Development and research of compound caffeine waterless swallowed granules based on reverse engineering / 药学学报

ABSTRACT

In this study, the reverse engineering technology was used to analyze the prescription and process of Doppelherz® Energy DIRECT, based on the composition of the prescription on the official website of the product, the detection method of composition is established according to the pharmacopoeia and literature information, combined with gravimetric analysis to complete prescription analysis. The prescription composition of the reference listed drug was determined to be composed of caffeine, taurine, vitamin B, anhydrous glucose, citric acid, sorbitol, sucralose, magnesium salts of fatty acids, in which the glucose content was 71.4%, the citric acid content was 7.0% and the magnesium salts of fatty acids content was < 5.8%. According to patent inquiry, Raman imaging and other technologies, the preparation process of the marketed preparation has been basically obtained, and the development of the self-made preparation has been completed on this basis. The study was approved by the Ethics Committee of the Academy of Military Medical Sciences. Combined with the results of the taste evaluation experiment and the caffeine dissolution test of the preparation in 1 min, the hot-melt extrusion technology was screened out as the taste-masking technology of the self-made preparation, the parameters of the hot-melt extrusion process were screened by differential scanning calorimetry analysis, and finally a product with good taste and qualified quality was obtained, which provided a reference method for the research and development of related preparations.