4%中性甲醛固定液制备及质量评价  

Preparation and quality control of 4% neutral formaldehyde fixative

作　　者：王友芳[1] 林媛[1] 饶万新[1] 洪清[1] 庄珊珊[2] 

机构地区：[1]福建医科大学附属第一医院药学部,福州350005 [2]福建医科大学药学院,福州350001

出　　处：《海峡药学》2013年第7期24-25,共2页Strait Pharmaceutical Journal

摘　　要：目的研制4%中性甲醛固定液并建立质量标准。方法制备4%中性甲醛固定液,检查性状、pH并进行鉴别,采用间接碘量法测定甲醛的含量。结果 4%中性甲醛固定液为无色澄清液体,有刺激性气味,pH为7.2～7.4,其检测浓度线性范围为29.60～51.80mg.mL-1,r=0.9999(n=7);平均回收率为99.91%,RSD=0.90%(n=9)。结论此试验含量测定线性关系良好,检测范围宽,系统适用性好,回收率、稳定性和精密度均符合要求。本质量控制方法简便,准确,可作为该制剂质量快速检验的方法 。OBJECTIVE To prepare 4% neutral formaldehyde fixative and establish its quality control meth- ods. METHODS Preparation 4% neutral formaldehyde fixative was prepared and pH traits was checked and identi- fied Indirect iodometric method was used to determin the content of formaldehyde. RESULTS The pH of 4% neu- tral formaldehyde fixative was 7.2 to 7.4, which is a colorless clear liquid with a pungent odor. The linear range of detection of 4% neutral formaldehyde fixative was 29. 60 to 51.80mg·mL-1, r = 0. 9999 （n = 7 ） ;the average recov- ery was 99. 91% ,RSD was 0. 90% （n =9）. CONCLUSION The method has is good linear relationship,wide de- tection range and system suitability Recovery, stability and precision were meet the requirements. It is simple, precise and can be used as a rapid testing method for the quality of the preparation.

关 键 词：中性甲醛 固定液 质量标准 

分 类 号：TQ460.4[化学工程—制药化工]