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Preparation of Glibenclamide Solid Dispersion and Compound Glibenclamide Capsules

Author: ZuoKeZuo
Tutor: WeiZhenPing;WangChunLong
School: Tianjin University
Course: Pharmaceutical Engineering
Keywords: Glibenclamide Solid dispersion Capsule Preparation Quality Research Stability
CLC: TQ463.2
Type: Master's thesis
Year: 2009
Downloads: 64
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Abstract


Preparation of glibenclamide solid dispersion and the urea biguanide compound capsules capsules , and its quality research and its stability. Orthogonal test glibenclamide solid dispersion preparation processes to PVP K30 as a carrier , methylene chloride as solvent , ultrasonic mixing, water bath , the solvent was evaporated under reduced pressure rotary evaporation , crushed and dried to obtain a solid dispersion . Preparation of three consecutive batches of samples , consistent with its in vitro dissolution curve . The process conditions are feasible , stable product quality. Differential thermal analysis , X-ray diffraction , infrared spectrometry for PVP K30, glyburide , glibenclamide solid dispersion for phase identification. Results Table Minge Glibenclamide after forming the solid dispersion in amorphous state . Establish gas chromatography solid dispersion dichloromethane residues , establish an HPLC method for the determination of solid dispersions of glibenclamide related substances . Three batches of samples were measured , the results meet the requirements. Solid dispersion through accelerated testing , long-term stability of 12 months , appearance, residual solvents , were found to be related substances . A total of 118 cases with reference to six bioavailability test results to determine the urea capsules biguanide (Ⅰ) specifications for glyburide 0.5mg / metformin hydrochloride 250mg; metformin, glyburide capsules (Ⅱ) specifications for glyburide 1.0 mg / metformin hydrochloride 250mg. Using lactose as a filler powder mixed directly loaded sac biguanide the urea capsules were prepared by a small test, test , production amplification, eighteen batches of samples meet quality requirements, formulation and process stability, production applicability good . To establish an HPLC method for the determination of urea capsules biguanide glibenclamide related substances , the content approach . Establishment of glibenclamide dissolution method . For identification , content uniformity , loss on drying research . Six batches of samples were measured , the results meet the requirements. After the urea capsules biguanide accelerated testing , long-term stability of 12 months , the content , dissolution , loss on drying , related substances are in line with requirements. Indications of the process , packaging materials and other factors make the product solid dispersion with ease aging ability that can protect the products relative stability .

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CLC: > Industrial Technology > Chemical Industry > Pharmaceutical chemical industry > Production of organic compounds in drug > Aliphatic compounds, drugs
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