乙型肝炎病毒5项标志物冻干质控品的研制

RESEARCH AND PREPARATION OF THE FREEZE DRIED QUALITY CONTROL MAT ERIALS ABOUT THE FIVE HBV MARKERS

为研制稳定、可靠、可长期保存的乙肝病毒标志物冻干质控品。通过配制蛋白保护液，调整、稀释各标志物的浓度。观察稳定性、批间差、批内差和冻干前后的差异及实际应用的效果。冻干质控品水份测定结果为２．０８％，瓶间差均在１０％以下，５６℃下放置９６ｈ，Ｓ／ＣＯ值无大变化。作为室内质控物在实际应用中，经室温放置１１个月后进行测定，Ｓ／ＣＯ值无明显变化。

The objective is to research and prepare the freeze dried quality control mater ials of the hepatitis B virus markers that can be stored for a long time.The sta bility and reliability can be kept by selecting the liquid that protects the pro tein and regulating the concentrations of various markers.The stability and diff erence between the groups,every ampule before and after beign freeze dried were determined.Results are:the moisture in the quality control materials was 2 08% ,the variation among the ampules was below 10%.After stored for 96 hours at 56℃ ,no significant differences in S/CO value were found.It was applied as the quali ty control materials in the laboratory.after stored for 11 months,the S/CO value had no obvious changes.Our conclusion is the freeze dried quality control mate rials are more advantageous than the liquid one.