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目的:制备优良的注射用酚磺乙胺。方法:采用正交设计试验对处方工艺进行研究,通过对甘露醇的量,活性炭用量和抗氧剂三因素的考察,以酚磺乙胺含量作为考察指标,按照确定的处方工艺中试三批样品,并将样品进行影响因素考察。结果:最佳甘露醇的量,活性炭的加入量和抗氧剂分别为10%,0.05%,0.02%亚硫酸氢钠,在光照和高温条件下考察10 d,各项指标均符合质量标准规定。结论:按该方法制备的注射用酚磺乙胺,完全符合质量标准。
OBJECTIVE: To prepare an excellent parenteral for injection. Methods: Orthogonal design test was used to study the prescription process. Based on the investigation of the amount of mannitol, the amount of activated carbon and the three factors of antioxidants, the content of ethanesulfonamide was taken as the index of investigation. According to the three prescriptions Samples, and the sample for influencing factors. Results: The optimum amount of mannitol, the amount of activated carbon and antioxidants were 10%, 0.05%, 0.02% sodium bisulfite, respectively, under light and high temperature conditions for 10 days, all the indicators are in line with the quality standards . CONCLUSION: PTSA prepared by this method fully meets the quality standard.