As the core vehicle for preserving and transmitting traditional Chinese medicine（TCM） academic thought and clinical experience， the establishment of a robust quality evaluation system for TCM clinical case reports is a crucial component in the current standardization and modernization of TCM. Based on the practical experience of constructing the China Clinical Cases Library of Traditional Chinese Medicine by the China Association of Chinese Medicine， this study conducted a comprehensive analysis of critical challenges， including insufficient authenticity and unfocused evaluation criteria. It proposed a three-dimensional evaluation framework grounded in the structure-process-outcome logic， encompassing three dimensions of authenticity and standardization， characteristics and advantages， application and translational impact. This framework integrated 12 key evaluation indicators in a systematic manner. The model preserved the academic characteristics of TCM syndrome differentiation and treatment， while aligning with modern scientific research standards， achieving a balance between individualized TCM experience and standardized evaluation. Concurrently， this study provided theoretical foundations and methodological guidance for evaluating the quality of TCM clinical cases， contributing significantly to the inheritance of TCM knowledge， evidence-based practice， and the reform of talent evaluation mechanisms.

Objective To evaluate the efficacy and safety of transcatheter arterial chemoembolization(TACE)followed by hepatic arterial infusion chemotherapy(HAIC)combined with TKI drugs and PD-1 inhibitors as the first-line treatment for advanced hepatocellular carcinoma(HCC).Methods We retrospectively analyzed the data of 70 patients with advanced HCC treated in the Department of Oncology of Guangdong Provincial Hospital of Integrated Traditional Chinese and Western Medicine between July,2020 and June,2023.23 of the patients received TACE combined with HAIC and TKI(TACE+HAIC+TKI group)and 47 received TACE combined with HAIC,PD-1 inhibitors and TKI(TACE+HAIC+PD-1+TKI group).The clinical characteristics,laboratory test results,efficacy,outcomes and adverse events of the patients were compared between the two groups.Results The TACE+HAIC+TKI and TACE+HAIC+PD-1+TKI groups had significantly different objective remission rates(ORR;60.87%vs 36.17%,P=0.031),comparable disease control rates(95.65%vs 93.62%,P=0.068),and different median progression-free survival(PFS)time(10.2 vs 11.8 months,P=0.003)and median overall survival(OS)time(15.7 vs 19.5 months,P=0.035).After propensity score matching(PSM),the median PFS and OS time of the two groups was 10.1 vs 14.5 months(P=0.024)and 14.2 vs 21.2 months(P=0.221),respectively.The 1-year PFS rates of the 2 groups were 24.0%vs 52.2%,and the 1-,2-and 3-year OS rates were 72.3%vs 93.1%,23.9%vs 63.8%,and 23.9%vs 36.5%,respectively.The incidence of proteinuria was significantly higher in TACE+HAIC+PD-1+TKI group than in TACE+HAIC+TKI group(21.28%vs 0,P=0.025),but the incidences of grade 3-4 treatment-related adverse events were all similar between the two groups.Conclusion The first-line treatment with TACE+HAIC+PD-1+TKI is safe and effective for advanced HCC and can significantly prolong the survival of the patients.

Objective To evaluate the efficacy and safety of transcatheter arterial chemoembolization(TACE)followed by hepatic arterial infusion chemotherapy(HAIC)combined with TKI drugs and PD-1 inhibitors as the first-line treatment for advanced hepatocellular carcinoma(HCC).Methods We retrospectively analyzed the data of 70 patients with advanced HCC treated in the Department of Oncology of Guangdong Provincial Hospital of Integrated Traditional Chinese and Western Medicine between July,2020 and June,2023.23 of the patients received TACE combined with HAIC and TKI(TACE+HAIC+TKI group)and 47 received TACE combined with HAIC,PD-1 inhibitors and TKI(TACE+HAIC+PD-1+TKI group).The clinical characteristics,laboratory test results,efficacy,outcomes and adverse events of the patients were compared between the two groups.Results The TACE+HAIC+TKI and TACE+HAIC+PD-1+TKI groups had significantly different objective remission rates(ORR;60.87%vs 36.17%,P=0.031),comparable disease control rates(95.65%vs 93.62%,P=0.068),and different median progression-free survival(PFS)time(10.2 vs 11.8 months,P=0.003)and median overall survival(OS)time(15.7 vs 19.5 months,P=0.035).After propensity score matching(PSM),the median PFS and OS time of the two groups was 10.1 vs 14.5 months(P=0.024)and 14.2 vs 21.2 months(P=0.221),respectively.The 1-year PFS rates of the 2 groups were 24.0%vs 52.2%,and the 1-,2-and 3-year OS rates were 72.3%vs 93.1%,23.9%vs 63.8%,and 23.9%vs 36.5%,respectively.The incidence of proteinuria was significantly higher in TACE+HAIC+PD-1+TKI group than in TACE+HAIC+TKI group(21.28%vs 0,P=0.025),but the incidences of grade 3-4 treatment-related adverse events were all similar between the two groups.Conclusion The first-line treatment with TACE+HAIC+PD-1+TKI is safe and effective for advanced HCC and can significantly prolong the survival of the patients.

AIM : To establish a HPLC method for simultaneous determination of rutin and naringenin-7-o-glucoside in Lysimachia clethroide Duby.METHODS: Using Diamonsil C_(18) (4.6 mm×250 mm,5 μm) as analytical column.The mobile phase consisted of acetonitrile (A) and 0.1% phosphoric acid ( B ) with gradient elution : 0～18rain,83%～80% B; 18～30 min,80%～86% B.The detection wavelength of rutin and naringenin-7-o-glucoside was at 254 nm and 281 nm,respectively.The flow rate was 1.0 mL/min; Column temperature was at 35 ℃.RESULTS: A better separating effect was obtained with the HPLC gradient elution method.The linear calibration curve of rutin and naringenin-7-o-glucoside were obtained in the concentration range of 1.00～48.00 μg/mL( r =0.999 3 ) and 0.64 ～ 40.72 μg/mL( r = 0.999 8 ),respectively.CONCLUSION : The HPLC method is accurate,simple and can be used to determine the contents of rutin and naringenin-7-o-glucoside in Lysimachia clethroide Duby simultaneously.

AIM: To establish the quality standards for Chinese extractum angelicae liquidum. METHODS: TLC was used to identify ferulic acid and ligustilide and HPLC to determine the content of ferulic acid and ligustil-ide. HPLC was performed on a Diamonsil ODS-C_(18) analytical column(250 mm×4.6 mm, 5 μm) with gradient elu-tion(0-15 min, 38%A; 15-20 min, 38%A-70%A; 20-40 min, 70%A; 40-45 min, 70%A-38%A) of methanol (A, containing 0.4% glacial acetic) and 0.4% glacial acetic acid(B) at the flow rate of 1.0 mL/min. The diode array detection wavelength was set at 323 nm and the column temperature was at 35℃. RESULTS: The linear range of ferulic acid and ligustilide were from 1.008 μg/mL to 10.08 μg/mL and 9.985 μg/mL to 99.85 μg/mL,the average recoveries of both were 98.11% and 101.61%, RSD were 1.58% and 1.32%. CONCLUSION: The method is rapid, simple and accurate with high reproducibility and can be used to control the quality of Chinese extractum angelicae liquidum.

OBJECTIVE: To improve the dissolution rate of nitrendipine in vitro using co-grinding method.METHODS: Single-factor test was adopted to detect effect of phases of co-grinding,category of excipients (MCC,PVPk30,HPC,HPMC),time (0,10,20,30,40,50,60 min) of co-grinding and ratio of principal component to excipients (1 ∶ 1,1 ∶ 2,1 ∶ 3,1 ∶ 4,1 ∶ 5,1 ∶ 6,1 ∶ 7,1 ∶ 8,1 ∶ 9) on in vitro dissolution of nitrendipine power and tablet.RESULTS: The condition of co-grinding method was as follows: dual co-grinding phase,HPC or MCC as excipients,co-grinding time of 40 min,ratio of principal component to excipients was 1 ∶ 4.Accumulative dissolution rate of nitrendipine powder was more than 80% within 10 min and that of nitrendipine tablet was more than 80% within 40 min.CONCLUSION: Co-grinding method can improve the dissolution rate of poorly water-soluble nitrendipine in vitro under suitable condition.

Objective To prepare osmotic pump-controlled release tablets of total flavones in Lysimachia clethroides.Methods Two components of the extract from L.clethroides,rutin and naringenin-7-O-glucoside were used to evaluate the release behavior of osmotic pump controlled release tablets.Single factor investigation was carried out on the membrane compositions and orifice variables,and uniform design was used to optimize the formulation of coating mambrane.Results The membrane weight,PEG400 content,and dibutyl phthalote(DBP) content were the main factors influencing the drug release,and based on 45% and 8.5% of cellulose acetate,respectively,to prepare osmotic pump-controlled release tablets could achieve the desired zero-order release profile.Conclusion The formulation and technology are simple and easy to be carried out.Osmotic pump-controlled release tablets have a stable drug release bahavior and a good reproducibility.

AIM:To establish a HPLC method for simultaneous determination of rutin and naringenin-7-o-glucoside in Lysimachia clethroide Duby.METHODS:Using Diamonsil C_ 18(4.6 mm ?250 mm,5?m)as analytical column.The mobile phase consisted of acetonitrile(A)and 0.1% phosphoric acid(B)with gradient elution:0~18 min,83%~80%B;18~30 min,80%~86%B.The detection wavelength of rutin and naringenin-7-o-glucoside was at 254 nm and 281 nm,respectively.The flow rate was 1.0 mL/min;Column temperature was at 35 ℃.RESULTS :A better separating effect was obtained with the HPLC gradient elution method.The linear calibration curve of rutin and naringenin-7-o-glucoside were obtained in the concentration range of 1.00~48.00 ?g/mL(r=0.999 3)and 0.64~40.72 ?g/mL(r=0.999 8),respectively.CONCLUSION:The HPLC method is accurate,simple and can be used to determine the contents of rutin and naringenin-7-o-glucoside in Lysimachia clethroide Duby simultaneously.

AIM: To establish the quality standards for Chinese extractum angelicae liquidum. METHODS: TLC was used to identify ferulic acid and ligustilide and HPLC to determine the content of ferulic acid and ligustilide.HPLC was performed on a Diamonsil ODS-C_18 analytical column(250 mm?4.6 mm,5 ?m) with gradient elution(0-15 min,38%A;15-20 min,38%A70%A;20-40 min,70%A;40-45 min,70%A-38%A) of methanol(A,containing 0.4% glacial acetic) and 0.4% glacial acetic acid(B) at the flow rate of 1.0 mL/min.The diode array detection wavelength was set at 323 nm and the column temperature was at 35 ℃. RESULTS: The linear range of ferulic acid and ligustilide were from 1.008 ?g/mL to 10.08 ?g/mL and 9.985 ?g/mL to 99.85 ?g/mL,the average recoveries of both were 98.11% and 101.61%,RSD were 1.58% and 1.32%.CONCLUSION: The method is rapid,simple and accurate with high reproducibility and can be used to control the quality of Chinese extractum angelicae liquidum.