Chinese Journal of Pharmacovigilance

Determination of Cefpiramide Concentration in Pancreatic Tissue of Mice by RP-HPLC

JIANG Jun, XIA Zong-ling, WANG Ming-li

2012, 9(12): 705-706.

Abstract ( 290 )

PDF (229KB) ( 180 )

ObjectiveTo establish a reversed-phase HPLC(RP-HPLC) technique for the quantification of the cefpiramide(CPM) concentration in pancreatic tissue. MethodsThe following RP-HPLC conditions were set up DISCOVERY ODS C18 column(5 m, 250 mm×4.6 mm) as stationary phase; a mixture of methanol, triethanolamine and water(27-0.2-72.8) at a flow rate of 1.0 mL ·min-1 as mobile phase; UV detection at 254 nm. ResultsCPM concentration of pancreatic tissue showed a linear plot in the range of 0.1~500.0μg ·mL-1(r=0.999 8). The minimal quantitative concentration was 0.1μg ·mL-1. The mean recovery at the quantitative concentrations of CPM was (97.18±0.74)%. The coefficients of variation for within-day performance were found to be less than 5%, and between-day performance less than 10%. ConclusionThe RP-HPLC is simple and sensitive to quantify cefpiramide concentration of pancreatic tissue, and may be used to monitor the PK parameters in tissues.

References | Related Articles | Metrics

Studies on the Acute Toxicity in Mice and Cytotoxicities of Impurities of Ondansetron

WANG Yue-hua ,YANG Hai-guang , LI li GUO Jing, TONG Yuan-feng, WU Song , DU Guan-hua

2012, 9(12): 707-709.

Abstract ( 380 )

PDF (361KB) ( 178 )

Objective To study the acute toxicity in mice and cytotoxicities of the impurities of Ondansetron. Methods pre-experiment to determine the initial dose, the mice were grouped randomly(half male and half female, 20 mice per group) in the formal experiment. The animal reactions and death were recorded for 14 days. The cytotoxicities on fibroblasts(L929), canine kidney cells(MDCK) and human umbilical vein endothelial cells(HUVEC) were measured. Results The LD50 and 95% confidence limit of the impurity 1 of Ondansetron(intragastric administration) was 1798.8± 178.2 mg ·kg-1, no apparent damage was discovered in the anatomy of the viscera. The LD50 and 95% confidence limit of the impurity 2 of Ondansetron injected intravenously in mice was 49.63± 7.63 mg ·kg-1, shortness of breath and convulsions were shown after intravenous injection and gradually ease, no apparent damage was shown in the anatomy of the viscera. The impurity 3 of Ondansetron was adminstrated intragastriclly to mice 2 000 mg ·kg-1 daily for 3 days, all mice was survived and no toxicity reactions were shown during the observed period． The purity 1,2, and 3 all significantly decreased the viability of L929 cells(P < 0.05). The impurity 3 of Ondansetron significantly promoted the proliferation of HUVEC(P < 0.05). Conclusion The impurity 1 and 2 of Ondansetron had certain toxicity to mice and cells. The toxicity of the impurity 3 of Ondansetron is low. The data can provide the experimental basis to establish the quality standards of Ondansetron, and improve the safety of clinic use.

References | Related Articles | Metrics

Effects of Sufentanil and Sexamethasone on Nerve Blocking Effect of Ropivacaine

ZHANG Da-zhi, LIU Yong-sheng, ZHOU Hai-bin, WANG Huai-jiang

2012, 9(12): 710-712.

Abstract ( 330 )

PDF (352KB) ( 307 )

ObjectiveTo compare effects of sufentanil and dexamethasone on the action of ropivacaine. Methods90 patients were randomly allocated into three groups with 30 cases each in a double-blinded method. Guided by a nerve stimulator, lumbar plexus combined sciatic nerve block was performed with 1%ropivacaine 20mL plus normal saline(NS) 30ml in group I,1%ropivacaine 20mL plus sufentanil 20 g(2mL) and normal saline(NS) 28mL in group II, or 1%ropivacaine 20mL plus dexamethasone 10mg and normal saline(NS) 28mL in group III, so as to observe the each target. ResultsThe durations of sensory and motor blockade in group I were lumbar plexus(7.9±3.6, 5.9±3.4)h and sciatic nerve(8.2±3.5,6.6±3.2)h, respectively ,which were significantly shorter than(15.1±2.4, 10.2±3.5)h and(16.3±2.7, 11.7±3.8)h in group II and(23.6±4.2, 14.7±5.6)h and(23.3±2.4, 14.1±5.1)h in group III(P <0.01). The durations of sensory and motor blockade in group II were significantly shorter than group III(P <0.01). The postoperative sufentanil consumption and PCA button press times in group I were more than that of group II and group III(P <0.05) at 48h after operation. ConclusionSufentanil 0.4 g ·mL-1 and 0.2mg ·mL-1 dexamethasone significantly prolonged the action of ropivacaine in lumbar plexus combined sciatic nerve block and dexamethasone prolonged the action of ropivacaine more than that of sufentanil.

References | Related Articles | Metrics

Experimental Study on the "Dose-time-toxicity" Relationship of Acute Hepatotoxicity Induced by Different Components from Rhizoma Menispermi in Mice

XIE Yuan-zhang, SUN Rong, WANG Yi, ZHANG Ya-nan, LUO Dong

2012, 9(12): 713-717.

Abstract ( 283 )

PDF (591KB) ( 131 )

Objective To study the "dose-time-toxicity" relationship of hepatotoxicity caused by single dose water extracted and alcohol extracted components from Rhizoma Menispermi in mice. Methods Mice are grouped according to different time or dose points, the death condition and toxicity of mice were observed, the activity of ALT、AST in serum were detected, liver index was calculated. Results Compared with the control group, ALT, AST level in serum of water extracted and alcohol extracted components are peaked after 4 hours' administration, and restored near normality after 48 hours; the water extracted components of(46.05~61.4)g ·kg-1 and alcohol extracted components of(8.45~15.02)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 gavages certain dose one time to mice could cause obvious acute hepatic injury, and there were certain time-toxicity and dose-toxicity relationships.

References | Related Articles | Metrics

Experimental Study on the "Dose-time-toxicity" Relationship of Hepatotoxicity Induced by Different Components from Rhizoma Menispermi in Mice

SUN Rong, ZHANG Ya-nan

2012, 9(12): 718-720.

Abstract ( 300 )

PDF (450KB) ( 126 )

Objective To investigate the "dose-time-toxicity" relationship of hepatotoxicity caused by multiple dose water extracted and alcohol extracted components from Rhizoma Menispermi to mice. Methods Mice are grouped according to different time or dose points, the death condition and toxicity of mice were observed, the activity of ALT、AST、ALP、ALB、TBI in serum were detected, liver index was calculated. Results Compared with the control group, the level of ALT, AST, ALP, TBI in serum of water extracted and alcohol extracted components increased, however the level of ALB reduced; and changes of the enzymatic activity in serum increased significantly with the dose increasing. Conclusion The continuous administration of different components from Rhizoma Menispermi to mice can induce obvious hepatotoxicity injury, and there were certain time-toxicity and dose-toxicity relationships.

References | Related Articles | Metrics

The Research of Oxidative Damage Mechanism in Hepatic Toxicity Injury Caused by Different Components from Rhizoma Menispermi in Mice

ZHANG Ya-nan, LUO Dong, SUN Rong

2012, 9(12): 721-724.

Abstract ( 264 )

PDF (446KB) ( 225 )

Objective To investigate the relationship of oxidative damage mechanism in hepatic toxicity caused by different components from Rhizoma Menispermi in mice. Methods Mice were administrated with water extracted and alcohol extracted components for 7 days. The level of MDA、SOD、NO、NOS、GSH、GSH-Px in serum and hepatic tissue were detected. Results The water extracted and alcohol extracted 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 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 water extracted and alcohol extracted components from Rhizoma Menispermi to mice can induce obvious hepato-toxicity injury; the approach of hepatic damage is related with the peroxidative damage mechanism.

References | Related Articles | Metrics

LC-MS Analysis of Saponins in Bupleurum Chinense DC

SUN Jian ,ZHANG Li-fu , FAN Bin , Lv Jun-hai

2012, 9(12): 725-727.

Abstract ( 311 )

PDF (484KB) ( 458 )

Objective To study investigate the saponins in Bupleurum Chinense DC. by LC-MS. Methods The sample was extracted with 60% ethanol. The structures were detected by LC-MS experiments. Results 23 saponins were identified from Bupleurum Chinense DC. Conclusion This method can be used for rapid and accurate identification of saponins in Bupleurum chinense DC.

References | Related Articles | Metrics

Study on Comparative Application of the Materials of Heart Stents

DONG Si-yuan

2012, 9(12): 728-730.

Abstract ( 478 )

PDF (434KB) ( 1413 )

The coronary implantation of heart stents is one of the important methods for the treatment of coronary heart disease. With the advances of biomaterial technology, rapid development has been achieved in the application of heart stents materials. The author introduced the evolution of heart stents materials in terms of metal stents, drug-eluting stents and soluble stents, and that the application of novel material stents is the important rout to reduce the rate of cardiovascular restenosis. Additionally, the future of materials of stents was also looked into.

References | Related Articles | Metrics

Research Development on Animal Models of Thromboangiitis Obliterans

WANG Yi, SUN Rong

2012, 9(12): 731-733.

Abstract ( 407 )

PDF (470KB) ( 160 )

objective To summarize preparation methods of TAO in animals, and find a more suitable method of making model in clinical research. Methods The related references in recent 20 years both at home and abroad about model making methods of TAO were analyzed, collated and summarized. Results In all the methods, rats were the first selected animal, and the methods of tobacco sensitization, cold aspic, injecting immune complex of TAO were better for making models, but each method had its merits and demerits. Method of injecting lauric acid into atreira cruralis without ZT viscose final encapsulation was most related to the clinical pathological changes, and was widely used in the research on pharmacology activity and efficacy evaluation. Conclusion The research on model making methods related with pathogenesis of TAO was rarely reported. So the research on methodology of model making related with the pathogenesis of TAO should be explored deeply, and that was the premise in discovery of innovation drug and evaluation of new drug efficacy.

References | Related Articles | Metrics

Analysis of Reports on Dialysis Device Adverse Events Monitoring in Guangdong Province

XIAO Yu-hua, WANG Hong, YANG Li-jun, LU Shu-tang, LIANG Yan, DENG Jian-xiong

2012, 9(12): 734-736.

Abstract ( 288 )

PDF (523KB) ( 311 )

Objective To analyze dialysis device adverse events via intensive monitoring. Methods To monitor 9 second-class hospitals randomly in Guangdong province, and to record the information of equipments and materials used by each dialysis patients in details with excel software and then to analyze the statistics. Results There are altogether 51 adverse events among 40 120. The main manifestations are dysarteriotony, suppression in the chest, vomiting, blood coagulation and air embolism. It is suspected that they are mainly caused by equipment materials and failures as well as irregular visits by the patients. Usually the measures taken to handle these performances are to terminate dialysis and ask the patients to have a good rest. Till now no death occured. Conclusion There has been no adverse events in Guangdong province till now. But as a regular treatment, with its increasing application and popularization of dialysis, suspected dialysis adverse events will increase, which will directly affect the life quality and even safety of patients. But because of medical workers' different views and vague understanding of adverse events, they may underreport or even fail to report these adverse events. Therefore, vocational training of monitoring workers at the grassroots level has to be strengthened, discriminating and analyzing ability of dialysis medical workers have to be improved and monitoring work has to be continued. So that administrative departments can take relevant executive measures to tackle potential events and offer scientific evidence for these measures. Ultimately adverse events can be timely and effectively controlled and prevented.

References | Related Articles | Metrics

The Clinical Analysis on Adverse Drug Reaction of 1447 Cases Caused by Oral Antidiabetic Drugs

ZHAO Heng, XU Hou-ming, YU Jiang-yi

2012, 9(12): 737-739.

Abstract ( 256 )

PDF (580KB) ( 210 )

ObjectiveThrough the clinical characteristics analysis of the adverse drug reaction cases caused by oral anti-diabetic drugs, provide reasonable advice for clinical use. MethodsTo retrieve the adverse drug reactions cases caused by oral antidiabetic drugs in the database of Center for ADR Monitoring of Jiangsu, and analyze the clinical manifestations time of onset, the system involved, types of drugs, etc by describing analysis. Results1447 cases were involved. 846 cases were male, 601 cases were female. More than half cases happened in one day. The types of the suspected drugs mostly were diguanides, sutfonylureasII and non-sulfonylurea drugs promoting insulin secretion. The systems involved of adverse drug reactions include gastrointestinal system, the skin and its appendages and the central and peripheral nervous system. All cases were healed or better after therapy. ConclusionStrictly master the indication of oral antidiabetic drugs, pay attention to the reasonable combination and rare adverse drug reactions, so as to ensure safe use.

References | Related Articles | Metrics

Analysis on the Common Risk Factors of Coronary Stent

ZHOU Ding-jie, ZHAO Yan, ZHOU Jing-xin

2012, 9(12): 740-744.

Abstract ( 337 )

PDF (1006KB) ( 413 )

Objective To explore the risk point of coronary stent adverse events and offer the risk control measures respectively. Methods A total of 108 cases of coronary stent adverse events were collected from the domestic literature and analyzed retrospectively. Results The primary lesions of coronary stent adverse events were grouped into three categories: the intraoperative and postoperative secondary diseases, the device operated differently than expected or device malfunction, the signs and symptoms after stent implanted. The most common event consequence was needed for internal, surgical treatment to avoid permanent damage to the body structure. Conclusion The injury of stent thrombosis was the most severe and the in-stent restenosis was the most common risk point in all of the coronary stent adverse events. The control measures should be taken at same time by the manufacturing enterprises of medical device, the medical institutions and the supervision departments to decrease the risk of coronary stent in clinic.

References | Related Articles | Metrics

The Establishing and Running of Pre-warning System on Adverse Event Cluster Signals

FENG Hong-yun, HOU Yong-fang, WU Gui-zhi, CHENG Gang

2012, 9(12): 745-747.

Abstract ( 767 )

PDF (630KB) ( 1777 )

To discovery the adverse event cluster signals earlier, a pre-warning system was established and running in national adverse drug reaction monitoring system. Related processes, including background, pre-warning regulations, all problems during pre-warning system running and adjustments were introduced. In order to test the sensitivity and accuracy of pre-warning regulations, the three important historical drug hazards were pre-warned by hand.

References | Related Articles | Metrics

Analysis of 2 666 Cases of Adverse Events of Contact Lens

OU-YANG Li-ming, LONG Li-ping, CHENG Xi, LIU Ning

2012, 9(12): 748-750.

Abstract ( 340 )

PDF (664KB) ( 294 )

ObjectiveTo provide reference for safe and effective use of contact lenses and reduce the incidence of adverse events by analyzing the data of the contact lens adverse event data. MethodsWith the description method, statistically analyze 2666 reports of contact lens collected in 2011 with the help of Microsoft Excel. ResultsThe cases reported by equipment production enterprises, monitoring bodies, medical institutions and pharmaceutical enterprises respectively accounted for 61.63%, 32.63%, 4.91% and 0.83% of the total number of items. According to the report the results, the ratio of men to women was 1:1.94, and there was the highest incidence between the ages ranged from 21 to 30 years old, accounts for 58.63% of the total number of cases. Eye foreign body sensation accounted for 33.05% of the adverse events. ConclusionIt's important to rationally use of contact lenses and reduce the incidence of contact lens adverse events. Propaganda and training were recommended to further promote the medical device adverse event monitoring and maintenance of public safety.

References | Related Articles | Metrics

Analysis of 270 Cases of Adverse Drug Reactions/Events Reports Caused by Xiyanping Injection

LIN Qiang, ZHANG Shu

2012, 9(12): 751-753.

Abstract ( 299 )

PDF (620KB) ( 734 )

Objection To explore the general characters of the adverse drug reactions/events caused by Xiyanping injection． Methods By retrospective study method, we analyzed the 270 spontaneous reports of adverse drug reaction/event collected by Center for ADR Monitoring of Fujian from 2004 to 2011. Results Among 270 reports,children aged under 14 years old accounted for 83.4%(225/270). The main adverse reactions/events were damage to skin and its attachment, and the major clinical manifestations were rash, urticaria, etc. Severe reaction could result in anaphylactic shock, allergic purpura, etc. Conclusion Xiyanping injection should be used strictly in accordance with the instructions of medication, and the process of medication should be monitored, in order to reduce or avoid ADR/ADE.

References | Related Articles | Metrics

Analysis of 53 Cases of Amitriptyline Adverse Reactions / Events

WANG Zhi-yi, XU Zuo-guo, SUI Zhong-qing

2012, 9(12): 754-756.

Abstract ( 275 )

PDF (617KB) ( 245 )

ObjectiveTo investigate amitriptyline adverse reaction event, provide a reference for clinical safety of drugs. MethodsTo analyze the 8 kinds of mental journal for the past 20 years, case reports of adverse reactions amitriptyline and clinical monitoring of author. ResultsAmitriptyline adverse reaction/event, included 10 major categories and 25 kinds of clinical manifestations. Newly discovered adverse reactions include mental disorders, leukopenia, teratogenic, etc. Long-term use may induce dependence. 84.91% adverse reaction occur within 15 days. ConclusionAmitriptyline adverse reactions are more, clinical use should be carefully, pay attention to observation.

References | Related Articles | Metrics

Analysis of the Instructions for Children of Ophthalmic Drugs for External Use

ZHANG Jing-jing

2012, 9(12): 757-759.

Abstract ( 304 )

PDF (652KB) ( 242 )

ObjectiveTo analyze the instructions for children of ophthalmic drugs for external use in our hospital. And provide reference for clinical physicians, manufacturers and related management institutions. MethodsAccording to the "drug administration law", "the drugs specification and tag management regulation", "Standard rule of specification of OTC drug ", "Standard detailed rule of specification of chemical drug and biological product for treatment", we have analyzed the children instructions of 24 species of ophthalmic drugs for external use. ResultsThere are 22 species which contain the children instructions, 2 species contain nothing for children. Except one kind of traditional Chinese medicine eye drops has nothing in "pharmacokinetic" item of specification and another is not clear. All of other "pharmacokinetic" data is based on health adult. ConclusionThe instructions for children of ophthalmic drugs for external use in our hospital is not complete, and expression is ambiguous, etc. It should be paid more attention and the related standards should be developed.

References | Related Articles | Metrics

Analysis of the Perioperative Utilization of Antibiotics in Gynecology

WANG Li-hua

2012, 9(12): 760-761.

Abstract ( 284 )

PDF (591KB) ( 197 )

ObjectiveTo investigate the perioperative utilization of antibiotics in gynecology of our hospital and provide references for the rational use of antimicrobial agents. MethodsWe randomly selected 308 medical records in our hospital from Jun. 2011 to Dec. 2011 and filled out the "surgery with the use of antibacterial agents in questionnaire", which were analyzed and appraised on antibacterial drug selection, use time, combined situation, prevent application, etc. ResultsOf all analytical cases, 308(100%) received antibacterial drugs, which involved in 10 classes and 25 varieties, such as aminoglycoside, cephalosporin, nitrate imidazoles and penicillin. Mono-drug administration, two-drug administration, three-drug administration, four or more-drug administration respectively accounted for 11.04%, 59.42%, 26.94%, 2.60%. The average use time was 8.08 d. ConclusionThe use of antimicrobial agents in gynecology was unreasonable in our hospital, and the duration of treatment was long. We should strengthen the management of antibiotics usage.

References | Related Articles | Metrics

Archive