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tianya716(金币+3, 翻译EPI+1):貌是工具翻译的 2010-05-18 22:23:13
sirljz:禁止工具直接翻译的回帖 2010-05-20 17:32:32
Abstract
objective
The purpose of this subject develop repaglinide, dispersible tablets, aims to improve the bioavailability of drugs, improve compliance and the establishment of scientific and strict quality control standards. Repaglinide dispersible tablets have been developed and ** transfer clinical trials and pharmaceutical companies on sale. This article developed from the microemulsion capsule repaglinide, aims to further improve the bioavailability of drugs and reduce drug side effects that may exist.
Methods
(1) repaglinide tablet formulation and technology of single factor experiments to spread the uniformity and dissolution rate as an index of the types of screening accessories; orthogonal test, to spread uniformity, dissolution rate for the index for accessories to optimize the dosage and ultimately determine the prescription. Single-factor test and the equivalent incremental mixing method - wet granulation process, solvent dispersion mixing method - wet granulation process and the equal incremental mixing method - the powder pellets technology, comparing the optimized process .
(2) Determination of repaglinide tablet study to recovery and durability for the evaluation of pH indicator, the three methods the determination of repaglinide tablets compared to finalize the United States Pharmacopoeia repaglinide Determination tablets better. And according to the United States Pharmacopoeia method for the determination of repaglinide tablets, dispersible tablets was established method for the determination of repaglinide.
(3) determination of repaglinide in tablet dissolution studies on repaglinide tablet dissolution medium and the speed of screening, the establishment of a scientific and reasonable method of dissolution test, and repaglinide were dispersible tablets In vitro evaluation.
(4) repaglinide tablet related substances by acid, alkali, heat broken ring test, the material on repaglinide may be isolated by diode array detector and the main peak of the purity of the drug inspection, the establishment of rigorous science and repaglinide repaglinide tablet Determination of related substances.
(5) the acceleration of dispersible tablets stability of repaglinide on repaglinide tablet was 6 months of accelerated stability test, and to predict the drug is valid for 2 years.
(6) repaglinide from microemulsion capsule by orthogonal experiment and the ternary phase diagram, with solubility, light transmittance, particle size index, selection repaglinide from microemulsion capsule formulation, and evaluated the quality of Stability study and preliminary.
Results
(1) successfully optimized repaglinide repaglinide tablet dispersible tablets prescription, and the establishment of a scientific rigorous quality standards. Home Repaglinide dispersible tablets compared with ordinary commercial dissolution rate and dissolution of 30min were significantly increased, initially to improve drug bioavailability purposes.
(2) of repaglinide from microemulsion capsule successfully optimized microemulsion capsules from prescription repaglinide, and the establishment of quality control and evaluation criteria. Repaglinide from microemulsion capsule, and general commercial and home-made capsules, tablets compared, the release rate and the dissolution of 30min were significantly increased, initially to improve drug bioavailability purposes.
Conclusion screening repaglinide tablet and capsule from the microemulsion reasonable prescription, preparation is simple and feasible, effective quality control quality standards. Preparation of repaglinide tablet and capsule from the microemulsion formulation meet quality requirements. In vitro evaluation studies, the development of repaglinide in tablet and capsule from the microemulsion, with commercially available conventional tablets and capsules, compared to significantly speed up the dissolution, initially to improve drug bioavailability purposes.
Keywords: Repaglinide; tablet; from microemulsion capsule; orthogonal test; quality standards; ternary phase diagram; Star points - response surface design |
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