目的:建立高效液相色谱法测定融合蛋白GGH原料和注射用粉针剂含量的方法,筛选制备粉针剂的辅料和p H,进行6个月的长期稳定性试验。方法:高效液相色谱采用Waters DELTA PAK C18色谱柱,流动相为乙腈和水,梯度洗脱20min,检测波长280nm。根据粉针剂的外形、复溶性、稳定性和活性保留率筛选填充剂及p H。结果:GGH在0.2~1.6mg/ml范围内线性关系良好,可用此方法进行制剂的含量检测;选用4%的甘露醇作为填充剂并调节p H为5.5,可以制备性质较为稳定的GGH冻干粉针剂。结论:可采用含量和纯度检测结合外观性状观察法用于粉针剂的制备工艺筛选,为申报新药提供参考。 OBJECTIVE: To establish a HPLC method for the determination of the contents of GGH fusion protein and injection powder, and to screen for the preparation of powder injection and p H for long-term stability test of 6 months. Methods: Waters DELTA PAK C18 column was used for HPLC. The mobile phase consisted of acetonitrile and water with a gradient of 20 min and a detection wavelength of 280 nm. According to the shape of the powder injection, solubility, stability and retention of activity screening fillers and p H. Results: The linearity of GGH in the range of 0.2-1.6mg / ml was good, and the content of GGH could be detected by this method. Using 4% mannitol as filler and adjusting pH 5.5, freeze-dried GGH with stable properties could be prepared Powder injection. Conclusion: The content and purity can be combined with the observation of appearance traits for the preparation of powder injection screening, to provide a reference for the declaration of new drugs.