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目的:研究葡萄糖氯化钠注射液不同中间体(半成品)pH对成品质量的影响。方法:检测不同中间体pH时成品的pH,A,α。结果:葡萄糖氯化钠注射液质量稳定的中间体pH值为3.0~4.0,结论:生产过程中,中间体pH应控制在3.6~4.0,并尽量减少重复回收。
Objective: To study the effect of different intermediate (semi-finished product) pH of glucose and sodium chloride injection on the quality of finished product. Methods: The pH, A, α of the finished product were measured at different pH values. Results: The pH value of the stable intermediate of glucose and sodium chloride injection was 3.0-4.0. Conclusion: During the production process, the pH of the intermediate should be controlled at 3.6-4.0, and the repeated recovery should be minimized.