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目的:探讨pH、焦亚硫酸钠及乙二胺四醋酸二钠对复方间苯二酚洗剂稳定性的影响,以缓减该制剂的变色。方法: 取复方间苯二酚洗剂适量,加稀盐酸调节、制成不同pH值的溶液;另取该样品,加不同量的焦亚硫酸钠制成溶液;再取该样品,加不同量的焦亚硫酸钠及乙二胺四醋酸二钠(0．05％)制成含混合稳定剂的溶液;上述三种溶液分别置60℃加热及照度 1 500 lx下照射,时间均为10 d,考察样品的外观、pH、吸收度的变化。另配制含0．1％焦亚硫酸钠的该制剂样品,室温放置6 月,考察外观、pH、吸收度及含量的变化。结果:pH3以下的样品,加热及光照后,颜色、吸收度随pH降低而降低。加0．1％焦亚硫酸钠的样品,加热及光照后吸收度均较小,外观为浅黄色;室温放置6月后,样品外观,含量等均符合规定。结论:复方间苯二酚洗剂中加入0．1％的焦亚硫酸钠,可以缓减该制剂的变色。
Objective: To investigate the effects of pH, sodium metabisulfite and disodium ethylenediaminetetraacetate on the stability of compound resorcinol lotion to reduce the discoloration of the preparation. Methods: Take the right amount of resorcinol compound lotion, add dilute hydrochloric acid to adjust, make the solution with different pH value; take this sample, add different amount of sodium metabisulfite to make solution; take this sample, add different amount of coke Sodium sulphite and ethylenediaminetetraacetic acid disodium (0.05%) were made with a mixed stabilizer solution; the above three solutions were placed under 60 ℃ heating and illumination at 1 500 lx irradiation, the time was 10 d, examine the sample Appearance, pH, absorbance changes. Another preparation of the preparation containing 0.1% sodium metabisulfite sample was placed at room temperature for 6 months to investigate the appearance, pH, absorption and content changes. Results: Samples with pH less than 3 showed a decrease in color and absorbance with decreasing pH after heating and illumination. Add 0.1% sodium metabisulfite sample, the heating and light absorption are small, the appearance of light yellow; at room temperature for 6 months, the sample appearance, content, etc. are in line with the provisions. CONCLUSION: The addition of 0.1% sodium metabisulfite to the compound resorcinol lotion can reduce the discoloration of the preparation.