Preparation and release of paliperidone palmitate injection:a study / 国际药学研究杂志

ABSTRACT

Objective To prepare paliperidone palmitate injection,establish the testing method for its release rate,and vali?date the methodology. Methods Wet grinding was used to prepare paliperidone palmitate injection,high performance liquid chroma?tography was adopted to establish release rate detection,and validate its methodology. Results The average particle diameter of home-made agent was about 1μm,and it was an irregular bulk observed under transmission electron microscope;the precision of es?tablished release rate detection was 1.5%,recovery rate was 100.70%and stability RSD was 0.33%. The average release rate in vitro of home-made agent in three batches was8.00%in 1.5min,62.26%in 20 min,and 85.44%in 45 min. Conclusion The particle size distribution and release rate of prepared sustained-release injection are consistent with those of original research,and the testing method of release rate is simple,sensitive and accurate,which could effectively monitor the product quality. The average release rates of agent in three batches are within the scope of quality standards.