复方皮炎平霜质量标准研究

Study on Quality Control Standard for Compound Piyanping Cream

目的制订复方皮炎平霜的质量控制标准。方法用四氮唑比色法测定制剂的醋酸地塞米松含量,用紫外分光光度(UV)法测定制剂的盐酸苯海拉明含量。结果醋酸地塞米松、盐酸苯海拉明检测浓度分别在7.5～37.5μg/mL和0.2～0.6mg/mL范围内与吸收度线性关系良好,r分别为0.9997和0.9996(n=5);平均回收率分别为99.92%(RSD=0.95%)和99.08%(RSD=1.03%)。结论方法准确、可靠,可用于该制剂的质量控制。

Objective To establish the quality control standard for Compound Piyanping Cream. Methods The tetrazoline colorimetry was used to determine the dexamethasone acetate content. The UV spectrophotometry was used to determine the diphenhydramine hydrochloride content. Results The calibration curves of dexamethasone acetate and diphenhydramine hydrochloride were linear in 7. 5-37.5 μg/mL, 0.2-0.6 mg/mL （r=0.999 7, 0.999 6, n=5） respectively. The average recovery rates were 99.92% （RSD=0.95%） and 99.08% （RSD = 1.03% ） respectively. Conclusion The method is simple and accurate with good repeatability for this compound preparation. It can be used for the quality control of Compound Piyanping Cream.