蒙维口腔溃疡膜的制备及质量控制

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。

Preparation and Quality Control of Mengwei Oral Ulcer Film

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.