1.Some issue of cleaning validation of Diclofenac sodium retard 100 mg tablets
Mongolian Pharmacy and Pharmacology 2022;21(2):10-16
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.
2.Assessment of midwifery integrated competencies of midwives in Mongolia, 2016
Suvd B ; Tsetsegmaa P ; Otgonbaatar J ; Purevsuren G ; Davaasuren S ; Buyanjargal YA
Mongolian Medical Sciences 2017;179(1):30-38
Background:
A midwifery services are recognized as one of essential health care and services. The amplification of trained midwives plays very important role to improve the quality of and access to health care services as highlighted in the global Human Development Report [1]. Obstetric care is the integrated specialized interventions aimed to detect, monitor, manage delivery, treat and prevent illnesses of mothers, fetus and newborns in pregnancy, childbirth and postnatal periods. Every year, 287,000 women die from complications related to pregnancy and childbirth, and 2.9 million newborns die before they reach the age of four weeks worldwide. The majority of the preventable maternal and newborn deaths occur in low-income countries [3].
Goal:
This assessment was aimed to review the current situation and legal framework of midwifery services and comprehensive competencies of midwives, and to provide baseline data for the project as well as evidence based recommendations for further improvement of midwifery services in Mongolia.
Materials and Methods:
In order to assess the current status of midwifery services and integrated competencies of midwives, a range of quantitative and qualitative methods were used. A cross- sectional study for assessing the quality of obstetric care and practice was conducted by using observation checklists, questionnaires and interview guides. Midwives who are providing obstetric care in Mongolia were involved in the assessment.
Results:
A total of 321 midwives from NCMCH, and 2 maternity hospitals of Ulaanbaatar and 21 aimags were involved in the assessment. Out of them 97.2% were female and the mean age was 37.2±10.1 [95%CI: 36.03-38.21]. The mean of working years in health sector was 14.54±10.9 years and mean of working years with the current institution was 11.7±10.1 years. Minimum work experience was few months and maximum was 38 years. A majority of the assessed midwives hold some abilities sufficiently such as keeping medical documents during pregnancy [4.23; 95%CI: 4.15-4.32], educating and giving advice to the customers about after and before the pregnancy period [4.01; 95%CI: 3.91-4.11]. A majority of the assessed midwives answered holding some abilities as important, such as basic knowledge of mother and child public health care in the fertility system [4.11; 95%CI:4.00-4.21], implementing experiences [4.07; 95%CI:3.97-4.19], and very important documents for the Obstetricians Association to know about midwives’ practical and professional activity [4.05; 95%CI:3.92-4.17]. None of the midwives took “A” or point indicates highest level. 40.5 percent of assessed midwives took “D” or “Able to make a relatively easy content; Lack of general knowledge, skills and practices”. One third of participated midwives took “F” indicating lack of knowledge, skill and practice. Moreover, one fifth of the midwives took “C” indicating average level, understood most of the content, skilled moderately, and prepared enough to practice more in this field. Even though rural midwives got average level (22.0%) score 4.1 functions more than city midwives, it didn’t have any difference in the statistic correlation. 3.3 percent of all participant 7 midwives took “B” indicating above the average level in the knowledge test. The midwives have told training for them hadn’t organized frequently which is shown in the quality assessment.
Conclusions
Furthermore, it is necessary to increase the skill of midwives who would perform complex care based on clinical evidence to reveal the risks faced to maternal and infant health, prevent from degradation and manage safe birth.
3.Saposhnikovia Divaricata (Turcz.) Schischk.): A review of its phytochemistry and pharmacology
Akhsholpan B ; Tsend-Ayush P ; Saikhanbayar P ; Davaasambuu T ; Oyunchimeg S ; Lkhagva L ; Tsetsegmaa S ; Khurelbaatar L ; Lkaasuren R
Mongolian Pharmacy and Pharmacology 2022;20(1):30-38
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 .