摘要
目的:制备盐酸莫西沙星泡腾片并建立其质量控制方法。方法:采用酸、碱原料分开法制备泡腾片;以高效液相色谱法测定其中主药含量。结果:所制制剂性状、鉴别、检查等均符合2005年版《中国药典》相关规定;盐酸莫西沙星进样量线性范围为0.4～3.0μg(r=0.9999);平均回收率为98.60%(RSD=0.57%,n=3)。结论:本制剂组方合理,制备工艺简便可行,质量稳定可控。
OBJECTIVE： To prepare moxifloxacin hydrochloride effervescent tablet and to establish a method for its quality control. METHODS： The tablet was prepared with acid resource and base resource respectively. The content of moxifloxacin was determined by HPLC. RESULTS： The preparation obtained was in conformity with the standard recommended by China Pharmacopeia （2005 edition） in description, identification, tests etc. The linear range of moxifloxacin was 0.4～ 3.0μg（r = 0.999 9） and its average recovery was 98.60% （RSD = 0.57%, n = 3） . CONCLUSION： The preparation is reasonable in formula, simple in technique, stable and reliable in quality.
出处
《中国药房》
CAS
CSCD
北大核心
2007年第19期1486-1487,共2页
China Pharmacy
关键词
盐酸莫西沙星
泡腾片
制备
质量控制
Moxifolxacin hydrochloride
Effervescent tablets
Preparation
Quality control
