Preparation of Ibuprofen and sodium chloride injection

OBJECTIVE To develop Ibuprofen and sodium chloride injection to meet the clinical requirements.According to relevant measures drug registration,screening for formulation was studied and determine the process parameters and establish its quality control method,the preliminary stability was investigated.METHODS In the experiment,dissolving agent,osmotic pressure,pH value,activated carbon ammount were screened and the formulation was optimized;Active carbon absorption conditions and sterilization conditions was verificated and confirm the preparation techniques;The property of preparation,identification,pH value,related materials and content determination were studied and set up quality control methods;The preliminary tability was investigated by influence factor test.RESULTS The optimun formula and preparation process were determined through the screening,the parameters of the process validation and influence factors test.The 3 batches sample of Ibuprofen and sodium chloride injection which prepared according to the optimized formula and preparation technique.Passed the quality evalution.CONCLUSION This formulation is reasonable,the preparation process is feasible.The quality can be controlled and the preliminary stability of the preparation is achieved.