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【应助】请帮忙 急 药典翻译

  • smilemliey
    2010/01/15
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专业英语

  • 我是做药品加工的贸易公司的一名职员,现在河北省药监局对于加工出口药品进行规范管理,现在都要去备案,要求资料提供,加工生产药品药典的中文翻译,实在是不在行这么专业,烦请各位专业人事,可以给帮忙一下!

    维生素B1/b6针:



    新建 Microsoft Word 文档 (2).doc
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  • 影子

    第1楼2010/01/15

    先贴出来,请大家共同翻译,能译多少译多少吧:
    Thiamine Hydrochloride Injection
    »Thiamine Hydrochloride Injection is a sterile solution of Thiamine Hydrochloride in Water for Injection.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of thiamine hydrochloride (C12H17ClN4OS•HCl).
    Packaging and storage— Preserve in single-dose or multiple-dose containers,preferably of Type Iglass,protected from light.
    USP Reference standards á11ñ— USP Endotoxin RS.USP Thiamine Hydrochloride RS.
    Identification—
    A: It yields a white precipitate with mercuric chloride TS,and a red-brown precipitate with iodine TS.It also yields a precipitate with mercuric-potassium iodide TS,and with trinitrophenol TS.
    B: Dilute a portion of Injection with water to a concentration of about 10mg of thiamine hydrochloride per mL.To 0.5mLof this solution add 5mLof 0.5Nsodium hydroxide,then add 0.5mLof potassium ferricyanide TSand 5mLof isobutyl alcohol,shake the mixture vigorously for 2minutes,and allow the liquid layers to separate:when illuminated from above by a vertical beam of UVlight and viewed at a right angle to this beam,the air-liquid meniscus shows a vivid blue fluorescence,which disappears when the mixture is slightly acidified,but reappears when it is again made alkaline.
    C: It responds to the tests forChloride á191ñ.
    Bacterial endotoxins á85ñ— It contains not more than 3.5USP Endotoxin Units per mg of thiamine hydrochloride.
    pHá791ñ: between 2.5and 4.5.
    Other requirements— It meets the requirements underInjections á1ñ.
    Assay—
    Mobile phase,Internal standard solution,Standard preparation,and Chromatographic system— Prepare as directed in theAssay underThiamine Hydrochloride Elixir(Oral Solution,Official June 1,2005).
    Assay preparation— Quantitatively dilute an accurately measured volume of Injection withMobile phase to obtain a solution containing about 500µg of thiamine hydrochloride per mL.Pipet 10mLof the resulting solution and 10mLofInternal standard solution into a 100-mLvolumetric flask,dilute withMobile phase to volume,and mix.
    Procedure— Proceed as directed forProcedure in theAssay underThiamine Hydrochloride Elixir Oral Solution,(Official June 1,2005).Calculate the quantity,in mg,of thiamine hydrochloride (C12H17ClN4OS•HCl)in each mLof the Injection taken by the formula:
    C(L/D)(RU/RS),
    in whichCis the concentration,in mg per mL,of USP Thiamine Hydrochloride RSin theStandard preparation;Lis the labeled quantity,in mg per mL,of thiamine hydrochloride in the Injection;Dis the concentration,in mg per mL,of thiamine hydrochloride in theAssay preparation on the basis of the labeled quantity and the extent of dilution;andRUandRSare the ratios of the peak responses of thiamine to methylparaben obtained from theAssay preparation and theStandard preparation,respectively.


    Pyridoxine Hydrochloride Injection
    »Pyridoxine Hydrochloride Injection is a sterile solution of Pyridoxine Hydrochloride in Water for Injection.It contains not less than 95.0percent and not more than 115.0percent of the labeled amount of Pyridoxine Hydrochloride (C8H11NO3•HCl).
    Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass,protected from light.
    USP Reference standards á11ñ— USP Endotoxin RS.USP Pyridoxine Hydrochloride RS.
    Identification— Evaporate a volume of Injection,equivalent to about 50mg of pyridoxine hydrochloride,on a steam bath to dryness.Add 5mLof dehydrated alcohol,and again evaporate to dryness.Dry the residue at 105 for 3hours:the residue so obtained responds to Identificationtests Aand Bunder Pyridoxine Hydrochloride.
    Bacterial endotoxins á85ñ— It contains not more than 0.4USP Endotoxin Unit per mg of pyridoxine hydrochloride.
    pHá791ñ: between 2.0and 3.8.
    Other requirements— It meets the requirements under Injections á1ñ.
    Change to read:
    Assay—
    Ammonium chloride–ammonium hydroxide buffer— Dissolve 16g of ammonium chloride in 70mLof water,add 16mLof ammonium hydroxide,dilute with water to 100mL,mix,and filter.
    Chlorimide solution— Dissolve 40mg of 2,6-dichloroquinone-chlorimide in 100mLof isopropyl alcohol.Store the solution in a refrigerator,and use within one month.Do not use the solution if it has become pink.
    Standard stock solution— Dissolve a suitable quantity of USP Pyridoxine Hydrochloride RS,accurately weighed,in 0.1Nhydrochloric acid,quantitatively dilute with the same solvent to obtain a solution having a known concentration of about 0.1mg per mL,and mix.Keep the solution in an amber bottle,in a cool place.
    Standard preparation— In a 100-mLvolumetric flask dilute 10.0mLof Standard stock solutionwith water to volume,and mix.Prepare this solution daily as needed.
    Assay preparation— Dilute an accurately measured volume of Injection,equivalent to about 100mg of pyridoxine hydrochloride,quantitatively and stepwise with water to a concentration of about 10µg of pyridoxine hydrochloride per mL.
    Procedure—
    (a)Pipet 5mLof the clear Assay preparationinto a flask,add 25.0mLof isopropyl alcohol,and mix.Pipet 5mLof the isopropyl alcohol dilution into a glass-stoppered,25-mLgraduated cylinder or test tube,and add in succession,mixing after each addition,1.0mLof Ammonium chloride–ammonium hydroxide buffer,1.0mLof sodium acetate solution (1in 5),and 1.0mLof water.Cool to about 25 ,then add 1.0mLof Chlorimide solution,shake vigorously for 10seconds,accurately timed.Sixty seconds,accurately timed,after the addition of the Chlorimide solution,determine the absorbance at the wavelength of maximum absorbance at about 650nm,with a suitable spectrophotometer,using water as the blank.[NOTE—Make the reading promptly to avoid errors due to fading of the color.]Designate the absorbance as AU.
    (b)Repeat procedure(a),but substitute 1.0mLof boric acid solution (1in 20)for the 1.0mLof water.Designate the absorbance as AU.
    (c)Repeat procedure(a),but substitute 5.0mLof the Standard preparationfor the 5.0mLof the Assay preparation.Designate the absorbance as AS.
    (d)Repeat procedure(c),but substitute 1.0mLof boric acid solution (1in 20)for the 1.0mLof water.Designate the absorbance as AS.
    Calculate the quantity,in mg,of Pyridoxine Hydrochloride (C8H11NO3•HCl)in each mLof the Injection taken by the formula:
    10(C/V)(AUAU)/(ASAS), USP28
    in which Cis the concentration,in µg per mL,of USP Pyridoxine Hydrochloride RSin the Standard preparation;Vis the volume,in mL,of Injection taken;and the other terms are as defined above. USP28

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  • 影子

    第2楼2010/01/15

    Thiamine Hydrochloride Injection
    »Thiamine Hydrochloride Injection is a sterile solution of Thiamine Hydrochloride in Water for Injection.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of thiamine hydrochloride (C12H17ClN4OS•HCl).
    Packaging and storage— Preserve in single-dose or multiple-dose containers,preferably of Type I glass,protected from light.
    USP Reference standards á11ñ— USP Endotoxin RS.USP Thiamine Hydrochloride RS.
    维生素B1注射液
    维生素B1注射液是维生素B1盐酸盐用注射用水制备的一种灭菌溶液。含维生素B1盐酸盐(C12H17ClN4OS•HCl)应为标示量的90.0%~110.0%。
    包装和贮存:保存在单剂量或多剂量容器中,最好是I型玻璃,避光保存。
    USP参照标准<11>- USP 内毒素RS,USP维生素B1盐酸盐RS。
    Identification—
    A: It yields a white precipitate with mercuric chloride TS,and a red-brown precipitate with iodine TS.It also yields a precipitate with mercuric-potassium iodide TS,and with trinitrophenol TS.
    鉴别:
    A:加氯化汞试液产生白色沉淀,加碘试液产生红褐色沉淀。加碘化汞钾试液和三硝基苯酚试液也产生白色沉淀。


    B: Dilute a portion of Injection with water to a concentration of about 10mg of thiamine hydrochloride per mL.To 0.5mLof this solution add 5mLof 0.5Nsodium hydroxide,then add 0.5mLof potassium ferricyanide TSand 5mLof isobutyl alcohol,shake the mixture vigorously for 2minutes,and allow the liquid layers to separate:when illuminated from above by a vertical beam of UVlight and viewed at a right angle to this beam,the air-liquid meniscus shows a vivid blue fluorescence,which disappears when the mixture is slightly acidified,but reappears when it is again made alkaline.
    B:取部分注射液用水稀释至含维生素B1约为10mg/ml的溶液。取此溶液0.5ml,加0.5N氢氧化钠溶液5ml,再加0.5ml铁氰化钾试液及5ml异丁醇,剧烈振摇2分钟。放置使分层:在紫外光灯下垂直照射,上层(注:与空气接触的液体弯月面是不是就是指最上层?)显示强烈的蓝色荧光,加弱酸荧光消失,当使之再呈碱性时荧光又出现。

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  • 该帖子已被版主-何当奇加6积分,加2经验;加分理由:应助
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  • 影子

    第3楼2010/01/16

    C: It responds to the tests forChloride á191ñ.
    Bacterial endotoxins á85ñ— It contains not more than 3.5USP Endotoxin Units per mg of thiamine hydrochloride.
    pHá791ñ: between 2.5and 4.5.
    Other requirements— It meets the requirements underInjections á1ñ.
    C:符合氯化物<191>项下的测试。
    细菌内毒素<85>:每克维生素B1盐酸盐含内毒素不超过3.5EU
    pH<791>:在2.5-4.5之间。
    其它要求:符合注射剂<1>项下的要求。

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  • 影子

    第4楼2010/01/16

    Assay—
    Mobile phase,Internal standard solution,Standard preparation,and Chromatographic system— Prepare as directed in theAssay underThiamine Hydrochloride Elixir(Oral Solution,Official June 1,2005).
    Assay preparation— Quantitatively dilute an accurately measured volume of Injection withMobile phase to obtain a solution containing about 500µg of thiamine hydrochloride per mL.Pipet 10mLof the resulting solution and 10mLofInternal standard solution into a 100-mLvolumetric flask,dilute withMobile phase to volume,and mix.
    Procedure— Proceed as directed forProcedure in theAssay underThiamine Hydrochloride Elixir Oral Solution,(Official June 1,2005).Calculate the quantity,in mg,of thiamine hydrochloride (C12H17ClN4OS•HCl)in each mLof the Injection taken by the formula:
    C(L/D)(RU/RS),
    in whichCis the concentration,in mg per mL,of USP Thiamine Hydrochloride RSin theStandard preparation;Lis the labeled quantity,in mg per mL,of thiamine hydrochloride in the Injection;Dis the concentration,in mg per mL,of thiamine hydrochloride in the Assay preparation on the basis of the labeled quantity and the extent of dilution;andRUandRSare the ratios of the peak responses of thiamine to methylparaben obtained from theAssay preparation and theStandard preparation,respectively.
    含量:流动相,内标溶液,标准溶液的制备以及系统适用性直接按维生素B1酏剂项下含量测试方法进行。(口服溶液)
    含量测试溶液制备:准确量取注射液适量,用流动相定量稀释至维生素B1盐酸盐浓度约为500µg /mL的溶液。吸取此溶液10ml以及内标溶液10ml,置于100ml量瓶中,用流动相稀释至刻度,混合。
    程序:直接按维生素B1酏剂口服溶液项下含量测试方法进行。按下列公式计算每ml中维生素B1盐酸盐(C12H17ClN4OS•HCl)的质量,以mg计:
    C(L/D)(RU/RS)
    式中:C表示维生素B1盐酸盐USP标准溶液的浓度(mg/ml),L表示注射液中维生素B1盐酸盐的标示量(mg/ml),D表示含量测试溶液中维生素B1盐酸盐的浓度(mg/ml),RU和RS分别表示含量测试溶液与标准溶液中所测得的维生素B1与对羟基苯甲酸甲脂峰响应值的比值。
    注:上面红色部分不太明白是啥意思?

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  • smilemliey

    第5楼2010/01/18

    我这有本中文的国外药典,翻译,关于含量这一项是这么写的,HPLC法。十八烷基硅烷键合硅胶,流动相为0.04M磷酸二氢钾-甲醇(55:45),检测波长为254nm,对二甲苯为内标。它是这么总结的!我这本书,只写结果如何判定,不详细中间检验过程,可是药监局明文要整个翻译过来,真是头大!

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  • 何当奇

    第6楼2010/01/18

    on the basis of the labeled quantity 根据标示量


    and RU and RS are the ratios of the peak responses of thiamine to methylparaben obtained from the Assay preparation and theStandard preparation,respectively.
    RU 和 RS 分别是测试液和标准液中维生素B1与对羟基苯甲酸甲脂的峰值之比

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  • smilemliey

    第7楼2010/01/20

    谢谢给我的解答!

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  • smilemliey

    第8楼2010/01/22

    能不能帮忙把B6针的也给翻译一下!先谢谢!

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  • smilemliey

    第9楼2010/01/22

    Pyridoxine Hydrochloride Injection
    »Pyridoxine Hydrochloride Injection is a sterile solution of Pyridoxine Hydrochloride in Water for Injection.It contains not less than 95.0percent and not more than 115.0percent of the labeled amount of Pyridoxine Hydrochloride (C8H11NO3•HCl).
    Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass,protected from light.
    USP Reference standards á11ñ— USP Endotoxin RS.USP Pyridoxine Hydrochloride RS.
    Identification— Evaporate a volume of Injection,equivalent to about 50mg of pyridoxine hydrochloride,on a steam bath to dryness.Add 5mLof dehydrated alcohol,and again evaporate to dryness.Dry the residue at 105 for 3hours:the residue so obtained responds to Identificationtests Aand Bunder Pyridoxine Hydrochloride.
    Bacterial endotoxins á85ñ— It contains not more than 0.4USP Endotoxin Unit per mg of pyridoxine hydrochloride.
    pHá791ñ: between 2.0and 3.8.
    Other requirements— It meets the requirements under Injections á1ñ.
    Change to read:
    Assay—
    Ammonium chloride–ammonium hydroxide buffer— Dissolve 16g of ammonium chloride in 70mLof water,add 16mLof ammonium hydroxide,dilute with water to 100mL,mix,and filter.
    Chlorimide solution— Dissolve 40mg of 2,6-dichloroquinone-chlorimide in 100mLof isopropyl alcohol.Store the solution in a refrigerator,and use within one month.Do not use the solution if it has become pink.
    Standard stock solution— Dissolve a suitable quantity of USP Pyridoxine Hydrochloride RS,accurately weighed,in 0.1Nhydrochloric acid,quantitatively dilute with the same solvent to obtain a solution having a known concentration of about 0.1mg per mL,and mix.Keep the solution in an amber bottle,in a cool place.
    Standard preparation— In a 100-mLvolumetric flask dilute 10.0mLof Standard stock solutionwith water to volume,and mix.Prepare this solution daily as needed.
    Assay preparation— Dilute an accurately measured volume of Injection,equivalent to about 100mg of pyridoxine hydrochloride,quantitatively and stepwise with water to a concentration of about 10µg of pyridoxine hydrochloride per mL.
    Procedure—
    (a)Pipet 5mLof the clear Assay preparationinto a flask,add 25.0mLof isopropyl alcohol,and mix.Pipet 5mLof the isopropyl alcohol dilution into a glass-stoppered,25-mLgraduated cylinder or test tube,and add in succession,mixing after each addition,1.0mLof Ammonium chloride–ammonium hydroxide buffer,1.0mLof sodium acetate solution (1in 5),and 1.0mLof water.Cool to about 25 ,then add 1.0mLof Chlorimide solution,shake vigorously for 10seconds,accurately timed.Sixty seconds,accurately timed,after the addition of the Chlorimide solution,determine the absorbance at the wavelength of maximum absorbance at about 650nm,with a suitable spectrophotometer,using water as the blank.[NOTE—Make the reading promptly to avoid errors due to fading of the color.]Designate the absorbance as AU.
    (b)Repeat procedure(a),but substitute 1.0mLof boric acid solution (1in 20)for the 1.0mLof water.Designate the absorbance as AU.
    (c)Repeat procedure(a),but substitute 5.0mLof the Standard preparationfor the 5.0mLof the Assay preparation.Designate the absorbance as AS.
    (d)Repeat procedure(c),but substitute 1.0mLof boric acid solution (1in 20)for the 1.0mLof water.Designate the absorbance as AS.
    Calculate the quantity,in mg,of Pyridoxine Hydrochloride (C8H11NO3•HCl)in each mLof the Injection taken by the formula:
    10(C/V)(AUAU)/(ASAS), USP28
    in which Cis the concentration,in µg per mL,of USP Pyridoxine Hydrochloride RSin the Standard preparation;Vis the volume,in mL,of Injection taken;and the other terms are as defined above. USP28

    smilemliey(smilemliey) 发表:能不能帮忙把B6针的也给翻译一下!先谢谢!

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  • 影子

    第10楼2010/01/22

    楼主应该是可以自己翻译的,大致差不多:




    维生素B6注射液
    维生素B6注射液是维生素B6盐酸盐用注射用水制备的一种灭菌溶液。含维生素B6盐酸盐(C8H11NO3•HCl)应为标示量的95.0%~115.0%。
    包装和贮存:保存在单剂量或多剂量容器中,最好是I型玻璃,避光保存。
    USP参照标准<11>- USP 内毒素RS,USP维生素B6盐酸盐RS。
    鉴别:
    A:取一定体积的注射液(约相当于维生素B6盐酸盐50mg),在蒸汽浴中蒸发至干。加5ml无水乙醇,再次蒸发至干。将残渣在105℃干燥3小时:取此残渣按维生素B6盐酸盐鉴别A和B项下的方法进行测试,应符合规定。
    细菌内毒素<85>:每克维生素B6盐酸盐含内毒素不超过0.4EU
    pH<791>:在2.0-3.8之间。
    其它要求:符合注射剂<1>项下的要求。

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