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08 May 2013, Volume 10 Issue 5 Previous Issue    Next Issue

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Study on the Effects of Radix Adenophorae Coadministrated with Veratrum nigrum L on Cytochrome P450 Subtype Enzymes Activities of Rats by Cocktail Approach Using Probe Drugs ZHU Guan-xiu ,WANG Yu-guang, LI Fei ,MA Zeng-chun ,LIANG Qian-de ,XIAO Cheng-rong ,TAN Hongling ,TANG Xiang -lin, ZHANG Bo -li ,GAO Yue 2013, 10(5): 257-262.  Abstract ( 267 )   PDF (654KB) ( 187 )   Objective To determine the influence of Radix Adenophorae Coadministrated with Veratrum nigrum L . on cytochrome P450 isoforms CYP1A2,CYP3A4, CYP2C9 and CYP2C19 by Cocktail probe drugs in rats, thus explore the in vivo evidence of the imcompatibility of them from the perspective of drug -drug interactions. Methods 24 male wistar rats were randomly divided into Radix Adenophorace group, Veratrum nigrum L., combined group and blank control group, which were given Radix Adenophorace decoction(13.5g·kg-1), Veratrum nigrum L. decoction (0.81g·kg-1), co-decoction(14.31g·kg-1) and normal saline for 7 days, then injected the mixture of4 probes through vena caudalis on the 8th day, and soon after the blood samples were obtained through extirpating the eyeballs at a series of time-points. HPLC method was used to determine the concentrations of probe drugs in rat plasma, and pharma-cokinetic parameters were estimated by WinNolin5.2. The effects of test drugs on the activities of cytochrome P450 isoforms were judged indirectly by comparing the pharmacokinetic parameters of treated groups with those of control group. Results Compared with the blank control group, Veratrum nigrum L. was decreased AUC(0～t) of tolbutamide and increased its Vz; Radix Adenophorae were decreased AUC(0～∞) of caffeine, significantly decreased AUC(0～t), AUC(0～∞) of tolbutamide, and was increased Vz, CL of tolbutamide, no significant difference of dapsoneand omeprazole. Compared with the Veratrum nigrum L. group, combination could increase MRT(0～t) of dapsone,decrease AUC(0～t), AUC(0～∞) of omeprazoleand, increase CL of it; Compared with the Radix Adenophorae group,combination could increase AUC(0～t) of omeprazole. Conclusion Compared with the blank control group,. can induce CYP2C19 activities; Radix Adenophorae can induce CYP1A2 and CYP2C9 activities significantlywith no effect on the activities of CYP3A4 and CYP2C19. Compared with the Veratrum nigrum L. group, CYP3A4 activities were inhibited in combined groups, and CYP2C19 activities were induced with no effects on the activities of CYP1A2 and CYP2C9. Compared with the Radix Adenophorae group, combination can inhibit the activities of CYP2C19. References | Related Articles | Metrics

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Simultaneous Determination of the Activities of Five Major Cytochrome P450 Enzymes by an in Vitro Cocktail Method Coupled with LC-MS/MS Assay YE Lin -Hu ,KONG Ling –Ti, XIAO Bing -Xin ,WANG Qian, HE Xiao –Xi, CAO Fang -Rui ,CHANG Qi 2013, 10(5): 263-268.  Abstract ( 310 )   PDF (521KB) ( 675 )   Objective To develop an in vitro Cocktail method coupled with liquid chromatography/tandem mass spectrometry ( LC -MS/ MS ) assay for simultaneous determination of the activities of five major cytochrome P450 (CYP450) isoenzymes by monitoring the metabolites of five probe substances including omeprazole(CYP2C19), dex-tromethorphan (CYP2D6), testosterone (CYP3A4), chlorzoxazone (CYP2E1), tolbutamide (CYP2C9). Methods The five probes were incubated with human microsome CYP450 isoenzymes at 37 ℃ in the presence of NATPH. The concentrations of produced metabolites in the reaction solution were determined by LC-MS/MS method, and compared for evaluating the activities of isoenzymes. Results The various conditions for enzyme reactions and LC -MS/MS method have been established for monitoring the activities of five CYPP450 isoenzymes. The data showed that the method possesseda good linearity and sensitivity, as well as the excellent accuracy and repeatability, and can be used for the rapid evaluation of drug -drug interactions. Conclusion A sensitive and validated Cocktail Method coupled with LC -MS/MS assay has been developed and can be applied to rapidly evaluate the CYP450 enzyme activities for predicting the potential drug-drug interactions. References | Related Articles | Metrics

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Curative Effect and Safety Study of Intramedullary Nailing with Autologous Iliac Bone Grafting for Treatment of Nonunion of Ulnar Fracture DU Zhi-gang 2013, 10(5): 269-271.  Abstract ( 218 )   PDF (410KB) ( 115 )   Objective To evaluate the curative effect and safety of ulnar nonunions with interlocking intramedullary nails and iliac bone grafts. Methods During the period of July 2004 to July 2008, 13 patients who had accepted nonoperative or operative treatment and diagnosed as ulnar nonunion were considered for the treatment of interlocking intramedullary nails together with autogenous bone graft. There were 9 men and4 women with an average age of 31.3 years(17～52 years). Plaster was used for immobilization postoperation ranging from4～8weeks with an average of 6.6 weeks. Passive and active motion were encouraged immediately after putting off the plaster. To evaluate union with X-ray pictures and evaluate the postoperative function with Rating system. Results All of the 13 patients accepted follow -up, with an average time of 16.1 months (9～21months). The X -ray pictures showed that one -stage union was in 12 patients(92%), witha meaning healing time of 5.6 months(4～8 months). One patient had to be performed with the treatment of vascularized fibular graft and changing the nail for 14 months of nonunion, then achieved union 6 months after the second operation. The Rating system scores of the 13 patients showed:5 patients(38%) had excellent Results ;6 patients(46%) had satisfactory Results ; 1 patient(8%) had satisfactory result and1 patient(8%) had failure result. No severe complications were observed during the treatment and follow -up. Conclusion Treatment of ulnar nonunions with interlocking intramedullary nails and iliac bone grafts is safe and effective. References | Related Articles | Metrics

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Sampling Results and Quality Assessment of Fenofibrate Preparation in 2011 LIU Min-hong ,DONG Jin LU Juan 2013, 10(5): 272-275.  Abstract ( 248 )   PDF (525KB) ( 217 )   Objective To evaluate the quality status of fenofibrate preparation and exsisting problems. Methods According to the general requirements of Jiangsu province assessment programs in 2011, use statutory testing Methods and combine with the exploratory research to examine samples, evaluate the quality status of fenofibrate preparation by statistical analysis of the Results . Results In 98 batches of samples, all products quality can meet the current standards (100% ) in terms of weight variation, disintegration time, dissolution, related substances and determination of content. Conclusion At present the preparation quality is generally good. But exploratory research shows that current standards are defective, the dissolution assay time is suggested to be added. References | Related Articles | Metrics

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Thoughts and Suggestions on Calculation of Risk Index in State Sampling Analysis for Quality Evaluation WANG Mei-bo ,SUN Jian, MAO Xiu-Hong, WANG Ke ,JI Shen 2013, 10(5): 276-277.  Abstract ( 271 )   PDF (578KB) ( 179 )   In application of the calculation template of risk index in state sampling analysis for quality evaluation, some problems have been identified. For example, we found that it was not very suitable for the calculation of content uniformity and weight variation. By considering these problems, some reasonable suggestions were provided. Related departments were suggested to further perfect the calculation template and to make it more suitable for the state sampling analysis for quality evaluation. References | Related Articles | Metrics

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Stage Characteristics of Prescription and Nonprescription Switch in China TANG Ren, XIA Dong-sheng ,TIAN Chun-hua, WANG Chun-ting 2013, 10(5): 278-281.  Abstract ( 319 )   PDF (612KB) ( 255 )   Objective To summarize characteristics of prescription drugs and nonprescription drugs switch in China by stage and to provide reference for the technical evaluation of the switch. Methods Collecting the regulations, technical norms and varieties released in prescription drugs and nonprescription drugs switch and analyzing the stage characteristics. Results and Conclusion With the general development of drug administration in China, the regulations and technical norms of prescription drugs and nonprescription drugs switch are being improved. The current regulations and technical norms are were suit for the development, application and evaluation of nonprescription drugs, but some improvements are still needed. References | Related Articles | Metrics

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The Introduction and Inspiration of Risk Evaluation and Mitigation Strategies in the Unite State LI Shu -fang, PAN Wen -hao 2013, 10(5): 283-285.  Abstract ( 281 )   PDF (659KB) ( 318 )   Objective To provide suggestions for drug risk evaluation and mitigation in China. Methods To study the material of Risk Evaluation and Mitigation Strategies(REMS) in US Food and Drug Administration(FDA) by literature. Results The development of FDA's REMS is more perfect, and will become standardized and systematized gradually. Conclusion The application of REMS and its standard measures are significant to the improvement of our Drug Risk Evaluation and Mitigation. References | Related Articles | Metrics

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Research Progress about Pharmacological Effect and Mechanism of Flavonoids in Traditional Chinese Medicine MA Rui ,WU Sheng-ben 2013, 10(5): 286-290.  Abstract ( 569 )   PDF (561KB) ( 1291 )   Abstrac：Objective To review and analyze the pharmacological effect and mechanism of flavonoids in traditional Chinese medicine. Methods The related references in recent years home and abroad about the pharmacological effect and mechanism of flavonoids in traditional Chinese medicine were summarized and analyzed. Results Flavonoids hada wide range of pharmacological effects such as antioxidant, anti -inflammatory and analgesic, regulating immunity, anti-aging, fall hematic fat, antitumor and pharmacological action and so on, and the mechanism of pharmacological effects may be related with the resistance to free radicals or antioxidant. Conclusion The flavonoid compounds were the effective composition of many Chinese herbal medicine, and hada wide range of biological activity, and its biological activity mechanism needed further in-depth research. References | Related Articles | Metrics

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Research Progress on Traditional Chinese Medicine Treatment of Gastric Cancer XIE Yuan -zhang ,SUN Rong 2013, 10(5): 291-293.  Abstract ( 267 )   PDF (576KB) ( 513 )   Objective The research of the Chinese medicine treatment of gastric cancer was reviewed, in order to summarize the characteristics of Chinese medicine treatment of gastric cancer, and provide literature basis for the de velopment of effective therapy of gastric cancer. Methods The literatures on Chinese medicine treatment of gastric cancer were collected, analyzed and summarized in the past twenty years. Results In clinical the separately use of traditional Chinese medicine to treat gastric cancer is not obvious, but the Chinese medicine combined with western medicine in treatment of gastric cancer can greatly improve the cure rate of the disease, and reduce the toxic side effects. Conclusion Although the surgery and chemotherapy is still the main method to treat gastric cancer, Chinese medicine for anti-tumor has the advantages of multi-target, multi-effect, safe and effective to be used. Therefore, the rational use of these advantages to develop anti-cancer drugs is the focus on the study of Chinese medicine. Integrative treatment of gastric cancer will become the development trend to treat gastric cancer. References | Related Articles | Metrics

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Current Situation Analysis on Hypophosphatemic Osteomalacia after Adefovir Dipivoxil Therapy for HepatitisB TIAN Yue-jie ,WANG Jin-ying, XIE Yan-jun, LU Chang-fei, LI Zhen-qing ,ZHANG Cui-fang 2013, 10(5): 294-298.  Abstract ( 239 )   PDF (680KB) ( 457 )   Current situation of hypophosphatemic osteomalacia after adefovir dipivoxil therapy for hepatitis B with low dosage home and abroad was retrospectively analyzed. Investigations revealed hypophosphatemic osteomalacia might occur in chronic hepatitis B patients with long -term use of adefovir dipivoxil at dosage of 10mg per day. The clinical features were slowly progressive distal muscle weakness, bone pain or even fracture. For it's difficulty to accurately diagnose in clinic and there is no warnings in the domestic drug specifications, more attention should be paid to the adverse reaction. The frequency and influence factors should be further researched. References | Related Articles | Metrics

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Literature Analysis on Adverse Reactions of Albendazole ZHAO Shi-dan ,WANG Hui, LIU Cui-li 2013, 10(5): 299-302.  Abstract ( 258 )   PDF (740KB) ( 606 )   Objective To understand the adverse reactions of albendazole especially common serious adverse reactions and to provide information for the clinical and general public safe use of albendazole. Methods The articles of case report were searched out from the Chinese National Knowledge Infrastructure and National Center for Biotechnology. Then the case materials and articles were organized, summarized and analyzed. Results The adverse reactions of albendazole generally involve the digestive system, skin and appendages, nervous system and blood system. Serious ADRs of albendazole are encephalitis/demyelinating, hepatic injury, anaemia and leucopenia. Conclusion Albendazole is surely effective for the treatment of parasitic diseases, but the occurrence of adverse reactions should be valued to promote the safety and reasonable use of drug. References | Related Articles | Metrics

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Study on Clinical Use Risk Management of High-Frequency Electrical Knife CHEN Xing-li ,ZHAO Yu-juan, ZHAO Yan 2013, 10(5): 303-305.  Abstract ( 259 )   PDF (669KB) ( 468 )   High-frequency electrical knife isa kind of medical equipment which has high safety requirements. This article introduces the composition and working principle of high -frequency electrical knife, discusses the common adverse events and their causes of high -frequency electrical knife from equipment failure and damage to human body, and summarizes precautions in its use. Some advices are given on risk management, so as to improve the level of risk management, and then to ensure safe and effective use of high-frequency electrical knife. References | Related Articles | Metrics

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Related Factors Analysis of Vomiting Caused by Commonly Used Antineoplastic HUNG Ping, WANG Tie-zhu, GE Wen-chao 2013, 10(5): 306-308.  Abstract ( 260 )   PDF (716KB) ( 221 )   Objective To investigate the related factors of vomiting in antineoplastic with the adverse drug reaction(ADR) database. Methods Using single factor and multiple logistic regression analysis Methods to analyze the influential factors of vomiting, while2 381 cases were selected in database as the purpose during the whole 2012. Results In 522 reports, multiple logistic regression analysis showed that patients who were female, with drinking history or cisplatin using were more susceptible to vomiting adverse reactions. Conclusion In this way we can understand the distribution of impact factors of vomiting in some antineoplastics. It makes for reducing the incidence of ADR on the individual situation of patients before chemotherapy and finding a new way for developing the study that is based on the ADR database. References | Related Articles | Metrics

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Analysis of 155 reports of ADR Induced by Quinolones ZHONG Han ,LIU Xiao-yan ,CUI Min ,SU Ying-jie 2013, 10(5): 309-311.  Abstract ( 238 )   PDF (651KB) ( 198 )   Abstract : Objective To determine adverse drug reaction (ADR ) occurrence associated with quinolones in clinical practices. Methods 155 reports of quinolones-induced ADR from 2010 to 2011 were analyzed. Results Nine drugs of quinolones were involved in 155 ADR reports, among which levofloxacin resulted in ADR most frequently(105 cases). The ADRs manifestations mainly covered allergies(40.4%) and digestive system disease symptoms(27.1%).Conclusion It is necessary to monitor clinical application of quinolones, therefore promote rational use of drug. References | Related Articles | Metrics

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Analysis of Adverse Event Reports of Surgicel in MAUDE Database Li Yu-ji ,SHI Yu-qing 2013, 10(5): 312-314.  Abstract ( 326 )   PDF (690KB) ( 267 )   Objective By analyzing the adverse everts of Surgicel which were collected from FDA MAUDE database on January 1,2008 to November 10,2012 and the characteristics of the adverse events, to provide strong technical support for the further development of adverse events of Surgicel monitoring work. Methods Statistically analyzed the collected data and discussed the safety of Surgicel. Results The manifestations of adverse events mainly included infection, incomplete absorption and allergies, possibly associated with material factor, patients factor and use factor. Conclusion By paying more attention to adverse events of absorbability hemostatic gauze, strengthening the analysis and utilization of the monitoring database, to provide effective information for the safe use of the medical device. References | Related Articles | Metrics