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Lyophilized tablet prepared from warfarin composition and preparation method thereof

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

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 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 warfarin sodium tablet freeze-dried tablets by freeze-drying process

Method used

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  • Lyophilized tablet prepared from warfarin composition and preparation method thereof
  • Lyophilized tablet prepared from warfarin composition and preparation method thereof
  • Lyophilized tablet prepared from warfarin composition and preparation method thereof

Examples

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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 7.2-8.3, then heat to 72°C and keep for 120 minutes to make 9% (W / V ) of 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 2.5 g of warfarin, add it into 1 L of corn-sucrose solution, and stir for 30 minutes.

[0031] E. After the warfarin content of the medicinal solution is determine...

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 7.2-8.3, then heat to 72°C and keep for 120 minutes to make 13% (W / V ) of 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 2.5 grams of warfarin (calculated as 1000 tablets), add 1L corn-sucrose solution, and stir for 30 minutes.

[0039] E. After the warfarin content of th...

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Abstract

The invention provides a lyophilized tablet prepared from a warfarin composition and a preparation method thereof and belongs to the technical of medicines and medicine production. The lyophilized tablet is prepared from warfarin, starch and sucrose, wherein the starch and the sucrose serve as adjuvants. By heating the common corn starch, the binding and disintegrating effects of the starch in the lyophilized tablet can be improved, and the formability of the lyophilized tablet can be improved. The adjuvants for preparing the lyophilized tablet only comprise the starch and the sucrose. The lyophilized tablet is prepared by decreasing temperature twice and increasing temperature twice, and the twice temperature decrease and twice temperature increase can ensure that the lyophilized tablet can be well formed, the dissolution rate of the lyophilized tablet can be increased and the bioavailability of the lyophilized tablet can be improved. The lyophilized tablet overcomes the defects of the ordinary tablet prepared from warfarin, is prepared by adopting a few kinds of and a small amount of adjuvants compared with the tablet prepared from warfarin, has high dissolution rate and high bioavailability, has a good clinical treatment effect and can be used for clinical treatment safely.

Description

technical field [0001] The invention relates to the technical field of medicine and medicine production, in particular to a warfarin composition freeze-dried tablet and a preparation method thereof. Background technique [0002] This product is a kind of coumarin anticoagulant, which has an anti-vitamin K effect in the body. It can inhibit the synthesis of coagulation factors Ⅱ, Ⅶ, Ⅸ and Ⅹ involved in vitamin K in the liver. It is mainly used to prevent and treat thromboembolic diseases. [0003] Molecular weight: 330.31 [0004] Ordinary warfarin sodium 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 Farin sodium tablets, the dissolution rate of Fahualin tablets is more than 70% in 45 minutes, which is qualified, and more and more studies have shown that the toxic...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/37A61K47/36A61K47/26A61P7/02
Inventor 程小敏汪宁卿李珠珠饶经纬李彪
Owner HAINAN WEI KANG PHARMA QIANSHAN
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