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Bezafibrate composition freeze-dried tablet and preparation method thereof
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A technology of bezafibrate and a composition is applied in the field of bezafibrate composition freeze-dried tablet and its preparation, and achieves the effects of improving dissolution rate, large dissolution rate and good formability
Inactive Publication Date: 2015-04-08
HAINAN WEI KANG PHARMA QIANSHAN
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[0007] 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 bezafibrate freeze-dried tablets by freeze-drying process
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Embodiment 1
[0026]
[0027] 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.
[0028] 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.
[0029] 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.
[0030] D. Weigh 200 g of bezafibrate, add it into 1 L of corn-sucrose solution, and stir for 30 minutes.
[0031] E. After measuring the content of bezafibrate in the medicinal solution...
Embodiment 2
[0034]
[0035] 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.
[0036] 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.
[0037] 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.
[0038] D. Weigh 200 grams of bezafibrate (calculated as 1000 tablets), add 1L corn-sucrose solution, and stir for 30 minutes.
[0039] E. After measuring the content of bezafibrate in ...
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Abstract
The invention provides a bezafibrate composition freeze-dried tablet and a preparation method thereof, and relates to the technical fields of medicines and medicine production. The bezafibrate composition freeze-dried tablet comprises bezafibrate, starch and sucrose; the starch and the sucrose are taken as auxiliary materials; and heating process treatment is carried out on ordinary corn starch, so that the bonding and disintegrating effects of the starch in the tablet can be improved; and the moldability of the tablet is improved. The bezafibrate composition freeze-dried tablet only requires two auxiliary materials namely the starch and the sucrose, and adopts a two-fall and two-lift freeze-drying process, so that the moldability of the tablet can be improved by cooling twice and heating twice; and the dissolution rate of the tablet is improved, thus the bioavailability of the tablet is improved; the defects of an ordinary bezafibrate tablet are overcome; the variety and the amount of auxiliary materials in the bezafibrate tablet are reduced; and the tablet is high in dissolution rate, and high in bioavailability; and the curative effect and the 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 bezafibrate composition and a preparation method thereof. Background technique [0002] This product is a clofibrate derivative blood lipid regulating drug. There are two mechanisms for its blood lipid-lowering effect. One is that this product increases the activity of lipoproteinlipase and liver lipase, promotes the catabolism of low-density lipoprotein, and reduces the level of blood triglyceride. The secretion of density lipoprotein is decreased. [0003] [0004] Ordinary bezafibrate 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), Zafibrate quality standard, the dissolution rate of bezafibrate tablets reaches 75% or more in 50 minutes is qualified, and...
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