Quality Standard Improvement Of Three Chinese Patent Medicines Including Yangwei Tablet

With the quick development of the pharmaceutical industry in China, varieties and output of Chinese Traditional Patent Medicines are increasing steadily year after year. As new varieties of Chinese Traditional Patent Medicine come forth continuously, its quality standard is showing its great importance in safe and efficient use for human being. Yangwei Tablet, Huoluo Zhentong Tablet and Shiquan Dabu Syrup was researched and developed by Tianjin Zhongxin Pharmaceutical group Longshunrong factory. According to the No. 35 document of SFDA registered [2004], we carried out an improving study on the quality standards of three Chinese Traditional Patent Medicine including Wangwei Tablet.Yangwei Tablet has the effects of stomach-tonic on digestion and alleviating pain by regulating Qi, which is composed by 15 traditional Chinese Medicines such as Cortex Magmoliae Officinalis, Radix Aucklandiae, Pericarpium Citri Reticulatae, Rhizoma Atractylodis Macrocephalae, Rhizoma Cyperi and Rhizoma Atractylodis, etc. It was included into the tenth volume of traditional Chinese Medicine edition of PPCM in 1997. The original standard in the PPCM adopt TLC on identification of Cortex Magmoliae Officinalis, which lacks of quantitative analysis method. This experiment has modified identification method of the original standard, and established the identification methods for Radix Aucklandiae, Rhizoma Cyperi, Pericarpium Citri Reticulatae, meanwhile, content determination method of Magnolol also has been established by using high performance liquid chromatography (HPLC) in this experiment.With effects of relaxing muscles and tendons and promoting blood circulation, dispelling blood stasis and relieving pain, Huoluo Zhentong Tablet is composed of Radix Angelicae Sinensis, Radix Angelicae Dahuricae,, and Radix Saposhnikoviae, etc. It was included into the fifteenth volume of traditional Chinese Medicine edition of PPCM in 1996, in which the standard of Huoluo Zhentong Tablet is in defect of quantitative analysis method. Based on the original standard in PPCM, this experiment established the identification methods of Radix Angelicae Sinensis, Radix Angelicae Dahuricae,, and Radix Saposhnikoviae with introduction of Thin-Layer Chromatography (TLC), established content determination of imperatorin by HPLC, which is the main active ingredient of Radix Angelicae Dahuricae.Shiquan Dabu Syrup is composed of ten herbal ingredients such as Radix Codonopsis Pilosulae, Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, Radix Paeoniae Alba, Radix Rehmanniae Preparata, and Radix Astragali Radix Astragali, etc., which could warm and tonify Qi and Blood. It was included into the twentieth volume of traditional Chinese Medicine edition of PPCM in 1998. Only has testing of alcohol amount, the original standard is deficient at aspect of qualitative and quantitative analysis. This experiment established the identification methods of Radix Paeoniae Alba, Radix Angelicae Sinensis, and Radix Astragali by TLC, and established content determination of paeoniflorin by HPLC, which is the main active ingredient of Radix Paeoniae Alba.The study established the foundation on quality improvement, safe and efficient of Yangwei Tablet, Huoluo Zhentong Tablet and Shiquan Dabu Syrup.