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目的:制备环孢素A壳聚糖眼用凝胶并建立其质量控制方法。方法:采用脱乙酰度90%的壳聚糖为凝胶基质、丙三醇为助溶剂和助悬剂制备眼用凝胶;采用高效液相色谱(HPLC)法测定其中主药的含量;并考察该制剂的稳定性;同时进行家兔刺激性及眼角膜滞留实验。结果:所制制剂为淡乳白色半透明凝胶,鉴别等符合2005年版《中国药典》中的相关规定;环孢素A检测浓度的线性范围为40~900mg·mL-1(r=0.9994),平均回收率为99.20%(RSD=0.61%,n=9);该制剂经冷冻、离心后未见分层和变色现象;对兔眼未见刺激性发生,在眼角膜滞留时间约为10~20min。结论:该制剂制备工艺简便可行,质量稳定可控。
Objective: To prepare cyclosporin A chitosan ophthalmic gel and establish its quality control method. Methods: Chitosan with 90% deacetylation degree was used as gel matrix. Glycerin was used as cosolvent and suspending agent to prepare ophthalmic gel. The main drug content was determined by high performance liquid chromatography (HPLC). Investigate the stability of the preparation; At the same time rabbits irritation and corneal retention test. Results: The preparation was light cream white translucent gel, and the identification was in accordance with the relevant provisions of the 2005 edition of Chinese Pharmacopoeia. The linear range of cyclosporin A was 40 ~ 900 mg · mL-1 (r = 0.9994) The average recovery rate was 99.20% (RSD = 0.61%, n = 9). The preparation was frozen and centrifuged and no delamination and discoloration occurred. No irritation was observed in rabbit eyes. The retention time in cornea was about 10 ~ 20min. Conclusion: The preparation process is simple and feasible, the quality is stable and controllable.