| Acne is one of common chronic skin diseases, whose incidence is quite high, in sebaceous gland folliculitis. The medication, Jiawei Pipa Qingfei capsule aiming at treating acne, consists of Folium Eriobotryae (stir-frying with honey), Cortex Mori, Rhizoma Coptidis, Cortex Phellodendri, Radix Scutellariae, Fructus Gardeniae, Fructus crataegi, Gypsum Fibrosum, Radix Glycyrrhizae and Radix Codonopsis. This medication is based on the classical prescription of Pipa Qingfei decoction recorded in the traditional Chinese scripture,named as Yizong Jinjian. In the prescription, Folium Eriobotryae and Cortex Mori are principal drugs, which serve to open the inhibited lung-energy and clear away the heat-evil. Besides, Rhizoma Coptidis,Cortex Phellodendri, Radix Scutellariae, Fructus Gardeniae are assistant drugs, which help clear away the heat-evil and expel superficial evils. Fructus crataegi and Gypsum Fibrosum are adjuvant drug used to remove blood stasis and turbid as well as enhance the effect of heat-clearing. And finally, Radix Glycyrrhizae and Radix Codonopsis are guiding drugs, which benefit vital energy and regulate the middle warmer thus functioning to protect spleen and stomach.A preliminary study of Jiawei Pipa Qingfei capsule has been carried out in terms of preparation technics, quality control, stability, rudiment pharmacodynamics as well as its acute toxicity test. And the main contents and outcomes are to be demonstrated as follows.1. Preparation technics of the capsule has been studied: nine herbaceous elements from the prescription were divided into four groups, each of which was treated for extraction and purification separately. Then 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%.2. The quality standard of the capsule has also been established. The elements of Folium Eriobotryae, Cortex Mori, Rhizoma Coptidis, Cortex Phellodendri, Radix Scutellariae, Fructus Gardeniae were identified by means of TLC. Berberine and Baicalin were determined by HPLC. The content of Berberin hydrochloride and Baicalin should not be less than 5.50mg and 21mg per capsule. The dissolution of capsule was determined in vitro, relative accumulative dissolution of Berberin hydrochloride and Baicalin were more than 70% within 45 min. 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).3. The preliminary stability of Jiawei Pipa Qingfei Capsule was studied in the test with conditions of high temperature, high moisture and exposure to heavy light which lasted for 3 months with acceleration. The result indicated that the character, identification, detection, content determination and hygienic quality remained unchanged. It showed that the quality of Jiawei Pipa Qingfei Capsule was stable.4. Rudimentary pharmacodynamics and acute toxicity test have been carried out. The preparation possesses antibacterial effects for Propionibacteria acnes and Staphylococcus aureus, the minimal inhibitory concentration on Propionibacteria acnes and Staphylococcus aureus were 5mg/mL and 40mg/mL respectively. Good anti-inflammatory effect on the edemas of the mice's ears induced by dimethyl benzene was observed. The Syrian Hamster Flank Organ was adopted as animal models to investigate the effect of the capsule on androgen in glandulae sebaceae. The results showed that it can decrease the area of the Syrian Hamster Flank Organ, which suggested that the capsule can inhibit androgen in glandulae sebaceae. The anti-inflammatory action and the inhibition action of androgen in glandulae sebaceae of the capsule were compared with the classical prescription and the additional drugs and test results are that they all have anti-inflammatory action to some extent, the effect of the capsule was better than the classical prescription and the additional drugs respectively, the combination of classical prescription and additional drugs has synergism effect on anti-inflammatory action. The classical prescription, the additional drugs and the capsule all can inhibit androgen in glandulae sebaceae, and the effect of the former was the same as that of the later. The combination of classical prescription and the additional drugs has no synergism effect on inhibition of androgen in glandulae sebaceae. Acute toxicity test showed that Jiawei Pipa Qingfei Capsule had no obvious toxic reaction. |
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