The rapeutic effect of Cefpodoxime proxetil granules in treatment of acute bronchitis in children / 中华实用儿科临床杂志

Objective To study the efficacy and safety of Cefpodoxime proxetil granules in the treatment of acute bronchitis in children.Methods One hundred and sixty children of the First People's Hospital of Nanning from June to December 2018 with acute bronchitis were randomly divided into cefpodoxime group and cefaclor group,with 80 cases in each group.All patients received routine treatment.On this basis,80 patients in the cefpodoxime group received oral Cefpodoxime proxetil granules 5 mg/kg (not more than 100 mg/time),twice a day;80 patients in the cefaclor group received oral Cefaclor.The granules were 10 mg/kg (not more than 250 mg/time),3 times a day,and the course of treatment was 5 days.The clinical efficacy and adverse reactions were observed.Results The cure rate and effective rate of Cefpodoxime group were 91.3％ (73/80 cases) and 95.0％ (76/80 cases),respectively,while the cure rate and effective rate of Cefaclor group were 66.3 ％ (53/80 cases) and 81.3％ (65/80 cases),respectively,and the differences between the 2 groups were statistically significant (x2 =14.94,7.23,all P ＜ 0.05).Sixty-three strains of pathogenic bacteria and 66 strains of pathogenic bacteria were obtained in Cefpodoxine group and Cefaclor group,respectively,and the detection rates of bacteria in the 2 groups were 78.75％ and 82.50％,respectively.There was no significant difference in the number of bacterial strains and strains detected in each group (x2 =0.36,P ＞ 0.05),but the total bacterial clearance rate in Cefpodoxine group was 88.9％ (56/63 cases) while the bacterial Clearance rate in Cefaclor group was 74.2％ (49/66 cases),and the difference between the 2 groups was statistically significant (x2 =4.57,P ＜ 0.05).In particular,the bacterial clearance rate in Cefpodoxine group to Streptococcus pneumoniae,Staphylococcus aureus and Klebsiella pneumoniae were significantly higher than those in Cefaclor group,while the bacterial Clearance rate of Proteus and Escherichia coli were lower than those in Cefaclor group.The incidence of adverse reactions in Cefpodoxine group and Cefaclor group were 5.0％ and 3.8％,respectively,with no significant difference (P ＞ 0.05).Conclusions The clinical effect of Cefpodoxime pro-xetil granules in treating children with acute bronchitis is more significant than that of Cefaclor.It has high safety and no serious side effect.

The rapeutic effect of Cefpodoxime proxetil granules in treatment of acute bronchitis in children / 中华实用儿科临床杂志

Objective@#To study the efficacy and safety of Cefpodoxime proxetil granules in the treatment of acute bronchitis in children.@*Methods@#One hundred and sixty children of the First People′s Hospital of Nanning from June to December 2018 with acute bronchitis were randomly divided into cefpodoxime group and cefaclor group, with 80 cases in each group.All patients received routine treatment.On this basis, 80 patients in the cefpodoxime group received oral Cefpodoxime proxetil granules 5 mg/kg (not more than 100 mg/time), twice a day; 80 patients in the cefaclor group received oral Cefaclor.The granules were 10 mg/kg (not more than 250 mg/time), 3 times a day, and the course of treatment was 5 days.The clinical efficacy and adverse reactions were observed.@*Results@#The cure rate and effective rate of Cefpodoxime group were 91.3% (73/80 cases) and 95.0% (76/80 cases), respectively, while the cure rate and effective rate of Cefaclor group were 66.3%(53/80 cases) and 81.3%(65/80 cases), respectively, and the differences between the 2 groups were statistically significant (χ2=14.94, 7.23, all P<0.05). Sixty-three strains of pathogenic bacteria and 66 strains of pathogenic bacteria were obtained in Cefpodoxine group and Cefaclor group, respectively, and the detection rates of bacteria in the 2 groups were 78.75% and 82.50%, respectively.There was no significant diffe-rence in the number of bacterial strains and strains detected in each group (χ2=0.36, P>0.05), but the total bacterial clearance rate in Cefpodoxine group was 88.9%(56/63 cases) while the bacterial Clearance rate in Cefaclor group was 74.2%(49/66 cases), and the difference between the 2 groups was statistically significant (χ2=4.57, P<0.05). In particular, the bacterial clearance rate in Cefpodoxine group to Streptococcus pneumoniae, Staphylococcus aureus and Klebsiella pneumoniae were significantly higher than those in Cefaclor group, while the bacterial Clearance rate of Proteus and Escherichia coli were lower than those in Cefaclor group.The incidence of adverse reactions in Cefpodoxine group and Cefaclor group were 5.0% and 3.8%, respectively, with no significant difference (P>0.05).@*Conclusions@#The clinical effect of Cefpodoxime pro-xetil granules in treating children with acute bronchitis is more significant than that of Cefaclor.It has high safety and no serious side effect.

Proper Cut-off Levels of Serum Specific IgE to Cefaclor for Patients with Cefaclor Allergy

PURPOSE: Cefaclor, a second-generation oral cephalosporin, is known to cause IgE-mediated hypersensitivity. Assays of serum-specific IgE (sIgE) to cefaclor are commercially available via the ImmunoCAP system (Thermo Fisher Scientific). While serum levels of sIgE >0.35 kU/L are considered indicative of an allergy, some patients with cefaclor allergy show low serum IgE levels. This study aimed to evaluate the proper cut-off levels of sIgE in the diagnosis of immediate hypersensitivity to cefaclor. MATERIALS AND METHODS: A total of 269 patients with drug allergy history, who underwent assays of sIgE to cefaclor at Ajou University hospital and Dong-A University Hospital, were reviewed retrospectively. Among them, 193 patients exhibited cefaclor-induced immediate hypersensitivity with certain or probable causality of an adverse drug reaction according to the WHO-UMC (the World Health Organization-the Uppsala Monitoring Centre) algorithm, and 76 controls showed delayed hypersensitivity reactions to non-antibiotics. RESULTS: In total, 126 of the 193 patients (65.3%) experienced anaphylaxis; they had higher serum sIgE levels than patients with immediate hypersensitivity who did not experience anaphylaxis (6.36±12.39 kU/L vs. 4.28±13.61 kU/L, p < 0.001). The best cut-off value for cefaclor-induced immediate hypersensitivity was 0.11 kU/L, with sensitivity of 80.2% and specificity of 81.6%. A cut-off value of 0.44 kU/L showed the best sensitivity (75.4%) and specificity (65.7%) for differentiating anaphylaxis from immediate hypersensitivity reactions. CONCLUSION: Patients with cefaclor anaphylaxis exhibit high serum IgE levels. A cut-off value of 0.11 kU/L of sIgE to cefaclor is proper for identifying patients with cefaclor allergy, and 0.44 kU/L may be useful to detect anaphylaxis.

Research on diminishing scheme of cefaclor sustained release tablets in the treatment of recurrent urinary tract infection / 中国感染控制杂志

Objective To explore the efficacy and adverse reactions of diminishing scheme of cefaclor sustained re-lease tablets in the treatment of recurrent urinary tract infection(RUTI).Methods 60 RUTI patients in a hospital were divided into treatment group(n=30)and control group (n=30),patients in treatment group were treated with diminishing scheme of cefaclor sustained release tablets,patients in control group were treated with diminishing scheme of levofloxacin tablets,clinical therapeutic efficacy and adverse reactions of two groups were observed. Results The curative rate in treatment group was higher than control group ([80.00%,n =24]vs [53.33%,n =16])(χ2 =4.80,P =0.028).The incidence of RUTI in treatment group was lower than control group ([6.67%,n=2]vs [26.67%,n=8])(χ2 =4.32,P =0.038).Incidence of adverse reactions in treatment group was lower than control group (16.67% vs 50.00%)(χ2 =7.50,P =0.006).Conclusion The diminishing scheme of cefaclor sus-tained release tablets in the treatment of RUTI has good curative efficacy,low recurrence rate,fewer adverse reac-tions,and can be used for the treatment of recurrence of RUTI.

Sterility and Radiostability of Amoxicillin and Cefaclor Antibiotics Sterilized by Gamma Irradiation.

Aim: The present investigations aimed at studying the effect of sterilization by gamma irradiation on amoxicillin and cefaclor antibiotics. They have been irradiated in solid dry state and the probable changes in physicochemical and microbiological properties were studied Place and Duration of Study: The study was carried out from 2011 to 2013 in the Drug Radiation Research Department, Egyptian Atomic Energy Authority. Methodology: Amoxicillin and cefaclor compounds in solid states were exposed to γ irradiation in air atmosphere at room temperature, with a dose of 25kGy and afterwards they had been subjected to microbiological and analytical tests checking their sterility and antibacterial activitiy it was tested against different pathogenic bacterial species by measuring MIC using Microdilution technique and microplate reader. Then their chemical stability were evaluated by different techniques. EPR, FTIR, UV analysis, mass spectroscopy, and melting point. Results and conclusion: The results showed that the majority of initial unirradiated compounds had a slight degree contamination with Bacillus, Micrococcus genera, and fungi. By applying γ irradiation at 25kGy it showed sterilization of the tested antibiotics and keeping their antibacterial activity. The EPR analysis results showed formation of free radicals. The other analytical tests (FTIR), (UV) analysis ,mass spectroscopy, and melting point results proved that the antibiotics analyzed are radioresistant and can be sterilized by irradiation with a dose of 25kGy, without any detrimental effect on their properities and antibacterial activity.

Immunologic Evaluation of Immediate Hypersensitivity to Cefaclor

PURPOSE: Cefaclor is widely prescribed for various infectious diseases. As its consumption increases, the number of hypersensitivity reactions to cefaclor has increased. This study aimed to evaluate the immunologic findings of immediate hypersensitivity to cefaclor. MATERIALS AND METHODS: We enrolled 47 patients with immediate hypersensitivity to cefaclor from Ajou University Hospital and Asan Medical Center. Serum specific IgE, IgG1, and IgG4 antibodies to cefaclor-human serum albumin (HSA) conjugate were measured by enzyme-linked immunosorbent assay (ELISA). RESULTS: The most common phenotype was anaphylaxis (Group I, 78.7%), followed by urticaria (Group II, 21.3%). The detection of specific IgE, IgG1, and IgG4 to cefaclor-HSA conjugate by ELISA tended to be higher in Group I (40.5%, 41.7%, 21.6%) than in Group II (20.0%, 20.0%, 0%) with no statistical significance. Significant associations were found between specific IgE and IgG1 or IgG4 (p<0.001, p=0.019). ELISA inhibition tests showed significant inhibitions by both free cefaclor and cefaclor-HSA conjugate. For basophil activation tests in patients having no specific IgE antibody, the CD63 expression level on basophils increased with incubations of free cefaclor. CONCLUSION: The most common manifestation of immediate hypersensitivity to cefaclor was anaphylaxis, most of which was mediated by IgE; however, a non-IgE mediated direct basophil activation mechanism was suggested in a subset of anaphylaxis patients.

Community-acquired Pneumonia.

Despite the availability of potent new antimicrobials and effective vaccines, community-acquired pneumonia (CAP) remains a common and potentially serious illness associated with considerable morbidity and mortality, particularly in elderly patients and those with significant comorbidities. The emergence of penicillin-resistant Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis, the pathogens that account for approximately 85% of CAP cases, is a serious threat to public health. Of additional concern is that penicillin-resistant organisms are also frequently resistant to other agents, particularly first-generation cephalosporins, erythromycin, tetracycline and trimethoprim-sulfamethoxazole. Cefaclor, a broad-spectrum semi-synthetic second-generation oral cephalosporin with documented activity against many gram-positive and gram-negative pathogens, as well as some anaerobes, is a good therapeutic option.

Review of Antibiotics in the Management of Respiratory Infections: Cefaclor vs Amoxicillin- Clavulanate.

Cefaclor, a broad-spectrum semi-synthetic second generation oral cephalosporin with documented activity against many grampositive and gram-negative pathogens, as well as some anaerobes has established a record of efficacy in the management of respiratory tract infections (RTIs). Despite over three decades of widespread use, it remains clinically effective in patients with RTIs, making it competitive with amoxicillin-clavulanate and with macrolides, and fluoroquinolones, including many newer agents used for RTIs. Factors contributing to the efficacy and tolerability of cefaclor include its molecular stability, activity against the most prevalent gram-positive and gram-negative respiratory tract pathogens, rapid absorption, >90% bioavailability and good penetration into respiratory mucosa. When compared to amoxicillin-clavulanate, it is much better tolerated with less gastrointestinal adverse events thus ensuring better patient compliance.

Analysis of Clinical Efficacy of Yiqing capsules and Cefaclor Tablets in Treatment of Simplex Anaphylactoid Purpura / 中国基层医药

Objective To investigate the efficacy of Yiqing capsules and Cefaclortablets in the treatment of simplex anaphylactoid purpura. Methods In this randomized,simple-blind, controlled study, all of 191 simplex anaphylactoid purpura patients,the throat secretion Group A βhemolytic streptococci antigen test was positive ,92 patients of control group were treated Cefaclor tablets and regular treatment,99 patients of test group were Yiqing capsules and Cefaclor tablets. Results After 10 days treatment,the clinical efficacy of the test group and the control group were 91.9% ,75.0% ,the test group was obviously higher than that of the control group(P ＜ 0.01), and the negative rate of the throat secretion Group A βhemolytic Streptococci antigen test of the test group was higher than that of control group, (P ＜0.01). the commencements of response of the test group was earlier than that of the control group(P ＜0. 01) ,the frequencies of recurrence of the test group were lower than that of the control group (P ＜ 0. 05).Conclusion Yiqing capsules combined cefaclor in treatment of simplex allergic purpura could improve efficacy, and reduce the treatment time.

A Clinical Study of Faropenem on Treatment of Acute Bacterial Infections / 天津医药

Objective: To evaluate the clinical efficacy and safety of domestic faropenem in the treatment of acute bacterial infections. Methods: A multicenter, randomized, double blind and double simulation clinical study was conducted to compare the efficacy and safety of faropenem and cefaclor in the treatment of acute bacterial infection. Patients in trial group(n = 122) were given faropenem 250 mg，and in control group (n = 118) were given cefaclor 200 mg，3 times daily for 7 to 10 days.Results: The clinical cure rates were 33.61% and 27.12% in trail and control groups respectively and the clinical effective rates were 87.70% and 83.05% respectively. There was no significant difference in terms of clinical effectiveness between the two groups（P > 0.05）. The adverse reaction rates were 7.32% in trial group and 3.36% in control group（P > 0.05）. The adverse reaction of the trial group was mainly exaltation of aminotransferase, which did not affect the therapy. No severe adverse reaction was found.Conclusion: Domestic faropenem is effective and safe for the treatment of bacterial respiratory tract and urinary tract infections.

Preparation and stability of compound cefaclor tablets / 中国基层医药

Objective To investigate the preparation and stability of compound cefaclor tablets.Methods The compound cefaclor tablets were prepared.The quality standard Were established.A HPLC method WaS established to determine the content and stability of samples.Results The prepared tablets was stable and the quality could be controlled.Conclusion The tablets were of reasonable formulation,good sample technology and good stability.The established method is accurate and reliable for the dissolution test for compound cefaclor tablets.The method can be used for quality control of compound cefaclor tablets.

Pharmacokinetic interaction between cefaclor and bromhexine in healthy Chinese volunteers / 中南大学学报(医学版)

Objective To determine the pharmacokinetic interaction between cefalor and bromhexine in healthy Chinese volunteers. Methods Twelve subjects received a cefaclor (CEF) treatment, a bromhexine (BHX) treatment, and a co-treatment of CEF and BHX with a 3 × 3 Latin square design. The wash-out time between periods was 14 days. The plasma and urine drug concentrations of CEF and BHX were detected by HPLC-UV and LC/MS, respectively. Results All the 12 volunteers completed the study. There were no significant differences in AUC0-t and Cmax of CEF in logarithm between the single administration group of CEF and the co-administration group of CEF with BHX. Two one sided t-test showed that CEF was bioequivalent in the 2 groups. There were no significant differences in tmax, MRT, t1/2, and Clr between the 2 groups. Vd/F was significantly lower in the single CEF group than in the co-administration group of CEF and BHX. There were no significant differences of AUC0-t and Cmax of BHX in logarithm between the single administration group of BHX and the co-administration group of BHX with CEF. Two one sided t-test showed that BHX was bioequivalent in the 2 groups. There were no significant differences in tmax, MRT, t1/2, Vd/F, and Clr between the 2 groups. Conclusion There is no significant pharmacokinetic parameter change in the drug absorption, metabolism, and excretion, but Va/F of CEF significant increases in the co-administration of CEF with BHX. The co-administration of CEF and BHX has no adverse drug interaction. The increase of Vd/F may be a favorable drug interaction, which may be the mechanism of the synergistic effect of the 2 drugs.

Clinical Research Acute Secretory Qtitis Media with BudesonideNasal Spray plus Gelomyrtol Forte / 医学研究杂志

Objective To observe the clinical curative effect of BudesonideNasal Spray plus Gelomyrtol Forte for acute secretory otitis media.Methods 80 Patients (108ears) and 60 patients (74ears) were treated by BudesonideNasal Spray be bound to Gelomyrtol Forte and Cefaclor Dispersible Tablets res pectively. After 10 days, observe the two groups’s clinical curative effect for acute secretory otitis media.Results The of treatment’s group efficient rate is 99.07, Cefaclor Dispersible Tablets 87.84, and the difference is (?2 =10.68 P0.05), and mild adverse reactions will be disappeared after stoping drugs. Conclusion The of BudesonideNasal Spray puls Gelomyrtol Forte is better than that of Cefaclor Dispersible Tablets for acute secretory otitis media. The mild adverse reaction is the same between the two groups.

Effects of co-administering probenecid orally on pharmacokinetics of cefaclor in rabbits / 中国临床药理学与治疗学

AIM: To investigate the effects and quantitative relations of co-administering probenecid OF different dosages on pharmacokinetics of cefaclor in rabbits and approach the possible mechanisms involved as well. METHODS: Monitor plasma and urine cefaclor concentrations. 24 male rabbits were randomly divided into 4 groups by Cefaclor 50 mg·kg-1,Cefaclor50 mg·kg-1+Probenecid 100 mg·kg-1,Cefaclor 50 mg·kg-1+Probenecid 250 mg·kg-1 and Cefaclor 50 mg·kg-1+Probenecid 625 mg·kg-1.Blood and urine samples were collected according to the regular time schedule after intragastric administration. The concentration of cefaclor in blood and urine were determined by HPLC. Pharmacokinetic parameters were calculated by DAS (Drug and Statistical) software. Measur plasma protein-binding rate of cefaclor. The experimental groups and drug dosage were same as described above. The blood sample was drawn at 1 hour after administration,and the protein-binding rate of cefaclor was determined by equilibrium dialysis. RESULTS: Within the dosages of probenecid ranged from 0-250 mg·kg-1,T1/2ka,Tmax,Cmax and AUC of cefaclor increased in accordance with increasing dosage of co-administering probenecid while CL/F and Vd/F were decreased(P＜0.01); However,when the dosage of co-administering probenecid was 625 mg·kg-1,Cmax of cefaclor strikingly decreased(P＜0.01),while AUC and CL/F maintained at the levels of those with probenecid250 mg·kg-1.In this experiment, urinary excretive peak time of cefaclor in its prototype pos tponed gradually,biological half life prolonged and urinary excretive accumulation percentage decreased obviously(P＜0.01).To the dosages of probenecid ranging from 0-250 mg·kg-1,protein-binding rate of cefaclor decreased notably(P＜0.01)going with increasing dosages of co-administration probenecid; While the dosage of co-administration probenecid reached 625 mg·kg-1,the protein-binding rate of cefaclor corresponded to that of cefaclor 50 mg·kg-1 without probenecid (P＜0.01).CONCLUSION: Co-administering probenecid can strikingly change pharmacokinetics of cefaclor and the influential degree of pharmacokinetics parameters is dependent on dosages of probenecid used in the experiment. Biological half life prolongs and urinary excretive accumulation percentage of cefaclor decreases obviously.

Study on Relative Bioavailability of Cefaclor Capsules in Human Body / 中国药房

OBJECTIVE:To evaluate the relative bioavailability of2kinds of preparations of cefaclor capsules.METH?ODS:The subjects'blood concentrations were determined by HPLC at different time after administered randomly crossover with single oral dose of cefaclor testing preparation or reference preparation.The actual values of C max and T max were adopted;AUC was calculated by trapezoid planimetry;the bioequiavailability of the2preparations were evaluated by two-sides and one-side t-test.RESULTS:The AUC 0～4 of the testing preparation and reference preparation were respectively(13.44?3.06)(?g?h)/ml and(14.19?3.28)(?g?h)/ml;their respective AUC 0～∞ were(13.80?3.08)(?g?h)/ml and(14.62?3.33)(?g?h)/ml;their respective C max were(11.65?2.39)?g/ml and(12.37?2.41)?g/ml;their respective t max were(0.57?0.24)h and(0.66?0.19)h.The relative bioavailability of testing preparation was(95.62?13.51)%.CON?CLUSION:The2preparations are bioequivalent.

A case of immediate hypersensitivity to cefaclor: serum specific IgE detection / 천식및알레르기

Cephalosporines are the most important beta-lactams inducing IgE-mediated reactions such as urticaria, angioedema and anaphylaxis. There have been a few reports that describes assays of serum specific IgE for cephalosporins. We experienced a case of cefaclor-induced anaphylaxis and detected serum specific IgE to cefalor-human serum albumin (HSA) conjugate. A 40-year-old man was hospitalized due to sudden dyspnea. generalized urticaria, facial edema 30 minutes after taking cefaclor (250mg, po) for an upper respiratory infection. His systolic blood pressure dropped to 50 mmHg at admission. He had been treated with cefaclor for chronic osteomyelitis of the right heel for 1 year without adverse reactions. He had no personal or family history of allergic disease nor penicillin hypersensitivity. Skin prick test with cefaclor showed a positive response and serum specific IgE to cefaclor-HSA conjugate was detected by ELISA inhibition test showed significant inhibitions with additions of cefaclor-HSA conjugate and cefaclor in a dose-dependent manner. In conclusion, we confirmed that cefaclor-induced anaphylaxis in this patient was an IgE-mediated reation to cefaclor-HSA conjugate.

A case of anaphylactic reaction to oral cefaclor / 대한내과학회지

Antibiotics induced anaphylaxis is one of the most acute and potentially fatal drug-related adverse reactions. Cefaclor, an oral second-generation cephalosporin with a beta lactam ring, is used various infectious diseases of the respiratory tract. Few cases of cefaclor anaphylaxis have been rarely reported. Here we report a case of anaphylactic reaction to cefaclor in a 40-year-old female patient. She developed systemic reaction comprised of generalized hives with itching, vomiting, abdominal pain, and hypotension. She was treated on our ER with intravenous fluids, intravenous diphenhydramine and subcutaneous epinephrine. Since four month ago, she had developed generalized pruritic eruptions with flu-like symptoms. The rash resolved the same day after treated with intravenous diphenhydramine. On detailed history taking for medication, we had known that she received a same prescription containing a cefaclor at every episode. Subsequently we tested the patient with cefaclor and conducted an intradermal skin test and an ELISA to cefaclor-HSA conjugate. She showed a positive response. Cefaclor is widely used for common infections, physicians should anticipate the possibility of anaphylactic reaction treated with this agent, particularly in cases of multiple exposure.

A case of bronchial asthma due to cefadroxil in a housewife / 천식및알레르기

Cephalosporins are the most important -lactams that induce IgE-mediated reactions. Also, cephalosporins have been known as a causative agent for occupational asthma in pharmaceutical workers. To our knowledge, this is the first report of cephalosporin-induced bronchial asthma in a housewife with no history of occupational exposure. We experienced a 30-year old female who had developed shortness of breath, coughing and itching sensation of the skin since 3 years ago whenever she handled drug powder for upper respiratory infections (URI) prescribed for her two sons with bronchial asthma. She had handled drug powder for 7 years because her sons had experienced frequent URI. Skin prick test with cefadroxil (10mg/ml) and cefaclor (10mg/ml) showed positive reactions. Bronchial challenge test with cefadroxil showed immediate asthmatic reaction, and bronchial challenge with cefaclor showed immediate urticaria and angioedema without significant fall in FEV1. We confirmed cefadroxil-induced bronchial asthma sensitized by intermittent inhalation in a non-occupational setting.

Studies on Pharmacokinetics and Relative Bioavailability of Two Kinds of Cefaclor Capsule in Healthy Volunteers / 中国药房

OBJECTIVE:To study the pharmacokinetics and relative bioavailability of two kinds of cefaclor capsule in healthy volunteersMETHODS:Plasma cefaclor concentrations were measured with HPLC methodEach subject was administered with a single oral dose of domestic or imported cefaclor capsule(500mg)in a randomized crossover studyRESULTS:Plasma concentration-time curves of domestic and imported cefaclor capsules fitted to a one-compartment open model with a first order absorptionThe peak plasma levels(Cmax)averaged(1324?242)and (1329?314)?g/ml,times to reach the peak level(Tmax)were (058?0192)and(055?010)h,the elimination half lives(T1/2)were (042?009)and(041?009)h,the areas under the plasma concentration-time curve(AUC0～T)were (1581?153)and(1568?197)h/(?g?ml)respectivelyCONCLUSION:The results of statistical analysis showed that the two formulations were bioequivalentThe relative bioavailability of domestic capsule was(10084?778)%

Relative bioavailablity of cefaclor effervescent tabletsin human volunteers / 中国临床药理学与治疗学

Aim To study relative bioavailablity of cefaclor effervescent tablets in healthy volunteers. Methods According to the crossover design, A volunteers were each orally given a single does of the 0.75 g cefaclor effervescent tablets and cefaclor capsules with an interval of 5 days between the two formulations.The plasma concentrations of the drug were determined by RP-HPLC.Pharmacokinetic parameters were obtained by ATPK programe,and calculated on the basis of open single compartment model.Results After a single oral dose, the peak levels in plasma averaged Cmax(31.27?5.81)?g?ml-1 and(30.56?5.25) ?g?ml-1 at (0.58?0.12)h and(0.73?0.17)h and AUC0～4(35.48?4.65) ?g?h?ml-1 and (35.89?2.90) ?g?h?ml-1 for tablet and capsule,respectively. Conclusion The result shows that two formulations are bioequivalence.