1.Oxidized related substance of methionine in compound amino acid injection (18AA-Ⅱ)
Tianshu SHAO ; Changming ZHOU ; Hui LI ; Lei GUO
Journal of China Pharmaceutical University 2021;52(6):713-718
TA method for the content determination of methionine sulfoxide and methionine sulfone in compound amino acid injection (18AA-II) was established in order to investigate their level in 155 batches of this product, and to explore the reason for the generation of these two impurities.The determination was performed on an Agilent Poroshell 120 EC-C18 column with mobile phases of sodium acetate/tetrahydrofuran solution (A) and sodium acetate solution -acetonitrile-methanol (B, 200∶400∶400) (gradient elution) at the flow rate of 0.5 mL/min.The excitation wavelength and the emission wavelength of the fluorescence detector were 233 nm and 441 nm, respectively.The column temperature was 40 °C, and the injection volume was 8 μL.The contents of methionine sulfoxide and methionine sulfone from 155 batches of compound amino acid injection (18AA-II) was determined using this method, and the residual oxygen content was detected by headspace gas analyzer.The results showed that the linear range of methionine sulfoxide and methionine sulfone were 0.128 1-10.250 0 μg/mL (r = 0.999 9) and 0.261 0-10.440 0 μg/mL (r = 0.999 8), respectively.The limits of quantitation were 0.13 μg/mL and 0.26 μg/mL, respectively; the limits of detection were 0.04 μg/mL and 0.09 μg/mL, respectively.RSDs of precision, stability and repetitive test were all lower than 1.3%.The recoveries ranged 98.00%-100.79% (RSD = 1.15%, n = 9) and 98.19%-102.31% (RSD = 1.33%, n = 9).The content level of oxidized related substances from different manufacturers showed significant difference, showing relevance with the residual oxygen content to some extent, yet no significant correlation with the added amount of antioxygen (sodium pyrosulfite).The method is validated to be useful for the content control of methionine sulfoxide and methionine sulfone in compound amino acid injection (18AA-II).It is quite necessary to include the determination of oxidized related substance into the quality specification.Manufacturers should strengthen the control of remaining oxygen in their products.
2.Clinical observation of phacoemulsification combined goniosynechialysis in treating absolute glaucoma after trabeculectomy
Jun-Yong, WANG ; Yi, SHAO ; Fang-Xing, ZHOU ; Hui, SUN
International Eye Science 2014;(10):1818-1821
AIM: To observe the effect of combined goniosynechialysis in treating absolute glaucoma after trabeculectomy.
METHODS:Phacoemulsification combined goniosynechialysis was performed on 16 patients ( 16 eyes ) with absolute glaucoma after trabeculectomy, and they were followed up for 6 ~12mo, The postoperative intraocular pressure ( IOP ) and anterior chamber depth, preoperative and postoperative medication types (quantity), preoperative and postoperative 1 month's status of anxiety and depression, symptoms of ocular surface were observed. RESULTS: The IOP decreased significantly after phacoemulsification combined goniosynechialysis. The mean IOP was 35. 00±15. 43mmHg preoperatively, and it was 12. 00±6. 69mmHg, 15. 00±4. 26mmHg and 15. 3±5.2mmHg on 1d, 6 and 12mo after the surgery. The statistic difference was found between preoperative and postoperative (t=6. 22, P<0. 05). The anterior chamber depth was 1. 45 ± 0. 19mm before the surgery, and increased to 3. 37±0. 13mm after the surgery (t=6. 65, P<0. 05). After the surgery, 2 patients needed two kinds of drugs, 2 patients needed one kind of drug. After 12mo of follow-up, anxiety and depression status were improved in all 16 patients. Subjective discomfort symptoms of 16 patients such as eye bilges, eye pain were relieved. All of the patients' eyeballs were preserved, and no serious complications.
CONCLUSION: Phacoemulsification combined goniosynechialysis in treating absolute glaucoma after trabeculectomy is a safe and effective surgical option.
3.Crowe IV developmental dysplasia treated by total hip arthroplasty with subtrochanteric osteotomy
Jianming GU ; Hui DU ; Hongyi SHAO ; Yixin ZHOU
Chinese Journal of Tissue Engineering Research 2013;(48):8331-8336
BACKGROUND:Crowe IV developmental dysplasia of the hip is rarely seen clinical y. However, when treated with routine total hip arthroplasty, severe deformities in the bone and soft tissue can lead to high rate of operation failure and increased occurrence of complications. Total hip arthroplasty in combination with subtrochanteric osteotomy may be an option to resolve this problem.
OBJECTIVE:To retrospectively analyze the clinical outcome and safety of Crowe IV developmental dysplasia of the hip treated by the combination of total hip arthroplasty and subtrochanteric osteotomy in 17 cases.
METHODS:Twenty-one hips (17 cases) of Crowe IV developmental dysplasia of the hip treated by the combination of total hip arthroplasty and subtrochanteric osteotomy were retrospectively analyzed and fol owed for at least 2 years from January 2006 to June 2011. Complications, hip function, and radiological changes were evaluated.
RESULTS AND CONCLUSION:The mean fol ow-up period was (48.0±20.5) months. Harris’s score was increased postoperatively (P<0.05). The main complains were lower limb length discrepancy, difficulty in standing up from squatting, muscle weakness, and soft tissue tightness. One greater trochanter fracture occurred and was fixed by hook plate fixation. There were four femoral shaft splits treated by cerclage. One patient represented with femoral nerve palsy and got partial recovery until the latest fol ow-up. There was no deep infection, dislocation or prosthesis loosening. Crowe IV developmental dysplasia of the hip could be effectively treated by total hip arthroplasty in combination with subtrochanteric osteotomy, which requires high surgical techniques to control the complications. Further fol ow-up is required for long-term results.
4.An experiment study on the prevention of scar formation of the filtering bleb by the application of anterior lens capsule in trabeculectomy with cataract surgery in rabbit eyes
Yi, SHAO ; Chong-Gang, PEI ; Qiong, ZHOU ; Hui, ZHOU ; Yong-Yan, LIU ; Gui-Ping, GAO
International Eye Science 2006;6(6):1237-1240
· AIM: This study was designed to evaluate the effectiveness of anterior lens capsule inclusion in combined trabeculectomy and cataract surgery in preventing scar formation of the filtering bleb in rabbit model.· METHODS: Twerty-Four eyes (12 rabbits) with glaucoma model were studied, anterior lens capsule inclusion in trabeculectomy with the small-incision cataract surgery were performed on all right eyes (experimental group) and no implants were applicator in trabeculectomy with the small-incision cataract surgery on all left eyes (control group). These operated eyes were followed up from day 1 to 6 months postoperatively. Intraocular pressure (IOP) was measured and filtering blebs were observed after surgery. Other main outcome measures: cornea、conjunctiva、formation of the anterior chamber, anterior chamber depth、inflammatory reaction、achievement ratio of operation and complications were analyzed. On week 1, 2, 4, 12 and 24 after surgery the animal were killed in batch. Tissue was harvested from the bleb area and was made pathological section. HE staining、light microscope and micro photo analysis technique were applied to observe the cytological and histopathologic characteristics of the filtering tunnels.· RESULTS: There were significant differences between the two groups on IOP (1, 2, 4 weeks)、filtration bleb, achievement ratio of operation and complications. In experimental group, at the first month postoperatively, anterior lens capsule absorption started with inflammatory characteristics. The peak of inflammatory reaction occurred 1 week after operation and all the cells in the filtrating tunnel disappeared 6month after surgery. The fibroblast proliferation in control group occurred at I week and the filtrating tunnel closed with angiogenesis at 1 month after surgery. Fibroblast proliferation started 1week after surgery with no statistical difference during the time course (P >0.05). Significant statistical differences were observed by comparing the fibro blasts numbers per unit area in the filtrating tunnel in experimental group and those in control groups (P<0.05).· CONCLUSION: Anterior lens capsule was totally absorbed at 6 months postoperatively. Anterior lens capsule inclusion in trabeculectomy with cataract surgery can possibly control intraocular pressure effectively, long-term sustainability of functional filtration bleb, inhibition of the proliferation of fibroblasts and opening of the filtrating pathway in the experimental animal models were satisfied. Compared to the control group, anterior lens capsule application has less complication.
5.Expression and Regulation of Cardiotrophin-1 in Ischemia1 Reinfusion Cardiac Muscle of Rats and Effect of Neuregwlin-1
hui, CHEN ; chao, LU ; xiao-song, SHAO ; yan, ZHOU ; sheng-hua, WU ; xiang-qing, KONG
Journal of Applied Clinical Pediatrics 1986;0(01):-
Objective To observe the expression of cardiotrophin-1(CT-1) in ischemia-reinfusion cardiac muscle of rats and the effect of neuregulin-1(NRG-1).Methods The model of ischemia-reinfusion cardiac muscle of rats were prepared,35 rats were randomly divided into 4 groups:model group(n=8),NRG-1 pretreatment group(n=9),pseudo-surgery group(n=8) and normal control group(n=10).The CT-1 mRNA in the observed cardiac muscle of all groups was measured by RT-PCR and the relative amount of CT-1 mRNA were calculated,and for statistical treatment.Results The CT-1 mRNA of model group was(63.96?9.34),and it was higher than that of pseudo-surgery group(36.16?5.43)and normal control group(36.84?4.64).The significant differences were found in 3 groups(F=47.37 P
6.DSA diagnosis and embolization therapy of gastrointestinal hemorrhage
Ru-Ming ZHOU ; Shui-Bo QIU ; Min-Hua LIU ; Hui-Jun YANG ; Shao-Yu ZHUANG ;
Chinese Journal of Radiology 1999;0(10):-
Objective To evaluate the effect of digital subtraction angiography and transcatheter embolization for gastrointestinal hemorrhage.Methods Twenty patients with gastrointestinal hemorrhage received celiac arteries,superior mesenteric arteries and inferior mesenteric arteries angiography. Superselective angiography were performed when the arteries were suspicious by clinic or angiogrraphy.Ten patients with definite diagnosis and manifestation of hemorrhagic arteries by angiography were embolized after superseleetive catheterization with gelfoam particles,gelfoam particles and coils,polyvinyl alcohol particles. Results The positive signs were observed in 13 cases.The DSA features including contrast medium accumulation in the gastrointestinal tract outside vascular,aneurysm,tumorous vascularization and staining, artery affect and local vasospasm.The bleedings were stopped immediately in 8 patients.No rebleeding and intestinal ischaemia or necrosis were observed in 30 days.One patient died in the second day after embolization from multiple organ failure.Rebleeding occurred 3 days after embolization in another patient, and was recovered after surgical operation.Conclusion DSA is more effective for the diagnosis of gastrointestinal vascular malformation and tumors complicating acute bleeding.Transcatheter embolization is effective and safe to control the hemorrhage.
7.Sky bone expander kyphoplasty for osteoporotic vertebral body compression fractures
Wei-Guo LIANG ; Zi-Qiang ZHOU ; Jing-Feng WU ; Shao-Hui YE ; Wei-Xiong YE ;
Chinese Journal of Trauma 2003;0(08):-
Objective To investigate surgical technique and clinical efficacy of Sky bone ex- pander kyphoplasty in the treatment of osteoporotic vertebral body compression fractures.Methods Eighteen cases with osteoporotic vertebral body compression fractures were treated with Sky bone expander kyphoplasty from August 2004 to November 2005.Under the local anesthesia,3.5-5ml of bone cements were injected into each pathologic vertebral body through unipedicle approach after reduction procedure was done with Sky bone expander.Results The postoperative follow-up ranged from 3 to 11 months, with an average of 4.5 months.Back pain was effectively relieved after the operation in all cases.No complications occurred.Conclusion The Sky bone expander kyphoplasty has the advantages of safe- ty,easy operation,minimal invasion,effective restoration of the vertebral body height and fast relief of pain.
8.Salmonella choleraesuis infection in children: chinical analysis of 21 cases.
Hui ZHOU ; Jian-Mei ZHAO ; Mei-Yu XU ; Shao-Peng ZHU ; Bin LI
Chinese Journal of Contemporary Pediatrics 2009;11(12):1012-1013
Child
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Child, Preschool
;
Female
;
Humans
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Infant
;
Male
;
Salmonella Infections
;
etiology
;
transmission
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Salmonella enterica
9.Silver impregnation and double immunostaining for alpha-smooth muscle actin and ED-1.
Yu-lan JIN ; Cheng TIAN ; Shao-hui SHI ; Quan ZHOU ; Hideaki ENZAN
Chinese Journal of Pathology 2007;36(3):210-211
Actins
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analysis
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Animals
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Dimethylnitrosamine
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Immunohistochemistry
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Liver
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metabolism
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pathology
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Male
;
Necrosis
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chemically induced
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pathology
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Rats
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Rats, Wistar
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Reticulin
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analysis
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Silver Staining
10.Physicochemical property and safety of nanometer human demineralized bone matrix composite
Lei FANG ; Xiongsheng CHEN ; Kai HUANG ; Shengyuan ZHOU ; Wei ZHU ; Hui WANG ; Jiang SHAO ; Lianshun JIA
Chinese Journal of Tissue Engineering Research 2013;(38):6701-6708
BACKGROUND: Demineralized bone matrix and bone morphogenetic protein have been shown to have good bone induction, but less studies concerned nanometer demineralized bone matrix. Its physical and chemical properties and biological security are not yet clear.
OBJECTIVE:On the basis of preparing the nanometer human demineralized bone matrix in previous experiment, we mixed the recombinant human bone morphogenetic protein-2 together to obtain the new bone graft substitute and to research its physical and chemical properties and biological security.
METHODS:The human demineralized bone matrixes were prepared by the method of modified Urist and nano-processed then mixed with the bone morphogenetic protein-2 in specific proportions in order to be lyophilized to complete the fol owing experiments. (1) Pyrogen experiment:the material extracts were injected in the rabbits by ear intravenous. (2) Toxicity experiments:material extracts and saline were separately injected via the tail vein of mice in vivo. (3) Implantation experiments:experimental materials andβ-tricalcium phosphate were implanted into rabbits on both sides of the hindlimb muscle.
RESULTS AND CONCLUSION:After lyophilized shaping, the nanometer demineralized bone matrix material had dense surface and it’s pore diameter was 100-400μm. The pore distribution was less uniform and the porosity was of less than 30%. The main elements were carbon, oxygen and nitrogen. Nanometer human demineralized bone matrix with recombinant human bone morphogenetic protein-2 did not have pyrogen effect and the rabbits’ body temperature had no significant fluctuations after injection. The acute systemic toxicity test results showed that the nanometer human demineralized bone matrix with recombinant human bone morphogenetic protein-2 complied with the relevant provisions of the State, without obvious toxic reaction. The inflammatory response of nanometer human demineralized bone matrix with recombinant human bone morphogenetic protein-2 was significantly lighter than the reaction ofβ-tricalcium phosphate. The results showed that the nanometer human demineralized bone matrix with recombinant human bone morphogenetic protein-2 is a nanometer al ogeneic bone graft substitutes with nontoxicity, good biocompatibility, high bioavailability, and less inflammatory reaction.