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

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。

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.