Pharmaceutical Research On Jiawei Pipa Qingfei Capsule

Acne is a chronic inflammatory dermatosis happened in the sebaceous follicles. Its incidence is high.On the basis of the classic prescription PiPaQingFei decoction which consists of Folium Eriobotryae（stir-frying with honey）,Cortex Mori,Rhizoma Coptis,Cortex Phellodendri,Radix Glycyrrhizae and Radix Codonopsis.,the research group has prepared the JiaWeiPiPaQingFei capsule to treat acne vulgaris,adding Chinese crude drug such as crataegi,according to modern clinical experience.A preliminary study of Jiawei Pipa Qingfei capsule has been carried out in terms of optimization of extraction and purification condition of the totoal effective constituent, preparation technics,quality control,stability and antibacterial effects And the main contents and outcomes are to be demonstrated as follows.1.Using total flavones yield and total triterpenes yield as technology indexes,the single factor and RSM experiments were carried out for the extraction and purification of the group of Folium Eriobotryae,Cortex Mori,Radix Et Rhizoma Glycyrrhizae,Radix Codonopsis and crataegus.The optimal technology was Chinese crude drugs weighed according to the proportion of the prescription were extracted three times with 16.5 times 66%alcohol,2.0hours each time.The extract was combined and concentrated and then the pH of extract was adjusted to 4.0 with acid.The acidifying extract was diluted with 1.5 times water of pH4,then centrifuged with 5000rpm.The supematant was acidified to pH 1.0,then centrifuged with 5000rpm.Both of the centrifuged preciptitate was washed colourless with water and put into the vacuum drying oven to get extractⅠ.In this condition,the yield of extract I was 0.04g/g,the yield of total flavones was 6.37mg·g^-1,the yield of total triterpenes was 32.15mg·g^-1 and the content of total effective constituent in extract I was 64.9%.Using total alkaloids yield as technology index,the single factor and RSM experiments were carried out for the extraction of the group of Rhizoma Coptis and Cortex Phellodendri Amurensis.The optimal technology was Chinese crude drugs weighed according to the proportion of the prescription were extracted four times with 18 times water,1hours each time.The total alkaloids were concentrated by acetic ether extraction under pH 12,with the ratio 1:1 of solvent to extract,and the extraction was repeated 6 times,the extraction is recovered acetic ether to get extractⅡ.In this condition,the yield of extractⅡwas 0.043g/g and the content of total alkaloids in extractⅡwas 66.13%. 2.Preparation technics of the capsule had been studied:distilled power from each group was mixed to be the principal drug according to different ratio,then added with satis quantum gesso and lactin as supplement.The technical process of granulation was screened through orthogonal tests which determined that the optimum granulate conditions were:the ratio of gesso and lactin was 1:1,50%alcohol as moistening agent whose dosage was 12%（that is 12ml50%Alcohol added to 100g medicine powder）.The tests also selected Gum Acacia as the glidant of capsule whose dosage was 0.4%.The bulk density of particle was 0.56g/ml,relatively critical humidity was 60%.3.The quality standard of the capsule had also been established.The elements of Folium Eriobotryae,Cortex Mori,Rhizoma Coptidis,Cortex Phellodendri were identified by means of TLC.Berberine was determined by HPLC.The content of Berberin hydrochloride should not be less than 5.00mg per capsule.The dissolution of capsule was determined in vitro.Moisture content,content uniformity,content of heavy metal were detected and the result was in accordance with the regulation set by Chinese Pharmacopeia（2005 edition）.4.The preliminary stability of Jiawei Pipa Qingfei Capsule was studied in the test and the result showed that the quality of Jiawei Pipa Qingfei Capsule was stable.5.The preparation possesses antibacterial effects for Propionibacteria acnes, Staphylococcus aureus,Malassezia furfur and Pseudomonas aeruginosa,the minimal inhibitory concentration on Propionibacteria acnes Staphylococcus aureus,Malassezia furfur and Pseudomonas aeruginosa were 7.5mg/ml,0.23mg/ml,3.75mg/ml,15 mg/ml respectively.