Objective: To investigate the correlation between color parameters (L^*, a^*, b^*, Eab^*) and the contents of reducing sugars, total polysaccharides, total oligosaccharides, as well as four saccharides (fructose, glucose, sucrose, and kestose) during the nine cycles of steaming and sun-drying processing of Polygonatum kingianum, and to preliminarily explore the optimal processing duration.
Methods: The color changes were objectively evaluated using a colorimeter. The anthrone-sulfuric acid method was employed to determine total polysaccharides and oligosaccharides. The 3,5-dinitrosalicylic acid (DNS) colorimetric method was used to measure total reducing sugar content. High-performance liquid chromatography coupled with charged aerosol detection (HPLC-CAD) was applied for quantitative analysis of fructose, glucose, sucrose, and kestose. Multivariate statistical analysis was conducted to assess samples from different processing stages.
Results: Significant variations in color and component contents were observed across processing stages. The herbal pieces progressively darkened with increased processing cycles: brightness (L^*) and total color difference (Eab^*) initially decreased then stabilized, while a^* (red-green) and b^* (yellow-blue) values first increased then declined. Total polysaccharides and oligosaccharides showed overall decreasing trends, whereas reducing sugars initially increased before stabilizing. Fructose and glucose levels rose continuously, while sucrose and kestose decreased progressively, becoming undetectable after five cycles.
Conclusion: The chromatic alteration and saccharide composition of P. kingianum showed significant correlation with processing duration. Both total color difference (Eab^*) and reducing sugar content stabilized after four processing cycles (12 hours), suggesting that four cycles of steaming and sun-drying may represent the optimal processing duration.

Objective: To investigate the correlation between the color parameters (L^*, a^*, b^*, Eab^* values) of Polygoni Multiflori Radix Praeparata powder prepared by different processing techniques and the contents of 2,3,5,4’-tetrahydroxystilbene-2-O-β-D-glucopyranoside, emodin, physcion, emodin-8-O-β-D-glucopyranoside, physcion-8-O-β-D-glucopyranoside.
Methods: The L^*, a^*, b^* and Eab^* values of Polygoni Multiflori Radix Praeparata powder prepared by different processing techniques were determined by spectrophotometer, and the contents of the five components were determined by high performance liquid chromatography. Secondly, SPSS 26.0 software and Simca 14.1 software were used to analyze the correlation.
Results: Through the hierarchical cluster analysis (HCA), it was found that the steamed samples and black bean steamed samples could be obviously divided into two categories: raw products and processed products. The processed products could be further divided into 2-8 h and 12-48 h. Pearson correlation analysis showed that the content of stilbene glycoside was significantly positively correlated with L^*, a^* and b^* values (P<0.01). The a^* value was significantly positively correlated with the content of emodin and physcion (P<0.01). Emodin-8-O-β-D-glucoside was positively correlated with L^* value and b^* value, while physcion-8-O-β-D-glucoside was negatively correlated with a^* value. Partial least squares discriminant analysis (PLS) showed that 2,3,5,4’-tetrahydroxystilbene-2-O-β-D-glucoside (VIP=1.69) and emodin-8-O-β-D-glucoside (VIP=1.06) were the key variables affecting chromaticity characteristics (P<0.01).
Conclusion: The three processes of steaming, black bean steaming and black bean stewing are consistent in composition transformation and chromaticity variation, and stilbene glycoside can be used as a specific index component to characterize the processed color. Chromatic parameters can effectively reflect the processing progression and serve as quality monitoring indicators during production.

Objective:To explore the early clinical effect of arthroplasty with rotating hinge knee prosthesis in the treatment of severe knee deformity.Methods:A retrospective study was conducted on 55 patients who underwent primary rotating hinge knee arthroplasty at Shanghai Sixth People's Hospital from January 2017 to October 2023, including 19 male patients and 36 female patients, with an average age of 60.9±9.0 years (ranging from 31 to 74 years). The four main indications were end-stage deformity of osteoarthritis (valgus/varus>20°, 16 cases), post-traumatic joint deformity (15 cases), severe joint ligament instability (12 cases), and neuromuscular or immune diseases (12 cases). The patients were divided into two age groups: ≥60 years old group (32 cases) and <60 years old group (23 cases). Various pre-operative and post-operative data, including knee society score (KSS), range of motion (ROM), forgotten joint score (FJS), degree of force line offset and post-operative complications, were collected and compared.Results:All the 55 cases successfully underwent the operation. The operation time was 102.3±15.8 min. The intraoperative blood loss was 63±23.7 ml. The follow-up time was 37.2±7.9 months. KSS clinical score increased from 27.5(12, 45) before surgery to 90.5(85, 95) after surgery ( P<0.001) and the mean score of KSS function increased from 50.4(45, 60) before surgery to 84.3(85, 95) after surgery ( P<0.001), both with significant difference ( P<0.05). Similarly, the average postoperative ROM improved from 97.2°±34.4° to 120.1°±10.9°with significant difference ( P<0.05). The postoperative FJS was 81.0±6.6. Up to the last follow-up, the implant survival rate was 98%[95% CI(90.4%, 99.6%)]. For the all four groups of end-stage deformity of osteoarthritis, post-traumatic joint deformity, severe joint ligament instability and neuromuscular or immune diseases, both the KSS score and the ROM of the knee joint were significantly improved. There was no significant difference in neither the KSS score or the ROM of the knee joint between the ≥60 years old group and the <60 years old group ( P>0.05). The incidence of complications was 24% (13/55). The complication rates for patients with end-stage deformity of osteoarthritis, post-traumatic joint deformity, severe joint ligament instability and neuromuscular or immune diseases were 12.5% (2/16), 20% (3/15), 25% (3/12), and 41.7% (5/12) respectively, without significant difference. The incidence of complications in elderly patients (85%, 11/13) was much higher than that in younger patients (5%, 2/42),with significant difference ( P<0.05). Conclusions:For end-stage deformity of osteoarthritis (valgus or varus >20°), post-traumatic joint deformity, severe joint ligament instability and neuromuscular or immune diseases, the rotating hinge knee can provide good clinical improvement effects. For neuromuscular or immune diseases, the incidence of complications was relatively high. The therapeutic effect of patients over 60 years old showed no significant difference in the early postoperative efficacy compared with younger patients, but the complications of elderly patients were much higher than those of younger patients.

As people’s attention to health continues to increase, the market demand for traditional Chinese medicine (TCM) is growing steadily. The quality and safety of Chinese medicinal materials have attracted unprecedented social attention. In particular, the issue of exogenous harmful residue pollution in TCM has become a hot topic of concern for both regulatory authorities and society. The Chinese Pharmacopoeia 2025 Edition further refines the detection methods and limit standards for exogenous harmful residues in TCM. This not only reflects China’s high-level emphasis on the quality and safety of TCM but also demonstrates the continuous progress made by China in the field of TCM safety supervision. Basis on this study, by systematically reviewing the development history of the detection standards for exogenous harmful residues in TCM and analyzing the revisions and updates of these detection standards in the Chinese Pharmacopoeia 2025 Edition, deeply explores the key points of the changes in the monitoring standards for exogenous harmful residues in TCM in the Chinese Pharmacopoeia 2025 Edition. Moreover, it interprets the future development directions of the detection of exogenous residues in TCM, aiming to provide a reference for the formulation of TCM safety supervision policies.

As people's attention to health continues to increase,the market demand for traditional Chinese medi-cine(TCM)is growing steadily.The quality and safety of Chinese medicinal materials have attracted unprecedent-ed social attention.In particular,the issue of exogenous harmful residue pollution in TCM has become a hot topic of concern for both regulatory authorities and society.The Chinese Pharmacopoeia 2025 Edition further refines the detection methods and limit standards for exogenous harmful residues in TCM .This not only reflects China's high-level emphasis on the quality and safety of TCM but also demonstrates the continuous progress made by China in the field of TCM safety supervision.Basis on this study,by systematically reviewing the development history of the detection standards for exogenous harmful residues in TCM and analyzing the revisions and updates of these detec-tion standards in the Chinese Pharmacopoeia 2025 Edition,deeply explores the key points of the changes in the monitoring standards for exogenous harmful residues in TCM in the Chinese Pharmacopoeia 2025 Edition.Moreo-ver,it interprets the future development directions of the detection of exogenous residues in TCM ,aiming to provide a reference for the formulation of TCM safety supervision policies.

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Objective:To explore the early clinical effect of arthroplasty with rotating hinge knee prosthesis in the treatment of severe knee deformity.Methods:A retrospective study was conducted on 55 patients who underwent primary rotating hinge knee arthroplasty at Shanghai Sixth People's Hospital from January 2017 to October 2023, including 19 male patients and 36 female patients, with an average age of 60.9±9.0 years (ranging from 31 to 74 years). The four main indications were end-stage deformity of osteoarthritis (valgus/varus>20°, 16 cases), post-traumatic joint deformity (15 cases), severe joint ligament instability (12 cases), and neuromuscular or immune diseases (12 cases). The patients were divided into two age groups: ≥60 years old group (32 cases) and <60 years old group (23 cases). Various pre-operative and post-operative data, including knee society score (KSS), range of motion (ROM), forgotten joint score (FJS), degree of force line offset and post-operative complications, were collected and compared.Results:All the 55 cases successfully underwent the operation. The operation time was 102.3±15.8 min. The intraoperative blood loss was 63±23.7 ml. The follow-up time was 37.2±7.9 months. KSS clinical score increased from 27.5(12, 45) before surgery to 90.5(85, 95) after surgery ( P<0.001) and the mean score of KSS function increased from 50.4(45, 60) before surgery to 84.3(85, 95) after surgery ( P<0.001), both with significant difference ( P<0.05). Similarly, the average postoperative ROM improved from 97.2°±34.4° to 120.1°±10.9°with significant difference ( P<0.05). The postoperative FJS was 81.0±6.6. Up to the last follow-up, the implant survival rate was 98%[95% CI(90.4%, 99.6%)]. For the all four groups of end-stage deformity of osteoarthritis, post-traumatic joint deformity, severe joint ligament instability and neuromuscular or immune diseases, both the KSS score and the ROM of the knee joint were significantly improved. There was no significant difference in neither the KSS score or the ROM of the knee joint between the ≥60 years old group and the <60 years old group ( P>0.05). The incidence of complications was 24% (13/55). The complication rates for patients with end-stage deformity of osteoarthritis, post-traumatic joint deformity, severe joint ligament instability and neuromuscular or immune diseases were 12.5% (2/16), 20% (3/15), 25% (3/12), and 41.7% (5/12) respectively, without significant difference. The incidence of complications in elderly patients (85%, 11/13) was much higher than that in younger patients (5%, 2/42),with significant difference ( P<0.05). Conclusions:For end-stage deformity of osteoarthritis (valgus or varus >20°), post-traumatic joint deformity, severe joint ligament instability and neuromuscular or immune diseases, the rotating hinge knee can provide good clinical improvement effects. For neuromuscular or immune diseases, the incidence of complications was relatively high. The therapeutic effect of patients over 60 years old showed no significant difference in the early postoperative efficacy compared with younger patients, but the complications of elderly patients were much higher than those of younger patients.

Objective:To assess the clinical efficacy and infection control outcomes of two-stage revision in managing periprosthetic joint infection (PJI) following primary total knee arthroplasty (TKA) utilizing either a low or high constrained prosthesis.Methods:A retrospective analysis was performed on 40 patients who underwent revision TKA in the Sixth People's Hospital Affiliated to Shanghai Jiao Tong University from February 2019 to February 2022. According to the type of prosthesis selected in primary TKA, they were divided into low constrained prosthesis group and high constrained prosthesis group. There were 28 patients (28 knees) in the low constrained group, including 12 males and 16 females, aged 69.0(63.0, 74.0) years, with a body mass index of 25.18±0.55 kg/m 2. And there were 12 patients (12 knees) in the high-constrained group, including 5 males and 7 females, aged 66.5(65.0, 71.5) years, with a body mass index of 23.94±0.51 kg/m 2. All patients underwent two-stage revision surgery, with RHK used in 1 case and LCCK in 27 cases in the low-constrained prosthesis group. In the high-constrained prosthesis group, 3 patients were treated with RHK, 1 patient with PFC Sigma MBT, and 8 patients with LCCK. The preoperative and postoperative range of motion (ROM), Knee Society score (KSS), and postoperative infection control rate were compared between the two groups. Results:All patients were followed up. The follow-up time was 22.79±8.02 months in the low-constrained prosthesis group and 23.92±7.04 months in the high-constrained prosthesis group, with no significant difference between the two groups ( t=0.426, P=0.680). At the last follow-up, the KSS and ROM in the low-constrained prosthesis group were 77.96±9.74 and 93.48°±7.45°, respectively, significantly higher than 38.93±8.01 and 68.89°±9.44° before the operation ( P<0.05). The KSS score and ROM in the high-constrained prosthesis group were 67.83±8.31 and 80.08°±5.89° at the last follow-up, which were also significantly higher than those before operation (34.25±6.31 and 66.50°±10.48°, P<0.05). There was no significant difference in KSS and ROM between the two groups before operation ( P>0.05), but the KSS score and ROM in the low-constrained prosthesis group were significantly higher than those in the high-constrained prosthesis group at the last follow-up ( P<0.05). Bacterial culture results revealed that the primary infectious agents were coagulase-negative Staphylococcus and Staphylococcus aureus, with an overall infection control rate of 80% (32/40). The infection control rate was 89% (25/28) in the low-constrained prosthesis group and 58% (7/12) in the high-constrained prosthesis group, but the difference between the two groups was not statistically significant (χ 2=3.283, P=0.070). Conclusion:Two-stage revision effectively controls PJI, and the clinical outcomes of two-stage revision for PJI after primary TKA with a high-constrained prosthesis are inferior to those with a low-constrained prosthesis. Further exploration is needed to enhance efficacy.

Objective To carry out a proficiency testing of content determination of geniposide in Gardeniae fructus,evaluate the content determination ability of index components in traditional Chinese medicine in the laboratory of inspection and detection in drug-related fields,and improve the quality control ability of content determination of related laboratories.Methods The laboratory's capability-verification activities were conducted based on the CNAS-RL02 Rules for Proficiency Testing and ISO/IEC 17043 Conformity Assessment-General Requirements for Proficiency Testing.After preparing the sample,the results of homogeneity and stability tests were analyzed according to CNAS-GL003 Guidance on Evaluating the Homogeneity and Stability of Samples Used for Proficiency Testing.After the test results were qualified,they were used as proficiency testing samples and randomly distributed to participants.The results were collected,and the robust statistical method and the Z scores were used to analyze the results of these laboratories'reports.Results 403 laboratories in this proficiency testing program reported the results,of which 367 results were acceptable,accounting for 91.07％,17(4.22％)laboratories obtained suspicious results,and 19 laboratories gave unsatisfactory results,with the dissatisfaction rate of 4.71％.Conclusion The majority of the 403 participant laboratories have the ability to determine the content of geniposide in Gardeniae fructus by HPLC and the laboratory testing ability and quality management level of the drug monitoring system are high.This proficiency testing provides a basis for understanding the technical reserve capacity and management level of China's pharmaceutical inspection and testing laboratories,and provides technical support for future government supervision.

Polygoni multiflori radix praeparata is a processed product of Polygoni multiflori radix(Polygonum multiflorum Thunb.),and its main components include stilbene glycosides,anthraquinones,flavonoids,alkaloids,phenolic acids,etc.It has antioxidant,antianemic,anti-tumor,hypoglycemic,anti-inflammatory effects,etc,and is widely used in clinical practice.The processing technology is mainly stewinging with black bean juice,steaming,processing for 9 times and braising and simmering.After processing,the color deepens and the content of composition changes.By consulting domestic and foreign literature,the research on Polygoni multiflori radix praeparata is not comprehensive enough compared with Polygoni multiflori radix.Therefore,this paper mainly summarizes the processing technology,chemical composition and pharmacological activity of Polygoni multiflori radix preparata reported in the past 20 years,and provides a reference for further development of Polygoni multiflori radix preparata.