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08 January 2015, Volume 12 Issue 1 Previous Issue    Next Issue

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Pharmacodynamical Study on 9 Component Compatibility of Processed Sanhuangxiexin Decoction GONG Lei-lei,YIN Xiao-jie,WANG Lan,XIAO Yong-qing,LI li,LIU Ying,YUAN Hui-jun,LIANG Ri-xin 2015, 12(1): 1-4.  Abstract ( 362 )   Objective To compare the pharmacodynamical actions of 9 component compatibility of processed Sanhuangxiexin decoction in terms of anti-inflammation, removing blood stasis and antipyretic effect, and the relationship between the composition and quantity ratio of chemical components from crude Raubarb, prepared Rhubarb and Rhubarb charcoal piece, based on the chemical composition compatibility of processed herbal pieces. Methods Rats were randomly divided into the following groups: control group, model group, positive medicine group(aspirin 0.2 g·kg-1) and 9 component compatibility groups. The dose for the rat was 0.5 g·kg-1 and 0.9 g·kg-1 for the mouse. All groups were treated continuously for 7 days. The acute blood stasis syndrome model was established by hypodermic injection of adrenalin combined with ice water bath. The indexes of hemorheology including whole blood viscosity, plasma viscosity, packed red cell volume, platelet aggregation and fibrinogen were detected under the different shear rate. The thrombin time and prothrombin time were examined. The mouse ear swelling model induced by dimethylbenzene was used to observe the anti-inflammatory action, the volume of the ear swelling was measured after the modeling, and the degrees of swelling (E%) and inhibiting(I%) were calculated. The rat fever model was made by hypodermic injection of 15% yeast saline, the temperature was measured at 0.5, 1, 2 and 4 h after administration. Results The component compatibility of No.7 group decreased the whole blood viscosity and plasma viscosity more significantly, and the obvious decrease of ear swelling rates was found in No. 2, 4 and 8 group when compared to other component compatibility groups. Conclusion Based on the Results , No.7 and 8 group were considered as optimal compatibility of the 9 groups. References | Related Articles | Metrics

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Acute Toxicity Experimental Study on Slightly Alkaline Embelin and Ammonia Solution Administered as Tail Vein Injection in Mic ZENG Xian-biao,MO Jie-ming,WEI Bao-wei,WEI Gui-ning,DENG Yu-yin 2015, 12(1): 5-7.  Abstract ( 347 )   Objective To study the acute toxicity reaction and to determine median lethal dose and its 99% confidence limit when mice received injection slightly alkaline embelin and ammonia solution from tail vein. Methods Mice received tail vein injection of slightly alkaline embelin and ammonia solution, pilot test was carried out to look for maximum 0% lethal dose and minimum 100% lethal dose. And then, twelve groups mice were injected slightly alkaline embelin and ammonia solution at 0.01 mL·g-1 from tail vein according to 1:0.8 geometric dilution, dose of each group was between minimum 0% lethal dose and maximum 100% lethal dose. Mice poisoning death in each group within 7 days after the treatment was observed. Dead mice were dissected to check primary organs. Median lethal dose and its 99% confidence limit were calculated. Results Mice mortality of the lowest dose group and the highest dose group was between 30% and 70%. There was approximate linear relationship between dosage logarithm and death probability unit, when tail vein injection dose was between 60 mg·kg-1 and 448 mg·kg-1. Median lethal dose and its 99% confidence limit were calculated by synthetic analyzing method. Conclusion With equivalent of embelin, mice received tail vein injection of slightly alkaline embelin and ammonia solution, median lethal dose was 153.525 mg·kg-1 and its 99% confidence limit was 153.525±40.815 mg·kg-1. References | Related Articles | Metrics

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Preventive Effect of Ondansetron,Droperidol,Dexamethasone and Combining the Latter Two on Postoperative Nausea and Vomiting from Continuous Sulfentany Analgesia in Cesarean Patients LI Li 2015, 12(1): 8-10.  Abstract ( 343 )   Objective To explore the preventive effect of ondansetron,droperidol,dexamethasone and combination of the latter two administered for postoperative nausea and vomiting from continous sulfentany analgesia in cesarean patients. Methods A total of 150 women scheduled for elective cesarean section under combined spinal-epidural anesthesia were randomly divided into five groups with 30 cases each. 10 mg dexamethasone was intravenously injected in group A while operation ended. 2.5 mg droperidol was added into sulfentany PCIA pump in group B. 4 mg ondansetron was added into sulfentany PCIA pump in group C. 1.25 mg droperidol was added into sulfentany PCIA pump plus dexamethasone 5 mg intravenous injection when operation ended in group D. Group E received 4 mL of normal saline when operation ended. All patients received postoperative pain control with sulfentany intravenous PCA. The nausea and vomiting and visal analogue pain scale at 1,6,12 and 24 h after operation were recorded. Results No significant difference was observed in the pain scales among the five groups.The assessment of nausea and vomiting showed that scoring in group E was higher than groups A,B,C and D (P <0.01), and in the groups A,B and C those were higher than the group D (P<0.05), while no difference among the groups A,B and C. Conclusion Ondansetron, droperidol and dexamethasone can prevent the incidence of nausea and vomiting during sulfentany analgesia,and it would be better when they were given by combining less droperidol into the PCIA pump of sulfentany and dexamethasone intravenous injection. Not only the amount of them is used less,but also complication is avoided and less expense is needed. References | Related Articles | Metrics

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Experimental Comparison Study on Acute Toxicity of Different Composition in Evodia Fructus on Mice with Stomach Cold-syndrome SUN Rong,HUANG Wei,YIN Li-shun,LI Xiao-yu,LV Li-li 2015, 12(1): 11-15.  Abstract ( 301 )   PDF (650KB) ( 242 )   Objective To compare the acute toxicity of water extraction components and volatile oil in Evodia fructus on mice of stomach cold-syndrome, making an observation and evaluation of acute toxicity to Evodia fructus herbs in the syndrome context in order to provide a experimental basis for safe and reasonable medication in clinic. Methods The method of stomach cold-syndrome model in mice was built by continuous swim, leading to exhaustion, and giving ice water mixture in the same time. Comparison of the acute toxicity of water extraction components and volatile oil in Evodia fructus on mice were studied in accordance with classical acute toxicity test Methods , and the experimental datas of LD50 and MTD are calculated by the Bliss method, with the continuous administration and observation for 14 days. Results Under the background of stomach cold syndrome, the LD50 of volatile oil of Evodia fructus is 2.75 mL·kg-1·d-1 and the 95% confidence interval is 2.66～2.86 mL·kg-1·d-1. The water extraction components of Evodia fructus are unable to make LD50, so the result of MTD was 160.0 g·kg-1·d-1 by calculating in accordance with crude drug content, which is equal to 2488.8 times of clinical daily dosage of 70 kg per kilogram of body weight. The main symptoms of acute toxicity in mice of stomach cold-syndrome are ennui energy, diarrhea, respiratory depression, and mice mostly died within 48 h after administration of volatile oil of Evodia fructus. Conclusion Different components of Evodia fructus could cause certain acute toxicity effect on mice with stomach cold-syndrome, and the volatile oil was with the greatest degree of toxicity, followed by the water extracted components. References | Related Articles | Metrics

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Research of Oxidative Damage Mechanism on Hepatotoxicity Caused by Volatile Oil from Evodia Fructus in Mice LI Xiao-yu,WU Xiao-wen,DOU Li-wen,YIN Li-shun,HUANG Wei,SUN Rong 2015, 12(1): 16-19.  Abstract ( 297 )   PDF (482KB) ( 184 )   Objective To investigate the relationship of oxidative damage mechanism on hepatic toxic injury caused by volatile oil from Evodia Fructus in mice. Methods Mice were administrated with volatile oil from Evodia Fructus for 7 days, and the high, middle and low dose groups were separately set 1.25, 1.0, 0.25 mL·kg-1. The level of MDA、SOD、NO、NOS、GSH、GSH-Px in serum and hepatic tissue were detected after administration of 7 d. Results The volatile oil from Evodia Fructus could cause the increased activity of MDA in serum and liver, reduced level of SOD, however, the level of NO and NOS were increased. In addition to the reduced activity of GSH and GSH-Px, all the changes were aggravated in accordance with the dosages. Conclusion The continuous administration of volatile oil from Evodia Fructus on mice can induce obvious hepato toxicity injury. The approach of hepatic damage is related with the peroxidative damage mechanism. References | Related Articles | Metrics

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Study on Chronic Toxicity of Volatile Oil from Evodia Fructus in Rats YIN Li-shun,LV Li-li,GONG Yan-sheng,LI Xiao-yu,HUANG Wei,SUN Rong* 2015, 12(1): 20-25.  Abstract ( 353 )   PDF (686KB) ( 165 )   Objective To observe the chronic toxicity damage and convalescence of the volatile oil components from Evodia Fructus in rats. Methods The volatile oil components with different doses from Evodia Fructus were separately orally given to rats, and the high, middle and low lose-group were separately 0.12, 0.06, 0.012 mL·kg-1·d-1 calculated by crude herbs. Besides the general conditions were observed ,the related indexes were detected, such as the routine control of blood,hepatic function,renal function,the metabolism condition of lipids and the glycometabolism indexes. The rats were dissected and the weight of heart, liver, spleen, lung, kidney, were precisely weighed and calculated the ratio of organ to body. The histopathologic examination of hepatic tissue was carried out. The remaining rats were not administrated, and recovered for 20 days, the recovery conditions of rats were observed, and the above indexes were also detected. Results The volatile oil components from Evodia Fructus with different doses could induce the body weight decreasing in rats,the level of alanine aminotransferase(ALT), aspartate aminotransferase (AST), alkaline phosphatase(ALP)and total protein(TPC) serum obviously increased, albumin (ALB) and the ratio of ALB to GLB in serum obviously decreased, the liver weight and the ratio of liver to body increased, and the hepatic tissue damage was obvious in the histopathologic examination of hepatic tissue. The above-mentioned changes gradually aggravated with dose increasing, and there was no obvious difference compared with control group. The influence on the content of total bilirubin (TBI), blood urea nitrogen(BUN), glucose(GLU), total cholesterol(CHO) and creatinine(Cr) was not obvious, and the hepatic toxicity degree had certain dose dependence relatonship. Except the ALT level of different doses group in the above indexes of recovered rats had significant difference compared with control group, as well as the AST level of high dose group also had significant difference, the other indexes had no significant difference. Conclusion The long term administration of volatile oil components from Evodia Fructus at certain dose in rats could induce obvious cumulative toxicity, and the mainly toxical injury sites were in liver, but after recovery period observation, the live injury was basically recovered. References | Related Articles | Metrics

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Determination of Catalpol,Verbascoside,Atractylenolide-I and Atractylenolide-Ⅲ in Dangshen Yangrong Pills by HPLC DENG Jia,CHEN Hua,JIN Wei-hua 2015, 12(1): 26-29.  Abstract ( 248 )   PDF (458KB) ( 260 )   Objective To establish a HPLC method for simultaneous determination of catalpol,verbascoside,atractylenolide-I and atractylenolide-Ⅲ in Dangshen Yangrong pills. Methods Chromatographic conditions concluded Hypersil C18(4.6 mm×200 mm,5 m) column with the mobile phase consisting of acetonitrile-0.1% phosphoric acid solution in gradient elution mode at the flow rate of 0.9 mL·min-1.The detection wavelengths were 210,210,276,276 nm respectively.Results Catalpol,verbascoside,atractylenolide-I and atractylenolide-Ⅲ in Dangshen Yangrong pills had good linearity in the ranges of 0.0586～1.1720 μg(r=0.9997),0.0124～0.2480 μg(r=0.9992),0.0106～0.2120 μg(r=0.9994),0.0172～0.3440 μg(r=0.9996) respectively. The average recoveries of four constituents were 97.85％(RSD=1.13％),96.71％(RSD=0.77％),97.55％(RSD=1.22％) and 98.01％(RSD=1.04％) respectively. Conclusion This method is simple, accurate, repeatable and can be used for the quality control of Dangshen Yangrong pills. References | Related Articles | Metrics

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Analysis of the Law and Policy Framework for Use of Electronic Health Data in FDA's Sentinel Initiative SHEN Lu 2015, 12(1): 30-33.  Abstract ( 326 )   PDF (528KB) ( 221 )   Objective To analyze the law and policy framework for use of electronic health data in FDA's Sentinel Initiative to give some suggestions and help for post-marketing drug safety surveillance, especially active safety surveillance, in China. Methods This article studies the sentinel data model, and summarizes how the initial pilot phase of the FDA's Sentinel Initiative, Mini-Sentinel, is being conducted in compliance with applicable federal and state laws. Results FDA is successful in building a good operation model: based on privacy and public trust, FDA established a distributed data system and asked all the participants to obey the mandatory policies and procedures to assure the fairness. Conclusion The privacy and public trust is the premise of drug safety surveillance. The mandatory policies and procedures are the base of implementing surveillance practices. The efficient data model is the tool and way of surveillance operation. References | Related Articles | Metrics

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American Consumer Behavior Studies in RX-OTC Switch and the Inspirations to Our Country XU Mei-ting,XUE Yun-li,YANG Yue 2015, 12(1): 34-37.  Abstract ( 249 )   PDF (493KB) ( 323 )   Objective To provide a new "people-oriented" thinking on Rx-OTC switch review process for our country. Methods By studying consumer behavior studies in the U.S., introduce three research tools: label comprehension studies, self-selection studies, consumer actual use studies, compare these three tools and their relationship, summarize the importance of consumer behavior studies in Rx-OTC switch. Results Bringing consumer behavior studies into Rx-OTC switch contributes to pharmaceutical manufactarers on drug switch, and thus as a new OTC status in the market. Conclusion American "people-oriented" new thinking is worth concerning seriously for our regulatory review division and pharmaceutical manufactarers. References | Related Articles | Metrics

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Contents and study of Regulated Product Submission ZHANG Shi-qing,LU Jing-yan,MIN Yue,WANG Yong-an 2015, 12(1): 38-40.  Abstract ( 330 )   PDF (582KB) ( 310 )   RPS is a message standard that can be used for the electronic submission of product information between a company and a regulatory agency for the purpose of gaining market authorization. Based on the lately progress of RPS, this article introduces the background, contents and purpose of RPS, and the positive promoting effect was discussed for the development of future medical device, evaluation and administration from medical device industry, international trade integration, reforming current evaluation and approval system, and constructing informationized administration in China. References | Related Articles | Metrics

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Analysis of Adverse Drug Reactions about Cardiovascular System Caused by Azithromycin LI Zong,SHEN Xiao-hua,WU Ze-han 2015, 12(1): 41-44.  Abstract ( 351 )   PDF (567KB) ( 269 )   Objection To explore the characters of the adverse reactions/events about cardiovascular system caused by azithromycin. Methods 1 321 reports of the adverse reactions/events about cardiovascular system caused by azithromycin were analyzed via retrospective study. Results Azithromycin may lead to adverse reactions such as palpitations, chest tightness, tachycardia,etc. The risk of intravenous delivery was dominant. The adverse reactions about cardiovascular system occurred within 30 min. Conclusion It is necessary to reevaluate the risk of azithromycin for specific populations of safety and adverse effects about cardiovascular system. On this basis, modify the drug instructions and make the necessary warning for the safety of its intravenous administration. References | Related Articles | Metrics

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Analysis of 409 Reports of Adverse Drug Reactions Caused by Vidarabine Monophosphate Injection WANG Li,LI Qiang 2015, 12(1): 45-48.  Abstract ( 373 )   PDF (687KB) ( 223 )   Objective To study the general pattern and characteristics of adverse drug reactions induced by vidarabine monophosphate injection to provide references for clinical rational use of drug. Methods 409 cases of ADR related to the vidarabine monophosphate injection from January 2004 to July 2014 in Henan province were analyzed using retrospective study method.The drug instructions of two domestic pharmaceutical enterprises were compared. Results Among 409 reports, children aged 14 years old accounted for 88.02%, but there was no children informations in the drug instructions. 215 cases of drug combination accounted for 52.57%, and the combination species were focused on antibiotics(68.38%). The main ADR was damage to skin and its attachment(56.55%), and the major clinical manifestations were skin rashs(44.40%), itching(5.69%), etc, and there was no warning of these in the drug instructions. Conclusion It's important to pay attention to the ADR caused by vidarabine monophosphate injection, and perfect drug instuctions, in order to improve rational use of medicines in clinic, ensure clinical medication safety. References | Related Articles | Metrics

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Meta-analysis of Adverse Reactions of Bromhexine ZHANG Wei,ZHANG Mei-xiang,TAN Lu,WANG Qu,WANG Shu-ping 2015, 12(1): 49-52.  Abstract ( 316 )   PDF (625KB) ( 351 )   Objective To preliminarily evaluate the safety of bromhexine in domestic application. Methods CNKI, VIP and WanFang database were retrieved, and randomized controlled trials involving bromhexine were included. Meta-analysis for adverse reaction rates of bromhexine was performed by using RevMan5.1. In addition, subgroup analysis including different formulations (injections and tablets), different indications (pneumonia and bronchitis) and different controlling measures (conventional measures and other medications) were performed according to PRISAM guidelines. Results Ten RCTs which involved 1987 patients met the inclusion criteria. The experimental group showed higher adverse reaction incidence than controlling group[OR=4.42, 95%CI(2.55, 7.66), P ＜0.00001], the difference was statistically significant. This difference also exists in each subgroup analysis: injection subgroup (OR=4.41, 95%CI[2.35, 8.28]); tablets subgroup(OR=4.44, 95%CI[1.44, 13.68]); pneumonia subgroup(OR=4.41, 95%CI[3.25, 8.28], P＜0.00001); bronchitis subgroup(OR=4.1, 95%CI[1.22, 13.79], P =0.02); conventional measures subgroup(OR=5.92, 95%CI[2.71, 12.91] P ＜0.00001); other medications subgroup(OR=2.96, 95%CI[1.34, 6.53], P=0.007). Conclusion Bromhexine treatment exhibits higher adverse reaction incidence than other treatment, and this risk should be concerned in clinical use, but the Results need more high-quality randomized controlled trials to testify. References | Related Articles | Metrics

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A Preliminary Study on Establishing the Set of Terms for Coding Clinical Trials of TCM Based on MedDRA Terminology LI Qing-na,LU Fang,ZHAO Yang,GAO Hong-yang,GAO Rui 2015, 12(1): 53-55.  Abstract ( 421 )   PDF (586KB) ( 551 )   MedDRA is a widely used coding dictionary for international medical terminology. Since part of TCM terminology has its different naming and connotation from the western medicine, the current MedDRA terminology cannot meet the demand of coding clinical trials of TCM. This article will preliminarily discuss on how to establish the set of terms for coding clinical trials of TCM based on MedDRA terminology. References | Related Articles | Metrics