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OBJECTIVE： To establish a method for determining the content of tetracaine hydrochloride （TCH） ethosomes， and to optimize the preparation technology. METHODS： The content of TCH was determined by HPLC. TCH ethosomes were prepared with injection-ultrasonic method. Using drug-loading amount， egg lecithin concentration and ethanol volume fraction as factor， encapsulation efficiency as index， central composite design-response surface methodology was used to optimize the prescription based on the single factor test. The prepared ethosomes were characterized and the stability was evaluated. RESULTS： The linear range of TCH was 10-100 μg/mL （r＝0.999 5）； the limit of quantification was 0.045 μg/mL， and detection limit was 0.021 μg/mL. RSD of precision， stability and repeatability tests were less than 2％. The recoveries ranged 97.80％-103.20％ （RSD＝0.36％， n＝9）. The optimal preparation technology included that the adding amount of TCH control was 1 mg； the concentration of egg lecithin was 7 mg/mL， and ethanol volume fraction was 33％. Under this technology， the average encapsulation efficiency was 64.50％ （n＝3）， the relative error of which from the predicted value （64.92％） was 0.64％. TCH ethosome was a clear blue liquid with a blue opalescence. Its appearance was spherical， its shape was round， smooth， uniform in size； the average particle size was （80.33±2.24） nm， and the average Zeta potential was （－22.6±1.33） mV. TCH ethosome was stable during 10 days under 4 ℃， sealed and protected from light. CONCLUSIONS： The optimal preparation process is stable and feasible. Established method is simple and rapid.
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Objective To establish an external calibration method of atomic absorption spectrometry-graphite furnace for determination of heavy metals Pb,Cd,Sb in tetracaine hydrochloride injection.Methods Microwave digestion for the pretreatment method was used,three kinds of heavy metal elements were determined by graphite atomic absorption spectrometry-graphite furnace Results The linear ranges of Pb,Cd,Sb were 0-80.0 ng/mL,0-2.0 ng/mL,0-40.0 ng/mL,therecovies were 92.7%-105.7%,95.8%-103.4%,92.1%-103.5%,respetively.The relative standard deviationless than 6.0%(n=9).Conclusion The method is simple and accurate,which can be used for the control of Pb,Cd,Sb in tetracaine hydrochloride injection.
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OBJECTIVE:To develop a method for determining the entrapment efficiency of tetracaine hydrochloride liposome.METHODS:The microcolumn centrifugation was adopted to separate the free tetracaine hydrochloride from liposomes;the content of tetracaine hydrochloride was determined by HPLC and the entrapment efficiency was computed.RESULTS:By microcolumn centrifugation,the liposomes and the free tetracaine hydrochloride were well-separated.The recovery rate of the blank liposomes was 90.4%～100.1%;the absorption rate of free tetracaine hydrochloride was 96.6%～99.2%;and the entrapment efficiencies of tetracaine liposomes stood at about 80%.CONCLUSION:This method established for determining the entrapment efficiency of tetracaine hydrochloride liposome is simple,rapid and reproducible.
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OBJECTIVE:To prepare qingdiyou emulsion and to establish its quality control.METHODS:Qindiyou emulsion was prepared by emulsification by using tetracaine hydrochloride as principal agent.The content of tetracaine hydrochloride was determined by UV spectrophotometry.The stability of 3 batches of samples was investigated.RESULTS:The preparation was white emulsion.The linear range of tetracaine hydrochloride was 3.168～9.504 ?g?mL-1(r=0.999 9),with an average recovery rate of 99.68%(RSD=0.49%).The 3 batches of sample preparations were proved to be stable in quality.CONCLUSION:This method is simple in operation,accurate in content determination,and stable and controllable in quality within expiration date.
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OBJECTIVE:To determine the contents of chlortetracycline hydrochloride and tetracaine hydrochloride in compound chlortetracycline hydrochloride ointment.METHODS:Dual wavelength spectrophotometry was used to determine the two components.The absorbance of the two components was determined at wavelength of 311 nm,368 nm and 387.5 nm,respectively;and the contents of which were computed as well.RESULTS:The linear ranges for chlortetracycline hydrochloride and tetracaine hydrochloride were 9.90～29.71 ?g?mL-1 and 5.99～17.98 ?g?mL-1(r=0.999 9),respectively,with average recovery rates at 99.37%(RSD=0.31%,n=9) and 98.31%(RSD=0.23%,n=9),respectively.CONCLUSION:The method is simple,rapid and accurate,and suitable for the determination of compound chlortetracycline hydrochloride ointment.
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OBJECTIVE:To establish a method for the content determination of tetracaine hydrochloride and ethyl hy-droxybenzoate in tetracaine hydrochloride mucilage by RP-HPLC.METHODS:C 8 was the chromatographic column,the mobile phase was methanol-absolute ethanol-water-triethylamine(70∶15∶15∶0.05),the detection wavelength was at280nm.RESULTS:The linear ranges of tetracaine hydrochloride and ethyl hydroxybenzoate were10～50?g/ml(r=0.9997)and2～10?g/ml(r=0.9999)respectively;the average recovery rate were100.82%and100.16%respectively.CONCLUSIONS:The method was simple,rapid and accurate,which can be used for the quality control of tetracaine hydrochloride mucilage.
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OBJECTIVE:To establish HPLC method for the simultaneous content determination of metronidazole,tetra-caine hydrochloride and dexamethasone acetate in metronidazole compound.METHODS:The content determination was per-formed on column C 18 ;the mobile phase consisted methanol-water-triethylamine(65∶35∶0.36),the detection wavelength of both metronidazole and tetracaine hydrochloride was310nm,and240nm for dexamethasone acetate,the flow rate was1ml/min and the column temperature was25℃.RESULTS:The linear ranges of metronidazole,tetracaine hydrochloride and dexameth_ asone acetate were0.412?g～2.06?g(r=0.9999),0.191?g～0.956?g(r=0.9999)and0.121?g～0.604?g(r=0.9998),respectively,and their average recoveries were100.69%(RSD=1.28%),101.37%(RSD=0.23%)and102.40%(RSD=0.89%),respectively.CONCLUSION:The method was simple,accurate,reproducible,and suitable for the quality control of metronidazole compound.
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Antibacterial effect of tetracaine hydrochloride was studied. Tetracaine hydrochloride (preservative free) were incubated with Staphylococcus aureus, coagulase negative staphylococcus and Pseudomonas aeruginosa respectively, for 18 hours and for 2 minutes. Then it was diluted and cultured on nutrient agar plate. Colony counts were done after 18 hours. In case of 18 hours incubation, there was no growth of microbials in 0.5%, 0.1% tetracaine hydrochloride, but there was no inhibitory effect of 0.02% tetracaine hydrochloride on growth of microbials, irrespective of inoculum amount. In case of 2 minutes incubation with 0.5% tetracaine hydrochloride, there was no difference between the amount of microbial inoculum and colony count. Above indicates that tetracaine hydrochloride has no inhibitory effect on bacterial growth after short exposure of less than 2 minutes.
Subject(s)
Anti-Bacterial Agents/pharmacology , Colony Count, Microbial , Pseudomonas aeruginosa/drug effects , Staphylococcus aureus/drug effects , Tetracaine/pharmacology , Time FactorsABSTRACT
The short time antibacterial effect of tetracaine hydrochloride was studied. S. aureus, Coagulase Negative Staphylococcus and P. aeruginosa were each incubated with tetracaine hydrochloride(preservative free) for 18 hours or for 2 minutes and then diluted and cultured on nutrient agar plate. Colony counts were done after 18 hours. In cases of 18 hours incubation, there was no growth of microbials in 0.5%, 0.1% tetracaine hydrochloride, but there was no inhibitory effect of 0.02% of tetracaine hydrochloride on growth of microbials, irrespective of inoculum amount. In cases of 2 minutes incubation with 0.5% tetracaine hydrochloride, there was no difference between the amount of microbial inoculum and colony count. Above in vitro study indicates that tetracaine hydrochloride has no inhibitory effect on bacterial growth in short time exposure less than 2 minutes.
Subject(s)
Agar , Coagulase , Staphylococcus , TetracaineABSTRACT
The short time antibacterial effect of tetracaine hydrochloride was studied. S. aureus, Coagulase Negative Staphylococcus and P. aeruginosa were each incubated with tetracaine hydrochloride(preservative free) for 18 hours or for 2 minutes and then diluted and cultured on nutrient agar plate. Colony counts were done after 18 hours. In cases of 18 hours incubation, there was no growth of microbials in 0.5%, 0.1% tetracaine hydrochloride, but there was no inhibitory effect of 0.02% of tetracaine hydrochloride on growth of microbials, irrespective of inoculum amount. In cases of 2 minutes incubation with 0.5% tetracaine hydrochloride, there was no difference between the amount of microbial inoculum and colony count. Above in vitro study indicates that tetracaine hydrochloride has no inhibitory effect on bacterial growth in short time exposure less than 2 minutes.