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 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.

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 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 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.

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

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 establish a method for simultaneous determination of chlorogenic acid, geniposide, berberine, baiealin, emodin and ehrysophanol in Niuhuang Shangqing pills (traditional Chinese medicines). METHODS: The separation was performed on a DIKMA Platisil ODS column (4.6 mm×5 μm) with gradient elution using methanol and 0.1% H3PO4 aqueous solution as mobile phase at the flow rate of 1 mL·min-1. The UV detection wavelength was set at 254 nm. RESULTS: Linear ranges of the calibration curves of chlorogenic acid, geniposide, berberine, baiealin, emodin and ehrysophanol were 0.11-2.2 μg (r=0.9996), 0.048-0.96 μg (r=0.9998), 0.073-1.46 μg (r=0.999 9), 0.1-2 μg (r=0.9999), 0.04-0.8 μg (r=0.9995), and 0.01-0.2 μg (r=0.9996), respectively. Their average recoveries fell between 98.26% and 99.44%. CONCLUSION: The established HPLC method can be used to determine the contents of chlorogenic acid, geniposide, berberine, baiealin, emodin and ehrysophanol in Niuhuang Shangqing pills. The method can also be used for the quality control of Niuhuang Shangqing pills.

Objective:To investigate the therapeutic effects of antibiotic articular cement spacer on shoulder joint infection in the elderly patients during stage-one operation.Methods:The data of 3 patients were analyzed retrospectively who had been treated at Department of Orthopaedics, The Sixth People's Hospital Affiliated to Shanghai Jiao Tong University for shoulder infection from May 2018 to December 2019. They were one man and 2 women with an average age of 65.3 years (from 64 to 67 years). One case of infection followed shoulder puncture, another proximal humeral fracture and another shoulder prosthesis replacement. All the 3 patients underwent radical debridement and implantation of antibiotic shoulder cement spacer in stage-one operation but no stage-two operation. The therapeutic effects were evaluated by American Shoulder and Elbow Surgeons (ASES) scoring, Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) scoring, Visual Analog Scale (VAS), and range of shoulder motion.Results:The 3 patients were followed up for 18 to 28 months (mean, 22.7 months). There was no recurrence of infection and the spacers were in good position. The microorganisms detected were Bifidobacterium brevis in one case and methicillin-resistant Staphylococcus aureus in 2 cases. At the final follow-up, the ASES scores averaged 54.4 (from 46.3 to 60.0), Quick-DASH scores 45.1 (from 40.8 to 50.0), VAS scores 2.3 (from 2 to 3), ranges of elevation 65.7 °, ranges of abduction 43.8° and ranges of external rotation 21.7°.Conclusion:For the elderly patients with shoulder infection, implantation of antibiotic shoulder cement spacer after radical debridement can well control infection, relieve pain and improve shoulder functions, sparing them secondary operation.