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: 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.

Introduction: Sea buckthorn (Hippophae rhamnoides L.) is a hardy deciduous shrub of family Elaeagnaceae. In traditional medicine, “Sea buckthorn-5” powder medicine and sea buckthorn extract for the treatment of lung diseases,“Sea buckthorn-11” and “Sea buckthorn-17”prsecriptions are used to treat gynecological diseases. Sea buckthorn fruit takes a lot of time to dry and prepare in the traditional way, and a small amount of raw material is obtained. Therefore, there is an urgent need to improve and standardize technology. Material and method: The study used “Sea buckthorn fruit” raw material harvested in September 2020 from the Botanical garden of medicinal plants of the Drug research institute and sea buckthorn dry extract purchased from China.Four types of samples were used as Dry fruit of sea buck- thorn (Sample 1), Sea buckthorn seeds (Sample 2), Natural dried sea buckthorn fruit (Sample 3), and sea buckthorn dry extract purchased from China (Sample 4).In each of these four samples, the total carotenoid was measured at 450 nm, the flavonoid at 500 nm, and the phenolic compound at 750 nm using a spectrophotometer. Result: The results show that Sample 1 contains the highest amount of carotenoids 56.29 ± 0.05%, Sample 2 contains the highest amount of flavonoids 32.19 ± 0.05%, and total phenolic compounds 41.67 ± 0.02%. Conclusion Dry fruit of sea buckthorn (Sample 1) has the highest content of carotenoids, sea buckthorn seeds (Sample 2)have the highest total flavonoids and total phenolic compounds, which is approximately to the content of natural sea buckthorn fruit.

Introduction: The Mongolian people have been using traditional medicine for hundreds of years. However, there is a need to produce traditional medicinal dosage forms such as capsules, tablets, decoctions easier to drink, store and transport, and to standardize not only finished product, but the raw materials used for traditional medicines in line with the current drug production, drug quality and safety requirements. Therefore, in this study, we aim to standardize five ingredients of a traditional powder medicine, which have been widely used for colds and flu in Mongolian, Chinese and Tibetan traditional medicine practice, and to convert the powder drug into tablet form using qualified raw materials. Materials and Methods: The study to convert multi-ingredient traditional powder into tablet was carried out at the Experimental production pharmaceutical technology unit and Pharmaceutical chemistry Laboratory of the Drug research institute, Monos Group, and the Quality control laboratory of medicine of Monos Pharm LLC. Result All raw materials were standardized and wet granulation method was used to prepare granules for the tableting with qualified raw materials. 4 different models of the tablet form was prepared and investigated. It was determined that model X-2 fully meets the general requirements for the tablet form.