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目的:由于不同工艺生产的氨苄西林钠粉针剂溶解性能上有很大差别,为了筛选溶解性能好、稳定性能高、价格合理的产品,故进行了溶解性能及稳定性考查。方法:取4个不同厂家生产的氨苄西林钠粉针剂,溶解于3种不同的注射液中(10%葡萄糖注射液,0.9%氯化钠注射液,灭茵注射用水),即时观察其溶解速度,用微粒仪测定其放置不同时间的微粒数,观察其不同时间颜色变化,用HPLC法测定其不同时间的含量。结果:用溶媒结晶法生产的氨苄西林钠溶解性要好于其它工艺生产的同一品种(t=2′37″,t_(其它)=3′39″),在10%葡萄糖注射液中氨苄西林钠稳定性差(C_(2h)=93.51%,C_(5h)=73.38%,C_(24h)=51.16%,而其它溶媒在24h以内,测量均在95%以上),这可能与溶媒pH值及葡萄糖有关,临床上不宜配伍。
OBJECTIVE: As the ampicillin sodium powder injection produced by different processes has very different dissolving properties, in order to screen the products with good solubility, high stability and reasonable price, the dissolution performance and stability were investigated. Methods: Ampicillin sodium injection from four different manufacturers was dissolved in 3 different injection solutions (10% glucose injection, 0.9% sodium chloride injection and injection of water for injection) to observe the dissolution rate , Using microparticle analyzer to measure the number of particles placed at different times, to observe the color change at different times, and to determine the content at different time by HPLC. Results: The ampicillin sodium produced by the solvent crystallization method had better solubility than the same variety produced by other processes (t = 2'37 “, t_ (others) = 3'39”), and ampicillin sodium (2h) = 93.51%, C_ (5h) = 73.38%, C_ (24h) = 51.16%, while the other solvents were all within 95% within 24 h), which may be related to the pH and glucose Relevant, clinical should not be compatible.