Preventive effect of octreotide combined with netilmicin sulfate on postoperative infection in suppurative appendicitis and its effect on Th17/Treg imbalance / 中国生化药物杂志

Objective To investigate the preventive effect of octreotide combined with netilmicin sulfate on postoperative infection in suppurative appendicitis and its effect on helper T cell 17(Th17)/regulatory T cells(Treg)imbalance.Methods 148 patients with acute suppurative appendicitis in Xiangshan Hospital of Traditional Chinese Medicine from August 2014 to May 2016 were randomly divided into observation group(n=74)and control group(n=74).All were underwent laparoscopic appendectomy surgery,the control group took netilmicin sulfate combined with ornidazole for anti-infection after operative,while the observation group added octreotide acetate subcutaneously.The levels of serum interleukin(IL)-4,IL-6,IL-10,IL-17,IL-23,transforming growth factor β(TGF-β),interferon γ(IFN-γ)and Th17,Treg cell ratio and expression levels of related transcription factorbefore and after treatment were detected,Th17/Treg change were analyzed.Results The levels of IL-4,IL-6,IL-10,IL-17,TGF-β were decreased,IFN-γ were increased after treatment(P<0.01),the improvement of those indicators in the observation group were supior than control group(P<0.05).Th17,Treg cell ratio and expression levels of related transcription factor orphan nuclear receptorγt(RORγt),Forkhead box protein P3(Foxp3)were decrease,Th17/Treg was reduced after treatment(P<0.01),those indexes in observation group were lower than those in control group(P<0.05).The wound infection,intra-abdominal infections and other adverse events had no significant difference in two groups.Conclusions Octreotide combined with netilmicin sulfate can prevent postoperative infection in suppurative appendicitis,regulate Th17/Treg imbalance,restore immune function,and no significant adverse reactions.

Reversed-Phase High Performance Liquid Chromatography Coupled with Pulsed Electrochemical Detection for the Determination of Related Substances in Netilmicin Sulfate Injection / 中国药学杂志

OBJECTIVE: To establish an improved reversed-phase high performance liquid chromatography method coupled with pulsed electrochemical detection for determining the related substances of netilmicin sulfate injection. METHODS: Agilent Proshell 120 SB-C18 column (4.6 mm×150 mm, 2.7 μm)and gradient elution were used. Mobile phase A was 0.2 mol·L-1 trifluoroacetic acid in 0.1 mol·L-1 sodium hydroxide solution-acetonitrile (97:3), mobile phase B was 0.1% pentafluoropropionic acid-acetonitrile (97:3), and the flow rate was 0.8 mL·min-1. A pulsed electrochemical detector was adopted, and the temperatures of detector and column were kept at 35℃. The working electrode was a gold electrode with diameter of 3 mm and a quadruple-potential waveform (QPW)was selected as detection waveform. The injection volume was 25 μL. NaOH solution of 0.8 mol·L-1 was added post-column at a flow rate of 0.3 mL·min-1. RESULTS: A total of 28 impurities could be detected and effective separation was achieved in the typical sample and most of which could not be separated in the method of Ch.P 2015. The linearity of the calibration curve for netilmicin ranged from 0.25 to 15 μg·mL-1 with a coefficient of determination equal to 0.999 1. The LOD and LOQ of netilmicin were found to be 0.25 ng and 1.25 ng, respectively. The repeatability RSD(n=6) of the single largest impurity and total impurities were 0.9% and 0.8%, respectively. The sample solution was stable within 24 h. CONCLUSION: Compared with previously published investigations, the improved method shows higher sensitivity, better separation ability and good reproducibility, especially for differentiating the origin of bulk drug for netilmicin sulfate injection, thus is more suitable for the determination of related substances of netilmicin sulfate injection.

Conjunctivitis due to Neisseria sicca: A case report.

We report the first case, in Medline-based literature, of conjunctivitis caused by gram negative diplococcus, Neisseria sicca. Although it is not widely accepted as such, isolation from cultures of repeated eye swab samples suggests that N. sicca may be a pathogen in conjunctival infections. Positive culture for this organism should not be readily dismissed. Such conjunctivitis responded favorably to treatment with netilmicin eye drops.

Determination and identification of related substances of etimicin sulfate by HPLC and liquid chromatography tandem mass spectrometry using pre-column derivatization with 9-fluorenylmethyloxycarbonyl chloride / 中国药学杂志

OBJECTIVE: To identify the related substances in etimicin sulfate by hyphenated techniques using pre-column derivatization with 9-fluorenylmethyloxycarbonyl chloride. METHODS: The analysis was carried out on a Lichrospher-C18 column (4.6 mm × 250 mm, 5 μm) by using acetonitrile-0.1% formic acid solution as the mobile phase with isocratic elution mode at a flow rate of 1.0 mL · min-1, and the detection was performed at 265 nm. LC-TOF and LC-MS/MS methods were employed for the identification of the major related substances. RESULTS: It was proved that the reaction was complete and the derivatives were stable. Good retention and separations were achieved. Twenty-five impurities were proposed based on comparison of their fragmentation patterns including 8 newly identified, and their formation mechanisms were also speculated. CONCLUSION: The established method is specific and accurate with very good ruggedness and thus is suitable for the determination of etimicin sulfate and its related substances.

Post Marketing Assessment of the Efficacy and Safety of Netromax (Netilmicin) in the Indian Pediatric Population.

Objective: A post-marketing study of Netilmicin (Netromax™) in Indian pediatric patients to assess the safety and efficacy of the drug in various susceptible infections. Method: The study was carried out by 129 pediatricians from across India in 10 states (Maharashtra, Delhi, Uttar Pradesh, Andhra Pradesh, Odisha, Chhattisgarh, Karnataka, Madhya Pradesh, West Bengal, and Bihar) from November 2011 to February 2012. A total number of 542 case report forms were collected and considered eligible for further analysis based upon the completeness of data. The disease profile of patients included bacteremia, septicemia (including neonatal sepsis), severe respiratory tract infections (RTI), intra-abdominal infections (including peritonitis), kidney and genitourinary tract infections, skin and soft tissue infections, burns, bone and joint infections, wounds and perioperative infections. Result: Demographic analysis showed the median age of patients to be 13 months and median duration of therapy was 5 days. Intravenous route (IV) (n= 340) was preferred over intramuscular route (IM) (n=202) by the physicians. Netilmicin was administered in the therapeutic dose range depending upon the age and severity of the condition. The results revealed a favorable clinical efficacy and safety profile of Netilmicin. Clinical Improvement was observed in 98% (n=532) of patients among whom, clinical resolution (Defined as the absence of the infection) was achieved in 63% (n=343) patients. Whereas, partial improvement (defined as partial disappearance of original symptoms and no further requirement of antibiotics) was observed in 35% (n=189) of patients. Adverse events were reported in 11% of the entire study population and were mild in nature. There was no serious adverse event reported during the study period. Conclusion: The present post-marketing study confirmed that at the given doses and duration of therapy, NetromaxTM exhibited remarkable antibacterial efficacy with no serious incidences of toxicity. Thereby giving evidence that NetromaxTM treatment is safe and effective among the Indian pediatric population.

Bioequivalence study of a single 150-mg dose of two intramuscular netilmicin products in Thai healthy volunteers.

Objective: Netilmicin, a broad-spectrum semisynthetic aminoglycoside antibiotic, is used in the treatment of a wide variety of bacterial infections. The purpose of this study is to compare the bioavailability of two products of 150 mg netilmicin by intramuscular administration in Thai healthy volunteers: The generic drug is Nelin® (test; Biolab Co., Ltd., Thailand) will be called “Test” and Netromycin® (reference; Schering-Plough Ltd., USA) will be called “Reference”. Methods: A single-dose, 2-treatment, 2-period, 2-sequence, randomized crossover study was conducted in 24 healthy Thai volunteers. Each volunteer received a 150 mg intramuscular injection of the reference or test drugs. Blood samples were collected before dosing and at various time points up to 48 hours after dosing and analyzed for netilmicin concentrations using a validated liquid chromatography-mass spectrometry (LC-MS/MS) method. The pharmacokinetic parameters including Cmax, AUC0-t, AUC0-¥, Tmax and t1/2 were analyzed using the non-compartmental model. Drug safety and tolerability were assessed. Results: Twenty-four volunteers completed both treatment periods. The geometric mean ratios (test/reference) between the two products of netilmicin were 100.30% (90% CI, 88.02%-114.28%) for Cmax, 94.94% (90% CI, 88.94%-101.34%) for AUC0-t, and 94.88% (90% CI, 88.85%-101.32%) for AUC0-¥. There was no significant difference of the Tmax values between the two studied products (P>0.05). No adverse events related to the study drugs were found. Conclusion: The two products of intramuscular netilmicin are bioequivalent. Both products are well tolerated.

Determination of Concentration of Netilmicin Sulfate in Human Serum by Ion-pair RP-HPLC / 中国药房

OBJECTIVE:To establish an ion-pair RP-HPLC method for determination of the concentration of netilmicin sulfate in human serum.METHODS:The determination was performed on Luna C18 column with column temperature set at 40℃;the mobile phase consisted of acetonitrile-water (15∶85,pH 2.0,containing 10 mmol?L-1 sodium heptanesulfonate) at a flow rate of 0.8 mL?min-1.The detection wavelength was set at 205 nm.RESULTS:The linear range of netilmicin was 2～20 mg?L-1(r=0.997 6) with a recovery rate of 93.66%～96.05%.The intra-day and inter-day RSD were both less than 10%,respectively.CONCLUSION:The method is sensitive and simple with accurate and reliable results,and it is able to satisfy the requirement for the determination of serum concentration of netilmicin.

Comparative Vestibulotoxicity of Different Aminoglycosides in the Guinea Pigs

The histopathological alterations in the vestibule due to aminoglycosides are well defined. Although there are reports comparing the vestibulotoxic effects of the many aminoglycosides, this is the first study to compare the effects of the most commonly used aminoglycosides i.e., streptomycin, gentamicin, amikacin and netilmicin administered both transtympanically and systemically. The transtympanic and systemic administration of each aminoglycoside caused similar histopathological alterations in the vestibule. The most severe degeneration in the cristae ampullaris, utriculus and sacculus was observed after streptomycine administration. The severity of the vestibular damage in terms of magnitude was in the order of streptomycine, gentamicin, amikacin, and netilmicin.

Adverse Reaction of Netilmicin / 中国药房

OBJECTIVE:To explore the relevant factors that led to the adverse drug reaction(ADR)of netilmicin.METHODS:ADR cases resulted from netilmicin reported in12kinds of Chinese periodicals from1998to2003were analyzed statistically.RESULTS:The ADR of netilmicin involved multiple organs and systems,the clinical manifestation were compli-cated and diversified,which manifested mainly on the renal toxicity,toxicity of nervous system and allergic reaction.CON-CLUSION:Clinician and pharmacists should be alert to the ADR of netilmicin and keep using drugs rationally.

Pharmacokinetics of netilmicin in patients with burns / 中国药学杂志

OBJECTIVE：To determine the pharmacokinetic parameters and- concentrations of netilmicin in the blood,exudate and urine in 10patients with burns.METHOD:The pharmacokinetic parameters and concentrations of Netilmicin in the blood,urine and exudate were determined by FPIA.Netilmicin was given at a single-dose of 6mg.kg-1 by intravenous infusion.RESULTS:The main pharmacokinetic parameters were t1/2=(240.28±109.98) mins,Cls=(0.0973±0.0198)mg.min-1.μg-1.ml-1.The mean blood concentration was (1.56±0.66)μg.ml-1 at 8h after administration.The elimination rates of netilmicin in urine were (73.36±10.04)% and (83.39±9.46)% after 12 h and 24 h respectively. CONCLUSION:Netilmicin(6mg.kg-1)can contre the burn infetion,but the pharmacokinetic parameters are varied in different individuals,the blood concentration must be monitored.

Determination of netilmicin sulfate in serum by high performance liquid chromatography-indirect photometric determination method / 中国药学杂志

OBJECTIVE: To determine the content of netilmicin sulfate in serum by a high performance liquid chromatography-indirect photometric determination (HPLC-IPD) method. METHOD: The chromatographic system consisted of Soheisorb C18 column and mobile phase of a solution of methyl alcohol-a buffer of phosphoric acid (pH=2.0) (20∶80), that contained 0.5 mmolL-1 of nicotinamide and 0.3 mmolL-1 of sodium seventhalkyl-sulphonate. The detected wave length was 268 nm. The serum simple of 4 patients was determined. RESULTS: The mean recovery of was 93.41% and detection limits was 50 μgL-1. CONCLUSION: The method is constant, sensitive, and has a good concentration. It is good for determination of netilmicin sulfate concentration in serum.

STUDIES ON SCALE-UP OF NETILMICIN FERMENTATION TECHNOLOGY / 微生物学通报

Netilmicin n etabolic characteristics of shaking-flask fermentation were investigated. In 12L glass fermentor, it was showed that phosphate and methionine stimulated growth of mycelia and increased the production of antibiotic.On this basis, netilmicin fermentation had been scaled up successfully according to the standard of the same agitated power per unit volume from 12L fermentor to 5t fermentor.

Relationship between Drug Serum Concentrations and Two Kinds of Dosage Regimen / 中国药房

OBJECTIVE To evaluate the clinical effects and toxicity of netilmicin with different administrations by de?termining its serum concentration in the treatment of lower respiratory tract infection.METHODS:22cases of lower respi?ratory tract infection were randomly divided into two groups.The drug serum concentrations were determined by TDx system.Clinical effects were compared;renal function and hearing ability were monitored.RESULTS:On the condition of the same total daily dosage,the peak concentrations in once-daily group(group QD)were significantly higher than those in twice-daily group(group BD)(P

A Clinical Study on Therapeutic Effects of Netilmicin (Neticin(R)) in Urinary Tract Infection / 대한비뇨기과학회지

A clinical study on therapeutic effects and toxicity of Netilmicin(Neticin(R)) in urinary tract infection was performed in 47 patients with various degrees of impairment of renal function and the following results were obtained. 1. Among 45 patients with various urinary tract infection, Netilmicin brought total elimination of the bacteria in 38 patients, persistent infection(one Serratia, one Pseudomonas fluoresce.) in 2 patients superinfection with a resistant strain of Psuedomonas fluoresces and a Netilmicin-sensitive