Pharmaceutical Research On The Classic Prescription Drugs Of JiaWeiPiPaQingFei Capsule

Acne is a chronic inflammatory dermatosis happened in the sebaceous follicles.Its incidence is high,if not being treated promptly,it will take serious physical and psychological consequences to patients.Owing to the pathogenesis of ance is complex,westen medicine has its localization,and also generally follows many adverse effects such as irritation to the skin, toxicity of genital system or drug resistance.It is a long history for traditional Chinese medicine to treat acne,curing it according to different disease type such as FeiJingFengRe Zheng, PiWeiShiRe Zheng and so on.PiPaQingFei decoction has been used to treat acne vulgaris,but up to now,the easily cpalended praeparatum of Chinese crude drug is still blank in the market.On the basis of the classic prescription PiPaQingFei decoction,the research group has prepared the JiaWeiPiPaQingFei capsule to treat acne vulgaris,adding many kinds of Chinese crude drug according to modern clinical experience. The research on the preparation technology , quality standard and rudiment pharmacodynamics of the intermediate of the classic prescription drugs was carried out in this thesis.The main contents and conclusions are as follow:1.According to the related literature, the classic prescription's function and property of every medical material,extraction and purification technologies were designed.Using total flavones yield and total triterpenes yield as technology indexes,the single factor and orthogonal experiments were carried out for the extraction and purification of the group of Folium Eriobotryae Praeparata Cum Melle,Cortex Mori,Radix Et Rhizoma Glycyrrhizae and Radix Codonopsis.The optimal technology is Chinese crude drugs weighed according to the proportion of the prescription are extracted three times with 8 times 70% alcohol,2.0hours each time.The pH of extract is adjusted to 4.0 with hydrochloric acid.The acidifying extract is diluted with 0.5 times water of pH4,then centrifuged with 5000rpm.The supernatant is recovered alcohol,acidified to pH 2.0,then centrifuged with 5000rpm.Both of the centrifuged preciptitate is washed colourless with water and put into the vacuum drying oven to get intermediateI.Using total alkaloids yield as technology index,the single factor and orthogonal experiments were carried out for the extraction of the group of Rhizoma Coptidis and Cortex Phellodendri Amurensis.The optimal technology is Chinese crude drugs weighed according to the proportion of the prescription are extracted three times with 8 times water, 1.5hours each time.The extract is mixed with 95%alcohol,stayed overnight,filtered,then recovered alcohol and diluted to metered volume with water as the sample solution. The resin selection, dynamic adsorption and orthogonal experiments were carded out for the purification of this medicine group. The optimal technology is that every 40mL sample solution(0.05g crude drugs/mL,pH8)is dealed with 5g AB-8 resin(humid weight), the flow rate is 0.5mL/min, then the resin is eluted with 50% alcohol. The eluant is recovered alcohol and cryodesiceated for 24hours to get intermediateâ…¡.2. The quality standards of Folium Eriobotryae Praeparata Cum Melle was established and Rhizoma Coptidis consummated. Folium Eriobotryae Praeparata Cum Melle is identified by TLC; Ursolic Acid(UA), Oleanolic Aeid(OA) and Berberine were detected by HPLC. The contents of UA and OA in Folium Eriobotryae Praeparata Cum Melle are respectively no less than 5.3mg/g and 1.8mg/g, the content of Berberine in Rhizoma Coptidis is no less than 30.0mg/g.3. The quality standard of the intermediate of the classic prescription drugs is established. Folium Eriobotryae Praeparata Cum Melle, Cortex Mori in intermediateâ… and Rhizoma Coptidis in intermediateâ…¡were identified by TLC; UA, OA and Berberine were detected by HPLC. The contents of UA and OA in intermediateI are respectively no less than 30.0mg/g and 8.0mg/g, the content of Berberine in intermediateâ…¡is no less than 200.0mg/g; The fingerprints of Rhizoma Coptidis, Cortex Phellodendri Amurensis and intermediatelI were preliminarily established. The similarity of fingerprints is larger than 0.95 with the vectorial angle method. All of the characteristic peaks in intermediatelI can be found in fingerprints of medical materials.4. Rudiment pharmacodynamics of the intermediate of the classic prescription drugs was carried out. The results of antibacterial test in vitro show it has good antibacterial effects on P. acnes and S. aureus, the minimal inhibitory concentrations are respectively 2.5mg/mL and 5mg/mL; The mice auricle swelling test shows it possesses good anti-inflammatory effect; It also can diminishes the area of the Syrian Hamster flank sebaceous glands.