Study On The Preparation Process Of Jie Jiu Bao Gan Granulas.

Objective: Jiejiubaogan granulas, a chinese herbs compound preparation, is composed of traditional chinese herbs that possess the capability of scavenging alcohol and protecting liver, and Xinjiang ethnic drug. To develop new preparation, this study addresses the extraction technology, miscellaneous object ablation technology, molding technology and quality standard of Jiejiubaogan granulas and its principium pharmacodynamics.Methods: 1. Extraction technology: Ethanol extraction was optimized via single-factor experiment and orthogonal technique, while water exraction via single-factor experiment; 2. Miscellaneous object ablation technology: Miscellaneous object ablation was performed and optimized by natural subsidence, wateral subsidence, high-speed centrifugation and ZTC-II clarifying agent; 3. Molding technology: Using hygroscopicity, formation and dissolution rates as indexes, we measured five pharmaceutical necessities. And the parameter of concrete granulas was also determined; 4. Quality standard: Puerariae root and common fenugreek seed were identified by thin-layer chromatography (TLC). The content of puerarin and trigonelline was assessed by high performance liquid chromatography (HPLC). Granulas total flavone was quantified by visible spectrophotometry (VIS); 5. Elementarily pharmacodynamic experiment: The levels of alanine aminotransferase (ALT), aspartic transaminase (AST), malondialdehyde (MDA) and glutathione peroxidase (GSH-px) in the blood serum of CCL4 and ethanol-exposed mouse were examined to elucidate the Jiejiubaogan granulas effect to protect liver.Results: 1. Extraction technology: Puerariae root, common fenugreek seed and schinsandra Chinese were milled and extracted together with 10-fold volume of 60% ethanol (v/v) for two hours,Then extract was filtrated, concentrated and evaporated; and this extraction was conducted twice. Liquorice, raisin tree seed and ethanol residue were milled and extracted together with 20-fold volume of purification water for two hours, and this extraction was conducted twice. Both ethanol and water extract were mixed, filtrated and concentrated; 2. Miscellaneous object ablation technology: Water extract was distilled through reducing pressure method continuously until the medicinal materials: solution ratio was 1: 1. Ethanol was added at the final concentration of 60% (v/v). Then extract was filtrated, concentrated and evaporated; 3. Molding technology: Granulas was made from actose and medicinal powder using 60% ethanol as bond. The ratio of actose to powder was 1.5: 1. All the parameters of granulas accorded with the requirement; 4. Quality standard: Plot of thin-layer chromatography identifying puerariae root and common fenugreek seed appeared the special spot with high-resolution. Quantity assay for puerarin and trigonelline using HPLC as well as for total flavone using visible spectrophotometry respectively demonstrated the feasibility and high-resolution;5. Elementarily pharmacodynamic experiment: Results from this study exhibited the activities of Jiejiubaogan granulas against CCL4 or alcohol-exposed liver injury.Conclusions: 1. Optimized technologies of extraction, miscellaneous object ablation and molding show their stabilization and feasibility, and might be applied to industry production; 2. Quality standard is feasible and praeparatum quality can be controlled; 3. Elementary pharmacodynamics suggests the prevention effect of Jiejiubaogan granulas on liver injury induced by chemical or alcohol.