1. Comparison of Analytical Methods for Related Substances of Sisomicin Sulfate Injection
Chinese Pharmaceutical Journal 2017;52(20):1780-1785
OBJECTIVE: To establish an HPLC-PAD method to determine the related substances of sisomicin sulfate injection and compare with the statutory method. METHODS: IonPac AMG C18(4.0 mm×150 mm, 3 μm)chromatographic column was used with acetonitrile-0.1 mol·L-1 trifluoroacetic acid (containing 0.025% of pentafluoropropionic acid, 5 mL of 50% NaOH solution without carbonate, pH of the aqueous solution adjusted to 2.3 with 50% NaOH solution.)as mobile phase at a flow rate of 0.7 mL·min-1. NaOH solution of 0.76 mol·L-1 was added post column at a flow rate of 0.35 mL·min-1. The column temperature was maintaine at 30 ℃. PAD detector was operated with the cell temperature set at 35 ℃. The working electrode was a gold electrode (diameter of 3 mm)and a quadruple-potential waveform was selected as detection waveform. The reference electrode was Ag/AgCl, the detection potential was four potential. The determination result of the related substances of sisomicin sulfate injection was compared with that of the statutory method. RESULTS: The peaks of sisomicin sulfate, gentamicin C1a and netilmicin could be completely separated, and other impurities could also be effectively separated. The blank sample had no interferences. The LOD and LOQ of etimicin were found to be 2 and 6 ng respectively, and the RSD of precision test (n=6) was 0.9%. Paired-samples t-test showed significance levels of P=0.034, P=0.364 and P=0.605 for total amount of impurities (%), the biggest single impurity (%)and content (%)respectively between the statutory method and the method of HPLC-PAD. CONCLUSION: Compared with the statutory method, this HPLC-PAD method shows higher sensitivity, and is accurate and reliable. It can be applied to the determination of related substances in sisomicin sulfate injection.
2.Infliximab versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate:a randomized double blind phase Ⅲ trial in China
Yong HOU ; Feng-Chun ZHANG ; Feng HUANG ; Donghai WU ; Chun-De BAO ; Li-Qing NI ; Chen YAO ;
Chinese Journal of Rheumatology 2003;0(11):-
Objective To evaluate the efficacy and safety of infliximab plus methotrexate combination therpy in Chinese with rheumatoid arthritis patients.Methods This was a double-blind placebo-controlled phaseⅢclinical trial,173 patients who had active rheumatoid arthritis were randomised to placebo(n=86)or infliximab(n=87)group on a background of a stable dosage of methotrexate.Patients were assessed at weeks 0,2,6,14 and 18.Results At week 2,the American College of Rheumatology(20)response criteria,which represent a 20% improvement from baseline,the same results with swollen joint count,tender joint count,du- ration of morning stiffness,VAS score,CRP,ESR were achieved in 52.9% of patients,compared with 14.0% of patients receiving placebo plus methotrexate.A 20% improvement was achieved in 75.9% of infliximab plus methotrexate at week 18,compared with 48.8% of patients on placebo plus methotrexate(P=0.0003).A 50% improvement was achieved in 43.7% of infliximab plus methotrexate at week 18,compared with 25.6% of pa- tients on placebo plus methotrexate(P=0.011).Infliximab was well-tolerated;withdrawals for adverse events as well as the occurrence of serious adverse events or serious infections were similar to those in the placebo group.There was only one case of tuberculosis in the treatment group.Conclusion Treatment with infliximab plus methotrexate is more effective than methotrexate alone in patients with active rheumatoid arthritis.It has rapid onset of effect and the efficacy is persistent.
3.Effect and impact of holmium laser versus thulium laser enucleation of the prostate on erectile function.
Kai HONG ; Yu-qing LIU ; Jian LU ; Chun-lei XIAO ; Yi HUANG ; Lu-lin MA
National Journal of Andrology 2015;21(3):245-250
OBJECTIVETo compare the effect and impact of holmium laser enucleation of the prostate (HoLEP) and 120-W thulium: YAG vapoenucleation of the prostate (ThuVEP) on erectile function in the treatment of benign prostatic hyperplasia (BPH).
METHODSWe retrospectively analyzed 93 cases of symptomatic BPH treated by HoLEP or 120 W ThuVEP. We made comparisons between the two groups of patients in the baseline and postoperative clinical and surgical indexes as well as their IPSS, quality of life (QOL), maximum flow rate (Qmax), postvoid residual urine volume (PVR), and IIEF-EF scores before surgery and during the 12-month follow-up.
RESULTSThuVEP, in comparison with HoLEP, achieved a significantly shorter operation time ([57.6 +/- 12. 8] vs. [70.4 +/- 21.8] min, P = 0.001) and a higher laser efficiency ([0.71 +/- 0.18] vs. [0.62 +/- 0.19] g/min, P = 0. 021). At 1, 6, or 12 months of follow-up, no significant differences were observed in IPSS, OOL, Omax, and PVR between the two groups (P > 0.05). Both the HoLEP and ThuVEP groups showed low incidences of complications and remarkably improved IIEF-EF scores at 12 months postoperatively, but with no significant differences (both P > 0.05). However, in those with relatively normal erectile functions before operation, the mean IIEF-EF score was reduced from 22.8 +/- 2.2 preoperatively to 21.0 +/- 2.7 after HoLEP, (P = 0.036).
CONCLUSIONBoth HoLEP and 120W ThuVEP are effective and safe in the treatment of BPH. Compared with HoLEP, 120 W ThuVEP has even a higher laser efficiency. However, neither can significantly improve erectile function, and HoLEP may have a short-term negative impact on the relatively normal erectile function of the patient.
Aged ; Holmium ; Humans ; Laser Therapy ; adverse effects ; methods ; Lasers, Solid-State ; therapeutic use ; Male ; Middle Aged ; Penile Erection ; Prostatectomy ; adverse effects ; methods ; Prostatic Hyperplasia ; surgery ; Quality of Life ; Retrospective Studies ; Thulium ; Transurethral Resection of Prostate ; Treatment Outcome ; Urine
4.Diagnosis and microsurgical treatment of intramedullary hemangioblastoma in cervical spinal cord
Xu-Hui HUI ; Chao YOU ; Rui-Chun LI ; Si-Qing HUANG ; Kai-Yong YANG ;
Chinese Journal of Microsurgery 2006;0(06):-
Objective To investigate the diagnosis and the microsurgical treatment of intramedullary hemangioblastoma in cervical spinal cord.Methods The signs of MRI,and the results of operations were analysed in 26 patients with the tumors.Rusults The tumors can be classified into two types:Solid type (14 cases)and cystic type(12 eases).All the tumors underwent total removal and were all hemangioblastoma confirmed by histopathologic examinations.Postoperatively,neurological status were improved in 17 patients, remained in 7 cases and worse in 2 cases.Conclusion For intrameduUary hemangioblastoma of cervical spinal cord MRI is of significant importance in the diagnosis of localization and the nature of the tumors which is conductive to selecting appropriate operative methods.There is high risk in operating at cervical section,but microsurgical total resection is the optimal method to stop the development of the clinical presentation.Opera- tive methods varied with the different typer of the tumor.It is the most important principal that dissection is performed along the correct interface and the tumor should be removed en bloc after it is devascularized.
5.Treatment of Refractory Rheumatoid Arthritis by Huayu Tongbi Recipe Combined Methotrexate.
Xiu-min CHEN ; Run-yue HUANG ; Jing-yao YAN ; Zhi-hong LIU ; Yong-liang CHU ; Qing-chun HUANG
Chinese Journal of Integrated Traditional and Western Medicine 2015;35(11):1326-1330
OBJECTIVETo evaluate the clinical efficacy and safety of Huayu Tongbi Recipe (HTR) combined methotrexate (MTX) in treating refractory rheumatoid arthritis (RRA).
METHODSTotally 167 RRA patients were assigned to the treatment group (73 cases) and the control group (94 cases) according to different therapeutic methods. Patients in the treatment group were treated with HTR combined MTX, while those in the control group were treated with leflunomide (LEF) combined MTX. Clinical signs and symptoms, RF, CRP, ESR, disease activity score 28 (DAS28), and safety indicators were compared between the two groups before treatment, at week 12 and 24 after treatment. The efficacy and safety indices were also evaluated.
RESULTSAt week 12 after treatment the total effective rate was 82.2% (60/73 cases) in the treatment group and 79.8% (75/94 cases) in the control group, showing no statistical difference between the two groups (chi2 = 0.15, P > 0.05). At week 24 after treatment the total effective rate was 78.1% (57/73 cases) in the treatment group and 755% (71/94 cases) in the control group, showing no statistical difference between the two groups (chi2 = 0.15, P > 0.05). There was statistical difference in the total effective rate between week 24 and week 12 in the control group (chi2 = 0.49, P < 0.05). Clinical signs and symptoms, RF, CRP, ESR, and DAS28 were significantly improved in the two groups after 12- and 24-week treatment (P < 0.01). There was no statistical difference in the improvement at week 12 after treatment between the two groups (P > 0.05). There was statistical difference in time of morning stiffness, tender joint numbers, swollen joint numbers, patient global assessment, RF, CRP, and DAS28 at week 24 after treatment between the two groups (P < 0.05). Besides, adverse reactions occurred less in the treatment group than in the control group (P < 0.01).
CONCLUSIONThe efficacy of HTR combined MTX was equivalent to that of LEF (10 mg per day) combined MTX, but with more stable therapeutic effects and less adverse reactions.
Antirheumatic Agents ; pharmacology ; therapeutic use ; Arthralgia ; Arthritis, Rheumatoid ; drug therapy ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; pharmacology ; therapeutic use ; Humans ; Isoxazoles ; Methotrexate ; pharmacology ; therapeutic use ; Phytotherapy ; Treatment Outcome
6.Efficacy of sublingual polyvalent bacterial vaccine (Lantigen B) in children with recurrent respiratory infection: a randomized double-blind controlled clinical trial.
Ai-huan CHEN ; Rong-chang CHEN ; Chun-qing ZHANG ; Denui CHEN ; Sui HUANG ; Yunen LIN ; Jieyi ZHAN ; Nanshan ZHONG
Chinese Journal of Pediatrics 2004;42(6):463-464
Administration, Sublingual
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Bacterial Vaccines
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administration & dosage
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immunology
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Child
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Child, Preschool
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Double-Blind Method
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Female
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Humans
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Immunoglobulin A
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blood
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Immunoglobulin A, Secretory
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analysis
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Male
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Pseudomonas Vaccines
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Recurrence
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Respiratory Tract Infections
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immunology
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prevention & control
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Treatment Outcome
8.Studies on the chemical constituents of Angelica sinensis.
Wei-hui HUANG ; Chun-qing SONG
Acta Pharmaceutica Sinica 2003;38(9):680-683
AIMTo investigate the chemical components of Agelica sinensis.
METHODSChromatographic technologies were used for separation and purification, while spectral analysis was measured for structure elucidation.
RESULTSFive compounds were isolated and their structures were identified as Homosenkyunolide H (1), Homosenkyunolide I(2), Neoligustilide (3), 6-methoxycoumarin (4), Hypoxanthine-9-beta-D-ribofuranoside (5).
CONCLUSIONCompounds 1 and 2 are new compounds. Compounds 3, 4 and 5 were isolated from Agelica sinensis for the first time.
Angelica sinensis ; chemistry ; Benzofurans ; chemistry ; isolation & purification ; Molecular Conformation ; Molecular Structure ; Plants, Medicinal ; chemistry ; Stereoisomerism
9.Study on the testing methods to determine the resistance to wet bacterial penetration about surgical gowns and drapes.
Wen-Qing WANG ; Ping WU ; Li HOU ; Xin WANG ; Jing-Chun HUANG
Chinese Journal of Medical Instrumentation 2008;32(4):290-292
The essay introduces the study on the performance monitoring tests for the resistance to wet bacterial penetration about surgical gowns and surgical drapes in accordance with ISO 22610.
Microbiological Techniques
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instrumentation
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methods
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Operating Rooms
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Protective Clothing
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microbiology
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standards
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Surgical Attire
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microbiology
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standards
10.The effect of partial body-weight supported treadmill training on hemiplegia patients caused by with cerebral infarction
Cui-Huan PAN ; Ai-Hua LUO ; En XU ; Wen-Wei WANG ; Qing-Chun GAO ; Tong YE ; Yi HUANG ;
Chinese Journal of Physical Medicine and Rehabilitation 2003;0(10):-
Objective To investigate the effect of partial body-weight supported treadmill training ( PBW- STT) on function of lower limbs, walk function, ADL performance and quality of life of hemiplegic patient induced by cerebral infarction. Methods A total of 132 cerebral infarction patients were divided into a control group (n = 69) and a training group( n = 63) randomly. Both groups accepted routine rehabilitation therapy, and the training group accepted PBWSTT at the same time in addition. Both groups were evaluated with regard to their walking ability, func- tion of lower limbs, ADL performance and their quality of life by using Functional Ambulation Category (FAC) , Fugl-Meyer assessment (FMA) , Barthel index (BI) and SF-36 before and after rehabilitation treatment. Results The function of lower limb, walking ability, ADL performance and the quality of life of both groups were improved significantly after treatment, and those in the training group were improved to a significantly greater extent than those in the control group ( P