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smilemliey

2010/03/05

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大家帮忙给翻译一下！在这里感谢大家啊！

影子 2010/03/05

[size=3][font=宋体]楼主好象求助过前面部分的相关内容。注射液的通则内容太多，没时间看，楼主先自行翻译吧。[/font][font=Arial][/font][/size] [size=3][b][font=Arial]Assay—[/font][/b][font=Arial] [/font][/size] [size=3][i][font=Arial]Mobile phase—[/font][/i][font=Arial] Prepare a filtered and degassed mixture of 0.04[i]M[/i]aqueous monobasic potassium phosphate and methanol (55:45).Make adjustments if necessary (see [i]System Suitability[/i]under [url=http://www.newdruginfo.com/pharmacopeia/usp28/v28230/usp28nf23s0_c621.htm#usp28nf23s0_c621][i]Chromatography [/i][font=Symbol]á[/font]621[font=Symbol]ñ[/font][/url]). [/font][/size] [size=3][i][font=Arial]Internal standard solution—[/font][/i][font=Arial] Prepare a solution of methylparaben in [i]Mobile phase[/i]having a concentration of about 100µg per mL. [/font][/size] [size=3][i][font=Arial]Standard preparation—[/font][/i][font=Arial] Prepare a solution of [url=http://www.newdruginfo.com/pharmacopeia/usp28/v28230/usp28nf23s0_alpha-18-1412.htm#usp28nf23s0_c11rs1158][i]USP Thiamine Hydrochloride RS[/i][/url]in [i]Mobile phase[/i]having an accurately known concentration of about 500µg per mL.Pipet 10mLof this solution and 10mLof [i]Internal standard solution[/i]into a 100-mLvolumetric flask,dilute with [i]Mobile phase[/i]to volume,and mix to obtain a [i]Standard preparation[/i]having a known concentration of about 50µg per mL. [/font][/size] [size=3][i][font=Arial]Assay preparation—[/font][/i][font=Arial] Quantitatively dilute an accurately measured volume of Oral Solution with [i]Mobile phase[/i]to obtain a solution containing about 500µg of thiamine hydrochloride per mL.Pipet 10mLof the resulting solution and 10mLof [i]Internal standard solution[/i]into a 100-mLvolumetric flask,dilute with [i]Mobile phase[/i]to volume,and mix. [/font][/size] [size=3][font=宋体]流动相[/font][font=Arial] - [/font][font=宋体]将[/font][font=Arial]0.04M[/font][font=宋体]的磷酸二氢钾水溶液与甲醇以[/font][font=Arial]55:45[/font][font=宋体]的比例混合后，过滤、脱气。如有必要，可适当调整（看色谱技术[/font][font=Arial]<621>[/font][font=宋体]项下的系统适用性）。[/font][font=Arial][/font][/size] [size=3][font=宋体]内标溶液[/font][font=Arial] – [/font][font=宋体]用流动相制备浓度为[/font][font=Arial]100µg/mL[/font][font=宋体]的对羟基苯甲酸甲酯溶液。[/font][font=Arial][/font][/size] [size=3][font=宋体]标准溶液[/font][font=Arial] -[/font][font=宋体]用流动相制备含准确浓度约为[/font][font=Arial]500µg/mL[/font][font=宋体]的[/font][font=Arial]USP[/font][font=宋体]维生素[/font][font=ˎ̥][font=Times New Roman]B1[/font][/font][font=宋体]溶液。取此溶液[/font][font=Arial]10ml[/font][font=宋体]及内标溶液[/font][font=Arial]10ml[/font][font=宋体]，置于[/font][font=Arial]100ml[/font][font=宋体]量瓶中，用流动相稀释至刻度，混匀后得到一已知浓度约为[/font][font=Arial]50µg/mL[/font][font=宋体]的标准溶液。[/font][font=Arial][/font][/size] [size=3][font=宋体]含量测试溶液[/font][font=Arial] – [/font][font=宋体]准确量取一定体积的口服溶液，用流动相定量稀释成含[/font][font=宋体]维生素[/font][font=ˎ̥][font=Times New Roman]B1[/font][/font][font=宋体]约为[/font][font=Arial]500µg/mL[/font][font=宋体]的溶液。取此溶液[/font][font=Arial]10ml[/font][font=宋体]及内标溶液[/font][font=Arial]10ml[/font][font=宋体]，置于[/font][font=Arial]100ml[/font][font=宋体]量瓶中，用流动相稀释至刻度，混匀。[/font][/size][font=Arial][/font]

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影子

第1楼2010/03/05

这个内容也太多了吧?楼主可以先自己翻译,然后大家帮你改?

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影子

第2楼2010/03/05

楼主好象求助过前面部分的相关内容。注射液的通则内容太多，没时间看，楼主先自行翻译吧。

Assay—

Mobile phase— Prepare a filtered and degassed mixture of 0.04Maqueous monobasic potassium phosphate and methanol (55:45).Make adjustments if necessary (see System Suitabilityunder Chromatography á621ñ).

Internal standard solution— Prepare a solution of methylparaben in Mobile phasehaving a concentration of about 100µg per mL.

Standard preparation— Prepare a solution of USP Thiamine Hydrochloride RSin Mobile phasehaving an accurately known concentration of about 500µg per mL.Pipet 10mLof this solution and 10mLof Internal standard solutioninto a 100-mLvolumetric flask,dilute with Mobile phaseto volume,and mix to obtain a Standard preparationhaving a known concentration of about 50µg per mL.

Assay preparation— Quantitatively dilute an accurately measured volume of Oral Solution with Mobile phaseto obtain a solution containing about 500µg of thiamine hydrochloride per mL.Pipet 10mLof the resulting solution and 10mLof Internal standard solutioninto a 100-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.

流动相 - 将0.04M的磷酸二氢钾水溶液与甲醇以55:45的比例混合后，过滤、脱气。如有必要，可适当调整（看色谱技术<621>项下的系统适用性）。

内标溶液 – 用流动相制备浓度为100µg/mL的对羟基苯甲酸甲酯溶液。

标准溶液 -用流动相制备含准确浓度约为500µg/mL的USP维生素B1溶液。取此溶液10ml及内标溶液10ml，置于100ml量瓶中，用流动相稀释至刻度，混匀后得到一已知浓度约为50µg/mL的标准溶液。

含量测试溶液 – 准确量取一定体积的口服溶液，用流动相定量稀释成含维生素B1约为500µg/mL的溶液。取此溶液10ml及内标溶液10ml，置于100ml量瓶中，用流动相稀释至刻度，混匀。

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第3楼2010/03/05

Chromatographic system(see Chromatography á621ñ)— The liquid chromatograph is equipped with a 254-nm detector and a 3.9-mm ×30-cm column that contains packing L1.The flow rate is about 1.0mLper minute.Chromatograph the Standard preparation,and record the peak responses as directed for Procedure:the relative retention times are about 0.35for thiamine and 1.0for methylparaben;the resolution,R,between the thiamine and methylparaben peaks is not less than 6.0;and the relative standard deviation for replicate injections is not more than 2.0%.

Procedure— Separately inject equal volumes (about 25µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of thiamine hydrochloride (C₁₂H₁₇ClN₄OS·HCl)in each mLof the Oral Solution taken by the formula: C(L/D)(R_U/R_S)

C(L/D)(R_U/R_S),
in which Cis the concentration,in mg per mL,of USP Thiamine Hydrochloride RSin the Standard preparation;Lis the labeled quantity,in mg per mL,of thiamine hydrochloride in the Oral Solution;Dis the concentration,in mg per mL,of thiamine hydrochloride in the Assay preparationon the basis of the labeled quantity and the extent of dilution;and R_Uand R_Sare the ratios of the peak responses of thiamine to methylparaben obtained from the Assay preparationand the Standard preparation,respectively.

(Official June 1,2005)

色谱系统（看色谱技术<621>）- 液相色谱的检测器波长为254nm，色谱柱型号为3.9mm×30cm，填料为L₁。流速约为1.0ml/min。将标准溶液进行色谱分析，并按下面的程序记录峰响应值：硫胺的相对保留时间约为0.35，对羟基苯甲酸甲酯的相对保留时间约为1.0；硫胺与对羟基苯甲酸甲酯峰之间的分离度不低于6.0；且重复进样的相对标准偏差不大于2.0%。

程序 - 分别将等体积（约25µL）的标准溶液与含量测试溶液注入液相色谱仪，记录色谱图并测量主峰的响应值。按下式计算每ml口服溶液中维生素B1(C₁₂H₁₇ClN₄OS·HCl)的量，以mg表示：

式中：C表示标准溶液中USP维生素B1的浓度（mg/ml）；L表示口服溶液中维生素B1的标示量（mg/ml）；D表示含量测试溶液中基于标示量与稀释倍数的维生素B1盐酸盐的浓度（mg/ml）[这句话译得不太顺畅，意思是不能仅仅将含量测试溶液的最终浓度代入公式计算，还需要考虑稀释倍数]，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与对羟基苯甲酸甲酯峰响应值的比值。