RESUMEN
Aim To develop an UPLC-MS/MS method to determine the concentration of lorcaserin hydrochloride in beagle plasma, and study the pharmacokinetics of osmotic pump controlled-release tablets of lorcaserin hydrochloride. Methods A randomized crossover design was used, carbamazepine as the internal standard(IS), and plasma protein precipitation with acetonitrile. The chromatographic was Phenomenex Polar C18 column(100 mm×2. 1 mm, 3 μm), and acetonitrile - water(containing 10 mmol·L-1 ammonium acetate and 0.1% formic acid)(40:60, V/V)was mobile phase. Multiple reaction monitoring mode and electrospray positive ionization were used to detect lorcaserin hydrochloride. The MS/MS ion transitions were monitored at m/z 196.2→129.2 for lorcaserin hydrochloride and m/z 237→194.1 for carbamazepine, respectively. Results The linear range was 1 to 500 μg·L-1(r=0.999 2), the extraction recovery rate ranged from 87.70% to 89.70%, the precision RSD was 9.7%. The accuracy and matrix effect met the requirements, and the stability of lorcaserin hydrochloride was good in -20 ℃ refrigerator for 45 d, repeated freezing and thawing for three times, placed at room temperature for 24 h, and the disposed samples placed in automatsampler for 6 h were stable. The main pharmacokinetic parameters of the controlled-release tablet and immediate-release tablet were as follows:Tmax was(8.00±1.27)h and(1.00±0.13)h, Cmax was(70.56±3.73)μg·L-1 and(176.33±16.73)μg·L-1, and AUC0-t was(966.33±7.56)μg·h·L-1 and(973.05±69.09)μg·h·L-1, respectively. Conclusions The established UPLC-MS/MS method can be used to study the pharmacokinetics of lorcaserin hydrochloride in the plasma of beagle dogs, and osmotic pump controlled-release tablets has sustained release effect.
RESUMEN
As an effective additive manufacturing technology, 3D printing technology has been widely used in aerospace, construction, machinery manufacturing and other fields, but it is rarely used in the pharmaceutical field, especially in the field of traditional Chinese medicine (TCM). In 2015, Spritam instant tablets produced by 3D printing technology greatly promoted the development and research of 3D printing technology in the pharmaceutical industry. In this paper, we reviewed three types of 3D printers (binder jet, material extrusion and inkjet printing) with high compatibility in the pharmaceutical industry, including the working principles, printing materials, product characteristics and others. In addition, the application prospects and existing problems of 3D printing technology in the production of innovative preparations of TCM, the development of innovative medical devices and the development of innovative functional foods were analyzed. The paper aimed to provide a reference for the development and preparation of innovative TCM by 3D printing technology.