【原创】happyjyl的翻译(二)--HPLC常用句型归纳

原文:Peak of each known impurity should be well separated from each other and from the drug peak and should be identified clearly in the chromatogram of impurity composite standard solution with drug.

翻译:在药品和杂质混合标准液色谱图中，每一已知杂质的峰都应完全分离，且与药品峰完全分离，并在色谱图中标示清楚。

原文：Procedure: Inject separately, 20 ul of mobile phase, impurity standard solution, and five injections of standard solution. Record the chromatograms. The relative standard deviation of five replicate injection of the standard solution is not more than 2.0%. Inject the 20 ul sample solution in duplicate and record the peak responses. The relative retention time of D(+) acid is about 0.28, trans-Lactam is about 0.72, and Cis(+) hydroxy lactam is 1.0.

翻译：流动相和杂质标准品溶液各进样20μl。标准品溶液进样5次，每次20μl。记录色谱图。标准品溶液5次重复进样的RSD不得超过2.0％。样品溶液进样2次，每次20μl。记录峰响应值。D(+)酸的相对保留时间约为0.28，反式内酰胺的相对保留时间约为0.72，顺(+)-羟基内酰胺的相对保留时间为1.0。



原文：Mobile phase: The mobile phase is prepared by adding the 300 ml n-Hexane to the 700 ml ethanol in small portions with continuous stirring until a clear solution is obtained.

翻译：流动相的制备：取乙醇700ml，加入正己烷300ml。加入正己烷时每次加入少许，持续搅拌直至溶液澄清。

中国药典上有关HPLC的常见句型和表达方式归纳:

1.流动相:

A-B为流动相
The mobile phase is A-B

以A和B的混合溶液作为流动相
use a mixture of A-B as the mobile phase

以A为填充剂,B-C-D为流动相
using a column packed with A and a mixture of B-C-D as the mobile phase

用……为流动相，流速为每分钟Aml
using …as the mobile phase with a flow rate A ml per minute

2.样品的称量和溶液的配制:


取本品约……mg,精称
Weigh accurately about …mg of


取本品约Amg,精密称定，置Bml量瓶中，加C溶液使溶解并稀释至刻度
Dissolve about A mg,accurately weighed, in C and dilute to volume in a B ml volumetric flask.



取本品约Amg,精密称定，置Bml量瓶中，精密加入C溶液Dml
Transfer about A mg, accurately weighed, into B ml volumetric flask, add C ml of D solution, accuratelt measured.


精密量取A与B各Cml,置Dml量瓶中，加E稀释至刻度
Transfer C ml each of A and B, both measured accurately, in a D ml volumetric flask, dilute with E to volume


用……稀释至刻度
dilute with … to volume


制成每ml中含Amg的溶液
dilute to a solution of A mg per ml


取……，加A制成每ml中含B mg的溶液
Prepare a B mg per ml solution of … in A.
Dissolve a quantity of … in A to produce a solution of about B mg per ml.


取1mol/L……溶液A ml与1mol/L……溶液B ml，置1000ml容量瓶中，混匀，加水稀释至刻度
Mix A ml of … solution and B ml of … solution, dilute with water to 1000 ml.


超声处理使溶解
ultrasonic to dissolve


取本品Amg,置Bml量瓶中，加C溶液Dml,超声处理使溶解
Dissolve A mg of … in D ml C in a B ml volumetric flask with ultrasonicate.


用……溶液提取A次,每次B ml
extract with A portions each of B ml of … solution


用……试液调节pH至10
adjust to pH 10 with ……


用A调节pH至B±C
adjust pH B±C with A


置分液漏斗中，加A……ml,振摇
in … ml of A in a separator with shaking


合并提取液
combine the extracts

3.色谱条件

pH适应范围应大于8
pH more than 8


A与B的分离度应符合规定
The resolution factor between the peaks of A and B complies with the related requirements.


检测波长为……nm
Detection wavelength is …… nm.


流速为每分钟……毫升
with a flowrate …… ml per minute


流速为每分钟Aml;柱温B℃
Maintain the column temperature at B℃ and flow rate at A ml per minute.


以A为填充剂,B-C-D为流动相
using a column packed with A and a mixture of B-C-D as the mobile phase


用……为流动相，流速为每分钟Aml
using …as the mobile phase with a flow rate A ml per minute


柱温A～B℃
maintain the column A～B℃

4.测定法


建立……测定的HPLC法
develop an HPLC method for determination of ……


将上述溶液取20μl注入液相色谱仪
Inject 20 μl of the resulting solution into the column


另取……对照品，同法测定。
Repeat the operation,using … CRS instead of the substance being examed.


理论塔板数按……峰计算应不低于1000。
The number of theoretical plates of the column is not less than 1000, calculated with reference to the peak of ….


记录色谱图
record the chromatogram
record the peak areas correspondingly obtained in the chromatogram


照……项下的方法进行含量测定
Carry out the Assay described under …


照高效液相色谱法（附录Ⅴ D）测定
Carry out the method for high performance liquid chromatography (Appendix Ⅴ D）

5.计算:


按干燥品计算
calculated on the dried basis


按无水物计算
calculated on the anhydrous basis


按无水物计算，含……不得少于96.0％。
It contains not less than 96.0% of …, calculated on the anhydrous basis.


按外标法以峰面积计算供试品中……的含量
Calculate the content of … with respect to the peak area obtained in the chromatogram by the external standard method.


本品含A按B（化学式)计算，应为标示量的90.0％～110.0％。
It contains not less than 90.0% and not more than 110.0% of the labelled amount of A, calculated as B （化学式).

时间和精力有限,所以只贴出了中国药典中有关HPLC的常用句型,不包括1-3楼中的句型,也不包括美国药典/英国药典/英文资料中的句型.而且只是医药行业中用到的.欢迎不同行业的网友把自己平时遇到的句型补充上去.

请问这些翻译是斑竹自己翻译的还是参考《中国药典》英文版的？还是USP版？