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目前,大多数胰岛素制剂的纯度较高,效价亦较稳定,这为采用物理化学方法测定效价提供方便。作者等探讨用梯度洗脱RP-HPLC 法取代法定的生物检定法测定胰岛素及其制剂效价的可行性。
At present, most of the insulin preparations have high purity and relatively stable potency, which is convenient for determining the titer by physicochemical methods. The authors discussed the feasibility of gradient elution RP-HPLC instead of the statutory bioassay for the determination of insulin and its potency.