[Objective] To establish a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection. [Methods] By adding the sample and factor Ⅶ deficient plasma to the sample cup and activating the reaction with prothrombin time assay reagent (PT reagent), the coagulation time of the sample was determined by the change in magnetic bead swing amplitude in the sample cup. The logarithm of coagulation time was inversely proportional to the logarithm of human factor Ⅶa potency. [Results] Under the experimental conditions, the specificity of the methodology was evaluated through spiked recovery, and the recovery rates ranged from 90.0% to 110.0%. Within the range from 0.125 to 1.000 IU/mL, there was a good linear response between the potency and coagulation time of the standard and sample, with correlation coefficients r>0.99. As for the accuracy and repeatability, the recovery rates of various concentrations detected in the stock solution were 101.0%, 100.0% and 112.0%, respectively, with RSD values of 2.6%, 4.0% and 0.0%, respectively. The recovery rates of various concentrations in finished product testing were 104.0%, 94.7% and 112.0%, respectively, with RSD values of 1.9%, 2.4% and 0.0%, respectively. As for the intermediate precision, the RSD were 4.5% and 3.7%, respectively. After treated with sample diluent, the sample was tested at room temperature for 6 hours and still exhibited relatively stable biological activity. [Conclusion] This detection method is accurate, stable, easy to operate and highly automated, and is suitable for detecting the potency of recombinant human coagulation factor Ⅶa for Injection.

Objective To comprehensively compare the quality and filtration efficiency of medicinal maltose between two domestic manufacturers(B,C)and one foreign manufacturer(A),compare their product quality as an excipient for in-travenous immunoglobulin(IVIG),so as to determine the feasibility and substitutability of maltose as an excipient for IVIG from different manufacturers.Methods Quality inspection and comparison of maltose from different manufacturers,small-scale filtration tests,and product quality comparision of IVIG(pH4)were conducted.Results The comparis on results showed that there was no significant difference in the quality of medicinal maltose between manufacturer B and A,and there was no significant difference in the quality of IVIG(pH4)produced.The quality of manufacturer C did not meet the require-ments.Conclusion There is no significant difference in the quality of medicinal maltose produced by manufacturer B and A,which can be used for the production of IVIG(pH4).

Objective To study the quality comparability of human coagulation factor Ⅷ(FⅧ)produced before and after the change of factory site.Methods A comparative study was carried out on quality quantitative indexes,related im-purities and stability data of FⅧ produced before and after the change of factory site.Results The FⅧ quantitative quality before and after the change of factory site all met the quality standard,and the related impurities including aluminum resi-due,tributyl phosphate residue,polysorbate 80 residue and PEG residue all met the quality standard.Other impurities in-cluding human fibrinogen,fibronectin,plasminogen,IgA,IgM and IgG were extremely low in content and equivalent in quality.The content of VWF(von Willebrand factor)had no obvious change before and after the change of factory site,but was significantly higher than that of other domestic manufacturers'commercial products.The results of accelerated stability and long-term stability tests showed that the titer of FⅧ fluctuated within the methodological error range,and the results all met the quality standard.Conclusion The change of factory site of FⅧ has no effect on the quality.

Objective:To evaluate the effect of workshop-based incontinence associated dermatitis (IAD) training course for geriatric nurse specialists, and to provide references and evidence for the application of workshop teaching model in specialized nursing training.Methods:The convenience sampling method was used to select 40 participants in the 9th Chongqing Geriatric Nurse Specialist Training Program in May 2021 as the intervention group, and IAD training was conducted using the workshop method. The 42 participants in the 8th Chongqing Geriatric Nurse Specialist Training Program in May 2020 were selected as the control group, who received IAD training through traditional teaching methods. After the training, the achievement of teaching objectives and teaching satisfaction were compared between the two groups using questionnaire survey, and IAD nursing knowledge and attitudes were compared using scales. SPSS 27.0 was used for the t-test and chi-square test. Results:The questionnaire survey showed that the intervention group achieved higher teaching objectives in all dimensions compared to the control group ( P<0.05). Compared with the control group, the intervention group had higher scores in teaching satisfaction regarding teaching format, interest in learning, practical skills, theoretical understanding, integration of theory and practice, and problem-solving abilities ( P<0.05). Compared with the control group, the intervention group demonstrated significantly higher scores in IAD nursing knowledge [(11.32±1.56) vs. (9.02±2.26), P<0.05] and attitudes [(37.63±3.54) vs. (32.81±2.97), P<0.05]. Conclusions:The workshop training has been highly recognized by the trainees, contributing to improved implementation effectiveness of teaching, enhancing the scores of IAD nursing knowledge and attitudes. This approach offers a new perspective for training with a practical focus in the specialized nursing field.

Objective:To investigate the application effect of virtual simulation combined with flipped classroom in experimental teaching of the nursing care of falls in the elderly.Methods:The 497 nursing undergraduates in the class of 2019 in Chongqing Medical University were selected as subjects and were then divided into control group (two classes with 251 students) and intervention group (two classes with 246 students). The students in the control group received traditional experimental teaching, and those in the intervention group received blended experimental teaching with virtual simulation combined with flipped classroom. At the end of the course, the use of virtual simulation platform was analyzed for the students in the intervention group, and a questionnaire survey and theoretical examination were used to compare the effect of experimental teaching between the two groups. SPSS 27.0 was used for the t-test and the chi-square test. Results:The frequency of use of the virtual simulation platform was (2.65±1.38) times per person in the intervention group, with an online learning time of 54.12-147.32 minutes. The questionnaire survey showed that compared with the control group, the intervention group had significantly higher scores of the achievement of teaching objectives and teaching satisfaction ( P<0.05). Compared with the control group after teaching, the intervention group had significantly higher scores of teaching promotion in terms of stimulating learning interest, cultivating self-learning ability, developing clinical thinking ability, improving innovation, and enhancing health education ability ( P<0.05). The intervention group had a significantly higher theoretical examination score than the control group [(79.38±5.09) vs. (77.88±4.97), P<0.05]. Conclusions:In the blended experimental teaching of the nursing care of falls in the elderly, virtual simulation combined with flipped classroom can help students master related knowledge and skills and cultivate their self-learning ability, clinical thinking ability, innovation ability, and health education ability.

Long-term care is a long-term guarantee mechanism to meet the care needs of the old adults and ensure the quality of life. Among them, the professionalism and stability of the care team is a key factor to ensure the development of long-term care work. This paper analyzes the possible reasons for slow development of time bank with volunteers as the main body in the process of localization, and constructs a new model of diversified caring bank from the construction of care team, so as to promote the high-quality and sustainable development of long-term care in China.

Objective:To explore the elements of the diversified caring bank based on long-term care insurance system to provide a basis for the construction of diversified caring bank framework system.Methods:The phenomenological research method was adopted to conduct semi-structured interviews with 15 nursing management personnel in pension institutions in Suzhou and Suzhou long-term care insurance policy implementation management personnel in March to May 2021. NVivo 11 was used to manage interview data, and applied Colaizzi 7-step analysis to conduct inductive analysis and extract the themes.Results:The elements of the diversified caring bank based on long-term care insurance system were divided into three main modules: diversified caring personnel, diversified caring content and diversified incentive measures. The diversified caring personnel module included full-time and part-time caring personnel. Diversified caring content included six elements: daily life assistance, professional life caring, professional medical caring, communication and emotional support, emergency caring and special disease caring. Diversified incentive measures module included two elements: labor currency and "benefit" care currency.Conclusions:The diversified caring personnel provides continuous power for disabled caring; diversified caring content provides ways to meet the various needs of the disabled elderly; diverse incentives are effective ways to attract and stabilize the caring workforce.

【Objective】 To establish and optimize a method for the determination of aluminum (Al) residue by inductively coupled plasma mass spectrometry (ICP-MS). 【Methods】 Nitric acid solution was used to treat samples and standards. The concentration of nitric acid solution and equipment parameters were optimized, and the specificity, linearity, repeatability, accuracy, detection limit, quantitative limit and intermediate precision of the optimized detection method were investigated to confirm whether it was suitable for the determination of Al residue in human serum albumin. 【Results】 The concentration of nitric acid was 5%, and digest time was 4 h. The equipment condition of ICP-MS was as follows: RF power: 1600 W, sampling depth: 10 mm, atomizer / carrier gas flow rate: 1.0 L/ min, compensation flow rate: 0.5 L/ min, experimental mode: standard mode, integration time: 0.2 s, data acquisition: 3 times. Specificity: The recoveries of Al: 92% (high concentration, RSD=3.5%), 98% (low concentration, RSD=4.9%). Linearity: In the range of (0~40) μg/L, the correlation coefficient between concentration and optical energy signal (CPS) of standard / sample were higher than 0.999 0. Accuracy/ Repeatability: The recoveries of sample (3 concentration): 108% (RSD=4.7%), 110% (RSD=4.9%) and 110% (RSD=2.8%). The detection limit was 0.006 μg/L, and the quantitation limit was 0.019 μg/L. Intermediate precision: personnel factor and date factor, P>0.05, RSD (12 times)=2%. Comparison between ICP-MS and atomic absorption spectrometry (AAS): the deviation between ICP-MS and AAS was 8%, and that of samples was 3%, with no significant difference noticed between the two methods. 【Conclusion】 After optimization, ICP-MS method has shown good performance in terms of specificity, linearity, repeatability, accuracy, detection limit, quantitative limit and intermediate precision, and is suitable for the determination of Al residue in human albumin products of our company.

【Objective】 To investigate the matrix effect on the determination of potency in Recombinant Human Coagulation Factor Ⅷ for Injection (rFⅧ). 【Methods】 Two different detection matrices were used to establish two methods for detecting the potency in Recombinant Human Coagulation Factor Ⅷ for Injection. And the matrix effect on the determination of potency was determined, including specificity, linearity, repeatability, accuracy and intermediate precision. 【Results】 As to the specificity, the recoveries of the two substrates at high vs low concentration level were 112% and 110% vs 104% and 109%, respectively. As to the linearity, in the range of (0.125-1.000) IU/mL, the correlation coefficient between concentration and coagulation time of standard/ sample was higher than 0.99. As to the accuracy/repeatability, the recoveries of two matrices was 104% and 102%, and RSD was 2.4% and 1.9%. As to the intermediate precision, personnel factor of two matrices was 0.72 and 0.23, date factor was 0.79 and 0.85, and RSD(for 12 times) was 4.2% and 3.0%. Comparison of two matrices was as follows: Deviation in test results of 6 batches of rFⅧ was all lower than 5%. There was no significant difference between two matrices. 【Conclusion】 The two matrices for potency detection show good performance including specificity, linearity, repeatability, accuracy, and intermediate precision. They are suitable for the determination of potency in rFⅧ products.

【Objective】 To improve method for determinating of biological potency of IgG Fc fragment in Chinese Pharmacopoeia and establish a method which is suitable for enzyme-labeled instrument. 【Methods】 The biological properties of FC fragment of IVIG in Chinese Pharmacopiea(General 3514) was adjusted, including sensitization process, sample treatment and dynamic curve parameters. Meanwhile, the kinetic curve of hemolysis was fitted with Origin, which made the method more suitable for enzyme plate. The biological properties of Fc fragment of IVIG was calculated by kinetics curve reaction of reference and sample. 【Results】 The method are stable, the RSD of repeatability and intermediate is 10%, also with significant improvement in efficiency. 【Conclusion】 The detection of properties of Fc fragment of IVIG is stable and efficient, it can be used for properties of Fc fragment of IVIG.