摘要
目的：提高医院制剂三酸散的质量标准。方法采用化学反应进行定性鉴别；采用高效液相色谱法同时测定制剂中水杨酸和苯甲酸的含量,采用滴定法测定制剂中硼酸的含量。结果鉴别反应专属性强。水杨酸在0.2-1.0 mg·mL-1范围内线性关系良好（r=0.9998）,平均回收率为99.85%,RSD为0.98%（n=9）；苯甲酸在0.2-1.0 mg·mL-1范围内线性关系良好（r=0.9999）,平均回收率为99.37%,RSD为0.90%（n=9）。硼酸在100-200 mg 范围内线性关系良好,平均回收率为99.74%,RSD 为0.99%（n=9）。结论提高后的质量标准可用于医院制剂三酸散的质量控制。
Objective To improve the hospital preparation quality standard of Tri-Acides Powder. Methods Chemical reactions were adopted for the qualitative identification.Salicylic acid and benzoic acid were determined by HPLC.Boric acid was determined by titration.Results The identification of reaction was highly specific.Within the range of 0.2-1.0 mg · mL-1 ,the calibration curve of salicylic acid was linear.The mean recovery rate （%）of salicylic acid was 99.85%,RSD=0.98% （n=9）;Within the range of 0.2-1.0 mg·mL-1 ,the calibration curve of benzoic acid was linear.The mean recovery rate （%） of benzoic acid was 99.37%,RSD=0.90% （n=9）.Within the range of 100-200 mg,the calibration curve of boric acid was linear.The mean recovery rate （%）of boric acid was 99.74%,RSD=0.99% （n=9）. Conclusion The improved standard could be used for the quality control of hospital preparation of Tri-Acides Powder.
出处
《中国药事》
CAS
2014年第9期1005-1008,共4页
Chinese Pharmaceutical Affairs
关键词
医院制剂
质量标准
三酸散
水杨酸
苯甲酸
硼酸
高效液相色谱法
滴定法
hospitalpreparation
qualitystandard
Tri-AcidesPowder
salicylicacid
benzoicacid
boric acid
HPLC
titration
