Wang, C; Luo, Lei; Wu, X; Luo, Y; Wang, S; Tan, M; Long, Fei
The present study was designed to screen out the optimal formulation and evaluate the quality of pridinol mesylate-diclofenac sodium injection, to accumulate information for registration of the injection. With the dosage of pridinol mesylate and diclofenac sodium (serving as the main drug) being fixed, the study adopted the clarity, stability and pH of the injection as the investigation indicators, and employed the single-factor test to screen out the types of excipients and the orthogonal test to determine the optimal dosage of the excipients. The main quality indicators, such as the character, identification, pH, pyrogen, osmotic pressure and concentration, were also evaluated. The optimal formulation of pridinol mesylate-diclofenac sodium injection was determined to consist of 0.2% Pridinol Mesylate, 2.5% di-clofenac sodium, 0.6% mannitol, 27% polyethylene glycol400 (PEG400), 4% benzyl alcohol and 0.3% sodium metabisulfite; its pH was adjusted to 7.5 by an appropriate amount of sodium hydroxide solution, and the volume was adjusted by water for injection. The quality indicators of the injection, such as character, identification, pH, pyrogen, osmotic pressure and concentration, were assured to meet the requirements of Chinese Pharmacopoeia on injection. In conclusion, formulation of pridinol mesylate-diclofenac sodium injection is reasonable and its main quality indicators meet relevant requirements on injection.