1.Clinical Observation on 45 Cases of Chronic Obstructive Pulmonary Disease in the Stable Phase with Qi Deficiency,Blood Stasis and Phlegm Obstruction Syndrome with Auxiliary Treated with Jinwei Guben Decoction (金卫固本汤) Combined with Bailing Capsule (百令胶囊)
Deyu KONG ; Xudong ZHENG ; Huimin ZHOU ; Ruitao WANG ; Benzhang ZHAO ; Jianjun WU
Journal of Traditional Chinese Medicine 2025;66(4):367-375
ObjectiveTo observe the clinical efficacy of modified Jinwei Guben Decoction (金卫固本汤, MJGD) combined with Bailing Capsule (百令胶囊, BC) in the treatment of chronic obstructive pulmonary disease (COPD) patients in the stable stage with qi deficiency, blood stasis and phlegm obstruction syndrome, in addition to conventional western medicine treatment. MethodsA total of 102 patients with stable COPD and qi deficiency, blood stasis, and phlegm obstruction syndrome were included in the study. According to the patients'preferences, they were divided into treatment group (49 cases) and control group (53 cases). The control group received conventional western medicine treatment, while the treatment group was given MJGD (1 dose daily) combined with BC (2.0 g each time, three times a day) additionally. The treatment period was 3 months, and the patients were followed up for 1 year after the treatment. The acute exacerbation frequency (mild, moderate, severe) before treatment, during treatment, at 6-month follow-up, and at 1-year follow-up was compared between groups. Additionally, the lung function indicators such as FEV1, FEV1%pred, FVC, and FEV1/FVC ratio, traditional Chinese medicine (TCM) syndrome scores, modified British Medical Research Council (mMRC) dyspnea scale, and the COPD Assessment Test (CAT) scores before and after treatment were compared. A logistic regression model was constructed to analyze the impact of MJGD combined with BC on clinical efficacy. ResultsFour patients dropped out from the treatment group and eight from the control group, leaving 45 patients of each group for statistical analysis. The number of mild and moderate acute exacerbations in the treatment group was lower than that in the control group during the treatment period, at 6-month follow-up and within 1 year of follow-up (P<0.05) .The number of severe acute exacerbations was only lower in the treatment group than in the control group at 6-month follow-up (P<0.05). Compared with that before treatment, the number of acute exacerbations of all degrees in the treatment group was significantly reduced within 1 year of follow-up (P<0.05),while only the number of mild acute exacerbations in the control group was significantly reduced within 1 year of follow-up (P<0.05). The treatment group showed significant improvement in FEV1 and FEV1%pred and FEV1/FEV, while the control group showed a significant decline in FEV1 and FVC (P<0.05). After treatment, both groups showed significant reductions in TCM syndrome scores, including coughing, sputum, wheezing, chest tightness, shortness of breath, and fatigue, as well as mMRC and CAT scores (P<0.05), with the treatment group having significantly lower scores than the control group (P<0.05). The overall clinical effective rate of in the treatment group was 93.33% (42/45), significantly higher than that of the control group, 75.56% (34/45, P<0.05). Multivariate logistic regression analysis showed that the use of MJGD combined with BC (OR = 4.68, 95%CI: 1.15 - 19.09, P = 0.03) was positively correlated with clinical efficacy. ConclusionsIn addition to conventional western medicine treatment, the combination of MJGD and BC can reduce the frequency of acute exacerbations, delay the decline of lung function, improve clinical symptoms, and significantly enhance the clinical efficacy in patients with stable COPD and qi deficiency, blood stasis, and phlegm obstruction syndrome.
2.Clinical Efficacy of Jinwei Pingchuan Decoction in Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease with Phlegm-heat Obstruction in Lung Syndrome
Xudong ZHENG ; Deyu KONG ; Benzhang ZHAO ; Huimin ZHOU ; Ruitao WANG ; Jianjun WU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):125-133
ObjectiveTo study the effect of Jinwei Pingchuan decoction combined with conventional Western medicine on the number of acute exacerbations, lung function, and clinical symptoms in patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) with phlegm-heat obstruction in lung syndrome. MethodsA non-randomized controlled trial was conducted to include 60 patients with acute exacerbation of COPD with phlegm-heat obstruction in lung syndrome. Patients were divided into a treatment group and a control group based on whether they received Jinwei Pingchuan decoction, with 30 patients in each group. The treatment group received Jinwei Pingchuan decoction combined with conventional Western medicine therapy, while the control group received conventional Western medicine therapy alone. Both groups received treatment for 7 days. The number of acute exacerbations and lung function indices were followed up and recorded before treatment and three months after treatment. The following outcomes were observed before and after treatment: the number of acute exacerbations, lung function indices (forced expiratory volume in one second [FEV1], percentage of predicted value [FEV1%pred], forced vital capacity [FVC], and FEV1/FVC ratio), the degree of acute exacerbation, TCM syndrome score, COPD assessment test (CAT) score, modified British Medical Research Council Dyspnea Questionnaire (mMRC) score, C-reactive protein (CRP), and white blood cell (WBC) count. ResultsAfter 3 months of follow-up, the treatment group showed a significant reduction in the number of acute exacerbations compared with the pre-treatment values (P<0.05). After treatment, the treatment group had fewer acute exacerbations than the control group (P<0.05). The degree of acute exacerbation in the treatment group improved significantly compared with the pre-treatment values (P<0.05). After treatment, the degree of acute exacerbation in the treatment group was improved compared to the control group (P<0.05). Regarding lung function, FEV1, FEV1%pred, FVC, and FEV1/FVC ratio increased significantly in the treatment group compared with the pre-treatment values (P<0.05), and similar improvements were observed in the control group (P<0.05). After treatment, FEV1 and FVC were higher in the treatment group than the control group (P<0.05). Regarding TCM syndrome scores, the scores for individual symptoms such as wheezing, cough, expectoration, chest tightness, shortness of breath, and fatigue, as well as the total score, decreased significantly in the treatment group compared with the pre-treatment values (P<0.05). In the control group, the scores for cough, expectoration, chest tightness, fatigue, and palpitation, as well as the total score, also decreased (P<0.05). After treatment, the treatment group showed significantly lower scores for wheezing, cough, chest tightness, shortness of breath, and the total score than the control group (P<0.05). Regarding the CAT score, the scores for cough, expectoration, chest tightness, climbing stairs, going out, activity, and energy, as well as the total score, decreased significantly in the treatment group compared with the pre-treatment values (P<0.05). In the control group, the scores for cough, expectoration, chest tightness, sleep, energy, and the total score decreased (P<0.05). After treatment, the treatment group showed significantly lower scores for cough, expectoration, chest tightness, activity, and going out than the control group (P<0.05). Regarding the mMRC score, CRP level, and WBC count, all these parameters decreased significantly in the treatment group compared with the pre-treatment values (P<0.05), and similar reductions were observed in the control group (P<0.05). ConclusionJinwei Pingchuan decoction can reduce the number of acute exacerbations and the degree of acute exacerbation in patients with acute exacerbation of COPD with phlegm-heat obstruction in lung syndrome. It also improves lung function and symptoms such as cough and chest tightness, thereby enhancing the quality of life of patients.
3.Clinical Efficacy of Jinwei Pingchuan Decoction in Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease with Phlegm-heat Obstruction in Lung Syndrome
Xudong ZHENG ; Deyu KONG ; Benzhang ZHAO ; Huimin ZHOU ; Ruitao WANG ; Jianjun WU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):125-133
ObjectiveTo study the effect of Jinwei Pingchuan decoction combined with conventional Western medicine on the number of acute exacerbations, lung function, and clinical symptoms in patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) with phlegm-heat obstruction in lung syndrome. MethodsA non-randomized controlled trial was conducted to include 60 patients with acute exacerbation of COPD with phlegm-heat obstruction in lung syndrome. Patients were divided into a treatment group and a control group based on whether they received Jinwei Pingchuan decoction, with 30 patients in each group. The treatment group received Jinwei Pingchuan decoction combined with conventional Western medicine therapy, while the control group received conventional Western medicine therapy alone. Both groups received treatment for 7 days. The number of acute exacerbations and lung function indices were followed up and recorded before treatment and three months after treatment. The following outcomes were observed before and after treatment: the number of acute exacerbations, lung function indices (forced expiratory volume in one second [FEV1], percentage of predicted value [FEV1%pred], forced vital capacity [FVC], and FEV1/FVC ratio), the degree of acute exacerbation, TCM syndrome score, COPD assessment test (CAT) score, modified British Medical Research Council Dyspnea Questionnaire (mMRC) score, C-reactive protein (CRP), and white blood cell (WBC) count. ResultsAfter 3 months of follow-up, the treatment group showed a significant reduction in the number of acute exacerbations compared with the pre-treatment values (P<0.05). After treatment, the treatment group had fewer acute exacerbations than the control group (P<0.05). The degree of acute exacerbation in the treatment group improved significantly compared with the pre-treatment values (P<0.05). After treatment, the degree of acute exacerbation in the treatment group was improved compared to the control group (P<0.05). Regarding lung function, FEV1, FEV1%pred, FVC, and FEV1/FVC ratio increased significantly in the treatment group compared with the pre-treatment values (P<0.05), and similar improvements were observed in the control group (P<0.05). After treatment, FEV1 and FVC were higher in the treatment group than the control group (P<0.05). Regarding TCM syndrome scores, the scores for individual symptoms such as wheezing, cough, expectoration, chest tightness, shortness of breath, and fatigue, as well as the total score, decreased significantly in the treatment group compared with the pre-treatment values (P<0.05). In the control group, the scores for cough, expectoration, chest tightness, fatigue, and palpitation, as well as the total score, also decreased (P<0.05). After treatment, the treatment group showed significantly lower scores for wheezing, cough, chest tightness, shortness of breath, and the total score than the control group (P<0.05). Regarding the CAT score, the scores for cough, expectoration, chest tightness, climbing stairs, going out, activity, and energy, as well as the total score, decreased significantly in the treatment group compared with the pre-treatment values (P<0.05). In the control group, the scores for cough, expectoration, chest tightness, sleep, energy, and the total score decreased (P<0.05). After treatment, the treatment group showed significantly lower scores for cough, expectoration, chest tightness, activity, and going out than the control group (P<0.05). Regarding the mMRC score, CRP level, and WBC count, all these parameters decreased significantly in the treatment group compared with the pre-treatment values (P<0.05), and similar reductions were observed in the control group (P<0.05). ConclusionJinwei Pingchuan decoction can reduce the number of acute exacerbations and the degree of acute exacerbation in patients with acute exacerbation of COPD with phlegm-heat obstruction in lung syndrome. It also improves lung function and symptoms such as cough and chest tightness, thereby enhancing the quality of life of patients.
4.AI-integrated IQPD framework of quality prediction and diagnostics in small-sample multi-unit pharmaceutical manufacturing: Advancing from experience-driven to data-driven manufacturing.
Kaiyi WANG ; Xinhai CHEN ; Nan LI ; Huimin FENG ; Xiaoyi LIU ; Yifei WANG ; Yanfei WU ; Yufeng GUO ; Shuoshuo XU ; Lu YAO ; Zhaohua ZHANG ; Jun JIA ; Zhishu TANG ; Zhisheng WU
Acta Pharmaceutica Sinica B 2025;15(8):4193-4209
The pharmaceutical industry faces challenges in quality digitization for complex multi-stage processes, especially in small-sample systems. Here, an intelligent quality prediction and diagnostic (IQPD) framework was developed and applied to Tong Ren Tang's Niuhuang Qingxin Pills, utilizing four years of data collected from four production units, covering the entire process from raw materials to finished products. In this framework, a novel path-enhanced double ensemble quality prediction model (PeDGAT) is proposed, which combines a graph attention network and path information to encode inter-unit long-range and sequential dependencies. Additionally, the double ensemble strategy enhances model stability in small samples. Compared to global traditional models, PeDGAT achieves state-of-the-art results, with an average improvement of 13.18% and 87.67% in prediction accuracy and stability on three indicators. Additionally, a more in-depth diagnostic model leveraging grey correlation analysis and expert knowledge reduces reliance on large samples, offering a panoramic view of attribute relationships across units and improving process transparency. Finally, the IQPD framework integrates into a Human-Cyber-Physical system, enabling faster decision-making and real-time quality adjustments for Tong Ren Tang's Niuhuang Qingxin Pills, a product with annual sales exceeding 100 million CNY. This facilitates the transition from experience-driven to data-driven manufacturing.
5.Analysis of Dengue virus nucleic acid testing screening among blood donors in Xishuangbanna Dai Autonomous Prefecture, China
Xinru LIU ; Shaofang LU ; Ying YAN ; Jing DONG ; Ji WU ; Jie MA ; Le CHANG ; Huimin JI ; Huizhen SUN ; Mingwen DENG ; Xiaoqian GAO ; Lunan WANG
Chinese Journal of Blood Transfusion 2025;38(12):1662-1668
Objective: To investigate the prevalence of Dengue virus (DENV) infection among voluntary blood donors in Xishuangbanna Dai Autonomous Prefecture, and to evaluate the necessity of implementing nucleic acid testing (NAT) for blood donors during the rainy season (May-October). Methods: Prior to initiating donor screening, the Xishuangbanna Central Blood Center conducted in-house validation of reagent performance and participated in external quality assessment (EQA) organized by the National Center for Clinical Laboratories (NCCL). During the surveillance period (August-October 2024), a total of 2 919 donor samples were screened using a 6-sample mini-pool NAT strategy. Daily internal quality controls were recorded. Samples that tested positive in pooled screening were deconvoluted and retested in duplicate; only those reactive in both replicate wells were sent to the NCCL for confirmatory testing. At NCCL, samples underwent re-testing using five domestic NAT reagents, as well as serological assays for NS1 antigen and DENV-specific IgG/IgM. Confirmed positive samples were further characterized by serotyping, envelope (E) gene sequencing, and phylogenetic analysis using the maximum likelihood method. Results: The DENV NAT reagent demonstrated consistent detection of 40 copies/mL controls in individual donor (ID)-NAT test (mean CT: 35.61±0.40). During the 63-day quality control monitoring, DENV detection remained stable (mean CT: 22.53±0.72). The center achieved full marks in EQA assessments for 2023 and 2024. Three reactive pools were identified in initial screening, and subsequent individual testing confirmed three DENV RNA-positive donors (sample numbers: 2401, 2402, and 2403). The confirmatory test results from NCCL were: all five NAT platforms consistently detected DENV RNA in the three samples; for serological tests, 2 samples (2402, 2403) were positive for NS1 antigen, while all three samples were negative for both IgG and IgM antibodies. DENV serotyping reagents identified DENV-2 in all cases, which were further confirmed as DENV-2 Genotype Ⅱ-Cosmopolitan by E gene sequencing. Phylogenetic analysis indicated that samples 2401 and 2402 clustered with Southeast Asian strains (Thailand/MZ636802.1, Laos/PQ775621.1), while sample 2403 closely matched a previously reported local Yunnan strain (PV544686.1). Conclusion: DENV-2 infection was detected among blood donors in Xishuangbanna during the rainy season, indicating concurrent risks of imported and local transmission. We recommend implementing pooled NAT screening for blood donors in high-risk areas during dengue epidemic seasons, along with strengthened laboratory quality control, to enhance blood safety.
6.Clinicopathological features and surgical methods of solitary papillary thyroid isthmus carcinoma
Jinxin ZHU ; Jia LIU ; Deqian WU ; Huimin QU ; Junli HAO
Chinese Journal of Endocrine Surgery 2024;18(5):685-690
Objective:To analyze the clinicopathological features of solitary papillary thyroid isthmus carcinoma (SPTIC) and the therapeutic effect and prognosis of different surgical methods.Methods:A total of 161 patients with SPTIC who underwent surgical treatment in the Department of Thyroid Surgery of the First Hospital of Jilin University from Dec. 2012 to Oct. 2021 were selected. Gender, age, body mass index and pathology of the patients were collected and the clinicopathological characteristics of SPTIC were analyzed. They were divided into three groups according to different surgical methods: group A underwent isthmic excision, group B underwent extended isthmic excision, and group C underwent total thyroidectomy. There were 47 patients in group A (8 males and 39 females with an average age of 42.6±9.1 years), 50 patients in group B (11 males and 39 females with an average age of 45.3±11.3 years), and 64 patients in group C (10 males and 54 females with an average age of 46.9±11.4 years). The clinicopathological features and therapeutic effect of the three groups were compared by ANOVA, multiple local rank sum test, χ2 test or Fisher's exact probability method, and the recurrence rate and recurrence free survival (RFS) of the three groups were compared after a follow-up of 6 to 126 months. Results:Among the 161 patients with SPTIC, 132 (82.0%) were female, 130 (80.7%) were younger than 55 years old, BMI (25.1±3.6) kg/m 2, 124 (77.0%) were combined with capsule invasion. There were 53 cases (32.9%) with central lymph node metastasis (CLNM). Subgroup analysis showed that the proportion of males in patients with tumor diameter > 1 cm, the proportion of patients with BMI≥26.0 kg/m 2, the rate of capsular invasion, the rate of extrandular invasion and the rate of CLNM were higher (30.0% vs. 14.0%, P=0.023; 60.0% vs. 33.9%, P=0.004; 97.5% vs. 70.2%, P< 0.001; 42.5% vs. 9.9%, P<0.001; 50.0% vs. 27.3%, P=0.008) ; The CLNM rate was higher in male patients with BMI≥26.0 kg/m 2 and tumor diameter > 1 cm (28.3% vs. 13.0%, P=0.017; 52.8% vs. 34.3%, P=0.024; 37.7% vs. 18.5%, P=0.008). Compared with groups A and B, group C had longer hospitalization days, higher hospitalization costs, longer operation time, more postoperative drainage flow and higher incidence of postoperative hypoparathyroidism, and the differences were statistically significant (all P< 0.05). Groups A and B were similar in all aspects, with no statistical significance ( P> 0.05 for all). During the follow-up, 3 patients in both group A and B relapsed, while no patients in group C relapsed, and there were no statistically significant differences in the recurrence rate ( P=0.059) or RFS ( P=0.082) among the three groups. Conclusions:The majority of SPTIC were microcarcinomas, but the incidence of tumor combined with capsule invasion was higher, and the tumor size of more than 1 cm was more invasive (capsule invasion rate and extrathyroid invasion rate were higher). SPTIC should be treated as conservatively as possible (isthmic excision or enlarged isthmic excision) .
7.Study of imaging characteristics of Kimura disease in the head and neck
Rui LUO ; Gongxin YANG ; Huimin SHI ; Yongshun HAN ; Yining HE ; Zhen TIAN ; Yingwei WU
Journal of Shanghai Jiaotong University(Medical Science) 2024;44(9):1182-1189
Objective·To investigate the imaging features of computed tomography(CT)and magnetic resonance imaging(MRI)in the patients with Kimura disease(KD)in the head and neck.Methods·Sixty-four cases of KD in the head and neck comfirmed by histopathology were retrospectively collected from 2009 to 2023 in Shanghai Ninth People's Hospital,Shanghai Jiao Tong University School of Medicine.All patients completed CT and/or MRI enhancement imaging before surgery.Clinical and imaging characteristics were collected,recorded and analyzed,including age,gender,peripheral blood eosinophilic ratio,serum IgE level,the lesion location,shape,size,CT density and degree of enhancement,MRI signal intensity and degree of enhancement,apparent diffusion coefficient(ADC),time-signal intensity curve(TIC)patterns,wash-in rate,and time to peak(TTP).Results·The average age of the 64 KD patients was(40±19)years,and 92.2%were males.A total of 73.5%of the patients showed an elevated ratio of peripheral blood eosinophil,and all 10 tested patients exhibited increased serum IgE levels.There were 82 extranodal(subcutaneous and glandular)lesions and 144 lymph node lesions detected by CT and MRI.Among the extranodal lesions,80.5%were subcutaneous or glandular patchy lesions with unclear boundaries,and the rest were nodular lesions with clear boundaries.All lesions exhibited isodensity on CT scans and showed isointensity on T1-weighted imaging(T1WI)and hyperintensity on T2-weighted imaging(T2WI)in MRI.Most extranodal lesions tended to show heterogeneous enhancement,while most lymph node lesions showed homogeneous enhancement.The median ADCs of the extranodal lesions and the lymph node lesions were 1.04×10-3 mm2/s and 0.67×10-3 mm2/s,respectively,which were significantly different(P=0.000).The dynamic contrast-enhanced magnetic resonance imaging(DCE-MRI)results showed that the TIC patterns of extranodal lesions were predominantly type Ⅰ andⅡ,accounting for 57.5%and 42.5%,respectively;while the TIC patterns of lymph node lesions were predominantly type Ⅱ(96.6%).The difference in the TTP and the wash-in rate between the extranodal lesions and the lymph node lesions were both statistically significant(P=0.000).Conclusion·Extranodal lesions and lymph node lesions of KD both show isodensity on CT,and isointensity on T1WI and hyperintensity on T2WI in MRI.Extranodal lesions often show high ADC,TIC type Ⅰ or Ⅱ,and mostly heterogeneous enhancement;lymph node lesions often show low ADC,TIC type Ⅱ,and mostly homogenous enhancement.
8.The GABAergic projections from the dorsal raphe nucleus to lateral habenula regulates anxiety-like behaviors in mice
Huimin WU ; Xiaoyu GUO ; Bingqing LI ; Dan WANG ; Hailong DONG
Chinese Journal of Neuroanatomy 2024;40(2):179-186
Objective:Combined retrograde tracing with optogenetic methods,we are investigating the functional role of dorsal raphe nucleus(DRN)GABAergic neurons projecting to lateral habenula(LHb)terminals in anxiety-like behaviors.Methods:The specific retrograde tracing virus AAVretro-Ef1α-DIO-mCherry was injected into the LHb of Vgat-Cre mice.After the viral expression,Multi-brain slides scanning microscope imaging scan and observe the up-stream distribution of GABAergic neural projection in LHb.By retrograde tracing,opto-activated virus AAV2/9-Ef1a-DIO-ChR2-mCherry(ChR2 group)and control virus AAV2/9-Ef1a-DIO-mCherry(mCherry group)were injected into the DRN of Vgat-cre mice respectively.Three weeks after virus expression,DRNGABA neurons and the DRNCABA-LHb neural terminals were activated by optogenetic to observe their role in anxiety-like behaviors.Results:According to the results of retrograde tracing,the midbrain DRN is one of the major GABAergic neural projection brain areas in the LHb nucleus.Optogenetic stimulation of DRNGABA neurons,compared with the mCherry group,the ChR2 group showed sig-nificantly longer total moving distance,central area moving time and distance in the open field test(OFT);In the ele-vated plus maze(EPM),the open arm moving time and distance was significantly increased.When DRN GABA-LHb neural terminals were stimulated,compared with the mCherry group,the ChR2 group showed a significantly longer cen-tral zone moving time,distance and total moving distance in the OFT.During the elevated plus maze(EPM),the open arm moving time was significantly increased.Conclusion:The specific activation of the DRNGABA neuron as well as the DRNGABA-LHb neural projections showed that both significantly improved anxiety-like behaviors in mice.This provides new ideas and evidence for the treatment of anxiety,depression and other psychiatric disorders.
9.HLA-B27 positive spinal arthritis-related eye disease
Chinese Journal of Experimental Ophthalmology 2024;42(8):780-784
Spondyloarthritis (SpA), an inflammatory rheumatic disease, is closely associated with human leukocyte antigen B27 (HLA-B27), which can affect the sacroiliac joints, spine, peripheral joints, and periarticular entheses, and is often accompanied by multisystem involvement beyond the joints.Ocular manifestations are common extra-articular features in HLA-B27 positive SpA, with prevalent acute anterior uveitis, and other ocular diseases such as episcleritis, scleritis, conjunctivitis, keratitis and so on.The etiology and pathogenesis of ocular complications in HLA-B27 positive SpA are not fully understood.Current research suggests that genetic susceptibility, alterations in gut microbiota, and cytokine imbalances might play significant roles.This review summarizes the pathogenesis, epidemiology, clinical characteristics, and treatment of ocular diseases associated with HLA-B27 positive SpA.
10.Preparation,Quality Standard and Preliminary Activity of Paclitaxel/Natural Borneol Compound Submicroemulsion
Xiaoling YE ; Hua NIE ; Bingming GU ; Xiaomin LIU ; Huimin WU ; Xiaoru YANG ; Jiawei TAN ; Junya XU
Herald of Medicine 2024;43(6):949-956
Objective To prepare paclitaxel-natural borneol complex,and to explore the prescription and preparation process of paclitaxel-natural borneol complex drug-loaded submicroemulsion,and its in vitro anti-tumor effect.Methods The Paclitaxel-natural borneol complex was prepared by grinding method and identified by Fourier Transform infrared spectroscopy(FT-IR)and differential scanning calorimetry(DSC).The compound drug-loaded submicroemulsion was prepared using a two-step high-pressure emulsification method.The single-factor investigation and the orthogonal experimental design were applied to optimize the formulation and preparation process.MTT assay,cell cloning assay,and cell scratch assay were used to evaluate the effect of this preparation on HCT-116 cells.Results The infrared spectral absorption peaks of taxol-natural borneol complex at 3 312.76 cm-1 and 3 513.92 cm-1 disappeared,and DSC analysis showed that a new absorption peak of taxol-natural borneol complex appeared at 154.56 ℃,indicating that taxol be coupled with natural borneol to form a new complex.The optimal prescription was 0.44%active pharmaceutical ingredient[paclitaxel-natural borneol(1∶3)],10%medium chain triglyceride,3%emulsifier[egg yolk lecithin-Poloxam 188(1∶2)],2%glycerol,0.3%oleate.The optimal process was emulsification at 80 ℃,60 MPa high pressure homogenization 10 times.The half inhibitory concentration(IC50)was 0.75 μg·mL-1 by MTT asssy in cell.In the cell cloning assay,the scratch healing area of blank control group,paclitaxel raw material and paclitaxel/natural borneol submicroemulsion were(36.44±3.35)%,(13.59±9.28)%,(8.30±4.09)%,respectively.The results were statistically significant(P<0.05).In the plate cloning experiment,the cell cloning rates of blank control group,paclitaxel bulk drug group and submicroemulsion group were(37.92±0.729)%,(9.16±1.335)%and(3.36±1.065)%,respectively,the differents were statistically significant(P<0.05).Conclusion This submicroemulsion has reasonable prescription,feasible process and good stability.Cell experiments showed that the submicronemulision effectively inhibits the proliferation and migration of HCT-116 cells,suggesting its potential as a promising antitumor agent.

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