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    08 June 2014, Volume 11 Issue 6 Previous Issue    Next Issue

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    Time-toxicity Relationship Study on Neurotoxicity Caused by Different Components of Radix Aconite Lateralis to Mice
    WANG Yi, SUN Rong
    2014, 11(6): 321-324. 
    Abstract ( 213 )   PDF (357KB) ( 82 )  
    ObjectiveTo study the time-toxicity relationship caused by different components of Radix Aconite Lateralis to mice. MethodsMice were grouped according to different time, to observe the death condition and toxicity of mice. The numbers of autonomic activities and rotarod test were observed and recorded. The changes of the activity of SOD, MDA, LDH and NSE were detected. ResultsThe changes of autonomic activities of mice with water extraction were strengthened and then weakened, the changes of LDH in serum were lifted marked at 30 minutes. The changes of autonomic activities and standing time of mice with alcohol extraction were weakened and then strengthened, significant reduction was at 60 minutes, the changes of SOD in serum were reducing marked from 15 to 120 minutes. The changes of autonomic activities and standing time of mice with whole components were reduced at 90 minutes, the changes of SOD in serum were reducing. The levels of neuron specific enolization enzyme(NSE) from the three groups' mice serum were changed to rise in different degree, and alcohol extraction > water extraction > the whole components. ConclusionSingle intragastric administrations of different components of Radix Aconite Lateralis with certain dosage may induce acute nerve injury in mice and show certain time-toxicity relationship. The study on damage mechanism and the change of behavioral science, neurotransmitter levels and neuron would be discussed in the following study.
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    Pharmacological Study of Jinhuang Zhike Granule on Relieving A Cough, Abolishing Phlegm and Anti-inflammation
    YANG Hong, KONG Dong-dong
    2014, 11(6): 325-327. 
    Abstract ( 192 )   PDF (395KB) ( 165 )  
    ObjectiveTo observe the cough relieving, sputum elimination and anti-inflammation effects of Jinhuang Zhike Granule(JHZK). MethodsThe cough relief effect of JHZK was observed by ammonia water causing cough in mice and citric acid causing cough in guinea pigs. The sputum elimination effect of JHZK was studied by the observation of tracheal phenol red shedding in mice. The anti-inflammatory effect was tested by xylene swelling inducing on mice and rat's toe swelling test caused by carrageen. ResultsJHZK could significantly inhibit the incubation period and cough frequency of the model mice and guinea pigs induced by ammonia water and citric acid, and notably improve the tracheal phenol red excretion volume in mice, and inhibit acute inflammatory response in mice and rat respectively induced by xylene and carrageen. ConclusionJHZK has certain effects of cough relief, sputum elimination and anti-inflammatory effects.
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    Determination of Schisandrin in Sanzi Jiangmei Capsules by HPLC
    SU Biao, ZHAO Yan, YANG Rong-yan, HUA Hui-ming
    2014, 11(6): 328-330. 
    Abstract ( 200 )   PDF (451KB) ( 143 )  
    ObjectiveTo establish a HPLC method for the determination of schisandrin in Sanzi Jiangmei Capsules. MethodsAgilent Eclipse XDB C18(4.6mm×250mm, 5μm) column was used.The mobile phase was methanol-water
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    Analysis of the Volatile Components of Xanthium Mongolicum Kitag by GC-MS
    YAO Hui-juan, YAO Hui-min, BU Shu-hong, LI Li-xia, LU Xiao-tong, ZHANG Jian
    2014, 11(6): 331-332. 
    Abstract ( 210 )   PDF (368KB) ( 231 )  
    ObjectiveTo analyze the volatile oil constituent of Xanthium mongolicum Kitag. MethodsThe volatile components were extracted by ultrasonic extraction, analyzed by capillary GC. The relative content of chemical components was calculated by peak area normalization method, the chemical components were identified by gas chromatography mass spectrometry(GC-MS). ResultsTwenty-three components were identified, the main identified chemical components account for 99.97% of the total volatile components, including isothiocyanato methane(2.92%), bis(trimethylsilyl)estradiol(1.85%), tocopherol(1.33%), schizandrin(1.78%), hiceinamide(3.09%), sitosterol(1.63%), 4,4-dimethylcholestan(15.54%), colchicin(1.86%), 1-hexadecyn-3-ol, 3,7,11,15-tetramethyl-(13.34%),α-linolenic acid(16.02%), γ-linolenic acid(30.12%), coprostene(2.56%), basic green 1(4.49%), stigmasterol(1.09%).ConclusionThe main chemical component of Xanthium mongolicum Kitag volatile components was linolenic acid, accounting for 46.14% of the total volatile components.
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    The Status and Prospective of PSUR in China
    YUAN Xing-dong GAO Jing ZHOU Juan ZHONG Chang-ming REN Jing-tian
    2014, 11(6): 333-335. 
    Abstract ( 256 )   PDF (426KB) ( 452 )  
    Periodic safety update report(PSUR) is a kind of report that pharmaceutical manufacturers regularly compile security informations about a drug to the drug regulatorg departments.This paper explained the relative articles of PSUR based on the regulation. The status of the implement ation on PSUR was introduced, and the problems were analysized in our province. These data are used to infer the situation throughout the country. Related recommendations were proposed to promote the work on PSUR.
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    Drug Quality Problem Analysis Based on KMRW Model
    FU Yi-jiao, WU Zhi-ang
    2014, 11(6): 336-339. 
    Abstract ( 211 )   PDF (523KB) ( 291 )  
    Objective The reputation theory in production of pharmaceutical manufacturers was used to identify the key factors that affect manufacturers integrity, in order to provide references to promote the integrity of our specification of phar-maceutical manufacturers. MethodsThe opportunistic behavior of pharmaceutical manufacturers was analyzed theoretically based on KMWR model of reputation theory, and identified the key factors that manufacturers implement the opportunistic behavior. Resultsand ConclusionUnder the conditions of incomplete information,pharmaceutical manufacturers have a tendency to take opportunistic behavior, and the signal display effect of reputation can inhibit the opportunistic behavior, and encourage manufacturers to maintain a good reputation, thereby improving product quality.
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    Thought and Application of Patient-reported Outcome in the Adverse Drug Reaction Report
    WANG Chun-ting
    2014, 11(6): 340-343. 
    Abstract ( 235 )   PDF (536KB) ( 310 )  
    Objective To explore the application of the patient-reported outcome in adverse drug reaction report. Methods Through the method of literature review, the background, drivers, current regulatory framework of patient-reported outcome adoption in foreign drugs safety studies are comprehensively reviewed. Results Limitations with current data collection, discordance between patients and prescribers, better patient context drive the adoption of patient-report outcome effectively, as well as the regulatory measures formulated by many countries such as America and Britain. Conclusion Patient-reported outcome with patient-centered, which provides a rich and valuable information for comprehensive analysis of the effectiveness, risks and outcomes of drug use, can be used as a supplement to the current pharmacovigilance and post-marketing studies, and provides an important reference for our country to adopt patient-reported outcome in drug safety studies.
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    Research Progress about Anaphylactoid Reactions
    GAO Jian-bo
    2014, 11(6): 344-346. 
    Abstract ( 256 )   PDF (490KB) ( 274 )  
    Objective To provide literature evidences for in-depth study of anaphylactoid reactions through reviewing and analyzing the symptoms, mechanism, evaluation methods and problems. Methods The related references in recent years at home and abroad about anaphylactoid reactions were collected and summarized. Results Although the symptoms are similar with allergic reactions, the mechanism is not same. The anaphylactoid reactions can occur at first contact without prior sensitization and antibody-mediated, the aftermath is serious. Currently, the detecting indicators include histamine, IgE, and so on. The diagnosis requires a overall judgment of characteristic symptoms and biological indicators. Conclusion It's urgent to establish viable preclinical evaluation methods about anaphylactoid reactions.
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    Literature Analysis of 53 Reports of Drug-induced Interstitial Pneumonia
    HU Mei-hui, SUN An-xiu
    2014, 11(6): 347-350. 
    Abstract ( 283 )   PDF (645KB) ( 297 )  
    ObjectiveTo study the drugs leading to interstitial pneumonia and analyze their clinical characteristics. MethodsWe searched the literatures from 1994 to 2013 by key words of "interstitial pneumonia" in China Digital Library, China National Knowledge Infrastructure, Wanfang Database, and summarized them. ResultsA total of 74 relevant articles were identified, which reported 53 cases of drug-induced interstitial neumonia, involving 15 kinds of drugs. The drugs included gefitinib(15), rituximab(9), leflunomide(8), amiodarone(8), erlotinib(5), interferon(2), 5-fluorouracil(1), granulocyte colony-stimulating factor(1), gemcitabine(1), carmustine(1), measles vaccine(1), paraquat(1), et al.The result showed that 53 cases contained 17 cases(33.33%) cured, 19 cases(37.26%) improved , 15 cases(29.41%) died and 2 cases unclear. ConclusionThe clinical manifestations of interstitial pneumonia induced by drugs were similar, but the pathogenesis was unknown. The drugs leading to higher incidence were gefitinib, rituximab,leflunomide, amiodarone and erlotinib.
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    Literature Analysis of 153 Cases of Adverse Drug Reactions Induced by Risperidone
    ZHOU Qiu-juan, WU Xiao-yan, CHEN Ying, CHAO Nan, QU Fa-lin, HUANG Jia-fu
    2014, 11(6): 351-354. 
    Abstract ( 206 )   PDF (649KB) ( 271 )  
    ObjectiveTo study the clinical features of adverse reaction induced by risperidone. Methods122 case reports of adverse drug reaction due to risperidone from 2000 to 2012 in China were collected and analyzed, which involved 153 patients. ResultsThe adverse reactions of risperidone were correlated with individual differences, which mainly occurred in central and peripheral nervous system. ConclusionPay attention to physical status of patients when use risperidone,slowly increase the dose and comply with the individualized principle.
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    Analysis of 109 Reports of Adverse Drug Reaction of Cefoperazone Sodium and Sulbactam Sodium for Injection
    LIU Xian-jun, FU Na
    2014, 11(6): 355-357. 
    Abstract ( 390 )   PDF (577KB) ( 556 )  
    Objective To investigate relevant factors of the adverse drug reaction induced by cefoperazone sodium and sulbactam sodium for injection to provide scientific reference for the safe and rational drug use in clinic. Methods 109 ADR reports of cefoperazone sodium and sulbactam sodium for injection collected by Beijing Center for ADR Monitoring from January 2010 to October 2010 were statistically analyzed retrospectively. Results The clinical manifestations of ADR involved skins and appendages damage, blood system damage, digestive system damage, hepatobiliary system damage and generalized lesion. Most ADR cases occurred in 30 minutes after medication, and drug combination maybe cause serious adverse reactions. Conclusion The ADR induced by cefoperazone sodium and sulbactam sodium for injection is associated with its chemical structure, individual diathesis, different diet, drug combination and so on. In order to avoid the occurrence of ADR induced by cefoporazone sodium and sulbactam sodium for injection, the drug must be used rationally and the patient should be intensively warded.
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    Application Evaluation and Literature Review of Hydroxyethyl Starch 130/0.4 Sodium Chloride Injection in Our Hospital
    CUI Xiang-li, QIU Shuang, SI Tu-wei, ZHAO Rui, WANG Ying, ZHOU Hong, HUANG Qian, GAI Di, LIU Li-hong
    2014, 11(6): 358-361. 
    Abstract ( 258 )   PDF (612KB) ( 351 )  
    Objective To evaluate the safety and prevent the risk of adverse drug reactions of hydroxyethyl starch 130/0.4 sodium chloride injection(HES) through analysis of HES usage in our hospital. Methods Indications, contrain-
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    Bibliometric Analysis on Adverse Reaction of Chinese Patent Drug
    WANG Shu-bin, SUI Xin, HUANG Rui, JI Zheng-han
    2014, 11(6): 362-365. 
    Abstract ( 232 )   PDF (737KB) ( 194 )  
    ObjectiveTo explore and evaluate the current situation of the related literature about Chinese patent drug adverse reaction in China, analyze reasons, and put forward suggestions, in order to promote the Chinese patent drug clinical medication safety. MethodsTo search China Journals Full-text Database(CNKI) for literatures related to adverse reaction of Chinese patent drug and then analyze the publish time, journal, author and keywords, etc. ResultsThe research on adverse reaction of Chinese patent drug is increasing year by year and the core authors have been formed. The literatures are mostly from Chinese medicine university as well as hospitals'pharmaceutical preparation section. Ten journals, such as China Pharmaceuticals, are the core journal in this field. Errors of clinical compatibility, syndrome differentiation and the route of administration are important causes of adverse reaction/event of Chinese medicine. ConclusionThe research progress of adverse reaction of Chinese patent drug in China developed smoothly. However the research should be expanded in content and the methodology should be improved.
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    Distribution and Antimicrobial Resistance Analysis for Commonly Used Antibiotics of 2 951 Pathogens
    LV Jian-hua, LI Gai-su LI, Yong-bing
    2014, 11(6): 366-368. 
    Abstract ( 226 )   PDF (652KB) ( 355 )  
    ObjectiveTo investigate the drug resistance of 2 951 pathogens for commonly used antibiotics. MethodsAntimicrobial susceptibility testing of 2 951 isolated bacteria was carried out. ResultsOf 2 951 clinical isolates gram-positive bacteria accounted for 17.45% and gram-negative bacteria accounted for 82.55%. Sensitivity of gram-positive cocci to vancomycin and linezolid was high; gram-negative bacilli showed higher sensitivity to cefoperazone sulbactam, piperacillin-tazobactam, imipenem and meropenem. ConclusionThe drug resistance rate of Escherichia coli was higher than Klebsiella pneumoniae; Acinetobacter baumannii and Pseudomonas aeruginosa display multiple drugs resistance.
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    Study on Compatible Stability of Nitroprusside Sodium for Injection with Sodium Chloride Injection
    LIN Xiao-ming, WEI Bao-han, ZENG Yi, WEI Ping-yuan, LIANG Han-qin, XIE Wei-qian, CHEN Ming-zhong
    2014, 11(6): 369-372. 
    Abstract ( 247 )   PDF (696KB) ( 199 )  
    Objective To investigate the compatible stability of nitroprusside sodium for injection(SNP) when mixed with sodium chloride injection. Methods SNP was prepared into solution according to clinical use. The stability of SNP solution was studied in different environment and at different time, including appearance, pH value, insoluble particle, ultraviolet-visible absorption and SNP content. Results SNP solutions of sodium chloride injection were stable for 26 hours after preparation in shading circumstances at 20℃ or 35℃.Under the direct incandescent lamp without lightproof covering or shading circumstances, the solution was very unstable. Conclusion In the dark condition, SNP was stable within 26h after mixing with sodium chloride injection.
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    Analysis of Infusion Solutions Clinical Application Status in Our Hospital
    WANG Zhi-ying, JIAO Can-wu
    2014, 11(6): 373-376. 
    Abstract ( 297 )   PDF (639KB) ( 297 )  
    ObjectiveTo investigate the application status of infusion solutions in our hospital and provide reference for rational drug use. MethodsBy a retrospective study, application data of infusion solutions from January to December of 2012 in our hospital were statistically analyzed. ResultsIn 2012, the total number of infusion solutions used in clinic reached 2 672 324 bottles, there were 495 272 patients registered for treatment, therefore per capita 5.4 bottles.The amount of infusion solutions accounted for 11.47% of all drugs. Maximum usage was nutrition and electrolyte infusion solutions, which reached to 4.4% and 1.38% of the total amount respectively. There were unreasonable applications such as no indications for medication, overmedication, incompatibility, improper dosage, etc. ConclusionInfusion solutions were extensively used in our hospital, simultaneously followed with lots of unreasonable application problems. So it's needed to further strengthen supervision and management on the rational administration of infusion solutions.
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