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    20 July 2016, Volume 13 Issue 7 Previous Issue    Next Issue

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    Protective Effect of Bicyclol on Glucosides of Tripterygium Wilfordii-induced Liver Injury in Mice
    LIU Ning, ZHANG You-wen, ZHANG Dan, BAO Xiu-qi, SUN Hua
    2016, 13(7): 385-388. 
    Abstract ( 313 )   PDF (4961KB) ( 80 )  
    Objective To study the protective effect of bicyclol on glucosides of Tripterygium wilfordii-induced liver injury in ICR mice. Methods ICR mice were given intragastric administration bicyclol (50, 100, 200 mg·kg-1) for three times. Two hours after the last administration, the mice were treated with glucosides of Tripterygium wilfordii 300 mg·kg-1 to establish the liver damage model. All animals were killed on 18 h after glucosides of Tripterygium wilfordii treatment. The activities of ALT, AST and LDH in serum were measured by automatic chemistry analyzer. Liver histopathological changes were examined by H.E. and light microscopy. Western blot was carried out to analyze the protein level of liver. Results Glucosides of Tripterygium wilfordii 300 mg·kg-1 could induce significant toxicity and liver damage, the mortality rate of mice was 41.67%. The levels of serum ALT, AST, LDH significantly increased and there were hepatocyte apoptosis and inflammatory cell infiltration in liver tissue. 50, 100, 200 mg·kg-1 bicyclol could reduce the mortality rate of mice and the blood biochemical indexes, including ALT, AST and LDH. The results of H.E. staining showed that bicyclol could prevent the steatosis of liver and colliquative necrosis of liver cells. The results of Western blot showed that bicyclol could simulate PI3K pathway, decrease the expression of Fas L, and increase the expression of connexin-43. Conclusion Bicyclol showed a significant protective effect on glucosides of Tripterygium wilfordii -induced liver injury in mice. This may be in connection with inhibiting apoptosis and recovering the gap junctions intercellular communication.
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    Study on Repeated Dose Toxicity of Dexrabeprazole Sodium Injection in Rats for 13 Weeks
    DAI Xiao-li, DAI Xue-dong, GUO Feng, HU Jian-ting, MA Yu-kui
    2016, 13(7): 389-393. 
    Abstract ( 307 )   PDF (4601KB) ( 99 )  
    Objective To observe the toxicity damage of dexrabeprazole sodium injection in rats for 13 Weeks. Methods One hundred and ninety rats(female half)were randomly divided into vehicle control group, rabeprazole sodium injection control group, three dexrabeprazole sodium injection groups with different dosages (80, 20 and 5 mg·kg-1), in addition, rabeprazole sodium injection and dexrabeprazole sodium injection satellite group. Then the group should be given the injection once a day for 13 weeks, after that, stopped to recovery for 4 weeks. During the test, all the animals should weigh weight and food intake. When stopped injection and finishing recovery, blood taken from abdominal aorta, organ coefficient and histopathology were measured for the overall toxicity assessment. Respectively, Satellite animals were taken the blood at first and last injection for toxicokinetics. Results The rats in the dexrabeprazole sodium injection group at 80, 20 mg·kg-1 apperanced shortness of breath, unsteady gait, prone motionless and other symptoms. The levels of RBC,HGB,HCT in the dexrabeprazole sodium injection group at 80, 20 mg·kg-1 were significantly lower than those in vehicle control group at 13 weeks (P<0.05). The change of these parameters regained to normal at 4 weeks after withdrawal. The amount of small follicular in the thyroid gland increased at 13 weeks, and failed to fully recover at 4 weeks after the withdrawal. Conclusion Repeated administration of dexrabeprazole Sodium injection (80, 20 mg·kg-1) for 13 weeks could lead to abnormal indicators related erythrocyte and pathological lesions of thyroid in rats.
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    Anti-virus Effects and Mechanism of Yinsongxiang Mixture in Vitro
    LIU Hong, YANG Hong , NING Zhen-xing, DI Sha, KONG Ran, LI Xian-yu, NONG Li-zheng, WU Yan, HUANG Dong-ye, HU Zhi-zhong, XU Shi-lei, LIAO Chao-zhi, YANG Long-yan
    2016, 13(7): 394-397. 
    Abstract ( 237 )   PDF (3805KB) ( 83 )  
    Objective To explore the antiviral activities and mechanism in vitro of the Yin-song-xiang. Methods The virus inhibition effects of Yinsongxiang on influenza A virus FM1 strain (strain of HPR8 (H1N1) subtype), parainfluenza virus 1 (PIV-1), HSV-1 infected (HSV-1), chimpanzee coryza agent (RSV), coxsackie B virus 4 (CoxB4) were examined in vitro, and the effects of Yinsongxiang to the release of inflammatory cytokines induced by influenza viruses were detected through multiplex bead analysis and its underlying mechanisms were analyzed. Results Research showed Yinsongxiang had a certain inhibition effect on the 5 kinds of viruses. Yinsongxiang could significantly reduce the release of various cytokines such as IL-2, IL-4, IL-5, IL-6, IL-18, TNF-a, IFN-g and GM-CSF (P < 0.05, P < 0.01) of A549 cells induced by influenza virus. Conclusion Yinsongxiang had inhibition effects on the 5 virus. Its potential mechanism may be related to its inhibition on the release of various inflammatory factors and alleviation on inflammatory injury.
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    Study on Preparation and Properties of Osthole-polyethyleneglycol 6000 Solid Dispersion
    YU Di-jia, LIU Yang, ZHU Ying
    2016, 13(7): 398-402. 
    Abstract ( 239 )   PDF (5074KB) ( 92 )  
    Objective To prepare osthole-PEG6000 solid dispersion in order to improve osthole dissolution rate in vitro and also improve its bioavailability. Methods The preparation methods of osthole-PEG6000 solid dispersion and the ratio of drug were screened by apparent solubility,dissolution rate and differential scanning calorimetry (DSC) spectra.The state of osthole in carrier of osthole -PEG6000 solid dispersion was further determined by using differential scanning calorimetry (DSC) and scanning electron micrograph (SEM). Results The osthole -PEG6000 solid dispersion which was prepared by melting method(the ratio of the drug to PEG6000 was 1:4)showed 60 min dissolution rate of 89.2% was far higher than osthle 60 min dissolution rate of 56.2%. The drug and carrier form a eutectic in solid dispersion and the majority of osthole existed in solid dispersion as amorphous forms or molecular state. Conclusion The dissolution rate in vitro of osthole -PEG6000 solid dispersion which was prepared by melting method(the ratio of the drug to PEG6000 was 1:4)is higher than the dissolution rate in vitro of osthole.
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    Consistency Evaluation of Dissolubility of Indapamide Tablets between Generic and Original Preparation
    ZHANG Xiang, SONG Jin-chun, CHEN Li
    2016, 13(7): 403-407. 
    Abstract ( 340 )   PDF (3910KB) ( 126 )  
    Objective To compare the dissolubility of three different domestic indapamide tablets with the original preparation in vitro, so as to evaluate the consistency. Methods HPLC method was adopted. The column was Agilent TC-C18, mobile phase was methanol-water-glacial acetic acid (55:45:0.1, V/V) with a flow rate of 1 mL·min-1, the detection wavelength was 240 nm, the column temperature was 30℃, the injection volume was 20 μL. The stirring paddle method was adopted, volume of dissolution medium was 900 mL and roating rate was 50 rpm. The dissolution mediums were water, hydrochloric acid solution (pH1.2), acetic acid-sodium acetate buffer solution (pH4.0) and phosphate buffer solution (pH6.8). The similarity of dissolution profile was evaluated by calculating similar factor (f2). Results Only the generic drug C has similar dissolution profile from reference preparation D, the consistency of dissolubility of A and B was considerablely different. Conclusion The dissolution profiles of some domestic indapamide tablets are not consistent with its original product in vitro, the production process needs to be further improved.
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    Optimized Signal Detection Model in Adverse Drug Reaction Monitoring System
    HOU Yong-fang, LIU Cui-li, SONG Hai-bo, WANG Ya-li, WANG Dan, ZOU Zhen-lei, WU Gui-zhi
    2016, 13(7): 408-409. 
    Abstract ( 347 )   PDF (3287KB) ( 210 )  
    Objective To optimize signal detection model to extract more valuable signals in adverse drug reaction monitoring system in china. Methods By data quality controlling, optimizing signal detection methods, building signal screening strategy, the signal detection model was optimized. Results The variable matching method was built to find and delete duplicate cases. Signal detection methods have been optimized by Shrinkage. Signal screening strategy was built to rank signals, which had veaducedced the false positive signals. Conclusion Optimized signal detection model can extract more valuable signals from ADR cases database.
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    Development and Origin of Pharmacovigilance
    PENG Li-Li, WANG Dang, SHENG Lu, DONG Duo
    2016, 13(7): 410-413. 
    Abstract ( 543 )   PDF (4418KB) ( 333 )  
    Pharmacovigilance is vigilance to all problems of drugs, not only limited to the drug’s safety, but also should contain all activities related to drugs, because it is throughout the whole life cycle of the drug. This article discusses the development and origin of the pharmacovigilance, summarizes the comprehension of different country during different period, and reviews its principles and methods, so as to strengthen the reader’s understanding about pharmacovigilance.
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    Analysis of Vancomycin Plasma Level and Adverse Reactions in Neonates
    GUO Xue-song, XIAO Feng
    2016, 13(7): 414-416. 
    Abstract ( 367 )   PDF (3279KB) ( 78 )  
    Objective To investigate the relationship between vancomycin plasma concentration and drug adverse reactions in neonates, provide a basis for the rational use of vancomycin in clinical practice. Methods One hundred and seventy neonates treated with vancomycin were recruited, and their plasma levels were monitored. The number of patients who had liver, kidney and hearing damage after treatment was observed and calculated. The correlations between three different plasma levels (<5 mg·L-1, 5~10 mg·L-1 and >10 mg·L-1) and adverse reactions were analyzed. Results The mean minimum, maximum level of vancomycin in serum was 4.96±2.35 mg·L-1 and 31.04±10.13 mg·L-1. The total incidence of adverse reactions was 17.65% (30/170 cases), the main adverse reactions included liver damage (10.00%, 17/170 cases) and hearing impairment (7.06%, 12/170 cases), one case showed renal injury. The incidence of renal injury was significantly lower than that of the liver damage and hearing impairment (χ2=18.162, P=0.000;χ2=12.795, P=0.000). The adverse reaction ratio among three different plasma levels (<5 mg·L-1, 5~10 mg·L-1 and >10 mg·L-1) was 16.81% (19/113 cases), 17.50% (7/40 cases) and 23.53% (4/17 cases), respectively. There was no significant difference between the serum concentrations and adverse reaction ratio (χ2=0.968, P=0.253). Moreover, the adverse reaction rates didn’t increase along with the serum levels of vancomycin (Z=0.941, P=0.226). The parameters of liver and kidney function (alanine transaminase, urea nitrogen, creatinine, uric acid) varied significantly after vancomycin treatment (P<0.05), but there was no clinical significance because the mean values were in normal range. Conclusion Neonates treated with vancomycin have relatively high ratio of the liver damage and hearing impairment, renal injury also takes place possibly. There is no significant correlation between vancomycin plasma level and adverse reactions in neonates.
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    Safety and Risk Factor Analysis on Arecae Semen Based on Literatures
    HOU Wen-zhen, MA Chang-hua*, YANG Le, GUO Xiao-xin, REN Jing-tian, SONG Hai-bo, PANG Yu
    2016, 13(7): 417-421. 
    Abstract ( 273 )   PDF (5009KB) ( 101 )  
    Objective To provide basis for the precautions of Arecae Semen. Methods The adverse event reports of Arecae Semen and Arecae Semen preparations were collected in the China national knowledge infrastructure(CNKI), the relationships were explored. Results Aqueous extract of Arecae Semen has carcinogenicity, mutagenicity reproduction toxicity and neurotoxicity. There has possibility of side effects during processing and eating, which should be regulated. And the processing technology, usage, dosage, etc between Arecae Semen for eating and medicinal are different, which should be treated different. Conclution There was no direct evidence for Arecae Semen can cause cancer, but it can not rule out the possibility.Great care should be required in clinical application of Arecae Semen.
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    Meta-analysis of Efficacy and Safety of Xianlinggubao Capsule in Adjuvant Treatment of Osteoporosis Pain
    SUN Li, TANG Han-wu
    2016, 13(7): 422-425. 
    Abstract ( 287 )   PDF (2945KB) ( 85 )  
    Objective To evaluate the efficacy and safety of Xianlinggubao capsule in the adjuvant treatment of osteoporosis pain, and provide evidence based reference for clinical treatment. Methods Retrieving CNKI, VIP and Wanfang database, randomized controlled trials(RCT)about Xianlinggubao capsule in the adjuvant treatment of osteoporosis pain were collected. After quanlity evaluation and data extraction,Meta-analysis was conducted by using Rev Man 5.3 statistics software. Results 6 RCTs and a total of 530 patients were included. Results of Meta-analysis indicated that, there was significant difference on the total effective rate [RR=1.27, 95%CI(1.16,1.40), P <0.000 01] and VAS [RR=-1.54, 95%CI(-2.40, -0.68), P <0.05]between 2 groups, there was no significant difference on safety [RR=0.6, 95% CI (0.17, 2.07), P >0.05] between 2 groups.Conclusion The clinical effects of the Xianlinggubao capsule group was better than that of the control group, along with a better pain relief and no more occurrence of adverse reactions. But because this study is a secondary research, the conclusion still remains to be further confirmed.
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    Analysis of 78 Cases of Drug Fever in Children
    GUO Shi, LI Rong
    2016, 13(7): 426-428. 
    Abstract ( 206 )   PDF (3737KB) ( 95 )  
    Objective To recognize drug fever and provide references for clinic. Methods A total of 78 cases of children undergoing drug fever was collected at our hospital, including the progress of diagnosis and treatment, medication and clinical manifestation. Results Antibaclerial accounted for 93.59% (73/75) of the total drugs which inducing drug fever. Pneumonia accounted for 65.38% (51/78) of the primary disease. Drug fever disappeared in 100% (78/78) cases in 1~2 days after suspedcted drugs were stopped. Conclusion Drug fever happens frequently in clinical treatments. The rules of drug fever needs to understand so as to reduce the harm.
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    Pharmaceutical Care Practice of Proton Pump Inhibitors and Its Interactions with Other Drugs
    LI Hai-yan, HU Bin
    2016, 13(7): 429-432. 
    Abstract ( 436 )   PDF (3715KB) ( 108 )  
    Objective To provide reference for clinical pharmacists to carry out drug-drug interactions based medication monitoring. Methods In clinical practice, clinical pharmacists often encounter drug-drug interaction instances of proton pump inhibitors (PPIs) with other drugs, the investigation in how to carry out clinical pharmacy care considering of medicine interactions as the main point helps to avoid reduced potency and adverse drug reactions due to medicine interactions. Results & Conclusion Only through participating in the clinical work, discovering potential drug-drug interactions and giving interventions on time, patient’s medication can be ensured safely. The clinical pharmacists must improve occupational sensitivity and find the right way to make full use of expertise and advantage.
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    Effects of Pharmaceutical Intervention on Rational Clinical Use of Compound Amino Acids (15) and Dipeptides (2) Injection
    ZHU Yuan-chao, LIANG Liang, ZHAO Ming, YANG Li-ping
    2016, 13(7): 433-436. 
    Abstract ( 309 )   PDF (3523KB) ( 88 )  
    Objective To evaluate the effects of pharmaceutical intervention on the rational use of compound amino acids (15) and dipeptides (2) injection. Methods Patients who received treatment with compound amino acids (15) and dipeptides (2) injection in Dec 2014 were checked to obtain baseline data. A series of pharmaceutical interventions were carried out. Then data from patients who received therapy with this drug in May 2015 were collected once again. The differences before and after the intervention were compared and analyzed. Results The consumption ratio of compound amino acids (15) and dipeptides (2) injection was reduced from 0.98% to 0.45% (P < 0.05). The rates of correct indication, correct route of administration after the intervention were significantly higher than those before the intervention (P <0.05). Conclusion Pharmaceutical intervention has a significant beneficial impact on the rational use of compound amino acids (15) and dipeptides (2) injection in our hospital.
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