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08 September 2013, Volume 10 Issue 9 Previous Issue    Next Issue

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Research of Liver Damage Mechanism of the Toxical and Side Effects Accompanied with Anti-inflammation Caused by Different Extracts from to Mice LUAN Yong-fu ,SUN Rong 2013, 10(9): 513-517.  Abstract ( 249 )   PDF (547KB) ( 113 )   Objective To research the mechanism based on liver oxidative damage path of the toxical and side effects accompanied with anti-inflammation of water and alcohol extract from . Thus, we try to provide experimental basis of intrahepatic material change for the study of correlation between toxicity and efficacy of Methods First, we made ear swelling model by compound recipe of croton oil and made granuloma model by injecting agar subcutaneously. Second, model mice were intragastricaly treated with different doses of water and alcohol extracts from for 3 and 7 days continually. Then the levels and activities of SOD, MDA, NO, NOS, GSH, GSH-Px of serum and hepatic tissue were detected after the last medication. Results The water extracted and alcohol extracted components could cause the level of MDA in serum and liver to increase, the activity of SOD corresponding declined, however the level of NO and NOS increased. In addition, the activity of GSH and GSH-Px declined. All the changes were aggravated in accordance with the enhancement of doses and time extension, and these parameters of all the medication administration groups had obvious difference with those of the blank control group. Conclusion The mechanism of the toxical and side effects on inflammatory mice caused by water and alcohol extract from may be related with the peroxidative damage mechanism. References | Related Articles | Metrics

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Clinical Observation on Lauromacrogol Combined with Surgery and Endovenous Laser Treatment in Therapy of Lower Limb Varicose Veins SUN Ai-jun ,TIAN Peng 2013, 10(9): 518-519.  Abstract ( 268 )   PDF (414KB) ( 325 )   Objective To investigate the clinical effectiveness of varicose veins using lauromacrogol local injection combined with surgery and endovenous laser treatment. Methods A total of 36 patients including 43 limbs with varicose veins were treated by the therapy as the above, observing the effectiveness with the check of color doppler ultrasound. Results Varicose veins disappeared in 39 limbs, a little remained in4 limbs, and disappeared with foam sclerotherapy again. The average follow-up time was8 months, the symptoms of all the patients were obviously relieved or disappeared, without serious complications. Conclusion Lauromacrogol used as foam sclerotherapy in treatment of vericose veins, has definite effectiveness, high safety and less side-effect. Combination with other minimally invasive therapies can improve the effectiveness of treatment in varicose veins and reduce the complications. References | Related Articles | Metrics

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Analysis of Blood Concentrations of Sodium Valproate in 248 Cases of Perioperative Patients with Brain Tumors LI Zheng-ran ,ZHU Yue-ting ,GAO Chen, HUANG Jia, LI Ji-yang ,CUI Xiang-li 2013, 10(9): 520-522.  Abstract ( 242 )   PDF (422KB) ( 215 )   Objective To discuss the role of blood concentration monitoring of sodidum valproate in preventing postoperative seizure. Methods 248 cases of sodium valproate blood concentration of brain tumor patients were retrospective analyzed in 2012, and the prophylaxis effect of epilepsy was assessed through the analysis of postoperative epilepspy in hospital. Results Normal treatment concentration was found in 160 cases(64.5%), 18 cases(7.3%) were higher than normal treatment concentration, and 70 cases(28.2% ) below the normal treatment concentration. Conclusion The blood concentration of sodium valproate was influenced by many factors. According to patients' basic situation and blood concentration monitoring, the individualized medication should be made so as to Keep an effective therapeutic concentration of sodium valproate to prevent seizares during the perioperative period. References | Related Articles | Metrics

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Study of Guideline for Drug Man ufacturer on Adverse Drug Reaction Reporting and Monitoring with Delphi Method DONG Duo, SUN Li-hua 2013, 10(9): 523-526.  Abstract ( 293 )   PDF (447KB) ( 227 )   Objective To build up Guideline for drug manufacturer on adverse drug reaction reporting and monitoring. Methods Using the Delphi method, experts were consulted in two rounds to confirm 15 critical items in the Guideline. Results The response rates of the two investigations were all 100% . The authority means of the two rounds were .86 and 0.87 respectively. 12 critical items are reached 75% concentration of expert consultations. Conclusion The enthusiasm and authority of the experts were good. An initial Guideline for drug manufacturer on adverse drug reaction reporting and monitoring has been set up. References | Related Articles | Metrics

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Analysis of Foreign Regulatory Policy for Pediatric Research and Development and Application LU Yu-mei 2013, 10(9): 527-532.  Abstract ( 440 )   PDF (524KB) ( 545 )   Children are in the developmental stages, and there is a big difference between the drugs for children and drugs for adult, so drug safety issues can not be ignored. Our market for drugs in children is not yet mature, and there are not relevant regulations and policies to specifically guide the drug use in children, which to some extent increases the risk of pediatric drugs. The U.S. and the EU have made great efforts in this regard, established the pediatric exclusive system to encourage enterprises to conduct pediatric research. Japan, WHO and other regions developed appropriate measures to promote the development of pediatric drug research and supervision. Based on the literatures home and abroad, we analyzed the regulatory policies for the research and development and application of pediatric drugs in U. S. and EU in order to provide recommendations for our drug policy. References | Related Articles | Metrics

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Inspiration from EudraVigilance Access Policy for Medicines for Human Use LIU Wei ,DU Xiao-xi ,SHEN Lu 2013, 10(9): 533-535.  Abstract ( 264 )   PDF (537KB) ( 364 )   This article reviews EudraVigilance Access Policy for Medicines for Human Use. The stakeholder groups granted access to EudraVigilance data can be summarized as follows: medicines regulatory authorities, the european Commission and the Agency, healthcare professionals and the general public, marketing authorisation holders and sponsors of clinical trials and research organizations. They have been granted different access authorization. The article analyses inspiration from EudraVigilance Access Policy. References | Related Articles | Metrics

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France and Canada Drug Regulatory Agencies and Implication ZHANG Hao, DONG Duo, CHENG Gang 2013, 10(3): 536-539.  Abstract ( 279 )   PDF (733KB) ( 399 )   Drug regulatory agency is the main body of implementing market regulation, the setting pattern and organizational system directly affects the efficiency of government regulation and the development of the pharmaceutical market's vitality. In this article France and Canada drug regulatory agencies were selected the research object. By searching their drug regulatory official websites and related literatures, we summarized the main responsibility of the drug administration, organization and supervisor and compared with drug regulatory institution setting and function of our country. The comments and suggestions were put forward for the construction and development of China's drug regulatory system. References | Related Articles | Metrics

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Using HPLC to Determine Adenosine in Cordyceps Mortierella Mycelia Capsules WU Wen, LIU Xiao-hong, ZHU Man-fang 2013, 10(9): 540-542.  Abstract ( 322 )   PDF (581KB) ( 165 )   Objective To establish a method of determining adenosine in Cordyceps Mortierella Mycelia Capsules. Methods We used HPLC to determine adenosine in Cordyceps Mortierella Mycelia Capsules. In this method, HypersilC18 column(4.6 mm×250 mm,5 μm) was used with the mobile phase of KDP buffer solution(0.05 mol·L-1)-methanol(85:15). The flow rate was 1.0 mL·min-1, and the wavelength was 260 nm. Results The linear relationship of adenosine within the range of 1.011-50.55g·mL-1 is fine. The linear equation is A=60901C-2347.7, r=1, and the average recovery μrate is 100.49%(n=6, RSD=1.1%). Conclusion Using HPLC to determine adenosine in Cordyceps Mortierella Mycelia Capsules is not only easy to operate but also without the interference of impurity. It has good precision and the result is reliable. It can be used asa method in the quality control of Cordyceps Mortierella Mycelia Capsules. References | Related Articles | Metrics

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A Method for Quantitative Determination of Schisandrim in Baojing Granule by RP-HPLC TANG Xiao-xia, CHEN Li ,SU Wan-fu 2013, 10(9): 543-544.  Abstract ( 223 )   PDF (572KB) ( 207 )   Objective To establish a method for quantitative determination of schisandrin in baojing granule. Methods HPLC was used. The samples were separated ona kromasil C18 column(250mm伊4.6mm,5μm) witha mobile phase of acetonitrile and water( 45:55,v/v) , pumped at the flow rate of 1.0 mL·min -1 and detected at 250 nm. Results The result showed that the average recovery of schisandrin was 100.7% (RSD=1.3% , n=6). Conclusion The method hasa good specificity and stability, which can be applied to the quality control of baojing granule. References | Related Articles | Metrics

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Research Development on Chemincal Compositions in Related with Efficacy and Toxicity HUANG Wei, LV Zheng ,SUN Rong 2013, 10(9): 545-548.  Abstract ( 363 )   PDF (605KB) ( 483 )   Objective By combing pertinent literature and summarizing the current states of chemical composition of Bupleurum Chinense related with its efficacy and toxicity, to identify its effective and toxical composition, offer the accordance and research ideas for further research on the relationship between efficacy, toxicity and chemical composition of Bupleurum Chinense. Methods The related references in recent 20 years at home and abroad about Bupleurum Chinense were analyzed, collated and summarized. Results The main chemical composition of was saikosaponin, naphtha, flavonoids, polysaccharide and plant sterol, etc, and the saikosapoin and naphtha were the main chemical compositions; the pharmacological activity research was focused on saikosaponin, naphtha, flavonoids and polysaccharide; the toxicity research was focused on the extracts of , saikosaponin and naphtha, and the toxical target organ was liver. Conclusion The saikosaponin and naphtha were not only effective compositions that protected the liver, but also the toxical composition that injured of the liver. How to maximize the "shuganjieyu" efficacy and limit the hepatotoxicity of "Chinense robbing hepatic yin" were the key that restricted the chemical composition research. The efficacy and toxicity research of should be put on the background of traditional Chinese medicine syndrome to make the comprehensive evaluation and scientific cognitive, to explore the "effective treatment window " and "drug safety window", and to insure the safety and effectiveness of clinical medication. References | Related Articles | Metrics

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Establishment and Discussion of the Drug Utility Related Risk Causal Model LI Chun-xiao, WU Zhi-ang ,HU Xin 2013, 10(9): 549-552.  Abstract ( 275 )   PDF (714KB) ( 197 )   Objective To establish and discuss the drug utility related risk causal model. Methods The works concerning the foundation of this article, namely risk theory and pharmacotherapeutics, were summarized and analyzed. Results & Conclusion Hazard, loss, peril were the three key elements of risk, they constituted the causal model together with contributory and intercept factors, which took important role in complex system. In the view of causal model, the drug characters were the hazard, which contributed most drug related peril and loss. The contributory factors included the healthcare staff's clinical decision and related implementation, as well as the condition of the patients. The regulation, SOPs and individual experience, perception and communication were acted as intercept factors. The casual model would give rise to the acknowledgement of the drug related risk source, process, which would enhance drug utility management. References | Related Articles | Metrics

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Post-marketing Safety Literature Analysis and Risk Control Recommendations of Shuxuening Injection YANG Le, WANG Yan-chun ,DU Xiao-xi, REN Jing-tian ,Song Hai-bo, LIU Xi-dan 2013, 10(9): 553-556.  Abstract ( 257 )   Shuxuening injection is the ginkgo preparation which is widely used in clinic. By retrospective study on shuxuening injection post-marketing safety status in the literature at home and abroad, it is found that the main adverse reactions of allergic reactions with the characteristics of immediate hypersensitivity, alone or in combination may cause risk. Serious adverse reactions mainly involved anaphylactoid reaction, allergic shock, respiratory system damage with difficult breathing, cardiovascular system damage with chest tightness and palpitation. There are very rare literatures reported bleeding. We put forward risk control measures in accordance with the drug itself characteristics, and suggestions for safe and rational use of the drug. References | Related Articles | Metrics

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Literature Analysis of 241 Cases of Adverse Drug Reactions Induced by Lincomycin CHEN Xing-Li ,LIAN Shi-tao ,DU-Yan ,HAN Da-bin, CHENG Xiao -ping 2013, 10(9): 557-559.  Abstract ( 242 )   PDF (671KB) ( 168 )   Objective To study the characteristics and regular patterns of adverse drug reactions(ADR) caused by lincomycin, and to provide a reference for clinical rational use of the drugs. Methods By searching literature in Chinese Journal Full-text Database from 1995 to 2013, 146 case reports of adverse drug reactions induced by lincomycin were analyzed retrospectively. Results and Conclusion Lincomycin inducing adverse reaction might be relevant to overdose, drip rate and route of administration, and so on. ADRs mostly occurred in the early stage of the drug administration. Monitoring should be strengthened clinical application to ensure drug safety. References | Related Articles | Metrics

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Literature Analysis of 97 Cases of Adverse Drug Reaction Induced by Fosfomycin Sodium TANG Ren ,GAO Yan ,FAN Yan 2013, 10(9): 560-562.  Abstract ( 258 )   PDF (768KB) ( 295 )   Objective To analyze the general characteristics of adverse drug reaction induced by fosfomycin sodium, provide reference for rational drug use in clinic. Methods Using "fosfomycin sodium" and "adverse drug reaction" as the keywords, searched the cases of the adverse drug reaction induced by fosfomycin sodium which were reported from Jan 1980 to Jan 2013. The data were analyzed in terms of occurrence time, original disease, clinical manifestation, prognosis, et al. Results There were 33 publications including 97 cases. Skin and appendages disorders were with the highest incidence, followed by the respiratory system disorders, systematic disorders and cardiovascular disorders. The main clinical manifestations were pruritus, rash, dyspnea, sense of suppression in the chest, et al. Most of adverse drug reactions got right after drug withdrawal and symptomatic treatment. Conclusion The adverse drug reactions induced by fosfomycin sodium were low, and prognosis was well. Attention should be paid to the adverse drug reactions induced by fosfomycin sodium in clinic, and the monitoring of medication should also be strengthened to ensure the safe medication. References | Related Articles | Metrics

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Analysis of 37 Cases of Adverse Drug Reaction Reports by Metformin SHI Hong-bo, CAI Qiang 2013, 10(9): 563-566.  Abstract ( 313 )   PDF (725KB) ( 390 )   Objective Through analysing 37 cases of adverse drug reaction(ADR) by metformin to explore the rules and causes of adverse reactions, provide a reference for clinical rational use of drugs. Methods By searching literature in Chinese Journal Full-text Database from 1979 to 2013, 32 ADR literatures of metformin involving 37 cases, were statistically analyzed. Results In the 37 cases of adverse drug reaction by metformin, the adverse reaction incidence of men was more than that of women, the 30-39 years old patients with the highest incidence; the used formulation of metformin involved tablet formulation,enteric-coated tablet and sustained-release tablet. The tablet formulation was the ordinary formulation, accounting for 89.19%; the fastest appearing time of adverse reaction was 30 minutes after administration, the longest time was a few years after administration, and most adverse reactions happpened within 1 day after administration. The ADRs involved many systems and organs, mainly manifested as skin and appendage damage, systemic damage and endocrine system damage followed by nervous system and gastrointestinal system disorders. Most adverse reactions were slight, even if some symptoms were severe, most symptoms could be improved and disappeared after timely drug withdraw or symptomatic drug treatment, but2 cases died of lactic acidosis after rescue. Conclusion The doctors and pharmacists should pay attention to the adverse reactions caused by metformin, and understand the rules and characteristics of adverse reactions, the dosages should be strictly controlled according to the diseases, and the clinical care should be strengthened so as to prevent the occurrence of adverse reactions. References | Related Articles | Metrics

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Study of Compatible Stability on Salvia Injection and Transfusion LIN Xiao -ming, HUANG Min ,ZHU Jian 2013, 10(9): 567-570.  Abstract ( 225 )   PDF (668KB) ( 332 )   Objective To investigate the effect of multiple factors on compatible stability in salvia injection and transfusion so as to achieve the optimal program. Methods The particle content was measured by GWF-5J particle analyzer with orthogonal test, and the particles in solution and protocatechuic aldehyde content were used as indicators. The protocatechuic aldehyde content in solution was determined by HPLC. Results Effect of compatible temperature and stored time on protocatechuic aldehyde content was statistically significant. In addition, effect of dose on particle content in solution was statistically significant. Conclusion The optimal compatible match of salvia injection was to combine with 100 mL sodium chloride injection at 25℃ for 2 hours. References | Related Articles | Metrics

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Analysis of the Infection Treatment after Surgery of Tibial Plateau Fracture Participated by Clinical Pharmacists LIN Yong-tang 2013, 10(9): 571-573.  Abstract ( 270 )   PDF (725KB) ( 289 )   Objective To explore the role of clinical pharmacists in the participation of clinical medication practice. Methods By reviewing one case of clinical pharmacists participating in the infection treatment after surgery of tibial plateau fracture, analyzed the clinical pharmacists' interventions. Results Clinical pharmacists can take advantage of their expertise to assist clinicians to adjust the therapeutic regimen, and improve the level of clinical drug treatment. Conclusion Clinical pharmacists should be actively involved in clinical practice, and provide active pharmaceutical care. References | Related Articles | Metrics