1. COMPARATIVE ANALYSIS OF SOME CAPSULES REGISTERED IN MONGOLIA
Ankhtuya B. ; Oyuntsetseg G. ; Purevsuren S.
Mongolian Pharmacy and Pharmacology 2013;2(1):42-
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
2.Study of warning infection whiten inpatient samples
Bayarjargal D ; Dorjkhand Kh ; Yesunzaya G ; Uyanga Ts ; Ankhtuya S
Health Laboratory 2019;10(2):34-41
Objective:
To retrospectively analyze the drug resistant characteristics and distribution of multi-drug resistant bacteria infection in State Second General Hospital.
Methods:
Total 772 cases treated in our hospital from January 2017 to September 2019 were selected as subjects. The automatic microorganism analyzer VITEC-2 and manual method were used for bacterial identification; Kirby-Bauer disk diffusion method was used for susceptibility test; WHONET 5.6.2019 software and EXCEL 2013 were used to analyze the distribution and drug sensitivity of isolated bacteria.
Results:
Among the 772 strains of multi drug resistant bacteria, the proportion of Gram-negative bacteria was 84.9%, and the proportion of Gram-positive bacteria was 15,1%; fluconazole resistant candida accounted for 3.2%. Multi -drug resistant bacteria mostly distributed in sputum, accounting for 23.5%; 50.5% multi-drug resistant strains were from intensive care unit.
Resistant rates of Escherichia Coli ESBL, Klebsiella ESBL and Enterobacter spp to cephalosporins and penicillin were 100%. Resistant rates of staphylococcus aureus to antibacterial agents; cephalosporins and penicillin were 100%.
Conclusion
Gram-negative bacteria were the main multi-drug resistant bacteria of our study in our hospital, mainly distributing in Intensive care unit patients. They are highly resistant to most antibacterial agents, which provides a theoretical basis for the prevention and control of multi-drug resistant bacteria infection in hospital.
3.Results of Determination of Mean Values and Reference Intervals for Some Vitamins
Enkhjargal Ts ; Khishigbuyan D ; Gantuya P ; Anujin O ; Sodnomtseren B ; Ganbileg D ; Altanchimeg N ; Ankhtuya S ; Naranbat N
Mongolian Medical Sciences 2022;199(1):3-6
Background:
Vitamins are nutrients essential for human health. They act as coenzymes that help trigger important chemical reactions necessary for energy production. Reference values for vitamins help physicians evaluate the health status of patients and make clinical decisions. The aim of this study was to determine the mean values and reference intervals for some water-soluble vitamins of Mongolian adults.
Materials and Methods:
Three hundred and forty healthy adults (170 males and 170 females) of 17 to 69 years of age were selected for the study based on CLSI C28-P3 criteria Defining, establishing & Verifying reference interval in the clinical laboratory; Proposed Guidelines. The study was approved by the Resolution No.76 of 2018 of the Medical Ethics Review Committee of the Ministry of Health. Informed consents were taken from the selected individuals. Morning blood samples of the participants were collected under aseptic conditions. Levels of vitamins B6, B9, B12 and vitamin C were measured using a high performance liquid chromatography method. The lower- and upper reference limits were defined as the 2.5th and 97.5th percentiles, respectively. The data were analyzed using SPSS and Excel programs.
Results:
The mean blood level of vitamin C was 11.88 mg/L (95% CI 10.47-13.29) for men and 9.62 mg/L (95% CI 8.11-11.13) for women. The calculated reference interval for males was 1.40-19.40 mg/L and 1.17-18.04 mg/L for females. The mean concentration of vitamin B12 in the blood of males was 938.45 ng/L (95% CI 747.22-1129.68) and that of females was 864.03 ng/L (95% CI 603.81-1124.25). The reference interval for vitamin B12 was 233.03-1597.00 ng/L in men and 132.45-1623.86 ng/L in women. The mean level of vitamin B9 was 8.47 ng/mL (95% CI 5.64-11.30) for men and 6.91 ng/mL (95% CI 4.89-8.93) for women. The calculated reference interval for this vitamin in males was 1.04-24.74 ng/mL and that in females was 1.04-21.46 ng/mL. As for vitamin B6, the mean concentration for men was 44.42 ng/mL (95% CI 37.01-51.83) and for women was 34.67 ng/mL (95% CI 29.97-39.39) with the reference intervals of 5.90-79.02 ng/mL for men and 5.27-61.72 ng/mL for women.
Conclusion
The reference values for vitamins B6, B9, B12 and vitamin C of Mongolian adults do not differ significantly from those observed in other populations. The calculated reference intervals can be used in the practice of health laboratories.
4.Mean Values and Reference Intervals for Some Minerals
Enkhjargal Ts ; Khishigbuyan D ; Sodnomtseren B ; Gantuya P ; Altanchimeg N ; Ganbileg D ; Ankhtuya S ; Naranbat N
Health Laboratory 2020;11(1):14-17
Background:
Minerals are important for the proper body functioning. They also play a role in preventing and fighting diseases. Reference values for minerals help physicians evaluate the mineral status of patients and
make clinical decisions. The aim of this study was to determine the mean values and reference intervals for some minerals to be used for evaluation of the nutrition status of Mongolians.
Materials and Methods:
Two hundred and forty healthy adults (120 males and 120 females) of 17 to 70 years of age were selected for the study based on CLSI C28-P3 criteria Defining, establishing & Verifying reference interval in the clinical laboratory; Proposed Guidelines. The study was approved by the ethical committee of the Ministry of Health of Mongolia. Informed consents were taken from the selected individuals. Morning blood samples of the participants were collected under aseptic conditions. Levels of iron (Fe), zinc (Zn) and copper (Cu) were measured by graphite furnace atomic absorption spectrometry. The lower and upper reference limits were defined as the 2.5th and 97.5th percentiles, respectively. The data were analyzed using SPSS and Excel programs.
Results:
The mean level of blood iron was 30.50 µmol/L (95% CI 29.71-31.29) for men and 30.91 µmol/L (95% CI 30.03-31.79) for women. The calculated reference interval for males was 21.39-37.72 µmol/L and 19.87-39.67 µmol/L for females. The mean concentration of zinc in the blood of males was 11.00 µmol/L (95% CI 10.69-11.31) and that of females was 11.79 µmol/L (95% CI 11.39-12.19). The reference interval for blood zinc was 8.20-14.92 µmol/L in men and 8.52-16.67 µmol/L in women. The mean level of blood copper was 15.28 µmol/L (95% CI 14.64-15.89) for men and 18.08 µmol/L (95% CI 17.30-18.86) for women. The calculated reference interval for copper in males was 9.72-22.34 µmol/L and that in females was 11.18-27.27 µmol/L.
Conclusion
The reference values for zinc, copper and iron of Mongolian adults do not differ significantly from those observed in other countries. The calculated reference intervals can be used for evaluation of the nutrition status and making clinical decisions.
5.Average values and reference ranges for some haematological parameters of Mongolian adults
Altanchimeg N ; Enkhjargal Ts ; Hishigbuyan D ; Sodnomtseren B ; Ganbileg D ; Ankhtuya S ; Naranbat N
Health Laboratory 2020;11(1):24-27
Background:
Reference values are very important for the clinical decisions in laboratory diagnosis and clinical management of patients.
Method:
A total of 340 adults (apparently healthy individuals) between 18 to 70 years resident in the Ulaanbaatar city were randomly selected and enrolled in this survey. 340 adults made up of 170 males, 170 females were assessed by a clinician to be healthy. About 5 ml of blood was collected with EDTA test tube and analyzed using automated analyser to enumerate the hematological parameters (red blood cell, white blood cell, hemoglobin and haematocrit). Reference values were determined at 2.5th and 97.5th percentiles.
Results:
Reference values estabilished include: red blood cell 4.69-6.04×1012/L, white blood cell 3.98-9.11×109/L, haemoglobin 145-176 g/L, haematocrit 42.6-52.9% for males and red blood cell 4.10-5.20×1012/L, white blood cell 3.50-9.08×109/L, haemoglobin 121.8-148.2 g/L, haematocrit 36-44.7% for females.
Conclusion
We were determined mean and reference range of haematological parameters (red blood cell, white blood cell, haemoglobin, haemotocrit) which are important for assessing the nutritional status of adults according to the international standard methodology. The international reference range shows that white blood cells counts do not indicate gender and our data (р=0.0964 are statistically insignificant) also offers no significant difference was found between samples for male and female subjects.
6.Average values and reference ranges for blood proteins of Mongolian adults
Gantuya P ; Enkhjargal Ts ; Khishigbuyan D ; Sodnomtseren B ; Altanchimeg N ; Ganbileg D ; Ankhtuya S ; Naranbat N
Health Laboratory 2020;11(1):28-32
Background:
We set the average value and reference range of blood plasma proteins (total protein, albumin, transferrin, retinol binding protein, prealbumin) to be used to assess the nutritional status of Mongolian adult. According to step by step research methodology, 170 women, 170 men and a total of 340 people were surveyed using a combination of questionnaires and analytic methods.
Methods:
The total protein and albumin content of the collected samples was analyzed by colorimetric method using “Humalyzer 2000” semi automatic analyzer and prealbumin, transferring and retinol binding protein was analyzed by ELISA method of “ELX 880”. The lower limit of the reference value of the identified parameters was calculated to be 2.5 per centil and the upper limit was 97.5 per centil.
Results:
Determining average and reference range of proteins in the plasma of a total 340 participants, the average of total protein was 74.54(CI 95%; 72.67-76.38) g/l for men, and 73.59(CI 95%; 72.39-74.79) g/l for women, while the reference range was 55.26-95.79 g/l for men and 58.38-84.72 g/l for women. According to determined above, there is no statistically significant difference in gender (p>0.40). The average albumin level is 48.20(CI 95%; 47.04-49.36) g/l for men and 46.28(CI 95%; 45.32-47.24) g/l for women, while reference range is 37.14-60.01 g/l for men and 34.97-57.60 g/l for women. It means there is a statistically significant difference for the gender (p=0.012). The average prealbum level is 332.43(CI 95%; 311.28-353.58) mg/l for men, 381.67(CI 95%; 360.98-402.36) mg/l for women, while reference range is 171.3-485.0 mg/l for men and 215.5-535.0 mg/l for women. It means there is a statistically significant difference for the gender (p=0.0012). The average range of transferrin 4.01(CI 95%; 3.76-4.26) g/l for men and 4.43(CI 95%; 4.20-4.66) g/l for women while reference range is 2.20-6.92 g/l for men and 2.58-7.05 g/l for women, is a statistically significant difference for the gender (p=0.017). The average level of retinol binding protein is 1.73(CI 95%; 1.61-1.85) μmol/l for men and 2.01(CI 95%; 1.89-2.13) μmol/l for women, while reference range is 0.73-3.08 μmol/l for men and 0.73-3.08 μmol/l for women, is a statistically significant difference for the gender (p=0.0017).
Conclusions
For the first time we conducted a study to determine the average amount and reference range of proteins needed to assess the nutritional status of adults (total protein, albumin, prealbumin, transferring, retinol binding protein) according to international standard methods, which is relatively high compared to other researchers. According to the result of the study, it is not possible to directly follow the result of researchers from other countries and the reference range of blood proteins directly to Mongolians. The result of this study has become an important innovation in practice and treatment, as medical professionals have been able to use it in their diagnosis and treatment.