Chinese Journal of Pharmacovigilance

The Bioavailability and Bioequivalence Analysis of Three Levornidazole Preparations in Healthy Volunteers

WANG XIAO-juan, YUAN Hong, SONG Min, TAN Hong-yi, HUANG Zhi-jun, LIU Chang, HUANG Yuan-yuan, FU Zhi-min, YANG Guo-ping

2011, 8(7): 385-387.

Abstract ( 154 )

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Objective To study the pharmacokinetics and bioequivalence of three Levornidazole preparations in healthy volunteers. Methods The study was conducted in twenty-four healthy male volunteers. After receiving a single dose of 500 mg Levornidazole dispersible tablet, Levornidazole capsule and Levornidazole tablet(Reference) in three crossed way, the drug concentrations in plasma were determined by HPLC-UV method, the pharmacokinetic parameters and the statistical analysis of bioequivalence were obtained by DAS Ver 2.1. Results The pharmacokinetic parameters for Levornidazole dispersible tablet, Levornidazole capsule and the reference Levornidazole tablet were as follows: Cmax were (10.6±3.5), (10.4±3.7) and (11.1±3.3)mg·L-1, tmax were(0.76±0.70), (1.35±0.80) and (0.92±0.84)h, t1/2 were(13.2±1.4), (12.9±1.7) and (12.3±1.9)h, AUC0→48 were(140.7±31.3 ), (149.5±28.5) and (143.2±37.2)mg·L-1·h, AUC0→∞ were (152.6±33.4), (162.0±31.8) and (153.7±30.1)mg·L-1·h. By evaluating AUC0→48 and AUC0→∞, the relative bioavailability of Levornidazole dispersible tablet and capsule to the reference were (98.3±12.0)%, (99.5±12.1)% and (104.9±9.5)%, (106.0±10.5)% respectively. Conclusion Levornidazole dispersible tablet, capsule and the reference tablets were bioequivalent.

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Protective Effect of Melatonin on Adriamycin-induced Myocardial Injury in Rats

SUN Yun-peng, ZHANG-Yu, LI Tian-Shu, WEN De-zhong, ZHANG Hong

2011, 8(7): 388-390.

Abstract ( 226 )

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Objective To observe the Melatonin(MLT) on Adriamycin induced neonatal rat cardiomyocytes in primary protective effect of dose-effect relationship. Methods Cultured neonatal rat cardiomyocytes with Adriamycin Preparation of cardiac cell injury model, experimental and normal control group(C group), Adriamycin Group(ADM in the culture medium Jiaru A lmg/L) and 30 minutes before joining the Adriamycin given MLT 50,100,200 μmol·L-1 group(M1, M2, M3 group). Observation of melatonin on cultured neonatal rat cardiomyocytes in each group malondialdehyde(MDA) and MTT metabolic rate. Results Myocardial cell injury and Adriamycin group, protection group, MDA release melatonin significantly reduced(P <0.01), and MTT metabolic rate was significantly higher(P <0.01), with a dose-dependent effect. Conclusion MLT on Adriamycin induced a protective effect of myocardial cell injury and a dose-dependent relationship.

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Study on the Anti-fatigue and Anti-anoxia Effects of Epimedium Polysaccharides on Mice

ZHANG Hong-xu, HAN Feng

2011, 8(7): 391-392.

Abstract ( 222 )

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Objective To study the anti-fatigue and anti-anoxia effects of Epimedium polysaccharides. Methods The burdened swimming tests and the hypoxia tolerance tests were adopted. Results The swimming time and the survival time of the experimental group also were longed significantly(P< 0.05). Conclusion Epimedium polysaccharides can improve the ability of the anti-fatigue and anti-anoxia of mice.

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Experimental Study on the "Dose-Time-Toxicity" Relationship of Single Dose Hepatotoxicity Induced by Different Components from Folium Artemisiae Argyi in Mice

HUANG Wei, ZHANG Ya-nan, WANG Hui, ZHU Lan-lan, SUN Rong

2011, 8(7): 392-396.

Abstract ( 206 )

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Objective To study the "dose-time-toxicity" relationship of hepatotoxicity caused by single dose water extracted and volatile oil components of Folium Artemisiae Argyi to mice. MethodsMice 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. ResultsCompared with the control group, ALT, AST level in serum of water extracted components are peaked after 2 hours' administration, and restored near normality after 72 hours. ALT level in serum of volatile oil components are peaked after 4 hours' administration, while AST level in serum of volatile oil components are peaked after 6 hours' administration, and they all restored near normality after 72 hours. The water extracted components of (8.0~1.33) g·kg-1 and volatile oil components of (0.34~0.13) mL·kg-1 have obvious damage to the liverorganization, and ALT, AST in serum increased significantly with the dose increasing. ConclusionThe water extracted and volatile oil 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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Experimental Study on the "Dose-Time-Toxicity" Relationship of Multi-dose Hepatotoxicity Induced by Different Components from Folium Artemisiae Argyi in Mice

HUANG Wei, ZHANG Ya-nan, WANG Hui, SUN Rong

2011, 8(7): 397-400.

Abstract ( 192 )

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Objective To study the "dosage-time-toxicity" relationship of hepatotoxicity induced by multiple intragastric administration of water extracted and volatile oil components of Folium Artemisiae Argyi to mice. Methods Mice are grouped according to different time or dose points, to observe the death condition and toxicity of mice. The changes of the activity of ALT, AST and liver, kidney index were detected. Results On the first day after administration the hepatotoxicity which displayed with obvious increase of activity in serum ALT, AST and hepar index appeared. On the 3th day the hepatotoxicity kept a higher level that the active units in serum ALT, AST were significantly higher than the normal group. On the 7th day after administration ALT, AST level in serum are restored near normality. Compared with the normal group, within 7 days after the administration, water extracted components in (1.14~9.0) g·kg-1 doses of scope, volatile oil components in (0.13~0.25) ml·kg-1 doses of scope, they all cause significant damage to liver, the activity of ALT, AST, AKP, TBI elevated, while ALB reduced, and liver ratio increased, it shows there were obvious "dosage-time-toxicity" relations, Hepatotoxic effects volatile oil components > water extracted components. Conclusion Multiple intragastric administrations of water extracted and volatile oil components of Folium Artemisiae Argyi 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 Chronic Toxicity in Rats Caused by Different Components of Folium Artemisiae Argyi

GONG Yan-sheng, HUANG Wei, QIAN Xiao-lu, WANG Hui, ZHANG Yong, SUN Rong

2011, 8(7): 401-406.

Abstract ( 222 )

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Objective The obvious toxic symptoms and signs, the toxic damage extents and reversibility were observed in rats caused by water extract and volatile oil components of Folium Artemisiae Argyi. Methods The 140 rats were divided into seven groups such as normal group、water extract components and volatile oil of high, medium and low dose. The general including the bodyweight、diet and behavior were observed, the blood routine, the biochemical indicators, organ/bodyweight rate, the important organs such as heart、liver、spleen、lung、kidney、brain and et al. and pathological changes were detected after 21 days administrated, and then we continued to observe the 20 days recovery period after drug discontinuance. Results The Wistar rat's weight、diet and drinking were decreased; the serum ALT、AST、AKP、TPC were increased; the ALB and the rate of A/G were decreased; the liver weight and volume ratio were increased after given volatile oil and water extract components from Folium Artemisiae Argyi to Wistar rats by There was little affect for routine blood and renal function; the damage of liver toxicity in rats show an obvious dosage relationship. and after 20 days, the partial lesions were irreversible. Conclusion The main chronic toxical damage is hepatic injury in rats caused by water extract and volatile oil components of Folium Artemisiae Argyi especially the volatile oil, and part of the lesions were irreversible.

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The Research of Oxidative Damage Mechanism in Hepatical Toxical Injury Caused by Different Components from Folium Artemisiae Argyi in Mice

GONG Yan-sheng, ZHANG Ya-nan, HUANG Wei, WANG Hui, SUN Rong

2011, 8(7): 407-409.

Abstract ( 232 )

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Objective To investigate the relationship of oxidative damage mechanism in hepatical toxical injury caused by different components from Folium Artemisiae Argyi in mice. Methods Mice were administrated with water extracted and volatile oil components according to 7 days toxicity test method. The level of MDA、SOD、NO、NOS、GSH、GSH-Px in serum and hepatic tissue were detected. Results The different components can cause the activity of MDA in serum and liver increased, the level of SOD corresponding induced, however the level of NO and NOS were increased. In addition the activity of GSH and GSH-Px reduced. All the changes were aggravated in accordance with the dosages. Conclusion The continuous administration of different components from Folium Artemisiae Argyi to mice can induce obvious hepato-toxicity injury, the approach of hepatic damage is related with the peroxidative damage mechanism.

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Methods and Significance of Constructing the Database of Adverse Drug Reaction Information

HAI Ying

2011, 8(7): 410-412.

Abstract ( 376 )

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Objective Construct the database of the adverse drug reaction information and explore the methods and significance which strengthen the efficiency and levels of the adverse drug reaction monitoring and promote it more legislative, more scientific and more transparent. Methods The researched objects are 26,000 pieces of package insert which were approved by SFDA. We dealed with the adverse drug reaction of the package insert in order that the information was more standardized and more structured. Results & Conclusion We obtained the criteria and procedures about constructing the database of the adverse drug reaction information and construct our database on the basis of them. That Database will actively promote and propel drug monitoring and evaluation or work quality and efficiency.

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Clinical Research Document Administration of Hospital Ethics Committees

CHAI Yi, ZHANG Fu-min, SUN Ning-sheng, LI Tian-ping, LI Ning-xia, LIANG Zhi, ZHAO Jun

2011, 8(7): 413-415.

Abstract ( 228 )

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This paper discussed the method about how to administrate and innovate the ethics comittees(EC) documents during the process of clinical research. By setting up the regulations of document administration, elevate the idea of EC secretary, and improve the level of EC document administration. By these method, we can truly show the process of EC review, ensure EC protecting the rights of subjects and provide the scientific, truly, accurate, integrated, credible evidence of clinical research.

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Medical Equipment Evaluation of Hospital

YIN Jun, CHEN Wei-ping, LIU Fu-bin

2011, 8(7): 416-418.

Abstract ( 199 )

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The whole life cycle medical equipment assessment concludes the pre-purchase evaluation, the use of benefit assessment, the use of risk assessment and the retirement assessment. Through the discussion of the whole life cycle medical equipment assessment and the purchase and use of the scientific guide hospital equipment, and also the standardization of the management, the equipment management of hospital meets the standards of ISO9001 and JCI.

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Literature Review of Post-marketing Drug Safety Monitoring in China

NING Yan-yang, YANG Yue, WEI Jing

2011, 8(7): 419-421.

Abstract ( 281 )

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Objective To master the research progress in the field of post-marketing drug safety monitoring in China.Methods This aticle searched and screened documents about post-marketing drug safety monitoring in CNKI from 2000 to 2010 April, included 28 instructive literatures. The article described the basic information of 28 literatures, and research status of post-marketing drug safety monitoring in China. The research of post-marketing drug safety monitoring in China was concentrated in ADR monitoring, pharmacovigilance and foreign information.Results＆Conclusion Number of literatures showed an overall upward trend. Study of post-marketing drug safety monitoring would get more and more attention.

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Investigation And Analysis of The Prophylactic Antibacterials Application During Perioperative Period

PAN Ping-jiang, TANG Bin, ZHANG Yan

2011, 8(7): 422-424.

Abstract ( 206 )

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Objective To investigate and analyze the prophylactic usage of antimierobial in perioperative period in our hospital in order to provide references for rationl use of anrimierobial in the clinic. Methods Unifed questionnaire was filled by clinieal pharmacists. In this retrospective survey, 200 medical charts of inpatients who discharged from five surgieal departments in our hospital from June to December in 2009 were seleeted randomly. The use of antimierobial was anaed statistieally. Results96.0% of the total 200 cases receiced antibacterials for prophhylaxis purpose for 6.5 days on average. Rational rate for the use of antimierobial was 59.0%, 23.0% received combination of two drugs, 6.0% received com bination of three drugs, 0.3% received combination of four drugs. Conclusion The usage rate of antimierobial was high in preioperative peried, the high class antibioties was used, the timing and duration of prophylactic use of drugs tends to be on the long side and execed the duration of antlbiotics instruetion principle in some cases. Therefore, intervention is urgenily needed toraekle these problems.

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Analysis of Current Situation of Specially Regulated Drugs in Basic Level Units

LIN Qing, PEI Xing-chen, LI Ning

2011, 8(7): 425-428.

Abstract ( 351 )

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Specially regulated drugs cover categories of narcotics, psychotropic drugs, radioactive drugs, drugs liable to produce poision. There are a variety of such drugs and chemical, which involve different areas and have high risks. Primary regulatory authority has a responsibility of supervision of drug using, management, scientific research. And regulatory duties on relevant entities are different. This paper analyzes the current regulatory situation by summarizing the data of specially regulated drugs.

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Analysis of the Basic Medical Institutions Prescription Charges in Yunnan Province

YIN Yuan-yuan, BAI Li-qin, HAN Hong-shen, LI Jian-li, DU Juan, FU Wen

2011, 8(7): 429-431.

Abstract ( 202 )

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Objective Reflecting of unreasonable phenomenon by analysis of the cost of prescription drugs, discuss its causes and get the suggestions for controlling prescription charges. Methods Choose the 11 177 copies of out-patient prescriptions from 10 primary medical institutions of Yunnan Province to the study, describe the distribution of prescription charges on the logarithmic conversion. Then analyze the charges by T-test and make the analysis of prescription charges. Results The prescription charges of urban is more than that of Villages and towns. The cost of Medicare health-care unit is more the that of none. Conclusion Controlling the growth of prescription charges by reasonable way, promote rational use of medicines, particular in prescription controls under the cost of medical insurance should be attention.

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Application and Review of Chinese Versions of Montreal Cognitive Assessment

JING Heng, HAN Tao, GUO Wei, SUN Rong, ZHANG Ting, CHEN Su-Ling, WANG Hui

2011, 8(7): 432-433.

Abstract ( 297 )

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Objective Research the difference in the 5 Chinese versions of Montreal Cognitive Assessment Scale, understand its local applicability. Methods Based on the application of the Montreal Cognitive Assessment Scale for an assessment on cognitive function of general elderly population and patients with ischemic stroke, appreciate the differences in the 5 Chinese versions. Results In the actual application, found the parts of the settings are not fully adapting to the local cultural background, it may cause a false positive rate of cognitive impairment increased, thus affecting the assessment of validity. Suggest the big Chinese region should study together and form an unified Chinese version of the cognitive function assessment scale as possible in order to facilitate evaluation of research results in related fields and exchange.

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Literature Analysis on the Characteristic of Distribution of Adverse Drug Reactions Induced by Main First-line Antituberculosis Drugs

SHI Fu-guo, GU Ming, MA Shi-ping

2011, 8(7): 434-437.

Abstract ( 285 )

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Objective To investigate the characteristics of distribution of adverse drug reaction induced by first-line antituberculosis drugs and to provide reference for clinical safety and proper administration. Methods The literature between January 1989 and December 2009 was retrieved. For four first-line drugs(isoniazid, rifampin, ethambutol, pyrazinamide), the time of occurrence of adverse reactions, age and gender distribution of cases and systems or system-organs related adverse reactions caused by individual drug were counted up, the characteristics and factors involved in individual adverse reactions were also analyzed. Results The total of 739 cases were collected, 437 in male, 299 in female, and 3 cases with unknown sex. Ages ranged from 3 months to 82 years old. The shortest time of occurrence of adverse reaction was 2 min and the longest about 50 years. The adverse reactions of antituberculosis drugs were widely distributed in 12 systems, such as the nervous system, urinary system, and hematological system and so on. Multiple adverse reactions included acute renal failure, drug-induced hepatic injury, anaphylactoid purpura, anaphylactic shock, optic neuritis and so on. Conclusion More attention should be paid to the characteristics and rule of distribution of adverse drug reaction of antituberculosis drugs induced in clinical and to ensure safety and proper administration.

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Analysis and Implications of Standardised MedDRA Queries

HOU Yong-fang, TIAN Chun-hua, LIU Cui-li, YANG Le, FENG Hong-yun, XIA Dong-sheng, MENG Kang-kang, WANG Ling

2011, 8(7): 438-441.

Abstract ( 569 )

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In 2003, Medical Dictionary for Regulatory Activities(MedDRA) Maintenance and Support Services Organization (MSSO) established Standardised MedDRA Queries(SMQ), which is a collection of a number of MedDRA terms and the query strategy based on them. The purpose for SMQ is to help identify and retrieve potentially relevant cases. Adverse drug reactions in China have currently more than 3 million case reports. And when we carry out the risk assessment for drug safety based on this data, the accuracy and completeness of the query strategy is the basis of scientific assessments. This article is to analyze the background and detailed design of SMQ, and to explore the establishment of standardised query of adverse reaction terms.

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