Study On Extraction Process And The Quality Standard HPLC Fingerprint Of Compound SIHUANG External Lotion

Objectiveusing orthogonal design method for optimizing the best extraction process,quantitative analysis of emodin and berberine hydrochloride in Compound SIHUANG External Lotion were carried out by HPLC,which provide a reliable basis scientific evaluation and effectively control its quality.tudy and raise the quality standard of Compound Sihuang External Lotion,so as to improve the controllability of the preparation.establish a HPLC fingerprint analysis method for Compound Sihuang External Lotion,and to provide basis for the identification and quality standard of the preparation.MethodsMainly divided into three aspects of Extraction Process and the quality stand and HPLC Fingerprint,respectively,from the four parts of the study:?1?Water extraction process selects emodin as the reference substance,with HPLC determination of emodin at 254 nm peak area,again according to the standard curve method to calcuLate Compound SIHUANG External Lotion content of emodin in the water extract medicine.In the L₉?3⁴?orthogonal experiment design,with dry extract of water extract and the emodin content as the indexes,inspect extracting times and extracting time,water volume,alcohol concentraction four factors effect on the extraction of emod ine;Alcohol extraction process selects berberine hydrochloride as the reference substance,with HPLC determination of berberine hydrochloride at 265 nm peak area,again according to the standard curve method to calcuLate Compound SIHUANG External Lotion content of berberine hydrochloride in the alcohol extract medicine.In the L₉?3⁴?orthogonal experiment design,with dry extract of alcohol extract and the berberine hydrochloride content as the indexes,inspect alcohol content,reflow time,alcohol concentraction,reflow times four factors effect on the extraction of berberine hydrochloride.?2?According to the Chinese Pharmacopoeia?Volume?,2015?,Guangdong Province Traditional Chinese Medicine Standard?Volume 1?and related literatures,in the preparation,the rhubarb,the Coptis,the chinensis Cork,the Scutellaria baicalensis,the Forsythia and the Polygonum cuspidatum were indentified by the TLC.?3?Zorbax SB C18?150 mm*4.6 mm,5?m??American Agilent company?;the mobile phase of 0.1%phosphoric acid?containing 0.03mol/L potassium dihydrogen phosphate??A?-acetonitrile?B?-methanol?C?;the detection wavelength of 254nm;column temperature was 25?,sampling the amount was 10?L,HPLC pattern analysis of Compound Sihuang External lotion,the chromatographic fingerprint similarity evaluation system"?2009?for similarity evaluation.Results?1?the best water extraction process for extracting times 3 times,extracting time for 1.5 h,8 times water,alcohol concentraction for 60%;the best water extraction process for alcohol concentraction for 70%,reflow times3 times,8 times alcohol,reflow time for 1 h.Conclution the process of test content determination method is accurate,simple,and reproducible,extraction technology and economic,reasonable and worthy of further promotion,to quality research of a good reference value.?2?The spots on TLC plates were clear without interference in the blank reference?3?Test the 10 different batches of Compound Sihuang External Lotion HPLC fingerprints and the similarity analysis,through the analysis of HPLC fingerprint to confirm,phillyrin and baicalin,berberine hydrochloride,Huang Sufeng,and the batch control map between the high degree of acquaintance.ConclutionThe method is accurate,simple and reproducible.The extraction process is reasonable and economical.It is worth to be popu Larized.The thin layer chromatography method and HPLC fingerprint method are simple,easy to operate,and can be used as a quality control method for compound four yellow lotion.