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Objective To abserve the acute toxicity in mice administered with Wuweizi Ningshen oral liquid.Methods The maximum administration dosage(MAD)of Wuweizi Ningshen oral liquid were determined by administration intragastricly in mice.Wuweizi Ningshen oral liquid was administered for 2 weeks,and the growth condition,body weight growth and index of main viscera were measured.Results The index of growth condition,body weight growth and index of main viscera were in normal ranges.Conclusion It could be concluded that Wuweizi Ningshen oral liquid is safe to be administered in the dose prescribed.
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BACKGROUND:Different methods and biomaterials have been applied in animal experiments and clinical practice to prevent the formation of epidural scars,Biodegradable and sticky semi-fluid gels are the most often used material.Salvia miltforrhiza radix (SMR) and carbomer have been clinically confirmed to be the safe and effective drugs and gel agents. OBJECTIVE:To observe the effect of SMR-gel on preventing epidural adhesion after laminectomy.DESIGN:A complete randomized grouping design, a controlled experiment. SETTING:Department of Orthopaedics,Shenzhen People's Hospital (Second Clinical College of Jinan University). MATERIALS:Thirty-six healthy pure New Zealand rabbits were used,either male of female,clean degree,2-3 years of age. They were randomly divided into four groups with 9 rabbits in each group:blank control group,gel contro group, HA group and SMR-gel group. Carbomer934 powder (Shanghai People's Pharmaceutical Factory, batch number: 20000510) , hyaluronic acid (HA) [Shandong Bausch & Lomb Freda Pharaceutical, Co., Ltd.,No.H10960136,2 mL (20 mg)].METHODS:The experiments were carried out in the animal laboratory of Shenzhen People's Hospital from April 2002 to August 2003.①Preparing SMR-gel:SMR was prepared into extract powder.Carbomer934 powder was added by water for dissolving and swelling and stayed overnight,then SMR-gel was prepared by dipping with triethanolamine,adding with SMR extract powder (2 g),then adding with purified water till 100.0 g and stirring uniformly.②The rabbits were anesthetized. and the lamina of vertebra was totally resected at L3 and L6 (reserving superior and Inferior articular processes).then defects of 10 mm×5 mm were made to expose the dura mater.The vertebral defects were added with 1 mL carbomer gel, 1 mL HA (20 g/L) and 1 mL SMR-gel in the gel control group,HA group and SMR-gel group respectively.whereas nothing was added in the blank control group.③Gross samples:Three rabbits were killed 4,6 and 8 weeks postoperatively in each group.vertebraI ventral fascia were stripped to remove the spinal segments (L3,L6) for operation completely,and totally 24 samples for each time.One sample was selected in each group 4 weeks postoperatively. and the samples were observed under H-600 transmission electron microscope (Hitachi). ④The adhesion compactness of scar tissue with dura mater was evaluated in the 24 samples of the 4 groups at 8 weeks postoperatively:There were 4 grades:No obvious adhesion between dural sac and scar tissue for grade O:Extensive and compact adhesion between dural sac and scar tissue. impossible blunt dissection between dural sac and scar tissue.incomplete dural sac after sharp dissection for grade Ⅲ.Each spinal segment was cut into 4 parts equally,and all were prepared into sections and stained,then the thickness of epidural scar was determined with Tiger2000 image analyzer. ⑤The rank sum test was used in the scar adhesion compactness grading evaluated with naked eyes,whereas analysis of variance.and two-two comparison were used in analyzing the thickness of epidural scar.P＜0.05 was considered as significant difference.MAIN OUTCOME MEASURES:①Results of gross scar adhesion compactness grading at 8 weeks and comparison of the thickness of epidural scar at 4.6 and 8 weeks;②Results of gross observation,histological examination and ultrastructure.RESULTS: All the 36 rabbits were involved in the analysis of results. ①Results of gross observation and pathohistological examination:There was compact adhesion at each time point in the blank control group,part adhesion in the gel control group and HA group, and no obvious adhesion in the SMR-gel group.②Results of quantitative analysis:The rabbits with lower scores of scar adhesion compactness grading In the blank control group,gel control group and HA group were obviously fewer than those in the SMR-gel group (W=45-52,P＜0.05-0.01).The scar thickness at 4 and 8 weeks in the SMR-gel group was obviously less than that in the other 3 groups(F=128.657,152.246,80.891,P＜0.01).③Results of observation under transmission electron microscope:The proliferation of fibroblasts at 4 week was active in the blank control group,gel control group and HA group,but inactive in the SMR-gel group.CONCLUSION:①SMR can inhibit the fibroblasts to proliferate,differentiate and synthetize into secretory collagens,and then inhibit the formation of epidural scar adhesion.②HA can be absorbed by organs very early,which reduces its role in preventing adhesion.Whereas carbomer gel can stay longer, and it plays a role in inhibiting and blocking adhesion in the whole process of wound repairing.
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OBJECTIVE:To prepare compound ofloxacin gel and to establish its quality control method.METHODS:Ofloxacin was used as principal agent to be mixed with dexamethasone sodium phosphate,carbomer 940 was taken as base material,the content of ofloxacin and dexamethasone were determined by HPLC method.RESULTS:The linear detection concentration ranges of ofloxacin and dexamethasone were 20～300?g/ml and 5～50?g/ml,respectively,the average recovery rates of which were (99.8?0.5)%(RSD=0.84%)and (100.6?0.8)%(RSD=0.87%),respectively.CONCLUSION:The preparation is stable in quality,the prepare technique is simple and the quality control is reliable.
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OBJECTIVE:To prepare diclofenac sodium controlled release pellets and investigate the mechanism of re?lease.METHODS:Single-factor method was used to investigate the influence of the composition of solvent system in coating solution,the concentration of coating material,porogenic agent and plastifier on the release rate of drug.RESULTS:When the concentration of coating material and the proportion of water increased,the release rate of pellets was increased;the release rate was further increased with PVP K30 added.CONCLUSION:The pellets belongs to the matrix-coating pellets,and the release mechanism varies with the change of coating thickness.
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OBJECTIVE:To prepare red sage gel for implantation and to establish a method for its quality control.METHODS:With carbamer934as vehicle,2%red sage gel was prepared;a HPLC method for the determination of tanshinone in gel was established.RESULTS:The calibration curve of tanshinoneⅡ A was linear in the concentration range of16.59～33.18ng/ml,Y=9723X—2569(n=5),r=0.9987.CONCLUSION:The preparation of red sage gel was simple,its quality was stable;the method of quality control was rapid and accurate.
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OBJECTIVE:To establish a RP-HPLC method for simultaneous determination of chlorapheniramine maleate,furacilin and ephedrine hydrochloride in Puma nose drops.METHODS:The analysis was carried on a XDB C 8 column;the mo?bile phase was composed of methanol(A),acetonitrile(B)and0.02mol/L potassium dihydrogen phosphate solutions(containing0.2%triethylamine and adjusted to pH3.0with phosphoric acid,C)with linear gradient elution(0min～3.5min,A∶B∶C=6∶13∶18,8.5min,A∶B∶C=6∶30∶64)and the flow rate was1.0ml/min;the detection wavelength was254nm and the column temperature was30℃.Chloramphenicol was used as the internal standard.RESULTS:The linear ranges were0.04～0.20mg/ml for chlorapheniramine maleate,0.02～0.10mg/ml for furacilin,0.50～2.50mg/ml for ephedrine hydrochlo?ride.The average recoveries were99.44%(RSD=0.48%,n=3)for chlorapheniramine maleate,101.36%(RSD=0.41%,n=3)for furacilin and99.43%(RSD=0.59%,n=3)for ephedrine hydrochloride.CONCLUSION:The method is reliable,accurate and suitable for quality control of Puma nose drops.
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OBJECTIVE: To study the antibacterial actions of Qinghou buccal tablets in vivo and in vitro. METHODS: Minimal inhibitory concentration (MIC) and minimal bactericidal concentration (MBC) of Qinghou buccal tablets were determined by standard test tube doubling dilution method;And the antibacterial action of which on staphylococcus aureus in mice in vivo were monitored. RESULTS: Qinghou buccal tablets had significant in vitro antibacterial action on staphylococcus aureus, ?-hemolytic streptococcus, ?-hemolytic streptococcus, streptococcus pneumoniae and hemophilus influenza, with MIC and MBC at 0.0 625～0.50g/ml and 0.125～1.0g/ml, respectively,and which had bacteriostatic action on mice that injected i.p. with staphylococcus aureus. CONCLUSION: Qinghou buccal tablets were proved to be of bacteriostatic actions in vitro and in vivo.
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OBJECTIVE:To establish a HPLC method to determine the content of compound tramadol tablets METHODS:Stationary phase:Kromasil C18 column,internal standard:phenacetin,mobile phase:methanol-water-triethlamine(55∶45∶0 2),adjusting pH to 4 2 with acetic acid,flow rate∶0 7ml/min,detecting wavelength∶267nm RESULTS:The linear range of tramadol (TR) was 50～500?g/ml(r=0 9 999,n=5) The linear range of nefopam(NFP) was 50～500?g/ml(r=0 9 999,n=5) The average recovery of TR was 99 69% The average content of TR was 100 71%,RSD=0 76%(n=5) The average recovery of NFP was 99 76% The average content of NFP was 99 64%,RSD=0 62%(n=5) CONCLUSION:The method is accurate,rapid and simple