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

Aim: Synthesized N-acylated chitosan(NAC) was used to anchor on the surface of plain docetaxel li-posomes( PDL) in order to to sustain drug release. Methods; NAC of low substitution degrees were prepared using hexanoic(C_6), lauric( C_(12)), and palmitic( C_(16)) anhydrides. W-palmitoyl chitosan was chosen to anchor the do-cetaxel liposomes. In vitro release profiles of conventional liposmes and the anchored liposomes was compared. Results: Hexanoic(C_6), lauric( C_(12)), and palmitic( C_(16)) -branched chitosans were synthesized. It was found that N-acylated chitosan-anchored DXL liposomes (NDL) increase stabilities of docetaxel liposomes. 70% of docetaxel was released from PDL in 24 hours but 39% from NDL Conclusion: Liposomes anchored by the low substituted N-acylated chitosan could decrease the drug release.

Objective:To compare the survival rate and adverse reactions of patients with advanced hypopharyngeal squamous cell carcinoma undergoing surgery combined with chemoradiotherapy, and to analyze the prognostic factors of patients.Methods:The clinicopathologic data of 78 patients with advanced hypopharyngeal squamous cell carcinoma admitted to the Department of Radiation Oncology of the First Affiliated Hospital of Bengbu Medical University from August 2013 to December 2018 were retrospectively analyzed. The patients were divided into surgery combined with chemoradiotherapy group ( n=27) and chemoradiotherapy group ( n=51) according to different treatment methods. The median follow-up time was 46 months (20-84 months). The main observation indicators were overall survival (OS), progression-free survival (PFS) and local control rate (LCR). Cox regression model was used to analyze the prognostic factors. Results:Until July 31, 2020, 51 of the 78 patients with advanced hypopharyngeal squamous cell carcinoma died, including 6 cases of local recurrence, 11 cases of distant metastasis, and 34 cases of other causes (15 cases of hemorrhage, 15 cases of cachexia, and 4 cases of other diseases). In the surgery combined with chemoradiotherapy group, 12 patients died, accounting for 44.44%. In the chemoradiotherapy group, 39 patients died, accounting for 76.47%. The 1-, 3- and 5-year OS rates of 78 patients were 57.7%, 36.3% and 27.2% respectively, the 1-, 2- and 3-year PFS rates were 49.5%, 38.7% and 32.6% respectively, and the 1-, 2- and 3-year LCR were 53.4%, 40.0% and 34.2% respectively. The 1-, 3- and 5-year OS rates in the surgery combined with chemoradiotherapy group were 74.1%, 50.1% and 44.6%, and those in the chemoradiotherapy group were 49.0%, 29.3% and 12.8%, with a statistically significant difference ( χ2=5.142, P=0.023). The 1-, 2- and 3-year PFS rates in the surgery combined with chemoradiotherapy group were 62.1%, 54.3% and 44.4%, and those in the chemoradiotherapy group were 43.1%, 30.6% and 26.7%, with no statistically significant difference ( χ2=3.222, P=0.073). The 1-, 2- and 3-year LCR of the surgery combined with chemoradiotherapy group were 69.8%, 54.3% and 44.4%, and those in the chemoradiotherapy group were 45.1%, 32.9% and 29.6%, with no statistically significant difference ( χ2=3.576, P=0.059). The results of univariate analysis showed that tumor T stage ( χ2=7.140, P=0.008), N stage ( χ2=4.493, P=0.034) and treatment method ( χ2=5.142, P=0.023) were all independent influencing factors of the OS of patient with advanced hypopharyngeal squamous cell carcinoma; T stage ( χ2=5.807, P=0.016) and N stage ( χ2=6.587, P=0.010) were both independent influencing factors of PFS. The results of multivariate analysis showed that tumor T stage ( HR=2.121, 95% CI: 1.142-3.938, P=0.017), N stage ( HR=2.088, 95% CI: 1.144-3.811, P=0.016) and treatment method ( HR=0.430, 95% CI: 0.226-0.815, P=0.010) were all independent prognostic factors of the OS of patients with advanced hypopharyngeal squamous cell carcinoma; T stage ( HR=1.884, 95% CI: 1.011-3.510, P=0.046) and N stage ( HR=1.904, 95% CI: 1.058-3.429, P=0.032) were both independent prognostic factors of PFS. During the treatment period, there were statistically significant differences in the incidences of radioactive pharyngitis [7.41% (2/27) vs. 39.22% (20/51), χ2=8.821, P=0.003] and radioactive dermatitis [3.70% (1/27) vs. 29.41% (15/51), χ2=7.156, P=0.007] between the surgery combined with chemoradiotherapy group and the chemoradiotherapy group. However, there were no statistically significant differences in the incidences of radioactive oral mucositis [11.11% (3/27) vs. 17.65% (9/51), χ2=0.186, P=0.666], bone marrow suppression [37.04% (10/27) vs. 50.98% (26/51), χ2=1.381, P=0.240], pharynx infection [11.11% (3/27) vs. 5.88% (3/51), χ2=0.143, P=0.706] and tracheal fistula [7.41% (2/27) vs. 0 (0/51), P=0.117] between the two groups. Conclusion:The 1-, 3- and 5-year OS rates in the surgery combined with chemoradiotherapy group are higher than those in the chemoradiotherapy group, and the incidences of adverse reactions are low. T stage, N stage and treatment method are independent prognostic factors for OS of advanced hypopharyngeal squamous cell carcinoma patients, while T stage and N stage are independent prognostic factors for PFS.

OBJECTIVETo determine butylidenephthalide in Ligusticum Chuanxiong with RP-HPLC.

METHODThe sample was extracted with methanol using sonication. The ESTD was used to quantify butylidenephthalide. HPLC separation was carried out in a Hypersil ODS columm (4.6 mm x 150 mm, 5 microm) , eluted at 1 mL x min(-1) with methanol-5% isopropyl alcohol (60: 40) at 25 degrees C. The detection wavelength was 230 nm.

RESULTThe linear range was 0.07-0.7 microg for butylidenephthalide. The average recovery was 95.3%, and RSD was 2.3% (n =6).

CONCLUSIONThis method was simple and could be used to determine butylidenephthalide with satisfactory accuracy and reproducibility.

China ; Chromatography, High Pressure Liquid ; instrumentation ; methods ; Light ; Ligusticum ; chemistry ; Phthalic Anhydrides ; analysis ; Plants, Medicinal ; chemistry ; Reproducibility of Results ; Rhizome ; chemistry ; Scattering, Radiation

Objective To express recombinant HBHAΔC and HBHAΔN protein,and compare the HBHA series protein activity with each other.It will be provide a experimental basis for the research on clinical diagnostic of HBHA.Methods The HBHAΔC and HBHAΔN gene fragments were cloned and expressed by transforming E.coli BL-21.Test the protein heparin binding ability by CL-6B column.And then added protein to the BCG 7H9 culture medium,to observe the induced BCG aggregation.Results nHB-HA,rHBHA and HBHAΔN protein have heparin binding ability.Meanwhile nHBHA,rHBHA and HBHA Δ C protein have in-duced BCG aggregation effect.Conclusion The HBHAΔC and HBHAΔN protein were successfully obtained.It was proved that the HBHA C-terminal could be combined with heparin and the N-terminal involved could induce the aggregation of BCG.This results provide a basis for further study on molecular mechanism of TB infection and clinical application.

Anxiety ; epidemiology ; China ; epidemiology ; Depression ; epidemiology ; Female ; Heroin Dependence ; drug therapy ; psychology ; Humans ; Male ; Methadone ; administration & dosage ; therapeutic use

ABSTRACT:The virulence genes ,hemolytic and antibiotic resistance characteristics from 19 isolated Streptococcus suis se‐rotype 2 in Anhui Province were investigated in this study .The PCR method was developed for detecting cps2J ,mrp ,ep f and sly gene;the plate method and micro‐ELISA were developed for detecting the hemolytic type and hemolytic titer ;the K‐B method was developed for detecting antibiotic resistance of 25 kinds of antibiotics .Results showed that there were 11 strains with the dominant virulence genotype of cps2J+ /mrp+ /ep f+ /sly+ accounting for 57 .9% .All strains were α‐hemolysis orβ‐hemolysis ,with hemolytic titer of 1∶4 to 1∶128 .Strains sensitive to rifapentine ,ceftazidime ,florfenicol and cefazolin was existed in high frequency with the sensitive rates for 84 .2% ,and the resistance to doxycycline ,tetracycline ,bacitracin and sul‐famethoxazole was existed in high frequency with the resistance rates for 82 .9% .The multi‐antibiogram typing was doxycyc‐line ,tetracycline ,bacitracin and sulfamethoxazole account for 63 .2% .In conclusion ,the distribution of virulence genes of S .suis 2 Anhui isolates was similar with that of domestic reported strains ,and there was some differences with that of over‐seas reported strains .CPS ,MRP ,EPF and SLY are important virulence factors and the incompleteness of sly gene had no effect to its haemolyticus .The multi‐antibiotic resistance of S .suis 2 Anhui isolates was serious .There is difference for anti‐biogram typing between S .suis 2 Anhui isolates and those in other areas .

OBJECTIVESTo explore the relationship between the expression of IL-10 and liver regeneration following reduced-size orthotopic liver transplantation in rats.

METHODSRats models with reduced-size orthotopic liver transplantation were established. The rats were divided in three groups: partial liver resection (I), orthotopic liver transplantations (II), and reduced-size orthotopic liver transplantation (III). The expression of IL-10 and regenerative response of liver in rats were evaluated by immunohistochemistry and flow cytometry on the 1st, 2nd, 4th and 7th days after the operations, respectively.

RESULTSThe liver grafts were capable of regeneration, the proliferation activity peaked on the fourth day with 26.3+/-0.9, 35.8+/-2.2, and 32.4+/-1.8 in I, II, and III groups, respectively. The expression of IL-10 was negative correlation to liver regeneration (r=-0.58, P<0.01).

CONCLUSIONSWhole and reduced-size transplanted livers show the same regenerative activity. The maximal regenerative response delayes slightly, compared with that after partial hepatectomy. IL-10 plays an important immunomodulatory role in liver regeneration,and the effect is affected by general immune system and other cytokines.

Animals ; Flow Cytometry ; Immunohistochemistry ; Interleukin-10 ; analysis ; Liver ; chemistry ; Liver Regeneration ; Liver Transplantation ; Male ; Rats ; Rats, Sprague-Dawley

Objective Nanobacteria are one of the factors for urinary calculi and its exact pathogenic mechanism is not yet clear.The aim of this study was to investigate the role of the CaSR -Claudin-14 regulatory channel in the formation of calculi . Methods Sixty Wistar male rats were equally randomized into a normal control group and nanobacterial group , the former injected via the tail vein with 1.2 mL of 0.9％ sodium chloride solution while the latter with 1.2 mL of nanobacterial suspension , both for once.Three of the rats in each group were sacrificed every week in the first 10 weeks after injection.Histopathological examination was performed every week to evaluate the stone formation in the kidneys of the rats , and the expressions of the CaSR and Claudin -14 proteins were determined by immunohistochemistry. Results From the 1st to the 10th week after injection, crystal particles were observed in the rat kidneys of the nanobacterial group, but not in the normal controls (52.4％ vs 0％, P<0.01).The expressions of CaSR and Claudin -14 showed no statistically significant differences between the nanobacterial and control groups in the first 3 weeks (P>0.05) but both gradually in-creased in the former group from the 4th to the 10th week as compared with the latter, mainly in membrane of the renal tubular epithelial cells. Conclusion The increased activity of the CaSR -Claudin-14 regulatory channel may play an important role in the formation of nanobacterial renal stone .