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Research on polymer impurities has always been important in the quality control of cephalosporins. Research on polymers in cephalosporins that lack active amino groups on the C-7 side chain has not been reported. Therefore, our study used cefazolin sodium, which is widely used in the clinic, as an example. The polymer in cefazolin sodium and its product "cefazolin sodium pentahydrate for injection" was analyzed by column switching liquid chromatography-high resolution mass spectrometry. Two polymer impurity peaks were detected and the possible structures of these polymers were suggested. Through two-dimensional liquid chromatography, the chromatographic peaks following Sephadex gel chromatography and high-performance gel chromatography were compared to those obtained by reverse high-performance liquid chromatography (HPLC) for cefazolin sodium as reported in the Chinese Pharmacopoeia. The HPLC method proves more suitable for polymer detection than Sephadex gel chromatography and high-performance gel chromatography. The method of polymer detection for cefazolin sodium was established using the method of related substances HPLC as described in the Chinese Pharmacopoeia.
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OBJECTIVE: To systematicly review and analyse the clinical characteristics of anaphylactic shock induced by cefazolin sodium with negative skin test, and provide a basis for the safe and reasonable application of cefazolin sodium. METHODS: Databases of PUBMED, EMBASE, CBM, CNKI, VIP and WANFANG data(from built to October 2017)were conducted for case reports published in English or Chinese involving anaphylactic shock induced by cefazolin sodium. Literatures were screened, extracted and statistic analysed by two authors independently. RESULTS: A total of 1 358 literatures were searched out and 18 were included involving 20 patients, the median age was 39.0 years, 60.0% of the patients had no history of penicillin or drug allergy, and 30.0% of the patients had used penicillin or cephalosporin antibiotics, and intravenous infusion was the main route of administration. Anaphylactic shock occurred within 30 min accouted for 47.6%, and the longest time occurred on the 7th day of medication. The clinical manifestations were mainly circulatory system damage, and the rescue measures included discontinuation of medicine immediately, prostration, establishment of intravenous channels, oxygen uptake, administration of vasoactive drugs and glucocorticoids, etc., all of which were eventually successfully rescued.The correlation evaluation of ADR was definite and probable in 1 and 19 cases, respectively. CONCLUSION: High attention should be put on anaphylactic shock induced by cefazolin sodium with negative skin test. The proportion of young people and immediate anaphylactic shock were high.The cefazolin sodium skin test is of little value in predicting anaphylaxis. History of medication and allergies of patients should be taken in detail before medication, and the whole-process of medication, especially within 30 min should be closely monitored. Emergency rescue measures of anaphylactic shock should be prepared in advance.
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OBJECTIVE:To compare the cost-effectiveness of cefazolin sodium pentahydrate versus cefazolin sodium in treat-ment of bacterial infection,and to provide reference for rational drug use in the clinic.METHODS:In retrospective study,207 bac-terial infection patients receiving cefazolin sodium pentahydrate or cefazolin sodium were selected from our hospital during Nov. 2014 to Dec. 2015,including 109 cases in cefazolin sodium pentahydrate group and 98 cases in cefazolin sodium group. Both groups received relevant medicine 2 g,bid,ivgtt,within 7 d. The clinical efficacies,bacteriological efficacies and safety of 2 groups were compared,and pharmacoeconomics of 2 therapy plans were evaluated.RESULTS:The clinical response rates of cefazo-lin sodium pentahydrate group and cefazolin sodium group were 89.91% and 74.49%,with statistical significance(P<0.05);bac-terial clearance rates were 76.32% and 72.13%,with no statistical significance(P>0.05). No drug-related ADR occurred in 2 groups during the treatment. Total shot-term(7 d)cost of cefazolin sodium pentahydrate group and cefazolin sodium group respec-tively were 4 391.43 yuan and 3 396.19 yuan. Using clinical response rate as effect index,cost-effectiveness ratio of them were 48.84 and 45.59,and incremental cost-effectiveness ratio was 64.55,which was lower than per capita GDP of Hengshui city. The sensitivity analysis results were in agreement with the cost-effectiveness analysis. CONCLUSIONS:Under the current economic sit-uation of Hengshui city,cefazolin sodium pentahydrate has cost-effectiveness advantage in the treatment of bacterial infection than cefazolin sodium.
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OBJECTIVE To investigate the effectof Myrtol combined with Cefazolin Sodium Pentahydrate in the treatment of acute suppurative otitis media in children. METHODS Totally 120 cases of pediatric acute suppurative otitis media were selected in our hospital from January 2014 to January 2016 and randomly divided into four groups, treated with Myrtol combined with Cefazolin Sodium Pentahydrate, Myrtol combined with Cefazolin Sodium, Cefazolin Sodium Pentahydrate, or Cefazolin Sodium, respectively. The effect and adverse reactions of the 4 groups were studied and compared. RESULTS There was no significant differences in age, sex, and average course of disease among the four groups. In Myrtol combined with Cefazolin Sodium Pentahydrate group, the clinical efficacy is better than that of the other three groups (P0.05), and both of them are better than cefazolin sodium group(P0.05). CONCLUSION Myrtol combined with Cefazolin Pentahydrate Sodium treatment was superior to the other three protocols in clinical efficacy for children with acute suppurative otitis media , and does do not increase the risk of safety.
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OBJECTIVE:To compare the cost-effectiveness of cefazolin sodium pentahydrate versus cefazolin sodium in treat-ment of bacterial infection,and to provide reference for rational drug use in the clinic.METHODS:In retrospective study,207 bac-terial infection patients receiving cefazolin sodium pentahydrate or cefazolin sodium were selected from our hospital during Nov. 2014 to Dec. 2015,including 109 cases in cefazolin sodium pentahydrate group and 98 cases in cefazolin sodium group. Both groups received relevant medicine 2 g,bid,ivgtt,within 7 d. The clinical efficacies,bacteriological efficacies and safety of 2 groups were compared,and pharmacoeconomics of 2 therapy plans were evaluated.RESULTS:The clinical response rates of cefazo-lin sodium pentahydrate group and cefazolin sodium group were 89.91% and 74.49%,with statistical significance(P<0.05);bac-terial clearance rates were 76.32% and 72.13%,with no statistical significance(P>0.05). No drug-related ADR occurred in 2 groups during the treatment. Total shot-term(7 d)cost of cefazolin sodium pentahydrate group and cefazolin sodium group respec-tively were 4 391.43 yuan and 3 396.19 yuan. Using clinical response rate as effect index,cost-effectiveness ratio of them were 48.84 and 45.59,and incremental cost-effectiveness ratio was 64.55,which was lower than per capita GDP of Hengshui city. The sensitivity analysis results were in agreement with the cost-effectiveness analysis. CONCLUSIONS:Under the current economic sit-uation of Hengshui city,cefazolin sodium pentahydrate has cost-effectiveness advantage in the treatment of bacterial infection than cefazolin sodium.
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A reversed-phase high performance liquid chromatography method was validated for the determination of cefazolin sodium in lyophilized powder for solution for injection to be applied for quality control in pharmaceutical industry. The liquid chromatography method was conducted on a Zorbax Eclipse Plus C18 column (250 x 4.6 mm, 5 μm), maintained at room temperature. The mobile phase consisted of purified water: acetonitrile (60: 40 v/v), adjusted to pH 8 with triethylamine. The flow rate was of 0.5 mL min-1 and effluents were monitored at 270 nm. The retention time for cefazolin sodium was 3.6 min. The method proved to be linear (r2=0.9999) over the concentration range of 30-80 µg mL-1. The selectivity of the method was proven through degradation studies. The method demonstrated satisfactory results for precision, accuracy, limits of detection and quantitation. The robustness of this method was evaluated using the Plackett–Burman fractional factorial experimental design with a matrix of 15 experiments and the statistical treatment proposed by Youden and Steiner. Finally, the proposed method could be also an advantageous option for the analysis of cefazolin sodium, contributing to improve the quality control and to assure the therapeutic efficacy.
Um método cromatográfico em fase reversa foi validado para a determinação de cefazolina sódica em pó liofilizado, a ser aplicado no controle de qualidade em indústrias farmacêuticas. O método por cromatografia líquida foi conduzido em coluna Zorbax Eclipse Plus C18 (250 × 4,6 mm, 5 µm) mantida à temperatura ambiente. A fase móvel consistiu de água purificada: acetonitrila (60 : 40 v/v), com o pH ajustado para 8 com trietilamina. A vazão usada foi de 0,5 mL min-1 e os analitos de interesse foram monitorizados a 270 nm. O tempo de retenção da cefazolina sódica foi de 3,6 min. As áreas dos picos de cefazolina sódica foram lineares na faixa de concentração de 30-80 µg mL-1 (r2 = 0,9999). A seletividade do método foi demonstrada através de estudos de degradação. O método demonstrou resultados satisfatórios para precisão, exatidão, limites de detecção e de quantificação. A robustez do método foi avaliada utilizando o esquema fatorial de Plackett-Burman com uma matriz de 15 experimentos simultâneos, e analisados por tratamento estatístico proposto por Youden e Steiner. Finalmente, o método proposto pode ser também uma opção de êxito para a análise de cefazolina sódica, contribuindo para o controle de qualidade e para garantir a eficácia terapêutica.
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Cefazolin/analysis , Chromatography, High Pressure Liquid/methods , Quality Control , Drug Industry/trends , Freeze Drying/methodsABSTRACT
Objective To investigate the compatibility of Shuanghuanglian Injection mixed with Cefazolin Sodium for Injection, Dexamethasone Sodium Phosphate Injection and Ribavirin Injection. Methods Under room temperature, the changes of appearance were determined by pH meter and particle counter for Shuanghuanglian Injection mixed with Cefazolin Sodium for Injection, Dexamethasone Sodium Phosphate Injection and Ribavirin Injection. Results There were no evident changes in appearance and pH of Shuanghuanglian Injection mixed with Cefazolin Sodium for Injection, Dexamethasone Sodium Phosphate Injection and Ribavirin Injection. The number of particles (diameter≥25 μm) of Shuanghuanglian Injection mixed with Cefazolin Sodium for Injection and Dexamethasone Sodium Phosphate Injection was increased after 0.5 h. Conclusion Shuanghuanglian Injection can be mixed with Cefazolin Sodium for Injection, Dexamethasone Sodium Phosphate Injection and Ribavirin Injection for bigeminy, while should not for multitherapy.
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OBJECTIVE:To probe into the interaction between the price of 7-amino-cephalsoranic acid(7-ACA) and the price of its preparation(cefazolin sodium) and to provide reference for price strategy of pharmaceutical enterprises.METHODS:Correlation analysis,autocorrelation analysis and auto-regressive distributed lag were applied to analyze the samples which were collected from monthly selling price of 7-ACA of China Shijiazhuang Pharmaceutical Group Co.,Ltd.during 24 months.RESULTS:There was positive correlation between the price of 7-ACA and the price of cefazolin sodium with correlation coefficient of 0.682 5.The price of 7-ACA and cefazolin sodium are autocorrelative respectively.The price of 7-ACA was influenced by previous price,besides raw material cost,production cost and selling expenditures.The price of 7-ACA changed 3 months later because of previous price.The price of 7-ACA would change 2 months later as the price of cefazolin sodium changed and it changed 1 month later as previous price changed.When the price of 7-ACA changed,the price of cefazolin sodium price would change one month later.CONCLUSION:Effective price strategy should be decided according to the interaction between the price of crude drug and the price of preparation besides the cost of raw materials,production costs and selling expenditures.
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0.05),the costs were 915.70 and 1 036.80 yuan(P
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Objective:To evaluate the accuracy of YLM-Ⅱ quick Cefazolin Sodium Skin Tester(Made in Guangzhou WeiJeiHua Tech.Develop Co.,Ltd.)Methods:Use same batch number of Cefazolin Sodium on a person,at the same time do traditional skin test on the same person to compare the difference of the two methods.Results:Among the result of skin test on 267 patients,1 patient is positive in both methods,263 patients are negetive in both,3 patients got false positive in traditional skin test but negetive in trail means,none got negative in the traditional skin test while positive in trail means.Conclusion:Comparing the traditional skin test method with YLM-Ⅱ skin-test apparatus,the latter is more accurate,painless,time-saver and efficient.