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    08 April 2015, Volume 12 Issue 4 Previous Issue    Next Issue

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    Inhibition Effects of Tannin Part of Tibetan Medicine Phyllanthi Fructus on the Transplanted Tumor in Mice
    FENG Guang-yuan,LI Deng-ke,WU Ling-fang,ZHANG Lan-zhen,SUN Zhen-xiao
    2015, 12(4): 193-196. 
    Abstract ( 302 )   PDF (348KB) ( 199 )  
    Objective To investigate the antitumor activity of tannin part of Phyllanthi fructus on S180 and H22 tumor-bearing mice. Methods The ICR mice were divided into control group, model group, tannin part of Phyllanthi fructus low (0.5 g·kg-1, the equivalent of crude drug 3.64 g·kg-1), medium (1.0 g·kg-1, the equivalent of crude drug 7.27 g·kg-1), high (2.0 g·kg-1, the equivalent of crude drug 14.54 g·kg-1) dose group, a separate cyclopho-sphamide group. After continuous intragastric administered 10 d(S180) and 12 d(H22), the tumor inhibition rate, thymus index and spleen index were calculated respectively. Results The tumor inhibition rate of low, medium and high dose groups of tannin part of Phyllanthi fructus on S180 tumor-bearing mice were 16.52%,40.08% (P<0.05),56.19%(P <0.01), on H22 tumor-bearing mice were 18.36%, 34.01% (P <0.05), 51.02% P <0.01). Compared to the model group, thymus index and spleen index of all tannin part of Phyllanthi fructus treated groups were not significantly different(P>0.05). Conclusion Intragastric administration of tannin part of Phyllanthi fructus significantly inhibited the tumor growth in the tumor-bearing mice in a dose-dependent manner. No obvious changes were detected in immune organs in the trial groups.
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    Effects of Astragalus on Intercellular Adhesion Molecule-1 and Vascular Cell Adhesion Molecule-1 in Rats of Acute Lung Injury
    ZHOU Yi,LI Huo-ping,XIA Guang-ming,ZHANG Hui,JIN Zhao-xia,ZHOU Fan,SHI Su-ping
    2015, 12(4): 197-199. 
    Abstract ( 259 )   PDF (347KB) ( 90 )  
    Objective To investigate the protective effects of Astragalus on acute lung injury and to explore the role of intercellular adhesion molecule-1 (ICAM-1) and vascular cell adhesion molecule-1 (VCAM-1) on acute lung injury in rats. Methods 30 Wistar rats were randomly divided into control group, model group and Astragalus group (n=10 , respectively). All rats were sacrificed 6 h after administration of Astragalus, removed lung tissue for pathological observation, and examined the expression of myeloperoxidase (MPO), superoxide dismutase (SOD) activity and ICAM-1, VCAM-1 in each group. Results Compared with control group, MPO activity and ICAM-1, VCAM-1 expression were significantly increased in model group and Astragalus group (P <0.05 or P <0.01 respectively).However, in Astragalus group, MPO activity and ICAM-1, VCAM-1 expression were significantly lower than that of model group (P <0.05 or P <0.01 respectively). Lung tissue SOD activity was significantly lower after lung injury(P <0.05 or P <0.01 respectively), but it was significantly enhanced after treatment with Astragalus (P <0.05). Conclusion Astragalus can play a protective effect on ALI, and the mechanism may relate to regulate the expression of ICAM-1, VCAM-1 and increase the activity of SOD.
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    Bupleurum Injection Quality Study and Reflection Based on"Effection - Toxicity " Related Patterns
    XU Nan,SUN Rong,LI Xiao-yu,WANG Yu-tuan,SHI Hai-yan
    2015, 12(4): 200-202. 
    Abstract ( 276 )   PDF (664KB) ( 290 )  
    Objective By evaluation of the quality of Bupleurum injection and study on its fingerprints, to provide evidence to enhance the quality standards of the product, ensure safety and efficacy and carry out material basis research of "toxicity-effection" for Bupleurum injection. Methods Under the current Ministry of Health ministerial standards, using gas chromatography to determinate Bupleurum injection's furfural content of different manufacturers and batches, compare the differences of Bupleurum injection fingerprint characteristics of different manufacturers and batches. Results Bupleurum injection furfural content of different manufacturers and batches is different. The number of peaks and the peak area before the 19 minutes in Bupleurum injection fingerprints exist significant differences.Conclusion Currently furfural content of Bupleurum injection conform with the current standard, Bupleurum injection chromatographic fingerprint method can be used to determine the different sources. To lay the foundation of the evaluation of Bupleurum injection for the construction of a comprehensive quality control system on "effection-toxicity" related patterns, it's necessary to further strengthen the toxic material basis research for Bupleurum injection.
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    Study on Rat's Antipyretic Effect Accompanied by Side Effects of Water Extraction Components of Bupleurum
    SHI Liang,,HUANG Na-na,SUN Xiao-qian,LI Xiao-yu,SUN Rong
    2015, 12(4): 203-206. 
    Abstract ( 346 )   PDF (479KB) ( 207 )  
    Objective To study the antipyretic effects and accompanied side effects of water extraction of Bupleurum components for rat fever model so as to provide the experimental basis for "efficacy- toxicity" correlation. Methods Rat fever model was established via the back injection of 2,4-dinitrophenol (DNP). Different doses of water extraction of Bupleurum components were given to rats by gavage. The temperature was detected in anus once every 30 minutes, continuously determined for 4 hours, recorded anal temperature and observed the antipyretic effect. At the same time, the levels of ALT, AST, TBA, TBIL, Cr and BUN in serum were detected and the heart, liver and kidney indexes were calculated. Efficacy and accompanied side effects were evaluated via all these data. Results Antipyretic effect was significantly reflected when rat fever model caused by DNP were treated with water extraction of Bupleurum components by gavage. The activities of ALT and AST increased obviously after administration for consecutive 3 days. Conclusion Water extraction of Bupleurum components has the effect of dropping in temperature to the rat fever model, which is accompanied by hepatotoxicity. The effect and hepatotoxicity all show a certain dose dependence relationships.
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    Research Development on Pharmacological Effects and Toxicity of Saikosaponin-d
    Li Xiao-yu,Dou Li-wen,,Sun Jia-hui,,SUN Rong
    2015, 12(4): 207-210. 
    Abstract ( 637 )   PDF (420KB) ( 476 )  
    Objective To review the researches of pharmacological effects and toxicity of saikosaponin-d, which is the chemical components of Bupleurum. Methods References in the last decades at home and abroad about the pharmacological effects and toxicity of saikosaponin-d were collated, analyzed and summarized, which was the main effective components of Bupleurum. Results Saikosaponin-d had the pharmacological effects of anti-tumor, liver protection, potential estrogen-like effect and nephropathy protection. Toxicology showed that saikosaponin-d had high toxicity, such as haemolytic effect, high hepatotoxicity in vitro. Conclusion Saikosaponin-d can induce the change of cell membrane penetrability, which lead to cell damage or necrocytosis. The toxic target organ may be liver and liver, injury may be connected with multiple pathways oxidative stress damage.
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    Recommendations on Risk Control and Analysis of the Problems Existing on Labeling Contents of Medicines Used for Pregnant and Lactating Women in Package Inserts in China
    XIA Dong-sheng
    2015, 12(4): 211-218. 
    Abstract ( 352 )   PDF (693KB) ( 592 )  
    Objective To promote the improvement and standardization of labeling contents of medicines used for pregnant and lactating women on package inserts in China, and to ensure the safety and effectiveness of medicines used for pregnant and lactating women. Methods By means of literature analysis, the problems existing on labeling contents of medicines used for pregnant and lactating women in package inserts in China were comprehensively summarized, then their causes were analyzed and the appropriate risk control recommendations were proposed. Results The labeling contents of medicines used for pregnant and lactating women in some package inserts were insufficient or imprecise in our country in present,which may be related to more factors, such as insufficient studies of medication for pregnant and lactating women, lack of the sense of responsibility of enterprises, etc. Conclusion Studies and evaluation of medicines used for pregnant and lactating women and the sense of responsibility of enterprises need to be further strengthened. Meanwhile, appropriate authoritative guidelines and standard terms about label and package inserts contents should be recommended to establish, the supervision of the label and package inserts also need to be strengthened. All of these will promote the improvement and standardization of the label and package inserts medication information used for pregnant and lactating women as far as possible, which also enhance medication guidance on this target population.
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    Research of Traditional Chinese Medicine Registered as Botanical New Drug in America
    SONG Yang,YU Zhi-bin,YANG Yue
    2015, 12(4): 219-223. 
    Abstract ( 443 )   PDF (643KB) ( 408 )  
    Objective According to the introduction of American New Drug Application for botanical drug, and the analysis of the characteristics of products which have been approved by FDA and our being declared products, practical advice and help were put forward to provide the example and reference for our traditional Chinese medicine enterprises. Methods Literature study was used to analyze the foreign and domestic materials. Case analysis was used to study the classic cases. Results The products which have been approved by FDA and our being declared products have the following characteristics: 1)Constituents/active ingredients are simple and clear. 2) Indications are single and mainly for the illness of unmet medical needs or chronic diseases. 3) Dosage forms are topical formulations or oral dosage forms. 4)Those products have a large number of basic researches and use experience. Conclusion Our traditional Chinese medicine enterprises should choose products with simple ingredients, topical formulations or oral dosage forms, and consider to develop international cooperation.
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    Research of the Present Situation of Construction and Countermeasures in Nationwide Provincial Adverse Drug Reaction Monitoring Organizations
    JIN Feng,QU Yi, FAN Ruo-xi,LI Xin-ling
    2015, 12(4): 224-228. 
    Abstract ( 366 )   PDF (685KB) ( 237 )  
    Objective Conduct research on the construction status of the national adverse drug (provincial level) reaction monitoring organization, understand the basic situation of the current provincial monitoring organization setting, and provide reference for the provincial medicine supervision and administration department to develop provincial level monitoring organizations. Methods The author used questionnaire survey to conduct research on the construction status of the national adverse drug reaction monitoring system. Results 29 provincial level medicine supervision and administration departments have completed the organization reform, which is 93.55% of all departments; 35 provincial level adverse drug reaction monitoring organizations are established currently in the country; 13 organizations have been approved by local authority, which accounts 41%; 25 organizations are government affiliated institutions, which accounts 73.52%; the total head counts approved by local authorities of the provincial level monitoring organizations in the country is 544, actual employed staff quantity is 466. Conclusion Further develop provincial organization approval process; setup monitoring organization as separate legal entity; the provincial level monitoring organization should have unified functions, the basic four functions should be adopted: adverse drug reaction monitoring, medical device adverse events monitoring, drug abuse monitoring, adverse cosmetic products reaction monitoring; ensure at least one special personnel per one million population.
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    Study on Adverse Drug Reaction Monitoring Based on Hospital Information System
    WANG Ling
    2015, 12(4): 229-231. 
    Abstract ( 343 )   PDF (628KB) ( 328 )  
    Objective To provide thought and references for the promotion of ADR monitoring in China. Methods The current state and the practical application by using of data from the HIS for pharmacovigilance were studied. The shortcomings were summarized and analyzed. Suggestions on improving ADR monitoring and post-marketing clinical studies based on HIS were put forward. Results &Conclusion It can get data from the real world to carry out the ADR monitoring by using HIS, improving the quality of case reporting at source and reducing the omission.To strengthen active surveillance can make up for the inadequacy of spontaneous reporting. It is a good way to improve the quality and the value of ADR monitoring.
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    Analysis of 102 Reports of ADR/ADE Induced by Posterior Pituitary Injection
    LI Wen-wu
    2015, 12(4): 232-234. 
    Abstract ( 306 )   PDF (657KB) ( 247 )  
    Objective To study the general pattern and characteristics of adverse drug reaction(ADR) induced by posterior pituitary injection to provide references for clinical rational use of the drugs. Methods 102 cases of ADR/ADE related to the posterior pituitary injection from January 2004 to June 2014 in Henan province were analyzed using retrospective study method.The drug instructions of three domestic pharmaceutical enterprises were compared. Results The main ADR/ADE damages involved gastrointestinal system(60.10%) and central nervous system (8.48%), the severe ADRs manifestations mainly covered unconsciousness, hyponatremia etc. There was no warning of hyponatremia in the drug instructions. Conclusion It should be concerned about hyponatremia induced by hypophysin, perfect the drug instruction, in order to reduce the incidence of severe ADR/ADE.
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    Related Factors Analysis of Infusion Pump Safety
    LIU Bin,ZHAI Wei,ZGONG Lei,ZHAN Si-yan
    2015, 12(4): 235-237. 
    Abstract ( 300 )   PDF (563KB) ( 656 )  
    Objective To investigate the related factors of infusion pump adverse events in Beijing. Methods Used Single factor and multiple logistic regression analysis Methods were used to analyze the influential factors of infusion pump adverse events, while 4 256 cases were collected in 108 hospitals. Results The incidence of infusion pumps adverse events was 21.3%. Multiple logistic regression analysis showed that infusion pump of domestic brands, or used in secondary hospital, emergency and ICU were more susceptible to adverse events. More than five years using life and low or high using frequency were the high impact factor also. Conclusion In this way we can understand the situation of impact factors of infusion pump adverse events and provide ideas to improve the infusion pump safety.
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    Comparative Study of Guidance Format of Medical Device for China and America
    FU Wei-wei,WEI Jing
    2015, 12(4): 238-240. 
    Abstract ( 279 )   PDF (551KB) ( 245 )  
    Objective Based on the research of the medical device guidances of China and the United States, to provide references for the improvement and development of medical devices guidance development format in China. Methods By guidance translation and inductive method, the FDA medical devices in the form of guidelines and format were analyzed. Results and Conclusion The FDA medical device guidance has general format, letter format, question-and-answer format, mostly using the general format. The guidance of the specific products mostly uses the general format, the guidance of explaining policy or a particular problem uses letters format or question-and-answer format. The FDA writes guidance according to specific content in different format. There is only one format of guidance in our country, namely the guidance format for the specific product registration, format is little, structure is simple. Through comparing the guidance format and structure of medical devices, references to perfect our country guidance format and structure of medical devices are provided.
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    Researches about the Relationship between Rotavirus Vaccine and Intussusception
    WANG Ya-li,DONG Duo
    2015, 12(4): 241-244. 
    Abstract ( 320 )   PDF (536KB) ( 136 )  
    Rotavirus is the main cause of diarrheal illness among children. In developed countries, it's a huge financial burden of emergency and hospitalization due to rotavirus infection. In developing countries, it's the main reason to children death. Vaccination is one of the effective Methods to prevent the disease. The first vaccine, RotaShield, was withdrawn from the market in 1999 because it was suspected to increase the risk of intussusception in recipients. In 2006, the new vaccine, RotaTeq and Rotarix, were introduced to the market. The relationship between rotavirus vaccine and intussusception is still the hot topic. There are still no changes of immunization program about rotavirus vaccine in the world.In the paper, the researches about rotavirus vaccine and intussusception are summarized.
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    Rational Use of Ceftriaxone with Calcium Products from the Changes of Rocephin Label
    GUAN Shang-wei,,ZHENG Ting-ting,ZHANG Wei
    2015, 12(4): 245-248. 
    Abstract ( 292 )   PDF (672KB) ( 788 )  
    Objective To provide the information about the clinical safety and rational use of ceftriaxone with calcium products. Methods In order to gain the method of rational use of cetriaxone with calcium products, there is a need to compare the changes of usage and dosage, adverse reactions, attentions and compatibilities about the use of cetriaxone with calcium products in six different editions of rocephin label in our country. Results From the fourth edition in 2009 to the latest one, it has been marked clearly that rocephin and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid but except the neonatal. Conclusion According to the label, using the ceftriaxone with calcium products intravenously in sequential is allowed while it still needs to use carefully in special patients and conditions.
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    Pharmaceutical Care of a Case of Advanced Esophageal Cancer by Clinical Pharmacists
    LIU Xiao-yan
    2015, 12(4): 249-251. 
    Abstract ( 275 )   PDF (631KB) ( 265 )  
    Objective To discuss the effect of medicine service provided by clinical pharmacists to patients with advanced cancer. Methods In the whole treatment process of an esophageal cancer patient, including pain-relieving and nutrient supporting, the degree of pain and nutrient condition was evaluated and scored. Pharmacy advice on therapeutic strategy was provided based on patient's status, and pharmacy surveillance was conducted during the treatment process. Results The cooperation between clinical pharmacist and physician successfully improved the patient's pain and nutrient condition. Conclusion The participation of clinical pharmacists in treatment of patients with advanced cancer increased the safety and rational drug application, improving the therapeutic effect.
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