Study On Qulity Of Netilmicin Sulfate Glucose Injection

Nanotubes sulfate is a kind of new semi-synthetic aminoglycoside broad spectrum antibiotics, with a wide range of anti-microbial action, mainly against gram-negative bacteria genus and a small number of Gram-positive bacteria. Nanotubes sulfate for glucose injection have higher bioavailability, toxicity, good tolerance and clinical efficacy in the prevention and treatment of bacterial infections, has a better therapeutic effect.Due to netilmicin sulfate soluble in water, thermally unstable, and easy to change the process of preparation and storage of the injection related substances likely to cause abnormal toxicity substandard clinical applications, it is easy to cause an allergic reaction caused by the medication does not security.But netilmicin sulfate glucose injection current standard related substances is using thin-layer chromatography of their control, but because the concentration of glucose netilmicin sulfate spots can not be separated and glucose spots impurities spots can not be seized out, so its related substances by thin layer chromatography were detected, the results are far from ideal.The sulfate Netilmicin content Determination pharmacopoeia both at home and abroad with antibiotics microbiological assay determination, complicated operation, time-consuming, but also due to the high concentration of glucose, in practice found that glucose meters star titer determination of impact of sulfuric acid Chennai behalf resulting in poor reproducibility, and the result is the main component of the drugs to their sum of related substances bacteriostatic, the measurement results can not reflect the real content of the drugs main component. Defects due to the quality standards, it is difficult to reflect the true quality of the product.Because the lack of strong UV absorption group netilmicin and other aminoglycoside structure, more difficult to apply the conventional HPLC-UV method detection, reported in the literature are mostly pre-column or post-column derivatization HPLC-UV method derivative of technology to solve problems in the quality analysis, but the cumbersome derivatization operation, time-consuming, the influencing factors of the experimental results are more derivatization reaction is more complicated reaction process may produce some side effects can not be successful for the class of drugs related substances.Specified in the2010version of" Chinese Pharmacopoeia " two sulfuric acid Netilmicin meters star raw materials and sulfuric acid Chennai behalf meters Stars Injection Determination of related substances detected by high-performance liquid chromatography evaporative light scattering detector (HPLC-ELSD) method, but this method can only detect two major impurities, this article by improving the selection of the mobile phase type and column chromatographic conditions, the final choice0.2mol/L trifluoroacetic acid-acetone (86:14) as the mobile phase, select a wide pH value (pH value range is1.0-9.0), the Ultimate LP-C18(Ⅱ) column; excellent reproducibility of analysis results, the peak, the impurity peaks and excipients peak can be sufficiently separated, can be detected for at least3impurities.Study of netilmicin sulfate glucose injection and related substances Determination Based on the sulfuric acid Chennai, establish reasonable detection method that HPLC-ELSD method for the determination of related substances and content; through destructive testing concluded netilmicin in stable under strong light, under conditions of high temperature strong acid, alkali and oxidative damage, decomposition products, high temperature oxygen, and the pH of the injection is the main factors caused netilmicin degradation.Netilmicin sulfuric is modified by the structure of sisomicin by a semi-synthetic aminoglycoside antibiotics, synthetic steps include acetylation, trimethylsilyl, then under anhydrous conditions by imine reduction, hydrolysis, separation, purification and the like, because such substances the structure of compounds containing one or more hydroxy primary amine or secondary amine groups, was weak alkaline, having a strong positive ions in the mass response, so this article through the use of highly efficient liquid chromatography-electrospray ion trap mass spectrometry combined with the method (HPLC-MSn) TFAfix sulfate Chennai behalf meters star raw materials related substances detected in nine presumed structure of the six substances. They are1-N-ethylgaramine, de-N-methyl-sisomicin, sisomicin,5-O-ethyl-netilmicin,3-N-propyl-etimicin,2’-N-ethyl-netilmicin,and the other threecompounds were deduced partially. By netilmicin synthesis process can be inferred.1-N-ethylgaramine is the main degradation product de-N-methyl-sisomicin may be the degradation products, it is also possible for the starting materials into, Sisomicin is the starting material5-O-ethyl-netilmicin and2’-N-ethyl-netilmicin are acetylation byproduct,3-N-propyl-etimicin should be a byproduct of the starting materials acetylated.In this paper, the method of orthogonal experimental design to examine the Alternate meters Stars glucose injection stability factors, choose the best production process parameters affect the sulfate Chennai, sulfate netilmicin sensitive to heat production to ensure that during the preparation process of low-temperature feeding, sterilization cooling time, the shorter the better, the sterilization conditions100℃×30min, from the ingredients until the filling to ensure that during the nitrogen effect, adjust the pH value to5.4to5.6, so this product is best taken sterile production, and confined in save the shade, to ensure product quality and medication safety.