Determination of Encapsulation Efficiency of Novel Solid Lipid Nanoparticles Containing Oleic Acid-CAT3 Conjugates by Mini-Column Centrifugation Method
WANG Hong-liang, XU Xue-qing, WANG Ru-bing, GAO Li-li, LIU Yu-ling*
State Key Laboratory of Bioactive Substance and Function of Natural Medicines, Beijing Key Laboratory of Drug Delivery Technology and Novel Formulation, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, China
Abstract：OBJECTIVE To establish a mini-column centrifugation method to determine the encapsulation efficiency (EE) of novel solid lipid nanoparticles containing oleic acid-CAT3 conjugates (OA-CAT3-SLN) and normal CAT3 SLN (CAT3-SLN). METHODS Sephadex G-50 mini-columns were used to separate the encapsulated drug and free drug in the solid lipid nanoparticles (SLN) with the help of centrifugation. The boundary point of the elution between the encapsulated drug and free drug was established by the elution curve. The encapsulated drug in the SLN was eluted with 1 mL water for three times. Then 2 mL of ethanol was used to elute the separated free drug for three times. The eluted CAT3 was quantified by the verified HPLC-UV method and used to calculate the EE. The method was verified with the recovery and repeatability test. Finally, the EE of three batches of OA-CAT3-SLN and CAT3-SLN were determined. RESULTS The mini-column centrifugation method could effectively separate the free drug from the encapsulated drug in SLN. The column recovery was (99.64±1.97)% (n=9), and the result of EE repeatability test of OA-CAT3-SLN was (83.71±0.70)% (n=5). The EE of OA-CAT3-SLN and CAT3-SLN were (86.26±2.65)% and (72.22±4.52)%, respectively (n=3). CONCLUSION The established separation method is simple and reliable, with high recovery and good repeatability, and can distinguish different preparation processes.
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2020, Vol. 55 
