1.Study on the Reaction Impurities Between Bromhexine Hydrochloride and Excipients in Bromhexine Hydrochloride Injection
Zhili ZENG ; Zhongli WU ; Baolin LIU ; Fei JIA ; Jinfang LOU ; Lushan YU
Chinese Journal of Modern Applied Pharmacy 2024;41(3):378-385
OBJECTIVE
To identify, synthesize and analyze the structure of unknown impurities unique to bromhexine hydrochloride injection and set the impurities as known impurity to control.
METHODS
The structure of unknown impurities was derived through two-dimensional liquid chromatography tandem mass spectrometry(2DLC-HRMS/MS), and the source of impurities was derived based on the product's prescription process. The mechanism of impurities generation was analyzed, and impurity monomers were obtained through directional synthesis. The structure of impurities was confirmed using techniques such as 2DLC-HRMS/MS and nuclear magnetic resonance. Finally, HPLC was used to verify the analysis method of impurities.
RESULTS
It was confirmed that such impurities were produced in a reaction between bromhexine and the excipient glucose. The correction factor of the two impurities were 2.2 and 2.4, the analytical method was specific and reproducible.
CONCLUSION
Name the two injection specific impurities as impurity 1 and impurity 2 respectively, and use them as known impurities to be included in the standard, calculate the impurity content using the self control and correction factor method. This study is of great significance in guiding the impurity control of bromhexine hydrochloride injection and the screening of excipient glucose.
2.Arthroscopic treatment for patients with borderline developmental dysplasia of the hip and cam-type femoroacetabular impingement syndrome
Yang LUO ; Jia ZHANG ; Jianping ZHANG ; Yidong WU ; Kangkang YU ; Haipeng LI ; Gang ZHAO ; Zhongli LI ; Yujie LIU ; Chunbao LI
Chinese Journal of Orthopaedics 2022;42(21):1416-1422
Objective:To evaluate the clinical outcomes of patients with borderline developmental dysplasia of the hip (BDDH) and cam-type femoroacetabular impingement syndrome (FAIS) after hip arthroscopy.Methods:Data were retrospectively reviewed for patients with BDDH and cam-type FAIS who underwent hip arthroscopy surgery from June 2017 to December 2019. A total of 32 patients were enrolled, with a mean age of 36.13±8.67 years (range, 20-50 years), including 15 males and 17 females. The preoperative lateral center-edge angle was 22.3°±1.6° (range 20.1°-24.7°), while the preoperative α angle was 64.1°±4.6° (range, 56.0°-69.8°). All patients were treated with arthroscopic limited acetabular plasty, labral repair, femoral osteoplasty, and capsular plication after excluding from external hip diseases by ultrasound-guided hip blocking test. The visual analogue scale (VAS), modified Harris Hip Scores (mHHS) and International Hip Outcome Tool-12 (iHOT-12) scores were used to evaluate the clinical effects.Results:All patients were followed up, and the mean follow-up time was 2.5±0.8 years (range, 2.0-4.7 years). The VAS score decreased from 6.07±1.56 to 1.96±0.92 at 1 year and to 1.86±1.01 at 2 years after operation ( F=112.64, P<0.001); the mHHS score increased from 53.87±13.04 to 86.12±8.64 at 1 year and to 88.71±8.15 at 2 years after operation ( F=101.70, P<0.001); the iHOT-12 score was improved from 40.00±7.33 to 76.27±9.50 at 1 year and to 78.67±10.31 at 2 years after operation ( F=134.91, P<0.001). The α angle improved to 40.27°±4.52° (range, 34.8°-49.7°) with significant difference ( t=9.24, P<0.001). Conclusion:Hip arthroscopy can achieve satisfied short-term outcomes in treating BDDH and cam-type FAIS with few complications and less trauma.
3.Early experience of robot assisted living donor kidney transplantation
Haohan ZHANG ; Turun SONG ; Ming MA ; Jiapei WU ; Yu FAN ; Xianding WANG ; Zhongli HUANG ; Tao LIN
Chinese Journal of Organ Transplantation 2022;43(6):334-339
Objective:To explore the safety and early prognosis of robot assisted living donor kidney transplantation(KT)and plot the learning curve of mastering the operation.Methods:From July 2020 to March 2021, 30 cases of living robot assisted KT were completed.The follow-up period was 3 months.Cumulative sum analysis was performed for plotting the learning curve.According to the learning curve, they were divided into two groups of practice period(the first 17 cases)and proficiency period(the last 13 cases). Time of each operative stage and early prognosis were compared.Kidney function and perioperative complications of two groups were compared for evaluating the safety and effectiveness of robot assisted KT.Results:The average operative duration was (221.4±36.1)min.No intestinal obstruction, delayed graft function, urinary leakage and incision infection occurred during perioperative period.The average anal exhaust time was(1.9±0.2)days.During follow-ups, both pulmonary infection(2 cases)and acute rejection(1 case)improved after treatment.According to the learning curve, venous anastomosis(10 cases), arterial anastomosis(12 cases), warm ischemic time(12 cases)and ureteral anastomosis(17 cases)should be performed for reaching a proficiency level.An average of 15 operations was required for achieving proficiency throughout operations.Significant inter-group differences existed in operative duration [(235.5±31.6)vs(203.0±34.3)min, P=0.012] and warm ischemic time [(63.7±24.9)vs(47.0±11.3)min, P=0.033]. At some postoperative timepoints, creatinine of proficiency group was lower than that of practice group, such as Day 7 post-operation [(192.7±135.2)vs(107.8±27.9)μmol/L, P=0.022] and Day 30 post-operation [(147.8±46.3)vs(112.3±28.0)μmol/L, P=0.021]. However, no significant difference existed in estimated glomerular filtration rate at Day 7 post-operation [(56.1±34.1)ml/(min·1.73m 2)vs(72.0±18.5)ml/(min·1.73m 2), P=0.14] and Day 30 post-operation [(56.2±18.9)ml/(min·1.73m 2)vs(68.7±15.3)ml/(min·1.73m 2), P=0.14]. Conclusions:Robot assisted KT is both safe and feasible.And the learning curve requires 17 cases for reaching a proficiency level.
4.Chirality Self-assembling peptide for rats endometrial regeneration model.
Shuyi WU ; Shijian LAN ; Jing WEN ; Tianxin ZHAO ; Lan HUANG ; Zhongli LUO
Chinese Journal of Biotechnology 2019;35(6):1079-1087
Here we investigate the physical and chemical properties of chiral self-assembling peptides and the role of uterine trauma regeneration. The circular dichroism was used to analyze secondary structure of chiral self-assembled peptide, and Congo red staining was used to observe the macroscopic process of peptide self-assembling. Erythrocyte lysis assay was used to examine the cleavage of peptide on cell membrane. The nanofiber scaffolds self-assembled by Chiral self-assembling peptides were used as the three-dimensional culture material to observe the growth effect of Hela cell. CCK-8 (cell counting kit-8) was used to study cell viability level between 2D (2-dimensional) and 3D (3-dimensional) culture environment. Rats endometrium curettage model was founded to evaluate the changes by immunohistochemistry staining and and HE staining. The secondary structure of chiral self-assembling peptides was stable β-sheet, and peptide could form dense membrane structure after 24 hours self-assembling cultured in salt ions. There was no harmful for the cell membrane of the peptide before and after self-assembling. Animal experiments show that chiral self-assembling peptide can significantly reduce the inflammatory response, promote the production of neovascularization, and accelerate the repair process. Chiral self-assembling peptide, as a new type of scaffold material, can construct a three-dimensional cell culture environment and used to repair uterine trauma.
Animals
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Endometrium
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Female
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HeLa Cells
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Humans
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Nanofibers
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Peptides
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Rats
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Regeneration
5.ABO-incompatible living donor kidney transplantation
Xianding WANG ; Yang QIU ; Yuanhang LYU ; Zilin XU ; Turun SONG ; Zhongli HUANG ; Lijuan WU ; Chunyan HUANG ; Xi TANG ; Li WANG ; Tao LIN
Chinese Journal of Organ Transplantation 2018;39(1):29-34
Objective To investigate the clinical efficacy and safety of individualized preconditioning in ABO-incompatible living donor kidney transplantation.Methods A series of 36 living donor kidney transplants across a wide range of ABO blood group incompatibilities using individualized preconditioning protocols were performed from September 2014 to June 2017.Preconditioning included oral immunosuppressants with or without the administration of rituximab,PE or DFPP.Medical records and electronic databases were reviewed for isoagglutinin titers,patient and graft survivals,graft function,rejections,infections as well as surgical complications.Results Of 30 ABO blood group incompatibilities,there were 6 cases of AB to A,2 cases of AB to B,4 cases of A to B,3 cases of B to A,13 cases of A to O (13),and 8 cases of B to O.Median initial ABO antibody titers were 1∶32 (1∶2-1∶256) (IgM) and 1 ∶ 8 (0-1∶64) (IgG),respectively.Individualized preconditioning included oral immunosuppressants alone (10 cases),oral immunosuppressants + PE (4 cases),oral immunosuppressants + PE + DFPP (1 case),oral immunosuppressants + rituximab + PE (16 cases),oral immunosuppressants + rituximab + DFPP (2 cases),and oral immunosuppressants + rituximab + PE+ DFPP (3 cases).After individualized preconditioning,an acceptable ABO antibody titer (≤1 ∶ 16) was obtained on the day of transplantation.Median follow-up duration was 12 months (1-33).Graft and patient survival rate was 94.4% (34/36) and 100% (36/36) respectively.Median value of serum creatinine at one year posttransplantation was 89 μmol/L,and eGFR was (81.07 mL/min/1.73 m2).In total,there was one episode of urinary tract infection and upper gastrointestinal tract hemorrhage,two cases of hyperacute rejection (leading to graft loss),acutecelluar-mediated rejection,delayed graft function,bone marrow suppression and pneumonia,and 3 cases of acute antibody-mediated rejection and wound fat liquefaction,respectively.Conclusion Our initial experience indicates that individualized preconditioning protocol based on initial ABO antibody titers is safe and technically feasible,and leads to excellent short-term survival of ABOi living donor kidney transplantation.
6.The effect of hyperbaric oxygen therapy combined with repetitive transcranial magnetic stimulation on patients with cognitive dysfunction after cerebral infarction
Yun REN ; Xudong GU ; Yunhai YAO ; Jianming FU ; Hankui YIN ; Liang LI ; Caihong WU ; Zhongli WANG ; Fang SHEN
Chinese Journal of Physical Medicine and Rehabilitation 2018;40(5):336-339
Objective To observe the effect of hyperbaric oxygen (HBO) therapy combined with repeated transcranial magnetic stimulation (rTMS) on patients with cognitive dysfunction after cerebral infarction.Methods A total of 81 patients with cognitive dysfunction after cerebral infarction were randomly divided into a control group,an HBO group and a combined treatment group,each of 27.In addition to basic medication and traditional rehabilitation therapy,the HBO group was also treated with hyperbaric oxygen,while the combined treatment group received both HBO and rTMS.The mini-mental state examination (MMSE) and the Montreal cognitive assessment (MoCA) were administered before and after the four weeks of treatment.Results The average MMSE scores of the HBO and combined treatment groups were both significantly higher than that of the control group,with the former significantly higher than the latter.Moreover,the average MoCA score of the HBO group was also significantly higher than that of the combined treatment group,and both were significantly higher than that of the control group.Conclusion Hyperbaric oxygen therapy can more effectively improve the cognitive function of patients with cognitive dysfunction after the cerebral infarction when it is combined with repeated transcranial magnetic stimulation.
7.Multi-b-value DWI in diagnosing of cancer and CIN Ⅲ of the cervix
Jie ZHANG ; Yali ZHANG ; Ruizhen LIN ; Zhongli DU ; Min CHEN ; Xueli WU
Journal of Practical Radiology 2017;33(5):715-719
Objective To analyze the characteristics of multi-b-value diffusion weighted imaging (DWI) of the normal cervical, cervical cancer and cervical intraepithelial neoplasia(CIN Ⅲ),and to assess the value of DWI in diagnosis and pathological staging for cervical cancer.Methods There were 54 patients with pathologically confirmed cervical cancer,including 36 squamous cell carcinoma,15 adenomatous carcinoma, and 3 neuroendocrine carcinoma.And other 9 patients with CIN Ⅲ were involved in the study.All patients underwent conventional MR scan with multi-b-value DWI sequence.The apparent diffusion coefficient (ADC) values of multi-b-value DWI were compared between normal cervical tissue and cervical cancer with its different pathology subtypes.Results The three normal structure of uterine cervix, including cervical endometrial, junctional zone and myometrium, can be clearly distinguished by different b-value DWI, with a statistical difference of ADC value (P<0.05).Further analysis showed that the average ADC values between normal cervix and cervical cancer had a statistical difference (P<0.05).The similar situation was presented among squamous cell carcinoma, adenomatous carcinoma, neuroendocrine carcinoma and CIN Ⅲ(P<0.05).Conclusion The ADC values of multi-b-value DWI could be helpful to diagnose cervical cancer and CIN Ⅲ,and it is correlated with the pathological type of cervical cancer.The application of multi-b-value DWI to cervical cancer and CIN Ⅲ could increase the accuracy of diagnosis.
8.Comparative analysis of acoustic features of spontaneous swallowing sounds between the young and the elderly
Yacen WU ; Feng LIN ; Zhongli JIANG
Chinese Journal of Physical Medicine and Rehabilitation 2017;39(12):912-914
Objective To observe the features of spontaneous swallowing sounds of both the young and the elderly.Methods One hundred healthy individuals were randomly divided into an elderly group (60-85 years old) and a youth group (19-30 years old),each of 50 (25 male and female individuals).Both groups were measured with regard to their neck circumference (neck circumference around the thyroid cartilage level) and body mass index (BMI).Spontaneous swallowing sounds were detected for 20 minutes on the thyroid cartilage below the left side of trachea.By using RavenProl.5.0,the swallowing sounds were segmented,tagged and calculated in terms of the spontaneous swallowing frequency per minute (SPM),swallowing duration,energy consumption,duration of half energy consumption and proportion of half energy consumption duration.All data were finally analyzed using R3.4.0.Results There was no significant difference in the average neck circumference between the youth group and the elderly group [(34.31±3.45) cm versus (33.95±3.00)cm] (P=0.5789).The BMI of the youth group was significantly lower than that of the elderly group [(21.97±2.65)kg/m2 vs (23.43±2.89)kg/m2].The SPM of the elderly group was significantly lower than that of the youth group [(0.39±0.34) /min vs (0.91±0.51)/min,P<0.0001].The length of swallowing,the energy consumption per swallowing and the duration of half energy consumption of the elderly group (0.92±0.29 seconds,76.88 ± 9.82 dB and 0.43 ± 0.24 seconds) were significantly higher than those of the youth group (0.84±0.26 seconds,75.43±8.93 dB and 0.38±0.19 seconds).However,no significant differences were found in the proportion of half energy consumption duration in the whole swallowing sound duration (P=0.6859).Conclusions Compared with the young,the frequency of spontaneous swallowing decreased and the swallowing duration prolonged significantly in the elderly.
9.Relationship between levels of serum gamma-glutamyltransferase and coronary heart disease in pilots
Na ZHANG ; Chao WU ; Mingyuan LIAO ; Cheng YU ; Jun WANG ; Zhongli MA ; Jianwei TIAN
The Journal of Practical Medicine 2016;32(11):1774-1777
Objective To investigate the correlation between serum level of gamma-glutamyl transferase (GGT) and coronary heart disease (CHD) in military pilots. Methods Sixty male military pilots hospitalized in Airforce General Hospital having coronary angiography examination(CAG) from March 2005 to May 2015 were involved then were divided into CHD group (n = 24) and control group (n = 36) according to the results of coronary angiography (CAG). The patients with CHD were divided into low score group (Gensini score ≤ 20) and high score group (Gensini score > 20) according to Gensini score. Results There were significant increase of the level of TG, GGT and decrease of the level of HDL-C in CHD group than those in control group(P<0.05);there was no significant difference with the level of GTT between high score group and low score group (P > 0.05); logistic regression analysis showed that serum GGT was an independent risk factor of CHD in military pilots (OR = 1.168, P < 0.01). Conclusion Serum GGT is associated with CHD in military pilots and is the independent risk factor of CHD in the pilots.
10.An empirical study on medical selection of flying cadets with heterophonies between PLAAF and USAF
Tengyun WU ; Zhikang ZOU ; Qing TIAN ; Caihui JIANG ; Linsong QI ; Zhongli MA ; Meiliang HUANG
Military Medical Sciences 2016;40(2):92-94,98
Objective To determine whether the candidates who were disqualified for having phoria or tropia in People′s Liberation Army Air Force ( PLAAF) medical selection of flying cadets are qualified or not according to United States Air Force ( USAF) Medical Standards Directory , and to raise suggestions on revising PLAAF medical standards . Methods All the candidates who had participated in the final medical selection of flying cadets were reevaluated and determined as qualified or not according to USAF Medical Standards Directory .Results There was a marked difference between disqualification rates of PLAAF and USAF .13.87%of the candidates who were regerded as disqualified by PLAAF standards were qualified according to USAF Medical Standards Directory .These cadets might be eliminated by mistake . Conclusion The standard on heterophonies of the PLAAF is more stringent than that of the USAF .We shoucd revise PLAAF standards using USAF standards for reference .


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