1.Key Information and Modern Clinical Application of Classic Formula Xiaoji Yinzi
Baolin WANG ; Lyuyuan LIANG ; Jialei CAO ; Chen CHEN ; Jinyu CHEN ; Chengxin LUO ; Bingqi WEI ; Kaili CHEN ; Peicong XU ; Wei DENG ; Bingxiang MA
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(6):189-198
Xiaoji Yinzi is one of the classic prescriptions for treating urinary diseases, originated from the Yan's Prescriptions to Aid the Living (Yan Shi Ji Sheng Fang) written by YAN Yonghe in the Song dynasty. Xiaoji Yinzi is composed of Rehmanniae Radix, Cirsii Herba, Talcum, Akebiae Caulis, Typhae Pollen, Nelumbinis Rhizomatis Nodus, Lophatheri Herba, Angelicae Sinensis Radix, Gardeniae Fructus, and Glycyrrhizae Radix et Rhizoma and has the effects of cooling blood and stopping bleeding, draining water and relieving stranguria. The medical experts of later generations have inherited the original prescription recorded in the Yan's Prescriptions to Aid the Living, while dispute has emerged during the inheritance of this prescription. In this study, the method of bibliometrics was employed to review and analyze the ancient documents and modern clinical studies involving Xiaoji Yinzi. The results showed that Xiaoji Yinzi has two dosage forms: powder and decoction. According to the measurement system in the Song Dynasty, the modern doses of hers in Xiaoji Yinzi were transformed. In the prepration of Xiaoji Yinzi powder, 149.2 g of Rehmanniae Radix and 20.65 g each of Cirsii Herba, Talcum, Akebiae Caulis, stir-fried Typhae Pollen, Nelumbinis Rhizomatis Nodus, Lophatheri Herba, wine-processed Angelicae Sinensis Radix, stir-fried Gardeniae Fructus, and stir-fried Glycyrrhizae Radix et Rhizoma are grounded into fine powder with the particle size of 4-10 meshes and a decocted with 450 mL water to reach a volume of 240 mL. After removal of the residue, the decoction was taken warm before meals, 3 times a day (i.e., 7.77 g Rehmanniae Radix and 0.97 g each of the other herbs each time). In the preparation of Xiaoji Yinzi decoction, 20.65 g each of the above 10 herbs are used, with stir-fried Typhae Pollen, wine-processed Angelica Sinensis Radix, stir-fired Gardeniae Fructus, stir-fired Glycyrrhizae Radix et Rhizoma, and raw materials of other herbs. Xiaoji Yinzi is specialized in treating hematuresis and blood stranguria due to heat accumulation in lower energizer, which causes injury of the blood collaterals of gallbladder and dysfunction of Qi transformation. In modern clinical practice, Xiaoji Yinzi is specifically used for treating urinary diseases and can be expanded to treat diseases of the cardiovascular system and other systems according to pathogenesis. The comprehensive research on the key information could provide a scientific reference for the future development of Xiaoji Yinzi.
2.Impact factors and reference range upper limit of thyroid volume in children aged 8-10 years old in Huangpu District, Shanghai
Weihua CHEN ; Chengdi SHAN ; Lili SONG ; Lifang MA ; Yun CAO ; Youshun QIAN ; Aina HE ; Jun XIAO
Journal of Environmental and Occupational Medicine 2025;42(2):205-210
Background As one of the key populations in the prevention and treatment of iodine deficiency disorders, it is important to continuously monitor the iodine nutritional level of school-age children. The current reference interval for thyroid volume in China is based on age only, without taking into account differences in individual developmental levels, and the distribution of thyroid volume may vary regionally due to economic, demographic, and environmental factors. The current reference cut-off points for thyroid volume proposed by the World Health Organization are not based on the Chinese population. Objective To understand the iodine nutritional status and distribution of thyroid volume (Tvol) among children aged 8-10 years in Huangpu District, Shanghai, China, to identify impact factors of Tvol, and to propose a reference range upper limit for local thyroid health surveillance, so as to provide a basis for goiter control and prevention. Methods Six hundred children aged 8-10 years in Huangpu District were recruited in 2017, 2020, and 2023, and body height, weight, thyroid volume, urinary iodine, and iodine content of household edible salt were determined. A multilevel model was constructed using population density and area as regional variables, and age, body surface area (BSA), and body mass index (BMI) as potential impact factors for at the individual level, to assess their effects on thyroid volume. Quantile regression of thyroid volume was performed, and the 98th percentile (P98) of thyroid volume was predicted based on age and BSA. Results The iodized salt coverage in the households of surveyed children in 2017, 2020, and 2023 was 72.0%, 57.0%, and 48.0%, respectively, and the iodized salt coverage decreased by year (χ2=24.31, P<0.001). The urinary iodine level of children in 2017 was higher than that in 2020 and 2023 (χ2=18.77, P<0.001). The Tvol medians of children in 2017, 2020, and 2023 were 2.29, 2.49, and 2.97 mL, respectively, and the Tvol increased by year (χ2=60.04, P<0.001). The proportion of goiter was higher in children in 2023 than in 2017 and 2020 (χ2=6.57, P<0.05). Sex differences were not statistically significant for urinary iodine levels, thyroid volume, and goiter. The median Tvol was 2.26, 2.58, and 2.76 mL in children of 8, 9, and 10 years old respectively, and the Tvol increased with age (χ2=49.02, P <0.001). Tvol was positively correlated with age, BSA, and BMI with correlation coefficients of
3.Changes and Trends in the microbiological-related standards in the Chinese Pharmacopoeia 2025 Edition
FAN Yiling ; ZHU Ran ; YANG Yan ; JIANG Bo ; SONG Minghui ; WANG Jing ; LI Qiongqiong ; LI Gaomin ; WANG Shujuan ; SHAO Hong ; MA Shihong ; CAO Xiaoyun ; HU Changqin ; MA Shuangcheng, ; YANG Meicheng
Drug Standards of China 2025;26(1):093-098
Objective: To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia (ChP) 2025 Edition, and explore its novel requirements in risk-based pharmaceutical product lifecycle management.
Methods: A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview, international harmonization of microbiological standards, risk-based quality management system, and novel tools and methods with Chinese characteristics.
Results: The ChP 2025 edition demonstrates three prominent features in microbiological-related standards: enhanced international harmonization, introduced emerging molecular biological technologies, and established a risk-based microbiological quality control system.
Conclusion: The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system, which significantly improves the scientificity, standardization and applicability of the standards, providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.
4.Stage Treatment of Squamous Cell Carcinoma Based on the Theory of Fire and Heat
Xinyi MA ; Luchang CAO ; Xinmiao WANG ; Guanghui ZHU ; Jie LI
Journal of Traditional Chinese Medicine 2025;66(6):575-580
It is believed that the occurrence and development of squamous cell carcinoma (SCC) is closely associated with inflammatory responses. The theory of fire and heat, advocated by LIU Wansu, provides significant clinical guidance for understanding the pathogenesis and treatment of SCC. Based on this theory, the pathological mechanisms and clinical characteristics of SCC at different stages were analyzed. In the precancerous and early stages, the primary pathogenesis is qi stagnation leading to internal generation of constrained heat; in post-surgery, the condition shifts to qi deficiency with latent yin fire; during the treatment phase, the pathogenesis involves accumulation of pathogenic factors, excess toxins, and severe heat toxicity; in the late stage, the main pathology is yin deficiency with toxic heat, and phlegm-stasis obstruction of the internal organs. Corresponding stage-based treatment strategies are proposed. In the early stage, regulating qi movement to dissipate constrained heat; for post-surgery, tonifying qi and raising yang to dispel latent fire; during treatment stage, clearing heat and detoxifying to eliminate cancerous toxins; and in the late stage, nourishing yin and unblocking the bowels to clear deficiency heat.
5.Forty Cases of Mid-Stage Diabetes Kidney Disease Patients of Blood Stasis Syndrome Treated with Huayu Tongluo Formula (化瘀通络方) as an Adjunct Therapy: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial
Yun MA ; Kaishuang WANG ; Shuang CAO ; Bingwu ZHAO ; Lu BAI ; Su WU ; Yuwei GAO ; Xinghua WANG ; Dong BIAN ; Zhiqiang CHEN
Journal of Traditional Chinese Medicine 2025;66(6):588-595
ObjectiveTo evaluate the clinical efficacy of Huayu Tongluo Formula (化瘀通络方, HTF) in patients with mid-stage diabetic kidney disease of blood stasis syndrome and explore its potential mechanisms. MethodsA multi-center, randomized, double-blind, placebo-controlled clinical trial was conducted. Ninety patients of mid-stage diabetic kidney disease of blood stasis syndrome were divided into a control group of 46 cases and a treatment group of 44 cases. Both groups received conventional western medicine treatment, the treatment group additionally taking HTF, while the control group taking a placebo of the formula. The treatment was administered once daily for 24 weeks. The primary outcomes included 24-hour urine total protein (24 h-UTP), serum albumin (Alb), glycated hemoglobin (HbA1c), and serum creatinine (Scr).The secondary outcomes included changes in levels of endothelin-1 (ET-1), nitric oxide (NO), vascular endothelial growth factor (VEGF), and traditional Chinese medicine (TCM) syndrome scores before and after treatment. Clinical efficacy was evaluated based on TCM syndrome scores and overall disease outcomes. Adverse reactions and endpoint events were recorded. ResultsIn the treatment group after treatment, 24 h-UTP, ET-1, and VEGF levels significantly decreased (P<0.05), Alb and NO levels significantly increased (P<0.05); while the TCM syndrome scores for edema, lumbar pain, numbness of limbs, dark purple lips, dark purple tongue or purpura, and thin, rough pulse all significantly decreased (P<0.05). In the control group, no significant changes were observed in any of the indicators after treatment (P>0.05).Compared with the control group, the treatment group showed significant reductions in 24 h-UTP, ET-1, and VEGF levels, and increases in Alb and NO levels (P<0.05). The TCM syndrome scores for edema, lumbar pain, dark purple tongue or purpura, and thin, rough pulse were all lower in the treatment group than in the control group (P<0.05). The total effective rate of TCM syndrome in the treatment group was 59.09% (26/44), and the overall clinical effective rate was 45.45% (20/44). In the control group, these rates were 15.22% (7/46) and 8.7% (4/46), respectively, with the treatment group showing significantly better outcomes (P<0.05). A total of 7 adverse events occurred across both groups, with no significant difference (P>0.05). No endpoint events occurred during the study. ConclusionOn the basis of conventional treatment of Western medicine, HTF can further reduce urinary protein levels and improve clinical symptoms in patients with mid-stage diabetic kidney disease of blood stasis syndrome. The mechanism may be related to its effects on endothelial function.
6.Textual Research on Historic Evolution and Ancient and Modern Application of Classic Prescription Huangqintang
Yuxin LI ; Lyuyuan LIANG ; Jialei CAO ; Tongyi HUANG ; Hejia WAN ; Bingqi WEI ; Mengting ZHAO ; Xiaoyang TIAN ; Bingxiang MA ; Weili DANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(3):184-191
Huangqintang, with its accurate efficacy, is a classic formula specialized in treating dysentery recommended and promoted by medical experts from successive generations, and it was included in the Catalogue of Ancient Classic Prescriptions (the Second Batch, Han Chinese medicine prescriptions) published by the National Administration of Traditional Chinses Medicine (TCM) in 2023. The method of bibliometrics was applied in this study to conduct textual research on the classic formula Huangqintang and provide a literature reference for the development of modern preparations of Huangqintang. A total of 2 026 pieces of ancient literature were searched with "Huangqintang" as the key word, and 23 pieces of effective data were selected, involving 15 ancient TCM books. The historic evolution, composition, dosage, origin, processing methods, preparation and decocting methods, efficiency, and application of Huangqintang were carefully reviewed. The results showed that Huangqintang was first recorded in the Treatise on Febrile Diseases written by ZHANG Zhongjing. It has the effect of clearing heat, stopping dysentery, regulating the middle, and downbearing counterflow and has become one of the classic formulas widely used in clinical practice. Because of its accurate efficacy, medical experts from later generations have modified it from its original composition. Though many prescriptions have different names, it is the manifestation of physicians' inheritance and development of the thought of ZHANG Zhongjing. Ancient literature showed this prescription had wide indications yet centered on digestive system diseases such as dysentery and abdominal pain. Modern applications of Huangqintang involve digestive, respiratory, ophthalmology and otolaryngology, gynecological, skin, musculoskeletal system, and connective tissue, and this prescription has great potential in treating ulcerative colitis, diarrhea, acute enteritis, and damp-heat dysentery. Through a systematic textual excavation and review of the ancient literature about Huangqintang, the paper has confirmed its key information, so as to provide a scientific basis for the clinical application and new drug development of classic formulas.
7.Textual Research of Key Information of Classic Formula Xieqingwan Based on Ancient and Modern Literature
Yujie CHANG ; Lyuyuan LIANG ; Jialei CAO ; Xinghang LYU ; Wenxi WEI ; Xiaofang WANG ; Huizhen ZHANG ; Sai REN ; Mengqi WANG ; Bingqi WEI ; Bingxiang MA
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(4):226-234
ObjectiveThis paper aims to systematically collect and organize ancient and modern clauses and studies containing Xieqingwan, excavate and analyze the key information of Xieqingwan, and provide a reference for facilitating the development of the classic formula Xieqingwan. MethodsThe composition, dosage, decocting methods, usage, and other key information of Xieqingwan in ancient traditional Chinese medicine books were collected and analyzed by means of literature research and metrological methods. The modern clinical application of Xieqingwan was summarized. ResultsA total of 42 pieces of effective data involving 32 ancient traditional Chinese medicine books were collected. Xieqingwan was first recorded in Xiaoer Yaozheng Zhijue. The drug origin of this formula is basically clear in the ancient traditional Chinese medicine books. The modern drug usage and decocting method were as follows: Angelicae Sinensis Radix, Gentianae Radix et Rhizoma, Chuanxiong Rhizoma, Gardenia seeds, Radix et Rhizoma Rhei, Notopterygii Rhizoma et Radix, and Saposhnikoviae Radix were grounded to fine powder, decocted with honey, and finally formed into pills with the size of a chicken head (1.5 g). It was suggested that half a pill or one pill were taken for one dose with warm Lophatheri decoction and sugar. The indications and clinical application had developed from the recordings in Xiaoer Yaozheng Zhijue and evolved from pediatrics to ophthalmic otolaryngology, neurology, dermatology, digestion, and respiratory diseases. The main pathogenesis of these diseases is heat in the liver meridian and is treated. The effect of Xieqingwan is "clearing away heat and toxicity, removing fire and relaxing the bowels, and dispersing swelling and relieving pain". It is recommended to use the corresponding preparation methods in the 2020 Edition of Pharmacopoeia of the People's Republic of China. Modern clinical studies are centered around the clinical application of Xieqingwan, which is often modified and used in treating Tourette syndrome, herpes, febrile convulsion, sleepwalking, and insomnia. ConclusionThis paper conducts a thorough textual research of the key information of Xieqingwan, induces its historic evolution, and confirms its key information, so as to provide a reference for the future development of Xieqingwan.
8.Research on Historical Evolution and Clinical Application of Shengyutang
Yuning CAO ; Wenpan LIU ; Tianyu MA ; Lanru CHEN ; Jiahao HUANG ; Yonghai MENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(4):235-243
Shengyutang is a famous classical formula of tonic, which is made from Siwutang with Ginseng Radix et Rhizoma and Astragali Radix. It is included in the Catalogue of Ancient Famous Classical Formulas(The First Batch). Based on the Principles of Key Information Research of Ancient Famous Classical Formulas, this paper used bibliometrics to sort out and research the key information of Shengyutang in the aspects of history, composition, origin and processing, dosage, decocting method, efficacy and indications. After research, it has been found that this formula was first recorded in Lanshi Micang written by LI Dongyuan during the Jin dynasty, composed of Rehmanniae Radix, Rehmanniae Radix Praeparata, Chuanxiong Rhizoma, Ginseng Radix et Rhizoma, Astragali Radix and Angelicae Sinensis taproot. The name of the formula passed down through generations was relatively unified, with clear origins and veins. In later generations, this formula was the mainstream, and adjustments were made to the dosage and composition according to the indication. In the formula, Astragalus membranaceus var. mongholicus was selected as the origin of Astragali Radix, and the origins of other medicinal materials were consistent with the 2020 edition of Chinese Pharmacopoeia. Except for Rehmanniae Radix Praeparata, the other medicinal materials were made from raw products, and the dosage form was boiled powder. According to the measurement standard in the Jin dynasty, the recommended usage and dosage were 1.24 g of Rehmanniae Radix, Rehmanniae Radix Praeparata, Chuanxiong Rhizoma, Ginseng Radix et Rhizoma each, 2.07 g of Astragali Radix and Angelicae Sinensis taproot each, crushed into coarse particles that pass through the 4 mesh sieve but can't pass through the 10 mesh sieve, added 1 200 mL of water and boiled to 300 mL, and removed the residue. Shengyutang has the functions of tonifying Qi and blood, and blood intake, treating various sores, and restlessness and insomnia caused by excessive blood flow. In ancient times, this formula was widely used in the treatment of surgical sores, gynecological diseases, deficiency syndrome, etc. In modern clinical practice, it is mostly used to treat gynecological, neurological, musculoskeletal, hematological diseases caused by Qi and blood deficiency. In this paper, the key information of Shengyutang was researched by reviewing relevant ancient literature, in order to provide reference for the modern application and development of this formula.
9.Textual Research and Analysis of Historic Origin and Ancient and Modern Application of Classic Formula Shengjiangsan
Lyuyuan LIANG ; Jialei CAO ; Xinghang LYU ; Weixiao LI ; Wenxi WEI ; Bingqi WEI ; Zhe WANG ; Yiping WANG ; Bingxiang MA ; Wenli SHI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(9):219-227
Shengjiangsan is a classic formula for treating warm diseases with wide clinical application and accurate efficacy. There are different opinions on the origin of this formula and lacks key information research on this formula. Therefore, in this study, we conducted systematic research into the historic origin, composition, and other key information of this Shengjiangsan. Results showed that Shengjiangsan has different versions, with "Neixian Fufang", "Jiawei Jianghuangwan", "Peizhensan", and "Taijiwan" being the same formula with different names. Shengjiangsan was first recorded as "Neixian Fufang" in Wanbing Huichun written by GONG Tingxian from the Ming dynasty, inherited and developed by YANG Lishan from Qing dynasty, and has been passed down to modern times. Pills and powder are two main forms of Shengjiangsan, and powder has become more popular nowadays. According to the measurement system of Ming and Qing dynasties, the recommended dosage and usage of Shengjiangsan are as follows. For the pill version of Shengjiangsan, Bombyx Batryticatus of 74.6 g, Curcumae Longae Rhizoma of 9.325 g, Cicadae Periostracum of 9.325 g, and Rhei Radix et Rhizoma of 149.2 g were processed into pills for preparation. Single dosage is Bombyx Batryticatus of 1.15 g, Curcumae Longae Rhizoma of 0.14 g, Cicadae Periostracum of 0.14 g, and Rhei Radix et Rhizoma of 2.3 g, with halved dosage applied for children. For the powder version of Shengjiangsan, the dosage varied in accordance with the severity of the disease. Bombyx Batryticatus of 1.84 g, Curcumae Longae Rhizoma of 0.28 g, Cicadae Periostracum of 0.92 g, and Rhei Radix et Rhizoma of 3.68 g were processed into powder for patients with mild symptoms. Bombyx Batryticatus of 2.48 g, Curcumae Longae Rhizoma of 0.37 g, Cicadae Periostracum of 1.23 g, and Rhei Radix et Rhizoma of 4.91 g were processed into powder for patients with severe symptoms. Bombyx Batryticatus of 3.68 g, Curcumae Longae Rhizoma of 1.84 g, Cicadae Periostracum of 0.55 g, and Rhei Radix et Rhizoma of 7.36 g were processed into powder for patients with critical conditions. In this formula, four herbs were ground to fine powder. For patients with mild symptoms, the whole formula was divided into four dosages, and each dosage weighed 6.71 g. The 200 mL yellow rice wine and 18.65 g honey were added, and the solution was stirred and taken cold till full recovery. For patients with severe symptoms, the whole formula was divided into three dosages, and each weighed 8.95 g. 300 mL yellow rice wine and 27.98 g honey were added, and the solution was stirred and taken cold. For patients with critical conditions, the whole formula was divided into two dosages, and each weighed 13.43 g. 400 mL yellow rice wine and 37.3 g honey were added, and the solution was stirred and taken cold. Shengjiangsan has the effect of ascending lucidity and descending turbidity, dissipating wind, and clearing heat. It is specialized in treating severe heat in exterior, interior, and triple energizers in warm diseases and has a wide modern clinical application. In this study, the historic evolution and key information of Shengjiangsan were reviewed and analyzed, and the key information table of Shengjiangsan was attached, serving as a reference for scholars' research and a theoretical basis for its market transformation.
10.Mechanism of Traditional Chinese Medicine Regulating JAK/STAT Signaling Pathway to Intervene in Lung Cancer: A Review
Jiarui CAO ; Bo FENG ; Chunzheng MA ; Weixia CHEN ; Jiangfan YU ; Shasha CAO ; Zhenyu ZHANG ; Wenhui OUYANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(9):265-276
Lung cancer is the malignant tumor with the highest incidence and mortality rates globally. Current treatment methods for lung cancer primarily include surgery, chemotherapy, targeted therapy, and immunotherapy. However, the main limitations of these treatments are their side effects, the drug resistance, and the economic burden they impose. As a critical cancer pathway, the Janus kinase (JAK)/signal transducer and activator of transcription (STAT) signaling pathway regulates tumor occurrence and development through multiple mechanisms by influencing various downstream targets. Consequently, the JAK/STAT signaling pathway offers a promising avenue for lung cancer treatment research. Numerous studies have demonstrated that the JAK/STAT signaling pathway plays a key role in the proliferation and growth of lung cancer cells, angiogenesis, epithelial-mesenchymal transition (EMT), metabolic alterations, remodeling of the immune microenvironment, and the development of treatment resistance. Traditional Chinese medicine (TCM) has garnered increasing attention due to its minimal side effects, low economic burden, and its potential to enhance efficacy and reduce toxicity when used in conjunction with Western medicine. In addition to traditional Chinese medicine compounds, a growing number of Chinese medicine monomers have come into the spotlight because of their more targeted effects. Numerous studies investigating the regulation of the JAK/STAT signaling pathway by TCM in the treatment of lung cancer have demonstrated that TCM can inhibit the proliferation and invasion of lung cancer cells, tumor angiogenesis, and EMT, improve the inflammatory and immunosuppressive microenvironments, and enhance treatment sensitivity by intervening in the JAK/STAT signaling pathway, thereby impeding the progression of lung cancer. In recent years, the research on the regulation of this pathway by TCM in the treatment of lung cancer has been updated rapidly. However, the summary of these studies has not been updated in time. This review summarizes and reflects on the recent research findings regarding the regulation of the JAK/STAT signaling pathway by TCM to intervene in lung cancer from three aspects, introducing the JAK/STAT pathway, elaborating the mechanism of this pathway in lung cancer, and exploring the intervention of TCM in the treatment of lung cancer through this pathway, to provide more reference for the treatment of lung cancer in the future.

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