The evolution of the quality control concepts of medical products within the global context and the development of the quality control technology of Chinese medicine are briefly described. Aimed at the bottlenecks in the regulation and quality control of Chinese medicine, using Big Data technology to address the significant challenges in Chinese medicine industry is proposed. For quality standard refinements and internationalization of Chinese medicine, a technological innovation strategy encompassing its methodology, and the R&D direction of the subsequent core technology are also presented.
Data Mining ; Databases, Factual ; Drug Industry ; organization & administration ; standards ; Drugs, Chinese Herbal ; analysis ; pharmacology ; standards ; Humans ; Quality Control

Objective To investigate the relation between serum adiponectin and coronary artery calcification score (CACS), and find the risk factors for CACS in patients with chronic kidney disease (CKD). Methods Twenty-nine patients with 3-5 stage CKD were selected. The serum adiponectin was measured by enzyme linked immunosorbent assay. The heart was scanned by 64-row spiral CT, and the CACS was calculated. The blood calcium, phosphorus, intact parathyroid hormone, total cholesterol, low density lipoprotein cholesterol, albumin, urea nitrogen, creatinine, uric acid and high sensitive C reactive protein levels were measured, and the calcium-phosphorus product and estimation glomerular filtration rate were calculated. Results In 29 patients with CKD, 24 cases (83%) had coronary artery calcification with different degree (CACS>0 score), and the average CACS was 508 (0-3 363) scores. There were statistical differences in systolic blood pressure, urea nitrogen and estimation glomerular filtration rate between CKD patients with CACS≥100 scores (15 cases) and CKD patients with CACS<100 scores (14 cases):(146.00± 13.00) mmHg (1 mmHg=0.133 kPa) vs. (123.00±9.00) mmHg, (15.44±8.36) mmol/L vs. (9.71±2.52) mmol/L and (21.77 ±11.81) ml/ (min·1.73 m2) vs. (38.71 ±11.56) ml/ (min·1.73 m2), P<0.01 or <0.05. Pearson correlation analysis results showed that CACS had positive correlation with systolic blood pressure, creatinine and uric acid, and negative correlation with albumin and estimation glomerular filtration rate. Mult-stepwise regression analysis results showed that systolic blood pressure and estimation glomerular filtration rate were the independent risk factors of CACS. Conclusions The patients with 3-5 stage CKD have severe coronary artery calcification. The systolic blood pressure and estimation glomerular filtration rate are the independent risk factors of coronary artery calcification.

Objective　To observe the effects of Ang-Ⅱ on expressions of c-fos mRNA and pro-α1［Ⅰ］mRNA in fibroblasts (FBC) of rat embryo in the course of collagen synthesis.Methods　The change of free Ca2+(［Ca2+］i) was tested in fluorometry and the expressions of c-fos mRNA and pro-α1［Ⅰ］mRNA were tested by RT-PCR method in incubated FBC.Results　The level of［Ca2+］i in FBC and the expressions of c-fos mRNA and pro-α1［Ⅰ］mRNA were enhanced with the increase of Ang-Ⅱ concentration(10-8～10-5and 10-7～10-6mol/L).Conclusions　The expressions of c-fos mRNA and pro-α1［Ⅰ］mRNA were induced by Ang-Ⅱ activating signal system in FBC.

Objective To establish a method for simultaneous determination of gentiopicroside, berberine hydrochloride and baicalin in Longze Xiongdan capsule. Methods The separation was performed on a DIKMA Platisil ODS column (250 mm × 4. 6 mm, 5 µm) with gradient elution using methanol and 0.1% H3PO4 aqueous solution as mobile phase. The detection wavelength was set at 275 nm. Results Linear ranges of gentiopicroside, berberine hydrochloride and baicalin concentrations were 0.019-0.38 µg (r=0.9999), 0.15-3.00 µg (r=1.0000) and 0.078-1.56 µg (r=0.9997),respectively. Their average recoveries fell between 98.97% and 101.30%. Conclusion The method can be used as the standard for the quality control of Longze Xiongdan capsule.

Acute Disease ; Adult ; Female ; Humans ; Male ; Middle Aged ; Phosphorus Compounds ; poisoning ; Retrospective Studies

Objective To establish the strain of immortalized human precartilaginous stem cells (PSCs) which can be a stable cell resource for study of the molecular mechanism of gene targeting on differ-entiation of PSCs. Methods Plasmid pCMVSV40T/PUR containing simian virus 40 large T antigen gene (SV40Tag) was transfected into human PSCs using lipofeetin transfection method. Colonies were isolated by puromycin selection and expanded by many passages. Immunohistochemistry, RT-PCR and Southern blot were used to identify the transfected cells and to detect the expression and integration of SV40Tag in expanded cell lines. Results The positive colonies were isolated and subcultured, named as immortalized precartilaginous stem cells (IPSCs), which were confirmed as positive to fibrnblast growth factor receptor-3 (FGFR-3). The existence of SV40Tag cDNA was detected by Southern blot and the expression of SV40Tag mRNA and protein by RT-PCR and immunohistochemistry. Conclusion IPSCs strain with SV40Tag can be constructed successfully.

Objective To explore the possible effects of nutritional supplements on brain function as reflected by Water Maze test performance in mice after +Gz exposure.Method Mice were arranged into control group (group A),+Gz group without nutritional supplementation (group B) and +Gz plus nutritional supplementation group (group C).Each group contains 12 mice.Mice in group A were not exposed to +Gz while mice in both group B and group C were exposed to 8 min +10 Gz.Distilled water was gavaged to group B mice 3 h before +Gz exposure.On the day before +Gz exposure pyridoxol fortified water was given and 3 h before exposure mixed amino acids solution were gavaged to group C mice.Water Maze test was done and scores were recorded in all groups.After the Water Maze test was completed,blood was collected through the eyes for serum amino acid determinations and brain tissue was collected by decollation for monoamine determination and γ-glutamyl transferase (GGT) activity evaluation. Result After +Gz exposure,longer completion time and more mistakes were observed in Water Maze test in group B as compared with group A and a trend of improvement in group C was noticed. The ratio of brain 5-HT to dopamine(DA) was significantly reduced in group C as compared with group B.Gamma glutamyl transferase (GGT) activity in brain tissue in group C and group B increased significantly. Conclusion High sustained +Gz exposure significantly reduces Water Maze test performance in mice (longer completion time and more mistakes).It seems that there is a trend of improvement in Water Maze performance in mice in dietary nutritional supplementation group,which might be due to significant reduction in ratio of brain 5-HT to DA in mice with nutritional supplementation.

Objective:To search for a method for radical resection of pancreatic and duodenal malignancy involving the mesentery root and for the long post-operation survival of patients.Methods:From Jan.2004 to Aug.2006,a total of 26(16 male and 10 female. aged 27-70)patients with pancreatic and duodenal malignancy involving the mesentery root were treated in our department.The patients included 3 with duodenal malignancy and 23 with pancreatic malignancy.Curative resection was performed by the extended pancreaticoduodenetomy(Whipple procedure)combined with mesentery root resection(MRR)for all patients.The outcomes,safety and the post-operation survival rate were analyzed retrospectively.Results:Thirteen patients were treated with Whipple procedures combined with MRR,9 were treated with partial portal vein/superior mesenteric vein(PV/SMV)and reconstruction of the vessel,and 4 patients received pre-shunt between PV and SMV with artificial vessel graft before the extended Whipple and MRR procedures.The operation time was 2.5 to 7(4.4?1.1)hour,and blood loss was 300 to 5 000(1892?1414)ml with the blood transfusion of 0 to 5 600(2 100?1 586)ml.There was no death in our group and 7(27%)had post-operation complication.The post-operation hospital stay was 10 to 30 days.The pathologic examination showed negative surgical margins for all specimens.The tumor size was 4 to 10 (6.17?2.03)cm.After a follow-up of 9 to 38 months,the pain was relieved in all patients.One of the 3 patients with duodenal adenocarcinoma had liver metastasis at 10 months after operation,and the other 2 survived 10 months and 27 months without evidence of tumor reccurence.The patient with pancreatic micro-adenocarcinoma died of local reccurence 9 months after operation.The patient with neuroendocrine carcinoma died of organ failure 24 months after operation.The patient with lymphoma have survived for 24 months after operation.The 1-year and 2-year accumulated survival rates in the 20 cases with pancreatic ductal cancer were 86.6% and 45.6%. respectively.Conclusion:The extended Whipple procedure with MRR is safe and effective.It can obtain R0 resection in patients with malignant tumors(over 5 cm in diameter)in the head,neck and uncinate process of the pancreas and duodenal.

Objective To investigate the relations between serum adiponectin and coronary artery calcification score (CACS) and to find the risk factors for coronary artery calcification in maintenance hemodialysis(MHD) patients.Methods Twenty-seven MHD patients(MHD group) and 13 healthy persons (control group) were enrolled in this study.The serum adiponectin was measured by enzyme-linked immunosorbent assay method.CACS was calculated by multi-row spiral CT.The circulating parameters such as hemoglobin (Hb),calcium,phosphate,calcium-phosphate product,intact parathyroid hormone (iPTH),total cholesterol (TC),low density lipoprotein cholesterol (LDL-C),albumin (Alb),high sensitive C-reactive protein (hs-CRP),and so on were detected.Results The level of serum adiponectin in MHD group [(15.00 ± 7.47) mg/L] was significantly higher than that in control group [(2.07 ± 0.83) mg/L],and there was significant difference (P＜ 0.01).Coronary artery calcification(CACS ＞ 0 score) was observed in 88.9％ (24/27) in MHD group and 10/13 in control group.The mean CACS in MHD group was significantly higher than that in control group [655 (0-3 570) scores vs.126 (0-731)scores],and there was significant difference (P ＜ 0.05).Eleven MHD patients and 1 healthy person had severe coronary artery calcifications,(CACS ≥ 400 scores).There was significan t difference in dialysis duration,diastolic pressure,phosphate calcium-phosphate product and adiponectin (P ＜ 0.05 or ＜ 0.01).Spearman analysis showed that CACS of MHD patients was positively correlated with dialysis duration,phosphate,calcium-phosphate product,serum creatinine and adiponectin (P ＜ 0.01 or ＜ 0.05).Only calcium-phosphate product remained as independent predictor of CACS in multivariate analysis (P ＜0.01).Conclusion Coronary artery calcification is common in MHD patients and which is correlated with dialysis duration,serum phosphate,calcium-phosphate product,serum creatinine and adiponectin.

Objective:To investigate the clinic effect of r-MHT and hematoma aspiration on the traumatic intracerebral hematoma.Methods:89 cases with traumatic intracerebral hematoma were given hematoma aspiration,47 of them were given r-MHT and hematoma aspiration,the clinic effect on the 1st,7th,14th day after treatment were evaluated by NIHSS,the hematoma volume before treatment on the 1st,7th,14th day after treatment were counted by Dotian formula.Results:The effective rate of treatment group was 93.6％,which was significantly higher than that of the control group (P＜0.05).The NIHSS score of treatment group was significantly higher than that of the control group(P＜0.05) on the 1 st day,1st,2nd week after treatment (P＜0.05).Conclusion:r-MHT and hematoma aspiration couldn effectively reduce the brain damage,improve the patient's neurological fumction in treating traumatic intracerebral hematoma.