Qingbi Particle Preparation Process And Quality Standards

The prescription of Qingbi is a proved clinical effective recipe which had been used several years by old TCM experts .It consists of Radix Gentianae Macrophyllae (qinjiao), Pheretima(dilong) ,and so on .It is beneficial for treating rheumatoid arthritis due to syndrome of heat-dampness . It has the effect of clearing heat and eliminating dampness, invigorating blood circulation and dredging channels and collaterals, relieving pain . My research was based on clinical soup dosage and processed study, by prescription analysis and dosage form selecting ,and prepared Qingbi granulea .The research dealed with preparation process study and quality standard study in order to research a safety, convenience, and effective new medicine which basic curative effect remained.The main contents of this paper were as following:Preparation process study:Optimization of the influence of the mixed volatile oil extracting was chosen the crude drugs broken to pieces, time of immersing and time of extracting .Results showed that extracting must elect broken drug A pieces and drug B slice ,adding water with 10 times, immersing 1 hour and extracting 6 hours. The degree of collection was approximate 0.90 ml/kg.Optimization of the influence of the alcohol-extracting of Radix Gentianae Macrophyllae and other drugs was chosen the extracting method, the crude drugs broken to pieces and mixed extracting or separate extracting. Results showed that extracting must select alcohol-extracting circumfluence , Radix Gentianae Macrophyllae mixed with other drugs slice.We used dry extract contents and Gentiopicroside as index to select the optimal procession by L9 ( 34) orthogonal test .The best conditions for alcohol-extracting were adding 75% alcohol 6 times , heating circumfluence 3 times for 1.5 hours per time.Optimization of the influence of the decocting of Radix Cyathulae (chuanniuxi) and orther drugs was chosen the crude drugs broken to pieces, time of immersing and. Results showed that extracting must select Cyathulae (chuanniuxi) slice which immersed 30 minutes with orther drugs slice which extracted mixed volatile oil first. We used contents of dry extract and the total polysaccharide as index to select the optimal procession by Ly ( 34 ) orthogonal test .The best conditions for decocting were adding water 15 times , decocting 3 times for 1.5 hours per time.Optimization of the processing of mixed volatile oil which wraped by β -cyclodextrin( β -CD) was chosen the utilization ratio of mixed volatile oil as the index . The factors affecting wraping procession were researched by L9 ( 34) orthogonal test .The best conditions for mixed volatile oil which enraped byβ -cyclodextrin( β -CD) were containing oil and β -CD with a ratio of 7:1, for 120 mintus of agitation time at 40 ℃ .The type and the quantity of adjuvant were selected .Quality standard study:Radix Gentianae Macrophyllae (qinjiao), Pheretima (dilong) in Qingbi granulea were identified by TLC. And Gentiopicroside in Qingbi granulea was determined by HPLC.The results showed that the stability, the rate of recovery, reproducibility and accuracy were satisfactory. Qingbi granulea was satisfied with all requirements of granulea in the 2000.edition C.P.(the first part).