摘要
目的:设计研究一种治疗口腔厌氧菌感染制剂的处方和制备工艺,建立制剂的含量测定方法,并对其稳定性进行初步探讨。方法:参照类似产品设计处方,双波长等吸收点法测定含量,加速试验法考查稳定性。结果:产品口惑较好,替硝唑(TN)的含量可于波长317 nm处直接测定,醋酸氯己定(CA)可于波长254 nm,波长273 nm处用双波长等吸收点法测定含贡,测定浓度低于10 mg·L-1时其收率较好,3个月的稳定性试验结果显示降解率分别为5.93%,7.30%。结论:制剂口惑好,含量测定方法简便可靠,稳定性符合要求,临床疗效有待于验证。
Abstract
OBJECTIVE: To use a gargle to treat anaerobic and other bacterial infection of oral cavity. METHODS:Dual-wavelength isobestic point spctrophotometry was used as the quantitative analysis method. Joel-Dvis method was used to study the stability. RESULTS: The content of tinidazol (TN ) was detected in wave length 317 nm directory Chlorhexidine acetate(CA) was assayed in wave length 254 nm and wave length 273 nm using dual-wavelength isobestic point spctrophotometry. Good recovery was noted when the detective concentration was less than 10 mg·L-1. The degration ratio of TN and CA was 5.95%and 7.30% respectively after 3-month stability test. CONCLUSION: The preparation's taste, quantitative analysis and stability are well acceptable. The clinical efficacy will be verified in the next study.
关键词
替硝唑 /
含漱剂 /
杭厌氧菌 /
醋酸氯己定
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Key words
tinidazol /
gargle /
anti-anaerobe /
chlorhexidine acetate
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湛建国;程泽能;张郁葱;.
复方替硝唑含漱剂的研制[J]. 中国药学杂志, 1997, 32(02): 94-96
Zhn Jinguo.
Preparation of compound tinidazol gargle[J]. Chinese Pharmaceutical Journal, 1997, 32(02): 94-96
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参考文献
1 中国医院制剂规范.第2版.中国医药科技出版社,1995:243
2 Martindale. The extra pharmacopeoa.ed 28.1982;529.
3 陈新谦,金有豫.新编药物学.第13版.北京:人民卫生出版社.1992:499.
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脚注
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