1.Multi-component Quality Consistency Evaluation of Leonuri Herba Granules Based on HPLC-DAD-CAD Multi-detector Technique and Chemometrics
Shuangyan LI ; Jun ZHANG ; Cong GUO ; Siyuan LI ; Jipeng DI ; Jiangmin SU ; An LIU ; Xiaodi KOU ; Yan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):174-181
ObjectiveTo systematically evaluate the content differences of 4 components in Leonuri Herba granules, reveal the quality fluctuation patterns of products from the same and different manufacturers, providing scientific basis for the optimization of production process and quality control. MethodsHigh performance liquid chromatography-diode array detector-charged aerosol detector(HPLC-DAD-CAD) was employed to determine the contents of 4 components(syringic acid, leonurine hydrochloride, ferulic acid, and stachydrine hydrochloride) in samples from 19 manufacturers(53 batches, 159 boxes). Additionally, fingerprint profiles were constructed, and the fingerprint dissimilarity(PS) and relative standard deviation(RSD) of different samples from the same manufacturer were calculated. A principal component analysis(PCA) model was established with PS and the RSD values of the 4 components as variables to classify the manufacturers. Finally, samples from 5 manufacturers(M1-M5) covering three consistency groups were selected to calculate three quality consistency parameters, namely intra-batch consistency(PA), inter-batch consistency(PB), and PS. Then, PCA was performed with PA, PB, and PS of these 5 manufacturers as variables. ResultsThe average total content of the 4 index components per bag across the 19 manufacturers ranged from 41.10 mg to 97.54 mg. Among them, the content of stachydrine hydrochloride(a pharmacopoeial quality control component) was 32.46-72.70 mg per bag, all meeting the requirements of the 2025 edition of the Pharmacopoeia of the People's Republic of China, with RSD of 1.7%-17.1%. The content ranges of the other 3 components were as follows:syringic acid of 1.43-41.92 mg per bag, leonurine hydrochloride of 0.67-11.85 mg per bag, and ferulic acid of 0.11-3.81 mg per bag. Notably, leonurine hydrochloride exhibited the most significant content fluctuation among samples from the same manufacturer(RSD of 4.8%-59.2%). PCA results showed that the 19 manufacturers could be classified into 3 categories. Samples from 8 manufacturers(M2, M6, M7, M8, M10, M15, M17, M18) demonstrated relatively high consistency, five manufacturers(M3, M9, M12, M13, M14) showed moderate consistency, six manufacturers(M1, M4, M5, M11, M16, M19) exhibited low consistency. The two methods yielded consistent classification results for the 5 representative manufacturers, verifying the reliability of the proposed method. Among these, manufacturer M2 showed the best quality consistency and the highest total content of indicator components among M1-M5. ConclusionThe HPLC-DAD-CAD multi-detector hyphenation technology established in this study enables the accurate detection of 4 components in Leonuri Herba granules. Significant differences in the total content of these four components are observed among products from 19 manufacturers. The application of 2 consistency evaluation methods combined with PCA can effectively classify their consistency into 3 categories, and the classification results of the 2 methods are highly consistent. This study provides scientific basis for the process optimization and quality standard improvement of Leonuri Herba granules.
2.Multi-component Quality Consistency Evaluation of Leonuri Herba Granules Based on HPLC-DAD-CAD Multi-detector Technique and Chemometrics
Shuangyan LI ; Jun ZHANG ; Cong GUO ; Siyuan LI ; Jipeng DI ; Jiangmin SU ; An LIU ; Xiaodi KOU ; Yan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):174-181
ObjectiveTo systematically evaluate the content differences of 4 components in Leonuri Herba granules, reveal the quality fluctuation patterns of products from the same and different manufacturers, providing scientific basis for the optimization of production process and quality control. MethodsHigh performance liquid chromatography-diode array detector-charged aerosol detector(HPLC-DAD-CAD) was employed to determine the contents of 4 components(syringic acid, leonurine hydrochloride, ferulic acid, and stachydrine hydrochloride) in samples from 19 manufacturers(53 batches, 159 boxes). Additionally, fingerprint profiles were constructed, and the fingerprint dissimilarity(PS) and relative standard deviation(RSD) of different samples from the same manufacturer were calculated. A principal component analysis(PCA) model was established with PS and the RSD values of the 4 components as variables to classify the manufacturers. Finally, samples from 5 manufacturers(M1-M5) covering three consistency groups were selected to calculate three quality consistency parameters, namely intra-batch consistency(PA), inter-batch consistency(PB), and PS. Then, PCA was performed with PA, PB, and PS of these 5 manufacturers as variables. ResultsThe average total content of the 4 index components per bag across the 19 manufacturers ranged from 41.10 mg to 97.54 mg. Among them, the content of stachydrine hydrochloride(a pharmacopoeial quality control component) was 32.46-72.70 mg per bag, all meeting the requirements of the 2025 edition of the Pharmacopoeia of the People's Republic of China, with RSD of 1.7%-17.1%. The content ranges of the other 3 components were as follows:syringic acid of 1.43-41.92 mg per bag, leonurine hydrochloride of 0.67-11.85 mg per bag, and ferulic acid of 0.11-3.81 mg per bag. Notably, leonurine hydrochloride exhibited the most significant content fluctuation among samples from the same manufacturer(RSD of 4.8%-59.2%). PCA results showed that the 19 manufacturers could be classified into 3 categories. Samples from 8 manufacturers(M2, M6, M7, M8, M10, M15, M17, M18) demonstrated relatively high consistency, five manufacturers(M3, M9, M12, M13, M14) showed moderate consistency, six manufacturers(M1, M4, M5, M11, M16, M19) exhibited low consistency. The two methods yielded consistent classification results for the 5 representative manufacturers, verifying the reliability of the proposed method. Among these, manufacturer M2 showed the best quality consistency and the highest total content of indicator components among M1-M5. ConclusionThe HPLC-DAD-CAD multi-detector hyphenation technology established in this study enables the accurate detection of 4 components in Leonuri Herba granules. Significant differences in the total content of these four components are observed among products from 19 manufacturers. The application of 2 consistency evaluation methods combined with PCA can effectively classify their consistency into 3 categories, and the classification results of the 2 methods are highly consistent. This study provides scientific basis for the process optimization and quality standard improvement of Leonuri Herba granules.
3.Adiponectin alleviates high glucose-induced retinal angiogenesis by inhibiting NLRP3 inflammasome
Yong ZHANG ; Xiaodi WANG ; Yixin ZHANG ; Guomin YAO
International Eye Science 2026;26(5):732-737
AIM: To explore the effect of adiponectin(ADPN)on angiogenesis of human retinal microvascular endothelial cells(hRMECs)in high glucose(HG)environment and role of NOD-like receptor family pyrin domain containing 3(NLRP3)inflammasome.METHODS: The hRMECs were divided into six groups, including control group(without treatment), HG group: incubated with D-glucose, ADPN group: pretreatment with ADPN and then incubated with D-glucose, CY-09 group: pretreatment with CY-09(an NLRP3 inhibitor)and then incubated with D-glucose, Nigericin group: pretreatment with nigericin(an NLRP3 activator)and then incubated with D-glucose, Nigericin+ADPN group: pretreatment with nigericin and ADPN and then incubated with D-glucose. NLRP3 level was detected using Western blot analysis. hRMECs migration was measured using scratch wound healing assay. The tube formation of hRMECs was detected using Matrigel.RESULTS: The NLRP3 expression in hRMECs cultured in an HG environment was significantly increased(P<0.01), while ADPN and CY-09 reduced the elevated NLRP3(both P<0.05 vs HG group). Nigericin significantly increased NLRP3 levels(P<0.01 vs control group)which was reversed by ADPN(P=0.032 vs Nigericin group). hRMECs migration ability(P<0.001), and total master segments length and number of meshes increased in HG group(P<0.001)while decreased in ADPN and CY-09 groups(all P<0.01 vs HG group). The hRMECs migration ability and tube formation(total master segments length and number of meshes)in HG environment were significantly increased by nigericin(P=0.003), while ADPN inversed the change. CONCLUSION: ADPN alleviates the migration and angiogenesis of hRMECs under HG conditions.
4.Preliminary Clinical Application Study on the Imaging Effects of Novel Cardiac Sympathetic Nerve Imaging Agent 18F-FPMBBG
Min JU ; Wanjie REN ; Ke WANG ; Zongyao ZHANG ; Kai HAN ; Xiaodi WANG ; Yumin ZHENG ; Lei WANG ; Wei FANG
Chinese Circulation Journal 2025;40(3):234-239
Objectives:To evaluate the imaging effects of the novel sympathetic nerve imaging agent 18F-FPMBBG in healthy volunteers and heart failure patients.Methods:Four healthy volunteers and four heart failure patients were selected to undergo 18F-FPMBBG positron emission tomography/computed tomography(PET/CT)dynamic imaging,the radioactivity distribution characteristics of 18F-FPMBBG in the heart and adjacent organs of the two groups were observed,and the uptake of 18F-FPMBBG by the left ventricular myocardium was compared in the two groups.Results:No adverse effects were observed in all subjects after intravenous injection of 18F-FPMBBG.In healthy volunteers,the heart uptake was rapid and stable,lung uptake was very low,and the blood pool and liver clearance were fast.The heart/liver uptake ratios at 30,60,and 90 minutes after injection were 2.33±0.81,3.29±0.90 and 3.80±1.07,respectively.The average standard uptake value(SUVmean)of 18F-FPMBBG in the heart failure group was significantly lower than that in the healthy volunteer group(P=0.003).The washout rate(WR)was significantly higher in the heart failure group([16.53±2.76]%vs.[3.88±4.51]%,P=0.003).Conclusions:18F-FPMBBG showed good imaging and diagnostic effects in the preliminary imaging of healthy subjects and heart failure patients,and it has the potential to become an ideal cardiac sympathetic nerve imaging agent.
5.The value of orthopedic metal artifact reduction technology in dual-layer detector CT for improving postoperative CT image quality in patients with lumbar internal fixation implants
Yuting WEN ; Yu YANG ; Xinyue LI ; Yan ZHENG ; Xuelin PAN ; Xiaodi ZHANG ; Huafeng CUI ; Zhenlin LI
Chinese Journal of Radiology 2025;59(5):591-598
Objective:To evaluate the clinical utility of dual-layer detector CT integrated with virtual monoenergetic imaging (VMI) and an orthopedic metal artifact reduction (O-MAR) algorithm in improving the image quality of patients after lumbar pedicle screw fixation surgery, and to analyze its impact on different types of artifacts and image quality of different tissues.Methods:The study was a prospective study, The study enrolled patients who underwent lumbar pedicle screw fixation at West China Hospital of Sichuan University between March and September 2024. All patients underwent lumbar CT scans using a dual-layer detector system, and four image sets were reconstructed. CLumbar routine scans were performed using dual-layer detector CT, and four image sets were reconstructed:onventional images (CI non-O-MAR), conventional images with O-MAR (CI O-MAR), virtual monoenergetic images (VMI non-O-MAR), and VMI with O-MAR (VMI O-MAR). Objective metrics including artifact index (AI), signal-to-noise ratio (SNR), and contrast-to-noise ratio (CNR) were quantified, alongside subjective image quality assessment. One-way ANOVA or Friedman test were used to compare the objective evaluation indicators of image quality between VMI non-O-MAR and VMI O-MAR at different energy levels. Paired t-test or Wilcoxon signed-rank test was used for CI non-O-MAR/VMI non-O-MAR versus CI O-MAR/VMI O-MAR comparisons. Results:A total of 30 patients were included, and all underwent internal fixation with titanium alloy pedicle screws. Objective analysis revealed that in both high-and low-density artifact regions, the AI values of the VMI O-MAR group decreased with the increase of energy levels, and were significantly lower than those of the corresponding VMI non-O-MAR group, with a statistically significant difference (all P<0.001). When the energy level≥140 keV, the AI value of the VMI O-MAR group was simultaneously lower than that of the CI non-O-MAR group and the CI O-MAR group, with statistically significant differences (all P<0.05). The SNR and CNR on the vertebral bodies in the VMI non-O-MAR group and the VMI O-MAR group showed a decreasing trend with increasing energy levels, and were always lower than those in the CI group at high energy levels (100-180 keV) (all P<0.05). At high energy levels (100-180 keV), the SNR of VMI O-MAR in the intervertebral disc and intraspinal tissues was higher than that of the VMI non-O-MAR group, with statistically significant differences (all P<0.05). Compared to other groups, subjective analysis indicated that the 140 keV VMI combined with O-MAR group received the highest image quality scores ( P<0.05). Conclusions:The combined application of VMI and O-MAR technology effectively reduces metal artifacts in post-lumbar fixation CT images. The 140 keV VMI with O-MAR reconstruction provides superior image quality and enhances diagnostic confidence.
6.Effect of AUD of carbapenems on hospital-associated infections caused by carbapenem-resistant gram-negative bacteria
Yunfei XIA ; Xiaodi ZHOU ; Biyang JIAO ; Shuai LIU ; Zhiru ZHANG ; Yanju ZHANG
Chinese Journal of Nosocomiology 2025;35(22):3442-3446
OBJECTIVE To understand the current status of antimicrobial agent usage intensity(AUD)of antibiot-ics,carbapenems(CB)and isolation rates of carbapenem-resistant gram-negative bacteria(CRGNB)and explore the effect of CB on hospital-associated CRGNB infections.METHODS A retrospective analysis was conducted on antimicrobial agent usage and clinical data of the patients who were hospitalized in Nantong University Affiliated Hospital from 2023 to 2024.The antimicrobial usage patterns,CB-AUD and isolation rates of CRGNB were sta-tistically analyzed.Additionally,the clinical data from 1933 confirmed hospital-acquired infection cases from 2023 to 2024 were retrospectively analyzed,and the patients were classified into two groups based on CRGNB resist-ance:the CRGNB-infected group with 376 cases and the non-CRGNB-infected group with 1557 cases.The risk factors for CRGNB infections were identified.RESULTS In the two years,the overall utilization rate of antimicro-bial drug and AUD fluctuated every six months(P<0.05).The overall define daily dose system(DDDs)and AUD of the three CBs(meropenem,imipenem/cilastatin and biapenem)increased every six months(P<0.05).The o-verall drug resistance rate of gram-negative bacilli to CB decreased every six months(P<0.05).The logistic re-gression analysis showed that the duration of use of CB and combined use of antibiotics were the risk factors for the CRGNB infections(with the OR values,1.445,2.479,1.958,respectively,all P<0.05).CONCLUSIONS The overall use of CB is on the rise.The use of CB,especially the duration of CB,increases the probability of CRGNB infection.Therefore,it is necessary for the hospital to strengthen the monitoring of CB-AUD and supervi-sion of CB.
7.Analysis on Quality Standard of Sennae Folium(Cassia angustifolia) Dispensing Granules Based on Standard Decoctions
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(9):192-200
ObjectiveTo establish the quality standards for Sennae Folium(Cassia angustifolia) dispensing granules based on standard decoctions. MethodsHigh performance liquid chromatography(HPLC) specific chromatograms were established for 15 batches of Sennae Folium(C. angustifolia) standard decoctions and 10 of Sennae Folium(C. angustifolia) dispensing granules from different manufacturers, and the similarity evaluation, hierarchical cluster analysis(HCA) and principal component analysis(PCA) were performed. Linear calibration with two reference substances(LCTRS) and quantitative analysis of multi-components by single-marker(QAMS) were established for the common peaks in the specific chromatograms to determine the contents of main components in the decoction pieces, standard decoctions and dispensing granules, and to calculate their transfer rates from decoction pieces to standard decoctions and dispensing granules. ResultsThe similarities of specific chromatograms of 15 batches of Sennae Folium(C. angustifolia) standard decoctions and 10 batches of Sennae Folium(C. angustifolia) dispensing granules were all greater than 0.95, and a total of 8 characteristic peaks were calibrated, and five of them were identified, including kaempferol-3,7-O-diglucoside, apigenin-6,8-di-C-glucoside, quercetin-3-O-gentianoside, sennoside B and sennoside A. HCA and PCA results showed that there were certain differences in the composition of different batches of standard decoctions, but no clustering was observed in the production area. As the standard decoctions, the extract rate of 15 batches of samples was 26.54%-45.38%, the contents of kaempferol-3,7-O-diglucoside, apigenin-6,8-di-C-glucoside, quercetin-3-O-gentianoside, sennoside B and sennoside A were 12.16-19.26, 2.57-4.94, 3.27-5.11, 6.75-11.39, 4.69-7.79 mg·g-1, and their transfer rates from decoction pieces to standard decoctions were 45.41%-79.02%, 29.12%-55.07%, 40.52%-67.90%, 24.72%-49.12%, 27.54%-49.34%, respectively. The extract rates of Sennae Folium(C. angustifolia) dispensing granules(C8-C10) were 38.10%-39.50%, the transfer rates of the above five components from decoction pieces to dispensing granules were 72.85%-73.58%, 53.43%-53.94%, 40.19%-40.74%, 24.62%-25.00%, 28.65%-29.11%, respectively, which were generally consistent with the transfer rates from decoction pieces to standard decoctions. ConclusionCompared with the relative retention time method, LCTRS has higher prediction accuracy and is more suitable for chromatographic columns. The established quality control standard of Sennae Folium(C. angustifolia) dispensing granules based on standard decoction is reasonable and reliable, and all indicators of samples from different manufacturers are within the range specified based on the standard decoction, which can provide reference for the quality control and process research of this dispensing granules.
8.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.
9.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.
10.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.

Result Analysis
Print
Save
E-mail