| Objective: Yunxiang Qufengzhitong tincture is recorded that takeing orally could treat a cold or the flu,rheumatism bone pain,headache,abdomen pain,the heart and stomach to be mad the pain,etc.But,in the clinical,the main application form of cloud essence is for external using,which greatly limited the scope of application of the essence cloud in the clinical,and also directly affected the enterprise sales.The significance of this study lies in: through the oral dosage forms and oral ways of cloud essence changing,toexpand its range of application and increase enterprise sales.Methods:The ratio of matrix,condensation agent,drug and matrix,the distance and the drop of temperature were investigating with single factor.On the basis,based on the matrix of dropping pill,dropping distance and drop of temperature as the independent variable,and based on thescattered time limit,the rate of finished products and appearance quality evaluation standard of the comprehensive score as the dependent variable,using three factors and three levels,optimizing the molding process of cloud dropping pill.The qualitativeidentification of angelica,asarum in theYunxiang Jing pill were used the thin layer chromatography TLC,the quantitative analysis of Yunxiangjing dropping pills was used the gas phase chromatography(GC).In the preliminary stability of the experimental study,the impact factors of the cloud essence pill test andaccelerated testwere used to understand the quality of the product characteristics and changes in the law.Results:The best forming process of the cloud essence dropping pill was the medicine and the matrix(PEG-6000: PEG-4000=2: 1)was 1: 5,the dropping distance was 3cm,the condensation agent was liquid paraffin,and the dripping system temperature was 85℃.Establishing the qualitative identification method and content determination method of cloud essence dripping pill could accurately control the quality of the product.In the preliminary stability test,there were no significant change between test index of the preparation and the "0" month.Conclusion:In this experiment,the best of the Yunxiang Jing dropping pill is stable,simple and reproducible.The quality standard and preliminary stability of the preparation were established,which provided a reliable quality control method for this product and laid a solid foundation for further research and large-scale industrial production in the future. |
