氯霉素炉甘石洗剂的工艺改进与质量稳定性研究

Improvement and Quality Stability of Chloramphenicol Calamine Lotion

目的改进氯霉素炉甘石洗剂的配制工艺,提高其质量稳定性。方法采用两因素三水平的设计方法,对氯霉素进行包合,并以氯霉素的含量为指标,通过恒温加速试验及长期稳定性试验,对包合效果进行评价。结果包合温度为60℃,氯霉素与环糊精的配比为1∶3及1∶6时,包合效果最好,加速试验6个月及长期试验12个月后,氯霉素含量均为98%以上。结论氯霉素被环糊精包合后,氯霉素炉甘石洗剂的质量稳定性大大提高。

OBJECTIVE Improve stability of the chloramphenicol calamine lotion by develop the preparation process. METHODS Using two factors three levels,through constant temperature accelerated test and long term stability test,to evaluate the effect of inclusion. RESULTS Inclusion temperature was 60℃,inclusion effect was best,when chloramphenicol and cyclodextrin ratio of 1 ∶ 3 and 1 ∶ 6,6 months accelerated test and long-term test after 12 months,chloramphenicol content was more than 98%. CONCLUSION Chloramphenicol was that of cyclodextrin chloramphenicol stability greatly improve the quality of calamine lotion.