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目的:优选盐酸地尔硫软膏的基质及处方组成。方法:采用析因分析法筛选出最优的基质处方,以外观性状、离心稳定性、耐寒耐热稳定性以及膏体延展性为考察指标对盐酸地尔硫的基质处方进行筛选,最后对优选出的处方进行质量控制。结果:最优化的处方为2%盐酸地尔硫,PEG400/4000比例为1.5:1,10%甘油,10%丙二醇,7%乙醇及2%月桂氮酮。结论:盐酸地尔硫乳膏制备方法简单,稠度与延展性适宜,性状稳定,质量可控。
Objective: To optimize the matrix and prescription of diltiazem hydrochloride ointment. Methods: The optimal matrix prescriptions were screened by factorial analysis. The matrix prescriptions of diltiazem hydrochloride were screened by the appearance, centrifugal stability, cold and heat stability and the ductility of the ointment. Finally, The preferred prescription for quality control. Results: The optimal formulation was 2% diltiazem hydrochloride with PEG400 / 4000 ratios of 1.5: 1, 10% glycerol, 10% propylene glycol, 7% ethanol and 2% lauropelitazone. Conclusion: Diltiazem Hydrochloride cream has the advantages of simple preparation method, suitable consistency and ductility, stable character and controllable quality.