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A1A0A2A32008A5A4A6A7A3A8A91目录摘要11前言211产品概述212生产现状及其发展趋势3121生产现状3122发展趋势413头孢霉素的介绍414头孢霉素生产工艺5141生产工艺流程5142材料和方法515质量安全体系的概述6151HACCP6152GMP6153SSOP6154HACCP的原则62头孢霉素生产过程中的安全控制体系的设计721头孢霉素GMP的设计722头孢霉素SSOP的设计823头孢霉素HACCP的设计1024头孢霉素质量安全追溯体系设计12参考文献13总结语14A1A0A2A32008A5A4A6A7A3A8A92摘要头孢霉素抗菌谱广(能对付不同特性的细菌),杀菌能力强,对胃酸稳定(有利于口服应用),对内酰胺酶(一种破坏抗生素的酶)稳定,副作用较小。本文,主要就头孢霉素的生产工艺以及质量安全体系进行了设计。通过对产品的概述,生产工艺的流程,GMP体系、SSOP体系、HACCP体系以及质量安全追溯体系的设计,来建立一个较为完整的头孢霉素生产过程的安全控制体系。关键词头孢霉素,发酵,概述,GMP,SSOP,HACCP设计G12573A1A0A2A32008A5A4A6A7A3A8A931前言11产品概述A10A11A12A13A14A15A16A13A17A18A19A20A21A22A237A24A25A10A11A26A27A28A29A30A31A32A20A33A14A21A10A11A12A13A34A35A36A37A32A20A31A28A36A37A38A39A40A41A42A21A31A34A43A10A11A12A13A38A44A33A45A46A47A15A16A13A48A10A11A12A13A38A49A50A42A51A52A53A54A21A44A14A15A16A13A48A18A55A56A57A58A59A60A61A62A63A10A11A12A13A64A10A65A12A13A31A66A67A21A68A44A69A10A11A12A13A70A71A63A72A73A65A13A48A74A14A15A16A13A75A76A77A78A79A12A79A80A81A21A46A47A82A83A79A12A84A85A31A86A12A87A54A88A31A89A54A90A91A92A93A33A79A12A94A95A31A96A97A98A99A94A95A100A79A12A101A102A103A100A104A105A103A100A106A103A100A107A108A103A109A110A111A112A113A48A114A90A79A12A115A90A116A23A79A80A117A118A16A119A31A120A79A80A121A21A122A123A18A79A80A81A31A28A39A21A79A80A115A90A124A23A79A80A31A79A80A121A122A123A125A18A79A80A81A31A126A127A10A11A12A13A128A39A129A21A130A101A131A132A31A133A134A21A76A135A136A137A138A139A140A65A13A14A141A119A142A143A144A145A4812生产现状及其发展趋势121生产现状A10A11A12A13A25A146A60A61A147A637A24A25A10A11A26A277ACAA31A148A18A149A150A151A152A153A48A10A11A14A15A16A13A70A154A62A63A437ADCAA63A22A23A64A437ACAA63A22A23A21A155A156A157A158A48A159A44A157A158A63A140A65A13A21A160A161A40A162A163A31A66A16A162A164A165A63A140A65A13A40A166A1677ADCAA45A46A47A10A11A12A13A31A168A169A162A163A18A170A10A11A24A171A100A10A11A172A24A171A100A10A11A173A174A100A10A11A175A176A100A10A11A177A178A179A113A180A181A182A163A33A183A184A44A157A158A63A10A11A12A13A21A157A158A162A163A31A66A16A162A164A165A63A10A11A12A13CA185A167A186A187A1677ACAA45A46A47A10A11A12A13A31A168A169A162A163A18A10A11A188A189A100A10A11A190A191A100A10A11A192A193A100A10A11A177A174A100A10A11A194A195A100A10A11A196A197A179A100A10A11A198A199A113A181A180A182A163A33A487ADCAA2007ACAA201A202A203A204A205A206A207A208A209A210A211A212A213A214A215A216A217A218A219A216A220A221A222A223A224A225A226A227A228A229A230A231A232A233A234A209A211A235A206A236A237A238A239A240A241A242A243A244A211BIOCHEMIEA245A246A247A244A211ANTIBIOTICOSA248A249A250A224A225A226A227A211A251A252A253A254A236A237A241A255A2217ACAA222A223A208A252A206A2111/2A34A0A2207ACAA211A254A206A12A1A2A224A225A226A227CA211A254A206A24180A224A3A222A223A224A225A226A227A211A224A4A5A6A7A830A2417ACAA211A224A201A4A5A6A7A825A220A229A20490A224A3A9A2417ACAA200A224A225A226A227A191A10A215A211A224A201A4A5A6A7A11A13A1410A233A15A241A235A16A17A18A6A7A19A11A13A20A202005A224A233A15A2207ACAA200A224A225A226A227A191A10A215A211A254A206A21A22A23A249A250A2112000A241A233A15A0A24A203100A241A220A244A25A214A215A245A26,A247A27A248A205A29A28A30A206A31A32A224A225A226A227CA1007ACAA254A153A33A253A254A35A36A211A236A237A241A249A250A220A31A32A224A254A224A225A226A227C245A241A2417ACA120A241A211A253A254A35A36A220A57A37A38A39A40A247A211A236A237A41A42A43A215A44A45A104A91A46A215A44A45A245A26,A247A27A91A47A244A48A49A50A242A104A51A248A52A53A54A55A216A217A2187ACAA56A58A32A224A225A226A227A191A10A215A220A59A60A205A297ACAA253A254A61A62A100A63A58A32A64A65A61A62A211A66A67A241A216A217A218A253A254A68A22A69A70A2A71A72A73A33A241A31A32A74A75A211A253A254A76A241A34A66A67A254A77A211A244A78A79A80A220A81A82A16A2411999A2247ACAA211A205A29A208A83A206A14500A241A233A15A241A205A29A191A10A215A211A211A254A206A84A85A35A86A87A240A88A253A254A211A208A252A241A228A229A89A90A1450A34A0A241A224A225A92A93A94A91A224A225A37A95A94A91A224A225A243A96A104A191A10A215A211A253A254A205A29A41A248A97A98A220A99A101A102A1032008A105A106A107A108A103A109A1104122发展趋势A111G17227G8505较G7214发展G17817G17907A72A205A224A225A226A227A194A25A253A227A234A209A253A254A112A113A40A114A241A115A209A210A116A6A241A231991A224A34A56A241A254A206A117A224A235A118A119A30A120A2201999A224A241A220A35A253A254A252A18A224A225A191A10A215600A241A233A15A91A121A881264A122A123A91A90A124A125A88A100A126A1271164A122A128A220A235A162000A224A191A10A215A129A206A19A130A20900A241A233A15A220A131品种较G4581结G7512不G2524G10714A72A205A2360A224A3A234A132A133A134A234A209A224A225A226A227A2411970A224A135A240A32A136A28A30A137A77A18A224A225A138A139A241A140A141A8A142A241A220A133A240A32A13611A137A77A18A241A143A423A137A77A18A144A14A133A134A234A209A219A216A241A145A224A146A147A14A253A254A211A77A18A4211A137A57A216A224A225A37A1A200A224A225A148A149A211A254A206A150A151A241A152A8A222A223A0A228A77A18A21120A220A57A216A241A90A124A77A185A137A241A154A155A156A77A186A137A174A157A28A30A3A211A254A776A18A241A28A158A3A2114A18A241A28A159A3A2111A18A2201999A160A161A162A163A164A165A166A167A168A164A165A169A170A171A164A165A172A173A175A176A177A178A179A180A181A182A183A164A165A175A176A177607A184A17884A185A186A187A188A189A190A192A193A161A195A163A164A165A196A197A17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