摘要
目的:考察炉甘石原料(饮片)中氧化锌含量控制的范围,补充洗剂中苯酚质量控制的内容,完善炉甘石洗剂质量控制的方法。方法:采用EDTA络合滴定法测量不同厂家不同批号的炉甘石(饮片)中氧化锌的含量,从而确立洗剂中氧化锌含量限度范围;分别采用紫外分光光度法、溴量法测定洗剂中的苯酚含量,并行方法学验证,建立洗剂中苯酚的质量标准结果:炉甘石(饮片)中氧化锌的平均含量为70.35%。紫外分光光度法测得炉甘石硫洗剂中苯酚平均回收率为101.65%,RSD为0.89%(n=6),含酚炉甘石洗剂中苯酚平均回收率为102.06%,RSD为1.64%(n=6);溴量法测得炉甘石硫洗剂中苯酚平均回收率为98.15%,RSD为0.98%(n=6),含酚炉甘石洗剂中苯酚平均回收率为98.15%,RSD为1.08%(n=6)结论:含酚炉甘石洗剂中氧化锌的含量下限为13.4%(g·ml^(-1));炉甘石硫洗剂中氧化锌的含量下限为10.6%(g·ml^(-1))溴量法简便,快速,准确,可作为洗剂中苯酚的含量测定方法。
To investigate the concentration control range of zinc oxide in the raw materials and explore the quality control method for phenol to improve the quality control of calamine lotions.Method:The zinc oxide concentration in calamine raw materials produced by different manufacturers with different batches was determined by EDTA compleximetry,and the concentration limils of zinc oxide were established.UV-spectrophotometry and bromometry were used to assay the phenol concentration in the lotions,and the methodology test was used to establish the quality standard of phenol.Result:The average zinc oxide concentration in calamine raw materials was 70.35%.The average recovery of phenol in calamine and sulfur lotions was 101.65%(RSD - 0.89%,n = 6),while 102.06%(RSD = 1.64%,n =6) in calamine lotions delected by UV-spectrophotometry.The average recovery of phenol in calamine and sulfur lotions was 98.15%(RSD =0.98%,n =6),while 98.15%(RSD = 1.08%,n=6) in calamine lotions detected by bromometry. Conclusion:The lower limit of the zinc oxide concentration in calamine lotions is 13.4%(g·ml^(-1) ),while 10.6%(g·ml^(-1) ) in calamine and sulfur lotions.Bromometry is simple,rapid and accurate,and suitable for the determination of the phenol concentration in the lotions.
出处
《中国药师》
CAS
2013年第7期1012-1014,共3页
China Pharmacist
关键词
炉甘石
氧化锌
苯酚
质量控制
Calamine
Zinc oxide
Phenol
Quality control