Evaluation on the release discipline of baicalin and its three solid preparations using a drug dissolution simulating system

Abstract

Abstract: AIM: To study the release features of the baicalin crude drug s and three baicalin so lid preparations such as ordinary tablets, sustained-release tablets and solid lipid nanoparticles by using a continuously dynamic drug dissolution simulating system (DDSS), and to provide a new technology and a new method for the study of devising drug preparations.METHODS: The DDSS method and the oar method were used to study their release features of three different baicalin solid preparations, respectively.Furthermore, the high performance liquid chromatography method was used to determine the contents of baicalin.The data were fitted by SPSS software, and the dissolution parameters such as T50, Td, m were extracted from the fittinge quations, and the correlation between the two systems were estimated.RESULTS: The release equations of the ordinary tablets and the sustained-release tablets of baicalin, in the two diffe rent systems, were Weibull and Higuchi equations, respectively.When the correlation of the release results of the baicalin tablets and the sustained-release tablets in the two different dissolution systems were evaluated, respectively, their corresponding correlational values were 0.975 and 0.9995, which were greater than the critical values (r4, 0.01 =0.917).It means they have a goo d correlation.The release features of the crude drug s and the solid lipid nanoparticles of baicalin on DDSS fit to Weibull equations. CONCLUSION: The DDSS simulates a drug release course which is continuously dynamic and close to the gastrointestinal tract environment. The release feature result s of DDSS and the oar methods embodied to Chinese Pharmacopoeia (edited in 2005) correlated well, which illustrated the reasonableness of the simulating systems to assess the release features of solid preparations.It provides a new technology plat form to the study of devising drug preparations.

Key words: Drug dissolution simulating system, Oar method, Baicalin, Release feature

CLC Number:

R969.1

ZHU Cheng-cheng, LI Zi-qiang, LIU Zhi-dong, GAO Guo-yi, HAJI Juma, SHU Le-xin, HE Xin. Evaluation on the release discipline of baicalin and its three solid preparations using a drug dissolution simulating system[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2010, 15(1): 11-20.

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