3 results about "Tobramycinum" patented technology

This invention relates to the field of pharmaceutical analysis technology, and more particularly to a method for detecting tobramycin-related substances in tobramycin products. The detection method provided by this invention utilizes HPLC-CAD to detect tobramycin-related substances. Based on the concept of quality analysis originating from design, it establishes a stable and reliable analytical method operation design region by systematically identifying and optimizing key method parameters. This overcomes the problems of low sensitivity, complex operation, and insufficient robustness in existing technologies, achieving rapid, accurate, and repeatable detection of related substances in tobramycin raw materials and their preparations.

The application discloses an analysis method of tobramycin sulfate injection and application thereof, and the analysis method comprises the following steps: performing a pre-column derivatization reaction on a sample containing tobramycin and impurities by using a derivatization reagent, and then performing high performance liquid chromatography analysis on the sample after derivatization. The analysis is performed by gradient elution of a mobile phase A and a mobile phase B composed of water, acetonitrile and phosphoric acid, wherein the content of acetonitrile in the mobile phase B is higher than that in the mobile phase A, and effective separation of tobramycin and related impurities is realized by multi-stage gradient elution. The method can simultaneously separate and detect process impurities, degradation impurities and unknown impurities, has good separation degree and stability indicating capacity, and is suitable for quality control and drug stability research of tobramycin sulfate injection.

This invention relates to a method for preparing tobramycin sulfate, comprising: S1, acidifying carbamoyl tobramycin fermentation broth, adsorbing it with a first cation exchange resin, sieving and washing it, packing it into a column, then eluting it with a first ammonia solution, while simultaneously decolorizing it with a decolorizing resin column in series, and collecting the eluent rich in carbamoyl tobramycin; S2, hydrolyzing the eluent rich in carbamoyl tobramycin under alkaline conditions to obtain a tobramycin hydrolysate; S3, adjusting the pH of the tobramycin hydrolysate to neutral, adsorbing it with a second cation exchange resin column, washing it with water, and then sequentially eluting it with a second ammonia solution of first, second, and third concentrations, collecting the eluent rich in tobramycin, concentrating it by nanofiltration, salting it, decolorizing it with activated carbon, and spray drying it to obtain the tobramycin sulfate; the first concentration is 0.05~0.1 mol / L, the ratio of the second concentration to the first concentration is 1.5~2, and the ratio of the third concentration to the second concentration is 1.2~1.5. The tobramycin sulfate prepared by the method of this invention has a purity ≥99% and a yield ≥50%.