［1］ ZHANG L， L Y. Polymorphism in solid chemical drugs and quality control［J］. Acta Pharm Sin (药学学报)， 2007， 42 (suppl): 201-202.
［2］ MAO L， ZHENG Q T， LV Y. Progress on the study of solid drug polymorphism［J］. Nat Prod Res Dev (天然产物研究与开发)， 2005， 17(3): 371-375.
［3］ NING L L. Consideration on the problem of polymorphism in the drug research［J］. Drug Eval (药品评价)， 2007， 4(4):304-306.
［4］ WU W，ZHU R. Regard the research of drug polymorphism［J］. China Pharm (中国药业)， 2004， 13 (11): 18-20.
［5］ NICHOLAS B， ROGER D. Polymorphs take shape［J］. Chem Br， 1999， 35(3): 44-47.
［6］ CHEMBURKAR S R， BAUER J， DEMING K， et al. Dealing with the impact of ritonavir polymorphs on the late stages of bulk drug process development［J］. Org Process Res Dev， 2000， 4 (5): 413-417.
［7］ FDA, ICH Q6A. Specifications for New Drug Substances and Products: Chemical Substances $$EB/OL$$. FDA, 2000: 83041-83063 $$2000-12-29$$. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129099.pdf.
［8］ EMEA, CPMP /ICH/ 367/ 96 corr. Specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substance $$EB/OL$$. EMEA, 1999: 9-31 $$Nov1999$$. http://www.ema.europa.eu/pdfs/human/ich/036796en.pdf.
［9］ FDA, CDER, Guidance for Industry ANDAs. Pharmaceutical Solid Polymorphism $$EB/OL$$. FDA, 2007: 1-10. $$July2007$$. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072866.pdf.
［10］ RAW A S， FURNESS M S， GILL D S， et al. Regulatory considerations of pharmaceutical solid polymorphism in Abbreviated New Drug Applications (ANDA)［J］. Adv Drug Del Rev， 2004， 56(3): 397-414.
［11］ FDA, CDER. Approved drug products with therapeutic equivalence evaluations (Orange Book) 29th ed $$EB/OL$$. FDA, 2009: $$2008-12-31$$. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/UCM071436.pdf.
［12］ FDA. 57 Federal Register $$EB/OL$$. FDA, 1992: 34733-34734 $$1992-08-06$$. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-Counter OTC Drugs/Statusof OTC Rulemakings/ucm116059.pdf.
［13］ GRANT D J W. Theory and origin of polymorphism. In: Britain HG， Polymorphism in Pharmaceutical Solids［M］. Vol 95. New York: Marcel Dekker， 1999: 1-33.
［14］ BYRN S， PFEIFFER R， GANEY M， et al. Pharmaceutical solids: a strategic approach to regulatory considerations［J］. Pharm Res， 1995， 12 (7): 945- 954.
［15］ YU L X， FURNESS M S， RAW A， et al. Scientific considerations of pharmaceutical solid polymorphism in abbreviated new drug applications［J］. Pharm Res， 2003， 20 (4):531-536.
［16］ GIRON B D. Monitoring of polymorphism-from detection to qualification［J］. Eng Life Sci， 2003， 3(3): 103-112.
［17］ BRITTAIN H G， GRANT D J W. Effect of Polymorphism and Solid-State Solvation on Solubility and Dissolution Rate［M］.Chapter 7.New York: Marcel Dekker， 1999: 279-330.
［18］ FDA, CDER. Guideline on General Principles of Process Validation $$EB/OL$$. FDA, 1987: 1-13 $$May,1987$$. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124720.htm.