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目的对本院自制的含替硝唑和醋酸地塞米松口腔溃疡双层膜进行质量控制。方法建立HPLC法测定药物含量,并对膜剂的体内外黏附时间、溶出等指标进行测定和评价。结果替硝唑在2~180 mg.L-1、醋酸地塞米松在0.25~22.5 mg.L-1时线性关系良好,平均提取回收率分别为101.59%(n=5,RSD=0.89%)和99.18%(n=5,RSD=1.35%)。膜剂在溶菌酶生理盐水中的平均溶解时间为25 min;体内外平均黏附时间分别为29.87和27.25 min;在37℃人工唾液中药物呈一级释放,替硝唑和醋酸地塞米松最大溶出度为80%和70%;在口腔黏膜处药物呈一级释放,30 min时释药率100%。结论本实验建立的膜剂药物HPLC测定方法及其他相应指标的测定方法简便合理,可很好控制该双层膜的质量。
Objective To control the quality of bilayer membrane of tinidazole and dexamethasone oral ulcer in our hospital. Methods HPLC method was established for the determination of drug content, and the adhesion and dissolution time and dissolution indexes of the film in vitro and in vivo were measured and evaluated. Results Tinidazole had a good linearity at the range of 2 ~ 180 mg.L-1 and dexamethasone at 0.25 ~ 22.5 mg.L-1. The average recoveries of tinidazole were 101.59% (n = 5, RSD = 0.89% And 99.18% (n = 5, RSD = 1.35%). The mean dissolution time of the film in lysozyme normal saline was 25 min and the average in vitro and in vivo adhesion times were 29.87 and 27.25 min respectively. The first release of the drug in artificial saliva at 37 ℃ was the strongest dissolution of tinidazole and dexamethasone acetate Degree of 80% and 70%; in the oral mucosa drug was first-class release, 30 min release rate of 100%. Conclusion The method of determination of drug by HPLC and the determination of other corresponding indexes established in this experiment are simple and reasonable, and can control the quality of the bilayer membrane well.