1.Quality Evaluation of Naomaili Granules Based on Multi-component Content Determination and Fingerprint and Screening of Its Anti-neuroinflammatory Substance Basis
Ya WANG ; Yanan KANG ; Bo LIU ; Zimo WANG ; Xuan ZHANG ; Wei LAN ; Wen ZHANG ; Lu YANG ; Yi SUN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(2):170-178
ObjectiveTo establish an ultra-performance liquid fingerprint and multi-components determination method for Naomaili granules. To evaluate the quality of different batches by chemometrics, and the anti-neuroinflammatory effects of water extract and main components of Naomaili granules were tested in vitro. MethodsThe similarity and common peaks of 27 batches of Naomaili granules were evaluated by using Ultra performance liquid chromatography (UPLC) fingerprint detection. Ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) technology was used to determine the content of the index components in Naomaili granules and to evaluate the quality of different batches of Naomaili granules by chemometrics. LPS-induced BV-2 cell inflammation model was used to investigate the anti-neuroinflammatory effects of the water extract and main components of Naomaili granules. ResultsThe similarity of fingerprints of 27 batches of samples was > 0.90. A total of 32 common peaks were calibrated, and 23 of them were identified and assigned. In 27 batches of Naomaili granules, the mass fractions of 14 components that were stachydrine hydrochloride, leonurine hydrochloride, calycosin-7-O-glucoside, calycosin,tanshinoneⅠ, cryptotanshinone, tanshinoneⅡA, ginsenoside Rb1, notoginsenoside R1, ginsenoside Rg1, paeoniflorin, albiflorin, lactiflorin, and salvianolic acid B were found to be 2.902-3.498, 0.233-0.343, 0.111-0.301, 0.07-0.152, 0.136-0.228, 0.195-0.390, 0.324-0.482, 1.056-1.435, 0.271-0.397, 1.318-1.649, 3.038-4.059, 2.263-3.455, 0.152-0.232, 2.931-3.991 mg∙g-1, respectively. Multivariate statistical analysis showed that paeoniflorin, ginsenoside Rg1, ginsenoside Rb1 and staphylline hydrochloride were quality difference markers to control the stability of the preparation. The results of bioactive experiment showed that the water extract of Naomaili granules and the eight main components with high content in the prescription had a dose-dependent inhibitory effect on the release of NO in the cell supernatant. Among them, salvianolic acid B and ginsenoside Rb1 had strong anti-inflammatory activity, with IC50 values of (36.11±0.15) mg∙L-1 and (27.24±0.54) mg∙L-1, respectively. ConclusionThe quality evaluation method of Naomaili granules established in this study was accurate and reproducible. Four quality difference markers were screened out, and eight key pharmacodynamic substances of Naomaili granules against neuroinflammation were screened out by in vitro cell experiments.
2.Effect of Ningying Formula (宁瘿方) Combined with Low-Dose Antithyroid Drugs on Reducing Relapse Risk for Patients with Graves' Hyperthyroidism in Remission Stage:A Retrospective Cohort Study
Yuqin HUANG ; Mingshuai ZHANG ; Shijian LIU ; Feng TAO ; Yi CHEN
Journal of Traditional Chinese Medicine 2026;67(1):45-52
ObjectiveTo evaluate the effect of Ningying Formula (宁瘿方) combined with low-dose antithyroid drugs (ATDs) on the relapse risk for patients with Graves' hyperthyroidism (GH) during the remission phase, and to analyze the related factors between GH relapse and thyrotropin receptor antibody (TRAb) negativity, so as to provide evidence for the standardized management of GH in remission stage. MethodsA single-center retrospective cohort study was conducted, including 269 GH patients in the remission stage. After propensity score matching (PSM), 102 matched pairs (204 patients) were established. The control group received low-dose ATDs as maintenance therapy, while the exposure group received the core Ningying Formula in addition to low-dose ATDs. The primary outcome was the GH recurrence rate; the secondary outcome was the thyrotropin receptor antibody (TRAb) negativity rate (TRAb<1.75 IU/L). Safety outcomes included treatment-related adverse events. Differences between groups were assessed using Cox regression models and Kaplan-Meier curves, with sensitivity analysis performed using inverse probability of treatment weighting (IPTW). ResultsThe median follow-up in the matched cohort was 28.07 months. Regarding the GH recurrence outcome, the recurrence rate in the exposure group (18/102, 17.6%) was significantly lower than that in the control group (31/102, 30.4%; χ²=4.539, P=0.033); regarding the TRAb negativity outcome, the TRAb negativity rate in the exposure group (50/102, 49.0%) was significantly higher than that in the control group (23/102, 22.5%; χ²=15.551, P<0.001). Multivariate Cox regression analysis for recurrence showed that Ningying Formula treatment reduced the risk of recurrence [HR=0.324, 95%CI(0.170, 0.617), P<0.001]. Male [HR=2.209, 95%CI(1.079, 4.520), P=0.030], higher initial TRAb level [per 1 IU/L increase: HR=1.033, 95%CI(1.003, 1.064), P=0.032], and larger thyroid volume [per 1 ml increase: HR=1.045, 95%CI(1.003, 1.088), P=0.035] were identified as independent risk factors for recurrence; multivariate Cox regression analysis for TRAb negativity indicated that Ningying Formula treatment promoted TRAb negativity [HR=1.826, 95%CI(1.091, 3.056), P=0.022], while a higher initial TRAb level was associated with a lower probability of negativity [HR=0.974, 95%CI(0.950, 0.998), P=0.032]. Survival analysis showed significant differences in relapse rate between groups (Log-Rank P=0.003) and in TRAb outcomes (Log-Rank P=0.034). The incidence of treatment-related adverse events was similar between groups (P=0.757). The IPTW sensitivity analysis was consistent with the primary analysis, indicating robust results. ConclusionThe Ningying Formula combined with low-dose ATDs can significantly reduce the risk of recurrence and can improve the TRAb negativity rate in GH patients during the remission stage, without increasing common adverse events, making it an optional strategy for reducing relapse risk during remission. Male gender, higher baseline TRAb level, and larger thyroid volume indicate a higher risk of recurrence, warranting focused follow-up and stratified management.
3.Mechanism of pachymic acid in ameliorating renal injury in pregnancy induced hypertension rats by regulating the Sirt1/PGC‑1α pathway
Junjiang ZHU ; Jincheng LIN ; Jiajian WU ; Yi ZENG ; Jun HU ; Min LI ; Hongying LIU ; Jinfen LI
China Pharmacy 2026;37(2):186-191
OBJECTIVE To investigate the mechanism of pachymic acid on renal injury in pregnancy induced hypertension (PIH) rats by regulating the silent information regulator transcript 1/peroxisome proliferator-activated receptor γ coactivator-1α (Sirt1/PGC-1α) pathway. METHODS Pregnant SD rats were prepared by co-caging and PIH model was induced using N-nitro-L- arginine methyl ester (L-NAME) method. PIH rats were randomly divided into model group, L-pachymic acid (low-dose pachymic acid, 10 mg/kg) group, H-pachymic acid (high-dose pachymic acid, 20 mg/kg) group, and H-pachymic acid+EX527 (20 mg/kg pachymic acid+10 mg/kg EX527) group, with 6 rats in each group. Another 6 normal pregnant rats were selected as blank group. Each group was given relevant medicine or solvent intragastrically or intraperitoneally daily, once a day, for 28 consecutive days. After the last administration, 24 h urinary protein and tail artery systolic blood pressure (SBP) were measured in pregnant rats from each group, along with the levels of serum creatinine (Scr), blood urea nitrogen (BUN),uric acid (UA), and cystatin C (Cys-C). The contents of superoxide dismutase (SOD), malondialdehyde (MDA), glutathione peroxidase (GSH-Px), and 8-hydroxy-2′-deoxyguanosine (8-OHdG) in renal tissue, as well as the mRNA and protein expression levels of Sirt1 and PGC-1α, were also determined. Meanwhile, renal histopathological changes in rats from each group were evaluated using hematoxylin-eosin (HE) staining and periodic acid-Schiff (PAS) staining. RESULTS Compared with model group, L-pachymic acid group and H-pachymic acid group exhibited significant decreases in 24 h urine protein quantification, tail artery SBP, Scr, BUN, UA, Cys-C levels, glomerulosclerosis index score of renal tissue, renal tubular injury score, the percentage of PAS positive area, MDA and 8-OHdG (P<0.05). Conversely, the contents of SOD and GSH-Px, along with the mRNA and protein expression levels of Sirt1 and PGC-1α, were significantly increased (P<0.05). Moreover, these improvements were more pronounced in H-pachymic acid group (P<0.05). Compared with H-pachymic acid group, the aforementioned indicators in pregnant rats from the H-pachymic acid+EX527 group showed significant reversal (P<0.05). CONCLUSIONS Pachymic acid significantly ameliorates renal injury induced by PIH in rats, potentially through activation of the Sirt1/PGC-1α pathway.
4.Meta-analysis of the efficacy and safety total glucosides of paeonia in the treatment of systemic lupus erythematosus
Xiangyan HAO ; Jiahui LENG ; Zhengqi LIU ; Xinchang WANG ; Cong HUANG ; Xiaopeng LI ; Yi LING
China Pharmacy 2026;37(2):232-237
OBJECTIVE To evaluate the efficacy and safety of total glucosides of paeonia (TGP) in the treatment of systemic lupus erythematosus (SLE). METHODS Randomized controlled trial (RCT) about TGP combined with western medicine versus western medicine alone for SLE treatment were retrieved from PubMed, Embase, Cochrane Library, Web of Science, CNKI, VIP, Wanfang Data, and CBM. The search period spanned from the inception of each database to June 1, 2025. After literature screening, data extraction, and quality assessment of the included studies, Meta-analysis was performed using RevMan 5.4 software. RESULTS Fifteen RCTs, involving 1 318 patients, were included. Meta-analysis results showed that compared with western medicine alone, TGP combined with western medicine significantly improved clinical efficacy [OR=4.96, 95%CI(3.41, 7.23), P<0.000 01], complement 3 [MD=0.18, 95%CI (0.13, 0.23), P<0.000 01] and complement 4[MD=0.08, 般021) 95%CI (0.04, 0.11), P<0.000 01], and reduced the levels of immunoglobulin G (IgG) [MD=-3.10, 95%CI (-3.59,-2.62), P<0.000 01], IgA [MD=-0.68, 95%CI (-0.78, -0.58), P<0.000 01], IgM [MD=-0.43, 95%CI (-0.53,-0.34), P<0.000 01], systemic lupus erythematosus disease activity index (SLEDAI) [MD=-1.59, 95%CI (-2.20, -0.99), P<0.000 01], recurrence rate [OR=0.23, 95%CI (0.13, 0.42), P<0.000 01] and the incidence of adverse drug reactions [OR= 0.54, 95%CI (0.36, 0.82), P=0.004]. CONCLUSIONS TGP therapy can improve clinical efficacy of SLE patients, promote the restoration of immunoglobulins and complements, reduce SLEDAI and recurrence rate and has good safety.
5.Expert consensus on neoadjuvant PD-1 inhibitors for locally advanced oral squamous cell carcinoma (2026)
LI Jinsong ; LIAO Guiqing ; LI Longjiang ; ZHANG Chenping ; SHANG Chenping ; ZHANG Jie ; ZHONG Laiping ; LIU Bing ; CHEN Gang ; WEI Jianhua ; JI Tong ; LI Chunjie ; LIN Lisong ; REN Guoxin ; LI Yi ; SHANG Wei ; HAN Bing ; JIANG Canhua ; ZHANG Sheng ; SONG Ming ; LIU Xuekui ; WANG Anxun ; LIU Shuguang ; CHEN Zhanhong ; WANG Youyuan ; LIN Zhaoyu ; LI Haigang ; DUAN Xiaohui ; YE Ling ; ZHENG Jun ; WANG Jun ; LV Xiaozhi ; ZHU Lijun ; CAO Haotian
Journal of Prevention and Treatment for Stomatological Diseases 2026;34(2):105-118
Oral squamous cell carcinoma (OSCC) is a common head and neck malignancy. Approximately 50% to 60% of patients with OSCC are diagnosed at a locally advanced stage (clinical staging III-IVa). Even with comprehensive and sequential treatment primarily based on surgery, the 5-year overall survival rate remains below 50%, and patients often suffer from postoperative functional impairments such as difficulties with speaking and swallowing. Programmed death receptor-1 (PD-1) inhibitors are increasingly used in the neoadjuvant treatment of locally advanced OSCC and have shown encouraging efficacy. However, clinical practice still faces key challenges, including the definition of indications, optimization of combination regimens, and standards for efficacy evaluation. Based on the latest research advances worldwide and the clinical experience of the expert group, this expert consensus systematically evaluates the application of PD-1 inhibitors in the neoadjuvant treatment of locally advanced OSCC, covering combination strategies, treatment cycles and surgical timing, efficacy assessment, use of biomarkers, management of special populations and immune related adverse events, principles for immunotherapy rechallenge, and function preservation strategies. After multiple rounds of panel discussion and through anonymous voting using the Delphi method, the following consensus statements have been formulated: 1) Neoadjuvant therapy with PD-1 inhibitors can be used preoperatively in patients with locally advanced OSCC. The preferred regimen is a PD-1 inhibitor combined with platinum based chemotherapy, administered for 2-3 cycles. 2) During the efficacy evaluation of neoadjuvant therapy, radiographic assessment should follow the dual criteria of Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and immune RECIST (iRECIST). After surgery, systematic pathological evaluation of both the primary lesion and regional lymph nodes is required. For combination chemotherapy regimens, PD-L1 expression and combined positive score need not be used as mandatory inclusion or exclusion criteria. 3) For special populations such as the elderly (≥ 70 years), individuals with stable HIV viral load, and carriers of chronic HBV/HCV, PD-1 inhibitors may be used cautiously under the guidance of a multidisciplinary team (MDT), with close monitoring for adverse events. 4) For patients with a poor response to neoadjuvant therapy, continuation of the original treatment regimen is not recommended; the subsequent treatment plan should be adjusted promptly after MDT assessment. Organ transplant recipients and patients with active autoimmune diseases are not recommended to receive neoadjuvant PD-1 inhibitor therapy due to the high risk of immune related activation. Rechallenge is generally not advised for patients who have experienced high risk immune related adverse events such as immune mediated myocarditis, neurotoxicity, or pneumonitis. 5) For patients with a good pathological response, individualized de escalation surgery and function preservation strategies can be explored. This consensus aims to promote the standardized, safe, and precise application of neoadjuvant PD-1 inhibitor strategies in the management of locally advanced OSCC patients.
6.Textual Research on Key Information of Famous Classical Formula Jiegengtang
Yang LEI ; Yuli LI ; Xiaoming XIE ; Zhen LIU ; Shanghua ZHANG ; Tieru CAI ; Ying TAN ; Weiqiang ZHOU ; Zhaoxu YI ; Yun TANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):182-190
Jiegengtang is a basic formula for treating sore throat and cough. By means of bibliometrics, this study conducted a textual research and analysis on the key information such as formula origin, decocting methods, and clinical application of Jiegengtang. After the research, it can be seen that Jiegengtang is firstly contained in Treatise on Febrile and Miscellaneous Disease, which is also known as Ganjietang, and it has been inherited and innovated by medical practitioners of various dynasties in later times. The origins of Chinese medicines in this formula is basically clear, Jiegeng is the dried roots of Platycodon grandiflorum, Gancao is the dried roots and rhizomes of Glycyrrhiza uralensis, the two medicines are selected raw products. The dosage is 27.60 g of Glycyrrhizae Radix et Rhizoma and 13.80 g of Platycodonis Radix, decocted with 600 mL of water to 200 mL, taken warmly after meals, twice a day, 100 mL for each time. In ancient times, Jiegengtang was mainly used for treating Shaoyin-heat invasion syndrome, with cough and sore throat as its core symptoms. In modern clinical practice, Jiegengtang is mainly used for respiratory diseases such as pharyngitis, esophagitis, tonsillitis and lung abscess, especially for pharyngitis and lung abscess with remarkable efficacy. This paper can provide literature reference basis for the modern clinical application and new drug development of Jiegengtang.
7.Textual Research on Key Information of Famous Classical Formula Jiegengtang
Yang LEI ; Yuli LI ; Xiaoming XIE ; Zhen LIU ; Shanghua ZHANG ; Tieru CAI ; Ying TAN ; Weiqiang ZHOU ; Zhaoxu YI ; Yun TANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):182-190
Jiegengtang is a basic formula for treating sore throat and cough. By means of bibliometrics, this study conducted a textual research and analysis on the key information such as formula origin, decocting methods, and clinical application of Jiegengtang. After the research, it can be seen that Jiegengtang is firstly contained in Treatise on Febrile and Miscellaneous Disease, which is also known as Ganjietang, and it has been inherited and innovated by medical practitioners of various dynasties in later times. The origins of Chinese medicines in this formula is basically clear, Jiegeng is the dried roots of Platycodon grandiflorum, Gancao is the dried roots and rhizomes of Glycyrrhiza uralensis, the two medicines are selected raw products. The dosage is 27.60 g of Glycyrrhizae Radix et Rhizoma and 13.80 g of Platycodonis Radix, decocted with 600 mL of water to 200 mL, taken warmly after meals, twice a day, 100 mL for each time. In ancient times, Jiegengtang was mainly used for treating Shaoyin-heat invasion syndrome, with cough and sore throat as its core symptoms. In modern clinical practice, Jiegengtang is mainly used for respiratory diseases such as pharyngitis, esophagitis, tonsillitis and lung abscess, especially for pharyngitis and lung abscess with remarkable efficacy. This paper can provide literature reference basis for the modern clinical application and new drug development of Jiegengtang.
8.Construction of a system for isolation and purification of NK cells from whole blood donations
Tengyu CAO ; Huayu LIN ; Xuanzhi ZHANG ; Cuimi DUAN ; Yi LIU ; Xiaonan XUE ; Liping SUN ; Yang YU
Chinese Journal of Blood Transfusion 2025;38(2):181-188
[Objective] To explore the feasibility of using whole blood as a source of NK cells for allogeneic CAR NK cell therapy and activated NK cell reinfusion therapy, and initially construct a technical system for the separation and purification of NK cells from whole blood. [Methods] All peripheral blood mononuclear cells (PBMCs) were enriched from 400 mL of whole blood by manual separation and machine separation, respectively. The erythrocyte loss rate, PBMCs number, NK cell purity of the two methods were compared. NK cells were sorted from PBMCs by three separation and enrichment methods as immunomagnetic bead negative selection method, platelet lysate culture expansion and PERCOLL density gradient separation method, and the purity and yield of NK cells, the activity of NK cells and the tumor-killing ability of the three separation and enrichment methods were compared. [Results] The proportion of NK cells in the lymphocyte population was higher in the manual separation method than in the machine separation method[(13.16±5.16)% vs (8.56±3.92)%, P<0.05]; the number PBMCs was lower in the manual separation method than in the machine separation method[(4.09±1.80)×108vs (6.49±2.16)×108, P<0.05], and there was no difference in the red blood cell loss between the two methods (P>0.05). The purity of NK cells isolated and enriched from PBMCs by manual separation method using immunomagnetic was (96.77±2.31)%; the yield was (56.27±10.47)%; the inhibition of tumor proliferation was (38.67±14.05)%; and the tumor killing rate was (19.90±8.05)%. The purity of NK cells isolated and enriched from PBMCs by manual separation method using platelet lysis culture expansion method was the highest at day 7, which was (54.84±15.80)%; the cell expansion multiple could reach 16.92±6.28 at day 7; the in vitro tumor killing rate of NK cells was (15.83±5.5)%; the tumor inhibition rate was (44.33±13.5)%; and there was no difference in the toxicity and activity of NK cells between the two methods (P>0.05). The purity of NK cells isolated and enriched by PERCOLL density gradient separation method was (15.83±5.82)%, and the yield was (14±6.25)%, which was significantly lower than the other two methods. [Conclusion] PBMCs isolated from whole blood by manual separation and NK cells enriched by negative selection with immunomagnetic beads have the potential to provide NK cell materials for CAR-NK cell therapy, and NK cells enriched by platelet lysate-conditioned medium have the potential to provide NK cells for large-scale NK cell activation reinfusion therapy.
9.Interpretation and thoughts on the formulation and revision of the standards for exogenous harmful residues in traditional Chinese medicinal materials in the Chinese Pharmacopoeia 2025 Edition
WANG Ying ; SHEN Mingrui ; LIU Yuanxi ; ZUO Tiantian ; WANG Dandan ; HE Yi ; CHENG Xianlong ; JIN Hongyu ; LIU Yongli ; WEI Feng ; MA Shuangcheng
Drug Standards of China 2025;26(1):083-092
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.
10.Progress in the application of poloxamer in new preparation technology
Xue QI ; Yi CHENG ; Nan LIU ; Zengming WANG ; Hui ZHANG ; Aiping ZHENG ; Dongzhou KANG
China Pharmacy 2025;36(5):630-635
Poloxamer, as a non-ionic surfactant, exhibits a unique triblock [polyethylene oxide-poly (propylene oxide)-polyethylene oxide] structure, which endows it with broad application potential in various fields, including solid dispersion technology, nanotechnology, gel technology, biologics, gene engineering and 3D printing. As a carrier, it enhances the solubility and bioavailability of poorly soluble drugs. In the field of nanotechnology, it serves as a stabilizer etc., enriching preparation methods. In gel technology, its self-assembly behavior and thermosensitive properties facilitate controlled drug release. In biologics, it improves targeting efficiency and reduces side effects. In gene engineering, it enhances delivery efficiency and expression levels. In 3D printing, it provides novel strategies for precise drug release control and the production of high-quality biological products. As a versatile material, poloxamer holds promising prospects in the pharmaceutical field.


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