EXERCISES For Pharmaceutical Analysis Study

药物分析双语教学练习题

一、 名词解释(127题)

1、 National drug standards国家药品标准

2、 good clinical practices(GCP) 药品临床管理规范

3、 good laboratory practices(GLP) 药品实验室管理规范

4、 good manufacturing practices(GMP) 药品生产质量管理规范

5、 good supply practices(GSP) 药品供应管理规范

6、 quality control(QC) 质量控制

7、 total quality control(TQC) 全面质量控制

8、 quality evaluation 质量评价

9、 quality standard 质量标准

10、Chinese Pharmacopoeia (ChP) 中国药典

11、The United States Pharmacopoeia(USP) 美国药典

12、The Pharmacopoeia of Japan(JP) 日本药局方

13、general notices (药典)凡例

14、monographs 正文

15、general requirements (药典)通则

16、dissolubility 溶解度

17、溶解

18、微溶

19、称定

20、精密称定

21、量取

22、精密量取

23、standard substance 标准物质

24、临床研究用药品质量标准

25、random sampling 随机抽样

26、identification 鉴别

27、Test 检查

28、Assay 含量测定

29、性状鉴别

30、显微鉴别

31、理化鉴别

32、生物鉴别

33、thin layer chromatography(TLC) 薄层色谱法

34、thiochrome reaction 硫色素反应

35、Limit test (杂质)限度(或限量)试验

36、limit control 限量控制

37、杂质检查的对照法

38、杂质检查的灵敏度法

39、optical activity 光学活性

40、optical isomerism 旋光异构

41、optical purity 光学纯度

42、nonspecific impurity 一般杂质

43、related substance 有关物质

44、replicate determination 平行测定

45、heavy metal 重金属

46、Gutzeit test 古蔡(检砷)法

47、Ag-DDC test

48、arsenic stain 砷斑

49、loss on drying 干燥失重

50、on the dried basis 按干燥品计

51、Dry to constant weight 干燥至恒重

52、ignition to constant weight 灼烧至恒重

53、residue on ignition 炽灼残渣

54、readily carbonizable substance 易炭化物

55、total ash 总灰分

56、Karl Fischer titration 卡尔·费歇尔滴定

57、Kjeldahl method for nitrogen 凯氏定氮法

58、undue toxicity 异常毒性

59、uniformity of dosage units 含量均匀度

60、uniformity of volume 装量均匀性(装量差异)

61、uniformity of weight 重量均匀性(片重差异)

62、standard color solution 标准比色液

63、thermal analysis 热分析法

64、thermogravimetric analysis(TGA) 热重分析法

65、specific absorbance 吸收系数

66、volumetric analysis 容量分析

67、titrimetric analysis 滴定分析法

68、volumetric solution(VS) 滴定液

69、oxidation-reduction titration 氧化还原滴定

70、residual titration 剩余滴定

71、nonaqueous acid-base titration 非水酸碱滴定

72、titer, titre 滴定度

73、titrant 滴定剂

74、stoichiometric point 化学计量点

75、pipet(te) 吸移管，精密量取

76、indicator 指示剂

77、indicator electrode 指示电极

78、gas chromatography(GC) 气相色谱法

79、programmed temperature gas chromatography 程序升温气相色谱法

80、high-performance liquid chromatography (HPLC) 高效液相色谱法

81、reversed phase chromatography 反相色谱法

82、packed column 填充柱

83、packing material 色谱柱填料

84、immobile phase 固定相

85、octadecylsilane chemically bonded silica 十八烷基硅烷键合硅胶

86、mobile phase 流动相

87、modifier 改性剂，调节剂

88、tailing-suppressing reagent 扫尾剂

89、tailing peak 拖尾峰

90、response time 响应时间

91、retention time 保留时间

92、photodiode array detector(DAD) 光电二极管阵列检测器

93、system suitability 系统适用性

94、height equivalent to a theoretical plate 理论塔板高度

95、height of an effective plate 有效塔板高度

96、efficiency of column 柱效

97、half peak width 半峰宽

98、resolution 分辨率，分离度

99、tailing factor 拖尾因子

100、 flow rate 流速

101、 gradient elution 梯度洗脱

102、 standard substance 标准物质

103、 nternal standard substance 内标物质

104、 millipore filtration 微孔过滤

105、 gel filtration chromatography 凝胶过滤色谱法

106、 gel permeation chromatography 凝胶渗透色谱法

107、 ion pair chromatography 离子对色谱

108、 ion suppression 离子抑制

109、 ionic strength 离子强度

110、 ion-pairing agent 离子对试剂

111、 labelled amount 标示量

112、 round 修约(数字)

113、 precision 精密度

114、 systematic error 系统误差

115、 titration error 滴定误差

116、 least square method 最小二乘法

117、 linearity and range 线性及范围

118、 limit of detection(LOD) 检测限

119、 limit of quantitation(LOQ) 定量限

120、 mean deviation 平均偏差

121、 standard deviation 标准差

122、 repeatability 重复性

123、 reproducibility 重现性

124、 recovery 回收率

125、 robustness 可靠性，稳定性

126、 specificity 专属性

127、 ruggedness 耐用性

二、简答题(76题)

1、鉴别检查在药品 质量控制中的意义及一般杂质检查的主要项目是什么?

What are the purposes of dnug identification and test? What are the usual ite ms of dnug tests?

2、 比色比浊操作应遵循的原则是什么?

What are the standard operation procedures for the clarity test?

3、试计算 葡萄糖重金属检查中标准铅溶液的取用量。

How much of the lead standard solution should be taken for the limit testfor heavy metals in this expe riment?

4、古蔡氏测试砷法中所 加各试剂的作用与操作注意点是什么?

What pre cautions should be taken for the limit test for arsenic ( method 1)? And what is thefiunction for each of the test solutions added?

5、根据样品取用量、杂质限量及标准砷溶液的浓度,计算标准砷溶液的取用量。

Figure out the amount of the arsenic standard solution that should be taken for the limit test for arsenic method I) (0.0001%) in this expe riment with the specifiedquantity of 2.0 g of sample.

6、 什么是恒重? 炽灼残渣测定的成败关键是什么?

What does ignite or dry to constant weight mean? What is the key step during the detemination of residue on ignition?

7、盐酸普鲁 卡因的鉴别原理是什么?

What are the principles of the identification of Procaine Hydrochloride?

8、 盐酸普鲁卡因注射液中为什么要检查对氨基苯甲酸?

Why is the limit of 4-amiinobenzoic acid tested for Procaine Hydrochloride?

9、薄层色谱法检查药物中检查有关物质的方法通常有哪几种类型? 与其它方法有何异同点?

How many kinds of the limit tests for related compounds are there?What are the differences between them? Which one is used for the limit test of 4 -am ino -benzoic acid in Procaine Hydrochloride Injection?

10、阿司匹林原料药物与及阿司匹林肠溶片在质量检验方面有哪些不同之处?为何不同?

What is the diference between the assay of aspirin and its ente ric-coatedtablets?

11、阿司匹林肠溶片释放度检查中为什么要更换溶剂?

Give an explanation of the purpose of the solvent changing during the drug release test of aspirin ente ric-coatedtable ts.

12、氢溴酸东莨菪碱的鉴别原理是什么?

What are the chemical re action characteristics of tropane alkaloids?

13、氢溴酸东莨菪减片含量测定的方法与原理是什么?

What kind of method is employed for the assay of scopolam ine hydrobromide tablets?

14、氢溴酸东莨菪碱片含量均匀度检查的意义是什么?

Why is the content unifomity tested for the scopolam ine hydrobrom ide table ts?

15、药品含量以干燥品计算或无水物计算有何不同?

What is the difference between the contenls of dnigs when it is calculated on the anhydrous bas is and on the dried basis?

16、写出盐酸克仑特中2, 4-二硝基苯肼鉴定的化学反应式。

What are the complete chemical processes of the idenification of clenbuterol hydrochloride by 2,4 -dinirophenyl hydrazine.

17、盐酸克仑特中总氯量测定的滴定方法是什么?滴定过程中加硝基苯并强力振摇的目 的是什么?

What kind of riration method is employed for the total chloride test forcle nbute rol hydrochloride? What is the purpose of the addition of3 ml of nitrobenzeneand shaking vigorously?

18、盐酸克仑特含量测定采用的永停滴定法的原理是什么?有哪些注意事项?

What is the principle of potentio-metric titration for the assay of clenbuterol hydrochloride?

What pre cautions should be taken during the titration?

19、 气相色谱法检查杂质有哪些方法，试比较各种方法的特点?

How many types of methods are there for the test of related compounds by the gas chromatography? What are the diferences between them?

20、 钠盐的焰色反应应注意什么?

What precautions should be taken during the flame reaction of sodium salts?

21、 药物晶型测定的常用方法有哪些，各有什么特点?

What are the commonly used me thods for the test of polymorphism? And what are the characte ristics of each ofthem?

22、吸收系数测定方法与要求?

What are the standard operation procedures for the establishment of specific absorbance?

23、写出异烟肼与溴酸钾的滴定反应式和滴定度的计算过程。

What are the chemical reaction equations and the equivalent relationship for the assay of isoniazid by the method of potassium bromate (0.01667 mol/L) VS titration.

24、当游离肼不合格吋，对测定有何影呵?

If the test for the free hydrazine does not comply, what will happen to the results of the assay of isoniazid by the potassium bromate titration?

25、萄糖旋光度法测定含量吋，为什么要加氨试液并放置后迸行测定?

Why should the ammonia TS be added to the solution which is then allowed to stand for 10 minutes in the assay of glucose by the method of optical rotation?

26、推算出旋光度法测定葡萄糖含量时的计算系数2.0852.

Figure out the coefficient of 2.0852 in the calculation of the glucose content in the assay of glucose by the method of optical rotation.

27、写出剩余碘量法测定葡萄糖化学碘量法反应过程。

Figure out the chemical reaction equations and the equivalent relationship for the assay of glucose by the method of iodine titration.

28、哪些巴比妥药物能用银量法迸行含量测定?为什么?

What kind of barbitals can be assayed by the potentiometric titration with silver nitrate?

29、水溶液银量法电位滴定中采用的电极系统是什么?

What type of electrode pairs should be used for the potentiometric titration with silver nitrate?

30、写出高氯酸滴定硫酸奎尼丁的滴定反应式并计算滴定度?

Figure out the chemical reaction equation of Quinidine Sulfate with perchloric acid and the equivalentre lationship.

31、非水滴定法中常见酸根的影响如何消除?

How to circumvent the interferences of other acid during the non-aque ous titration of basic dnugs with pe rchloric acid?

32、非水滴定的注意事项有哪些?常用终点指示方法是什么?

What pre cautions should be taken during the non-aque ous titration? What are the commonly used methods forthe end-point indicating during the titration?

33、写出亚硝酸钠滴定盐酸普鲁卡因的滴定反应式并计算滴定度?

Figure out the chemical reaction equation of Procaine Hydrochloride with sodium nitrite and thee quivalent relationship.

34、亚硝酸钠滴定的适用范围是什么?注意事项有哪些?常用终点指示方法有哪些?

What type of compounds may be assayed with the dead-stop titration by sodium nitrite? What precautions should be taken in the dead-stop titration? What other end pointindicating methods are there?

35、氧瓶燃烧操作的注意事项有哪些?

What pre cautions should be taken to conduct the oxygen flask combustion method?

36、如何选择氧瓶燃烧法的吸收溶液?

How to select the absorbing liquid for the oxygen flask combustion method?

37、氧瓶燃烧法在药物分析中的主要应用有哪些?

What are the major applications of the oxygen flask combustion method in the analysis of drugs?

38、 各国药典中维生素A的含量测定为什么都采用分光亮度方法?

Why are the spectrophotometric assay method used for the assay of Vitamin A in all the phammacopoeias?

39、试述气相色谱法的特点及分析适用范围。

Give an explanation of the features and applications of GC method?

40、气相色谱测定维生素 E含量时为什么使用内标法?

Why is the intemal references tandard me thod employed for the assay of Vitamin E by GC?

41、维生素E含量测定的其它方法有哪些?各有什么特点?

What other methods are there for the assay of Vitamin E?

42、分别说明本品中磺胺甲噁唑和甲氧苄啶双波长法含量测定时波长选择的依据.

Give an explanation of the basis of the wavelength selection for the dete m ination ofsulfame thoxazole and trime thoprim, respectively.

43、为何甲氧苄啶含量测定时供试液的稀释倍数与磺胺甲噁唑测定时的要不同?

Why is the more diluted solution used for the assay of trimethoprim than that fors ulfame thoxazole?

44、HPLC法检验色谱系统适用性试验有什么意义?

What is the system suitability test of the HPLC method? Give an explanation of the importance of the system suitaility test of the HPLC method during the assay and the test of related substances.

45、试述抗生素药物有关物质检查的意义?

What is the importance of the test of related substances for antibiotics.

46、 抗生素类药物的鉴别和检查有何特点?

What are the characteristics for the identification and tests of antibiotics?

47、头孢克洛水分测定的意义?

What is the purpose for the test and control of water content for antibiotics?

48、抗生素药物含量或效价测定的方法有哪些?各有什么特点?

What other methods are there for the assay of antibiotics? Give an explanation of the characteristics of each method.

49、醋酸氢化可的松的鉴别原理是什幺?

What are the principles of the ide nification of hydrocoris one ace tate?

50、甾体激素中“ 其它体甾体”检查的检查意义和常用方法是什么?

What are the commonly used method for and the signjficance of the limit test for other steroids for the ste roidaldrugs?

51、哪类甾体激素可与四氮唑蓝产生反应，是结构中的何基团参与了基团反应，反应式是什

反应么?

What kind of steroidal dnugs can react with the alkaline tetrazolium blue TS?

What is the chemical re action equation?

52、槐花的主要化学成分有梛些?

What kind of chemicals are there in the Flos Sophorae?

53、药材浸出测定方法中，冷浸法与热浸法各有什么特点?水浸出物-与醇浸出物有什么区别? What is the difference between the hot and cold extraction methods as described under the determination of extractives? What is the difference between thee thanol-soluble and watler soluble extractives?

54、槐花与镁粉-盐酸反应鉴别的化合物分别是什么?反应原理是什么?

What kind of compounds are identified by the color reaction with a small quantity of magnesium powder and 2~3 drops of hydrochloric acid? What are the re action processes?

55、槐花比色法含量测定的原理是什么?先加乙醚加热回流提取的目的是什么?

What is the principle of the photometric assay of this drug? What is the purpose of the soxhiet's extraction with ether?

56、石菖蒲的主要化学成分有梛些?

What kinds of components are there in the volatile oil obtained under the Assay?

57、石菖蒲挥发油用甲法进行测定：若用乙法测定须加入二甲苯1.0ml, 其目的是什么? .

The first method for the de te m ination of volatile oil is employed for the assay. What isthe purpose for the addition of 1.0 ml of xylene if the second me thod was employed?

58、供挥发油测定用的供试品，须粉碎使能通过二号至三号筛，为什么?

What should be done to the dnig before the de te mm ination of volatile oil?

59、中成药含量测定及鉴别试验中检测对象的选择原则有哪些?

What is the principle for the assay and identification of traditional Chinese materia medica?

60、在中成药及中药材的薄层色谱鉴别中何时采用对照药材法?

When should the reference dnug be used for the ide ntification of traditional Chinese materia medica?

61、中药材或制剂高效液相色谱测定的注意事项有哪些?

What precautions should be taken for the assay of traditional Chinese materia medica ?

62、黄芩苷高效液相色谱含量测定中，流动相中的冰乙酸有何作用?

What kind of influence was produced by the acetic acid in the mobile phase for the HPLC assay ofbaicalin in this drug?

63、血浆蛋白血浆干扰的消除方法是什么?常用的其它方法有那些?各有什么特点?

What is the method used for the e lim ination of the plasma protein interferences in this analys is? What otherusual me thods are the re for the e lim ination of the plasma prote in interferences? What are the respective charucte ristics of them?

64、阿司匹林标准溶液在4℃贮藏的目的是什么?为什么冰冻的阿司匹林血浆祥品在冰水浴中解冻?

What are the purposes to keep the ASA standard solution at 4C? Whyshould the frozen plasma samples be thawed in the ice-water bath?

65、阿司匹林血浆样品处理辻程中加0.5mol/L样盐酸0.1ml的目的是什么?

What are the aims of adding 0.1ml of 0.5mol/L hydrochloric acid during the sample pre paration?

66、实验中添加内标物标邻甲基苯甲酸的目的是什么?

Why should the MBA be added as the internal standard in the test?

67、回收率试验的目 的和意义是什么?

What are the aims and significances of the recovery test?

三、计算题

1、茶苯海明中氯化物检查：取本品0.30g置200ml量瓶中，加水50ml、氨试液3ml和10%硝酸铵溶液6ml，置水浴上加热5min，加硝酸银试液25ml，摇匀，再置水浴上加热15min，并时时振摇，放冷，加水稀释至刻度，摇匀，放置15min，滤过，取续滤液25ml置纳氏比色管中，加稀硝酸10ml，加水稀释成50ml，摇匀，在暗处放置5min，与标准氯化钠溶液(10μgCl/ml)1.5ml制成的对照液比较，求氯化物的限量?

2、谷氨酸钠中重金属的检查：取本品1.0g，加水23ml溶解后，加醋酸盐缓冲液(pH3.5)2ml，依法检查，与标准铅溶液(10μg Pb/ml)所呈颜色相比较，不得更深，重金属限量为百万分之十，求取标准铅溶液多少毫升?

3、检查某药物中的砷盐，取标准砷溶液2ml(每1ml相当于1mg的As)制备标准砷斑，砷盐限量为0.0001%，供试品的量应取多少?

4、检查维生素C中的重金属时，若取样量为1.0g，要求含重金属不得过百万分之十，问应吸取标准铅溶液(每1ml=0.01mg的Pb)多少ml?

5、中国药典(2015年版)规定，磷酸可待因中吗啡的检查方法：取本品0.10g，加盐酸溶液(9→1000)，使溶解成5ml，加亚硝酸钠试液2ml，放置15min，加氨试液3ml，与吗啡溶液[取无水吗啡2.0mg，加盐酸溶液(9 → 1000)使溶解成100ml]5.0ml用同一方法制成的对照液比较，不得更深。则其限量是多少?

6、用直接滴定法测定阿司匹林原料药的含量，若供试品的称样质量为m(g)，氢氧化钠滴定液的浓度为c(mol/l)，消耗氢氧化钠滴定液的体积为V(ml)，1ml氢氧化钠滴定液(0.1mol/l)相当于18.02mg的阿司匹林，含量的计算公式是什么?

7、取维生素C注射液(本品规定为2m1:0.1g) 4ml，加水15ml与丙酮2ml，摇匀，放置5分钟，加稀醋酸4ml与淀粉指示液1ml，用碘滴定液(0.1molL) 滴定，至溶液显蓝色并持续30秒不褪，消耗碘滴定液(0.1mol/L，F=1.025) 22.10ml。已知每1ml碘滴定液(0.1mol/L)相当于8.806mg的维生素C，求维生素C注射液的百分含量。

8、司可巴比妥钠的含量测定：精密称取0.1053g，置250mL碘瓶中，加水10mL，振摇使溶解，精密加入溴滴定液(0.1mol/L)25ml，再加盐酸5ml，密塞振摇，暗处放置15min，加碘化钾试液10ml摇匀，用0.1003mol/L硫代硫酸钠滴定液滴定，做空白校正。1mL溴滴定液相当于13.01mg的司可巴比妥。已知样品消耗硫代硫酸钠滴定液17.10ml，空白消耗硫代硫酸钠滴定液25.12ml，计算司可巴比妥钠的含量。

9、盐酸氯丙嗪(规格1ml:10mg，E1%1cm=915)的含量测定：精密量取本品5ml，置200ml量瓶中，用盐酸溶液(9→1000)稀释至刻度，摇匀;精密量取2ml，置100ml量瓶中，用盐酸溶液(9→1000)稀释至刻度，摇匀，在254nm波长处测定吸光度为0.469。计算其百分含量。

10、取某药物供试品20片，总重量为2.5130g，研细，称片粉0.2386g，置500ml量瓶，加稀盐酸至刻度，摇匀滤过，精密量取续滤液5ml，置100ml量瓶中，加稀盐酸稀释至刻度，摇匀，在254nm波长处测得吸收度为0.435，按百分吸收系数为915计算，求其标示量的百分含量。已知标示量为25mg/片。