Résumé
Objective To establish assay methods for the determination of dissolution,content and related substances of vita-min K1 self-nanoemulsifying drug delivery system(VK1-SNEDDS),and investigate the physico-chemical properties of the preparation. Methods The UV method was established to determine the dissolution of VK1-SNEDDS. The content and related substances were de-termined by HPLC. The appearance,self-emulsification time,micro-morphology,droplet size and zeta potential were also investigat-ed. Results The linearity range of established UV and HPLC methods was 0.85-20.4 and 2.16-216μg/ml,respectively,and all the recovery,precision,specificity and sensitivity met requirements. VK1-SNEDDS could disperse quickly after dilution. The transmission electron microscope(TEM)image of the optimized liquid SNEDDS showed that most of the emulsion droplets were of uniform size with no signs of coalescence. Droplet size of optimal formulation was revealed as 47.74 nm with polydispersibility index(PDI)of 0.248,and zeta potential was found to be-20.53 mV. Conclusion VK1-SNEDDS could form homogeneous and stable nanoemulsion when dilut-ed with aqueous phase and increase the dissolution of lipophilic drug. The methods are reliable,accurate and suitable for quality con-trol of VK1-SNEDDS.
Résumé
To develop a portable medicine coffer for medical support in order to standardize the management of special medicine. The coffer with double-fingerprint cryptography and internal mechanical lock was com-posed of a body and a cap. The coffer had the body made of high-intensity plastics or light alloy, monitor made of high-intensity abrasion-resistant glass as well as rechargeable lithium battery. The coffer eliminated the deficiencies of traditional medicine chest. The portable coffer standardizes the management of special medicine for medical support.