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• 22 November 2016 Volume 35 Issue 11

    

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  World Health Organization Pharmacovigilance Indicators and Their Application

  Fandian ZENG

  2016, 35(11): 1159-1163. https://doi.org/10.3870/j.issn.1004-0781.2016.11.001

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  Pharmacovigilance is an important means to ensure drug safety.With the rapid development of the pharmaceutical and healthcare fields,the drug safety monitoring system is continuously improving and the laws and regulations related to pharmacovigilance are gradually building in China.To establish a perfect unity of drug safety monitoring system and implement pharmacovigilance activities to be in line with international standards,this article introduces the definition,functions,characteristics and classification of WHO pharmacovigilance indicators (issue date: 2015) and its important values for the drug safety monitoring system in details.It is emphasized that the series of pharmacovigilance indicators in WHO are especially significant values for constructing the efficient and normative drug safety monitoring system in China.

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  Effect of Dexmedetomidine on Propofol-induced Neuroapoptosis by Reducing the Mitochondrial Membrane Potential in Primary Cultured Cortical Neurons of Rat

  Jianli LI,Hongxia GUO,Wei LIANG,Junfang RONG,Rui LIU

  2016, 35(11): 1164-1168. https://doi.org/10.3870/j.issn.1004-0781.2016.11.002

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  ObjectiveTo investigate the effects and mechanism of dexmedetomidine on propofol-induced neuroapoptosis in primary cultured cortical neurons. MethodsAfter the neurons being cultured for 7 days,they were divided into vehicle control group (equal volume of 20% fat emulsion),propofol group(500 μmol·L^-1) and dexmedetomidine+propofol group (dexmedetomidine at 0.001,0.01,0.1 1 μmol·L^-1and propofol at 500 μmol·L^-1).Twelve hours after treatments,neuron viability was measured by MTT assay,neuron structure was analyzed by microscope.Neuroapoptosis was detected by Hoechst33258 staining and mitochondrial membrane potential was measured by the fluorescent dye rhodamine 123 (Rh123). ResultsCompared with the vehicle control group,propofol inhibited neuron viability greatly(P<0.05).Compared with propofol treatment group,dexmedetomidine increased neuron viability in a dose-dependent manner (P<0.01).Lack of three-dimensional sense,faded color and unclear outline were observed,fractured neuron axons or neurons death were also observed in neurons treated by 500 μmol·L^-1 propofol.While dexmedetomidine inhibited propofol-induced morphological damage,propofol (500 μmol·L^-1) markedly increased the number of apoptotic neurons (P<0.01) and decreased the mitochondrial membrane potential greatly (P<0.01).Dexmedetomidine (0.1 μmol·L^-1) significantly decreased the number of apoptotic neurons (P<0.01) and increased the mitochondrial membrane potential (P<0.01). ConclusionDexmedetomidine exerts its neuroprotective effects against propfol-induced neuroapoptosis by protecting the mitochondrial membrane potential.
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  Interference of Niaoduling Reverses TGF-β₁-induced Epithelial-mesenchymal Transition in HK-2 Cells

  Zechun DANG,Xiaohong YUAN

  2016, 35(11): 1168-1172. https://doi.org/10.3870/j.issn.1004-0781.2016.11.003

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  ObjectiveTo investigate the effect of Niaoduling on cell proliferation and morphological changes in the process of epithelial-mesenchymal transition (EMT) of renal tubular epithelial cells induced by TGF-β₁. MethodsHK-2 cells were treated with various concentrations of TGF-β₁ for 24,48 and 72 h,respectively.According to the cell proliferation and morphological changes,the best concentration and time points was selected to induce EMT.HK-2 cells were divided into nromal control group,model control group,treatment group in control condition and treatment group in model condition.The cell proliferation was detected by MTT and the cell morphological changes was observed by microscope. ResultsTGF-β₁ inhibited cell proliferation and 5 ng·mL^-1 for 72 h has the strongest effect (P<0.05).Under this condition,cells had the most obvious EMT-like appearance.Compared with the model control group,inhibition induced by TGF-β₁ could be significantly reversed by Niaoduling at the dosage of 160 μg·mL^-1 (P<0.05).Morphological observation showed that Niaoduling could maintain normal cell morphology as paving stone,prevent fibrosis induced by TGF-β₁. ConclusionNiaoduling can partly reverse EMT induced by TGF-β₁ in HK-2 cells.
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  Effect of All-trans Retinoic Acid on High Glucose Induced-Expression of Inflammatory Factors in HK-2 Cells

  Yanxia CHEN,Weiping TU,Xiangdong FANG,Xiaohua QIN,Chong HUANG,Hongchang ZOU,Gaosi XU

  2016, 35(11): 1173-1176. https://doi.org/10.3870/j.issn.1004-0781.2016.11.004

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  ObjectiveTo explore the effect of all-trans retinoic acid(ATRA) on inflammatory cytokines expression in human renal tubular epithelial cells under high glucose condition and its possible mechanisms. MethodsHK-2 cells were randomly divided into seven groups: blank control group, high glucose group, hypertonic group, ATRA intervention groups and Rho kinase inhibitor (Y27632) intervention group.All groups were treated for 48 hours.Reverse transcription polymerase chain reaction (RT-PCR) was used to evaluate RhoA and ROCK1 mRNA levels.ELISA was used to detect interleukin-6 (IL-6) and tumor necrosis factor-α (TNF- α) expression in HK-2 cells. ResultsRT-PCR showed that mRNA expressions of RhoA and ROCK1 were not different between the hypertonic group and the blank group (P>0.05), but were significantly increased in the high glucose group (P<0.05).In the ATRA treatment group,RhoA and ROCK1 mRNA expressions were significantly decreased compared with the high glucose group in a concentration-dependent manner.RhoA mRNA expressions showed no difference between the Y27632 intervention group and the high glucose group, but ROCK1 mRNA expression was significantly reduced (P<0.05).By Pearson correlation analysis, we found that there was a positive correlation between RhoA and ROCK1 mRNA expressions in the high glucose group and the ATRA treatment group.ELISA showed that the IL-6 and TNF-α protein levels were not different between the control and the hypertonic group (P>0.05), but were significantly increased in the high glucose group and decreased in the ATRA or Y27632 treatment groups (P<0.05). ConclusionATRA decreases IL-6 and TNF-α protein levels in HK-2 cells induced by high glucose.The underlying mechanism may be associated with the RhoA/ROCK signaling pathway.
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  Limited Sampling Strategy for the Estimation of Mycophenolate Sodium Area Under Concentration-Time Curve and Pharmacokinetic Study

  Na LI,Zhenfeng ZHU,Guiwen FENG,Jun ZHANG,Mengmeng JIA,Lihua ZUO,Xiaojian ZHANG

  2016, 35(11): 1177-1180. https://doi.org/10.3870/j.issn.1004-0781.2016.11.005

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  ObjectiveTo establish a model for estimating area under the concentration -time curve(AUC) of mycophenolic acid (MPA) by a limited sampling strategy. MethodsSixteen renal allograft recipients were treated with enteric coated mycophenolate sodium (EC-MPS) twice a day respectively.The blood samples were collected on postoperative days 4 and 7 before and 0.5,1,1.5,2,3,4,6,8,10,12 h after EC-MPS oral administration.Ultra performance liquid chromatography-UV (UPLC-UV) method was employed to determine the plasma concentration of MPA.Pharmacokinetic parameters of MPA were calculated by DAS 2.0 software.Areas under curve over the period of 0 to 12 h (AUC_{0-12 h} ) were calculated by using linear trapezoidal rule.The limited sampling model and relevant parameters were established by multivariate linear stepwise regression analysis with SPSS 17.0. ResultsThe main pharmacokinetic parameters on postoperative days 4 and 7 were as follows: t_1/2 were (6.93±6.51) and (8.18±5.06) h (P>0.05); C_max were (10.10±6.44) and (17.26±11.67) mg·L^-1 (P<0.05); AUC_{0-12 h} were (32.47±15.53) and (41.88±18.30) mg·h·L^-1(P<0.05).Some patients' concentration-time curves were bimodal.The second peak appeared at 4~12 h after treatment and the peak obviously decreased compared with the first one.No single plasma concentration can accurately predict AUC_{0-12 h}.After analyzing the correlation between multiple plasma concentrations of MPA and AUC_{0-12 h} by the multivariate linear stepwise regression analysis method,we selected the 0,4,1.5,8 h plasma concentrations of MPA to estimate AUC_{0-12 h}.The computational formula was AUC_{0-12 h} =6.207+C₀×6.881+C₄×2.388+C_1.5×0.541+C₈×4.252 (r²=0.888).The predicted value has a good correlation with the measured value (r²=0.918) and the relative prediction error was in the acceptable range. ConclusionThe multivariate regression model of four points sampling method is a better predictor of MPA- AUC_{0-12 h}.This simple method will be conducive to the further application and popularization in clinic,improve the rational use of mycophenolate sodium,and realize the purpose of curative effect and adverse reaction prediction.
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  Effect of Naringin and Naringenin on Atherosclerotic Plaque Development Aorta in ApoE^-/- Mice

  Ying YANG,Hui LUO,Zhan LYU

  2016, 35(11): 1181-1185. https://doi.org/10.3870/j.issn.1004-0781.2016.11.006

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  ObjectiveTo explore the effect of naringin/naringenin on atherosclerotic plaque development of aorta in ApoE^-/-mice. MethodsApoE^-/- mice were randomly assigned to model control group, naringin or naringenin treatment groups.Each group was fed with high-fat diet.After 12 weeks,we examined the plasma level of lipid and homocysteine, the area of the atherosclerotic plaque and the expression of SR-A, LOX-1,ACAT1andABCA1/G1 in mice. ResultsThere was no significant change in blood lipid levels between model control group and the naringin/naringenin treatment groups (P>0.05).In contrast to other groups,the formation of atherosclerotic plaque in ApoE^-/- mice was significantly inhibited innaringin/naringenin treatment groups (P<0.05).The expression of SR-A,LOX-1 and ACAT1 were down-regulated (P<0.05)while the expression of ABCA1/G1 was up-regulated (P<0.05).The plasma level of homocysteine was reduced (P<0.05). ConclusionThe formation of atherosclerotic plaque in ApoE^-/- mice can be inhibited by high doses of naringin/naringenin.
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  Preparation and Assessment of the Antitumor Effect of Ginsenoside Rg3 Nanocrystals

  Yanjin XIE,Tingting YU,Wei LOU

  2016, 35(11): 1186-1189. https://doi.org/10.3870/j.issn.1004-0781.2016.11.007

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  ObjectiveTo investigate the inhibitory effects of ginsenoside Rg3 nanocrystals and Shenyi capsule against the proliferation of A549 and HepG₂ cells in vitro. MethodsThe ginsenoside Rg3 nanocrystals were prepared by precipitation combined with high pressure homogenization technique.Particle size and polydispersity index were measured by TEM,and MTT assay was performed to evaluate the inhibitory effects of ginsenoside Rg3 nanocrystals and Shenyi capsule on A549 and HepG₂ cells. ResultsThe average particle size of ginsenoside Rg3 nanocrystals was (284±14) nm,and the PI was 0.156±0.007.The IC₅₀ values of nanocrystals and Shenyi capsule in HepG₂ cells were (65.59±3.62) and (97.64±10.48) μg·mL^-1.They were (56.36±2.14) and (83.26±7.44)μg·mL^-1 in A549 cells.The differences were significant(P<0.01). ConclusionGinsenoside Rg3 nanocrystals prepared by precipitation combined with high pressure homogenization technique had a small particle size,an ideal polydispersity coefficient and a better stability.In contrast to Shenyi capsule,Ginsenoside Rg3 nanocrystals showed higher anti-tumour activities in vitro.There was a significant difference between two groups at high dosages.Ginsenoside Rg3 showed a higher anti-proliferative activity in A549 than in HepG₂ cells.
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  Orginal Article

  Effect of Sijunzi Decoction on Expression of Claudin-1 and Claudin-3 in Mouse Model of Ulcerative Colitis

  Aiming HE,Tao ZHANG

  2016, 35(11): 1190-1194. https://doi.org/10.3870/j.issn.1004-0781.2016.11.008

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  ObjectiveTo explore the therapeutic effects of Sijunzi decoction in mice model of ulcerative colitis,including the ultrastructural changes in colon mucosa and the protein and mRNA expressions of claudin-1 and claudin-3. MethodsNinety Balb/c mice were divided into normal control group,model control group,mesalazine group and low, medium and high dose Sijunzi decoction group.All mice were fed with 3% DSS solution for two weeks to establish the ulcerative colitis model except the normal control group.From the third week,the mesalazine group were treated with mesalazine, and Sijunzi decoction group were intragastric administrated once daily for 7 days.Ultra structural changes in colon mucosa were analyzed by transmission electron microscope and the expression of claudin-1 and claudin-3 was detected by Real-time PCR and Western-blot. ResultsThe ulcerative colitis is characterized by sparsity of epithelial villus,widen of epithelial connection,reduction of goblet cells and swelling of mitochondria.The Sijunzi decoction groups were characterized by regular arrangement of microvillus and increment of goblet cells,as well as mitochondria swelling and rough endoplasmic reticulum dilatation.The expressions of claudin-1 and claudin-3 were decreased in model control group while they were increased in the Sijunzi Decoction group and the difference is significant (P<0.05).Expressions of claudin-1 and claudin-3 were not significantly different between normal control group and Sijunzi Decoction group. ConclusionSijunzi decoction has effects of ulcer colitis remission and intestinal epithelial restoration by regulating the expression of claudin-1 and claudin-3.
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  Effect of Naringin on Trefoil Factor 2 Content in Serum and Gastric Mucosal Tissue in Rats with Gastric Ulcer

  Jianshe QIN,Bo ZHENG

  2016, 35(11): 1194-1197. https://doi.org/10.3870/j.issn.1004-0781.2016.11.009

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  ObjectiveTo explore the effects of naringin on trefoil factor 2 (TFF2) content in serum and gastric mucosa tissue in gastric ulcer rats induced by acetic acid and its therapeutic effects on gastric ulcer. MethodsForty-five rats were randomly divided into normal control group,model control group and naringin high and low dose groups.The acetic acid gastric ulcer model was established by modified okabe method.On the next day,model control group was given 0.9% sodium chloride solution 1 mL·(100 g)^-1,naringin low-dose group was given 50 mg·kg^-1, and naringin high-dose group was given 100 mg·kg^-1,all by gastric perfusion once-daily for 7 days.Gastric ulcer area was measured,and the contents of TFF2 in serum and gastric mucosa tissue were detected by enzyme linked immunosorbent assay (ELISA). ResultsCompared with the model control group,the ulcer index in naringin treatment groups were significantly decreased (P<0.01),and the contents of TFF2 in serum and gastric mucosa tissue were significantly increased (P<0.05).The high dose group was obviously superior to the low dose group (P<0.01). ConclusionNaringin has significant anti-gastric ulcer effects and the mechanism may be associated with the increased content of TFF2 in serum and gastric mucosa tissue.
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  Preventive Effect of Aprepitant on Highly Emetogenic Chemotherapy-induced Vomiting in Patients with Bone and Soft Tissue Sarcoma

  Chen GONG,Hua XIONG,Jianhua WANG,Peng ZHANG,Jing ZHANG,Tengfei CHAO,Huihua XIONG

  2016, 35(11): 1198-1201. https://doi.org/10.3870/j.issn.1004-0781.2016.11.010

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  ObjectiveTo evaluate the effects of aprepitant on highly emetogenic chemotherapy-induced nausea and vomiting (CINV) in patients with bone and soft tissue sarcoma. MethodsA total of 20 patients of bone and soft tissue sarcoma who received 86 cycles chemotherapy were divided into treatment group treatment group (n=10, 45 cycles, aprepitant+palonosetron+dexamethasone) and control group (n=10, 41 cycles, palonosetron+dexamethasone).The preventive effect of aprepitant on chemotherapy-induced vomiting (CIV) was observed. ResultsThe complete remission rate of CIV in treatment group and control group were 68.89% and 51.22% respectively (P>0.05),and the incidence rates of delayed vomiting were 17.78% and 36.59% (P<0.05).The adverse effects such as constipation,appetite reduction and headache were well tolerated within two groups (P>0.05),but the incidence of fatigue in treatment group was higher than that in the control group. ConclusionAprepitant can significantly decrease the incidence of delayed CIV in bone and soft tissue sarcoma patients,and the adverse reaction is slight.
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  Curative Effect of Rhubarb Choleretic Capsule on Prevention of Gallstone Recurrence after Minimal Invasive Gallstone Surgery

  Huanhuan JIANG,Xia ZHANG,Yujie YAN,Wenze DU,Bei LU

  2016, 35(11): 1201-1204. https://doi.org/10.3870/j.issn.1004-0781.2016.11.011

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  ObjectiveTo observe the effect of rhubarb choleretic capsule on preventing gallstone recurrence after minimal invasive gallstone surgery. MethodsSixty patients with gallstone who received laparoscopic-choledochoscopy-assisted removal of cholecystolithotomy(LRCL) were divided into treatment group and control group.The treatment group was treated with rhubarb choleretic capsule after surgery,while the control group took no medicine.The patients were followed up and took B ultrasonic testing after surgery.The gallstonere currence rate,gallbladder wall thickness as well as gallbladder contraction efficiency were recorded. ResultsCompared with 2 days before operation,the gallbladder wall thickness were remarkably decreased in both groups (treatment group,t=16.391,P<0.01;control group,t=7.004,P<0.01),and the results were statistically significant.The gallbladder contraction ratios were markedly increased and there are statistically significant differences(treatment group,t=-42.817,P<0.01;control group,t=-23.066,P<0.01).Compared with the control group,the gallbladder wallthickness in rhubarb choleretic capsule treatment group decreased significantly (t=-7.813,P<0.01),while the gallbladder contraction ratio increased significantly(t=12.693,P<0.01) .The gallstone recurrence rate of the treatment group were obviously lower than the control group (χ²=4.32,P<0.05),the results were significant. ConclusionThere is a positive effect of taking rhubarb choleretic capsule after minimal invasive gallstone surgery to prevent the gallstone recurrence.
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  Efficacy and Safety of Saccharomyces Boulardii in the Prevention of Antibiotic Associated Diarrhea in Children: Meta Analysis

  Chunsong YANG,Lingli ZHANG,Sisi ZHANG,Yaya YANG,Cairong ZHU

  2016, 35(11): 1211-1219. https://doi.org/10.3807/j.issn.1004-0781.2016.11.014

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  ObjectiveTo systematically evaluate the efficacy and safety of Saccharomyces boulardii in the prevention of antibiotic associated diarrhea (AAD) in children. MethodsThey searched the Cochrane library,PubMed,Cochrane,EMBASE,CBM,CNKI,VIP and Wanfang database for randomized controlled trial (RCTs) in evaluating the efficacy and safety of Saccharomyces boulardii in the prevention of AAD.Meta-analysis was conducted based on the methods recommended by the Cochrane Collaboration. ResultsTwenty-three studies (3 939 patients)were included,twenty-two RCTs used open control as control and one used placebo.Meta analysis of twenty-one studies (3 534 patients) showed Saccharomyces boulardii group could significantly reduced the diarrhea rate compared with open control group in the prevention of AAD (RR=0.47, 95%CI (0.42,0.53), I²=0%).Meta analysis of 7 studies (523 patients) showed that the efficacy rate of Saccharomyces boulardii group was significantly higher than open control group in the prevention of AAD (RR=1.34, 95%CI (1.22,1.47),I²=0%).Twelve studies reported adverse reactions, nine studies reported there was no ADR,three studies reported specific ADR.The most common AEs were rash,dry mouth,gastrointestinal discomfort and antibiotics delayed type hypersensitivity. ConclusionThe available clinical evidence suggested that Saccharomyces boulardii was effective in the prevention of AAD and was well tolerant.However due to limited study sample and quality, the long-term efficacy and safety studies are required to confirmit.
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  Orginal Article

  Therapeutic Effects of Kouchuang 1 on 30 Heart and Spleen Accumulated Heat of Recurrent Aphthous Ulcer Patients with Constipation

  Hanming WANG,Min HUANG,Xiaomi ZHU,Yinzong QU,Jing LEI,Juan YI

  2016, 35(11): 1220-1222. https://doi.org/10.3870/j.issn.1004-0781.2016.11.015

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  ObjectiveTo observe the clinical effects and safety of Kouchuang 1 on recurrent aphthous ulcer (RAU) patients and constipation with brimming heat of heart and spleen. MethodsA total of 60 RAU patients (also diagnosed as brimming heat of heart and spleen,BHHS type) with constipation were divided into two groups,each group contained 30 cases.The control group was treated with Niuhuangjiedu tablets and the treatment group was given Kouchuang 1 by oral administration for 14 days.Oral healing rate (including the average duration of ulcer, pain index and efficiency),constipation cure rate(including defecation, stool,defecation difficulty, first defecation period and efficiency) and the adverse drug reactions in two groups were compared. ResultsThere was no significant difference in defecation,defecation difficulty, first period defecation and constipation efficiency between two groups(P>0.05).After 14 days, the aphthous ulcer healing rate was 96.7% in the treatment group and 76.7% in the control group.The average duration of ulcer and pain index in the treatment group were significantly reduced(P<0.05).We did not observe obvious adverse drug reactions in the treatment group, while there were more ADRs in the control group. ConclusionKouchuang 1 has a positive effect in treating recurrent RAU patients with constipation.The overall efficacy and safety of Kouchuang 1 is better than Niuhuangjiedu tablets.
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  Research Progress in Combination Therapy of Dipeptidyl Peptidase-IV Inhibitors with Metformin

  Peifang HE,Hui LIU

  2016, 35(11): 1223-1226. https://doi.org/10.3870/j.issn.1004-0781.2016.11.016

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  Dipeptidyl peptidase -4 (DPP-4) inhibitors are a new type of drugs for diabetes.They have remarkable hypoglycemic effect and fewer adverse drug reactions.They do not increase the risk of hypoglycemia.Currently in clinic,DPP-4 inhibitors are often used in combination with metformin in type 2 diabetes mellitus (T2DM) patients.They can lower blood sugar and glycosylated hemoglobin (HbA1c),and do not gain body weight.They are well tolerated with a low incidence of hypoglycemia.The research progress of combination therapy of DPP-4 inhibitors and metformin was reviewed in this paper.

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  Orginal Article

  Research Progress in Onychium japonicum

  Yu FANG,Peipei CHENG,Ye XIA,Minggao ZHANG,Xiuqiao ZHANG

  2016, 35(11): 1226-1229. https://doi.org/10.3870/j.issn.1004-0781.2016.11.017

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  To classify and describe the resource distribution,morphological characteristics,chemical constituents,pharmacological effects and main active ingredient onychin from the literatures of Onychium japonicum.Thirty-five compounds have been isolated from this plant,including flavonoids,coumarins,and indene ketone.Pharmacological research showed that Onychium japonicum has anti-inflammatory,analgesic,detoxifying,spasmolytic,and antitumor effects.Onychin is the main active ingredient,and it has endothelial cells protection,anti-atherosclerosis and anti-tumor effects.

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  Orginal Article

  Improving the Quality Standard of Shengya Capsules

  Ying WANG,Wan LEI,Yuxia KANG,Weiyu CAO,Xiaojuan WANG

  2016, 35(11): 1238-1242. https://doi.org/10.3870/j.issn.1004-0781.2016.11.020

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  ObjectiveTo revise the quality standard of shengya capsules. MethodsThe Astragalus membranaceus,Dried ginger,Stir-baked Paeoniae Alba Radix and Sun-dried ginseng of capsules were identified by microscopic identification.Baikal Skullcap Root,stir-baked Paeoniae Alba Radix,Fructus Aurantii,Sun-dried ginseng,dried ginger and Tangerine peel were identified qualitatively by thin-layer chromatography (TLC).The contents of paeoniflorin was detected by high performance liquid chromatography (HPLC).Chromatographic condition included a DiamonsilC₁₈(2) column (4.6 mm×250 mm,5 μm),acetonitrile-0.1% phosphoric acid-water solution (14:86,V/V) as the mobile phase,and detection wave length at 230 nm. ResultsThe character of power was clear and evident,specific by microscopic identification.TLC showed that spot was clear,specific and Rf was moderate.The concentration of paeoniflorin was linear at the range of 53.12-180.60 μg·mL^-1 (r=0.999 9).The average recovery was 95.89% and RSD was 1.58% (n=9). ConclusionThe method is simple,sensitive,accurate and reproducible.It can be used for the quality control of Shengya capsules.
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  Orginal Article

  Analysis of Aroma Components in Agarwood by SHS-GC-MS Combined with Retention Index

  Qiuping ZHONG,Zhaojian ZHONG,Xiaodong CHEN,Ning YUAN,Song ZHAN,Xiaoxia GAO,Xiaoying CHEN

  2016, 35(11): 1243-1249. https://doi.org/10.3870/j.issn.1004-0781.2016.11.021

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  ObjectiveTo analyze aroma components of agarwood by static headspace sampling gas chromatography-mass spectrometry(SHS-GC-MS) combined with retention index (RI). MethodsAroma components of white-wood,artificial agarwood and natural agarwood were heated and extracted directly for analysis by SHS-GC-MS without any chemical process,and the components were identified by using automated mass spectral deconvolution & identification system (AMDIS) combined with retention index. ResultsThere were 55 aroma components identi?ed in this study,like aldehydes,ketones,phenol alcohols,esters,naphthalenes,hydrocarbons,and 2-(2-phenylethyl) chromones.There were seven common components present in the artificial and natural agarwood,mainly belong to ketones,alcohols and phenols.And the 7 components only present in the natural agarwood belong to phenol alcohols,ketones and naphthalenes.Ketones and phenol alcohols possess the highest content in artificial agarwood and natural agarwood,respectively.There were significant differences in aroma components between artificial agarwood and natural agarwood. ConclusionThis method is effective and feasible for quality evaluation of agarwood.
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  Orginal Article

  Preparation Technology of American Ginseng Dropping Pills

  Jiyong YAN,Aiyun LI,Kunmiao FENG,Qiang ZHANG,Yaotian CUI,Panpan ZHANG,Chunchao HAN

  2016, 35(11): 1249-1253. https://doi.org/10.3870/j.issn.1004-0781.2016.11.022

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  ObjectiveTo optimize the preparation technology of American ginseng dropping pills. MethodsBased on preliminary experiments, the ratio of drugs/matrix,temperature of dripping,and condensing as inspective factors.Chosen dropping pills forming as optimizing index,optimized the preparation technology of American ginseng dropping pills by response surface methodology. ResultsThe optimized preparation condition was as follows: matrix PEG4000 to PEG6000 at 1:1,drug to matrix at 1:6,condensing agents used as liquid paraffin,dripping temperature at 90 ℃,and condensing temperature at 2 ℃,respectively. ConclusionThe American ginseng dropping pills made by this method have better properties of hardness,roundness,and forming rate,and complies with the quality requirements.The process can be used for the preparation of American ginseng dropping pills.
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  Preparation and Optimization of Hydroxycamptothecin Loaded GA-PEI-PLGA Nanoparticles

  Jingkang LIANG,Detian WU,Qiaohong HU,Yaqiong WU

  2016, 35(11): 1254-1258. https://doi.org/10.3870/j.issn.1004-0781.2016.11.023

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  ObjectiveTo prepare hydroxycamptothecin(HCPT)loaded glycyrrhetinic acid modified polyethyleneimine-poly(lactic-co-glycolic acid)(GA-PEI-PLGA)nanoparticles. MethodsEmulsion-solvent evaporation method was used to prepare HCPT-loaded GA-PEI-PLGA nanoparticles.Based on the single-factor experiments, drug/GA-PEI-PLGA ratio, oil phase/water phase ratio, sonication timeand power were further investigated.The formulation and process were optimized by orthogonal testingdesign using entrapment efficiency and drug loading efficiency as indexes.HCPT-loaded GA-PEI-PLGA nanoparticles'diameter and zeta potential were determined. ResultsHCPT-loaded GA-PEI-PLGA nanoparticles were successfully prepared by emulsion-solvent evaporation method.Drug/GA-PEI-PLGA ratio, in particular, had the uniform particle on the preparation of HCPT-loaded nanoparticles.The optimal process was as follows:drug/GA-PEI-PLGA ratio of 3 to10, oil phase/water phase ratio of 1 to 9, sonication power of 570 W and sonication time of 15 min.The entrapment efficiency and drug loading efficiency of HCPT-loaded GA-PEI-PLGA nanoparticles were(87.52±3.91)%and(20.10±4.72)%, respectively.The average particle size was(218.1±3.23)nm and the zeta potential was(34.98±3.56) mV. ConclusionEmulsion-solvent evaporation method was feasible for preparing HCPT-loaded GA-PEI-PLGA nanoparticles, with uniform particel size distribution, good stability, high entrapment and drug loading efficiency.
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  Orginal Article

  Comparative Study of Technical Innovation Efficiency of Pharmaceutical Manufacturing in Eastern,Central and Western Regions of China

  Su WANG,Yulin SU,Yuwen CHEN

  2016, 35(11): 1276-1280. https://doi.org/10.3870/j.issn.1004-0781.2016.11.031

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  ObjectiveTo compare the differences of technical innovation efficiency of pharmaceutical manufacturing in the eastern,central and western regions of China,and put forward relevant countermeasures and suggestions on the basis of empirical results. MethodsThe pharmaceutical manufacturing crste,vrste,scale were compared among the Eastern,Central and Western regions from 2002 to 2013 by DEA method. ResultsThree regions are all in a non-active DEA state and the technical innovation resources are seriously lack of input redundancy and output in central region. ConclusionTechnical innovation efficiency of pharmaceutical manufacturing in the eastern and western regions was significantly higher than the under developed central region.