中药国际化的实践:化橘红美国药典标准的起草

**部分 化橘红药材质量标准草案及起草说明 The Part I Monograph and Research Document of Citri Grandis Exocarpium ( Huajuhong ) Citri Grandis Exocarpium Powdered Citri Grandis Exocarpium Research Materials of Citri Grandis Exocarpium I Introduction II Collection of Citri Grandis Exocarpium III Identification 1.1 Apparatus 1.2 Reagents 1.3 Investigation of sample preparation method 1.3.1 Chromatographic system 1.3.2 Extraction solvent 1.3.3 Volume of solvent 1.3.4 Time of extraction 1.4 Investigation of chromatographic system 1.4.1 Application method 1.4.2 Method for development 1.5 Validation of chromatographic identification method 1.5.1 Specificity 1.5.2 Stability 1.5.3 Robustness 1.6 Identification of 100 batches of Citri Grandis Exocarpium IV Composition 1.1 Apparatus 1.2 Reagents 1.3 Investigation of sample preparation 1.3.1 Chromatographic system 1.3.2 Extraction methods 1.4 Investigation of chromatographic system 1.4.1 Determination of maximum wavelength 1.4.2 Selection of chromatographic column 1.4.3 Selection of chromatographic column length 1.4.4 Selection of mobile phase 1.4.5 Selection of flow rate 1.4.6 Selection of column temperature 1.4.7 Selection of injection volume 1.5 Validation of method 1.5.1 Specificity 1.5.2 Linearity and range 1.5.3 Precision 1.5.4 Accuracy 1.5.5 Stability 1.5.6 Ruggedness 1.6 Content of 100 batches of Citri Grandis Exocarpium V Specific tests 1.1 Botanic characteristics 1.1.1 Macroscopic 1.1.2 Histology 1.2 Loss on drying 1.2.1 Apparatus 1.2.2 Method 1.2.3 Result 1.3 Total ash VI Additional requirements VII References VIII Illustration appendix 1.1 Blustration appendix I 1.2 Illustration appendix II 第二部分 化橘红提取物质量标准草案及起草说明 The Part II Monograph and Research Document of Powdered Citri Grandis Exocarpium Extract Powdered Citri Grandis Exocarpium Extract Research Materials of Powdered Citri Grandis Exocarpium Extract I Introduction II Collection powdered of Citri Grandis Exocarpium extract III Identification 1.1 Apparatus 1.2 Reagents 1.3 Chromatographic system and sample preparation method 1.4 Volume of application 1.5 Identification of 8 batches of powdered Citri Grandis Exocarpium extract IV Composition 1.1 Apparatus 1.2 Reagents 1.3 Investigation of sample preparation 1.3.1 Chromatographic system 1.3.2 Solvent volumes 1.3.3 Extraction time 1.4 Investigation of chromatographic system 1.4.1 Selection of mobile phase 1.4.2 Selection of flow rate 1.4.3 Selection of column temperature 1.4.4 Selection of injection volume 1.5 Validation of method 1.5.1 Specificity 1.5.2 Linearity and range 1.5.3 Precision 1.5.4 Accuracy 1.5.5 Stability 1.5.6 Ruggedness 1.6 Content of 8 batches of powdered Citri Grandis Exocarpium extract V Specific tests Loss on drying 1.1.1 Apparatus 1.1.2 Method 1.1.3 Result VI Additional requirements