At present, the cause of traditional Chinese medicine(TCM) in China has entered a new period of high-quality development. How to strengthen the foundation for the TCM industry from the source is an important issue that deserves the attention of the authorities, industry, and academia. This study systematically analyzed the regulatory system of TCM raw materials and preparations. The study took the TCM industry chain and the product life cycle as a clue and focused on the dimensions of TCM resource protection and plant cultivation(farming), production and quality supervision of TCM raw materials and preparations, and their market access and distribution. It analyzed the current situation of the regulation of TCM raw materials and preparations under the regulatory system of drugs, discussed the main problems, and put forward corresponding suggestions. The results can provide an important reference value for the subsequent improvement of the regulatory system of drugs and the construction of a prominent regulatory system of drugs in accordance with TCM characteristics.
Drugs, Chinese Herbal/economics* ; Medicine, Chinese Traditional/standards* ; China ; Quality Control ; Humans ; Plants, Medicinal/chemistry*

Objective:To explore the clinical features and molecular etiology of a patient with Dent disease due to variant of CLCN5 gene. Methods:A male patient with Dent disease diagnosed at the First Affiliated Hospital of Zhengzhou University in September 2023 was selected as the study subject. Clinical data of the patient were collected. Whole exome sequencing (WES) was carried out for the patient and his family members. Pathogenicity of candidate variant was verified by Sanger sequencing and bioinformatic analysis. This study has been approved by the Medical Ethics Committee of the Hospital (Ethics No. KS-2018-KY-36).Results:The patient, a 15-year-old male, was admitted due to proteinuria and hematuria. Ultrasonography showed diffuse echogenic changes in both kidneys. Renal biopsy revealed structural dysfunction of renal tubules. Electron microscopy revealed minor tubular and glomerular lesions. The patient was found to harbor a hemizygous c. 701dupA (p.Y234Ter) variant of the CLCN5 gene, which was derived from his mother. Based on the guidelines from the American College of Medical Genetics and Genomics (ACMG), the variant was rated as pathogenic (PVS1+ PM2_Supporting). Bioinformatic analysis using multiple software predicted the deleterious effect of the variant. Conclusion:The hemizygous c.701dupA (p.Y234Ter) variant of the CLCN5 gene probably underlay the pathogenesis of Dent disease in this patient. Above finding has enriched the mutational spectrum of the CLCN5 gene.

Objective To investigate the causal relationship between hyperthyroidism and systemic lu-pus erythematosus(SLE).Methods According to the current summary data of genome-wide association studies(GWAS),the screened single nucleotide polymorphism(SNP)was selected as the instrumental varia-bles,hyperthyroidism served as the exposure factor and SLE as the outcome variable,and the Mendelian ran-domization analysis(MR)analysis method was used for conducting the study.Among them,the inverse vari-ance weighting(IVW)was the main MR analysis method,the MR-Egger regression method was used to the test for horizontal pleiotropy,and the sensitivity adopted the leave-one-method test,and the MR results con-ducted the visualized analysis by scatter plot,forest plot and funnel plot.Results Ten valid SNP were screened.In the MR analysis,IVW supported a causal relationship between hyperthyroidism and SLE(OR=1.838,95%CI:1.302-2.593,P<0.001);the MR-egger regression method supported the relationship be-tween hyperthyroidism and SLE(OR=4.070,95%CI:1.961-8.449,P=0.003);in addition,the weighted median method also supported the relationship between hyperthyroidism and SLE(OR=1.685,95%CI:1.238-2.294,P<0.001).Conclusion There appears to be a causal relationship between hyperthyroidism and SLE.

OBJECTIVE: To explore the clinical features and molecular etiology of a patient with Dent disease due to variant of CLCN5 gene. METHODS: A male patient with Dent disease diagnosed at the First Affiliated Hospital of Zhengzhou University in September 2023 was selected as the study subject. Clinical data of the patient were collected. Whole exome sequencing (WES) was carried out for the patient and his family members. Pathogenicity of candidate variant was verified by Sanger sequencing and bioinformatic analysis. This study has been approved by the Medical Ethics Committee of the Hospital (Ethics No. KS-2018-KY-36). RESULTS: The patient, a 15-year-old male, was admitted due to proteinuria and hematuria. Ultrasonography showed diffuse echogenic changes in both kidneys. Renal biopsy revealed structural dysfunction of renal tubules. Electron microscopy revealed minor tubular and glomerular lesions. The patient was found to harbor a hemizygous c.701dupA (p.Y234Ter) variant of the CLCN5 gene, which was derived from his mother. Based on the guidelines from the American College of Medical Genetics and Genomics (ACMG), the variant was rated as pathogenic (PVS1+PM2). Bioinformatic analysis using multiple software predicted the deleterious effect of the variant. CONCLUSION The hemizygous c.701dupA (p.Y234Ter) variant of the CLCN5 gene probably underlay the pathogenesis of Dent disease in this patient. Above finding has enriched the mutational spectrum of the CLCN5 gene.
Adolescent ; Female ; Humans ; Male ; Chloride Channels/genetics* ; Dent Disease/genetics* ; Exome Sequencing ; Mutation ; Pedigree

Objective:To explore the clinical features and molecular etiology of a patient with Dent disease due to variant of CLCN5 gene. Methods:A male patient with Dent disease diagnosed at the First Affiliated Hospital of Zhengzhou University in September 2023 was selected as the study subject. Clinical data of the patient were collected. Whole exome sequencing (WES) was carried out for the patient and his family members. Pathogenicity of candidate variant was verified by Sanger sequencing and bioinformatic analysis. This study has been approved by the Medical Ethics Committee of the Hospital (Ethics No. KS-2018-KY-36).Results:The patient, a 15-year-old male, was admitted due to proteinuria and hematuria. Ultrasonography showed diffuse echogenic changes in both kidneys. Renal biopsy revealed structural dysfunction of renal tubules. Electron microscopy revealed minor tubular and glomerular lesions. The patient was found to harbor a hemizygous c. 701dupA (p.Y234Ter) variant of the CLCN5 gene, which was derived from his mother. Based on the guidelines from the American College of Medical Genetics and Genomics (ACMG), the variant was rated as pathogenic (PVS1+ PM2_Supporting). Bioinformatic analysis using multiple software predicted the deleterious effect of the variant. Conclusion:The hemizygous c.701dupA (p.Y234Ter) variant of the CLCN5 gene probably underlay the pathogenesis of Dent disease in this patient. Above finding has enriched the mutational spectrum of the CLCN5 gene.

OBJECTIVE To explore the effect and potential mechanism of the compatibility of Astragali Radix-Puerariae Lobatae Radix on ferroptosis of liver cells in type 2 diabetes mellitus (T2DM) insulin resistance (IR) rats.METHODS Sixty male SD rats were randomly divided into control group (12 rats) and modeling group (48 rats).The modeling group was fed with a high-fat diet for 4 consecutive weeks and then given a one-time tail vein injection of 1％ streptozotocin to establish T2DM IR model.The model rats were randomly divided into model group,the compatibility of Astragali Radix-Puerariae Lobatae Radix group[QG group,4.05 g/(kg·d),intragastric administration],ferroptosis inhibitor ferrostatin-1 group[Fer-1 group,5 mg/kg by intraperitoneal injection,once every other day],the compatibility of Astragali Radix-Puerariae Lobatae Radix+ferroptosis inducer erastin group[QG+erastin group,4.05 g/(kg·d) by intragastric administration+erastin 10 mg/(kg·d),intraperitoneal injection].After 4 weeks of intervention,serum fasting blood glucose (FBG) and fasting insulin (FINS) were measured in each group of rats,and homeostasis model assessment of insulin resistance (HOMA-IR) and the natural logarithm of insulin action index(IAI) were calculated;the serum levels of total cholesterol (TC),triglyceride (TG),low-density lipoprotein cholesterol (LDL-C),high-density lipoprotein cholesterol (HDL-C),aspartate transaminase (AST) and alanine transaminase (ALT),Fe2+and Fe content,glutathione (GSH),malondialdehyde (MDA) and superoxide dismutase (SOD) levels,NADP+/NADPH ratio and reactive oxygen species (ROS) were determined.The pathological morphology of its liver tissue was observed;the protein expressions of glutathione peroxidase 4 (GPX4),ferritin heavy chain 1 (FTH1),long-chain acyl-CoA synthetase 3 (ACSL3),ACSL4,ferritin mitochondrial (FTMT),and cystine/glutamate anti-porter (xCT) in the liver tissue of rats were detected.RESULTS Compared with control group,the liver cells in the model group of rats showed disordered arrangement,swelling,deepened nuclear staining,and more infiltration of inflammatory cells,as well as a large number of hepatocyte vacuoles and steatosis;FBG (after medication),the levels of TC,TG,LDL-C,AST,ALT,FINS,MDA and ROS,HOMA-IR,Fe2+and Fe content,NADP+/NADPH ratio and protein expression of ACSL4 were significantly increased or up-regulated,while the levels of HDL-C,GSH and SOD,IAI,protein expressions of GPX4,FTH1,ACSL3,FTMT and xCT were significantly reduced or down-regulated (P<0.01).Compared with the model group,both QG group and Fer-1 group showed varying degrees of improvement in pathological damage of liver tissue and the levels of the above indicators,the differences in the changes of most indicators were statistically significant (P<0.01 or P<0.05).Compared with QG group,the improvement of the above indexes of QG+erastin group had been reversed significantly (P<0.01).CONCLUSIONS The compatibility decoction of Astragali Radix-Puerariae Lobatae Radix can reduce the level of FBG in T2DM IR rats,and alleviate IR degree,ion overload and pathological damage of liver tissue.The above effects are related to the inhibition of ferroptosis.

Objective:To determine the content of the released nickel ion through the 7 extraction media to extract the Ni-Ti wires and to plot the curve of the released nickel ion so as to identify a leaching medium that can be substituted for blood for in vitro Ni release evaluation. Methods:The release of Ni through microwave digestion/inductively coupled plasma mass spectrometry (ICP-MS) in the goat serum was determined. Because of the high content of Ni release, it could be determined by diluting the extraction medium, and other extraction media could be determined directly. Ni release standard curves were plotted by the release amount and different time point variables. Though the different extraction media Ni release curves confirm the specificity of extraction media instead of blood.Results:By analyzing the Ni release curves of seven leaching media, it was found that none of these seven extraction media was suitable for the evaluation of Ni release in in vitro leaching media. Considering the safety of the leaching medium and the simplicity of preparation, hydrochloric acid solution was chosen as the leaching medium, but the concentration needed to be diluted accordingly. Finally, a hydrochloric acid solution was created as an alternative to blood for the in vitro study of Ni release from Ni-Ti alloy cardiovascular products, with a volume fraction of 0.005%. Conclusions:The in vitro leaching medium that can replace blood was found to be hydrochloric acid for the time being, but its concentration was too high, resulting in too much Ni release as well, which deviated from the actual situation. Therefore, the hydrochloric acid solution was diluted step by step, and the Ni release curve was examined until it was close to the clinical release level, and the actual concentration was determined, thus laying a solid foundation for the subsequent evaluation of the safety and risk.

Objective To establish and interpret of the Pharmacopoeia of the People's Republic of China(2025 Edition),to determine particulate matter in pharmaceutical packaging materials,and to provide further guidance and support for the later use of the standard.Methods By reviewing the existing problems in the use of Chinese pharmaceutical packaging materials standards(YBB standards)standards combined with the construction of new standard system for pharmaceutical packaging materials in the Pharmacopoeia of the People's Republic of China,also about the validation data of the pharmaceutical packaging materials,the scope、testing methods、requirements and the experimental parameters of the Pharmacopoeia of the People's Republic of China determination of particulate matter in pharmaceutical packaging materials are studied and interpreted in detail.Results Compared with the current YBB standard,the Pharmacopoeia of the People's Republic of China-determination of particulate matter in pharmaceutical packaging materials has solved the problems of incomplete application scope and unreasonable requirements and parameters in the YBB standard.Conclusion The content of the Pharmacopoeia of the People's Republic of China(2025 Edition)determination of the particulate matter in drug packaging materials method is more scientific、applicable and operable.This method can standardize the determination of a particulate matter in drug packaging materials and can also play a supporting role in the construction of the standard system to promote industrial development.

Objective To compare the effects of intratracheal instillation by lumbar spinal needle and intratracheal atomization on bleomycin-induced pulmonary fibrosis modeling in mice,to determine the optimal modeling method.Methods Seventy-two C57BL/6J mice were divided randomly into control,lumbar spinal needle and aerosolization groups,according to body weight(n=24 mice per group).Mice in the control and lumbar spinal needle groups received intratracheal instillation of saline or bleomycin,respectively,and mice in the aerosolization group received aerosolized bleomycin intracheally by microsprayer aerosolizer.Micro-computed tomography(CT),histopathological changes,hydroxyproline(HYP)levels,Collagen Ⅰ(COL Ⅰ)and α-smooth muscle actin(α-SMA)protein expression were examined on days 14 and 21 to evaluate the degree of pulmonary fibrosis in each group.Results Mice in the two model groups showed listlessness,slow responses,and decreased body weights on days 14 and 21,compared with the control group(P＜0.001).Micro-CT showed white shadows surrounding the trachea in the lumbar spinal needle group,while the shadows were more diffuse in the aerosol group.The degrees of alveolitis and pulmonary fibrosis were highest in the aerosolization group,with a time-dependent trend.The hydroxyproline contents were significantly increased in the two model groups on days 14 and 21 after modeling(P＜0.05),with the increase on day 21 being more significant and stable(P＜0.001).COL Ⅰ expression was significantly increased in both the lumbar spinal needle group and aerosolization group on days 21 after modeling,especially in the aerosolization group(P＜0.001).Expression levels of α-SMA were significantly higher in the lumbar spinal needle group and aerosolization group compared with the control group on days 21(P＜0.001);however,there was no significant difference between the two model groups.Conclusions intratracheal atomization of bleomycin is the optimal method for establishing a mouse model of pulmonary fibrosis.

Objective To compare the effects of intratracheal instillation by lumbar spinal needle and intratracheal atomization on bleomycin-induced pulmonary fibrosis modeling in mice,to determine the optimal modeling method.Methods Seventy-two C57BL/6J mice were divided randomly into control,lumbar spinal needle and aerosolization groups,according to body weight(n=24 mice per group).Mice in the control and lumbar spinal needle groups received intratracheal instillation of saline or bleomycin,respectively,and mice in the aerosolization group received aerosolized bleomycin intracheally by microsprayer aerosolizer.Micro-computed tomography(CT),histopathological changes,hydroxyproline(HYP)levels,Collagen Ⅰ(COL Ⅰ)and α-smooth muscle actin(α-SMA)protein expression were examined on days 14 and 21 to evaluate the degree of pulmonary fibrosis in each group.Results Mice in the two model groups showed listlessness,slow responses,and decreased body weights on days 14 and 21,compared with the control group(P＜0.001).Micro-CT showed white shadows surrounding the trachea in the lumbar spinal needle group,while the shadows were more diffuse in the aerosol group.The degrees of alveolitis and pulmonary fibrosis were highest in the aerosolization group,with a time-dependent trend.The hydroxyproline contents were significantly increased in the two model groups on days 14 and 21 after modeling(P＜0.05),with the increase on day 21 being more significant and stable(P＜0.001).COL Ⅰ expression was significantly increased in both the lumbar spinal needle group and aerosolization group on days 21 after modeling,especially in the aerosolization group(P＜0.001).Expression levels of α-SMA were significantly higher in the lumbar spinal needle group and aerosolization group compared with the control group on days 21(P＜0.001);however,there was no significant difference between the two model groups.Conclusions intratracheal atomization of bleomycin is the optimal method for establishing a mouse model of pulmonary fibrosis.