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08 April 2014, Volume 11 Issue 4 Previous Issue    Next Issue

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Effects of Radix Polygoni Multiflori Preparata and Quantitative Exercise on Rat Liver Microcirculation and Liver Function CHANG Qing, ZHAO Hai-juan, LI Chun, LIAO Fu-long, WANG Jia-bo, XIAO Xiao-he, YOU Yun 2014, 11(4): 193-197.  Abstract ( 231 )   PDF (468KB) ( 175 )   ObjectiveTo investigate the long-term effects of taking Radix Polygoni multiflori Preparata combined quantitative exercise on hepatic microcirculation and liver function. Methods2×2 factor experimental design was used. Rats were randomly divided into four groups, namely, static without drug group(S/C), static with drug group (S/D), swim without drug group(SW/C), swim with drug group(SW/D), given the different levels of Radix Polygoni multiflori Preparata alcohol extract (0g·kg-1, 20g·kg-1 p.o) and different levels of swimming(0h, 1h). After 30 days, using Laser Doppler blood flow imaging system to monitor the change of rat hepatic microcirculation blood flow; the serums of rats were collected to determine the content of NOS3 and the biochemical indexes of liver function. ResultsCompared with S/C group, Radix Polygoni multiflori Preparata alcohol extract significantly reduced the mean perfusion unit of hepatic microcirculation and serum endothelial nitric oxide synthase(NOS3) content(P <0.05) in rats, while significantly elevated serum total bilirubin(TBIL), direct bilirubin(DBIL), reduced indirect bilirubin(IBIL) References | Related Articles | Metrics

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Protective Effect of Water Soluble Biphenyl Compound WLP-S-14 on Experimental Liver Injury Model MIAO Lu-yang, TONG Yuan-feng, WU Song, WEI Huai-ling, BAO Xiu-qi, ZHANG Dan, ZHANG Yu-yang, SUN Hua 2014, 11(4): 198-202.  Abstract ( 198 )   PDF (478KB) ( 179 )   ObjectiveTo assess the hepatoprotective effect of a water solubility derivative of biphenyl by three acute liver failure models. MethodsTwo mice models of acute liver failure were established by injection with carbon tetrachlo-ride(CCl4) or concanavalin A(Con A) respectively. Mice were intraperitoneally injected with two doses of WLP-S-14(100 200 mg·kg-1) before administration of CCl4 and Con A. Serum alanine aminotransferase(ALT) and glutamate oxaloacetate transaminase(AST) were detected by automatic chemistry analyzer(TBA-40FR). At the same time, oxaliplatin and 5-fluorouracil were injected to induce liver failure in Lewis-bearing mice. WLP-S-14(100,200mg·kg-1) was pretreated 2hr before the injection of oxaliplatin/5-fluorouracil. The activities of ALT and AST in serum were measured by automatic chemistry analyzer and liver histopathological changes were examined by H.E. and light microscopy. ResultsIn CCl4-induced liver damage mice, WLP-S-14 100mg·kg-1 significantly reduced the elevated serum AST and ALT levels induced by CCl4. WLP-S-14 200mg·kg-1 also markedly decreased sersum ALT, but there was no significantly statistical significance on the decrease of AST when compared with the model group. In Con A-induced immunologic liver injury mice, pretreation of WLP-S-14(100 200mg·kg-1) both markedly decreased the elevated ALT and AST induced by Con A. WLP-S-14(100, 200mg·kg-1) also showed a significant protection in oxaliplatin/5-fluorouracil-induced liver damage mice, as evidenced by the improvement of histopathological injury and the decrease of elevated serum aminotransferases. There was no decline to tumor inhibition rate produced by oxaliplatin/5-fluorouracilwhenco-administration WLP-S-14 100mg·kg-1. ConclusionWLP-S-14 showed potent protective activities against CCl4, Con A or oxaliplatin/5-fluorouracil-induced liver damage. It is worth exploring for future study. References | Related Articles | Metrics

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LC-MSn Analysis of the Components in Bulbus Fritillariae Ussuriensis and the Urine of Rats after Oral Administered Bulbus Fritillariae Ussuriensis ZHANG Li-fu, SUN Jian, WEN Qinghui, MA Yanyan, Feng-Lan Niu 2014, 11(4): 203-205.  Abstract ( 199 )   PDF (502KB) ( 205 )   References | Related Articles | Metrics

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Analysis of Uncertainty of Measurement in the Determination of Curcumin in Tiaozhi Granules ZANG Ya-ju 2014, 11(4): 206-209.  Abstract ( 196 )   PDF (511KB) ( 174 )   ObjectiveTo analyze the measurement uncertainty in determination of curcumin in Tiaozhi granules. MethodsAccording to the measurement uncertainty principle and National Measurement Technology Criterion, mathematic model of HPLC was established to analyze the effects of many uncertain factors on measurement results. Combined standard uncertainty and expanded standard uncertainty were calculated. ResultsThe expanded uncertainty was 8mg per bag and the results of determination could be expressed as(97.7±8.0)mg per bag(k=2). ConclusionThe established analytical method is applicable to the uncertainty analysis in the content determination of Tiaozhi granules. References | Related Articles | Metrics

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Transitioning from Periodic Safety Update Report to Periodic Benefit-Risk Evaluation Report: Initial Experience and Challenges ZHANG, Xiao-lan, Lester REICH, LIANG Bing, Donald PUCCIO, Craig HARTFORD 2014, 11(4): 210-215.  Abstract ( 653 )   PDF (591KB) ( 933 )   Periodic safety update reports addressing the worldwide safety experience of medicinal products must be provided to regulatory authorities at defined time intervals after products are marketed. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use(ICH) provides guidelines for the Periodic Safety Update Report((PSUR), ICH E2C(R1) Guideline) and the more recent Periodic Benefit-Risk Evaluation Report((PBRER), ICH E2C(R2) Guideline). The PBRER is an evolution of the PSUR, enabling a shift from the more traditional post-approval pharmacovigilance periodic summary report to a modern periodic summary report presenting the current benefit-risk assessment of the approved indications for a product based on cumulative efficacy and safety information. This paper summarizes key differences between the ICH E2C PSUR and PBRER Guidelines, describes the initial experience and challenges encountered by a multinational pharmaceutical company in effecting the transition from PSUR to PBRER format and content, and discusses the potential for implementation of the PBRER in China in the context of China's evolving pharmacovigilance system. References | Related Articles | Metrics

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Research on the Theoretical Basis to the Drug Emergency Inspection Management GAO Zhi-feng, LIN Lan, YANG, Hua-xin 2014, 11(4): 216-218.  Abstract ( 222 )   PDF (581KB) ( 253 )   The drug incidents occurred frequently in our country in recent years. As the technical supports for drug supervision, the institutions for drug control should be urgent to enhance the response capabilities to solve these problems. This paper would research the theoretical basis to the drug emergency inspection management from three aspects, the emergency management, the drug daily inspection, the drug emergency inspection, and then sum up the practical ideas of emergency management to the drug emergency inspection by analyzing the results. In the end, some effective measures and suggestions would be made to define the disposal methods and deal with the drug incidents. References | Related Articles | Metrics

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Advances in Establishments of Animal Models with Rheumatoid Arthritis and Thinking about Efficacy Evaluation of TCM LUAN Yong-fu, SUN Rong 2014, 11(4): 219-221.  Abstract ( 234 )   PDF (573KB) ( 245 )   Objective To introduce the research development on the establishments of animal models with rheumatoid arthritis, and think about efficacy evaluation of TCM. Methods References in the last decades at home and abroad about RA model were collated, analyzed and summarized. Results and Conclusion The main RA model are AA, CIA and so on. We should select suitable animal model on the basis of TCM's characteristic to screen out medicine and to evaluate the efficacy of medicine, and combine closely the research of RA's animal model with clinical disease to ensure the stability and reliability of animal model. And then to offer methodological ensurance for TCM's pharmacological preclinical research and efficacy evaluation. References | Related Articles | Metrics

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Analysis of Training Programs for Clinical Trial Researchers on Traditional Chinese Medicine REN Jun, YANG Guo-yan, HAN Mei LIU Jian-ping 2014, 11(4): 222-224.  Abstract ( 222 )   PDF (499KB) ( 189 )   The competence of clinical trial researchers is essential to assure the quality and accomplishment of clinical trials on traditional Chinese medicine. This paper will discuss how to develop a training program for clinical trial researchers on traditional Chinese medicine, according to the research purpose and protocol, from the following six aspects training participants, objectives, contents, approaches, teachers and evaluation, in order to further standardize the clinical trials of traditional Chinese medicine. References | Related Articles | Metrics

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Literature Analysis of 420 Cases of Adverse Drug Reactions Induced by Allopurinol ZHENG Ming-jie, TANG Ren, WANG Chun-ting 2014, 11(4): 225-228.  Abstract ( 218 )   PDF (702KB) ( 397 )   Objective To probe into the status,characterstics and influencing factors of ADR cases induced by allopurinol, for providing a reference for clinical treatment. Methods Data were collected from domestic published literatures from "China Journal Full-text Database" before 2013, and 420 case reports of adverse drug reactions induced by allopurinol were analyzed retrospectively. Results Older male patients appear to be with a high rate. Organs involved mainly are skin and its appendages(42.33%), systemic damage(22.77%), hepatobiliary system damage(9.90%). Severe damages to the skin are erythema multiforme system eruption , exfoliative dermatitis and hypersensitivity syndrome. Conclusion Allopurinol should be used reasonably, and the monitoring of clinical use should be strengthened to ensure the safety of medication. References | Related Articles | Metrics

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Literature Analysis of 505 Cases of Adverse Drug Reactions Induced by Sodium Aescinate for Injection XIE Xiao-yan, LI Qing-fang, ZHANG Hui-xia, WANG Li 2014, 11(4): 229-231.  Abstract ( 263 )   PDF (613KB) ( 418 )   ObjectiveTo investigate the general rule, characteristics and risks of adverse drug reaction(ADR) induced by sodium aescinate injection, in order to provide theoretic support for drug Safety in clinical administration. MethodsUse "Sodium aescinate"and"adverse drug reaction"as key words, searching and retrieving references in the following databases as CBM, CNKI, VIP and WanFang Data. 47 references which met the inclusion and exclusion criteria were extracted and analyzed. ResultsThe adverse reactions may involve multiple organs and systems, The most common reactions are phlebitis, allergic reaction,etc. Severe cases can cause anaphylactic shock, renal failure, liver and kidney damage, and skin necrosis. ConclusionIt is important to pay attention to the adverse reactions caused by sodium aescinate when administrating by injection, preventing severe adverse drug reactions from happening, and ensuring the Safety of clinical administration. References | Related Articles | Metrics

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Analysis of Sensitivity Study of Drug Abuse Detection by Colloidal Gold Method LV Yun-feng 2014, 11(4): 232-234.  Abstract ( 280 )   PDF (560KB) ( 421 )   The purpose of this article is to discuss the main points of sensitivity study of drug abuse detection reagents. Considering the characteristics of drug abuse detection reagents, recommendations on several aspects of the sensitivity study methods were made including the combination activity of antigen with antibody, the low detection limit establishment and validation, and the low detection limit of structural analogues, providing a reference for the sensitivity study of the reagent's research and development . References | Related Articles | Metrics

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Analysis and Discussion of 272 Cases of Class I Medical Device Recalls by FDA WEN Qiang, XIA Shi-tao, ZHONG Ling, ZHONG Dai-di, MIAO Yu 2014, 11(4): 235-240.  Abstract ( 266 )   PDF (715KB) ( 288 )   ObjectiveTo investigate the occurrence of serious medical device risks and provide reference for the post-marketing medical device risk management through statistical analysis on 272 cases of FDA class I medical device recalls. MethodsStatistical analysis is applied to the retrieval of 2001~2012 the most serious class I medical device recalls from FDA website which does not involve the cases caused by illegal factors. ResultsThe constituent ratio of the top 10 categories of products accounts for 90% of the number of cases. Energy hazard is the main form, accounting for 79.4%. The product component failure is the main direct reason, accounting for 76.1%. ConclusionSerious medical device risks are mainly related to applied part, component reliability and function, energy control, References | Related Articles | Metrics

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Retrospective Analysis of 257 Cases of Children's Medication Consultation YANG Zhi, ZHANG Hai-xia, JIANG Zhi-ping, HE Zhou-kang 2014, 11(4): 241-244.  Abstract ( 306 )   PDF (670KB) ( 237 )   ObjectiveTo review the children's medicine consultation work for further promotion of drug consultation service and improvementof the quality of pharmaceutical care for children in our hospital. MethodsThe records of medicine consultation service were collected during January, 2010 to December, 2012 and the the inquisitor's identity, the classification of drugs and advisory content were retrospectively analysed. ResultsThe identities of inquisitors were mainly children's parents. The others were medical staff and pharmacist/medical technologists. Antibiotic agents are the most frequently counseled and secondly the clinical common drugs and digestive agents. The contents of consultation are mainly about usage and dosage of drugs(48.16%), then the adverse reactions and cautions(14.72%), indications(11.37%), drug interaction and incompatibility(8.03%). ConclusionMedication consultation plays an important role in the pediatric pharmaceutical service. This work could be an important way to improve the safety and rationality of children's drug use, and can increase the drug use compliance and ensure safety and effectiveness of pediatric medication. References | Related Articles | Metrics

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Pharmaceutical Care of Clinical Pharmacists on a Cancer Patient with Severe Pain ZHANG Dong-lei, WEI Qing, Tong Ben-ding, Wu Nan, Ding Xuan-sheng 2014, 11(4): 245-247.  Abstract ( 280 )   PDF (595KB) ( 245 )   ObjectiveTo describe the clinical pharmacists' way in carrying out pharmaceutical care for cancer patients with severe pain. MethodsCombining with the clinical experience, make the targeted treatment scheme with the physicians together and adjust the scheme according the condition change. Pay close attentions on the patients and make reasonable suggestions as to the adverse drug reactions to guarantee the rational use of drug. ResultsClinical pharmacists can assist clinicians to adjust the therapeutic regimen from the perspective of pharmacists, and improve the level of clinical drug treatment. ConclusionPharmaceutical care on cancer patients with severe pain is needed, as it can improve the safety and rationality of taking drugs so that improve the efficacy of the treatment scheme. References | Related Articles | Metrics