1.Invasion and Metastasis in Colorectal Cancer Mediated by Traditional Chinese Medicine via Cell Signaling Pathway: A Review
Min GUO ; Wenyan YU ; Naicheng ZHU ; Yuwei YAN ; Chen ZHONG ; Xiudan CHEN ; Nanxin LI ; Guojuan WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(4):323-330
Colorectal cancer is a common and malignant tumor in the digestive tract. Invasion and metastasis of cancer cells are key factors leading to the high mortality rate and postoperative recurrence of colorectal cancer. Chemotherapy is the main treatment method for preventing recurrence of this disease. However, there are many toxic side effects in clinical application, which seriously hinder the treatment process. Therefore, it is imperative to search for efficient and low-toxicity drugs. Traditional Chinese medicine (TCM) has a long history of treating colorectal cancer and offers advantages such as safety, effectiveness, multiple targets, multiple pathways and minimal toxic side effects, which have made it increasingly popular worldwide. According to TCM, the pathogenesis of colorectal cancer is rooted in both deficiency and excess. TCM formulas mainly focus on tonifying the body to address the invasion and metastasis of colorectal cancer, such as Jianpi compound, Jianpi Xiaoai decoction, and Bushen Jiedu Sanjie decoction. TCM monomers, such as emodin, berberine, and tanshinone, mainly focus on clearing heat and removing toxin, circulating blood and transforming stasis, and resolving swelling and dispersing nodules. Signaling pathways play a crucial role for analyzing invasion and metastasis, and research has shown that pathways such as Wnt/β-catenin, phosphatidylinositol-3 kinase/protein kinase (PI3K/Akt), Janus kinase 2/signal transduction and transcription activating factor 3 (JAK2/STAT3), nuclear factors-κB (NF-κB), vascular endothelial growth factor (VEGF) play important roles in the invasion and metastasis of colorectal cancer. The invasion and metastasis of colorectal cancer can be inhibited via regulating the key proteins and related factors in these pathways. In this review, we searched various literature databases, such as PubMed, China National Knowledge Infrastructure (CNKI), and VIP, using keywords such as "colorectal cancer", "signaling pathway", "invasion and metastasis", and "traditional Chinese medicine", to summarize and analyze the relevant pathways of TCM compounds and monomers against invasion and metastasis of colorectal cancer published in the past five years. The review aims to provide new insights and references for in-depth research on the therapy for invasion and metastasis of colorectal cancer and new drug development.
2.The level of HBV cccDNA in liver tissue and its clinical significance in patients in the convalescence stage of hepatitis B virus-related acute-on-chronic liver failure
Zhekai CAI ; Long XU ; Wenli LIU ; Yingqun XIAO ; Qingmei ZHONG ; Wei ZHANG ; Min WU
Journal of Clinical Hepatology 2025;41(1):57-62
ObjectiveTo investigate the expression level of HBV cccDNA in patients in the convalescence stage of hepatitis B virus-related acute-on-chronic liver failure (HBV-ACLF) and its correlation with HBV markers and liver histopathological changes. MethodsA total of 30 patients in the convalescence stage of HBV-ACL who were hospitalized in The Ninth Hospital of Nanchang from January 2015 to October 2023 were enrolled as liver failure group, and 9 patients with chronic hepatitis B (CHB), matched for sex and age, were enrolled as control group. The content of HBV cccDNA in liver tissue was measured, and its correlation with clinical data and laboratory markers was analyzed. The independent-samples t test or the Mann-Whitney U test was used for comparison of continuous data between two groups, and a one-way analysis of variance or the Kruskal-Wallis H test was used for comparison between multiple groups; the Fisher’s exact test was used for comparison of categorical data between groups. A Spearman correlation analysis was performed. ResultsThe liver failure group had a significantly lower content of HBV cccDNA in liver tissue than the control group (-0.92±0.70 log10 copies/cell vs -0.13±0.91 log10 copies/cell, t=2.761, P=0.009). In the liver failure group, there was no significant difference in the content of HBV cccDNA in liver tissue between the HBeAg-positive patients and the HBeAg-negative patients (P>0.05); there was no significant difference in the content of HBV cccDNA in liver tissue between the patients with different grades (G0-G2, G3, and G4) of liver inflammatory activity (P>0.05); there was no significant difference in the content of HBV cccDNA in liver tissue between the patients with different stages (S0-S2, S3, and S4) of liver fibrosis (P>0.05); there was no significant difference in the content of HBV cccDNA in liver tissue between the patients with negative HBV DNA and those with positive HBV DNA (P>0.05). For the liver failure group, the content of HBV cccDNA in liver tissue was positively correlated with the content of HBV DNA in liver tissue (r=0.426, P=0.043) and was not significantly correlated with the content of HBV DNA in serum (P>0.05). ConclusionThere is a significant reduction in the content of HBV cccDNA in liver tissue in the convalescence stage of HBV-ACLF. HBV cccDNA exists continuously and stably in liver tissue and can better reflect the persistent infection and replication of HBV than HBV DNA in serum and liver tissue.
3.Exploring Mechanism of Breast Cancer Prevention by Liuwei Dihuangwan, Erzhiwan and Zuoguiwan Based on Macrophage Phagocytosis
Lixiang ZHENG ; Yishan CHEN ; Wei QUAN ; Youbao ZHONG ; Zifeng GUO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(10):10-17
ObjectiveTo investigate the effects of three traditional Chinese medicine formulas for nourishing kidney Yin on the occurrence of breast cancer, including Zuoguiwan(ZGW), Liuwei Dihuangwan(LWDHW) and Erzhiwan(EZW), and to explore their preventive mechanisms from the phagocytic function of macrophages. MethodsTen-month-old post-breeding female mice were randomly divided into the blank group, soy isoflavone group(0.13 g·kg-1·d-1, mixed with feed), ZGW group(2.34 g·kg-1·d-1), LWDHW group(0.56 g·kg-1·d-1), and EZW group(4.68 g·kg-1·d-1). The mice were palpated every 3 d until the age of 18 months, and those with detected lumps were confirmed for tumor development through hematoxylin-eosin(HE) staining, and the incidence of breast cancer in mice was calculated. A total of 40 SPF-grade female SD rats were randomly divided into the blank serum group(physiological saline), ZGW drug-containing serum group(16.20 g·kg-1·d-1of ZGW), LWDHW drug-containing serum group(3.89 g·kg-1·d-1 of LWDHW) and EZW drug-containing serum group(32.40 g·kg-1·d-1 of EZW), each group was orally administered 3 times a day for 5 consecutive days. On the 5th day, blood was collected from the abdominal aorta 1 h after the last gavage to prepare drug-containing serum. The effect of drug-containing serum with different concentrations on the viability of RAW264.7 cells was assessed by cell counting kit-8(CCK-8). Taking 20% of drug-containing serum concentration as the research object, its effect on the expression levels of major histocompatibility complex-Ⅱ(MHC-Ⅱ), CD80 and CD86 on the surface of RAW264.7 cells was detected by immunofluorescence(IF), the phagocytic function of RAW264.7 cells was examined by flow cytometry, and the levels of interleukin-6(IL-6) and nitric oxide(NO) in RAW264.7 cells in the conditioned medium(CM) co culture system of 4T1 cells were detected by enzyme-linked immunosorbent assay(ELISA) and Griess assay. ResultsAfter prophylactic administration, the tumor incidence rates in the soy isoflavone group(4%), ZGW group(4%), LWDHW group(4%), and EZW group(6%) were lower than that in the blank group(8%). Compared with the blank serum group, the drug-containing serum of the three nourishing kidney Yin formulas could enhance the expression levels of MHC-Ⅱ, CD80 and CD86 on the surface of RAW264.7 cells, enhance phagocytic ability towards tumor cells, and reduce the content of IL-6 and increase the level of NO(P<0.05, P<0.01). ConclusionThe three nourishing kidney Yin formulas can reduce the incidence of tumor in mice, the mechanism may be related to activating RAW264.7 cells, increasing their phagocytosis to breast cancer cells, and regulating the secretion of IL-6 and NO.
4.Optimization of Processing Technology of Honey Bran-fried Rosae Laevigatae Fructus and Analysis of Its Mechanism in Treatment of Ulcerative Colitis
Bin LIU ; Lingyun ZHONG ; Hongbing LUO ; Qi DENG ; Fuyu XU ; Simin ZHONG ; Ying ZHOU ; Xide YE ; Feipeng GONG ; Yuncheng GU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(16):216-224
ObjectiveTo optimize the processing technology of honey bran-fried Rosae Laevigatae Fructus(h-RLF), formulate relevant quality standards, and explore its improving effect and mechanism on mice with ulcerative colitis(UC) induced by dextran sodium sulfate(DSS). MethodsTaking the content of polysaccharides and water-soluble extract as the indexes, L9(34) orthogonal test was used to optimize parameters of the amount of honey bran, frying time and frying temperature. The quality of 15 batches of h-RLF decoction pieces was evaluated according to the optimized process, and the inspection limit standard was preliminarily drawn up. Eighty SPF male Kunming mice were randomly divided into 8 groups, including the blank group, model group, mesalazine group(0.13 g·kg-1), RLF group(3.77 g·kg-1), bran-fried RLF group(3.77 g·kg-1), h-RLF low, medium and high dose groups(1.89, 3.77, 7.54 g·kg-1), with 10 mice in each group. The mice in the blank group were free to drink pure water, and the other groups were free to drink 3% DSS solution for 7 days to prepare UC mouse model. Each treatment group was given corresponding drugs by intragastric administration, and the blank and model groups were given equal volume of normal saline. The body weight of mice was recorded daily and the disease activity index(DAI) was calculated. After the administration, the colon tissues of mice were collected to observe the pathological changes by hematoxylin-eosin(HE) staining. The levels of tumor necrosis factor(TNF)-α, interleukin(IL)-1β, IL-6 and IL-10 in the colon of mice were detected by enzyme-linked immunosorbent assay(ELISA). Western blot was used to detect the expression levels of phosphorylation nuclear transcription factor-κB p65(p-NF-κB p65), Toll-like receptor 4(TLR4), p-p38 mitogen-activated protein kinase(p-p38 MAPK), p-extracellular signal-regulated kinase(p-ERK) and p-c-Jun N-terminal kinase(p-JNK) proteins in colon tissues. ResultsThe optimum processing technology of h-RLF was 20 g honey bran per 100 g RLF, and stir-frying at 200 ℃ for 8 min. The limit standard under the examination of h-RLF was preliminarily formulated as follows:the polysaccharide content should not be less than 25% based on anhydrous glucose(C6H12O6), the content of water-soluble extract should not be less than 38%, the moisture content should not be more than 12.0%, the total ash content should not be more than 5.0%, and the acid-insoluble ash content should not be more than 1.0%. The cluster heat map analysis showed that the quality of RLF from Huanggang, Hubei province was better. Animal experiments showed that compared with the blank group, the DAI score of the model group was significantly increased, the levels of TNF-α, IL-1β and IL-6 in the colon tissue were significantly increased, the IL-10 level was significantly decreased, the colonic mucosa was seriously damaged, accompanied by a large number of inflammatory cell infiltration, tissue congestion and a significant reduction in glands, and the expression levels of p-NF-κB p65, TLR4, p-p38 MAPK, p-ERK and p-JNK proteins were significantly increased(P<0.01). Compared with the model group, each administration group could alleviate the symptoms of colonic ulcer, the structure of colonic crypt was basically intact, and the glands were arranged in an orderly manner. Among them, the high-dose group of h-RLF had a better effect, which could significantly reduce the DAI score and the levels of TNF-α, IL-1β and IL-6 in colon tissue(P<0.01), and significantly increase the level of IL-10(P<0.01), alleviate the colonic mucosal injury, and effectively inhibit the expression levels of p-NF-κB p65, TLR4, p-p38 MAPK, p-ERK and p-JNK proteins(P<0.01). ConclusionThe key parameters of the processing technology of h-RLF are determined, and the optimized technology is stable and feasible. The established quality standard is simple and reliable, and can be used for the quality control. h-RLF can effectively alleviate DSS-induced UC, and its mechanism may be related to inhibiting the activation of NF-κB/TLR4/MAPK pathway.
5.Efficacy analysis of plasma exchange treatment for thymoma-associated myasthenia gravis
Miao HONG ; Dongdong CAI ; Caihui WEI ; Bing HU ; Kun XIAO ; Fangming RUAN ; Piaoping HU ; Aiping LE ; Zhanglin ZHANG ; Chang ZHONG
Chinese Journal of Blood Transfusion 2025;38(9):1188-1194
Objective: To evaluate the efficacy and safety of plasma exchange (PE) in thymoma-associated myasthenia gravis (MG), thereby to provide theoretical support for its application in the treatment of thymoma-associated MG. Methods: A total of 133 patients with thymoma-associated MG admitted from January 2018 to September 2024 were retrospectively analyzed. Patients were matched using propensity score to reduce selection bias, yielding 22 matched pairs for both PE group (n=22) and non-PE group (n=22). Patient characteristics including gender, age of disease onset, course of disease, history of thymoma resection, clinical absolute scores [clinical absolute scores (CAS) and clinical relative scores (CRS)], and synchronized immunotherapy regimen of the two groups were analyzed. The CAS scores before and after treatment were compared between the two groups, and the CRS was used to assess the treatment efficiency. Safety of the two treatment regimens were also compared. Continuous variables were compared using the t-test or ANOVA, while categorical data were compared by the chi-square test. Results: A total of 133 patients were included and divided into two groups according to whether they underwent plasma exchange treatment: the PE group (n=22) and the non-PE group (n=111). To exclude bias caused by large difference in the number of cases between the two groups, we performed propensity score matching. After matching, the number of cases in both groups was 22. There was no significant difference in baseline clinical characteristics between the two groups (P>0.05), including gender, age of onset, duration of disease course, history of thymectomy and baseline CAS score before treatment. Compared to the non-PE group, patients in the PE group showed more significant improvement in CAS score (5.09±1.95 vs 3.59±1.50, P<0.05) and a higher CRS score (75.00% vs 50.00%, P<0.001). Compared to the non-PE group, PE group had significantly longer ICU stay, longer hospital stay and higher hospitalization cost (P<0.05). There was no statistically significant difference in adverse events between the two groups during treatment (P>0.05). During long-term follow-up, both the PE and non-PE groups showed relatively low 1-, 3-, and 5-year recurrence rate, with no significant difference between the two groups (P>0.05). Conclusion: This study indicates that plasma exchange has clear value in the treatment of patients with thymoma-associated myasthenia gravis. It can not only significantly improve patients' muscle strength to alleviate motor dysfunction and enhance quality of life, but also does not significantly increase the incidence of adverse reactions. Therefore, it can be regarded as one of the preferred treatment options that achieve a "balance between efficacy and safety" for such patients, and provides an important basis for optimizing treatment strategies, improving prognosis, and promoting the application of subsequent treatment regimens.
6.Exploring Common Principles and Characteristic Differences in Stir-frying Through Varied Processing Techniques
Hong LIU ; Lingyun ZHONG ; Yanwen DENG ; Xingmei LU ; Shuo WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(22):282-290
As the core technology of processing, the stir-frying method of traditional Chinese medicine(TCM) realizes the regulation of efficacy of medicinal substances through the coordination of fire gradient and excipients. This study aims to systematically analyze the influence of different stir-frying degrees(stir-frying until yellow, stir-frying to brown, stir-frying to charcoal) and excipient types(solid excipients such as rice, wheat bran, soil, liquid excipients such as rice wine, vinegar, honey) on the physicochemical properties, efficacy and toxicity of TCM, summarizing their common regulatory mechanisms and characteristics. Then, the three-dimensional regulatory common mechanisms and five-dimensional regulatory specificity mechanisms of different stir-frying processes were obtained. The three-dimensional regulatory common mechanisms are as follows:①Thermal effects break down inherent barriers of medicinal materials and improve the dissolution of components. ②Inducing Maillard reaction, carbonization and other reactions of medicinal materials to promote the transformation of components. ③Combining the catalytic and harmonizing effects of excipients to achieve targeted enrichment of efficacious substances and precise control of toxic components. The five-dimensional regulatory specificity mechanisms manifest as:①The efficacy gradient pattern where stir-frying until yellow strengthens the spleen, stir-frying to brown aids digestion, and stir-frying to charcoal stops bleeding. ②According to the polarity difference and intrinsic properties, the liquid excipients form a directional synergistic mechanism of wine processing enhances ascending nature, ginger processing to warm and disperse, salt processing directs effects to the kidneys, vinegar processing targets the liver, honey processing imparts sweetness and moderation. ③Through porous structure and interfacial properties, solid excipients give the synergistic effect of rice processing for diarrhea relief, bran processing for stomach tonification, soil processing for warming the middle warmer, and clam powder/talcum powder/sand processing for texture optimization. ④Thermal effects induce decomposition/oxidation/polymerization and other reactions to reshape the material basis, directing changes in the efficacy. ⑤The targeted distribution of efficacy is regulated by component enrichment and meridian-guiding effect, and the meridian tropism is changed. The system, driven by thermal effect, excipient synergy and physicochemical reconstruction, integrates five-dimensional regulation of fire, solvent, interface, composition and distribution. It systematically explains the inherent law of efficacy-substance-process of traditional stir-frying, and provides theoretical basis and practical guidance for standardizing TCM processing and enhancing the efficacy.
7.Meridian sinew manipulation releasing technique combined with heat-sensitive moxibustion for 29 cases of simple obesity.
Yongsen ZHU ; Xilin OUYANG ; Genping ZHONG ; Menghui XIAO ; Lin JIAO
Chinese Acupuncture & Moxibustion 2025;45(7):918-922
OBJECTIVE:
To observe the clinical efficacy of meridian sinew manipulation releasing technique combined with heat-sensitive moxibustion for simple obesity.
METHODS:
Twenty-nine patients with simple obesity were selected, on the basis of the conventional treatment, the patients were treated with meridian sinew manipulation releasing technique on the affected meridian sinews in the abdomen and lower limbs, about 30 min a time. After releasing, using the moxibustion sensation localization method in the abdominal regions with high heat-sensitivity frequency (including acupoints such as Zhongwan [CV12], Tianshu [ST25], Qihai [CV6], Guanyuan [CV4]), 2 heat-sensitive acupoints were selected for moxibustion and moxibustion was applied at each acupoint for 40 min, or until the heat-sensitive moxibustion sensation disappeared. The patients were treated once every other day for a total of 20 times. The weight, body mass index (BMI), body fat rate, waist circumference and hip circumference of the patients before and after treatment were observed, and the clinical efficacy was evaluated after treatment.
RESULTS:
After treatment, the weight, BMI, body fat rate, waist circumference and hip circumference of the patients were decreased compared with those before treatment (P<0.05). The total effective rate was 93.1% (27/29).
CONCLUSION
Meridian sinew manipulation releasing technique combined with heat-sensitive moxibustion can effectively treat simple obesity, the treatment from the perspective of meridian sinews provides a new idea and plan for simple obesity.
Humans
;
Moxibustion
;
Female
;
Male
;
Obesity/physiopathology*
;
Adult
;
Middle Aged
;
Acupuncture Points
;
Meridians
;
Young Adult
;
Treatment Outcome
;
Aged
;
Combined Modality Therapy
8.Programmed death-ligand 1 tumor proportion score in predicting the safety and efficacy of PD-1/PD-L1 antibody-based therapy in patients with advanced non-small cell lung cancer: A retrospective, multicenter, observational study.
Yuequan SHI ; Xiaoyan LIU ; Anwen LIU ; Jian FANG ; Qingwei MENG ; Cuimin DING ; Bin AI ; Yangchun GU ; Cuiying ZHANG ; Chengzhi ZHOU ; Yan WANG ; Yongjie SHUI ; Siyuan YU ; Dongming ZHANG ; Jia LIU ; Haoran ZHANG ; Qing ZHOU ; Xiaoxing GAO ; Minjiang CHEN ; Jing ZHAO ; Wei ZHONG ; Yan XU ; Mengzhao WANG
Chinese Medical Journal 2025;138(14):1730-1740
BACKGROUND:
This study aimed to investigate programmed death-ligand 1 tumor proportion score in predicting the safety and efficacy of PD-1/PD-L1 antibody-based therapy in treating patients with advanced non-small cell lung cancer (NSCLC) in a real-world setting.
METHODS:
This retrospective, multicenter, observational study enrolled adult patients who received PD-1/PD-L1 antibody-based therapy in China and met the following criteria: (1) had pathologically confirmed, unresectable stage III-IV NSCLC; (2) had a baseline PD-L1 tumor proportion score (TPS); and (3) had confirmed efficacy evaluation results after PD-1/PD-L1 treatment. Logistic regression, Kaplan-Meier analysis, and Cox regression were used to assess the progression-free survival (PFS), overall survival (OS), and immune-related adverse events (irAEs) as appropriate.
RESULTS:
A total of 409 patients, 65.0% ( n = 266) with a positive PD-L1 TPS (≥1%) and 32.8% ( n = 134) with PD-L1 TPS ≥50%, were included in this study. Cox regression confirmed that patients with a PD-L1 TPS ≥1% had significantly improved PFS (hazard ratio [HR] 0.747, 95% confidence interval [CI] 0.573-0.975, P = 0.032). A total of 160 (39.1%) patients experienced 206 irAEs, and 27 (6.6%) patients experienced 31 grade 3-5 irAEs. The organs most frequently associated with irAEs were the skin (52/409, 12.7%), thyroid (40/409, 9.8%), and lung (34/409, 8.3%). Multivariate logistic regression revealed that a PD-L1 TPS ≥1% (odds ratio [OR] 1.713, 95% CI 1.054-2.784, P = 0.030) was an independent risk factor for irAEs. Other risk factors for irAEs included pretreatment absolute lymphocyte count >2.5 × 10 9 /L (OR 3.772, 95% CI 1.377-10.329, P = 0.010) and pretreatment absolute eosinophil count >0.2 × 10 9 /L (OR 2.006, 95% CI 1.219-3.302, P = 0.006). Moreover, patients who developed irAEs demonstrated improved PFS (13.7 months vs. 8.4 months, P <0.001) and OS (28.0 months vs. 18.0 months, P = 0.007) compared with patients without irAEs.
CONCLUSIONS
A positive PD-L1 TPS (≥1%) was associated with improved PFS and an increased risk of irAEs in a real-world setting. The onset of irAEs was associated with improved PFS and OS in patients with advanced NSCLC receiving PD-1/PD-L1-based therapy.
Humans
;
Carcinoma, Non-Small-Cell Lung/metabolism*
;
Male
;
Female
;
Retrospective Studies
;
Middle Aged
;
Lung Neoplasms/metabolism*
;
Aged
;
B7-H1 Antigen/metabolism*
;
Programmed Cell Death 1 Receptor/metabolism*
;
Adult
;
Aged, 80 and over
;
Immune Checkpoint Inhibitors/therapeutic use*
9.Research progress on pharmacological effects and mechanism of α-asarone and β-asarone in Acori Tatarinowii Rhizoma.
Hao WANG ; Lei GAO ; Jin-Lian ZHANG ; Ling-Yun ZHONG ; Shu-Han JIN ; Xiao-Yan CHEN ; Wen ZHANG ; Jia-Wen WEN
China Journal of Chinese Materia Medica 2025;50(9):2305-2316
Acori Tatarinowii Rhizoma is the dried rhizome of Acorus tatarinowii in the family of Tennantiaceae, which has the efficacy of opening up the orifices and expelling phlegm, awakening the mind and wisdom, and resolving dampness and opening up the stomach. Modern studies have shown that volatile oil is the main active ingredient of Acori Tatarinowii Rhizoma, and α-asarone and β-asarone have been proved to be the active ingredients in the volatile oil of Acori Tatarinowii Rhizoma, with pharmacological effects such as anti-Alzheimer's disease, antiepileptic, anti-Parkinson's disease, antidepressant, anticerebral ischemia/reperfusion injury, anti-thrombosis, lipid-lowering, and antitumor. By summarising and outlining the pharmacological effects of α-asarone and β-asarone and elucidating the possible mechanisms of their pharmacological effects, we can provide theoretical basis for the further research and clinical application of Acori Tatarinowii Rhizoma.
Allylbenzene Derivatives
;
Acorus/chemistry*
;
Anisoles/chemistry*
;
Rhizome/chemistry*
;
Drugs, Chinese Herbal/chemistry*
;
Humans
;
Animals
10.Research on software development and smart manufacturing platform incorporating near-infrared spectroscopy for measuring traditional Chinese medicine manufacturing process.
Yan-Fei WU ; Hui XU ; Kai-Yi WANG ; Hui-Min FENG ; Xiao-Yi LIU ; Nan LI ; Zhi-Jian ZHONG ; Ze-Xiu ZHANG ; Zhi-Sheng WU
China Journal of Chinese Materia Medica 2025;50(9):2324-2333
Process analytical technology(PAT) is a key means for digital transformation and upgrading of the traditional Chinese medicine(TCM) manufacturing process, serving as an important guarantee for consistent and controllable TCM product quality. Near-infrared(NIR) spectroscopy has become the core technology for measuring the TCM manufacturing process. By incorporating NIR spectroscopy into PAT and starting from the construction of a smart platform for the TCM manufacturing process, this paper systematically described the development history and innovative application of the combination of NIR spectroscopy with chemometrics in measuring the TCM manufacturing process by the research team over the past two decades. Additionally, it explored the application of a validation method based on accuracy profile(AP) in the practice of NIR spectroscopy. Furthermore, the software development progress driven by NIR spectroscopy supported by modeling technology was analyzed, and the prospect of integrating NIR spectroscopy in smart factory control platforms was exemplified with the construction practices of related platforms. By integrating with the smart platform, NIR spectroscopy could improve production efficiency and guarantee product quality. Finally, the prospect of the smart platform application in measuring the TCM manufacturing process was projected. It is believed that the software development for NIR spectroscopy and the smart manufacturing platform will provide strong technical support for TCM digitalization and industrialization.
Spectroscopy, Near-Infrared/methods*
;
Drugs, Chinese Herbal/analysis*
;
Software
;
Medicine, Chinese Traditional
;
Quality Control

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