Inagaki K, Gill M A, Okamoto M P, Takagi J
School of Pharmacy, University of Southern California, Los Angeles 90033.
J Parenter Sci Technol. 1993 Jan-Feb;47(1):35-9.
The stability of cefmetazole sodium and ranitidine hydrochloride was studied under conditions simulating administration via a Y-injection site into a primary infusion line. Cefmetazole sodium was reconstituted with both 0.9% sodium chloride injection (50 mL or 100 mL) and 5% dextrose injection (50 mL) to produce premixing concentrations of cefmetazole 10 and 20 mg/mL. Ranitidine hydrochloride injection was diluted with 50 mL 0.9% sodium chloride injection to give premixing concentrations of ranitidine 1 mg/mL. To simulate Y-site administration, 2 mL of cefmetazole was mixed with 2 mL of ranitidine in a 10-mL glass test tube. All study mixtures were prepared in triplicate and stored at room temperature (22-23 degrees C) under normal fluorescent room lighting. Samples of these admixtures were inspected for visual changes and tested for pH. The concentrations of two drugs were immediately determined by stability-indicating high-performance liquid chromatographic assay methods after mixing and at 1, 2, and 4 hours. No visual changes were observed. The pH in the admixtures was influenced by concentrations of the two drugs. The pH of each single-drug solution did not change during the study period. On the other hand, the pH of any admixtures of cefmetazole and ranitidine solutions prepared with 0.9% sodium chloride or 5% dextrose injection, decreased. Cefmetazole in any of the admixtures with ranitidine retained greater than 95% of its original concentration for 4 hours.(ABSTRACT TRUNCATED AT 250 WORDS)
在模拟通过 Y 型注射部位注入主输液管的给药条件下,研究了头孢美唑钠和盐酸雷尼替丁的稳定性。头孢美唑钠分别用 0.9%氯化钠注射液(50 mL 或 100 mL)和 5%葡萄糖注射液(50 mL)复溶,制成头孢美唑预混浓度为 10 和 20 mg/mL 的溶液。盐酸雷尼替丁注射液用 50 mL 0.9%氯化钠注射液稀释,制成雷尼替丁预混浓度为 1 mg/mL 的溶液。为模拟 Y 型部位给药,在一个 10 mL 的玻璃试管中将 2 mL 头孢美唑与 2 mL 雷尼替丁混合。所有研究混合物均一式三份制备,并在室温(22 - 23 摄氏度)、正常荧光室内照明条件下储存。检查这些混合液样品的外观变化并测试 pH 值。混合后及 1、2 和 4 小时后,立即通过稳定性指示高效液相色谱分析方法测定两种药物的浓度。未观察到外观变化。混合液的 pH 值受两种药物浓度的影响。每种单一药物溶液的 pH 值在研究期间未发生变化。另一方面,用 0.9%氯化钠或 5%葡萄糖注射液制备的头孢美唑和雷尼替丁溶液的任何混合液的 pH 值均降低。在与雷尼替丁的任何混合液中,头孢美唑在 4 小时内保持其原始浓度的 95%以上。(摘要截断于 250 字)