1.Establishment of a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection
Rong WU ; Liping WANG ; Jinye LANG ; Yue ZHU ; Jing ZHOU ; Xun LIU ; Jing NI ; Shunbo ZHOU ; Yaling DING
Chinese Journal of Blood Transfusion 2025;38(3):415-420
[Objective] To establish a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection. [Methods] By adding the sample and factor Ⅶ deficient plasma to the sample cup and activating the reaction with prothrombin time assay reagent (PT reagent), the coagulation time of the sample was determined by the change in magnetic bead swing amplitude in the sample cup. The logarithm of coagulation time was inversely proportional to the logarithm of human factor Ⅶa potency. [Results] Under the experimental conditions, the specificity of the methodology was evaluated through spiked recovery, and the recovery rates ranged from 90.0% to 110.0%. Within the range from 0.125 to 1.000 IU/mL, there was a good linear response between the potency and coagulation time of the standard and sample, with correlation coefficients r>0.99. As for the accuracy and repeatability, the recovery rates of various concentrations detected in the stock solution were 101.0%, 100.0% and 112.0%, respectively, with RSD values of 2.6%, 4.0% and 0.0%, respectively. The recovery rates of various concentrations in finished product testing were 104.0%, 94.7% and 112.0%, respectively, with RSD values of 1.9%, 2.4% and 0.0%, respectively. As for the intermediate precision, the RSD were 4.5% and 3.7%, respectively. After treated with sample diluent, the sample was tested at room temperature for 6 hours and still exhibited relatively stable biological activity. [Conclusion] This detection method is accurate, stable, easy to operate and highly automated, and is suitable for detecting the potency of recombinant human coagulation factor Ⅶa for Injection.
2.Study on HPLC fingerprint and quantitative analysis of multi-components by single-marker content determination method for Shechuan naolitong granules
Xiaoyan ZHANG ; Kairu DING ; Hong ZHANG ; Wenbing ZHI ; Shengnan JIANG ; Zongren XU ; Ni CUI ; Xiangfeng WEI ; Yang LIU
China Pharmacy 2025;36(19):2409-2414
OBJECTIVE To provide a reference for optimizing and promoting the quality standards of Shechuan naolitong granules. METHODS Fifteen batches of Shechuan naolitong granules were used as samples to establish HPLC fingerprints using the Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine (2012 edition). Similarity evaluation and common peak identification were performed, and orthogonal partial least squares discriminant analysis (OPLS-DA) was used to assess quality differences among different batches and to screen quality differential components. Using salvianolic acid B(SAB) as the internal reference, quantitative analysis of multi-components by single-marker (QAMS) was developed to simultaneously determine geniposidic acid (GA), chlorogenic acid (CA), vaccarin (VA), ferulic acid (FA) and senkyunolide I (SI). The results were compared with those obtained by the external standard method. RESULTS A total of 13 common peaks were identified in the HPLC fingerprints of 15 batches of samples, and the similarities of the spectra were all above 0.96. Seven chromatographic peaks were identified as GA (peak 3), CA (peak 6), VA (peak 8), FA (peak 9), SI (peak 11), SAB(peak 12) and TA(peak 13). OPLS-DA indicated that the differential quality markers among 15 batches were peaks 5, 11 (SI), and 12 (SAB).Using SAB as the internal reference, the relative correction factors for GA, CA, VA, FA and SI were calculated as 1.058 4, 0.594 3, 0.643 3, 0.342 7 and 0.262 8, respectively. The mean content of GA, CA, VA, FA, SI and SAB across the 15 batches of samples were 0.155 0, 0.085 4, 0.140 3, 0.071 8, 0.072 7, 1.276 3 mg/g, respectively, showing no significant difference compared with the ESM (P>0.05). CONCLUSIONS The established HPLC fingerprint and QAMS are simple, efficient and economical, providing a reference for the quality control and further development of Shechuan naolitong granules.
3.Comparison and study of multiple scales results in children with cochlear reimplantation, mainly the speech, spatial, and other qualities of hearing scale for parents.
Tian NI ; Jinyuan SI ; Haotian LIU ; Xinyi YAO ; Xiangling ZHANG ; Huilin YIN ; Lin ZHANG ; Xiuyong DING ; Yu ZHAO
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(5):433-442
Objective:To compare the outcomes of multiple scales, primarily the speech, spatial, and other qualities of hearing scale for parents(SSQ-P), in children with ipsilateral vs. Contralateral cochleareimplantat ion(CRI). Methods: A total of 69 children who received cochlear implantation surgery from April 1999 to June 2024 were included. Patients were divided into two groups based on whether the implantation was on the same side. General information such as gender, age, age at initial implantation and reimplantation was collected. The primary caregivers of the children were followed up by telephone using the categories of auditory performance(CAP), speech intelligibility rating(SIR), and SSQ-P questionnaires. Statistical methods including stepwise regression, linear regression, and permutation tests were employed to investigate if there were any statistically significant differences in the scores of CAP, SIR, SSQ-P total, SSQ-P speech perception, SSQ-P spatial hearing, and SSQ-P auditory quality dimensions between the ipsilateral and contralateral reimplantation groups. Results:Of the 69 children included, 62 were in the ipsilateral reimplantation group with a mean age of 11.1 years, and 7 were in the contralateral reimplantation group with a mean age of 11.7 years. Statistical analysis showed that patients in the contralateral reimplantation group had significantly lower SSQ-P total scores (P<0.05) and spatial hearing dimension scores (P<0.05) than those in the ipsilateral reimplantation group after controlling for the corresponding confounders. Conclusion:The effect of ipsilateral reimplantation of cochlear implants is superior to that of contralateral reimplantation in terms of overall auditory function and spatial hearing in daily life for children, but the mechanisms require further investigation.
Humans
;
Cochlear Implantation
;
Child
;
Parents
;
Speech Perception
;
Male
;
Cochlear Implants
;
Female
;
Hearing
;
Surveys and Questionnaires
;
Speech
;
Child, Preschool
4.Cancer-Associated Fibroblasts Interact with Schwann Cells for Tumor Perineural Invasion by Oral Squamous Cell Carcinoma.
Xinwen ZHANG ; Yijia HE ; Shixin XIE ; Yuxian SONG ; Xiaofeng HUANG ; Qingang HU ; Yanhong NI ; Yi WANG ; Yong FU ; Liang DING
Neuroscience Bulletin 2025;41(6):1003-1020
Perineural invasion (PNI) by tumor cells is a key phenotype of highly-invasive oral squamous cell carcinoma (OSCC). Since Schwann cells (SCs) and fibroblasts maintain the physiological homeostasis of the peripheral nervous system, and we have focused on cancer-associated fibroblasts (CAFs) for decades, it's imperative to elucidate the impact of CAFs on SCs in PNI+ OSCCs. We describe a disease progression-driven shift of PNI- towards PNI+ during the progression of early-stage OSCC (31%, n = 125) to late-stage OSCC (53%, n = 97), characterized by abundant CAFs and nerve demyelination. CAFs inhibited SC proliferation/migration and reduced neurotrophic factors and myelin in vitro, and this involved up-regulated ER stress and decreased MAPK signals. Moreover, CAFs also aggravated the paralysis of the hind limb and PNI in vivo. Unexpectedly, leukemia inhibitory factor (LIF) was exclusively expressed on CAFs and up-regulated in metastatic OSCC. The LIF inhibitor EC330 restored CAF-induced SC inactivation. Thus, OSCC-derived CAFs inactivate SCs to aggravate nerve injury and PNI development.
Schwann Cells/metabolism*
;
Mouth Neoplasms/metabolism*
;
Humans
;
Cancer-Associated Fibroblasts/metabolism*
;
Animals
;
Carcinoma, Squamous Cell/metabolism*
;
Neoplasm Invasiveness/pathology*
;
Male
;
Female
;
Mice
;
Cell Movement/physiology*
;
Cell Proliferation/physiology*
;
Cell Line, Tumor
;
Leukemia Inhibitory Factor/metabolism*
;
Middle Aged
5.Diagnostic value of HPV-DNA typing combined with serum NLR and DCLK1 for cervical cancer
Hongmiao NI ; Hui ZENG ; Lisheng DING
China Modern Doctor 2024;62(8):12-16
Objective To investigate the value of receiver operating curve human papilloma virus(HPV)-DNA typing combined with serum neutrophil lymphocyte ratio(NLR)and bicorticoid kinase 1(DCLK1)levels in the early diagnosis of cervical cancer.Methods A total of 120 patients with early cervical cancer diagnosed in our obstetrics and gynecology department from August 2018 to June 2022 were randomly included as cervical cancer group,and 120 patients with benign lesions were included as benign group.The level of DCLK1 was detected by ELISA;NLR was detected by automatic blood cell analyzer;HPV subtypes in cervical secretions were detected by HPV genotyping gene chip detection system;the cut-off values of serum NLR and DCLK1 levels in the diagnosis of cervical cancer were analyzed by using the receiver operator curve(ROC);four table method was applied to analyze the diagnostic value of HPV-DNA typing,serum NLR,DCLK1 levels alone and in combination for cervical cancer.Results Compared with benign group,the levels of serum NLR and DCLK1 in cervical cancer group were obviously higher(P<0.05).The positive rate of HR-HPV in cervical cancer group was obviously higher than that in benign group(P<0.05).The ROC curve was drawn with serum NLR and DCLK1 levels as test variables,the results showed that the AUC of serum NLR and DCLK1 predicting early cervical cancer was 0.724 and 0.718,respectively,and the cut-off value was 3.08 and 3.32,respectively.HPV-DNA typing combined with serum NLR and DCLK1 detected 18 false positives and 17 false negatives,Kappa value was 0.725,which was consistent with pathological results.The sensitivity,negative predictive value and accuracy of HPV-DNA typing combined with serum NLR and DCLK1 levels in the diagnosis of early cervical cancer were obviously higher than those of HPV-DNA typing,serum NLR and DCLK1 levels alone(P<0.05).Conclusion The results of HPV-DNA typing combined with NLR and DCLK1 in the diagnosis of early cervical cancer are highly consistent with the pathological results,and the sensitivity and accuracy are obviously improved.
6.Application of pneumoperitoneum-free single-hole endoscopy com-bined with ropivacaine in pregnancy with ovarian tumor
Chengcheng ZHU ; Yonghong LUO ; Jin DING ; Huixian CHENG ; Guantai NI
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(5):561-568
AIM:To evaluate the clinical efficacy and safety of pneumoperitoneum-free single-hole endoscopy combined with ropivacaine local infiltra-tion anesthesia in pregnancy with ovarian tumor.METHODS:Twenty-eight pregnant women with ovarian tumor were randomly divided into two groups:observation group(n=16)and control group(n=12).The first time out of bed,ventilation time,postoperative hospital stay,non-invasive blood pressure,heart rate(HR),respiratory fre-quency(RR)and blood oxygen saturation(SpO2)were compared between the two groups.Pain score,Ramsay sedation score,SAS anxiety score,postoperative complications,patient satisfaction and recovery quality scale QoR15 were evaluated at 6,24 and 48 hours after operation.RESULTS:There was no significant difference in postopera-tive hospital stay,Ramsay score,RR,SpO2 and the incidence of complications between the two groups(P>0.05),but the time of getting out of bed and ventilation time were shortened,the scores of non-invasive blood pressure,HR,pain and anxiety in the observation group were lower than those in the control group,and the scores of patient satisfac-tion and QoR15 in the observation group were bet-ter than those in the control group(P<0.05).CON-CLUSION:The application of pneumoperitoneum-free single-hole endoscope combined with ropiva-caine local infiltration anesthesia in pregnancy with ovarian tumor can reach satisfactory clinical re-sults,including reducing postoperative pain and anxiety,which is worth popularizing.
7.Effects of gastrodin on the expression of BDNF and IL-6 in the stria-tum of rats with cerebral ischemia
Min LIU ; Yanxia DING ; Yegui ZHANG ; Cuicui CHAN ; Rujie GONG ; Jingzhong NI
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(4):440-446
AIM:To investigate the effect of gastro-din on the expression of brain-derived neurotroph-ic factor(BDNF)and interleukin-6(IL-6)in the stria-tum of cerebral ischemia rats,and to explore the potential mechanism of gastrodin in treating cere-bral ischemia.METHODS:The rats were randomly divided into four groups:normal,sham,model,and gastrodin groups,each consisting of 10 rats.After successful modeling using middle cerebral artery occlusion(MCAO),the gastrodin group received in-traperitoneal injection of gastrodin injection at a dose of 10 mg/kg once a day for 14 consecutive days.Pathological changes in striatal neurons were observed using Nissl staining.Immunohistochemis-try was utilized to detect positive expression of BDNF and IL-6 proteins in the striatum.Additional-ly,immunoblot analysis was performed to deter-mine the expression levels of BDNF and IL-6 pro-teins in the striatum.RESULTS:Nissl staining re-vealed clear and intact structures of striatal neu-rons in the normal and sham groups,with tightly arranged cells.In the model group,the number of cells was significantly reduced compared to the sham group(P<0.01),and there was a noticeable cytosolic atrophy and loose cell arrangement.The gastrodin group showed a significant increase in the number of Nissl-positive neurons compared to the model group(P<0.01),and there was also a sig-nificant improvement in cell morphology.The re-sults of immunohistochemistry and immunoblot were consistent,and there was no statistically sig-nificant difference in BDNF and IL-6 protein expres-sion between the normal group and the sham group(P>0.05).Compared to the sham group,the model group showed a decrease in the protein ex-pression level of BDNF in the striatum on the isch-emic side(P<0.01)and an increase in the protein expression level of IL-6(P<0.05,P<0.01).In con-trast,the gastrodin group showed an increase in the protein expression level of BDNF in the stria-tum on the ischemic side(P<0.05,P<0.01)and a decrease in the protein expression level of IL-6(P<0.05,P<0.01)compared to the model group.CON-CLUSION:Gastrodin has a significant protective ef-fect on striatal injury caused by cerebral ischemia,and its mechanism may be related to the up-regula-tion of the anti-inflammatory factor BDNF and the down-regulation of the pro-inflammatory factor IL-6.
8.Effects of gastrodin on the expression of BDNF and IL-6 in the stria-tum of rats with cerebral ischemia
Min LIU ; Yanxia DING ; Yegui ZHANG ; Cuicui CHAN ; Rujie GONG ; Jingzhong NI
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(4):440-446
AIM:To investigate the effect of gastro-din on the expression of brain-derived neurotroph-ic factor(BDNF)and interleukin-6(IL-6)in the stria-tum of cerebral ischemia rats,and to explore the potential mechanism of gastrodin in treating cere-bral ischemia.METHODS:The rats were randomly divided into four groups:normal,sham,model,and gastrodin groups,each consisting of 10 rats.After successful modeling using middle cerebral artery occlusion(MCAO),the gastrodin group received in-traperitoneal injection of gastrodin injection at a dose of 10 mg/kg once a day for 14 consecutive days.Pathological changes in striatal neurons were observed using Nissl staining.Immunohistochemis-try was utilized to detect positive expression of BDNF and IL-6 proteins in the striatum.Additional-ly,immunoblot analysis was performed to deter-mine the expression levels of BDNF and IL-6 pro-teins in the striatum.RESULTS:Nissl staining re-vealed clear and intact structures of striatal neu-rons in the normal and sham groups,with tightly arranged cells.In the model group,the number of cells was significantly reduced compared to the sham group(P<0.01),and there was a noticeable cytosolic atrophy and loose cell arrangement.The gastrodin group showed a significant increase in the number of Nissl-positive neurons compared to the model group(P<0.01),and there was also a sig-nificant improvement in cell morphology.The re-sults of immunohistochemistry and immunoblot were consistent,and there was no statistically sig-nificant difference in BDNF and IL-6 protein expres-sion between the normal group and the sham group(P>0.05).Compared to the sham group,the model group showed a decrease in the protein ex-pression level of BDNF in the striatum on the isch-emic side(P<0.01)and an increase in the protein expression level of IL-6(P<0.05,P<0.01).In con-trast,the gastrodin group showed an increase in the protein expression level of BDNF in the stria-tum on the ischemic side(P<0.05,P<0.01)and a decrease in the protein expression level of IL-6(P<0.05,P<0.01)compared to the model group.CON-CLUSION:Gastrodin has a significant protective ef-fect on striatal injury caused by cerebral ischemia,and its mechanism may be related to the up-regula-tion of the anti-inflammatory factor BDNF and the down-regulation of the pro-inflammatory factor IL-6.
9.Effects of gastrodin on the expression of BDNF and IL-6 in the stria-tum of rats with cerebral ischemia
Min LIU ; Yanxia DING ; Yegui ZHANG ; Cuicui CHAN ; Rujie GONG ; Jingzhong NI
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(4):440-446
AIM:To investigate the effect of gastro-din on the expression of brain-derived neurotroph-ic factor(BDNF)and interleukin-6(IL-6)in the stria-tum of cerebral ischemia rats,and to explore the potential mechanism of gastrodin in treating cere-bral ischemia.METHODS:The rats were randomly divided into four groups:normal,sham,model,and gastrodin groups,each consisting of 10 rats.After successful modeling using middle cerebral artery occlusion(MCAO),the gastrodin group received in-traperitoneal injection of gastrodin injection at a dose of 10 mg/kg once a day for 14 consecutive days.Pathological changes in striatal neurons were observed using Nissl staining.Immunohistochemis-try was utilized to detect positive expression of BDNF and IL-6 proteins in the striatum.Additional-ly,immunoblot analysis was performed to deter-mine the expression levels of BDNF and IL-6 pro-teins in the striatum.RESULTS:Nissl staining re-vealed clear and intact structures of striatal neu-rons in the normal and sham groups,with tightly arranged cells.In the model group,the number of cells was significantly reduced compared to the sham group(P<0.01),and there was a noticeable cytosolic atrophy and loose cell arrangement.The gastrodin group showed a significant increase in the number of Nissl-positive neurons compared to the model group(P<0.01),and there was also a sig-nificant improvement in cell morphology.The re-sults of immunohistochemistry and immunoblot were consistent,and there was no statistically sig-nificant difference in BDNF and IL-6 protein expres-sion between the normal group and the sham group(P>0.05).Compared to the sham group,the model group showed a decrease in the protein ex-pression level of BDNF in the striatum on the isch-emic side(P<0.01)and an increase in the protein expression level of IL-6(P<0.05,P<0.01).In con-trast,the gastrodin group showed an increase in the protein expression level of BDNF in the stria-tum on the ischemic side(P<0.05,P<0.01)and a decrease in the protein expression level of IL-6(P<0.05,P<0.01)compared to the model group.CON-CLUSION:Gastrodin has a significant protective ef-fect on striatal injury caused by cerebral ischemia,and its mechanism may be related to the up-regula-tion of the anti-inflammatory factor BDNF and the down-regulation of the pro-inflammatory factor IL-6.
10.Effects of gastrodin on the expression of BDNF and IL-6 in the stria-tum of rats with cerebral ischemia
Min LIU ; Yanxia DING ; Yegui ZHANG ; Cuicui CHAN ; Rujie GONG ; Jingzhong NI
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(4):440-446
AIM:To investigate the effect of gastro-din on the expression of brain-derived neurotroph-ic factor(BDNF)and interleukin-6(IL-6)in the stria-tum of cerebral ischemia rats,and to explore the potential mechanism of gastrodin in treating cere-bral ischemia.METHODS:The rats were randomly divided into four groups:normal,sham,model,and gastrodin groups,each consisting of 10 rats.After successful modeling using middle cerebral artery occlusion(MCAO),the gastrodin group received in-traperitoneal injection of gastrodin injection at a dose of 10 mg/kg once a day for 14 consecutive days.Pathological changes in striatal neurons were observed using Nissl staining.Immunohistochemis-try was utilized to detect positive expression of BDNF and IL-6 proteins in the striatum.Additional-ly,immunoblot analysis was performed to deter-mine the expression levels of BDNF and IL-6 pro-teins in the striatum.RESULTS:Nissl staining re-vealed clear and intact structures of striatal neu-rons in the normal and sham groups,with tightly arranged cells.In the model group,the number of cells was significantly reduced compared to the sham group(P<0.01),and there was a noticeable cytosolic atrophy and loose cell arrangement.The gastrodin group showed a significant increase in the number of Nissl-positive neurons compared to the model group(P<0.01),and there was also a sig-nificant improvement in cell morphology.The re-sults of immunohistochemistry and immunoblot were consistent,and there was no statistically sig-nificant difference in BDNF and IL-6 protein expres-sion between the normal group and the sham group(P>0.05).Compared to the sham group,the model group showed a decrease in the protein ex-pression level of BDNF in the striatum on the isch-emic side(P<0.01)and an increase in the protein expression level of IL-6(P<0.05,P<0.01).In con-trast,the gastrodin group showed an increase in the protein expression level of BDNF in the stria-tum on the ischemic side(P<0.05,P<0.01)and a decrease in the protein expression level of IL-6(P<0.05,P<0.01)compared to the model group.CON-CLUSION:Gastrodin has a significant protective ef-fect on striatal injury caused by cerebral ischemia,and its mechanism may be related to the up-regula-tion of the anti-inflammatory factor BDNF and the down-regulation of the pro-inflammatory factor IL-6.

Result Analysis
Print
Save
E-mail