The Study On Preparation Process And Quality Standard Of Yinhua Jiedu Granules

Objective:Study on preparation technology,quality standard and stability of Yinhua jiedu granules Methods:(1)Single factor test combined with star-point response surface method was used to evaluate the technological parameters of water extraction of prescription herbs with the comprehensive scores of chlorogenic acid,rutin,baicalin content and extract yield.Study on the Optimum Molding Technology of granules.(2)The constituents of Flos Lonicerae,Scutellaria baicalensis and Forsythia suspensa in granules were identified by TLC.The contents of chlorogenic acid,in the preparation were determined by HPLC and the quality standard was established;(3)Study on the stability of Yinhua jiedu granules by classical constant temperature accelerated experiment Results:(1)The chromatographic conditions of the extraction process are as follows: mobile phase of acetonitrile-0.1% phosphoric acid for gradient elution(0–20 min,13%A;20–30min,13%–18%A;30–55 min,18%–20%A;55–65 min,20%–23%A)and detection wavelengthes of 327 nm and 256 nm for chlorogenic acid and total flavonoids respectively.the column temperature was 30 ? and the flow rate was 1.0mL/min.(2)The best molding technology is to use 88%% ethanol as wetting agent,adding extract powder,1/3salvia miltiorrhiza powder and peony peel powder to granulate.(3)A TLC method for identification of Lonicerae japonica and Radix Scutellariae was established.The content of chlorogenie acid,in Yinhua jiedu granules was determined by HPLC,and the chromatographic conditions are acetonitrile-0.1% phosphoric acid solution(13? 87).The classical constant temperature accelerated experiment of Yinhua jiedu granule was carried out,and the validity period was determined to be 15 months.Conclusion:The production process of Yinhua jiedu granules is reasonable and feasible.The established quality standard is simple,rapid and accurate,and can effectively control the quality of the preparation.