The national occupational standarts of pharmacy technician / Монголын эм зүй, эм судлал

Abstract@#National Occupational Standards specify standards of performance that people are expected to achieve in their work, and the knowledge and skills they need to perform effectively. The National occupational standards for supporting teaching and learning in schools were developed to help improve the capacity and capability of the school workforce; they can make an important contribution to raising standards in schools.</br> National Occupational Standards describe best practice by bringing together skills, knowledge and values. They are valuable tools as benchmarks for qualifications as well as for defining roles at work, staff recruitment, supervision and appraisal.</br> Globally the roles and scope of work for technicians and pharmacy support workforce cadres vary greatly according to country and practice areas within that country. The School of Pharmacy MNUMS and Mongolian Association of Clinical Pharmacist and Association of Pharmaceutical Management has developed 4 phases National Occupational Standards.

Total phenolic, flavonoid, alkaloid and iridoid content and preventive effect of Lider-7-tang on lipopolysaccharide-induced acute lung injury in rats.

Lider-7-tang, a medicine used for the treatment of respiratory diseases especially pneumonia and fever in Mongolian Traditional Medicine, was selected for this phytochemical and pharmacological study. The objectives of the study were to determine total biological active substances and analyze the effects of Lider-7-tang treatment in rats with acute lung injury (ALI). Quantitative determination of the total active constituents (phenolic, flavonoid, iridoid and alkaloid) of the methanol extract of Lider-7-tang was performed using Folin-Ciocalteu reagent, aluminum chloride reagent, Trim-Hill reagent, and Bromocresol green reagent, respectively. A total of fifty 8-10-week-old male Wistar rats (200-240 g) were randomized into three groups: control group, lipopolysaccharide (LPS) group (7.5 mg/kg) and LPS+Lider-7 group (90 mg/kg Lider-7-tang before LPS administration). The total content of alkaloids was 0.2±0.043%, total phenols 7.8±0.67%, flavonoids 3.12±0.206%, and iridoids 0.308±0.0095%. This study also evaluated the effects of Lider-7 on levels of inflammatory mediators by observing histopathological features associated with LPS-induced ALI. The rats pretreated with Lider-7 had significantly lower levels of IL-6 (at 3 and 6 h), and TNF-α (at 3, 6, 9, and 12 h). The current study showed that Lider-7 exerted a preventive effect against LPS-induced ALI, which appeared to be mediated by inhibiting the release of pro-inflammatory cytokines.

Total phenolic, flavonoid, alkaloid and iridoid content and preventive effect of Lider-7-tang on lipopolysaccharide-induced acute lung injury in rats

Lider-7-tang, a medicine used for the treatment of respiratory diseases especially pneumonia and fever in Mongolian Traditional Medicine, was selected for this phytochemical and pharmacological study. The objectives of the study were to determine total biological active substances and analyze the effects of Lider-7-tang treatment in rats with acute lung injury (ALI). Quantitative determination of the total active constituents (phenolic, flavonoid, iridoid and alkaloid) of the methanol extract of Lider-7-tang was performed using Folin-Ciocalteu reagent, aluminum chloride reagent, Trim-Hill reagent, and Bromocresol green reagent, respectively. A total of fifty 8-10-week-old male Wistar rats (200-240 g) were randomized into three groups: control group, lipopolysaccharide (LPS) group (7.5 mg/kg) and LPS+Lider-7 group (90 mg/kg Lider-7-tang before LPS administration). The total content of alkaloids was 0.2±0.043%, total phenols 7.8±0.67%, flavonoids 3.12±0.206%, and iridoids 0.308±0.0095%. This study also evaluated the effects of Lider-7 on levels of inflammatory mediators by observing histopathological features associated with LPS-induced ALI. The rats pretreated with Lider-7 had significantly lower levels of IL-6 (at 3 and 6 h), and TNF-α (at 3, 6, 9, and 12 h). The current study showed that Lider-7 exerted a preventive effect against LPS-induced ALI, which appeared to be mediated by inhibiting the release of pro-inflammatory cytokines.

Public Health Service Needs of Pharmacy Customers / Шинэ санаа Шинэ нээлт

Although all the pharmacy programs (1 public and 2 private) in Mongolia comply with the national standard for pharmacy higher education D 723400 (MNS 5323-126: 2012), competence based learning has not been introduced yet. Also, pharmaceutical public health service needs have not been assessed in community pharmacies of Mongolia. Our goal was to assess the learning needs of pharmacists’ public health competencies and link pharmacy education with the health needs of populations.This cross-sectional, in-pharmacy survey was conducted in a simple random sample of community pharmacies in 6 districts of Ulaanbaatar city central region, which provide price discount on selected drugs through national health insurance. The survey was developed with evidence for reliability and validity and focused on two main needs assessment: pharmaceutical public health (PPH) serviceprovision and PPH competencies learning. Open ended and 3 point scale (1=great benefit; 2=some benefit; 3=no benefit) questions were used to obtain: general information, public health service knowledge, and needs of learning PPH competencies. Descriptive statistics and comparisons using STATA 13 were performed.A total of 248 surveys were obtained (pharmacists n=82; customers n=166). Pharmacist knowledge/skills greatly impacted the public’s decision to use expanded services. The customers reported high levels (75.3%) of needs with pharmacists providing advice on health promotion and healthy life style. 47.6% of the pharmacists replied having knowledge on health promotion and disease prevention is a great benefit to their practice.Our findings indicate that the public is very interested in pharmaceutical public health services and believe they will benefit. Also pharmacists need to be trained ecessary competencies.

Results of ongoing stability studies of medicines / Монголын Анагаах Ухаан

Introduction. The safety and effi cacy of fi nished pharmaceutical products depend on its stabilityattribute. Stability requirements were included for fi rst time in Good manufacturing practice standardMNS 5524:2014. The pharmaceutical manufacturer is responsible to conduct stability studies and tosubmit the report as part of marketing authorization documentation.Purpose of the study. The purpose of this study is to conduct ongoing stability study of the mostlyproduced domestic medicine to monitor the product over its shelf-life.Materials and Methods. As a material used 2 locally produced Paracetamol (Acetaminophen INN) 500mg tablets (local manufacturer (LM) 1 with batch number 271110, LM 2 with batch number 441110). Asa method we used shelf-life specifi cation: Mongolian national standard of Paracetamol 500 mg tablets,MNS 4358:2007. Testing frequency was at 0 time (when tablets were produced) and at 12, 24 and 36months (study was covered the shelf-life).Results. In frame of this study we defi ned the most produced product as Paracetamol (AcetaminophenINN) 500 mg tablets. From the LICEMED- medicines registration record we found 8 tablets, containingAcetaminophen in 500 mg. Two of them were produced locally. These two products were involved inongoing stability study. Testing results showed that no any stability issues over the defi ned shelf life.Discussion. The shelf life was defi ned as 36 months, initially by manufacturers before productsregistered. After a marketing authorization has been granted, the stability of the fi nished pharmaceuticalproducts should be monitored according to a continuous appropriate program that should be permittedthe detection of any stability issue associated with the formulation in the container closure system inwhich it is marketed.Conclusions. After 36 months, testing results were in acceptable limits, selected products wereremaining their quality over the shelf-life.

Results of the assessment study of GMP implementation level among local pharmaceutical manufacturers / Монголын Анагаах Ухаан

IntroductionCurrently there are 31 pharmaceutical manufacturers in Mongolia. The first standard on Goodmanufacturing practice was adopted in 2005 and during these 9 years the Good manufacturing practicestandard was upgraded twice in 2011 and 2014, and the latest version reached to WHO GMP guidelinelevel.Purpose of the studyAccording to the Law of Medicine and medical devices of Mongolia, all pharmaceutical manufacturersshould comply with the Good manufacturing practice standard MNS 5524:2014. The study was aimedto asses GMP implementation level among local pharmaceutical manufacturers and to define mostlyobserved deficiencies in three categories as “critical”, “major” and “minor”.Materials and MethodAll stable operating pharmaceutical manufacturers were asked to be involved in this study accordingto the Helsinki declaration and 11 of them were involved. Direct observation method was used for thisstudy. WHO guideline on Good manufacturing practice: Main principles and on Sterile products wasused as the criteria of the assessment.ResultsAll deficiencies observed during the study were classified into three groups as critical, major and minorand the frequency was defined.Conclusions:The critical deficiencies are related mainly with the design and general layout of the premises and heatingventilation and air conditioning system. It requires investment and proper planning from the manufacturers.The major deficiencies are mainly related to documentation, qualification and validation.The minor deficiencies are with regard of documentation system, technical requirements of equipmentand storage area condition and its management.For taking corrective actions of major and minor deficiencies do not require investment, but it requirestime, training, implementation, monitoring and continuous improvement from the manufacturer.

Extracts from Leonurus sibiricus L. increase insulin secretion and proliferation of rat INS-1E insulinoma cells.

ETHNOPHARMACOLOGICAL RELEVANCE: Traditional Mongolian medicine (TMM) uses preparations from herbs as one form of medication for the treatment of a diversity of diseases including diabetes mellitus (DM). We evaluated the effect of extracts from the plant Leonurus sibiricus L. (LS), used in TMM to treat typical symptoms of type 2 DM, on insulin secretion, electrophysiological properties, intracellular calcium concentration and cell proliferation of INS-1E insulinoma cells under standard cell culture conditions (SCC; 11.1mM glucose). MATERIALS AND METHODS: Insulin secretion was measured by ELISA, electrical properties were assessed by whole cell patch clamping, intracellular calcium concentration (Cai) by Fluo-4 time lapse imaging, insulin receptor expression was verified by RT-PCR and cell proliferation assessed by CellTiter-Glo® cell viability assay. RESULTS: Insulin released from INS-1E cells into the culture medium over 24h was significantly increased in presence of 500 mg/L aqueous LS extract (LS OWE) as well as methanolic LS extract (LS MeOH/H2O) but not in the presence of the butanol-soluble extract (LS MeOH/BuOH). Acute application of LS OWE resulted in a depolarization of the cell membrane potential paralleled by an initial increase and subsequent decline and silencing of action potential frequency, by KATP channel inhibition, persisting depolarization and an increase in Cai. The electrophysiological effects were comparable to those of 100 µM tolbutamide, which, however failed to elevate insulin secretion under SCC. Furthermore all LS extracts stimulated INS-1E cell proliferation. CONCLUSIONS: The finding that extracts from Leonurus sibiricus L. enhance insulin secretion and/or foster cell proliferation may provide possible explanations for the underlying therapeutic principles in the empirical use of LS-containing formulations in DM and DM-related disorders as applied in TMM.

COMPARATIVE ANALYSIS OF SOME CAPSULES REGISTERED IN MONGOLIA / Монголын эм зүй, эм судлал

Introduction: Mongolian national drug manufacturers produce only 20% of required medicines and most raw materials used for the manufacturing are imported from China [1]. 2574 medicines and active pharmaceutical ingredients were registered in 2011 and 488 of them were antibiotics [2]. There were 36 medicine manufacturers and only two of them manufactured antibiotic capsules in 2010 [3]. In last year number of manufacturing capsule has been increasing.Aim: The main aim of this investigation was to define items of imported and manufactured capsules and do comparative analysis of some capsules and determine types of the capsule drugs registered in Mongolia.Material and methods: Registered medicine list of Mongolia and questionnaire with 22 questions, and capsules of 2 domestic and 3 foreign manufacturers were used for this investigation. Pharmacists working in seven domestic manufacturers were involved in the questionnaire study. Capsules were analyzed at the Drug Control Laboratory of Monos Pharm Manufacturer.Results, conclusion: 10.84% of registered medicines are capsules, of which 16.33% from India, 7.82% from China, 5.78% from Indonesia, 8.5% from Slovenia, and other countries. 3.4% of registered capsules are manufactured in Mongolia.All medicine manufacturers import hard gelatin capsules from China and use for the manufacturing. 71.4% of domestic manufacturers use technological parameters, 57.1% stability and dissolution, 28.5% chemical properties and interaction with active pharmaceutical ingredients and excepients as the main criteria for the capsule selection used for the manufacturing. 40.0% of capsules used for the manufacturing are 0 size capsule.72.2% of manufactured capsules are antibiotics. Quality parameters of imported and manufactured Quality of manufactured and imported Ampicilline capsules were determined in the frame of this investigation. All Ampicilline capsules were met the requirements of MNS 5097:2007.Conclusion: Items of imported and manufactured capsules, selection criteria of capsules used for the manufacturing were determined. Comparative quality analysis of Ampicilline capsule was done and some quality parameters of imported and manufactured Ampicilline capsule were in accordance of MNS 5097:2007.Key words: Ampicillin trihydrate 500 mg, dissolution testReference:1. д. Цэндээхүү, “Эмийн чанарûн хяналтûн зарим асуудалд”, “зшЭ-ийн хүртээмж, хэрэглээ, чанар, аюулгүй байдлûн талаар туршлага солилцъё” олон улсûн бага хурлûн илтгэлийн хураангуй; 2006.2. Эрүүл мэндийн үзүүлэлт 2011. згха-Эмг. уБ. 20113. Эрүүл мэндийн үзүүлэлт 2010. згха-Эмг. уБ. 20104. монгол улсûн эмийн бүртгэлийн жагсаалт 2013

The knowledge about anatomy in the “Four medical tantras” / Монголын Анагаах Ухаан

The exposition of the anatomy of the body has four aspects: (a) the anatomical presentation of the quantities of the bodily constituents; (b) the anatomical presentation of the circulatory system; (c) the anatomical presentation of the delicate, vital points; and (d) the anatomical presentation of thepathways and orifices. The amount of wind (in the body) would fill the urinary bladder whilst the quantity of bile wouldfill the scrotum.1 The quantity of phlegm would fill three cupped handfuls and the amounts of bloodand stool would each fill seven cupped handfuls. The amounts of urine and lymph would each fill fourcupped handfuls whereas the quantities of body oil and fat would each fill two cupped handfuls. Thequantities of nutritive essence and semen would each fill a single handful whilst the amount of brain would fill a single cupped handful. The quantity of flesh is five hundred fist-sizes with the (total) addition of twenty fist-sizes for the thighs and breasts of women and (the amount of menstrual bloodin women would fill two cupped handfuls). The quantity of bones includes twenty-three types. The spinal column consists of twenty-eightvertebrae whilst the ribs number twenty-four. There are thirty-two teeth, three hundred and sixtyfractional bones, twelve types of major joints, two hundred and ten minor joints, sixteen (large)ligaments (behind the knees, in the ankles, in the ante cubital fossae and in the wrists, two adjacent tothe spine, two inside the spine, two in the throat and two in the neck) and nine hundred tendons. There are twenty-one thousand hairs (on the head) and (thirty-five) million hair-pores [sevenmillion above the neck, three million five-hundred thousand on each limb and fourteen million on therest of the body]. Also there are five vital organs, six vessel organs and nine orifices. The ideal size of the (human) body on earth is six feet square (four cubits) (from head to toe and fromfingertips to fingertips of outstretched arms), whereas a malformed body is three and a half of its ownforearm span square.

Trends of health care professionals toward adverse drug reaction reporting / Монголын Анагаах Ухаан

IntroductionThe detection of adverse drug reactions has become increasingly significant because of introduction of a large number of potent toxic chemicals as drugs in the last two or three decades. Adverse drug reaction (ADR) monitoring and reporting activity is in its infancy in Mongolia. The important reason is lack of awareness and lack of interest of healthcare professionals in ADR reporting and documentation.GoalTo evaluate implementation and trends of health care professionals toward adverse drug reaction reporting at first, second and tertiary level hospitals.Materials and MethodA prospective study was carried out in first and second level hospitals of Khentii, Dundgovi, GoviAltai, Selenge and Uvurkhangai provinces, Sukhbaatar, Songinokhairkhan district hospital and First maternaty hospital. From tertiary level hospitals were selected First national hospital, Third national hospital, National center of oncolgy, National center of traumatolgy. The questionnaire survey involved total of 175 doctors and pharmacists.ResultsThe study result have shown that most of health care profeesionals (76 – 80%) of first and tertiary level hospitals have known about legal bases and theie duties for the ADR reporting than health care professionals (69%) of secondary level hospitals. And, pharmacists more activily involve in ADR reporting than doctors. The main reasons of healthcare professionals ADR underreporting were lack of time to report, lack of awarness about ADR and not knowing importance of ADR repoting. The implementetion extent of ADR reporting was in tertiary level hospital better than in secondary level hospitals. Lacking of clinical pharmacists and clinical pharmacologists and unproper activitity of Drug therapeutic committee in secondary level hospitals were the reason of poor implementing and underreporting of ADR.ConclusionThe study result has shown that there is needed to encourage doctors to the adverse drug reporting activity and implementation of drug safety should be strengthen in each level of health care system.

The result of quality parameters determination of amlodipine 10 mg tablet / Монголын Анагаах Ухаан

BackgroundAmlodipine is one of the products included in Mongolian Essential Medicine list. Local drug manufacturers don’t produce this product and our country imports this product from several countries. Drug research institute has developed the technology to produce Amlodipine 10 mg tablet on the scientific basis and quality determination and stability study have to be performed.GoalThe main aim of this study was to perform quality determination of Amlodipine 10 mg tablet. In the framework of this study quality criteria were determined and HPLC method to determine amlodipine content was developed.Materials and MethodsThe appearance and average weight of tablet determined visual and weight test method instead of Mongolian national Pharmacopeia. Friability, disintegration time, dissolution characteristics determined SY-6D tablet tester equipment. Assay method was instead of British and Russian pharmacopeia used by Shimadzu HPLC equipment[3, 4]. Amlodidine besilate standard substance was made by Sigma-Aldrich company. The microbial limit test determined instead of Mongolian national Pharmacopeia.ResultsOn the result of this study the following results were received: average weight 0.177 g, weight range +6.5, - 2.1; tablet friability 99.57%, disintegration time 7 seconds, dissolution 97%, meet the requirement uniformity of dosage unit. HPLC method to determine amlodipine content was developed and suitable condition for HPLC was: column - octadecylsilane 5μm, 4.6 x 150 mm, mobile phase buffer-acetonitrile-methanol (50:15:35), detection - 237 mn. Bacteria, yeasts, mould and Escherichia coli were absence in Amlodipine 10 mg tablet.ConclusionsDetermined quality requirement of Amlodipine 10 mg tablet. The assay method developed suitable condition of HPLC instead of British pharmacopeia. Bacteria, moulds, yeast and Escherichia coli were absence in Amlodipine 10 mg tablet.