Department of Pharmacy, Wuhan Fourth Hospital, Puai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Department of Pharmacy, Renmin Hospital of Wuhan University, Wuhan, China.
Medicine (Baltimore). 2022 Jul 15;101(28):e29674. doi: 10.1097/MD.0000000000029674.
A combination of methylprednisolone sodium succinate (MSS) and granisetron hydrochloride (GH) is generally devoted to treating the chemotherapy-induced nausea and vomiting. To date, none of these novel mixtures have been commercially available. The present study was aimed at investigating physical and chemical compatibility and stability of a combination of MSS with GH in 0.9% sodium chloride injection for 72 hours at 4°C and 25°C. A mixture of MSS (0.4-0.8 mg/mL) with GH (0.03 mg/mL) was prepared and stored in both polyvinyl chloride bags and glass bottles using 0.9% sodium chloride injection as a diluent. The study was performed using a validated and stability-indicating high-performance liquid chromatography method. The physical compatibility was assessed by a spectrometer. Furthermore, the pH measurement of each sample was measured electronically. All test solutions stored at 4°C or 25°C had a no >2% loss of the initial concentration throughout the 72-hour study period. All solutions remained clear and colorless throughout the study and were without precipitation or turbidity in any of the batches. The drug mixtures of MSS (0.4-0.8 mg/mL) and GH (0.03 mg/mL) in 0.9% sodium chloride injections were physically and chemically stable for at least 72 hours when stored at 4°C or 25°C in polyvinyl chloride bags or glass bottles.
甲泼尼龙琥珀酸钠（MSS）和盐酸格拉司琼（GH）的组合通常用于治疗化疗引起的恶心和呕吐。迄今为止，这些新的混合物都没有商品化。本研究旨在研究 MSS 与 GH 在 0.9%氯化钠注射液中的物理和化学相容性以及在 4°C 和 25°C 下 72 小时的稳定性。将 MSS（0.4-0.8mg/mL）与 GH（0.03mg/mL）的混合物用 0.9%氯化钠注射液作为稀释剂分别配制并储存在聚氯乙烯袋和玻璃瓶中。该研究采用经过验证和具有稳定性指示的高效液相色谱法进行。通过分光光度计评估物理相容性。此外，还通过电子方式测量每个样品的 pH 值。在整个 72 小时的研究期间，所有在 4°C 或 25°C 下储存的测试溶液的初始浓度均无 >2%的损失。在整个研究过程中，所有溶液均保持澄清无色，且在任何一批次中均无沉淀或浑浊。当 MSS（0.4-0.8mg/mL）和 GH（0.03mg/mL）的药物混合物在 0.9%氯化钠注射液中于 4°C 或 25°C 下于聚氯乙烯袋或玻璃瓶中储存时，至少在 72 小时内保持物理和化学稳定。
