OBJECTIVE To optimize the system of patent linkage system and provide a reference for encouraging generic drugs to apply for listing. METHODS On the basis of literature research， combined with the author’s work experience， the situation of generic drug application and patent challenge were analyzed comparatively after the implementation of the patent linkage system in China. Based on the patent linkage system， the reasons for the insufficient incentive for the challenge of generic drug patents in China were analyzed； corresponding countermeasures and suggestions were proposed. RESULTS & CONCLUSIONS The patent linkage system in China was implemented in 2021， but due to the implementation of the system being still in its initial stage， the relevant documents for practical guidance are not yet complete， and the supporting incentive mechanism is not yet sound， resulting in a weak willingness of generic pharmaceutical enterprises to initiate patent challenges. It is suggested that China can further improve the patent linkage system by improving the patent information registration platform of generic drugs， developing professional drug patent agencies， and establishing the patent common challenges platform of the first generic drug， in order to incentivize Chinese generic drug enterprises to increase innovation motivation， challenge original research drug patents， and apply for listing， achieving the effect of suppressing drug prices and benefiting the people through full competition.

OBJECTIVE To analyze quality maker （Q-marker） of Ka nggongyan soft capsule （KSC）. METHODS The fingerprints of 20 batches of KSC were established by ultra high performance liquid chromatography （UPLC）method. Similarity Evaluation System of TCM Chromatographic Fingerprint （2012 edition）were used to evaluate the similarity and confirm common peaks. The contents of norisoboldine ，leonurine hydrochloride ，forsythoside B ，acteoside，poliumoside and isoacteoside were determined by the same UPLC method. Targets and pathways related to KSC in the treatment of cervicitis were screened and analyzed by network pharmacology and molecular docking method to construct a “component-target-pathway”network，and analyze its potential Q-marker. RESULTS Twelve common peaks were identified in the fingerprints of 20 batches of KSC ，and the similarity was greater than 0.99. Six common peaks were identified ，including norisoboldine ，leonurine hydrochloride ，forsythoside B，acteoside，poliumoside and isoacteoside. The contents of the above 6 components were 1.336-1.774，0.093-0.143，4.970-5.888， 0.505-0.623，5.206-6.226 and 0.785-0.895 mg/g，respectively. By network pharmacology analysis ，14 key targets and 94 pathways were obtained ，and their binding energies to the core targets （protein kinase B 1，tumor necrosis factor ）were all less than －6.4 kJ/cal. CONCLUSIONS Six components such as norisoboldine and leonurine hydrochloride are potential Q-marker of KSC.

Objective To investigate the bacterial community diversity in human Demodex mites, so as to provide insights into unraveling the role of human Demodex mites in them caused infectious diseases. Methods From June to July 2023, Demodex mites were collected from the faces of college students in a university in Wuhu City using the adhesive tape method, and the V4 region of 16S ribosomal RNA (16S rRNA) gene and the internal transcribed spacer (ITS) gene of nuclear ribosomal DNA were amplified on an Illumina PE250 high-throughput sequencing platform. Sequencing data were spliced according to the overlapping relations and filtered to yield effective sequences, and operational taxonomic units (OTUs) was clustered. The diversity index of obtained OUTs was analyzed, and the structure of the bacterial community was analyzed at various taxonomic levels. Results A total of 57 483 valid sequences were obtained using 16S rRNA gene sequencing, and 159 OUTs were classified according to similarity. Then, OUTs at a 97% similarity were included for taxonomic analyses, and the bacteria in Demodex mites belonged to 14 phyla, 20 classes, 51 orders, 72 families, and 94 genera. Proteobacteria was the dominant phylum, and Vibrio, Bradyrhizobium and Variovorax were dominant genera. A total of 56 362 valid sequences were obtained using ITS gene sequencing, and 147 OTUs were obtained, which belonged to 5 phyla, 17 classes, 34 orders, 68 families, and 93 genera and were annotated to Ascomycota, Basidiomycota and Chytridiomycota, with Ascomycota as the dominant phylum, and Alternaria alternata, Epicoccum, Penicillium, and Sarocladium as dominant genera. Conclusions There is a high diversity in the composition of bacterial communities in human Demodex mites, with multiple types of microorganisms and high species abundance.