Objective: To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia (ChP) 2025 Edition, and explore its novel requirements in risk-based pharmaceutical product lifecycle management.
Methods: A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview, international harmonization of microbiological standards, risk-based quality management system, and novel tools and methods with Chinese characteristics.
Results: The ChP 2025 edition demonstrates three prominent features in microbiological-related standards: enhanced international harmonization, introduced emerging molecular biological technologies, and established a risk-based microbiological quality control system.
Conclusion: The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system, which significantly improves the scientificity, standardization and applicability of the standards, providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.

ObjectiveTo evaluate the inhibitory effect of online-sold “preservative-free” cosmetics against contaminated microorganisms during storage and use, to establish a method for assessing the preservative efficacy of such cosmetics, and to provide data support for the formulation of relevant standards. MethodsA total of 16 batches of cosmetics claiming preservative free were collected to determine their pH value, water activity, total aerobic microbial count (TAMC) and total molds and yeasts count (TYMC). Meanwhile, preservatives not listed in the Safety and Technical Standards for Cosmetics (2015 edition) (referred to as “unlisted preservatives”) were screened. In addition, a preservative challenge test was conducted on these cosmetics. ResultsAll the 16 batches of samples were generally weakly acidic, and with a water activity ≥0.6, which were suitable for microbial growth. Unlisted preservative not labeled on the package was detected in one batch of cosmetic. The results of neutralizer verification showed that three batches required further dilution to eliminate the antimicrobial interference. After inoculation with challenge microorganisms and cultivation for 7 days, two batches of cosmetics did not achieve a bacterial reduction rate of 99.90%, and the fungal reduction rate did not reach 90.00% either. While another two batches of cosmetics experienced microbial growth during testing, indicating a failure of the preservative challenge test. The overall pass rate was 75.00%. ConclusionSome online-sold preservative free cosmetics have insufficient preservation efficacy and pose a certain risk of microbial contamination.

ObjectiveTo observe the effect of Coptidis Rhizoma and Ophiopogonis Radix on renal tissue injury and epidermal growth factor receptor （EGFR）/phosphatidylinositol 3-kinase （PI3K）/protein kinase B （Akt） signaling pathway in rats with diabetic nephropathy （DN） and explore its possible mechanism of delaying DN. MethodThirty-six male Wistar rats were randomly divided into a normal group （6 rats） and a model group （30 rats）. The model group was fed with a high-fat and high-sugar diet combined with streptozotocin （STZ） to establish a rat model of type 2 diabetes. After the successful preparation of the model， the rats were randomly divided into the model group， low， medium， and high dose groups of Coptidis Rhizoma and Ophiopogonis Radix （100， 200， 400 mg·kg^-1）， and metformin group （200 mg·kg^-1）. After administration， the levels of fasting blood glucose （FBG）， 24 h urine protein （24 h-UTP）， creatinine （SCr）， urea nitrogen （BUN）， and uric acid （UA） were detected. Hematoxylin-eosin （HE） staining and Masson staining were used to observe the pathological changes of renal tissue in rats. Western blot and Real-time fluorescence quantitative polymerase chain reaction （Real-time PCR） were used to detect the related protein expression of EGFR， PI3K， and Akt and their mRNA expression levels in the renal tissue of rats in each group. ResultsCompared with the normal group， the levels of FBG， SCr， BUN， UA， 24 h-UTP， and kidney index in the model group were significantly increased （P<0.01）， most renal tubular epithelial cells were necrotic， and the content of collagen in glomeruli was significantly increased （P<0.01）. Compared with the model group， the above indexes of rats in each administration group were improved to varying degrees. The FBG， SCr， BUN， UA， 24 h-UTP， and kidney index of rats in each dose group and metformin group were significantly decreased （P<0.01， P<0.05）. The necrosis degree of renal tubular epithelial cells was reduced， and the fibrosis area was decreased （P<0.01）. There related protein and mRNA expressions of EGFR， PI3K， and Akt were significantly increased （P<0.05， P<0.01）. ConclusionCoptidis Rhizoma and Ophiopogonis Radix can alleviate renal tissue injury in rats with DN， and their mechanism may be related to the regulation of the EGFR/PI3K/Akt signaling pathway.

OBJECTIVE To identify and classify the chemical components and components absorbed into blood of Sishen Pills u-sing ultra-high performance liquid chromatography-quadrupole-orbitrap high resolution mass spectrometry.METHODS SD rats were divided into blank group and drug administration group.The rats in drug administration group were given water extract of Sishen Pills formula intragastrically,and blank and drug-containing plasma were collected respectively.A Hypersil GOLD VANQUISH column(2.1 mm×100 mm,1.9 μm)was used,with 0.1%formic acid water acetonitrile as the mobile phase,gradient elution,volume flow rate of 0.3 mL·min-1,and column temperature of 35℃.Electrospray ion source(ESI)with positive and negative ion scanning mode was used for chromatographic separation and mass spectrometry data acquisition.The chemical components of Sishen Pills were identi-fied by comparing the exact molecular mass,fragment ion information and relative retention time with the map of reference substance,matching with the self-established database and combining with literature reports.On this basis,the components absorbed into blood of Sishen Pills were analyzed by comparing the blank plasma and drug-containing plasma.RESULTS A total of 181 chemical compo-nents were identified from Sishen Pills,mainly including flavonoids,alkaloids,lignans and other components.A total of 49 prototype blood components were identified from the plasma samples,mainly including flavonoids,alkaloids and other components.CONCLU-SION A variety of chemical components in Sishen Pills and drug-containing plasma are comprehensively,accurately and quickly i-dentified,and all of them are assigned to the various medicinal materials in the prescription.This study provides reference for the qual-ity control,basic research on medicinal effect materials and clinical application of Sishen Pills.

Objective To investigate the microbial contamination in 54 batches of commercial honey. Methods Aerobic plate colony counts for bacteria and colonies of mould and osmophilic yeasts in honey were determined according to the National Food Safety Standard. The bacteria and fungi in unqualified samples were further identified and analyzed by morphology， MALDI-TOF-MS and large subunit （LSU） rRNA gene sequence. Results Three unqualified batches were found. One batch had aerobic plate colony counts exceeding the standard， with a variety of bacteria including Bacillus sp.， Paenibacillus sp. and Brevibacillus sp. Two batches had mould counts exceeding the standard. Aspergillus sp was detected in both samples （from the same manufacturer）， and the DNA sequence homology was very high， suggesting the mould might come from the same pollution source. Conclusion There are many kinds of microbial contamination in honey. Manufacturers should strengthen the microbe control in monitoring process to avoid the repeated microbial contamination.

ObjectiveA rapid enrichment and detection method for Escherichia coli O157∶H7 was developed by using multienzyme isothermal rapid amplification （MIRA） fluorescence method combined with metal organic frameworks immunomagnetic beads. MethodsUsing rfbE gene as the target， the primers， probes and reaction system were screened， and the specificity， sensitivity and practical application of this method were investigated. ResultsThe detection limit of Escherichia coli O157∶H7 was 1.18×10⁵ CFU‧mL^-1， and the detection limit of DNA concentration was 9 pg‧μL^-1. The detection process was completed in 20 minutes. The test results of 47 strains （24 target strains and 23 non-target strains） were consistent with real-time PCR （RT-PCR）. ConclusionA method based on metal-organic framework immunomagnetic beads enrichment combined with MIRA assay is developed in this study. The method is simple， rapid and suitable for rapid enrichment and detection of Escherichia coli O157∶H7 in food.

OBJECTIVE：To compare the difference of microbiological limit test and criteria of TCM decoction pieces among 43 edition of United States Pharmacopeia （USP43），10.0 edition of European Pharmacopeia （EP10.0），17 edition of Japanese Pharmacopeia （JP17）and 2020 edition of Chinese Pharmacopeia （ChP2020），and to provide refernce for the revision and improvement of microbiological standards for TCM decoction pieces in China. METHODS ：The differences in the microbial enumeration tests method （including sampling and sample preparation ，selection of bacteria and culture medium ，count of microorganisms and heat-resistant bacteria ，etc.），tests for specified microorganisms （including sample pretreatment ，enrichment， separation and identification ，etc.）and microbial related limit criteria were compared among USP 43，EP10.0，JP17 and ChP 2020. RESULTS & CONCLUSIONS ：In terms of microbiological examination of TCM decoction pieces ，USP43，EP10.0，JP17 had their own independent provisions. Chp 2020 added“general rule 1108”. In terms of inspection items ，in addition to the total aerobic bacteria count and total combined yeasts and molds count ，ChP2020 and EP 10.0 provided three methods for the inspection of control bacteria （bile-resistant Gram-negative bacteria ， Escherichia coli ， Salmonella）. On the basis ， JP17 supplemented Staphylococcus aureus test；However，USP43 added Clostridium test method and put forward the concept of objectionable microorganisms risk assessment ；ChP2020 also added a new method for counting heat-resistant bacteria. In terms of microbial limit criteria，USP43 was the most detailed in the classification of TCM decoction pieces ，which was more strict than EP 10.0 and JP 17； ChP2020 had not set up a unified limit for the inspection of control bacteria of TCM decoction pieces. ChP 2020 revised the “microbial limit standard for TCM extracts and TCM decoction pieces ”，but it was not perfect compared with the Pharmacopoeia of the United States ，Europe and Japan. It is suggested that according to the current situation of microbial contamination and control of TCM decoction pieces ，the microbial limit test and criteria of TCM related products in Pharmacopoeia should be gradually improved ，and the microbial limit level of corresponding products should be reasonably refined.

Objective: To analyze epidemiological characteristics of influenza-like illness outbreaks in mainland China during 2017-2018 surveillance season, and to provide scientific evidence for developing influenza prevention and control strategies. Methods: We collected the data on reported influenza outbreaks in 2017-2018 surveillance season from China Influenza Surveillance Information System and China Public Health Emergency Management Information System and analyzed the data of laboratory-confirmed influenza-like illness outbreaks by descriptive epidemiological methods. Results: During the surveillance season, a total of 2 398 influenza-like illness outbreaks (with 10 or more incidences in an outbreak) in mainland China were reported, involving 87 084 patients, of which 2 323 were influenza outbreaks, involving 85 531 patients. The reported influenza-like illness outbreaks occurred most frequently from November 2017 to January 2018 in both the southern and northern regions and the highest peaks were in December 2017. During the period 1 850 influenza-like illness outbreaks (77.15%) were reported in the southern region, and 548 influenza-like illness outbreaks (22.85%) were reported in the northern region. The most of the outbreaks occurred in primary, secondary schools and nursery care schools, with a total of 2 210 reports (92.16%). And the majority of the outbreaks involved 10-29 incident cases. The dominant isolated virus strains for the outbreaks were influenza B (1 505 outbreaks, 62.76% of all the outbreaks). Conclusion Seasonality of influenza outbreaks were observed in mainland China during 2017-2018 surveillance season and the reported influenza outbreaks were most frequently occurred in autumn-winter season and in southern China. Primary, secondary schools and nursery care schools are high-risk places for outbreaks, and the dominant isolated virus strains for the outbreaks were influenza B.

Objective To analyze epidemiological characteristics of influenza?like illness outbreaks in mainland China during 2017-2018 surveillance season, and to provide scientific evidence for developing influenza prevention and control strategies. Methods We collected the data on reported influenza outbreaks in 2017-2018 surveillance season from China Influenza Surveillance Information System and China Public Health Emergency Management Information System and analyzed the data of laboratory?confirmed influenza?like illness outbreaks by descriptive epidemiological methods. Results During the surveillance season, a total of 2 398 influenza?like illness outbreaks (with 10 or more incidences in an outbreak) in mainland China were reported, involving 87 084 patients, of which 2 323 were influenza outbreaks, involving 85 531 patients. The reported influenza?like illness outbreaks occurred most frequently from November 2017 to January 2018 in both the southern and northern regions and the highest peaks were in December 2017. During the period 1 850 influenza?like illness outbreaks (77.15%) were reported in the southern region, and 548 influenza?like illness outbreaks (22.85%) were reported in the northern region. The most of the outbreaks occurred in primary, secondary schools and nursery care schools, with a total of 2 210 reports (92.16%). And the majority of the outbreaks involved 10-29 incident cases. The dominant isolated virus strains for the outbreaks were influenza B (1 505 outbreaks, 62.76% of all the outbreaks). Conclusion Seasonality of influenza outbreaks were observed in mainland China during 2017-2018 surveillance season and the reported influenza outbreaks were most frequently occurred in autumn?winter season and in southern China. Primary, secondary schools and nursery care schools are high?risk places for outbreaks, and the dominant isolated virus strains for the outbreaks were influenza B.

Objective To analyze epidemiological characteristics of influenza?like illness outbreaks in mainland China during 2017-2018 surveillance season, and to provide scientific evidence for developing influenza prevention and control strategies. Methods We collected the data on reported influenza outbreaks in 2017-2018 surveillance season from China Influenza Surveillance Information System and China Public Health Emergency Management Information System and analyzed the data of laboratory?confirmed influenza?like illness outbreaks by descriptive epidemiological methods. Results During the surveillance season, a total of 2 398 influenza?like illness outbreaks (with 10 or more incidences in an outbreak) in mainland China were reported, involving 87 084 patients, of which 2 323 were influenza outbreaks, involving 85 531 patients. The reported influenza?like illness outbreaks occurred most frequently from November 2017 to January 2018 in both the southern and northern regions and the highest peaks were in December 2017. During the period 1 850 influenza?like illness outbreaks (77.15%) were reported in the southern region, and 548 influenza?like illness outbreaks (22.85%) were reported in the northern region. The most of the outbreaks occurred in primary, secondary schools and nursery care schools, with a total of 2 210 reports (92.16%). And the majority of the outbreaks involved 10-29 incident cases. The dominant isolated virus strains for the outbreaks were influenza B (1 505 outbreaks, 62.76% of all the outbreaks). Conclusion Seasonality of influenza outbreaks were observed in mainland China during 2017-2018 surveillance season and the reported influenza outbreaks were most frequently occurred in autumn?winter season and in southern China. Primary, secondary schools and nursery care schools are high?risk places for outbreaks, and the dominant isolated virus strains for the outbreaks were influenza B.