Study On The Preparation Technology And Quality Standard Of Fufangjinqin Granules

Purpose: Fufangjinqin granules has obvious curative effect on upper respiratory tractinfection, acute pharyngitis, acute tracheitis and bronchitis in order to wind-heat as the mainclinical.Fufangjinqin granules belongs to the sixth type of new traditional Chinese medicine.The pharmaceutical research contents including preparation process and quality controlstandards were established in accordance with the procedures for examination and approval ofnew drugs.Methods: Fufangjinqin granules is prepared by extracting from six kinds of TraditionalChinese Medicine including H. cordata, honeysuckle, radix peucedani, folium isatidis, radixscutellariae, and rhizoma belamcandae,established by orthogonal test volatile oil extractionprocess and the inclusion process;Using TLC experiments of H. cordata, radixpeucedani,foliumisatidis, radix scutellariae, and rhizoma belamcandae,establish a qualitativeidentification for the preparation;Using HPLC for content determination in order tochlorogenic acid in honeysuckle as a determination indicators. In accordance with ChinesePharmacopoeia,the study on quality standard of Fufangjinqin granules has been established.Results: Using orthogonal test method, preferred the volatile oil β-cyclodextrin inclusionprocess.The proportion of volatile oil and β-cyclodextrin was1:8,the inclusion temperaturewas45℃,and the inclusion time was3h. The best extraction parameters were determined bythe chlorogenic acid.The prescription was boiled with50%ethanol for twice, eight times the50%ethanol of its own weight was added, each decoction lasted1.0hours. The fried liquidwas gathered, then filtered. Two times the dextrin of dry extract powder own weight wasadded,80%ethanol and2.5%steviosin were added and mixed, soft material was obtainedgranulated formability and good fluidity. Provided for the preparation of chlorogenic acidcontent limits, the amount of chlorogenic acid (C₁₆H₁₈O₉) in Fufangjinqin granules weremeasured to be not less than2.5mg per gram.Conclusion: The preparation process of Fufangjinqin granules was simple andconvenient that can be used for industrial production.Materials such as H. cordata, radixpeucedani, folium isatidis, radix scutellariae, and rhizoma belamcandae were identificated byTLC, the samples had the same colors in the same locations with the reference substance, andthe negative samples has no interference.This methed can be used as the quality of Fufangjinqin granules. The determination of content was simple, accurate andreproducible,which provided a stable and controllable quality standards for Fufangjinqingranules.