Hech Soft Capsule Bulk Drugs And Their Preparation Quality Standards

Hech, also called folial black bupleurum chinense is a Tibet drug (Bupleurum smithiiWolff Var.parvifolium) which was mainly used in the treatment of icteric hepatitis with itseffective part. Hech was discovered to be of dispersing the depressed liver-energy andcholagogue and antiinflammation. Hech capsula mollis is Chinese materia medicapreparation for oral administration which consists of more than 50％effective parts ofthe raw material. This paper includes three parts: Study on the quality criteria of thecrude drug of hech capsula mollis; Study on the quality criteria of hech capsula mollispreparation; Study on the finger printing of Hech extractive. We mainly investigatedthe quality criteria of the crude drug of hech capsula mollis and its preparation, whichcould make it safe and controllable in preparation and quality norm of the drugproduction as well as provide pharmaceutical research data for developing newtraditional Chinese medicine.Study on the quality criteria of the crude drug of hech capsula mollis. Throughpharmacodynamics research and component analysis we discovered that totalflavonoids is the effective part of Hech which worked on normalizing gallbladder tocure jaundice and antiinflammation.According to the demand of new traditionalChinese medicine development, the effective part of Hech capsula mollis accouted for50％, and thus we extracted preparation technology and made quality criteria for rawmaterial. First, We took orthogonal design and the best technology method to obtainthe effective part of Hech whose total flavonoids was 50％higher than that of thecrude drug; We also administered plate chromatography to appreciate thin-layerchromatography and investigated the detection wavelength,menstruum,ultrasoundtime,dosage of developer and time of color reaction in the crude drug which bestturned to be 510nm in wavelength,30％alcohol in menstruum and 30 min in ultrasound. The assaying of rutoside was best to be mobile phase of acetonitrile-aqua(18:82) and 20 min in ultrasonic extraction. The recovery rate of sample applicationpresented to be 100.16％and 101.52％in total flavonoids and rutoside undermethodology investigation. We also determinated the content of total flavonoids withchromatomety and rutoside with high efficiency liquid chromatography. Accordingly,this method was exact,reliable and could be applied in quality control of the crudedrug.Study on the quality criteria of hech capsula mollis preparation. We choseappropriate prescription on adjuvant materials of the capsula mollis content and itscomponent as well as differentiation of thin-layer chromatography with platechromatography. Meanwhile we examined the differences of its capacity anddisintegration time which turned to be coincidence with pharmacopeia. 30 min ofultrasonic time showed best in investigating the assayint of capsula mollis and nointerference was found in the samples. The recovery rate of sample application in totalflavonoids and rutoside was 99.92％and 99.45％respectively. The content of totalflavonoids and rutoside in each sample should be no less than 100mg and 15mgrespectively. We also determinated the content of total flavonoids with chromatometyand rutoside with high efficiency liquid chromatography. Accordingly, this methodwas exact,reliable and could be applied in quality control of the crude drug.Study on the finger printing of Hech extractive. Hech finger printing wasfirstinvestigated in five different areas (within the QingHai Province). Results: Therewere significant differences of finger printing among various areas, thus provided uswith valuable parameter in controlling Hech crude drug's quality.We first took the effective part of Tibet drug Hech for material to finish the bestextracting technology and mass detection of its dispersing the depressed liver-energyand cholagogue and antiinflammation, and to investigate the quality criteria of capsulamollis preparation which has basically finished the principle researches of capsula mollis preparation pre-clinically and the finger printing researches of different Hechhabitats. Our research work of preclinical practice provided a creative mind andreferences in developing the poor national medicine and made some promotion indeveloping local national economics.