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08 December 2015, Volume 12 Issue 12 Previous Issue    Next Issue
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Influence of Different Extraction Methods on Acute Toxicity and Toxicity Target Organs of Herba Leonuri in Mice LV Li-li, ZHAO Hong, LI Shi-min, HUANG Na-na, SUN Xiao-qian, LI Xiao-yu, SUN Rong 2015, 12(12): 705-710.  Abstract ( 301 )   PDF (818KB) ( 188 )   ObjectiveTo study the influence of water and alcohol extracting process from Herba Leonuri on acute toxicity and the damage degree of toxicity target organs. MethodsUV spectrophotometry was used to measure the content of total alkaloids and the method of acute toxicity was used to compare the difference of acute toxicity between different extracting processes, and recording its toxic symptoms, cumulative mortality and weight change in mice. Seven days after administration, blood was taken and the contents of serum biochemical indicators were detected while the liver and kidney were taken for organ coefficient. ResultsThe contents of total alkaloids in alcohol extracts and water extracts from Herba Leonuri were separately 0.82% and 0.50%. The LD50 of alcohol extracts from Herba Leonuri is 118.68 g·kg-1,which is equal to 276.9 times of 70 kg human daily dried medicinal herb dose. The 95% confidence interval is 112.84~124.89 g·kg-1, which is equal to 263.3~291.4 times of 70 kg human daily dried medicinal herb dose. The MTD of water extracts form Herba Leonuri is 88.0 g·kg-1, which is equal to 205.3 times of 70 kg human daily dried medicinal herb dose. Alcohol extraction and water extraction from Herba Leonuri all could lead to significant increase (P<0.001) of mice's BUN and Cr levels. Kidney coefficient increased significantly, compared with normal control group, the statistical tests showed varying degree difference. Compared with water extract, the BUN and Cr levels in group 1~4 of alcohol extraction increased (P>0.05). Kidney coefficient increased significantly, and the statistical test showed that only group 1 of alcohol extraction had very significant difference. The group 1 and 2 of alcohol extraction and water extraction from Herba Leonuri showed increased ALT and AST. Compared with normal control group, the statistical tests showed the varying degree difference. Group 1 of alcohol extraction could lead to liver coefficient increase which showed very significant difference (P<0.01). Compared with water extract, the ALT level and liver coefficient of group 1 of alcohol extraction showed very significant difference(P<0.01). Liver and kidney pathology showed that there were no obvious pathological changes in liver and kidney tissues of mice. ConclusionAcute toxicity test showed that the toxicity target organs of Herba Leonuri were mainly kidney and liver. It proved that the BUN and Cr levels significantly increased, the ALT and AST levels increased, liver and kidney coefficients increased. The toxicity of kidney was higher than that of liver, and the toxicity of alcohol extract is higher than that of water extract. Combined with assay data of alcohol and water extracts from Herba Leonuri, it is suggested that the toxicity of Herba Leonuri's extracts and total alkaloids content showed a certain correlation, and we need to further explore the correlation of total alkaloids and renal toxicity. References | Related Articles | Metrics

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Influence of Water Precipitating on Acute Toxicity and Toxicity Target Organs of Alcohol Extracts from Herba Leonuri in Mice SUN Ling, LI Xiao-yu, SUN Xiao-qian, DOU Li-wen, SHI Liang, ZHAO Hong, SUN Rong 2015, 12(12): 711-716.  Abstract ( 272 )   PDF (690KB) ( 120 )   ObjectiveTo study the influence of water precipitating on alcohol extracts from Herba Leonuri for acute toxicity and damage degree of toxicity target organs in mice. MethodsUV spectrophotometry was used to measure the content of total alkaloids and the method of acute toxicity was used to compare the difference of acute toxicity between different alcohol extraction processes, and its toxic symptoms, cumulative mortality and weight change in mice were recorded. Seven days after administration, blood was taken, the contents of serum biochemical indicators were detected, livers and kidneys were taken for organ coefficient. ResultsThe contents of total alkaloids in the alcohol extracts and water precipitated alcohol extracts of Herba Leonuri were separately 0.82% and 0.65%. The LD50 of alcohol extracts from Herba Leonuri is 118.68 g·kg-1, which is equal to 276.9 times of human daily dried medicinal herb dose. The 95% confidence interval is 112.84~124.89 g·kg-1, which is equal to 263.3~291.4 times of human daily dried medicinal herb dose. The MLD of water precipitated alcohol extracts from Herba Leonuri is 433.20 g·kg-1, which is equal to 1 010.8 times of human daily dried medicinal herb dose. The alcohol extracts and water precipitated alcohol extracts of Herba Leonuri all could lead to significant increase (P <0.001) of mice's BUN and Cr levels. Compared with normal control group, kidney coefficient increased significantly, and the statistical tests showed varying degree difference. Compared with water precipitated alcohol extracts of Herba Leonuri, the BUN and Cr levels increased in group 1~4 of alcohol extracts, and the statistical tests showed varying degree difference. Kidney coefficient increased significantly, and the statistical tests showed varying degree difference. The group 1~2 of alcohol extracts and water precipitated alcohol extracts from Herba Leonuri could result in increased ALT and AST. Compared with normal control group, the statistical tests showed the varying degree difference. Group 1 of alcohol extracts could lead to liver coefficient increase which showed very significant difference (P <0.01). Compared with water precipitated alcohol extracts of Herba Leonuri, the ALT and AST levels and liver coefficient in group 1~2 of alcohol extracts increased. The statistical tests showed the varying degree difference. Liver and kidney pathology showed that there were no obvious pathological changes in liver and kidney tissues in mice. ConclusionAcute toxicity test showed that the toxicity target organs of Herba Leonuri were mainly kidney and liver. It proved that BUN and Cr levels significantly increased, ALT and AST levels increased, liver and kidney coefficients increased. The toxicity of kidney was higher than that of liver, and the toxicity of alcohol extract is higher than that of water precipitated alcohol extract. Combined with assay data of alcohol extract and water precipitated alcohol extract from Herba Leonuri, it is suggested that the toxicity of Herba Leonuri's extracts and total alkaloids content showed a certain correlation. Alcohol extracts with water precipitating can reduce toxicity significantly and the content of total alkaloids. Maybe water precipitating can remove the lipid soluble impurities which is also the toxic components of Herba Leonuri. But the specific toxic substances need to be further studied. References | Related Articles | Metrics

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Influence of Alcohol Precipitating on Acute Toxicity and Toxicity Target Organs of Water Extracts from Herba Leonuri in Mice SUN Xiao-qian, HUANG Na-na, YIN Li-shun, LI Xiao-yu, LV Li-li, ZHAO Hong, SUN Rong 2015, 12(12): 717-721.  Abstract ( 289 )   PDF (620KB) ( 194 )   Objective To study the influence of alcohol precipitating on water extracts from Herba Leonuri for acute toxicity, the damage degree of toxicity target organs in mice. Method UV spectrophotometry was used to measure the content of total alkaloids, the method of acute toxicity was used to compare the difference of acute toxicity between different water extracting processes. The toxic symptoms, cumulative mortality, weight changes of mice were recorded. Seven days after administration, blood was taken, the contents of serum biochemical indicators were detected while the liver, kidney were taken for organ coefficient. Results The contents of total alkaloids of Herba Leonuri in water extracts, alcohol precipitated water extracts were separately0.50%, 0.27%. MTD of water extracts, alcohol precipitated water extracts were88.0g·kg-1, 187.5g·kg-1, which were respectively equal to205.3, 437.5times of70kg human daily dried medicinal herb doses. There was one mouse died in each group. Compared with normal control group, the water extracts, alcohol precipitated water extracts from Herba Leonuri all could lead to significant increase of mice's BUN, Cr levels, kidney coefficient increased significantly. Compared with alcohol precipitated water extracts, the BUN, Cr levels of water extract group increased, kidney coefficient increased significantly. Compared with normal control group, the ALT, AST levels of water extract group increased. Alcohol precipitated water extracts could lead to AST level increasing, liver coefficient increased. Compare with alcohol precipitated water extracts, the ALT, AST, liver coefficient of water extract increased. Liver, kidney pathology showed that there were no obvious pathological changes in the liver, kidney tissues of mice. Conclusion Acute toxicity test showed that the toxicity target organs of Herba Leonuri were mainly kidney, liver. It proved that BUN, Cr levels significantly increased, ALT, AST levels increased, liver, kidney coefficients increased. The toxicity of kidney was higher than that of liver, the toxicity of water extract was higher than alcohol precipitated water extract. Combined with assay data of water extract, alcohol precipitated water extract from Herba Leonuri, it is suggested that the toxicity of Herba Leonuri's extracts, total alkaloids content showed a certain correlation. The toxicity, content of total alkaloids significantly decreased through alcohol precipitating process. Maybe alcohol precipitating process removed water soluble impurities, but the material base is still to be further studied References | Related Articles | Metrics

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Research Progress on Pharmacology and Toxicology in Alkaloid of Leonurus ZHAO Hong, LI Shi-min, DOU Li-wen, YIN Li-shun, SUN Xiao-qian, LI Xiao-yu, SUN Ling, SUN Rong 2015, 12(12): 722-726.  Abstract ( 315 )   PDF (487KB) ( 452 )   ObjectiveTo provide references for rational use of drugs by summarizing and analyzing the study of pharmacology and toxicology in alkaloid of Leonurus. MethodsThe literatures which were published in the last twenty years were sorted, concluded and analyzed. ResultsAlkaloid of Leonurus has regulation of uterus, hemostasis, anti-inflammation and analgesia, diuresis and other pharmacological effects, which has good effect on postpartum hemorrhage of eutocia and caesarean secion. However clinical ADR and renal toxicity report showed that long-term use can cause liver and kidney damage and other toxic side effects. ConclusionThe total alkaloids from Leonurus containing drugs involve capsules and injections. Paying attention to toxic side effects and target mechanism in the process of drug efficacy study will provide data supporting for early warning method of clinical adverse reactions and scientific measures and provide beneficial reference of clinical safe medication of Herba Leonuri preparation. References | Related Articles | Metrics

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Construction and Practice of Early Warning System Sharing Platform on Cluster Adverse Drug Events FENG Hong-yun, GE Wen-chao, XIA Xu-dong, LU Chang-fei, LV Xiao-qin, LIN Yan-fen 2015, 12(12): 727-730.  Abstract ( 352 )   PDF (629KB) ( 538 )   The characteristics of cluster adverse drug events are shown as multiple adverse drug events with similar clinical manifestations centrally occuring in the same drug of the same or adjacent batch number manufactured by the same manufacturer within a short-term period. By analysis and evaluation on cluster adverse drug events, it is determined whether cluster adverse drug event is constituted. The early warning system on the cluster adverse drug events, which has been built by the National Center for ADR Monitoring, China, has an important role to monitor, feedback rapidly and control the suspicious product quality events. However, the warning information, based on the national database of the ADR individual case reports, could not present on the provincial work interface simultaneously. So the events settlement between national center and provincial centers did not keep consistency and continuity. In order to deal with the problem, the early warning system sharing platform was designed and practiced in the national database of the ADR individual case reports. References | Related Articles | Metrics

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Research and Application of Adverse Drug Reaction Rapid Reporting and Intelligent Searching System Based on HIS DENG Jian-xiong, WANG Ling, CHEN Wen-ge, SHU Ting, ZHANG Ye-xiang 2015, 12(12): 731-734.  Abstract ( 312 )   PDF (663KB) ( 335 )   ObjectiveTo introduce the ADR rapid reporting and intelligent searching system which is based on HIS system with a purpose of setting up a information technology support platform for carrying out active monitoring of drug safety and evaluation, and improving traditional methods of drug safety monitoring and evaluation. MethodsThe ADR rapid reporting and intelligent searching system was established through the literature research and on the basis of in-depth business analysis and technology research, adopting J2EE, Enterprise Java Bean and other JAVA-based technology. And the system was carried on practical application in multiple medical institutions of Guangdong, Guizhou and other places for the purpose of testing and improving. ResultsThe development of ADR rapid reporting and intelligent searching system based on HIS significantly solved under reporting, misinformation, delay reporting and other issues of adverse drug reactions, achieved rapid reporting and intelligent searching functions, improved the hospital's ADR reporting rate and the reporter's initiative, and let the adverse drug reaction monitoring mode turn from the traditional "passive" to the "active". ConclusionThe ADR rapid reporting and intelligent searching system effectively enhances the capacity of drug post-marketing surveillance, and greatly improves the rational drug use in medical institutions, and it is of significant importance to strengthen drug safety monitoring and evaluation in our country. References | Related Articles | Metrics

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First Risk Minimization Program for Preventing Foetal Exposure of Revlimid in China ZHAN Xiao-jing，LI Min，ZOU Jian-jun，BWIRE Robert，LONDON Calvin 2015, 12(12): 735-739.  Abstract ( 450 )   PDF (600KB) ( 235 )   Objective To discuss the design, implementation, and the outcome from the first eighteen months of the Celgene product Revlimid project, RevCare . Methods RevCare was developed based on the global principles and requirements of Celgene RMP, and the unique medical practices in China. RevCare consists of 3 core elements. Meanwhile, i-access , a IT system, has been developed to serve as the database for RevCare , and also contributes to the compliance control of the program. Results Prescribers and pharmacists are key players in the program. The impact on their daily work brought by RevCare is considered as reasonable. The compliance rate of RevCare is high during the first eighteen months of implementation since the launch of Revlimid and there is no report of pregnancy related to the use of the drug. It suggests the effectiveness of the program in controlling the risk of Revlimid fetal exposure. Conclusion RevCare , the first PPP requires significant interaction and collaboration between Celgene with prescribers and pharmacists. The first eighteen months of implementation, general acceptance by the healthcare community and high levels of compliance suggest its effectiveness in minimizing risk of Revlimid fetal exposure, and consequently protecting the safety of Chinese patients in the need of medicine. References | Related Articles | Metrics

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Investigation on Work State of Adverse Drug Reaction Reporting in Some West Provinces ZHANG Xue-mei, GUO Jia-dong, FENG Bian-ling, YANG Shi-min 2015, 12(12): 740-743.  Abstract ( 374 )   PDF (604KB) ( 129 )   ObjectiveTo investigate the present situation of ADR monitoring of the reporting entities in some west provinces and analyze the existing problems and provide practical recommendations. MethodsThe drug manufacturers, drug distributors and medical institutions of Shanxi and Sichuan province were employed as the subjects. The returned questionnaires were analyzed via SPSS 18.0. Results198 questionnaires were received. The informations of the ADR monitoring present situation were obtained in terms of structure, staff, system, fund, training, reporting and valuation. ConclusionThe ADR monitoring situation was in good condition. It is necessary to strengthen the training in Shanxi province, and the staff, fund, information feedback should be improved. References | Related Articles | Metrics

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Rapid Analysis of Multi-indicators in Ginkgo Biloba by Near Infrared Spectroscopy XIANG Yan-hua, SUN Shu-na, WANG Lei, GENG Shu, CHEN Yong 2015, 12(12): 744-747.  Abstract ( 246 )   PDF (636KB) ( 177 )   ObjectiveTo determine the index ingredient rapidly in Ginkgo biloba with near infrared (NIR) spectroscopy. MethodsHPLC method was used to determine the content of total flavonoids (quercetin, kaempferol and isorhamnetin) in Ginkgo biloba leaves, and near infrared (NIR) spectroscopy was applied to quantitative analysis of the content of flavones in Ginkgo biloba and peak area ratio of quercetin and kaempferol with PLS regression model. ResultsThe correlation coefficient R was 0.9443 and 0.8963 respectively. The root mean square error of cross validation RMSECV was 0.104 and 0.149 respectively. The root mean square error of prediction RMSEP is 0.082 and 0.206 respectively. The root square error of prediction RSEP (%) is 8.69 and 7.29 respectively. ConclusionThe results are good and the method can be applied to the quantitative analysis of index ingredients of Ginkgo biloba. References | Related Articles | Metrics

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Research on Isotretinoin Post-Marketing Risk Control in America LIU Si-qi, LIU Wen-yuan, YANG Yue 2015, 12(12): 748-752.  Abstract ( 335 )   PDF (663KB) ( 326 )   ObjectiveTo research isotretinoin post-marketing risk control in America, and make reference for developing sophisticated drug post-marketing risk management system in our country. MethodsDrug post-marketing risk management regulation and guidance of America were looked up, the risk control measurements against teratogenesis and depression induced by isotretinoin were analyzed, and the risk control carried out by America and China were compared. ResultsFDA conducts a series of risk manage measures, such as medication guide dispensed with prescription, specific requirement which prescribers, patients, pharmacies and wholesalers must follow to assure safe use, evaluating the effect of risk mitigation periodically and improving accordingly, as a result, they control the risk to a large extent. ConclusionDrug post-marketing risk control concepts and designs are useful references for China. References | Related Articles | Metrics

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Literature Analysis of Clinical Application and Adverse Drug Reaction/Event of Lianhua Qingwen Capsule PENG Li-li, LI Lan, SHEN Lu, LI Xing-ling 2015, 12(12): 753-755.  Abstract ( 9012 )   PDF (642KB) ( 2215 )   ObjectiveTo investigate and analyze the literatures on clinical application and ADR/ADE induced by Lianhua Qingwen Capsule to provide reference for its rational use in clinic. MethodsThe literatures for ADR/ADE of Lianhua Qingwen Capsule were retrieved in the databases of CNKI、Wangfang data for the last 10 years, which were screened out and analyzed by evidence-based medicine method and bibliometric statistical method. ResultsThirty-eight literatures were included and toltal 122 adverse drug reaction cases were collected. Most drug adverse reactions occurred after first use, primarily involved gastrointestinal system(73.9%), skin and its appendaes (9.6%), including nausea, vomiting, abdominal distention, diarrhea, skin rashes, itching, etc. ConclusionWe should reinforce the clinical application of Lianhua Qingwen Capsule, standardize and improve the drug package inserts, promote the rational use of drug and guarantee the safety of patients. References | Related Articles | Metrics

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Literature Bibliometric Analysis of Polymyxin Renal Toxicity Based on Web of Science LIANG Bei-bei, WANG Rui, WANG Jin 2015, 12(12): 756-759.  Abstract ( 270 )   PDF (645KB) ( 265 )   Objective To understand the current situation and progress trends of research on polymyxin renal toxicity and reflect major scientific advances and influence in this field. Methods The literatures of polymyxin renal toxicity were retrieved based on Web of Science TM database from 1995 to 2015. The retrieving strategy was TS=(TI=polymyxin or TI=colistin) AND(TI=renal toxicity or TI=nephrotoxicity). All retrieved literatures were given statistical analysis from aspects of years, countries/regions, authors, periodical distribution and high-frequency cited literatures of polymyxin renal toxicity by using bibliometric method. Results There were totally 386 literatures retrieved, and quantity of issued papers increased year by year. The level of research on polymyxin renal toxicity is the highest in USA, and higher in Greece and Australia. The authors with higher output and impact mostly came from Australia and Greece. Results from the research shoued that most often polymyxin nephrotoxicity was mild to moderate in magnitude and reversible in nature. Clinicians must weigh the risk and benefit of continuing versus stopping polymyxin treatment and optimize medication strategies to reduce polymyxin-induced toxicities. Conclusion The research of polymyxin renal toxicity has been developed rapidly in the world and there are some unclear questions which need further research. References | Related Articles | Metrics

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Effect Analysis of Antimicrobial Prescription Review on Medical Records DENG Yong-kun, YANG Xing-biao, ZHANG Rong-ping, ZHANG Cheng-cheng, WU Xiu-zhi, UAN Fang, ZHAO Yu 2015, 12(12): 760-762.  Abstract ( 376 )   PDF (612KB) ( 259 )   Objective To evaluate the effect of antimicrobial prescription by review on medical records and improve comment methods. Methods The percentage of antimicrobial use, combined use rate, antimicrobial use density (AUD), pathogenic test rate on therapeutic use antimicrobial, AUD of each clinical department and AUD constituent ratios of different generation cephalosporinsins from October 2014 to April 2015 were analyzed. Results The usage percentage, combined use rate and AUD of antimicrobial decreased from 61.48%, 42.81% and 55.23 DDDs to 57.82%, 35.52% and 50.84 DDDs, respectively. Fall ratio is 5.95%,17.03% and 7.95% in turn. Pathogenic test rate on therapeutic medication increased from 28.41% to 38.80%, rise ratio is 36.57%. AUD constituent ratios of the first and second generation cephalosporins increased from 2.54% to 30.75%.Statistics by department, 15 of 22 clinical departments have different decline of AUD. Conclusion Antimicrobial prescription review on medical records has received good results for promoting rational use of antimicrobial in our hospital. References | Related Articles | Metrics