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Gliclazide composition freeze-drying tablets and preparation method thereof
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A technology of freeze-dried tablet and composition, which is applied in the field of gliclazide composition freeze-dried tablet and its preparation, and achieves the effect of improving dissolution rate, large dissolution rate and good formability
Inactive Publication Date: 2015-04-29
HAINAN WEI KANG PHARMA QIANSHAN
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[0009] 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 cheap and easy to obtain, and is safe for the human body. However, starch is used alone as an excipient There is no report on the production of gliclazide freeze-dried tablets by freeze-drying process
Method used
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Embodiment 1
[0028]
[0029]
[0030] 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) cornstarch solution.
[0031] 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.
[0032] 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.
[0033] D. Weigh 80 g of gliclazide, add it into 1 L of corn-sucrose solution, and stir for 30 minutes.
[0034] E. After measuring the content of gliclazide in the medicinal...
Embodiment 2
[0037]
[0038] 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.
[0039] 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.
[0040] 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.
[0041] D. Weigh 80 grams of gliclazide (calculated as 1000 tablets), add 1L of corn-sucrose solution, and stir for 30 minutes.
[0042] E. After measuring the content of gliclazide in ...
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Abstract
The invention provides gliclazide composition freeze-drying tablets and a preparation method thereof, and relates to the technical field of medicine and medicine production. The gliclazide composition freeze-drying tablets comprise gliclazide, starch and canesugar; the starch and the canesugar are adopted as auxiliary materials; common corn starch is subjected to heating technology treatment; the adhesion and disintegration function of the starch in the tablets can be improved; the formability of the tablets is improved; the gliclazide composition freeze-drying tablets just need the two auxiliary materials of the starch and the canesugar. The gliclazide composition freeze-drying tablets adopt a reduction for two times and increment for two times technology; temperature reduction for two times and temperature increment for two times enable the formability of the tablets to be better; the dissolution rate of the tablets is improved, so as to improve the bioavailability of the tablets; the tablets overcome the defects of common gliclazide tablets, reduce the kinds and using amount of the auxiliary materials in the gliclazide tablets, are high in dissolution rate and bioavailability, and ensure the curative effect and safety of clinical medication.
Description
technical field [0001] The invention relates to the technical field of medicine and medicine production, in particular to a gliclazide composition freeze-dried tablet and a preparation method thereof. Background technique [0002] This product is a second-generation sulfonylureaoral hypoglycemicdrug, which has hypoglycemic effects on both normal people and diabetic patients. Its hypoglycemic strength is between tolbutamide and glyburide. This product mainly has a direct effect on the pancreas, promoting the transport of Ca++ to the islet β cells, and stimulating the secretion of insulin. At the same time, it can also improve the metabolism of glucose in the surrounding tissues, thereby reducing blood sugar. [0003] In addition, this product can inhibit the release of arachidonic acid from phospholipids in platelets, thereby reducing the synthesis of thromboxane (TXA3), and also inhibiting various coagulation factors (such as V, VIII, XI), and can increase fibrinolysis. ...
Claims
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