1.Interpretation for the General Chapter 0237 the preparation and establishment of national biological reference standards in Chinese Pharmacopoeia 2025 Edition Volume Ⅲ
WANG Yiping ; MAO Qunying ; WANG Xiaojuan ; LIANG Zhenglun
Drug Standards of China 2025;26(1):099-104
The Chinese Pharmacopoeia 2025 Edition is about to be officially released. Based on multiple meetings and extensive consultations the vaccine products professional committee of the 12th pharmacopoeia commission, has revised and formed the general chapter 0237 for the preparation of national biological reference standards in Chinese Pharmacopoeia 2025 Edition volume Ⅲ. General chapter 0237, integrating the cutting-edge concepts from WHO’s related guidelines and the practical experience of biological reference standards both domestically, has revised the names of this chapter, updated and improved the technical requirements for candidate reference materials, collaborative calibration and value assignment, as well as stability research and monitoring. It also newly proposes the calculation of uncertainty of biological reference materials and emphasizes to pay attention to commutability. The implementation of general chapter 0237 will play a guiding role in improving the research and application level of biological reference materials in China. This article, by interpreting the revised content of general chapter 0237, aims to provide a reference for the researchers of biological reference materials.
2.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.
3.Analysis of Ancient and Modern Literature of Xiaoyaosan and Examination of Its Key Information
Zhe WANG ; Jialei CAO ; Lyuyuan LIANG ; Yiping WANG ; Chen CHEN ; Weixiao LI ; Bingqi WEI ; Yinli LI ; Yongbin YAN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(15):227-237
First recorded in an official medical book from the Northern Song Dynasty called Taiping Huimin Heji Ju Fang (Prescriptions of the Bureau of Taiping People's Welfare Pharmacy), Xiaoyaosan has been developed and refined over generations and is preserved to this day. It specializes in soothing the liver,resolving stagnation,fortifying the spleen,and nourishing blood. In this study,ancient traditional Chinese medicine (TCM) books and contemporary studies were reviewed to obtain information on Xiaoyaosan using bibliometrics,including its historical development,dosage,origin,processing methods,decoction dosage,and ancient and modern indications. Furthermore,a question regarding the presence of Zingiberis Rhizoma Recens and Menthae Haplocalycis Herba in Xiaoyaosan was investigated,and a table of key information on Xiaoyaosan was compiled,providing references for developing Xiaoyaosan preparations. According to the weight and measurement system of the Song dynasty,the contemporary equivalent formulation of the decocted Xiaoyaosan consists of 20.65 g of Glycyrrhizae Radix et Rhizoma and 41.3 g of Angelica Sinensis Radix,Poria,Paeoniae Radix Alba,Atractylodis Macrocephalae Rhizoma,and Bupleuri Radix. The formulation is processed to obtain a mixed powder with a particle size of 10 mesh. For each dose,8.25 g of the mixed powder is combined with 1 g of unprocessed Zingiberis Rhizoma Recens and 0.62 g of Menthae Haplocalycis Herba in 300 mL of water. The mixture is decocted until the volume reaches 210 mL,and the residue is then removed,with no specific timing required for administration. After the processing,each dose consists of approximately 0.75 g of Glycyrrhizae Radix et Rhizoma and 1.50 g of Radix Angelica Sinensis,Poria,Paeoniae Radix Alba,Atractylodis Macrocephalae Rhizoma,and Bupleuri Radix. Ancient medical literature shows that Xiaoyaosan primarily treats blood deficiency and overstrain,specifically for symptoms including heat caused by blood deficiency and fatigue,irregular menstruation,headache,eye soreness,pain in the ribs and limbs,and emaciation and bone steaming. In the Qing Dynasty,ZHANG Lu clearly proposed the pathogenesis of liver depression,and since then,the use of Xiaoyaosan in treating various syndromes associated with liver depression has been highly praised by physicians in the Qing dynasty and modern times. Xiaoyaosan has a wide application in modern clinical practices,involving digestive diseases,gynecological diseases,psychological diseases,nervous system diseases,and otorhinolaryngologic diseases. Moreover,it is most commonly used to treat depression and other diseases complicated with depression,hyperplasia of the mammary gland,etc. The key information on Xiaoyaosan and its clinical applications in ancient and modern times investigated in the study could serve as a scientific reference for in-depth research and extended clinical applications of the prescription.
4.Textual Research and Clinical Application of Chaihu Guizhi Ganjiangtang
Xuejie WANG ; Lyuyuan LIANG ; Jialei CAO ; Lan LIU ; Weixiao LI ; Yiping WANG ; Bingqi WEI ; Bingxiang MA ; Wenli SHI
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(12):136-146
Chaihu Guizhi Ganjiangtang with a definite clinical effect has been widely used and recorded since the Han Dynasty. As a classic prescription of Chaihu classic formula praised by doctors ofsuccessive generations, it has been included in the Ancient Classic Prescription Catalogue (Second Batch): Han Medicine published by the National Administration of Traditional Chinese Medicine in August 2023. We carried out a bibliometric study involved 34 ancient books of traditional Chinese medicine, with 37 records including the name and composition of the prescription. This paper summarizes the source name, composition, original medicinal plant, dose, preparation method, usage, ancient and modern indications, and clinical application of Chaihu Guizhi Ganjiangtang. The results of textual research show that Chaihu Guizhi Ganjiangtang is derived from the Treatise on Febrile Diseases (Shanghanlun) written by ZHANG Zhongjing in the Han dynasty, and the original plants of medicines in this prescription are basically the same in ancient and modern times. Most records about the doses in ancient books are consistent with those in the Treatise on Febrile Diseases (Shanghanlun). The efficacy of Chaihu Guizhi Ganjiangtang is to harmonize lesser yang and resolve water retention by warming. This prescription was used to treat a variety of diseases, especially those caused by disturbance of Qi movement in the greater Yang and lesser Yang. It is now mainly used to treat the diseases in the digestive system, respiratory system, dermatology, nervous system, etc., being effective for difficult and complicated diseases. Through the excavation and combing of the ancient records of Chaihu Guizhi Ganjiangtang, this paper clarifies the key information, providing a reference for the clinical application of classical prescriptions and the development of new drugs.
5.Textual Analysis of Classical Prescription Yangweitang Based on Ancient Literature
Lyuyuan LIANG ; Jialei CAO ; Yiping WANG ; Mengmeng GENG ; Lujun ZHU ; Wenxin WEI ; Bingqi WEI ; Wenli SHI ; Bingxiang MA
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(12):147-157
The classical prescription Yangweitang, derived from Zhengzhi Zhunsheng, is specialized in treating syndromes of chill and fever due to exogenous pathogens, inner-cooling, and malaria, and it has been included in the Catalogue of Ancient Classical Formulas (the First Batch) published by the National Administration of Traditional Chinese Medicine (TCM) in 2018. Through bibliographical research, the relevant ancient books and modern documents were systematically sorted out, and it was found that there were many prescriptions related to the Yangweitang from Zhengzhi Zhunsheng. They were interwoven with Yangweitang from Zhengzhi Zhunsheng and widely used in clinical practice. In order to clarify their history and evolution, this paper combed the historical origin of Yangweitang and its related prescriptions and conducted textual analysis on key information such as semantic composition, herb origin, processing method, and efficacy. A total of 896 pieces of data on Yangweitang from Zhengzhi Zhunsheng were collected. 26 pieces of effective data were included after the screening, involving 17 ancient TCM books. Then, a total of 28 pieces of data on prescriptions related to the Yangweitang from Zhengzhi Zhunsheng were included, involving 23 ancient TCM books for reference. The textual analysis showed that Yangweitang originated from the Renshen Yangweitang recorded in Taiping Huimin Heji Jufang in the Song dynasty. Based on the original formula, medical experts from later generations have modified it into many different versions. A comparative analysis showed that Yangweitang from different generations had similar compositions, and the herb origin and processing method were basically clear. The recommended prescriptions are as follows: 37.3 g of Pinelliae Rhizoma Praeparatum Cum Alumine, Magnoliae Officinalis Cortex(fried with ginger juice), and frying with rice water Atractlodis Rhizoma, 27.98 g of Citri Exocarpium Rubrum, 18.65 g of Pogostemon cablin leaf, Tsaoko Fructus, Poria, and Ginseng Radix et Rhizoma, and 9.33 g of Glycyrrhizae Radix et Rhizoma. They could be ground into a coarse powder, with 14.92 g for every dose, and they could be orally taken after being decocted with 450 mL of water, 7 g of fresh ginger, and 2 g of Mume Fructus to 270 mL in warm conditions. Yangweitang from Zhengzhi Zhunsheng has the effect of warming the middle and releasing the external, and it can treat many syndromes including spleen and stomach disharmony caused by chill and fever due to exogenous pathogens and inner-cooling, as well as all kinds of malaria. Modern clinical applications mainly focus on chronic atrophic gastritis and other digestive system diseases.
6.Application effect of rehabilitation instruction based on resourcefulness theory on exercise behavior implementation intention in patients with first-episode stroke
Yiping QUAN ; Fangfang ZHAO ; Jun SUN ; Wenjuan GUAN ; Haiying HU ; Hui ZHANG ; Fei XIE ; Yu LIANG ; Xia CHEN
Modern Clinical Nursing 2024;23(4):47-53
Objective To investigate the effect of rehabilitation instruction based on resourceful theory on the execution intention of exercise behaviour in patient with the first-episode stroke.Methods From September 2022 to February 2023,a total of 80 inpatients with first-episode stroke from a general hospital in Anhui Province participated in the study.Patients in Wards Ⅰ and Ⅱ were assigned to an intervention group,while those in Wards Ⅲ and Ⅳ were assigned to a control group,with 40 patients per group.The patients in control group received standard interventions,while those in the intervention group were offered with a rehabilitation instruction based on resourceful theory in addition to the standard interventions.Stroke patient rehabilitation exercise behaviour execution intention questionnaire,resourcefulness scale and modified Barthel were employed for assessments before and after the intervention.Results After the intervention,the intervention group showed significantly higher scores inexecutive intention of exercise behaviour,resourcefulness level and daily living activities compared to those in the control group(all P<0.01).Conclusion Rehabilitation instruction based on the theory of resourcefulness can effectively increase the executive intention of exercise behaviour in the patients with first-episode stroke,improve the resourcefulness thinking levels and enhance the daily living activity of the patients.
7.Clinical characteristics and prognostic analysis of 34 patients with primary thyroid lymphoma
Lei YANG ; Lijie ZENG ; Jin YE ; Liqiang WEI ; Jia CONG ; Xin LI ; Na YAO ; Jing YANG ; Henan WANG ; Liwei LYU ; Yiping WU ; Liang WANG
Chinese Journal of Hematology 2024;45(5):495-499
Objective:To investigate the clinical characteristics, diagnosis, treatment, and prognosis of primary thyroid lymphoma (PTL) .Methods:A retrospective analysis was conducted on the clinical and pathological data of 34 newly diagnosed PTL patients admitted to Beijing Tongren Hospital from September 2010 to February 2023. The Kaplan-Meier survival curve and Log-rank test were used for survival analysis, and the Cox regression model was applied for univariate analysis of prognostic factors.Results:All 34 PTL patients presented with cervical mass as the initial clinical manifestation. There were 9 males and 25 females. The pathological diagnosis was diffuse large B-cell lymphoma (DLBCL) in 29 patients and mucosa-associated lymphoid tissue (MALT) lymphoma in 5 patients. Among the DLBCL patients, 6 had B symptoms, 17 had an Eastern Cooperative Oncology Group (ECOG) score of ≥2, the Ann Arbor staging was stage Ⅰ-Ⅱ in 21 cases and stage Ⅲ-Ⅳ in 8 cases, the tumor diameter was ≥10 cm in 4 cases, and 14 had concurrent Hashimoto thyroiditis; 27 cases received chemotherapy, with 21 cases achieving complete remission (CR), 2 cases partial remission (PR), and 6 cases of disease progression; the 5-year progression-free survival and overall survival rates were 78.9% and 77.4%, respectively; univariate survival analysis showed that B symptoms, tumor diameter ≥10 cm, and Ann Arbor stage Ⅲ-Ⅳ were significant factors affecting patient prognosis ( P<0.05). MALT lymphoma patients were all in stages Ⅰ-Ⅱ, had an ECOG score of 0-1, and were without B symptoms. All patients underwent surgical resection, with 4 cases achieving CR and 1 case PR. Conclusion:PTL is more common in females with concurrent Hashimoto thyroiditis, with the majority of pathological types being B-cell lymphoma. The main treatment is chemotherapy, supplemented by radiotherapy and surgery, and the prognosis is relatively favorable.
8.Effect of nicorandil combined with rosuvastatin calcium in treatment of patients with slow coronary flow
Zhiqin FANG ; Huiqing LIANG ; Pengxiang ZHANG ; Kun ZHAO ; Yiping MA ; Yaling WANG ; Fangjiang LI ; Jun LI ; Pingping LI
Journal of Clinical Medicine in Practice 2024;28(15):70-75
Objective To investigate the effects of nicorandil combined with rosuvastatin calcium on monocyte-to-high density lipoprotein cholesterol ratio (MHR), systemic immune-inflammation index (SII), and cardiac function in patients with coronary slow flow (CSF). Methods A group case-control study was used to select 240 patients with CSF confirmed by coronary angiography, and they were randomly divided into observation group and control group, with 120 patients in each group. On the basis of conventional drug treatment, the control group was treated with rosuvastatin calcium, while the observation group was treated with nicorandil combined with rosuvastatin calcium for 6 months. Clinical efficacy, inflammatory markers[high-sensitivity C-reactive protein (hs-CRP), MHR, SII], corrected TIMI frame count (CTFC) of major coronary branches [left anterior descending branch (LAD), left circumflex branch (LCX), right coronary artery (RCA)], cardiac function indicators[left ventricular ejection fraction (LVEF), left ventricular end-diastolic diameter (LVEDD), global longitudinal strain (GLS)], and the occurrence of major adverse cardiovascular events (MACE) were compared between the two groups. Results The total effective rate in the observation groupwas significantly higher than that in the control group (95.00% versus 80.00%,
9.Experience in Diagnosis and Treatment of Oculomotor Nerve Palsy based on Channel Pattern Differentiation
Tao ZHU ; Xingyou DENG ; Yanping GUO ; Song LI ; Jun LIANG ; Yunli DIAN ; Lijun HUANG ; Jing SHI ; Yiping LIN
Journal of Traditional Chinese Medicine 2023;64(22):2372-2376
It is believed that the basic pathogenesis of oculomotor nerve paralysis (ONP) is qi and blood depletion and channel obstruction. Taking channel pattern differentiation as the core, it is recommended to use acupuncture mainly based on location, syndrome and channel deficiency-excess differentiation. Location and channel tropism differentiation mainly follows the principle of “where the channels and collaterals pass, the main treatment can reach”, and commonly uses acupuncture points on Dumai (督脉), the hand Shaoyang (少阳) Sanjiao (三焦) channel, the hand Taiyang (太阳) small intestine channel, three yang channels of the foot, the hand Shaoyin (少阴) heart channel, the foot Jueyin (厥阴) liver channel, and others, and combines scalp acupuncture with electro-acupuncture to enhance channel stimulation. Pattern and channel tropism differentiation is to differentiate the entered channel according to clinical symptoms and zang-fu patterns. The differentiation of deficiency-excess should be payed attention to, and the principle of “supplementing the deficiency, and draining the excess” should be followed. The supplementing and draining method should be used rationally by considering the differences in the supplementing and draining acupoints themselves, as well as the actual condition of the patients. Simultaneously, it is suggested to combine manipulation and stimulation amount and effect in clinical practice.
10.The antiretroviral treatment effect and drug resistance mutation of antiretroviral treatment for HIV-1 infected patients using second-line regimen in some areas of Sichuan Province
Dan YUAN ; Yiping LI ; Shujuan YANG ; Fang LIU ; Xiaoling HUANG ; Liang YAO ; Ling LI ; Chang ZHOU ; Li YE ; Yali ZENG ; Shu LIANG
Chinese Journal of Epidemiology 2023;44(2):276-284
Objective:To analyze the treatment effect and drug resistance mutation of HIV-1 infected patients who changed to the second-line antiretroviral treatment regimen after they had developed drug-resistance with first-line antiretroviral treatment regimen in some areas of Sichuan Province.Methods:Using the cohort study method, the patients who had developed drug resistance with the first-line regimen were followed up for two years from 1 January 2019 to 31 December 2021.The changes of CD4 +T lymphocytes (CD4) counts and viral load (VL) at the endline and the detection of drug-resistant mutation sites were analyzed using the chi-square test. Multivariate logistic regression model was used to analyze the influencing factors of antiretroviral treatment effect in patients who had good compliance after switching to the second-line regimen. Results:A total of 737 patients were recruited. Among the cases with continuous good compliance, those who timely changed to the second-line regimen had higher proportion of maintaining continuous CD4 >200 cells/μl and sustained virus inhibition ( P<0.05). Among the patients with different levels of drug resistance at baseline, there was no significant difference in continuous CD4 >200 cells/μl and sustained VL <200 copies/ml ( P>0.05). After changing to the second-line regimen, the drug-resistant mutation sites of some protease inhibitors showed an upward trend, while those of the non-nucleoside reverse transcriptase inhibitors showed a downward trend ( P<0.05). Multivariate logistic regression analysis showed that, among patients who had good compliance and who had switched to the second-line regimen, mother-to-child-transmitted patients had 3.01 times higher risk than heterosexual sexually transmitted infection (95% CI:1.29-7.00), failure to change the second-line protocol in time brought 2.55 times higher risk than that of timely changing to the second-line regimen (95% CI:1.41-4.62) and patients who infected with CRF85_BC subtype had 3.32 times higher risk than those infected with CRF01_AE subtype (95% CI:1.49-7.42). Conclusions:Difference in the drug resistance levels with the first-line regimen does not affect patients' antiretroviral treatment effect after changing to the second-line regimen in Sichuan Province. Changing to the second-line regimen in time and maintaining good compliance are beneficial to higher immune levels and lower VLs in drug-resistant patients. Among patients who changed to the second-line regimen, mother-to-child transmission, failure to change the second-line program in time, and infection with CRF85_BC virus are risk factors endangering antiretroviral treatment success after changing to the second-line regimen.


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