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 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 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 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.

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 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.

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 establish and implement the drug delivery service mode as part of internet healthcare in hospitals, and evaluate its practical effectiveness,in order to grand out the last mile of the internet patient service and provide valuable experience and reference for better serving patients. METHODS Based on the requirements of relevant national laws and regulations and the actual situation of our hospital, the drug delivery process was designed, and the distributable drug list was established. The drug delivery service was carried out by making full use of information technology and logistics system through comprehensive and detailed system construction and process design. Drug orders issued until April 30,2024 were collected and the economic and social benefits generated by the delivery of drug were analyzed. RESULTS A safe and controllable drug delivery service mode was established as part of the internet healthcare with the characteristics of hospitals. By April 30, 2024, 94 370 drug orders had been distributed, covering 31 provinces and cities in China. Taking the closest patients from Hebei province as an example, each patient can save 660 yuan on transportation and accommodation expenses per visit, patients in this province have saved about a total of 15 million yuan in expenses. CONCLUSION The development of internet-based diagnosis and treatment effectively solves the problem of patient follow-up visits, and drug delivery is a key link in the process of internet healthcare. Sending drugs to the hands of patients not only saves the patient's economic cost and time cost, but also ensures the continuity of patient treatment during epidemics such as COVID-19 and H1N1. With the expansion of the scope of online medical insurance settlement, this model will provide efficient and convenient services to more patients.

OBJECTIVE To identify the chemical constituents in flower of Fritillaria unibracteata P. K. Hsiao et K. C. Hsia (F-F, Chinese: Anzibeimu Hua) by employing ultra high performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry(UHPLC-Q-TOF-MS) for the optimal utilization of Fritillaria cirrhosa D. Don (Chinese: Chuanbeimu) resources. METHODS The separation was conducted on Thermo Hypersil GOLD aQ column (2.1 mm×150 mm, 1.9 μm) eluted with methanol-0.1% formic acid in a gradient mode at a flow rate of 0.3 mL·min^-1, the column temperature was maintained at 35 ℃, and positive and negative electrospray ionization(ESI) was adopted for determine the chromatographic effluents. RESULTS Through comparison with reference standards, precise molecular weight determination from primary mass spectrometry, and analysis of fragmentation patterns from secondary mass spectrometry, combined with existing literature, 71 chemical constituents were identified in F-F. These identified compounds encompass 24 alkaloids, 12 flavonoids, 9 amino acids, and additional substances, including the notable detection of peimine and peiminine within F-F. CONCLUSION This study employs UHPLC-Q-TOF-MS technology to conduct an exhaustive analysis of the chemical composition of F-F. From the results, it can be seen that the F-F possess potential medicinal value. This study provides scientific basis for the rational development and sustainable utilization of its resources.