Protein Succinic Acid Iron Preparation Of Raw Materials And Oral Solution

Objective: protein succinic acid iron is a safe,iron agent,compared with the traditional class ferrous sulfate iron agent,protein succinic acid are more likely to absorb iron,side effects and lighter.Based on protein succinic acid iron process method and testing method of research,can find a suitable for large-scale pharmaceutical production and review of GMP protein succinic acid iron raw material preparation technology and testing methods.Methods: by collecting protein succinic acid iron preparation technology patents,published literature information,such as initial design the product process,the preparation methods of screening to determine reasonable through technology,and design the initial raw materials and end products of quality and technical requirements,test in via,the scale of production test determine product production technology and production process,technical parameters of making reasonable review of the large-scale production and GMP requirements of raw materials,production process and the stability test was carried out on the preparation of samples,to prepare for the product declaration.Results: through the test in more than one batch test result,preliminary screening protein of succinic acid iron production preparation plan,at the same time,preliminary determine the quality and technical requirements of the original material.In a simulated production conditions,in accordance with the requirements of the GMP enlarge pilot workshop production experiments,through to the pilot production test results further screening the applicability of the original design process,at the same time planning the requirements of technical parameters in production.Collected through pilot tests of technical parameters on the formulation of production procedures,and designed the technology monitoring points and monitoring index,operation method of optimized production technology,design the production operation procedures.Conclusion: after enlarge pilot test preparation of protein succinic acid iron raw materials and preparations,the internal control of quality standard,inspection,conform to the requirements of the inspection standards,can be used as declaration process.