Compound Xiangdan Granules Preparation Process,Quality Standard And Pharmacokinetic Study

Compound Xiangdan granules are developed by a clinical prescription summarized to prevent and treat the coronary heart disease with qi stagnation and blood stasis according to the analysis of clinical experience and pharmaceutics of traditional Chinese medicine by Xiyuan Hospital elementary laboratory.The compound granules are composed of four Chinese herbal medicines including radix salviae miltiorrhizae,radix ginseng,hawthorn leaf extract and moschus artificialis.Under the guidance of the modern Chinese medicine theory,the quality control standard of Xiangdan compound granules is established by using the modern pharmaceutical theory and method and selecting the best extraction process of compound Xiangdan granules.Then the preliminary study is conducted on pharmacokinetics,which helps to lay the foundation in developing compound Xiangdan granules-the new traditional Chinese medicine of which preparation technology is reasonable and quality is controllable to prevent and treat coronary heart disease with qi stagnation and blood stasis.Objectives:1.To screen the best extraction process of radix salviae miltiorrhizae,radix ginseng,hawthorn leaf extract and moschus artificialis from the prescription by using the orthogonal test method,and determine the preparation technology of compound Xiangdan granules by test.2.To determine contents of tanshinone ⅡA and hyperoside in compound Xiangdan granules by using a HPLC method and the quality standard of granules on this basis.3.To establish the method of determining plasma concentration of ginsenoside Re,Rg1,Rd,Rbl after administration of compound Xiangdan granules inside albino ral’s body by using LC-MS method,determine plasma concentration of Xiangdan granules extract after administration of compound Xiangd.an granules inside albino ral’s body,and make clear pharmacokinetics parameters of each composition in the body.Results:1.To determine the best extraction process of compound Xiangdan granules:radix salviae miltiorrhizae is extracted by 8 times quantity of 60%ethanol for two times,two hours each time;radix ginseng is extracted by 6 times quantity of 70%ethanol for two times,two hours each time;hawthorn leaf extract is extracted by 12 times quantity of 40%ethanol for one time,one hour each time;moschus artificialis β-cyclodextrin is included.Dextrin is selected as excipient,the ratio of medicinal materials and dextrin is 1:1.5,85%ethanol is the wetting agent,through wet granulation,compound Xiangdan granules preparation is completed.2.The contents of tanshinone ⅡA and Hyperoside in the preparation are determined by using HPLC method,the quality standard of compound Xiangdan granules is established;research of preliminary stability test is conducted and storage condition and vadality are determined in the preparation.3.Methodology study is completed on the determination of effective components in albino ral’s plasma after administration of compound Xiangdan particles and determination of effective components of compound Xiangdan granules is completed inside albino ral’s plasma.Conclusion:The technical line of extraction techniques of compound Xiangdan particles in the study is reasonable and feasible and the granules produecd have controllable quality and good stability.Thus,it lays the foundation for the development of compound Xiangdan granules-the new traditional Chinese medicine to prevent and treat coronary heart disease with qi stagnation and blood stasis.The content determination of effective components of compound Xiangdan granules is conducted by LC-MS method,providing pharmacokinetic research basis for further optimization of prescription compatibility.