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对复方健甲液的制备、质量控制方法进行了研究 ,制定出制剂的制备工艺和含量测定方法 ,并进行了临床疗效观察。方法 :以 95%乙醇为空白 ,采用褶合光谱法 ,不经分离 ,同时测定两组份含量。结果 :含量测定方法的平均回收率 :萘替芬为99 .86% ,水杨酸为 10 0 .4 8%。RSD :萘替芬为3.4 8% ,水杨酸为 0 .87%。结论 :该制剂制备工艺简便 ,质控方法精确 ,临床 6个月治愈率达 87.2 5%。
The preparation and quality control methods of compound Jiajirui were studied, and the preparation technology and content determination method of formulation were worked out, and the clinical curative effect was observed. Methods: 95% ethanol was used as a blank, and convolutional spectrometry was used to determine the content of the two components without separation. Results: The average recovery of the content determination method was 99.86% for naftifine and 100.48% for salicylic acid. RSD: naftifine is 3.4 8%, salicylic acid is 0.87%. Conclusion: The preparation method is simple, the quality control method is accurate, and the cure rate of clinical 6 months is 87.2 5%.