Objective Exploring the ideas for coordinating the implementation of residual solvent control and ICH Q3C in the Chinese Pharmacopoeia standards for pharmaceutical excipients.Methods The relevant situation of residual solvent control in the current pharmaceutical excipient standards in Chinese pharmacopoeia was analyzed,and the progress of the International Conference on Harmonistion of Human Drug Registration Technology's Guidelines for Residual Solvents(ICH Q3C)and the coordination of foreign pharmacopoeias were compared and were analyzed.Results Proposed a coordination and implementation strategy between the Chinese Pharmacopoeia pharmaceutical excipient standards and ICH Q3C based on the association review mechanism.Conclusions The proposed coordinated implementation plan helps to improve the international integration of Chinese pharmaceutical excipient standard system,enhance the scientific and effective control of residual solvents in pharmaceutical excipients by regulatory authorities and the pharmaceutical industry,and comprehensively promote the translation and implementation of ICH Q3C guiding principles in Chinese pharmaceutical excipient standards.

[Objective] To analyse and predict the tendencies of using erythrocyte blood in Changsha based on the autoregressive integrated moving average (ARIMA) model, long short-term memory (LSTM) and ARIMA-LSTM combination model, so as to provide reliable basis for designing a feasible and effective blood inventory management strategy. [Methods] The data of erythrocyte usage from hospitals in Changsha between January 2012 and December 2023 were collected, and ARIMA model, LSTM model and ARIMA-LSTM combination model were established. The actual erythrocyte consumption from January to May 2024 were used to assess and verify the prediction effect of the models. The extrapolation prediction accuracy of the models were tested using two evaluation indicators: mean absolute percentage error (MAPE) and root mean square error (RMSE), and then the prediction performance of the model was compared. [Results] The RMSE of LSTM model, optimal model ARIMA(1,1,1)(1,1,1)12 and ARIMA-LSTM combination model were respectively 5 206.66, 3 096.43 and 2 745.75, and the MAPE were 18.78%,11.54% and 9.76% respectively, which indicated that the ARIMA-LSTM combination model was more accurate than the ARIMA model and LSTM model, and the prediction results was basically consistent with the actual situation. [Conclusion] The ARIMA-LSTM model can better predict the clinical erythrocyte consumption in Changsha in the short term.

Objective:To explore the stratified treatment plan process for neonatal congenital chylothorax by summarizing its clinical treatment characteristics.Methods:A retrospective analysis was conducted on the clinical data of 36 neonates with congenital chylothorax treated at the Department of Neonatology of Beijing Children's Hospital, Capital Medical University, from January 1, 2010, to December 31, 2021. Based on different treatment methods and initial drainage volumes, the cases were divided into the conservative treatment group [initial drainage volume<20 ml/(kg·d), n=20], octreotide group [initial drainage volume ≥20-<30 ml/(kg·d), n=4], erythromycin group [initial drainage volume ≥30-<50 ml/(kg·d), n=6], and octreotide plus erythromycin group [initial drainage volume≥50 ml/(kg·d), n=6]. The clinical characteristics and treatment effects of the children in different treatment groups, as well as the choice of further treatment plans, were summarized to determine the timing of different treatment methods. A more standardized stratified treatment plan was formulated by combining the literature. Results:Among the 36 cases of congenital chylothorax, 18 cases (50.0%) were diagnosed in utero, with no intrauterine intervention. In the conservative treatment group, 20 cases were treated with respiratory support, thoracic drainage, and nutritional therapy. Except for one case who was discharged after abandoning treatment, the remaining 19 cases were cured. In the octreotide group, four children received continuous intravenous infusion of octreotide at doses ranging from 1 to 10 μg/(kg·h), with three cases improving and one case being cured. No adverse effects such as hypoglycemia, thyroid dysfunction, or neonatal necrotizing enterocolitis occurred. In the group of six children who received intrapleural erythromycin injections, the dosage of erythromycin was 25-30 mg/kg, and the median thoracic drainage volume was reduced to approximately 50% of the pre-treatment volume after 3-5 injections, with four cases improving and two cases being cured. In the group of six children who received octreotide combined with erythromycin, treatment involved the intravenous infusion of octreotide along with intrapleural erythromycin injections. Four cases showed improvement, and two cases were cured. Based on previous treatments and a comprehensive review of the literature, a stratified treatment flowchart with invasiveness ranging from low to high was finally formed. Conclusions:For congenital chylothorax, a stratified treatment approach is recommended based on initial drainage volume and the response to treatment. This approach ranges from conservative treatment to pharmacological treatment (intravenous infusion of octreotide). For children with poor outcomes, surgical treatment (intrapleural erythromycin injection or other surgical interventions) can be added.

Objective Exploring the ideas for coordinating the implementation of residual solvent control and ICH Q3C in the Chinese Pharmacopoeia standards for pharmaceutical excipients.Methods The relevant situation of residual solvent control in the current pharmaceutical excipient standards in Chinese pharmacopoeia was analyzed,and the progress of the International Conference on Harmonistion of Human Drug Registration Technology's Guidelines for Residual Solvents(ICH Q3C)and the coordination of foreign pharmacopoeias were compared and were analyzed.Results Proposed a coordination and implementation strategy between the Chinese Pharmacopoeia pharmaceutical excipient standards and ICH Q3C based on the association review mechanism.Conclusions The proposed coordinated implementation plan helps to improve the international integration of Chinese pharmaceutical excipient standard system,enhance the scientific and effective control of residual solvents in pharmaceutical excipients by regulatory authorities and the pharmaceutical industry,and comprehensively promote the translation and implementation of ICH Q3C guiding principles in Chinese pharmaceutical excipient standards.

Objective:To explore the stratified treatment plan process for neonatal congenital chylothorax by summarizing its clinical treatment characteristics.Methods:A retrospective analysis was conducted on the clinical data of 36 neonates with congenital chylothorax treated at the Department of Neonatology of Beijing Children's Hospital, Capital Medical University, from January 1, 2010, to December 31, 2021. Based on different treatment methods and initial drainage volumes, the cases were divided into the conservative treatment group [initial drainage volume<20 ml/(kg·d), n=20], octreotide group [initial drainage volume ≥20-<30 ml/(kg·d), n=4], erythromycin group [initial drainage volume ≥30-<50 ml/(kg·d), n=6], and octreotide plus erythromycin group [initial drainage volume≥50 ml/(kg·d), n=6]. The clinical characteristics and treatment effects of the children in different treatment groups, as well as the choice of further treatment plans, were summarized to determine the timing of different treatment methods. A more standardized stratified treatment plan was formulated by combining the literature. Results:Among the 36 cases of congenital chylothorax, 18 cases (50.0%) were diagnosed in utero, with no intrauterine intervention. In the conservative treatment group, 20 cases were treated with respiratory support, thoracic drainage, and nutritional therapy. Except for one case who was discharged after abandoning treatment, the remaining 19 cases were cured. In the octreotide group, four children received continuous intravenous infusion of octreotide at doses ranging from 1 to 10 μg/(kg·h), with three cases improving and one case being cured. No adverse effects such as hypoglycemia, thyroid dysfunction, or neonatal necrotizing enterocolitis occurred. In the group of six children who received intrapleural erythromycin injections, the dosage of erythromycin was 25-30 mg/kg, and the median thoracic drainage volume was reduced to approximately 50% of the pre-treatment volume after 3-5 injections, with four cases improving and two cases being cured. In the group of six children who received octreotide combined with erythromycin, treatment involved the intravenous infusion of octreotide along with intrapleural erythromycin injections. Four cases showed improvement, and two cases were cured. Based on previous treatments and a comprehensive review of the literature, a stratified treatment flowchart with invasiveness ranging from low to high was finally formed. Conclusions:For congenital chylothorax, a stratified treatment approach is recommended based on initial drainage volume and the response to treatment. This approach ranges from conservative treatment to pharmacological treatment (intravenous infusion of octreotide). For children with poor outcomes, surgical treatment (intrapleural erythromycin injection or other surgical interventions) can be added.

In the process of promoting the implementation and transformation of the Q3D guideline of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in China, the risk assessment of elemental impurities in naturally sourced excipients often faces challenges such as multiple types of elemental impurities and insufficient detection methods. In this paper, an inductively coupled plasma mass spectrometry (ICP-MS) method for screening 12 elemental impurities in titanium dioxide was established using the optimized acid extraction pre-treatment method. The accuracy and repeatability of the method were good. The recoveries of cadmium, lead, mercury, cobalt, nickel, lithium, barium, molybdenum, copper, chromium and iron were 83.6%−101.6%, the recovery of antimony was 54.1%, and the RSD was 1.1%−10.2% (n=6). The evaluation results of elemental impurities showed that the risk of cadmium, mercury, cobalt, nickel, lithium, barium, molybdenum, copper, chromium and antimony was low, while the risk of lead was high, and it is recommended that a lead salt test be added to the pharmacopoeia standard for this product. Based on the statistical data, the differences in the control levels of elemental impurities and whiteness of 29 batches of titanium dioxide samples from 10 domestic and foreign manufacturers were compared and analyzed. The Pearson correlation coefficient method was used to analyze the correlation between residual elemental impurities and whiteness, and a heat map was used to visualize the results. The results showed that whiteness was significantly negatively correlated with the amount of residual barium and the sum of residual elemental impurities. It is suggested that the manufactures should include whiteness as an internally controlled indicator to further improve the quality of titanium dioxide used as a pharmaceutical excipient.

Objective:To investigate the epidemic distribution and characteristics of brucellosis in Heze City, and to provide a basis for formulating prevention and control measures in the future.Methods:The data of Heze City brucellosis reported from January 1, 2017 to December 31, 2021, were collected from the China Disease Prevention and Control Information System. The epidemiological case questionnaires of brucellosis in Heze City from January 1, 2017 to December 31, 2021 were collected from the centers for disease control and prevention of various cities, counties and districts. Retrospective analysis was used to conduct a descriptive analysis of the distributions, clinical manifestations and epidemiological history 3 weeks prior to the onset of the disease in Heze City from 2017 to 2021.Results:From 2017 to 2021, a total of 1 543 cases of brucellosis were reported in Heze City, with no death. The highest incidence was in 2018 (5.16/100 000). The peak period was from March to June each year (759 cases). There were cases reported in all counties (districts) of the city, and the counties (districts) with more cases were Mudan District (386 cases), Cao County (271 cases), Yuncheng County (251 cases), Shan County (138 cases) and Juye County (132 cases). The minimum age of onset was 11 months, and the maximum was 84 years old, mainly between the ages of 20 to 69 (1 381 cases). The gender ratio between males and females was 2.50 ∶ 1.00 (1 102 ∶ 441). Farmers had the highest incidence of the disease (1 329 cases). Main clinical manifestations were fever, hyperhidrosis, fatigue, muscle and joint soreness. Epidemiological history investigation within 3 weeks before the onset of the disease revealed 1 124 cases of close contact with animals, including 1 044 cases of contact with sheep.Conclusions:From 2017 to 2021, the incidence of brucellosis in Heze City shows a trend of first rising and then decreasing, and the epidemic affects all counties (districts) of the city, mainly middle-aged and elderly men. In the future, it is necessary to strictly control the flow of diseased animals, increase immunization and quarantine, and block the transmission route.

Objective:To summarize the first aid and nursing experience of a patient with upper gastrointestinal bleeding induced by Dieulafoy disease after liver transplantation.Methods:One case with upper gastrointestinal bleeding induced by Dieulafoy disease after liver transplantation was given a series of treatment and nursing measures, including identify bleeding manifestations, providing emergency nursing measures, nutritional support treatment, establishing infection prevention and control system, implementing prone ventilation and pulmonary function rehabilitation, precise immunosuppressive therapy, various forms of psychological care in the First Hospital of Jilin University in November 22, 2021.Results:After 58 d of careful treatment and nursing, the patient recovered and was discharged.Conclusions:Dieulafoy disease is a critical disease, and early diagnosis and targeted first aid and predictive care for liver transplant patients with such diseases are the key to promoting recovery.

Objective:To explore the status quo and influencing factors of death anxiety among middle-aged and young adult patients with chronic heart failure (CHF) .Methods:Totally 176 middle-aged and young adult CHF patients treated at Fuwai Central China Cardiovascular Hospital between January 2021 and February 2023 were selected by convenience sampling and investigated with a general information questionnaire, the Medical Coping Modes Questionnaire (MCMQ), and the Death Anxiety Scale.Results:A total of 176 questionnaires were distributed, with 170 valid responses, yielding an effective response rate of 96.59%. Among the 170 middle-aged and young adult CHF patients, 136 had low death anxiety, while 34 had high death anxiety. Multiple linear regression analysis showed that educational level, per capita monthly family income, duration of illness, cardiac function classification, physical exercise, and coping style (yielding) were influencing factors of death anxiety in middle-aged and young adult CHF patients ( P<0.05) . Conclusions:Death anxiety in middle-aged and young adult CHF patients is primarily associated with educational level, per capita monthly family income, duration of illness, cardiac function classification, physical exercise, and coping style (yielding). Clinical assessments should focus on these factors to provide timely and targeted psychological interventions.

Objective:To establish an inductively coupled plasma-mass spectrometry(ICP-MS)method for the determination of 24 elements in polysorbate 80,and evaluate the results.Methods:The elements were determined by ICP-MS,statistical analysis was conducted using SPSS 26,and the risk assessment was carried out with reference to ICH Q3D guidelines.Results:The standard curves showed good linear relationship in the corresponding concentration range(r=0.997-0.999).The recoveries were 88.81％-134.64％(RSD＜5％,n=6).None of the elements recommended for evaluation exceeded the control threshold.Conclusion:The method is accurate,reliable and easy-to-operate,and the risk of elemental impurities in this sample is low.