摘要
目的：制备盐酸利多卡因乳剂并建立其质量控制方法。方法：取盐酸利多卡因及其它辅料制成乳剂，并采用高效液相色谱法测定主药含量。结果：所制乳剂为乳白色半透明粘稠液体，所建立的方法能很好分离被测组分与杂质，盐酸利多卡因检测浓度在0．05～0．6mg／ml范围内线性关系良好（r=0．9998），平均回收率为99．8％，RSD=0．057％。结论：本制剂制备方法简便，含量测定方法准确、可靠、灵敏，可用于其质量控制。
OBJECTIVE： To study the preparation process and method of quality control of hydrochloride lidocaine emulsion. METHODS：The emulsion was prepared with hydrochloride lidocaine and others, and the contents were determinated by HPLC respectively.RESULTS： The linear range of hydrochloride lidocaine was 0. 05- 0. 6mg/ ml（ r = 0.9 998）, the average recovery rate was 99.8%,RSD： O. 057% .CONCLUSION：The method is simple, accurate and suitable for the quality control of this preparation.
出处
《中国药房》
CAS
CSCD
北大核心
2006年第1期29-30,共2页
China Pharmacy
关键词
盐酸利多卡因
乳剂
制备
质量控制
Hydroehloride lidoeaine
Emulsion
Preparation
Quality control
