OBJECTIVE To establish a quality consistency evaluation method reflecting the overall pharmacodynamic characteristics of multi-batch Chinese medicine compound preparations. METHODS Establish a drug absorption simulating system(DASS) standardized absorption biomimetic system module using a flipped intestinal sac model, and prepare intestinal absorption samples of Danggui buxue tang from different sources and batches; Drawing on the concept of consistency evaluation of biopharmaceuticals, a cell biological effect characterization module was established using Real-time cell analysis(RTCA) to monitor the cell response curves of 15 batches of Danggui buxue tang samples. RESULTS The combination of DASS-RTCA was used to extract the characteristic parameters of time-dependent cell response patterns (TCRPs) maps from 15 batches of Danggui buxue tang samples. The RSD of each characteristic parameter was less than 5.1%, indicating that the differences in cell effect characterization of Danggui buxue tang (DBT) were small and the similarity of TCRPs maps was high. Through similarity analysis, cluster analysis, radar chart analysis, etc., it is reflected that the quality of different batches of DBT has high consistency. CONCLUSION The quality consistency evaluation method established by DASS-RTCA can reflect the overall quality of the preparations and provide new ideas and methods for the evaluation of batch-to-batch quality consistency of traditional Chinese medicines.

OBJECTIVE To establish a quantitative proton nuclear magnetic resonance (qHNMR) method for determination of the reference standards of moxifloxacin hydrochloride impurities A, B, C and D. METHODS Proton nuclear magnetic resonance (¹H-NMR) spectra of four reference standards of impurities were obtained in dimethylsulfoxide-d₆ (DMSO-d₆) or chloroform-d (CDCl₃) using a nuclear magnetic resonance spectrometer. The internal standard was 1,3,5-trimethoxybenzene. All ¹H-NMR spectra for quantitative analysis were measured with noesyigld1d pulse sequence using the following experimental parameters: 32 number of scans (NS), relaxation delay time (D1) of 30 s, 25 ℃ testing temperature. RESULTS The quantitative peak signals of four moxifloxacin hydrochloride impurities and 1, 3, 5-trimethoxybenzene were well separated on ¹H-NMR spectra, and the linear relationship was good within the linear range (r²>0.999 4). The injection precision and repeatability of the method were good. The contents of four reference standards of impurities determined by qHNMR method were basically consistent with those determined by mass balance method. CONCLUSION The established qHNMR method is accurate, reliable, simple, fast, which provides a new way for content determination of these impurities and can also be used as a mutual verification method for the calibration results of these reference substance by the mass balance method.

Active ingredients in Chinese medicine have great potential to be used in breast cancer treatment to improve the efficacy of existing breast cancer treatment strategies. By influencing different signaling pathways to produce different mechanisms of action, active ingredients in Chinese medicine enhance the sensitivity of tumor cells to the effects of chemical, hormonal or gene therapeutic agents, reduce toxic side effects or inhibit the efflux of anticancer drugs. In this paper, it is reviewed the strategies for the combination of Chinese herbal active ingredients with other breast cancer therapeutic agents, such as chemotherapeutic agents, hormones, gene agents, small molecule inhibitors and inorganic mixtures, and intelligently design nano-delivery systems to co-deliver Chinese herbal active ingredients and other breast cancer therapeutic agents for the synergistic treatment of breast cancer. Nanocarriers offer various advantages including improved solubility, increased stability and enhanced tumor targeting, thus overcoming the clinical application limitations of the active ingredients of TCM.

OBJECTIVE This study aimed to investigate the role and potential mechanisms of Icotinib (ICO) on pulmonary fibrosis. METHODS C57BL/6 mice were randomly divided into Sham group, PF group, ICO 30 mg·kg^-1 group and ICO 60 mg·kg^-1 group, 8 rats in each group. A mouse model of PF was induced by intratracheal injection of bleomycin (3 mg·kg^-1). Hematoxylin-eosin staining and Masson trichrome staining for lung tissues were performed to observe the pathological alterations and collagen deposition. Immunohistochemical detection of lung tissue collagen type Ⅰ (collagen Ⅰ) expression. In vitro, the lung epithelial cells were divided into control group, epidermal growth factor (EGF) group, EGF combined with ICO (0.1, 1, 10 mmol·L^-1) groups. The protein expression of E-cadherin, α-SMA and nuclear transfer of NF-κB p65 were detected by immunofluorescence. The protein levels of Collagen Ⅰ, E-cadherin, α-SMA, Vimentin, phosphorylation epidermal growth factor receptor (p-EGFR), p-IκBα, p-NF-κB p65 and nuclear NF-κB p65 were detected by Western blot analysis in lung tissue and (or) cells. RESULTS The results demonstrated that ICO inhibited bleomycin-induced collagen deposition, reduced type Ⅰ collagen expression, alleviated bleomycin-induced EMT (increased E-cadherin expression and decreased Vimentin and α-SMA expression), and decreased phosphorylation of EGFR, IκBα, NF-κB p65 and nuclear translocation of NF-κB p65 in vivo. Furthermore, incubation of lung epithelial cells with EGF activated EMT and EGFR/NF-κB signaling pathway, and these effects were reversed by ICO In vitro. CONCLUSION In conclusion, ICO attenuates EGF-induced EMT in lung epithelial cells and bleomycin-induced pulmonary fibrosis in mice by downregulating EGFR/NF-κB pathway.

OBJECTIVE To explore the feasibility of using cyclic olefin polymer (COP) as packaging material for human albumin products. METHODS Human albumin products were stored in COP bottles. Under the conditions of long-term stability (2-8 ℃ for 24 months) and accelerated stability [(25±2) ℃ for 12 months], the key quality indexes of albumin and the probable extracts of COP material were analyzed, and the seal integrity of COP packages was tested. RESULTS Under both test conditions, the appearance, visible foreign matter, numbers of insoluble particles, pH, purity, polymer content, residual aluminum content, protein content, activity of prekallikrein activator and abnormal toxicity of the albumin products all conformed to the quality standards and met the requirements of Chinese Pharmacopoeia. In the products, the contents of molybdenum, nickel, methylbenzene, and cyclohexane that may be produced by COP bottles were all lower than the quality standard limits. Moreover, the human albumin packaging container assembled by COP bottle, halogenated butyl rubber plug and aluminum-plastic combination cap showed excellent package integrity. CONCLUSION COP can be used in the storage and transport of human albumin.

OBJECTIVE To discuss the occurrence and clinical characteristics of Kounis syndrome (KS) induced by antibacterial drugs containing sulbactam in order to provide references for clinical safety drug use. METHODS The case reports of KS induced by antibacterial drugs containing sulbactam were retrieved from PubMed, Embase, Cochrane Library, CNKI, Wanfang and VIP database from establishment of each database to October 2023. The relevant data were collected and analyzed. RESULTS A total of 11 cases from 11 articles were identified and included in the analysis. There were 7 males (63.6%) and 4 females (36.4%). The patients were aged from 44 to 89 years with an average age of (70.0±13.1) years old, and there were 9 patients aged 70 and above (81.8%). The drugs involved included cefoperazone sulbactam in 5 cases (45.5%), ampicillin sulbactam in 4 cases (36.4%) and piperacillin sulbactam in 2 cases (18.2%). The 81.8% of the patients developed acute anaphylaxis within 30 min after treatment and electrocardiogram indicated abnormal ST segment changes. Type Ⅰ, Ⅱ and Ⅲ KS were 8 cases (72.7%), 2 cases (18.2%) and 1 case (9.1%), respectively. After anti-allergic and anti-myocardial ischemia therapy, 10 patients (90.9%) had good prognosis, and 1 patient (9.1%) died of cardiogenic shock. CONCLUSION KS could be induced by a variety of antibacterial drugs containing sulbactam, especially in older patients and mostly within 30 min. KS should be highly suspected once acute anaphylaxis accompanied by abnormal changes in electrocardiogram. Timely withdrawal of medication and targeted treatment according to KS types are the key to improve the prognosis of patients.

OBJECTIVE To establish a method for bacterial endotoxin test of active pharmaceutical ingredient (API) of insoluble adrenaline. METHODS According to the bacterial endotoxin test (BET) method in the general rule 1143 in the Chinese Pharmacopoeia (2020 Edition, Volume Ⅳ), adrenaline API was dissolved with hydrochloric acid and diluted with BET water. The gel method and kinetic turbidimetric assay were used to carry out interference test and endotoxin recovery interference verification test. RESULTS Adrenaline API was dissolved with 0.1 mol·L^-1 hydrochloric acid to 10 mg·mL^-1, and then diluted 200 times or more by BET water, which had no interference effects to bacterial endotoxin test. CONCLUSION The BET method established in this study can be used for the bacterial endotoxin test of adrenaline API of adrenaline to control the product quality.

Targeted nano-drug delivery system (TNDDS) offers prominent advantages in drug delivery for treatment of hepatocellular carcinoma, targeting the tumor site via ligand-receptor interaction. TNDDS reduces the dosage of drug to fulfill the therapeutic index requirement, improving pharmacokinetics and biodistribution. Besides, it can sustain drug release for several days after single-dose administration. In recent years, glycyrrhetinic acid (GA) attracts much attention as a highly efficient ligand targeting to liver tumor. The superiority of GA is mainly reflected in its combination of efficient liver tumor targeting, superior anti-tumor activity and favorable biocompatibility. GA-based TNDDS to liver tumor possesses high site-specificity and therapeutic efficiency for chemotherapeutic drugs or genetic materials delivering. This paper focuses on the basic theory of GA as a ligand targeting to liver tumor and the researches advances in the development of GA-based nano-delivery systems. Through the review and summary in this paper, it is expected to systematically present current progress of GA-based liver tumor TNDDS for interested researchers, and provide references for the development of new delivery systems.

OBJECTIVE To investigate metagenomic sequencing in the identification and tracing of bacteria contaminating drugs, and evaluate its application value. METHODS Both metagenomic sequencing and isolation culturing were employed to identify and type bacteria in two batches of Chinese patent medicines and environmental samples from the testing laboratory. The metagenomic sequencing results were analyzed at the strain level using MetaPhlan and StrainSifter software. RESULTS The analysis revealed a substantial contamination of Bacillus cereus-like organisms in both medicines and environmental samples, with the presence of the same B. cereus-like strain in medicine B18 and environmental sample HJ2. Through isolation culturing, five B. cereus-like strains were obtained from the medicines and environment. A phylogenetic tree was constructed based on the gyrA and panC gene sequences amplified by B. cereus-specific PCR, and multilocus sequence typing (MLST) results, all of which demonstrated that the B. cereus-like strain in medicine B18 belonged to the same group as one strain from the environment. CONCLUSION These findings indicate that metagenomic sequencing technology is reliable and has advantage over isolation culturing in comprehensively detecting potentially hazardous bacterial species and accurately performing strain-level traceability analysis. It holds significant application value in identification and tracing of pharmaceutical contamination.

Circular RNAs (circRNAs) are a class of single-stranded RNA molecules with covalently closed continuous loops which are involved in the occurrence and development of diseases. Neurovascular units(NVU) refer to the cellular and molecular interfaces between the circulatory system and central nervous system(CNS), mainly composed of microvascular cells, glial cells, neurons, and extracellular matrix, which are of great significance for maintaining brain homeostasis. However, the role of circRNA on NVU remains unknown. This article summarizes the latest research progress, with the aim of providing new targets and strategies for the treatment of related diseases.