Preparation and quality control of pemirolast potassium nasal spray / 中国生化药物杂志

ABSTRACT

Objective To prepare pemirolast potassium nasal spray which could be used in treatment of allergic rhinitis and make a quality control standard for the preparation.Methods The preparation materials of nasal spray was selected which could meet the physical and chemical properties of pemirolast potassium as well as the characteristics of intranasal administration.The quality control standards for pemirolast potassium nasal spray was made according to the nasal spray quality standards for the formulation pH, property, loading capacity, total bottle spray times, puff volume, sedimentation volume ratio and detection of content of “Chinese Pharmacopoeia” two section (2010 edition).Results The formulation prescription of pemirolast potassium nasal spray was0.1% potassium pemirolast, 0.8% CMC-Na, 0.01% benzalkonium bromide, glacial acetic acid ( pH adjusting agent) and the solution was 5% mannitol.The formulation was a white suspension, pH=7.The mean value of installed capacity was (25.12 ±0.16) mL and installed capacity of each bottle was above 23.75 mL(95%); total spray times of each bottle was above 160 sprays and spray volume was above 0.140 0 g/press; sedimentation volume ratio was 1, the above testing programmes of quality standard met the requirements and were controlled.The standard curve of pemirolast potassium reference substance was Y=81085X+15264(r=0.999 8), linearity range was 0.5~25.0μg/mL.The average recovery rate of pemirolast potassium sample was 99.39%, and precision met the requirements.The pemirolast potassium content of test sample was 99.2% of labeled amount.Conclusion The formulation prescription of pemirolast potassium nasal spray is suitable and the preparation is possessed several advantages such as stability, well-distributed spray, application convenience and quality controlled.Therefore, nasal administrated formulation of pemirolast potassium is potentially in further.