Improvement On The Preparation Of Paracetamol Enema For Children And Quality Research

Acetaminophen is often used in the treatment of fever,joint pain,neuralgia,migraine and postoperative pain relief.Acetaminophen is widely used in tablets,injections,oral solutions and other dosage forms,which are made of acetaminophen as the main raw material.The test results of the product produced by the original formulation and preparation process of paracetamol enema solution for children fluctuated greatly and the stability was poor.Therefore,it is necessary to re-establish the type and dosage of paracetamol,improve the stability of paracetamol in the system,optimize the whole production process,and make it suitable for industrial production.Through the study of paracetamol enema for children,the formulation and preparation process were improved,and the formulation and process were determined again.And the stability of the product is studied in detail.Through the research of the self-made paracetamol enema for children,the purpose of improving the quality of the product is achieved and the quality of the product is stable within the validity period.Referring to the original prescription and preparation process,the new prescription and preparation process were re determined through experiments.Firstly,propylene glycol and polyethylene glycol 400 were heated to 80 ?,then sodium pyrosulfite and disodium EDTA were dissolved in a proper amount of 80 ? purified water,and the above two liquids were mixed.Then,the amount of paracetamol specified in the prescription was added to the mixed liquid until paracetamol was finished After complete dissolution,add the prescribed amount of benzyl alcohol,stir the liquid until it is uniform,filter it with the corresponding filter material,then fill it,and conduct the full inspection to prepare the Pediatric Paracetamol enema liquid.Three batches of samples were trial manufactured and the quality standard of three batches of samples was studied.The determination of microbial limit and content was verified by inspection methodology.The stability,accelerated test and long-term test were carried out.Through the study on the stability of three consecutive batches of pilot production products,there was no significant change in the inspection indexes of paracetamol enema liquid for children produced by the improved formulation and preparation process compared with that of 0 month.This project solved the problem of poor water solubility,instability and easy to be oxidized of paracetamol,determined the name and dosage of the solvent,achieved the purpose of solubilizing paracetamol,and made paracetamol stable in the solution system,and then made the quality of children's Paracetamol enema liquid stable.According to the current national drug standards and pharmacopoeia quality standards of the people's Republic of China,the product quality is controllable and stable.It shows that the improvement of formulation and preparation process is feasible and can be well applied to the actual production.