Archive

08 October 2014, Volume 11 Issue 10 Previous Issue    Next Issue
---
英文栏目



For Selected:

Download Citations EndNote Ris BibTeX

Toggle Thumbnails

Select

WANG Ying-ting (First People Hospital of Jining, Shandong Jining 272000, China) 2014, 11(10): 577-579.  Abstract ( 244 )   PDF (505KB) ( 154 )   Objective To study the acute toxicity of the pH-triggered Jie-chang-ning colon-targeted pellets to mice, provide important basic data for further safety evaluation. Methods On the basis of the acute toxicity pre-experiment, the maximum daily dosage test was finished.40mice were randomly divided into drug-treated, control groups. The drug-treated mice were administrated orally with the pH-triggered Jie-chang-ning colon-targeted pellets with intragastric volume40mL·kg-1·d-1. The clinical responses were observed. The mice weight on the1st, 7th, 14th day, was weighed, compared. The viscera index of liver, kidney, spleen was compared on the14th day. Results The mice didn't die in the acute toxicity experiment, but erect hairs, slight tremor body, dull, hunger, frequent defecation, pale retina appeared. The half lethal dosewasn't determined. The viscera index of liver, kidney, spleen wasn't significantly different between the drug-treated, the control groups. The maximum daily dosage was78.496g·kg-1·d-1, which was237.9~314.0times of adult people. Conclusion The maximum daily dosage was more than100times dose of adult people, which explains the pH-triggered Jie-chang-ning colon-targeted pellets is safe within the recommended dosage range. The symptoms in the mice acute toxicity explain that side effects maybe appear for excessive use References | Related Articles | Metrics

Select

Comparative Study on the Clinical Effects of Risperidone and Modified Electroconvulsive Therapy for Refractory Schizophrenia YAO Shi-xiong, TAN Wei 2014, 11(10): 580-583.  Abstract ( 239 )   PDF (506KB) ( 206 )   Objective To study the clinical effects of risperidone and modified electroconvulsive therapy for refractory schizophrenia. Methods 104 patients with refractory schizophrenia in our hospital from October 2012 to October 2013 were selected, randomly divided into the observation group and the control group with 52 cases for each one. Modified electroconvulsive therapy was used in the observation group. Risperidone was used in the control group. Results Observation showed that TESS score and efficiency during treatment had no significant difference (P>0.05). After treatment, PANSS scores of two groups were better than before (P <0.05). But PANSS scores of observation group in 2 week and 4 week were better than control group (P <0.05). The cost of treatment was also better than control group (P <0.05). Conclusion These results show that risperidone and modified electroconvulsive therapy for refractory schizophrenia have the equal efficacy and safety, but the speed of onset and treatment cost of modified electroconvulsive therapy have advantages. References | Related Articles | Metrics

Select

Experimental Study on "Dose-time- efficacy" Relationship of Blood Pressure Induced by Aconite Water Extract LI Xiao-yu, ZHAO Qing-hua, LV Li-li, WANG Yi, YAN Min, SUN Rong 2014, 11(10): 584-586.  Abstract ( 208 )   PDF (598KB) ( 92 )   ObjectiveTo study the influences of "dose-time-efficacy" relationship on normal rat blood pressure from a single administration of Aconite water extract in pharmacopoeia dose. MethodsThe 5 different Aconite water extract doses of 1.35, 1.08, 0.81, 0.54, 0.27 g·kg-1 (which correspond in the pharmacopoeia Aconite dose 15, 12, 9, 6, 3 g) were prepared, and rats were given Aconite water extract by gavage respectively. Changes of rat blood pressure according to different time and dose were observed in 15, 30, 60, 90, 120 min respectively by BP-100A automatic non-invasive blood pressure measurement system. And the ED50 of Aconite water extract was tested. ResultsThe "dose-time-efficacy" relationship showed that: compared with normal group, the changes of blood pressure in rat were increasing marks from 15 min to 120 min. The systolic pressure in five dose groups hit the peak in 30 min and Aconite water extract high dose (1.35g·kg-1) is the largest. In 120 min, the systolic pressure in five dose groups were basically back to the front of the gavage. The diastolic blood pressure of rats by Aconite water extract was increasing marks from 15 min to 120 min to some extent. The ED50 and its 95% confidence limit of Aconite water extract were 0.1474 (2.3411~0.3482) g·kg-1. ConclusionAconite water extract in the pharmacopoeia dose range elevates rats systolic blood pressure, and there is a certain relationship of "dose-time-efficacy": higher dose, greater pressor effects and longer action time. References | Related Articles | Metrics

Select

Relevance Evaluation Research about Toxicity and Efficacy of the Influence on the Rats' Cardiac Function with Medicated Serum from Aconite Water Extract SUN Rong, YAN Min, WANG Yi, FENG Qun, Li Xiao-yu 2014, 11(10): 587-591.  Abstract ( 221 )   PDF (713KB) ( 159 )   ObjectiveTo study the influence of cardiac function with the drug serum in Aconite water extract and explore the correlation between efficacy and toxicity of Radix Aconite. MethodsTake the myocardial perfusion experiment named Langedorff to observe the changes of cardiac output and myocardial contractility in isolated heart with different doses from pharmacopoeia prescribed doses to high doses. ResultsThe cardiac output and myocardial contraction force of isolated heart could be significantly increased with the pharmacopoeia prescribed doses' medicated serum, and the increase amplitude was connected with doses obviously. But in large doses, the cardiac output and cardiac muscle contraction force could not be increased much more. There were no significant changes in heart rate of all doses. ConclusionUnder the pharmacopoeia prescribed doses, the cardiac function of isolated heart could be increased with Aconite water extract and present a certain "dose-efficacy" relationship. But in large doses, the myocardial contraction force of isolated heart was insufficient and the cardiac output was decreased along with the increasing dose, and presented a certain "dose-toxicity" relationship. Therefore, the monitoring work of toxicity below the high doses should be paid attention to and the relevancy between efficacy and toxicity should be researched, so as to find a reasonable and effective dosage range, and to provide guidance for clinical safe drug use. References | Related Articles | Metrics

英文栏目

Select

Experimental Study on "Dose-time-toxicity" Relationship of Cardiotoxicity Induced by Multiple Doses Aconite Water Extract on Mice FENG Qun, LUAN Yong-fu, SUN Rong, YAN Min 2014, 11(10): 592-595.  DOI: DOI Abstract ( 233 )   PDF (580KB) ( 228 )   ObjectiveTo study the influences of "dose-toxicity" relationship and "time-toxicity" relationship of cardiotoxicity, through electrocardiogram (ECG) and serum biochemical indexes changes caused by multiple doses Aconite water extract on mice. MethodsMice were grouped according to different time or dose points, and given multiple doses of Aconite water extract by gavage respectively. Changes of ECG were observed. The ratio of heart, liver and kidney to body was measured, the contents of CK and LDH related to cardiotoxicity in serum were detected. ResultsThe "time- toxicity" relationship showed that the heart rate of mice dropped 24 hours later of administration compared with normal group. The duration of P extended and the amplitude enlarged. P-R interval, QRS extended and QT interval reduced. Cardiac index decreased while the contents of CK and LDH increased. All changes of them were more statistically significant 48 hours later. The "dose- toxicity" relationship showed that the heart rate of mice and the contents of CK and LDH in serum elevated. P-R interval, QRS and QT interval extended and the length of QT interval was inversely proportional to heart rate. Cardiac index decreased and there was no significant change of liver index and kidney index among different groups. All changes of them showed a dose dependent manner. ConclusionAconite water extract which is gavaged with a single dose to mice can cause cardiotoxicity and there is a certain relationship of "dose-time-toxicity". However the mechanism of cardiotoxicity will obviously require further investigation. References | Related Articles | Metrics

Select

Research on the Dissolution Profiles of Rosuvastatin Calcium Tablets CAI Yin, MIAO Yan, WU Li, ZHOU Zhi-liang, ZHU Jin-lian, SHEN Xiao-feng 2014, 11(10): 596-600.  Abstract ( 300 )   PDF (569KB) ( 303 )   ObjectiveTo establish the dissolution method of rosuvastatin calcium tablets. MethodsColumn: Agilent Extend C18 (4.6×250 mm, 5 μm), eluted with acetonitrile and 0.02% TFA in gradient mode. The ratio of acetonitrile kept 37% in 13 min and increased to 90% from 13~27 min at a flow rate of 1.0 mL·min-1 when the detective wavelength was set at 242 nm, plus the rosuvastatin and (3S, 5S)-rosuvastatin calcium peak area to calculate the cumulative release amount (%). ResultsRosuvastatin calcium was instabile in pH 1.0 hydrochloric acid solution and degraded to (3S, 5S)-rosuvastatin calcium, rosuvastatin-5S-lactone and rosuvastatin-5R-lactone, when treated with alkali and regenerated to rosuvastatin and (3S, 5S)-Rosuvastatin calcium, also the dissolution profile of rosuvastatin calcium tablets in pH1.0 hydrochloric acid solution was the slowest one. ConclusionThe dissolution profile of rosuvastatin calcium tablets in pH 1.0 hydrochloric acid solution can be used as the basis for formulation screening. References | Related Articles | Metrics

Select

Study on Extraction Process of White Peony Root and Scutellaria Radix from Yingui Kangxian Tablets LI Jing, ZHAO Yu-jun, ZOU Jian-fang 2014, 11(10): 601-605.  Abstract ( 186 )   PDF (570KB) ( 117 )   Objective To optimize the extraction process of white peony root and scutellaria radix in Yingui kangxian tablets. Methods Taking the concentration and consumption of ethanol, extraction times, extraction time as factors, the paeoniflorin content as index, the L9(34) orthogonal test was adopted to optimize alcohol extraction of seven Chinese herbs including white peony root. Taking the amount of water,extraction times,extraction time as factors,with the baicalin content as evaluation, orthogonal test was similarly adopted to optimize water extraction process of six Chinese herbs. Results The best alcohol extraction conditions with white peony root were as follows: extracted three times with ten times the amount of 75% ethanol, 1.5 hours per time. Optimum water extraction conditions with scutellaria radix were as follows: extracted three times with eight times the volume of water, 2 hours per time. Conclusion Optimized extraction process was stable and feasible, which could provide a reference for rational development of Yingui kangxian tablets. References | Related Articles | Metrics

Select

Study on Mode of Drug Standard in America GAO Jing, LIU Si-qi, YANG Yue 2014, 11(10): 606-610.  Abstract ( 259 )   PDF (738KB) ( 247 )   ObjectiveTo provide references for establishing Chinese drug standard management system. MethodsThe mode of drug standard in America was briefly introduced. The managerial experience and features of maintaining the authority, scientificity and progressiveness of drug standard were explored and some revelations were put forward. ResultsThe USA has basically developed the perfect drug standard management system. The robust legal system defines USP-NF as the authority of drug standard. The scientific management by United States Pharmacopeial Convention, transparency and communication with the public and participation of enterprises ensure the scientificity of standard. Flexible Accelerated Revision Processes and USP Monograph Update Program involve stakeholders to join in the revision activities of drug standard, thus ensuring the progressiveness of drug standard. ConclusionWe should bring in advanced management concept, improve related laws and regulations, drug standard establishment and revision process and introduce public review mechanism as well as intensify the main position of enterprises in standardization activities, thus establishing drug standard management system which conforms to national conditions. References | Related Articles | Metrics

Select

Introduction of Management and Reporting of Adverse Reactions to Medicinal Products in European Union DONG Duo, LIU Wei, YANG Le, LIU Cui-li, CHENG Gang 2014, 11(10): 611-613.  Abstract ( 296 )   PDF (633KB) ( 518 )   By introducing good pharmacovigilance prctice on management and reporting of adverse reactions to medicinal products in EU, it was more cleared to know the definition of adverse reactions and working process in EU, such ascollection of reports, validation of reports, follow-up of reports, data management, quality management.It provided the example and refrence for perfecting and developing drug adverse reaction reporting and monitoring system in China. References | Related Articles | Metrics

Select

Discussion on the Monitoring of the Adverse Reaction and the Risk Management of Essential Medicines LIU Cui-li, XIA Dong-sheng 2014, 11(10): 614-617.  Abstract ( 244 )   PDF (674KB) ( 135 )   References | Related Articles | Metrics

Select

Analysis of Status and Measures of Patient-reported Adverse Drug Reaction in China ZHENG Ming-jie WANG Chun-ting 2014, 11(10): 618-620.  Abstract ( 213 )   PDF (669KB) ( 260 )   ObjectiveTo understand the status of patient-reported ADR in our country, analyze the problems and reasons, and promote the patients to report ADR. MethodsLiterature review was used to understand the relevant provisions of patient-reported ADR, and to analyze the problems and reasons. Resultsand ConclusionLow cognition degree of ADR, distemperedness of relevant laws and regulations, deficient awareness of ADR report, suffocated report approach, and lack of compensation mechanism are related to the low proportion of patient-reported ADR. And further improvement measures are put forward. References | Related Articles | Metrics

Select

Investigation on the Current Situation of Adverse Drug Reaction Monitoring in Agricultural Reclamation of Heilongjiang Province CHEN Hao-qun, XIA Hong-bo, ZHAO Shi-dan, HU Chen-xia, JIANG Zhi-yuan 2014, 11(10): 621-623.  Abstract ( 238 )   PDF (703KB) ( 141 )   ObjectiveTo explore the intervention measures of the adverse drug reaction(ADR) monitoring in agricultural reclamation area of Heilongjiang province. MethodsOn the basis of literature research, a questionnaire survey on 2010~2012 ADR monitoring of the agricultural reclamation area medical institutions was conducted. ResultsThere were some issues in the ADR management system, medical staff training and the medical institutions, and ADR monitoring department of construction. ConclusionTo enhance the effective monitoring of the ADR in the agricultural reclamation area, the ADR monitoring management departments should be improved, the ADR monitoring system construction of the medical institutions should be given a guarantee, propaganda and training methods of adverse drug reactions should be innovated. References | Related Articles | Metrics

Select

Literature Analysis of Adverse Reactions Induced by Fat Soluble Vitamin Injections(Ⅰ)、(Ⅱ) LIU Gui-Ping, QI Tong-Zhen 2014, 11(10): 624-627.  Abstract ( 281 )   PDF (700KB) ( 197 )   Objective To explore the characteristics and general features of adverse reactions induced by the fat soluble vitamin injections(Ⅰ)、(Ⅱ), and provide reference for rational clinical use of drugs. Methods To retrieval journals database from January 2001 to May 2014 by using keywords which are "fat soluble vitamin injections(Ⅰ) and (Ⅱ)" and "adverse reaction" reported in the literatures, then these results should be analyzed statistically. Results This paper includes 21 literatures and 23 cases. The fat soluble vitamins involve 2 varieties which are fat soluble vitamin (Ⅰ)and fat soluble vitamin(Ⅱ).The constituent ratio for patients aged 50 and above is the largest, accounting for 47.82%. The sex ratio of adverse reactions is 1: 1.09. Among adverse reactions, the allergic shock caused by the allergic reaction was the most(16 cases). The adverse reaction occurs mostly in the 1 ~ 15min, accounting for 56.52%. The adverse reaction involves the skin, respiratory, circulatory, nervous, digestive and other systems. Conclusion Adverse reaction for most of the fat soluble vitamins are allergic reactions (especially anaphylactic shock). Adverse reactions have nothing to do with the sex, relate with the age, history of allergies, and medication time. Therefore, we must ask the allergy history clinically, and pay attention to adverse reactions, especially adverse reactions in 15 minutes. When adverse reactions occur, we should deal with the problems in time and ensure security. References | Related Articles | Metrics

Select

Considerations on Clinical Study of Transcatheter Aortic Valve Implantation CHENG Mao-bo, SHI Xin-li, MIAO Jing-jing, LIU Wei, NIE Fei-long 2014, 11(10): 628-631.  Abstract ( 329 )   PDF (614KB) ( 297 )   Transcatheter aortic valve implantation for the patients suffering from severe aortic stenosis has emerged as a promising technique alternative to conventional surgical aortic valve replacement, the guidances of clinical study to evaluate the safety and efficacy of the products have not been drafted as so far. The recommendations which were drafted according to the existing clinical data and guideline for valvular heart disease and expert advice were introduced in the article in order to provide a guidance to manufacturers. Feasibility study to see if a larger pivotal study is practical and to refine the study protocol for the pivotal study was recommended firstly, the hypothesis of pivotal study was built in accordance with benefit-risk analysis, the aortic stenosis patients who cannot undergo surgery was preferentially treated in clinical trial. References | Related Articles | Metrics

Select

Clinical Trail of Diagnostic Reagents for IgM Antibody to Toxoplasma gondii LV Yun-feng 2014, 11(10): 632-634.  Abstract ( 213 )   PDF (672KB) ( 264 )   Objective To discuss the main points of clinical trails of diagnostic reagents for IgM antibody to Toxoplasma gondii. Methods Considering both the active regulations of IVD and the reagent's own characteristics, the feature of clinical trails of diagnostic reagents for IgM antibody to Toxoplasma gondii were analysised. Results Significant problems have been settled such as classification, study method, clinical trail scheme setup, sample selection, statistical analysis of results and reports composing. Conclusion Clinical trails of diagnostic reagents for IgM antibody to Toxoplasma gondii reagents should be carried out scientifically and focus on the accuracy and specificity, based on the active regulations and it's own clinical use. References | Related Articles | Metrics