1.Comparison of SEC-RI-MALLS and SEC-RID methods for determining molecular weight and molecular weight distribution of PLGA
WANG Baocheng ; ZHANG Xiaoyan ; ZHOU Xiaohua ; ZHAO Xun ; MA Congyu ; GAO Zhengsong ; SHI Haiwei ; YUAN Yaozuo ; HANG Taijun
Drug Standards of China 2025;26(1):110-116
Objective: To establish a method for determining the molecular weight and molecular weight distribution of Poly(Lactide-co-Glycolide Acid) (PLGA) using Size Exclusion Chromatography-Refractive Index-Multiangle Laser Light Scattering (SEC-RI-MALLS) and Size Exclusion Chromatography-Refractive Index (SEC-RID), and to compare the results obtained from these two methods.
Methods: For SEC-RI-MALLS, tetrahydrofuran was used as the mobile phase, Shodex GPC KF-803L was employed as the chromatographic column with a flow rate of 1 mL·min-1, column temperature at 30 ℃, and an injection volume of 100 μL. For SEC-RID, tetrahydrofuran was also used as the mobile phase, Agilent PLgel 5 μm MIXD-D was used as the chromatographic column with a flow rate of 1 mL·min-1, column temperature at 30 ℃, differential detector temperature at 35 ℃, and an injection volume of 20 μL. The molecular weight and molecular weight distribution were calculated using Agilent’s GPC software. The newly established methods were validated methodologically, and the molecular weight and molecular weight distribution of 13 batches of samples were determined.
Results: The precision, accuracy, stability, and repeatability tests for SEC-RI-MALLS showed RSD values of 1.35%, 1.58%, 1.53%, and 1.26%, respectively. The SEC-RID method exhibited good linearity (r=0.999 9), with RSD values for precision, accuracy, stability, and repeatability tests (n=6) of 2.05%, 1.62%, 1.30%, and 2.97%, respectively. The results obtained from SEC-RI-MALLS were lower than those from SEC-RID, and the molecular weight distribution coefficient was smaller, but the results from the paired T-test performed with the value measured by SEC-RID method and the value measured by SEC-RI-MALLS method multiplied a conversion coefficient of 1.5 showed no significant difference between the two methods.
Conclusion: Both methods are stable and reliable, and can be used for the determination of PLGA molecular weight and molecular weight distribution based on the specific situations.
2.Investigation on the rapid determination of lactose content by polarimetry
Haodong ZHAO ; Xiaohua ZHOU ; Xun ZHAO ; Lin ZHU ; Haiwei SHI ; Qing HUANG ; Yaozuo YUAN
Drug Standards of China 2024;25(5):512-516
Objective:To established a rapid method for the determination of lactose(C12 H22 O11)content.Methods:The specific rotation([α]20D)of pure lactose was measured with lactose extract product,and the correc-tion coefficient was calculated.The measured rotatory value of the sample was multiplied by the correction coeffi-cient to obtain the mass(g)of lactose in the test product,and the lactose content was calculated.The equivalence of the newly established polarimetric method and the legal test method(HPLC-RID method)for the determination of lactose content was studied.Results:The linear relation of established method was excellent with the range of 0.05-0.20 g·mL-1(r=1.000 0)and the method also had good reproducibility(RSD=0.07%(n=6)).The lactose content of 141 batches samples measured by polarimetry was compared with the results determined by official analytical procedure,and the results showed the relative deviation between the same batches was less than 1.0%.The results of one-way ANOVA also showed that there was no significant difference between two groups(Sig.>0.05).Conclusion:The performance of polarimetry is comparable to HPLC-RID in the Chinese Pharma-copoeia 2020 Vol Ⅳ.Meanwhile,the polarimetry can reduce the test cost,shorten the test time and meet the requirements of the quality control.
3.Longmu Anshen prescription alleviates anxiety behavior in CRS mice by regulating polarization of microglia in medial prefrontal cortex
Xiaoming PENG ; Xiaohua DING ; Zhenwen ZHANG ; Jianjun ZHAO ; Ke TANG
Chinese Journal of Immunology 2024;40(11):2316-2321,2329
Objective:To investigate the effects of Longmu Anshen prescription on microglia(MG)polarization in the medial prefrontal cortex(mPFC)and anxiety behavior of chronic restraint stress(CRS)mice.Methods:Forty-eight healthy male KM mice were randomly divided into normal group,paroxetine hydrochloride group and Longmu Anshen prescription high,middle and low dose groups.From the 15th day,after 30 minutes of CRS every day,the normal group and the model were given distilled water by gavage,the paroxetine hydrochloride group was given paroxetine hydrochloride(2.6 mg/kg)by gavage,and the traditional Chinese medicine group was given Longmu Anshen prescription at high,medium and low doses(4.16,2.08,1.04 g/kg)by gavage for 21 days.The changes of anxiety behavior in mice were evaluated by light-dark boxes experiment and elevated plus maze;ELISA was used to detect IL-1β,IL-6,TNF-α and IL-10 levels;protein expression of inducible nitric oxide synthase(iNOS)and arginase-1(Arg-1)in mice mPFC tissue were detected by Western blot;mRNA expression of ionized calcium binding adaptor molecule-1(Iba-1),iNOS and Arg-1 in mice mPFC tissue were detected by RT-PCR;the protein expression of Iba-1 in mice hippocampal tissue was detected by immuno-histochemistry(IHC).Results:Compared with normal group,the residence time in the light boxes,the number of times of shuttle between the light-dark boxes,the percentage of times of entering the open arm(OE%)and the percentage of time spent in the open arm(OT%)of mice in model group were significantly reduced(P<0.01);moreover,in the mPFC tissue of the model group mice,the protein and mRNA expressions of Iba-1 and iNOS were significantly increased(P<0.01),and the levels of IL-1β,IL-6 and TNF-α were significantly increased(P<0.01),while the protein and mRNA expressions of Arg-1 were significantly decreased(P<0.01),and the level of IL-10 was significantly decreased(P<0.01).Compared with model group,the residence time in the light boxes,the number of shuttles between the light-dark boxes,the OE%and OT%of mice in the paroxetine hydrochloride group and the high and medium dose groups of Longmu Anshen prescription were significantly increased(P<0.01);the expression levels of Iba-1 and iNOS protein and mRNA in mPFC tissue were significantly decreased(P<0.05,P<0.01),and the levels of IL-1β,IL-6 and TNF-α were significantly decreased(P<0.01),while the expression levels of Arg-1 protein and mRNA were significantly increased(P<0.01).IL-10 level was significantly increased(P<0.01).Conclusion:Longmu Anshen prescription can inhibit the activation of MG in mPFC tissues of CRS mice and may reduce nerve inflammation and increase the level of anti-inflammatory cytokines by regulating the polarization phenotype of M1/M2,thereby ameliorate CRS-induced anxiety behavior.
4.Psychometric properties of the Chinese version of the Pediatric Epilepsy-Specific Health-Related Quality of Life in children aged 5 to 7 years old and their parents
Yiming ZHANG ; Anwei XIE ; Xiaohua WANG ; Li TIAN ; Lu LIN ; Lihua SUN ; Feng MIAO ; Xuan ZHAO
Chinese Journal of Modern Nursing 2024;30(30):4096-4104
Objective:To translate the Pediatric Epilepsy-Specific Health-Related Quality of Life (PedsQL TM Epilepsy Module) into Chinese and test its reliability and validity in children aged 5 to 7 years old and their parents. Methods:Brislin translation model was used for forward translation, back translation, harmonization, and proofreading of the PedsQL TM Epilepsy Module. Chinese version of PedsQL TM Epilepsy Module beta version was developed through cognitive interviews, expert consultations, and pre-surveys for cross-cultural adaptation of the scale. From April to November 2023, convenience sampling was used to select 420 children with epilepsy and their parents admitted to the Children's Hospital of Soochow University as participants for a questionnaire survey to test its reliability and validity. Results:A total of 840 questionnaires were distributed (420 for children and 420 for parents), and 394 valid questionnaires were collected from children and 400 valid questionnaires were collected from parents, and the effective response rates of the questionnaires were 93.81% (394/420) and 95.24% (400/420), respectively. Chinese version of PedsQL TM Epilepsy Module (child report version) included five dimensions and 28 items. Chinese version of PedsQL TM Epilepsy Module (parent agent report version) consisted of five dimensions and 29 items. The content validity indices at the item level were 0.800 to 1.00, while the content validity indices at the scale level were 0.978 and 0.979, respectively. Exploratory factor analysis of two versions of the scale showed that five common factors were extracted, with cumulative variance contribution rates of 64.557% and 75.205%, respectively. Confirmatory factor analysis showed that the models of the two scales fitted well. The total Cronbach's α coefficients of the two scales were 0.906 and 0.914, respectively, with Cronbach's α coefficients for each dimension ranging from 0.869 to 0.991. The total test-retest reliability coefficients of the scale were 0.998 and 0.995, respectively, and the test-retest reliability coefficients of each dimension were 0.803 to 0.995. Conclusions:Chinese version of the PedsQL TM Epilepsy Module has good reliability and validity, and is suitable for evaluating the health-related quality of life of children with epilepsy aged 5 to 7 years old in China.
5.Effect of acute ozone exposure on miRNA expression profile of exosomes in alveolar lavage fluid of rats
Qingcheng YANG ; Jiao ZHAO ; Renxin YANG ; Zhangong YAN ; Zhuge XI ; Xiaohua LIU
Acta Laboratorium Animalis Scientia Sinica 2024;32(7):836-845
Objective To clarify the changes in the microRNA(miRNA)expression profile of rat alveolar lavage-fluid-derived exosomes after acute ozone exposure and analyze its potential relationship with lung injury.Methods Adult male Wistar rats were exposed to 0 ppm,0.5 ppm,and 2 ppm ozone for 6 h in a gas exposure chamber.After 24 h,the rats were anesthetized,the alveolar lavage fluid was collected,and exosomes were extracted.Differentially expressed miRNAs in exosomes were detected by miRNA-seq technology.miRDB databases were used to predict the target genes of the top 10 differentially expressed miRNAs among the groups,and Gene Ontology function enrichment and KEGG Pathway analyses were performed on the target genes.The differentially expressed miRNAs with high expression abundance and good uniformity were verified by quantitative reverse-transcription PCR(qRT-PCR).Results Compared with the findings in the 0 ppm group,there were 8 up-regulated and 55 down-regulated miRNAs in the 0.5 ppm group,and 32 up-regulated and 61 down-regulated miRNAs in the 2 ppm group.Compared with the findings in the 0.5 ppm group,90 exosomal miRNAs were up-regulated and 74 were down-regulated in the 2 ppm group.The target genes of top 10 differentially expressed miRNAs were mainly involved in regulating DNA binding,heterocyclic compound binding,and affecting transcription,and were closely related to cancer,MAPK,PIK3-AKT,TNF,ErbB,mitophagy,and FoxO signaling pathways.The qRT-PCR showed that the sequencing result were basically reliable.Conclusions Acute ozone exposure can lead to changes in the expression profile of exosomal miRNA in the alveolar lavage fluid of rats.Differentially expressed miRNAs may be involved in pathological processes,such as lung tissue inflammation and lung injury,caused by ozone exposure.
6.A review of research advances in virtual reality-based interventions for children with autism
Yu FANG ; Wenhao LIN ; Xiaohua SUN ; Yuan ZHAO ; Liying DONG ; Haidong SONG
Chinese Mental Health Journal 2024;38(5):394-399
This paper analyzes the literature on virtual reality(VR)technology interventions for autistic children published from 2014 to 2022.It shows that different VR systems in these studies have improved different symptoms of autism,and points out the feasibility of VR technology interventions for autistic children.
7.Assessment of the aging phenomenon of the glomerular filtration rate
Xiaohua PEI ; Xue SHEN ; Juan ZHANG ; Yan GU ; Min CHEN ; Yao MA ; Zhenzhu YONG ; Yun BAI ; Qun ZHANG ; Weihong ZHAO
Chinese Journal of Geriatrics 2024;43(6):710-715
Objective:To construct an estimating equation to accurately reflect the aging phenomenon of the glomerular filtration rate(GFR).Methods:Healthy subjects receiving physical examinations at the First Affiliated Hospital of Nanjing Medical University between January 2017 and April 2018 were included in the study, and the aging phenomenon of renal function indicators such as serum creatinine(Scr)was used as the reference standard to evaluate the accuracy of four Scr-based GFR equations during GFR aging, including the full age spectrum(FAS)equation, the Chronic Kidney Disease Epidemiology Collaboration(CKD-EPI)equation, the Osaka equation and the Xiangya equation.Results:Of 37 636 individuals receiving physical examinations, 6 534 met the criteria specified in this study.Scr, serum urea nitrogen, serum uric acid, and serum albumin showed a significant aging phenomenon( H=191.640, 196.693, 83.271, 414.585, P<0.001 for all).The GFR estimated by the four equations all decreased with aging, but the starting point and rate of decline were significantly different.The GFR aging phenomenon estimated by the FAS equation was closer to the trend of renal function indicators. Conclusions:The FAS equation may be more applicable to healthy people to understand the aging phenomenon of GFR.
8.Background, design, and preliminary implementation of China prospective multicenter birth cohort
Si ZHOU ; Liping GUAN ; Hanbo ZHANG ; Wenzhi YANG ; Qiaoling GENG ; Niya ZHOU ; Wenrui ZHAO ; Jia LI ; Zhiguang ZHAO ; Xi PU ; Dan ZHENG ; Hua JIN ; Fei HOU ; Jie GAO ; Wendi WANG ; Xiaohua WANG ; Aiju LIU ; Luming SUN ; Jing YI ; Zhang MAO ; Zhixu QIU ; Shuzhen WU ; Dongqun HUANG ; Xiaohang CHEN ; Fengxiang WEI ; Lianshuai ZHENG ; Xiao YANG ; Jianguo ZHANG ; Zhongjun LI ; Qingsong LIU ; Leilei WANG ; Lijian ZHAO ; Hongbo QI
Chinese Journal of Perinatal Medicine 2024;27(9):750-755
China prospective multicenter birth cohort (Prospective Omics Health Atlas birth cohort, POHA birth cohort) study was officially launched in 2022. This study, in collaboration with 12 participating units, aims to establish a high-quality, multidimensional cohort comprising 20 000 naturally conceived families and assisted reproductive families. The study involves long-term follow-up of parents and offspring, with corresponding biological samples collected at key time points. Through multi-omics testing and analysis, the study aims to conduct multi-omics big data research across the entire maternal and infant life cycle. The goal is to identify new biomarkers for maternal and infant diseases and provide scientific evidence for risk prediction related to maternal diseases and neonatal health.
9.Prenatal ultrasound for diagnosis and classification of hypospadias
Xiaohua LI ; Wei ZHAO ; Aqing LIU
Chinese Journal of Perinatal Medicine 2024;27(9):768-773
Objective:To explore the diagnostic and classification value of prenatal ultrasound for hypospadias.Methods:A retrospective analysis was conducted on fetuses suspected of hypospadias based on prenatal ultrasound, who were treated at the Affiliated Hospital of Jining Medical University from July 2012 to June 2023. Hypospadias was classified as a severe or mild type based on ultrasound images. Postnatal diagnostic conditions of the live-born infants and fetal autopsy findings were obtained, and the diagnostic value and classification consistency of prenatal ultrasound for hypospadias, severe hypospadias, and mild hypospadias were analyzed. Descriptive statistical analysis was used for data analysis.Results:(1) A total of 70 fetuses were included in the study; among them, 64 were singletons (91.4%), and six were twins (8.6%). The maternal age was (31.3±5.1) years, ranging from 21 to 50 years. The gestational age at diagnosis was (29.7±4.5) weeks, ranging from 21 +3 to 39 weeks. Fifteen mothers (21.4%) had a history of early pregnancy preservation (including the six twin pregnancies), nine mothers (12.8%) had previously given birth to fetuses with hypospadias, and four fathers (5.7%) had a history of reproductive surgery (specifics not detailed). Among the 70 cases, 49 (70.0%) were diagnosed with hypospadias after birth and 17 (24.3%) pregnancies were terminated, with a gestational age of (30.2±5.3) weeks, ranging from 26 +4 to 36 weeks. The post-delivery pathological autopsy confirmed hypospadias in all 17 cases, including two isolated hypospadias and 15 combined with other abnormalities. (2) Among the 70 cases, 53 (75.7%) were diagnosed with hypospadias by prenatal ultrasound, including 29 severe and 24 mild cases; the remaining 17 cases were not diagnosed with hypospadias prenatally. Postnatal (post-delivery) diagnosis confirmed hypospadias in 49 cases, including 28 severe and 21 mild cases. Additionally, 21 cases were confirmed to have no hypospadias. (3) A total of 36 cases were detected with hypospadias and other abnormalities by prenatal ultrasound. Among the 28 cases diagnosed with severe hypospadias postnatally (after delivery), 24 cases (85.7%) had other ultrasound abnormalities. Among the 21 cases of mild hypospadias, 12 (57.1%) had other ultrasound abnormalities. Among the 53 fetuses diagnosed with hypospadias prenatally via ultrasound, 46 were confirmed postnatally (after induced labor); out of the 29 cases diagnosed prenatally as severe hypospadias, 27 were confirmed; and among the 24 cases diagnosed prenatally as mild hypospadias, 19 were confirmed. The positive predictive values of prenatal ultrasound for hypospadias, severe hypospadias, and mild hypospadias were 86.8% (46/53), 93.1% (27/29), and 79.2% (19/24), respectively. Among the 49 cases confirmed postnatally (after delivery), three cases (6.1%) were missed by prenatal ultrasound, and seven cases (14.3%) were misdiagnosed by ultrasound, possibly due to the failure to observe the fetal penile tip in detail on the median sagittal plane. Conclusions:Prenatal ultrasound has certain diagnostic and classification values for hypospadias. During the examination, it is necessary to observe the fetal penile tip in multiple planes and comprehensively analyze ultrasound characteristics to improve diagnostic accuracy.
10.Clinical effect of trapezoidal transparent corneal incision during phacoemulsi-fication
Chaofeng YUAN ; Fei CHEN ; Wenna GAO ; Chengxia MA ; Xiaohua ZHAO ; Ling ZHANG ; Fengyan ZHANG
Recent Advances in Ophthalmology 2024;44(8):619-622
Objective To explore the clinical effect of a trapezoidal transparent corneal incision during phacoemulsi-fication.Methods A total of 57 patients(68 eyes)undergoing phacoemulsification were selected and divided into a con-ventional incision group and a trapezoidal incision group using a random number table method.There were 28 patients(34 eyes)in the conventional incision group,including 15 eyes(males)and 19 eyes(females),with an age range of 41-82(65.0±10.1)years;and there were 29 patients(34 eyes)in the trapezoidal incision group,including 21 eyes(males)and 13 eyes(females),with an age range of 46-87(66.0±11.1)years.All patients underwent cataract phacoemulsification combined with intraocular lens(IOL)implantation.A 3.0 mm transparent corneal incision was made for patients in the conventional incision group,while an improved trapezoidal transparent corneal incision was made for patients in the trape-zoidal incision group.The uncorrected visual acuity,intraocular pressure,corneal astigmatism,and incidence of intraoper-ative and postoperative complications were compared between the two groups.Results The uncorrected visual acuity of patients in the trapezoidal incision group was better than that of patients in the conventional incision group at 1 week and 3 months after surgery,and the differences were statistically significant(both P<0.05).There was no statistically significant difference in intraocular pressure and corneal astigmatism between the two groups of patients at 1 week,1 month,and 3 months after surgery(all P>0.05).The number of eyes with anterior chamber collapse and the number of eyes requiring a watertight incision in the conventional incision group were greater than those in the trapezoidal incision group during sur-gery,and the differences were statistically significant(both P<0.05).The number of eyes with incision edema and the number of eyes with incision gap in the conventional incision group were greater than those in the trapezoidal incision group after surgery,and the differences were statistically significant(both P<0.05).In the conventional incision group,IOL was displaced in 18 eyes due to the shallow anterior chamber and then returned to normal after the formation of the anterior chamber through a watertight incision during surgery;during the formation,iris prolapse and incarceration occurred in 2 eyes,and IOL rotation or incarceration occurred in 3 eyes.In the trapezoidal incision group,3 eyes had a shallow anterior chamber after surgery,and a watertight incision was used to form the anterior chamber;there was no IOL incarceration or displacement or iris prolapse.Conclusion The improved trapezoidal transparent corneal incision can effectively prevent IOL displacement caused by anterior chamber collapse during cataract surgery while ensuring the stability of the anterior chamber.It can also reduce the related complications caused by the watertight incision using a flushing needle and restore patients'vision as early as possible.

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