内眼灌注液的制备及质量控制

Preparation and Quality Control of Internal Eye Perfuse Aqua

目的：制备内眼灌注液并建立其质量控制方法。方法：按无菌制剂标准制备，并进行含量测定和稳定性等指标考察。结果：制剂中总氯量和镁、钙标示量均为98．9％～100．6％。结论：本处方设计合理，质量控制方法简便、准确、可行，制剂稳定性好，值得临床推广应用。

OBJECTIVE：To prepare internal eye perfuse aqua and establish a method for its quantity control.METHODS： The internal eye perfuse aqua was prepared in a germ free preparation standards, assaying was performed, and indexes like stability, etc .were investigated .RESULTS： The total chlorine amount, labeled amounts of magnesium and calcium in perfuse aqua all stood at 98.9%- 100.6% .CONCLUSIONS： The preparation is reasonable in performulation, and simple, accurate and feasible in quality control, the preparation is stable and deserves to be popularized in the clinic.