ObjectiveA qualitative analysis method was established for the composition of Astragali Radix（AR） before and after rice stir-frying. On the basis of systematic characterization of the chemical compositions in AR and stir-fried AR with rice（ARR）， the structures of their major compounds were deduced and identified， and the differential compositions between them were analyzed. MethodsUltra performance liquid chromatography-quadrupole-time-of-flight mass spectrometry（UPLC-Q-TOF-MS/MS） was used to detect the samples of AR and ARR in positive and negative ion modes， respectively. The compounds were analyzed and identified through self-constructed databases， literature， and reference standards， etc. And the data were analyzed by chemometrics， in order to screen for the differential components between AR and ARR. ResultsA total of 123 compounds were identified in AR and ARR， including 41 flavonoids， 19 terpenoids， 26 organic acids， 8 amino acids， 5 nucleotides， 5 carbohydrates and 19 other compounds. Among them， there were 95 common components in both， 18 unique components in AR， and 10 unique components in ARR. Principal component analysis（PCA） and orthogonal partial least squares-discriminant analysis（OPLS-DA） results both showed that there were significant differences in the chemical constituents of AR before and after rice stir-frying， and a total of 26 constituents with differences in the content were screened out， including L-canavanine， L-pyroglutamic acid， L-phenylalanine， cis-caffeic acid， and malonylastragaloside Ⅰ. Among them， 19 constituents of ARR were down-regulated and 7 constituents were up-regulated by comparing with AR. ConclusionThis study clarifies that the chemical composition of AR and ARR is mainly composed of flavonoids， terpenoids， and organic acids， and analyzes the components with significant differences in content between the two in combination with chemometrics， and the differential components are dominated by amino acids， organic acids and terpenoids， which can provide reference for the subsequent quality control and material basis research.

Objective:To analyze the effects of shift work on the renal function of oil workers and investigate whether there is a measured response relationship between shift work and renal dysfunction.Methods:In this study, oil workers who participated in physical examinations at the North China Oilfield Downhole Hospital were selected as the study subjects, and the physical examinations as well as questionnaires of the study subjects in 2017 and 2018 were collected as the baseline data, which included blood biochemical indexes, socio-demographic characteristics, history of life behaviors, occupational exposures, and occupational histories. Three follow-up surveys were subsequently conducted in April 2019, April 2020, and January 2021. The presence of renal dysfunction in the study population was determined based on the glomerular filtration rate tested at the medical examination hospital. The exposure of the study subjects to shift work was assessed using the weighted shift index (WSI), the relationship between different levels of shift work and renal dysfunction was analyzed using Cox regression, and the measure of WSI and renal dysfunction was explored by restricted cubic spline (RCS). response relationship.Results:A total of 2292 study participants were included in this study, and the prevalence density of renal dysfunction was 87.44 k/year, of which the prevalence of renal dysfunction in females (30.31%), those with per capita monthly income <2, 000 yuan (27.00%), those who consume alcohol (27.10%), those who are hypertensive (23.05%), those who are exposed to high temperatures (27.37%), those who are exposed to organic solvents (30.42%), and those who are engaged in shift work (25.87%) were to be found had a higher prevalence of renal dysfunction ( P<0.05). After correcting for age, sex, and other risk factors, there was a nonlinear association between intensity of shift work and renal dysfunction, with a hazard ratio ( HR) of 1.29 (95% CI: 0.98-1.59) for the development of renal dysfunction in petroleum workers for shift work performed at higher intensities, and moderate intensity of exposure to shift work reduced the risk of renal dysfunction in petroleum workers ( HR=0.54 with a 95% CI: 0.39-0.75, P<0.001) . Conclusion:Prolonged shift work increases the risk of renal dysfunction in oil workers, and the occurrence of renal dysfunction in oil workers is influenced by multiple factors.

Objective:To analyze the effects of shift work on the renal function of oil workers and investigate whether there is a measured response relationship between shift work and renal dysfunction.Methods:In this study, oil workers who participated in physical examinations at the North China Oilfield Downhole Hospital were selected as the study subjects, and the physical examinations as well as questionnaires of the study subjects in 2017 and 2018 were collected as the baseline data, which included blood biochemical indexes, socio-demographic characteristics, history of life behaviors, occupational exposures, and occupational histories. Three follow-up surveys were subsequently conducted in April 2019, April 2020, and January 2021. The presence of renal dysfunction in the study population was determined based on the glomerular filtration rate tested at the medical examination hospital. The exposure of the study subjects to shift work was assessed using the weighted shift index (WSI), the relationship between different levels of shift work and renal dysfunction was analyzed using Cox regression, and the measure of WSI and renal dysfunction was explored by restricted cubic spline (RCS). response relationship.Results:A total of 2292 study participants were included in this study, and the prevalence density of renal dysfunction was 87.44 k/year, of which the prevalence of renal dysfunction in females (30.31%), those with per capita monthly income <2, 000 yuan (27.00%), those who consume alcohol (27.10%), those who are hypertensive (23.05%), those who are exposed to high temperatures (27.37%), those who are exposed to organic solvents (30.42%), and those who are engaged in shift work (25.87%) were to be found had a higher prevalence of renal dysfunction ( P<0.05). After correcting for age, sex, and other risk factors, there was a nonlinear association between intensity of shift work and renal dysfunction, with a hazard ratio ( HR) of 1.29 (95% CI: 0.98-1.59) for the development of renal dysfunction in petroleum workers for shift work performed at higher intensities, and moderate intensity of exposure to shift work reduced the risk of renal dysfunction in petroleum workers ( HR=0.54 with a 95% CI: 0.39-0.75, P<0.001) . Conclusion:Prolonged shift work increases the risk of renal dysfunction in oil workers, and the occurrence of renal dysfunction in oil workers is influenced by multiple factors.

3D printing, an emerging technology, can assist improving surgical efficiency of liver surgery. 3D-printed organ models facilitate surgeons in surgical planning, enabling the simulation of surgical procedures and guiding interventions through surgical navigation. Furthermore, 3D printing harnesses the potential of utilizing tissue or cells from specific individuals to generate grafts for liver surgeries, thereby addressing the issue of graft shortage and advancing the development of personalized medicine.

Objective:To investigate the association between triglyceride-glucose (TyG) index and all-cause mortality in elderly patients with hypertension and coronary artery disease.Methods:This was a retrospective cohort study, a total of 5 640 elderly inpatients (≥65 years) with hypertension and coronary artery disease who were admitted to the Department of Cardiology, Liberation Army General Hospital from August 2008 to July 2018 were enrolled in this study. The baseline clinical data of the patients were collected and the TyG index was calculated. Patients were divided into four groups according to their TyG index quartiles: TyG index<8.31 ( Q1 group, n=1 392), 8.31≤TyG index<8.67 ( Q2 group, n=1 417), 8.67≤TyG index<9.07 ( Q3 group, n=1 427), and TyG index≥9.07 ( Q4 group, n=1 404). All patients were followed up by obtaining outpatient/rehospitalization records or by telephone. The primary endpoint was all-cause mortality. Log-rank test was used to compare the cumulative all-cause mortality among groups. Cox proportional hazard regression model was used to analyze the risk of all-cause mortality in each group (the Q2 group with the lowest all-cause mortality was used as a reference), after adjusting for confounding factors, Restricted cubic spline analysis (RCS) was used to determine the association between TyG index and risk of all-cause mortality. Results:During a follow-up of 6.44 (4.70, 8.85) years, 1 037 all-cause deaths (18.39 %) were documented. The cumulative all-cause mortality in Q1- Q4 groups was 16.52%, 16.51%, 17.59% and 22.93%, respectively, and the difference was statistically significant ( χ2=26.49, P<0.01). In the Cox regression model, compared with Q2 group (reference), the HR (95% CI) for all-cause mortality was 1.06 (0.88-1.28) in the Q1 group, 1.23 (1.02-1.48) in the Q3 group and 1.48 (1.23-1.77) in the Q4 group, respectively ( P for trend<0.01). RCS curve analysis showed that when the TyG index was greater than 8.67, the risk of all-cause mortality increased with the TyG index, and there was a linear relationship between TyG index and all-cause mortality in this patient cohort (non-linearity P=0.31). Conclusion:The elevated TyG index is significantly associated with a higher risk for all-cause mortality in elderly hypertension and coronary artery disease patients.

Objective:This article analyzed the current situation, similarities and differences and main problems of the registration and management systems of innovative medical devices in China and the United States.Methods:This article summarized the requirements and policies for the registration management of innovative medical devices in China and the United States, as well as the development and differences of the registration of innovative medical devices in China and the United States, and the main problems in the registration management of innovative medical devices in China.Results:At present, the development level of medical device industry in China and the United States was different, facing different development problems, and there were differences in the access standards and management methods of innovative medical devices. The registration management system established for innovative medical devices in China was gradually improving, and to a certain extent, it had promoted the enthusiasm of innovative product research and development and registration applications, but there were also problems such as unclear innovation evaluation scales, insufficient early intervention of review resources, and insufficient utilization of post-marketing data.Conclusions:Drawing on the beneficial experience of breakthrough device registration management in the United States, we will improve the registration management system for innovative products and shorten the review and approval cycle by clarifying the identification criteria for innovative medical devices, promoting the placement of review resources in the R&D stage, and further strengthening the use of post-marketing data and regulatory scientific research.

Objective Based on the framework of"quantitative analysis of supporting policies",this study focuses on the formulation and implementation of supporting policies for pharmaceutical science and technology innovative enterprises in China,so as to provide a certain reference for the implementation and improvement of policies for pharmaceutical science and technology innovative enterprises in China.Methods This study used Roy Rothwell and Walter Zegveld's innovative policy tools as the basis for analysis,and combined with the dimension of policy type,the policy was quantitatively analyzed.Results A total of 47 effective policy documents were selected,including 22 issued by the state and 25 issued by Beijing municipal government.A total of 104 policy instruments were included through the dismantling of policy provisions.Specifically,environment-based policy tools accounted for the highest proportion(60.58%),while demand-based and supply-based policy tools were relatively few.From the perspective of policy types,there were more planning policy documents(25 articles),while there were relatively few specific implementation policies(22 articles).Conclusion It is necessary to focus on optimizing the formulation stage of support policies and improving the use of supply-oriented and demand-oriented policy tools to better meet the needs of pharmaceutical science and technology innovative enterprises.

OBJECTIVE To explore the mechanism of Kuaisong yin in the prevention and treatment of constipation. METHODS Slow transit constipation （STC） model was established with Compound difenoxylate tablet in mice and rats. Two batches of mice were divided into blank group， model group， positive control group （Maren soft capsule， 0.64 g/kg）， Kuaisong yin low-dose， medium-dose and high-dose groups （3.2， 6.4， 12.8 g/kg）， with 10 mice in each group. The effect of Kuaisong yin on constipation in mice was evaluated by intestinal propulsion experiment and defecation experiment. Rats were divided into blank group， model group， positive control group （Maren soft capsule，0.36 g/kg）， Kuaisong yin low-dose and high-dose groups （2.4， 4.8 g/kg）， with 7 or 8 rats in each group. They were given relevant medicine once a day for 1 week. The metabonomics of serum and urine of rats were analyzed by UPLC-Q-TOF-MS/MS technology. RESULTS Compared with model group， the ink propulsion rate and 5 h defecation volume of mice in Kuaisong yin high-dose group were significantly increased （P＜0.05）； the first defecation time of mice in Kuaisong yin medium-dose and high-dose groups was significantly shortened， and the quality of defecation was significantly reduced within 5 h （P＜0.05 or P＜0.01）. Serum metabonomics screened 16 compounds （such as proline， propionylcarnitine， hemolytic phosphatidylcholine， etc.） and 6 metabolic pathways （such as sphingomyelin metabolism， arginine and proline metabolism， sphingolipid biosynthesis-lactose and neolactone series）. Urine metabonomics screened 20 different metabolites （such as prostaglandin A2， L-valine， phosphatidylcholine， sphingomyelin， etc.） and 8 metabolic pathways （such as valine， leucine and isoleucine biosynthesis， sphingomyelin metabolism， pyruvate metabolism， etc.）. CONCLUSIONS Kuaisong yin can play a role in improving constipation by regulating different metabolites such as hemolytic phosphatidylcholine， phosphatidylcholine， prostaglandin A2， L-valine， proline， and regulating metabolic pathways such as multiple amino acid metabolism， sphingomyelin metabolism， etc.

OBJECTIVE To study the mechanism of Compound zaoren granule in improving insomnia. METHODS Forty-nine mice were divided into blank group， model group， positive control group 1 （Estazolam tablets 0.5 mg/kg），control group 2 （Shumian capsule 0.6 g/kg）， Compound zaoren granule low-dose， medium-dose and high-dose groups （2.5， 5， 10 g/kg）， with 7 mice in each group. The insomnia model was established by chronic unpredictable mild stress combined with 4-chloro-DL- phenylacetic acid. The behavioral changes of mice were investigated through open field test and pentobarbital sodium synergistic hypnosis experiment， as well as the pathomorphology of mice hypothalamus tissue was observed by HE staining. The metabonomics analysis and multivariate statistical analysis of serum in mice were performed by UHPLC-Q-TOF-MS/MS， and the differential metabolites were screened out； the metabolic pathway analysis was conducted based on MetaboAnalyst 5.0 database. RESULTS Compared with blank group， the total travelling distance， the number of entering the central region and the moving distance in the central region of the model group were significantly reduced （P＜0.05）， the proportion of total rest time was significantly increased （P＜0.05）， the sleep duration of mice was significantly shortened （P＜0.05）， and hypothalamic nerve cells damaged and severely vacuolated. Compared with model group， the total travelling distance of Compound zaoren granule low-dose and medium-dose groups were increased significantly and the proportions of total rest time of those groups were decreased significantly （P＜0.05）， and the sleep duration of mice in Compound zaoren granule high-dose group was prolonged significantly （P＜0.05）； the hypothalamic nerve cells of mice in each administration group recovered to varying degrees， and the hypothalamus histiocytes of mice in the Compound zaoren granules high-dose group were closer to those in the blank group. A total of 18 differential metabolites （such as phenylalanine， taurine， norvaline， methionine） and 4 important amino acid metabolic pathways （L-phenylalanine， tyrosine and tryptophan biosynthesis； taurine and hypotaurine metabolism； L-phenylalanine metabolism； cysteine and methionine metabolism） were identified through metabolomics analysis. CONCLUSIONS Compound zaoren granules can normalize the disordered metabolism in vivo by regulating differential metabolites such as phenylalanine， taurine， and four amino acid metabolic pathways， so as to improve insomnia.

Objective:To evaluate the role of Sigma-1 receptor (Sigma-1R) in pentazoxine-induced reduction of oxygen-glucose deprivation and restoration (OGD/R) injury in SH-SY5Y cells and the relationship with endoplasmic reticulum stress (ERS).Methods:The well-growing SH-SY5Y cells were divided into 4 groups ( n=6 each) using a random number table method: control group (group C), OGD/R group (group O), OGD/R+ pentazoxin group (group OP) and OGD/R+ pintazoxin+ BD1047 group (group OPB). The cells in group C were normally cultured. In O group, OP group and OPB group, the culture medium was replaced with EBSS medium, and then the cells were cultured in an incubator of 5% CO 2-95% N 2 at 37 ℃ for 4 h, then replaced with DMEM/F12 medium containing 10% fetal bovine serum for restoration of O 2-glucose supply for 18 h, and in addition pentazoxin (final concentration 10 μmmol/L) was added during restoration in OP group, and pentazoxin (final concentration 10 μmmol/L) and Sigma-1R blocker BD1047 (final concentration 20 μmol/L) were added during restoration in OPB group. The apoptosis rate was detected by flow cytometry at the end of restoration, and the expression of Sigma-1R, C/EBP homologous protein (CHOP), phosphorylated inositol-requiring enzyme 1 (p-IRE1), spliced X-box binding protein 1 (XBP1s), and activated caspase-3 (c-cas-3) was detected by Western blot. Results:Compared with group C, the apoptosis rate was significantly increased, and the expression of CHOP and p-IRE1 was up-regulated in O group, OP group and OPB group, the expression of XBP1s and c-cas-3 was significantly up-regulated in O group and OPB group ( P<0.05), and no significant change was found in the expression of Sigma-1R, XBP1s and c-cas-3 in OP group ( P>0.05). Compared with O group, the apoptosis rate was significantly decreased, the expression of Sigma-1R was up-regulated, and the expression of CHOP, p-IRE1, XBP1s and c-cas-3 was down-regulated in OP group ( P<0.05). Compared with OP group, the apoptosis rate was significantly increased, the expression of Sigma-1R was down-regulated, and the expression of CHOP, p-IRE1, XBP1s and c-cas-3 was up-regulated in OPB group ( P<0.05). Conclusions:Sigma-1R is involved in pentazoxine-induced reduction of OGD/R injury in SH-SY5Y cells, and the mechanism may be related to inhibition of endoplasmic reticulum stress.