OBJECTIVE To establish the HPLC fingerprints and content determination method of five index components of Dashanzha pills(DSZP), and evaluate the quality combined with chemical pattern recognition. METHODS The analysis was performed on an Eclipse plus C₁₈ column (4.6 mm×250 mm, 5 μm) at 30 ℃. Acetonitrile-0.1% formic acid aqueous solution was used as the mobile phase for gradient elution at flow rate of 1.0 mL·min^-1. The detection wavelength was set at 250 nm, and the injection volume was 10 μL. Based on 51 batches of DSZP samples, the fingerprint was established, and five index components were identified and quantitatively determined.Cluster analysis, principal component analysis and orthogonal partial least squares discriminant analysis were used to comprehensively analyze 51 batches of samples. RESULTS The fingerprints of DSZP were established, sixteen peaks were identified, and five chemical components were identified. They were chlorogenic acid (peak 5), vanillic acid (peak 6), hyperoside (peak 7), isochlorogenic acid B (peak 9), and isochlorogenic acid A (peak 10).The linear relationship of the five index components was good (r>0.998), and the recovery rate was 96.27%-109.35%, and the RSD was 2.83%-4.07%. The contents of chlorogenic acid, vanillicacid, hyperoside, isochlorogenic acid B, and isochlorogenic acid A were 0.047 2-0.227 0, 0.009 7-0.036 2, 0.023 0-0.370 2, 0.006 4-0.063 2 and 0.021 7-0.064 5 mg·g^-1, respectively. Except for manufacturer Q2, the contents of the products from the other manufacturers samples were maintained at (100±30)% of their respective average values, and the contents of the five components of manufacturer Q2 were mostly higher than 30% of the average value of all samples, indicating that there were great differences in product quality among different enterprises. The results of chemical pattern recognition showed that all samples could be roughly divided into two categories, indicating that the preparation process was relatively stable within the enterprise, but there were some differences between enterprises. The difference markers of the screened samples included the target components chlorogenic acid, hyperoside, and isochlorogenic acid B. CONCLUSION The quantitative method is accurate, rapid and feasible. Combined with chemical pattern recognition method, it can be used to evaluate the quality of DSZP.

OBJECTIVE To thoroughly interpret the newly introduced requirements set forth in the 2024 edition of the “Emergency Response Plan Management Measures” for the management of drug safety emergency plans. Furthermore, to delve into the methods for constructing a robust and comprehensive drug safety emergency management system tailored to the current circumstances, ultimately enhancing our emergency management capabilities. METHODS A detailed analysis of the new edition of the “Measures” was conducted. Based on this analysis, several key strategies were proposed. Firstly, the strengthening of the risk assessment system was emphasized, advocating for a more precise and forward-looking approach to identifying potential risks of the drug. Secondly, cross-regional collaboration was highlighted as essential for efficient resource allocation were swift response during emergencies. This involved breaking down barriers between regions and fostering seamless cooperation among different stakeholders. Thirdly, the standardization and dynamic refinement of plan formulation and implementation were emphasized. This ensured that emergency plans remained relevant and effective in the face of evolving challenges. Lastly, the development of an intelligent emergency response plan management platform was proposed, leveraging modern information technology to streamline processes, enhance data analysis, and improve overall efficiency. RESULTS The anticipated outcomes of implementing these strategies were multifaceted. The risk assessment system would be significantly enhanced, providing a more accurate picture of potential threats and enabling proactive measures to be taken. Cross-regional collaboration would lead to the establishment of efficient linkages, ensuring that resources could be quickly mobilized where they were needed most. The standardization and dynamic refinement of plans would guarantee that they were not only well-structured but also adaptable to new situations. Moreover, the introduction of an intelligent management platform would revolutionize the way emergency plans were managed, making the entire process more efficient, transparent, and data-driven. CONCLUSION The implementation of the 2024 edition of the “Emergency Response Plan Management Measures” represents a significant step forward in the field of drug safety emergency management. By adopting the proposed strategies, we can expect to witness a paradigm shift in the way these emergencies are handled. The resulting innovations and improvements will undoubtedly bolster our response capabilities, minimize the impact of drug safety incidents, and ultimately safeguard the public's well-being.

OBJECTIVE To analyze the intervention effect of prescription pre-review and Six Sigma management model on the qualified rate of outpatient prescriptions to improve the quality of pharmaceutical care and ensure the safety, rationality, and effectiveness of medication in patients. METHODS The qualified rates of outpatient prescriptions in Beijing Hospital from April 2020 to March 2024 were collected. The multi-stage model of interrupted time series analysis (ITSA) was used to analyze the changes in the qualified rate of outpatient prescriptions in three stages: before and after the pre-review system was implemented in the whole department, as well as the implementation of Six Sigma management method based on the pre-review. RESULTS The ITSA showed that the qualified rate of outpatient prescriptions in our hospital was stable around 86.56% before the pre-review was carried out in all departments. After the implementation of pre-review, the qualified rate of prescriptions in that month increased by 9.81%. In November 2021, after the implementation of define measure analyze improve control (DMAIC) management based on prescription pre-review, the qualified rate of prescriptions in the month increased to 98.07%, reaching the target value, and the qualified rate of prescriptions continued to increase with a monthly trend of 0.05%. CONCLUSION The implementation of prescription pre-review and Six Sigma management is conducive to the formation of a closed-loop management model of pre-review, in-process intervention, post-comment, result publicity, and timely communication and feedback, which significantly improves the level of rational drug use in the outpatient department, better standardizes the prescribing behavior of doctors, promotes the communication and cooperation between pharmacists and physicians, and ensures the medication safety of drug use for patients.

OBJECTIVE In the digital era, the digital transformation of traditional Chinese medicine standards has become an inevitable trend to improve the quality control of traditional Chinese medicine and promote the high-quality development of the industry. METHODS The research team has leveraged AI technology's advantages in image recognition and analysis, data mining and processing, model prediction, and decision support to carry out the digital transformation of traditional Chinese medicine standards. RESULTS AND CONCLUSION They aim to construct a new form of traditional Chinese medicine digital standards that is machine-readable, executable, interpretable, and decision-capable without human intervention. This effort actively promotes the digitalization, networking, and intelligent development of traditional Chinese medicine standards, contributing to the national strategic goal of continuously improving the level of standard digitization.

Polyporus umbellatus, a traditional medicinal fungus in China, is used medicinally for its sclerotium. It is commonly categorized into two types, Zhushiling and Jishiling, based on the morphology of the sclerotia. Cultivation of Polyporus umbellatus heavily relies on the asexual reproduction of its sclerotia and the absence of clear distinction between Zhushiling and Jishiling often results in the confusion and intermixing of seed sclerotia. This can lead to the instability in quality and yield of Polyporus umbellatus medicinal materials, thereby adversely affecting the robust development of the Polyporus umbellatus industry. This article provides a comparative overview of Zhushiling and Jishiling in 4 aspects: morphology, quality, genetics and spawn cultivation. The results indicate that although the differentiation between Zhushiling and Jishiling based on morphological features such as sclerotium branches and surface characteristics holds certain significance, there remains a necessity to develop more scientific and precise criteria for this classification. The traditional perspective that Zhushiling is of superior quality compared with Jishiling is often based on empirical observations rather than rigorous scientific evidence. It is imperative to conduct comprehensive and systematic studies to objectively evaluate the quality and medicinal properties of both types. The variation in the sclerotial morphology of Polyporus umbellatus may be the result of a complex interplay among genetic, geographic, environmental factors, as well as other factors that have yet to be identified. Key technological breakthroughs in cultivation of the Polyporus umbellatus spawn leading to the formation of the sclerotia have not yet been achieved. However, the strains of Jishiling may possess greater potential for the development of spawn cultivation techniques. Zhushiling and Jishiling exhibit differences across 4 distinct aspects. Conducting the systematic analysis of Polyporus umbellatus from various perspectives is significantly important for the evaluation of its resources and for maximizing its potential value.

Since the end of 2019, the new coronavirus swept the world, causing irreversible harm to social economy and human health, so the search for corresponding antiviral drugs has aroused wide attention. SARS-CoV-2 is mainly transmitted by droplets, and after the process of replication, transcription and translation in the host cell, the mature virus is excreted in the form of endocytosis, forming a closed loop of infection. Notably, the papain like protease (PL^pro) encoded by non-structural protein 3 (nsp3) plays an important role in this process. At the same time, PL^pro also helps the virus evade the corresponding immune response in inflammatory reactions such as deubiquitination. Therefore, targeted inhibition of PL^pro can not only block the overall replication process of the virus, but also restore the host's own immune function, so as to achieve a better anti-SARS-CoV-2 effect. In summary, based on the different structures of the compounds, this paper intends to conduct an exploratory summary of the recent studies on inhibitor targeting SARS-CoV-2 PL^pro, in order to provide theoretical reference for the discovery of anti-SARS-CoV-2 drugs.

OBJECTIVE To investigate the chemical constituents from Ferula bungeana Kitagawa. METHODS The chemical constituents from Ferula bungeana Kitagawa were investigated by silica gel chromatography, TLC, preparative HPLC, NMR, and HR-MS. RESULTS Thirty-three compounds were isolated from Ferula bungeana Kitagawa and identified, namely palmitic acid(1), oleic acid(2), linoleic acid(3), linolenic acid(4), dehydrofalcarinol(5), falcarinol(6), β-itosterol(7), 2, 6, 11, 15-tetramethyl-2, 6, 10, 14-hexadecanetetraene(8), arteordoyn A(9), falcarindiol(10), dehydrofalcarindiol(11), umbelliprenin(12), conferone(13), farnesiferone A(14), ferukrinone(15), polyanthinin(16), assafoetidnol B(17), actylfekrynol(18), fekrynol(19), kellerin(20), mogoltacin(21), gummosin(22), farnesiferol A(23), ferukrin(24), deacetylkellerin(25), assafoetidnol A(26), karatavicinol (27), 14'-hydroxy-karatavicinol (28), galbanic acid(29), 6, 7-dimethoxycoumarin(30), vanillin(31), 7-hydroxycoumarin(32) and 6, 7-dihydroxycoumarin(33). CONCLUSION Compounds 5-6, 9-11 are isolated in this genus for the first time, and others are isolated from this plant for the time.

OBJECTIVE To provide reference for reasonable protection, development and utilization of Codonopsis pilosula germplasm resources. METHODS Variation analysis, correlation analysis, principal components analysis, cluster analysis, piecewise linear regression analysis, and stepwise multiple regression analysis were conducted on the main agronomic traits and representative components of 106 Codonopsis pilosula germplasm resources. RESULTS The genetic variability of the 106 Codonopsis pilosula germplasm resources was rich, with the coefficients of variation of the 106 Codonopsis pilosula trait indexes ranging from 9.331% to 86.948%, among which the coefficient of variation of the degree of variability of atractylenolide Ⅲ was the highest, 86.948%; the indexes of genetic diversity ranged from 1.587 to 2.039, with syringin 1.587, and root length, number of branches, and Codonopsis polysaccharide were 2.027,2.039 and 2.032, respectively. Correlation analysis showed that most of the 14 traits had significant or highly significant relationships with each other. The seven principal component factors available for principal component analysis could explain most of the information of the 14 indicators, with eigenvalues of 4.172, 2.427, 1.646, 1.196, 0.943, 0.872 and 0.75, respectively, and the cumulative contribution rate reached 85.760%. Using the DTOPSIS method to score the germplasm resources of Codonopsis pilosula, the top 15 were No.13, No.20, No.21, No.18, No.73, No.77, No.90, No.78, No.88, No.72, No.74, No.80, No.79, No.34 and No.14, respectively.Clustering analysis showed that 106 codonopsis germplasm could be classified into five taxa, among which the agronomic traits and quality indexes except syringin at a higher level in taxon Ⅰ. The overall performance was better, and it could be promoted for cultivation. stepwise multiple regression analysis showed that root length, luxia diameter, dry weight, drying rate, total amino acid, tryptophan, tangshenoside Ⅰ and atractylenolide Ⅲ had significant effects on fresh weight. Root length, total amino acid. Codonopsis polysaccharide, tryptophan, syringin, tangshenoside Ⅰ and atractylenolide Ⅲ had significant effects on extractum. Extractum had significant effects on codonopsis polysaccharide. Total amino acids, tryptophan and syringin had significant effects on lobetyolin. CONCLUSION The results of this study can serve as a reference for screening high-quality germplasm resources and cultivating varieties of Codonopsis pilosula.

OBJECTIVE To investigate the mechanism by which Danggui Buxue Decoction (DBD) regulates oxidative stress in rats with rheumatoid arthritis based on phosphatidylinositol 3-kinase (PI3K)/protein kinase B(Akt)/nuclear factor E2-related factor 2(Nrf2) signaling pathway. METHODS Forty-eight Wistar rats were randomly divided into 6 groups [normal group, model group, tripterygium glycosides tablets group(9.45 mg·kg^-1), DBD low dose (3.75 g·kg^-1), medium dose(7.5 g·kg^-1) and high dose group(15 g·kg^-1)]. In addition to the normal group, the other groups were constructed collagen-induced arthritis (CIA) rat model, and given the corresponding drug treatment for 28 days. During the period, the body weight of the rats, the degree of ankle swelling, and the arthritis score were recorded regularly. The levels of superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), catalase (CAT) and malondialdehyde (MDA) in serum of rats were determined by ELISA. The spleen index and thymus index were calculated. HE staining and safranin O-fast green staining were used to observe the pathological morphology of synovial membrane of knee joint in rats. The expression of PI3K, AKT, Nrf2 and HO-1 mRNA in synovial tissue was determined by qPCR. The expression of p-PI3K/PI3K, p-Akt/Akt, Nrf2 and HO-1 protein in synovial tissue was determined by Western blot. RESULTS Compared with the normal group, the body weight of the rats in the model group was lower (P<0.05), and the bilateral hind limbs were obviously red and swollen or even deformed. Compared with the model group, the body weight of rats in each administration group increased gently (P<0.05), the swelling degree of bilateral hind limbs was significantly reduced (P<0.05), and the arthritis score was significantly decreased (P<0.05). The level of MDA in joint tissue decreased (P<0.05), and the levels of GSH-Px, CAT and SOD increased (P<0.05). The expression of PI3K, Akt, Nrf2 and HO-1 mRNA in PI3K/Akt/Nrf2 pathway was increased (P<0.05). The ratio of p-PI3K/PI3K, p-Akt/Akt and the expression of Nrf2 and HO-1 protein were significantly increased (P<0.05). CONCLUSION DBD may inhibit the level of oxidative stress, attenuate the oxidative damage of synovial tissues and improve the pathological changes of synovium by regulating the PI3K/Akt/Nrf2 pathway in CIA rats, thus exerting an anti-RA effect.

OBJECTIVE To study the extraction method, quality, transdermal permeability, and transdermal promoting effects of Chuanxiong Rhizoma Hort. volatile oil (LVO) and Angelicase Sinensis Radix volatile oil (AVO) combined with the characteristic advantages of “unification of drugs and excipients” of traditional Chinese medicine volatile oil. METHODS The orthogonal design was used to screen and optimize extraction process of LVO and AVO. Quality control was carried out by detecting the physical parameters and indicator component content of LVO and AVO. Franz diffusion cells were used to conduct the studies of skin permeation in vitro. The contents of ligustilide and resveratrol(RSV) were determined by HPLC, and the steady-state transdermal rate(Jss) and enhancement factor (EF) compared with blank were used as evaluation indicators. And the transdermal permeability and transdermal promoting effects of different concentrations of LVO, AVO and mixed were investigated respectively. RESULTS The extraction process for LVO and AVO involves 8 times the amount of water, heating and refluxing for 8 h, collecting with ethyl acetate, dehydrating anhydrous sodium sulfate, and then volatilizing under reduced pressure. Perfect quality control methods were established for LVO and AVO, including the properties, relative density, pH, optical rotation, viscosity and ligustilide content. LVO and AVO have good permeability and promote RSV transdermal effect in vitro, and the maximum Jss values within 10 h were (48.23±6.53) and (27.84±3.03), respectively, and the maximum EF values were 4.51 and 19.34, respectively. CONCLUSION LVO and AVO have good transdermal permeability and transdermal promoting effects of RSV when used alone or in combination. The transdermal permeability of LVO was significantly higher than that of AVO, while the transdermal promoting effects of AVO was higher than that of LVO. The combination of LVO and AVO's own pharmacological effects and good transdermal absorption promoting effect plays a role of “unification of drugs and excipients”, which has a good advantage in clinical use, and lays a foundation for their development and application in transdermal drug delivery preparations of traditional Chinese medicine.