| Objective: To preparate and evaluate the Traditional Chinese Medicine named Kubai Jieyin Suppository used to improve the symptom of Vaginitis,and study on its preparation process,quality standard,irritation,and Allergic test.Method:Through pharmacodynamics experiment results for main index,the suppository matrixes and the proportion of drug forming process are optimized by single factor test and orthogonal test. Using the thin layer chromatography(TLC) to define each other medicines,and the HPLC analytical method has been developed for he assay of some medicine drug in this prescription,formulating optimal quality standards; Within big ear white rabbits and guinea pig as experimental animal,study on the product’s stimulation and examine the allergic.Result:The preparation process: volatile oil of Clove were collected by steam distillation extraction, remaining volatile oil and water solution;Clove drugs is mixed with five drugs,such as Cortex Phellodendri,using the boiling water extract two times, merging the solution and water extraction liquid after volatile oil. When the decoction’s relative density gets some level,adding alcohol to 60%,washing the precipitate,and mixed the recovery alcohol into Vacuum, and concentrated to thick paste,adding polysorbate-80,mixed with Fatty acid esters of glycerol,then blend,cool,and fill.With TLC study,earthworm,Sophora flavescens,clove,wild chrysanthemum for test and control substances on the corresponding position are the same color spots in the chromatographic.Studying by the content determination method,the content of berberine hydrochloride in this product should not be less than 1.1mg per particle,the content of eugenol should not be less than11.0mg per particle.Conclusion:Kubai Jieyin suppository preparation process is stable and suitable for mass production process.The method of quality control is accurate,the level of quality control is good,this product has good stability and high safety,the preparation is effective to cure vaginitis. |
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