OBJECTIVE To explain the main content of the Special Regulations on the Management of Traditional Chinese Medicine Standards and propose suggestions on management of traditional Chinese medicine standards. METHODS The main content and key features of the Special Regulations on the Management of Traditional Chinese Medicine Standards was analyzed, and the suggestions were proposed to strengthen the management of traditional Chinese medicine standards. RESULTS The Special Regulations on the Management of Traditional Chinese Medicine Standards was focused on the reform of mechanism of management of Chinese medicine standards, such as building standard system that conforms to the key characteristics of traditional Chinese medicine, optimizing the management program of traditional Chinese medicine standards, clarifying the responsibilities of interested parties, and improving the technical system of traditional Chinese medicine standards. CONCLUSION The mechanism for traditional Chinese medicine standards should be optimized, the technical requirements related to traditional Chinese medicine standards should be improved, and all kinds of standards should be coordinated.

OBJECTIVE To establish a Chinese medicine standard based onprocessing, reflect the quality characteristics of Chinese medicine decoction pieces and provide a basis forquality control andevaluation of Chinese medicine decoction piece. METHODS Encouraged by the Special Regulations on the Management of Traditional Chinese Medicine Standards, highlighting the characteristics of traditional Chinese medicine processing and emphasizing the research and inheritance of traditional processing experience as the guiding principle, taking Chinese medicine processing technology as the starting point for establishing quality standards for Chinese medicine decoction pieces, summarizing processing experience and technology, comprehensively proposing the items and indicators that should be paid attention to in the standard formulation process, and making suggestions based on the problems existing in the current Chinese medicine decoction piece quality standards.RESULTS Establishing Chinese medicine standards that meet the quality characteristics of traditional Chinese medicine decoction pieces should be able to explain the scientific connotation of processing, with a focus on the changes in chemical composition or component groups caused by different processing purposes. In addition, attention should be paid to the scientificity and specificity of indicators, their correlation with drug efficacy, and their content limits.CONCLUSION It is recommended to conduct comprehensive and in-depth research to grasp the changes in the material basis of traditional Chinese medicine decoction pieces before and after processing, establish scientific, reasonable, and feasible quality control projects and indicators, and achieve control and evaluation of the quality of traditional Chinese medicine.

In recent years, National Medical Products Administration has successively issued special documents such as “Several Measures to Further Strengthen the Scientific Regulation of Traditional Chinese Medicine(TCM) and Promote the Inheritance, Innovation and Development of TCM”, “Special Regulations on Registration and Management of TCM” and “Special Regulations on the Management of TCM Standards”, which put forward new requirements for the research, formulation and management of TCM standards, and is of great significance for the comprehensive construction of a new system for the management of TCM standards, the establishment of the most rigorous TCM standards, and the promotion of high-quality development of TCM industry. Due to the natural source of TCM, the complex composition of drug components, the unique theoretical system and the safety and effectiveness derived from clinical practice, it is difficult to objectively evaluate and effectively control the quality of TCM preparations based on qualitative and quantitative quality control models based on chemical components and the quality standards established thereby. How to realize the advanced characterization and objective identification of TCM quality based on the characteristics of TCM, and to study and establish the corresponding quality standard of TCM preparation has become an important content of TCM quality research, the focus and difficulty of TCM supervision scientific research, and the bottleneck of TCM quality improvement and standard formulation. At present, the quality control of TCM preparations has established a whole process quality control system from TCM crude drugs, decoction pieces to preparations, and formed a quality standard system of TCM preparations based on the characteristics of TCM consisting of the standards of TCM crude drugs, decoction pieces, extracts and preparations. By sorting out the development history of TCM quality standards, this paper analyzs the problems and challenges in the research of TCM quality standards, and discusss the strategies and methods for the research of TCM preparation quality standards based on the characteristics of TCM in combination with the scientific research results of TCM regulatory science in recent years, and the actual research and development and review of TCM, so as to provide reference for colleagues in the industry.

OBJECTIVE To strengthen the role of Chinese medicine standards in ensuring drug quality, based on the analysis of Special Regulations on the Management of Traditional Chinese Medicine Standards, propose the suggestions on establishment of standard system conforming to the characteristics of traditional Chinese medicine. METHODS The scientific connotation of standard system conforming to the characteristics of traditional Chinese medicine was analyzed, the basic considerations for construction of traditional Chinese medicine standard system were proposed. RESULTS The scientific connotation of standard system conforming to the characteristics of traditional Chinese medicine mainly includes respecting the tradition of Chinese medicine, complying with the theory of traditional Chinese medicine and observing the objective laws of traditional Chinese medicine. CONCLUSION In the process of establishment of standard system conforming to the characteristics of traditional Chinese medicine, the quality control strategies of comprehensive quality evaluation and key quality factors should be persisted, the quality control strategies of inheritance and innovation should be persisted. Moreover, the traditional thinking of Chinese medicine should be reflected in Chinese medicine standards.

With the continuous progress of biotechnology and drug research and development, small molecule drugs play an increasingly important role in the treatment of nervous system diseases because of their unique physical and chemical properties and biological effects. However, most of the previous studies tried to increase the brain exposure and retention time of the subjects, while ignoring the brain transport and efflux clearance pathways. In this paper, the recent research progress on the efflux clearance pathway of small molecule drugs in the brain was reviewed, focusing on the involvement of blood-brain barrier transport, metabolic enzymes in the brain, and aquaporin-4(AQP4) pathway, in order to further understand the efflux clearance pathway of small molecule drugs in the brain, which will not only help optimize the efficacy of existing drugs and reduce the adverse reactions caused by drug accumulation. It can also provide new ideas and directions for the research and development of drugs for neurological diseases in the future.

Ganoderma lucidum is a fungus belonging to the genus Ganoderma in the family of Polyporaceae. As a precious medicinal herb which can be used for both medicine and food, it has various biological activities such as antioxidant, antibacterial, anti-tumor, anti-inflammatory, and neuroprotective properties. However, due to the difficulty in dissolution, low bioavailability, difficulty in absorption by the human body, and the increased burden on liver injury patients caused by direct use, the application of Ganoderma lucidum is greatly limited. In recent years, in order to improve the application efficiency of Ganoderma lucidum and expand its scope of application, the research on its nanoparticle size has received widespread attention from researchers. The article introduces the preparation of Ganoderma lucidum nanoparticles (including biological, chemical and physical methods) and their applications and mechanisms of action in different fields such as biomedicine, health care, environment and agriculture. It points out the shortcomings of existing related research and future development directions, and provides reference for in-depth research on Ganoderma lucidum nanoparticles.

"Osteoimmunology" is a field that emphasizes the interaction between the immune system and skeletal system cells. Specifically, it explores how dysregulation of the immune system can result in inflammatory stimulation and the release of inflammatory factors, which significantly impact bone metabolism. Periodontitis is an inflammatory destructive disease of periodontal tissue, triggered initially by dental plaque and influenced by host immune inflammatory responses, genetic factors, and environmental factors. Inflammatory response and alveolar bone resorption stand out as prominent features of periodontitis, with immune system imbalance disrupting bone homeostasis, resulting in alveolar bone loss due to the imbalance of bone formation and resorption. Flavonoid natural products exhibit biological activities such as anti-inflammatory, antioxidant, osteogenic promotion, and antimicrobial effects, effectively ameliorating inflammatory damage to periodontal tissues. This paper provides an overview of nine classical inflammatory signaling pathways potentially involved in alveolar bone inflammatory resorption and reviews advancements in the mechanisms of action of 20 flavonoids reported for inhibiting periodontal tissue destruction associated with periodontitis by suppressing inflammatory responses and modulating inflammatory signaling pathways. The aim is to offer theoretical foundations and novel insights to enhance the treatment strategy of periodontitis.

OBJECTIVE To establish a method for determining the entrapment efficiency of alprostadil injection, compare the differences between ultrafiltration centrifugation and microcolumn centrifugation methods for determining the entrapment efficiency of alprostadil injection, and select the optimal method. METHODS High pressure homogenization method was used to prepare alprostadil injection. Ultrafiltration membrane with different molecular weights were used to establish the ultrafiltration centrifugation method by selecting the centrifugation speed and time. The micro column was prepared with Sephadex G-50, and the encapsulated and free drugs were separated by centrifugal elution. The separation effect was evaluated by establishing the elution curve of soybean oil and free alprostadil. At the same time, the difference between different elution solvents was investigated, the optimal elution solvent was screened, and the microcolumn centrifugation method was established. The drug content was determined by high-performance liquid chromatography and post column derivatization device, and the entrapment efficiency was calculated. RESULTS The entrapment efficiency of three batches of alprostadil injection measured by ultrafiltration centrifugation method ranged from 98.6% to 99.5%, while the entrapment efficiency measured by microcolumn centrifugation method ranged from 89.5% to 91.3%. CONCLUSION The results of the ultrafiltration centrifugation method for determining the entrapment efficiency are too high and not suitable for the determination of the entrapment efficiency of this product. The microcolumn centrifugation method using glycerol aqueous solution as the eluting solvent is suitable for the determination of the entrapment efficiency of this product.

OBJECTIVE To establish a quantitative analysis of multi-components by single marker (QAMS) for the simultaneous determination of hypoxanthine, vanillic acid, magnolithine, demethyleneberberine, Columbamine, Jatrorrhizine hydrochloride, coptisine hydrochloride, palmatine hydrochloride and berberine hydrochloride in Xiaoxianxiong decoction. METHODS The separation was performed on a Spursil C₁₈ column (4.6 mm×250 mm, 5 μm) with acetonitrile and 0.05 mol·L^-1 potassium dihydrogen phosphate solution plus phosphoric acid adjusted to pH=4.0 as the mobile phases. Detection wavelength: 0-20 min: 290 nm; 20-45 min: 300 nm, column temperature 30 ℃, injection volume 10 μL. Using berberine hydrochloride as the internal reference material, the relative correction factors of the remaining eight components were calculated and the content of each component was calculated, and the results were compared with those of the external standard method (ESM) and the QAMS method. The differences between the results of the external standard method (ESM) and QAMS method were compared. RESULTS The nine components of Xiaoxianxiong decoction showed a good linear relationship with peak area in a certain concentration range (r>0.998 0), with the average spiked recoveries of 94.36%-105.57% and the RSD was 0.52%-3.48%, and the results of component contents determined by QAMS and ESM were not statistically significant. CONCLUSION The results of the established QAMS for Xiaoxianxiong decoction are accurate and reliable, and the method is simple and easy to be applied to the quality control of Xiaoxianxiong Decoction.

OBJECTIVE To analyze the consistency and correlation between UHPLC-MS/MS and chemiluminescence microparticle immune assay (CMIA) in measuring vancomycin concentration in serum.METHODS The concentration of vancomycin was measured by UHPLC-MS/MS and CMIA methods respectively in 95 serum samples of patients receiving vancomycin treatment. A correlation analysis and an agreement analysis were conducted for the two methods used linear regression and Bland-Altman method. RESULTS Based on the results of UHPLC-MS/MS(x) and CMIA(y), the linear regression equation was determined as follows: y=1.088x+0.174. Spearmen correlation analysis indicated a significant correlation between the results by the two methods (P<0.05), and the Spearmen correlation coefficient was 0.969 1. There was statistical difference between vancomycin serum concentrations measured by these two methods. The result was higher by CMIA compared with UHPLC-MS/MS. CONCLUSION The results of the two methods can be calculated to one another by equation, which provides reference for the formulation of clinical individualized medication plan.

OBJECTIVE To develop a quantitative proton nuclear magnetic resonance (qHNMR) method for the determination of 1,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC). METHODS A Bruker AVANCE Ⅱ 600 MHz NMR resonance spectra was utilized to acquire the NMR spectra of DOPC. The compound 1,3,5-trimethoxybenzene served as the internal standard, deuterated chloroform as the solvent, with 30° pulses, 16 scans, a test temperature of 25 ℃, and an acquisition time (AQ) of 5 s. The relaxation delay time (D1) was set at 35 s for quantitative analysis of DOPC. RESULTS The sample's ¹H-NMR spectra displayed a methyl proton signal at chemical shift δ 0.87; the quantitative peak signals of DOPC and internal standard were well resolved on the ¹H-NMR spectra with good linear relationship for DOPC (r>0.9996). The method demonstrated accuracy and repeatability with DOPC content ranging from 96.7% to 98.7%, consistent with results obtained from phosphomolybdic acid colorimetry. CONCLUSION The established qHNMR method accurately quantifies DOPC, is faster than the classical phosphomolybdate colometry method, requires no complex pretreatment operations.

OBJECTIVE To investigate the effects of DL-3-n-butylphthalide (NBP) soft capsules combined with levodopa and benserazide (LB) on the motor function and serum homocysteine (Hcy) and insulin-like growth factor 1 (IGF-1) levels in elderly patients with Parkinson's disease (PD). METHODS One hundred elderly patients with mid to late-stage PD admitted to our hospital from March 2021 to March 2023 were included in this retrospective study and divided into control group (n=50) and observation group (n=50) based on different treatment methods. The control group received treatment with LB, while the observation group received treatment with LB and NBP soft capsules for a duration of 1 year. The clinical efficacy, Unified Parkinson's Disease Rating Scale (UPDRS) scores, Hoehn-Yahr stage, UPDRS-Ⅲ scores, serum Hcy levels, and IGF-1 levels before and after treatment were compared. RESULTS The clinical effect of the observation group was dramatically better than that of the control group (P<0.05). After 1 year of treatment, both groups showed significant reduction in UPDRS scores, Hoehn-Yahr stage, and UPDRS-Ⅲ scores compared to baseline. Furthermore, the observation group had dramatically lower UPDRS scores, Hoehn-Yahr stage, and UPDRS-Ⅲ scores compared to the control group (P<0.05). After 1 year of treatment, serum Hcy levels were dramatically lower in the observation group compared to the control group, while serum IGF-1 levels were dramatically higher (P<0.05). CONCLUSION In elderly patients with mid to late-stage PD, NBP soft capsules combined with LB can significantly reduce serum Hcy levels, increase IGF-1 levels, and improve motor function in patients with PD.

OBJECTIVE To evaluate the efficacy and cost-effectiveness of enarodustat in the treatment of renal anemia in non-dialysis patients. METHODS A matched-adjusted indirect comparison of the efficacy of enarodustat and roxadustat was conducted based on their respective phase Ⅲ clinical trials, and the results were used for cost-utility analysis of enarodustat in the treatment of renal anemia in non-dialysis patients. The robustness of the incremental cost-effectiveness ratio was verified through sensitivity analysis and scenario analysis. RESULTS After matching and adjusting the baseline characteristics of the trial population, it was shown that enarodustat was able to significantly increase the proportion of subjects with average hemoglobin ≥10.0 g·dL^-1 at weeks 7-9 compared with roxadustat (73.5% vs 61.0%, MD=12.5%, P<0.001); the results of cost-utility analysis showed that compared with roxadustat, enarodustat increased patients' quality-adjusted life years and saved costs, making it an absolutely superior solution.CONCLUSION Compared with roxadustat, enarodustat is more effective and economical in treating renal anemia in patients with non-dialysis chronic kidney disease.

OBJECTIVE To identify the factors affecting the efficiency of the review and approval process of innovative drugs based on the industrial perspective to provide reference for further strengthening the capacity building and accelerating the review and approval of the marketing of innovative drugs. METHODS Using the grounded theory, this study conducted semi-structured interviews with 15 experts in the field of drug registration from March to May 2023, and Nvivo node coding was used as a traction to construct a model of factors influencing the efficiency of China's innovative drug marketing review and approval. RESULTS We have extracted 14 initial concepts, six initial areas and three main areas, i.e., “review and approval of institutional and team building”“accelerated assessment and approval policies” and “drug technological guidance system”. CONCLUSION The efficiency of review and approval of the marketing of innovative drugs in China is constrained by a variety of factors, and under the industrial perspective, accelerated assessment and approval policies, review and approval team building, and drug technological guidance system still need to be improved and optimized especially.