Study On The Preparation Process And Quality Standard Of Jianxin Granule

Objective:This subject is instructed by the theory of Traditional Chinese Medicine.Applying modern pharmaceutical theory and technology,we study on the preparation process,quality standard and preliminary stability of Jianxin Granule,and lay the foundation for producing the new traditional Chinese compound preparation that have a good therapeutic effect.Methods:1.In the study of the preparation process,the best technology extracted by ethanol for Radix Salviae Miltiorrhizae and the best technology extracted by water for six traditional Chinese drugs such as Radix Astragali are screened by orthogonal experiments. The technology of producing granules is studied by experiments.2.We have established the thin layer chromatography identifiction of Radix Astragali, Radix Ginseng Rubra, Radix Salviae Miltiorrhizae and Pollen Typhae in the quality standard. The content of Salvianolic acid B in the Radix Salviae Miltiorrhizae and the content of Ginsenoside Rg1, Ginsenoside Re and Ginsenoside Rb1in the Radix Ginseng Rubra are measured by High Performance Liquid Chromatography. The quality specification draft of Jianxin Granule was instituted according to the research.3.Explore three samples in normal room temperature with6month, and study every examining item of the quality standard.Result:1.The optimum preparation process is confirmed as follows:Extract Radix Salviae Miltiorrhizae for2times under reflux with70%ethanol for1hour,the ethanol volume is5times more than that of the material. Extract the dregs of Radix Salviae Miltiorrhizae and six traditional Chinese drugs such as Radix Astragali for2times under decoction with water for1hour,the water volume is10times more than that of the material. Concentrate the combined filtrate with the density about1.18~1.22(50℃). Put red ginseng powder and dextrin in it,mix thoroughly,granulation than12mesh,50℃drying.2.Established the TLC identification of Radix Astragali, Radix Ginseng Rubra, Radix Salviae Miltiorrhizae and Pollen Typhae; Content determination Salvianolic acid B,Ginsenoside Rg1,Ginsenoside Re and Ginsenoside Rb1in the preparation assayed by HPLC; Each inspection item meets the standard of the Chinese pharmacopeia2010version1about granules. The methods of the quality standard are simple, specific and reproducible.3. The preliminary stability studies of three samples demonstrate the every inspection item meets the standard of the Chinese pharmacopeia, and the quality of finished product is stable.Conclusion:By researching the preparation process of Jianxin Granule, the best technology route is screened.It is reasonable and practical. The quality of finished product is controllable and stable.This research offers the basis for the produce of the new traditional Chinese compound preparation.