论文部分内容阅读
目的:制备0.05%环孢素滴眼液(微乳型),建立其质量控制方法,并考察其稳定性。方法:采用高效液相色谱法对其进行含量及有关物质的检测,并依据《中国药典》制剂稳定性指导原则的要求,将其分别置于高温、高湿、光照条件下进行影响因素试验,在(25±2)℃,湿度(60%±10%)Rh的条件下进行加速实验,在(6±2)℃的条件下进行长期实验,考察其稳定性。结果:0.05%环孢素滴眼液(微乳型)在100.28~350.98μg·mL-1浓度范围内呈良好的线性关系,回归方程为A=19 749.21C+76 828.91,r=0.999 9。环孢素日内和日间精密度RSD为0.45%和1.07%(n=6)。3批样品中环孢素标示量均在90%~110%的范围之内,有关物质小于1.5%,符合相关规定。在各项稳定性试验观察中,其各项指标与0月同批样品结果进行比较,均无明显变化。结论:该方法稳定,重复性好,可作为0.05%环孢素滴眼液(微乳型)的含量及有关物质的检测方法。稳定性检测结果符合要求。
OBJECTIVE: To prepare 0.05% cyclosporine eye drops (microemulsion type), establish its quality control method and investigate its stability. Methods: The contents and related substances were detected by high performance liquid chromatography (HPLC). According to the requirements of the guidelines of stability of preparation of Chinese Pharmacopoeia, the effect factors were put under high temperature, high humidity and light conditions respectively, Accelerated experiments were carried out under the conditions of (25 ± 2) ℃ and humidity (60% ± 10%) Rh, and the long-term experiment was carried out under the condition of (6 ± 2) ℃. Results: 0.05% cyclosporine eye drops (microemulsion) showed a good linear relationship in the concentration range of 100.28 ~ 350.98μg · mL-1, the regression equation was A = 19 749.21C + 76 828.91, r = 0.999 9. The intra-and inter-day cyclosporine RSDs were 0.45% and 1.07% (n = 6). The contents of cyclosporine in 3 batches of samples were within the range of 90% -110%, and the related substances were less than 1.5%, which met the relevant regulations. In the stability of the observation, the indicators of the same batch of samples in October compared with the results, no significant changes. Conclusion: The method is stable and reproducible, and can be used as a detection method of 0.05% cyclosporine eye drops (microemulsion type) and related substances. Stability test results meet the requirements.