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  • 按照中国药典2010版用薄层色谱法进行青蒿素的杂质检查,取本品,加丙酮溶解并稀释制成每1ml中含15mg的溶液,作为供试品溶液;精密量取0.5ml,置100ml量瓶中,用丙酮稀释至刻度,作为对照溶液(1);精密量取对照溶液(15ml,置10ml量瓶中,用丙酮稀释至刻度,作为对照溶液(2)。用薄层色谱法,吸取上述3种溶液各10ul,分别点于同一硅胶G薄层板上,以石油醚-丙酮-冰醋酸(820.1)为展开进,展开15cm以上,取出,晾干,喷以含2%香草醛的20%硫酸乙醇溶液,在85℃加热10~20分钟至斑点清晰。供试品溶液如显杂质斑点,深于对照溶液(2)主斑点颜色(0.25%)且不深于对照溶液(1)主斑点颜色(0.5%)的斑点不得多于1个,其他杂质斑点均不得深于对照溶液(2)所显主斑点的颜色(0.25%)。

    结果符合规定。

    取本品适量,加流动相溶解并稀释制成每1ml0.5mg的溶液,作为对照品溶液;精密量取适量,用流动相定量稀释制成每1ml15ug的溶液,作为对照溶液。用高效液相色谱法测定。用十八烷基硅烷键合硅胶为填充剂;以乙腈-0.1%三氯乙酸溶液-磷酸(20800.035)为流动相;检测波长为349nm。理论板数按磷酸哌喹峰计算不低于1000。取对照溶液20ul注入液相色谱仪;再精密量取供试品溶液与对照溶液各20ul,分别注入液相色谱仪,记录色谱图至主成分峰保留时间的3倍。供试品的色谱图中如有杂质峰,各杂质峰面积的和不得大于对照溶液主峰面积的2倍(6.0%)。

    结果符合规定
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  • 影子

    第1楼2011/01/19

    这么多啊楼主?其实这些可以参照USP或EP进行翻译,很多用语药典上都有的

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  • betty0919

    第2楼2011/01/19

    是哦,我知道药典上有的,只是时间来不及了,,明天就需要,而手里还有好多别的急事。所以只有想到这里请帮忙了。谢谢!!

    影子(hyheying) 发表:这么多啊楼主?其实这些可以参照USP或EP进行翻译,很多用语药典上都有的

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  • rohsweee

    第3楼2011/01/19

    按照中国药典2010版用薄层色谱法进行青蒿素的杂质检查,取本品,加丙酮溶解并稀释制成每1ml中含15mg的溶液,According to Chinese Pharmacopoeia 2010 edition of artemisinin by thin layer chromatography of impurities in check, take this product, add dissolved and diluted into acetone containing 15mg per 1ml of solution,作为供试品溶液;精密量取0.5ml,置100ml量瓶中,用丙酮稀释至刻度,作为对照溶液As the test solution; precise amount of 0.5ml, home 100ml volumetric flask, dilute with acetone to the mark, as the control solution(1);精密量取对照溶液(1)5ml,置10ml量瓶中,用丙酮稀释至刻度,作为对照溶液(1); precise amount of control solution (1) 5ml, 10ml volumetric flask set with acetone diluted to the mark, as the control solution(2)。用薄层色谱法,吸取上述3种溶液各10ul,分别点于同一硅胶G薄层板上,以石油醚-丙酮-冰醋酸(8:2:0.1)为展开进,展开15cm以上,取出,晾干,喷以含2%香草醛的20%硫酸乙醇溶液,在85℃加热10~20分钟至斑点清晰。供试品溶液如显杂质斑点,深于对照溶液(2)主斑点颜色(0.25%)且不深于对照溶液(1)主斑点颜色(0.5%)的斑点不得多于1个,其他杂质斑点均不得深于对照溶液(2)所显主斑点的颜色(0.25%)。(2). TLC, to learn the solution of 3 10ul, respectively, points on the same silica gel G TLC plate, petroleum ether - acetone - acetic acid (8:2:0.1) as the forward, started more than 15cm, remove, Dried, sprayed with 2% vanillin in 20% sulfuric acid in ethanol, heated at 85 ℃ for 10 to 20 minutes to spot clear. The test solution were impurities such as spots, deep in the control solution (2) The main spot color (0.25%) and no deeper than the control solution (1) The main spot color (0.5%) not more than one spot, and other impurities spots Shall not be darker than the control solution (2) were the main spots of the color (0.25%).

    结果符合规定。 The results are in order.

    取本品适量,加流动相溶解并稀释制成每1ml含0.5mg的溶液,作为对照品溶液;精密量取适量,用流动相定量稀释制成每1ml含15ug的溶液,作为对照溶液。Take some, add dissolved and diluted into mobile phase containing 0.5mg per 1ml of solution, as the reference solution; precise amount of the check amount, diluted with the mobile phase is made quantitative with 15ug per 1ml of the solution, as a control solution.用高效液相色谱法测定。用十八烷基硅烷键合硅胶为填充剂;以乙腈-0.1%三氯乙酸溶液-磷酸(20:80:0.035)为流动相;检测波长为349nm。High performance liquid chromatography. With octadecyl silane bonded silica as a filler; acetonitrile -0.1% trichloroacetic acid solution - phosphate (20:80:0.035) as mobile phase; the detection wavelength was 349nm.理论板数按磷酸哌喹峰计算不低于1000。取对照溶液20ul注入液相色谱仪;再精密量取供试品溶液与对照溶液各20ul,分别注入液相色谱仪,记录色谱图至主成分峰保留时间的3倍。供试品的色谱图中如有杂质峰,各杂质峰面积的和不得大于对照溶液主峰面积的2倍(6.0%)。Number of theoretical plates piperaquine phosphate peak calculated by not less than 1000. 20ul take control solution into the liquid chromatograph; be precise amount of the test solution and control solution of 20ul, were injected into the liquid chromatograph, record the chromatogram to the main component peak 3 times the retention time. The test of any impurity peak in the chromatogram, each peak area of impurity control solution and not more than 2 times the peak area (6.0%).


    结果符合规定 The results of compliance













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  • 该帖子已被版主-影子加10积分,加2经验;加分理由:鼓励新手积极参与应助
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  • betty0919

    第4楼2011/01/19

    rohsweee(rohsweee) 发表:按照中国药典2010版用薄层色谱法进行青蒿素的杂质检查,取本品,加丙酮溶解并稀释制成每1ml中含15mg的溶液,According to Chinese Pharmacopoeia 2010 edition of artemisinin by thin layer chromatography of impurities in check, take this product, add dissolved and diluted into acetone containing 15mg per 1ml of solution,作为供试品溶液;精密量取0.5ml,置100ml量瓶中,用丙酮稀释至刻度,作为对照溶液As the test solution; precise amount of 0.5ml, home 100ml volumetric flask, dilute with acetone to the mark, as the control solution(1);精密量取对照溶液(1)5ml,置10ml量瓶中,用丙酮稀释至刻度,作为对照溶液(1); precise amount of control solution (1) 5ml, 10ml volumetric flask set with acetone diluted to the mark, as the control solution(2)。用薄层色谱法,吸取上述3种溶液各10ul,分别点于同一硅胶G薄层板上,以石油醚-丙酮-冰醋酸(8:2:0.1)为展开进,展开15cm以上,取出,晾干,喷以含2%香草醛的20%硫酸乙醇溶液,在85℃加热10~20分钟至斑点清晰。供试品溶液如显杂质斑点,深于对照溶液(2)主斑点颜色(0.25%)且不深于对照溶液(1)主斑点颜色(0.5%)的斑点不得多于1个,其他杂质斑点均不得深于对照溶液(2)所显主斑点的颜色(0.25%)。(2). TLC, to learn the solution of 3 10ul, respectively, points on the same silica gel G TLC plate, petroleum ether - acetone - acetic acid (8:2:0.1) as the forward, started more than 15cm, remove, Dried, sprayed with 2% vanillin in 20% sulfuric acid in ethanol, heated at 85 ℃ for 10 to 20 minutes to spot clear. The test solution were impurities such as spots, deep in the control solution (2) The main spot color (0.25%) and no deeper than the control solution (1) The main spot color (0.5%) not more than one spot, and other impurities spots Shall not be darker than the control solution (2) were the main spots of the color (0.25%).

    结果符合规定。 The results are in order.

    取本品适量,加流动相溶解并稀释制成每1ml含0.5mg的溶液,作为对照品溶液;精密量取适量,用流动相定量稀释制成每1ml含15ug的溶液,作为对照溶液。Take some, add dissolved and diluted into mobile phase containing 0.5mg per 1ml of solution, as the reference solution; precise amount of the check amount, diluted with the mobile phase is made quantitative with 15ug per 1ml of the solution, as a control solution.用高效液相色谱法测定。用十八烷基硅烷键合硅胶为填充剂;以乙腈-0.1%三氯乙酸溶液-磷酸(20:80:0.035)为流动相;检测波长为349nm。High performance liquid chromatography. With octadecyl silane bonded silica as a filler; acetonitrile -0.1% trichloroacetic acid solution - phosphate (20:80:0.035) as mobile phase; the detection wavelength was 349nm.理论板数按磷酸哌喹峰计算不低于1000。取对照溶液20ul注入液相色谱仪;再精密量取供试品溶液与对照溶液各20ul,分别注入液相色谱仪,记录色谱图至主成分峰保留时间的3倍。供试品的色谱图中如有杂质峰,各杂质峰面积的和不得大于对照溶液主峰面积的2倍(6.0%)。Number of theoretical plates piperaquine phosphate peak calculated by not less than 1000. 20ul take control solution into the liquid chromatograph; be precise amount of the test solution and control solution of 20ul, were injected into the liquid chromatograph, record the chromatogram to the main component peak 3 times the retention time. The test of any impurity peak in the chromatogram, each peak area of impurity control solution and not more than 2 times the peak area (6.0%).

    结果符合规定 The results of compliance

    太感谢了!!!

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  • ja19840616

    第6楼2011/01/24

    这个有人看过吗? add dissolved and diluted into acetone containing 15mg per 1ml of solution 这句话啥意思?还有这句precise amount of the check amount?等等
    药典上也是这样表述的?哪位给指点下?

    rohsweee(rohsweee) 发表:按照中国药典2010版用薄层色谱法进行青蒿素的杂质检查,取本品,加丙酮溶解并稀释制成每1ml中含15mg的溶液,According to Chinese Pharmacopoeia 2010 edition of artemisinin by thin layer chromatography of impurities in check, take this product, add dissolved and diluted into acetone containing 15mg per 1ml of solution,作为供试品溶液;精密量取0.5ml,置100ml量瓶中,用丙酮稀释至刻度,作为对照溶液As the test solution; precise amount of 0.5ml, home 100ml volumetric flask, dilute with acetone to the mark, as the control solution(1);精密量取对照溶液(1)5ml,置10ml量瓶中,用丙酮稀释至刻度,作为对照溶液(1); precise amount of control solution (1) 5ml, 10ml volumetric flask set with acetone diluted to the mark, as the control solution(2)。用薄层色谱法,吸取上述3种溶液各10ul,分别点于同一硅胶G薄层板上,以石油醚-丙酮-冰醋酸(8:2:0.1)为展开进,展开15cm以上,取出,晾干,喷以含2%香草醛的20%硫酸乙醇溶液,在85℃加热10~20分钟至斑点清晰。供试品溶液如显杂质斑点,深于对照溶液(2)主斑点颜色(0.25%)且不深于对照溶液(1)主斑点颜色(0.5%)的斑点不得多于1个,其他杂质斑点均不得深于对照溶液(2)所显主斑点的颜色(0.25%)。(2). TLC, to learn the solution of 3 10ul, respectively, points on the same silica gel G TLC plate, petroleum ether - acetone - acetic acid (8:2:0.1) as the forward, started more than 15cm, remove, Dried, sprayed with 2% vanillin in 20% sulfuric acid in ethanol, heated at 85 ℃ for 10 to 20 minutes to spot clear. The test solution were impurities such as spots, deep in the control solution (2) The main spot color (0.25%) and no deeper than the control solution (1) The main spot color (0.5%) not more than one spot, and other impurities spots Shall not be darker than the control solution (2) were the main spots of the color (0.25%).

    结果符合规定。 The results are in order.

    取本品适量,加流动相溶解并稀释制成每1ml含0.5mg的溶液,作为对照品溶液;精密量取适量,用流动相定量稀释制成每1ml含15ug的溶液,作为对照溶液。Take some, add dissolved and diluted into mobile phase containing 0.5mg per 1ml of solution, as the reference solution; precise amount of the check amount, diluted with the mobile phase is made quantitative with 15ug per 1ml of the solution, as a control solution.用高效液相色谱法测定。用十八烷基硅烷键合硅胶为填充剂;以乙腈-0.1%三氯乙酸溶液-磷酸(20:80:0.035)为流动相;检测波长为349nm。High performance liquid chromatography. With octadecyl silane bonded silica as a filler; acetonitrile -0.1% trichloroacetic acid solution - phosphate (20:80:0.035) as mobile phase; the detection wavelength was 349nm.理论板数按磷酸哌喹峰计算不低于1000。取对照溶液20ul注入液相色谱仪;再精密量取供试品溶液与对照溶液各20ul,分别注入液相色谱仪,记录色谱图至主成分峰保留时间的3倍。供试品的色谱图中如有杂质峰,各杂质峰面积的和不得大于对照溶液主峰面积的2倍(6.0%)。Number of theoretical plates piperaquine phosphate peak calculated by not less than 1000. 20ul take control solution into the liquid chromatograph; be precise amount of the test solution and control solution of 20ul, were injected into the liquid chromatograph, record the chromatogram to the main component peak 3 times the retention time. The test of any impurity peak in the chromatogram, each peak area of impurity control solution and not more than 2 times the peak area (6.0%).

    结果符合规定 The results of compliance

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  • 影子

    第7楼2011/01/24



    取本品适量,加流动相溶解并稀释制成每1ml0.5mg的溶液,作为对照品溶液;精密量取适量,用流动相定量稀释制成每1ml15ug
    的溶液,作为对照溶液。
    对照品溶液与对照溶液,国外药典通常是一个意思,其实前面的对照品溶液在进样的时候没有用到,这里可以不译,参照USP,这段话可译为:

    Dissolve an accurately weighed quantity of the sample in Mobile phase, and dilute in Mobile phase to
    obtain a solution having a known concentration of 0.5 mg per ml. Dilete an accurately measured volume
    of this solution quantitatively, and stepwise if necessary, with Mobile phase to obtain a solution
    containing 15 ug per ml, as a reference solution.

    ja19840616(ja19840616) 发表:结果符合规定 The results of compliance

    这个有人看过吗? add dissolved and diluted into acetone containing 15mg per 1ml of solution 这句话啥意思?还有这句precise amount of the check amount?等等
    药典上也是这样表述的?哪位给指点下?

0
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  • 影子

    第8楼2011/01/24

    rohsweee版友的翻译与USP或EP的用语习惯还是相差很大的

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  • ja19840616

    第9楼2011/01/24

    呵呵 手打辛苦了 这个很好
    主要是觉得add dissolved and diluted into acetone containing 15mg per 1ml of solution 和
    precise amount of the check amount这两句翻得有点问题 确实是不太适应

    影子(hyheying) 发表:

    取本品适量,加流动相溶解并稀释制成每1ml0.5mg的溶液,作为对照品溶液;精密量取适量,用流动相定量稀释制成每1ml15ug
    的溶液,作为对照溶液。
    对照品溶液与对照溶液,国外药典通常是一个意思,其实前面的对照品溶液在进样的时候没有用到,这里可以不译,参照USP,这段话可译为:

    Dissolve an accurately weighed quantity of the sample in Mobile phase, and dilute in Mobile phase to
    obtain a solution having a known concentration of 0.5 mg per ml. Dilete an accurately measured volume
    of this solution quantitatively, and stepwise if necessary, with Mobile phase to obtain a solution
    containing 15 ug per ml, as a reference solution.

0
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