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  • 01 January 2019 Volume 38 Issue 1
      

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  • Huiying XUE,Juan LI
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    The 2018 edition of the "National Essential Medicines List" is a major adjustment in China's essential Medicines list after a lapse of six years. The publish of the National Essential Medicines List is aimed to further deepen the medical reform system,to safeguard the medical needs of the people and solve the difficult of "seeing a doctor". By comparing the differences between the 2018 edition and the 2012 edition of the National Essential Medicines List,we conducted a statistical analysis from the aspects of variety classification,dosage form specification distribution,and prescription qualification requirements. The 2018 edition of the National Essential Medicines List added 165 varieties,of which chemicals and biological products added by 100 varieties,and 65 varieties of Chinese patent medicine,an increase of about 31.5% and 32.0%,respectively. The newly added varieties are mainly concentrated in the treatment of chronic diseases such as cardiovascular diseases and liver diseases,drugs for tumor diseases,innovative medicines,and clinically urgently needed medicines for children. In addition,we discussed the issues involved in the 2018 edition of the catalogue change and makes corresponding recommendations.

  • Jing YI,Hongwei DUAN,Hong GAO,Qingfan ZENG,Zijun WANG,Guilong WANG,Yanqiu LIU
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    Objective To investigate the effect of hydromorphone postconditioning on the reperfusion arrhythmia and the expression of myocardial connexin 43 (Cx43) during ischemia-reperfusion in isolated rat hearts and its mechanism. Methods The SD rats (n=24) were randomly divided into three groups: control group (group C,n=18),ischemia-reperfusion group(group I/R,n=8),hydromorphone post-treatment group(group HM,n=8).The langendorff heart or isolated perfused heart assay was established. The heart rate (HR) and ECG during the whole experiment period were recorded . And the reperfusion arrhythmia during the period of reperfusion were detected by ECG. The expression of Akt and Cx43 protein were detected by Western blotting technique. Results Although the HR at different time points and the reperfusion arrhythmia score of three groups were not statistically significant(P>0.05), the duration of reperfusion arrhythmia of group HM was significantly shorter than that of group IR, and the incidence of ventricular tachycardia and ventricular fibrillation in group HM were also less than that in group IR (P<0.05). When Akt expression level in group IR was compared with group C, there was no significant differences(P>0.05), but Akt expression level in group HM was obviously increased; Cx43 expression level in group IR and group HM were both significantly reduced. While compared with the group IR, Cx43 expression level in group HM was significantly increased(P<0.05). Conclusion The mechanism by which hydromorphone post-treatment inhibits reperfusion arrhythmia induced by myocardial IR is associated with up-regulated expression of myocardial Cx43 after activation of Akt signaling pathway during ischemia-reperfusion in isolated rat hearts.

  • Qian SHEN,Yong LIU,Shiying YU
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    Objective To investigate the effect of Jab1 on trastuzumab (Ttzm) treatment sensitivity in HER2 positive breast cancer. Methods q-PCR was performed to detect the expression of Jab1 in 26 HER2 positive breast cancer patient with Ttzm treatment 14 patients were sensitive to Ttzm, while 12 patients were were Ttzm-resistant. The expression of Jab1 was examined by Western blotting in Ttzm-sensitive and resistant breast cancer cell lines. With the knockdown of Jab1 by siRNA, the sensitivity to the drug and the Ttzm-induced apoptosis were measured in related cell lines. Results The expression of Jab1 in Ttzm resistant breast cancer patient was significantly higher than these Ttzm sensitive patient(P<0.05). In Ttzm-sensitive breast cancer cell line C5 and C6, the expression of Jab1 was significantly lower than that in the Ttzm-resistant cells. After konckdown of Jab1 in Ttzm-resistant cells, C5 and C6 cells were re-sensitive to the Ttzm treatment, and the Ttzm-induced apoptosis was observed to be more obvious. In C5 cell line, after 24 hours of Ttzm treatment, the apoptotic rates in Jab1 knockdown group and the control group were (12.8±2.9)% and (2.7±0.5)%(P<0.05), while in the C6 cell line, the apoptosic rates were (18.8±3.6)% and (4.1±1.1)%(P<0.05), respectively. Conclusion Up-regulated expression of Jab1 is associated with the reduction of Ttzm treatment sensitivity in breast cancer cells. Knockdown of Jab1 might be a potential mechanism to antagonize the Ttzm-resistance.

  • Jing LI,Zanzhang YANG,Yue ZHANG,Feimeng GAO,Peipei JIA,Zhijin LI
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    Objective To investigate the distribution of captopril tablet in the ocular tissue of rabbit eye after intragastrical administration. Methods Captopril tablet was administrated to rabbits intragastrically, 5 mg for every time, twice a day, for 6 days running.Rabbits were sacrificed 1 h after the last administration, and the tissues including cornea, iris, aqueous humor, lens, vitreous and retina were collected. Captopril in the tissues were determined by HPLC-UV. Results The content of captopril in retina, iris, aqueous humor, vitreous, lens, cornea were(111.0±15.6), (61.1±28.6), (35.7±18.5), (16.6±2.4), (8.6±4.0), (4.1±1.4) μg·g-1, respectively. Conclusion After continuous administration of captopril ,there were difference in the distribution of captopril in various tissues of the eye, with the highest concentration in the retina, the second in the iris, the lowest in the lens and cornea.

  • Yan ZOU,Yuan DU,Fenghua FU
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    Objective To investigate the antidepressant effect of Jieyu Anshen granules (JY) on post-stroke depression (PSD) mouse model. Methods PSD mouse model was established by bilateral common carotid artery occlusion followed by chronic unpredictable mild stress. The mice were divided into six groups: normal control group, model control group, escitloapram group (5 mg·kg-1), low-, medium- and high-dose JY groups (JY 0.75, 1.50 and 3.00 g·kg-1), 12 per group. The tail suspension and forced swim tests were used to assess depression-like behaviors of mice. The levels of NE, DA and 5-HT in hippocampus were measured by HPLC. The expression of hippocampal 5-HT1AR was evaluated by western blotting. Results Compared with the normal control group, the suspension and swimming immobility time significantly increased (P<0.05). Compared with the model control group, the immobility time of PSD mice in the low-, medium- and high-dose JY groups in the model significantly reduced (P<0.05, P<0.01). Compared with the normal control group, the levels of hippocampal NE, DA and 5-HT control group were decreased(P<0.05, P<0.01), and the expression of hippocampal 5-HT1AR in the model control group was reduced(P<0.05). Compared with the model control group, the levels of hippocampal NE, DA and 5-HT increased(P<0.05, P<0.01), and the expression of hippocampal 5-HT1AR in medium- and high-dose JY groups. Conclusion JY has exerted antidepressant effect on PSD mouse model, which may be ascribed to the up-regulation of the level of NE, DA and 5-HT, and the expression of hippocampal 5-HT1AR.

  • Guangyu HOU,Mengquan LI,Pengcheng ZHAO,Yicheng WANG,Lishuang ZHU,Shudi DU
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    Objective To prepare Keerkang granule and observe its anti-tumor effects in vitro on tumor cell A549. Methods Crude drugs in prescription were extracted with water and concentrated under reduced pressure. Granule was made from the concentrate with starch and dextrin which served as excipients. HPLC was used for the quality control of the granule and baicalin served as the recognized ingredient. After treated with different concentrations of Keerkang granule, cell morphology and karyon morphology of A549 tumor cells were observed by optical microscope and fluorescence microscope with 4',6-diamidino-2-phenylindole(DAPI) staining, respectively. Cell proliferation was measured with MTT test. The genes mRNA expressions of c-myc, c-fos, bax/bcl-2, and caspase-9 were detected with real-time PCR. Results Keerkang granule was prepared and its HPLC quality control was set up. The linear coefficient (r) was 0.9929; Average recovery was 98.03%; RSD was 2.571% and the content of the recognized ingredient baicalin was 0.3498‰. Compared with negative control, after cultured with different concentrations of Keerkang granule, tumor cells A549 appeared shrinkage and nuclear chromatin condensation; Cell proliferation was inhibited in concentration-dependent manner and its IC50 was 74.07 g·L-1; proto-oncogenes mRNA expressions of c-myc and c-fos were decreased; the apoptosis genes mRNA expressions of bax/bcl-2 and caspase-9 were increased. Conclusion Keerkang granule is demonstrated to have the anti-tumor effects in vitro.

  • Kun WU,Guang LI,Yihang LI,Yana LYU,Jianqin XIAO,Huifeng SUN
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    Objective To investigate the anti-apoptotic effect of Dracaena cochinchinensis flavonoids (DCF) on H9c2 cardiacmyocytes in a hypoxia / reoxygenation injury model and its mechanism. Methods The H9c2 cardiac myocytes were randomly divided into five groups: normal control group,model control group, DCF group(20, 10, 5 μg·mL-1). Each group received the corresponding treatment. Cell survival rate was tested by CCK-8 methods. Apoptotic rate was evaluated by propidium iodide (PI) staining and flow cytometry(FCM). The levels of PI3K/Akt, Bax, Bcl-2, Cleaved Caspase-3, and cleaved Caspase-8 were evaluated by Western blotting. Results The DCF(10,5 μg·mL-1)could significantly protect the H9c2 cardiacmyocytes from the hypoxia/reoxygenation injury with increasing cell survival rate. It also decreased the apoptotic percentage and unregulated the level of PI3K/Akt and inhibited the expression of Bax, Cleaved Caspase-3, Cleaved Caspase-8. Conclusion DCF has the effect of anti-apoptosis on H9c2 cardiacmyocytes exposed to hypoxia/reoxygenation injury via PI3K/Akt and apoptotic signal pathway.

  • Yizhu DONG,Mengzhen CHU,Bing ZHANG,Xiaomeng ZHANG,Zhijian LIN,Jiarui WU
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    Objective Through the combing and research of toxic Chinese medicines of grass classification in the Compendium of Materia Medica, the paper summarizethe pharmacovigilance thought of “cognition, application, prevention and rescue of drug toxicity ”, in order to provide important guarantee for the clinical safety and rational use of toxic traditional Chinese medicine. Methods Based on Excel 2016, the toxicity, property and flavor, processing methods, indications, compatibility of Chinese herbal medicines in the Compendium of Materia Medica (Jinling Edition) were applied to analyze with statistical methods. ResultsThere were 74 kinds of toxic Chinese medicines in the grass classification, accounting for 16.8% of the total number of Chinese herbal medicines in the grass classification. A total of 84 drug-containing parts consisted of roots stems, leaves, flowers including 11 major poisonous drugs, 42 toxic drugs, 29 small posionous drugs and 2 micro-toxic drug. It has been found that the toxic Chinese medicines of grass classification are mostly processed ones, and they focus on compatibility and attenuation. ConclusionThe pharmacovigilance thought and experience of toxic Chinese medicine are effective and valuable,and they are worth exploring and inheriting by us.

  • Pengjie GUO,Xiao WANG,Xiaomeng ZHANG,Bing ZHANG,Zhijian LIN,Jiarui WU
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    Objective Based on the whole pharmacovigilance theoretical frame that is formed by cognition,application,prevention and rescue of drug toxicity, the warning information of the Chinese medicine in the Compendium of Materia Medica was combed in order to provide ideas for the rational use of insect drugs in modern clinical practice. Methods Based on the Excel 2016 extraction (Jinling-edition) of the toxicity, flavor-nature, indications, processing and compatibility of the Chinese medicine recorded in the Compendium of Materia Medica, categorical statistics were used according to the classification of drug recognition, drug use, toxcity defense and detoxification. Results Among the 131 kinds of insect drugs, 41 species were indentified toxic, and the category of toxic ones was found the most, accounting for 68.3%. It has been found that most insect drugs were processed products mainly for external use and some toxic Chinese medicines had specific methods of detoxification and rescue of drug toxicity. Conclusion The insect drugs are effective for the prevention of drug toxicity and detoxification, and can be used as reference in modern times.

  • Min LI,Congcong QU,Xiaomeng ZHANG,Bing ZHANG,Zhijian LIN,Jiarui WU
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    Objective Based on the whole pharmacovigilance theoretical frame that is formed by cognition,application,prevention and rescue of drug toxicity, the current study was designed to excavate and comb the warning measures of toxic Chinese medicine of Jinshi classification in the Compendium of Materia Medica, and analyze Li shizhen's application of and vigilance consciousness on the toxic Chinese medicine of Jinshi. Methods This paper sorted out the problems of toxicity, processing, compatibility and application of Chinese medicine of Jinshi classification. Results A total of 33 kinds of toxic Chinese medicines were recorded, and they were classified into three categories: toxicity, middle toxicity, little toxicity. Conclusion This article explained the pharmacovigilance of toxic Chinese medicines in the "Compendium of Materia Medica" from the aspects of cognition,application,prevention and rescue, and provinded referential evidence for the safety of modern clinical medical practices.

  • Tingting WU
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    Objective A retrospective analysis of adverse drug reactions of Shuxuening injection in Xi'an from 2013 to 2017 was carried out to promote the rational use of drugs. Methods The ADR reports of Shuxuening injection received by Center for ADR Monitoring of Xi'an in 2013-2017 were analyzed, focusing on the number of ADRs reported, patient information, drugs used, adverse reaction time,the organs involved, the main clinical manifestations, the outcome of ADRs, the types of ADR, the types of reporters. Results From 2013 to 2017, the number of adverse drug reactions of shuxuening injection in Xi'an rised at first and then decreased among the 208 ADRs, the gender ratio was 1:1.10, the proportion of patients (31.73%) older than 71 years old was the highest;the injection of shuxuemin 20 mL was used the most, accounting for 84.61%;37.50% of Shuxuening adverse reactions occurred within 30 minutes of medication; the cardiovascular system was involved the most in the ARDs (21.19%); the new and severe ADR cases accouted for 17.79%; the reporters were mainly medical institutions(97.60 %), and the individual reporters were mainly doctors(42.79%) and pharmacists(31.73%). Conclusion Clinical use of Shuxuening injection should be standardized according to the instructions of medication, and medical workers should strengthen their monitoring of drug use to reduce the incidence of adverse drug reactions.

  • Jiafang SONG,He ZHU,Sheng HAN
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    Objective To provide inspiration for the active monitoring of adverse drug reactions in China through analyzing the OHDSI/OMOP CDM methods. Methods Based on document research, this paper introduced the experience of the observational health data sciences and informatics (OHDSI) and the observational medical outcomes partnership (OMOP) common data model (CDM). OHDSI/OMOP CDM was analyzed and its applications for active monitoring of adverse drug reactions were discussed. Results OHDSI/OMOP CDM were useful for clinical observational research, especially for integrating heterogeneous data for scientific research, improving research quality, ensuring rapid and effective study, and providing new ideas for collaboration network. Conclusion The relevant experience of OHDSI/OMOP CDM certain reference value and could be learned active monitoring of adverse drug reactions.

  • Xudong LYU,Lanlan GONG,Jiqiao CHAI
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    Objective To investigate the clinical efficacy of vitreous cavity injection of triamcinolone acetonide (IVTA) combined with laser photocoagulation in the treatment of diabetic macular edema (DME). Methods 87 eyes from 64 patients with DME were enrolled in this study. They were divided into two groups by random number table. The treatment group consisted of 32 cases (46 eyes), and the control group consisted of 32 cases (41 eyes). The control group was treated with laser photocoagulation, and the treatment group was treated with laser photocoagulation and IVTA treatment. Then the therapeutic effects were compared between the two groups Results The effective rate of the treatment group and the control group was 95.65% and 80.49%, respectively (P<0.05), and the efficacy of the treatment group stage II DME patients was better than that of the control group stage II DME patients. There was no significant difference in efficiency between the two groups in stage III and IV (P>0.05). The retinal thickness and average retinal nerve fiber layer thickness of the macular area were significantly decreased in the two groups at 1, 3 and 6 months after operation. The thickness of the retina and average retinal nerve fiber layer in the macular area at 1, 3 and 6 months after operation were significantly lower than the control group (P<0.05). Conclusion Laser photocoagulation combined with IVTA is more effective than single laser photocoagulation in the treatment of DME, especially for early DME patients, the treatment effect is more obvious and worthy of clinical application.

  • Ping ZHOU,Wei ZHOU,Qiang ZHANG
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    Objective To investigate the clinical significance of Child-Pugh grading of liver function in patients with general anesthesia induced by propofol induction. Methods The 126 patients with liver cirrhosis undergoing elective abdominal surgery were divided into group A, B, C, which meet the standard of Child-Pugh A, B, C grade respectively according to the classification of Child-Pugh liver function, with 42 patients in each. In addition, 42 patients with normal liver function and elective abdominal surgery were selected as the control group. All patients with general anesthesia were induced by propofol target controlled infusion anesthesia. When reaching the same sedative effect [alert sedation (OAA/S) score ≤1], the indexes of liver metabolism [alanine aminotransferase (ALT) and aspartate aminotransferase (AST), albumin (ALB), total bilirubin (T-BiL), prothrombin time (PT)], hemodynamics[systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR)], arterial blood gas monitoring [arterial oxygen saturation (SaO2), arterial oxygen pressure (PaO2), arterial carbon dioxide pressure (PaCO2)], BIS and propofol concentration in four groups were compared. Results The content of ALB in the control group, group A, B and C tended to decreased, and the content of T-BiL, PT showed an increasing trend (P<0.05). When the OAA/S score was less than 1 points, four groups of SBP, DBP, MAP, BIS were below baseline (P<0.05). In all the groups, group A, B and C, the SBP, DBP, MAP and effect-site concentration of propofol, tended to decrease (P<0.05). The incidence of hypotension in group B and C was significantly higher than that in control group (P<0.05). The incidence of bradycardia and myocardial ischemia in group A and B was significantly higher than that in group C (P<0.05). Conclusion It is beneficial to control the dosage of propofol, reduce the adverse event, and improve surgical safety and prognosis in patients with general anesthesia by evaluating the liver function using Child-Pugh grading.

  • Liang KONG,Xiurong MENG,Yongjun CHEN,Degang LI,Guiying LI,Jianlin ZHANG,Wei JI,Hong ZHOU
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    Objective To evaluate the different analgesia mode for pain control in patients who undergo a procedure for prolapse and hemorrhoids. Methods Sixty patients who were undergoing the procedure for prolapse and hemorrhoids with combined spinal epidural anesthesia were randomized into two groups (30 patients each group). Group PCIA had the patient-controlled intravenous analgesia with sufentanil 100 μg and tropisetron 10 mg with 0.9% sodium chloride soution to 100 mL, the input background dose was 2 mL·h-1, the single PCA was 1 mL, the time interval was 15 min. Group PCEA had the patient-controlled epidural analgesia with 0.179% ropivacaine mesylate and sufentanil 40 μg with 0.9% sodium chloride soution to 200 mL, the input background dose was 4 mL·h-1, the single PCA was 2 mL, the time interval was 15 min, daily intravenous administration of tropisetron 5 mg. Recorded the Ramsay sedation score (RSS), the visual analogue scale (VAS), the comfortable satisfaction score (BCS) well as the improved Bromage classification at 6, 12, 24 and 48 hours after surgery. The frequencies of actual and effective pressing were also observed at the time point of 24 and 48 hours after surgery. Postoperative complications, including pruritus, nausea, headaches, and urinary retention, were also recorded. Results Compare to group PCEA, the Ramsay sedation score and the VAS score were significantly higher and the comfortable satisfaction score was significantly lower in group PCIA at 12, 24 h after the surgery(P<0.05), the improved Bromage classification was significantly lower in group PCIA at 6 h after the surgery(P<0.05). At the time of 24, 48 h after the operation, the frequencies of actual and effective pressing were significantly higher in group PCIA than those in group PCEA(P<0.05). Complications were more common in group PCIA, five patients presented postoperative nausea and vomiting(P<0.05). Conclusion The PCEA could provide more comfortable better postoperative analgesia and more comfortable than the PCIA for patients undergoing the procedure for prolapse and hemorrhoids.

  • Shaolin REN,Xinyin FU,Wenjing YI
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    To discuss the topic of heparin-poloxamer 407 compound in medical progress by consulting relative literature. After that, heparin-poloxamer 407 compound used in vascular anastomosis、combined with growth factor for target therapy,vascular,etal spinal cord cell and uterine cavity repaired and has become a new methods according to the characteristics of it's form. Heparin-poloxamer 407 compound is not only a new form with the characteristics of high-affinity,anticoagulant biological activity,slow and controlled-release, but also can assist surgical operation of vessel anastomosis, and become a good assistant of some kinds of disease.

  • Xiurong GAO,Xiaohong XU,Hengbo YANG,Xu ZHANG,Wang LI,Shao WANG
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    Objective To establish a method of simultaneous determination of tanshinoneⅠ,tanshinonⅡA and cryptotanshinone, three liposoluble constitue of salvia miltiorrhiza and investigate of its dissolution behavior in vitro. Methods An HPLC gradient elution method and Agilent HC-C18 (4. 6 mm×250 mm,5 μm)column was used in this study the mobile phase was acetonitrile-water(0.1% acetate acid). Contents of the three liposoluble components were determinated simultaneously. And the effects on the three liposoluble components of the SDS concentration,the pH value and the rotation speed of dissolution apparatus were investigated. Results The corresponding linear equation for tanshinoneⅠwas Y= 0.202 3X+0.296 7(R2=0.999 2) , the linear range was 1.45-93.00 μg· mL-1;the corresponding linear equation for tanshinone ⅡA was Y=0.445 6X+0.527 2(R2 = 0.999 4) , the linear range was 1.29-82.50 μg·mL-1; the corresponding linear equation for cryptotanshinone was Y=0.131 8X+0.000 2(R2 =1.000) ,the linear range was 0.90-57.50 μg· mL-1,The method had well accuracy and recovery rate,with the increase of SDS concentration in the solution, the dissolution rate three liposoluble components increased gradually. There was no significant effect on the dissolution of the three components in vitro by the pH value of the solution and the rotating speed of the dissolution apparatus. Conclusion The established HPLC methods can detect three liposoluble components of salvia miltiorrhiza accurately and sensitiviely. The addition of SDS can promote the dissolution of three liposoluble components of salvia miltiorrhiza. The pH value of the dissolution solution and the rotational speed of dissolution apparatus had no effects on the dissolution of the three components in vitro.

  • Hongfang LAI,Liwei PAN,Xiuxiang HUANG,Guangquan QIN
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    Objective To investigate the best purification conditions of the dephnoretin from Wikstroemia indica Linn by macroporous resin. Methods The content of dephnoretin was determined by HPLC method. The 8 kinds of macroporous resins was selected by static and dynamic adsorption and desorption ,and the purification parameters was optimized. Results HPD600 was the best resin to purifiy daphne of Wikstroemia indica Linn; The optimum adsorption conditions for the sample concentration was 90 μg·mL-1, the upper sample volume was 45 mL,the sample rate was 1.5 mL·min-1, the adsorption rate reached 97.5%; the ethanol concentration was 90% for better conditions of elution, the eluent volume was 30 mL,the elution rate was 1.5 mL·min-1, the desorption rate was 96.4%. Conclusion HPD600 macroporous adsorption resin can effectively separate and purify dephnoretin of Wikstroemia indica Linn.

  • Ming LI
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    Objective To identify the content of rutin and quercitin in Polygonum hydropiper Linn in 16 different locations. To provide a reference for determining the best producing area of Polygonum Hydropiper Linn. Methods The contents of rutin and quercitin were determined by HPLC. Producing areas were classified by the method of Ward clustering analysis using SAS 9.0. Results The established HPLC method was stable, accurate,and reproducible. Linearity, precision, reproducibility, sample recovery rate were qualified.The contents of rutin and quercitin from 16 localities were determined. The content of rutin was 0.657 8-0.997 5 mg·g-1,the content of quercitin was 0.498 7-0.686 0 mg·g-1. Polygonum bydropiper L. from 16 localities were divided into two categories by cluster analysis, the first 9 were South Polygonum Hydropiper Linn and the latter 7 were North Polygonum Hydropiper Linn.The contents of rutin and quercitin were higher in the first 9 categories. Conclusion Different areas result in different qualities.There is a certain correlation between locality and quality.

  • Yanmei XU,Lijuan PEI,Gaofeng DU,Gengshen SONG
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    Objective To establish a method for the determination of the genotoxic impurities (methyl methanesulfonate, ethyl methanesulfonate and isopropyl methanesulfonate) in edoxaban with internal standard method. Methods A head-space GC-MS method was used. The column was DB-WAX capillary column (30 m×0.25 mm,0.25 μm) by programmed temperature, carrier gas was high purity helium, column flow was 0.6 mL·min-1, the inlet temperature was 110 ℃, sample mode split injection with a split ratio of 20:1;Head-space samp-ling was conducted, equilibrium temperature was 60 ℃, equilibrium time was 30 min, injection volume was 1 mL; Detector was a mass spectrometer detector, the ion source was EI source and source temperature was 200 ℃, the interface temperature was 150 ℃, scanning method was selective ion monitoring, electron energy was 70 eV. Results The linear range of methyl methanesulfonate, ethyl methanesulfonate and isopropyl methanesulfonate were 0.05-3.0 μg·mL-1(r≥0.998 5); Recoveries were 96.4%,96.1% and 96.5%, respectively, and RSD were 2.0%,1.9% and 1.9%(n=6). Conclusion This method is simple, rapid, sensitive, with good specificity, and it can provide a reference for the quality control of edoxaban raw material with internal standard.

  • Jun LI,Huatian HUANG,Ganping ZHOU
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    Objective By analyzing of the correlation between plasma concentration and acute renal injury of the vancomycin in elderly patients with methicillin-resistant staphylococcus aureus(MRSA)bloodstream infection in intensive care unit(ICU). Methods By selecting 48 cases of ICU elderly patients who met the criteria from July 2016 to May 2017 , the vancomycin twice a day with a dose of 1 g·d-1 were given according to the drug instructions for the elderly patients. Then a HPLC method was established for the determination of the serum trough and peak concentration of vancomycin after 5 half-lives(5t1/2).The cases were divided into two groups of AKI and non-AKI according to the diagnostic criteria for acute kidney injury (AKI).After that, the clinical pharmacists could help to adjust the clinical medication regimen according to the results of TDM monitoring and the patients' individual courses. At last, the differences of the average trough and the average peak concentration of vancomycin concentration after 5t1/2 and 7days between the two groups were compared. Results After 5t1/2 of vancomycin,the trough and peak concentration of vancomycin in the treatment window were only 36.46% and the trough concentration lower than the treatment window were 43.75%.Among the 48 cases,27 cases(56.25%) caught the AKI while the other 21 cases(43.75%) didn’t. The rate of occurrence of AKI was 23.81%, 77.78% and 88.89%, respectively, in the patients with the trough concentration of 5-10 mg·L-1 ,>10-20 mg·L-1 and >20 mg·L-1. There were significant differences in the probability of catching a AKI between different trough concentrations. Among the 48 cases,35 cases(72.92%) caught the AKI while the other 13 cases (27.08%) didn’t after the dosage adjustment for 7days according to the results of vancomycin TDM monitoring. Compared with the trough concentration between the two groups, the difference was statistically significant after 5t1/2 of vancomycin while had no statistical significance after 7days. Conclusion The elderly patients with critical diseases have special pathophysiological status. When using the vancomycin, they should be strengthened the TDM monitoring because the effective concentrations of the drugs varied in different patients. In addition to considering the concentration of vancomycin, the age、underlying diseases and the severity of the infection should be taken into consideration.

  • Yunlan CHENG,Chunyan QIAN,Ling YANG,Xuemin CHEN,Yin XU,Yan ZHANG,Xiaoyan XUE
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    Objective To evaluate the therapeutic effects of delayed infusion and normal infusion in patients with complicated intra-abdominal infections and to promote rational and effective use of drugs. Methods A total of 52 patients with severe abdominal infection in the First People's Hospital of Changzhou from 2011 to 2015 were divided into delayed infusion group (treatment group, 0.3 g biapenem, ivgtt,q6h/q8h, for 3 h) and normal infusion group (control group, 0.3 g biapenem, ivgtt, q6h/q8h, for 0.5 h) according to administration route. The currative effect was compared between two groups. Results The fever clearance time of treatment group and control group was (13.5±8.3) and (16.7±14.9) d; the length of hospital stay was (38.9±16.9) and (45.8±13.6) d; and the decrease rate of procalcitonin was (7.284±10.126) and (5.234±8.004) μg·L-1,repectively.The curative effect of treatment group was better than control group. Conclusion For patients with complicated intra-abdominal infections, prolonged infusion is better than normal infusion of biapenem.

  • Zhongyi ZHANG,Huan LIU,Yue YANG
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    To provide enlightenments for monitoring post-marketing new drugs in China. Through literature analysis, new drug re-examination system in Japan was introduced and analyzed from the perspective of system implementation objects, implementation methods and implementation results. The Japanese Ministry of Health, Labor and Welfare assigns specific re-examination periods for different types of new active ingredients, dosages, routes of administration and indications when approving new drugs. During the re-examination period, marketing authorization holders must fulfill their obligations to conduct post-marketing investigations. The application for re-examination is submitted within 3 months after the end of the re-examination period, and the Ministry of Health, Labour and Welfare re-evaluates the safety and effectiveness of the new drugs. After elaborating the characteristics of each link of the new drug re-examination periods, it puts forward some enlightenments perfecting the new drug monitoring system in China. It is recommended to expand the monitoring scope of new drugs, developing more inspection methods of re-registration application materials, and solve the problem of association with drug re-registration after the new drug monitoring period.