1.Standardization of dried tuber of Jerusalem Artichoke (Helianthus tuberosus L.)
Batdorj D ; Maral L ; Maralgua A ; Nomin J ; Battulga B ; Tserenkhand G ; Lkhaasuren R ; Khurelbaatar L ; Badamtsetseg S
Mongolian Pharmacy and Pharmacology 2024;25(2):45-51
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.
2.HPLC method for quantification of salidroside for quality control of golden root (Rhodiola Rosea L, Rhodiola Crenulata L.) dry extract
Battulga B ; Badamtsetseg S ; Lkhaasuren R ; Odontuya G ; Khurelbaatar L
Mongolian Pharmacy and Pharmacology 2024;25(2):52-57
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.
3.Interdependence of hepatitis B and C virus infection with M2BPGi marker
Battulga M ; Erdembayar O ; Munkhzaya D ; Bayanmunkh B ; Oyuntsetseg D ; Enkhjin B ; Undarmaa G ; Otgontungalag D ; Bolor A
Health Laboratory 2021;13(1):21-25
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.
4.Method validation of total iridoids in “Darmon” tablets by spectrophotometric method
Selbenchal B ; Sugarmaa B ; Odchimeg B ; Ganchimeg G ; Battulga B ; Badamtsetseg S ; Bayanmunkh A ; Tsetsegmaa S ; Lkhagva L ; Khurelbaatar L ; Lkhaasuren R
Mongolian Pharmacy and Pharmacology 2021;19(2):6-12
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.
5.Determination of inuline contents in heat and cold processed Helianthus Tuberosus L.
Ganchimeg G ; Batdorj D ; Lkhaasuren R ; Odchimeg B ; Battulga B ; Orkhon N ; Ulziimunkh B ; Bayanmunkh A ; Tsetsegmaa S ; Lkhagva L ; Khurelbaatar L
Mongolian Pharmacy and Pharmacology 2021;19(2):38-42
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.
6.Hormonal and lipid profile in infertility women with polycystic ovary syndrome
Algirmaa N ; Amarjargal O ; Battulga G ; Altaisaikhan Kh ; Munkhtsetseg D ; Bolorchimeg B
Mongolian Medical Sciences 2020;194(4):17-24
Introduction:
PCOS prevalence is 5-10 percent among reproductive age women in worldwide. It is caused by
imbalance of sex hormones which ultimately leads to menstrual irregularities, infertility, anovulation
and other metabolic disturbances. Most women with chronic anovulation is caused by polycystic
ovary syndrome [PCOS] The Rotterdam criteria is useful diagnostic tool for PCOS. In Mongolia
there is almost no study on PCOS related infertility and there are increasing trend infertility among
reproductive aged women with PCOS, lead us to conduct the study.
Objective:
The aim of this study was to estimate incidence of PCOS and to study clinical and biochemical
characteristics of PCOS among infertility women.
Material and Methods:
We used the cross-sectional and case control study designs. Total 1334 infertility women enrolled
in this study. The study was conducted after approval from the Ethical and research review board of
the hospital, and written informed consent was taken from all the women. Among 114 women with
PCOS were found by Rotterdam’s criteria at the Infertility and reproductive department, National
Center for Maternal and Child Health, between December, 2018 - 2019. Total of 43 females with
PCOS were screened among 1334 infertile women. All parameters were assessed either with ELISA
in 43 infertile PCOS women and 17 age matched apparently healthy controls diagnosed according
to Rotterdam consensus. IDF diagnostic criteria for MS was used. The PCOS patients divided into
following groups: (1) with MS ( n=42) and (2) without MS (n=72).
Results:
The main age, body mass index (BMI), and duration of infertility were 28.7±4.1 years, 27.3±5.2 kg/
m² and 4.4±3.1y, respectively. Among patients 57.9% of them have oligomenorrhea, 22.8% with
amenorrhea, primary infertility 57.0% and 51.9% with hirsutism and acne 50.8%. As a result of
hormone assays were LH 9.3±3.5mIU/ml, LH/FSH 1.6 ±0.83 [0.1-3.6], AMH 6.1ng/ml ±3.6 /2.9-21.0/.
The prevalence of MS was 36.8%. The variables including age (30.9±4.9), body mass (75.9±11.6kg)
and also some metabolic parameters which is hypertension (133.6/88.4±13.6 mm Hg), WC (94.1±8.6
cm) and high triglyceride (1.8±1.0 mmol/l) were observed in MS group compared to without MS group.
Conclusion
Among 1334 women with infertility, the incidence of PCOS 8.7% (116), close to the prevalence in
other countries. Considering the diagnose was confirmed of three criteria by the Rotterdam criteria.
We found out that the prevalence of metabolic syndrome was 35.3% among infertility women with
PCOS. Age, BMI, WC, amenorrhea, acne and acanthosis nigricans, were highly related to metabolic
syndrome.
7. Human fetal eyeball layers’ structure, differentiation and vascularization
Battulga G ; Uranchimeg D ; Amgalanbaatar D
Innovation 2015;9(Ophthalmology):28-32
Studying formation and development of fetal organ system, it has reliable information in medical theory as well as practical importance for the medical diagnosis, treatment and prevention in certain country. Introducing the modern advanced methods of fetal study in our country, it willbe possible to get the necessary information of prenatal organ development, formation and differentiation. Currently, the research works of eyeball development, topography, structures have not been accomplished yet in the Mongolian human fetuses. Therefore, the aim of thiswork was to make an evaluation of the development of the human eye during the fetal life. In our study, the 66 eyeballs of 33 human fetuses were examined.It was observed that the axial length, corneal diameter and equatorial diameter of the eye were increased simultaneously in the early fetal period. In the late period the axial length was increased slightly and equatorial diameter was increased rapidly. In the histological observation, the thickness of the eyeball layers were increased regularly from the early fetal period until the late fetal period. Thickness of the choroid and retina were increasing irregularly. Anti VEGFantibody was high distinguished detected in the choroid and retina in the early fetal period but it was middle distinguished detected in the late fetal period by immunohistochemistry.
8.Chemical analysis of animal and plants origin raw materials to improve body potential and strength
Battulga B ; Badamtsetseg S ; Oyunchimeg B ; Battulga G ; Khurelbaatar L
Mongolian Medical Sciences 2014;169(3):51-54
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.
9.Technological and standardization study of Dentos 1% gel medicine
Erdenetuya O ; Battulga G ; Munkhjargal N ; Khashchuluu B ; Chimgee TS ; Lkhagva L ; Hurelbaatar L
Mongolian Medical Sciences 2014;169(3):59-66
BackgroundMonos Pharm LLC has been started production of Dentamon which is an elixir medicine for gumtissues and a oral cavity inflammation and consumer product has been under appreciated today since1998. Now days, as the technology develops, improved levels of consumer demand for consumptionand they want the product easier to use. In this study, sustainable refers to both the technology andstandardization characteristics of gel medicine for a new Dentamon or Dentos gels were prepared using20% ethanol extract for mixture of Chamaenerion angustifolium L, Stellera chamajasme L and Oxytropispseudoglandulosa which are pharmacological active for gum tissues and a oral cavity inflammation.GoalThe aim of this work was to standardize of Dentamon elixir gel medicine and make technological studyof Dentamon.Materials and MethodsThe present study included plant species which were Chamaenerion angustifolium L, Stellerachamajasme L and Oxytropis pseudoglandulosa. Those three medicinal plants were collected fromdifferent regions of Mongolia and samples their upper part of ground. The plants were used for thepurpose of their phytochemical analysis and technological study of gel formulation. For the contentof flavonoids, total coumarin and tannin in the gel and extract of those plants were determined byspectrophotometric method. The direct measurement of the microbiological climacteric was determinedin extract by according to Mongolian National Pharmacopeia and the viscosity property of gel medicinewas identified using viscometer.ResultsThis study has revealed the presence of photochemical considered as active medicinal chemicalconstituents. Chemical tests of the screening and identification of main active components in the plantsunder study were carried out in the ethanol extract (20, 40, 70%) and aqueous extract using generalextraction method. The tannin content of the upper part in water and three different concentrated ethanolextract was found to be (2.16±0.04%, 1.73±0.04%, 2.58±0.04% and 1.74±0.02%), respectively. Thetannin content of upper part in 40% of ethanol extract of the plants was 7.40±0.21% and coumarin contentwas 3.01+0.09% and the total flavanoids content were 0.70+0.03%. There were not detected Esherichiacoli, Salmonella, Pseudomonas aeruginosa and Staphylococcus aureus in plant extracts. The gelmedicine was prepared from concentrated plant extract using dispersion method and and gel formingmaterial selection using 0.5%, 1%, 1.5% and 2% of carbomer. The results from gel formulation assay,the 0.5% of the gel was turbid liquid state, and 1% of the gel was a colorless, clear liquid state, 1.5% gelwas colorless, created very clear and 2% gel was colorless but it was very dense. The pH condition ofthe 1% of Dentos gel was 7.6 and the viscosity property was 7400000 mPa/sec, the flavonoid contentwas 0.165%, the total coumarin content was 0.69 and Pseudomonas aeruginosa, Staphylococcusaureus, Enterobacteriaceae did not detected. Dentos 1% gel was compared its pharmacological trialwith Hi Ora gel which is produced by Himalaya LLC. On the treatment 14 days, Dentos gel more reduced45.9% of wound area index than Hi Ora gel.ConclusionThe 40% ethanolic extracts of the studied plants contained many bioactive chemical constituentsincluding alkoloids, flavonoids, tannin and coumarin. The 1.5% of carbomer was most effectivefor make a new Dentos gel and also new generated gel was most effective against Pseudomonasaeruginosa, Staphylococcus aureus, Enterobacteriaceae. The new generated gel was standardizedby its appearance, viscosity property and content of coumarin, alkaliod, flavonoids and microbiologicalpurity characteristics.
10. TECHNOLOGICAL AND STANDARDIZATION STUDY OF “CHLORPHENOS”100 ML SYRUP MEDICINE
Battulga G. ; Oyunbileg S. ; Byambadulam G. ; Khurelbaatar L.
Mongolian Pharmacy and Pharmacology 2013;2(1):46-
Background: The investigational new medicine “Chlorphenos 100 ml” is being developed to treat allergy, flu, and inflammatory diseases.[1] The main biologically active substance chlorphenamine maleate blocks histamine H1 receptors and reduces tearing and swelling of the nasal mucosa.[7,9] In this study, “Chlorphenos 100 ml” was tested to see if it met standards for a syrup medicine published in national and international pharmacopeia.[1,7]Goals: The aim of this study was todevelop a new generic syrup medicine technology and standardization procedures.Materials and Methods: “Chlorphenos 100 ml” was prepared following general methods used to produce syrup medicines.[4] Based on the standardization protocols of national and international pharmacopeia, the presence of chlorphenamine maleate was determined using thin-layer chromatograpy and the chlorphenamine maleate content was established using spectrophotometer techniques.[2,3, 8] The pH and the density of the syrup medicine were determined using potentiometric and hydrometric methods respectively. [4,5]Results: The Rf value of the sample from the syrup medicineandthestandardchlorphenaminemaleatewas identical. The main active ingredient chlorphenamine maleate concentration was determined to be 0.43 mg/ ml. The pH of the syrup was measured to be 4.17 and the density was 1.174 mg/ml.Conclusion: The results of this study indicated that the investigational new drug Chlorphenos 100 ml meet the standards set forth in the national and international pharmacopeia. Theseresult also validate thetechnological protocol used to produce Chlorphenos 100 ml syrup. Therefore this medicine is determined to be suitable for factory production.Key words: Chlorphenaminemaleat, Chlorphenos syrupReferences1. China pharmacopeia 2005, page 185 chlorphenamine maleate2. Derivative Spectrophotometry for Simultaneous Analysis of Chlorpheniramine Maleate, Phenylephrine HCl, and Phenylpropanolamine HCl in Ternary Mixtures and Pharmaceutical Dosage Forms. Maryam Kazemipouraand Mehdi Ansarib*3. Simultaneous spectrophotometric determination of paracetamol, phenylephrine and chlropheniramine in pharmaceuticals using chemometric approaches. Khoshayand M.R., Abdollahi H., Ghaffari A., Shariatpanahi M., Farzanegan H.4. Erdenetsetseg G, Khandsuren S, “Medicinetechnologicalvolume I”sweet juice syrup, page 3145. Mongolian national pharmacopeia 2011 page 541, 5446. Friedrich Kluge, Etymologisches Wörterbuch derdeutschen Sprache 2002, 24. Auflage.7. Gisela Wurm, Galenische Uebungen, 1989, 12Auflage, S 1588. EuropianPharmacopia, Fifth edition, Volume 1, S 609

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