1.HPLC method for quantification of salidroside for quality control of golden root (Rhodiola Rosea L, Rhodiola Crenulata L.) dry extract
Battulga B ; Badamtsetseg S ; Lkhaasuren R ; Odontuya G ; Khurelbaatar L
Mongolian Pharmacy and Pharmacology 2024;25(2):52-57
Background:
The high-performance liquid chromatography (HPLC) method was developed to select
salidroside in tablet formulation dietary supplements, raw material 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, syst em suitability, and ruggedness.
The developed method exhibited the best results in terms of the validation above parameters. The other
components and additives did not interfere with their determinations. The method was found to be selective,
simple, economical, accurate, reproducible, rapid, and reliable for routine estimation purposes of salidroside
in golden root dry extract. The goal of this study was to develop the validation method of salidroside in the
dietary supplement.
Material and Methods:
The Rhodiola rosae L. dry extract was supplied Arshin Co.ltd in People’s Republic of
China. The standard salidroside was supplied from Sigma Aldrich Co Ltd. We used solvents for HPLC grade
(methanol, acetonitrile). Chromatographic conditions: A gradient HPLC (Shimadzu CBM20AD) with serial
dual plunger pump; analytical column: Shimadzu GIST С18 150 x 4.6 mm, particle size 5 μm; flow rate: 1
ml/min; column temperature: 400C, detection: UV 275 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 15 minutes.
Results
The calibration curves for the salidroside 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 of 100-800 µg/mL. The linear correlation coefficient (r2=1) for all calibration
curves was higher than 1 for all analytes. The LOD and LOQ for salidroside were golden root dry extract
in 8.788 µg/mL and 26.61 µg/mL, respectively. Accuracy and precision were assessed by analyzing five
samples independently prepared at low, middle, and high concentrations. The RSD values of repeatability
and intermediate precision were below 1.12%, 1.19 and 1.79%. The accuracy remains between 91 to 109%.
The resulting accuracy data were satisfactory for the quantitative analysis of salidroside in golden root dry
extract. This article presents a simple, accurate, reproducible, and thoroughly validated HPLC-based method
for qualitative and quantitative analysis of salidroside, as part of the quality assessment of golden root dry
extract.
2.A review of clinical research on the five medicinal herb soak therapy
Enkhbold G ; Badamtsetseg S ; Munkhzaya B ; Lkhaasuren R ; Khurelbaatar L
Mongolian Pharmacy and Pharmacology 2024;25(2):100-110
Introduction:
The Five Medicinal Herb Soak Therapy, as described in the 23rd chapter of “The Secret
Quintessential Instructions on the Eight Branches of the Ambrosia Essence Tantra,” a key text in traditional medicine, is noted for its therapeutic applications. It is recommended for conditions such as joint stiffness, tumors, acute and chronic wound swelling, sores, abscesses, hunchback, muscle rheumatism, anthrax, scattered heat and wind disorders. The Five Medicinal Herb Soak consists of Ledum palustre L., Juniperus pseudosabia Fisch.Et M., Myricaria alopecuroides Schrenk., Ephedra Przewalskii Stapf., and Artemisia frigida Willd. This therapy is widely practiced in Mongolia, China, the Inner Mongolia Autonomous Region, the Tibetan Autonomous Region, the Qinghai Province, and the Gansu Province. This clinical observational study review aims to predict treatment outcomes, establish treatment guidelines, and facilitate the development of other pharmaceutical forms. It is anticipated that this review will serve as a scientific reference for the application of the Five Medicinal Herb Soak Therapy.
Objective:
The objective of this review is to analyze and synthesize clinical studies on the Five Medicinal
Herb Soak Therapy.
Methods:
Keywords “五味甘露” (Wu wei gan lu), “Tibetan medicine five-flavor Manna” were used to search
for relevant research articles and theses in biomedical databases, including PubMed (https://pubmed.ncbi.
nlm.nih.gov/) and the China National Knowledge Infrastructure CNKI (https://www.cnki.net/). The collected
data were systematically analyzed and reviewed.
Conclusion
The Five Medicinal Herb Soak Therapy demonstrates significant therapeutic value in treating
conditions such as gout, rheumatic joint inflammations, digestive disorders, female reproductive system
diseases, spinal herniation, arthritis, varicose veins, and scurvy. Integrating this therapy with Mongolian,
Tibetan, Chinese, and European medical practices can enhance treatment efficacy by reducing treatment
duration, alleviating symptoms, and preventing recurrence. Furthermore, developing more efficient
pharmaceutical forms of the Five Medicinal Herb Soak could improve its effectiveness and reduce potential
side effects.
3.Some results of studies of “Монгол хунчир” injection
Tsendbadam B ; Lkhaasuren R ; Battulga B ; Baljinnyam I ; Tsetsegmaa S ; Khurelbaatar L ; Munkhtsetseg R
Mongolian Pharmacy and Pharmacology 2021;19(2):93-99
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.
4.Effects of some syrups on citric acid induced cough in rat
Munkh-Erdene R ; Davaasambuu V ; Bat-Oyun U ; Ahsholpan B ; Badamtsetseg S ; LKhaasuren R ; Hurelbaatar L
Mongolian Pharmacy and Pharmacology 2023;23(2):20-25
Abstract:
In Mongolia, flu and flu-like diseases affect many people, and pneumonia is a public health concern. Therefore, we have an urgent need to research and develop a new medicinal syrup to replace imported products using raw materials grown in Mongolia and to compare it with similar products. There are imported cough syrup products on the pharmaceutical market of Mongolia, but there are domestic pharmaceutical products. Moreover, there is limited research data on cough relief. The main goal of the research team is to compare the experimentally obtained syrup containing Plantago asiatica L, Malva Sylvestris L. and syrup containing Plantago major L. Juice, honey that produced by Monos Pharm LLC whish the cough relieving drug Gerbion syrup.
Material and methods:
The vivarium of the pharmacology laboratory, Drug research institute,
TPC7062Ti mark IVC system (Shanghai Pretty Industries Co.,Ltd, China) in a special environment
with one care and one feeding regimen (Lab Mice Diet, Constant Formula Balanced Nutrition,
Jiangsu Xietong Pharmaceutical Bio- Engineering Co., LTD, China, www.jsxtsw.com ) used 64
non-WISTAR white rats weighing 180-218 g. Experimental rats were smoked with an aerosol of
17% citric acid aqueous solution for 5 minutes. The statistical processing of the research results
was done using the One-Way ANOVA/Multiple comparisons data of the GraphPad Prism 8 program.
Results and conclusion
Expressing the number of coughs produced in the experimental rats as
a percentage (%), the control group showed 3.95% cough relief, and the experimental group-1 by
48.4%, experimental group-2 by 71.1%, comparison group by 74.6%, respectively has reduced.
Experimental group -2 and comparison group for dry cough caused by citric acid 17%, it affects
the cough receptors in the mucous membrane of the respiratory tract and relaxes the bronchial
muscles (A and C fiber).
5.High performance liquid chromatograohy method for determination of alkaloid, method validation in Norbu-7 granule
Sugarmaa B ; Battulga B ; Lkhaasuren R ; Badamtsetseg S ; Tsetsegmaa S ; Khurelbaatar L
Mongolian Medical Sciences 2021;195(1):64-69
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.
6.Determining the effects of Ami barigch (Srog’dzin-) 5 prescription on depression
Odonchimeg B ; Davaasambuu T ; Sumyakhorol G ; Lkhaasuren R ; Bold Sh
Mongolian Pharmacy and Pharmacology 2021;19(2):88-92
Introduction:
Nowadays people are restricting their use of chemical drugs as much as possible, creating a growing need for a systematic study of the use of herbal, animal and mineral medicines at a new level through traditional and innovative methods. Based on the study of traditional national technologies, it is important to study and apply in practice the drugs and pharmaceutical ingredients that contain the most modern scientific achievements including cardiovascular drugs, obtained from ancient rare scriptures.
Research materials and methods:
Data collected from the Clinical Department of Stress-Related Mental Disorders of the National Center for Mental Health was the primary source for this study. Secondary sources included statistics on the hospital’s website, internal reports of the organization, research related to health services, and legal documents.
Research method:
Serum cortisol levels were determined with a STATFAX-2100 ELISA (450 nm) according to the manufacturer’s specific methodology (www.melsin.com, Human Cortisol, ELISA KIT- CAT. NO:EKHU-0704).
The amount of cortisol in human serum was calculated as a linear quantitative assay by diluting 7.5 ug/L-90 ug/L in a standard working solution.
Conclusion
“Srog ‘dzin-5” has a clinical effect of reducing serum cortisol by an average of 27.3%. The statistic (p<0.01) is likely to increase this percentage depending on the time taken. Clinical observations have shown that “Srog ‘dzin-5” has pharmacological action against stress, depression and mental illness.
7.Some technological studies on obtaining granular drug formulation from “Shimshin-6” traditional prescription
Narankhuu M ; Tserendulam L ; Altansukh Ts ; Lkhaasuren R ; Tserendolgor B
Mongolian Pharmacy and Pharmacology 2022;20(1):21-24
Introduction:
Amenorrhea has still been listed as one of common diseases among women in Mongolia. Some traditional prescription for amenorrhea, used commonly in Mongolian traditional medicine, needs more attention to dig out its scientific proof of therapeutic effect on pathogenesis of some diseases. Therefore, we aimed to research Shimshin-6 traditional prescription to develop a granule formulation for amenorrhea and other female reproductive diseases, and study its qualitative and quantitative characteristics.
Material and method:
In this study, Shimshin-6 traditional prescription was randomly collected from 5 pharmaceutical manufacturers named as “Х-1, Х-2, Х-3, Х-4 and Х-5”. The collected prescriptions were granulated and optimized by a wet-granulation method. Then, granule spill weight and flow quality were detected in obtained granule formulation.
Result:
20 types of granule formulation from Shimshin-6 were obtained by using 8% and 10% of gelatin, 6% and 8% of polyvinylpyrrolidone as a binder in these formulations. As a result, the suitable binder in this formulation was detected 6% of polyvinylpyrrolidone after researching the granule spill weight and flow rate. For the granule formulations of X-1, X-2 and X-5 prescriptions, the polyvinylpyrrolidone was chosen as the suitable binder due to the result from granule spill weight of the formulation. As for the X-3 and X-4 prescriptions, gelatin was the suitable binder in these formulations. After studying the flow quality of newly obtained granule formulations from “Х- 1, Х-2, Х-3, Х-4 and Х-5”, the most suitable binder was polyvinylpyrrolidone.
Conclusion
Altogether, these results showed that the most suitable binder for granulating Shimshin-6 traditional medicine was 6% of polyvinylpyrrolidone due to the results from granule spill weight and flow rate.
8.Pharmaceutical coating: A review
Maralgua A ; Maral L ; Munkhzaya B ; Bujinlkham B ; Saikhanbayar P ; Lkhaasuren R ; Akhsholpan B
Mongolian Pharmacy and Pharmacology 2024;24(1):63-67
Coating agents are used in medicine to protect tablets from air or moisture, to mask bitter tastes, or to
provide special characteristics for drug release, such as enteric release. There are three main coatings: sugar coating , film coating, and enteric-coating. In this review, we discuss the status of the most commonly used pharmaceutical film coating materials and data were obtained from electronic databases such as PubMed, Google Scholar, and other scientific websites. There are various materials for creating a tablet coating, but the most commonly used material is a water soluble polymer which is used for making a water-soluble film coating.
9.Incompatibility of drug excipients: A review
Maral L ; Maralgua A ; Munkhzaya B ; Bujinlkham B ; Saikhanbayar P ; Lkhaasuren R ; Akhsholpan B
Mongolian Pharmacy and Pharmacology 2024;24(1):68-71
Excipients are important in the composition of drugs and are the most important requirements for maintaining
the stability of drug form, dosage, and physicochemical parameters. Excipients act as protective agents,
bulking agents and can also be used to improve bioavailability of drugs in some instances Auxiliary
substances included in the composition of medicines are classified as natural, animal, synthetic and
semisynthetic. Excipients can become inactive due to chemical, microbiological and physiological effects.
Commonly used pharmaceutical excipients are fillers, stabilizers, preservatives, flavor and aroma modifiers,
binders, disintegrants, lubricants, lubricants, solvents, and coating agents. Excipients can be considered as
indispensible component of medicinal products and in most of the formulations they are present in greater
proportion with regards to active pharmaceutical ingredient, as it forms the bulk of the formulation it is
always necessary to select an excipient which satisfies the ideal properties for a particular excipient. In this
review, materials about coating agents widely used in pharmaceutical practice were compiled from electronic
databases such as Pubmed, Google Scholar, and other scientific web pages, using keywords such as Drug
excipient interaction, Stability in Oral Solid, and Excipient. .
10.Review of medicinal plant decontamination methods to ensure microbiological aspects
Munkhzaya B ; Saikhanbayar P ; Maral L ; Maralgua A ; Bujinlkham B ; Lkhaasuren R ; Akhsholpan B
Mongolian Pharmacy and Pharmacology 2024;24(1):72-79
The incorporation of botanical elements such as Inula helenium L., Astragalus mongolicus Bge.,
Iris tenuifolia Pall., Ribes diacanthum Pall., and Oxytropis pseudoglandulosa Grubov plays a pivotal role in the formulation of immune-enhancing and kidney-protective Mongolian traditional medicines. These herbal constituents bear rich historical significance in traditional remedies. Ensuring the purity of these herbs is a vital stride in the production of efficacious supplements and medications. Thus, meticulous decontamination of microorganisms assumes paramount importance. The selection of an appropriate sterilization method is important for manufacturers. Sterilization methods divide within three main categories: thermal, chemical, and radiation. This spectrum encompasses many techniques, ranging from moist heat and dry heat to gamma irradiation, ethylene oxide, ozone, and UV treatment. This comprehensive review discusses the efficacy of gamma irradiation, dry heat, moist heat, and chemical treatments, presenting a comparative analysis of their merits. Practically, heat sterilization emerges as a simple and cost-efficient choice. The utilization of an autoclave, subjecting powdered spice paprika to temperatures between 108-125°C for 120 seconds, yielded a substantial reduction in microbial load without compromising the integral bioactive compounds. Gamma
irradiation, a common practice in the healthcare and pharmaceutical sectors, stands as another choice in the area of sterilization techniques. Beyond sterilization, upholding rigorous standards of sanitation and hygiene remains a key in the preparations of medicinal plants.