氟化钠凝胶的研制及质量控制  

Preparation and Quality Control of Sodium Fluoride Gel

作　　者：任耘[1] 盛秉丽[2] 张秋爽[3] 

机构地区：[1]天津医科大学总医院药剂科,300052 [2]天津医科大学总医院口腔科 [3]天津医科大学药学院

出　　处：《中国药师》2001年第2期104-106,共3页China Pharmacist

摘　　要：目的:对氟化钠糊剂剂型进行改进,研制了氟化钠凝胶,以延长作用时间,提高临床疗效方法:采用正交试验法筛选基质最佳配方,并建立了酸碱度、微生物限度检查、含量测定等质量控制标准,同时,对制剂稳定性进行了考察,结果:pH 6. 0-7. 0,微生物限度检查符合规定,试验前后凝胶稳定性无变化,平均回收率为99. 9％。结论:制备该凝胶工艺简单,所得制剂质量可控,性质稳定。Objectives: To improve the dosage form of sodium fluoride paste to prolong its action time and raise the clinical curative effect. Methods: Optimum stroma composition was screened by the orthogonal design test, and the quality control standards involving pH, microbial limits examination, and content determination were established; in the mean while, the preparation stability was also investigated. Results: pH of the preparation was 6.0-7.0. the examination of microbial limitation accorded with standard; the average recovery was 99.9 % . In addition, the gel was stable and no change occurred after stability test. Conclusions:This gel can be easily prepared. I he quality was stable and could be controlled. It s suitable for hospital preparation.

关 键 词：氟化钠 凝胶剂 卡波姆 质量控制 牙齿敏感症 

分 类 号：R988.2[医药卫生—药品] R781.205[医药卫生—药学]