1.Predictive model for severe adverse reaction associated with bevacizumab based on the global trigger tool and machine learning
Yongfei FU ; Xin LONG ; Hongzhen XU ; Jian TANG ; Xiangqing LI ; Yucheng LONG ; Dong QIN
China Pharmacy 2026;37(4):497-503
OBJECTIVE To confirm trigger items for adverse drug reaction (ADR) induced by bevacizumab, to identify and analyze the occurrence of related ADR, and to establish a predictive model for severe adverse reaction (SAR) caused by this drug. METHODS Based on the global trigger tool (GTT) theory, and referencing the GTT White Paper, drug package inserts and relevant literature, trigger items for bevacizumab-related ADR were confirmed using a single-round Delphi method. Utilizing these established items, electronic medical records of relevant patients at Guilin People’s Hospital from January 2020 to September 2024 were actively screened via the China Hospital Pharmacovigilance System. Pharmacists then identified and tallied the occurrence of bevacizumab-induced ADR. Data from patients with any positive trigger item served as the study subjects (divided into training and test sets at a ratio of 7∶3), candidate feature variables were selected from 39 related variables using the Boruta algorithm, and the multivariable Logistic regression analysis was performed with the occurrence of SAR as the dependent variable. Based on these candidate features, Logistic Regression, Extreme Gradient Boosting, Light Gradient Boosting Machine, Random Forest, and Categorical Boosting models were constructed. Model performance was evaluated using metrics including the area under the curve (AUC) of receiver operating characteristic curve and recall rate. The Shapley Additive exPlanations (SHAP) method was applied to analyze and interpret the contribution of each variable. A nomogram was constructed based on the optimal model. RESULTS A total of 38 trigger items for active monitoring of bevacizumab-related ADR were determined, comprising 17 laboratory indicators, 13 clinical manifestations, and 8 intervention measures. In total, 483 patients with positive trigger items were included, and 318 patients with bevacizumab-induced ADR were identified, including 83 SARs. The positive predictive values for the trigger items and cases were 43.57% (708/1 625) and 63.84% (318/483), respectively. Bevacizumab-induced ADR involved 7 systems/organs, with the hematological system being the most frequently involved (64.15%). The Boruta algorithm selected 7 vari ables: serum potassium, hematocrit, albumin-to-globulin ratio, prealbumin, hypertension history, age and red blood cell count. Multivariable Logistic regression showed that elevated serum potassium levels were associated with a decreased risk of bevacizumab-induced SAR (OR=0.234, P =0.002), while a history of hypertension (OR=2.642, P =0.006) and increased age (OR=1.040, P =0.025) were associated with an increased risk. The Logistic Regression model demonstrated superior performance with higher AUC, F1 score and recall rate (0.761, 0.447, 0.607), compared to other models. SHAP evaluation results indicated that variables such as serum potassium, hematocrit, and age ranked highest in importance. CONCLUSIONS Totally 38 trigger entries have been successfully identified for active screening of bevacizumab-related ADR. Elevated serum potassium levels are a protective factor against bevacizumab-induced SAR, whereas the hypertension history and increased age are risk factors. The Logistic Regression model is the optimal predictive model.
2.Effect of Heat-sensitive Moxibustion on Quality of Life and Immune Function in Non-Small Cell Lung Cancer Patients with Qi Deficiency and Phlegm Stasis Syndrome Undergoing Chemotherapy:A Randomized Controlled Trial
Wenhao ZHAN ; Qian DING ; Zhiwei DONG ; Ting LI ; Shumei FU ; Ning TIAN
Journal of Traditional Chinese Medicine 2026;67(12):1289-1296
ObjectiveTo observe the effect of heat-sensitive moxibustion on quality of life and immune function in non-small cell lung cancer (NSCLC) patients undergoing chemotherapy. MethodsSeventy NSCLC patients with qi deficiency and phlegm stasis syndrome were randomly divided into an intervention group and a control group, with 35 cases in each group. The control group received chemotherapy combined with routine symptomatic treatment, while the intervention group additionally received heat-sensitive moxibustion since the first day of chemotherapy. Acupoints included Dazhui (GV14), bilateral Feishu (BL13), Zhongwan (CV12), Qihai (CV6), and Guanyuan (CV4). The site exhibiting the strongest heat-sensitization response was selected for moxibustion. Treatment was administered for 45 minutes per session, three times weekly for three consecutive weeks, totaling nine sessions. Before and after treatment, quality of life was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), and traditional Chinese medicine (TCM) syndrome scores were evaluated. Peripheral blood levels of natural killer (NK) cells and T-lymphocyte subsets including CD3+, CD4+, and CD8+, and CD4+/CD8+ ratio were measured. Levels of programmed cell death protein-1 (PD-1), including PD-1⁺CD4⁺ and PD-1⁺CD8⁺ cells, were also assessed. Liver and renal function were monitored before and after treatment, and adverse events were recorded. ResultsIn the intervention group, 1 participant withdrew and 1 was excluded, while in the control group, 2 participants withdrew. Ultimately, 33 participants in each group were included in the final analysis. The intervention group showed significant improvements in physical, role, emotional, cognitive, and social functioning, as well as global health status after treatment, while scores for fatigue, nausea and vomiting, dyspnea, appetite loss, diarrhea, and TCM syndrome scale were significantly decreased (P<0.05). Moreover, the intervention group demonstrated higher scores in physical functioning, role functioning, and global health status, as well as lower scores for fatigue, nausea and vomiting, dyspnea, appetite loss, diarrhea, and the TCM syndrome scale than the control group (P<0.05). After treatment, the levels of peripheral NK cells and PD-1⁺CD8⁺ T cells in the intervention group increased significantly; furthermore, the intervention group exhibited higher peripheral NK cell levels and lower PD-1⁺CD8⁺ T cell levels than the control group (P<0.05). No significant differences were found in liver or renal function between the two groups (P>0.05). In addition, no adverse events such as burns or moxibustion-induced syncope occurred during the study. ConclusionHeat-sensitive moxibustion as an adjunctive therapy may enhance immune function, alleviate clinical symptoms, and improve quality of life, while demonstrating a favorable safety profile in NSCLC patients with qi deficiency and phlegm stasis.
3.Detection of Heavy Metal Content in White Peony by Laser-Induced Breakdown Spectroscopy Combined with Semi-Supervised Metric Learning
Yan-Hong GU ; Fan-Ding LI ; Fu-Dong NIAN
Chinese Journal of Analytical Chemistry 2025;53(4):669-679
To address the economic challenge associated with acquiring labeled sample data for white paeony,a semi-supervised learning model based on metric learning and consistency constraints was proposed to predict the content of trace heavy metal pollutants Pb and Cd in white paeony.The model was comprised of two multi-task deep learning networks with the same structure but different parameters,namely the teacher model and the student model.The multi-task deep learning network utilized metric learning within the classification branch to ensure the clustering of different samples,thereby enhancing the predictive performance of the regression branch for heavy metal content in white peony samples.The student model effectively utilized unlabeled data by constraining the consistency of outputs between the teacher and student models.Experimental results showed that the proposed multi-task deep learning network combined with the regression subnetwork model significantly reduced the average relative errors of Pb and Cd in the test set to 7.01%and 8.16%when predicting trace heavy metal pollutants in paeony.Furthermore,after integrating the metric learning loss function-constrained and the consistency-constrained teacher-student semi-supervised learning model,the same samples exhibited clustering phenomena,with faster convergence speed and convergence values closer to 0 in the loss function,reducing the average relative errors of Pb and Cd in the test set to 3.32%and 4.77%.The above results indicated that the model proposed in this work could effectively enhance the accuracy and reliability of LIBS in quantitative analysis of trace heavy metal elements in paeony,strengthening the advantages of LIBS in practical applications for quality supervision in the traditional Chinese medicine market.
4.Simultaneous Determination of Four Off-flavors in Freshwater Fish by Gas Chromatography-Mass Spectrometry Combined with Silica Solid Phase Extraction
Liang-Liang TIAN ; Dong-Mei HUANG ; Yuan WANG ; Xuan-Yun HUANG ; Yong-Fu SHI ; Hong-Li YE
Chinese Journal of Analytical Chemistry 2025;53(7):1158-1166
An effective method for simultaneously detecting four semivolatile earthy-musty odors in freshwater fish by gas chromatography-mass spectrometry(GC-MS)was developed.The concurrent extraction of geosmin(GSM),2-methylisoborneol(MIB),2-isopropyl-3-methoxypyrazine(IPMP),and 2-isobutyl-3-methoxypyrazine(IBMP)in fish tissue was conducted with n-hexane.The optimized QuEChERS material was implemented,and it was found that C18,primary secondary amine(PSA)and MgSO4 could adsorb the target analytes in n-hexane.So only the graphitized carbon black(GCB)could be used to purify the extraction.The adsorption rates of different materials for the four kinds of odors materials were explored in n-hexane and ethyl acetate.The experimental results revealed that the adsorption rates of silica for the four targets were 99.5%-100%in n-hexane and 0.7%-5.0%in ethyl acetate respectively.Then the silica solid phase extraction(SPE)method was utilized to eluent the compounds using 1.0 mL n-hexane/ethyl acetate in different proportions.The results of the comparative analysis demonstrated that n-hexane/ethyl acetate(4∶1,V/V)was the optimized eluent.Based on the obtained results,n-hexane extraction and GCB purification combined with silica SPE were used to isolate GSM,MIB,IPMP and IBMP from fish and the method was validated.It was found that the method showed good linearity in the range of 0.5-200 ng/mL,and with detection limits of 0.6 μg/kg for GSM and MIB,0.2 μg/kg for IPMP and IBMP.The limits of quantitation(LOQ)were 1.0 μg/kg for GSM and MIB,0.6 μg/kg for IPMP and IBMP.Good recoveries(77.5%-112.0%)and relative standard deviations(1.56%-9.42%)were also obtained.The use of silica SPE greatly mitigated the issue that the off-flavor compounds were easily lost in the gas blowing concentration process.There was no cross contamination in this method because the sample pretreatments were conducted separately,which was different with the most commonly used HS-SPME method for detecting semi-volatile substances.The sensitivity of this method was high enough to produce good quantitative results below the odor thresholds of the examined off-flavor compounds.
5.Elucidating the therapeutic potential of Maimendong decoction in pulmonary fibrosis: A molecular perspective
Shuangshuang He ; Lan Zhang ; Fang Zhang ; Yuanrong Wang ; Kai Wamg ; Shanshan Guo ; Yuqi Wang ; Wenqing Dong ; Min Fu ; Yu Li
Journal of Traditional Chinese Medical Sciences 2025;2025(2):231-245
ObjectiveTo identify the active components in Maimendong decoction (MMDD) against pulmonary fibrosis (PF) and validate their molecular effects in vitro, while focusing on the role of methylophiopogonanone B in regulating fibrosis.MethodsData on MMDD components and targets were gathered from databases including BATMAN-TCM and PubMed, whereas the PF gene data were sourced from GeneCards, OMIM, and TTD. Shared targets were determined using the STRING database, and molecular docking was used to analyze the essential molecules associated with fibrosis. To simulate PF conditions, human embryonic lung fibroblasts (HPF) and A549 cells were exposed to transforming growth factor-β1 (TGF-β1). Various assays were used to determine the effects of MMDD and methylophiopogonanone B on signaling pathways, apoptosis, and epithelial–mesenchymal transition.ResultsWe identified 11 active components from MMDD extracts that targeted 511 shared proteins associated with PF, revealing 10 key targets in network analysis. Gene ontology analysis indicated that processes and pathways such as apoptosis regulation and PI3K/Akt signaling were involved. In vitro experiments revealed that MMDD downregulated the expression of α-smooth muscle actin (α-SMA), collagen type I (COL-I), and collagen type III and regulated Bcl-2/Bax signaling pathways to promote apoptosis. The flow cytometry apoptosis assay revealed that MMDD promoted the TGF-β1-induced apoptosis of myofibroblasts. The primary active ingredient in MMDD, methylophiopogonanone B, reduced α-SMA, COL-I, and PI3K/Akt/mTOR-related protein levels in TGF-β1-treated HPF cells, decreased Bcl-2 and cleaved caspase 3, and increased Bax. Moreover, methylophiopogonanone B increased E-cadherin levels and reduced α-SMA, fibronectin, N-cadherin, vimentin, and snail in TGF-β1-treated A549 cells.ConclusionMethylophiopogonanone B demonstrated the potential to treat PF by inducing myofibroblast apoptosis and inhibiting EMT. However, despite encouraging initial results, further clinical research is warranted to verify the safety and efficacy of methylophiopogonanone B in the management of PF
6.Decompression mechanism of symmetrically adduction of lumbar decompression induced resorption of herniated nucleus pulpous
Chunlin ZHANG ; Zhaohua HOU ; Xu YAN ; Yan JIANG ; Su FU ; Yongming NING ; Dongzhe LI ; Chao DONG ; Xiaokang LIU ; Yongkui WANG ; Zhengming CAO ; Tengyue YANG
Chinese Journal of Tissue Engineering Research 2025;29(9):1810-1819
BACKGROUND:Traditional surgery for lumbar disc herniation involves extensive excision of tissue surrounding the nerve for decompression and removal of protruding lumbar intervertebral discs,which poses various risks and complications such as nerve damage causing paralysis,lumbar instability,herniation recurrence,intervertebral space infection,and adjacent vertebral diseases. OBJECTIVE:To propose the symmetrically adduction of lumbar decompression induced resorption of herniated nucleus pulpous technique for lumbar spine symmetrically decompression,showing the induced resorption of herniated nucleus pulpous phenomenon and early clinical efficacy,and then analyze its decompression mechanism. METHODS:214 patients with lumbar disc herniation at Department of Orthopedics,First Affiliated Hospital of Zhengzhou University from March 2021 to May 2023 were enrolled in this study.Among them,81 patients received conservative treatment as the control group,and 133 patients received symmetrically adduction of lumbar decompression induced resorption of herniated nucleus pulpous treatment as the trial group.Before surgery,immediately after surgery(7-14 days),and early after surgery(over 1 year),MRI images were used to measure the volume changes of lumbar disc herniation.CT images were used to measure the posterior displacement distance of the lumbar spinous process ligament complex,as well as the width and height of the lateral recess.Japanese Orthopaedic Association scores were used to evaluate the patient's neurological function recovery. RESULTS AND CONCLUSION:(1)Control group:81 patients with lumbar disc herniation were treated conservatively,with a total of 171 herniated lumbar discs.The average follow-up time was(22.7±23.1)months.The first and second MRI measurements of 171 herniated lumbar discs showed herniated lumbar disc volumes of(551.6±257.9)mm3 and(792.2±330.4)mm3,respectively,with an average volume increase rate of(53.2±44.4)%,showing statistically significant differences(P<0.001).Out of 171 herniated lumbar discs,4 experienced natural shrinkage,with an absorption ratio of 2.3%(4/171)and an absorption rate of(24.5±9.9)%.(2)Trial group:133 patients with lumbar disc herniation had a total of 285 herniated lumbar discs.(1)Immediately after surgery:All patients were followed up immediately after surgery.229 out of 285 herniated lumbar discs experienced retraction,with an absorption ratio of 80.3%(229/285)and an average absorption rate of(21.5±20.9)%,with significant and complete absorption accounting for 6.5%.There were a total of 70 herniated lumbar discs in the upper lumbar spine,with an absorption ratio of 85.7%(60/70),an average absorption rate of(23.1±19.5)%,and a maximum absorption rate of 86.6%.There were 215 herniated lumbar discs in the lower lumbar spine,with an absorption ratio of 78.6%(169/215),an average absorption rate of(21.0±21.3)%,and a maximum absorption rate of 83.2%.Significant and complete absorption of the upper and lower lumbar vertebrae accounted for 5.7%and 6.5%,respectively,with no statistically significant difference(P>0.05).The average distance of posterior displacement of the spinous process ligament complex immediately after surgery was(5.2±2.8)mm.There were no significant differences in the width and height of the left and right lateral recess before and immediately after surgery(P>0.05).The Japanese Orthopaedic Association score immediately after surgery increased from(10.1±3.4)before surgery to(17.0±4.8),and the immediate effective rate after surgery reached 95.6%.(2)Early postoperative period:Among them,46 patients completed the early postoperative follow-up.There were 101 herniated lumbar discs,with an absorption ratio of 94%(95/101)and an average absorption rate of(36.9±23.7)%.Significant and complete absorption accounted for 30.6%,with a maximum absorption rate of 100%.Out of 101 herniated lumbar discs,3 remained unchanged in volume,with a volume invariance rate of 2.97%(3/101).Out of 101 herniated lumbar discs,3 had an increased volume of herniated lumbar discs,with an increase ratio of 2.97%(3/101)and an increase rate of(18.5±18.4)%.The Japanese Orthopaedic Association score increased from preoperative(9.3±5.1)to(23.5±4.0),with an excellent and good rate of 93.4%.(3)The early postoperative lumbar disc herniation absorption ratios of the control group and trial group were 2.3%and 85.9%,respectively,with statistically significant differences(P<0.001).(4)Complications:There were two cases of incision exudation and delayed healing in the trial group.After conservative treatment such as dressing change,no nerve injury or death occurred in the incision healing,and no cases underwent a second surgery.(5)It is concluded that symmetrically adduction of lumbar decompression induced resorption of herniated nucleus pulpous is a new method for treating lumbar disc herniation that can avoid extensive excision of the"ring"nerve and achieve satisfactory early clinical efficacy.It does not damage the lumbar facet joints or alter the basic anatomical structure of the lateral recess,fully preserves the herniated lumbar discs,and can induce significant or even complete induced resorption of herniated nucleus pulpous.Symmetrically adduction of lumbar decompression induced resorption of herniated nucleus pulpous provides a new basis and method for the clinical treatment of lumbar disc herniation.
7.Clinical Efficacy of Tonifying Kidney and Replenishing Essence on Asthenospermia Patients with Syndrome of Kidney Essence Deficiency and Effect of This Method on Expression Levels of AMPK/mTORC1 Signaling Pathway-associated Proteins
Yuanjie FU ; Fuhao LI ; Chenghua PENG ; Dong XU ; Guoan YIN ; Xiaopeng HUANG ; Degui CHANG ; Liang DONG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):141-147
ObjectiveTo observe the clinical efficacy of tonifying kidney and replenishing essence on asthenozoospermia patients with the syndrome of kidney essence deficiency and the effects of this method on the adenosine 5′-monophosphate-activated protein kinase (AMPK)/mammalian target of rapamycin complex 1 (mTORC1) signaling pathway. MethodsSeventy-two eligible asthenozoospermia patients with the syndrome of kidney essence deficiency treated in the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine from February 2023 to January 2024 were selected and randomly assigned into an observation group and a control group, with 36 patients in each group. The observation group received oral administration of Guilu Tianjing capsules, while the control group received oral administration of L-carnitine oral solution. The treatment course lasted for 4 weeks in both groups. The observed indicators included sperm progressive motility rate (PR), total sperm motility (PR+NP), percentage of normal mitochondrial membrane potential (MMP), and traditional Chinese medicine (TCM) symptom scores before and after treatment in both groups. A three-month follow-up was instituted to record the conception status of the patients’ spouses. Additionally, eight patients were randomly selected from the eligible patients in the observation group, and four healthy males with normal semen routine examination results were included as the control group for the determination of protein expression. Western blotting was conducted to assess the expression of AMPK, phosphorylated (p)-AMPK, regulatory-associated protein of mTOR (RAPTOR) and p-RAPTOR, and PTEN-induced putative kinase 1 (PINK1) in sperms from the observation group before and after treatment, as well as in the sperms of the control group. ResultsThe pregnancy rate of spouses in the observation group was 9.09% (3/33), which was higher than that (3.33%, 1/30) in the control group. The total response rate was 84.8% (28/33) in the observation group and 66.7% (20/30) in the control group, with no statistically significant difference. After treatment, both groups were improved considering PR, PR+NP, MMP, and TCM symptom scores (P<0.01). Moreover, the observation group exhibited more pronounced decreases in TCM symptom scores than the control group (P<0.05), while the changes in PR, PR+NP, and MMP showed no statistical significance between groups. Compared with the control group, the asthenozoospermia group exhibited upregulations in phosphorylation levels of AMPK and RAPTOR and protein level of PINK (P<0.01). The administration of Guilu Tianjing Capsules led to downregulations in the phosphorylation levels of AMPK and RAPTOR and protein level of PINK1 (P<0.01). However, the protein levels of AMPK and RAPTOR demonstrated no significant difference between before and after treatment. During the study period, neither group of patients exhibited any notable adverse reactions. ConclusionGuilu Tianjing capsules can enhance the sperm motility and percentage of normal mitochondrial membrane potential in asthenozoospermia patients with the syndrome of kidney essence deficiency by downregulating the AMPK/mTORC1 signaling pathway, lowering the protein level of PINK1, and inhibiting excessive activation of mitophagy.
8.Clinical Efficacy of Tonifying Kidney and Replenishing Essence on Asthenospermia Patients with Syndrome of Kidney Essence Deficiency and Effect of This Method on Expression Levels of AMPK/mTORC1 Signaling Pathway-associated Proteins
Yuanjie FU ; Fuhao LI ; Chenghua PENG ; Dong XU ; Guoan YIN ; Xiaopeng HUANG ; Degui CHANG ; Liang DONG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):141-147
ObjectiveTo observe the clinical efficacy of tonifying kidney and replenishing essence on asthenozoospermia patients with the syndrome of kidney essence deficiency and the effects of this method on the adenosine 5′-monophosphate-activated protein kinase (AMPK)/mammalian target of rapamycin complex 1 (mTORC1) signaling pathway. MethodsSeventy-two eligible asthenozoospermia patients with the syndrome of kidney essence deficiency treated in the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine from February 2023 to January 2024 were selected and randomly assigned into an observation group and a control group, with 36 patients in each group. The observation group received oral administration of Guilu Tianjing capsules, while the control group received oral administration of L-carnitine oral solution. The treatment course lasted for 4 weeks in both groups. The observed indicators included sperm progressive motility rate (PR), total sperm motility (PR+NP), percentage of normal mitochondrial membrane potential (MMP), and traditional Chinese medicine (TCM) symptom scores before and after treatment in both groups. A three-month follow-up was instituted to record the conception status of the patients’ spouses. Additionally, eight patients were randomly selected from the eligible patients in the observation group, and four healthy males with normal semen routine examination results were included as the control group for the determination of protein expression. Western blotting was conducted to assess the expression of AMPK, phosphorylated (p)-AMPK, regulatory-associated protein of mTOR (RAPTOR) and p-RAPTOR, and PTEN-induced putative kinase 1 (PINK1) in sperms from the observation group before and after treatment, as well as in the sperms of the control group. ResultsThe pregnancy rate of spouses in the observation group was 9.09% (3/33), which was higher than that (3.33%, 1/30) in the control group. The total response rate was 84.8% (28/33) in the observation group and 66.7% (20/30) in the control group, with no statistically significant difference. After treatment, both groups were improved considering PR, PR+NP, MMP, and TCM symptom scores (P<0.01). Moreover, the observation group exhibited more pronounced decreases in TCM symptom scores than the control group (P<0.05), while the changes in PR, PR+NP, and MMP showed no statistical significance between groups. Compared with the control group, the asthenozoospermia group exhibited upregulations in phosphorylation levels of AMPK and RAPTOR and protein level of PINK (P<0.01). The administration of Guilu Tianjing Capsules led to downregulations in the phosphorylation levels of AMPK and RAPTOR and protein level of PINK1 (P<0.01). However, the protein levels of AMPK and RAPTOR demonstrated no significant difference between before and after treatment. During the study period, neither group of patients exhibited any notable adverse reactions. ConclusionGuilu Tianjing capsules can enhance the sperm motility and percentage of normal mitochondrial membrane potential in asthenozoospermia patients with the syndrome of kidney essence deficiency by downregulating the AMPK/mTORC1 signaling pathway, lowering the protein level of PINK1, and inhibiting excessive activation of mitophagy.
9.Role of miR-140-5p/BCL2L1 in apoptosis and autophagy of HFOB1.19 and effect of Bushen Jianpi Huoxue Decoction.
Tong-Ying CHEN ; Sai FU ; Xiao-Yun LI ; Shu-Hua LIU ; Yi-Fu YANG ; Dong-Sheng YANG ; Yun-Jie ZENG ; Yang-Bo LI ; Dan LUO ; Hong-Xing HUANG ; Lei WAN
China Journal of Chinese Materia Medica 2025;50(3):583-589
Osteoporosis(OP) is a senile bone disease characterized by an imbalance between bone remodeling and bone formation. Targeting pathogenesis of kidney deficiency, spleen deficiency, and blood stasis, Bushen Jianpi Huoxue Decoction has a significant effect on the treatment of OP by tonifying kidney, invigorating spleen, and activating blood circulation. MicroRNA(miRNA) and the anti-apoptotic protein B-cell lymphoma-2-like protein 1(BCL2L1) are closely related to bone cell metabolism. Therefore, in this study, the binding of miR-140-5p to BCL2L1 was detected by dual luciferase assay and polymerase chain reaction(PCR). After silencing or overexpressing miR-140-5p, the apoptosis, autophagy, and osteogenic function of human fetal osteoblast cell line 1.19(HFOB1.19) were observed by flow cytometry and Western blot. Bushen Jianpi Huoxue Decoction-containing serum was prepared by intragastric administration of Bushen Jianpi Huoxue Decoction in rats. Different concentrations of Bushen Jianpi Huoxue Decoction-containing serum were used to treat HFOB1.19 with or without miR-140-5p mimic. The expression of osteogenic proteins in each group was observed, and the role of miR-140-5p/BCL2L1 in apoptosis and autophagy of HFOB1.19 was studied, along with the effect of Bushen Jianpi Huoxue Decoction on these processes. As indicated by the dual luciferase assay, miR-140-5p bound to BCL2L1. Flow cytometry and Western blot showed that miR-140-5p promoted apoptosis and inhibited autophagy in HFOB1.19. After intervention with high, medium, and low doses of Bushen Jianpi Huoxue Decoction-medicated serum, compared with the miR-140-5p NC group, the expression of osteocalcin(OCN), osteopontin(OPN), Runt-related transcription factor 2(RUNX2), and transforming growth factor beta 1(TGF-β1) decreased in the miR-140-5p mimic group, while the expression of bone morphogenetic protein 2(BMP2) showed no significant difference under high-dose intervention. Therefore, miR-140-5p/BCL2L1 can promote apoptosis and inhibit autophagy in HFOB1.19. Bushen Jianpi Huoxue Decoction can affect the osteogenic effect of miR-140-5p through BMP2.
MicroRNAs/metabolism*
;
Autophagy/drug effects*
;
Apoptosis/drug effects*
;
Humans
;
Drugs, Chinese Herbal/administration & dosage*
;
Animals
;
Cell Line
;
bcl-X Protein/metabolism*
;
Osteoblasts/metabolism*
;
Rats
;
Osteoporosis/physiopathology*
;
Male
;
Rats, Sprague-Dawley
;
Osteogenesis/drug effects*
10.Analysis and application thinking of standards for 500 kinds of traditional Chinese medicine formula granules on base of industrial practice.
Yong LIU ; Jun ZHANG ; Xin-Hai DONG ; Lin ZHOU ; Dong-Mei SUN ; Fu-Lin MAO ; Zhen-Yu LI ; Lei HUANG ; Jin-Lai LIU
China Journal of Chinese Materia Medica 2025;50(5):1427-1436
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*


Result Analysis
Print
Save
E-mail