Studies On The Preparation Technology And Quality Standard Of Kangfu Capsules

Kangfu capsules is a chinese medicine preparation,which is made of 6 traditional chinese medicines including Milkvetch Root,Radix Salvia Miltiorrhiza,Poria,Rhizoma Dioscoreae,Rhizoma Rinelliae Praeparatum,Rhizoma Atractylodis etc.There are many effectivenesses about this prescription such as drying the wetness-evil and eliminating phlegm,activating blood circulation to dissipate blood stasis,invigorating the kidney and spleen and so on,as well as the polycystic ovary syndrome can be healed by it.This topic was mainly to systematically study the technology,quality standard and the initial stability test of the preparation.With the guidance of the theories of Traditional Chinese Medicine Kangfu capsules was studied with modern pharmaceutical technology.And the route and condition of the technology was established on the prerequisite of the clinical efficacy.On the basis of effective components and parts as well as the characters of components of the herbs,traditional decoction was transformed into granules by The crashing of the raw medicine,the technology of Volatile oil,water and alcohol extraction were the principal researches.Water and alcohol extraction process have been ascertained by using the orthogonal experimental method and the solids of Astragaloside and TanshinoneⅡA as the quota targets.The methods of the thin-layer chromatography of Milkvetch Root,Radix Salvia Miltiorrhiza,Rhizoma Atractylodis have been established in studying the quality standard,we adopted the conventional quality examination in the capsules and the assay of the TanshinoneⅡA has been constructed and the low limit of the contents has been defined.In the study of the preparation stability,three semi-works productions have been examined for 0～6 months and the results showed that all indexes were consistent with the regulation.The findings suggested that the technology of the preparation is reasonable and desirable,the quality is stable and controllable and accord with the needs of treatment of polycystic ovary syndrome.Kangfu capsules has broad prospects in application.