Studies On The Quality Control Of Leonuri Granules

Herba Leonuri is the aerial parts of Leonurus japonicus Houtt, which is traditional ChineseMedicine of gynecology with the functions of promoting blood circulation and diuresis. Leonurusgranule is a single medicinal preparation processed by the water extract of Herba Leonuri. Totalalkaloid ingredients or stachydrine hydrochloride are used as the standards in the most leonurusgranules, but some of them did not set up any identification method. The purposes of the presentstudy are to (1) unify and perfect the quality control of Leonurus granule by studying its methods foridentification and determination on the basis of National Drug Compliance Inspection project in2012, and (2) study the problems existed in the process of production and material to provide ascientific basis for controlling quality more comprehensively and effectively using newly establishedmethods.Four identification methods of Leonurus granule were established and unified. A method for theidentification of stachydrine hydrochloride in Leonurus granule was established withacetone-ethanol-hydrochloric acid (10:6:1) as developing agent, the mixture of bismuth potassiumiodide-1%ferric chloride ethanol solution (10:1) as chromogenic reagent. Another TLC method wasset up to identify the flavonoids in Leonurus granule using ethyl acetate-butanone-formicacid-water(7:3:1:1) as developer, and2%aluminium chloride ethanol solution as coloration. TheHPLC method using acetonitrile-0.1phosphoric acid solution of0.4%sodium octanesulfonate (24:76)as the mobile phase and detection wavelength of277nm was established to identify the alkaloids inLeonurus granule. The HPLC method for the identification of specific chromatogram of Leonurusgranule was also established with the mobile phase of acetonitrile-phosphoric acid solution (5mlphosphoric acid in1000ml water, adjusted to pH4.0with triethylamine)(90:10), detected at195nm.Hence, it turned out that the four methods mentioned above were simple, convenient and repeatable,and can be used to identify for different dosage forms of Leonurus granule.A HPLC method for the determination of stachydrine hydrochloride in Leonurus granule wasunified. A mobile phase composed of acetonitrile-phosphoric acid solution(5ml phosphoric acid in1000ml water, adjusted to pH4.0with triethylamine)(90:10) were used, at detection wavelength of195nm. The results showed a good linear relationship ranged from0.3729mg/ml to5.5935mg/ml, y=1.92×10~6x+2.81×10~5(R~2=0.999), the average recoveries were96.8%, the relative standarddeviations were1.7%～1.0%. Hence, the established method in present study was simple, convenientand practicable, and can be used to control the quality of Leonurus granule.Besides, we tested these projects above with these established methods, and compared with theresults using present methods. We studied the phenomena of fake materials and adding Stachydrinedirectly with the newly established methods as well, which provides scientific supports for ensuringthe authenticity and reliability of producing process strictly.