The Standard Research On The Quality Standard Of Guangdong Fructus Citri Sarcodactylis Granule

Fructus Citri Sarcodactylis (FCS) is one of the common used traditional Chinese medicines. It has the function of dispersing stagnated liver qi and regulating qi-flowing, regulating stomach for alleviating pain. This species is widely distributed in Guangdong, Sichuan and Zhejiang, etc. Guangdong FCS is one of the Ahentic herbs in Guangdong, which is well-known by its excellent quality. Researches and developments of Chinese medicinal granule's quality standard are the base and precondition for its widely clinical application. In order to control the quality of Guangdong FCS granule and assure its Clinical results, we did a system study on Guangdong FCS's material quality standard, preparation process and quality standard of Guangdong FCS granule under the guidance of the theories of Traditional Chinese Medicine (TCM) and pharmacy, according to "Standards of the Quality Standards of the Piece of TCM (try out) " and "the Technical Requirements of Research on the Quality Standards of Chinese Medicine Granule" .In the quality research of the raw materials, the TLC method in China Pharmacopeia (2005 edition) was improved and a characteristic components, 5, 7-dimethoxycoumarin (limettin), was added as the marker substance. A suitable extracting method was determined through comparing different solvents and different extracting conditions. The standard curve (r=0. 9999) of 5, 7-dimethoxycoumarin was established and a sensitive and reliable HPLC method for determining the content of 5, 7-dimethoxycoumarin was set up. The HPLC fingerprints (HPLC-FPS) of Guangdong FCS were established and evaluated the similarity with the similarity evaluation software. The results indicated that the similarities among Guangdong FCS were all bigger than 0.940, the similarities between FCS from other cultural areas and Guangdong FCS' common pattern were all smaller than this value. In the thesis, IR was firstly used on identification of FCS from different cultural areas and the range of Ivalue in different cultural areas was given as a quantifying Index. The chemical components in the essential oil extracted from FCS by steam distillation were analysised by GOMS. Through comparing relevant data, we found that o-cymene was a characteristic component in the oil of FCS. Some determination indexes were determined. For example, ash contents, extracts, heavy metal and pesticide residues, etc.In the research of preparation process, according to the characters of traditional decoction, the extraction conditions were optimized by orthogonal design, using the content of 5, 7-dimethoxycoumarin as the index. Among different extract methods of essential oil, the maximum yield only was 0. 0702%, so essential oil extracted was not instructed. Two impurity removal process, alcohol deposition and centrifugal, were compared on the content of characteristic components, the HPLC-FPS and pharmacodynamics. The determined impurity removal conditions were 0.3g/ml on concentration and 50 % ethanol. Also, the spray drying conditions were optimized by orthogonal design. Different rotate speeds and pressures were examined to determine a scientific preparation process.Preliminary experiments on stability and pharmacodynamics showed that the preparation process determined on this thesis was stable and believable, was fit for actual industrial production. The products were safe and effective. The quality of the Guangdong FCS granule was greatly improved. The determined methods to control both the raw materials and the granule were simple, rapid, standard and scientific. The results were stable and believable. This thesis provided complete and reliable basis for controlling the quality of Guangdong FCS and its products.