ABSTRACT
Introduction@#<i>Astragalus</i> is the largest member of the <i>Fabaceae</i> family of about 3,000 species on all continents except Australia, and the <i>Astragalus mongholicus</i> Bunge and the <i>Astragalus membranaceus</i> (Fisch.) Bge are studied and widely used. <i>Astragalus</i> 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 <i>Astragalus mongholicus</i> 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.
ABSTRACT
Introduction@#Carthamus tinctorius L. widely accepted as Safflower or false saffron, belongs to the Compositae or Asteraceae family. Hydroxysafflor yellow A is the main active chemical compound present in florets of Carthamus tinctorius L. A joint research team of the “Tsombo Pharm” Co., LTD and the Drug research Institute is conducting an experiment to produce a solution of “Carthamus tinctorius” injection prepared by Carthamus tinctorius L. @*Goal @#The aim of this study was to develop the validation method of hydroxysafflor yellow A in “Carthamus tinctorius” injection.@*Material and Methods @#As a test sample “Carthamus tinctorius” injection was produced by “Tsombo pharma” Co., LTD. The standard Hydroxysafflor yellow A was supplied from Sigma-Aldrich Co., Ltd. The reagent were high-performance liquid chromatography grade acetonitrile, phosphoric acid, methanol and purified water. </br> Shimadzu HPLC (CMB-20 A, UV detector Shimadzu SPD-20A was used as the analytical instrument and the analysis conditions were as follows Table 1. @*Results@#A Shimpack С18 column was used with methanol:acetonitrile:0.7% phosphoric acid as the mobile phase under the condition of gradient elution. The hydroxysafflor yellow A were analyzed by using a timed wavelength measure according to their maximum absorption wavelength. Accuracy and precision were assessed by analyzing five sets of samples, independently prepared at low (50%) middle (100%) and high (150%) concentrations. The intraday and interday precisions of the investigated compound were less than 1.59 % and the average recoveries ranged from 81.9% to 101.5%. </br> There were good linear correlations between the concentrations of the hydroxysafflor yellow A and its chromatographic peak areas (R2 = 0.998), the proposed method was successfully applied to determine the hydroxysafflor yellow A in “Carthamus tinctorius” injection. @*Conclusions@#The results indicated that the proposed method is simple, stable, and accurate and could be readily utilized as a quality control method for manufacturing process of “Carthamus tinctorius” injection.
ABSTRACT
Introduction@#Calycosin-7-O-β-D-glucoside is a glycosyloxyisoflavone that is calycosin substituted by a beta-D-glucopyranosyl residue at position at 7 via a glycosidic linkage. calycosin-7-O-β-D-glucoside, a calycosin derivative compound derived from Astragali Radix, has protective effect against ischemia/ reperfusion injury as well as bacterial endotoxin-induced vascular cell injury. A joint research team of the “Tsombo Pharm” Co., LTD and the Drug research Institute is conducting an experiment to produce a solution of “Astragalus mongholicus” injection prepared by Astragalus mongholicus bunge.@*Goal @#The aim of this study was to develop the validation method of Calycosin-7-O-β-D-glucoside in “Astragalus mongholicus” injection. @*Material and Methods@#As a test sample “Astragalus mongholicus” injection was produced by “Tsombo pharma” Co., LTD. The starndard Calycosin-7-O-β-D-glucoside was supplied from Xilong Scientific Co., Ltd. The reagent were high-performance liquid chromatography (HPLC) grade acetonitrile, formic acid, methanol and purified water. Shimadzu HPLC (CMB-20 A, UV detector Shimadzu SPD-20A was used as the analytical instrument and the analysis conditions were as follows Table 1.@*Results@#The calibration curves for Calycosin-7-O-β-D-glucoside 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 12.5-100µg/ml. The linear correlation coefficient (R2) for all calibration curves was higher than 0.9981 for all analytes. The limit of detection and limit of quantitation for Calycosin-7-O-β-D-glucoside were in 10.37 µg/ml and 31.45 µg/ml. Accuracy and precision were assessed by analyzing five sets of samples, independently prepared at low (50%) middle (100%) and high (150%) concentrations. The RSD values of both repeatability and intermediate precision were below 0.68% and 0.618% the accuracy remaining between 95.55 to 101.71%. The resulting accuracy data were satisfactory for the quantitative analysis of Calycosin-7-O-β-D-glucoside in “Astragalus mongholicus” injection.@*Conclusions@#Finally, this method can be employed conveniently, reliably and successfully for the estimation of Calycosin-7-O-β-D-glucoside for routine quality contral and stability studies in “Astragalus mongholicus” injection.