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Tinidazole is a new generation of nitroimidazoles, metronidazole B sulfonyl derivative, has a good anti-anaerobic bacteria and antiprotozoal activity, and its activity is 2 to 4 times higher than metronidazole, and toxicity than The metronidazole is low. Advantages of tinidazole has good absorption, rapid onset, long half-life, is one of the best drugs in current clinical anti-anaerobic treatment. Tinidazole has been widely used in clinical practice, the type of preparation of a variety of rapid development. Based on the the tinidazole pharmacodynamic experimental determine tinidazole tinidazole Gargle content of 0.11%, and the effects of pH this gargle stability; determined by orthogonal experiments alternate optimal amount of metronidazole gargle several flavoring agents, and ultimately determine tinidazole gargle preparation process: prescription tinidazole dissolved in an appropriate amount of distilled water, then add 0.025% sodium cyclamate 0.025% saccharin sodium, 0.025% sodium glutamate, 0.01% flavor, stir evenly, adjusted to pH 5.0 to 7.0, filtration, filter replenishment to the full amount, packed in sterile dry container ho net, that is, too. The effects of alternate nitrate Wow gargle preparation process on the basis of The tinidazole gargle quality control, divided into: 1, content limits; traits: color, clarity; 3, the differential: thin layer chromatography, spectrophotometry; 4, general inspection: PH value, the color of the solution, the amount of difference, clarity, degradation products, microbial limit test; 5, assay. The study concluded that: 1, tinidazole Gargle approved content difference is not, Meipingzhuang amount of not less than 95% of the labeled installed, the amount of average installed not less than the labeled amount of installed; alternate nitrate azole gargle for almost colorless or yellowish green clear liquid, take the 5 batches of samples investigated traits; 3, TLC examination showed that the main spots of the test solution and reference the color and location are consistent; UV spectrophotometry examination showed that tinidazole Gargle the maximum absorption wavelength at 317nm, and tinidazole standard; 4, tinidazole Gargle pH of about 6.5, the color of the solution were found to be degradation products with microbial limit test to meet the requirements; 5, the maximum absorption wavelength determination of the content of tinidazole, get tinidazole regression equation C = -0.03968 27.491A r = 0.9999, precision and recovery.
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