Preparation Research Of Triamcinolon Acetonide Intralipid For Injection Based On The Concept Of Quqlity By Design

In recent years,with Chinese FDA to launch a quality consistency evaluation for generic drugs,Hengrui Medicine and Harbin Pharmaceutical Group as the representative of the rapid development of domestic pharmaceutical companies,and strive to international standards,the level of drug quality has been greatly improved,and they emphasis on "Quality from design(QbD)" concept,based on scientific and risk assessment to ensure product quality and process level.In this concept,this article is in-depth studied the triamcinolone acetonide intralipid for injection.Triamcinolone acetonide is an adrenal cortex hormone drug,with anti-inflammatory and anti-allergic and immune suppression and other pharmacological effects.Commercially available products of triamcinolone acetonide are suspended Injection,clinical application of skin atrophy,bleeding or ulcers and other issues because triamcinolone acetonide is difficult to dissolve in water and make liquid preparations.Now triamcinolone acetonide is made into(o/w)submicron emulsion with medium chain triglycerides as the dispersed phase,with egg yolk lecithin as emulsifier,targeted and can also be used to improve the efficacy of the drug,and reduce the side effects.In this article,its prescription is optimized through risk assessment and experiments base on the QbD concept.Then,design of experiment(DoE)tool is used to optimize primary emulsions process and refine emulsions process of the product by factorial design on Minitab software,to obtain the best preparation process.According to the optimized formula and process,the triamcinolone acetonide lipid emulsion injection was made,and the quality of the emulsion was the same as the expected target.This product and the commercially available similar products(domestic TRANSTON?,FDA TRIESENCE?),were subjected to high temperature,light and other influencing factors test and stability acceleration test.The product content,related substances and other quality indicators not less than commercial products,according to the characteristics of this product,adding particle size,free fatty acids,osmotic pressure,entrapment rate and other quality indicators,which also meet the quality requirements.Therefore,the triamcinolone acetonide intralipid mainly is used for injection both not less than the quality of commercially available products,but also have a lot of intralipid characteristics: to improve drug solubility and product stability etc.