Fig. 2 Relationships among the design space knowledge space and control space 1 Fig. 1 Graphical abstract of the pharma

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1 38 6 徐冰 1, 史新元 1,2*, 乔延江 1,2*, 吴志生 1 1, 林兆洲 ( 1. 北京中医药大学中药信息工程研究中心, 北京 ; 2. 教育部中药制药与新药开发关键技术工程研究中心, 北京 ) quality by design QbD QbD design space FDA cgmp FDA PAT 7 PAT ICH 2005 ICH Q8 process analytical technology PAT Q8 R2 Q9 Q ICH Q8 quality by design QbD QbD PAT PAT ISPE 2007 product quality lifecycle implementation PQLI 9 QbD ZX * Tel yjqiao@ 263. net * Tel com Tel btcm@ 163. com GMP QbD QbD ICH Q8

38 6 18 13 14 15 16 2 2. 1 1 2 Fig. 2 Relationships among the design space knowledge space and control space 1 Fig.

2 Fig. 2 Relationships among the design space knowledge space and control space 1 Fig. 1 Graphical abstract of the pharmaceutical manufacturing process 3 critical quality attribute CQA critical process 3. 1 parameter CPP ICH Q8 CQA CPP CQA CPP 17 CQA 19 CQA CPP 1 CPP ICH Q8 CPP 2. 2 CPP CQA knowledge space control space

38 6 1 2010 Table 1 Ranges of process parameters of some Preparations specified in Chinese Pharmacopeia 1. 5 ~2 h 70 ~80 80% ~90% 70 ~75 1. 20 ~ 1.

3 Table 1 Ranges of process parameters of some Preparations specified in Chinese Pharmacopeia 1. 5 ~2 h 70 ~80 80% ~90% 70 ~ ~ % ~80% 24 ~72 h 7 ~9 h 1 ~3 ml min ~ g 35 ~ 50 g 8. 5 ~9. 0 proven acceptable range PAR ph 1 PAR 4. 1 CPP CQA CPP CQA ICH ICH Q9 CPP CQA HACCP FMEA CPP Plackett-Burman CQA CPP CQA A B 3 Fig. 3 A comparison of manufacturing process based on fixed process parameters and design space for Chinese medicine preparations

4 38 6 CQA CPP CQA 4. 4 ICH Q ISPE PQLI ICH CPP CQA CQA 2 Table 2 PQLI 3 Three levels in the PQLI control strategy model 1 CQA 2 CPP PAT PAT PAT CPP PAT PAT CQA CPP Y1 Y2 CQA 50% ~ 95% 30 ~ 180 min 10 ~ 25 CPP 90% 18 4 α Design Expert CQA CPP PAT 2 Overlay Plot 4 PAT 927

38 6 4 Fig. 4 Design space for the alcohol extraction process of lotus leaf J. 2008 11 5 121. 2 Huang H S Xie Q S Li S B.

5 Fig. 4 Design space for the alcohol extraction process of lotus leaf J Huang H S Xie Q S Li S B. An operation mode of manufacturing system for traditional Chinese medicine based on equipment integration C. Beijing Second pacific-asia conference on circuits communications and system PACCS Berridge J C. PQLI current status and future plans J. J Pharm D Innov Xu B Wu Z S Lin Z Z et al. NIR analysis for batch process of ethanol precipitation coupled with a new calibration model updating strategy J. Anal Chim Acta Wu Z S Xu B Du M et al. Validation of a NIR quantification method for the determination of chlorogenic acid in Lonicera japonica solution in ethanol precipitation process J. J Pharmaceut Biomed Anal U. S. Food and Drug Administration FDA. Pharmaceutical cgmps for the 21st century EB /OL http / /www. fda. gov / Drugs / DevelopmentApprovalProcess / Manufacturing / QuestionsandAnswersonCurrent Good Manufacturing Practicesc 928 GMP for Drugs / UCM U. S. Food and Drug Administration FDA. Guidance for industry PAT 2004 EB /OL http / /www. fda. gov / downloads /Drugs /... /Guidances /ucm pdf. 8 Baber N. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use ICH J. Br J Clin Pharmacol Gelsey A Schwabacher M Smith D. Using modeling knowledge to guide design space search J. Artificial Intelligence / Gries M. Methods for evaluating and covering the design space during early design development J. Integration Cavin L Fischer U Mǒsat A et al. Batch process optimization in a multipurpose plant using Tabu search with a design-space diversification J. Comput Chem Eng Giordano A Barresi A A Fissore D. On the use of mathematical models to build the design space for the primary drying phase of a pharmaceutical lyophilization process J. J Pharm Sci 2011

6 Adam S Suzzi D Radeke C et al. An integrated quality by design QbD approach towards design space definition of a blending unit operation by discrete element method DEM simulation J. Eur J Pharm Sci / Huang J Kaul G Cai C et al. Quality by design case study an integrated multivariate approach to drug product and process development J. Int J Pharm / Streefland M Van Herpen P F G Van de Waterbeemd B et al. A practical approach for exploration and modeling of the design space of a bacterial vaccine cultivation process J. Biotechnol Bioeng Nosal R Schultz T. PQLI definition of criticality J. J Pharm Innov García-Mu oz S Dolph S Ward II H W. Handling uncertainty in the establishment of a design space for the manufacture of a pharmaceutical product J. Comput Chem Eng Lepore J Spavins J. PQLI design space J. J Pharm Innov M S Davis B Lundsberg L Cook G. PQLI control strategy model and J concepts J. J Pharm Innov D J UPLC-ELSD J J Plackett-Burman Box-Behnken J D J J J D Jia D Li S Xia L. Supercritical CO 2 extraction of plumula nelumbinis oil experiments and modeling J. J Supercrit Fluid BP J Establishment of design space for production process of traditional Chinese medicine preparation XU Bing 1 SHI Xin-yuan 1 2* QIAO Yan-jiang 1 2* WU Zhi-sheng 1 LIN Zhao-zhou 1 1. Research Center of Traditional Chinese Medicine Information Engineering Beijing University of Chinese Medicine Beijing China 2. Engineering Research Center of Key Technologies for Chinese Medicine Production and New Drug Development Ministry of Education of People's Republic of China Beijing China Abstract The philosophy of quality by design QbD is now leading the changes in the drug manufacturing mode from the conventional test-based approach to the science and risk based approach focusing on the detailed research and understanding of the production process. Along with the constant deepening of the understanding of the manufacturing process the design space will be determined and the emphasis of quality control will be shifted from the quality standards to the design space. Therefore the establishment of the design space is core step in the implementation of QbD and it is of great importance to study the methods for building the design space. This essay proposes the concept of design space for the production process of traditional Chinese medicine TCM preparations gives a systematic introduction of the concept of the design space analyzes the feasibility and significance to build the design space in the production process of traditional Chinese medicine preparations and proposes study approaches on the basis of examples that comply with the characteristics of traditional Chinese medicine preparations as well as future study orientations. Key words design space traditional Chinese medicine preparation production process quality by design QbD criticality control strategy doi /cjcmm

404 中草药 Chinese Traditional and Herbal Drugs 第 42 卷第 2 期 2011 年 2 月加入的十二烷基磺酸钠活性剂 1.23 g, 在球磨机转速 600 r/min 的条件下球磨 8 h, 所得粉

404 中草药 Chinese Traditional and Herbal Drugs 第 42 卷第 2 期 2011 年 2 月加入的十二烷基磺酸钠活性剂 1.23 g, 在球磨机转速 600 r/min 的条件下球磨 8 h, 所得粉中草药 Chinese Traditional and Herbal Drugs 第 42 卷第 2 期 2011 年 2 月 403 纳米技术在中药领域的研究进展 1, 吴芸 2 1,, 严国俊 2, 蔡宝昌 1, 2, 3* 1. 国家中医药管理局中药炮制标准重点研究实验室, 江苏南京 210046 2. 国