Abstract 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 we 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. Prevention of cross contamination is one of the most significant conditions of Good Manufacturing Practices for drugs. This is especially topical for a multipurpose (shared) manufacture where several medicinal products, including drugs of different pharmacotherapeutic groups, are produced using the same facilities (manufacturing areas, workrooms, and equipment). The industry is able to achieve these key goals with the help of implementation of GMP. Therefore, a perfect cleaning method is required for avoiding the possibilities of contamination and cross contamination, for this a validated program is required, this program is known as cleaning validation. “Cleaning validation is documented evidence which assure that cleaning of equipment, piece of equipment or system will obtain pre-determined and acceptable limits”.

Introduction: Nowadays, there is a growing trend to use natural medicines with low side effects, and research on medicinal raw materials used in traditional medicine has become more widespread. Therefore, it is important to obtain a suitable drug form from Plantago Major L and to conduct chemical and pharmaceutical technology research. Material and method: The research was conducted in the pharmaceutical industry and technology laboratory. A granule formulation with several variants consisting of a concentrated extract and excipients was obtained. The sum of flavonoids of Plantago Major L extracts and Granular Dosage Forms was detected by thin-layer chromatography in a suitable solvent system prepared in the ratio of ethyl acetate, formic acid, glacial acetic acid, and water (100: 11:11:26). The total flavonoid content of the drug forms was determined by spectrophotometry. Result: Technological researches were carried out with lactose and glucose fillers, gelatin 8%, polyvinyl chloride (PVP) 6%, starch 5% binders, talc 1%, magnesium stearate 1% sliding and lubricating agents and the wet granulation method was used to obtain granules in several variants and was determined by using parameters such as particle spill weight and flow quality. In this research, the flow rate of Plantago Major L grains with lactose as a filler and PVP as a binder was -2.8 ± 0.18 g / sec (p <0.001) and the spill weight was -0.54 ± 0.03 g /cm3 (p <0.001). Based on the results of the above research, lactose was added as a filler, PVP as a binder, 6% as a slide and lubricant, 3% as talc and 1% as magnesium stearate, and the granular drug technology was developed by wet granulation. Analysis of the total flavonoids by thin-layer chromatography revealed the same level of yellow-brown spots (Rf = 0.4) on the plate. The total flavonoid content of the granules from Plantago Major L was 3.8 ± 0.2% (p <0.002). Conclusion In this study, a simple and suitable drug formulation from Plantago Major L was successfully obtained and it was a basic research to make new drug formulations in further needs.

Abstract: The basis of the development of traditional medicine in the XXI century is to study the old medical books and scriptures created by ancient Mongolian doctors and scientists of previous generations. For example, it is important to deepen the scientific understanding of “Man ngag rin chen ‘byung” written by Mongolian doctor ‘Jam dpal chos kyi bstan ‘dzin phrin las in Tibetan, and to understand the content and charms of the Man ngag rin chen ‘byung. Purpose: Sampling and analysis of experimental prescriptions in the “Man ngag rin chen ‘byung” written by Mongolian doctor ‘Jam dpal chos kyi bstan ‘dzin phrin las in Tibetan. Research methods: Methodologies of ancient textbook analysis and check list of textbook were used. Conclusion In the concluding remarks of the “Man ngag rin chen ‘byung” written by Mongolian doctor ‘Jam dpal chos kyi bstan ‘dzin phrin las, it was stated that there are many medicinal raw materials in the practice. He mentioned that: “I have summarized the benefits of medical literature written by the ancient doctors of Mongolian medicine to facilitate for people to learn.” An analysis of this sentence reveals that in the current understanding of medical science, it is evidence-based practice (EBP).

Introduction : The roots of Sophora Flavescentis is one of the key ingredient in Norbu 7 traditional medicine, the bioactive compound being quinolizidine alkaloids, matrine and oxymatrine. A high performance liquid chromatography (HPLC) method was used to determine matrine, oxymatrine simultaneously in the traditional medicine. The HPLC method was tested and validated for selective determination of matrine and oxymatrine in the Norbu 7 granule. 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. Goal: The goal of this study was to develop validated determination method of alkaloid in Norbu 7 granule for quality control. Material and Method: HPLC analysis was performed on Chromecore amino bonded silica gel as the stationary phase (250 mm : 4.6 mm i.d., 5µm) using mixture of acetonitrile, dehydrated ethanol and 3% phosphoric acid (80:10:10) as the mobile phase, 220 nm as the UV light detection.
The research methodology was approved by Research Ethic Review Committee of Mongolian University of Pharmaceutical Science on 16th of November, 2020. Results: The calibration curve of oxymatrine showed good linearity (R2=0.9955) within the established range of 8 – 64 µg/ml. The limit of detection (LOD) and quantification (LOQ) were 10.13 µg/ml and 30.71 µg/ ml respectively. Good results were achieved with repeatability (%RSD < 2.0) and recovery (93.08 – 104.32%). Conclusion The method was found to be selective, accurate, reproducible and the other components did not interfere with determinations. It was successfully used to analyze the granule traditional medicine with 7 different plant formulation and additives. The HPLC method can be used to evaluate and control quality, stability of Norbu 7 granules.

Introduction: Astragalus is the largest member of the Fabaceae family of about 3,000 species on all continents except Australia, and the Astragalus mongholicus Bunge and the Astragalus membranaceus (Fisch.) Bge are studied and widely used. Astragalus contains polysaccharides, saponins, flavonoids, amino acids and trace elements, so it has a variety of pharmacological effects and is active in supporting the immune system and protecting the liver, heart and kidneys. Objectives: A joint research team of the “Tsombo Pharm” Co., LTD and the Drug research Institute is conducting an experiment to produce an injectable solution from Astragalus mongholicus Bunge. The aim is to expand these previous studies to determine the main parameters of the “Монгол хунчир” injection drug technology. Methods: The quality of the injection was assessed by the following parameters. These include: appearance, color of the injection solution, mechanical mixture sensing method, solution filling volume method, solution environment potentiometry method, solution clarity comparison method, insoluble particle size microscopy method, heavy metal mixture atomic absorption spectroscopy method and calicosine-7-o-β-d-glycoside content was determined by HPLC. Results: According to the results of the study, the injectable drug was weak yellow, clear, free of mechanical impurities and heavy metal content, filling 2 ± 0.001 ml, pH 6.5, insoluble particle size greater than 10 μm, 3 particles per 1 ml, small particles larger than 25 μm were present in 1 ml. Calicosin-7-o-β-d-glycosides were identified in the “Монгол хунчир” injection as having the same standard and sample peak times, with the standard substance being detected at 9.003 minutes and the sample solution at 9.016 minutes (Picture 1, 2). In addition, the injection sample contained 0.0477 ± 0.0021 mg / g of calicosin-7-o-β-d-glycoside, and 0.0451-0.0551 mg / g was considered appropriate for further standardization. Conclusions The “Монгол хунчир” injection meets the general requirements for injection in accordance with the Mongolian National Pharmacopeia 2011. This shows that the technological parameters developed by our research team are appropriate.

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.

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.

Introduction: Pyridoxine hydrochloride is least expensive supplement named as a vitamin 6¹. Pyridoxal kinase is the enzyme that produces pyridoxal phosphate which known as pyridoxine hydrochloride that occurs in the human body. Diabetes, age and neurodegenerative diseases complications can be reduced by pyridoxine hydrochloride^{2 3}. Quantification of pyridoxine hydrochloride in neurorubin as an injection form was developed by high performance liquid chromatography (HPLC) method. 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 roughness. The developed method exhibited the best results in terms of the aforesaid validation parameters. The method was found to be selective, simple, economical, accurate, reproducible, rapid and reliable for routine estimation purpose of pyridoxine hydrochloride in injection. Goal: The aim of this study was to develop the validation method of pyridoxine hydrochloride in injection. Material and Methods:
I) Test Article. As a test article neurorubin injection was produced by Tsombo Farm LLC. The standard pyridoxine hydrochloride was supplied from Sigma Aldrich Co.
II) Reagents and Equipment. The reagents were HPLC grade acetonitrile methanol, and purified water. Balance, and micropipette used as equipment. Shimadzu HPLC (LC20AD) was used as the analytical instrument and the analysis conditions were as follows (Table 1). Results The calibration curves for pyridoxine hydrochloride 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 12.5-100 pg/mL. The linear correlation coefficient (R²) for all calibration curves was higher than 0.995 for all analytes. The LOD and LOQ for pyridoxine hydrochloride were in 15.29 pg/mL and 46.33 pg/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 1.669 % and 1.678 % the accuracy remaining between 95.25 to 102.775 %. The resulting accuracy data were satisfactory for the quantitative analysis of pyridoxine hydrochloride in neurorubin injection.
The results of summarized in table 2, 3, 4. This article presents a simple, accurate, reproducible, and thoroughly validated HPLC-based method for qualitative and quantitative analysis of pyridoxine hydrochloride, as part of the quality assessment of products containing in injection.

Introduction: Shilajit and Rhodiola Rosa L are widely used in Mongolian Traditional medicine for the management of diseases and for fracture healing. The aim of this study was to evaluate the pharmacology effects of the “Vitos” Shilajit Shot preparation on fracture healing and callus stages in rats by X-ray. Material and methods: We used non-liner Wistar rats for in vivo experiments, there are sixteen rats were randomly grouped as a positive control, negative control, “Vitos” Shilajit shot experimental and standard groups. The positive group was as healthy animals and other groups were created femoral fracture by Bonnaren’s device. Then negative control group was oral administered distilled water, whereas 4.1ml/kg of “Vitos’ Shilajit shot administrated via oral gavage to experimental group through 56 days. X-rays were performed to assess fracture healing effects within 14, 28, 42, 56 days and callus stages. Results: Significantly higher callus volume and callus staging were observed in the “Vitos” Shilajit shot group compared with the negative control and standard groups. Also “Vitos” Shilajit shot group was becoming as bridging between both end of fractures and get hard callus formulation ready observation of X-Ray radiograph on 4 weeks post fracture. The fracture healing process was slightly reached to callus remodulation such as final stage of bone formulation on 56^th day. Conclusion The results of this study reveal that, “Vitos’ shot preparation, which contains an extract of Rhodiola Rosa L and thick extract of Shijilat has a treatment effect and enhancing and supporting callus of bone fracture healing.

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.