Study On Quality Standard Of Kanggongyan Series

Kanggongyan series( Kanggongya Tabletsts, Kanggongyan capsules,Kanggongyan particles) consists of three components(Callicarpa kwangtungensis Chun, Lindera aggregata(Sims) Kosterm, Leonurus japonicus Houtt). Its’ functions include removing heat,qushi,dispersing blood stasis and check vaginal discharge,Also used for treating leukorrhagia, cervical erosion,caused by leukorrheal diseases.Callicarpa kwangtungensis Chun is the plant of verbenaceae which is used as medicine by dry stem branches and leaves,Its’ functions include Convergence bleeding, scattered stasis, heat-clearing and detoxifying.Lindera aggregata(Sims)Kosterm is the plant of Lauraceae which is used as medicine by dry root. Its’ functions include promoting qi circulation to relieve pain and warming kidney for dispelling cold.Leonurus japonicus Houttof is the plant of Lamiaceae which is used as medicine by dry herb.Its’ functions include promoting blood flow for regulating menstruatior,diuretic swelling and clearing heat antitoxicant. Kanggongya Tabletsts and Kanggongyan capsules is a drug contained by the The Pharmacopoeia of the PRC2010 edition,Kanggongyan particles perform standard to State Food and Drug Administration YBZ00372004(trial).Kanggongyan Tabletsts and capsules consists of three components(Callicarpa kwangtungensis Chun dry extract, Lindera aggregatadry dry extract, Leonurus japonicus Houtt dry extract).Three types of dry extractdry are extracted by Callicarpa kwangtungensis Chun, Lindera aggregata and Leonurus japonicus Houtt,using the method of boiling water and filtration.The filtrate to concentrate dense paste and drying under reduced pressure.Kanggongyan particles is extracted by Callicarpa kwangtungensis Chun, Lindera aggregata and Leonurus japonicus Houtt,using the method of boiling water and filtration,the filtrate to concentrate dense paste and drying under reduced pressure.For the unified Kanggongyan series of quality standards and scientific evaluation and control the quality of medicinal materials and drug products,Kanggongyan series have been studied systematically. The main research work of this thesis issummarized as follow:1.To establish analysis ethods for fingerprint of Kanggongyan series by HPLC.Ten common peaks were selected as characteristic peaks in the chromatogram of 15 batches of Kanggongyan particles,Eleven common peaks were selected as characteristic peaks in the chromatogram of 20 batches of Kanggongyan Tabletsts and15 batches of capsules,the similarities were greater than 0.9 among all batches. The method is simple Conclusion:The method is simple,steady and repea Tablets.It provides a basis for the quality control of Kanggongyan series.2.Kanggongyan particles existing standard is not perfect, there is biggish difference Kanggongyan Tabletst and capsule. Determination of Forsythiaside B and Poliumoside content in Kanggongyan Tabletst and capsule by HPLC and TLC identification for Lindera aggregata and Leonurus japonicus Houtt. Determination of Stachydrine hydrochloride was developed with TLC in Kanggongyan particles and identification for Lindera aggregata and Callicarpa kwangtungensis Chun. Its TLC are not good enough of, so the methods were revised. For the unified Kanggongyan series of quality standards, we build a content determination of Forsythiaside B and Poliumoside in Kanggongyan particles with HPLC and TLC identification for Lindera aggregata and Callicarpa kwangtungensis Chun were revised in order to unified Kanggongyan series of quality standards.3.Lindera aggregata dry extract is extracted by Lindera aggregata,using the method of boiling water. We build a content determination of Norisoboldine in Lindera aggregata dry extract with HPLC. According to the The Pharmacopoeia of the PRC 2010 edition,its moisture content, total ash, the organochlorine pesticide residues, heavy metals and harmful elements were studied and determined.In conclusion, through the above research including the characteristics of fingerprint and content determination and thin layer identification Kanggongyan series quality analysis method, the completion of the study work to ensure the quality of Kanggongyan series of controllable will produce positive and effective.