第一章一般性实验指导
Chapter 1 General Instructions
第一节 实验室安全守则
Section 1 Laboratory Safety
第二节 天平使用规程
Section 2 Protocol for Using Balance
第三节 有效数字的修约
Section 3 Rounding of Significant Figures
第四节 一般性规定
Section 4 General Notices
第五节 实验记录及报告格式
Section 5 Experiment Record and Report Format
第二章药物的性状、鉴别和检查
Chapter 2 Description， Identification and Tests of Drugs
实验一 葡萄糖的性状、鉴别和检查
Experiment 1 Description， Identification and Tests of Glucose
实验二 乙酸氢化可的松或乙酸氢化可的松片的鉴别和检查
Experiment 2 Description， Identification and Tests of Hydrocortison
Acetate or Hydrocortisone Acetate Tablets
实验三 甲苯咪唑的性状、鉴别和检查
Experiment 3 Description， Identification and Tests of Mebendazole
实验四 典型中药的鉴别
Experiment 4 Description， Identification and Test of Typical TCM
第三章药物的含量测定
Chapter 3 Determination of Drugs
实验五 硫酸奎尼丁及其片剂的含量测定
Experiment 5 Assay of Quinidine Sulfate and Quinidine
Sulfate Tablets
实验六 盐酸普鲁卡因或注射用盐酸普鲁卡因的含量测定
Experiment 6 Assay of Procaine Hydrochloride or Procaine
Hydrochloride for Injection
实验七 碘苯酯及其注射液的含量测定
Experiment 7 Assay of Iophendylate and Iophendylate Injection
实验八 头孢拉定及其片剂的含量测定
Experiment 8 Assay of Cefradine and Cefradine Tablets
第四章药物质量的全检验
Chapter 4 Drug Analysis
实验九 维生素E或维生素E软胶囊的质量检查
Experiment 9 Analysis of Vitamin E and Vitamin E Soft Capsules
实验十 阿司匹林与阿司匹林肠溶片的质量分析
Experiment 10 Analysis of Aspirin and Aspirin Enteric—coated Tablets
实验十一 复方磺胺甲唑片的质量分析
Experiment 11 Analysis of Compound Sulfamethoxazole Tablets
实验十二 头孢克洛或头孢克洛胶囊的质量分析
Experiment 12 Analysis of Cefaclor or Cefaclor Capsules
实验十三 石菖蒲的质量检验
Experiment 13 Analysis of Acori Talarinowii Rhizoma
实验十四 六味地黄丸的质量检验
Experiment 14 Analysis of Liuwei Dihuang Wan
实验十五 双黄连口服液的质量检验
Experiment 15 Analysis of Shuanghuanglian Koufuye
第五章生物样本中药物的分析
Chapter 5 Quantitation of Drugs in Biological Matrix
实验十六兔血清中茶碱的高效液相色谱法测定
Experiment 16 Detemunation of Theophylline in Rabbit's Serum by HPLC
实验十七 阿司匹林代谢产物水杨酸的血浆浓度测定
Experiment 17 Determination of Salicylic Acid （ SA） ， Metabolite of Aspirin （ASA） in Human's Plasma by HPLC
实验十八 高效液相色谱法测定尿液中苯巴比妥的浓度
Experiment 18 Determination of Phenobarbital in Human's Urine by HPLC
实验十九 LC—MS／MS法测定比格犬血浆中阿奇霉素的含量
Experiment 19 Determination of Azithromycin in Beagle's Plasma by LC—MS／MS
第六章设计类实验
Chapter 6 Designing Experiment
实验二十 兰索拉唑的鉴别实验
EXDeriment 20 Identification of Lansoprazole
实验二十一 兰索拉唑的杂质检查实验
Experiment 21 Examination for Impurities in Lansoprazole
实验二十二 兰索拉唑的含量测定实
Experiment 22 Content Determination of Lansoprazole
实验二十三 酮康唑的血药浓度测定
Experiment 23 Determination of Ketoconazole Concentration in Plasma
实验二十四 清开灵口服液的质量分析
Experiment 24 Analysis of Qingkailing Koufuye
第七章分析方法验证
Chapter 7 Validation of Analysis Method
一、药品质量标准分析方法验证指导原则
二、生物样品分析方法的基本要求
1.A Guideline for the Validation of Analytical Method Adopted in Pharmaceutical
2.The Basic Requirements for Analytical Methods of Biological Specimen
附录 实验室常用英语
Appendix Laboratory Commonly Used in English
Sample Pages Preview
If the spectrum obtained in the solid state with the substance being examined and the reference substance show differences due to polymorphism of solid specimen， in this case， after excluding the possibility of external or human factors， the substance being examined should be pre—treated according to the method for specified substance described in Atlas of the—lnfrared Spectra of Drugs or individual monograph， and then record the spectrum again.If the crystalline form and suitable pre—treatment method are not specified， the reference substance may be used， the substance being examined and the reference substance are re—crystallized using suitable solvent under the same condition and then be determined and compared.If the crystalline form is specified， the reference substance with corresponding crystalline form should be used.
When the solid sample preparation technique is not satisfactory for identification， Prepare a solution in a suitable solvent may be an alternative method used for comparison of spectrum.
b.Identification for preparations The specimen should be prepared as described in the individual monograph， and solvent extraction method is often used.ln order to minimize the interference of excipients and avoid the potential change of crystalline form as far as possible， suitable solvent should be chose for the extraction procedure， carry out the test for identification after the extract specimen has been dried by a suitable method.
