Quality Standard Improvement Of Four Chinese Patent Medicines Including Qinxinniuhuang Tablet

The quality control of Chinese patent Medicine is the base for its safety and efficacy. Qingxinniuhuang Tablet, Ruchuang Pill, Tiaojinghuayu Pill and Jubanzhizhu Pill were reasearched and developed by Tianjin Lerentang Phamaceutical Factory. In order to guarantee the result of using drug in clinic and making sure the life safe of the patient, We carried out an improving study on the quality standard of the four Chinese Patent Medicines including Qingxinniuhuang Tablet.Qingxinniuhuang Tablet has the effects of eliminating heat of the heart by diluting sputum, putting down convulsions by dispelling Feng,helping blood and Qi move and making brains clear. It is composed by 27 sorts of drug materials such as Radix paeoniae alba,Cortex cinnamomi, Radix etrhizoma glycyrrhizae,Radix codonopsis,Radix angelicae sinensis, Rhizoma chuanxiong, Rhizoma atractylodis macrocephalae and so on. It was recorded in the nineteenth volume of Traditional Chinese Medicines edition of PPCM in 1998. The original standard in the PPCM only has general item including disintegration time limited and microbial limit, which lacks of qualitative and quantitative analysis. This thesis established the identification method for Radix angelicae sinensis,Radix scutellariae,Calculus bovis and Borneolum syntheticum by using thin layer chromatography(TLC). Meanwhile, the identification method of bilirubin in Calculus bovis and content determination method of Paeoniflorin in Radix paeoniae alba also has been established by using high performance liquid chromatography (HPLC). Finally, titrametric analysis method was used to determine the contention of AS2S2 in Realgar.Ruchuang Pill has the effects of detoxifying poisonous, diminishing inflammation, alleviating pain and eliminating swell, which is composed by 12 sorts of drug materials such as Flos lonicerae japonicae, Fructus forsythiae, Radix trichosanthis and Squama manis, etc. It was recorded in the third volume of Traditional Chinese Medicine edition of PPCM in 1991. Only has determination of the general item including moisture content, dissolve time limited and microbial limit. The original standard is deficient at the aspect of qualitative and quantitative analysis. This thesis established the identification methods of Fructus forsythiae, Flos lonicerae japonicae and Radix angelicae sinensis by TLC, and established the content determination of chlorgenic acid by HPLC, Which is the main active ingredient of Flos lonicerae japonicae.With the effects of adjusting menses by moving blood and dispelling blood stasis by regulating Qi, Tiaojinghuayu Pill is composed of Rhizoma cyperi, Folium artemisiae argyi, Radix angelicae sinensis, Radix rehmanniae, Rhizoma chuanxiong and Radix paeoniae rubra, etc. It was recorded in the first volume of Traditional Chinese Medicines edition of PPCC in 1989, in which the standard of Tiaojinghuayu Pill is in defect of qualitative and quantitative analysis method. It only has the determination of the general item including moisture content, dissolve time limited and microbial limit. This thesis established the identification method for Rhizoma cyperi and Radix angelicae sinensis with introduction of TLC, and established the content determination method of Paeoniflorin by HPLC, which is the main active ingredient of Radix paeoniae rubra.Jubanzhizhu Pill has the effects of stomach-tonic on digestion and preventing vomit by regulating stomach. It was composed of Rhizoma atractylodis macrocephalae, Pericarpium citri reticulatae,Radix platycodonis and Radix scutellariae, etc. It was recorded in the nineteenth volume of Traditional Chinese Medicine edition of PPCM in 1998. The original standard in the PPCM only has the general item including moisture content, dissolve time limited and microbial limit. This thesis has supplemented the original standard and established the identification method for Rhizoma atractylodis macrocephalae, Feuctus aurantii immaturus, Pericarpium citri reticulatae, meanwhile content determination method of Baicalin in Radix scutellariae also has been established by using HPLC.The study above improved the controllability of the drug quality for Qingxinniuhuang Tablet, Ruchuang Pill, Tiaojinghuayu Pill and Jubanzhizhu Pill. Meanwhile, it provides the patients a guarantee for the safety and effeciency of medication.