National Institutes for Food and Drug Control (NIFDC), Beijing, China.
Sci Rep. 2023 Nov 28;13(1):20996. doi: 10.1038/s41598-023-48410-z.
The conditions and mechanisms leading to stability differences between ceftriaxone sodium products were examined to ensure drug quality and efficacy. We used a combination of powder X-ray diffraction and thermogravimetric analysis to examine the differences between preparations for injection from different pharmaceutical processes to elucidate the changed processes by exposing samples to different humidity and high-temperature conditions. Water loss or absorption due to varying environmental humidity levels did not adversely affect the crystal structure, but could lead to the reversible redistribution of hepta-hydrate in the unit cell of generic products, causing its stability change. The irreversible distribution of hydrate may occur when generic drugs stored at 25 °C, whereas the brand-name products remained stable at 40 °C. Therefore, generic ceftriaxone sodium and its powder preparations would be acceptable by better controlled sealing and storing under cool conditions during storage period to meet the efficacy and stability.
考察了导致头孢曲松钠产品稳定性差异的条件和机制，以确保药物质量和疗效。我们采用粉末 X 射线衍射和热重分析相结合的方法，研究了来自不同制药工艺的注射用制剂之间的差异，通过将样品暴露于不同的湿度和高温条件下，阐明了变化的过程。由于环境湿度水平的变化而导致的水分损失或吸收不会对晶体结构产生不利影响，但可能导致普通产品的单位晶胞中七水合物的可逆重新分布，从而导致其稳定性发生变化。当普通药品在 25°C 下储存时，可能会发生水合物的不可逆分布，而品牌药品在 40°C 下仍保持稳定。因此，通过更好地控制密封和在储存期间在凉爽条件下储存，可以接受普通头孢曲松钠及其粉针制剂，以满足疗效和稳定性的要求。
