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08 September 2010, Volume 7 Issue 9 Previous Issue    Next Issue

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Determination of Isofraxidin in Medofenoxate Fruits by HPLC ZHANG Hai-feng ,TENG Kun ,ZHU Jun-yi 2010, 7(9): 513-514.  Abstract ( 174 )   PDF (265KB) ( 387 )   Objective To establisha HPLC method for the determination of isofraxidin in medofenoxate fruits. Methods Agilent XDB C18(4.6 mm伊150 mm,5μm) column was applied, using methanol-0.2% phosphoric acid (27：73)as mobile phase with the rate of 1.0mL·min-1. The column temperature was room temperature, the injection volumn was 10μL and the detective wavelength was 343 nm. Results A good linearity was obtained over the range of 0.835～4.176μg·mL-1 for isofraxidin(r=0.9996). The average recovery(n=6) was 100.74%(RSD=0.44%). Conclusion The method is practical, convenient, accurate, and can be used as the determination of isofraxidin in medofenoxate fruits. References | Related Articles | Metrics

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The Clinical Effect of Dexmedetomidine in Ventilated Patients Sedation TIAN Zhao-tao ,HUANG He 2010, 7(9): 515-516.  Abstract ( 224 )   PDF (290KB) ( 141 )   Objective To explore the sedative effects of dexmedetomidine asa ward-based sedation on ventilated patients in intensive care unit. Methods Forty ventilated patients were divided into midazolam group(group A) and midazolam+ dexmedetomidine group(group B),with 20 patients in each group. Recorded the APACHE II score, Ramsay score and PaO2/FiO2 indicators before sedation. Heart rate, blood pressure and respiration were recorded at 4h, 6h and 12h of sedation. The infusion were ceased after 12h, then the sedative degree was assessed every 30 min, recover time, time to achieve satisfactory sedation and the sedation level were recorded. Results 90% of patients could achieve satisfactory sedation using dexmedetomidine alone, if the joint use of midazolam has only very low doses. The midazolam dosage, time to achieve satisfactory sedation and recover time in group B decreased significantly than those in Group A( P<0.05). Satisfactory degree of sedation in group B were higher than those in group A( P<0.05). Conclusion In medical ventilated patients, dexmedetomidine can improve the sedative efect of midazolam. References | Related Articles | Metrics

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Inhibitory Effect of Radix Seutellariae on Genetic Damage Induced by CdSO4 and MMC in Mice WU Guang-heng, SUN Jian ,ZHU Zhu, WEN De-zhong, LU Pei-xin ,ZHANG Hong 2010, 7(9): 517-519.  Abstract ( 183 )   PDF (376KB) ( 156 )   Objective To study the inhibitory effect of Radix seutellariae on genetic damage induced by CdSO4 and MMC in mice. Methods The micronucleus test of mouse bone marrow cell(MNT) was used, to detect the micronucleus rate in mouse bone marrow cell, and to analysis the micronucleus rates by the statistical compution. Results The frequency of micronucleus in mouse bone marrow induced by CdSO4 and MMC in mice was reduced significantly, showed significant difference(P <0.01). There is no significant difference in there groups of Radix Seutellariae and CdSO4 at the same time( P>0.05). Conclusion Radix Seutellariae has the effect of antimutation under the experimental conditions,and it may be an antimutagen. References | Related Articles | Metrics

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Experimental Study on Mice's Acute Toxicity of Total Bupleurum Saponin Extracts HUANG Wei, SUN Rong,ZHANG Zuo -ping 2010, 7(9): 520-523.  Abstract ( 185 )   PDF (587KB) ( 236 )   Objective To discuss the effect of total Bupleurum Saponin extracts on mice's acute toxicity. Methods Make the study on mice's acute toxicity of the total Bupleurum Saponin extracts in accordance with classical acute toxicity test methods. Results Caculated by dried medicinal herbs, the LD50 of the total Bupleurum Saponin extracts is 94.974g·kg-1·d-1, which is equal to 422.8 times of 70kg people's daily dried medicinal herb expenses,and the 95% confidence interval is 88.742～103.76g·kg-1·d-1, which is equal to 414.1～484.2 times of 70kg people's daily dried medicinal herb expenses;caculated by total saikosaponin, the LD50 is5 231.5 mg·kg-1·d-1, and the 95% confidence interval is4 886.1～5 721.2 mg·kg-1·d-1. The main acute toxicity symptoms of dead mice are negligent action,then arising from unsteady gait, abdominal lying sleeping, rapid heart rate, shortness of breath, continuous convulsions, neurological inhibition, and eventually to death. The surviving mice's weight gainings are slow in 14d observation period and there are no other obvious abnormalities. Conclusion The Bupleurum herb hasa certain toxicity, which is consistent with the clinical report. The total saikosaponin is not only the mainly effective chemical components but also its mainly toxical material basis. Its toxical sites and the "dose-time-poison" relationships of accumulated toxicity relations are all to be further studied. References | Related Articles | Metrics

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Experimental Study on Rat's Acute Toxicity of Total Bupleurum Saponin Extracts HUANG Wei ,SUN Rong 2010, 7(9): 524-526.  Abstract ( 186 )   PDF (493KB) ( 139 )   Objective To discuss the effect of total Bupleurum Saponin extracts on rat's acute toxicity. Methods Make the study on rat's acute toxicity of thetotal Bupleurum Saponin extracts in accordance with classical acute toxicity test methods. Results Caculated by totalsaikosaponin, the LD50 is 2 255.6 mg·kg-1·d-1, and the 95% confidence interval is 2 057.2～2 452.9 mg·kg-1·d-1.The main acute toxicity symptoms of dead rat are negligent action,then arising from unsteady gait, abdominal lying sleeping, rapid heart rate, shortness of breath, continuous convulsions, neurological in hibition, and eventually to death. The surviving rat's weight gainings are slow in 14d observation period and there are no other obvious abnormalities. Conclusion The total Bupleurum Saponin extracts can induce all rats to be dead, and its toxicity on rats is smaller than the mice. The toxical location and mechanism are all to be further studied. References | Related Articles | Metrics

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Experimental Study on Mice's Acute Toxicity of Refined Products of Bupleurum Saikkosaponin by Alcohol Elution HUANG Wei ,SUN Rong, REN Hai -yong, MIAO De -yu 2010, 7(9): 527-529.  Abstract ( 171 )   PDF (534KB) ( 215 )   Objective To discuss the effect of refined products of by alcohol elution on mice's acute toxicity. Methods Make the study on mice's acute toxicity of the refined products of Bupleurum Saikkosaponin by alcohol elution in accordance with classical acute toxicity test methods. Results Caculated by total saikkosaponin ,the LD50 of the refined products of by alcohol elution is 446.7 mg·kg-1·, and the 95% confidence interval is 386.13～513.66 mg·kg-1·d -1. The main acute toxicity symptoms and signs of dead mice are negligent action, then arising from unsteady gait, abdominal lying sleeping, rapid heart rate, shortness of breath, continuous convulsions, neurological inhibition, and eventually to death. The surviving mice's weight gainings are slow in 14d obervation period and there are noother obvious abnormalities. Conclusion The acute toxicity of refined products of Bupleurum Saikkosaponin by alcohol elution is bigger than the total extracts, and we further confirm that the total saikkosaponinis mainly toxical material basis of Bupleurum . The "dose-time-poison" relationships of accumulated toxicity are to be further studied. References | Related Articles | Metrics

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Experimental Study on Rat's Acute Toxicity of Refined Products of Bupleurum Saikosaponin by Alcohol Elution HUANG Wei SUN Rong 2010, 7(9): 530-532.  Abstract ( 171 )   PDF (515KB) ( 197 )   Objective To discuss the effect of refined products of Bupleurum saikosaponin by alcohol elution on rat's acute toxicity. Methods Make the study on rat's acute toxicity of the refined products of Bupleurum saikosaponin by alcohol elution in accordance with classical acute toxicity test methods. Results Caculated by total saikosaponin the LD50 of the refined products of Bupleurum saikosaponin by alcohol elution is 591.95 mg·kg-1·d-1, and the 95%(,) confidence limit is 490.96～713.7 mg·kg-1·d-1. The main acute toxicity symptoms and signs of dead rats are negligent action,then arising from unsteady gait, abdominal lying sleeping, rapid heart rate, shortness of breath, ontinuous convulsions, neurological inhibition, and eventually to death. The surviving rats' weight gainings are slow in 14d obervation period and there are no other obvious abnormalities. The acute toxicity of refined products of Bupleurum saikosaponin by alcohol elution is bigger than the total Bupleurum saikosaponin extracts,but it's smaller than the mice's. Conclusion The total saikosaponin is mainly toxical material basis of Bupleurum . The toxical location and mechanismare to be further studied. References | Related Articles | Metrics

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Explaining Methods of the Safety with the Thought of Pharmacovigilance of Traditional Chinese Medicine in Literatures WANG Jian, BAN Bing -kun ,GAO Tian ,HE Yan ,ZHOU Ya -li, HUANG Wen -zhi, YANG Juan ,WU Cheng -yun ,LUO Qun -ying ,LAN Shan 2010, 7(9): 533-535.  Abstract ( 186 )   PDF (504KB) ( 264 )   In order to provide theoretical basis for studying the content of adverse reaction/event of Traditional Chinese Medicine(TCM), exploring the Methods and rules of controlling toxicity and guiding rational use TCM in clinical, analysis the safety and pharmacovigilance of TCM in literatures. Our research shows: from the record of history, the doctors and pharmacists were pay much more attention to the safety of TCM and using "poison" explained the safety of TCM and pharmacovigilance. Also in order to ensure the safety of using TCM in clinical, reducing toxicity by controlling doses, processing and modification according to varies symptoms, etc. It is worth researching on the safety of TCM, since it contains extremely rich theoretical knowledge and valuable clinical experiences. References | Related Articles | Metrics

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Study on Pharmacovigilance System Construction and Scientific Development in Bases LI Pan-hai ,FENG Qiao-qiao, HUANG Chuan-hai, TIAN Yue –jie 2010, 7(9): 536-539.  Abstract ( 358 )   PDF (538KB) ( 222 )   The achievements and main problems of pharmacovigilance in bases were reviewed and analyzed. It also explored the situation,role, objectives and tasks of adverse drug reaction(ADR) monitoring in bases, combining with status of ADR monitoring in Shandong province. Advice for pharmacovigilance system construction and development in bases was proposed. References | Related Articles | Metrics

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The Status quo and Thought of Traditional Chinese Medicine Injections in Oncology ZHANG Xia, LI Juan 2010, 7(9): 540-541.  Abstract ( 200 )   PDF (559KB) ( 221 )   Absract: To discuss the research mode and direction of Traditional Chinese Medicine (TCM) injections in oncology by analyzing manufacturing and clinical status quo. The clinical utilization of TCM injection is becoming more and more common. Needs from social economy, hospital and patients push forward the manufacture and clinical usage of them. In the mean time there are many problems in basic research, approval, advertisement, usage, adverse reaction monitoring,etc. Regulating basic research principles and supervising every link of manufacturing and utilizing are necessary to promote healthy development of traditional Chinese medicine injections in oncology. References | Related Articles | Metrics

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The Integrity Analysis of Suspicious Medical Device Adverse Event Reporting Form NUERJIANG·shabukai ,YU Yong-qiang ,JIANG Dong -gui, ZHU Shu -bing ,GUO Xue 2010, 7(9): 542-546.  Abstract ( 221 )   PDF (580KB) ( 449 )   Objective To bring Methods and make suggestions for the quality of suspicious Medical Device Adverse Event(MDAE )reports, we statisticed, analysised and evaluated all suspicious MDAE reports from 2002,Jan.1st to 2008, Dec.31th. Methods 2 166 reports were randomly sampled from the database of National Center for ADR Monitoring, Excel and SPSS statistical software package were used to analysis the loss rates after adopting these reports. The contents of 2 166 reports were compared with the current international reports. Results &Conclusion This study adopted randomly sample, and sample rate was 5%, so the representative of samples was better, and the method was sensitive, and the Conclusion was credible. The statistically significant deficiencies in total 39 accounts for 88.6% of the total number of items. This study indicated that the firstly loss rate was coming from using department, mainly including study de-partment's name and reporter's occupation. The secondly loss rate was coming from management corparation or manufacture corparation. At present, there were many deficiencies of Chinese MDAE reports, the reports' quality should be further enhanced. References | Related Articles | Metrics

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The Investigation for Perform the Quality Management of Medical Device During the Whole Process of Clinical Trial LU Fei ,CHENG Yun-Zhang 2010, 7(9): 547-550.  Abstract ( 231 )   PDF (630KB) ( 146 )   The developing of medical device requires the application of advanced scientific technology. Clinical trial is one of the most important Methods to obtain the basic clinical evaluation data. The truthful, accuracy and scientific of the data have a serious relationship with the safety and efficiency of the products and the life safety of human. Therefore, it is very important to scientific monitor and control the whole process of clinical trial. References | Related Articles | Metrics

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Research of Evaluation Index System of Retail Pharmacy LU Shuang, ZHU Wen-tao 2010, 7(9): 551-553.  Abstract ( 239 )   PDF (509KB) ( 258 )   The article introduces several kinds of the evaluation index system, including the pharmacy services, operating performance and GSP standards. But they all have shortcomings. In order to promote the evaluation Methods and certification standards of the evaluation index system. The author suggest to establish a new evaluation index system.A drug quality management is the important part of it, but it also contains important factors which affect the safety of medicines, the revised GSP which is better than before and some quantization standard. References | Related Articles | Metrics

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Adverse Drug Reaction Induced by Antidepressants of SSRI and SNRI ZHANG Ying ,CUI Xiang-li ,YANG Ping, JIA Ying, LIU Jing, PAN Hua ,ZHAO Zhi-gang 2010, 7(9): 554-555.  Abstract ( 313 )   PDF (531KB) ( 636 )   Objective To study the clinical syndrom of adverse drug reaction(ADR) induced by SSRI or SNRI, and the treatment of ADR. Methods 24 depression cases with ADR induced by SSRI or SNRI were collected in neurological outpatients from January,2010 to June,2010, we analysised the clinical syndroms of ADR induced by SSRI or SNRI, and de-scribed the treatment of different ADR. Results The most common ADR is Gastrointestinal tract reaction, less comman ADR are Psychiatric symptoms, autonomic nervous system dysfunction and extrapyramidal reaction. Conclusion Although SSRI and SNRI are most safe antidepressants, neurologists should pay much attention to their ADR, and grasp the treatment measures. References | Related Articles | Metrics

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Analysis of 106 Cases of Adverse Drug Reactions Induced by Antibacterials ZHANG Hua-feng, LUO Ting ,XU Jing LI Li, PENG Gui-qing, ZHU Yu-hua 2010, 7(9): 556-557.  Abstract ( 250 )   PDF (520KB) ( 185 )   Objective To study the occurrence and distribution of adverse drug reactions(ADR) induced by antibacterials in our hospital to provide reference to clinical rational drug use of antibacterial agents. Methods 106 reports of ADR cases induced by antibacterials from 2009 in our hospital clinical departments were collected and analyzed retrospectively by drug types, drug names, route of administration and clinical manifestations. Results Antibacterials had occupied the first place in our hospital's adverse drug reaction, most of them resulted from cephalosporins, macrolides and quinolones. Conclusion It is necessary to pay more attention the ADR induced by antibacterials to promote the rational use of antibacterials. References | Related Articles | Metrics

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Retrospective Study of 109 cases of Adverse Drug Reactions of Xiyanping Injection MA Guan-qun KUANG Jun-jian 2010, 7(9): 558-560.  Abstract ( 198 )   PDF (627KB) ( 433 )   Objective To explore the general pattern and characteristics of adverse drug reaction(ADR) induced by Xiyanping injection so as to provide references for clinical rational drug use. Methods A statistical analysis was retrospectively investigated on 109 Xiyanping injection-induced ADR case reported in domestic medical journals. Results ADR of Xiyanping injection were mostly occur in the <10 group. They usually occurred in the first 30 minutes affter taking the drug. The main ADR of Xiyanping injection was in the Allergic reaction. The mortality rate is 0.92%. Conclusion Doctors and pharmacists should know the pattern and characteristics of ADR, and the use of Xiyanping injection should be under strict monitoring to reduce the occur of serious ADR. References | Related Articles | Metrics

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Analysis of 140 Cases of Adverse Drug Reaction Reports and Cost CHEN Chong-Ze 2010, 7(9): 561-563.  Abstract ( 219 )   PDF (592KB) ( 180 )   Objective Analysis of adverse drug reaction and their treatment costs for clinical therapy to reduce the medical expenses the cost of providinga scientific basis. Methods Retrospective analysis of 140 cases of adverse drug reaction caused by the direct costs and indirect costs were analyzed. Results 140 cases of adverse drug reaction cases. Mainly for anti-infective drugs(50.71%), followed by cardiovascular drugs(12.14%), ADR mainly the skin and appendages, was followed by the digestive system, nervous system. The average treatment time per patient is 2.69 days per patient due to adverse drug reaction due to the direct cost to 112.11 yuan, an indirect cost of 100.10 yuan. Conclusion Based on the analysis of treatment costs of adverse drug reaction, ADR occurred to patients and society of the heavy financial burden, should be greater monitoring of economic costs of ADR, and to take measures to mitigate the social costs and patients ADR. References | Related Articles | Metrics

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The Data Analysis of 454 Cases of Adverse Drug Reactions to Essential Drug JING Yun-yun, LI Yan-bo 2010, 7(9): 564-566.  Abstract ( 220 )   PDF (649KB) ( 222 )   Objective The references were applied to ensure safe application of essential drug acrossing to analyze the report of the 454 cases of essential drug. Methods 454 ADR reports collected by Linyi County for ADR Monitoring were analyzed using retrospective study method from January to December 2009. Results &Conclusion High ADR occurrence was observed in the injection.,and most of ADR cases were antimicrobial drugs. Further strengthen the focus on monitoring of essential medicines to ensure safe public drug. References | Related Articles | Metrics