| Ganzhixiao Granule is a compound preparation which consists of ten Chinese herbs, such as HERBA ARTEMISIAE SCOPARIAE, FRUCTUS CRATAEGI, RHIZOMA POLYGONATI, GANODERMA, RADIX ET RHIZOMA SALVIAE MILTIORRHIZAE, RHIZOMA PINELLIAE, and so on.It has an efficacy with cheolesterol lowing and hepatic-protection. It is mainly used for the treatment of liver steatosis and fatty liver. Based on the results of literatures investigation and the active ingredients of the different Chinese medicinal materials, refer to the established extract technology of the same active ingredients from the same Chinese medicinal materials as to preparaing other Chinese patent medicine, the extract processes of the main active ingredients were defined respectively and the extraction technology parameters were optimized, thus the scientific and reasonable extraction and preparation technology were determined. Using modern analysis technologies such as the thin layer chromatography (TLC) method and the high performance liquid chromatography (HPLC), quality standards of the preparation were set up. The preliminary stability studies of the preparation were carried out according the official study methods.In the extraction process, the effects of various ingredients by different extraction methods on the impact of the standard decoction fingerprint were studied to divide the extraction process into two parts, which was the alcohol extract and water extract. And orthogonal test L9(34) was used to excellent choose the extraction parameters of the Ganzhixiao Pellets. The best results of extraction of optimization are: RADIX ET RHIZOMA SALVIAE MILTIORRHIZAE, GANODERMA and SEMEN CASSIAE were added to 8 times the amount of 70% ethanol refluxing extract 3 times, each time 1.5h;by alcohol extract of the fingerprint peaks, which are mostly standard soup agent peaks. Best water extraction as:cotton residue with the rest of capillaries and other seven Chinese herbs 8 times the amount of water heating reflux extraction twice, each time 1.5h; by water extract of decoction of the fingerprint was similar to the standard fingerprint.In concentration,drying process, the respective effects of different temperature on the concentration of alcohol extract and water extract of the contents of index components and fingerprints were studied. The result of alcohol extract concentration was at 60℃, the content of index components was higher retention rate than before, and the fingerprint is similar as before; water extracts in the concentration at 80℃, the content of index components was higher retention rate than before, and basically the same fingerprint after enrichment. Using vacuum drying and microwave drying on the index components in two ways to study the impact of the content and fingerprints. The results of microwave drying has a high retention rate on components, and the fingerprint was similar to standard decoction.In the molding process, the effects of the type and amount of materials, the type of wetting agent, and the finished angle of repose, moisture content, solubility, critical relative humidity were measured indicators and components of product content and fingerprints were determined. Results preferred materials as follows:soluble starch:microcrystalline cellulose = 2:3; with 90% ethanol as wetting agent; measured angle of repose is 24.78°; water solubility, critical relative humidity of compliance; indicators of the Content To; fingerprint similar to the standard decoction.The TLC method was selected to establish the quality standards. The TLC were carried out to identify the 2 herbs such as SEMEN CASSIAE, GANODERMA. The relevant spots were clear and specific strong compared with their control. These illuminated that the 2 herbs were vald. The content of Chlorogenic Acid and Salvianolic acid B that were contained in HERBA ARTEMISIAE SCOPARIAE, GANODERMA were determined using the HPLC method. The mobile phase was methyl alcohol-0.05% phosphoric acid(gradient elution) and detection wavelength of Salvianolic acid B was 286nm while Chlorogenic Acid was 327, flow rate was 1.0 mL·min-1. As a result, the regression equation of the Chlorogenic Acid was Y=3433582.99X-3105.54, r=0.9999, and the calibration curve was linear within a range of 0.0226～0.4520μg. The average recovery rate was 97.5%, and the RSD was 2.5%. And the regression equation of the Salvianolic acid B was Y=930920.90X-12208.93, r=0.9999, and the calibration curve was linear within a range of 0.0943～1.8857μg. The average recovery rate was97.0%, and the RSD was 1.5%. The Chlorogenic Acid content were controlled between 10.48-10.60mg each bag(10g) while Salvianolic acid B content were controlled between 94.92-96.68mg. The method of fingerprint analysis on Ganzhixiao granule was establish. RP-HPLC with Phenomenex Synergi 4μHydro-RP 80A was used, methanol-0.1% H3PO4 solution (gradient elution) as a mobile phase and detection wavelength at 280 nm, flow rate was 1.OmL/min, and column temperature was 30℃.As a result,17 common peaks were separated in 10 bathches of Ganzhixiao Granules.In one word, the preparation method was applicable, and the quality of the preparations could be controlled.Further studies was value to be carried out to develop Ganzhixiao Granules as a new Chinese Traditional Medicine. |
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