摘要
对氯强油搽剂制备工艺及处方进行优化选择,并建立该制剂质量标准。通过处方及工艺优化确定制备工艺;用HPLC法对强的松和氯霉素进行定量研究。该法所制成品稳定;节约无水乙醇用量30%,制备时间相应缩短。氯霉素与强的松检测浓度分别在0.30~1.50mg·mL-1、0.02~0.10mg·mL-1范围内线性关系良好,氯霉素和强的松的平均回收率分别为100.65%和101.70%。超声波法制备氯强油搽剂工艺合理,生产成本低,成品质量稳定可控。
The prearation of the Lvqiangyou Liniment was studied. A method of its physical stability was established and the best amount of anhydrous ethanol was explored. The optimal conditions, formulation and technology for preparing Lvqiangyou Liniment was selected. The product was stability and saved 30% ethanol content. The preparation time was shortened considerably. A good linearity of ehoramphenicol was obtained within 0.30~1.50mg·mL^-1 and prednisone was within 0.02~0.10mg·mL^-1. The average recoveries of choramphenicol was 100.65% and prednisone was 101.70%, respectively. The optimized preparation techniqe is stable and high sfficiency for preparation of Lvqiangyou Liniment. The quality control method is accurate and can be used to control the quality of Lvqiangyou Liniment.
出处
《中国药事》
CAS
2008年第10期892-894,共3页
Chinese Pharmaceutical Affairs