1.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.
2. SOME QUESTIONS OF FORENSIC MENTAL EXAMINATION IN THE PERIOD OF 2006-2013 YEARS
Battulga L ; Amgalan E ; Nasantsengel L ; Gantsetseg T
Innovation 2015;9(1):92-94
To analyze the results of the forensic psychiatric examination in the period of time from 2006 to 2013 year.We analyze retrospectively 7180 material of clients attended to forensic mental examination in the National center of mental health from 2006 to 2013 year.From all 7180 clients that attended to forensic mental examination in the 2006-2013 the 1165 clients or 16.2% were with mental disorders. The 543 clients or 7.5% of all attended to examination were with mental retardation and 59.8% of mentally retarded clients were with mild mental retardation, 33.8% with moderate, 5.3% with severe and 0.9% with profound mental retardation. The 97.3% (n=6989) of all clients investigated first time, 158 or 2.2% second time, and 33 or 0.45% third or fourth time. From 7062 criminal cases 4.98% or 352 investigated clientsdeemed incompetent and from 115 civil cases 57.3% or 66 clients deemed incompetent. From the clients with mental retardation deemed incompetent in criminal cases the 23.5% and 7.5% in civil cases.Results of the analysis show that about 16.2% of all investigated clients have some mental disorders and 46.6% of them have mild mental retardation.
3.Comparative study of fatty acid composition of anti-cancer Ellipin preparation at the production stage
Badamtsetseg S ; Bayanmunkh A ; Uuganbayar M ; Battulga B ; Radnaeva L D ; Lkhagva L ; Khurelbaatar L
Mongolian Medical Sciences 2014;170(4):73-77
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.
4.Technological and standardization study of “tomuun ” 100 ml syrup medicine
Battulga G ; Oyunbileg S ; Khurelbaatar L
Mongolian Medical Sciences 2012;162(4):98-102
BackgroundOn the basis of criteria and indicators of national and international pharmacopoeia pharmacopoeia medicament in syrup determined the composition. On formulations of sweet juice syrup medicine Tomuun received 100 ml. Improved composition drazhzhe “Tomuun 5g,” which made us and added substance has antihistaminic action - chlorphenamine maleate. This additional structure of the flu as well as infectious and inflammatory diseases have a symptomatic effect, that is, reduces tearing, nasal swelling of the nasal mucosa. As the research result shows, Tomuun syrup 100 ml contains ascorbic acid 10.2 ml / mg, paracetamol 2.5 mg / ml, chlorphenamine maleate 0.41 mg / ml.GoalsThe aim of this study was to develop a new generic medicine’s technology and standardization producers. Materials and MethodsSeveral methods have been used for technological producers and chemical analysis in this study. “Tomuun 100 ml” syrup medicine prepared for general cooking techniques syrup medicine. Indicators for Standardization syrup medicine “Tomuun 100 ml” developed on the basic documents of national and international pharmacopoeia. The thin-layer chromatography and HPLC methods used for determining the content of paracetamol and ascorbic acid.ResultsWe have researched the indication syrup medicine for production technology and projected the standardization producers on syrup medicine according to national and international pharmacopoeias.ConclusionAs results from this study shows that “Tomuun” syrup medicine is suitable for several above mentioned criteria and used technological and chemical methods such as HPLC and thin layer chromatography are acceptable for generic medicine’s standard documentation for this medicine.
5. 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
6.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.
7.The study of plants and minerals with wound-healing activities
Erdenetuya O ; Munkhjargal N ; Battulga G ; Davaasambuu T ; Narangerel B ; Hurelbaatar L
Mongolian Medical Sciences 2012;162(4):91-97
BackgroundThe works done during the research include: conducting photochemical study on the surface of the piece of land on which the medicinal herbs chosen as samples for the research grow; extracting dry infusion from plants; identifying main substance and antibacterial activity of dry infusion; conducting pilot pharmacological experiment with mineral samples.GoalBased on the results of these experiments, we aimed at finding out wound healing functions of Chelidonium majus. L, Stellerae chamaejasme.L etc, widely used in both conventional and modern medicine as well as of such minerals as Sinder, Zeolite, Tormohon, Baragshun after selecting from them.Materials and MethodsAlkaloid, a biologically active substance found in surface of plant land and dry infusion, was determined by titration method, alkaloids such as protopine and berberine by high performance liquid chromatography, coumarin and flavonoid by spectrophotometric method, the amount of infusible substance by scale method. The methodologies of Gatsura.N and Avtandilov.G.G were adopted to make artificial wound on skin and to heal a wound respectively.ResultsAs the research result shows, the surface of the area where Stellerae chamaejasme.L grow, contains 0.33% ±0.004 total coumarin, 0.19 % ±0.002 flavonoid and 37.14 % ±0.61 infusible substance while that of Chelidonium majus.L contains 0.19% ±0.003 total alkaloid, 0.12 % ±0.004 flavonoid, 0.09 % ±0.002 coumarin and 36.27%±0.74 infusible substance. After the infusion was extracted from Stellerae chamaejasme.L and Chelidonium majus.L through method of percolation with mixer, there were 16% and 14.5% dry substance remained in the infusions respectively. These figures were reduced to 12.6% and 11.4% after freezing them in -500C for 72 hours in dry freezing. The fact that total coumarin contained in dry infusion of Stellerae chamaejasme.L is 2.95% and protopine and berberine in that of Chelidonium majus.L, is 28 мг,% and 3.7 мг,% respectively meets the requirements for medicinal plant extracts. It was found during the pharmacological experiment of preparing 25% oil ointment composed of minerals including Sinder, Tormohon, Zeolite, Baragshun that zeolite was the highest effective mineral in healing a wound by wound index. Therefore, we chose zeolite as an ingredient of the wound ointment. Oil ointments of 6 variations with 5% and 10% content were prepared from the dry infusion as well as minerals of the study plants, and pilot pharmacological experiment was conducted on an experimental mouse that had an artificial wound. The result of the experiment proved that oil ointments with 5% content of Stellerae chamaejasme.L, Chelidonium majus.L and zeolite were more effective in healing the wound than others.ConclusionBy photochemical analysis, the chosen plants proved to be meeting the requirements for medicinal plants. Pilot pharmacological experiment showed that zeolite was the one that accelerated a wound healing process more efficiently than others. Oil ointments with 5% content of dry infusion and 5% of zeolite were effective in healing a wound quickly.
8.To the problem of colorectal cancer and its pathological diagnose
Adilzaya D ; Galtsog L ; Hosbayar T ; Battulga A ; Tuul B ; Bayarmaa E
Mongolian Medical Sciences 2010;153(3):42-47
BackgroundColorectal cancer takes the second place in the highly developed countries morbidity increases, for females it takes place after breast cancer, for males after lung cancer colorectal cancer occupies about 3-5% from the cancer of digestive tract. In the western Europe, united states of America it occuries 12.6% on males and 14% on females, for Pathological structure it occurs mostly in the proximal part and adenocarcinoma is diagnosed 95%. Colorectal carcinoma occurs more at the age of 20-40 but people aged 40-50 are mostly affected and males are affected more. Lately it has tendency of increasing amond the population 40-120 case on 100000 in a year approximately 5-10 people are affected newly. For our country by health statistical information colon cancer was 94 from it 49 occur on females, cancer of rectal and anus canal was 237, from it 99 occur on females, 37 case of colorectal cancer are registered newly in a year approximately, 19 occurs on females cancer of rectal and anus canal was 45 from them 16 are registered newly on females the number of patients with colorectal cancer has tendency of increasing. Among Mongolian population morbidity of colorectal cancer is increasing nowadays but any research has not been done to reveal pathology early and to diagnose. This became base of our research work.GoalAim of our study is to define peculiarity of colorectal cancer and its early pathology and to study some factor of aetiology connectea with cancer forming.Objectives:1. To define peculiarity of pathology of colorectal cancer.2. To diagnose early pathology of colorectal cancer by pathological method.3. To diagnose colorectal carcinoma by international histological classification and determine cell secretion degree.4. To define some genetic peculiarity of factors which affects to colorectal carcinoma.Novelty of research workNovelty of research work is to study colorectal carcinoma and its early pathology in combination with the method of endoscopy and molecular biology.Materials and MethodsIn the research 315 biopsy material of 142 patients with colorectal carcinoma of 2004-2008, 56 biopsy material of colorectal endoscopy of 2007-2008 are involved.1. Histological basic painting method.2. Method of molecular biology. We revealed affect of human papilloma virus infection in 39 surgical and endoscopyic material by using general GP5, GP6, MY11 primer in PSR.ResultsIn our study totally 198 people were involved from them (average age 45.8+ - 0.4), 46.0%(n=91)-male, 54% (n=107) female. If we see people involved in the study by age classification, 8 (5.9%) at the age of 20-29, 21 (10.3%) at the age of 30-39, 39 (19.3%) at the age of 40-49,45 (22.4%) at the age of 50-59, 56 (27.7%) at the age of 60-69, over 70-79 (14.3%). If we see colorectal carcinoma by anatomical location most location was in 45 (22.7%) in sigma, 52 (26.2%) in rectus. Seeing from endoscopic biopsy analyse pathology which involved whole colorectus occupied 10 (35.6%). By international histological classification of cancer which was adopted from WHO. In our study polyp occupies 21 (10.6%), adenoma 24(12.1%), adenocarcinoma 137 (69.2%), metastatic carcinoma 6 (3%), chronic inflammation or with change dysplasia 10 (5.1%). If we see endoscopic biopsy analyse it is 56 (28.3%) of people involved in the research. Hyper plastic polyp 21 (36.1%), adenoma 6 (25%), adenomatous polyp 8 (33.3%) occupces, Tubular adenoma polyp 7 (29.2%), villous adenoma 3 (12.5%) from carcinoma adenomatous carcinoma occupces 98 (71.5%), mucous carcinoma 7 (5.1%), carcinoma with flat cell 8 (5.8%), carcinoma with ring cell 5 (5.1%), carcinoma witout secretion 13 (9.5%), carcinoma with metastases 6 (4.3%), one of factors of etiology which affects to colorectal carcinoma is human papilloma virus. In the biopsy material of surgery and endoscope involved in the research it reveals negative in sensitive primer which reveals all the type of papilloma virus.Conclusions:1. Colorectal carcinoma occurs 19.3% at the age of 40-49, 22.4% at the age of 50-59, 27.7% at the age of 60-69, it has tendency of increasing rohen age becomes older. It occurs 14% over 70.2. By location of anatomy colorectal carcinoma it occupies 50-60% in sigma and rectus.3. Noncarcinomous polyp of colorectal carcinoma is situated in many parts of intestine carcinoma with many polyp occupies 35.6%of total carcinoma.4. By histological classification mostly carcinomous and noncarcinomous carcinoma of epithel and adenomous cell originated occupy.5. Papilloma virus hasn’t been releaved in the sample endoscopic sample.
9.Investigation of bile secretion and hepatoprotective effects of “Sillichol” biological active product
Badamtsetseg S ; Davaasambuu T ; Oyunchimeg B ; Battulga B ; Odchimeg B ; Sosorburam B ; Chimgee TS ; Ariunsaikhan TS ; Lkhagva L ; Hurelbaatar L
Mongolian Medical Sciences 2016;176(2):52-59
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.
10.Method Validation of Dihydromyricetin in Anti-hangover preparation by High Performance Liquid Chromatography
Battulga B ; Badamtsetseg S ; Bayanmunkh A ; Tsetsegmaa S ; Lkhagva L ; Khurelbaatar L
Mongolian Medical Sciences 2019;189(3):54-61
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.