辅酶Q_(10)氯化钠注射液的制备工艺

Preparation Process of Coenzyme Q_(10) and Sodium Chloride Injections

目的：制备优良的辅酶Q10氯化钠注射液。方法：采用正交设计试验对处方工艺进行研究,对关键生产技术进行控制,保证产品质量,按照确定的处方工艺中试3批样品,并将样品进行影响因素考察。结果：最佳配制温度、聚山梨酯80的加入量、抗氧剂和络合剂分别为4550℃、0.1%、0.01%亚硫酸氢钠和0.01%依地酸钙钠。结论：按该方法制备的辅酶Q10氯化钠注射液,完全符合自拟质量标准。

Objective：To prepare coenzyme Q10 and sodium chloride injections.Method：The formula and preparation process of coenzyme Q10 and sodium chloride injections were studied by an orthogonal design.The key production technology was controlled to ensure the quality.Three batches of samples were prepared in accordance with the optimal formula and technology,and inspected by stress testing.Result：The optimum conditions were follows：the preparation temperature was 45-50℃,the amount of polysorlwte 80, antioxidant sodium hydrogen sulfite and complexing agent sodium calcium edetale was 0.1%,0.01%and 0.01%,respectively.Conclusion：Coenzyme Q10 and sodium chloride injections prepared by the optimized method can fully comply with the quality standard established by our company.