| Zitongxiaobai granule is on the base of hospital pharmaceutical preparation to provide the basis for clinical study and the new drug development by the preparation reform.zitongxiaobai granule,which is made from eleve medicinal miltiorrhizae as follows:Radix salviae Mitiorrhizae,Radix arnebiae,Fructus tribuli,Flos carthami,Herba spirodelae, Radix curcumae,Fructus Liquidambaris,Semen Juglandis etc,is an effective prescription in treating vitiligo due to disharmonany befween qi and xue and deficiency of kidney and liver.The auther has made a study on its preparation and quality satandard in order to assure its safety and effection.1.Study on the preparation In accordance with properties of medicinal materials and specificity of indications of the presciription,the granule was selected as the drug preparation.Its optimum extraction process was as follows according to the physical and chemical properties of each medicinal material.Firstly,Radix salviae Miltiorrhizae and Radix arnebiae were extracted with alcohol and Orthogonal design was applied to optimize the extraction process with the content of tanshioneâ…¡A as the dective marker,secondly,mixed their remains of being extracted by alcohol with other medicinal material, extracting with water and opitimized the extraction process by orthogonal design with yield of extract and the content of danshesu Na as thd dective makers,At last,on the basis of these studies,combining specifity of medicinal materials and requirements of the dosage form,the preparation process was ascertained for the zitongxiaobai granule.2.Stady on quality standardTLC was performed to identify Radix salviae Miltiorrhizae. Radix arnebiae and Radix curcumae.HPLC was used to determine the content of tanshioneâ…¡A,the average recovery was 99.45%and RSD was 3.78%,on the basis of all above mentioned quantitative analysis method,it was simple,realizable and reprodicible.It can be used effectively for the quality control of Zitongxiaobai granule. |