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08 August 2014, Volume 11 Issue 8 Previous Issue    Next Issue

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Experimental Study on Mice's Acute Toxicity of Saikosaponin a LI Xiao-yu, YIN Li-shun, SUN Rong 2014, 11(8): 449-452.  Abstract ( 309 )   PDF (400KB) ( 253 )   ObjectiveTo discuss the effect of Saikosaponin a on mice's acute toxicity. MethodsMice's acute toxicities of different drug-delivery ways were tested respectively by the classic methods of acute toxicity. The MLD of ig and the LD50 of ip were calculated by a kilogram of body weight method, and continuously observing for 14 days.ResultsCaculated by Saikosaponin a, the MLD of ig is 790.5 mg·kg-1·d-1, the LD50 of ip is 72.511 mg·kg-1·d-1,and the 95% confidence interval is 66.523~78.894 mg·kg-1·d-1. The main acute toxicity symptoms and signs of dead mice are negligent action, then arising from rear limb weakness, unsteady gait, abdominal lying sleeping, drooping eyelids, lethargy, shortness of breath, continuous convulsions of hind legs, neurological inhibition, and eventually to death by ip. The surviving mice's weight gainings are more slower in 14 d obervation period and by anatomical observation of death mice, there are no other obvious abnormalities except hepatic pathological changes. ConclusionThe acute toxicity of intraperitoneal injection of Saikosaponin a is bigger than ig and we further confirm that Saikosaponin a is one of mainly toxical material compositions of Bupleurum. The "dose-time-poison"relationships of accumulated toxicity, biotransformation process in vivo and vitro, and the position and mechanism of toxic effects are to be further studied. References | Related Articles | Metrics

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Effects of Total Glucoside of on Intrahepatic Cholestasis in Mice Induced by α-Naphthylisothiocyanate LIANG Xiao-Dong, Zhang Li ,JIA Zhi-Dan, WEI Huai-Ling ,BAO Xiu-Qi, ZHANG Dan ,SUN Hua 2014, 11(8): 453-456.  Abstract ( 271 )   PDF (436KB) ( 130 )   Objective To investigate the protective effects of total glucoside of Picrorhiza scrophulariflora (TGP) on intrahepatic cholestasis induced by α-naphthylisothiocyanate (ANIT) in ICR mice. Methods TGP (0.33~9 mg·kg-1 per day) were injectively given to experimental mice for five consecutive days. A single dose of ANIT (80 mg·kg-1) was orally given to mice on the third day to induce intrahepatic cholestasis. All animals were killed on 2 h after TGP final administration. The levels of serum ALT,AST,ALB,ALP,TBIL,DBIL and TBA were measured by automatic chemistry analyzer (TBA-40FR). Liver histopathological changes were examined by H.E and light microscopy. Results ANIT 80 mg·kg-1 could induced significant liver damage and jaundice, expressed in the higher serum ALT,AST,ALP,TBIL,DBIL,TBA activities and the apoptosis or bile canaliculus injury in liver tissue. TGF injection (0.33~9 mg·kg-1) showed significantly protective effects to liver damage and jaundice induced by ANIT. Compared with the model group, TGP could significantly reduce the elevated serum ALT,AST,ALP,TBIL,DBIL,TBA and relieve the liver pathological injury. There is a dose-dependent relationship between 0.33~3 mg·kg-1 dose range. Conclusion TGP injection showed the significant action of reducing serum bilirubin and transaminase and improving liver tissue injury of experimental cholestasis induced by ANIT. The optimum doses are 1~3 mg·kg-1. It should be careful to make the dose choice in clinical trial. References | Related Articles | Metrics

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Experimental Study on Long-term Toxicity of ISMN Valsartan Spironolactone Antihypertensive Compound in Rats LI Xin, LI Bin, ZHAO Tao, MOU Li-li, FENG Zhong, YAO Jing-chun 2014, 11(8): 457-461.  Abstract ( 309 )   PDF (459KB) ( 176 )   Objective To observe the toxicity of antihypertensive compound (ingredients: isosorbide mononitrate, valsartan, spironolactone) in rats for 6 months by oral administration, and whether the toxicity was increased or not, and whether new toxicity was generated after three ingredients combined application compared with valsartan used alone were also observed. Methods 200 healthy Sprague-Dawley(SD) rats, were randomly disvided into control, valsartan, low-, mid-, and high-dose (73, 244, and 733 mg·kg-1) valsartan compound groups, 40 in each group. Dose volume was 10 mL·kg-1, with ig administration for 6 months, 6 d per week, and observed for 4 weeks after the last administration. During the experiment, the general conditions of animals were observed daily. Body weight and food consumption were weighed weekly. The related indexes including blood pressure , blood routine, and blood biochemistry were detected at different time points such as month 3 and 6 of administration, and week 4 in recovery period. Then the rats were dissected and histopathologic examination was carried out. Results Compared with control group, the blood pressure in all the drug groups declined obviously but returned to normal after drug withdrawal. In 244, 733 mg·kg-1 combination groups and valsartan group, the blood routine RBC, HCT, HGB and Ret decreased obviously, the serum CREA, UREA and K+ were increased after given drug for 3 months, no obvious pathological changes in organs were observed except kidney appeared server inflammation. These abnormal indexes can return to normal after drug withdrawal. Conclusion In this study, the no observed adverse effect level(NOAEL) of antihypertensive compound is 73 mg·kg-1 in rat for 6 months by oral administration. The toxicity of blood routine and kidney was found at dosage of 244 mg·kg-1. The damage was reversible, it can return to normal after drug withdrawal. The toxicity was not increased and new toxicity was not generated compared with valsartan used alone after three ingredients combined application. References | Related Articles | Metrics

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Effect for Improving Living Quality of Intracerebral Hemorrhage with Blood-activating and Stasis-removing Therapy CHEN Che, YUAN Li-xin, LI Jing-ya, ZHANG Gen-ming 2014, 11(8): 462-464.  Abstract ( 264 )   PDF (436KB) ( 151 )   ObjectiveTo observe the effect for improving living quality of intracerebral hemorrhage with blood-activating and stasis-removing therapy. MethodsA total of 228 cases with cerebral hemorrhage were randomly divided into the treatment group (n=114) and the control group (n=114). The control group was treated with the basic treatment of internal medicine. On the basis of it, the treatment group received intravenous infusion with Xingnaojing injection for 2 weeks and was given TCM granules for 21 days dynamically and dialectically. After these, the treatment group was asked to drink Naoxueshu oral liquid until the 3rd month of incidence. The clinical outcome assessment of patient reported outcomes(PRO) scores were observed in two groups. ResultsCompared with the first day, the treatment group PRO scores were superior to control group in 21th day and 3rd month after entering the group (P <0.05). And the single index in some time was also lower than the control group (P<0.05). ConclusionIntracerebral hemorrhage with blood-activating and stasis-removing therapy had an effective result in improving living quality in a certain period of time. It is good to improve the clinical efficacy. References | Related Articles | Metrics

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TLCIdentificationandHPLCDetermination of 2,3,5,4'-tetrahydroxystil bene-2-O- -D-glucosde in Yansheng Capsules MAYu SONGYing YANGRong-yan 2014, 11(8): 468-471.  Abstract ( 258 )   PDF (581KB) ( 93 )   Objective To establish identification and quantitative determination method of Yansheng capules. Methods TLC was employed to identify six crude herbal elements in Yansheng capules and the content of 2,3,5,4'-tetrahy-droxystil bene-2-O- -D-glucosde was determined by HPLC. Results The spot developed on TLC was fairly clear. The average recovery of 2,3,5,4'-tetrahydroxystil bene-2-O- -D-glucosde was 98.3% with RSD1.16%.Conclusion The identification method is repeatable and specific, and the quantitative determination method is sim-ple and accurate, which can be used for the quality control of Yansheng capsules. References | Related Articles | Metrics

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Management of the Prescription and Non-Prescription Drugs Classification in EU LIU Jing-jie, YANG Yue 2014, 11(8): 472-477.  Abstract ( 439 )   PDF (704KB) ( 320 )   ObjectiveTo make suggestion to regulatory authorities on the management of the classification, by exploring the classification framework of prescription and non-prescription drugs in EU, and analyzing the main regulatory areas and the change of classification of a medicinal product. MethodsLiterature study was used to research the experience of EU's management, then use the comparative study to analyze the differences. ResultsEU has rounded classification system, brilliant supporting measures and strict supervision of major field, which are worth reference. ConclusionWe need further improvement in the regulatory system, labeling, advertisement, supporting measure and switching. References | Related Articles | Metrics

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Overview of Pharmacovigilance Inspection in UK DONG Duo, WU Gui-zhi, WANG Dan, FENG Hong-yun, WANG Ya-li, CHENG Gang 2014, 11(8): 478-481.  Abstract ( 470 )   PDF (667KB) ( 263 )   To promote pharmaceutical manufacturer, the first person for products safety to undertake post-marketing surveillance responsibility,UK initiated pharmacovigilance inspection programme in 2003, and now it formed a set of complete inspection system.This article introduced pharmacovigilance inspection type, process, findings and so on in UK, and proposed recommendation on adverse drug reaction report and monitoring inspection responsiblity division, guideline, self-checking indicatior system and information communication. References | Related Articles | Metrics

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Research Development on Toxicity of Psoralea corylifolia L. Related to Efficacy and Chemical Material Basis ZHAO Qing-hua, SUN Rong 2014, 11(8): 482-484.  Abstract ( 285 )   PDF (578KB) ( 425 )   ObjectiveTo provide literature evidence and research ideas for determining the correlation of efficacious and toxic substance basis as well as the correlation of its efficacy and toxicity of Psoralea corylifolia, making safety standards, and studying its toxicity based on its efficacious substance basis. MethodsReferences in old days and last decades at home and abroad about Psoralea corylifolia were collated, analyzed and summarized. ResultsThe references in old days were lacking in the records of toxicity of Psoralea corylifolia. The recent researches were confined to the isolated aspect such as pharmacology, toxicology, chemical constituents and lacked the correlations of efficacy, toxicity and material basis. Consequently, blameless safely using standards should be made based on efficacy and material basis, and insure that its toxicity could be scientifically controlled. ConclusionOnly study Psoralea corylifolia's toxicity and control safely the toxic material basis during the expression of effectiveness and the separation and quality controlling of efficacious material basis, could we put forward early-warning scheme and treatment measures of adverse reaction in clinical usage, so as to ensure the safe use of Psoralea corylifolia as a clinical drug. References | Related Articles | Metrics

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Risk Analysis and Measures of Toxic Epidermal Necrosis Caused by Allopurinol LIANG Xiao-Dong, Zhang Li JIA, Zhi-Dan WEI, Huai-Ling ,BAO Xiu-Qi, ZHANG Dan ,SUN Hua 2014, 11(8): 485-487.  Abstract ( 252 )   PDF (676KB) ( 199 )   By analyzing clinical symptoms and pathogenesis of toxic epidermal necrolysis induced by allopurinol, various risk factors of its toxic epidermal necrolysis were discussed including age, sex, liver and kidney dysfunction, daily dose and duration of use, drug interactions, and special populations, et al. Measures to control serious adverse reactions were proposed. It hopes to provide references for clinical safe use of allopurinol, effective prevention and control of its harm. References | Related Articles | Metrics

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Preliminary Study of Risk Management Mode of New Drug Clinical Trials in China XUE Wei ,DONG Fan ,LI Ke-Xin 2014, 11(8): 488-491.  Abstract ( 539 )   PDF (585KB) ( 542 )   Objective To provide references for establishment and implementation of risk management in new drug clinical trials, from the perspectives of investigators. Methods General modes and constructions of risk management were analyzed, and regulations and principles for drug risk management in developed country were used for comprehensive references. Moreover, the present situation of drug risk management in clinical trial in China was discussed. Results and Conclusion Based on the preliminary exploration, we proposed the new risk management mode for clinical trials of new drugs suitable for China. References | Related Articles | Metrics

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Signal Detection Methods Based on False Discovery Rate of Adverse Drug Reaction GUO Xiao-jing, YE Xiao-fei ,ZHANG Xiao ,XU Jin-fang, HE Jia 2014, 11(8): 492-494.  Abstract ( 246 )   PDF (549KB) ( 259 )   Conventional signal detection methods based on disproportionality analysis are playing an important role in the process of signal detection of adverse drug reaction. However, these methods have their own drawbacks and the detection results are influenced greatly by the multiple hypothesis testing. These problems should be solved through new analysis strategy. In this article, we present the impact of multiple hypothesis testing on the signal detection and introduce the false discovery rate (FDR) methods that should solve the problem. References | Related Articles | Metrics

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Quality Risk Management in Production of Black Plaster GUO Xin-miao 2014, 11(8): 495-497.  Abstract ( 257 )   PDF (562KB) ( 412 )   This paper introduces the concept, advantages and applied principles of hazard analysis and critical control point(HACCP). HACCP was applied in production of black plaster to carry out quality risk management of black plaster. 11 critical control points were obtained by hazard analysis of the production process of black plaster. Some measures such as control of critical control point, confirmation of key limit value, implementation of the preventive measures were taken to carry out quality risk management of black plaster. References | Related Articles | Metrics

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Clinical Pharmacists Participating in the Treatment of Lung Infection and Delayed Diabetes Insipidus after Traumatic Brain Injury ZHOU Yi, TAN Lu, ZHANG Hui, LI Huo-ping, XU Chun-lin 2014, 11(8): 498-500.  Abstract ( 222 )   PDF (582KB) ( 150 )   Objective To investigate the method of individualized medication and pharmaceutical care for patient with lung infection and delayed diabetes insipidus. Methods Pharmacists participated in a case of postoperative cerebral trauma treatment, made the lung infection and delayed diabetes insipidus as a therapeutic breakthrough, used pharmaceutical knowledge for pharmaceutical intervention and pharmaceutical care. Results With the clinical pharmacists'active participation in pharmaceutical care, doctors successfully treated the patient. The doctors also had a new understanding of the medication plan for patient after brain trauma operation with pharmacists participating in the treatment. Conclusion It is necessary for clinical pharmacists to participate in clinical treatment, making individualized treatment plan for the patients, which can effectively promote the rational clinical drug use, ensure the drug safety,and improve the medication level. References | Related Articles | Metrics

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Clinical Pharmacists Participating in Drug Analysis and Adjustment for a Patient with Drug-induced Liver Injury HUANG Hai-hua, DENG Ang, KONG Xu-dong, TANG Kun 2014, 11(8): 501-503.  Abstract ( 204 )   PDF (601KB) ( 162 )   ObjectiveTo provide reference for nephrology clinical pharmacist participating in the therapy for a patient with drug-induced liver injury. MethodsClinical pharmacists participated in analysis and adjustment of therapeutic scheme for a patient with drug-induced liver injury. In consideration of the characteristics of the patient,such as the age, nephrotic syndrome with hypokalemia and miliary tuberculosis, it is suggested that physician discontinued the suspicious drugs and adjusted the liver protective drugs. ResultsTaking the characteristics of the patient into consideration, clinical pharmacists assisted physician actively to provide reasonable drug therapy scheme for patient from drug interaction and adverse reaction. The liver function of the patient recovered after treatment. ConclusionClinical pharmacist in nephrology department participating in clinical practice can play advantages from the perspective of pharmacy to optimize therapeutic scheme. References | Related Articles | Metrics