Gliquidone composition freeze-dried tablet and preparation method thereof
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A technology of gliquizone and composition, which is applied in the field of freeze-dried tablet of gliquizone composition and preparation thereof, and achieves the effects of improving dissolution rate, large dissolution rate and good formability
Inactive Publication Date: 2015-04-22
HAINAN WEI KANG PHARMA QIANSHAN
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[0008] Starch is the basic excipient of oral solid preparations. It is formed by the polymerization of glucose molecules. It is often used as a binder, diluent and disintegrating agent in tablets. It is
Method used
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Embodiment 1
[0027]
[0028] A. Weigh 100g of cornstarch, add 900ml of purified water and stir, use a pH regulator to control the pH of the solution at 5-7.5, then heat to 72°C and keep for 120 minutes to make 9% (W / V ) of cornstarch solution.
[0029] B. Measure 45ml of purified water, boil, add 85g of sucrose, stir, after dissolving, continue heating to 100°C, filter with refined cotton, wash the filter with an appropriate amount of hot distilled water, combine the lotion and filtrate, let cool, add Add appropriate amount of distilled water to make the whole volume into 100mL, stir well to obtain B solution.
[0030] C. Mix the solution obtained in step A with the solution obtained in step B, fully stir for 30 minutes, and then lower the solution to normal temperature to obtain a corn-sucrose solution.
[0031] D. Weigh 30 g of gliquidone, add it into 1 L of corn-sucrose solution, and stir for 30 minutes.
[0032] E. After measuring the content of gliquidone in the medicinal solutio...
Embodiment 2
[0035]
[0036] A. Weigh 130g of cornstarch, add 900ml of purified water and stir, use a pH regulator to control the pH of the solution at 5-7.5, then heat to 72°C and keep for 120 minutes to make 13% (W / V) cornstarch solution.
[0037] B. Measure 45ml of purified water, boil, add 85g of sucrose, stir, after dissolving, continue heating to 100°C, filter with refined cotton, wash the filter with an appropriate amount of hot distilled water, combine the lotion and filtrate, let cool, add Add appropriate amount of distilled water to make the whole volume into 100mL, stir well to obtain B solution.
[0038] C. Mix the solution obtained in step A with the solution obtained in step B, fully stir for 30 minutes, and then lower the solution to normal temperature to obtain a corn-sucrose solution.
[0039] D, take by weighing 30 grams of gliquidone (calculated as 1000 tablets), add 1L of corn-sucrose solution, and stir for 30 minutes.
[0040] E. After measuring the content of gli...
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Abstract
The invention provides a gliquidone composition freeze-dried tablet and a preparation method thereof, and relates to the technical fields of medicines and medicine production. The gliquidone composition freeze-dried tablet contains gliquidone, starch and cane sugar. The starch and the cane sugar are taken as accessories; common corn starch is treated by use of a heating process so that the binding and disintegration effects of the starch in the tablet can be improved and the formability of the tablet can be improved; the gliquidone composition freeze-dried tablet only needs two accessories, namely the starch and the cane sugar. The gliquidone composition freeze-dried tablet is produced by use of a freeze-drying process of twice temperature dropping and twice temperature rising; due to twice temperature dropping and twice temperature rising, the formability of the tablet is better, the dissolubility of the tablet is increased, and therefore, the bioavailability of the tablet is improved; the tablet has the advantages that the defects of the common gliquidone tablet are overcome, the types and the dosage of the accessories in the gliquidone tablet are reduced, the dissolubility and the bioavailability of the tablet are high, and the curative effect and safety of clinical medication are ensured.
Description
technical field [0001] The invention relates to the technical field of medicine and medicine production, in particular to a freeze-dried tablet of a gliquidone composition and a preparation method thereof. Background technique [0002] Gliquidone is the second-generation oral sulfonylurea hypoglycemic drug, which is a highly active pro-islet β-cell agent. It binds to specific receptors on the islet β-cell membrane and can induce the production of an appropriate amount of insulin to reduce blood sugar concentration. [0003] [0004] Molecular weight: 527.64 [0005] Ordinary gliquidone tablets contain many types and quantities of excipients. Generally, fillers, lubricants, disintegrants, binders, flavoring agents, etc. are used. According to the second part of the Chinese Pharmacopoeia (2010 edition), According to the quality standard of gliquidone tablets, the dissolution rate of gliquidone tablets reaches more than 70% in 45 minutes, which is qualified, and more and mo...
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