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目的研制低浓度的环孢素眼用乳剂,并建立该制剂的质量控制方法。方法采用羟丙甲纤维素为增稠剂,按处方制备低浓度的环孢素眼用乳剂,用高效液相色谱法测定环孢素的含量,观察家兔眼部刺激性,并对制剂的稳定性进行考察。结果环孢素在5～60 mg/L浓度范围内线性关系良好(r=0.9999),平均回收率为100.39%,相对标准偏差(RSD)为1.15%。滴眼后无刺激性,而且稳定性较好。结论该制剂制备工艺简单,含量测定方法简便、准确,质量稳定,对眼部无刺激性,是一种较理想的眼用制剂,可用于干眼症及其他眼部免疫性疾病的治疗。
Objective To develop a low concentration of cyclosporin ophthalmic emulsion and establish the quality control method of the preparation. Methods hypocrellin was used as thickener, cyclosporin ophthalmic emulsion was prepared according to the prescription, and the content of cyclosporine was determined by HPLC. The eye irritation of rabbits was observed. Stability of the inspection. Results Cyclosporine had good linearity (r = 0.9999) in the range of 5 ~ 60 mg / L with the average recovery of 100.39% and relative standard deviation (RSD) of 1.15%. No eye irritation, and stability is better. Conclusion The preparation method of the preparation is simple, the determination method is simple, accurate, stable in quality and non-irritating to eyes. It is an ideal ophthalmic preparation for the treatment of dry eye syndrome and other ophthalmic immune diseases.