Pharmaceutical Study Of Qigui Tangbikang Granules

Objective: For the treatment of complications of diabetes peripheral neuropathy TCM named Qigui Tangbikang Granules,and to study its process parameters, and quality standards and to inspect preliminary stability.Methods: By single factor test and orthogonal test method, multi index optimization of each ingredient preparation process parameters; and the effects of the granules moulding process.Anointed rate and the content of astragalus IV and puerarin are used to determinethe detail technological parameter. And investigate the stability of the preparation. TLC other Astragalus, angelica, corydalis vinegar, arrowroot, Millettia qualitative identification using HPLC method herbs Astragalus Astragaloside and minister of drug Pueraria puerarin determination.Samples were retained for stability test and pharmacodynamics. This product is finished and a preliminary stability study. Results: The best preparation technology was: malt vinegar fumarate crushed into fine powder, spare; Astragalus, Angelica, pueraria lobata, Millettia boiling water twice, once with 10 times the amount, plus 8 times the amount of the second refluxed for 2 hours, filtered and the combined filtrate concentrated under reduced pressure to a relative density of 1.15 ~ 1.20(60 ℃) Qing cream, add the above powder and starch, sucralose powder amount of bottom powder, granulation step, mixed uniform, made of particles 1000 g, spray drying, blending, Packaging. Test products for chromatography in spots with the reference substance corresponding position was the same color. The content of astragalus membranaceus was no less than 0.08mg/g and the purity of pueraria lobata was no less than 3.20mg/g. Conclusion: The preparation process of the Qigui Tangbikang Granules was steady; the quality of the Granules can be controlled and the determination methods can be reproduced; The effective Granules can be used to treat diabetic complications peripheral neuropathy.