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目的:研究消旋山莨菪碱滴眼液的制备方法,并对其进行质量控制。方法:取处方量的消旋山莨菪碱、硼酸等,经溶解、过滤除茵后,分装制得消旋山莨菪碱滴眼液;消旋山莨菪碱含量测定采用高效液相色谱法,流动相为0.02%三乙胺溶液-甲醇(50:50),检测波长为220nm。结果:该制剂设计合理,含量检测方法准确可靠,精密度高,稳定性好。结论:工艺制备简单,检测结果准确。
Objective: To study the preparation method of racemic anisodamine eye drops and to carry out quality control. Method: Take a prescription of racemic anisodamine, boric acid, etc. After dissolving, filtering and deodorizing, prepare the racemic anisodamine eye drops by dispensing; The content of racemic anisodamine is determined by high performance liquid chromatography. The mobile phase was 0.02% triethylamine solution - methanol (50:50) and the detection wavelength was 220 nm. Results: The preparation has reasonable design, accurate and reliable content detection method, high precision and good stability. Conclusion: The process preparation is simple and the test results are accurate.