中国医药科学
中國醫藥科學
중국의약과학
CHINA MEDICINE AND PHARMACY
2013年
21期
36-37,68
,共3页
盐酸莫西沙星%泡腾片%研制%质量控制
鹽痠莫西沙星%泡騰片%研製%質量控製
염산막서사성%포등편%연제%질량공제
Moxifolxacin hydrochloride%Effervescent tablets%Preparation%Quality control
目的：研制盐酸莫西沙星泡腾片并建立制剂的质量控制标准。方法用酸、碱分开制法制备盐酸莫西沙星泡腾片，并对其性状、重量差异、崩解时限、酸度、鉴别、含量测定、稳定性等进行了检测。结果莫西沙星检测浓度在0.4～3μg/mL浓度范围内，线性关系良好（R2=0.9995），平均回收率96.14%（RSD=1.7%，n=5）。结论本品处方、制备工艺简单、质量稳定，本品可作为盐酸莫西沙星制剂新品种的开发。
目的：研製鹽痠莫西沙星泡騰片併建立製劑的質量控製標準。方法用痠、堿分開製法製備鹽痠莫西沙星泡騰片，併對其性狀、重量差異、崩解時限、痠度、鑒彆、含量測定、穩定性等進行瞭檢測。結果莫西沙星檢測濃度在0.4～3μg/mL濃度範圍內，線性關繫良好（R2=0.9995），平均迴收率96.14%（RSD=1.7%，n=5）。結論本品處方、製備工藝簡單、質量穩定，本品可作為鹽痠莫西沙星製劑新品種的開髮。
목적：연제염산막서사성포등편병건립제제적질량공제표준。방법용산、감분개제법제비염산막서사성포등편，병대기성상、중량차이、붕해시한、산도、감별、함량측정、은정성등진행료검측。결과막서사성검측농도재0.4～3μg/mL농도범위내，선성관계량호（R2=0.9995），평균회수솔96.14%（RSD=1.7%，n=5）。결론본품처방、제비공예간단、질량은정，본품가작위염산막서사성제제신품충적개발。
Objective To prepare effervescent tablets of moxifolxacin hydrochloride and to establish the quality preparation. Methods The character, weight deviation, disintegration time, pH, content stability of moxifolxacin hydrochloride were tested. Results The linear of moxifolxacin was 0.4-3μg/mL (R2=0.9995) and the average recovery was 96.14% (RSD=1.7%, n=5). Conclusion The preparation method is simple and the preparation is stable. It is valuable for the further study as a new preparation of moxifolxacin hydrochloride.
