To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.

To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.

Objective To establish sensitive indicators for the evaluation of emergency nursing quality in patients with acute aortic dissection. Methods Based on the three-dimensional quality theory model of "structure-process-outcome", evidence-based nursing methods were used to synthesize evidence and conduct two rounds of expert consultation to determine sensitive indicators for the quality of emergency nursing in patients with acute aortic dissection. Results The effective recovery rates of the two rounds of expert consultation questionnaires were 100.00% and 94.12%, respectively. The judgment basis coefficients (Ca) of the experts who participated in the two rounds of consultation were 0.893 and 0.914, respectively, and the familiarity coefficients (Cs) were 0.902 and 0.921, respectively, and the authority coefficients (Cr) were 0.898 and 0.918, respectively. The Kendall coefficients of the first round of consultation experts for the first, second, and third-level indicators were 0.212, 0.247, and 0.327, respectively, and were 0.225, 0.349, and 0.257, respectively in the second round of consultation experts. Finally, the sensitive indicators for the quality of emergency nursing of AAD patients were constructed, including 3 first-level indicators, 8 second-level indicators, and 29 third-level indicators. Conclusion The sensitive indicators for the quality of emergency nursing of AAD patients constructed in this study can be used as a basis for evaluating the quality of emergency nursing in patients with acute aortic dissection.

Objective To investigate the effect of Echinococcus granulosus cyst fluid(EgCF) on the cytoskeletal rearrangement and phagocytosis and the migration of macrophages induced by lipopolysaccharide(LPS). Methods Peritoneal macrophages of C57BL/6 mice were isolated and cultured in vitro, and divided into control group and LPS group and LPS combined with EgCF group. After 48 hours of treatment, filamentous actin (F-actin) changes were observed with rhodamine-labelled phalloidin staining and fluorescence microscopy; Transwell^TM chamber was used to test cell migration ability and flow cytometry to test cell phagocytosis. After 1 hour of treatment, PI3K and AKT, phosphorylated AKT (p-AKT), Rac1, guanosine triphospho-Rac1 (GTP-Rac1), WASP and Arp2 protein expressions were detected with Western blot analysis. Results Compared with the control group, after LPS stimulation, macrophages were deformed significantly; pseudopodia increased; actin cytoskeleton increased and was more distributed in pseudopodia; the ability of migration and phagocytosis were significantly improved, and the expression of PI3K, p-AKT, GTP-Rac1, WASP and Arp2 proteins significantly increased. EgCF treatment caused cell shrinkage and disappearance of pseudopodia protrusions of LPS-activated cells, and led to the reduced phagocytic and migratory of cells; the protein expression of PI3K, p-AKT, GTP-Rac1, WASP and Arp2 decreased significantly compared with the LPS group. Conclusion LPS induces the migration and enhances phagocytosis of macrophages while EgCF inhibits these effects, which is related to actin cytoskeleton rearrangement.
Mice ; Animals ; Lipopolysaccharides/pharmacology* ; Echinococcus granulosus/metabolism* ; Proto-Oncogene Proteins c-akt ; Cyst Fluid/metabolism* ; Mice, Inbred C57BL ; Macrophages/metabolism* ; Phagocytosis ; Actins/metabolism* ; Phosphatidylinositol 3-Kinases/metabolism* ; Guanosine Triphosphate/pharmacology*

Objective:To compare the clinical outcomes between modified percutaneous kyphoplasty (PKP) and conventional PKP in the treatment of Kümmell disease.Methods:A retrospective cohort study was conducted of the 57 patients with single level kummell disease who had undergone PKP between January 2015 and December 2017 at Department of Spinal Surgery, Jiangmen Hospital Affiliated to Sun Yat-sen Uni-versity.Of them, 36 received modified PKP and 21 conventional PKP.In the modified PKP group, there were 24 males and 12 females with an age of 73.9 years±9.4 years and a course of disease of 2.2 months±1.5 months; the disease was located at a thorocic vertebra in 20 cases and at a lumbar vertebra in 16.In the conventional PKP group, there were 15 males and 6 females with an age of 72.6 years±11.9 years and a course of disease of 1.8 months±1.1 months; the disease was located at a thorocic vertebra in 10 cases and at a lumbar vertebra in 11.The 2 groups were compared in terms of operation time, bone cement volume, cement leakage, visual analogue scale (VAS), Oswestry disability index (ODI), anterior and middle heights and cobb angle of injured vertebra at postoperative 3 days, 1 and 3 months, and final follow-up.Results:There were no significant differences in the general clinical data between the 2 groups, showing compatibility between groups ( P>0.05).All the operations were accomplished uneventfully with no such serious complications as spinal cord nerve injury, wound infection, pulmonary embolism, bone cement poisoning reaction or death. There was no significant difference between the 2 groups in operation time or bone cement volume ( P>0.05).The rate of cement leakage in the modified PKP group [33.3%(9/27)] was significantly lower than that [52.4%(11/21)] in the conventional PKP group ( P<0.05).There were no significant differences be-tween the 2 groups in VAS, ODI, anterior or middle height of injured vertebra or cobb angle at postoperative 3 days or one month ( P>0.05), but the postoperative values were improved compared to the preoperative ones.At postoperative 3 months and final follow-up, the modified PKP group was significantly better in all the indexes than the conventional PKP group ( P<0.05). Conclusion:Compared with conventional PKP, the modified PKP may lead to better outcomes for Kümmell disease.

Objective To observe the gastric changes in adult male Sprague-Dawly (SD) rats irradiated by the single large dose electron beam,providing animal experimental evidence for intraoperative radiotherapy for gastric cancer.Methods Thirty-eight SD rats were randomly divided into the control and experimental groups.The stomach of the rats in the experimental group were subject to single 6 MeV 20 Gy irridiation by using the patent technology of Accurate Irradiation Experiment Table for Small Animal Radiation.The general conditions,gastric injury and body weight change were observed at different days following irradiation.Results The most severe gastric damage of rats was observed on the 14th d after irradiation.The gastric injury was gradually repaired accompanied with glandular atrophy at 28 d postirradiation,and the gastric injury was manifested as cellulose fibrinous repair on the 56th d after irradiation.Within 1 week post-irradiation,weight loss was noted in the experimental group,which significantly differed from the rats in the control group (P＜0.05).During the 2nd week,the body weight was increased in the experimental group,significantly lower compared with the rats in the control group (P＜ 0.05).The body weight of rats did not significantly differ between two groups at 6 weeks after irradiation (P＞ 0.05).Conclusions The most severe gastric injury is observed at 2 weeks after the single-dose 6 MeV electron beam 20 Gy irradiation,whereas no gastric perforation occurs.The gastric injury can be restored to normal status within 8 weeks following irradiation.

Objective To observe the corneal nerve fibres damage in different stage of diabetic retinopathy (DR) with type 2 diabetes.Methods A cross-sectional study.One hundred and twenty eyes of 120 patients with type 2 diabetes served as diabetes group.According to International Clinical Diabetic Retinopathy Disease Severity Scales (2002),diabetes patients were classified into 4 subgroups:patients without diabetic retinopathy (NDR),patients with mild or moderate non-proliferative diabetic retinopathy (mNPDR),patients with severe non-proliferative diabetic retinopathy (sNPDR) and patients with proliferative diabetic retinopathy (PDR),each subgroup has 30 eyes of 30 patients.Another 30 eyes of 30 healthy participants served as control group.All eyes were scanned with HRT3 in vivo corneal confocal microscopy.Images of sub-basal nerve plexus were quantified including nerve fiber length (NFL),nerve fiber density (NFD),nerve fiber branch density (NFB),and nerve tortuosity (NT).The correlations of corneal nerve fiber with age,duration of diabetes and glycated hemoglobin (HbA1 c) were analyzed using Spearman correlation analysis.Results NFL,NFD and NFB were found to be significantly lower in diabetic patients (F=147.315,142.586,65.898;P=0.000,0.000,0.000),NT was significantly greater in diabetic patients (F=39.431,P=0.000),when compared to control group.In diabetic patients,NFL,NFD and NFB were gradually reduced with DR severity,NT was gradually increased with DR severity.While the difference ofNFL,NFD,NFB,NT was not statistically significant between sNPDR and PDR subgroups (P＞.0.05),but was statistically significant between other subgroups (P＜0.05).Spearman correlation analysis results showed that age (r=-0.071,-0.080,0.001,0.100;P=0.391,0.328,0.991,0.224) and HbAlc (r=-0.109,-0.115,-0.126,0.025;P=0.238,0.211,0.169,0.781) had no correlation with NFL,NFD,NFB,NT.Duration of diabetes was negatively correlated with the NFL,NFD (r=-0.212,-0.264;P=0.020,0.004),positive correlated with NT (r=0.261,P=0.004),and had no correlation with NFB (r=-0.119,P=0.194).Conclusions Corneal nerve fiber loss and nerve tortuosity increased were found in patients with type 2 diabetes,and even without diabetic retinopathy.The progress of corneal neuropathy was correlated with the severity of DR,but it was not change significantly between sNPDR and PDR.

BACKGROUND:At present, occlusion of the drainage tube was commonly used to reduce the drainage volume after total hip arthroplasty so as to promote the incision healing and hip function rehabilitation. However, the occlusion time is a problem deserving further investigations. OBJECTIVE:To research the effects of temporarily clamping drainage tube on drainage volume in early stage after total hip arthroplasty. METHODS:From January to October 2013, 112 patients received unilateral total hip arthroplasty in the First Ward, Department of Orthopedics, First Affiliated Hospital, Zhengzhou University in China. They were randomly divided into four groups according to the admission time (n=28):occlusion of the drainage tube for 2, 4 and 6 hours and without occlusion of the drainage tube. Al tubes were pul ed out in postoperative 48 hours. Moreover, 48-hour postoperative hemoglobin and drainage volume, the healing of incision and the score of hip joint function when patients were fol owed up at 1.5 months postoperatively were recorded accurately. RESULTS AND CONCLUSION:48-hour hemoglobin drop level and 48-hour incision drainage volume were highest in the non-occlusion group, fol owed by 2-hour occlusion group, 4-hour occlusion group and 6-hour occlusion group (P<0.05). However, no significant differences in the healing time of postoperative incision and the Harris score of hip joint function when patients were fol owed up at 1.5 months postoperatively were detected among groups (P>0.05). Incision infection and tension split were not seen in each group. Six cases affected subcutaneous ecchymosis and swel ing accompanied by pain and four cases suffered from the venous plexus thrombosis of the calf muscle in the 6-hour occlusion group. One case experienced fat liquefaction separately in the 4-hour occlusion group and non-occlusion group. These results suggested that temporary occlusion of the drainage tube in the early stage of total hip arthroplasty could reduce the drainage volume of incision. The suitable time of clamping drainage tube was 4 hours, and there were no adverse effects on healing of incision and recovery of hip function.

Flavonoids, which is composed of a C6-C3-C6 backbone, is a kind of secondary metabolites of Chinese materia medica (CMM). It has received extensive attention from all over the world and obtained a rapid develop-ment due to its widespread distribution, structural complexity and active diversity. This article has summarized the progress of flavonoids both in antioxidant activity and in mechanism, so as to provide some references for the re-search and development of new medicine of flavonoids with antioxidant activity.

Objective To improve overall value of healthcare industry through setting up critical inpatient medical services strategic plan.Methods Identify major objectives which the local government expects to achieve through strategic map; Standardize inpatient output and assign weight to each group through diagonosis related groups; Translate the objectives of strategic map and result of diagnosis related group to Balanced Score-card; Finally build up strategic map and according action plans.ResultsPreliminarily established 16 objectives、23 measures and 13 tasks in four perspectives including customer,internal work flow,learning and growing and finance.ConclusionThe strategy map and the balanced score-card can help implement full strategic plan of regional inpatient medical services; DRGs is a core management tool of patient-centred service output management; Balanced Score-card is able to realize continuous improvement of Beijing inpatient medical services from macro to micro persoetive.