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目的:建立并验证检测注射用特立帕肽生物活性的细胞增殖法。方法:采用MC3T3-E1细胞增殖法检测不同浓度注射用特立帕肽的生物活性,通过检测特异性拮抗剂TIP-39对特立帕肽促MC3T3-E1细胞增殖的抑制作用以验证方法的专属性,同时验证方法的重复性、线性和检测范围并用确立的方法将不同批次的注射用特立帕肽与上市对照品进行活性对比。结果:建立的细胞增殖法专属性和重复性良好,有效检测范围是1.25～80 nmol.L-1,促增殖活性为20%～85%,线性相关系数=0.989 8,且自制注射用特立帕肽活性与上市对照品一致。结论:建立的细胞增殖法能有效用于注射用特立帕肽的体外生物活性测定。
OBJECTIVE: To establish and validate a cell proliferation assay for detecting the bioactivity of teriparatide for injection. Methods: The biological activity of teriparatide for injection at different concentrations was tested by MC3T3-E1 cell proliferation assay. The inhibitory effect of TIP-39, a specific antagonist, on the proliferation of MC3T3-E1 cells was detected by the method of MC3T3- The method was also validated for repeatability, linearity and detection range and the different batches of teriparatide for injection were compared against the listed reference substance using established methods. RESULTS: The cell proliferation assay was established with specificity and reproducibility. The effective detection range was 1.25-80 nmol.L-1, the proliferation-promoting activity was 20% -85%, the linear correlation coefficient was 0.989 8, Paclitaxel activity and the listing of the same reference substance. CONCLUSION: The established cell proliferation assay can be effectively used for the in vitro bioactivity assay of teriparatide for injection.