of burn wounds caused by experimental rats. It has also been shown to have pharmacological action to regenerate skin tissue and suppress inflammation caused by burns. Inclusion of Chinese white cinder in “CIBO” ointment promotes regeneration and healing of “CIBO” ointment.
ABSTRACT
Introduction@#During many decides, compounds derived from natural raw materials have demonstrated their effectiveness as therapeutic agents in different areas, such as metabolic disorder, immune system diseases and its regulations. Natural based products, like herbal medicines and minerals are implicated in the regulation of immune function. They control the immune system in a pleiotropic manner and participate in various processes of the adaptive/innate immunity. Therefore, natural raw material has great potential for targeted immune modulators, in the treatment of certain types of immunologic and inflammatory diseases, like rheumatoid arthritis, plaque psoriasis, ankylosing spondylitis and immune deficiency. The purpose of this survey was to study influence of “Shilajit +Golden Rosa” combined shot preparation named by Vitos on immune system in the experimental and preclinical circumstances.@*Goal@#The purpose of this survey was to study influence of “Shilajit +Golden Rosa” Vitos shot preparation on immune system in the experimental and preclinical circumstances.@*Material and Methods@#The immune deficiency was to created by Azathioprine through 5 days in the Balb/c mice after that control group, preparation of “Shilajit +Golden Rosa” Vitos shot were administrated appropriate doses by oral during 10 days. Then we collected blood and quantified amount of CD4+, CD8+, IgG and CD64 (Mouse Elisa Kit Assay: Catalog.No:WAM-568, Elisa Reader, 450 <b>нм</b>, Melsin Medical Co.LTD, www. melsin.com) on the 5<sup>th</sup>, 10<sup>th</sup> days.@*Results@#All statistical analyses were conducted with SPSS version 20.0 software (IBM, Armonk, NY). Oneway ANOVA was used to assess statistical significance between “Shilajit +Golden Rosa” Vitos shot group and days of observation. Mean values of CD4+, CD8+, CD4/CD8 ratio, IgG, CD64 levels determined in the control and sample group. CD4+, CD8+, CD4/CD8 ratio, IgG and CD64 levels were significantly increased in the “Shilajit +Golden Rosa” Vitos shot group compared with control group by 20.8-67.8 per cent (p<0.05, p<0.01).@*Conclusion@#It’s concluded that, “Shilajit +Golden Rosa” Vitos shot preparation shows immune-stimulator activity not only in the level of cellular (T cells:CD4+, CD8+) but also humoral immunity (B cells: IgG, CD64) in the previously using Azathioprine (75mg/kg) to provoke pathological model of immunosuppression
ABSTRACT
Abstract@#Saposhnikovia divaricata, a perennial herb belonging to the family Umbelliferae, is widely distributed in many provinces of Mongolia. The dried root of Saposhnikovia divaricata has been used for the treatment of arthritis and as a painkiller in Mongolian folk medicine. Moreover, its dried root (Radix Saposhnikoviae) is used as a Chinese herbal medicine for the therapy of immune system, nervous system, and respiratory diseases. According to phytochemical and pharmacological studies, the main ingredients of Saposhnikovia divaricata are chromones, coumarins, acid esters, and polyacetylenes. These compounds indicate anti-inflammatory, antioxidant, analgesic, antiproliferative, and immunoregulatory activities. Cimifugin is an active ketone ingredient from Saposhnikovia divaricate, Rhizoma cimicifugae. Cimifugin has been reported to have bacteriostatic and antiviral effects. Studies have reported that cimifugin inhibits allergic inflammation by reducing the levels of cytokines. The aim of this review is to provide extensive information on the traditional use, ethnopharmacology, phytochemistry, pharmacology mechanism of action, and health products from Saposhnikovia divaricata .
ABSTRACT
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.
ABSTRACT
Introduction@#Sea buckthorn (<i>Hippophae rhamnoides</i> L.) is a hardy deciduous shrub of family <i>Elaeagnaceae.</i> In traditional medicine, “Sea buckthorn-5” powder medicine and sea buckthorn extract for the treatment of lung diseases,“Sea buckthorn-11” and “Sea buckthorn-17”prsecriptions are used to treat gynecological diseases. Sea buckthorn fruit takes a lot of time to dry and prepare in the traditional way, and a small amount of raw material is obtained. Therefore, there is an urgent need to improve and standardize technology.@*Material and method@#The study used “Sea buckthorn fruit” raw material harvested in September 2020 from the Botanical garden of medicinal plants of the Drug research institute and sea buckthorn dry extract purchased from China.Four types of samples were used as Dry fruit of sea buck- thorn (Sample 1), Sea buckthorn seeds (Sample 2), Natural dried sea buckthorn fruit (Sample 3), and sea buckthorn dry extract purchased from China (Sample 4).In each of these four samples, the total carotenoid was measured at 450 nm, the flavonoid at 500 nm, and the phenolic compound at 750 nm using a spectrophotometer.@*Result@#The results show that Sample 1 contains the highest amount of carotenoids 56.29 ± 0.05%, Sample 2 contains the highest amount of flavonoids 32.19 ± 0.05%, and total phenolic compounds 41.67 ± 0.02%.@*Conclusion@#Dry fruit of sea buckthorn (Sample 1) has the highest content of carotenoids, sea buckthorn seeds (Sample 2)have the highest total flavonoids and total phenolic compounds, which is approximately to the content of natural sea buckthorn fruit.
ABSTRACT
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.
ABSTRACT
Introduction@#Shilajit and Rhodiola Rosa L are widely used in Mongolian Traditional medicine for the management of diseases and for fracture healing. The aim of this study was to evaluate the pharmacology effects of the “Vitos” Shilajit Shot preparation on fracture healing and callus stages in rats by X-ray.@*Material and methods@#We used non-liner Wistar rats for <i>in vivo</i> experiments, there are sixteen rats were randomly grouped as a positive control, negative control, “Vitos” Shilajit shot experimental and standard groups. The positive group was as healthy animals and other groups were created femoral fracture by Bonnaren’s device. Then negative control group was oral administered distilled water, whereas 4.1ml/kg of “Vitos’ Shilajit shot administrated via oral gavage to experimental group through 56 days. X-rays were performed to assess fracture healing effects within 14, 28, 42, 56 days and callus stages.@*Results@#Significantly higher callus volume and callus staging were observed in the “Vitos” Shilajit shot group compared with the negative control and standard groups. Also “Vitos” Shilajit shot group was becoming as bridging between both end of fractures and get hard callus formulation ready observation of X-Ray radiograph on 4 weeks post fracture. The fracture healing process was slightly reached to callus remodulation such as final stage of bone formulation on 56<sup>th</sup> day.@*Conclusion@#The results of this study reveal that, “Vitos’ shot preparation, which contains an extract of <i>Rhodiola Rosa L</i> and thick extract of Shijilat has a treatment effect and enhancing and supporting callus of bone fracture healing.
ABSTRACT
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.
ABSTRACT
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.
ABSTRACT
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.
ABSTRACT
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.
ABSTRACT
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.
ABSTRACT
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.
ABSTRACT
Abstract@#There is a growing need for a systematic study of the use of medicines prepared from herbal, animal, and mineral raw materials in traditional Mongolian medicine to a new level. Based on traditional medicine technology and use, the study identified the most suitable modern medicinal ingredients for the human body, namely a medicine that can be used for depression in the ancient scripture, “Ngo mtshar dga’ ston gter mdzod” by Gelen Choijamts and further practical application is imperative. @*Purpose@#To study the effects of Srog dzin-5 prescription on pathogenesis model of acute stress and animal models of depressive disor- ders. @*Conclusion@#</br>1. In the pathogenesis model of acute stress disorder caused by restricted mobility, Srog dzin-5 prescription prevents stress-induced thymic involution and enlargement of adrenal glands. </br>2. In the pathogenesis model of ethanol-induced depression, Srog dzin-5 prescription increased physical activity, reduced despair, and prevented anxiety according to behavioral assessment.