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 In order to provide the basis for establishment of food allergy models , we compared the differences of sensitivity and alterations of intestinal flora of food allergy models in two strains of mice .Methods Forty 4-5-week old female BALB/c and Kunmimg mice were divided into control group ( n=10) and food allergy goup ( n=30), respectively.Ovalbumin (OVA) was injected to the mice to establish food allergy models .Serum OVA-specific IgE of the mice was assayed by ELISA .The jejunum tissue was examined by pathology with HE staining .The changes of fecal flora were detected by denaturing gradient gel electrophoresis (DGGE).Results (1)Among the sensitized 60 mice, OVA-sIgE levels were significantly increased in 27/30 BALB/c mice and 21/30 KM mice compared with those of control groups(P<0.001).Moreover, there were more evident inflammatory cell infiltration , epithelial cell shedding and cytolysis in the jejunal villi of BALB/c mice than those of KM mice.(2) After food allergy modeling, there were significant changes of intestinal flora in the BALB/c mice (P<0.001), while only significant change of evenness was found in the KM mice (P<0.05).(3)There were changes of abundance , Shannon index and evenness of intestinal flora in the model groups of BALB/c and KM mice.Conclusions BALB/c mice are more sensitive to OVA allergy than KM mice .The composition of intestinal flora is different among different strains of mice .The changes of intestinal flora after OVA challenge in BALB /c mice are more obvious than those in KM mice .

Objective To investigate the feasibility and clinical application of prospective ECG-gated scan and adaptive cardio se-quence scan of dual-source CT coronary angiography.Methods 255 patients who underwent coronary CT angiography using a dual-source CT scanner were divided into two groups:group A underwent prospective scan,group B underwent retrospective scan.The two groups were further subdivided into low heart rate group and high heart rate group,recorded as A1(n=51),A2(n=89),B1(n=26), B2(n=89),respectively.Group A1 preceded with prospective ECG gated scan;group A2 performed with adaptive cardio sequence scan;group B1 and B2 underwent retrospective scan.All of them applied ATCM (automatic tube current modulation)technique. Effective dose was recorded.The image quality was assessed by two experienced radiologists with a four-point grading scale.Results The excellent or good image quality (score 1 and 2)of the four groups were above 95%,and no statistical differences in images scores was detected in A1 and B1 (P =0.726),A2 and B2 (P =0.079).Effective dose was significantly different in A1 and B1(P <0.001),A2 and B2 (P <0.001),and the former decreased 50% and 40% as compared with the latter.Conclusion Using prospective ECG gated scan and adaptive cardio sequence scan,assessable image quality of coronary artery can be acquired with dual source CT (heart rate<90 beast per minute),and radiation dose can be obviously reduced.

Objective To evaluate the diagnostic value of quantitative analysis parameters of dynamic contrast-enhanced magnetic resonance imaging (MRI) in differential diagnosis of prostatic disease.Methods 12 patients with prostate cancer and 16 patients with benign disease underwent DCE-MRI examination.Region of interest (ROI) were drawn in areas of cancerous foci,normal prostate peripheral zone and normal prostate central gland to measure the values of Ktrans (transport constant),Kep (rate constant),Ve (extravascular extracellular volume fraction).Values of the three parameters were analyzed by ANOVA and the differences were compared between the different tissues.Results The values of Ktrans,Kep and Ve were (0.42±0.10)/min,(0.64±0.11)/min,(0.61±0.14) respectively in the area of cancerous foci,while (0.17 ±0.08)/min,(0.32 ±0.10)/min,(0.59±0.11) respectively in normal prostate peripheral zone,and (0.33±0.12)/min,(0.50± 0.16)/min,(0.62 ±0.07) respectively in normal prostate central gland.The differences in Ktrans,Kep values were statistically significant between cancerous foci,normal prostate peripheral zone and normal prostate central gland (F =31.646,27.196,respectively,all P ＜ 0.05),but no statistically significant difference was found in the Ve value between the three different tissues (F=0.533,P＞ 0.05).Conclusions Quantitative analysis of DCE-MBI can be used to differentiate benign from malignant prostatic diseases,which hasa great application prospect.

Objective To investigate the application of respiratory navigator echo triggered black blood contrast FSE in cardiac MRI. Methods The respiratory navigator echo trigger technique combining with black blood FSE (NAV-FSE) was tested on 11 volunteers and 5 patients in free breathing,using breath-hold FSE (BH-FSE) with the same imaging protocals as control. The imaging efficiency and the image sharpness were compared between NAV-FSE and BH-FSE and t-test was used for the statistics. Results All NAV-FSE acquisitions were completed in sixteen subjects while 4 BH-FSE acquisitions failed because of poor breath holding. The efficiencies of NAV-FSE were (42. 95±11.50)%, (56. 14±11.40)% and (55.25± 14. 70)% when echo train length (ETL) were 24, 16 and 8, respectively. When ETL were 16 and 24, the sharpness of NAV-FSE ( 0. 43±0. 02 vs 0. 36±0. 02 ) and BH-FSE ( 0. 36±0. 03 vs 0. 35±0. 02 ) were statistically different (t =4. 26, 5. 53 ,respectively; P <0. 05). NAV-FSE could have a shorter ETL setting without consideration of breath holding. Conclusion The navigator echo trigger technique could be compatible with black blood contrast FSE to image the heart without the restriction of breath holding and it allows to optimize the parameters to improve the image quality.

Objective: To evaluate the feasibility,the safety and the effect of early postoperative enteral nutrition in patients with esophageal cancer.Methods: On the first postoperative day,40 patients were randomly divided into two groups.One group was given isocaloric total parenteral nutrition through central vein(TPN group) and the other group was fed with enteral nutrition through nasoenteric tubes or jejunostomy tubes which were inserted during the operation(EEN group).All variables were measured before operation and on postoperative day 1 and 8.Blood was drawn at different time points to assess albumin,prealbumin and transferrin.Immune response was determined by immunoglobins,total lymphocytes,T-lymphocyte subsets and NK cells. Inflammatory response were determined by C-reactive protein,IL-6 and TNF-?.Morbidity,mortality and length of hospital stay were also evaluated. Results: Tolerance of enteral nutrition was excellent.Neither mortality nor serious morbidity occurred in all patients during the period of study.After the study,the levels of serum prealbumin,total lymphocytes,CD3,CD4 and CD4/CD8 ratio in the EEN group were significantly higher than the levels in the TPN group.The concentrations of IL-6 and the length of hospital stay in the EEN group were significantly lower than in the TPN group.Conclusion: Early postoperative enteral nutrition in patients with esophageal cancer is safe,and also has the benefit effects of enhancing the body status of nutrition and immune function,and reducing the inflammatory response and the length of hospital stay.

Objective To observe effects of electro-acupuncture (EA) on the expression of apoptosis related protein B-cell lymphoma/leukemia gene 2 (Bcl-2) and Bcl-associated protein X (Bax) in the hippoeampal CA1 region of rats with cerebral infarction,and on their behavior. MethodsAn animal model of cerebral ischemia was established by right side middle cerebral artery occlusion using thread in 48 male,adult Wistar rats,who were then randomly divided equally into an EA group and a control group.Both groups were sub-divided into 1 week,2 weeks and 3 weeks subgroups.The EA group began receiving EA 24h after the occlusion,applied at the Baihui (DU20) and Dazhui (BU14) points,once daily,for one,two or three weeks.The control group was reared conventionally and was not given any special treatment.The rats'learning and memory,motion and neural function were evaluated.The expression of Bcl-2 and Bax in the CA1 region of the hippocampus on the infarcted side and changes of apoptosis indexes were detected using immunohistochemical techniques.ResultsThe learning,memory,motion and neural function of the EA group rats were better on average than those of the control group at all observation time points.The expression of Bcl-2 protein increased along with reduced expression of Bax protein in the EA group significantly more than among the controls.TUNEL positive cells in the CA1 region of the hippocampus were reduced significantly in the EA group compared with the control group.ConclusionsBehavioral ability after cerebral infarction can be improved by EA at the Baihui (DU20) and Dazhui (BU14) points.EA can up-regulate the expression of Bcl-2 and down-regulate the expression of Bax and reduce TUNEL positive cells in the CA1 region of the hippocampus after cerebral infarction,which might be the mechanism of its neuroprotection.

Objective To explore the effect of 1a,25(OH)2 D3 on circadian clock gene expressions in cardiac myocytes.Methods Cultured cardiac myocytes isolated from 7 -day -old Sprague -Dawley(SD)rats were identified by immunofluorescence.The medium including 1a,25 (OH)2 D3 (final concentrations were 0 nmol/L,1 nmol/L, 10 nmol/L,50 nmol/L and 100 nmol/L)were added to primary myocardial cells to culture for 2 h and then total RNA was extracted.Real -time polymerase chain reaction (RT -PCR)was applied to analyze myocardial cells circadian clock gene (Bmal1,Per2,Rev -erba)transcript levels to determine optimum concentration of 1a,25(OH)2 D3 .Then, the primary myocardial cells cultured for 72 h were divided into 3 groups:the control group was of serum -free culture medium;serum shock group was of DMEMcontaining 50%volume fraction of horse serum cultured 2 h;1a,25(OH)2 D3 treatment group receiving 1a,25 (OH)2 D3 at optimal concentration cultured 2 h.The cells were collected at 7 time points (0 h,4 h,8 h,12 h,16 h,20 h,24 h)and then total RNA was extracted.RT -PCR was applied to analyze circa-dian clock gene (Bmal1,Per2,Rev -erba)transcript levels in the myocardial cells.Results In the presence of 50 nmol/L 1 a,25(OH)2 D3 ,the Bmal1 mRNA expression showed the highest level,but the Per2 and Rev -erba mRNA expression levels were minimum.Compared with the control group,both 1a,25 (OH)2 D3 treatment group and serum shock group caused day -cycle rhythmic oscillation in circadian clock genes(Bmal1,Per2,Rev -erba)in the cardiac myocytes.And the expressions pattern of Bmal1 and Per2 genes were in the opposite phase.While Bmal1 gene expres-sion appeared at peak at 12 h,Per2 gene expression appeared in a trough.Expression of Rev -erba gene trend began to rise at 8 h,and the highest expression level appeared at 12 -16 h.Conclusions 1a,25(OH)2 D3 can affect Bmal1, Per2 and Rev -erba mRNA expressions of circadian clock genes in the cardiac myocytes.

Objective To explore the application effect of a new lighted surgical aspirator in deep brain hematoma removal operation.Methods Totally 153 patients of non-traumatic basis festival area cerebral hemorrhage were randomly divided into a control group and a treatment group.Both the groups underwent clearance of intracranial hematoma and decompressive craniectomy surgical operation in the operating room,with the common aspirator involved in the control group and the lighted one in the treatment group.Results There was no significant difference between the rates of hematomal removal in the groups (P＞0.05).The treatment group had the operating time less by 59.85 min and the hospital stay decreased by 15.23 d than those in the control group (P＜0.05).The GOS score and daily viability of the treatment group was also statistically higher than those of the control group (P＜0.05),and the effective rate in the treatment group was also more than that in the control group by 24.9％ (P＜0.05).Conclusion The new aspirator solves the problems in visual field and light source,decreases the operating time and improves the disease prognosis.

Alteration in the structural appearance of the optic disk and retinal nerve fiber layer usually precedes the development of reproducible glaucomatous visual field defects.Identification of these changes is important in the diagnosis and treatment of glaucoma at an early to moderate stage and in monitoring its clinical course.This paper reviews the optical coherence tomography(OCT),Heidelberg retina tomography(HRT),optic nerve head stereophotograph(ONHP)and scanning laser polarimetry(SLP) in the field of open angle glaucoma.