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目的研究低温乙醇法工艺生产的抗人T细胞猪免疫球蛋白的有效期。方法将3批经全面检定合格的抗人T细胞猪免疫球蛋白置(6±2)℃贮存36个月,分别于0、3、6、9、12、18、24、30、36个月取样,参考《中国药典》三部(2005版)中抗人T细胞猪免疫球蛋白检测方法和标准,对制品外观、pH值、纯度、蛋白含量、分子大小分布以及效价进行检定。将E玫瑰花环形成抑制试验及淋巴细胞毒试验的标示量与贮存时间结果导入Excel,使用6SQ统计加载项,进行一元线性回归,选择时间和预测区间的上或下限作散点图,在散点图中选择添加趋势线,如可观察到预测区间的上限值呈线性,可在趋势预测/回归分析类型中选择线性,获得拟合方程,将标示量带入方程中,计算获得有效期。结果根据E玫瑰花环形成抑制试验效价测定结果,理论推算在(6±2)℃条件下保存时,有效期可达41~100个月;根据淋巴细胞毒试验效价测定结果,理论推算在(6±2)℃条件下保存时,有效期可达47.9~64.3个月。结论初步确定抗人T细胞猪免疫球蛋白制品有效期为30个月。
Objective To study the expiration date of anti-human T cell immunoglobulin produced by low temperature ethanol process. Methods Three batches of fully immunoprecipitated anti-human T cell porcine immunoglobulin were stored for 36 months at 0, 6, 6, 12, 12, 24, 30, 36 months Sampling, reference to the “Chinese Pharmacopoeia” (2005 version) anti-human T cell immunoglobulin detection methods and standards, the appearance of the product, pH, purity, protein content, molecular size distribution and potency were tested. The E-rosette formation inhibition test and lymphocyte cytotoxicity test labeled amount and storage time results into Excel, the use of 6SQ statistical add-ons, a linear regression, the choice of time and the upper or lower range of the forecast interval for the scatter plot at the scatter In the figure, add the trend line. If the upper limit of the forecast interval is linear, select Linear in the Trend Forecasting / Regression analysis type to obtain the fitting equation, and bring the labeled quantity into the equation to calculate the expiration date. Results According to the results of determination of potency of inhibition test of E rosette formation, the theoretical predictions could be 41 to 100 months when stored at (6 ± 2) ℃. According to the results of lymphocyte cytotoxicity test, 6 ± 2) ℃, the effective period can reach 47.9 ~ 64.3 months. Conclusion The initial determination of anti-human T cell immunoglobulin products is valid for 30 months.