Under the new situation of establishing the new standard system for pharmaceutical packaging materials in the 2025 edition of the Chinese Pharmacopoeia and promulgating the appendix on pharmaceutical packaging ma-terials in the Good Manufacturing Practice for Drugs,it is urgently necessary to introduce relevant standards for quality agreements on pharmaceutical packaging materials.This article focuses on analyzing the development of group standards for pharmaceutical packaging materials under the new situation,the role and significance of quality agreements for pharmaceutical packaging materials,as well as the interpretation of key parts of the"Guidelines for the Management of Quality Agreements for Pharmaceutical Packaging Materials",in order to help enterprises quick-ly shift from the original"standard-only"approach to strengthening the quality management of the entire product life cycle through quality agreements.

Under the new situation of establishing the new standard system for pharmaceutical packaging materials in the 2025 edition of the Chinese Pharmacopoeia and promulgating the appendix on pharmaceutical packaging ma-terials in the Good Manufacturing Practice for Drugs,it is urgently necessary to introduce relevant standards for quality agreements on pharmaceutical packaging materials.This article focuses on analyzing the development of group standards for pharmaceutical packaging materials under the new situation,the role and significance of quality agreements for pharmaceutical packaging materials,as well as the interpretation of key parts of the"Guidelines for the Management of Quality Agreements for Pharmaceutical Packaging Materials",in order to help enterprises quick-ly shift from the original"standard-only"approach to strengthening the quality management of the entire product life cycle through quality agreements.

Methods: Patients with dry eye who were treated in the Ophthalmology Ward and Outpatient Department of the First Hospital of Hunan University of Chinese Medicine from October 1, 2020, to October 30, 2021 were enrolled as the research participants in the study. They were assigned to two groups based on traditional Chinese medicine (TCM) syndrome types: heat stagnation in liver meridian pattern group and Qi-Yin deficiency pattern group. Healthy volunteers who underwent health check-ups in the Health Management Department were included as healthy group following the random number table method. The tears of the patients and the healthy volunteer participants were tested by high-performance liquid chromatography-mass spectrometry (LC-MS). The differential metabolites were screened out by multivariate statistical analysis, and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment was performed on the differential metabolites. Finally, the association analysis of differential proteins and metabolites was conducted to verify and supplement the metabolites. Results: A total of 32 dry eye patients were enrolled, including 16 cases with heat stagnation in liver meridian pattern and 16 cases with Qi-Yin deficiency pattern. Fourteen healthy volunteers were included as healthy group. There were no significant differences in baseline characteristics among the three groups (P > 0.05). A total of 412 biomarkers were determined in Qi-Yin deficiency pattern group, mainly including lipids, lipid-like molecules, organic acids and their derivatives, organic heterocyclic compounds, and nucleosides and their analogues. For heat stagnation in liver meridian pattern group, 112 metabolites were determined, mainly including organic acids and their derivatives, lipids, and lipid-like molecules. The KEGG enrichment results of pathways and the relative content analysis of differential markers demonstrate that purine metabolism and caffeine metabolism pathways are common metabolic characteristics of all dry eyes. Among them, deoxyinosine monophosphate (dIMP) and 2-(formamido)-N1-(5-phospha-D-ribosyl) acetamidine can serve as their biomarkers. The main characteristics of Qi-Yin deficiency syndrome pattern were the significant enhancement of metabolic pathways such as lysine degradation, ovarian steroidogenesis, cholesterol metabolism, pyrimidine metabolism, and bile secretion (P < 0.05). Dry eye associated with the heat stagnation in liver meridian pattern is mainly characterized by inhibition of the valine, leucine, and isoleucine biosynthesis pathways (P < 0.05). Conclusion Metabolomics can be used as an effective basis for TCM syndrome classification. Different patterns of dry eye syndrome exhibit typical characteristics in the types and concentrations of metabolites, which correspond to the syndrome classification in TCM. This study initially confirms the rationality of TCM syndrome classification and provides significant reference for the mechanism of dry eye and drug development.

Objective:To analyze the detection strategy and basic detection situation of markers of infectious diseases transmitted by transfusion in blood testing laboratories of blood stations in China.Methods:Based on the data of practice comparison working party of Blood Stations in Mainland of China from 2017 to 2021, the data on the testing strategies and the basic detection information of the markers for the transmission of infectious diseases through transfusion in the member laboratories of the practice comparison working party of Blood Stations in Mainland of China from 2017 to 2021 were collected, and the situation of the selection for testing markers, testing strategy and the testing method and other relevant aspects were sorted out and analyzed by charts.Results:The selection of the testing markers was consistent, but HTLV testing item was added in some member laboratories. The detection strategy of using two ELISA reagents and one nucleic acid testing (NAT) reagent simultaneously was adopted in 47 member blood stations; 3) NAT method was dominated by mini pool-NAT in member laboratories. The number of members adopting mini-pools of 8 (MP8)-NAT decreased from 17 in 2017 to 14 in 2021, while the number of members adopting mini-pools of 6 (MP6)-NAT increased from 13 in 2017 to 22 in 2021; Roche NAT system accounted for the largest proportion.Conclusions:In order to ensure blood safety and avoid missing detection, the blood stations still adopt the detection strategy of using two ELISA reagents and one nucleic acid testing (NAT) reagent simultaneously; Meanwhile, in order to increase the NAT positive rate, the proportion of mini pool-NAT mainly decreased year by year despite its dominating role, while the proportion of individual donation-NAT increased year by year; NAT method is transiting from mini-pools of 8 (MP8) to mini-pools of 6 (MP6); The proportion of imported NAT system used in NAT laboratory is relatively large.

Malignancies are diseases resulting from an imbalance of cell growth and proliferation， endangering human health and life. Currently， there is no clinically effective treatment for tumors. Tumor cells may alter cell adhesion and tumor cell migration and movement by degrading the extracellular matrix， generating vascular factors， affecting epithelial-mesenchymal transformation， or altering the tumor microenvironment. The mechanisms which lead to multidrug resistance （MDR） are the regulation of membrane proteins， apoptosis-regulated gene expression， enzyme-mediated multidrug resistance， DNA damage repair， and epithelial-stromal transformation， resulting in ineffective treatment of tumors. Therefore， the search for natural， safe， and effective chemosensitizers has become a critical part in tumor research. Due to the increasing use of Chinese medicine in cancer treatment， researchers have conducted more extensive studies on its monomers and compounds. In addition， the mechanisms of Chinese medicine in inhibiting tumor invasion and metastasis and reversing drug resistance are gradually unraveled. The monomers and compounds of Chinese medicine may inhibit tumor invasion， metastasis， and drug resistance by enhancing the sensitivity of chemotherapy drugs and adjuvant properties. Furthermore， they can also improve the tolerance of patients to chemotherapy drugs， relieve side effects of chemotherapy， reduce the chance of recurrence， and prolong the life of patients. The development of traditional Chinese medicine plays an important role in reducing tumor recurrence and metastasis， reversing drug resistance， prolonging the prognosis of cancer patients， improving their quality of life， and prolonging their survival time. Currently， various types of Chinese medicines have been proven to be capable of reducing tumor invasion and metastasis， and reversing drug resistance. The present article reviewed development and findings of Chinese medicine as an anti-tumor invasion， anti-metastasis， and anti-tumor resistance therapy in recent years， in order to provide ideas for future research on anti-tumor effect of active components in Chinese medicine.

Objective:To compare the result of nucleic acid detection between anal swabs and nasal swabs in confirmed cases of COVID-19.Methods:The result of nucleic acid detection between anal swabs and nasal swabs collected simultaneously at various time points after illness onset were analyzed retrospectively.Results:Totally, 46 matched result of anal swabs and nasal swabs in confirmed cases of COVID-19 collected at various intervals after illness onset in 31 patients were analyzed. All the result of nucleic acid detection were positive for anal swabs. The highest concordance rate of nucleic acid positive of COVID-19 (80%) between anal swabs and nasal swabs was observed 0-3 days after illness onset; while the value declined to 28.57% ≥16 days after illness onset. The longer the interval between sampling and illness onset, the lower the concordance rate.Conclusions:Besides two negative result from respiratory tract specimens, the negative result of anal swabs should be added as an important reference of releasing from quarantine.

Objective: Report the experience of autologous fat grafting forfacial contouring and rejuvenation patients. Methods: Retrospective analysis the treatment of 450 facial contouring and rejuvenation patients with global optimization autologous fat grafting in Plastic Surgery Hospital of Chinese Academy of Medical Sciences from January 2011 to December 2017. Using low negative pressure liposuction technical and blunt cannula (diameter 2.5 mm and 2.0 mm), different fat particle was harvested and concentrated by a cotton pad. The one-hole blunt cannula was used for fat grafting with multi tunnel and multi-point and two layer(deep and superficial)injection ways, regularly following up and taking picture for imaging evaluation. Results: All patients were successfully performed with fat grafting. Grafted fat volume was 15-65 ml. There were 132 cases of local skin bruising after operation, which gradually subsided about 2 weeks, no severe complications occurred. 450 patients were followed up for 6-12 months. Facial contour and skin texture were improved without subcutaneous nodules and irregularity. The outcome of all patients were satisfactory. Of a total of 450 patients, 319 (70.89%) were evaluated as very good result, 94 (20.89%) as good result, and 37(8.22%) asregular result. Conclusions Optimization autologous fat grafting can improve the facial contouring and rejuvenation with little complications and satisfactory results.

Objective To evaluate the therapeutic effects of Power PICC saline only locking option(SOLO)catheter in tumor patients.Methods One hundred and ten tumor patients admitted into the Tumor Diagnosis and Treatment Center of the hospital from April 2017 to July 2017 were recruited as research subjects.In accordance with different ways of catheterization,the patients were di-vided into two groups,each consisting of 55 patients.The observation group underwent Power PICC SOLO catheterization, while the control group had Power PICC catheterization.Then, incidence of complications during catheterization was compared between the 2 groups.Results There was only one case of thrombosis(1.8%)and no case of vessel obstruction(0%),which were significantly low-er than those of the control group [respectively 6(10.9%)and 3 cases(5.4%)],and there was statistical significance when compar-isons were made between them(P<0.05).Conclusion Power PICC SOLO catheter had the advantages of fewer complications,lighter nursing load,and it could meet treatment needs during different stages of treatment.More importantly,it was beneficial to those patients with blood coagulation disorder.

Objective To investigate the cellular immunologic response of TH 17/Treg cells in the peripheral blood of pelvic tuberculosis patients and explore their roles in the pathogenesis of pelvic tuberculosis.Methods The intracellular flow cytometry was performed to evaluate the expressions of TH 17 and Treg cells in 46 pelvic tuberculosis patients and 25 healthy controls in childbearing age.Twenty-eight of the 46 pelvic tuberculosis patients were followed up to monitor the variation of the TH17/Treg cells after 3 months and 6 months of anti-tuberculosis treatment.Results The percentage of TH 17 cells in the peripheral blood of pelvic tuberculosis patients was (3.26 ± 1.30) ％ which was significantly lower than that of healthy controls [(4.92 ± 1.71) ％,P ＜ 0.01].The percentage of Treg cells in the patients was (5.18 ± 1.53) ％ which was significantly higher than that of healthy controls [(3.26 ± 1.10) ％,P ＜ 0.01].The percentage of TH17 cells in the pelvic tuberculosis patients after 6 months of treatment was (4.67 ± 1.75) ％ which was significantly higher than that in the patients before treatment and after 3 months treatment [(3.26 ± 1.30) ％,P ＜ 0.01 and (3.70 ± 1.06) ％,P ＜0.01,respectively].The percentage of Treg cells in pelvic tuberculosis patient after 6 months of treatment was (3.93 ±0.94)％ which was significantly lower than that in the patients before treatment and after 3 months of treatment [(5.18 ± 1.53)％,P ＜0.01 and (4.94 ± 1.51) ％,P ＜ 0.01,respectively].The percentage of Treg cells in the patients after 6 months of treatment was still significantly higher than that of controls (P ＜ 0.05).The TH 17/Treg ratio before treatment was significantly lower than that of healthy controls (P ＜ 0.01),and the TH 17/Treg ratio was increased after 3 months of treatment but it did not show significant difference compared with that before treatment.The TH 17/Treg ratio after 6 months of treatment (1.18 ± 0.34) ％ was significantly increased in contrast to those after 3 months of treatment and before treatment [(0.77 ± 0.21) ％,P ＜ 0.01 and (0.55 ± 0.13) ％,P ＜ 0.01,respectively].The TH 17/Treg ratio could not rise to the normal level even after 6 months of treatment.Conclusion Both the TH 17 and Treg cells may involve in the immunologic responses of pelvic tuberculosis patients and the imbalance of TH1T/Treg cells may remain persistently.

Objective To analysis and research the clinical pathological characteristics with papillary thyroid carcinoma(PTC)and nodular goiter.Methods 100 cases with thyroid disease were selected,the preoperative ultra-sound diagnosis and pathological diagnosis results were compared,and pathological features were analyzed.Results Ultrasound results:ther were 72 cases with PTC,and 28 cases with NG,and pathologically confirmed 48 cases with PTC,52 cases with NG.The difference of two diagnostic result was statistically significant (χ2 =5.263,P <0.05). Compared with 48 PTC cases,the ratio of single nodule in 52 NG patients was smaller,while multiple nodules and cystic lesions proportion were higher,the differences were statistically significant (χ2 =58.19,73.97,25.40,all P <0.05).PTC was characterized by solid nodules of gray matter,often located near the thyroid capsule.Large tumors may be cystic.NG was characterized by single or multiple nodules,with different size,and some nodules with incomplete capsule,some with thick fibrous capsule.Nodular cystic necrosis hemorrhage was common.Conclusion Ultrasound diagnosis and can make a more accurate judgment between NG and PTC,but there are still misdiagnosed on the two diseases,for PTC and NG accurate judgment also need to rely on pathological identification,so grasping the pathologi-cal features of both can improve diagnostic accuracy.