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08 October 2013, Volume 10 Issue 10 Previous Issue    Next Issue

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Four Weeks Intravenous Repeated Dose Toxicity of Clarithromycin for Injection in Beagle Dogs MA Yu -kui DAI Xiao -li DAI Xue –dong 2013, 10(10): 580-582.  Abstract ( 318 )   PDF (415KB) ( 210 )   Objective To investigate the repeated dose toxicity of clarithromycin for injection in dogs. Methods The normal dogs were administered with clarithromycin for injection by intravenous injection for four weeks. The body weight,blood biochemistry, hematology, viscera relative weight and histopathology were measured for the overall toxicity assessment. Results The normal dogs administered with clarithromycin for injection( 80mg·kg-1) showed abnormal escalation of the levels of aspartic transaminase(AST), alanine aminotransferase(ALT), urea nitrogen(BUN). Histopathological examination indicated that the liver cells were cord -like arranged and perisinusoidal space was broadened,some liver cells degenerated, necrosed or appeared karyopyknosis. Renal capillary dilatation and congestion, epithelial cell degeneration, necrosis or pyknosis of partial renal tubular were also found by histopathological examination. Conclusion Repeated administration of clarithromycin at high dose could lead to abnormal biochemical index and pathological lesions of liver and kidney in dogs. References | Related Articles | Metrics

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Comparative Study on Acute Toxicity of Different Components of on Normal Mice Li Xiao-jiaoyang ,LUAN Yong-fu ,SUN Rong 2013, 10(10): 583-587.  Abstract ( 389 )   PDF (726KB) ( 308 )   Objective To compare the acute toxicity effect of different components of Aconite on normal mice and observe/evaluate the acute toxicity of Aconite herbs. Thus, we try to provide a foundation for rational drug use in clinic. Methods Preparing the all-components, water extracted components and alcohol extracted components, then ig. all-components, water extracted components and alcohol extracted components of Aconite to mice and the MLD, LD50 were tested respectively by the classic Methods of acute toxicity. Results The LD50 and 95% confidence limit of alcohol extracted components was 11.7 g·kg-1·d-1 and 11.1~12.4 g·kg-1·d-1 respectively, which was equal to 54.6 times of the clinical daily dosage in 70kg humans. The MLD of all-components was 16.0 g·kg-1·d-1 and the MLD of water extracted components was 14.4 g·kg-1·d-1, which was respectively equal to 74.7 times and 67.2 times of the clinical daily dosage in 70kg humans. By observing, we found that hypokinesia, nausea, quadriplegia, hyperspasmia, consequence and prostrate motionlessness were the main acute toxical symptoms and signs caused by Aconite, and these occurred in six hours after gavage administration. Conclusion Different components of Aconite can cause certain acute toxicity effect on normal mice, and the alcohol extracted components are with the greatest degree of toxicity, followed by water extracted components, and the least is the all-components. References | Related Articles | Metrics

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Comparative Study on Acute Toxicity of Different Components of on Algesic Mice SUN Rong ,LUAN Yong-fu 2013, 10(10): 594-599.  Abstract ( 268 )   PDF (551KB) ( 444 )   Objective To compare the acute toxicity effect of different components of Aconite on algesic mice and observe/evaluate the acute toxicity of Aconite herbs. Thus, we try to provide a foundation for rational drug use in clinic. Methods We made algesic mice model with 0.6% acetic acid, prepared the all -components, water extracted components and alcohol extracted components, then ig. all -components, water extracted components and alcohol extracted components of Aconite to mice and the MTD, LD50 were tested respectively by the classic Methods of acute toxicity. Results We found that the LD50 of alcohol extracted components was 13.6g·kg-1·d-1, which was equal to 63.5 times of the clinical daily dosage in 70kg humans. The MTD of all-components and water extracted components was respectively 8.0g·kg-1·d-1 and 14.4g·kg-1·d-1, which was respectively equal to 37.3 times and 67.2 times of the clinical daily dosage in 70 kg humans. By observing, we found that hypokinesia, nausea, quadriplegia, hyperspasmia, consequence and prostrate motionlessness were the main acute toxical symptoms caused by Aconite after gavage adminis-tration, and these symptoms mostly occurred in six hours. Conclusion Different components of Aconite could cause certain acute toxicity effect on algesic mice, and the alcohol extracted components were with the greatest degree of toxicity followed by the all-components, and the least was the water extracted components. References | Related Articles | Metrics

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The Thinking of Administration on Safe Medication of the Blind in China DONG Duo ,HU Jian ,WU Gui -zhi ,WANG Dan ,LIU Na ,ZHANG Hao, CHENG Gang 2013, 10(10): 600-601.  Abstract ( 272 )   PDF (567KB) ( 222 )   By introducing the current situation of administration on safe medication of the blind in China and taking example by experience of western countries, it put forward the model that policy is oriented, manufacture is responsibility main body and multidisciplinary agencies totally corporate. And also advised the related medicine scope, technical tools to ensure safe medication of the blind. References | Related Articles | Metrics

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A Comparative Resea rch and Enlightenment on Policies about Over-the-Counter Drug and Adverse Drug Reaction Monitoring in China XIA Dong-sheng ,WANG Chun-ting ,LIU Cui-li, Tang Ren, FAN Yan ,XU Shuai ,TIAN Chun-hua 2013, 10(10): 602-606.  Abstract ( 274 )   PDF (670KB) ( 240 )   Objective To strengthen the safety monitoring of Over-the-Counter(OTC) drug and ensure the safety of OTC drug. Methods Through the comparative research and analysis on policies about OTC drug and adverse drug reaction monitoring at present in our country, we could get the enlightenment about safety monitoring of OTC drug. Results and Conclusion To advise that we should establish drug safety monitoring system and measures on OTC drug in the aspect of policy according to the characteristics of OTC drug. References | Related Articles | Metrics

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The Research of Patient Direct Reporting in Pharmacovigilance BIAN Lei ,ZHAO Pin ,YANG Yue 2013, 10(10): 609-613.  Abstract ( 255 )   PDF (567KB) ( 214 )   Objective To introduce the implementation of direct reporting of patients in pharmacovigilance, in order to provide references for our patient reporting. Methods Analyze the importance, operation and international experience of patient direct reporting by literature and make recommendations combined with China's national conditions accordingly. Results and Conclusion Patient reporting has the advantages of rich qualitative description with more details, increasing the number of ADR reports and new ADR symptoms, helping early detection of ADR and so on. It provides the evidence for regulatory decision-making as an important complement to the reporting system. In China, the level of patient reporting is still very low. Particularly in the implementation process, there are still many problems. Therefore, we should actively carry out the research of reporting routes, forms and coding based on the existing situation. We should widely publicize the importance of patient reporting, timely provide patient education, and increase the public awareness of the reporting. References | Related Articles | Metrics

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Determination of Emodin in Zhijiangning Tablet by HPLC GENG Hai -xia, WANG Hong -ming 2013, 10(10): 614-615.  Abstract ( 235 )   PDF (616KB) ( 95 )   Objective To establisha RP -HPLC method for the determination of emodin in Zhijiangning tablet. Methods Agilent Extend C18 column was used. The mobile phase was methanol -0.1% phosphoric acid (80:20). The detection wavelength was set at 290nm. Results A good linearity was obtained in the range of 0.005025μg to 0.1005μg(r=0.9999).The average recovery was 99.2%. Conclusion The method is simple,accurate and repeatable and can be used for the quality control. References | Related Articles | Metrics

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The Chiral Factor of Aadverse Drug Reaction SONG Hai -bo ,YANG Le ,GUO Xiao -xin ,DU Xiao –xi 2013, 10(10): 616-619.  Abstract ( 249 )   PDF (587KB) ( 573 )   This paper gives an overview about the current status of domestic and foreign research progress of chiral drugs, summarizes the risk factors of adverse reactions induced by the pharmacodynamics and pharmacokinetic differences between racemates and enantiomers, describes the research Methods of chiral drug safety. To prevent and control the adverse reactions of chiral drugs, it is essential to strengthen the research. References | Related Articles | Metrics

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Analysis of Reduning Injection Related Risk Factors LI Ji-you ,SUN Jun ,ZHOU Jing, HUANG Pei-qi 2013, 10(10): 627-630.  Abstract ( 295 )   PDF (721KB) ( 196 )   We conducteda statistical analysis of Reduning injection adverse reaction reports collected by the voluntary reporting system in Jiangsu province from 2009 to 2012, using serious adverse reactions and new adverse reactions as risk factors to test the influence of gender, age, indication, drug dosage and combined medication on risk. The Results suggest that age and combined medication may be risk factors, clinical studies are needed to verify. References | Related Articles | Metrics