摘要
目的：建立重组人淋巴毒素α衍生物(rhLT α)生物学活性测定用国家标准品。方法：标准品按WHO重组细胞因子要求制备、检测，采用L929细胞毒法测定rhLT α的生物学活性，并以NBSB提供的国际标准品为标准，由2家实验室对rhLT α国家标准品的效价进行协作标定。结果：rhLT α国家标准品经检定各项指标均符合要求，效价协作标定结果经统计学分析，均数的95％可信区间为4．21×10^4～4．52×10^4IU／支，单次测定的95％标准值范围为3．07×10^4～6．19×10^4IU／支。这批国家标准品效价确定为4．40×10^4IU／支。加速热稳定性实验表明活性在-20℃，4℃，25℃条件下20个月保持稳定。结论：该批rhLT α经协作标定，质量可靠，效价稳定，可作国家标准品使用。
Objective:To establish national standard of rhLT α for bioassay. Methods:National standard of rhLT α was prepared according to WHO requirement for biological standards and assayed against international standard for rhLT α (NBSB 87/640)by L929 cytotoxicity assay. The collaborative studies have been carried out in two laboratories. Results:Based on statistical analysis the results showed that mean of 95% confidence interval was 4. 21×104-4. 52×104 IU per ampoule,the 95% reference range is 3. 07×104-6. 19×104 IU per ampoule. Through these analysis,the potency of rhLT α standard is defined as 4. 40 × 104 IU per ampoule. Stability tests indicated that the bioactivity has not been changed significantly under the storage of -20℃,4℃,25℃ for 20 months. Bioassay of rhLT α can be controlled effectively by this stable national standard.
出处
《中国药品标准》
CAS
2004年第3期7-9,共3页
Drug Standards of China
基金
国家高技术发展计划项目(863计划)
负责人:王军志
合同编号:2001AA215071
