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Study on Sustained-Release Tablets of Tramadol Hydrochloride
Corresponding Author(s) : Chenyang Guo
Asian Journal of Chemistry,
Vol. 26 No. 15 (2014): Vol 26 Issue 15
Abstract
Tramadol hydrochloride has a potential role in the central nervous system of potent non-narcotic analgesics, no respiratory depression and cardiovascular reactions, is a non-morphine-like analgesics. In order to improve the analgesic effect time of tramadol hydrochloride, we study on 2 times a day for 12 h sustained-release tablets, single factor is determined by the release of different viscosity hydroxypropyl methyl cellulose (HPMC), identified by model K15M HPMC as hydrophilic matrix, orthogonal design study factors affecting sustained-release tablets, the prescription of 1000 tramadol hydrochloride sustained-release tablets is tramadol hydrochloride 69 g, carboxymethyl cellulose of sodium 20 g, hydroxypropyl methyl cellulose 27 g, PEG 15.41 g, ethyl cellulose 13.40 g, magnesium stearate 6 g, starch 2 g, the limitation of l, 2, 4, 8 h of dissolution for tramadol hydrochloride are 32, 42, 68 and 85 %, the average tablet weight 0.15 g, hardness 5.28 kg in the pharmacopoeia range. The stability of tablets is measured in the illumination of 2000-4000 LX, quality does not change and no degradation products, when the tablets are put in a high temperature of 80 °C, the surface of the tablets become yellow, so tablets should be sealed and placed in cool place.
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References
X.P. Zhang and S.J. Li, Modern J. Integr. Tradit. Chin. Western Med., 14, 1920 (2005).
A. Anderson, T. Stadler and J. Olligs, Chinese J. Pain Med., 4, 251 (1998).
S. Nossol, M. Schwarzbold and T H. Stadles, Chinese J. Pain Med., 6, 59 (2000).
R.A. Moore and H.J. McQuay and F. Luo, Chinese J. Pain Med., 5, 121 (1999).
Y. Yang and B.W. Song, Chinese Med. Bull., 10, 396 (1994).
State Pharmacopeia Committee of China, Chinese Pharmacopoeia (2010 version Appendix), Chinese Medical Science and Technology Press, Appendix 201 (2010).
C. Gustafsson, M.C. Bonferoni, C. Caramella, H. Lennholm and C. Nyström, Eur. J. Pharm. Sci., 9, 171 (1999); doi:10.1016/S0928-0987(99)00054-8.