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目的筛选注射用雷贝拉唑钠处方及制备工艺,并对制剂的安全性进行评价。方法应用化学动力学原理考察雷贝拉唑钠降解规律;通过对pH、溶媒、金属离子、支撑剂、抗氧剂及活性炭用量等因素进行考察,筛选出最佳处方和工艺,并进行了血管刺激性、溶血及过敏试验。结果雷贝拉唑钠对碱度的敏感度最大,液体状态下需要调节pH11以上,并筛选得到合适的支撑剂、抗氧剂及活性炭的用量;制备的冻干粉针无血管刺激性、无溶血现象、无过敏反应。结论制备所得的制剂质量稳定,制备工艺简单可行,制备的制剂安全性好。
Objective To screen prescription and preparation process of rabeprazole sodium for injection and to evaluate the safety of the preparation. Methods The principle of chemical kinetics was used to investigate the regularity of rabeprazole sodium degradation. The optimal prescription and technique were screened out by the factors such as pH, solvent, metal ions, proppant, antioxidant and activated carbon, and the blood vessels Irritating, hemolysis and allergy tests. Results Sodium rabeprazole had the highest sensitivity to alkalinity, and the pH value should be adjusted to be above 11 in liquid state. Appropriate amount of proppants, antioxidants and activated carbons were screened out. The prepared lyophilized powder needles without vascular irritation, no Hemolysis, no allergic reaction. Conclusion The prepared preparation has stable quality, simple and feasible preparation process and good preparation safety.