1.Severity Assessment Parameters and Diagnostic Technologies of Obstructive Sleep Apnea
Zhuo-Zhi FU ; Ya-Cen WU ; Mei-Xi LI ; Ping-Ping YIN ; Hai-Jun LIN ; Fu ZHANG ; Yu-Xiang YANG
Progress in Biochemistry and Biophysics 2025;52(1):147-161
Obstructive sleep apnea (OSA) is an increasingly widespread sleep-breathing disordered disease, and is an independent risk factor for many high-risk chronic diseases such as hypertension, coronary heart disease, stroke, arrhythmias and diabetes, which is potentially fatal. The key to the prevention and treatment of OSA is early diagnosis and treatment, so the assessment and diagnostic technologies of OSA have become a research hotspot. This paper reviews the research progresses of severity assessment parameters and diagnostic technologies of OSA, and discusses their future development trends. In terms of severity assessment parameters of OSA, apnea hypopnea index (AHI), as the gold standard, together with the percentage of duration of apnea hypopnea (AH%), lowest oxygen saturation (LSpO2), heart rate variability (HRV), oxygen desaturation index (ODI) and the emerging biomarkers, constitute a multi-dimensional evaluation system. Specifically, the AHI, which measures the frequency of sleep respiratory events per hour, does not fully reflect the patients’ overall sleep quality or the extent of their daytime functional impairments. To address this limitation, the AH%, which measures the proportion of the entire sleep cycle affected by apneas and hypopneas, deepens our understanding of the impact on sleep quality. The LSpO2 plays a critical role in highlighting the potential severe hypoxic episodes during sleep, while the HRV offers a different perspective by analyzing the fluctuations in heart rate thereby revealing the activity of the autonomic nervous system. The ODI provides a direct and objective measure of patients’ nocturnal oxygenation stability by calculating the number of desaturation events per hour, and the biomarkers offers novel insights into the diagnosis and management of OSA, and fosters the development of more precise and tailored OSA therapeutic strategies. In terms of diagnostic techniques of OSA, the standardized questionnaire and Epworth sleepiness scale (ESS) is a simple and effective method for preliminary screening of OSA, and the polysomnography (PSG) which is based on recording multiple physiological signals stands for gold standard, but it has limitations of complex operations, high costs and inconvenience. As a convenient alternative, the home sleep apnea testing (HSAT) allows patients to monitor their sleep with simplified equipment in the comfort of their own homes, and the cardiopulmonary coupling (CPC) offers a minimal version that simply analyzes the electrocardiogram (ECG) signals. As an emerging diagnostic technology of OSA, machine learning (ML) and artificial intelligence (AI) adeptly pinpoint respiratory incidents and expose delicate physiological changes, thus casting new light on the diagnostic approach to OSA. In addition, imaging examination utilizes detailed visual representations of the airway’s structure and assists in recognizing structural abnormalities that may result in obstructed airways, while sound monitoring technology records and analyzes snoring and breathing sounds to detect the condition subtly, and thus further expands our medical diagnostic toolkit. As for the future development directions, it can be predicted that interdisciplinary integrated researches, the construction of personalized diagnosis and treatment models, and the popularization of high-tech in clinical applications will become the development trends in the field of OSA evaluation and diagnosis.
2.Identification of Alumen and Ammonium alum Based on XRD, FTIR, TG-DTA Combined with Chemometrics
Bin WANG ; Jingwei ZHOU ; Huangsheng ZHANG ; Jian FENG ; Hanxi LI ; Guorong MEI ; Jiaquan JIANG ; Hongping CHEN ; Fu WANG ; Yuan HU ; Youping LIU ; Shilin CHEN ; Lin CHEN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):178-186
ObjectiveTo establish the multi-technique characteristic profiles of Alumen by X-ray diffraction(XRD), Fourier-transform infrared spectroscopy(FTIR) and thermogravimetric-differential thermal analysis(TG-DTA), and to explore the spectral characteristics for rapid identification of Alumen and its potential adulterant, Ammonium alum. MethodsA total of 27 batches of Alumen samples from 8 production regions were collected for preliminary identification based on visual characteristics. The PDF standard cards of XRD were used to differentiate Alumen from A. alum, and the XRD characteristic profiles of Alumen were established, and then the common peaks were screened. Based on hierarchical clustering analysis(HCA) and orthogonal partial least squares-discriminant analysis(OPLS-DA), the characteristic information that could be used for identification of Alumen was selected with variable importance in the projection(VIP) value>1. FTIR characteristic profiles of Alumen were established, and key wavenumbers for identification were screened by HCA and OPLS-DA with VIP value>1. Meanwhile, the thermogravimetric differences between Alumen and A. alum were analyzed by TG-DTA, and the thermogravimetric traits that could be used for identification were screened. ResultsAlumen and A. alum could not be effectively distinguished by traits alone. However, by comparing the PDF standard cards of XRD, 15 batches of Alumen and 12 batches of A. alum could be distinguished. In the XRD profiles, 10 characteristic peaks were confirmed, corresponding to diffraction angles of 14.560°, 24.316°, 12.620°, 32.122°, 17.898°, 34.642°, 27.496°, 46.048°, 40.697° and 21.973°. In the FTIR profiles, 4 wavenumber ranges(399.193-403.050, 1 186.010-1 471.420, 1 801.190-2 620.790, 3 612.020-3 997.710 cm-1) and 12 characteristic wavenumbers(1 428.994, 1 430.922, 1 432.851, 1 434.779, 1 436.708, 1 438.636, 1 440.565, 1 442.493, 1 444.422, 1 446.350, 1 448.279, 1 450.207 cm-1) were identified. In the TG-DTA profiles, there were characteristic decomposition peaks of ammonium ion and mass reduction features near 555.34 ℃ for A. alum. These characteristics could serve as important criteria for distinguishing the authenticity of Alumen. ConclusionXRD, FTIR and TG-DTA can be used to rapidly detect Alumen and A. alum, and combined with the discriminant features selected through chemometrics, the rapid and accurate identification of Alumen and A. alum can be achieved. The research findings provide new approaches for the rapid identification of Alumen.
3.Identification of Alumen and Ammonium alum Based on XRD, FTIR, TG-DTA Combined with Chemometrics
Bin WANG ; Jingwei ZHOU ; Huangsheng ZHANG ; Jian FENG ; Hanxi LI ; Guorong MEI ; Jiaquan JIANG ; Hongping CHEN ; Fu WANG ; Yuan HU ; Youping LIU ; Shilin CHEN ; Lin CHEN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):178-186
ObjectiveTo establish the multi-technique characteristic profiles of Alumen by X-ray diffraction(XRD), Fourier-transform infrared spectroscopy(FTIR) and thermogravimetric-differential thermal analysis(TG-DTA), and to explore the spectral characteristics for rapid identification of Alumen and its potential adulterant, Ammonium alum. MethodsA total of 27 batches of Alumen samples from 8 production regions were collected for preliminary identification based on visual characteristics. The PDF standard cards of XRD were used to differentiate Alumen from A. alum, and the XRD characteristic profiles of Alumen were established, and then the common peaks were screened. Based on hierarchical clustering analysis(HCA) and orthogonal partial least squares-discriminant analysis(OPLS-DA), the characteristic information that could be used for identification of Alumen was selected with variable importance in the projection(VIP) value>1. FTIR characteristic profiles of Alumen were established, and key wavenumbers for identification were screened by HCA and OPLS-DA with VIP value>1. Meanwhile, the thermogravimetric differences between Alumen and A. alum were analyzed by TG-DTA, and the thermogravimetric traits that could be used for identification were screened. ResultsAlumen and A. alum could not be effectively distinguished by traits alone. However, by comparing the PDF standard cards of XRD, 15 batches of Alumen and 12 batches of A. alum could be distinguished. In the XRD profiles, 10 characteristic peaks were confirmed, corresponding to diffraction angles of 14.560°, 24.316°, 12.620°, 32.122°, 17.898°, 34.642°, 27.496°, 46.048°, 40.697° and 21.973°. In the FTIR profiles, 4 wavenumber ranges(399.193-403.050, 1 186.010-1 471.420, 1 801.190-2 620.790, 3 612.020-3 997.710 cm-1) and 12 characteristic wavenumbers(1 428.994, 1 430.922, 1 432.851, 1 434.779, 1 436.708, 1 438.636, 1 440.565, 1 442.493, 1 444.422, 1 446.350, 1 448.279, 1 450.207 cm-1) were identified. In the TG-DTA profiles, there were characteristic decomposition peaks of ammonium ion and mass reduction features near 555.34 ℃ for A. alum. These characteristics could serve as important criteria for distinguishing the authenticity of Alumen. ConclusionXRD, FTIR and TG-DTA can be used to rapidly detect Alumen and A. alum, and combined with the discriminant features selected through chemometrics, the rapid and accurate identification of Alumen and A. alum can be achieved. The research findings provide new approaches for the rapid identification of Alumen.
4.Prediction of lymph node metastasis in invasive lung adenocarcinoma based on radiomics of the primary lesion, peritumoral region, and tumor habitat: A single-center retrospective study
Hongchang WANG ; Yan GU ; Wenhao ZHANG ; Guang MU ; Wentao XUE ; Mengen WANG ; Chenghao FU ; Liang CHEN ; Mei YUAN ; Jun WANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(08):1079-1085
Objective To predict the lymph node metastasis status of patients with invasive pulmonary adenocarcinoma by constructing machine learning models based on primary tumor radiomics, peritumoral radiomics, and habitat radiomics, and to evaluate the predictive performance and generalization ability of different imaging features. Methods A retrospective analysis was performed on the clinical data of 1 263 patients with invasive pulmonary adenocarcinoma who underwent surgery at the Department of Thoracic Surgery, Jiangsu Province Hospital, from 2016 to 2019. Habitat regions were delineated by applying K-means clustering (average cluster number of 2) to the grayscale values of CT images. The peritumoral region was defined as a uniformly expanded area of 3 mm around the primary tumor. The primary tumor region was automatically segmented using V-net combined with manual correction and annotation. Subsequently, radiomics features were extracted based on these regions, and stacked machine learning models were constructed. Model performance was evaluated on the training, testing, and internal validation sets using the area under the receiver operating characteristic curve (AUC), F1 score, recall, and precision. Results After excluding patients who did not meet the screening criteria, a total of 651 patients were included. The training set consisted of 468 patients (181 males, 287 females) with an average age of (58.39±11.23) years, ranging from 29 to 78 years, the testing set included 140 patients (56 males, 84 females) with an average age of (58.81±10.70) years, ranging from 34 to 82 years, and the internal validation set comprised 43 patients (14 males, 29 females) with an average age of (60.16±10.68) years, ranging from 29 to 78 years. Although the habitat radiomics model did not show the optimal performance in the training set, it exhibited superior performance in the internal validation set, with an AUC of 0.952 [95%CI (0.87, 1.00)], an F1 score of 84.62%, and a precision-recall AUC of 0.892, outperforming the models based on the primary tumor and peritumoral regions. Conclusion The model constructed based on habitat radiomics demonstrated superior performance in the internal validation set, suggesting its potential for better generalization ability and clinical application in predicting lymph node metastasis status in pulmonary adenocarcinoma.
5.Telpegfilgrastim for chemotherapy-induced neutropenia in breast cancer: A multicenter, randomized, phase 3 study.
Yuankai SHI ; Qingyuan ZHANG ; Junsheng WANG ; Zhong OUYANG ; Tienan YI ; Jiazhuan MEI ; Xinshuai WANG ; Zhidong PEI ; Tao SUN ; Junheng BAI ; Shundong CANG ; Yarong LI ; Guohong FU ; Tianjiang MA ; Huaqiu SHI ; Jinping LIU ; Xiaojia WANG ; Hongrui NIU ; Yanzhen GUO ; Shengyu ZHOU ; Li SUN
Chinese Medical Journal 2025;138(4):496-498
6.Clinical practice guidelines for perioperative multimodality treatment of non-small cell lung cancer.
Wenjie JIAO ; Liang ZHAO ; Jiandong MEI ; Jia ZHONG ; Yongfeng YU ; Nan BI ; Lan ZHANG ; Lvhua WANG ; Xiaolong FU ; Jie WANG ; Shun LU ; Lunxu LIU ; Shugeng GAO
Chinese Medical Journal 2025;138(21):2702-2721
BACKGROUND:
Lung cancer is currently the most prevalent malignancy and the leading cause of cancer deaths worldwide. Although the early stage non-small cell lung cancer (NSCLC) presents a relatively good prognosis, a considerable number of lung cancer cases are still detected and diagnosed at locally advanced or late stages. Surgical treatment combined with perioperative multimodality treatment is the mainstay of treatment for locally advanced NSCLC and has been shown to improve patient survival. Following the standard methods of neoadjuvant therapy, perioperative management, postoperative adjuvant therapy, and other therapeutic strategies are important for improving patients' prognosis and quality of life. However, controversies remain over the perioperative management of NSCLC and presently consensus and standardized guidelines are lacking for addressing critical clinical issues in multimodality treatment.
METHODS:
The working group consisted of 125 multidisciplinary experts from thoracic surgery, medical oncology, radiotherapy, epidemiology, and psychology. This guideline was developed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. The clinical questions were collected and selected based on preliminary open-ended questionnaires and subsequent discussions during the Guideline Working Group meetings. PubMed, Web of Science, Cochrane Library, Scopus, and China National Knowledge Infrastructure (CNKI) were searched for available evidence. The GRADE system was used to evaluate the quality of evidence and grade the strengths of recommendations. Finally, the recommendations were developed through a structured consensus-building process.
RESULTS:
The Guideline Development Group initially collected a total of 62 important clinical questions. After a series of consensus-building conferences, 24 clinical questions were identified and corresponding recommendations were ultimately developed, focusing on neoadjuvant therapy, perioperative management, adjuvant therapy, postoperative psychological rehabilitation, prognosis assement, and follow-up protocols for NSCLC.
CONCLUSIONS
This guideline puts forward reasonable recommendations focusing on neoadjuvant therapy, perioperative management, adjuvant therapy, postoperative psychological rehabilitation, prognosis assessment, and follow-up protocol of NSCLC. It standardizes perioperative multimodality treatment and provides guidance for clinical practice among thoracic surgeons, medical oncologists, and radiotherapists, aiming to reduce postoperative recurrence, improve patient survival, accelerate recovery, and minimize postoperative complications such as atelectasis.
Humans
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Carcinoma, Non-Small-Cell Lung/therapy*
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Lung Neoplasms/therapy*
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Combined Modality Therapy
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Perioperative Care
7.Disulfiram alleviates cardiac hypertrophic injury by inhibiting TAK1-mediated PANoptosis.
Wei-Dong LI ; Xuan-Yang SHEN ; Xiao-Lu JIANG ; Hong-Fu WEN ; Yuan SHEN ; Mei-Qi ZHANG ; Wen-Tao TAN
Acta Physiologica Sinica 2025;77(2):222-230
The study aims to examine the effects and potential mechanisms of disulfiram (DSF) on cardiac hypertrophic injury, focusing on the role of transforming growth factor-β-activated kinase 1 (TAK1)-mediated pan-apoptosis (PANoptosis). H9C2 cardiomyocytes were treated with angiotensin II (Ang II, 1 µmol/L) to establish an in vitro model of myocardial hypertrophy. DSF (40 µmol/L) was used to treat cardiomyocyte hypertrophic injury models, either along or in combination with the TAK1 inhibitor, 5z-7-oxozeaenol (5z-7, 0.1 µmol/L). We assessed cell damage using propidium iodide (PI) staining, measured cell viability with CCK8 assay, quantified inflammatory factor levels in cell culture media via ELISA, detected TAK1 and RIPK1 binding rates using immunoprecipitation, and analyzed the protein expression levels of key proteins in the TAK1-mediated PANoptosis pathway using Western blot. In addition, the surface area of cardiomyocytes was measured with Phalloidin staining. The results showed that Ang II significantly reduced the cellular viability of H9C2 cardiomyocytes and the binding rate of TAK1 and RIPK1, significantly increased the surface area of H9C2 cardiomyocytes, PI staining positive rate, levels of inflammatory factors [interleukin-1β (IL-1β), IL-18, and tumor necrosis factor α (TNF-α)] in cell culture media and p-TAK1/TAK1 ratio, and significantly up-regulated key proteins in the PANoptosis pathway [pyroptosis-related proteins NLRP3, Caspase-1 (p20), and GSDMD-N (p30), apoptosis-related proteins Caspase-3 (p17), Caspase-7 (p20), and Caspase-8 (p18), as well as necroptosis-related proteins p-MLKL, RIPK1, and RIPK3]. DSF significantly reversed the above changes induced by Ang II. Both 5z-7 and exogenous IL-1β weakened these cardioprotective effects of DSF. These results suggest that DSF may alleviate cardiac hypertrophic injury by inhibiting TAK1-mediated PANoptosis.
Animals
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MAP Kinase Kinase Kinases/physiology*
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Rats
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Myocytes, Cardiac/pathology*
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Disulfiram/pharmacology*
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Cardiomegaly
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Apoptosis/drug effects*
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Cell Line
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Angiotensin II
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Necroptosis/drug effects*
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Interleukin-1beta/metabolism*
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Receptor-Interacting Protein Serine-Threonine Kinases/metabolism*
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Lactones
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Resorcinols
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Zearalenone/administration & dosage*
8.Effect of Eucommiae Cortex extract mediated by ERβ/JNK pathway on learning and memory ability of APP/PS1 double-transgenic mice.
Yue LI ; Li-Li ZHANG ; Can ZHAO ; Hong-Mei ZHAO ; Yan WANG ; Jin-Lei FU ; Jie ZHANG ; Ning ZHANG ; Hong-Dan XU
China Journal of Chinese Materia Medica 2025;50(2):285-293
To study the ameliorative effect of Eucommiae Cortex extract on spatial learning disabilities in APP/PS1 double-transgenic mice and explore its relationship with estrogen receptor β(ERβ)/c-Jun N-terminal kinase(JNK) signaling pathway, sixty 3-month-old male APP/PS1 mice were randomly divided into a model group, an anti-brain failure capsule group(0.585 g·kg~(-1)), a donepezil hydrochloride group(0.65 mg·kg~(-1)), and a Eucommiae Cortex extract group(1.3 g·kg~(-1)), and 15 C57BL/6 mice of the same genetic background were set as WT control group. The learning and memory ability of mice was assessed by the Morris water maze test(MWM), the passive avoidance test(PAT), and the novel object recognition test(NOR). The histomorphological and cellular ultrastructural features of the hippocampal region of the mice were observed by hematoxylin-eosin(HE) staining and transmission electron microscopy(TEM); the molecular docking validation of the key active ingredients and the key targets was performed by using AutoDock Vina software, and the immunohistochemical method(IHC) was used to detect the ERβ expression in the dentate gyrus(DG) area of mouse hippocampus. Western blot(WB) was utilized to detect the expression of ERβ, p-JNK, and JNK in mouse hippocampal area. Compared with those in the WT control group, the results of behavioral experiments showed that the latency of the mice in the model group was significantly increased, the number of platform traversals, and the target quadrant residence time were significantly decreased in the MWM. The evasion latency was significantly reduced, and the number of errors was significantly increased in the PAT. The index of recognition of novel objects was significantly reduced in the NOR. The results of HE staining indicated that the hippocampal area of mice in the model group showed a decrease in the number of neurons, disorganization of pyramidal cell arrangement, nucleus consolidation, and other changes. TEM results showed that some neuronal nuclei in the hippocampal area had a consolidated state, slightly thickened and aberrant nuclear membranes, and fewer intracytoplasmic nidus bodies; the IHC results showed that the expression of ERβ in the hippocampal DG area of the mice was reduced. The WB results showed that the ERβ expression in the hippocampal tissue was decreased, and the p-JNK/JNK level was elevated. Compared with the model group, the Eucommiae Cortex extract group showed a significant decrease in latency, and increase in number of platform traversals and target quadrant residence time in the MWM, a significant increase in evasion latency and decrease in number of errors in the PAT, and a significant increase in the index of recognition of novel objects in the NOR. In addition, there was an increase in the number of neurons in the hippocampal area of mice. The pyramidal cells tended to be arranged in an orderly manner; the nuclei of neurons in the hippocampal area were in a better state; the expression of ERβ in the hippocampal DG area of the mice was elevated; the expression of ERβ in the hippocampal tissue was elevated, and the level of p-JNK/JNK was reduced. The effects of donepezil hydrochloride group and anti-brain failure capsule on APP/PS1 mice in terms of behavioral, HE, and TEM indexes were similar to those of Eucommiae Cortex extract, and there was no significant difference between donepezil hydrochloride group and the model group in IHC and WB experiments, and the results of molecular docking indicated that the estrogen-like components in Eucommiae Cortex extract were tightly bound to ERβ. In conclusion, the binding of Eucommiae Cortex extract to estrogen receptors, regulation of ERβ expression, and activation of ERβ/JNK signaling pathway may be one of the key mechanisms by which it improves the learning and memory ability of APP/PS1 mice.
Animals
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Male
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Mice
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Mice, Transgenic
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Memory/drug effects*
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Mice, Inbred C57BL
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Estrogen Receptor beta/genetics*
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Eucommiaceae/chemistry*
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Alzheimer Disease/psychology*
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Amyloid beta-Protein Precursor/metabolism*
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Presenilin-1/metabolism*
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Humans
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MAP Kinase Signaling System/drug effects*
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Drugs, Chinese Herbal/administration & dosage*
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Hippocampus/metabolism*
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Maze Learning/drug effects*
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Learning/drug effects*
9.Phase changes and quantity-quality transfer of raw material, calcined decoction pieces, and standard decoction of Ostreae Concha (Ostrea rivularis).
Hong-Yi ZHANG ; Jing-Wei ZHOU ; Jia-Wen LIU ; Wen-Bo FEI ; Shi-Ru HUANG ; Yu-Mei CHEN ; Chong-Yang LI ; Fei-Fei LI ; Qiao-Ling MA ; Fu WANG ; Yuan HU ; You-Ping LIU ; Shi-Lin CHEN ; Lin CHEN ; Hong-Ping CHEN
China Journal of Chinese Materia Medica 2025;50(5):1209-1223
The phase changes and quantity-quality transfer of 17 batches of Ostreae Concha(Ostrea rivularis) during the raw material-calcined decoction pieces-standard decoction process were analyzed. The content of calcium carbonate(CaCO_3), the main component, was determined by chemical titration, and the extract yield and transfer rate were calculated. The CaCO_3 content in the raw material, calcined decoction pieces, and standard decoction was 94.39%-98.80%, 95.03%-99.22%, and 84.58%-90.47%, respectively. The process of raw material to calcined decoction pieces showed the yield range of 96.85% to 98.55% and the CaCO_3 transfer rate range of 96.92% to 99.27%. The process of calcined decoction pieces to standard decoction showed the extract yield range of 2.86% to 5.48% and the CaCO_3 transfer rate range of 2.59% to 5.13%. The results of X-ray fluorescence(XRF) assay showed that the raw material, calcined decoction pieces, and standard decoction mainly contained Ca, Na, Mg, Si, Br, Cl, Al, Fe, Cr, Mn, and K. The chemometric results showed an increase in the relative content of Cr, Fe, and Si from raw material to calcined decoction pieces and an increase in the relative content of Mg, Al, Br, K, Cl, and Na from calcined decoction pieces to standard decoction. X-ray diffraction(XRD) was employed to establish XRD characteristic patterns of the raw material, calcined decoction pieces, and standard decoction. The XRD results showed that the main phase of all three was calcite, and no transformation of crystalline form or generation of new phase was observed. Fourier transform infrared spectroscopy(FTIR) was employed to establish the FTIR characteristic spectra of the raw material, calcined decoction pieces, and standard decoction. The FTIR results showed that the raw material had internal vibrations of O-H, C-H, C=O, C-O, and CO■ groups. Due to the loss of organic matter components after calcination, no information about the vibrations of C-H, C=O, and C-O groups was observed in the spectra of calcined decoction pieces and standard decoction. In summary, this study elucidated the quantity-quality transfer and phase changes in the raw material-calcined decoction pieces-standard decoction process by determining the CaCO_3 content, calculating the extract yield and transfer rate, and comparing the element changes, FTIR characteristic spectra, and XRD characteristic pattern. The results were reasonable and reliable, laying a foundation for the subsequent process research and quality control of the formula granules of calcined Ostreae Concha(O. rivularis Gould), and providing ideas and methods for the quality control of the whole process of raw material-decoction pieces-standard decoction-formula granules of Ostreae Concha and other testacean traditional Chinese medicine.
Drugs, Chinese Herbal/isolation & purification*
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Calcium Carbonate/analysis*
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Quality Control
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*
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Quality Control
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Medicine, Chinese Traditional/standards*
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China
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Drug Industry/standards*

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