What Is Cefuroxime Axetil?

This product is white or almost white powder; almost odorless and bitter. This product is easily soluble in acetone, soluble in chloroform, slightly soluble in methanol or ethanol, slightly soluble in ether, and insoluble in water. Take the appropriate amount of this product, accurately weigh it, add methanol to dissolve and make a solution containing 15 g per 1 ml, and use the spectrophotometry (Appendix IVA) to measure the absorbance at a wavelength of 271 nm. The absorption coefficient (E1% 1cm) It is 390 to 420.

Cefuroxime Ester

This product is white or almost white powder; almost odorless and bitter. This product is in

beta-lactam antibiotics,

This product is acetoethyl ethyl cefuroxime. Released after in vivo hydrolysis

This product is suitable for

oral. Adults usually 0.5g a day;

The product is generally well tolerated, and common adverse reactions are gastrointestinal reactions such as nausea, vomiting, diarrhea, and loose stools. Occasionally

People who are allergic to this product and other cephalosporins have penicillin

1. This product has cross-allergic reactions with penicillins or cephamycins. Therefore, those who are allergic to penicillins, penicillin derivatives, penicillamine and cephalomycin should be used with caution.

2. Patients with renal dysfunction and liver function impairment should be used with caution.

Strong furosemide such as tofuremide, itanilide, bumetanide,

1. Recorded under the content determination item

Take this product for crystallinity and determine it according to law (Appendix D). There should be no extinction position and birefringence.

According to

Cefuroxime Ester Experimental Section

Apparatus and reagents: Shimadzu HPLC, CLASSLC10A, SPD10A UV detector, CR6A data processor. Cefuroxime ester raw materials (provided by a pharmaceutical company in Guangzhou), methanol (chromatographically pure), dihydrogen phosphate (analytical grade).

Chromatographic conditions Chromatographic column, Dickma C18 column (5 m, 150 mm × 46 mm); mobile phase A: 0.2 mol / L dihydrogen phosphate solution, mobile phase B: methanol; flow rate, 1.3 mL / min, gradient elution; detection wavelength, 278 nm ; Injection volume, 20 L.

Cefuroxime method results

Precisely weigh 75mg of the test product, place it in a 50mL volumetric flask, add methanol to dissolve and dilute it to the mark, shake well, and use it as the test solution; also accurately draw 5mL of the test fluid, place it in a 100mL volumetric flask, and dilute to the mark with methanol Pipette 1mL into a 25mL volumetric flask, add methanol to the mark and dilute it as the control solution; take methanol as a blank solution, take 20L each, and inject separately, gradient elution, 0 ~ 5min, the proportion of mobile phase B from 15% Increased to 35% and maintained for 10min; at 60min, the proportion of mobile phase B increased to 48%; at 65min, the proportion of mobile phase B increased to 70%; when maintained for 5min, at 75min, the proportion of mobile phase A increased to 85%, Hold for 10min. Calculate the content of each impurity and total impurities by external standard method.

Cefuroxime Expert Discussion

The main impurities of cefuroxime ester are cefuroxime 3 isomer (produced by thermal degradation), anti-cefuroxime ester isomer (produced by photolysis), and other by-products and other impurities brought into the synthesis . According to reports, ICP has reached a consensus on the inspection of impurities in the development of new drugs: all impurities greater than 0.1% are in principle controlled. Obviously, the content of 3 isomer and anti-cefuroxime isomer in the raw materials of cefuroxime ester are more than 0.1%. If the limit method of CHP2000 is adopted, only the amount of total impurities is controlled. Impurities are not specified, which seems unreasonable.

BP2000 specifies the limits of several major impurities separately, but uses a simple normalization method. Because the impurity content and the main component content are greatly different, it is difficult to accurately measure the main component peak area and impurity peak area at the same time, and the parameters The effect of the setting on the measurement accuracy of large and small peak areas will also cause calculation errors. Some experts have proposed that the use of self-control method not only overcomes the shortcomings of the simple normalization method, but also solves the problem of the lack of impurity reference materials. The sample solution was taken in a 60 ° C water bath for 1 h and 254 nm UV irradiation for 24 h. The mixed solutions were separated by gradient elution and constant elution respectively. Both methods can separate cefuroxime sulfate (isomers B, A ), Cefuroxime 3 isomers, transcefuroxime esters (isomers B, A) and other impurities. The gradient elution method has better peak shape and resolution than the constant elution method, and it can separate more impurities, such as di--cefuroxime ether isomers and other impurities.