OBJECTIVE To develop the methods for biological activity assay and immunological characteristics analysis of anti-SARS-CoV-2 neutralizing antibodies. METHODS The binding affinity of 9MW3311 Fab and S1-RBD were analyzed by biolayer interferometry. Enzyme linked immunosorbent assay (ELSA) and fluorescence activated cell sorter (FACS) were used to evaluate the relative binding activity to S protein and blocking activity to angiotensin converting enzyme 2(ACE2) of 9MW3311 antigenbinding fragments (Fab). In vitro cytological activity of neutralizing antibody was evaluated by pseudovirus system. The binding affinities of neutralizing antibody Fc with Fc receptor (Fcγ) and Fc receptor neonatal (FcRn) receptor were determined by surface plasmon resonance (SPR). The binding activity of Fc and complement component 1 (C1q) receptor was determined by ELISA. The antibody-dependent cell-mediated cytotoxicity(ADCC) and complement dependent cytotoxicity(CDC) of neutralizing antibodies were determined by peripheral blood mononuclear cell (PBMC) method. The antibody-dependent enhancement (ADE) effect was evaluated using pseudovirus system. RESULTS The affinity constants (KD) of 9MW3311 and reference to S1-RBD were 1.15×10^-9, 1.01×10^-9, 1.15×10^-9 and 9.45×10^-10, respectively. ELISA and FACS showed that the binding activities of neutralizing antibodies were 101%, 96%, 100% and 98%, 113%, 108%, respectively. ELISA and FACS showed that the blocking activities of neutralizing antibodies against ACE2 were 100%, 95%, 91% and 94%, 101%, 94%, respectively. The neutralizing activities of the three batches of neutralizing antibodies against pseudovirus were 91%, 93% and 108%, respectively. The three batches of 9MW3311 and reference showed the same affinity constants (KD) with Fcγ and FcRn. 9MW3311 showed no ADCC and CDC activity. L234A/L235A (LALA) mutant of 9MW3311 could effectively avoid ADE effect. CONCLUSION The methods for analysis of the biological activity and immunological characteristics of anti-SARS-CoV-2 neutralizing antibodies are preliminarily established and can be used for routine quality control and release.

OBJECTIVE To evaluate the cost-effectiveness of PEG-rhG-CSF versus rhG-CSF in patients with epithelial ovarian cancer in central China for preventing chemotherapy-induced neutropenia. METHODS Two Markov models form healthcare system perspective were developed to evaluate the economics of PEG-rhG-CSF versus rhG-CSF using cost-utility analysis. Cost and probability input data were primarily obtained from a retrospective real-world study conducted in four tertiary hospitals from January 2019 to December 2020. One-way sensitivity analysis,probability sensitivity analysis and scenario analysis were used to verify the robustness of the results. RESULTS The basic analysis showed that, compared with rhG-CSF, PEG-rhG-CSF resulted in higher QALYs and lower cost, gained 0.27 QALYs more while spending 2279.63 yuan less, and the incremental cost-effectiveness ratios were ￥-8393.9/QALY. Sensitivity analysis and scenario analysis revealed robust results. CONCLUSION PEG-rhG-CSF is economically advantageous in Chinese patients with epithelial ovarian cancer for preventing chemotherapy-induced neutropenia.

OBJECTIVE To explore the quality control of real-world data in the drug clinical comprehensive evaluation, and promote the scientific and rational application of real-world data in the drug comprehensive clinical evaluation. METHODS Literature on the quality control of real-world research data in drug clinical comprehensive evaluation was reviewed, and the work experience of the drug clinical comprehensive evaluation center in the province where the author is located was integrated to explore the content and process of quality control of real-world research data in drug clinical comprehensive evaluation. RESULTS AND CONCLUSION Quality control of real-world research data generally includes internal and external controls. Evaluation methods comprise qualitative assessment, quantitative assessment, and comprehensive assessment. The implementation phase can be divided into the project initiation phase and the data governance phase, with a round of data quality control conducted in each phase. This study summarizes the content and process of quality control for real-world research data in the drug clinical comprehensive evaluation, providing a reference for researchers and decision-makers to correctly produce and use evidence from real-world data for drug clinical comprehensive evaluation.

In recent years, transdermal delivery has proven to be one of the most favorable methods among novel drug delivery systems due to avoiding the gastrointestinal tract and reducing systemic side effects. Skin is one of the most immunologically active organs due to the presence of immune cells, such as Langerhans cells(LCs), dermal dendritic cells(dDCs), and T cells. Unique immune properties of the skin offer excellent opportunities for transdermal treatment of autoimmune diseases(ADs). This review highlights the pathogenic mechanism of ADs caused by various reasons such as loss of immune self-tolerance and abnormal autoreactive T cells, and the advantages of transdermal drug delivery for the treatment of ADs, as well as expounds on the application of transdermal drug delivery systems(TDDS) in the treatment of several typical ADs. TDDS will provide new ideas and methods for the treatment and research of autoimmune diseases.

Rheumatoid arthritis(RA) is a chronic, systemic, and abnormal inflammatory immune response. It is characterized by the involvement of synovium and multiple organs and the destruction of joints and articular cartilage. In the past 30 years, some promising new compounds and antibodies have been developed to treat RA. The introduction of RA therapeutic drugs and the development of precision medicine have also given rise to several problems related to patients' access to new treatments, choice of the best regimen, cost-effectiveness, prognosis monitoring and efficacy monitoring, especially in terms of low drug response rate, drug resistance and adverse side effects. People attach great importance to the best combination of drugs for the treatment of RA, especially in patients with severe symptoms or early progression. New treatments and mechanisms are needed to solve these problems, and accurate guidelines for drug selection and drug recombination are established. According to the clinical trial database of the National Library of Medicine, this study summarizes the exciting new drugs, and discusses the trends and challenges in the development of RA drugs, which provides a meaningful reference for the accurate treatment and future research direction of RA.

Cell membrane chromatography is a bioaffinity chromatography method which has been developing rapidly in recent years, where the carriers coated with receptor-containing biomembrane are packed to stationary phase and the bioaffinity between compound and membrane receptor presents in chromatography process. This method has the advantages of biomimetic, high efficiency and low cost, and has been widely used in drug screening and identifying the affinity between membrane receptor and candidate ligand. Mitochondria, a crucial functional intracellular membrane system, with various drug targets residing in membrane. Recently, significant research advancements have been made in mitochondrial membrane chromatography technology. In this paper, the recent progresses and applications of cell membrane chromatography and mitochondria membrane chromatography are reviewed.

OBJECTIVE To screen one Monascus purpureus stain that has high yield of lovastatin and provide potential strains for the development of red yeast rice(RYR) industry. OBJECTIVE Twelve RYR samples were collected, and Monascus sp. was isolated from these samples using traditional isolation technology and identified by morphology and ITS sequencing. All M. purpureus strains were screened and their total lovastatin contents [including lactone lovastatin(C₂₄H₃₆O₅) and acid lovastatin(C₂₄H₃₈O₆)] were determined by high performance liquid chromatography(HPLC). Soft SPSS 25.0 was used for variance analysis. RESULTS A total of 35 Monascus sp. strains were isolated and 23 of them were identified at specie level, including 11 M. purpureus strains, 10 M. ruber strains and 2 M. aurantiacus strains. There was significant difference(P<0.05) in lovastatin production among 11 M. purpureus strains. Among them, SM-1 isolate produced the highest amount of total lovastatin, with the value reaching (4.652±0.001) mg·g^-1, followed by M4-1, F1-3, and F5-3 strains with the value reaching (2.903±0.033) and (3.108±0.009) mg·g^-1, respectively. M4-5 isolate produced the lowest amount of lovastatin with the value of (2.712±0.014) mg·g^-1. CONCLUSION Fungal strain is chaotic in the fermentation of RYR on the market. A high-yielding lovastatin strain SM-1 is screened and can be used a potential strain for RYR production.

OBJECTIVE To design and synthesize N-substituted methylene-3-(4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzohydrazide derivatives, and evaluate their anticancer activities. OBJECTIVE Using 3-aminobenzoic acid ethyl ester as the starting reagent, a series of target compounds 4a-4p were synthesized in a 4-step reaction, and all of the target compounds were structurally characterized by ¹H-NMR, ¹³C-NMR and HRMS. MTT assay was used to detect the inhibitory effect of synthetic compounds on breast cancer cells. RESULTS It's showed that the target compounds had certain inhibitory activity on the growth of breast cancer cells, among which compound 4e was the best one, showing obvious inhibitory effect on breast cancer cells. The IC₅₀ value of breast cancer cell line MCF-7 was (2.30±0.34)μmol·L^-1, and the toxicity of 4e to normal mammary epithelial cells was low(IC₅₀>100 μmol·L^-1). Thus, 4e is better than the positive drug cisplatin. In addition, 4e could significantly up-regulate the protein expression level of Nur77 and induce the S-phase arrest of MCF-7. CONCLUSION This series of compounds have good anti-cancer activity and are of interest for further study.

OBJECTIVE To study the chemical constituents of Pinellia ternata(Thunb).Breit.. OBJECTIVE The 60% ethanol extract of Pinellia ternata(Thunb). Breit. was isolated and purified by silica, MCI, ODS and preparative HPLC, and the structures of obtained compounds were identified by physico-chemical properties and MS、NMR data. RESULTS The compound are kaempferol-3-O-β-D-rutinoside(1), inosine(2), lactariolide I(3), (2E,4E,1'S,2'R,4'S,6'R)-dihydrophaseic acid(4), tryptophan(5), 1-oleoyl-3-O-β-D-galactopyranosyl-sn-glycerol(6), 6'-O-linoleylsucrose(7), 6'-O-palmitoylsucrose(8), gingerglycolipid C(9), (2S)-1-O-6'-O-(α-D-galactopyranosyl)-β-D-galactopyranosyl-3-O-palmitoyl glyceride(10), 1-O-hexadecanoyl-3-O-β-D-galatopyranosylglycerol(11), tianshic acid(12), 4-(2-hydroxyethyl)phenol(13), phenylpropionic acid(14), 3-phenyllactic acid(15), trans-cinnamic acid(16). CONCLUSION Compound 1, 2, 3, 4, 6-13, 15-16 are firstly isolated from the genus Pinellia.

OBJECTIVE To study the protective effect of petroleum ether fraction(AERP) and water soluble fraction(AERW) of Arnebia euchroma(Royle) Johnst. on acute liver injury in mice, and to isolate the effective components of petroleum ether fraction with better effect, and to study the antihepatitis B virus effect of its effective components. OBJECTIVE Forty eight C57 mice were randomly divided into 6 groups. After 14 days of administration, lipopolysaccharide/D-galactosamine(LPS/D-Galn) was used to induce acute liver injury with inflammatory infiltration at the last 2 hours. The liver and spleen index, the content of AST and ALT in mouse serum and the content of NO in liver homogenate were measured, and the pathological section of liver tissue was investigated. The petroleum ether extract was separated by normal silica gel, reverse silica gel and thin layer preparation plate, and four active naphthoquinones were obtained. The antihepatitis B virus activity of the four active naphthoquinones on HepG2.2.15 cells was detected by MTT method. RESULTS Both AERW high-dose group and AERP low-dose group can reduce the activity of AST and ALT in serum and the content of NO in liver tissue of mice to varying degrees, and improve the pathological changes of liver tissue to varying degrees. After comparative analysis, AERP has better liver protective and anti-inflammatory effects. The extraction method of AERP was optimized to obtain AERP with more effective components, and four active naphthoquinones were isolated: isovalerylshikonin, acetylshikonin, 2,3-dimethylpentenylshikonin and shikonin. Four active naphthoquinones have good inhibitory effects on HepG2.2.15 cells. CONCLUSION The results show that AERW and AERP have a good protective effect on acute liver injury. The liver protective effect of AERP is better than that of AERW. The four active components of AERP have a good inhibitory effect on HBV. AER extract has a significant liver protective effect, and the active components of AER have a significant inhibitory effect on hepatitis B virus.