Dissolution Determination Method of Fermented Cordyceps Mycelia Powder Tablets
Objective:To establish a dissolution determination method in order to evaluate the quality differences of related prod-ucts.Methods:Using dissolution determination method(small cup method),hydrochloric acid solution(pH 1.2)was used as the dissolution medium.The speed was 50 r·min-1.The temperature was 37 ℃,and the samples were taken at 5,10,20,30,45,and 60 minutes.The determination method was HPLC,and the chromatographic column was C18(250 mm ×4.6 mm,5 μm).The mobile phase was methanol:0.1 mol·L-1 potassium dihydrogen phosphate(10:90),and the flow rate was 1.0 mL·min-1.The detection wavelength was 254 nm.Quantitative calculation was through the external standard method.Results:Adenosine was 2.043 7-51.019 6 µg·mL-1,there was a good linear relationship between peak area and concentration(r=0.999),the aver-age recovery rate was 98.1-100.1％and the RSD of was 0.6％(n=6).Among the 15 batches of products,the dissolution rate of 11 batches was Above than 80％,the dissolution rate of 4 batches was under than 80％.There are differences in the dissolution curves of products between different enterprises,and there are also differences in products within enterprises.Conclusion:The method was easy to operate,and has strong specificity,good precision,stability,repeatability,and accuracy,and can reflect the quality differences of different batches of products from different enterprises.It can provide reference for the quality control of fermented cordyceps powder solid preparations.
万方数据
维普
