OBJECTIVE To provide scientific reference for perfecting the record-filing management policy of traditional Chinese medicine preparations formulated via traditional processes for medical applications （hereinafter referred to as “TCM preparations”） in medical institutions， and further promote the sound development of the research and record-filing work of such preparations. METHODS A literature review combined with cross-sectional research was carried out. We collected policy documents and preparation information related to the record-filing of TCM preparations issued by national and provincial drug administration authorities on official websites during 2018-2025. A comparative analysis was conducted on the implementation and revision of core policy documents for the registration management of TCM preparations across provinces， the scope of record-filing dosage forms， conditions for rejection of record-filing， and exemptions for registration materials. Statistical analysis on the quantity and dosage forms of record-filing preparations in each province was conducted by means of data induction and trend chart plotting， and targeted suggestions were put forward to optimize the management pathway of record-filing. RESULTS CONCLUSIONS There was obvious heterogeneity in record-filing policies among provinces. Twelve provinces refined the applicable dosage forms for record-filing， fifteen provinces supplemented conditions for rejection of record-filing （16 items in total）， and nine provinces expanded the scope of material exemptions. The number of recorded preparations presented a striking regional imbalance：Qinghai had the largest quantity of 4 269 varieties， while Hainan only had 14 varieties， with a gap of more than 300 times. The recorded preparations were mainly traditional dosage forms including pills （6 928 varieties） and powders （4 360 varieties）. Only 12 provinces formulated the provincial catalog for TCM preparations allocation. In most regions， preparation circulation was only permitted within medical consortia， leading to a low transformation rate of scientific and technological achievements of preparations. It is recommended to optimize the record-filing management pathway from three aspects： strengthening policy standardization while maintaining flexibility， streamlining record-filing procedures and documentary requirements， and reinforcing technical support and achievement transformation. These measures can reduce regional policy differences， improve work efficiency of record-filing， and advance the standardized development and clinical value transformation of hospital-made TCM preparations.

OBJECTIVE To provide scientific reference for perfecting the record-filing management policy of traditional Chinese medicine preparations formulated via traditional processes for medical applications （hereinafter referred to as “TCM preparations”） in medical institutions， and further promote the sound development of the research and record-filing work of such preparations. METHODS A literature review combined with cross-sectional research was carried out. We collected policy documents and preparation information related to the record-filing of TCM preparations issued by national and provincial drug administration authorities on official websites during 2018-2025. A comparative analysis was conducted on the implementation and revision of core policy documents for the registration management of TCM preparations across provinces， the scope of record-filing dosage forms， conditions for rejection of record-filing， and exemptions for registration materials. Statistical analysis on the quantity and dosage forms of record-filing preparations in each province was conducted by means of data induction and trend chart plotting， and targeted suggestions were put forward to optimize the management pathway of record-filing. RESULTS CONCLUSIONS There was obvious heterogeneity in record-filing policies among provinces. Twelve provinces refined the applicable dosage forms for record-filing， fifteen provinces supplemented conditions for rejection of record-filing （16 items in total）， and nine provinces expanded the scope of material exemptions. The number of recorded preparations presented a striking regional imbalance：Qinghai had the largest quantity of 4 269 varieties， while Hainan only had 14 varieties， with a gap of more than 300 times. The recorded preparations were mainly traditional dosage forms including pills （6 928 varieties） and powders （4 360 varieties）. Only 12 provinces formulated the provincial catalog for TCM preparations allocation. In most regions， preparation circulation was only permitted within medical consortia， leading to a low transformation rate of scientific and technological achievements of preparations. It is recommended to optimize the record-filing management pathway from three aspects： strengthening policy standardization while maintaining flexibility， streamlining record-filing procedures and documentary requirements， and reinforcing technical support and achievement transformation. These measures can reduce regional policy differences， improve work efficiency of record-filing， and advance the standardized development and clinical value transformation of hospital-made TCM preparations.

ObjectiveTo evaluate the efficacy of Sanhua essential oil inhalation as aromatherapy in patients with breast cancer-related depression.MethodsIn total, 144 patients with breast cancer-related depression who underwent postoperative chemotherapy were recruited. The participants in the control group (n = 52) were offered a placebo (sunflower oil) daily, whereas those in the essential oil group (n = 52) were administered Sanhua essential oil. This study evaluated depression improvement, Hamilton Depression Scale score, scores of symptoms in traditional Chinese medicine (TCM), Pittsburgh Sleepiness Quotient Index score, incidence of nausea and vomiting, and signal changes on functional magnetic resonance imaging.ResultsDepression improved by 48.1% and 21.2% in the essential oil and control groups, respectively (P = .010). The Hamilton Depression Scale score (P = .017), scores for symptoms in TCM (P = .002), and the incidence of nausea and vomiting in the acute and delayed phases were lower in the essential oil group than in the control group (nausea in the acute phase, P = .017; nausea in the delayed phase, P = .039; vomiting in the acute phase, P = .008; vomiting in the delayed phase, P = .081). The Pittsburgh Sleepiness Quotient Index score was lower in the essential oil group than in the control group (P = .005). Significant differences existed between the two groups in the left superior parietal gyrus, right precuneus, left dorsolateral superior frontal gyrus, and right precentral gyrus according to functional connectivity on functional magnetic resonance imaging.ConclusionInhalation of Sanhua essential oil alleviated depression in patients undergoing chemotherapy for breast cancer, improved sleep quality, relieved TCM symptoms, reduced nausea and vomiting, and regulated activities in the brain regions.

Objective:To characterize the vaginal flora of pregnant women during the second trimester using full-length 16S rRNA sequencing.Methods:A total of 142 pregnant women were systematically sampled from a pregnancy cohort. Vaginal swabs were collected for full-length 16S rRNA gene sequencing，and bioinformatics analysis was performed to characterize the vaginal microbiota and identify associated influencing factors.Results:Among the 142 pregnant women，the most frequently detected species were Lactobacillus iners（83.10%，118/142）and Lactobacillus crispatus（49.30%，70/142）. The majority of samples（90.85%，129/142）were classified as Lactobacillus-dominant vagitypes，with the Lactobacillus iners vagitype accounting for 48.59%（69/142）and the Lactobacillus crispatus vagitype accounting for 38.73%（55/142）. The vaginal microbiota was clustered into five community state types（CSTs）：Ⅰa，Ⅰb，Ⅲa，Ⅲb，and Ⅳ. The most prevalent CSTs were Lactobacillus iners-dominated CST-Ⅲ（51.41%，73/142）and Lactobacillus crispatus-dominated CST-Ⅰ（24.65%，35/142）. No samples were classified as CST-Ⅱ or CST-Ⅴ. A significant negative correlation was observed between Lactobacill and vaginosis-associated bacteria. Age，alcohol consumption，smoking，and vaginal treatments showed significant associations or trends toward significance with various Alpha diversity indices. Vaginal douching was associated with CST clustering，while obstetric history（primiparity，previous miscarriage history）was associated with vagitype classification. However，no significant associations were identified between maternal baseline characteristics and Beta diversity indices. Conclusions:Full-length 16S rRNA gene sequencing reveals that the vaginal microbiota of pregnant women is dominated by Lactobacillus iners and Lactobacillus crispatus. Maternal age，lifestyle factors such as smoking and alcohol consumption，and obstetric history are significantly associated with variations in vaginal microbiota composition.

Microbial communities such as those residing in the human gut are highly diverse and complex, and many with important implications for health and diseases. The effects and functions of these microbial communities are determined not only by their species compositions and diversities but also by the dynamic intra- and inter-cellular states at the transcriptional level. Powerful and scalable technologies capable of acquiring single-microbe-resolution RNA sequencing information in order to achieve a comprehensive understanding of complex microbial communities together with their hosts are therefore utterly needed. Here we report the development and utilization of a droplet-based smRNA-seq (single-microbe RNA sequencing) method capable of identifying large species varieties in human samples, which we name smRandom-seq2. Together with a triple-module computational pipeline designed for the bacteria and bacteriophage sequencing data by smRandom-seq2 in four human gut samples, we established a single-cell level bacterial transcriptional landscape of human gut microbiome, which included 29,742 single microbes and 329 unique species. Distinct adaptive response states among species in Prevotella and Roseburia genera and intrinsic adaptive strategy heterogeneity in Phascolarctobacterium succinatutens were uncovered. Additionally, we identified hundreds of novel host-phage transcriptional activity associations in the human gut microbiome. Our results indicated that smRandom-seq2 is a high-throughput and high-resolution smRNA-seq technique that is highly adaptable to complex microbial communities in real-world situations and promises new perspectives in the understanding of human microbiomes.
Humans ; Gastrointestinal Microbiome/genetics* ; Bacteriophages/physiology* ; High-Throughput Nucleotide Sequencing ; Sequence Analysis, RNA/methods* ; Bacteria/virology*

Objective:To investigate the effects of moxibustion,filiform needle acupuncture,and electroacupuncture on synovial hypoxia and expression of synovial fibrosis markers[transforming growth factor(TGF)-β and collagen alpha-1(Ⅰ)chain(COL1A1)]in knee osteoarthritis(KOA)rats.Methods:Fifty Sprague-Dawley rats were randomly divided into a normal group,a model group,a moxibustion group,an acupuncture group,and an electroacupuncture group,with 10 rats in each group.Except for the normal group,rats in the other four groups were injected with sodium iodoacetate into the right knee joint cavity to establish KOA models.The right Futu(ST32)and Zusanli(ST36)were selected in the moxibustion,acupuncture,and electroacupuncture groups to perform the mild moxibustion with moxa sticks,filiform needle acupuncture,or electroacupuncture,respectively.Each intervention lasted 15 min,once every other day,and continued for 4 weeks,with a total of 14 interventions.The Lequesne score was used to evaluate the degree of knee dysfunction before and after intervention,and the rat's right knee joint diameter was measured to evaluate the degree of knee swelling.Morphological changes of the right knee joint synovial tissue were observed using hematoxylin-eosin staining.Hypoxia probe immunofluorescence staining was used to observe the degree of synovial hypoxia in rats.Western blotting was used to detect the protein expression levels of hypoxia-inducible factor(HIF)-1α,TGF-β,and COL1A1 in the synovial tissue of the right knee joints.Results:Before intervention,the Lequesne score and the right knee joint diameter in the other four groups increased significantly compared to the normal group(P<0.01).After intervention,the Lequesne score and the right knee joint diameter increased significantly in the model group compared to the normal group(P<0.01)together with worsened cartilage deformation and osteophytes,inflammatory cell infiltration and fibrosis in synovial tissue,and hypoxia degree,and the expression levels of HIF-1α,TGF-β,and COL1A1 proteins in the knee joint synovial tissue of rats increased(P<0.01).The Lequesne score and the right knee joint diameter decreased significantly(P<0.01 or P<0.05),the cartilage morphology was normal without obvious osteophytes,and the hypoxia degree reduced in the three intervention groups compared to the model group.Among them,the moxibustion group had the most notable improvement in hypoxia,synovial tissue fibrosis,angiogenesis,and inflammatory cell infiltration.The expression levels of HIF-1α,TGF-β,and COL1A1 proteins decreased in the moxibustion and electroacupuncture groups(P<0.01),and the expression levels of HIF-1α and TGF-β proteins were decreased in the acupuncture group(P<0.01).Conclusion:Moxibustion,filiform needle acupuncture,and electroacupuncture improve knee joint function and reduce knee joint swelling in KOA rats.The mechanism may be to improve synovial fibrosis of the knee joint by regulating HIF-1α;moxibustion has the best effect on improving hypoxia among the three interventions,but the effect of filiform needle acupuncture on COL1A1 is not significant.

Objective:To characterize the vaginal flora of pregnant women during the second trimester using full-length 16S rRNA sequencing.Methods:A total of 142 pregnant women were systematically sampled from a pregnancy cohort. Vaginal swabs were collected for full-length 16S rRNA gene sequencing，and bioinformatics analysis was performed to characterize the vaginal microbiota and identify associated influencing factors.Results:Among the 142 pregnant women，the most frequently detected species were Lactobacillus iners（83.10%，118/142）and Lactobacillus crispatus（49.30%，70/142）. The majority of samples（90.85%，129/142）were classified as Lactobacillus-dominant vagitypes，with the Lactobacillus iners vagitype accounting for 48.59%（69/142）and the Lactobacillus crispatus vagitype accounting for 38.73%（55/142）. The vaginal microbiota was clustered into five community state types（CSTs）：Ⅰa，Ⅰb，Ⅲa，Ⅲb，and Ⅳ. The most prevalent CSTs were Lactobacillus iners-dominated CST-Ⅲ（51.41%，73/142）and Lactobacillus crispatus-dominated CST-Ⅰ（24.65%，35/142）. No samples were classified as CST-Ⅱ or CST-Ⅴ. A significant negative correlation was observed between Lactobacill and vaginosis-associated bacteria. Age，alcohol consumption，smoking，and vaginal treatments showed significant associations or trends toward significance with various Alpha diversity indices. Vaginal douching was associated with CST clustering，while obstetric history（primiparity，previous miscarriage history）was associated with vagitype classification. However，no significant associations were identified between maternal baseline characteristics and Beta diversity indices. Conclusions:Full-length 16S rRNA gene sequencing reveals that the vaginal microbiota of pregnant women is dominated by Lactobacillus iners and Lactobacillus crispatus. Maternal age，lifestyle factors such as smoking and alcohol consumption，and obstetric history are significantly associated with variations in vaginal microbiota composition.

Objective:To establish a rapid quantitative model of sodium chloride content in Halitum of traditional Chinese medicine by using X-ray diffraction technology and machine learning algorithm.Methods:The data of X-ray diffraction patterns of 90 batches of Halitum samples were collected,and the rapid prediction models of X-ray diffraction were constructed by using partial least squares(PLS),support vector regression(SVR)long short-term memory(LSTM)according to the reference values determined by the content determination method of Halitum in the Chinese Pharmacopoeia 2020 edition.Results:The data preprocessed by multivariate scatter correction(MSC)and selected by competitive adaptive reweighted sampling(CARS)were better in PLS model and LSTM model.The data pretreated by standard normal transformation(SNV)and selected by CARS feature variable perform well in SVR.Conclusion:The three models show good prediction potential,which shows that the combination of X-ray diffraction technology and machine learning algorithm is feasible for accurate prediction of the content of Halitum in traditional Chinese medicine.

Objective:To establish a rapid quantitative model for the determination of moisture,extractives,and content in Pollen Typhae.Methods:Near-infrared spectra of 91 batches of Pollen Typhae samples were collected.Spectral preprocessing was performed using S-G,MSC,SNV,and CWT methods.Variable selection was conducted using CARS,SPA,and VIP methods,and compared with full-spectrum modeling.Partial least squares(PLS)mod-els were established for the quantitative determination of moisture,total ash,extractives,and content.The model performance was evaluated by calculating the coefficient of determination for the calibration set and validation set(R2 c,R2v),root mean square error of calibration and validation(RMSEc,RMSEv),and residual prediction devia-tion(RPD).Results:The PLS models for moisture,extractives,and content in Pollen Typhae showed R2c and R2v values greater than 0.9,RMSEc and RMSEv values approaching 0,and RPD values greater than 3.Conclusion:In this study,near-infrared spectroscopy was used to construct quantitative prediction models for moisture,extractives,typhaneoside,and isorhamnetin-3-O-neohesperidoside content in Pollen Typhae.This method enables rapid detection of the main quality control indicators of Pollen Typhae,providing strong technical support for its quality supervision.

Objective:To investigate the effects of moxibustion,filiform needle acupuncture,and electroacupuncture on synovial hypoxia and expression of synovial fibrosis markers[transforming growth factor(TGF)-β and collagen alpha-1(Ⅰ)chain(COL1A1)]in knee osteoarthritis(KOA)rats.Methods:Fifty Sprague-Dawley rats were randomly divided into a normal group,a model group,a moxibustion group,an acupuncture group,and an electroacupuncture group,with 10 rats in each group.Except for the normal group,rats in the other four groups were injected with sodium iodoacetate into the right knee joint cavity to establish KOA models.The right Futu(ST32)and Zusanli(ST36)were selected in the moxibustion,acupuncture,and electroacupuncture groups to perform the mild moxibustion with moxa sticks,filiform needle acupuncture,or electroacupuncture,respectively.Each intervention lasted 15 min,once every other day,and continued for 4 weeks,with a total of 14 interventions.The Lequesne score was used to evaluate the degree of knee dysfunction before and after intervention,and the rat's right knee joint diameter was measured to evaluate the degree of knee swelling.Morphological changes of the right knee joint synovial tissue were observed using hematoxylin-eosin staining.Hypoxia probe immunofluorescence staining was used to observe the degree of synovial hypoxia in rats.Western blotting was used to detect the protein expression levels of hypoxia-inducible factor(HIF)-1α,TGF-β,and COL1A1 in the synovial tissue of the right knee joints.Results:Before intervention,the Lequesne score and the right knee joint diameter in the other four groups increased significantly compared to the normal group(P<0.01).After intervention,the Lequesne score and the right knee joint diameter increased significantly in the model group compared to the normal group(P<0.01)together with worsened cartilage deformation and osteophytes,inflammatory cell infiltration and fibrosis in synovial tissue,and hypoxia degree,and the expression levels of HIF-1α,TGF-β,and COL1A1 proteins in the knee joint synovial tissue of rats increased(P<0.01).The Lequesne score and the right knee joint diameter decreased significantly(P<0.01 or P<0.05),the cartilage morphology was normal without obvious osteophytes,and the hypoxia degree reduced in the three intervention groups compared to the model group.Among them,the moxibustion group had the most notable improvement in hypoxia,synovial tissue fibrosis,angiogenesis,and inflammatory cell infiltration.The expression levels of HIF-1α,TGF-β,and COL1A1 proteins decreased in the moxibustion and electroacupuncture groups(P<0.01),and the expression levels of HIF-1α and TGF-β proteins were decreased in the acupuncture group(P<0.01).Conclusion:Moxibustion,filiform needle acupuncture,and electroacupuncture improve knee joint function and reduce knee joint swelling in KOA rats.The mechanism may be to improve synovial fibrosis of the knee joint by regulating HIF-1α;moxibustion has the best effect on improving hypoxia among the three interventions,but the effect of filiform needle acupuncture on COL1A1 is not significant.