目的 研究前列地爾注射液的穩(wěn)定性，為其生產(chǎn)、包裝、貯存、運(yùn)輸條件提供理論依據(jù)。方法 采用高效液相色譜法，測定前列地爾注射液中前列地爾及其有關(guān)物質(zhì)A1的量，并考察強(qiáng)光照（4 500 lx）、高溫（40℃、60℃）、加速、長期試驗(yàn)對(duì)其穩(wěn)定性的影響，分別測定各項(xiàng)指標(biāo)與原始數(shù)據(jù)進(jìn)行比較。結(jié)果 前列地爾和A1的線性、精密度、穩(wěn)定性、回收率均符合要求；強(qiáng)光及高溫條件下放置較長時(shí)間（10 d），前列地爾注射液色澤則明顯加深，pH值幾乎沒改變，含量明顯降低，同時(shí)降解成的有關(guān)物質(zhì)則明顯增加；25℃加速試驗(yàn)6個(gè)月，其pH值略有下降。3批樣品在4℃下存放，長期試驗(yàn)12個(gè)月后，其外觀性狀、有關(guān)物質(zhì)及含量等各項(xiàng)指標(biāo)均符合相關(guān)要求。結(jié)論 前列地爾注射液對(duì)光、熱不穩(wěn)定，容易降解，本品應(yīng)避光、冷藏貯存，有效期可暫定為1年。

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.