1.A Multi-dimensional Indicator-based Approach for Quality Evaluation of Chinese Patent Medicines
Shuangyan LI ; Siyuan LI ; Sha CHEN ; Yue GUO ; Jun ZHANG ; Cong GUO ; Yan LIU ; An LIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(19):229-237
Chinese patent medicines are the core preparations for disease prevention and treatment in clinical traditional Chinese medicine (TCM). Their quality is the key to ensuring safe and effective medication and promoting the high-quality development of the TCM industry. At present, the quality evaluation of Chinese patent medicines faces prominent problems, such as inadequate control of quality consistency, over-reliance on single indicators, one-sided evaluation dimensions, unstable statistical methods, and poor implementability of research findings. These defects lead to insufficient scientificity of evaluation results, making it difficult to support the implementation of policies including centralized procurement, high quality, and favorable prices for Chinese patent medicines. According to the core requirements of quality evaluation for Chinese patent medicines, this study established a four-dimensional comprehensive evaluation system encompassing consistency index(CI), content index(MI), effect index(EI), and preparation index(PI). All evaluation indicators were normalized to achieve horizontal comparability. Meanwhile, an improved radar chart was introduced to realize the visualization of evaluation results. This method can systematically integrate four types of core quality attributes: Quality consistency, component content, biological activity, and preparation characteristics. It can effectively distinguish quality differences among products of the same specification from different manufacturers. The evaluation results are unique, stable, and not affected by the addition or reduction of samples, which takes scientificity, objectivity, and operability into account. This method can provide scientific and technical support for screening high-quality Chinese patent medicines and implementing policies of centralized procurement, high quality, and favorable prices. Moreover, it has important practical significance for improving the quality evaluation system of Chinese patent medicines and advancing the standard and modern development of TCM.
2.Phenylpropanoids from roots of Berberis polyantha.
Dong-Mei SHA ; Shuai-Cong NI ; Li-Niu SHA-MA ; Hai-Xiao-Lin-Mo MA ; Xiao-Yong HE ; Bin HE ; Shao-Shan ZHANG ; Ying LI ; Jing WEN ; Yuan LIU ; Xin-Jia YAN
China Journal of Chinese Materia Medica 2025;50(6):1564-1568
The chemical constituents were systematically separated from the roots of Berberis polyantha by various chromatographic methods, including silica gel column chromatography, HP20 column chromatography, polyamide column chromatography, reversed-phase C_(18) column chromatography, and preparative high-performance liquid chromatography. The structures of the compounds were identified by physicochemical properties and spectroscopic techniques(1D NMR, 2D NMR, UV, MS, and CD). Four phenylpropanoids were isolated from the methanol extract of the roots of B. polyantha, and they were identified as(2R)-1-(4-hydroxy-3,5-dimethoxyphenyl)-1-propanone-O-β-D-glucopyranoside(1), methyl 4-hydroxy-3,5-dimethoxybenzoate(2),(+)-syringaresinol(3), and syringaresinol-4-O-β-D-glucopyranoside(4). Compound 1 was a new compound, and other compounds were isolated from this plant for the first time. The anti-inflammatory activity of these compounds was evaluated based on the release of nitric oxide(NO) in the culture of lipopolysaccharide(LPS)-induced RAW264.7 macrophages. At a concentration of 10 μmol·L~(-1), all the four compounds inhibited the LPS-induced release of NO in RAW264.7 cells, demonstrating potential anti-inflammatory properties.
Plant Roots/chemistry*
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Animals
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Mice
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Berberis/chemistry*
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RAW 264.7 Cells
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Macrophages/immunology*
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Drugs, Chinese Herbal/isolation & purification*
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Nitric Oxide/metabolism*
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Molecular Structure
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Anti-Inflammatory Agents/isolation & purification*
3.Analysis of Quality Difference Factors of Perillae Caulis Based on Chemometrics Combined with TOPSIS Model
Maoqing WANG ; Sha CHEN ; Qian MA ; Jun ZHANG ; Qingxia XU ; Cong GUO ; Rui SHEN ; Yan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(17):168-175
ObjectiveTo explore quality difference factors of Perillae Caulis based on the contents of multiple chemical components and comprehensively evaluate the quality. MethodsA total of 32 batches of Perillae Caulis samples were collected from 12 producing areas such as Hebei, Anhui and Guangdong, and their diameter range, epidermis color and producing areas were recorded. Total flavonoids, total phenols, volatile oils, 5 active components and 84 volatile components in 32 batches of samples were quantitatively or semi-quantitatively determined by colorimetry, ultra performance liquid chromatography-photodiode array detector(UPLC-PDA) and gas chromatography-mass spectrometry(GC-MS). Then the differences between the contents of these components were analyzed by principal component analysis(PCA) and non-parametric test. According to the weights of the index components determined by PCA model, entropy weight-technique for order preference by similarity to ideal solution(TOPSIS) model was constructed to evaluate the quality of Perillae Caulis with different characters and origins. ResultsThere were significant differences in the composition of Perillae Caulis with different diameters, epidermis colors and producing areas, and 9 differential components were screened out, including 6 index constituents(total flavonoids, total phenols, caffeic acid, scutellarin, rosmarinic acid and luteolin) and 3 volatile components(caryophyllene oxide, (-)-humulene epoxide Ⅱ, 14-hydroxycaryophyllene), of which 6 index constituents were higher in samples with small diameter, purple-brown epidermis and southern origin, while the contents of 3 volatile components were higher in samples with large diameter, dark-brown epidermis and northern origin. A significant difference was shown in the model scores of different diameters, epidermis colors and origins(P<0.05), and the scores of Perillae Caulis with small diameter and purple-brown epidermis from southern area, especially Guangdong, had a high score. ConclusionThere are significant differences in the composition and content of chemical constituents between different diameters, epidermal colors and production areas of Perillae Caulis, samples showing small diameter, owing purple-brown epidermis, and originating from Guangdong were of higher-quality due to their higher content of 8 key indices.
4.Analysis of Quality Difference Factors of Perillae Caulis Based on Chemometrics Combined with TOPSIS Model
Maoqing WANG ; Sha CHEN ; Qian MA ; Jun ZHANG ; Qingxia XU ; Cong GUO ; Rui SHEN ; Yan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(17):168-175
ObjectiveTo explore quality difference factors of Perillae Caulis based on the contents of multiple chemical components and comprehensively evaluate the quality. MethodsA total of 32 batches of Perillae Caulis samples were collected from 12 producing areas such as Hebei, Anhui and Guangdong, and their diameter range, epidermis color and producing areas were recorded. Total flavonoids, total phenols, volatile oils, 5 active components and 84 volatile components in 32 batches of samples were quantitatively or semi-quantitatively determined by colorimetry, ultra performance liquid chromatography-photodiode array detector(UPLC-PDA) and gas chromatography-mass spectrometry(GC-MS). Then the differences between the contents of these components were analyzed by principal component analysis(PCA) and non-parametric test. According to the weights of the index components determined by PCA model, entropy weight-technique for order preference by similarity to ideal solution(TOPSIS) model was constructed to evaluate the quality of Perillae Caulis with different characters and origins. ResultsThere were significant differences in the composition of Perillae Caulis with different diameters, epidermis colors and producing areas, and 9 differential components were screened out, including 6 index constituents(total flavonoids, total phenols, caffeic acid, scutellarin, rosmarinic acid and luteolin) and 3 volatile components(caryophyllene oxide, (-)-humulene epoxide Ⅱ, 14-hydroxycaryophyllene), of which 6 index constituents were higher in samples with small diameter, purple-brown epidermis and southern origin, while the contents of 3 volatile components were higher in samples with large diameter, dark-brown epidermis and northern origin. A significant difference was shown in the model scores of different diameters, epidermis colors and origins(P<0.05), and the scores of Perillae Caulis with small diameter and purple-brown epidermis from southern area, especially Guangdong, had a high score. ConclusionThere are significant differences in the composition and content of chemical constituents between different diameters, epidermal colors and production areas of Perillae Caulis, samples showing small diameter, owing purple-brown epidermis, and originating from Guangdong were of higher-quality due to their higher content of 8 key indices.
5.Cannabidiol alleviates methamphetamine addiction via targeting ATP5A1 and modulating the ATP-ADO-A1R signaling pathway.
Sha JIN ; Cong LIN ; Peipei LI ; Xue WANG ; Yibo WANG ; Cong ZHANG ; Xuenan WANG ; Yinghua PENG ; Haohong LI ; Yuyuan LU ; Xiaohui WANG
Acta Pharmaceutica Sinica B 2025;15(10):5261-5276
Cannabidiol (CBD), a non-psychoactive cannabinoid, shows great promise in treating methamphetamine (METH) addiction. Nonetheless, the molecular target and the mechanism through which CBD treats METH addiction remain unexplored. Herein, CBD was shown to counteract METH-induced locomotor sensitization and conditioned place preference. Additionally, CBD mitigated the adverse effects of METH, such as cristae loss, a decline in ATP content, and a reduction in membrane potential. Employing an activity-based protein profiling approach, a target fishing strategy was used to uncover CBD's direct target. ATP5A1, a subunit of ATP synthase, was identified and validated as a CBD target. Moreover, CBD demonstrated the ability to ameliorate METH-induced ubiquitination of ATP5A1 via the D376 residue, thereby reversing the METH-induced reduction of ATP5A1 and promoting the assembly of ATP synthase. Pharmacological inhibition of the ATP efflux channel pannexin 1, blockade of ATP hydrolysis by a CD39 inhibitor, and blocking the adenosine A1 receptor (A1R) all attenuated the therapeutic benefits of CBD in mitigating METH-induced behavioral sensitization and CPP. Moreover, the RNA interference of ATP5A1 in the ventral tegmental area resulted in the reversal of CBD's therapeutic efficacy against METH addiction. Collectively, these data show that ATP5A1 is a target for CBD to inhibit METH-induced addiction behaviors through the ADO-A1R signaling pathway.
6.Sinicization of Evidence-Informed Decision-Making Competence Measure for nurses and its reliability and validity test
Yongting WEI ; Shumei TIAN ; Jiao YANG ; Lianghuan YU ; Fu NI ; Yuqing FAN ; Yao XIAO ; Zuyang XI ; Juyan SHA ; Cong LIU
Chinese Journal of Nursing 2025;60(6):736-742
Objective To translate Evidence-Informed Decision-Making Competence Measure for Chinese nurses and test its validity and reliability.Methods A research group was set up to use the Brislin translation model to translate the original scale into Chinese,and the back translation,cross-cultural adaptation,pre-experiment and cognitive interview were conducted to finally form the Chinese version of the Evidence-Informed Decision-Making Competence Measure for nurses.A total of 1 247 nurses from 7 tertiary A hospitals in Beijing,Hubei,Hunan and Xinjiang were selected by convenience sampling method in April 2024 to test its reliability and validity.Results 1 026 effective question-naires were collected,with an effective recovery rate of 82.28%.The Chinese version of the Evidence-Informed Decision-Making Competence Measure included 25 items,including knowledge/skill,attitude and behavior.A total of 3 common factors were extracted from exploratory factor analysis,and the cumulative variance contribution rate was 91.725%.The content validity index at the item level was 0.83-1.00;the content validity index at the scale level was 0.988;the calibration association validity was 0.496.The Cronbach's α coefficient of the whole scale was 0.992;the half-point reliability was 0.930;the retest reliability was 0.927.Conclusion The Chinese version of Evidence-Informed Decision-Making Competence Measure for nurses has good reliability and validity,and it can be used to evaluate the evidence-informed decision-making competence of Chinese nurses,provide references for promoting evidence-based nursing practice and evidence-informed decision-making.
7.Sinicization of Evidence-Informed Decision-Making Competence Measure for nurses and its reliability and validity test
Yongting WEI ; Shumei TIAN ; Jiao YANG ; Lianghuan YU ; Fu NI ; Yuqing FAN ; Yao XIAO ; Zuyang XI ; Juyan SHA ; Cong LIU
Chinese Journal of Nursing 2025;60(6):736-742
Objective To translate Evidence-Informed Decision-Making Competence Measure for Chinese nurses and test its validity and reliability.Methods A research group was set up to use the Brislin translation model to translate the original scale into Chinese,and the back translation,cross-cultural adaptation,pre-experiment and cognitive interview were conducted to finally form the Chinese version of the Evidence-Informed Decision-Making Competence Measure for nurses.A total of 1 247 nurses from 7 tertiary A hospitals in Beijing,Hubei,Hunan and Xinjiang were selected by convenience sampling method in April 2024 to test its reliability and validity.Results 1 026 effective question-naires were collected,with an effective recovery rate of 82.28%.The Chinese version of the Evidence-Informed Decision-Making Competence Measure included 25 items,including knowledge/skill,attitude and behavior.A total of 3 common factors were extracted from exploratory factor analysis,and the cumulative variance contribution rate was 91.725%.The content validity index at the item level was 0.83-1.00;the content validity index at the scale level was 0.988;the calibration association validity was 0.496.The Cronbach's α coefficient of the whole scale was 0.992;the half-point reliability was 0.930;the retest reliability was 0.927.Conclusion The Chinese version of Evidence-Informed Decision-Making Competence Measure for nurses has good reliability and validity,and it can be used to evaluate the evidence-informed decision-making competence of Chinese nurses,provide references for promoting evidence-based nursing practice and evidence-informed decision-making.
8.Historical Evolution and Key Information Research on Pediatric Famous Classical Formula Yigongsan
Jiangmin SU ; Jun ZHANG ; Cong GUO ; Anyi ZHAO ; Liang JIANG ; Heng ZHANG ; Jipeng DI ; Sha CHEN ; Li LIU ; Yan LIU ; An LIU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(7):205-214
Yigongsan is derived from Xiaoer Yaozheng Zhijue written by QIAN Yi in the Northern Song dynasty, which is the No. 3 formula in the Catalogue of Ancient Famous Classical Formulas(The Second Batch of Pediatrics) released by the National Administration of Traditional Chinese Medicine(TCM) in September 2022, and it can be developed as a class 3.1 new TCM drug. By referring to ancient medical books and modern literature, this study conducted herbal textual research on Yigongsan from five aspects, including historical evolution, origin and processing, dosage conversion, usage and preparation methods, and functional application, then formed the key information table of this formula, in order to provide reference for the development of reference samples and preparations of Yigongsan. Based on the results of the study, it is recommended that Panax ginseng should be removed the basal part of stem(rhizoma), Poria cocos should be removed the peel, Citrus reticulata should be cut into shreds and Glycyrrhiza uralensis should be used. According to 4.13 g/Qian(钱), 1 g/slice for ginger, 3 g for each jujube and 300 mL/Zhan(盏), the doses of Ginseng Radix, Poria, Atractylodis Macrocephalae Rhizoma, Glycyrrhizae Radix et Rhizoma, Citri Reticulatae Pericarpium, Zingiberis Rhizoma Recens, Jujubae Fructus were 1.652, 1.652, 1.652, 1.652, 1.652, 5, 6 g, and the total amount was 19.26 g. The decocting method was to crush the medicinal materials into fine powder with 50-80 mesh, add 300 mL of water and decoct to 210 mL for each dose, then remove the dregs and take it warmly. This formula was recorded in ancient books as the main treatment for the cold-deficiency of spleen and stomach, and Qi stagnation in children with vomiting and diarrhea and lack of appetite. It has been flexibly applied by later generations of physicians, and is often used to treat anorexia, inflammation of the digestive tract, diarrhea and other diseases in children.
9.Circular RNA hsa_circUCK2 involved in regulation of pulmonary fibrosis induced by silicon dioxide
Cong ZHANG ; Wei LUO ; Sha WANG ; Jie CHAO
Journal of Environmental and Occupational Medicine 2024;41(4):362-366
Background Pulmonary fibrosis currently lacks screening and diagnostic methods in the early stages and effective treatments in the later stages, so there is an urgent need to explore the mechanisms and develop targeted treatments. Objective To screen the expression of differentially expressed circular RNA (circRNA) hsa_circUCK2 under pathological conditions and to explore its effect on pulmonary fibrosis. Methods In the cell-based experiments, hsa_circUCK2 was knocked down in HPF-a cells using small interfering RNA (siRNA), and HPF-a cells were stimulated by TGF-β1. Four groups were set up: si-NC group, si-circUCK2 group, si-NC+TGF-β1-treated group, and si-circUCK2+TGF-β1-treated group. Western blot assay was used to detect the expression of fibronectin (FN1) in HPF-a cells of the four groups, scratch assay was used to detect the migration ability of HPF-a cells, and CCK-8 assay was used to detect the proliferation ability of HPF-a cells in the two groups with TGF-β1 stimulation, the si-NC+TGF-β1-treated group and the si-circUCK2+TGF-β1-treated group. In the animal experiments, forty-eighty healthy SPF-grade male C57BL/6 mice were randomly divided into four groups: saline+si-con group, saline+si-circ_0000115 group, SiO2+si-con group, and SiO2+si-circ_0000115 group. Mouse lung circRNA mmu_circ_0000115 (mouse homolog of hsa_circUCK2) was knocked down by tracheal drip injection of siRNA, and a mouse lung fibrosis model was constructed by tracheal drip injection of SiO2 suspension (0.2 g·kg−1, 50 mg·mL−1) after 48 h. Real-time fluorescence quantitative PCR was used to detect the knockout efficiency in each organ of the mouse, Western blot was applied to detect the expression of type I collagen α2 (COL1A2) in the lung tissues, and Sirius red was used to detect collagen synthesis in the lung tissues. Results In the cell-based experiments, after the knockdown of hsa_circUCK2, the Western blot results showed that the expression level of the FN1 protein in TGF-β1-stimulated HPF-a cells was significantly down-regulated (P <0.05); the CCK-8 assay and cell scratch assay showed that the down-regulation of hsa_circUCK2 gene significantly inhibited the proliferation and migration of HPF-a cells (P<0.01). In the animal experiments, the real-time fluorescence quantitative PCR results showed that among the detected organs, mmu_circ_0000115 was significantly knocked down only in the lung tissues (P<0.0001); the Western blot results showed that knocking down mmu_circ_0000115 significantly reduced the COL1A2 protein expression level when compared with the SiO2+si-con group (P<0.0001); the Sirius red results showed that knocking down mmu_circ_0000115 significantly reduced collagen production and deposition in lung tissues of mice in the model group. Conclusion Knockdown of hsa_circUCK2 inhibits fibroblast activation and reduces collagen deposition in lung fibrosis model mice. It is suggested that the hsa_circUCK2 is involved in the process of pulmonary fibrosis and may be a potential therapeutic target for pulmonary fibrosis.
10.Quality Uniformity Analysis of 7 Commercially Available Yangyin Qingfei Preparations
Jiangmin SU ; Yongzhen LAO ; Sha CHEN ; Jun ZHANG ; Cong GUO ; Anyi ZHAO ; Jipeng DI ; An LIU ; Yan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(18):164-170
ObjectiveTo establish the fingerprint of seven commercially available Yangyin Qingfei preparations, to quantitatively analyze the index components, to evaluate their quality uniformity with multivariate statistical analysis, and to explore the quality differences among different dosage forms. MethodA total of 33 batches of commercially available 7 kinds of Yangyin Qingfei preparations were analyzed by high performance liquid chromatography(HPLC), the fingerprints were established and the common peaks were identified. Paeoniflorin, verbascoside, harpagoside, glycyrrhizic acid and paeonol were selected as the indicators of quality attributes to quantitatively analyze 33 batches of preparations. Based on the administration methods of Yangyin Qingfei preparations, the daily intake was calculated and the radar charts were poltted, and cluster analysis and principal component analysis were used to explore the quality differences of 7 kinds of Yangyin Qingfei preparations and the quality uniformity among different batches of the same dosage form. ResultThe similarity of fingerprints of 7 dosage forms was 0.248-0.956, suggesting that there were significant differences among different dosage forms of Yangyin Qingfei preparations, and a total of 15 common peaks were calibrated, of which peak 7, peak 8, peak 11, peak 13 and peak 15 were paeoniflorin, verbascoside, harpagoside, glycyrrhizic acid and paeonol, respectively. The radar plots showed that the average total daily intake of large honeyed pills and water honeyed pills was the highest, and the uniformity of pill components was better. The quality of 33 batches of samples was divided into poor quality and high quality by cluster analysis. Principal component analysis showed that the uniformity and dosage form of different dosage forms were significantly different, the oral liquid had the best quality homogeneity with the minimum dispersion. And the content of paeonol in different dosage forms was significantly different, which was the key component of quality control of Yangyin Qingfei preparations. ConclusionYangyin Qingfei large honeyed pills and water honeyed pills show high content and good uniformity, which are relatively preferred dosage forms. Different preparation processes have a great influence on the content of paeonol, and its quality control should be emphasized during production. This study provides a scientific method for the comparison of product quality of different dosage forms of traditional Chinese medicine prescriptions, which is helpful for the development of preferred dosage forms of different prescriptions, and provides a reference for efficient use of medication in the clinical practice.

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