Study On Preparation Technology And Quality Standard Of Acyclovir Tablets

Herpes-type diseases are still one of the intractable diseases that plague people.Acyclovir is the first selective inhibitor of herpes simplex virus and herpes zoster virus.It has high selectivity and is less toxic to normal cells.Successfully opened up a new milestone in anti-herpes virus treatment.In this experiment,the acyclovir tablet of the original GlaxoSmithKline was selected as a reference preparation,and the prescription process was preliminarily determined by the prescription and quality analysis of the reference preparation;the compatibility of the raw materials and the auxiliary materials was initially determined.The type of excipients selected;after further screening of the types and amounts of fillers,binders,disintegrants and lubricants,the formulation of this product is determined to be lactose,microcrystalline cellulose,crospovidone,sodium carboxymethyl starch,Povidone K30,magnesium stearate and ethanol,through the small test and the pilot production verification,the final confirmation of the product prescription.Through the process research,this experiment systematically investigates the initial mixing time and drying temperature of key process parameters,and clarifies that the mixing time is 2 hours to make the uniformity of the mixed powder pass,and achieve the effect of mixing uniformity;combined with the common temperature of production,the drying temperature is determined.55℃-65℃,can not only ensure the water is qualified,but also meet the requirements of tableting.This process has been verified by multiple batches of pilot production,indicating that the process is stable and feasible.In this test,the quality standard of acyclovir tablets was prepared by comparing the quality of self-developed products with reference preparations.The determination methods of traits,identification,dissolution,related substances,content and weight of acyclovir tablets were established,and the method was proved to be accurate and feasible.Among them,the linearity of the dissolution in the range of 5.980～11.95 μg/mL is good,the recovery rate can reach 100.0%,the accuracy of this method is good;the determination method of the related substances has a good linear relationship in the range of 0.1005-2.412μg/mL,and can be impurities For effective separation,the accuracy and specificity of this method are good;the content has a good linear relationship in the range of 0.06800-0.1260mg/mL,and the recovery rate can reach 99.6%,indicating that the accuracy of this method is good.This draft standard effectively controls the quality of the product.This study investigated the stability of acyclovir tablets and placed them under accelerated conditions for 6 months,placed under long-term stability conditions.Months,all test indicators meet the quality standards,and there is no significant change compared with the 0-day results,indicating that its product stability is better.Through the research on the prescription process,quality standard and stability of acyclovir tablets,this test proves that the quality of self-developed products and reference preparations is equivalent,and the safety and effectiveness can basically reach the level of reference preparations.Industrial production,to achieve its economic and social value,can bring good news to the majority of herpes patients in the country.