Development and research of compound caffeine waterless swallowed granules based on reverse engineering
10.16438/j.0513-4870.2022-0117
- VernacularTitle:基于逆向工程的复方咖啡因无水吞服颗粒的开发及研究
- Author:
Kun FAN
1
;
Pei DING
2
;
Xiao-lu HAN
1
;
Zeng-ming WANG
1
;
Meng LI
1
;
Yan-zhou YU
2
;
Ai-ping ZHENG
1
Author Information
1. Institute of Toxicology and Pharmacology, Academy of Military Medical Sciences, Beijing 100850, China
2. Sports Medical Department of Military Sports Training Center, Beijing 100851, China
- Publication Type:Research Article
- Keywords:
reverse engineering;
caffeine;
fatigue;
taste masking technology;
hot-melt extrusion
- From:
Acta Pharmaceutica Sinica
2022;57(8):2512-2519
- CountryChina
- Language:Chinese
-
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.
