蒙维口腔溃疡膜的制备及质量控制

Preparation and Quality Control of Mengwei Oral Ulcer Film

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.