张影;鲁旭;梁昊宇;胡玥;幺山山;曾明;王斌;

• 1:中国食品药品检定研究院

摘要(Abstract)：

目的筛选一种简便、易行的苯酚含量测定方法,作为螨变应原制品中苯酚含量测定的通用方法。方法建立比色法测定苯酚含量的标准曲线,并确定线性及测定范围;用比色法测定4种螨变应原制品中的苯酚含量,进行精密性和准确性验证;将比色法与企业标准规定方法测定结果进行比较。结果比色法6次检测结果显示,苯酚浓度在0～40μg/mL范围内与吸光度值呈良好的线性关系,R2均≥0. 999 8;比色法测定4种螨变应原制品苯酚含量,日内精密性相对标准偏差(relative standard deviation,RSD)不超过2. 3%,日间精密性RSD不超过3. 5%;准确性验证回收率为98%～104%。比色法测定3家企业螨变应原制品苯酚含量,结果全部符合质量标准规定,且与各自企业标准中规定方法的测定结果一致,差异无统计学意义(P> 0. 05)。结论利用比色法测定螨变应原制品中苯酚含量,重复性好,准确度高,操作简便,可用作该制品苯酚含量测定的通用方法。

关键词(KeyWords)： 螨变应原制品;苯酚;比色法;滴定法;高效液相色谱法;质量标准

Abstract:

Keywords:

基金项目(Foundation): 国家药典委员会药品医疗器械审评审批制度改革药品标准研究课题(No.ZG2016-3-02);; 中国医学科学院中央级公益性科研院所基本科研业务费项目(2018PT34046)

作者(Authors): 张影;鲁旭;梁昊宇;胡玥;幺山山;曾明;王斌;

DOI: 10.13200/j.cnki.cjb.002727

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