Since the promulgation of the first Drug Administration Law of the People's Republic of China 40 years ago in 1984, China has undergone four main stages in the traditional Chinese medicine(TCM) regulation: the initial establishment of TCM regulation rules(1984-1997), the formation of a modern TCM regulatory system(1998-2014), the reform of the review and approval system for new TCM drugs(2015-2018), and the construction of a scientific regulation system for TCM(2019-2024). Over the past five years, a series of milestone achievements of TCM regulation in China have been achieved in the six aspects, including its strategic objectives and the establishment of a science-based regulatory system, the reform of the review and approval system for new TCM drugs, the optimization and improvement of the TCM standard system and its formation mechanism, comprehensive enhancement of regulatory capabilities for TCM safety, international harmonization of TCM regulation and its role in promoting innovation. Looking ahead, centered on advancing TCMRS to establish a sound regulatory framework tailored to the unique characteristics of TCM, TCM regulation will evolve into new reform patterns, advancing and extending across eight critical fronts, including the legal framework and policy architecture, the review and approval system for new TCM drugs, the quality standard and management system of TCM, the comprehensive quality & safety regulation and traceability system, the research and transformation system for TCMRS, AI-driven innovations in TCM regulation, the coordination between high-quality industrial development and high-level regulation, and the leadership in international cooperation and regulatory harmonization. In this way, a unique path for the development of modern TCM regulation with Chinese characteristics will be pioneered.
Humans ; China ; Drugs, Chinese Herbal/standards* ; History, 20th Century ; History, 21st Century ; Medicine, Chinese Traditional/trends*

ObjectiveTo investigate the role of 4-week high-intensity interval training (HIIT) in modulating the metabolic homeostasis of the pyruvate-lactate axis in the hippocampus of rats with chronic unpredictable mild stress (CUMS) to improve their depressive-like behavior. MethodsForty-eight SPF-grade 8-week-old male SD rats were randomly divided into 4 groups: the normal quiet group (C), the CUMS quiet group (M), the normal exercise group (HC), and the CUMS exercise group (HM). The M and HM groups received 8 weeks of CUMS modeling, while the HC and HM groups were exposed to 4 weeks of HIIT starting from the 5th week (3 min (85%-90%) S_max+1 min (50%-55%) S_max, 3-5 cycles, S_max is the maximum movement speed). A lactate analyzer was used to detect the blood lactate concentration in the quiet state of rats in the HC and HM groups at week 4 and in the 0, 2, 4, 8, 12, and 24 h after exercise, as well as in the quiet state of rats in each group at week 8. Behavioral indexes such as sucrose preference rate, number of times of uprightness and number of traversing frames in the absenteeism experiment, and other behavioral indexes were used to assess the depressive-like behavior of the rats at week 4 and week 8. The rats were anesthetized on the next day after the behavioral test in week 8, and hippocampal tissues were taken for assay. LC-MS non-targeted metabolomics, target quantification, ELISA and Western blot were used to detect the changes in metabolite content, lactate and pyruvate concentration, the content of key metabolic enzymes in the pyruvate-lactate axis, and the protein expression levels of monocarboxylate transporters (MCTs). Results4-week HIIT intervention significantly increased the sucrose preference rate, the number of uprights and the number of traversed frames in the absent field experiment in CUMS rats; non-targeted metabolomics assay found that 21 metabolites were significantly changed in group M compared to group C, and 14 and 11 differential metabolites were significantly dialed back in the HC and HM groups, respectively, after the 4-week HIIT intervention; the quantitative results of the targeting showed that, compared to group C, lactate concentration in the hippocampal tissues of M group, compared with group C, lactate concentration in hippocampal tissue was significantly reduced and pyruvate concentration was significantly increased, and 4-week HIIT intervention significantly increased the concentration of lactate and pyruvate in hippocampal tissue of HM group; the trend of changes in blood lactate concentration was consistent with the change in lactate concentration in hippocampal tissue; compared with group C, the LDHB content of group M was significantly increased, the content of PKM2 and PDH, as well as the protein expression level of MCT2 and MCT4 were significantly reduced. The 4-week HIIT intervention upregulated the PKM2 and PDH content as well as the protein expression levels of MCT2 and MCT4 in the HM group. ConclusionThe 4-week HIIT intervention upregulated blood lactate concentration and PKM2 and PDH metabolizing enzymes in hippocampal tissues of CUMS rats, and upregulated the expression of MCT2 and MCT4 transport carrier proteins to promote central lactate uptake and utilization, which regulated metabolic homeostasis of the pyruvate-lactate axis and improved depressive-like behaviors.

Objective To establish a stable,reliable,and clinically relevant porcine model of endotoxin-induced acute respiratory distress syndrome(ARDS).Methods Ten 8-month-old male Bama minipigs were deeply sedated,followed by invasive mechanical ventilation and electrocardiographic monitoring.Lipopolysaccharide(LPS)was intravenously pumped at 600 μg/(kg·h)for 3 hours,then maintained at 15 μg/(kg·h)thereafter.Dynamic monitoring was performed at five time points after LPS injection(LPS 0,1,3,5,and 8 h),including arterial blood gas analysis and chest computed tomography(CT)scans.Pathological examination of lung tissues obtained via bronchoscopic biopsy(HE staining and transmission electron microscopy)was conducted.These indicators were comprehensively used to evaluate the success of the animal model.Results At 5 hours after LPS administration,8 minipigs developed symptoms such as skin cyanosis,elevated body temperature,and respiratory distress.The oxygenation index decreased to<300 mmHg.Chest CT scans showed diffuse pulmonary infiltrates.Histopathology revealed alveolar edema and hyaline membrane formation.Transmission electron microscopy demonstrated disruption of pulmonary blood-air barrier,depletion of lamellar bodies in type Ⅱ pneumocytes,inflammatory cell infiltration,and exudation of plasma proteins and fibrin.Compared with LPS 0 h,at LPS 8 h,the oxygenation index and arterial blood pH were significantly decreased(P<0.001),while blood lactic acid and serum potassium were significantly increased(P<0.05);serum calcium and base excess were significantly decreased(P<0.05),and the lung injury score based on HE-stained lung sections was significantly increased(P<0.01).Conclusion The porcine ARDS model established by continuous LPS injection can dynamically simulate the pathophysiological characteristics and typical pathological manifestations of clinical septic ARDS,making it an effective tool to study the pathogenesis,prevention,and treatment strategies of septic ARDS.

Objective To evaluate the clinical efficacy of Xiaojianzhong Decoction plus Dachaihu Decoction in the treatment of chronic atrophic gastritis(CAG),and to provide scientific evidence for the clinical application of the formula.Methods The clinical observation was carried out in 80 CAG patients with spleen deficiency and stasis-heat syndrome of normal-people pulse type(the ratio of patients'pulse to the number of respirations within one minute being 4-5 evaluated by Changsangjun pulse-taking method)who attended the clinic of the Department of Gastroenterology of Shunde Hospital,Guangzhou University of Chinese Medicine,from January 2020 to December 2023.According to the treatment method,the patients were divided into the treatment group and the control group,with 40 cases in each group.The control group was given conventional western medicine treatment,and the treatment group was given Xiaojianzhong Decoction plus Dachaihu Decoction.Seven days constituted one course of treatment,and the treatment covered 6 months.The changes of traditional Chinese medicine(TCM)syndrome score,gastroscopy score,pathological score and gastric function indicators in the two groups were observed before and after the treatment.After treatment,the clinical efficacy and safety of the two groups were evaluated.Results(1)After 6 months of treatment,the total effective rate of the treatment group was 90.00%(36/40),and that of the control group was 60.00%(24/40).The intergroup comparison(tested by chi-square test)showed that the efficacy of the treatment group was significantly superior to that of the control group(P＜0.05).(2)After treatment,the scores of TCM syndromes in the two groups were significantly lower than those before treatment(P＜0.05),and the decrease of the scores in the treatment group was superior to that in the control group(P＜0.05).(3)After treatment,the gastroscopy scores of the two groups were significantly lower than those before treatment(P＜0.05),but there was no significant difference between the two groups after treatment(P＞0.05).(4)After treatment,the total pathological scores of the two groups and the scores of the gastric mucosal atrophy and intestinal metaplasia of the gastric antrum,gastric angle and gastric body in the treatment group were significantly improved compared with those before treatment(P＜0.05),and the improvement of the gastroscopy scores in the treatment group was significantly superior to that in the control group(P＜0.05).No statistically significant differences were presented in the scores of the gastric mucosal dysplasia and chronic inflammation of gastric antrum,gastric angle and gastric body in the two groups and in the scores of the gastric mucosal atrophy and intestinal metaplasia of gastric antrum,gastric angle and gastric body in the control group when compared with those before treatment(P＞0.05).(5)After treatment,the serum levels of gastric function indicators of pepsinogen Ⅰ(PGⅠ),pepsinogen Ⅱ(PGⅡ)and gastrin 17(G-17)in the two groups were significantly decreased compared with those before treatment(P＜0.05),and the decrease in the treatment group was significantly superior to that in the control group(P＜0.05).(6)There were no obvious adverse reactions occurring in the two groups during the treatment,with high safety.Conclusion Xiaojianzhong Decoction plus Dachaihu Decoction can significantly enhance the clinical efficacy of CAG patients with spleen deficiency and stasis-heat syndrome of normal-people pulse type,significantly improve the gastrointestinal function and pathological scores of the patients,and has high safety.

Aim In this study, a mouse model of psoriasis-like lesions induced by 62. 5 mg imiquimod was used to explore the effect and mechanism of Sophorae Flavescentis Radix and Rhizoma Smilacis Glabrae combination for the topical treatment of psoriasis. Methods Firstly, the topical administration of Sophorae Flavescentis Radix and Rhizoma Smilacis Glabrae combination for treating psoriasis in progressive and recurrent stages was evaluated by psoriatic mouse model and HE staining. Secondly, immunohistochemistry was used to study the regulatory effects of Sophorae Flavescentis Radix and Rhizoma Smilacis Glabrae combination on the pivotal pathological mechanism of psoriasis-the positive feedback loop between the abnormal proliferation of keratinocytes and skin immune microenvironment. Finally, metabolomics technology was used to explore whether Sophorae Flavescentis Radix and Rhizoma Smilacis Glabrae combination topically treat psoriasis by regulating inflammation-related metabolism and lipid metabolism pathways. Results The combination of Sophorae Flavescentis Radix and Rhizoma Smilacis Glabrae alleviated psoriasis-like lesions in mice. It effectively relieved the recurrence after the cure of psoriatic lesions in mice, and the efficacy is comparable to that of benweimod. The combination of Sophorae Flavescentis Radix and Rhizoma Smilacis Glabrae inhibited the proliferation of mouse epidermal keratinocytes and reduced the number of T cells in the skin. The potential molecular mechanism was that the combination of Sophorae Flavescentis Radix and Rhizoma Smilacis Glabrae regulated arachidonic acid metabolism, sphin- golipid metabolism, tryptophan metabolism and phenylalanine metabolism. Conclusions The combination of Sophora Flavescens Radix and Rhizoma Smilacis Glabrae can relieve psoriasis-like lesions in mice by inhibiting the proliferation of epidermal keratinocytes and reducing the number of T cells in the skin and regulating metabolism to intervene psoriasis recurrence. This study provides a potential topical drug of psoriasis for relieving psoriasis recurrence.

Objective To study the effect of notoginsenoside R2(NGR2)on palmitic acid(PA)-induced lipotoxicity in H9c2 cardiomyocytes.Methods The H9c2 cells were divided into control group,model group and experimental-L,-H groups.The control group was treated with 10％bovine serum albumin(BSA);the model group was treated with 250 μmol·L-1 PA to establish the lipotoxicity model;the experimental-L,-H groups were treated with 50,100 μmol·L-1 NGR2 and 250 μmol·L-1 PA.The accumulation of cellular lipid droplets was observed by oil red O staining and Bodipy staining;the mRNA expression levels of fatty acid synthase(FASN),stearoyl coenzyme A desaturase 1(SCD1)were detected by real time quantitative polymerase chain reaction;the protein expression levels of FASN and SCD1 were detected by Western blot.Results The absorbance of lipid droplet quantification after oil red O staining in the control group,the model group,the experimental-L,-H groups were 0.12±0.03,0.19±0.02,0.14±0.05 and 0.11±0.03;the relative fluorescence intensity quantified by Bodipy staining were(100.00±15.83)％,(249.65±6.44)％,(160.88±17.34)％and(136.84±4.83)％;FASN mRNA expression levels were 1.00±0.07,1.33±0.13,1.21±0.16 and 1.05±0.09;SCD1 mRNA expression levels were 1.00±0.04,1.26±0.07,1.24±0.15 and 1.02±0.09;the expression levels of FASN protein were 1.00±0.00,1.03±0.02,1.01±0.06 and 0.92±0.08;the expression levels of SCD1 protein were 1.00±0.00,1.08±0.08,0.98±0.15 and 0.87±0.18.In the above indicators,there were statistically significant differences between model group and control group,between experimental-H group and model group(P＜0.05,P＜0.01);there were significant differences in oil red O staining and Bodipy staining quantification of experimental-L group and model group(P＜0.05,P＜0.01).Conclusion NGR2 may reduce lipid accumulation and alleviate lipotoxicity in PA-induced H9c2 cardiomyocytes by decreasing the mRNA and protein expression of FASN and SCD1.

Objective To study the effect of notoginsenoside R2(NGR2)on palmitic acid(PA)-induced lipotoxicity in H9c2 cardiomyocytes.Methods The H9c2 cells were divided into control group,model group and experimental-L,-H groups.The control group was treated with 10％bovine serum albumin(BSA);the model group was treated with 250 μmol·L-1 PA to establish the lipotoxicity model;the experimental-L,-H groups were treated with 50,100 μmol·L-1 NGR2 and 250 μmol·L-1 PA.The accumulation of cellular lipid droplets was observed by oil red O staining and Bodipy staining;the mRNA expression levels of fatty acid synthase(FASN),stearoyl coenzyme A desaturase 1(SCD1)were detected by real time quantitative polymerase chain reaction;the protein expression levels of FASN and SCD1 were detected by Western blot.Results The absorbance of lipid droplet quantification after oil red O staining in the control group,the model group,the experimental-L,-H groups were 0.12±0.03,0.19±0.02,0.14±0.05 and 0.11±0.03;the relative fluorescence intensity quantified by Bodipy staining were(100.00±15.83)％,(249.65±6.44)％,(160.88±17.34)％and(136.84±4.83)％;FASN mRNA expression levels were 1.00±0.07,1.33±0.13,1.21±0.16 and 1.05±0.09;SCD1 mRNA expression levels were 1.00±0.04,1.26±0.07,1.24±0.15 and 1.02±0.09;the expression levels of FASN protein were 1.00±0.00,1.03±0.02,1.01±0.06 and 0.92±0.08;the expression levels of SCD1 protein were 1.00±0.00,1.08±0.08,0.98±0.15 and 0.87±0.18.In the above indicators,there were statistically significant differences between model group and control group,between experimental-H group and model group(P＜0.05,P＜0.01);there were significant differences in oil red O staining and Bodipy staining quantification of experimental-L group and model group(P＜0.05,P＜0.01).Conclusion NGR2 may reduce lipid accumulation and alleviate lipotoxicity in PA-induced H9c2 cardiomyocytes by decreasing the mRNA and protein expression of FASN and SCD1.

AIM:To investigate the effects and mechanisms of curcumin on apoptosis of retinal ganglion cells(RGCs)in chronic ocular hypertension rats.METHODS:A total of 21 Spraque-Dawley(SD)rats were randomly divided into 3 groups with 7 rats in each group. The rat models of chronic ocular hypertension were established by cauterization of the superior scleral veins in the high intraocular pressure model group and the curcumin treatment group, and the sham operation group only cut the conjunctiva without the cauterization of the superior scleral veins; the rats in the curcumin treatment group were intragastrically treated with curcumin at a dose of 4mL/kg, and the rats in the sham operation group and the high intraocular pressure model group were treated with pure water at a dose of 4mL/kg for 3wk. After 3wk, HE staining was used to observe the morphological and pathological changes of retina, the number of RGCs and the thickness of ganglion cell layer(GCL)in each group of rats; TUNEL staining was used to observe the apoptosis of RGCs and retinal cells in each group of rats; the expression levels of glutamate-cysteine ligase modifier subunit(GCLM)and heme oxygenase-1(HO-1)in the retina of each group of rats were detected by real-time fluorescence quantitative PCR, immunohistochemical staining and Western blot.RESULTS:Compared with the sham operation group, the retinal morphology of rats in the high intraocular pressure model group and the curcumin treatment group was disorganized, the number of RGCs was reduced, the GCL was thinner, the apoptosis rate of RGCs and retinal cells increased, and the expression levels of GCLM and HO-1 increased. Compared with the high intraocular pressure model group, the retinal morphology of rats in the curcumin treatment group was basically normal, the number of RGCs increased, the GCL thickened, the apoptosis rate of RGCs and retinal cells decreased, and the expression levels of GCLM and HO-1 increased.CONCLUSION:Curcumin can inhibit the apoptosis of RGCs in the rat model of chronic ocular hypertension by up-regulating the expression of antioxidant genes GCLM and HO-1.

Artemisia stolonifera is a relative of A. argyi. The two species are difficult to be distinguished due to the similarity in leaf shape and have even less distinctive features after processing. This study aims to establish a method to quickly distinguish between them. At the same time, we examined the reasonability and applicability of the specific polymerase chain reaction(PCR) method. The C/T single nucleotide polymorphism was detected at the position 202 of the sequence, based on which specific primers were designed to identify these two species. The PCR with the specific primer JNC-F and the universal primer ITS3R produced a specific band at 218 bp for A. argyi and no band for A. stolonifera, which can be used to detect at least 3% of A. argyi samples mixed in A. stolonifera samples. The PCR with the specific primer KY-F and the universal primer ITS3R produced a specific band at 218 bp for A. stolonifera and no band for A. argyi, which can be used to detect at least 5% of A. stolonifera samples mixed with A. argyi. The limit of detection of the established method was 5 ng DNA. The established PCR method can accurately distinguish between A. stolonifera and A. argyi, which provides an experimental basis for the quality control of A. stolonifera and determines whether the herbs are adulterated.
Artemisia/genetics* ; Trichomes ; Polymerase Chain Reaction ; Nucleic Acid Amplification Techniques ; Plant Leaves/genetics*

OBJECTIVE: To investigate the effect and relative mechanism of Recombinant Human Thrombopoietin (rhTPO) on long-term hematopoietic recovery in mice with acute radiation sickness. METHODS: Mice were intramuscularly injected with rhTPO (100 μg/kg) 2 hours after total body irradiation with ⁶⁰Co γ-rays (6.5 Gy). Moreover, six months after irradiation, peripheral blood, hematopoietic stem cells (HSC) ratio, competitive transplantation survival rate and chimerization rate, senescence rate of c-kit⁺ HSC, and p16 and p38 mRNA expression of c-kit⁺ HSC were detected. RESULTS: Six months after 6.5 Gy γ-ray irradiation, there were no differences in peripheral blood white blood cells, red blood cells, platelets, neutrophils and bone marrow nucleated cells in normal group, irradiated group and rhTPO group (P>0.05). The proportion of hematopoietic stem cells and multipotent progenitor cells in mice of irradiated group was significantly decreased after irradiation (P<0.05), but there was no significant changes in rhTPO group (P>0.05). The counts of CFU-MK and BFU-E in irradiated group were significantly lower than that in normal group, and rhTPO group was higher than that of the irradiated group(P<0.05). The 70 day survival rate of recipient mice in normal group and rhTPO group was 100%, and all mice died in irradiation group. The senescence positive rates of c-kit⁺ HSC in normal group, irradiation group and rhTPO group were 6.11%, 9.54% and 6.01%, respectively (P<0.01). Compared with the normal group, the p16 and p38 mRNA expression of c-kit⁺ HSC in the irradiated mice were significantly increased (P<0.01), and it was markedly decreased after rhTPO administration (P<0.01). CONCLUSION The hematopoietic function of mice is still decreased 6 months after 6.5 Gy γ-ray irradiation, suggesting that there may be long-term damage. High-dose administration of rhTPO in the treatment of acute radiation sickness can reduce the senescence of HSC through p38-p16 pathway and improve the long-term damage of hematopoietic function in mice with acute radiation sickness.
Humans ; Mice ; Animals ; Thrombopoietin/metabolism* ; Hematopoietic Stem Cells ; Blood Platelets ; Recombinant Proteins/therapeutic use* ; Radiation Injuries ; RNA, Messenger/metabolism*