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    10 January 2011, Volume 8 Issue 1 Previous Issue    Next Issue

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    Comparative Study on the Influence of Different Alcohol Extracted Crafts on the Content of Total Alkaloid and Acute Toxicity of Rhizoma Pinelliae in Mice
    Gong Yan-sheng, BAO Zhi-ye, HUANG You-yi, HUANG wei, SUN Rong
    2011, 8(1): 1-5. 
    Abstract ( 239 )   PDF (422KB) ( 210 )  
    ObjectiveThe influence of different alcohol extraction on the content of total alkaloid and acute toxicity of Rhizoma Pinelliae caused by different extracted crafts was compared, in order to provide a basis for safe and reasonable medication in clinic. MethodsUsing different alcohol extracted crafts to prepare the samples. UV method was used to determine the content of total alkaloid at 416nm wavelength. The classical acute toxicity methods were used in this study. The MTD value of acid-water extracted group and acid-alcohol extracted group were calculated by mg/kg basis; and the LD50 value of acid-water filtered group and acid-alcohol filtered group were tested by bliss method. Administration and observation the mice for 14 days, and the change of mice weight, the acute toxical symptoms, signs, death time and accumulated death rate were recorded. ResultsThe content of total alkaloid is: acid-alcohol filtered group>acid-alcohol extracted group>acid-water filtered group>acid-water extracted group.The MTD value of acid-water extracted group and acid-alcohol extracted group is 29.6 g·kg-1·d-1 and 27.2 g·kg-1·d-1 respectively, which are equal to 230.2 and 211.6 times of daily dosage in clinic;the LD50 value of acid-water filtered group and acid-alcohol filtered group is 14.15 g·kg-1·d-1 and 14.27 g·kg-1·d-1 respectively, 95% confidence interval is respectively 12.981~15.563g·kg-1·d-1 and 13.167~15.204 g·kg-1·d-1, which are equal to 110.0 and 111.0 times of daily dosage in clinic. According to the observation of acute toxity tests, respiratory depression, hyperspasmia, diarrhea, dysphoria, vomit and tears running are the main acute toxical symptoms of different alcohol extractions. ConclusionTotal alkaloid is one of toxic substances of Rhizoma Pinelliae which has obvious toxity. The temperature has great impact on the content of total alkaloid.which shows that some toxic ingredients could be destroyed by temperature easily.
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    Comparative Study on the Influence of Different Alcohol Extracted Crafts on the Content of Toxical Substances and Acute Toxicity of Rhizoma Pinelliae in Mice
    BAO Zhi-ye, LU Yong-hui, HUANG You-yi, SUN Rong
    2011, 8(1): 6-10. 
    Abstract ( 196 )   PDF (388KB) ( 179 )  
    Objective The influence of different alcohol extraction on the content of total alkaloid, total organic acid and acute toxicity of Rhizoma Pinelliae caused by different extracted crafts was compared, in order to provide a basis for safe and reasonable medication in clinic. Methods Using different alcohol extracted crafts to prepare the samples. UV method was used to determine the content of total alkaloid at 416nm wavelength, and the content of total organic acid in different samples were determined by acid-base titration. The classical acute toxicity methods were used in this study. The MTD value of 75% alcohol-group, 75% alcohol-extracted group, MLD value of 30% alcohol-filtered group, 30% alcohol-extracted group were tested by mg/kg basis. Administration and observation the mice for 14 days, and the change of mice weight, the acute toxical symptoms, signs, death time and accumulated death rate were recorded. Results The content of total alkaloid is: 75% alcohol-filtered group>75% alcohol-extracted group>30% alcohol-filtered group>30% alcohol-extracted group; the content of total organic acid is: 75% alcohol-filtered group>75% alcohol-extracted group>30% alcohol-extracted group>30% alcohol-filtered group.The MTD value of 75% alcohol-filtered group and 75% alcohol-extracted group is 94.4 g·kg-1·d-1 and 99.2 g·kg-1·d-1 respectively, which are equal to 734.2 and 771.6 times of daily dosage in clinic;the MLD value of 30% alcohol-filtered group and 30% alcohol-extracted group is 295.2 g·kg-1·d-1 and 291.6g·kg-1·d-1 respectively, which are equal to 2 296.0 and 2 268.0 times of daily dosage in clinic. Conclusion Extracting temperature and alcohol concentration have great influence on the content of toxical substances of Rhizoma Pinelliae, total alkaloid and total organic acid are mostly in high-concentration alcohol extractions. The temperature mainly impact the content of total alkaloid, while has small impact on the content of total organic acid. The results also shows that the acute toxity of different alcohol extracted samples have some relevance with the content of total organic acid and total alkaloid.
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    Experimental Study on the "Dosage-Time-Toxicity" Relationship of Acute Hepatotoxicity Induced by Water Extraction from Rhizoma Pinelliae in Mice
    ZHANG Li-mei, BAO Zhi-ye, HUANG You-yi, HUANG wei, ZHANG Ya-nan, SUN Rong
    2011, 8(1): 11-14. 
    Abstract ( 244 )   PDF (458KB) ( 210 )  
    ObjectiveTo study the "dosage-time-toxicity" relationship of hepatotoxicity induced by single intragastric administration of water extraction from Rhizoma Pinelliae. Methods"time-toxicity" relationship study:preparing water extraction of 62.5 g·kg-1, ig it of 25 mL·kg-1 to mice once,then get their blood sampling after administration at different times(0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72h). The changes of the activity of ALT, AST and hepar index were detected and the histopathological study was performed; kg-1、70.1 g·kg-1、59.6 g·kg-1、50.7 g·kg-1、43.1 g·kg-1、36.6 g·kg-1, ig them to mice once,while ig distilled water to control group, then do the detecting work 4 hours later as above. Results"time-toxicity"relationship study indicates that the activity of serum ALT, AST is changing with the time, its toxic peak appears at 4th hour after administration and last for about 48 hours; "dosage-toxicity" relationship study indicates that the active of serum ALT, AST of high dosage groups were significantly increased than that of normal group.Hepatic tissue pathomorphology examination also shows that hydroncus, fatty degeneration and necrosis in hepatocyte could be induced after administration the high dosage samples,while the low dosage groups have no differences. ConclusionSingle intragastric administration of water extraction from Rhizoma Pinelliae with certain dosage may induce acute hepatotoxical injury in mice and show an obvious "dosage-time-toxicity" relationship.
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    Experimental Study on the “Dosage-Time-Toxicity” Relationship of Acute Hepatotoxicity Induced by Percolation Liquid of Acid from Rhizoma Pinelliae in Mice
    ZHANG Ya-nan, HUANG You-yi, BAO Zhi-ye, HUANG Wei, SUN Rong
    2011, 8(1): 15-19. 
    Abstract ( 256 )   PDF (1130KB) ( 153 )  
    Objective To study the "dosage-time-toxicity" relationship of hepatotoxicity caused by single dosage percolation liquid of acid from Rhizoma Pinelliae to mice. Methods Mice are grouped according to different time or dosage points, to observe the death condition and toxicity of mice, detect ALT、AST in serum, calculate liver index, and the morphological changes of liver tissue under light microscope. Results Compared with the control group, ALT, AST level in serum are peaked after 2 hours' administration, and restored near normality after 72 hours. Compared with the normal group, high dosage group percolation liquid of acid extracts produces significant liver injury, and ALT, AST in serum increase significantly with the dosage increased. Under light microscope, the different dosages' liver tissue of mice all have different degree's edema and fatty degeneration in liver cells, and the high-dose group appears to be necrosis, lobular structure unclear. Conclision The percolation liquid of acid extracts from Rhizoma Pinelliae gavaged a single dose to mice can cause acute liver injury and even death, and there are certain time-toxicity and dosage-toxicity relationships.
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    Study on Acute Toxicity of Semen Euphorbiae Prior to and After Making Frostlike Powder
    SUN Fu-jun, SONG Wei-guo, LI Ying-xia
    2011, 8(1): 20-22. 
    Abstract ( 246 )   PDF (433KB) ( 467 )  
    ObjectiveTo study the relationship between acute toxicity of Semen Euphorbiae and the content of fatty oil, and the reasonable fatty oil standard of Semen Euphorbiae Pulveratun. MethodsIg Semen Euphorbiae, fatty oil in Semen Euphorbiae, Semen Euphorbiae Pulveratun having different fatty oil(0%, 22.3%, 25.0%and 28.4%) to mice and test the weight and LD50 of oral dose by the conven-tional method for measuring acute toxicity. We compared the time and degree appearing the slight ill symptom such as lying, less food, wetting fur in mice. ResultsAll of the mice tested survive and the LD50 of oral dose to mice is not possible to determine. The maximum dosage of fatty oil in mice is 96g/kg/d and is 39.96g/kg/d either Semen Euphorbiae or Semen Euphorbiae Pulveratun for mice. The time for the occurrence of slight symptom and the degree in mice given Semen Euphorbiae Pulveratun having different fatty oil(22.3%, 25.0% and 28.4%) were different slightly. The more the fatty oil in Semen Euphorbiae Pulveratun, the earlier and the more serious appearance of the ill symptom. ConclusionThe fatty oil in Semen Euphorbiae is the main toxicity contents and the chief toxicity symptom of Semen Euphorbiae is diarrhoea and back bowing. A new standard for the safety content range of fatty oil of 18.0% ~ 22.0% is proposed for Semen Euphorbiae Pulveratun on the basis of the results given above and actual situation of frostlike powder processing of Semen Euphorbiae.
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    Graded Compression Ultrasound Evaluation of Acute Appendicitis in the Old People with Atypical Symptoms
    ZHANG Xiao-ying, YANG Jing-guo
    2011, 8(1): 23-25. 
    Abstract ( 224 )   PDF (442KB) ( 182 )  
    Objective We mainly discuss the sonographic value of the diagnosis of acute appendicitis in the old people with atypical clinical symptoms. Methods There were 240 old patients with stomach-ache performed by ultrasound with the graded compression technique at the front abdomen wall, the appendix was visualized by the method from flank to ileocecum with the graded compression technique or scanned in the most painful spot that the patients felt, meanwhile the appendix imaging was improved both in the fundamental imaging and in the tissue harmonic imaging. We elucidated the different pattern imaging characteristic. Results The ultrasound findings included the following: 182 cases(75.8%) with no mass, either only with local bowel dilation or with local anechoic in the right abdominal periappendix, 20 cases(8.3%) with complex mass, 38 cases(15.8%) with atypical mass but with the characteristic of the anechoic tubular. All were validated by operation and pathology or treatment and follow-up. The ultrasound results were consistent with the pathological findings.The ultrsound patterns of acute appendicitis were charaterized by these appearances of the appendix on transverse scan or on sagittal scan:the thickened wall, the discontinuity, hyperechoic in the extraappendix, the local bowel dilation or the local anechoic in the extraappendix and the sonogram of acute appendicitis with complications such as perforation, the periappendiceal abscess or the omentum wrapping the appendix. Conclution Finally, abdominal ultrasound has proven to be useful in distinguishing the appendicitis from anechoic to the complex mass or the dilated appendix in the extraappendix area and the severity of the appendicitis especially in the old patients with the abdominal abnormality.
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    Risk Analysis for Pharmaceutical Production and Circulation Regulatory
    LIU Zhi-yin, LIU Zhi-yong
    2011, 8(1): 26-28. 
    Abstract ( 233 )   PDF (429KB) ( 351 )  
    Recent years, the drug hurt events occurred frequently and the public concern about drug grown much. The State Food and Drug Administration stepped up the safety, effectiveness and control regulation for drug, and strengthened drug life-cycle risk management. From this point of view, the paper intend to come up to suggestion for the risk management in the pharmaceutical regulation area with the special analysis for pharmaceutical production and circulation risk.
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    Analysis of EU 2009 Edition “GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM”
    CHEN Yong-qiang
    2011, 8(1): 29-31. 
    Abstract ( 258 )   PDF (596KB) ( 290 )  
    By introducing the goals and changesof the EU 2009 edition of "GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM", to analyse and explain the two signals delivered by the Guidelines. Then it describes the control objects of the Guidelines, the responsibilities of all parties in the Medical Devices Vigilance System, and the top concern problems, by the medical devices manufacturers, such as the report range of medical devices adverse events and the due time of the reports in detail.
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    Showing a Potential Risks of Using Medicine Beyond Medicine Instruction by a Lawsuit an “Experimental Therapy”
    YU Xing, GUO Xian-xi, YANG Jian, TANG Rong-fu
    2011, 8(1): 32-33. 
    Abstract ( 213 )   PDF (475KB) ( 325 )  
    Using medicine beyond instruction is contrary to thought of rational use of medicine. By the prescription with case explaining by a fact that substance of experimental therapy is using medicine beyond instruction which becomes breakthrough of irrational using medicine ,has potnetial risks and threatenas seiously to safety use of medicine.
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    The Study of Active Medical Device Adverse Events’ Causation Model Based on Tracks Crossing Theory
    WEN Qiang, XIONG Xue-cai
    2011, 8(1): 34-37. 
    Abstract ( 479 )   PDF (492KB) ( 288 )  
    In research on medical device adverse events, tracks crossing theory can be applied to the cause and effect analysis on post-marketing active medical device accidents. Based on 40 post-marketing active medical device accidents, a medical device adverse events' causation model is introduced. It provided the theoretical support for safety evaluation of post-marketing active medical devices.
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    Research Development on Hepatoprotective Effect and Hepatotoxicity Based on Bupleurum Saikosaponin Components
    HUANG Wei, ZHAO Yan, SUN Rong
    2011, 8(1): 38-40. 
    Abstract ( 320 )   PDF (531KB) ( 567 )  
    ObjectiveBy summarizing the latest research development on the hepatoprotective effect and hepatotoxicity based on Bupleurum saikosaponin components,to provide the literature accordance and research ideas for dicussing the relevance between the "shuganjieyu" effect and hepatotoxicity of Bupleurum. MethodsThe related references in recent 5~10 years both at home and abroad about Bupleurum saikosaponin components were collated, analyzed and summarized. ResultsThe Bupleurum saikosaponin components were the mainly chemical components of Bupleurum which had the hapatoprotective effect, and it played the "shuganjieyu"effect in clinic by multi-channel and multi-effect; the toxicity of Bupleurum saikosaponin components were gradually cognized on the process of clinical application and modern research, the mainly toxical target organ was liver, and the hepatic damage mechanism and channel were mainly related with the multi-channel oxdative injury. ConclusionOnly on the process of the "shuganjieyu"effect expression and the effctive material basis separation and control of Bupleurun, to make the toxicity research and the safety control of toxical material basis, propose the early adverse reaction warning program and early diagonosis treatment measures, gurantee the clinical safety use of Bupleurum, and scitifically resolve the related problems of Bupleurum toxicity at home and abroad.
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    The Drug Interactions with Warfarlin and the Traditional Chinese Medicines
    ZHANG Yan-li, WANG Jing-hong, GU Yuan-yuan, GUI Yue
    2011, 8(1): 41-45. 
    Abstract ( 512 )   PDF (602KB) ( 1036 )  
    Objective To summarize the drug interactions with warfarlin and the traditional chinese medicines at home and abroad, it provided reference for clinical medication. Methods The related articles in recent years on the development and the occurrence mechanism of drug interactions with warfarlin and the traditional chinese medicines are extensively reviewed. Results Some traditional chinese medicines can alter the anticoagulation effect of warfarlin such as angelica sinensis, pyrola, garlic, et al. Conclusion The drug interactions were existed between warfarlin and the traditional chinese medicines. Pay attention to the effect of the traditional chinese medicines with the prescription of warfarlin, in order to improve the safety and effectiveness for clinical medication.
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    Safety Evaluation of Mailuoning Injection
    LU Ye, XU Lu, XU Hou-ming, YU Hao
    2011, 8(1): 46-49. 
    Abstract ( 239 )   PDF (622KB) ( 142 )  
    ObjectiveIn order to provide the basis for clinical drug safety, observed the adverse reaction incidences, types, proportions and risk factors of Mailuoning injection. MethodsUsing "mailuoning","adverse reaction","treat","case report", etc. as the key words, original case reports were downloaded from Chinese Journal Full-text Database(1990 ~2009) in CNKI. Picked out 314 literatures from the whole 428 results, including 217 pieces of adverse reaction incidences and 97 pieces of adverse reaction types. ResultsThe incidence of adverse events occurred to 1.898%, the type of systemic skin damage, categories, gastrointestinal system and its attachments, damage, the respiratory system, cardiovascular central and peripheral nervous system etc, which constitute systemic damage than for 20.93%, respiratory damage than for 20.06% form. 70.24% patients were circulatory disease, time focused on after 10 minutes, and 60 people on an adverse reactions. ConclusionBy intensively warded the suffers and perfecting the content of the drug manual and the clinician's rational drug use,to avoid occurrence of serious adverse reactions.
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    The Quality Evaluation of State Contraceptives Adverse Reaction Reports in 2009
    CHEN Ying, ZHU Xiang-jun, LI Ying
    2011, 8(1): 50-51. 
    Abstract ( 230 )   PDF (590KB) ( 160 )  
    Objective To evaluate the quality of the adverse drug reaction reports of the State Contraceptives Adverse Reaction Surveillance Center(SCARS). Methods 325 contraceptives adverse reaction(CAR) cases collected by SCARS in 2009 have been scored and analyzed from authenticity, normalization and integrality. Results There are 58.46% reports score above 90. Mistakes that happened concentrate on the following items: adverse drug reaction(ADR) process description was incomplete, item vacancies, ADR analysis and evaluation opinion were incompatible, and haven't receive any relative medical reports. Conclusion Totally the quality of CAR reports are fine, but there are still a few quality problems in common. According to the above results, SCARS can elevate the quality of CAR reports by more training.
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    Analysis of 94 Cases of Suspected Death Caused by Drugs
    LV Xiao-qin, CHEN Zhi-gen
    2011, 8(1): 52-56. 
    Abstract ( 237 )   PDF (764KB) ( 139 )  
    ObjectiveTo investigate the features and general pattern of suspected death caused by drugs, and provide references of clinical rational and safety use of drug. MethodsA total of 94 cases collected in zhejiang center for ADR monitoring from Jan. 2008 to Jun. 2010 were analyzed retrospectively. ResultsA total of 132 drugs were involved in the 94 cases, mainly anti-infective drugs(48.5%), followed by traditional Chinese Medicine injections(9.1%). The main route of administration was by intravenously guttae(67.4%). More than half of the cases appeared symptoms of adverse reactions within 2 hours after taking drugs. Allergic-like reaction and anaphylactic shock leading to death was the most common(48.9%), followed by circulatory system damage, circulation-respiratory injury. ConclusionADR monitoring and reporting should be strengthened to ensure safe, effective and rational drug use in the clinic. The suspected death caused by drugs were mainly induced by the popular use of anti-infective drugs and traditiona Chinese Medicine injection, mainly drugs use by intravenously guttae and uneven qualities of drugs. Measures should be taken to tighten control on rational drug use.
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    Analysis of 30 Cases on Adverse Drug Reaction of Ossotide Injection
    SUN Jian-jun
    2011, 8(1): 57-58. 
    Abstract ( 263 )   PDF (577KB) ( 652 )  
    ObjectiveTo summarize Adverse Drug Reaction of ossotide for jection, more attention would been paid for ADR of ossotide in the clinical. MethodsThirty cases reports on ADR of ossotide for injection ranging from 2005 to 2009 were collected by statistically classified and analyzed. ResultsThe allergic reaction was most common in the case reports on ADR of ossotide for jection abount 70%. Ossotide all caused other ADR, such as high level of WBC or calcium, and so on. ConclusionAttention should be paid to ADR of ossotide for injection to ensure safe and rational drug use.
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    One Case of Sever Drug Eruptions Induced by Cefuroxime Sodium for Injection
    ZHANGHong-xu, HANFeng
    2011, 8(1): 59-59. 
    Abstract ( 241 )   PDF (538KB) ( 229 )  
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    One Case of Drug Eruption Induced by Phenobarbital Sodiumfor Injection
    MAOLu
    2011, 8(1): 60-60. 
    Abstract ( 223 )   PDF (527KB) ( 282 )  
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    One Case of Drug Hepatitis and Coagulation Disorder Induced by Fluconazole Injection and Warfarin Tablets
    LAN An-jie, DINGChun-lei, LUOJing, LIU Li-hong
    2011, 8(1): 61-61. 
    Abstract ( 259 )   PDF (529KB) ( 204 )  
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    Medication Errors in Elderly People: Contributing Factors and Future Perspectives
    WANG Jia-yi(Translation), SUN Pei-nan, WANG Da-you(Proofreading)
    2011, 8(1): 62-64. 
    Abstract ( 227 )   PDF (582KB) ( 164 )  
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