The Study On Quality Standard And Stability Of Andrographis Ultrafine Powders

Objective:The quality standards and the stability of Andrographis paniculata ultrafi ne powder were developed to provide reference for the development and clinical appli cation of Andrographis ultrafine powder.Methods:The impact factor tests were made to optimalize the ultrafine grinding process of Andrographis.The Andrographis ultrafine powder was identifitified by TLC.Andrograp holide and dehydration andrographolide who were the the main component of Androgr aphis were measured by high performance liquid chromatography. Morever,the finger print of Andrographis paniculata ultrafine powder, the long-term test and the optimal ization of the suitable stabilizers and packaging were all finished by the HPLC.Results:(1) The processes experimental results show that the better pulverization condition con-tained that the 65% charge proportion, ultrafine grinding time of 10min,3.03% hu midity.(2) The TLC identification of Andrographis superfine powder was established accordin-g to Veterinary Pharmacopoeia 2010. The content determination was done by HP LC,with which the total of andrographolide (7.24mg/g)and dehydroandrographolide (3.94mg/g) were detected more than 0.8%.(3) There were 11 common peaks in total by analyzing the HPLC fingerprint of Andr-ographis ultrafine powder(4) Under the conditions of high temperature, high humidity and strong light, the co-ntent of andrographolide was in decline along with the extension of the trial time, and the high temperature play a more role than other conditions.(5) According to the SPSS of stabilizers and packaging screening test, the vacuum pa-ckaging of PET was found better than other packaging methods for Andrographis ultrafine powder; BHT and erythorbic acid were superior to other stabilizers(6) The content of andrographolide in Andrographis ultrafine powder reduced to 90.26 %compared to the original. after six months long-term testConclusionThe best pulverization condition contained that the 65% charge proportion, ultrafine grinding time of 10min,and 3.03% humidity.TLC method established according to Veter-inary Pharmacopoeia 2010 is suitable for the identification of Andrographis ultrafine po-wder quality; the high temperature, high humidity and strong light had significant imp a-cts on the active ingredient of Andrographis ultrafine powder; LDPE vacuum packagi-ng method and erythorbic adid、BHT were beneficial for Andrographis ultrafine powder stability. The content of andrographolide in Andrographis ultrafine powder reduced to 90.26%compared to the original. after six months long-term test...