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08 September 2014, Volume 11 Issue 9 Previous Issue    Next Issue

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Pharmacodynamic Study on Antipyretic, Anti-inflammatory and Analgesic Effects of Yiye Anti-influenza Capsules GUO Shan-shan, MA Xue-ping, GAO Ying-jie, JIN Ya-hong, CUI Xiao-lan 2014, 11(9): 513-515.  Abstract ( 240 )   PDF (429KB) ( 179 )   Objective To evaluate the pharmacodynamic effects of Yiye anti-influenza capsules (YYAFC). Methods The relieving fever effect was observed on Saccharomyces siccum induced fever model of rats; the analgesic effect was investigated by hot plate method and body twist method; the anti-inflammatory effect was observed by the capillary permeability augmentation of mice induced by acetic acid. Results High-dose and medial-dose of YYAFC could significantly decrease the raised body temperature caused by Saccharomyces siccum in rats, depress the torsion body of mice and increased the pain thresholds for 1 hour(P < 0.05). It also could significantly inhibit capillary permeability augmentation caused by acetic acid in mice. Conclusion YYAFC has better effects on relieving fever, analgesia and anti-inflammation. References | Related Articles | Metrics

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Experimental Study on Chronic Toxicity of Kangguzhizengsheng Capsules in Rats FANG Xia 2014, 11(9): 516-520.  Abstract ( 226 )   PDF (513KB) ( 74 )   ObjectiveTo observe the chronic toxicity and severity occurred after administration of Kangguzhizengsheng capsules in rats. MethodsWistar rats were randomly divided into 4 groups. Each group was given Kangguzhizengsheng capsule at dose of 0.6g/100 g, 0.3 g/100 g, 0.15 g/100 g daily for up to 13 weeks, respectively. Blank control group was given same bulk of distilled water. After the withdrawal of the drug for 4 weeks the rats' body weight, hematology, blood biochemistry analysis and organ coefficients were measured, and organ coefficient were measured and main organs were examined by pathological method. ResultsThe outer appearance and behavior, body weights, organ coefficients, the indexes of hematology and biochemistry analysis in rats of drug taking groups showed no significant difference from those of control group. Pathological examination discovered no obvious pathological changes related to drug toxicity and no delayed toxicity reaction after drug withdrawal. ConclusionKangguzhizengsheng capsules had no obvious toxicity in rats for long-term administration, and is safe to use with clinical dosage. References | Related Articles | Metrics

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Research of Dose-efficacy on Suppression of Tripterygium Wilfordii Tablets and Tripterygium Wilfordii Polyglycoside Tablets on Acute Inflammation FENG Qun, SUN Rong, SUN Xiao-qian 2014, 11(9): 521-523.  Abstract ( 278 )   PDF (521KB) ( 209 )   ObjectiveTo explore the dose range of anti-inflammatory effect of Tripterygium wilfordii tablets (TWT) and Tripterygium wilfordii polyglycoside (TWP)tablets and compare with the results of them, so as to provide the basis for clinical medication. MethodsMice were respectively given the different doses of TWT and TWP for 3 consecutive days by gavage. The anti-inflammatory effects of TWT and TWP were explored according to the model of ear edema by mixture of compound croton oil we made. ED50 and ED95 of anti-inflammatory efficacy and LD50 and LD5 of acute toxicity test were calculated. ResultsED50 and 95% confidence limit of TWT and TWP were respectively 17.753 (13.567~21.448) μg·kg-1, 9.236 (5.570~ 11.915) mg·kg-1, which were equal to triptolide of 17.753 μg·kg-1, 8.922 μg·kg-1. They were respectively equal to 20.30 and 10.21 times of 70 kg person's daily dried medicine expenses. ConclusionTWT and TWP show good suppression on the acute inflammation caused by mixture of compound croton oil. The potency of TWP is better than that of TWT. Triptolide with good effect of anti-inflammation shows a good "dose-effect" relationship. But it is not the only material basis of Tripterygium wilfordii for anti-inflammatory effect. The effective dose ranges of them show a certain dose-effect relationship. The mechanism of anti-inflammatory effect needs a further study. References | Related Articles | Metrics

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HPLC Ddouble Wavelength Simultaneous Determination of Four Components in Paeonia lactiflora Pall LIU Meng-ting, FANG Jing, SUN Hao, WU Hong-wei, FU Mei-hong1YANG Hong-jun 2014, 11(9): 524-527.  Abstract ( 287 )   PDF (568KB) ( 586 )   ObjectiveTo establish a HPLC method for determining the content of catechin, paeoniflorin, benzoic acid and paeonol in Paeonia lactiflora Pall at different wavelength. MethodsIt was performed on Diamonsil colunm C18 5 m 250×4.6 mm, mobile phase was 0.1% methanoic acid-methyl cyanide, gradient elute, detection wavelength was 230 nm (catechin, paeoniflorin, benzoic acid) and 275 nm (paeonol), flow rate was 1mL·min-1, and colunm temperature was 30℃. ResultsThe contents of four active components in Paeonia Lactiflora Pall from different habitats were quite different. The contents of catechin, paeoniflorin, benzoic acid and paeonol were 0%~0.052%, 1.044~4.326%, 0.126~0.249%, 0.022~1.060% respectively. ConclusionThe method is simple and accurate with good reproducibility, it is suitable for determining the contents of catechin, paeoniflorin, benzoic acid and paeonol in Paeonia lactiflora Pall. References | Related Articles | Metrics

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Research for Homobarringtonie and Related Substances of Its Preparations GUO Huan-ying, WANG Xiao-gong, ZHANG Xiao-min, Gao Min, DING Li-fang, WU Jian-zhong, LIU Hai-jing 2014, 11(9): 528-530.  Abstract ( 237 )   PDF (496KB) ( 193 )   ObjectiveTo build up RP-HPLC method for measuring homobarringtonie and related substances of its preparations, and to analyze the content of homobarringtonie related substances after different treatment. MethodsApply Germsil-P C18 chromatographic column (250×4.6 mm, 5 μm)and use 10 mmol·L-1 monopotassium phosphate as flow phase A while methanol as B. Apply gradient elution with the flow rate 1 mL·min-1, check the wavelength 288 nm with column temperature at 30 ℃. ResultsHomobarringtonie presented great linear relationship with peak area in the range of 2 ~30μg, with r=0.9996; when loading 20 μg homobarringtonie in 6 repeats, impurity A, impurity B, and homobarringtonie RSD were 3.28%, 4.69%, and 1.12%, respectively. ConclusionApplying this method can precisely measure the content of homobarringtonie, and related substances, such as impurity A and impurity B. References | Related Articles | Metrics

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Research on the Dissolution Profiles of Atorvastatin Calcium Tablets CAI Yin, ZHU Jin-lian, WU Li, ZHOU Zhi-liang, MIAO Yan, Dai Lin-dong 2014, 11(9): 531-535.  Abstract ( 273 )   PDF (593KB) ( 719 )   ObjectiveTo establish the dissolution method of atorvastatin calcium tablets. MethodsColumn Agilent TC-C18(4.6×250 mm, 5μm) with mobile phase consisted of acetonitrile: tetrahydrofuran: 0.05 M ammonium citrate buffer pH 4.0 (27:20:53) at a flow rate of 1.5 mL·min-1 when the detective wavelength was set at 244 nm, plus the atorvastatin and atorvastatin related compound H peak area to calculate the cumulative release amount(%); ResultsAtorvastatin calcium was instable in pH 1.0 hydrochloric acid solution and acetic acid- ammonium acetate buffer (pH 4.5) and degrade to atorvastatin related compound H, the pH 1.0 hydrochloric acid solution dissolution profile of atorvastatin calcium tablets was the slowest one. ConclusionThe pH 1.0 hydrochloric acid solution dissolution profile of atorvastatin calcium tablets can be used as the basis for formulation screening. References | Related Articles | Metrics

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Construction of the Data Sharing Platform of Adverse Drug Reaction Reporting and Thinking on Risk Communication Wang Ling, Huang Ling 2014, 11(9): 536-541.  Abstract ( 245 )   PDF (678KB) ( 324 )   ObjectiveTo provide references for the promotion of effective communication and use of drug safety information in China. MethodsThe construction and the application of the data sharing platform of monitoring system were introduced and analyzed, the comparative study on the related methods and practices of information disclosure at home and abroad were carried out. Suggestions on improving the exchange of drug safety information and risk communication in China were made. Resultsand ConclusionAt present, ADR reporting system, principle of drug safety information openness have been carried out in China. The construction and the application of the data sharing platform in ADR data sharing made a new progress. Risk communication is an important link of the drug risk management, the government departments should learn some experiences from those advanced countries. It is suggested to perfect drug safety information public issue mechanism, standardize drug safety information dissemination content, form and process, ensure the authority, standardization and timelines of information and enhance information utilization to play an important role on guiding clinical rational use of drug. References | Related Articles | Metrics

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Legal Issues about Drug Labeling Defects LI Ming-shi, YANG Yue 2014, 11(9): 542-546.  Abstract ( 222 )   PDF (692KB) ( 329 )   ObjectiveTo propose suggestions to improve drug labeling management of China, provide reference for regulation revise. MethodsBy collecting current labeling documents in CFDA and FDA, analyze drug labeling management from legal perspective. Resultsand ConclusionCurrently, our country should clearly define drug labeling defects, make sure the standard of how to recognize labeling defects and the labeling defects liability, take steps to revise the regulations to guide drug labeling design, make the drug use safer and more effective. References | Related Articles | Metrics

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Role of Pharmaceutical Enterprise in Periodic Safety Update Report WEI Shu-min, ZHEN Zhi-qin, LI Ke-nan 2014, 11(9): 547-549.  Abstract ( 315 )   PDF (720KB) ( 282 )   The periodic safety update report (PSUR) as an important tool for pharmacovigilance is to improve our adverse drug reaction reporting system, meanwhile it is an important method for drug safety administration of post-marketing drugs. PSUR should be submitted by pharmaceutical enterprises at defined time point. This paper analyzed and evaluated the present situation of PSUR in our country together with responsibility and challenge of pharmaceutical enterprises to bring up corresponding suggestion． References | Related Articles | Metrics

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Reasons for Nizoral Withdrawal from the Market and Reflections on Risk Management WANG Dan, WU Gui-zhi, NIE Xiao-lu 2014, 11(9): 550-553.  Abstract ( 257 )   PDF (657KB) ( 432 )   This article reviews the recent domestic and international activities of ketoconazole regulation, analyzes systematically the reasons of Nizoral (ketoconazole tablets) withdrawal from aspects of drug adverse reaction, clinical usage, risk management and benefit-risk balance, and provides a reference case to further elucidates the mechanism of drugs out of market and the role of risk management in the drug life cycle. References | Related Articles | Metrics

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YANG Yue-ming1 TIAN Chun-hua2 WEI Jing1 JIN Dan1 MA Hui1 WANG Yu-xin1 WANG Li-gang1 YANG Hua1 GENG Feng-ying1 (1Liaoning Adverse Drug Reaction Monitoring Center, Liaoning Shenyang 110003, China; 2014, 11(9): 554-556.  Abstract ( 267 )   PDF (643KB) ( 178 )   The retrospective study was used to review the adverse drug reaction of paracetamol, ibuprofen, alidine, analgin and aspirin-DL-lysine. Using method of comparative study, we introduced the medication guide, risk management strategy and risk intervention measures of FDA and EMA.Comparing pediatric labeling of paracetamol and ibuprofen between China and the U.S. This paper analyzed the reasons of problems existing in different aspects of pediatric antipyretic administration and gave proposals for its use. References | Related Articles | Metrics

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Retrospective Analysis of 34 Cases of Adverse Reactions Induced by Methotrexate YANG Yu-wei, DONG Di, SONG Fei 2014, 11(9): 557-560.  Abstract ( 215 )   PDF (711KB) ( 322 )   ObjectiveTo investigate the clinical features of the adverse reactions caused by methotrexate, provide reference for rational use of methotrexate. Methods 34 cases of methotrexate adverse reaction reports in Beijing Jishuitan hospital were retrospectively analyzed on the age, sex, administration and dosage, the type of adverse reactions, the main clinical manifestations from 2005 to 2012. Results24 patients (70.59%) were male in 34 cases and 10 were female (29.41%). Age range was 8 to 33 years old, 15 cases were 11 to 15 years old (44.12%). The adverse reactions induced by methotrexate could occur in ten minutes after administration, could also occur in seven days. Adverse reactions involved multiple systems, and the clinical manifestations were complicated and diversified. Damage to the skin and its appendages was the hightest, followed by the digestive system, systemic damage, nervous system, mucosal damage and reproductive system. ConclusionThe analysis concludes that adverse events of high-dosage methotrexate deserve more clinical attention, strengthening the monitoring of adverse reactions, early detecting of symptomatic treatment and protecting patients medication safely. References | Related Articles | Metrics

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Study on the Evaluation for Quality of Adverse Drug Reaction Reports in China LIU Wei, LI Xin-lin CHEN Gang, SHEN Lu, DONG Duo, LIU Cui-li, WANG Ya-li 2014, 11(9): 561-563.  Abstract ( 218 )   PDF (692KB) ( 311 )   ObjectiveTo review the progress of the evaluation for the quality of the adverse drug reactions(ADR) in China. MethodsProgress of the evaluation for the quality of the ICSRS and the ADR database in China were reviewed and summarized. ResultsBy the evaluation for the quality of the ICSRS, the detail problems such as spelling could be found. By the evaluation for the quality of the ADR database, the macroscopic problems such as the method and the trend could be found. They complement each other and play a positive role for the healthy development of ADR monitoring. ConclusionThe quality of ADR report is an important content of the ADR monitoring, so it is very necessary to establish scientific and operable evaluation system and methods. References | Related Articles | Metrics

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Application and Risk Evaluation of Electrospinning Nanofibers in Dressing XU Yun, DENG Jie 2014, 11(9): 564-566.  Abstract ( 320 )   PDF (690KB) ( 501 )   Electrospinning is an important method that produces continuous polymer fibers with diameters in the range of nanometer to micrometer, which has been used in the process of medical dressing. Since the special physicochemical and biological features of nanomaterials, many focus has been raised on the usage in medical area. We discussed the progress of medical dressing made with electrospinning and the risk management thereof. References | Related Articles | Metrics