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10 December 2011, Volume 8 Issue 12 Previous Issue    Next Issue

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Preparation and Release Behavior of Paracetamol Sustained-Selease Pellets XIONG Xiao-bin, LI Jin-ming, LI xiang, LI Xin 2011, 8(12): 705-708.  Abstract ( 217 )   PDF (355KB) ( 301 )   Objective In this paper we wanted to prepare paracetamol sustaied-release pellets and to study their release behavior. Methods Cenrifugal granulation method was used to prepare MCC pellets and paracetamol pellets respectively. On that basis Eudragit RS30D/RL30D as a coating material was adopted to coat the paracetamol pellets with a fluid bed spray processor. HPLC method was utilized to determine the release behavior of paracetamol sustained-release pellets. The coating prescription parameters were investigated and optimized with single factor experiments. Results The paracetamol sustained-release pellets coated with 10％coating material sustained released best, and the coating material consisted of Eudragit RS30D/RL30D(15:l,w/w), TEC(25％,w/w) and talc(40％,w/w). Conclusion These showed that paracetamol sustained-release pellets contained a characteristic of sustained-release and the established process and formula were simple and stable. References | Related Articles | Metrics

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Contents Determination of Cinobufagin and Resibufogenin in Shuanglong Capsule by RP-HPLC TANG Xiao-xia, LI Ping, WU Fei 2011, 8(12): 709-710.  Abstract ( 195 )   PDF (404KB) ( 191 )   Objective To develop a method for the content determination of cinobufagin and resibufogenin in shuanglong capsule. Methods Analysis was carried out on a Phenomenex luna C18(250 mm×4.6 mm, 5μm) column, the mobile phase was acetonitrile water(50:50,v/v) at the flow rate of 0.8mL·min-1, and the detection wavelength was set at 296nm. Results The result showed that the method of analysis established in this study have good reproducibility and stability. The cinobufagin average recovery was 98.5% (RSD=0.55%,n=6); The resibufogenin average recovery was 101.0%(RSD=0.67%,n=6). Conclusion The method is accurate and repeatable, and it can be applied to control the quality of this drug. References | Related Articles | Metrics

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Clinical Observation on Lanqin Oral Liquid Combined with Ribavirin Aerosol on Herpangina HU Zhi-qiang 2011, 8(12): 711-712.  Abstract ( 225 )   PDF (331KB) ( 398 )   Objective To observe the clinical effect of Lanqin oral liquid combined with Ribavirin aerosol on herpangina. Methods 60 cases of children patients who had herpangina were divided into 2 groups randomly. The control group received Cefuroxime Sodium, Vitamin C, Ribavirin Aerosol; and the treatment group received Lanqin Oral Liquid additionally. The effect was evaluated according to herpangina control index. Results The remission time of clinical symptoms and signs and total course of disease in treatment group were significantly(P <0.05) shorter than in control group. Conclusion Lanqin oral Liquid combined with Ribavirin aerosol is effective for herpangina, and is worth popularizing. References | Related Articles | Metrics

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Study on Quality Control Methodology of Menispermine from Rhizoma Menispermi under the Guidance of Toxicity ZHENG Li-na, SUN Rong, YANG Qian 2011, 8(12): 713-715.  Abstract ( 155 )   PDF (397KB) ( 288 )   Objective Under the guidance of the acute toxicity of different components of Rhizoma Menispermi, the quality control methodology of Menispermine from Rhizoma Menispermi was studied. Methods HPLC was used to determine the content of Menispermine in all-components, water extract,alcohol extract of Rhizoma Menispermi. The C18 column(250mm×4.6mm,5μm)with the solvent system consisting of acetonitrile -0.05% triethylamine(40:60)was used.The detection wavelength was at 282nm by UV spectrometry and the column temperature was 30℃. The flow rate was 1.0mL/min. Results During 0.82~9.84 g, the linear regression of menispermine was favorable. The average recovery rates were 98.7%. In the determination of Menispermine in different components of Rhizoma Menispermi, it was found that the size order of the content of Menispermine was all-component > water extract > alcohol extract. Conclusion The method that Menispermine was determined by HPLC had good linearity, precision, stability and reproducibility, high recovery. There was a certain relationship between the content of Menispermine and acute toxicity in different components of Rhizoma Menispermi, but not completelyconsistent. It was proved that Chinese medicine was complex, and Menispermine was not the only toxic material basis of Rhizoma Menispermi. So Looking for other toxic ingredients to control the quality of Rhizoma Menispermi by more component index had an important role in the toxicity study of Rhizoma Menispermi. References | Related Articles | Metrics

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Research Report of the United States Medical Device Recall Information ZHENG Li-jia, ZHAO Yan, GUO Xue, WANG Gang, DONG Fang 2011, 8(12): 716-718.  Abstract ( 183 )   PDF (564KB) ( 369 )   By analyzing the laws and regulations of America, introduced the medical device recall information; based on the United States medical devices recall database for depth study, also for our country to carry out medical device recall. Related Articles | Metrics

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The Study on Implementation Strategies of Medical Device Recall WEN Qiang, DONG Fang, WANG Gang, GUO Xue, ZHAO Yan, ZHENG Li-jia 2011, 8(12): 719-721.  Abstract ( 183 )   PDF (474KB) ( 197 )   Nowadays, implementing the defective medical device recall is the international practice, which has played an important role in keeping the public safety. The study, based on the regulation of medical device recall in China, has analysed 5 aspects of the medical device recall. Srategies including Problem identification, Depth determination, Methods choice, Information release and Effect evaluation. References | Related Articles | Metrics

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The Study on Medical Device Recall Typical Cases ZHAO Yan, ZHENG Li-jia, WANG Gang, GUO Xue, DONG Fang 2011, 8(12): 722-724.  Abstract ( 229 )   PDF (475KB) ( 483 )   By analyzing the medical device recall typical cases at home and abroad, to explain the treating process and fundamental of medical device recall. Aims to provide some references to the improvement of recall system in China. References | Related Articles | Metrics

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Safety Monitoring of Influenza A（H1N1）Vaccine in US WANG Dan, DONG Duo, WANG Ya-li, HOU Yong-fang, WANG Chun-ting, LIU Cui-li 2011, 8(12): 725-728.  Abstract ( 180 )   PDF (497KB) ( 213 )   Vaccination campaigns were initiated in many countries after 2009 H1N1 influenza pandemic had occurred. This article will discuss the activities of safety monitoring after immunization at the level of US governments, to compare the difference between the US and China in adverse events monitoring and provide reference for the profound development of China pharmacovigilance. References | Related Articles | Metrics

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Post-marketing Safty and Risk Analysis of Xiyanping Injection YANG Le 2011, 8(12): 729-730.  Abstract ( 166 )   PDF (530KB) ( 270 )   By reviewing the relevant references and reports of the adverse drug reaction cases of Xiyanping in China, and analyzing the post marketing safety studies, the safety and risks in post-marketing period of Xiyanping is reevaluated in this article. The author puts forward risk management measures according to the characteristics of medicine. Suggestions are proposed for a safe and rational use of this medicine. References | Related Articles | Metrics

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Analysis of Adverse Reaction/Events Induced by 465 Chinese Crude Drug and Chinese Herbal Pieces on the Literature LIU Xin, JIN Rui, CUI Yi-Ran, ZHANG Qian, ZHANG Bing 2011, 8(12): 731-734.  Abstract ( 216 )   PDF (529KB) ( 621 )   Objective To analyze and summarize the adverse reactions or vent information of 465 traditional Chinese drugs Based on reported in the literature. Methods The reports in the literature of Chinese Crude Drug/Chinese Herbal Pieces were searched and analyzed by bibliometrics and statistic methods. Results The 1 256 reports about adverse reactions with 8 560 cases were collected, in the 465 Common Chinese Herbal Pieces. By analyzing again, It was found that 177 Chinese Herbal Pieces, 716 literatures, 2 208 clinical cases in the usage of convention and the correct route of administration. According to reported in the literature analysis, Chinese Crude Drug/Chinese Herbal Pieces adverse reactions take place mainly due to excessive doses, length time, in the process of Concocting and individual difference and so on. In the convention usage and dosage, Chinese Herbal Pieces reports of adverse reactions is relatively small, and mainly concentrated in the allergic population and is generally considered the drugs which were not regarded as adverse reactions. Fewer report adverse reactions about toxic traditional Chinese medicine was found, due to the results of all of its prevention. Conclusion I believe that the Chinese Crude Drug/Chinese Herbal Pieces of adverse reactions should be neither exaggerated nor ignored and should be an objective understanding and evaluation of Chinese Herbal Pieces of adverse reactions. References | Related Articles | Metrics

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The Investigation and Analysis of Drug Use in the Pediatric Clinic of One Hospital ZHANG Chuan-jun, FENG Jian-zhong, LIU Yong, SUN Ji-zhan, LIU Wen-dong, JI Chang-cun 2011, 8(12): 735-737.  Abstract ( 205 )   PDF (489KB) ( 176 )   Objective To investigate and analysis the medicine prescription indicators and antimicrobial drugs in the pediatric clinic of one hospital,so as to provide reference and caution for clinical medication, and calls for attention to children's drug treatment. Methods To obtain outpatient prescription provided by HIS data, and a random sample of electronic prescribing information in one hospital from 2008 to 2010, refer to 2011 edition of "three-level general hospitals of medical quality management and control indicators " and statistical analysis the indicators of drug treatment. Results The average number of drugs were 3.55 species in each pediatric outpatient visit, the average drug cost per treatment was 72.6~87.58 yuan, the percentage of injecting drug used was 77.46%, national essential medicines used in the percentage was 49.68%, treatment with antibiotics was 64.09~65.75%, the ratio of two or more use of antibiotics was more than 30%. Conclusion The children outpatient prescription was over-emphasis on intravenous medicines use, reasonable use of antibiotics should be taken enough attention seriously. References | Related Articles | Metrics

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Monitoring and Analysis of Suspected Adverse Events on Medical Suture Line in Guangdong YANG Li-jun, WANG Hong, DENG Jian-xiong LU Shu-tang 2011, 8(12): 738-740.  Abstract ( 202 )   PDF (621KB) ( 502 )   Objective Analyzing suspicious adverse events induced by medical suture line through emphasis on monitoring. Methods Information of suspicious adverse events caused by medical suture line in 42 hospitals in Guangdong were monitored. Data was inputted in Epidata 3.02 software and was analyzed statistically by Excel. Results In all 88 suspected adverse events, the percentage of which caused by absorbable medical suture line is 53.4%. These events were mainly showed as sutures easy to break, infection, suture reaction, no absorption or delayed absorption, and poor wound healing. The agents may include product quality, patients' body constitution, users' operation. 88.6% of these patients need further treatment to prevent further injury. Conclusion It is considerable that the adverse events caused by medical suture line could be. It's safety should be specially monitored in long term. References | Related Articles | Metrics

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Progress In Structural Modification Of Puerarin WU Jing, GAO Xing, Zhang Yu, WU Lan-tuo-ya 2011, 8(12): 741-743.  Abstract ( 191 )   PDF (584KB) ( 541 )   Puerarin, as one of the important active components of pueraria lobato(Wild) Ohwi.,puerarin(4',7-dihydroxy-8-C-β-D-gluco-isoflavone) has broad pharmacological activities, such as vasodilating function, distinct improving brain microcirc ulation, peripheral circulation, etc. It is applied clinically for cardiovascular diseases, such as cardiac angina, miocardial infarction, blood hyperviscosity, etc. However the puerarin's clinical application had been restricted because of its bad water solubility and liposolubility. So it seemed urgent to improve its solubility and to make structural modification to puerarin to get good character derivates of puerarin. This review describes the structural modification of puerarin recently in order to provide the reference for the study on puerarin in the future. References | Related Articles | Metrics

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Research on the Chemical Constituents and Pharmacological Activities of Polygonum orientale L. LV Jun-hai, ZHANG Hai-feng, TENG Kun, SUN Jian 2011, 8(12): 744-745.  Abstract ( 225 )   PDF (549KB) ( 335 )   Polygonum orientale L. is important and valuable medicinal plants．The study showed that the plants contain flavonoids, lignanoids, limonins and other chemical constituents． Pharmacological effects：improve immune, against myocardial ischemia and anti-tumor, anti-oxidation．This article presented a review on chemical components, pharmacological effects, which gave a reference for further research in future． References | Related Articles | Metrics

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Research Development on Chemical Composition in Herba Menthae Related with Efficacy and Toxicity HE Xi-wang, LI Xiao-yu, SUN Rong 2011, 8(12): 746-749.  Abstract ( 287 )   PDF (663KB) ( 392 )   Objective Summarizing the current states of chemical composition of Herba Menthae related with its efficacy and toxicity, in order to identify its effective and toxical composition and offer the accordance and research ideas for further research on the relationship between efficacy, toxicity and chemical composition of Herba Menthae. Methods Ancient books and the related literatures in the recent years of Herba Menthae were collated, analyzed and summarized. Results Volatile oil are both the main material basis for efficacy and toxicity in Herba Menthae; the research about efficacy, material basis and toxicity of Herba Menthae is isolated and short of relevance. The research for its basis of extraction and separation technology research and quality control is also seldom-reported. Conclusion As a common-used record of TCM, Herba Menthae is urgent to be studied, based on the efficacy and chemicals related basic and "keep- efficacy" and "control- toxicity" research to provide experimental basement and literature reference for rational use in clinic. References | Related Articles | Metrics

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Retrospective Analysis of 229 Cases of the Adverse Drug Reaction on Children GUO Fang-fang, XIE qing, ZHOU Wen 2011, 8(12): 750-752.  Abstract ( 252 )   PDF (569KB) ( 205 )   Objective To investigate the adverse drug reaction(ADR) on children in our hospital, and explore the related factors. Methods Retrospective analyses of ADR were performed on the children cases voluntarily submitted by the medical staff of pediatrics in our hospital. Results A total of 266 suspected medicines were involved in 229 ADR cases, among which 170 cases of anti-infective drugs followed by 25 cases of traditional Chinese medicine injection. 61.65% of anti-infective drugs were antibiotics, and 55 cases were the third generation cephalosporin. Intravenous route was the most common routes for ADR. Skin and appendages damage were observed in 66.9% of cases. 167 patients were cured and 62 cases were improved after drug was withdrawn or receiving the appropriate treatment. Conclusion ADRs were related to many factors, and rational use of drugs was needed to reduce the incidence of ADR. References | Related Articles | Metrics

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Analysis on 748 Cases ofβ-lactam Antibiotics Drug Adverse Reaction ZHANG Shu-qiang, XING Rong, WANG Qun, SHI Pei-lan, XIE Dong-mei, XU Jian 2011, 8(12): 753-754.  Abstract ( 202 )   PDF (687KB) ( 271 )   Objective To investigate the situation of β-lactam antibiotics drug adverse reactions in Bengbu region. Method According to gender, age, administration route, drug category, organs or systems, clinical manifestations Involved with ADR, and so on, 748 cases of β-lactam antibiotics drug adverse reactions in Bengbu region reported from Jan 2010 to Dec 2010 were analyzed. Results 26 β-lactam antibiotics drugs were involved with ADR. As to the ADR frequence, the highest was related to amoxicillin, and then were related to cephalexin and cephradine. The major organ-system damage involved in ADR was skin and appendages disorders, which accounted for 47.48% of the total, and a serious ADR occurred. Conclusion Clinical appliance of β-lactam antibiotics drug should be standardized to reduce the ADR incidence. References | Related Articles | Metrics

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Analysis On the 405 New/Serious ADR Cases' Adverse Reaction in Baoshan District LI Qing, SHENG Hong-bin 2011, 8(12): 755-758.  Abstract ( 225 )   PDF (637KB) ( 189 )   Objective To explore the warning signal, improve the quality of adverse drug reaction(ADR) supervision and promote clinical drug safety through the statistical analysis of adverse drug reaction(ADR). Methods Choose the new & serious 405 ADRs cases in Baoshan District from January to June in 2010 as a sample, on which do statistical analysis in various ways by EXCEL and manual screening. Results In the 405 cases, including 192 cases who are over 60a(47.1%), ADRs are mainly caused by Chinese patent medicines(37.8%), anti-microbiology medicine(33.9%) and intravenous injection(57.7%). ADRs mainly affects the digestive system, skin and nervous system ,which respectively accounted for 34.1%,22.3% and 20.9%. Conclusion ADRs are caused by many factors, including patient`s age, drug types and the way of use, It must pay great attention to Chinese patent medicines and anti-microbiology medicine. The clinical manifestation is also becoming more and more pluralistic. Therefore, we should strengthen the monitoring method and rational use of drugs to ensure medication safety and efficiency. References | Related Articles | Metrics

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Literature Analysis on 189 Cases Adverse Reaction of Chuanhuning Injection ZENG Cong-yan, QIU Kai-yue 2011, 8(12): 759-762.  Abstract ( 206 )   PDF (682KB) ( 327 )   Objective To explore the general pattern and characteristics of adverse drug reactions(ADR) induced by Chuanhuning injection so as to provide references for clinical rational drug use. Methods ADR cases induced by Chuanhuning injection that retrieved from domestic medical journals during 1998~2010 were analyzed statistically. Results ADR of Chuanhuning injection were independent of patient's sex, and mostly occurred in the <10 group. They usually occurred in the first 30 minutes after taking the drug. ADR could involve in multiple organs and systems, and clinical manifestations were various, mainly were allergic reaction and thrombocytopenia,symptomatic treatment,prognosis much good. Conclusion Doctors and pharmacists should know the pattern and characteristics of ADR, and the use of Chuanhuning injection should be under strict monitoring to reduce the occurrence of serious ADR. References | Related Articles | Metrics