Following the release of the Technical Requirements on Quality Control and Standard Establishment of Traditional Chinese Medicine Formula Granules by the National Medical Products Administration in 2021, Chinese Pharmacopoeia Commission has promulgated 296 national drug standards so far, and most provinces have started the work of establishing provincial standards as supplements. The promulgation of standards fostered high-quality development of the industry. Since the implementation of national and provincial standards for more than three years, enterprises have gained deep understanding and hands-on experiences on the characteristics, technical requirements, production process, and quality control of traditional Chinese medicine(TCM) formula granules. Meanwhile, challenges have emerged restricting the high-quality development of this industry, including how to formulate quality control strategies for medicinal materials and decoction pieces, how to reduce manufacturing costs, and how to improve the pass rate and product stability under high standards. Based on the work experiences from standard management and process research, this article analyzed the distribution of sources, processing methods, dry extract rate ranges, process requirements for volatile oil-containing decoction pieces, control measures of safety indices, characteristics and trends of setting characteristic chromatograms or fingerprints, characteristics and trends of setting content ranges, and main differences between national standards and provincial standards. On the one hand, this article aims to present main characteristics for deeply understanding different indicators in standards and provide basic ideas for establishing quality and process control systems. On the other hand, from the perspective of industrial practice, suggestions are put forward on the important aspects that need to be focused on in the quality and process control of TCM formula granules.
Drugs, Chinese Herbal/chemistry* ; Quality Control ; Medicine, Chinese Traditional/standards* ; China ; Drug Industry/standards*

Objective To analyze the caregiver presence needs and their influencing factors among hospitalized elderly non-surgical patients and provide a basis for formulating relevant policies.Methods A descriptive qualitative study method was adopted.Through purposive sampling,semi-structured interviews were conducted on elderly non-surgical patients and their families and medical staff in Peking Union Medical College Hospital from September to October 2023.MAXQDA 2020 and the 7-step phenomenological analysis method of Colaizzi were used to classify and code the interview contents and identify themes.Results The categories of caregiver presence needs of elderly non-surgical patients included basic living assistance needs,disease monitoring needs,psychological support needs,as well as the needs for family members to provide economic support and participate in treatment decision-making.The influencing factors included advanced age,frailty,the lack of self-care ability in patients with comorbidities,the susceptibility of patients to sudden situations during the disease exacerbation period,the increased risk of unexpected events in patients with psychological distress,and patients' concerns about social support and medical decision-making.Conclusion The caregiver presence needs of elderly non-surgical patients during hospitalization are high and influenced by multiple factors.
Humans ; Caregivers/psychology* ; Aged ; Hospitalization ; Social Support ; Male ; Qualitative Research ; Female

Y chromosome microdeletions are an important cause of male infertility. At present, research on the Y chromosome is mainly focused on analyzing the loss of large segments of the azoospermia factor a/b/c (AZFa/b/c) gene, and few studies have reported the impact of unit point deletion in the AZF band on fertility. This study analyzed the effect of sperm quality after sY1192 loss in 116 patients. The sY1192-independent deletion accounted for 41.4% (48/116). Eight patterns were found in the deletions associated with sY1192. The rate of sperm detection was similar in the semen of patients with the independent sY1192 deletion and the combined sY1192 deletions (52.1% vs 50.0%). The patients with only sY1192 gene loss had a higher probability of sperm detection than the patients whose sY1192 gene locus existed, but other gene loci were lost (52.1% vs 32.0%). The hormone levels were similar in patients with sY1192 deletion alone and in those with sY1192 deletion and other types of microdeletions in the presence of the sY1192 locus. After multiple intracytoplasmic sperm injection (ICSI) attempts, the pregnancy rate of spouses of men with sY1192-independent deletions was similar to that of other types of microdeletions, but the fertilization and cleavage rates were higher. We observed that eight deletion patterns were observed for sY1192 microdeletions of AZFb/c, dominated by the independent deletion of sY1192. After ICSI, the fertilization rate and cleavage rate of the sY1192-independent microdeletion were higher than those of other Y chromosome microdeletion types, but there was no significant difference in pregnancy outcomes.
Humans ; Female ; Pregnancy ; Male ; Chromosomes, Human, Y/genetics* ; Adult ; Chromosome Deletion ; Pregnancy Outcome/genetics* ; Infertility, Male/genetics* ; Spermatozoa/physiology* ; Semen Analysis ; Sex Chromosome Disorders of Sex Development/genetics* ; Sperm Injections, Intracytoplasmic ; Azoospermia/genetics* ; Sex Chromosome Aberrations

Objective: To study the correlation between short sleep duration and screening myopia among primary and middle school students in Beijing, so as to provide a scientific basis for the comprehensive prevention and control of myopia among students. Methods: Using a stratified cluster random sampling, 25 593 primary and middle school students from 16 districts of Beijing were selected from September to November 2023. The National Common Diseases and Health Influencing Factors Monitoring Survey Questionnaire was used to conduct a questionnaire survey, and visual acuity was tested according to the Specification for the Screening of Refractive Error in Primary and Middle School Students. The reporting rates of short sleep duration and detection rates of screening myopia among primary and middle school students were compared using the Chi square test. Binary Logistic regression was used to analyze the correlation between short sleep duration and screening myopia. Results: About 68.63% of students reported short sleep duration. There was a statistically significant difference in the reporting rate of short sleep duration among students in different school stages ( χ 2=981.18, P <0.01), with the lowest reporting rate of vocational high school students (47.07%) and the highest reporting rate of ordinary high school students (76.17%). The detection rates of screening myopia among primary school students ( 57.09% ) and middle school students (76.53%) who reported short sleep duration were higher than those who reported enough sleep duration (52.65%, 71.94%), with satistically significant differences ( χ 2=14.83, 17.96, P <0.01). The results of binary Logistic regression analysis showed that primary and middle school students with short sleep duration had a higher risk of developing screening myopia, compared to students with enough sleep duration ( OR =1.25); after adjusting for confounding factors such as educational stage, gender, region, boarding situation, primary and secondary school students with short sleep duration still had a higher risk of screening myopia ( OR =1.26) ( P <0.01). The analysis results stratified by educational stage showed that primary school students from grades 4-6 and middle school students with short sleep duration had a higher risk of screening myopia ( OR=1.18, 1.20, P <0.01). Conclusions Primary and secondary school students in Beijing with short sleep duration sleep have a higher risk of developing screening myopia. Families, schools, and society should ensure enough sleep duration to reduce the occurrence of myopia among students.

Objective To explore the application value of fractional anisotropy(FA)analysis of RGB component transformation in different directions of fibers in substantia nigra in Parkinson's disease(PD).Methods There were 35 cases of PD and 37 cases of normal control group.After being performed by brain diffusion tensor imaging(DTI)scanning,the sequence was imported into 3DSlicense 5.6.0,and the diffusion module was used to implement pseudo color mapping based on FA,locate and segment substantia nigra,and use the substantia nigra mask as the tracking starting point.After forming tracing,fibers were imported into DTIANALYSIS 1.51,converting the RGB components into FA values for analysis,and visualized the analysis result.At the same time,fiber length,fiber density,and segmented FA point cloud percentage were compared.Results Compared with the normal group,the length of substantia nigra fibers in the PD group was shorter[(95.14±19.85)mm vs(115.99±21.39)mm,P＜0.01],and there was a statistical difference between the two groups.There was no statistical difference in fiber density[(0.07±0.05)/mm3 vs(0.10±0.12)/mm3,P＞0.05]between control group and PD group.The percentage of FA segment point clouds in the PD group was lower than that in the normal group at 0.9-1,but the principal component characteristics of the point cloud ratios in each FA segment were not significant.Conclusion Based on the transformation of RGB components into FA analysis,the length,density,and FA values of substantia nigra nerve fibers in PD patients can be quantified and visualized,providing a basis for the study of PD neural pathways.

Objective To compare the differences in exosomes derived from testicular tissue between WT(wild type)mice and sdy mice with dysbindin-1(dystrobrevin binding protein 1)deletion mutations,and identify their protein components to explore the possible role of dysbindin-1 in the formation of exosomes derived from mouse testicular tissue.Methods The exosomes derived from mouse testicular tissue of WT and sdy mice were isolated by sucrose ultracentrifugation method.The expression of exosomes proteins was analyzed by Western blotting,the morphology of exosomes was observed by negative staining under transmission electron microscope(TEM),the particle size and distribution were analyzed by dynamic light scattering particle size analyzer,and the protein contents of exosomes were detected by mass spectrometry analysis.CD63+exosomes were obtained by immunoprecipitation with magnetic beads.Krt5(keratin5)protein was selected for validation.Results Dysbindin-1 deletion did not affect the morphology and quantity of exosomes,but decreased the expression of CD63,a marker of exosomes.Compared with the WT mice,there were 159 proteins that were highly expressed,209 proteins that were lowly expressed,and 184 proteins that were specifically expressed in the exosomes derived from sdy mice testicular tissue.In this experiment,CD63+exosomes from testicular tissue were obtained and 12 proteins were screened.There was indeed an interaction between krt5 protein and dysbindin-1.Interestingly,it was found that the expression of krt5 in the exosomes derived from sdy mice testicular tissue decreased after dysbindin-1 deletion.Conclusion After dysbindin-1 deletion,the morphology and quantity of exosomes derived from mouse testicular tissue are not affected,but dysbindin-1 may affect the types and content of exosomal proteins,by affecting the transport of exosome proteins through protein interactions.

Objective To explore the effects of pretreatment with rehmannia glutinosa polysaccharide(RGP)and basic fibroblast growth factor(FGF-2)alone or in combination on the differentiation of bone marrow mesenchymal stem cells(BMSCs)into cardiomyoid cells and the related mechanisms.Methods BMSCs pretreated with FGF-2 and RGP alone or in combination were cultured for 1,2,and 4 weeks.The expression levels of NKx2.5 and GATA-4 were detected by Real-time PCR.BMSCs pretreated with FGF-2 or RGP alone and PI3K/Akt signaling pathway inhibitor LY294002 were used to detect the expression levels of myocardial specific proteins and related pathway proteins by Western blotting.Results Compared with the blank control group,pretreatment with FGF-2 or RGP alone increased the expression rate of myocardial specific markers,and the effect of combined pretreatment with FGF-2 and RGP was more obvious(P＜0.05).Compared with pretreatment with FGF-2 or RGP alone,pretreatment with LY294002 combined with FGF-2 or RGP significantly down-regulated the expression of cardiac-specific proteins in BMSCs and inhibited the phosphorylation of Akt(P＜0.05).Conclusion Both FGF-2 and RGP can induce BMSCs to differentiate into cardiomyocyte-like cells by regulating PI3K/Akt signaling pathway,and the combination of FGF-2 and RGP has a better inductive effect.

Parabacteroides distasonis is a gram-negative bacterium initially isolated from a clinical specimen in the 1930s. The strain was re-classified to form the new genus Parabacteroides in 2006. P. distasonis can regulate intestinal barrier function and plays a key role in immune response and metabolic regulation of bodies. Traditional Chinese medicine(TCM) is closely related to the intestinal microbiota. Polysaccharides, saponins, and other ingredients of TCM can treat diseases by interacting with P. distasonis, but the specific mechanisms underlying these processes are still unclear, requiring further exploration. This study reviewed the roles and related mechanisms of P. distasonis in inflammatory-immune diseases, metabolic diseases, cardiovascular disease, neuropsychiatric diseases, cancer, and other diseases and summarized the relevant research results of TCM to prevent and treat diseases by regulating P. distasonis. This study provides a reference for subsequent exploration of P. distasonis and research on the interaction between TCM and intestinal microbiota.
Humans ; Gastrointestinal Microbiome/drug effects* ; Medicine, Chinese Traditional ; Animals ; Bacteroidetes ; Drugs, Chinese Herbal/pharmacology*

Objective: To analyze the status of health risk behaviors among middle school students in Beijing City from 2018 to 2022, in order to provide reference for scientific and effective intervention. Methods: Using multi stage stratified cluster random sampling method,data of student health and associated factors monitoring among 84 712 middle school students from 16 districts of Beijing during 2018 to 2022 were compared regarding the differences of health risk behaviors among students in different groups by Chi quare test. And their change trends were evaluated by annual percentage change (APC). Results: In the five surveys during 2018 to 2022,reporting rates of unhealthy diet, unintentional injury, intentional injury, substance abuse and Internet addiction (only in 2018 and 2020) behaviors were higher in boys than in girls ( χ 2=4.91-297.52, P ＜0.05).Reporting rate of physical inactivity behavior in girls was higher than that in boys ( χ 2=56.49-160.88, P ＜0.05). Reporting rates of unhealthy diet, physical inactivity, unintentional injury (except 2021), substance abuse and Internet addiction (only in 2018 and 2019) behaviors were the highest in vocational high school, followed by general high school, and the lowest in junior middle school ( χ 2=23.30-1 285.98, P ＜0.01). Intentional injury behavior was highest in junior high school, followed by vocational high school, and lowest in general high school ( χ 2=96.18-378.32, P ＜0.01).Reporting rate of Internet addiction (2020-2022) behavior was highest in general high school, followed by vocational high school, and lowest in junior high school ( χ 2=16.93-60.11, P＜0.01). Reporting rates of unhealthy diet, intentional injury (2020 and 2022) and substance abuse (except 2018) behaviors were higher in suburban areas than in urban areas (χ 2=6.70-117.56, P＜0.05). Reporting rates of physical inactivity, unintentional injury, intentional injury (2018 and 2019) and Internet addiction behaviors were higher in urban areas than in suburban areas (χ2=3.90-130.80, P＜0.05). Standardized rates of unintentional injury, intentional injury, substance abuse and Internet addiction behaviors showed a statistically significant downward trend from 2018 to 2022 (APC=-14.16, -13.43, -16.03, -8.48, t =-6.94, -4.46, -11.98, -4.36, P ＜0.05). Conclusions During 2018-2022, unintentional injury, intentional injury, substance abuse and Internet addiction behaviors of middle school students in Beijing City have improved, and the reporting rates of unhealthy diet and physical inactivity behaviors are high and don t show a downward trend. Efforts should be made to strengthen intervention in unhealthy diet and physical inactivity behaviors among middle school students, in order to reduce the occurrence of health risk behaviors.