Study On The Preparation And Quality Of Acetaminophen Tablets

Objective Acetaminophen is one of the most popular and commonly used analgesic and antipyretic drugs in the world.However,in industrial production,acetaminophen tablets are prone to problems such as fragmentation and cracking due to their low hardness during production and transportation.In addition,poor finish and large differences in sheet weight are also one of the main problems facing acetaminophen in industrial production.These problems are not conducive to the quality control of preparations and the guarantee of curative effect.Therefore,this subject screened and optimized each process link of auxiliary materials and granulation technology,in order to realize the preparation process of acetaminophen tablets with stable quality of finished products.Methods In this article,an analytical method for acetaminophen tablets was established.The maximum detection wavelength of acetaminophen and the standard curve for the content analysis of acetaminophen was established by ultraviolet spectrophotometry.The method for the detection of related substances in acetaminophen tablets was also established by high-performance liquid chromatography.The pre-formulation study of acetaminophen tablets was investigated using the method of Chinese Pharmacopoeia 2020,including the solubility,purity,melting point,hygroscopicity,and compatibility with various excipients.The effects of different excipients(disintegrants,lubricants,fillers,and binders)and preparation methods(wet granulation,centrifugal granulation,and spray granulation)on tablet quality were investigated by using granule content,moisture,density,tableting conditions,friability and hardness,disintegration time limit,and dissolution rate as indicators.influences.The appearance,shape,content uniformity,tablet weight difference,hardness,friability,disintegration time limit and dissolution rate of the prepared acetaminophen tablets were investigated by the tablet quality evaluation method in the Chinese Pharmacopoeia 2020.Results The in vitro analytical methods for acetaminophen and related substances were constructed,with a good linear relationship in the range of 2.5μg/mL-12μg/mL.The results of the pre-formulation study of acetaminophen tablets showed that the acetaminophen raw material is slightly soluble in water and easily soluble in methanol and acetonitrile.In addition,the melting point of acetaminophen raw material was 169℃,which showed slight wetting properties.Compatibility results of raw and auxiliary materials showed that acetaminophen had good compatibility with raw and auxiliary materials under three conditions high temperature,high humidity and light.The results of the formulation process indicated that the centrifugal granulation method was used to obtain acetaminophen tablets of good quality with pregelatinized starch,PVP K30,croscarmellose sodium,sodium stearate and water as raw materials.The quality evaluation results showed that the prepared acetaminophen tablets had a complete and smooth appearance,uniform color,no mottled foreign matter,and uniform content.In addition,acetaminophen tablets could achieve complete disintegration within 1.02 minutes and complete release within 60 minutes.In the investigation of the stability test,the properties,content,dissolution rate and content of related substances of the prepared acetaminophen tablets have no obvious changes under the conditions of high temperature,high humidity and strong light irradiation,which shows that the acetaminophen tablets have good stability.After intragastric administration to rats,after paracetamol was made into tablets,the half-life,area under the drug-time curve,and peak concentration of paracetamol were all significantly improved,respectively increasing and prolonging by 1.12 times,1.71 times and 1.85 times.Conclusion The article successfully prepared acetaminophen tablets with a round appearance,uniform color,good hardness and friability.In addition,the prepared acetaminophen tablets can achieve complete disintegration and complete release within the prescribed time.These results show that the prepared acetaminophen has good quality,and the research on this subject has reached the expected research goals.In addition,making acetaminophen into tablets can significantly improve the transport and absorption of acetaminophen,improve its oral bioavailability,and provide a theoretical basis for the oral delivery of acetaminophen.