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目的 :考核胸腺肽注射液产品质量。方法 :用高效凝胶过滤色谱法测定胸腺肽注射液的分子量及其分布。结果 :胸腺肽注射液由 5~ 6个肽组成 ,分子量为 0 .70~ 5 .6 90kD ,其中 3.0 0 0~ 4.0 0 0kD的组分占 6 2 %以上。结论 :经数批样品的分别测定 ,分子量均未超过 10kD的规定限度。
Objective: To assess the product quality of thymosin injection. Methods: The molecular weight and its distribution of thymosin injection were determined by high performance gel filtration chromatography. Results: Thymosin injection consisted of 5 ~ 6 peptides with a molecular weight of 0.70 ~ 5 .6 90 kD, of which 3.0 0 0 ~ 4.0 0 0 kD accounted for more than 62%. Conclusion: The determination of the number of batches of samples, the molecular weight did not exceed the prescribed limit of 10kD.