新型浊度标准液研究及澄清度检查法通则修订  

Investigation on new turbidity standard solution and revision of general chapters for clarity and degree of opalescence of liquids

作　　者：侯金凤 刘海涛 寇晋萍 黄晓春 车宝泉 HOU Jinfeng;LIU Haitao;KOU Jinping;HUANG Xiaochun;CHE Baoquan(Beijing Institute for Drug Control,NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing 102206,China)

机构地区：[1]北京市药品检验研究院国家药品监督管理局仿制药研究与评价重点实验室中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《中国药品标准》2023年第4期343-350,共8页Drug Standards of China

基　　金：国家药典委员会药品标准制修订研究课题(2020Y03)。

摘　　要：目的:优化福尔马肼浊度标准液的制备以保证浊度的准确性,筛选并研究新型浊度标准液。方法:对福尔马肼浊度标准液的制备过程、吸光度与浊度的关系进行研究,对聚合物浊度标准液线性、重复性、稳定性等进行考察,并对以上2种浊度标准液进行比较研究。结果:严格规范福尔马肼浊度标准液的制备过程,能够保证浊度的准确性和标准物质的可溯源性;浊度与吸光度无相关性,用吸光度范围限定浊度不合理;聚合物浊度标准液稀释后线性关系良好、重复性好、稳定性好、无毒、环保,适合用于药品澄清度检查。结论:拟规定目视法和浊度仪法2种方法可以相互替代,修订福尔马肼制备过程,删除用吸光度限定浊度,增订聚合物浊度标准液。Objective:To standardize the preparation of formazin turbidity standard solution in order to ensure the accuracy of turbidity,and to screen and research new turbidity standard solution.Methods:The preparation process of formazin turbidity standard,the relationship between the absorbance and the turbidity of formazin standard solution were studied.Linearity,repeatability,and stability of polymer standard solution also were investigated.Then,a comparative study of the above two turbidity standards was carried out.Results:The accuracy and traceability of turbidity could be ensured by strictly regulating the preparation process of standard solution of formazin turbidity,the turbidity has no correlation with the absorbance,and it was not reasonable to limit the turbidity by the absorbance range.The polymer turbidity standard solution showed good linearity,good repeatability and stability after dilution.It was also non-poisonous,eco-friendly,so it was suitable for drug clarity inspection.Conclusion:It is proposed to specify that visual comparison method and instrumental method can be substituted for each other.The preparation process of formazin turbidity standard is revised,the turbidity defined by the absorbance is deleted,and the standard solution of polymer turbidity is added.

关 键 词：澄清度 福尔马肼浊度标准液 聚合物浊度标准液 吸光度 浊度 

分 类 号：R921.2[医药卫生—药学]