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  • Cytotoxic Studies on Raw Materials, Excipients and Injection of Armillarisin A
    WANG Yuxin,TANG Wan,LIU Yang,MENG Changhong,LU Yihong2,SHI Qingshui,WANG Guangji
    2020, 39(2): 135-139. https://doi.org/10.3870/j.issn.1004-0781.2020.02.001
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    Objective To compare the cytotoxicity of raw materials, excipients and injection of armillarisin A on cells. Methods The vigorously proliferative L929 cells, which had been cultured for 48-72 hours, were digested, diluted and then cultured in 12-well cell culture plates.A series of raw materials, excipients and injections of armillarisin A was then incubated with the cultured cells in the plates.After 72 hours, the treated cells were observed and counted by cell counting instrument.The inhibitory rate on cell growth of each concentration was calculated.IC50 was then estimated by Graphpad Prism 5 software, and the cytotoxicity was compared. Results The cytotoxicity of armillarisin A injections was significantly higher than that of powder for injection against L929 cells.The IC50were 0.005 83-0.010 25 mg·mL-1, 0.060 49-0.175 3 mg·mL-1 ,respectively. The toxicity of excipients, N, N- dimethyl acetamide (API IC50 was 0.007 172 mg·mL-1 ) and propylene glycol (API IC50 was 0.018 53 mg·mL-1), were relatively higher, which led to an increased cytotoxicity of the total mixture of excipients (API IC50was 0.016 59 mg·mL-1), thus increasing the cytotoxicity of the injection. Conclusion It is necessary to further optimize the prescription and production process of armillarisin A injection to reduce the possible adverse reactions caused by pharmaceutical excipients, so as to ensure the drug safety for patients.
  • Effect and Mechanism of Sevoflurane Exposure on the Plasticity of Hippocampal Neurons in Developing Rats
    ZONG Chuanyue,LI Mao
    2020, 39(2): 139-145. https://doi.org/10.3870/j.issn.1004-0781.2020.02.002
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    Objective To analyze the effect and its mechanism of sevoflurane exposure on the plasticity of hippocampal neurons in developing rats. Methods Sixty healthy offspring rats on the 7th day of postpartum were divided into control group, 3% sevoflurane 1 h exposed group (Sev 1 h group), and 6 h exposed group (Sev 6 h group).Sev 1 h group and Sev 6 h group rats were placed with 3.0% sevoflurane in a sealed box with air ventilation for 1 h and 6 h, respectively.The control group received air without anesthetic exposure.In the water maze experiment of each group, the escape latency period, the activity time of platform quadrant, and the times of crossing platform were recorded, and the time and discrimination index of the new object recognition task of rats were also recorded.Western blotting was performed to analyze syntaxin, SNAP25 and alpha synuclein in hippocampal sections of rats.Golgi staining was used to detect dendritic spine density.The ultrastructure of hippocampal synapses was observed by transmission electron microscopy.The excitatory postsynaptic potential (EPSP), high frequency stimulation (HFS) or low frequency stimulation (LFS), and long-term drepression (LTD), long-term potentiation (LTP) of vertebral cells in the CA1 area of hippocampal slice were recorded. Results Compared with the control group, the detection time and escape latency of the Sev 6 h group were prolonged, and the number of entrance points in the platform quadrant was less than that of the Sev 1 h group and the control group (P<0.05).In the new object recognition task, DI of the control group was higher than that of the Sev 6 h group (P<0.05).Compared with the control group, the expression of syntaxin and SNAP-25 was increased in the Sev 6 h group, while the expression of syntaxin was increased in both the Sev 6 h group and Sev 1 h group (P<0.05).Compared with the control group, the number of synapses decreased and the synaptic gap widened in the Sev 6 h group, and the mitochondria in the anterior part of the hippocampal synapses in the Sev 6 h group showed swelling, shrinkage, vacuolation and other pathological changes.In the Sev 1 h group, the width of synaptic gap increased while the number of synapses remained unchanged.The EPSP slope of Sev 6 h group was lower than that of control group and Sev 1 h group (P<0.05).Before the application of LFS, there was no statistically significant difference in EPSP slope baseline among the three groups (P>0.05).After 15 min of LFS, the EPSP slope decreased. Conclusion The duration of anesthesia exposure may have different effects on neuroplasticity and neurocognitive performance.
  • Mechanism of Ketoconazole Inhibits Oxidized Linoleic Acid Metabolite-mediated Peripheral Inflammatory Pain
    HUANG Wentao,CHENG Lu,ZHANG Geng,HU Song
    2020, 39(2): 146-150. https://doi.org/10.3870/j.issn.1004-0781.2020.02.003
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    Objective To explore the mechanism of cytochrome P450 inhibitor ketoconazole inhibiting peripheral inflammatory pain mediated by oxidized linoleic acid metabolites (OLAM). Methods The role of OLAM in inflammatory process and the effect of cytochrome P450 enzyme on hyperalgesia were studied by using Freund's adjuvant model. Results The cultured TG neurons were pretreated with a transmitter, followed by linoleic acid (LA) stimulation, and [Ca2+]i showed a 3-fold increase to (0.156±0.01).Ketoconazole pretreatment eliminated the effect of LA on [Ca2+]i enhancement (P<0.05).The application of the resuspended extract on cultured TG neurons resulted in an increase in calcitonin gene related peptide (CGRP) release to (980.39±21.04)%, a significant decrease in CGRP release to (200.31±10.01)% in the extract treated with TRPV1 antagonist I-RTX, and (498.03±13.02)% in the CFA/ ketoconazole + transmitter treated extract.In the control group (uninflamed), injection of LA did not significantly increase the duration of spontaneous injurious reactivity.24 h after the establishment of CFA inflammation, the plantar injection of LA produced a dose-dependent analgesic effect, and the time of spontaneous injurious response was up-regulated to (148.92±13.42) s.Pretreatment with blockers can reduce the nonsynthetic behavior evoked.Compared with wild-type mice, la-induced pain was significantly reduced in the mice with the gene deletion TRPV1 (5.31±0.41) s for the noncompre-hensive behavior).Plantar injection of anti-9 and anti-13-hode antibodies reduced LA induced injurious behavior by about 72%, compared to the control group receiving anti-goat IgG or vector (HBSS).Ketoconazole was used to pretreat inflamed rat hindpaw 30 min before injection of LA, and the inhibitory effect of ketoconazole on LA was observed to reach 70%, and the time of harmful behavior was reduced to (11.28±4.10)s. Conclusion OLAM can induce peripheral inflammatory hyperalgesia, and cytochrome P450 plays an important role in regulating the role of OLAM in inflammatory hyperalgesia.
  • Study on the Toxicity of TQ17 to Rat Embryo-Fetal Development
    GONG Xiashi,MAO Shanshan,PANG Cong,ZHOU Wen,LI Jihong
    2020, 39(2): 151-155. https://doi.org/10.3870/j.issn.1004-0781.2020.02.004
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    Objective To observe the maternal and embryo-fetal development toxicity of TQ17 in pregnant rats after the drug administration in the teratogenic sensitive period. Methods SD rats including 120 females, 90 males, and 90 successfully mated females were randomly divided into 4 groups: TQ17 low dose and high dose groups (30, 350 mg·kg-1·d-1), cyclophosphamide group (cyclophosphamide 15 mg·kg-1·d-1) and model control group (0.5% sodium carboxymethylcellulose solution, 0.5% CMC-Na).These rats were orally administered by gavage with TQ17 or 0.5% CMC-Na in low and high dose groups and model control groups from the 6th day to the 15th day of pregnancy.The cyclophosphamide group was injected subcutaneously with cyclophosphamide on the 12th day of pregnancy.The general conditions of the pregnant rats, such as growth, food, and water intake were recorded, and the rats were weighed weekly.The rats were sacrificed on the 20th day of pregnancy, and the number of corpus luteums, the uterus, the number of implantation, dead or live fetus, the sex, the length of top buttock and tail, and the body weight were recorded.The appearance of live fetus was identified for abnormality.Half fetuses in each litter were examined for skeletal deformity and the other half was used for viscera check. Results Compared with the model control group, the body weight of rats in TQ17 high dose group decreased significantly. At the same time, the cases of sternal malformation or variation increased significantly in fetal rats.Under the conditions of this experiment, TQ17 at the dose of 30 mg· kg-1·d-1 had no effect on the general condition of the mother and the growth of the offspring, while the dose of 350 mg· kg-1·d-1 had toxic effect on the development of the fetal sternum.Thus. Conclusion TQ17 have the risk of teratogenicity on rat embryo-fetal development.
  • Analysis of the Use of the First-line Antihypertensive Agents in Senile Patients with Hypertension: A National Multicenter Study
    WU Bin,QIN Zhou,XU Ting
    2020, 39(2): 156-160. https://doi.org/10.3870/j.issn.1004-0781.2020.02.005
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    Objective To provide reference data for rational use of antihypertensive agents for senile patients, according to the analysis of five first line antihypertensive agents’ utilization characteristics for elderly patients in 8 cities in 2017. Methods Based on the prescription data, which was randomly selected from the “2017 Hospital Prescription Analysis Cooperation Project”, the number, amount and daily dose of the top five prescriptions of various antihypertensive drugs were analyzed using a drug utilization analysis method. Results A total of 904 296 prescriptions were obtained from 101 hospitals in 8 cities.The ratio of male to female was 1.01.The median age was 76 years old.CCB, β-B and ARB were the top 3 antihypertensive agent types.The largest prescriptions of each type were amlodipine (15.85%), metoprolol (14.60%), valsartan (6.97%), spironolactone (3.69%) and perindopril (2.06%).The highest median costs per prescription for each kind of agents were losartan (139.16 yuan), nifedipine (107.80 yuan), arolol (104.40 yuan), perindopril (97.80 yuan) and tolasemide (36.40 yuan).The mean PDD/DDD value of ACEI, ARB and CCB was greater than 1, with the values of 1.52, 1.42 and 1.29, respectively.The PDD/DDD values of the 5 types of agents for patients with renal complications were higher than those for patients without complications, and the PDD/DDD values of ACEI, ARB and DU for patients with liver complications were higher than those for patients without complications. Conclusion CCB, β-B and ARB were the three most commonly used antihypertensive agent types in senile hypertension, especially amlodipine, metoprolol and valsartan.It is still necessary to pay attention to the contraindication of antihypertensive drugs in elderly patients with hypertension, and pay more attention to the drug dosage management in patients with kidney and liver disease.
  • Value Evaluation of Pharmaceutical Care for Chronic Diseases Based on Willingness to Pay Method
    XIAO Guirong,CHEN Yanhua,WU Bin,XU Ting
    2020, 39(2): 160-163. https://doi.org/10.3870/j.issn.1004-0781.2020.02.006
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    Objective To review the literature that used the willingness to pay method to value chronic disease pharmaceutical services. Methods Relevant studies published in the Chinese or English language were identified searching CNKI,VIP,CBM,WANFANG,PUBMED,MEDLINE,Cochrane,and International Pharmaceutical Abstracts databases from databases builded to May 2019, only studies that specifically elicited willingness to pay for chronic disease pharmaceutical services were included. Results Thirteen studies using the willingness to pay for chronic disease pharmaceutical services were identified.These studies included different patients or consumers and different willingness to pay from 5% to 100% and from a few dollars to tens of dollars for different chronic disease include asthma,diabetes disease,hypertension,chronic kidney disease,dyslipidemia and menopausal symptoms management. Conclusion A limited number of studies have been conducted, but need further research of willingness to pay for chronic disease pharmaceutical services.Understanding the level of their monetary willingness to pay for chronic disease pharmaceutical services will provide evidence for the value of pharmaceutical service.
  • Evaluation of Effect of Clinical Pharmacists’ Participation in Chronic Disease Management on Gout: A Prospective Randomized Controlled Study
    GUO Zhilei,WANG Wei,WANG Zhihong,ZHANG Xiaoling,WANG Yuanmei,WANG Junqun,SONG Hongping
    2020, 39(2): 164-168. https://doi.org/10.3870/j.issn.1004-0781.2020.02.007
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    Objective To evaluate the effect of clinical pharmacists' participation in chronic disease management on gout through a prospective randomized controlled study. Methods The patients were randomly divided into control group (46 cases) and observation group (46 cases).And the two groups received a standard treatment after discharge.The clinical pharmacists followed up regularly every three-month in one year for the observation group, and the observation group was additionally provided with medication education, health education, and lifestyle intervention according to the patients' uric acid standard. Results In the 6th, 9th and12th months of the the follow-up, the recovery rates of uric acid to the standard level in the observation group were 70.83%, 78.35% and 80.46%, which were significantly higher than that in the control group (51.33%, 55.78% and 53.95%), respectively (P<0.05).The rates of good medication compliance in the observation group were 91.1%, 82.2% and 71.1%, which were significantly higher than that in the control group (73.9%, 60.9% and 50.0%).The mastery score of gout related knowledge and the proportion of abstaining from alcohol in the observation group were gradually increasing, which were significantly higher than that in the control group at the same time (P<0.05).The numbers of gout attacks in the observation group and the control group were also gradually increased, and the attack frequency in the control group was significantly more than that in the observation group with the rate of 17.4% vs 4.44% and 19.6% vs 4.44% from the 9th and 12th month (P<0.05), respectively. Conclusion The participation of clinical pharmacists in the management of gout could help to improve the recovery rate of uric acid to reach the standard and drug compliance, correct their bad living habits, and reduce the incidence rate of gout.It is a worthy model of clinical recommendation and promotion on the prevention and treatment of gout.
  • Analysis of Drug Use of Elderly Patients with Chronic Disease by Pharmaceutical Care Network Europe Classification System
    WU Tingxi,YU Junxian,XING Yunli,ZHAO Zhigang
    2020, 39(2): 168-171. https://doi.org/10.3870/j.issn.1004-0781.2020.02.008
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    Objective To explore the application of pharmaceutical care network Europe(PCNE) classification system by clinical pharmacists in pharmaceutical care for elderly patients. Methods The PCNE (8.03 edition) classification system was used to analyze drug-related problems (DRPs) in four typical cases of pharmaceutical care in elderly patients with chronic diseases. Results One to three DRPs occurred in four cases.Drug selection, dosage form selection, dosage and inappropriate medication of patients were the main causes of DRPs.Pharmacists used PCNE system to quickly judge and intervene by informing doctors and patients, and collaborating with doctors to formulate drug treatment programs. Conclusion PCNE system is helpful to realize the precision and standardization of pharmaceutical care model, improve the rationality of drug use, and ensure the safety of drug use of patients.
  • Cost-effectiveness Analysis of Anlotinib for Advanced Non-Small Cell Lung Cancer
    ZHAN Mei,WU Bin,WU Fengbo,XU Ting
    2020, 39(2): 172-175. https://doi.org/10.3870/j.issn.1004-0781.2020.02.009
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    Objective To evaluate the cost-effectiveness of anlotinib as a third-line or further treatment of advanced non-small cell lung cancer (NSCLC). Methods Based on the published ALTER 0303 trial, Markov model was established to calculate the incremental cost-effectiveness ratio (ICER) of anlotinib according to the disease development process of patients with advanced NSCLC,which was divided into non-progression survival state, disease progression state and death state.The cost information came from the charging standards of West China Hospital of Sichuan University in 2019, and the effect was expressed by the quality of life adjustment year (QALYs).Model robustness was verified using sensitivity analysis. Results Compared with placebo, the cost of anlotinib in the treatment of advanced NSCLC was estimated to increase by 15 767.67 yuan, with the effect increment of 0.11 QALYs, resulting in an ICER of 370 295.45 yuan per QALY. Conclusion Compared with placebo, anlotinib has no cost-effectiveness in the treatment of advanced NSCLC.
  • Systematic Evaluation of Effect of Deprescription Intervention on the Potential Inappropriate Prescription in Elderly Patients
    TIAN Fangyuan,CHEN Zhaoyan,LI Haixia,XU Ting
    2020, 39(2): 176-180. https://doi.org/10.3870/j.issn.1004-0781.2020.02.010
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    Objective To systematically evaluate the intervention effect of deprescribing on the potential inappropriate use of drugs in elderly patients. Methods The database searches were carried out through PubMed, EMBase, The Cochrane Library (Issue 5, 2019), CBM, CNKI, VIP and Wanfang Data to collect randomized controlled trials (RCTs) data about the deprescribing of potential inappropriate medication for elderly patients until May 2019.Two reviewers independently screened the literatures, extracted data and assessed the quality.Then Meta-analysis was conducted using RevMan 5.3 software. Results A total of 12 studies involving 4 056 patients were included.The results of Meta-analysis showed that compared with no deprescribing, the elderly patients with deprescribing did not significantly reduce the mortality rate: RR=1.09, 95%CI ( 0.94, 1.27), P=0.27, admission rate: RR=0.89, 95%CI (0.59, 1.35), P=0.59, recurrence rate of potential inappropriate drugs: RR=0.57, 95%CI (0.26, 1.27), P=0.17, and the differences were not statistically significant (P>0.05).However, it could effectively reduce the incidence of falls in patients: RR=0.82, 95%CI (0.72, 0.95), P=0.007, and the difference was statistically significant (P<0.05). Conclusion This study shows that the deprescribing for the potential inappropriate medication in elderly patients could effectively reduce the incidence of falls.
  • Correlation Between Statins and Clopidogrel Dynamic Resistance in Patients with Cerebral Infarction
    SHI Hongting,YAO Huiyan,DONG Yaxian,ZHONG Gaoxian,DIAO Fangming,LI Quilin,XU Junyang,CHEN Xiaoliang
    2020, 39(2): 181-186. https://doi.org/10.3870/j.issn.1004-0781.2020.02.011
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    Objective To investigate the effect of different CYP3A4-metabolized statins on the development of clopidogrel dynamic resistance in patients with cerebral infarction. Methods A total of 150 patients with cerebral infarction, non-clopidogrel resistance (NCR) patients were identified and randomly divided into atorvastatin group (atorvastatin 20 mg·d-1+ clopidogrel 75 mg·d-1, AC group) and rosuvastatin group (rosuvastatin10 mg·d-1 + clopidogrel 75 mg·d-1, RC group). The NCR patients were further divided into dynamic clopidogrel resistance (DCR) and continuous NCR (CNCR) subgroups. Platelet aggregation rate (PAR) of all patients before and 2 weeks after clopidogrel administration was measured by turbidimetric method. PAR of NCR patients after 1 and 3 months of posttreatment with clopidogrel plus statins was also evaluated. Results Compared with the DCR ratio (19 cases, 33.9%) of the AC group, the DCR ratio (6 cases, 11.3%) of the RC group was significantly different (P<0.05). Before taking statin, there was no significant difference in PAR between AC and RC groups (P>0.05). However, after taking statin, significant difference in PAR was observed between the AC and RC groups at different time points (F=13.913, P<0.01). Total cholesterol [OR=3.27, 95% CI (1.56, 6.84), P =0.002], triglycerides [OR =2.35, 95% CI (1.21, 4.57), P=0.012] and diabetes history [OR =5.06, 95% CI (1.13, 22.67), P=0.034] were independent risk factors for DCR. There were significant differences in PAR between DCR groups and CNCR groups in different time periods (F =116.680, P<0.01). Conclusion Statins, which were metabolized via CYP3A4, could affect the antiplatelet function of clopidogrel and increase the incidence of DCR. Meanwhile, the occurrence of DCR may be correlated with total cholesterol, triglycerides and previous diabetes history.
  • Effect of Dexmedetomidine Hydrochloride Combined with Oxycodone Hydrochloride on Recovery Quality in Patients with Abdominal Blunt Trauma
    ZHANG Jinli,YAN Hongli,ZHANG Yixuan
    2020, 39(2): 189-194. https://doi.org/10.3870/j.issn.1004-0781.2020.02.013
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    Objective To investigate the effect of dexmedetomidine hydrochloride combined with oxycodone hydrochloride on the recovery quality and stress response of patients during general anesthesia recovery period after emergency abdominal surgery for abdominal blunt trauma. Methods A total of 60 patients undergoing emergency open surgery was selected and randomly divided by 30 cases each into treatment group and control group.After the induction of anesthesia, the patients in the treatment group were intravenously infused or pumped with dexmedetomidine hydrochloride (1 μg·kg-1) and oxycodone hydrochloride (0.1 mg·kg-1) within 15 minutes.The control group was infused with an equal volume of 0.9% sodium chloride solution. Systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were recorded before induction of anesthesia (t0), extubation immediately (t1), 1 minute after extubation (t2), 10 minutes after extubation (t3), and 30 minutes after extubation (t4).The recovery time of spontaneous breathing, resuscitation time and extubation time were evaluated, and the visual analogue scale (VAS), restlessness score, sedation score (Ramsey) were recorded at the time of t1, t2, t3, and t4.Adverse drug reactions were observed and plasma cortisol (Cor), epinephrine (E), norepinephrine (NE), blood glucose concentration (Glu) concentrations were determined at t0, t1, t3 and t4. Results Compared with the control group, the SBP, DBP and HR measured at t1, t2 and t3 time points in the treatment group were significantly lower (P<0.01).There was no significant differences in recovery time, resuscitation time and extubation time between the two groups (P>0.05).The VAS scores and RSS scores of the treatment group at t2, t3, and t4 were significantly lower than those of the control group (P<0.01).There was no significant difference in Ramsay scores between the two groups at all time points (P>0.05).The incidences of nausea, vomiting, arrhythmia and drowsiness were similar in both groups, and there were no respiratory depression and pruritus (P>0.05).At the t1, t3 and t4 time points, plasma Cor, E, NE, and Glu concentrations were significantly higher than those at t0 (P<0.01).In the treatment group, plasma concentrations of Cor,E,NE, and Glu at t1, t3, and t4 were significantly lower than those of the control group (P<0.01). Conclusion The combined use of dexmedetomidine hydrochloride and oxycodone hydrochloride for advanced anesthesia could provide more stable hemodynamic environment for patients undergoing open surgery to relieve the pain reaction and the degree of restlessness, and reduce stress response during extubation.
  • Research Progress on the Effect of Intestinal Microflora on in Vivo Glucocorticoid Metabolism
    JI Kefei,ZHANG Yu,ZHANG Wenting
    2020, 39(2): 195-198. https://doi.org/10.3870/j.issn.1004-0781.2020.02.014
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    Intestinal microflora participate not only in human metabolism and immune regulation, but also in the metabolic process of some drugs in human body, and directly affect the pharmacokinetics of drugs, leading to drug activation, deactivation and toxicity.This paper reviews recent studies on the roles of intestinal microflora in the metabolism of glucocorticoids in human body, and analyzes the possible mechanisms and countermeasures of some clinical manifestations (e.g.apparent mineralocorticoid excess) from a new perspective.

  • Molding Process of Sugarless Yinhua Ganmao Granules
    LIU Bentao,LIANG Xuhua,ZHAO Yanyan,JIA Zhao,WEI Gelong,ZHOU Wei,SUN Jinjuan,CHENG Min
    2020, 39(2): 202-207. https://doi.org/10.3870/j.issn.1004-0781.2020.02.016
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    Objective To study the best formulation process for sugarless Yinhua Ganmao granules. Methods To investigate effects of different excipients on the formability, solubility, fluidity, and hydroscopicity of particles; The optimum excipients for the preparation of sugarless Yinhua Ganmao granules were screened by a comprehensive scoring method, and the best ratio among the excipients was determined.Box-Behnken response surface method was used to optimize three formulation process parameters, including the amount of excipients, the volume fraction of ethanol, and the amount of ethanol. Results The optimum process conditions for the granules were dextrin-lactose-mannitol =0.5:1:1.5, extract powder-excipients =1:2, 90 % ethanol as a wetting agent, and the dosage as 10% of the mixed powder.In order to reduce the influence of water on the properties and stability of the formulation, the environmental humidity should be controlled below 54%. Conclusion The process was reliable, stable, and reproducible.The granules met the requirements for “granules” in the fourth part of Pharmacopoeia of the Peoples Republic of China (2015 Edition).This study provided a reference for the production of sugarless Yinhua Ganmao granules.
  • Preparation and Characterization of NGR-Modified Ultrasound Sensitive Liposomes
    CHEN Chunliang,KUANG Changchun,CHEN Zhilong,FU Xudong,LIU Hui,XIE Xiangyang
    2020, 39(2): 208-211. https://doi.org/10.3870/j.issn.1004-0781.2019.10.017
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    Objective To prepare and characterize the NGR peptides modified ultrasound sensitive liposome loaded with small interfering RNA (siRNA). Methods The NGR peptides reacted with DSPE-PEG-MALs to obtain DSPE-PEG2000-NGR. The ultrasound sensitive liposomes siRNA/NGR-LPs were prepared by film hydration and membrane-extrusion method. The liposomes were characterized by transmission electron microscope and laser light scattering particle size analyzer. Results The siRNA/NGR-LPs were spherical in shape and uniform in size, with the mean particle size of (101.56±9.82) nm, zeta potential of (3.68±1.08) mV, and siRNA entrapment efficiency of (74.52±2.49)%. The siRNA/NGR-LPs were stable during the storage at 4 ℃ for 30 d, and the particle size and zeta potential did not change significantly. And the liposomes remained stable after 48 hours incubation in the plasma. When triggered by ultrasound, the siRNA/NGR-LPs could release the siRNA efficiently. Conclusion The prepared NGR peptide modified sound sensitive liposomes have good physicochemical properties, stable characteristics, and ultrasonic sensitive properties.
  • HPLC Fingerprint Spectrum Analysis of Zhenggushui
    FAN Weifeng,HU Qin,DUAN Tingting,YE Zhiwen
    2020, 39(2): 212-216. https://doi.org/10.3870/j.issn.1004-0781.2020.02.018
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    Objective To establish an HPLC chromatographic fingerprint analysis method for the quality evaluation of Zhenggushui preparation. Methods The chromatographic fingerprint was obtained by HPLC. The similarity was calculated by using Similarity Evaluation System of Traditional Chinese Medicine Fingerprint. Results The methodology study showed that the precision, repeatability, and stability of the established HPLC method for Zhenggushui could meet the requirements for the fingerprint chromatographic analysis. There were 22 common peaks in the HPLC fingerprint spectrum, among which 3 peaks were identified. The similarity of the fingerprints from 19 batches was more than 0.99. Conclusion The established HPLC fingerprint method could provide comprehensive information of the components in Zhenggushui. It could be used for quality evaluation of the drug.
  • Optimization of Forming Process of Chaigui Jieyu granules by Response Surface Method
    YANG Jingyao,QIU Zhidong,WANG Chang,ZHANG Xinshu,ZHENG Guanghua,ZHENG Aizhu,DONG Xuelian,JIA Ailing
    2020, 39(2): 216-220. https://doi.org/10.3870/j.issn.1004-0781.2020.02.019
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    Objective To optimize the forming process of Chaigui Jieyu granules. Methods A single factor test method was used to investigate the types and proportion of excipients using both the solubility and the first forming rate of the granules as indicators.The ratios of 4:1, 2:1, 8:7 for the powder to maltodextrin, dextrin and soluble starch were used for optimization.Based on the first forming rate of granules, the Box-Behnken design method was used to optimize the process parameters such as the tableting pressing frequency, the feeding frequency, and the granulation frequency in the dry granulation process, and the preferred process parameters were verified. Results The best excipient was dextrin with the optimum excipient ratio of powder:dextrin=2:1; the optimum granulation process conditions were tablet pressing frequency 16 Hz, feeding frequency 20Hz, granulation frequency 15 Hz, whole granule.The volatile oil was added with appropriate amount of ethanol for dissolving, and the solution was then evenly sprayed on the surface of the granule to form drug granules.The process validation results showed that the granule yields were 82.10%, 82.39% and 82.24%, respectively. Conclusion The optimized forming process is simple, stable and feasible, which could lay a foundation for the future development of new drugs.
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    Influencing Factors Analysis of the Conversion of Cyclosporine from Intravenous Infusion to Oral Administration in Patients with Allogeneic Hematopoietic Stem Cell Transplantation
    LING Jing,ZOU Sulan,DONG Lulu,HU Nan,JIANG Yan
    2020, 39(2): 221-225. https://doi.org/10.3870/j.issn.1004-0781.2020.02.020
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    Objective To explore the dose conversion ratio of cyclosporine (CsA) from intravenous infusion to oral administration in patients with allogeneic hematopoietic stem cell transplantation (HSCT), and to analyze variable factors affecting the dose conversion ratio so as to provide references for clinical rational drug use. Methods The clinical medical records of patients using CsA after HSCT were collected retrospectively, including gender, age, bodyweight, corresponding biochemical indexes, drug combination, graft versus host disease (GVHD), and adverse drug reactions. The last plasma concentration/daily dose ratio (C0/Div) of CsA before the switch from intravenous infusion to oral administration was recorded, and compared with the plasma concentration/daily dose ratio (C0/Dpo) in 3-5 days after the switch. Bioavailability was calculated by dividing the dose-corrected CsA concentration in oral administration by the dose-corrected CsA concentration in intravenous administration [(C0/Dpo)/(C0/Div)]. The SPSS software was used to analyze the correlation between (C0/Dpo)/(C0/Div) and various factors. Results A total of 57 HSCT recipients were included in the study for analysis. The median value of C0/Div in intravenous administration was significantly higher than that of C0/Dpo in oral administration [3.15 (1.08-4.89) vs 0.88 (0.14-2.32), P<0.05]. The median (C0/Dpo)/(C0/Div) value was 0.3 (0.11-0.63). The ratio of dosages in the switch from intravenous to oral administration was 1:3, in which the combined itraconazole could significantly increase the (C0/Dpo)/(C0/Div) of CsA. A lower conversion ratio of 1:2.5 was applied in patients taking oral itraconazole. (C0/Dpo)/(C0/Div) was co-related to the GVHD and adverse drug reactions. The patients whose (C0/Dpo)/(C0/Div) values were less than 0.23 were more likely to get GVHD (P<0.05), and patients whose (C0/Dpo)/(C0/Div) values were more than 0.36 were more likely to have adverse drug reactions (P<0.05). Conclusion In HSCT patients, the dose conversion from intravenous infusion to oral administration at a ratio of 1:3 appeared to be appropriate. In patients combined with oral itraconazole, a lower conversion ratio of 1:2.5 was suitable. In order to ensure the concentration within the therapeutic window to improve the effectiveness of CsA treatment, CsA concentration should be monitored when switching the route of administration.
    • 临床药师交流园地
  • 临床药师交流园地
    Practice and Establishment of Pharmacy Consultation Pathway for Maintenance Dialysis Patients with Parenteral Nutrition
    LI Lulu,YANG Xiangyu,GUO Heng,ZHANG Shaohui
    2020, 39(2): 231-234. https://doi.org/10.3870/j.issn.1004-0781.2020.02.022
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    Objective To establish a consultation pathway in the pharmacy care for dialysis patients with parenteral nutrition in order to ensure the standardization of pharmacy consultation. Methods The consultation pathway was divided into three phases: information construction of parenteral nutrition preparation, consultation prescription design pathway, consultation follow-up and monitoring pathway.The professional knowledge which was involved in the consultation pathway could be pointed out and confirmed. Results Through the development of pharmacy consultation pathway for dialysis patients, the work of pharmacy consultation was further standardized.The number of nutrition related pharmacy consultation increased by 74.0%, and the acceptance rate of pharmacy consultation increased from 92.4% to 97.9%.Furthermore, the rate of the rational parenteral nutrition prescriptions was increased significantly from 33.0% to 88.0%. Conclusion Establishment of a pharmacy consultation pathway is an effective way to improve the acceptance rate of pharmacy consultation, achieve the inheritance of professional knowledge and work experience, and promote the standardization of pharmacy care.
    • 药品不良反应与不良事件
  • 药品不良反应与不良事件
    Retrospective Analysis of Oxaliplatin related Adverse Reactions/Events Based on a Database
    ZHONG Qiaoni,LI Min,SHANGGUAN Xiaofang,ZHAO Li,CHENG Sijin,ZHANG Chengliang
    2020, 39(2): 239-243. https://doi.org/10.3870/j.issn.1004-0781.2020.02.024
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    Objective To explore the characteristics and patterns of oxaliplatin (OXA) induced adverse reactions/events (ADR/ADE), so as to provide a basis for the safe and rational drug use in clinic. Methods Retrospective study was conducted on 1627 cases of adverse reactions caused by OXA, which were collected in Hubei Provincial Drug (Medical Devices) Adverse Reactions Monitoring Center from January 2012 to December 2018.Statistical analysis was carried out according to gender, age, route of administration, time of occurrence of ADR/ADE, and clinical manifestations. Results In OXA -induced ADR/ADE cases, the male-female ratio was 1.32:1, and the age of the patients was mainly distributed between 41 and 80 years old (92.87%).Most of OXA-induced ADR/ADE occurred mainly from intravenous administration.Most patients developed ADR/ADE at 1-24 h and 1-7 d after the drug administration.OXA-induced ADR/ADE involved various systems, including digestive system injury, central and peripheral nervous system injury, blood system injury, and allergic reactions. Conclusion OXA-induced ADR/ADE was common in clinic, and could cause severe organ injury.Clinical medication should be closely monitored in patients, and appropriate treatment measures should be taken to improve the safety of medication.
  • Construction of Irrational Prescription Intervention Management System Based on PDCA Cycle in Hospital Outpatients
    SUN Mengru,JIANG Jun,YOU Yizhong,WANG Liying,XIE Yin
    2020, 39(2): 250-255. https://doi.org/10.3870/j.issn.1004-0781.2020.02.030
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    Objective To construct a management system for irrational prescription intervention in outpatients based on PDCA cycle. Methods Examined the irrational prescriptions in outpatients, and analyze the causes of the cases: incorrect setting of cipher prescription, unfamiliar cross-department drug use, system-limited prescription from self-department diagnosis, hasty diagnosis writing, pharmacists’ inadequate feedback, patients’ additional requests for other medicines, no intervention from the medical management department, no qualified usage and dosage options, and incomplete doctors’ pharmaceutical knowledge. In response to the above issues, continuous improvement was implemented from March 2017 to August 2017 using the PDCA management model. Results The irrational prescription rate in outpatients was reduced from 1.15% to 0.45%, and the improvement rate was 60.9%. Conclusion PDCA cycle management could effectively reduce the irrational rate of outpatient prescriptions, improve the quality of outpatient prescriptions, and promote rational drug use.
  • Application of Quality Control Circle in Improving the Effective Rate of Drug Intervention in Lung Cancer Patients with Moderate to Severe Pain
    LI Shijun,GU Ming,LUO Juan,LIU Jinmei,SHI Chen
    2020, 39(2): 255-260. https://doi.org/10.3870/j.issn.1004-0781.2020.02.031
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    Objective To evaluate the effect of Quality Control Circle (QCC) in improving the effective rate of drug intervention in lung cancer patients with moderate to severe pain. Methods From January 2017 to July 2017, the lung cancer patients with moderate to severe pain were intervened with drugs, and the total number of interventions was 3072. The reasons for poor effective rate of drug intervention in lung cancer patients with moderate to severe pain were analyzed by QCC. The countermeasures were applied to improve the effective rate of drug intervention, including setting up a pain management training school, compiling a medication education manual, and formulating the standard operating procedures for the administration of narcotic drugs. The effective rate of drug intervention before and after QCC in lung cancer patients with moderate to severe pain and the scores of various activities of the QCC members were statistically analyzed. Results The effective rate of drug intervention for moderate to severe pain in lung cancer patients increased from 56.28% before the implementation of QCC activities to 85.29% after activities. The target compliance rate was 106.26%, and the improvement rate was 51.55%. Circle members had significant improvement in the sense of honor, responsibility, self-confidence, QCC skills, communication, and team cohesion. Conclusion QCC activities could effectively improve the effective rate of drug intervention and the quality of life in lung cancer patients with moderate to severe pain.
  • Application of Triggering and Feedback in ADR Monitoring and CDR System Design
    WANG Yulai,ZHOU Benhong,ZHAO Xian,JIANG Chen
    2020, 39(2): 261-264. https://doi.org/10.3870/j.issn.1004-0781.2020.02.032
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    Objective To explore and share the experience of pharmacy professionals that involved in the hospital ADR monitoring and the design of clinical data repository (CDR) during the establishment of 7-level HIMSS (Healthcare Information Management System society) in Huangshi Central Hospital. Methods A variety of mechanisms, such as feature texts, typical medication orders, and abnormal test values, was set up to trigger the ADR reporting.And grading alarm in the CDR system was achieved on patients who was prescribed ADR related medication again. Results After the ADR reporting system was embedded in the CDR, the convenience, compliance, timeliness, and integrity of hospital ADR reporting had been significantly improved, and the recurrence of drug-induced injury had also been effectively reduced. Conclusion By monitoring of clinical data to drive the ADR information reporting, the ADR monitoring is changed from offline to online, and ADR reporting is changed from passive into active.At the same time, the closed loop of drug safety management is constructed.
  • Effect of Chinese Hospital Pharmacovigilance System on the Reporting of Adverse Drug Reactions in a Hospital
    LI Hongling,TAN Na,ZHUANG Hongling,TAO En,QIN Zhengbi
    2020, 39(2): 265-267. https://doi.org/10.3870/j.issn.1004-0781.2020.02.033
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    Objective To explore the effect of Chinese Hospital Pharmacovigilance System (CHPS) on reporting adverse drug reaction (ADR) in hospitals. Methods The ADR report form before the installation of CHPS was used as the control group, and the ADR report in the same period after the installation of CHPS was used as the research group. The number of ADR reports, new cases/serious cases proportion, missing items reporting, and ADR process descriptions of the two groups in the same period were compared through data collection and statistical analysis. Results After the installation of CHPS, the number of ADR reports increased significantly at the percentage of 181.25%. The proportion of new/serious ADR reports reached 50%, and the number of missing items in the reports decreased significantly (P<0.05). And the ADR process description was more detailed. Conclusion The CHPS system has the advantages of convenience, practicality, and rapidity. And it has a significant effect on the quantity and quality of ADR reporting in our hospital.
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