复方替硝唑喷雾剂的质量控制与稳定性研究

Quality Control of Compound Tinidazole Sprayer And Study on Its Stability

目的目前替硝唑已有注射剂、片剂、胶囊、栓剂等多种剂型,在此基础上开发了复方替硝唑喷雾剂(替硝唑和硫酸锌),用于口腔厌氧茵感染的治疗。方法确定了处方和制备工艺,建立了制荆的含量测定方法,并对其影响因素、光照、高温进行了考察,确定了降解产物,同时进行了加速实验的研究。结果K_(25℃)=1.122×10.4,t_(0.9)=2.6年。结论样品在模拟临床上市条件下,稳定性良好。

Present Tinidazole exists injection tablets capsules suppositories dosage and so on, To develop compound tinidazole sprayer, use tinidazle and zinc sulfate to treat anaerobic and other bacterial infection of oral cavity. METHODS: define presription and preparation, and estab- lish the method of assay, explore the effection of illumination high temperature on it, determine the product of degration and proceed the accleration test. RESULTS: K_(25℃)1.122×10.4, t 0.9= 6.8 years. CONCLUSION: its stability is good at the clinical application conditions.