1.Analysis on Quality Standard of Hedyotis Herba Dispensing Granules Based on Standard Decoction
Jinghua ZHANG ; Nana WU ; Yanan LYU ; Guiyun CAO ; Jiacheng XU ; Yongqiang LIN ; Xiaodi DONG ; Jinxin LI ; Zhaoqing MENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(10):210-217
ObjectiveTo establish the specific chromatogram and quantitative analysis of multi-components by single-marker(QAMS) based on linear calibration using two reference substances(LCTRS), explore the consistency between Hedyotis Herba dispensing granules and standard decoction, and evaluate the quality of the dispensing granules. MethodsHigh performance liquid chromatography(HPLC) specific chromatogram was established based on 15 batches of Hedyotis Herba standard decoction and 10 batches of the dispensing granules, and LCTRS was used to locate chromatographic peaks. The actual retention times of 7 characteristic peaks in the specific chromatogram was measured on 24 different types of C18 columns, taking deacetyl asperulosidic acid and asperulosidic acid as the dual standard compounds, the retention times of the other 5 characteristic peaks were predicted and validated. Based on this, QAMS was developed to determine the contents of four components(deacetyl asperulosidic acid, deacetyl asperulosidic acid methyl ester, asperulosidic acid, and p-coumaric acid). Then, the relative correction factors of deacetyl asperulosidic acid, deacetyl asperulosidic acid methyl ester and p-coumaric acid were calculated using the reference peak of asperulosidic acid in the dual standard compounds, and each component was quantified accordingly. Finally, the consistency between the dispensing granules and standard decoction was assessed by taking extract rate of the standard decoction, consistency of the specific chromatograms, contents and transfer rates of the indicator components as indexes, and the quality of the dispensing granules was evaluated. ResultsThere were 7 common peaks in the characteristic chromatogram of samples of Hedyotis Herba standard decoction and the dispensing granules, and four of them were identified by reference standards, namely deacetyl asperulosidic acid(peak 1), deacetyl asperulosidic acid methyl ester(peak 3), asperulosidic acid(peak 6) and p-coumaric acid(peak 7). The similarity between the dispensing granules and the standard decoction was >0.9. The absolute deviation in the predicted retention time for each component by LCTRS was lower than that of the relative retention time method. The extract rate of the 15 batches of Hedyotis Herba standard decoction ranged from 7.89% to 14.60%, the contents of deacetyl asperulosidic acid, deacetyl asperulosidic acid methyl ester, asperulosidic acid and p-coumaric acid were 6.62-19.70, 3.83-17.99, 1.57-6.69, 1.62-4.52 mg·g-1, and the transfer rates of these components from decoction pieces to the standard decoction were 22.89%-39.60%, 34.03%-62.24%, 24.25%-43.70%, and 40.58%-73.71%, respectively. The extract rate, index component contents and transfer rates from decoction pieces to the three batches of Hedyotis Herba dispensing granules(P1-P3), produced by manufacturer A, were similar to those of the standard decoction prepared from the same batch of decoction pieces, and all fell within the specified range. The contents of the 4 indicator components in 7 batches of the dispensing granules(P4-P10) from manufacturers B-E were all within the range of the content converted from the standard decoction based on the quantity of the dispensing granules. ConclusionThe established specific chromatogram and QAMS based on LCTRS are reasonable and reliable. Based on the evaluation indicators of standard decoction yield, consistency of specific chromatograms, contents and transfer rates of the four index components, the 10 batches of Hedyotis Herba dispensing granules from various manufacturers have exhibited good consistency with the standard decoction, indicating that the current production process is relatively reasonable.
2.Features of HBV RNA level in different stages of the natural history of chronic hepatitis B virus infection and its correlation with HBV DNA and HBsAg
Han GAO ; Juanli WU ; Yushuang ZHANG ; Yiheng ZHANG ; Lei WANG ; Tao LI ; Lixin ZHANG
Journal of Clinical Hepatology 2025;41(4):637-642
ObjectiveTo investigate the features of serum HBV RNA in different stages of the natural history of chronic hepatitis B virus (HBV) infection without antiviral treatment, as well as its correlation with serum HBV DNA and HBsAg. MethodsA total of 306 treatment-naïve patients with chronic HBV infection who attended Department of Infections Diseases and Hepatoloty, the Second Hospital of Shandong University from January 2023 to June 2024 were divided into six groups based on the different stages of natural history, i.e., HBeAg-positive chronic HBV infection group with 29 patients, HBeAg-positive chronic hepatitis B (CHB) group with 107 patients, HBeAg-negative chronic HBV infection group with 18 patients, HBeAg-negative CHB group with 60 patients, HBeAg-positive indeterminate-phase chronic HBV infection group with 7 patients, and HBeAg-negative indeterminate-phase chronic HBV infection group with 85 patients. Real-time isothermal RNA amplification was used to measure serum high-sensitivity HBV RNA. The Kruskal-Wallis H test was used for comparison between multiple groups of continuous data, while the Mann-Whitney U test was used for comparison between two groups. The Spearman method was used to investigate the correlation of HBV RNA with HBV DNA and HBsAg. ResultsThe HBeAg-positive chronic HBV infection group showed the highest level of serum HBV RNA [7.5 (7.4 — 7.9) log10 copies/mL], followed by the HBeAg-positive CHB group [7.4 (6.4 — 7.9) log10 copies/mL], the HBeAg-negative CHB group [4.5 (3.0 — 5.7) log10 copies/mL], and the HBeAg-negative chronic HBV infection group [1.0 (1.0 — 2.0) log10 copies/mL]; the HBeAg-positive indeterminate-phase chronic HBV infection group had a serum HBV RNA level of 3.9 (3.7 — 5.7) log10 copies/mL, and the HBeAg-negative indeterminate-phase chronic HBV infection group had a serum HBV RNA level of 2.0 (1.0 — 3.0) log10 copies/mL; there was a significant difference in serum HBV RNA level between the six groups (H=830.770, P<0.001). There was a significant difference in HBV RNA level between the HBeAg-positive chronic HBV infection group and all the other groups except the HBeAg-positive CHB group (all P<0.001). In the 306 patients with HBV infection, HBV RNA was strongly correlated with HBV DNA (r=0.92, P<0.001) and was moderately correlated with HBsAg (r=0.67, P<0.001). The correlation between serum HBV RNA and HBsAg in HBeAg-positive patients (r=0.61, P<0.001) was stronger than that in HBeAg-negative patients (r=0.31, P<0.001). For the patients with HBeAg-positive chronic HBV infection, the male patients with ALT>30 U/L and the female patients with ALT>19 U/L had a significantly lower serum HBV RNA level than the male patients with ALT≤30 U/L and the female patients with ALT≤19 U/L (P<0.001), and there was no significant difference in serum HBV RNA level between the latter group of patients and the HBeAg-positive CHB group (P>0.05). ConclusionIn patients with chronic HBV infection who do not receive antiviral therapy, there is a difference in serum HBV RNA level in different stages of natural history, and serum HBV RNA level has the strongest correlation with HBV DNA and a relatively weak correlation with HBsAg. In patients with HBeAg-positive chronic HBV infection, serum HBV RNA level in male patients with ALT>30 U/L and female patients with ALT>19 U/L are in the transition stage between HBeAg-positive chronic HBV infection and HBeAg-positive CHB.
3.Application of utricle function testing in different clinical stages of Meniere’s disease
Yuanling LI ; Xiaofei LI ; Yongdong SONG ; Yafeng LÜ ; Yueling CHEN ; Daogong ZHANG
Chinese Journal of Clinical Medicine 2025;32(2):171-176
Objective To explore the role of ocular vestibular evoked myogenic potential (oVEMP) and unilateral centrifugation subjective visual vertical (UC-SVV) tests in evaluating the utricular function of patients with Meniere’s disease (MD) at different clinical stages. Methods A total of 97 unilateral MD patients at Shandong Provincial ENT Hospital from July 2019 to September 2021 were selected. All patients underwent oVEMP, UC-SVV, and pure tone audiometry tests. MD patients were classified into clinical stages 1, 2, 3, and 4, with stages 1 and 2 defined as early stage and stages 3 and 4 as late stage. The results of utricular function tests (abnormal rates of oVEMP, UC-SVV, and oVEMP+UC-SVV) were compared among patients at different stages. Spearman correlation analysis was used to evaluate the correlation between utricular function and clinical staging. Results Among the 97 MD patients, the abnormal rate of oVEMP was 66.0% (64/97), and the abnormal rate of UC-SVV was 55.7% (54/97). The abnormal rates of oVEMP and oVEMP+UC-SVV in early-stage patients were significantly lower than those in late-stage patients (P<0.05), while the difference in UC-SVV abnormal rates between the two groups was not statistically significant. Intra-group comparisons showed that the abnormal rate of oVEMP+UC-SVV in stage 1 patients was significantly lower than that in stage 2 patients (P<0.05), without significant difference in the other indices. There were no significant differences among the three indices in stages 3 and 4 patients. Spearman correlation test results indicated that the abnormal rate of oVEMP (r=0.336, P=0.001) and the abnormal rate of oVEMP+UC-SVV (r=0.301, P=0.003) were weakly positively correlated with clinical staging, while there was no correlation between the abnormal rate of UC-SVV and clinical staging (r=0.022, P=0.832). Conclusions Both oVEMP and UC-SVV tests can assess utricular function in MD patients at different clinical stages. Their combination is helpful of early-stage (stages 1 and 2) MD diagnosis.
4.Quality Evaluation of Chuanxiong Rhizoma Dispensing Granules Based on HPLC Specific Chromatogram and Two Reference Substances for Determination of Multiple Components
Jinxin LI ; Xue DONG ; Shuai DUAN ; Guiyun CAO ; Jinghua ZHANG ; Yongfu LUAN ; Yongqiang LIN ; Xiaodi DONG ; Zhaoqing MENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):246-253
ObjectiveTo establish the specific chromatogram of Chuanxiong Rhizoma dispensing granules(CRdg), and to evaluate its quality by chemometrics and two reference substances for determination of multiple components(TRSDMC). MethodsHigh performance liquid chromatography(HPLC) specific chromatograms were established using 13 batches of CRdg from 7 manufacturers, and preliminary quality evaluation was performed by similarity evaluation and chemometrics analysis. Eight characteristic peaks in the specific chromatogram of CRdg were measured on 22 different types of C18 columns, and the actual retention times were recorded. Taking chlorogenic acid(peak 1) and senkyunolide A(peak 8) as double standard compounds, the retention times of the eight characteristic peaks were predicted by linear calibration using two reference substances(LCTRS), and the method was validated on three other columns of different brands. Taking chlorogenic acid as reference peak, the relative correction factor method(RCFM) was used to quantify cryptochlorogenic acid, caffeic acid, ferulic acid, senkyunolide I and senkyunolide A, and the results were compared with the external standard method(ESM). ResultsThe similarities of specific chromatograms of 13 batches of CRdg were all >0.90, and a total of 8 characteristic peaks were calibrated, and six of them were identified, including chlorogenic acid(peak 1), cryptochlorogenic acid(peak 2), caffeic acid(peak 3), ferulic acid(peak 5), senkyunolide I(peak 6) and senkyunolide A(peak 8). Through chemometric analysis, it was found that ferulic acid, chlorogenic acid, senkyunolide I and cryptochlorogenic acid were the main components causing quality difference in CRdg, and the accuracy of LCTRS in predicting the retention time of 8 characteristic peaks was superior to that of the relative retention time method(RRT). Further comparison of the results obtained from RCFM and ESM showed that there was no statistically significant difference between the two methods. ConclusionA quality evaluation method for CRdg based on HPLC specific chromatogram and TRSDMC is established, its qualitative accuracy is better than that of RRT, the quantitative accuracy is similar to that of ESM, and 4 quality-differentiated components among different manufacturers are found. This method is stable and reliable, and has reference value for the quality evaluation of other dispensing granules.
5.Quality Evaluation of Chuanxiong Rhizoma Dispensing Granules Based on HPLC Specific Chromatogram and Two Reference Substances for Determination of Multiple Components
Jinxin LI ; Xue DONG ; Shuai DUAN ; Guiyun CAO ; Jinghua ZHANG ; Yongfu LUAN ; Yongqiang LIN ; Xiaodi DONG ; Zhaoqing MENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):246-253
ObjectiveTo establish the specific chromatogram of Chuanxiong Rhizoma dispensing granules(CRdg), and to evaluate its quality by chemometrics and two reference substances for determination of multiple components(TRSDMC). MethodsHigh performance liquid chromatography(HPLC) specific chromatograms were established using 13 batches of CRdg from 7 manufacturers, and preliminary quality evaluation was performed by similarity evaluation and chemometrics analysis. Eight characteristic peaks in the specific chromatogram of CRdg were measured on 22 different types of C18 columns, and the actual retention times were recorded. Taking chlorogenic acid(peak 1) and senkyunolide A(peak 8) as double standard compounds, the retention times of the eight characteristic peaks were predicted by linear calibration using two reference substances(LCTRS), and the method was validated on three other columns of different brands. Taking chlorogenic acid as reference peak, the relative correction factor method(RCFM) was used to quantify cryptochlorogenic acid, caffeic acid, ferulic acid, senkyunolide I and senkyunolide A, and the results were compared with the external standard method(ESM). ResultsThe similarities of specific chromatograms of 13 batches of CRdg were all >0.90, and a total of 8 characteristic peaks were calibrated, and six of them were identified, including chlorogenic acid(peak 1), cryptochlorogenic acid(peak 2), caffeic acid(peak 3), ferulic acid(peak 5), senkyunolide I(peak 6) and senkyunolide A(peak 8). Through chemometric analysis, it was found that ferulic acid, chlorogenic acid, senkyunolide I and cryptochlorogenic acid were the main components causing quality difference in CRdg, and the accuracy of LCTRS in predicting the retention time of 8 characteristic peaks was superior to that of the relative retention time method(RRT). Further comparison of the results obtained from RCFM and ESM showed that there was no statistically significant difference between the two methods. ConclusionA quality evaluation method for CRdg based on HPLC specific chromatogram and TRSDMC is established, its qualitative accuracy is better than that of RRT, the quantitative accuracy is similar to that of ESM, and 4 quality-differentiated components among different manufacturers are found. This method is stable and reliable, and has reference value for the quality evaluation of other dispensing granules.
6.Modern Medicine Insights into Strengthening the Spleen and Resolving Dampness for Treating Spleen Deficiency with Dyslipidemia Based on the Theory of "the Spleen Governs the Dispersion of Essence"
Shijia LIU ; Yiguo WANG ; Qiming ZHANG
Journal of Traditional Chinese Medicine 2025;66(10):981-986
The traditional theory of "the spleen governs the dispersion of essence" refers to the spleen's pivotal role in distributing refined nutrients throughout the body. In traditional Chinese medicine (TCM), lipids are categorized under "gaozhi (膏脂)", and their transportation and metabolism via apolipoproteins are believed to be closely related to the spleen's dispersing function. The liver, which synthesizes apolipoproteins, is functionally linked to the spleen system in TCM. Impaired dispersion of essence by the spleen and disrupted transportation of gaozhi constitute the pathological mechanism of dyslipidemia due to spleen deficiency. Strengthening the spleen and resolving dampness is the core therapeutic principle. From the perspective of modern medicine, this may involve promoting hepatic functional recovery related to lipid metabolism, thereby enhancing lipid processing and reducing the levels of abnormally accumulated lipids in the bloodstream.
7.Compatibility Principle and Efficacy Characteristics of Fuzi Shanzhuyutang from Perspective of Tangye Jingfa Tu
Xuxiao LYU ; Mingyue QI ; Hui ZHANG ; Rui JIN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(12):210-216
Tangye Jingfa Tu is an important content in the ancient book Fuxingjue from Dunhuang, implying the fundamental principles of formula compatibility in traditional Chinese medicine (TCM). Our research group has delved into nearly 200 formulas (both classical and contemporary formulas) recorded in the Fangjixue under the theoretical framework of the deficiency or excess syndrome of five Zang-organs together with the reinforcing and reducing effects of Chinese medicinal materials of five flavors. We have initially elucidated the essential principles of the correspondence between formulas and syndromes, revealing the deep-level logic of medicinal material selection and compatibility, thus enriching the understanding about the core characteristics and essence of the diseases and syndromes targeted by formulas. The lunar year of 2024 is Jia Chen year. The formula recorded in Sanyin Jiyi Bingzheng Fanglun for treating the epidemic diseases characterized by excessive earth, prevalent dampness and wetness, and invasion of pathogenic factors into the kidney water in Jia Chen year is Fuzi Shanzhuyutang. Therefore, elucidating the compatibility principle of Fuzi Shanzhuyutang is of great significance for clinical prescription and medication modification in Jia Chen year. According to the Tangye Jingfa Tu theory on the deficiency or excess of syndrome of five Zang-organs and the reinforcing and reducing effects of Chinese medicinal materials of five flavors, this article dissects Fuzi Shanzhuyutang regarding the etiology and pathogenesis of the main indications, as well as the five-element properties and efficacy characteristics of Chinese medicinal materials constituting this formula. It explains the compatibility principles of Fuzi Shanzhuyutang and puts forward suggestions for modifying the formula to address different indications, providing a reference for guiding clinical syndrome differentiation and treatment.
8.Compatibility Principle and Efficacy Characteristics of Fuzi Shanzhuyutang from Perspective of Tangye Jingfa Tu
Xuxiao LYU ; Mingyue QI ; Hui ZHANG ; Rui JIN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(12):210-216
Tangye Jingfa Tu is an important content in the ancient book Fuxingjue from Dunhuang, implying the fundamental principles of formula compatibility in traditional Chinese medicine (TCM). Our research group has delved into nearly 200 formulas (both classical and contemporary formulas) recorded in the Fangjixue under the theoretical framework of the deficiency or excess syndrome of five Zang-organs together with the reinforcing and reducing effects of Chinese medicinal materials of five flavors. We have initially elucidated the essential principles of the correspondence between formulas and syndromes, revealing the deep-level logic of medicinal material selection and compatibility, thus enriching the understanding about the core characteristics and essence of the diseases and syndromes targeted by formulas. The lunar year of 2024 is Jia Chen year. The formula recorded in Sanyin Jiyi Bingzheng Fanglun for treating the epidemic diseases characterized by excessive earth, prevalent dampness and wetness, and invasion of pathogenic factors into the kidney water in Jia Chen year is Fuzi Shanzhuyutang. Therefore, elucidating the compatibility principle of Fuzi Shanzhuyutang is of great significance for clinical prescription and medication modification in Jia Chen year. According to the Tangye Jingfa Tu theory on the deficiency or excess of syndrome of five Zang-organs and the reinforcing and reducing effects of Chinese medicinal materials of five flavors, this article dissects Fuzi Shanzhuyutang regarding the etiology and pathogenesis of the main indications, as well as the five-element properties and efficacy characteristics of Chinese medicinal materials constituting this formula. It explains the compatibility principles of Fuzi Shanzhuyutang and puts forward suggestions for modifying the formula to address different indications, providing a reference for guiding clinical syndrome differentiation and treatment.
9.Investigation and Trend Prediction of Disease Burden of Hypertensionin the Elderly Population Globally and in China from 1990 to 2021
Xiaoxiao ZHAO ; Xiaohui LU ; Lixin KE ; Wulin GAO ; Xiangran MENG ; Lili REN ; Yunhan DING ; Qiang ZHANG ; Yangqin XUN ; Jibiao WU ; Cuncun LU
Medical Journal of Peking Union Medical College Hospital 2025;16(3):647-658
To analyze the disease burden of hypertension in the elderly population from 1990 to 2021 and to predict future trends in China and globally, thereby providing insights for public health decision-making regarding older adults with hypertension in China. Data on hypertension-related deaths and disability adjusted life years (DALYs) for individuals aged ≥60 years was extracted from the Global Burden of Disease (GBD)2021 database for the world, China, and five sociodemographic index (SDI) regions. Age-standardized mortality and DALYs rates for hypertension in the elderly population were calculated, and Joinpoint regression was used to assess trend changes of disease burden, with results reported as average annual percentage change (AAPC). Additionally, subgroup analyses were conducted based on age and sex. The relative impact of aging, population growth, and epidemiological changes on disease burden was analyzed using a three-factor decomposition method. Future projections for the disease burden from 2022 to 2040 were performed using a Bayesian model. From 1990 to 2021, both age-standardized mortality and DALYs rates for hypertension in the elderly population demonstrated a significant downward trend globally and in China (both AAPC values were negative, all Although age-standardized mortality and DALYs rates for hypertension among the elderly in China have shown a downward trend over the past three decades, the absolute burden remains substantial. There is an urgent need for the formulation and implementation of more effective public health policies and clinical interventions to address this critical public health challenge.
10.Experimental validation of the accuracy of reported dose-length product values in different CT scanner models
Bin YANG ; Shicai ZHANG ; Xiankai HUO ; Zhenhe LIU ; Pengcheng WANG
Chinese Journal of Radiological Health 2025;34(2):155-160
Objective To evaluate the accuracy of dose-length product (DLP) values in CT dose reports by comparing them with the DLP values measured using a pencil-type ionization chamber. Methods Experiments were conducted using four CT scanners with different detector row numbers from two manufacturers (A and B), along with a head phantom and a pencil-type ionization chamber. Other scanning parameters were fixed, while pairwise combinations of kV and mAs were tested. The DLP values were measured under various scanning conditions using the pencil-type ionization chamber (DLPmeasured) and the corresponding DLP values in CT dose reports were recorded (DLPreported). All data were subjected to statistical analysis. Results Differences were observed between DLPreported and DLPmeasured values. The smallest mean absolute value of ΔDLP was approximately 2.526 mGy·cm observed on the 40-row CT scanner of manufacturer A. There was a difference between the ΔDLPs of the four CT scanners. Both DLPreported and DLPmeasured exhibited a linear relationship with mAs. Conclusion The percentage errors between DLPreported and DLPmeasured values for all four CT scanners were within the national standard tolerance of 15%. DLP values in CT dose reports can serve as a reference for assessing patient radiation dose during scanning. However, for radiation dose-related research, data measured using dosimetric instruments such as pencil-type ionization chamber are recommended.

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