摘要
目的:制备蒙维口腔溃疡膜并建立其质量控制方法。方法:以羧甲基纤维素钠为主要辅料,蒙脱石、维生素C为主药制备膜剂;采用高效液相色谱法测定其中主药维生素C的含量。结果:所制制剂为乳白色膜状制剂,鉴别、检查项均符合2005年版《中国药典》中的相关要求;维生素C检测浓度的线性范围为0.08~0.4mg·mL-1(r=0.9998),平均回收率为98.95%(RSD=1.43%)。结论:本制剂制备工艺简便可行,质量稳定可控。
OBJECTIVE: To prepare mengwei oral ulcer film and establish a method for its quality control. METHODS: Mengwei oral ulcer film was prepared using CMC-Na as principal matrix and smectite, vitamin C as principal agents. The content of vitamin C was determined by HPLC. RESULTS: The preparation was lacte film with identification and test all in line with the specification stated in Chinese Pharmacopoeia (2005 edition). The linear range of vitamin C was 0.08-0.4 mg ·mL^-1(r =0.999 8) and the average recovery was 98.95% (RSD = 1.43%) . CONCLUSION: The preparation is simple in preparation process, and its quality is stable and controllable.
出处
《中国药房》
CAS
CSCD
北大核心
2008年第19期1486-1487,共2页
China Pharmacy