| 摘要: |
| [摘要]目的：考察注射用盐酸罗沙替丁醋酸酯（ROX）与葡萄糖氯化钠注射液、木糖醇注射液、果糖注射液、转化糖注射液及10%葡萄糖注射液配伍的稳定性。方法：注射用ROX与5种溶媒配伍后，在室温（25±1）℃及高温（40±1）℃条件下，于0、1、2、4、6、8、12、24 h取样，观察各配伍液的外观变化，测定pH值和不溶性微粒计数，采用高效液相色谱法测定ROX的含量。结果：在上述条件下，各配伍液外观均无色澄清透明，无气泡及沉淀产生，各配伍液pH值无明显变化，RSD<2%（n=8）。注射用ROX与葡萄糖氯化钠注射液组成的配伍液室温12 h后pH值分别为3.96、3.91，高温8 h后配伍液pH值分别为3.95、3.92、3.86，其他配伍液pH值在4.40~6.31之间。24 h内各配伍液的不溶性微粒未明显增加，均符合规定。注射用ROX与木糖醇注射液、果糖注射液、转化糖注射液、10%葡萄糖注射液组成的配伍液24 h内药物含量变化均<5%，RSD<2%；与葡萄糖氯化钠注射液组成的配伍液含量呈下降趋势，24 h药物含量变化>10%，RSD分别为4.52%（室温，n=8）、4.43%（高温，n=8）。结论：注射用ROX与木糖醇注射液、果糖注射液、转化糖注射液、10%葡萄糖注射液配伍后应在24 h内使用，与葡萄糖氯化钠注射液配伍应在12 h内使用。 |
| 关键词: 盐酸罗沙替丁醋酸酯 溶媒 配伍 稳定性 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2020.01.011 |
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| 基金项目:湖北省十堰市科学技术研究与开发项目,编号 17Y33。 |
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| Compatible Stability of Roxatidine Acetate Hydrochloride for Injection with Common Solvents |
| Hu Xiao1, Chen Fuchao2, Wang Linhai1, Yu Shirong1, Yu Huibin1, Liu Yanhong1 |
| (1. Shiyan People’s Hospital, People’s Hospital of Hubei Medical College, Hubei Shiyan 442000, China; 2. Dongfeng Hospital Affiliated to Hubei University of Medicine, Hubei Shiyan 442008, China) |
| Abstract: |
| [Abstract] Objective: To investigate the compatible stability of roxatidine acetate hydrochloride (ROX) for injection with glucose sodium chloride injection, xylitol injection, fructose injection, invert sugar injection and 10% glucose injection. Methods: After the combination of ROX for injection and five solvents, samples were taken at 0, 1, 2, 4, 6, 8, 12, 24 h at room temperature (25±1) °C and high temperature (40±1) °C, the appearance of the mixed infusions were observed, the pH value and the number of insoluble particles were measured, and the content of ROX was determined by high performance liquid chromatography. Results: Under the above conditions, the appearance of each of the compatibility solution was clear and transparent, no bubbles and precipitates were produced. There was no significant change in pH of each compatibility solution, RSD<2% (n=8). However, the pH of the compatibility of the drug and glucose sodium chloride injection solution were 3.96 and 3.91 after 12 and 24 h at room temperature, the pH values were 3.95, 3.92 and 3.86 after 8, 12 and 24 h at high temperature, and the pH values of other compatibility solution ranged from 4.40 to 6.31. The insoluble particles of compatibility solution did not increase significantly within 24 h, and all met the requirements. The drug content changes in the mixture of ROX and xylitol injection, fructose injection, invert sugar injection, 10% glucose injection within 24 h were <5%, RSD<2%. The content of the combination of ROX and glucose sodium chloride injection showed the downward trend, the drug content changed by >10% within 24 h, the RSD was 4.52% (room temperature, n=8) and 4.43% (high temperature, n=8). Conclusion: ROX for injection combination with xylitol injection, fructose injection, invert sugar injection and 10% glucose injection should be used within 24 h, and combination with glucose sodium chloride injection should be used within 12 h. |
| Key words: roxatidine acetate hydrochloride solvents compatibility stability |
