Thousands of variant gene sequences of SARS-CoV-2 have been emerged since the COVID-19 epidemic broke out in Dec.2019.Alpha(B.1.1.7),Beta(B.1.351),Gamma(P.1),Delta(B.1.617.2)and Omicron(B.1.1.529)were the most representative variants.With the continuous emergence of new variants,the predomi-nant strain in the global pandemic as of Jan.2025 is the Omicron BA.2.86-derived mutant,JN.1.The effectiveness of drugs against Omicron variants remains a key research focus in the treatment of SARS-CoV-2 infections.The infectiousness and pathogenicity of the variants altered remarkably due to mutations in the genome on S protein of the mutant strains,and these emerging variants are more likely to evade immunity and were more infectious than the previous prevalent variants.During the process of combating with the constantly emerging novel variants,drugs showed various effects on treatment of diseases caused by different variants.New drugs and treatment coun-termeasures are constantly updated with the prevalence of various variants.The current status of research on pres-ent drugs for treatment of SARS-CoV-2 and the therapeutic effects on emerging variants are reviewed in the article so as to provide reference for prevention and treatment of the upcoming evolved variants.

Objective·To evaluate the relationships between disc-condyle distance and anterior disc displacement,as well as between disc-condyle distance and disc morphology,in patients with temporomandibular disorders(TMD)using magnetic resonance imaging(MRI)of the temporomandibular joint(TMJ).Methods·From September 2023 to March 2024,90 patients(180 TMJs)who visited the TMJ clinic of Department of Stomatology,The Second Affiliated Hospital of Anhui Medical University,with clinical symptoms of TMD and were diagnosed via MRI with either anterior disc displacement or no significant displacement,were included.Clinical data were collected,and MRI images were used to measure the angle of disc displacement,disc-condyle distance,disc length,and thickness.The degree of disc deformation was assessed.The relationships between clinical symptoms and anterior disc displacement,between anterior disc displacement and both disc morphology and disc-condyle distance,and between disc-condyle distance and disc morphology were analyzed.Results·Among the 90 patients,there were 16 males and 74 females,with a mean age of(28.1±14.5)years.Among the 180 TMJs,175 had clinical symptoms and 5 were asymptomatic.There were 40 joints with no displacement,78 with reducible anterior disc displacement,and 62 with irreducible anterior disc displacement.In the joints with irreducible anterior disc displacement,the proportion of those with two or more symptoms was slightly higher at 62.9%,but the difference was not statistically significant compared with the joints with no displacement or reducible anterior disc displacement.MRI assessment revealed that in the joints with irreducible anterior disc displacement,the proportion of disc deformation type Ⅲ or higher was significantly higher compared with the non-displaced joints(P<0.001).The disc length was significantly shorter(P<0.001),and the intermediate zone thickness was significantly greater(P<0.001)compared with the non-displaced joints.The disc displacement angles at centric closure and maximum opening were also significantly larger(P<0.001).The disc-condyle distance was 3.10(2.70,3.70)mm for non-displaced joints,3.40(3.00,4.00)mm for joints with reducible anterior disc displacement,and 6.60(4.78,7.90)mm for joints with irreducible anterior disc displacement,with significant differences(P<0.001).The disc-condyle distance was 3.10(2.80,3.60)mm for type Ⅰ discs,3.70(3.10,4.60)mm for type Ⅱ discs,5.10(4.00,7.30)mm for type Ⅲ discs,and 6.80(4.98,8.20)mm for type Ⅳ/Ⅴ discs,with significant differences(P<0.001).The disc-condyle distance was negatively correlated with disc length(rs=-0.469,P<0.001),positively correlated with intermediate zone thickness(rs=0.319,P<0.001),and positively correlated with disc displacement angle at centric closure(rs=0.626,P<0.001).Conclusion·With increasing severity of disc deformation,intermediate zone thickness,and disc displacement angle at centric closure,as well as decreasing disc length,the disc-condyle distance increases.The disc-condyle distance is an important indicator for MRI assessment of pathological changes in TMD.

Objective This study aims to conduct a comprehensive analysis of the domestic and international standards for prefilled syringes to advance the scientific and international alignment of China's PFS standard system.Methods A thorough review of the framework,scope,and quality control key points of the 2015 national pharmaceutical packaging material standards(abbreviated as YBB standards),the ISO 11040 international standard system and the United States Pharmacopeia standard system was conducted.Comparative analysis was employed to reveal the similarities and differences among the three,thereby uncovering the unique characteristics of each.Results The YBB standards emphasize quality control for prefilled syringes,offering clear and operational guidelines that provide companies with precise directives for production and testing.However,the scope of these standards is relatively limited.ISO standards apply to a wide range of products,featuring comprehensive coverage and a degree of flexibility.They emphasize the universality of products and compatibility with other international standards,which facilitates global production and trade.USP includes several chapters related to prefilled syringes but lacks a certain level of specificity and systematic approach.Conclusion By thoroughly studying and drawing upon the quality control philosophies,standard frameworks,and key control points of prefilled syringes from both domestic and international standards,we aim to provide valuable references for the development of a robust prefilled syringe standard system within the Chinese Pharmacopoeia.

Objective This study aims to comprehensively analyze the overall framework and key quality attributes of the proposed standard system for prefilled syringes through key clause analysis.Methods Based on a thorough understanding of market product conditions and the current status of domestic and international standards;the critical quality attributes of pre-filled syringe container systems were identified.Results A new standard system for prefilled syringes was constructed to meet the regulatory and industry development needs of China.Conclusions The proposed standard system for prefilled syringes is designed with both rigidity and flexibility,meeting regulatory needs and facilitating industry development.

Thousands of variant gene sequences of SARS-CoV-2 have been emerged since the COVID-19 epidemic broke out in Dec.2019.Alpha(B.1.1.7),Beta(B.1.351),Gamma(P.1),Delta(B.1.617.2)and Omicron(B.1.1.529)were the most representative variants.With the continuous emergence of new variants,the predomi-nant strain in the global pandemic as of Jan.2025 is the Omicron BA.2.86-derived mutant,JN.1.The effectiveness of drugs against Omicron variants remains a key research focus in the treatment of SARS-CoV-2 infections.The infectiousness and pathogenicity of the variants altered remarkably due to mutations in the genome on S protein of the mutant strains,and these emerging variants are more likely to evade immunity and were more infectious than the previous prevalent variants.During the process of combating with the constantly emerging novel variants,drugs showed various effects on treatment of diseases caused by different variants.New drugs and treatment coun-termeasures are constantly updated with the prevalence of various variants.The current status of research on pres-ent drugs for treatment of SARS-CoV-2 and the therapeutic effects on emerging variants are reviewed in the article so as to provide reference for prevention and treatment of the upcoming evolved variants.

Objective·To evaluate the relationships between disc-condyle distance and anterior disc displacement,as well as between disc-condyle distance and disc morphology,in patients with temporomandibular disorders(TMD)using magnetic resonance imaging(MRI)of the temporomandibular joint(TMJ).Methods·From September 2023 to March 2024,90 patients(180 TMJs)who visited the TMJ clinic of Department of Stomatology,The Second Affiliated Hospital of Anhui Medical University,with clinical symptoms of TMD and were diagnosed via MRI with either anterior disc displacement or no significant displacement,were included.Clinical data were collected,and MRI images were used to measure the angle of disc displacement,disc-condyle distance,disc length,and thickness.The degree of disc deformation was assessed.The relationships between clinical symptoms and anterior disc displacement,between anterior disc displacement and both disc morphology and disc-condyle distance,and between disc-condyle distance and disc morphology were analyzed.Results·Among the 90 patients,there were 16 males and 74 females,with a mean age of(28.1±14.5)years.Among the 180 TMJs,175 had clinical symptoms and 5 were asymptomatic.There were 40 joints with no displacement,78 with reducible anterior disc displacement,and 62 with irreducible anterior disc displacement.In the joints with irreducible anterior disc displacement,the proportion of those with two or more symptoms was slightly higher at 62.9%,but the difference was not statistically significant compared with the joints with no displacement or reducible anterior disc displacement.MRI assessment revealed that in the joints with irreducible anterior disc displacement,the proportion of disc deformation type Ⅲ or higher was significantly higher compared with the non-displaced joints(P<0.001).The disc length was significantly shorter(P<0.001),and the intermediate zone thickness was significantly greater(P<0.001)compared with the non-displaced joints.The disc displacement angles at centric closure and maximum opening were also significantly larger(P<0.001).The disc-condyle distance was 3.10(2.70,3.70)mm for non-displaced joints,3.40(3.00,4.00)mm for joints with reducible anterior disc displacement,and 6.60(4.78,7.90)mm for joints with irreducible anterior disc displacement,with significant differences(P<0.001).The disc-condyle distance was 3.10(2.80,3.60)mm for type Ⅰ discs,3.70(3.10,4.60)mm for type Ⅱ discs,5.10(4.00,7.30)mm for type Ⅲ discs,and 6.80(4.98,8.20)mm for type Ⅳ/Ⅴ discs,with significant differences(P<0.001).The disc-condyle distance was negatively correlated with disc length(rs=-0.469,P<0.001),positively correlated with intermediate zone thickness(rs=0.319,P<0.001),and positively correlated with disc displacement angle at centric closure(rs=0.626,P<0.001).Conclusion·With increasing severity of disc deformation,intermediate zone thickness,and disc displacement angle at centric closure,as well as decreasing disc length,the disc-condyle distance increases.The disc-condyle distance is an important indicator for MRI assessment of pathological changes in TMD.

To provide an in-depth interpretation of the background and rationale behind the development of the standard for plastic bottle systems and components for eye drops as outlined in the 2025 edition of the Pharmacopoeia of the People's Republic of China(referred as the Chinese Pharmacopoeia),to facilitate stakeholders thorough understanding of the standard content,and to offer a strong support for its subsequent smooth implementation.Starting from the background of standard construction,an in-depth exploration was conducted into the quality control requirements for plastic bottle systems and components used for eye drops,and a detailed analysis was provided of the logic and rationale behind the establishment of quality control items.Related parties should develop product quality standards based on the general requirements of the guidelines for plastic materials and containers used in pharmaceutical packaging,taking into account the specific characteristics and practical application scenarios of plastic bottle systems and components for eye drops.The standard for plastic bottle systems and components for eye drops in the 2025 edition of the Chinese Pharmacopoeia are more scientific and flexible,which will help improve the quality of eye drop products in our country while also promoting innovation and development in the eye drop packaging industry.

Objective To formulate the drug packaging material method standards in the 2025 edition of the Pharmacopoeia of the People's Republic of China(referred to as the"Chinese Pharmacopoeia"),to develop the method for the determination of extractable tungsten for prefilled syringes,and to interpret the content of the method to provide guidance and help for its subsequent implementation.Methods The formulation process of"Determination of Extractable Tungsten for Prefilled Syringes"was described.Combining the current domestic and foreign relevant standards,the extraction conditions of samples were explored and verified,and the determination methods of inductively coupled plasma optical emission spectrometer(ICP-OES)and inductively coupled plasma mass spectrometer(ICP-MS)were verified.Results A method was established for extracting tungsten from glass prefilled syringes utilizing water and 0.01 mol·L-1 sodium hydroxide solution as extraction media,respectively,at 75 ℃ through ultrasound.The dissolution amount of tungsten was determined by inductively coupled plasma opticalemission spectrometry(ICP-OES)and inductively coupled plasma mass spectrometry(ICP-MS).Among them,the extraction using 0.01 mol·L-1 sodium hydroxide solution as the extraction medium is a stricter and acceptable alternative approach.Conclusion According to the quality control requirements of products,corporations can choose the appropriate extraction medium according to the method in this standard for the determination of tungsten dissolution in the prefilled syringes.

To provide an in-depth interpretation of the background and rationale behind the development of the standard for plastic bottle systems and components for eye drops as outlined in the 2025 edition of the Pharmacopoeia of the People's Republic of China(referred as the Chinese Pharmacopoeia),to facilitate stakeholders thorough understanding of the standard content,and to offer a strong support for its subsequent smooth implementation.Starting from the background of standard construction,an in-depth exploration was conducted into the quality control requirements for plastic bottle systems and components used for eye drops,and a detailed analysis was provided of the logic and rationale behind the establishment of quality control items.Related parties should develop product quality standards based on the general requirements of the guidelines for plastic materials and containers used in pharmaceutical packaging,taking into account the specific characteristics and practical application scenarios of plastic bottle systems and components for eye drops.The standard for plastic bottle systems and components for eye drops in the 2025 edition of the Chinese Pharmacopoeia are more scientific and flexible,which will help improve the quality of eye drop products in our country while also promoting innovation and development in the eye drop packaging industry.

Objective To formulate the drug packaging material method standards in the 2025 edition of the Pharmacopoeia of the People's Republic of China(referred to as the"Chinese Pharmacopoeia"),to develop the method for the determination of extractable tungsten for prefilled syringes,and to interpret the content of the method to provide guidance and help for its subsequent implementation.Methods The formulation process of"Determination of Extractable Tungsten for Prefilled Syringes"was described.Combining the current domestic and foreign relevant standards,the extraction conditions of samples were explored and verified,and the determination methods of inductively coupled plasma optical emission spectrometer(ICP-OES)and inductively coupled plasma mass spectrometer(ICP-MS)were verified.Results A method was established for extracting tungsten from glass prefilled syringes utilizing water and 0.01 mol·L-1 sodium hydroxide solution as extraction media,respectively,at 75 ℃ through ultrasound.The dissolution amount of tungsten was determined by inductively coupled plasma opticalemission spectrometry(ICP-OES)and inductively coupled plasma mass spectrometry(ICP-MS).Among them,the extraction using 0.01 mol·L-1 sodium hydroxide solution as the extraction medium is a stricter and acceptable alternative approach.Conclusion According to the quality control requirements of products,corporations can choose the appropriate extraction medium according to the method in this standard for the determination of tungsten dissolution in the prefilled syringes.