新霉素氧化锌糊的制备及质量控制

The preparation and quality control of neomycin sulfate and zinc oxide paste

目的制备新霉素氧化锌糊剂,建立其质量控制方法。方法取处方量羊毛脂、凡士林加热熔化,至70℃时,在搅拌下加入已过筛且混匀的淀粉、氧化锌及硫酸新霉素,冷凝,即得新霉素氧化锌糊。采用抗生素微生物检定法和配位滴定法分别测定新霉素和氧化锌的含量。结果新霉素氧化锌糊处方工艺合理可行;新霉素在4.0155～24.0930 u/mL浓度范围内线性关系良好（r=0.9997）,其平均回收率为95.09%,RSD为0.22%;氧化锌在0.02504~0.1252 g/mL浓度范围内线性关系良好（r=0.9999）,其平均回收率为98.96%,RSD为0.38%。结论本制剂处方工艺合理、简单、可行,质量可控,稳定性良好,临床应用安全有效。

【Objective】 To prepare neomycin sulfate and zinc oxide paste and to establish its quality control method.【Methods】The prescription amount of lanolin and petroleum were taken and heated themselves to melting.When the temperature was 70℃,the uniform mixtures of sieved starch,zinc oxide and neomycin sulfate were added under stirring conditions.Once condensate,Neomycin sulfate and zinc oxide paste was made.The content of neomycin and zinc oxide were determined by antibiotics microbial detection and coordination titration,respectively.【Results】The formula and preparation technique of neomycin sulfate and zinc oxide paste was reasonable and feasible.The linear relation of neomycin was good in the concentration range of 4.0155～24.0930 u/mL（r =0.9997）.The average recovery was 95.09% and RSD was 0.22%.The linear relation of zinc oxide was good in the concentration range of 0.02504～0.1252 g/mL（r =0.9999）.The average recovery was 98.96% and RSD was 0.38%.【Conclusion】 The preparation was reasonable in formulation,simple and practical in preparation technique,accurate in quality control,good in stability,safe and effective in clinical application.