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复方水杨酸氯霉素凝胶的制备和质量控制
Preparation and quality control of compound salicylic acid and chloramphenicol gel
【摘要】 目的制备复方水杨酸氯霉素凝胶,并建立质量控制方法。方法用正交试验法筛选基质处方,以羧甲基纤维素钠为基质,加入水杨酸、氯霉素、薄荷脑、甘油等制成凝胶剂;建立鉴别、含量测定等质控方法,进行离心试验,耐寒耐热试验。结果水杨酸、氯霉素在10~30ug/ml线性关系良好,平均回收率分别为99.1%(RSD=0.8%,n=6)、101.6%(RSD=1.3%,n=6),其他符合相关规定。结论本制剂制备工艺简单,性质稳定,质量可控,适用于医院制剂。
【Abstract】 Objective To prepare compound salicylic acid and chloramphenicol gel and establish a method for its quality control.Methods To choose the best basic formula with orthogonal design test.Sodium carboxymethyl cellulose was taken as basic material,salicylic acid and were added to the gel;The quality control methods for alkalinity,content determination etc were established.The tests of impulse,centrifugation,cold-resistant were prosecuted.Results The linear of salicylic acid and chloramphenicol in 10~30ug/ml were good,The average recover of salicylic acid and chloramphenicol were 99.1%(RSD=0.8%,n=6),101.6%(RSD=1.3%,n=6).Other tests accord wih the requirements of gel.Conclusion The preparation of the gel is simple.The gel stable and its quality can be controlled.
【Key words】 Salicylic acid; Chloramphenicol; Gel; Preparation; Quality control;
- 【文献出处】 中国现代药物应用 ,Chinese Journal of Modern Drug Application , 编辑部邮箱 ,2008年18期
- 【分类号】R94
- 【被引频次】3
- 【下载频次】177