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liuchenjie

金虫 (小有名气)

金刚

[交流] 帮我翻译一下吧 很难

IBUPROFEN
Ibuprofenum
C13H18O2 Mr 206.3
[15687-27-1]
DEFINITION
(2RS)-2-[4-(2-Methylpropyl)phenyl]propanoic acid.
Content : 98.5 per cent to 101.0 per cent (dried substance).
CHARACTERS
Appearance: white or almost white, crystalline powder or
colourless crystals.
Solubility : practically insoluble in water, freely soluble in
acetone, in methanol and in methylene chloride. It dissolves
in dilute solutions of alkali hydroxides and carbonates.
IDENTIFICATION
First identification : A, C.
Second identification : A, B, D.
A. Melting point (2.2.14) : 75 °C to 78 °C.
B. Dissolve 50.0 mg in a 4 g/l solution of sodium
hydroxide R and dilute to 100.0 ml with the same
alkaline solution. Examined between 240 nm and
300 nm (2.2.25), using a spectrophotometer with a band
width of 1.0 nm and a scan speed of not more than
50 nm/min, the solution shows a shoulder at 258 nm and
2 absorption maxima, at 264 nm and 272 nm. The ratio of
the absorbance measured at the maximum at 264 nm to
that measured at the shoulder at 258 nm is 1.20 to 1.30.
The ratio of the absorbance measured at the maximum at
272 nm to that measured at the shoulder at 258 nm is
1.00 to 1.10.
C. Infrared absorption spectrophotometry (2.2.24).
Preparation: discs.
Comparison: ibuprofen CRS.
D. Thin-layer chromatography (2.2.27).
Test solution. Dissolve 50 mg of the substance to be
examined in methylene chloride R and dilute to 10 ml
with the same solvent.
Reference solution. Dissolve 50 mg of ibuprofen CRS in
methylene chloride R and dilute to 10 ml with the same
solvent.
Plate : TLC silica gel plate R.
Mobile phase: anhydrous acetic acid R, ethyl acetate R,
hexane R (5:24:71 V/V/V).
Application: 5 μl.
Development: over a path of 10 cm.
Drying: at 120 °C for 30min.
Detection: lightly spray with a 10 g/l solution of
potassium permanganate R in dilute sulphuric acid R
and heat at 120 °C for 20 min. Examine in ultraviolet
light at 365 nm.
Results : the principal spot in the chromatogram obtained
with the test solution is similar in position, colour and
size to the principal spot in the chromatogram obtained
with the reference solution.
TESTS
Solution S. Dissolve 2.0 g in methanol R and dilute to 20 ml
with the same solvent.
Appearance of solution. Solution S is clear (2.2.1) and
colourless (2.2.2, Method II).
Angle of optical rotation (2.2.7) : − 0.05° to + 0.05°.
Dissolve 0.50 g in methanol R and dilute to 20.0 ml with
the same solvent.
Related substances. Liquid chromatography (2.2.29).
Test solution. Dissolve 20 mg of the substance to be
examined in 2 ml of acetonitrile R and dilute to 10.0 ml with
mobile phase A.
Reference solution (a). Dilute 1.0 ml of the test solution to
100.0 ml with mobile phase A.
Reference solution (b). Dissolve 20mg of ibuprofen CRS in
2 ml of acetonitrile R, add 1.0 ml of a 0.06 g/l solution of
ibuprofen impurity B CRS in acetonitrile R and dilute to
10.0 ml with mobile phase A.
Column:
— size: l = 0.15 m, Ø = 4.6 mm,
— stationary phase: octadecylsilyl silica gel for
chromatography R (5 μm).
Mobile phase:
— mobile phase A: mix 0.5 volumes of phosphoric acid R,
340 volumes of acetonitrile R and 600 volumes of
water R; allow to equilibrate and dilute to 1000 volumes
with water R,
— mobile phase B: acetonitrile R,
Time
(min)
Mobile phase A
(per cent V/V)
Mobile phase B
(per cent V/V)
0 - 25 100 0
25 - 55 100 → 15 0 → 85
55 - 70 15 85
70 - 75 15 → 100 85 → 0
Flow rate: 2ml/min.
Detection: spectrophotometer at 214 nm.
Equilibration : for about 45 min with mobile phase A.
Injection: 20 μl.
System suitability : reference solution (b) :
— peak-to-valley ratio : minimum of 1.5, where Hp = height
above the baseline of the peak due to impurity B, and
Hv = height above the baseline of the lowest point of
the curve separating this peak from the peak due to
ibuprofen. If necessary, adjust the concentration of
acetonitrile in mobile phase A.
Limits :
— impurity B: not more than the area of the corresponding
peak in the chromatogram obtained with reference
solution (b) (0.3 per cent),
— any other impurity : not more than 0.3 times the area of
the principal peak in the chromatogram obtained with
reference solution (a) (0.3 per cent),
— total of all impurities apart from impurity B: not more
than 0.7 times the area of the principal peak in the
chromatogram obtained with reference solution (a)
(0.7 per cent),
General Notices (1) apply to all monographs and other texts 2119
Ibuprofen EUROPEAN PHARMACOPOEIA 6.0
— disregard limit : 0.05 times the area of the principal peak
in the chromatogram obtained with reference solution (a)
(0.05 per cent).
Impurity F. Gas chromatography (2.2.28) : use the
normalisation procedure.
Methylating solution. Dilute1mlof N,N-dimethylformamide
dimethyl acetal R and 1 ml of pyridine R to 10 ml with ethyl
acetate R.
Test solution. Weigh about 50.0mg of the substance to be
examined into a sealable vial, dissolve in 1.0 ml of ethyl
acetate R, add 1 ml of methylating solution, seal and heat at
100 °C in a block heater for 20 min. Allow to cool. Remove
the reagents under a stream of nitrogen at room temperature.
Dissolve the residue in 5 ml of ethyl acetate R.
Reference solution (a). Dissolve 0.5 mg of ibuprofen
impurity F CRS in ethyl acetate R and dilute to 10.0 ml with
the same solvent.
Reference solution (b). Weigh about 50.0mg of
ibuprofen CRS into a sealable vial, dissolve in 1.0 ml of
reference solution (a), add 1 ml of methylating solution,
seal and heat at 100 °C in a block heater for 20 min. Allow
to cool. Remove the reagents under a stream of nitrogen
at room temperature. Dissolve the residue in 5 ml of ethyl
acetate R.
Column:
— material: fused-silica,
— size: l = 25 m, Ø = 0.53 mm,
— stationary phase: macrogol 20 000 R (film thickness
2 μm).
Carrier gas: helium for chromatography R.
Flow rate: 5.0ml/min.
Temperature :
— column: 150 °C,
— injection port : 200 °C,
— detector : 250 °C.
Detection: flame-ionisation.
Injection: 1 μl ; inject the test solution and reference
solution (b).
Run time: twice the retention time of ibuprofen.
System suitability :
— relative retention with reference to ibuprofen (retention
time = about 17 min) : impurity F = about 1.5.
Limit :
— impurity F: maximum 0.1 per cent.
Heavy metals (2.4.8) : maximum 10 ppm.
12 ml of solution S complies with limit test B. Prepare the
standard using lead standard solution (1 ppm Pb) prepared
by diluting lead standard solution (100 ppm Pb) R with
methanol R.
Loss on drying (2.2.32) : maximum 0.5 per cent, determined
on 1.000 g by drying in vacuo over diphosphorus
pentoxide R.
Sulphated ash (2.4.14) : maximum 0.1 per cent, determined
on 1.0 g.
ASSAY
Dissolve 0.450 g in 50 ml of methanol R. Add 0.4 ml of
phenolphthalein solution R1. Titrate with 0.1 M sodium
hydroxide until a red colour is obtained. Carry out a blank
titration.
1 ml of 0.1 M sodium hydroxide is equivalent to 20.63 mg of
C13H18O2.
IMPURITIES
Specified impurities : A, B, C, D, E.
Other detectable impurities : F, G, H, I, J, K, L, M, N, O, P,
Q, R.
A. R1 = OH, R2 = CH2-CH(CH3)2, R3 = H:
(2RS)-2-[3-(2-methylpropyl)phenyl]propanoic
acid,
B. R1 = OH, R2 = H, R3 = [CH2]3-CH3: (2RS)-2-(4-
butylphenyl)propanoic acid,
C. R1 = NH2, R2 = H, R3 = CH2-CH(CH3)2 :
(2RS)-2-[4-(2-methylpropyl)phenyl]propanamide,
D. R1 = OH, R2 = H, R3 = CH3 : (2RS)-2-(4-
methylphenyl)propanoic acid,
E. 1-[4-(2-methylpropyl)phenyl]ethanone,
F. 3-[4-(2-methylpropyl)phenyl]propanoic acid,
G. cis-7-(2-methylpropyl)-1-[4-(2-methylpropyl)phenyl]-1,2,3,
4-tetrahydronaphthalene-1,4-dicarboxylic acid,
H. X = O: (3RS)-1,3-bis[4-(2-methylpropyl)phenyl]butan-1-one,
I. X = H2: (3RS)-1,3-bis[4-(2-methylpropyl)phenyl]butane,
2120 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 6.0 Iceland moss
J. R = H, R4 = CO-CH(CH3)2: (2RS)-2-[4-(2-
methylpropanoyl)phenyl]propanoic acid,
K. R = H, R4 = CHO: (2RS)-2-(4-formylphenyl)propanoic acid,
L. R = H, R4 = CHOH-CH(CH3)2 : 2-[4-(1-hydroxy-2-
methylpropyl)phenyl]propanoic acid,
M. R = OH, R4 = CH2-CH(CH3)2: (2RS)-2-hydroxy-2-[4-(2-
methylpropyl)phenyl]propanoic acid,
N. R = H, R4 = C2H5: (2RS)-2-(4-ethylphenyl)propanoic acid,
O. R = H, R4 = CH(CH3)-C2H5 : 2-[4-(1-methylpropyl)
phenyl]propanoic acid,
P. R = CH3: (2RS)-2-[4-(2-methylpropyl)phenyl]propan-1-ol,
Q. R = H: 2-[4-(2-methylpropyl)phenyl]ethanol,
R. 1,1-bis[4-(2-methylpropyl)phenyl]ethane.
01/2008:1439
corrected
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1楼 2009-09-02 13:31:58
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wangkt

木虫 (正式写手)
★ ★ ★
qingfeng877680(金币+3,VIP+0):代楼主发下金币。 10-10 18:47
药物介绍啊？
IBUPROFEN          布洛芬（止痛药）
Ibuprofenum
C13H18O2 Mr 206.3    分子式和分子量
[15687-27-1]            应该的编号
DEFINITION             定义（名称，下面一行）
(2RS)-2-[4-(2-Methylpropyl)phenyl]propanoic acid.
Content : 98.5 per cent to 101.0 per cent (dried substance). 含量
CHARACTERS                                                  性质
Appearance: white or almost white, crystalline powder or colourless crystals 白色或接近白色的晶体粉末或无色晶体
.
Solubility : practically insoluble in water, freely soluble in acetone, in methanol and in methylene chloride. It dissolves in dilute solutions of alkali hydroxides and carbonates 溶解性：几乎不溶于水，完全溶解于丙酮、甲醇、二氯甲烷，也溶于稀的碱或碳酸盐溶液
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2楼2009-09-02 16:05:52
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liuchenjie

金虫 (小有名气)

金刚

呵呵

写完啊  谢谢
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3楼2009-09-02 16:26:33
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wangkt

木虫 (正式写手)
★ ★ ★ ★ ★ ★ ★ ★
liuchenjie(金币+8,VIP+0):不是很全啊 呵呵 9-2 17:11
IDENTIFICATION                              成分证明
First identification : A, C.                 第一鉴定:A，C
Second identification : A, B, D.        第二鉴定：A,B,D
A. Melting point (2.2.14) : 75 °C to 78 °C.    A.熔点 75 °C to 78 °C
B. Dissolve 50.0 mg in a 4 g/l solution of sodium  B.50毫克溶于4 g/l 的含钠溶液
hydroxide R and dilute to 100.0 ml with the same alkaline solution. Examined between 240 nm and 300 nm (2.2.25), using a spectrophotometer with a band width of 1.0 nm and a scan speed of not more than 50 nm/min, the solution shows a shoulder at 258 nm and 2 absorption maxima, at 264 nm and 272 nm. The ratio of the absorbance measured at the maximum at 264 nm to that measured at the shoulder at 258 nm is 1.20 to 1.30.
The ratio of the absorbance measured at the maximum at
272 nm to that measured at the shoulder at 258 nm is
1.00 to 1.10. 氢氧化物 R 用同样的碱性溶液稀释到100ml。用分光光度计检测在240nm和300nm间，峰宽1.0nm，扫描速度不超过50 nm/min，溶液在258nm出现一个肩峰，在264nm和272nm有两个最大吸收峰。
C. Infrared absorption spectrophotometry (2.2.24).  红外吸收
Preparation: discs.   准备：磁盘
Comparison: ibuprofen CRS.  比较
D. Thin-layer chromatography (2.2.27).  薄层分离法
Test solution. Dissolve 50 mg of the substance to be
examined in methylene chloride R and dilute to 10 ml
with the same solvent. 试液：溶解50mg于二氯甲烷R，用同样的溶剂稀释至10ml

Reference solution. Dissolve 50 mg of ibuprofen CRS in
methylene chloride R and dilute to 10 ml with the same
solvent. 参考溶液：溶解50mg  ibuprofen CRS 在二氯甲烷R 稀释至10ml
Plate : TLC silica gel plate R.  板块：TLC硅胶板R
Mobile phase: anhydrous acetic acid R, ethyl acetate R, 流动相：无水乙酸
hexane R (5:24:71 V/V/V). 乙烷
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4楼2009-09-02 16:32:23
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wangkt

木虫 (正式写手)
很长，我也不是专业的，不好意思
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5楼2009-09-02 16:33:16
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liuchenjie

金虫 (小有名气)

金刚

呵呵

非常感谢
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6楼2009-09-02 17:10:55
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liuchenjie

金虫 (小有名气)

金刚
我翻译完了   呵呵  不过有的很不通顺
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7楼2009-09-02 17:12:02
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wangkt

木虫 (正式写手)
把你认为不通的段落再拿出来讨论，其实内容不是很多，但的确很费时间。
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8楼2009-09-02 17:37:28
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liuchenjie

金虫 (小有名气)

金刚
System suitability : reference solution (b) :
— peak-to-valley ratio : minimum of 1.5, where Hp = height
above the baseline of the peak due to impurity B, and
Hv = height above the baseline of the lowest point of
the curve separating this peak from the peak due to
ibuprofen. If necessary, adjust the concentration of
aceB. Dissolve 50.0 mg in a 4 g/l solution of sodium
hydroxide R and dilute to 100.0 ml with the same
alkaline solution. Examined between 240 nm and
300 nm (2.2.25), using a spectrophotometer with a band
width of 1.0 nm and a scan speed of not more than
50 nm/min, the solution shows a shoulder at 258 nm and
2 absorption maxima, at 264 nm and 272 nm. The ratio of
the absorbance measured at the maximum at 264 nm to
that measured at the shoulder at 258 nm is 1.20 to 1.30.
The ratio of the absorbance measured at the maximum at
272 nm to that measured at the shoulder at 258 nm is
1.00 to 1.10.
tonitrile in mobile phase A.
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9楼2009-09-03 09:14:04
已阅   关注TA 给TA发消息 送TA红花 TA的回帖

wangkt

木虫 (正式写手)
★ ★
liuchenjie(金币+2,VIP+0):谢谢啦 10-10 10:00
System suitability : reference solution (b) :  合适的体系：参考溶液（b）
— peak-to-valley ratio : minimum of 1.5, where Hp = height峰谷比率：最小值1.5，这句不会翻了
above the baseline of the peak due to impurity B, and上面峰的基线由于杂质B和Hv = height ，
above the baseline of the lowest point of Hv = height the curve separating this peak from the peak due to
ibuprofen 使得基线的最低处的峰从这个峰弯曲分离，这是因为布洛芬的影响
. If necessary, adjust the concentration of aceB.如果需要可以调节B的浓度。 Dissolve 50.0 mg in a 4 g/l solution of sodium hydroxide R and dilute to 100.0 ml with the same alkaline solution溶解50.0mg物质在4 g/l 的氢氧化钠溶液稀释至100ml.
. Examined between 240 nm and 300 nm (2.2.25),using spectrophotometer with a band width of 1.0 nm and a scan speed of not more than 50 nm/min          在240nm和300nm处检测，分光光度计的狭缝宽度为1.0nm，扫描速度不超过50 nm/min
, the solution shows a shoulder at 258 nm and溶液在258nm出现一个肩峰
2 absorption maxima, at 264 nm and 272 nm. 在264nm,272nm出现两个最大峰
The ratio of  the absorbance measured at the maximum at 264 nm to
that measured at the shoulder at 258 nm is 1.20 to 1.30.  264nm的最大吸收和258nm的肩峰吸收比率为1.2到1.3.
The ratio of the absorbance measured at the maximum at
272 nm to that measured at the shoulder at 258 nm is
1.00 to 1.10.   272nm的最大吸收和258nm的肩峰吸收比率在1.00到1.10
tonitrile in mobile phase A.
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10楼2009-09-03 10:38:01
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