Department of Pharmacy, Wuhan Third Hospital, Tongren Hospital of Wuhan University, Wuhan, Hubei 430060, People's Republic of China.
Department of Pharmacy, Renmin Hospital of Wuhan University, Wuhan, Hubei 430060, People's Republic of China.
Drug Des Devel Ther. 2020 Mar 17;14:1169-1176. doi: 10.2147/DDDT.S244439. eCollection 2020.
Combination antiemetic therapy has become a common practice for the prevention of postoperative nausea and vomiting (PONV). The aim of the present study was to evaluate the stability and compatibility of ramosetron hydrochloride and midazolam in 0.9% sodium chloride injection when stored at 4°C and 25°C for up to 14 days.
Admixtures were assessed initially and for 14 days after preparation in polyolefin bags and glass bottles using 0.9% sodium chloride injection as the diluent and stored at 4°C or 25°C. The initial concentrations were 0.3 mg/100 mL ramosetron hydrochloride and 0.5 mg/100 mL midazolam hydrochloride. For all samples, the compatibility parameters (including precipitation, cloudiness, discoloration and pH values) were evaluated. Chemical stability was also determined using high-performance liquid chromatography (HPLC) analysis.
After a 14-day period of storage at 4°C or 25°C, the percent of the initial concentration of ramosetron hydrochloride and midazolam hydrochloride in the various solutions were maintained at a minimum of 97%. All of the mixtures remained clear and colourless throughout the observation period, and no colour change or precipitation was observed.
The results indicate that admixtures of 0.3 mg/100 mL ramosetron hydrochloride and 0.5 mg/100 mL midazolam hydrochloride in normal saline were stable for 14 days at 4°C or 25°C when packaged in polyolefin bags or glass bottles and protected from light.
联合止吐疗法已成为预防术后恶心和呕吐（PONV）的常见做法。本研究旨在评估盐酸雷莫司琼和咪达唑仑在 0.9%氯化钠注射液中在 4°C 和 25°C 下储存长达 14 天时的稳定性和相容性。
将混合物在聚烯烃袋和玻璃瓶中用 0.9%氯化钠注射液作为稀释剂进行初始评估，并在 4°C 或 25°C 下储存 14 天。初始浓度为 0.3mg/100mL 盐酸雷莫司琼和 0.5mg/100mL 盐酸咪达唑仑。所有样品均评估了相容性参数（包括沉淀、浑浊、变色和 pH 值）。还使用高效液相色谱（HPLC）分析确定化学稳定性。
在 4°C 或 25°C 下储存 14 天后，各溶液中盐酸雷莫司琼和盐酸咪达唑仑初始浓度的百分比均保持在 97%以上。在整个观察期间，所有混合物均保持澄清无色，未观察到颜色变化或沉淀。
结果表明，在聚烯烃袋或玻璃瓶中包装并避光的情况下，0.3mg/100mL 盐酸雷莫司琼和 0.5mg/100mL 盐酸咪达唑仑在 0.9%氯化钠注射液中的混合物在 4°C 或 25°C 下可稳定 14 天。
