As a new type of high-risk packaging container, prefilled syringes are more widely used, and concerns regarding their effectiveness, stability and safety in clinical use have become prominent increasingly. However, the leachable substances from prefilled syringes may cause harm to humans in different degrees. Therefore, this paper reviews the research progress of leachable substances in prefilled syringes, which is not only of great significance for the quality control of prefilled syringe products, but also contributes to the healthy development of the industry.
Syringes ; Drug Packaging ; Quality Control

A method for determining volatile organic compounds (VOCs) emitted from medical molecular sieve oxygen concentrators was developed using thermal desorption-gas chromatography-mass spectrometry (TD-GC-MS). The oxygen concentrator gas was sampled at a flow rate of 0.5 L/min through a branched sampling system onto Tenax GR/carbopack B adsorption tubes. The adsorbed compounds were desorbed and introduced using a programmed temperature vaporization inlet system, followed by chromatographic separation on an SH-I-624Sil MS column. Four VOCs (BHT-Q, PTBP, BHT-quinol, and EHB) were detected in the medical oxygen concentrator using this method. Calibration curves for these compounds exhibited excellent linearity ( R ²>0.99) within the range of 3~100 ng. With a sampling volume of 20 L, the detection limit of the four VOCs ranged from 0.003 9 to 0.022 2 μg/m ³. Spike recovery rates for the four VOCs were between 95% and 115%, with relative standard deviations (RSDs) below 5% ( n=6). The method is simple, rapid, highly sensitive, and accurate, making it suitable for VOCs detection in medical molecular sieve oxygen concentrators.
Volatile Organic Compounds/analysis* ; Gas Chromatography-Mass Spectrometry/methods* ; Oxygen

BACKGROUND:The structure,physical and chemical properties(such as rheological properties)and biological activity of hyaluronic acid with different molecular weights are quite different.When the degradation degree of non-cross-linked hyaluronic acid is too large and the high-molecular-weight hyaluronic acid is degraded to low-molecular-weight hyaluronic acid,the properties and biological functions of the product will also change,which will affect the use of the product. OBJECTIVE:To review the mechanism of molecular weight degradation of non-cross-linked hyaluronic acid and the impacts of molecular weight degradation on the structure,rheological properties,biological activity and applications of non-cross-linked hyaluronic acid. METHODS:The first author searched the articles related to the molecular weight of hyaluronic acid collected in PubMed,CNKI database and other databases.The high-quality articles with high correlation were screened according to the inclusion and exclusion criteria.The search time was from January 2017 to December 2022.The Chinese and English search terms were"hyaluronic acid,non-cross-linked hyaluronic acid,molecular weight,degradation,structure,rheological properties,biologic activity".Finally,47 articles were included for review and analysis. RESULTS AND CONCLUSION:(1)The molecular weight of non-cross-linked hyaluronic acid is mainly degraded by specific enzymatic hydrolysis and non-specific free radical degradation.(2)The molecular weight degradation of non-cross-linked hyaluronic acid will change its structure and rheological properties,resulting in the untie of polymer network structure,the decrease of rheological properties such as viscosity and viscoelasticity,and the decrease of mechanical properties,which will eventually affect the practical application effect of the product.(3)The biological activity of non-cross-linked hyaluronic acid is molecular weight dependent,and the biological activity of different molecular weight hyaluronic acid is different.Even the same receptor combined with high-molecular-weight hyaluronic acid and low-molecular-weight hyaluronic acid will express completely opposite biological effects.(4)The degradation of molecular weights of non-cross-linked hyaluronic acid will reduce the safety and efficacy of the products,affect their service life and application performance,and ultimately influence the clinical application results.(5)Non-cross-linked hyaluronic acid has great potential as a biodegradable biomaterial in wound healing,tissue engineering,aesthetic medicine and other fields,and further research and understanding of the correlation between molecular weight degradation of non-cross-linked hyaluronic acid and bioactivity is a prerequisite for better development of wound dressings,drug delivery systems and tissue-engineered scaffolds.(6)However,there are currently few studies on the molecular weight degradation of non-cross-linked hyaluronic acid,and it is unclear how to effectively avoid the potential risks associated with the molecular weight degradation of non-cross-linked hyaluronic acid in clinical applications.(7)Therefore,a series of potential risks associated with the molecular weight degradation of non-cross-linked hyaluronic acid during its application,including the effects on its structure,properties and biological activity,and the resulting changes on the body,is one of the future directions that need to be closely investigated.

Ophthalmic drug-device combination products are a new method of ophthalmic disease treatment,which is characterized by high bioavailability,strong targeting and good compliance.However,it is difficult for products to be developed and regulated due to the complexity of the human eye structure,drug-device interactions,and other factors.To provide a basis for guaranteeing the safety and efficacy of products development and management,the related regulations,current research,and evaluation of the quality of products are summarized in this paper.

With the development of the economy and technological progress,more and more animal-derived mesh products are being utilized in the medical field for tissue and organ repair and replacement.Owing to the complexity of their structure and production process,these animal-derived meshes still face several challenges in practical applications,such as insufficient mechanical strength,rapid degradation rates,and the detection of harmful leachable substances.Among these challenges,the production process is a key factor affecting product quality.This paper reviews the key aspects of the production process and quality control for animal-derived meshes in China,offering new insights for the quality control and regulatory oversight of such products.

The rise of internet thinking, along with the growing acceptance of the " patient-centered" concept, has played a significant role in driving the development of electronic patient-reported outcomes (ePROs) in the field of clinical evaluation. While several large-scale and well-established ePROs evaluation systems have been widely adopted and implemented worldwide, China has lagged behind in ePROs research and electronic application. Therefore, the purpose of this paper is to comprehensively analyze and summarize the concepts, types, characteristics, state of development, and application of ePROs. Specifically, it focuses on analyzing the structure and content of ePROs evaluation network systems in the United States, France, and the United Kingdom. The ultimate objective is to provide insightful analysis and useful suggestions to aid in the development and evolution of ePROs in China.

Pulmonary endothelial barrier dysfunction is a hallmark of clinical pulmonary edema and contributes to the development of acute lung injury (ALI). Here we reported that ruscogenin (RUS), an effective steroidal sapogenin of Radix Ophiopogon japonicus, attenuated lipopolysaccharides (LPS)-induced pulmonary endothelial barrier disruption through mediating non-muscle myosin heavy chain IIA (NMMHC IIA)‒Toll-like receptor 4 (TLR4) interactions. By in vivo and in vitro experiments, we observed that RUS administration significantly ameliorated LPS-triggered pulmonary endothelial barrier dysfunction and ALI. Moreover, we identified that RUS directly targeted NMMHC IIA on its N-terminal and head domain by serial affinity chromatography, molecular docking, biolayer interferometry, and microscale thermophoresis analyses. Downregulation of endothelial NMMHC IIA expression in vivo and in vitro abolished the protective effect of RUS. It was also observed that NMMHC IIA was dissociated from TLR4 and then activating TLR4 downstream Src/vascular endothelial cadherin (VE-cadherin) signaling in pulmonary vascular endothelial cells after LPS treatment, which could be restored by RUS. Collectively, these findings provide pharmacological evidence showing that RUS attenuates LPS-induced pulmonary endothelial barrier dysfunction by inhibiting TLR4/Src/VE-cadherin pathway through targeting NMMHC IIA and mediating NMMHC IIA‒TLR4 interactions.

[This corrects the article DOI: 10.1016/j.apsb.2021.09.017.].

OBJECTIVE：To study the mechanism of improvement effects of Fupi rougan granule （FRG）on hepatic fibrosis model rats. METHODS ：The rats were randomly divided into blank group ，model group ，Colchicine tablet group （chemical positive control ，0.2 mg/kg），Fuzheng huayu capsule group （TCM positive control ，0.415 g/kg），FRG low-dose ，medium-dose and high-dose groups （20，40，80 g/kg），with 10 rats in each group ，except for 11 rats in blank group and model group （one rat was used to judge whether the modeling was successful ）. Except for blank group ，other groups were given intraperitoneal injection of 50％ CCl4 olive oil solution and intragastric administration of 30％ ethanol to induce hepatic fibrosis model. After modeling ， administration groups were given relevant medicine intragastrically ；blank group and model group were given constant volume of normal saline intragastrically ，once a day ，for consecutive 4 weeks. After last administration ，morphology changes of liver tissue in rats were observed. The serum levels of HA ，LN，PCⅢ and Col Ⅳ in rats were detected ，and protein expression of Beclin- 1 and LC3-Ⅱin liver tissue were also determined. mRNA and protein expression of Akt ，AMPK，mTOR，p70S6K were detected in liver tissues of rats. RESULTS ：Compared with blank group ，the structure of hepatic lobules in the model group was disordered ，the proliferation of fibrous tissue was obvious ，and some pseudolobules were formed ；the serum levels of HA ，LN，PCⅢ and Col Ⅳ， the protein expression of Beclin- 1 and LC 3-Ⅱ in liver tissue as well as mRNA and protein expression of Akt ，AMPK，mTOR and p70S6K were increased significantly （P＜0.01）. Compared with model group ，the liver injury of rats in FRG groups was significantly relieved ，and the levels of the above indexes in serum and liver tissue （except for LN and PC Ⅲ in FRG low-dose group） were significantly reduced （P＜0.05 or P＜0.01）. CONCLUSIONS ：FRG can improve hepatic fibrosis in rats ，the mechanism of which may be associated with down-regulating the expression of autophagy associated protein and Akt/AMPK/mTOR/ p70S6K signaling pathway related protein.