融合蛋白GGH粉针剂制备工艺研究

Study on the Preparation Technology of Injectable Powder of Fusion Protein GGH

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 an HPLC method for the determination of content of GGH and its injectable powder. To screen the supplementary materials and p H and study on the stability for 6 months.Methods： The Waters DELTA PAK C18 column was used,and the mobile phase was acetonitrile and water with gradient elution for 20 minutes. The detection wavelength was 280 nm. Screened the fillers and p H according to the powder shape,solubility,stability and activity. Results： The calibration curve was linear in the range of0. 2 ~ 1. 6mg / ml,R^2= 0. 999,which could be used to the content detection of the powder. Four percent mannitol and p H5. 5 were selected to prepare the GGH injectable powder with stable quality. Conclusions： The determination of purity and activity,together with the appearance observation method,could be used for the study of preparation technology,which provided references for the application of new drugs.