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目的:筛选灰黄霉素溶液处方,建立质量控制标准,并对pH、含量稳定性进行考察。方法:采用紫外分光光度法测定灰黄霉素含量,利用单因素试验初步考察灰黄霉素溶液处方中各成分对pH的影响,再运用混合水平的正交表,以pH、含量为指标,对试验结果进行极差和方差分析。结果:灰黄霉素在2.5～20.0μg·ml~(-1)浓度范围内呈良好的线性关系,r=0.999 9;灰黄霉素溶液pH不稳定受各因素综合影响所致,影响大小为:贮存温度>N,N-二甲基甲酰胺(DMF)>包装材料。有效期内灰黄霉素含量稳定。灰黄霉素溶液处方引入缓冲体系后,6月内溶液pH控制在4.0～5.0。结论:筛选所得灰黄霉素溶液处方的含量、pH稳定,生产工艺简便,含量测定法准确可靠,适于质控。
Objective: To screen the prescription of griseofulvin solution, establish the quality control standard, and inspect the stability of pH and content. Methods: The content of griseofulvin was determined by ultraviolet spectrophotometry. The influence of each component of griseofulvin solution on pH was investigated by single factor test. Then the orthogonal test was used to determine the content of griseofulvin. Using pH and content as indexes, The test results were very poor and analysis of variance. Results: There was a good linear relationship between griseofulvin and 2.5 ~ 20.0μg · ml ~ (-1) concentration, r = 0.999 9. The pH of griseofulvin solution was affected by the combined effects of various factors, affecting the size As: storage temperature> N, N-dimethylformamide (DMF)> packaging material. Griseofulvin content is stable within the validity period. After the griseofulvin solution was introduced into the buffer system, the solution pH was controlled at 4.0-5.0 in June. Conclusion: The contents of the obtained griseofulvin solution are stable, the pH is stable, the production process is simple, the content determination method is accurate and reliable, and it is suitable for quality control.