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Delay bound with pH-sensitive colon targeting agents

Author: MaJin
Tutor: WangYuRong
School: Beijing University of Traditional Chinese Medicine
Course: Chinese medicine pharmacy
Keywords: Berberine hydrochloride Delays pH-sensitive Colon Coated tablets In vitro release Body positioning
CLC: R283
Type: Master's thesis
Year: 2009
Downloads: 316
Quote: 0
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Abstract


Objective: The traditional Chinese medicine (by the extract of berberine and woody composition) to prepare a colon new agents. The extracts of berberine and woody materials with a suitable mixing, wet granulation and tabletting, prepared by dissolution of the tablet core faster; Then the tablet cores were coated with a coating pan, through the delay packet clothing layer (time control layer), enteric coating layer (pH sensitive layer) to complete the preparation of colon Preparation of tablets. By in vitro dissolution and in vivo biological validation of the Chinese herbal compound preparation of oral administration preparation colon preliminary evaluation of the feasibility for the development of traditional Chinese medicine orally administered agent colon basis. Methods: (1) Formulation Process: Through single factor experiment, preferably die best materials and preparation process; using pan coating method for the preparation of colon-coated tablets, preferably excipients and coating process; using in vitro dissolution Methods Eudragit ? with Surelease ? two kinds of coating materials and coating weight ratio were optimized; (2) in vitro release: effects of pH, gastric residence time, speed, and other right-coated tablets release media release behavior of (3) experimental animals in vivo biological validation: Preparation for oral administration in rats 3mm colon coated tablets and oral administration study in rats each time point after the distribution of drugs in the gastrointestinal tract, to verify whether the oral formulation colon delivery systems. (4) Quality Standard: Develop preparations appearance, qualitative identification, assay and other quality standards; (5) compound berberine colon coated tablets release mechanism of: water-swellable coated tablets through experiments on package coated tablets release mechanism. Results: (1) The screening process, the optimal preparation process: wood extract, berberine and microcrystalline cellulose, sodium carboxymethyl starch, mixing, wet granulation with 70% ethanol, dried 0.5 % magnesium stearate as a lubricant to obtain tabletting die, the die hardness 4kg, in vitro release studies have shown that the die can be in the rapid dissolution in the dissolution medium, 10min of drug dissolution of more than 90%, the tablet core will not become block release factors; would die from the inside to the outside layer, respectively, and pH on the package delay sensitive layer (enteric coating layer), in vitro release tests showed that when the pH-sensitive layer weight gain 4% increase in delay layer weight 6%, it can control the drug release 3h after reaching the small intestine, and is not emptying, reaching the colon preparations in vitro release requirements. (2) in rats in vivo biological validation show that this formulation can be safely through rat stomach, small intestine front and middle end of drugs, primarily released in the small intestine, cecum and colon, reaches the colon preparation in vivo drug release requirements. Conclusion: Based on the die by adjusting the delay layer, the enteric coating layer thickness, coated tablets can basically achieve colon delivery of the expected results. Berberine colon coated tablets in vitro and in vivo drug release were characterized with colon and drug release formulations in the gut only to the site in which the relevant.

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CLC: > Medicine, health > Chinese Medicine > Of Pharmacy > Chinese medicine processing,preparation
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