It is imperative to apply information technology in the area of management of clinical research so as to ensure the quality of clinical trials and to improve management efficiency.In this study,the based analysis method was the quality function deployment (QFD).This methodology is used to analysis the clinical trials management information system on a hospital directly under the Ministry of Health.It ensured user participation,lay a solid foundation for software engineers on system design.

Objective To investigate the association between serum ferritin(SF) level at early and mid trimester of pregnancy and gestational diabetes mellitus (GDM) and insulin resistance (IR).Methods A total of 192 cases of women who were accepted antenatal examination from the first trimester of pregnancy at Yueqing People Hospital from July,2012 to October,2013 was prospectively analyzed and followed up.All cases were divided into two groups:96 cases of GDM pregnant women who were diagnosed as GDM at mid trimester of pregnancy as GDM group,and 96 cases of pregnant women with normal glucose tolerance at the same time as the control,normal glucose tolerance (NGT group).The differences in clinical data were compared between two groups.The relationship between SF level and fasting plasma glucose (FPG),fasting insulin (FINS),homeostasis model assessment insulin resistance (HOMA-IR),and C-peptide was investigated with Spearman rank correlation analysis.The predictive values of SF and relative variables to GDM were calculated by receiver operating characteristic curve (ROC) or Logistic regression analysis.Results (1) There was statistically significant difference in body weight and body mass index (BMI) at prepregnancy and mid trimester of pregnancy,Hb,FPG,FINS,SF,and C-peptide at the first trimester of pregnancy,SF level and FPG and HOMA-IR and C-peptide at mid trimester of pregnancy between two groups (P ＜ 0.01 or P ＜ 0.05).(2) As showed by Spearman rank correlation analysis,there was statistical correlation between SF at mid trimester of pregnancy,and FPG,FINS,HOMA-IR and C-peptide (P ＜0.01 or P ＜ 0.05);while no statistical correlation was found between SF at the first trimester of pregnancy and the same factors above (P ＞ 0.05).(3) The area under the ROC curve of SF at mid trimester of pregnancy for GDM was 0.653.The sensitivity and specificity were 68.8％ and 59.4％ in predicting GDM at the cut-off value of 16.61 ng/ml.As showed by Logistic regression analysis,high level of SF at mid trimester of pregnancy was a independent risk factor for GDM.Odds ratio (OR) was 1.032 (95％ CI:1.008 ～ 1.058,P ＜ 0.01).Conclusions The relationship between SF at different trimester of pregnancy and GDM is variant.There is relationship between high level SF of mid trimester of pregnancy in GDM pregnant women and IR.The level of SF might predict the occurrence of GDM.

Objective To establish the base of molecular system-theory on medicinal plants of Angelica L.and to offer molecular gists for finding the efficacy difference of them.Methods The PCR technique was utilized together with the clone technique to get the ITS gene and measure its genic sequence.Statistical analyzing and branch analyzing were carried out by Phylip software and genetic distance difference in every kinds can be calculated with MEGA3.Results ITS1-5.8 S-ITS2,belongs to one of medicinal plants of Angelica L.,its sequence length extents 600 to 629 bp.Subtracting 5.8 S,its length is 165 bp,the length of ITS is 468 bp.The medicinal plants of Angelica L.are divided into two groups by dendrogram.The genetic distance of A.sinensis from Gansu Province is obviously different from the other medicinal plants of Angelica L.,but the distance difference compared with Levisicum officinale is smaller.Conclusion It suggests that the above result be identical to the efficacy of medicinal plants of Angelica L.It may be an important reason of explaining why the efficacy between A.sinensis and other medicinal plants of Angelica L.is so different.

Although the essential oil of Xiangfu Siwu decoction (XFSWD) has strong pharmacological activity, its special physical and chemical properties restrict the clinical application and curative effect. In this paper, Xiangfu Siwu decoction essential oil (XFS-WO) was prepared by forming inclusion complex with β-cyclodextrin (β-CD). The present study is to investigate the effect of β-CD inclusion complex on the transport of major components of XFSWO using Caco-2 cell monolayer model, thus to research the effect of this formation on the absorption of drugs with low solubility and high permeability, which belong to class 2 in biopharmaceutics classification system. A sensitive and rapid UPLC-MS/MS method was developed for simultaneous quantification of senkyunolide A, 3-n-butylphthalide, Z-ligustilide, dehydrocostus lactone and α-cyperone, which are active compounds in XFSWO. The transport parameters were analyzed and compared in free oil and its β-CD inclusion complex. The result revealed that the formation of XFSWO/β-CD inclusion complex has significantly increased the transportation and absorption of major active ingredients than free oil. Accordingly, it can be speculated that cyclodextrin inclusion complex can improve bioavailability of poorly water-soluble drugs. Above all these mentioned researches, it provided foundation and basis for physiological disposition and pharmaceutical study of XFSWD.
Biological Transport ; Caco-2 Cells ; Drugs, Chinese Herbal ; analysis ; Humans ; Oils, Volatile ; analysis ; beta-Cyclodextrins ; pharmacology

OBJECTIVE: To observe the effect and mechanism of avandia and puerarin used in combination for diabetic nephropathy. METHODS: A total of 180 patients with diabetic nephropathy were randomly divided into 3 groups. The control group (58 patients, group A) were treated with routine therapy including controlling the blood glucose and blood pressure, while 60 patients in group B were treated by avandia besides routine treatment of the control group. Anoter 62 cases in group C were administered with puerarin combined with avandia for 12 weeks. The indexes such as urea nitrogen, serum creatinine, triglyceride, cholesterol, low density lipoprotein, high density lipoprotein, mean arterial pressure, fasting blood glucose, 2h plasma glucose, glycosylated hemoglobin, and 24 h urinary albumin excretion rate were tested before and after the treatment . RESULTS: No significant differences were found in the indexes such as triglyceride, serum cholesterol, low density lipoprotein, high density lipoprotein, glycosylated hemoglobin, malonaldehyde, erythrocuprein, blood urea nitrogen, serum creatinine and 24 h urinary albumin excretion rate among the 3 groups (P>0.05). There were no significant differences in all indexes before and after the treatment in group A (P>0.05) . After the treatment, 24 h urinary albumin excretion, urea nitrogen, serum creatinine, mean arterial pressure, fasting blood glucose, 2 h plasma glucose, glycosylated hemoglobin, triglyceride, serum cholesterol, low density lipoprotein decreased significant (P<0 05) while high density lipoprotein increased significant (P<0.05). CONCLUSION Avandia has better effect on adjusting the blood lipid and decreasing the urinary albumin excretion rate. Puerarin combined with avandia is more effective for improving the renal function and remission of islet function than using avandia alone. Puerarin and avandia have significant synergism.
Adult ; Aged ; Diabetes Mellitus, Type 2 ; complications ; Diabetic Nephropathies ; drug therapy ; etiology ; Drug Therapy, Combination ; Female ; Humans ; Isoflavones ; therapeutic use ; Male ; Middle Aged ; Rosiglitazone ; Thiazolidinediones ; therapeutic use

To improve the quality standard of Angelica sinensis, solve the problem of lacking relevant reference substance, a new method-based on the standard reference extract (SRE) was applied to achieve the quality control of Angelica sinensis. SRE of Angelica sinensis was obtained by chromatographic separation technology. After calibration of three makers of the SRE, an UPLC analytical method was developed to determinate the contents of the makers. T-test was used for comparison of the determination results of two methods (reference substances and SRE as reference, respectively), and the results demonstrated that there is no significant difference between the two methods. The presented method is very convenient and practical, which can be used for the quality control of Angelica sinensis.
Angelica sinensis ; chemistry ; Calibration ; Chromatography, High Pressure Liquid ; standards ; Drugs, Chinese Herbal ; chemistry ; standards ; Quality Control ; Reference Standards

Naringin has been reported to possess a wild range of biological activities. However, the route and metabolites of naringin produced by intestinal bacteria are not well understood. In this paper, different bacteria were isolated from human feces and their abilities to convert naringin to different metabolites were studied. Ultra performance liquid chromatography-quadrupole time-of-flight mass spectrometry (UPLC-Q-TOF/MS) with automated data analysis software (MetaboLynx) was applied to fast analysis of naringin metabolites. Using MSE and mass defect filter techniques, three metabolites were detected and tentatively identified. The results indicated that acetylation, hydrolyzation and hydrolyzation with hydrogenation were the major metabolic pathways of naringin in vitro. Then, we studied the gene sequence of the 16S rRNA of the bacteria by extraction of genomic DNA of the strain, PCR amplification and clone of the 16S rRNA. The consequence proved that Enterococcus sp.30, Bacillus sp.46, Escherichia sp.54 and Escherichia sp.63 have the peculiar metabolism characteristic of naringin.
Bacillus ; genetics ; isolation & purification ; metabolism ; Chromatography, High Pressure Liquid ; Enterococcus ; genetics ; isolation & purification ; metabolism ; Escherichia ; genetics ; isolation & purification ; metabolism ; Feces ; microbiology ; Female ; Flavanones ; metabolism ; Humans ; Metabolic Networks and Pathways ; Phylogeny ; RNA, Ribosomal, 16S ; genetics ; Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization

The study aims to screen the ability of the bacteria to metabolize ononin and assess the effect of ononin on the intestinal bacteria. Fresh human fecal sample was obtained from a healthy volunteer, diluted serially in sterile water and sixty-nine different bacterial colonies were picked out ultimately. UPLC-Q-TOF/MS with automated data analysis software (MetaboLynx) was applied to fast analysis of ononin metabolites. Furthermore, an E(max) precision microplate reader was employed to determine the growth situation of Enterococcous sp., Enterobacter sp., Lactobacilli sp., and Bifidobacteria sp. Results indicated that hydrogenation, demethylation, hydroxylation and deglycosylation were the major metabolic pathways of ononin by human intestinal bacteria in vitro. Ononin can inhibit the growth of pathogen such as Enterococcus sp., Enterobacter sp. and can promote the growth of probiotics such as Bifidobacteria sp. and Lactobacilli sp. This study suggested that intestinal bacteria have the metabolic effects of ononin and the biotransformation was completed by different bacteria. And ononin can affect the balance of intestinal flora and the degree of influence varies depending on the bacterial species and the concentration of ononin.
Bacteria ; metabolism ; Biotransformation ; Feces ; microbiology ; Glucosides ; metabolism ; Humans ; Intestines ; microbiology ; Isoflavones ; metabolism ; Metabolic Networks and Pathways

To investigate the optimum harvesting time and utilization of mulberry leaves during different growth periods based on the content of alkaloids and flavonoids, 88 samples of 11 species of mulberry leaves were collected and analyzed. UPLC-TQ/MS method was applied and the results showed that the ingredients of alkaloids and flavonoids in mulberry leaves are quite different in different growth periods and different species. There was a sharp decline of the average content of alkaloids in all samples from October, while the content of flavonoids dropped either from October but with less volatile. The content of flavonoids in M. atropurpurea was much higher than alkaloids, while M. australis was opposite completely. There was a sharp decline of alkaloids in M. cathayana and M. mongolica from Tuly to August, however, the content of alkaloids and flavonoids in M. alba is neither too high nor too low. In summary, it is more suitable to harvest tender mulberry leaves harvested from the end of September to beginning of October that provide a scientific evidence for rational harvest and comprehensive utilization of mulberry leaves.
Alkaloids ; analysis ; isolation & purification ; Chromatography, High Pressure Liquid ; Drug Stability ; Drugs, Chinese Herbal ; analysis ; isolation & purification ; Flavonoids ; analysis ; isolation & purification ; Mass Spectrometry ; Medicine, Chinese Traditional ; Morus ; chemistry ; Plant Leaves ; chemistry ; Plants, Medicinal ; Reproducibility of Results ; Seasons

Haizao Yuhu decoction (HYD) is a formula that has been used for approximately 500 years and famous for its efficiency in treating thyroid-related diseases in traditional Chinese medicine (TCM). HYD was first presented by Chen Shi-gong in a famous surgical monograph named Waike Zhengzong during the Ming Dynasty. We conducted the research to investigate the possible pharmacokinetic profile of different prescriptions of HYD in rats, in order to reveal the interactions of Haizao and Gancao drug pair with other herbs in HYD. Liquiritin, naringin, besperidin, peimine, peiminine liquiritigenin, glycyrrhizic acid, hergapten, nobiletin, osthole, glycyrrhetinic acid in blood samples were determined by UPLC-MS/MS. The result revealed tbat Haizao could enhance the peak concentration of glycyrrhizic acid. The other herbs in HYD may promote'the absorption of flavonoids in Gancao in normal rats, but inhibit the absorption of saponins and accelerate their metabolism. Gancao and Haizao drug pair could enhance the bioavailability of hesperidin, peimine, bergapten, nobiletin and osthole and prolong the elimination of peimine and naringin.
Animals ; Chromatography, High Pressure Liquid ; Drugs, Chinese Herbal ; chemistry ; pharmacokinetics ; Magnetic Resonance Spectroscopy ; Male ; Mass Spectrometry ; Plasma ; chemistry ; Rats ; Rats, Wistar