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    20 March 2017, Volume 14 Issue 3 Previous Issue    Next Issue

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    Orginal Article
    Effect of Neferine on Expression of NF-κB Signaling Pathway and Correlation Factors in LPS-induced Human Umbilical Vein Endothelial Injury
    DAI Zhun, SONG Jin-chun
    2017, 14(3): 129-132. 
    Abstract ( 337 )   PDF (3689KB) ( 131 )  
    Objective To observe the anti-atherosclerosis effect of neferine on activiation of NF-κB and correction factors by establishing of VEC-SMC co-culture system induced by LPS. Methods An indirect co-cultivating system between VEC and SMC was constructed by planting VEC in Transwell cell’s upper chamber and SMC in lower chamber. The injuring condition of VEC was built after stimulating VEC using LPS, which was treated with neferine in different concentrations (0, 0.1, 0.3, 1, 3 μmol·L-1) for 24 h. The protein levels of IκB-ɑ, NF-κB p65 were detected by Western blotting. The mRNA expression of TNF-ɑ and ICAM-1 were determined by RT-PCR. Results After treated with Nef, the expression of NF-κB p65, TNF-ɑ mRNA and ICAM-1 mRNA in HUVECs injured by LPS were decreased, while the expression of IκB-ɑ was increased in a concentration-dependent manner. Conclusion Neferine may inhibit NF-κB signaling pathway and decrease the expression of correction factors, in order to reduce the inflammatory reaction in HUVECs and alleviate the atherosclerosis.
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    Study on Acute Toxicity of Aqueous Extracts from Gynura Divaricata
    YUE Tun, MOU Hua-ming, LI Jing, SHU, Chao-lin
    2017, 14(3): 133-136. 
    Abstract ( 334 )   PDF (4056KB) ( 85 )  
    Objective To investigate the safety of aqueous extracts from Gynura divaricata, so as to provide a theoretical foundation for further research and development. Methods Preparing the aqueous extracts from Gynura divaricata, the LD50, MTD were tested by the classical methods of acute toxicity. Five groups of Kunming mice were used for pre-experiment by different concentrations of aqueous extracts from Gynura divaricata, the survival rate of mice were observed, so as to determine the LD50. Mice were given relevant drugs intragastrically every 4 h in 24 h in experimental group, at the same times the blank control group mice were given constant distilled water, and the general symptom, death and weight of mice were observed. Mice were sacrificed 14 days later, and blood was detected, and organs were observed by eyes, the liver and kidney were examined histopathology, and MTD was counted. Results The LD50 of mice was not detected by the pre-experiment, the MTD of acute toxicity test was 120 g·kg-1. The mice’s weight change was not significantly different between the control group and the experimental group (P < 0.05). ALT, AST, ALP, Urea, Cr, TP, ALB, Glu and T-Bil of mice were showed no obvious abnormalities. The pathological changes of liver and kidney were not obvious in the control group and the control group. Conclusion Aqueous extracts from Gynura divaricata had no obvious toxicity for Kunming mice.
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    Pharmacodynamics Research of Yanhouning Oral Liquid Treatment on Acute or Chronic Pharygitis
    SUN Jing, GUO Shan-shan, ZHAO Rong-hua, LU Sai-wei, GAO Ying-jie, SHI Yu-jing, CUI Xiao-lan
    2017, 14(3): 137-141. 
    Abstract ( 375 )   PDF (4602KB) ( 82 )  
    Objective To evaluate the pharmacodynamic effects of Yanhouning oral liquid (YHNOL) on acute or chronic pharygitis. Methods The protective effect against acute pharyngitis was observed by spraying with 15% ammonia and injecting of beta hemolytic streptococcus at pharyngeal mucosa of rat. The protective effect against chronic pharyngitis was observed by spraying with 2.5% ammonia and injecting of turpentine into pharyngeal mucosa of rabbit. The anti-inflammatory effect was observed by the capillary permeability augmentation of mice induced by acetic acid and cotton pellet granuloma of rats. The analgesic effect was investigated by body twist method. Results Three dose of YHNOL could significantly relieve pharyngeal lesions of rats and rabbits. YHNOL could also significantly inhibit capillary permeability augmentation caused by acetic acid in mice, lighten the dry weight of granuloma induced by cotton ball in rat, depress the torsion body of mice. Conclusion YHNOL could effectively alleviate the symptoms of acute or chronic pharyngitis. It also has significant effect of anti-inflammation and abirritation.
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    Effect of Oral Tongxinluo Capsule on Endothelial Microparticles and Matrix Metalloproteinase-9 in Serum of Patients with Acute Myocardial Infarction after Percutaneous Coronary Intervention
    LIU Xue-wu, ZHANG Xia-zhi, ZHANG Fang-lan
    2017, 14(3): 142-144. 
    Abstract ( 272 )   PDF (3125KB) ( 59 )  
    Objective To investigate the effect of oral Tongxinluo capsule on endothelial microparticles (EMPs) and matrix metalloproteinase-9 (MMP-9) level in serum of patients with acute myocardial infarction (AMI) after percutaneous coronary intervention (PCI). Methods 144 cases of AMI patients in our hospital from August 2013 to January 2016 were randomly selected for the study and were treated with PCI. The patients were divided into the observation group and the control group by random number table. 72 patients in the control group received conventional treatment after PCI, while patients in the observation group were administered oral Tongxinluo capsule based on the conventional treatment. EMPs and MMP-9 levels of the two groups of patients before and 7 days after PCI were tested. Results EMPs and MMP-9 levels after PCI treatment of both the two groups of patients were lower than that before surgery, and the difference was statistically significant (P <0.05). EMPs and MMP-9 levels of the patients in the observation group were lower than that of the control group, and the difference was statistically significant (P <0.05). MMP-9 levels of the two groups of patients before and 7 days after PCI were both positively correlated with EMPs level (P <0.05). Conclusion Oral Tongxinluo capsule after PCI treatment for AMI patients helps to reduce EMPs and MMP-9 levels in peripheral blood, and contributes to maintain intravascular plaque stability and improve endothelial cell function.
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    Effects of Tirofiban Intracoronary Administration on the Interventional Therapy and Peripheral Blood PMPs Level in Patients with Acute ST-segment Elevation Myocardial Infarction
    GUO Hua, WANG Tong, SUN Xiao-mei
    2017, 14(3): 145-149. 
    Abstract ( 305 )   PDF (4537KB) ( 82 )  
    Objective To investigate the effects of tirofiban intracoronary administration on the interventional therapy and peripheral blood PMPs level in patients with acute ST-segment elevation myocardial infarction. Methods Totally 124 STEMI patients undergoing PCI were selected and divided into control group (n=62) and tirofiban group (n=62), the tirofiban group was received tirofiban combined PCI and the control group was treated with PCI. The basic clinical features before PCI, the thrombolysis in myocardial infarction (TIMI) flow grade 3, corrected TIMI flow counting frame count (CTFC), myocardial perfusion (TMPG) grade 3, resolution of the sum of ST-segment elevation (sumSTR) in 90 minutes; peak-value and peak-time of phosphoric acid creatine kinase isoenzyme (CK-MB), peak-value of cardiac troponin I (cTnI), the left ventricular ejection fraction (LVEF), left ventricular end-diastolic diameter (LVEDD) and left ventricular end-systolic diameter (LVESD) after PCI were observed and compared between the two groups. The peripheral blood PMPs levels before and after PCI were analyzed, as well as major adverse cardiovascular events (MACE) and incidence of bleeding within 3 months after PCI were observed and compared between the two groups. Results There was no statistical difference in basic clinical features between the two groups before PCI. The incidence rate of TMPG grade 3, TIMI grade 3 and sumSTR>50% in the tirofiban group were significantly higher than those of the control group (P <0.05), CTFC was significantly lower than that of the control group (P <0.05). The level of LVEF of the tirofiban group was significantly higher than that of the control group after operation, while the LVESD and LVEDD were significantly lower than those of the control group after operation (P <0.05). There was no significantly difference of PMPs levels before PCI between the two groups, the PMPs levels of the two group after operation were significantly lower than those of the preoperation, as well as the tirofiban group were significantly lower than that of the control group (P <0.05). The incidence rate of MACE was significantly lower in tirofiban group than that in control group within 3 months postoperatively. There was no significantly difference of incidence rate of bleeding between the two groups(P >0.05). Conclusion In patients with STEMI, tirofiban intracoronary administration can significantly improve myocardial reperfusion , inhibit the PMPs level and incidence rate of MACE, and would not increase the incidence of bleeding complications, it is safe and effective in STEMI patients treated with PCI.
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    Analysis of Pharmocovigilance and Difference with the ADR Monitoring in China
    WANG Dan, PENG Li-li, LIU Cui-li, LIU Jia, WANG Tao, DONG Duo
    2017, 14(3): 150-152. 
    Abstract ( 2424 )   PDF (3574KB) ( 655 )  
    Objective To explore the application of pharmacovigilance in China. Methods The concept of parmocovigilance and the differences between pharmacovigilance and ADR Monitoring were disserted. Results There is a gap between ADR monitoring and pharmacovigilance in the aspect of object, scope and method. However, ADR monitoring is in keeping with international pharmacovigilance theoretically and is developing towards it. Conclusion Pharmacovigilancecan provide growth space for development of ADR monitoring in china.
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    A Comparative Study on ADR Monitoring Systems between Chinese Hong Kong and Mainland
    ZHONG Ling, XIAO Xiao, MAO Qiu-rong, CHENG Bin
    2017, 14(3): 153-157. 
    Abstract ( 452 )   PDF (5331KB) ( 244 )  
    Objective To introduce the specificity of ADR monitoring system in Hong Kong, and to comparatively analyze the differences between the ADR monitoring systems performed in Chinese Hong Kong and mainland, so as to propose the constructive suggestions and comments for improvements on the works in Chinese mainland. Methods In order to investigate laws and regulations of drug administration and ADR monitoring system in Hong Kong,we apply the methods including: local area investigations and professional conferences on subject discussions, in combination with the studies on data mining in research publications and website news reports. Results Existences of simplifier organization structure for ADR monitoring and suitable to the local drug supervision and administration system, together with effective information for ADR monitoring, were found in Hong Kong. Conclusion It has reference value from Hong Kong in the part of mechanism for drug supervision and administration system, and to raise the constructive proposals for the improvements on realization of responsibility for business administrations, the collections of severe ADR data and the consolidations on the legal and regulation systems in mainland.
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    Research on System of Post-marketing Evaluation in Japan
    LIU Jia, LI Cheng-lin, GUO Li-hong, Kawai Hideaki, Terai Yoshiya, Iwasaki Noriyuki, Suzuki Miwako, YANG Wei
    2017, 14(3): 158-160. 
    Abstract ( 747 )   PDF (3379KB) ( 310 )  
    Objective To provide references for the post-marketing evaluation system in china by studying and summarizing the design and framework of the post-marketing drug evaluation system in developed countries. Methods The related literatures of post-marketing evaluation in Japan were reviewed and summarized. Results Japan has established a post-marketing drug evaluation system which is based on the adverse drug reactions and infection reporting system. The reexamination system that includes Early Post-marketing Phase Vigilance (EPPV), Period Safety Update Report (PSUR), Risk Management Plan (RMP) and drug use investigation is the main line for this post-marketing drug evaluation system. The implement of the system must be follow Good Vigilance Practice (GVP) and Good Post-marketing Study Practice (GPSP). Additionally, an Ad Hoc reevaluation system is established as a part of post-marketing drug evaluation system for the drugs out of the reexamination period. Conclusion Japan has developed a comprehensive system for drug post-marketing evaluation. The experience in the post-marketing evaluation system from Japan has a reference value for China to carry out related work.
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    Simultaneous Determination of Three Alkaloids in Extracts from Gelsemium elegans Benth. by HPLC
    WANG Lin, SUN Lin, LIU Hui-ying, ZHAO Nan, MENG Fan-hao
    2017, 14(3): 161-164. 
    Abstract ( 296 )   PDF (3379KB) ( 54 )  
    Objective To develop a method for the determination of three alkaloids in extracts from Gelsemium elegans Benth. by HPLC. Methods YMC C18 (250 mm × 4. 6 mm, 5 μm) column was used with acetonitriles-0.025 mol·L-1 KH2PO4 solution (phosphoric acid was used to adjust pH to 3.0) with gradient elution as the mobile phase and 1.0 mL·min-1 as the flow rate. The detection wavelength was 254 nm. Results The linear ranges of koumine, gelsemine and 16-epivoacarpine were 32.2~322, 34.4~344, 6.2~62 μg·mL-1, respectively. The average recoveries were 98.6%, 101.1%, 98.3% with RSD of 1.7%, 1.3%, 1.1%, respectively. Conclusion This method is accurate, simple and reliable, and can be used for quality control of extracts from Gelsemium elegans Benth.
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    Study on Extraction Technology for Fufangchaihugegen Particles
    SONG Jin-chun, ZHANG Xiang
    2017, 14(3): 165-168. 
    Abstract ( 298 )   PDF (3822KB) ( 89 )  
    Objective To screen the best extraction technology of fufangchaihugegen granules by evaluating the transfer rate of active constituent, and anti-inflammatory analgesic activity. Methods HPLC method was used to investigate the transfer rate of baicalin, puerarin, and forsythin under different extraction processes. The ear swelling rate of mice and acetic acid-induced writhing test in mice were used to investigate the anti-inflammatory analgesic activity of fufangchaihugegen granules under different extraction processes. Results The best extraction technology is NO.4. The volatile oil of notopterygium, bupleuri, and forsythia was extracted by steam distillation method. The residue was decocted three times, combined with isatis root and platycodon grandiflorum to obtain liquid extract. Then puerarin and baicalin were extracted by 60% alcohol, and concentrated it as liquid extract by alcohol. The two-part flow extract was combined and the volatile oil was added. Conclusion The extraction process of fufangchaihugegen granules screened by the active component transfer rate experiment and the anti-inflammatory analgesic activity is scientific, reasonable, and feasible. It is suitable for the research and development of the traditional Chinese medicine preparation.
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    Overview of the Japanese Drug Clinical Trials Review Mechanism and Its Enlightenment to China
    WEI Fen-fang, SUN Yu-xin, CHEN Jian-gang, YANG Yue
    2017, 14(3): 169-175. 
    Abstract ( 609 )   PDF (6699KB) ( 167 )  
    Objective To introduce the general situation of the examination mechanism of Japanese drug clinical trial and put forward some preliminary suggestions for the review of the mechanism of drug clinical trial in China. Methods The relevant laws and regulations of Japanese drug clinical trials were reviewed, and the differences between Japanese and Chinese drug clinical trial review mechanism were studied by literature research and comparative method. Results &Conclusion By comparing, it was found that the Japanese clinical trial review was divided into the main review process and the corresponding supporting mechanism. This management mechanism can speed up the review of the Japanese drug market speed and reduce the administrative burden, it is worth our reference.
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    Practice of Pharmacy Journals Serving Safe Medication
    FAN Yan, TANG Ren, JING Chun-mei, GAO Yan LI, Xin-ling, HU Jun
    2017, 14(3): 176-178. 
    Abstract ( 337 )   PDF (3325KB) ( 116 )  
    Pharmacy journal is the carrier of reporting research results of pharmacy as well as related disciplines. Safe medication information is the important content of pharmacy journal. Pharmacy journal is the main medium for the public to gain safe medication information. Chinese Journal of Pharmacovigilance has always been to promote the public's safe medication for the principle. On the basis of safe medication supervision informations, through editorial practice such as the editorial board member and specialist, topics planning, academic exchange, popular science propaganda, etc., it aims to explore a new mode of pharmacy journal serving public's safe medication, highlight the characteristics of journal brand effect, enchance pharmacy journal social public's welfare, and make continuous efforts to the public's safe medication level.
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    Reach Progress on Animal Models with Hepatic Fibrosis and Its Application in Efficacy Evaluation of Traditional Chinese Medicine
    DOU Li-wen, SUN Rong
    2017, 14(3): 179-182. 
    Abstract ( 285 )   PDF (4689KB) ( 103 )  
    Objective To establish the animal model of hepatic fibrosis with the basis of etiology and pathogenesis of hepatic fibrosis and the clinical practice of traditional Chinese medicine (TCM), which is stable and reliable and is suitable for the activity and efficacy of TCM.Methods References in the last decades at home and abroad about the animal model of hepatic fibrosis were collated, summarized and analyzed. Results There are many medical pathologicals of hepatic fibrosis at present, though the mechanisms and applications of models are different. There are also many problems in the study of the efficacy evaluation and pathological mechanism of TCM, such as sensitivity, reliability and stability of the model. Conclusion We should research hepatic fibrosis animal model which is more in line with actual clinical syndromes and TCM theory on the basis of guidance of Chinese medicine theory, TCM clinical manifestations of hepatic fibrosis, combining modern etiology and pathogenesis study, in order to study the nature of hepatic fibrosis and liver medicine to provide better tools for evaluation,.
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    Pareto Chart Analysis of Irrational Prescriptions in the Pharmacy Intravenous Admixture Service
    ZHANG Xu, NIU Jia, WU Xiao-yu, WANG Yu, FANG Zhe
    2017, 14(3): 183-185. 
    Abstract ( 300 )   PDF (3354KB) ( 118 )  
    Objective Through the Pareto chart analysis of the unreasonable prescription of pharmacy intravenous admixture services (PIVAS), we found the main factors of irrational drug use, and the tendency of irrational drug concentration, to provide the basis for clinical pharmacists’ work. Methods Divided 2 769 irrational prescriptions of PIVAS from 2013 to 2014 into 10 categories and analyzed by Pareto chart. Results Unreasonable solvent selection and solvent dose is the main factor of causing PIVAS irrational prescription, unreasonable drug route, and drug dose are the secondary factors of causing unreasonable drug use, The remaining 6 items are the general factors. Conclusion Using Pareto chart, the unreasonable use were effectively intervented, to improve the rationality of clinical use of drugs.
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    Analysis of 502 Cases of Off-label Use of Breviscapine for Injection
    XIAO Wang-zhong, DAI Bing, OU YANG, Lin-qi, DENG Gui-ming, HUANG Li, GUO Yu-ge
    2017, 14(3): 186-188. 
    Abstract ( 319 )   PDF (2845KB) ( 148 )  
    Objective To understand the off-label use of breviscapine for injection in clinic, promote reasonable application of traditional Chinese medicine injection. Methods 502 medical records of hospitalized patients using breviscapine for injection in 2015 were retrospectively analyzed. Results There were 241 cases for off-label indications, 23 cases for overdosage, 34 cases for off-label concentration, and 7 cases for improper frequency, involving 18 cases in children. Conclusion The off-label use of breviscapine for injection in clinic affects patients’ medication safety. It is suggested that the use of TCM injection should keep in accordance with its instruction strictly.
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