Study on stability of Alprostadil Injection / 药物评价研究

ABSTRACT

Objective To study the stability of Alprostadil Injection,and provide theoretical basis for its production,packaging,storage,and transportation conditions.Methods The contents of PGE1 and A1 in Alprostadil Injection were determined by HPLC method through strengthen test,accelerated test,and longterm test.The stability of Alprostadil Injection was investigated.Results Linearity,precision,stability,and recovery rate of E1 and A1 met the requirements;Placed for 10 d under high light and high temperature conditions,the color was obviously deepened,the pH value was almost unchanged,the content decreased significantly and degradation of related substances increased significantly;At 25 ℃ and after 6 months of acceleration test,the PH value decreased slightly and the content changed obviously.Three batches of samples were stored at 4℃ and long-term tested after 12 months,its appearance traits,related substances,and content of the indicators were in line with the relevant requirements.Conclusion Alprostadil Injection is unstable to light and heat,easy degradation,this product should be stored in dark and cold conditions,with the validity for one year.