1.Some results of the study to establish the quality indicators of tsusan bolor capsules
Burenbat Bo ; Tsetsegmaa S ; Choijamts J ; Dungerdorj D
Mongolian Medical Sciences 2012;162(4):73-77
Introduction
Along with the changes occurred in nutrition, climate over the years, the prevalence of blood disorder related diseases, such as Аllergic purpura (AP), Idiopathic thrombocytopenic purpura (ITP) is increasing. The current perspective of health service is focused on the treatment of AP and ITP by using combined therapeutic methods of modern and Mongolian medical approach. Mongolian traditional medicine has an advantage of reducing complications in reducing the recovery duration and also preventing from re-occurrence. Consequently, there is a need for investigation of formulating clinically effective preparation that complies with pharmaceutical standards.
Objective
The objective of this study was to develop the technology to obtain Tsusan Bolor capsules and establish its some quality criteria indicators.
Materials and Methods
The medicinal raw materials Gardenia Jasminoides Ellis, Rubia cordiofolia L, Picrorhiza serophulariflora Pennell, Arnebia guttatа, Crocus sativus, L, Pulvis Cornus Bubali and Artificial Bezoar were provided by Traditional medicine factory of the Inner Mongolian University for Nationalities, PRC. The L9(34) experiment test was used to obtain the extracts from crude medicinal plants and TLC, HPLS and pharmacopeias methods were used for the establishing quality criteria indicators of the capsules.
Results
Within the technological study the appropriate methods to obtain alcohol and water extracts from the medicinal raw materials and the technological scheme to obtain Tsusan bolor capsules were developed. As the results of quality criteria investigation indicated, the total content of gardenia glycoside is 1.71±0.02 mg, water content- 6.25±0.1%, heavy metal and arsenic content less than 10 μg/g and 2μg/g and disintegration time of the capsules is 20±3.
2.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.
3.A review article on cleaning validation in pharmaceutical industry
Mongolian Pharmacy and Pharmacology 2022;21(2):27-34
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”.
4.Effects of Srog dzin-5 prescription on animal models of depressive disorders
Altantuya Ts ; Tsetsegmaa S ; Bold Sh
Mongolian Pharmacy and Pharmacology 2020;17(2):71-78
Abstract:
Ngo mtshar dga’ ston gter mdzod” by gelong (Fully ordained monk, Tib. དགེ་སློང་) Choijamts is one of the important medical books of traditional medicine. From this book, we found the Srog dzin-5 prescription and the purpose of the study is to determine acute and chronic toxicity of the prescription, and to identify its effect on animal models of depressive disorders.
Methods:
1. The study was conducted using quantitative research method by experimental research model.
2. Determination of acute and chronic toxicity.
3. Chronic Unpredictable Mild Stress (CUMS) Procedure.
Conclusion
1. Srog dzin-5 prescription (LD50 = 25.8 (24-29) g/kg) has been shown to be non-toxic according to the generally accepted classification of K.Sidorov and B.Berezovskaya. When conducting histological studies, it was found that the surface of the liver, kidneys and adrenals is smooth. Color, shape and size of organs are normal.
2. In the model of chronic stress-induced depression, the Srog dzin-5 prescription increases physical activity, reduce tears, prevent anxiety and weight loss.
5.Effects of Srog dzin-5 prescription on pathogenesis model of acute stress and animal models of depressive disorders
Altantuya Ts ; Tsetsegmaa S ; Bold Sh
Mongolian Pharmacy and Pharmacology 2020;17(2):79-87
Abstract:
There is a growing need for a systematic study of the use of medicines prepared from herbal, animal, and mineral raw materials in traditional Mongolian medicine to a new level. Based on traditional medicine technology and use, the study identified the most suitable modern medicinal ingredients for the human body, namely a medicine that can be used for depression in the ancient scripture, “Ngo mtshar dga’ ston gter mdzod” by Gelen Choijamts and further practical application is imperative.
Purpose:
To study the effects of Srog dzin-5 prescription on pathogenesis model of acute stress and animal models of depressive disor- ders.
Conclusion
1. In the pathogenesis model of acute stress disorder caused by restricted mobility, Srog dzin-5 prescription prevents stress-induced thymic involution and enlargement of adrenal glands.
2. In the pathogenesis model of ethanol-induced depression, Srog dzin-5 prescription increased physical activity, reduced despair, and prevented anxiety according to behavioral assessment.
6.Review of wheatgrass /Triticum Aestivum Linn/
Mongolian Pharmacy and Pharmacology 2022;21(2):50-56
Introduction:
It is important to standardize a tincture prepared from the herb and root of Paeonia anomala L, which is widely used as a sedative in traditional medicine, based on the results of the studies its chemical composition, biological and pharmacological activities. Moreover, there is a need to carry out a quantitative stability testing in order to establish the ability to maintain quality under certain storage condition, shelf-life and to develop suitable packaging information.
Materials and methods:
Standardization parameters of prepared Paeonia anomala tincture have been evaluated according to WHO guidelines for the determination of crude drug material, plant preparations and finished products technical parameters, along with the Mongolian National Pharmacopoeian (MNP) and Russian XIV Pharmacopoeian methods for tincture. The color of a tincture, dry residue, special density, alcohol content, and microbiological content were determined according to the methods described in MNP. A qualitative analysis of biological active constituents has been evaluated by thin-layer chromatography, the total phenolic compounds were determined by the reaction with Folin Chicalteu reagent and total monoterpene glycosides by the reaction with hydroxylamine in alkaline solution and ferric (III) chloride following spectrophotometric examination, respectively.
The stability testing study was performed according to the “General requirements for the stability testing study of drug-active compounds” MNS-6439-2014 using the real-time methods for the standardization parameters of the tincture.
Conclusions
The standardized parameters of tincture prepared from the herb and root of Paeonia anomala L. were approved by the National Reference Laboratory for Food Safety analysis. Consequently, the Mongolian pharmacopoeian article on Paeonia anomala tincture was officially permitted under the number ҮФӨ-0327-2017.
The stability study of tincture was carried out according to the MNS-6439-2014 by real-time tests for 24 months which provided that the changes in tincture quality were within the permitted limits. Consequently, it can conclude that the storage condition and shelf-time of Paeonia anomala tincture are 2 years under not above 25°С.
7.Review of modern methods to study of polysaccharides with biological activities in medicinal mushrooms
Unursaikhan S ; Naranmandakh SH ; Erdenebayasgalan G ; Tsetsegmaa E
Mongolian Medical Sciences 2012;161(3):78-84
The number of mushrooms on Earth is estimated at 140,000, of which maybe only 10 % are known. Meanwhile, ca.14, 000 species that we know today, about 50 % are considered to possess varying degrees of edibility, and about 700 species are medicinal mushrooms. Medicinal mushrooms such as Ganoderma lucidum (Reishi, Lingzhi), Lentinus edodes (Shiitake, Xiang gu), Inonotus obliquus (Chaga, Hei hua mo) and many others have been collected and used for hundreds of years in Korea, China, Japan, and eastern Russia. Those practices still form the basis of modern scientific studies of fungal medical activities, especially in the field of stomach, prostrate, and lung cancers. It is notable and remarkable how reliable the facts collected by traditional eastern medicine are in the study of medicinal mushrooms. Mushrooms of their high fiber content, sterols, proteins, microelements and a low calorific value, are almost ideal for diets designed to prevent cardiovascular diseases as first suggested by Traditional Chinese Medicine. Several mushroom species have been studied for anti-inflammatory and antioxidant activities and patents have been established for these usages. Fruit-bodies of Ganoderma lucidum and Lentinus edodes have long been a major factor in folk medicine for the treatment of chronic hepatitis. Polysaccharides belong to a structurally diverse class of macromolecules, in which monosaccharide residues join to each other by glycosidic linkages to form polymer. It is noteworthy that, in comparison with other biopolymers such as proteins and nucleic acids, polysaccharides offer the highest capacity for carrying biological information because they have the greatest potential for structural variability. Mushroom polysaccharides exert their antitumor action mostly via activation of the immune response of the host organism.
8.A collection of Chinese medicinal raw materials and prescriptions in Zorigt wang’s “Mthong ba dga’ byad” sutra and their explanations
Khastana M ; Baolidao ; Tsetsegmaa S ; Bold Sh
Mongolian Pharmacy and Pharmacology 2020;17(2):54-58
Abstract:
In addition to citing from the old medical scriptures by Indian, Tibetan, and Mongolian medical scholars, “Mthong ba dga’ byad” by Jigmeddanzanjamts, also contains a number of prescriptions of Chinese medicine that were widely used in Chinese medical practice at that time. Therefore, crude drugs and prescriptions of Chinese medicine in this book has a great significance, but there are few studies done in the last decades.
Purpose:
To make selection of Chinese herbal medicines and recipes from the book “Mthong ba dga’ byad” by Jigmeddanzanjamts and explain them.
Research methods:
Research methods in ancient textbook, check list, analysis and synthesis methods were used.
Conclusion
It was clarified that in the book “Mthong ba dga’ byad” by Jigmeddanzanjamts there are 44 names of herbal medicines and prescriptions of Chinese origin, and some prescriptions are explained. According to these herbal medicines and prescriptions, Mongolian doctors and maarambas used not only Indian Ayurvedic and Tibetan medicines, but also Chinese medicines and prescriptions in their medical care.
9.Results of ongoing stability studies of medicines
Tsatsral I ; Purevsuren S ; Tsendeekhuu D ; Uransolongo L ; Tsetsegmaa N
Mongolian Medical Sciences 2015;174(4):36-40
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.
10.Analyzing an evidence-based prescription in the “Man ngag rin chen ‘Byung”
Enkhjin G ; Gerelmaa B ; Tsetsegmaa S ; Bold Sh
Mongolian Pharmacy and Pharmacology 2020;17(2):59-63
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).