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    10 April 2011, Volume 8 Issue 4 Previous Issue    Next Issue

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    Experimental Study on the "Dose-Time-Toxicity "Relationship of Acute Hepatotoxicity Induced by Different Components from Polygonum multiflorum in Mice
    HUANG Wei, ZHANG Ya-nan, SUN Rong
    2011, 8(4): 193-196. 
    Abstract ( 222 )   PDF (432KB) ( 246 )  
    Objective To study the "dose-time-toxicity" relationship of hepatotoxicity caused by single dose water extracted and alcohol extracted components of Polygonum multiflorum to mice. Methodse Mice are grouped according to different time or dose points, to observe the death condition and toxicity of mice, detect ALT、AST in serum, calculate liver, spleen, thymus index. Results Compared with the control group, ALT, AST level in serum of water extracted components are peaked after 4 hours' administration, and restored near normality after 24 hours; ALT, AST level in serum of alcohol extracted components are peaked after 2 hours' administration, and restored near normality after 48 hours; The water extracted components of (5.5~30.75)g·kg-1 and alcohol extracted components of (8.5~24.5)g·kg-1 have obvious damage to the liver organization, and ALT, AST in serum increased significantly with the dose increasing. Conclusion The water extracted and alcohol extracted components gavaged certain dose one time to mice could cause obvious acute hepa-injury, and there were certain time-toxicity and dose-toxicity relationships.
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    The Experiment of Bacterial Endotoxin Test for Esmolol Hydrochloride Injection
    ZHOU Xiu-sen
    2011, 8(4): 197-198. 
    Abstract ( 211 )   PDF (312KB) ( 217 )  
    Objective To establish the bacterial endotoxins determination method for esmolol hydrochloride injection. Methodse According to the method in the appendix of the Chinese Pharmacopoeia(edition 2010), the bacterial endotoxin test was carried out. Results The maximum non-disturb concentration of esmolol hydrochloride is 1.2mg·mL-1.Conclusion The method of bacterial endotoxin test is feasible with the limit of 0.20 EU·mg-1 for esmolol hydrochlo-ride injection.
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    Determination of the Contents of 2,3,5,4' -tetrahydroxystilbene 2-O-β-D-Glucopyranoside,Emodi and Physcion in Yangxue Shengfa Capsules by HPLC
    ZHENG Li-na, REN Hai-yong, ZHANG Zuo-ping, SUN Rong
    2011, 8(4): 199-201. 
    Abstract ( 208 )   PDF (516KB) ( 218 )  
    Objective To develop an HPLC method for determination of 2,3,5,4'-tetrahydroxystilbene 2-O-β-D-Glucopyranoside, emodin and physcion in Yangxue Shengfa Capsules, to explore the relationship of toxicity of Yangxue Shengfa Capsules and Radix Polygoni multiflori from the perspective of index constituents, and to provide evidence for the quality reseach of Yangxue Shengfa Capsules. Methodse HPLC, Hypersil C18 column(4.6mm× 250mm, 5μm)was adopted; The solvent system consisting of acetonitrile-water(19:81) was used in the determination of 2,3,5,4'-tetrahydroxystilbene 2-O-β-D-Glucopyranoside,and the detection wavelength was at 320nm. The solvent system consisting of methanol-0.1% phosphoric acid(80:20)was used in the determination of emodin and physcion, and the detection wavelength was at 254nm. Results The linear ranges of 2,3,5,4'-tetrahydroxystilbene 2-O-β-D-Glucopyranoside, emodin and physcion were 0.005~0.5mg/mL, 0.00168~0.084mg/mL, and 0.00104~0.052 mg/mL,respec-Tively. The average recoveries were 98.67% (RSD=1.23%), 95.80% (RSD=1.63%), 97.70%(RSD=1.89%), respectively. Conclusion The Methodse are rapid, accurate, and with good linear relationship, good reproducibility, good stability, and high recovery, can be used for the determination of Yangxue Shengfa Capsules. It is initially confirmed that the toxicity of Yangxue Shengfa Capsules may be related with Radix Polygoni multiflori, and anthraquinone may be toxic components.
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    Pathologic Research on Hepatotoxicity in Mice Caused by Yangxue Shengfa Capsules
    LV Li-li, XIE Yuan-zhang, QIAN Xiao-lu, YANG Qian, SUN Rong
    2011, 8(4): 202-204. 
    Abstract ( 210 )   PDF (375KB) ( 156 )  
    Objective To investigate the pathologic injury degree of hepatotoxicity in mice induced by single administration of Yangxue Shengfa Capsules and provide pathohistological basis for its hepatotoxical injury. Methodse The pathologic changes of mice in the study on "dose-time-toxicity"relationship of hepatotoxicity caused by Yangxue Shengfa Capsules was observed with light microscope and image analysis after HE stain. Results The study on the "time-toxicity" relationship indicated that the hepatotoxicity occurred at 2h after administration and expressed obviously in the range from 6h to 24h after administration. The study on the "dose-toxicity"relationship showed that pathohistological injury of different degree can be induced by drug of (2.5~12.0)g·okg-1 and acidophilia, hyalinization, vacuolus were the main pathologic changes. Conclusion Once oral administration of Yangxue Shengfa Capsules with certain dosage may induce acute hepatotoxical injury in mice and show an obvious "dose-time-toxicity" relationship. It can cause pathologic changes such as acidophilia, hyalinization, vacuolus to hepatic cells.
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    Experimental Study on the "Dose-Time-Toxicity" Relationship of Acute Hepatotoxicity Induced by Yangxue Shengfa Capsules to Mice
    LI Xiao-yu, SUN Rong, LV Li-li
    2011, 8(4): 204-207. 
    Abstract ( 209 )   PDF (544KB) ( 192 )  
    Objective To study the "dose-time-toxicity" relationship of hepatotoxicity caused by Yangxue Shengfa capsules to mice. Methodse Study on the "time-toxicity" relationship: Ig Yangxue Shengfa capsules of certain dosage to mice and the changes of the level of ALT, AST, TBI in serum and organ index of liver, spleen and thoracic gland were tested at different time points after administration. Study on the "dosage-toxicity" relationship: Ig Yangxue Shengfa capsules of different dosages to mice and the corresponding treatment was performed at 2h after administration in accordance with the method of study on"time-toxicity" relationship. Results The study on the "time-toxicity" relationship indicated that the level of ALT,AST,TBI in serum reached to the peak at 2h after once administration of Yangxue Shengfa capsulesof higher dosage and all recovered to normal value at 8h after ig. The liver index raised to its topmost at 12h. and recovered to normal value at 48h after ig. The study on the "dosage-toxicity" relationship indicated that conspicuous hepartotoxical injury can be induced by Yangxue Shengfa capsules of (2.50~12.00)ml·kg-1 and the level of ALT, AST,TBI increased significantly with the increase of dosage. Conclusion once oral administration of Yangxue Shengfa capsuleswith large dosage may induce acute hepatotoxical injury in mice and show an obvious "dosage-time-toxicity" relationship and Its hepatic injury mechanism needs further research.
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    Experimental Study on Mice's Acute Toxicity of Yangxue Shengfa Capsules
    XIE Yuan-zhang, SUN Rong, ZHANG Ya-nan, QIAN Xiao-lu
    2011, 8(4): 208-210. 
    Abstract ( 227 )   PDF (589KB) ( 292 )  
    Objective To discuss the effect of Yangxue Shengfa capsules on mice's acute toxicity. Methodse The classical method of acute toxicity were used to study on mice's caused by Yangxue Shengfa capsules. Results Caculated by Yangxue Shengfa capsules,the MLD is 24.0g·kg-1·d-1, which is equal to 420.0 times of 70kg people’s daily dried medicinal herb expenses. The main acute toxicity symptoms of mouse are negligent action, diarrhea and hypokinesia. Compared with the control group, The mice's body-weight gainings were slow after 1 day's administration, which gradually normal after 5 day's administration and there were no other obvious abnormalities. The serum concentration of ALT and AST, the liver-body ratio all increased after 2 hours' administration. Conclusion The mice's acute toxicity of Yangxue Shengfa capsules could induce the liver injury although could not make the LD50 and MTD, and the mice did not appear dead. It demonstrated that the drug gavages certain dose to mice could cause obvious hepa-injury, which in accordance with the clinical ADR report.
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    Reviewing Drug Safety Risk Management Based on Drug Withdrawl Experiences in USA.
    GUO Xiao-xin, DU Xiao-xi, XUE Song-lin
    2011, 8(4): 212-215. 
    Abstract ( 304 )   PDF (403KB) ( 495 )  
    Objective To analyze causes of drug withdrawls in USA and to emphasize that risk management of post-marketing drugs is very important to the public health. Methodse Medical literatures and US FDA website were searched and analyzed regarding information on drugs that have been withdrawn or removed from the market in USA. Results A total of 72 products were withdrawn or removed from USA during 1964 and 2009. The common safety causes of withdrawal include cardiovascular events, carcinogenic risk, liver toxicity, blood disorders, skin disorders, neurologic/mental disorders, renal toxicity, and so on. Conclusion Risk management should be considered throughout a drug’s lifecycle from development to post-market usage. Risk management of post-marketing drugs is particularly important. Drug withdrawal is the last approach for post-marketing safety risk management.
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    Investigation and Analysis on Antibacterial Drug Use in Four Cities of China
    JING Chun-mei, XIAO Ai-li, Yan Lin, Cheng Gang
    2011, 8(4): 216-219. 
    Abstract ( 211 )   PDF (595KB) ( 233 )  
    Objective Understand the status of antibacterial drug use and administration at hospitals of China, identify the problems in the process of use, and put forward the feasible suggestions. Methodse A sampling investigation was carried out on the antibacterial rational drug use indicators of antibiotics at 15 hospitals of Beijing, Shanghai, Guangzhou and Chengdu. Data statistics was analyzed by SPSS11.0 software. Results The average frequency of antibacterial drug use for non-surgical inpatients at 15 grade-3 hospitals is 49.1%, while for surgical inpatients, the average is 94.6%. In the inpatients who used antibacterial drugs, the average number of categories is 2. The average cost of antibacterial drugs for inpatients is 970.7 Yuan, accounting for 27.8% of the total cost of all drugs. The average duration of therapy with antibacterial drugs is 5.8 days. The average number of days at hospital is 16.8 days. The ratio of patients receiving antibacterial drug-sensitivity tests is 9.7%. The average number of antibacterial drug use for outpatients is 2.5.The average percentage of antibacterial drug use is 21.9%. The average percentage of injection use is 10.4%. The average cost of drugs is 200.3 Yuan. Conclusion Using the international rational drug use indicators of antibacterial drugs can evaluate the antibacterial drug use level Objectively and scientifically, provide evidence for intervention, offer reference for the monitoring of antibacterial drug use indicators.
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    Discussion on the Technical Development of Pediatric Pharmacovigilance
    SHEN Lu, DU Xiao-xi
    2011, 8(4): 220-224. 
    Abstract ( 208 )   PDF (498KB) ( 114 )  
    This article is based on the theory and the practice of pharmacovigilance(PV), and combined with the essential character of pediatric medication. The writer discusses on the special characteristics of pediatric PV, the role and responsibilities of different stakeholders, PV before authorization of a pediatric indication and PV for products on the market. We try to establish the frame of pediatric PV, and hope this pilot helpful for the practice of PV on special population like children.
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    Discussion on the Situation of Drug Post-marketed Reassessment in China
    LI Man, WANG Zhong, ZHANG Xiang-lin
    2011, 8(4): 225-228. 
    Abstract ( 236 )   PDF (554KB) ( 499 )  
    On the basis of expounding the situation of drug post-marketed reassessment, the problems of reassessment status have been analyzed. And relevant suggestions have been provided for improving drug post-marketed reassessment.
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    Safety Evaluation of Infusion Sets for Clinical Medication
    DENG Jie
    2011, 8(4): 229-232. 
    Abstract ( 221 )   PDF (626KB) ( 371 )  
    This article discusses the basic requirements of safety evaluation on infusion sets for single use. And the article also puts forward to the points in the following: Infusion sets for single use with complicated producing process have many factors on influencing safety and need to be controlled strictly in all links to ensure the safety in clinical application. The safety of infusion sets for single use depends on new technology, new materials and new procedure, so we need strengthen the study above and establish and revise the raw material standards. To strengthen the control of product procedure and further study the research and development of infusion sets for single use.
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    Unreasonable Phenomena Excation about Medicine Use Found in the Process of Advisory Service
    XU Li-fen
    2011, 8(4): 233-234. 
    Abstract ( 224 )   PDF (583KB) ( 365 )  
    The purpose of setting up an open clinic drugstore is for the convenience between pharmacists and patients communicating face to face and easy to carry out the service work of medication information. The pharmacists find some unreasonable phenomena existent in the patients’ taking medicine during the service work. In this essay, the author summarizes the unreasonable medication reason and the result that may lead to. The corresponding measures are also taken to deal with the pertinent phenomenon to attach importance to each hospital and every pharmacist of sales department.
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    The Discussion about Control Measures for the Risk of Using Medicines Which Coming from Hospital Operating Room
    LIU Yan-xue, DENG Wei-sheng
    2011, 8(4): 235-236. 
    Abstract ( 193 )   PDF (599KB) ( 296 )  
    Taking some measures, such as strengthen the management of drug quality, setting up a strict medication verification system and Training Nurses some drug knowledge, is good to control the risk of using medicines in hospital operating room.
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    Recent Advance on the Association Between HLA-B*1502 Allele and Severe Cutaneous Adverse Reactions in Different Race Induced by Anti-epileptic Drugs
    CHENG Xin-min, LI Li, TIANYue-jie
    2011, 8(4): 237-239. 
    Abstract ( 251 )   PDF (553KB) ( 574 )  
    To present a review on the research of the association between HLA-B*1502 allele and the severe cutaneous adverse reactions in different race induced by anti-epileptic drugs in recent years. The mechanisms were preliminary analysised to provide reference on the rational use of anti-epileptic drugs and prevent and reduce the serious adverse events.
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    The Survey of Healthcare Professionals on Cognition Degree for Adverse Drug Reaction in Jiayuguan
    HAO Jun-xiang, YAN Shu, LIU Guang-bin, LIU Xiao-shuan, YANG Dong-rui, ZHANG Li, LI Run-jun, LIU Hu
    2011, 8(4): 240-243. 
    Abstract ( 185 )   PDF (601KB) ( 193 )  
    Objective To investigate the cognition degree on adverse drug reactions(ADR) among healthcare profes-sionals as to improve and promote the ADR reporting and monitoring. Methodse A questionnaire survey was conducted among the healthcare professionals of different level hospitals and cliniques in Jiayuguan. Results The healthcare professionals’ knowledge was difference on ADR concept, ADR happening scope,(P <0.05); cognition degree on adverse drug reaction was significant difference between different profession(P <0.05), where in the recognition degree of pharmacy staff was the highest, managers had the lowest awareness. Conclusion Both propaganda and education should be strengthened to improve the cognition degree about ADR during the healthcare professionals and to elevate their consciousness in the ADR monitoring.
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    Pharmaceutical Care on a Patient with G6PD Deficiency Having Acute Hemolytic Syndrome by Postoperative Medication
    KUANG Jun-jian
    2011, 8(4): 244-245. 
    Abstract ( 256 )   PDF (575KB) ( 240 )  
    Objective Clinical pharmacists can utilize knowledge of specialty to assist doctors taking pharmaceutical care of a patient with G6PD deficiency having acute hemolytic syndrome by postoperative medication. Methodse Clinical pharmacists timely participated in the drug therapy, combining with the blood test Results. Liver protective and alkaline urine were selected as the treatment. Results The patient discharged from hospital when the symptom improved. Conclusion The clinical pharmacists could coordinate the doctors to optimize the medication therapy by participating in the pharmaceutical care combined with the patients' actual conditions.
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    The Review of the Adverse Drug Reaction Using Ibuprofen Suspension
    WAN Xue-qin, ZHANG Hua-feng
    2011, 8(4): 246-247. 
    Abstract ( 279 )   PDF (563KB) ( 468 )  
    This article introduces the occurrenc and distribution of adverse drug reactions(ADR) induced by Ibuprofen Suspension, With "Ibuprofen" as key word, literatures were retrieved from CNKI and CQVIP from Jan. 2000 to Jun. 2010. 4 literatures including 5 cases were analyzed statistically, and another case happened in our hospital Main clinical manifestation of ADR cases were digestive system, Blood system, Nervous system, lesion of skin and its appendants. We should strengthen to monitor the ADR of Ibuprofen Suspension and ensure rational and standardized use of children, avoid or reduce the occurrence of severe ADR.
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    The Adverse Events of Cimetidine and Its Clinical Misdiagnosis
    GU Jia-fu, YANG Xiao-feng
    2011, 8(4): 248-249. 
    Abstract ( 259 )   PDF (706KB) ( 343 )  
    Objective To summarize the clinical super-dose of cimetidine injection in clinical misdiagnosis factors. Methodse A retrospective study from February 2006 to August 2009 in our hospital the incidence of adverse drug reactions. Results 126 cases of adverse drug reactions, including 30 cases of irrational drug overdose are triggered, causing clinical misdiagnosis. Conclusion The dose of cimetidine super easy to cause adverse drug events, and cause clinical misdiagnosis.
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    Two Cases of Drug Fever Induced by Riboflavin Sodium Phosphate Injection
    XUXiu-yu
    2011, 8(4): 249-249. 
    Abstract ( 234 )   PDF (557KB) ( 229 )  
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    One Case of Hepatic Lesion Induced by Zhiyanxiao Capsules
    ZHAOLi
    2011, 8(4): 250-250. 
    Abstract ( 230 )   PDF (550KB) ( 183 )  
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    One Case of Severe Erythra Induced by Tongzhisurunjiang Capsules
    Mamat-Aly, Gul-Nar, Tur-Gun
    2011, 8(4): 251-251. 
    Abstract ( 267 )   PDF (550KB) ( 215 )  
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    Guidelines for Good Pharmacoepidemiology Practices
    RENJing-tian, WANGBo(Translation), LI Li-ming(Proofreading)
    2011, 8(4): 252-256. 
    Abstract ( 358 )   PDF (703KB) ( 890 )  
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