论文部分内容阅读
目的:制备甲冰缓释膜并建立其质量控制方法。方法:以甲硝唑、冰片为主药制备缓释膜;采用紫外分光光度法测定其中甲硝唑的含量。结果:所制制剂为类白色片状薄膜,鉴别、检查均符合2005年版《中国药典》中的相关规定;甲硝唑检测浓度的线性范围为4.00～24.00μg·mL-1,平均回收率为100.03%(RSD=0.57%,n=6)。结论:本制剂制备工艺简便可行,质量稳定可控。
Objective: To prepare a sustained-release film of icy and establish its quality control method. Methods: Metronidazole and borneol were used as the drug to prepare sustained-release film. The content of metronidazole was determined by UV spectrophotometry. Results: The prepared preparations were white flake films. The identification and inspection of the preparations were in accordance with the relevant provisions of the 2005 edition of Chinese Pharmacopoeia. The linear range of metronidazole detection was 4.00-24.00 μg · mL-1. The average recovery was 100.03% (RSD = 0.57%, n = 6). Conclusion: The preparation process is simple and feasible, the quality is stable and controllable.