Tranexamic acid composition lyophilized tablet and preparation method thereof

A technology of tranexamic acid and its composition, which is applied in the field of tranexamic acid composition freeze-dried tablets and its preparation, to achieve the effects of improving bioavailability, improving formability, and improving dissolution rate

Inactive Publication Date: 2015-04-08
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[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 c

Method used

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  • Tranexamic acid composition lyophilized tablet and preparation method thereof
  • Tranexamic acid composition lyophilized tablet and preparation method thereof
  • Tranexamic acid composition lyophilized tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

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 7.0-8.0, 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 125 g of tranexamic acid, add it into 1 L of corn-sucrose solution, and stir for 30 minutes.

[0031] E. After measuring the content of tranexamic acid in the medicina...

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 7.0-8.0, 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, take by weighing 125 grams of tranexamic acid (calculated as 1000 tablets), add 1L corn-sucrose solution, and stir for 30 minutes.

[0039] E. After measuring the content o...

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Abstract

The invention provides a tranexamic acid composition lyophilized tablet and a preparation method thereof, and relates to the technical field of medicines and medicine production. The tablet is prepared from tranexamic acid, starch and can sugar, wherein starch and cane sugar are used as auxiliaries, common corn starch is subjected to heating treatment to improve the adhering and disintegrating effects of the starch in the tablet, so that the moldability of the tablet can be improved. The tranexamic acid composition lyophilized tablet only needs starch and cane sugar two auxiliaries. According to the preparation method, a twice-cooling twice-heating lyophilizing process is adopted for the tranexamic acid composition lyophilized tablet, the moldability of the tablet can be better by means of twice cooling and twice heating, the solubility of the tablet can be improved, and the bioavailability of the tablet can be improved; the tablet is capable of overcoming the defect of conventional tranexamic acid tablets and reducing the types and usage of auxiliaries in the tranexamic acid tablets, is high in solubility and high in bioavailability, and can be used for guaranteeing the curative effect and safety of clinical administration.

Description

technical field [0001] The invention relates to the technical field of medicine and medicine production, in particular to a tranexamic acid composition freeze-dried tablet and a preparation method thereof. Background technique [0002] Tranexamic acid can competitively inhibit the action of plasminogen activators, preventing plasminogen from being activated into plasmin, thereby inhibiting fibrinolysis to achieve hemostatic effect. Clinically, it is mainly used to prevent and treat bleeding caused by hyperfunction in the process of fibrinolysis, such as abnormal bleeding after surgery on uterus, thyroid, prostate, liver and spleen. [0003] Structural formula: Molecular weight: 157.21 [0004] Ordinary tranexamic acid 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), ammonia The quality standard of trane...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/195A61K47/36A61K47/26A61P7/04
Inventor 汪余胜汪宁卿李珠珠饶经纬李彪
Owner HAINAN WEI KANG PHARMA QIANSHAN
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