The Preparation Process And Study On Quality Standard Of Tang Yikang Granules

Objective: To prepare and evaluate TangYikang Granules which used to treat Latent Autoimmune Diabetes In Adults. Then study on the preparation technology and formulate quality standard to provide quality assurance for clinical application.Methods: Using orthogonal design method to optimize the best extraction technology. By using superfine grinding technology, The dissolved quantity of effective components in Ginseng are taken as indexes to contrast dissolution between ultrafine powders of Ginseng and common powders of Ginseng, determine the form of Ginseng used as medicine. Used the shaping rate and appearance shape as index to investigated the influence of accessories and wetting agent for the optimum proeessing technology. Astragali Radix, Ophiopgonis Radix, Coptidis Rhizoma were identified by TLC, the content of Ginsenoside Rg1, Ginsenoside Re, Ginsenoside Rb1 was determined by HPLC to establish its quality standard.Results: The best technology of ethanol reflux extraction is that extracting three times with 12 times of 70% ethanol, one hour per time. The best technology of water-extraction is that extracting three times with 12 times of water, one hour per time.Extrusion granulation is used in granular molding process, 85% ethanol is taken as wetting agent, the scale between powder and lactose is 1:1.5. In the quality standards research, the TLC identification method of Astragali Radix, Ophiopgonis Radix, Coptidis Rhizoma are determined and the content of Ginsenoside Rg1, Ginsenoside Re,Ginsenoside Rb1 is determined by HPLC. The Ginsenoside Rg1, Ginsenoside Re,Ginsenoside Rb1 of this product are tentatively not less than 3.3 mg/bag, 1.4 mg/bag, 3.8mg/bag.Conclusion: The experiment successfully prepared TangYikang Granule, theextraction, and forming processes were simple, reasonable, accurate and practicable. TCL and determination method are simple, stable and specific. The quality standards of the preparation were controllable which lay the ground for the further reformation of formulation.