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Dry hemostatic compositions and methods for their preparation

A composition and substance technology, applied in the field of /gm, /g, which can solve problems such as reduced stability

Inactive Publication Date: 2013-05-08
BAXTER INT INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The stability of gelatin is believed to be reduced by hydrolysis of the packaging hydrogel

Method used

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  • Dry hemostatic compositions and methods for their preparation
  • Dry hemostatic compositions and methods for their preparation
  • Dry hemostatic compositions and methods for their preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Embodiment 1: the preparation of gelatin powder

[0025]Suspend the cowhide strips in a sodium hydroxide solution with a concentration of 1M-2M, keep at room temperature for 1 hour, neutralize it with phosphoric acid, and then wash it. The treated strips were then resuspended in deionized water, adjusted to pH 7-8, and heated to 70°C. Use a homogenizer to further reduce the bar size. After 1 hour at 70°C, the skins mostly dissolved into gelatin. The amount of hide is chosen such that the resulting gelatin solution has a solids content of about 3-10% (w / w), typically 7-10%. The solution was then coated with Teflon cast in thin layers on metal pans, dried and ground into gelatin powder.

Embodiment 2

[0026] Embodiment 2: Preparation of "modified gelatin powder"

[0027] The rehydration aid (Table 1) was dissolved in 500 mL of 50° C. deionized water, and then a certain amount of kraft-derived gelatin powder prepared as in Example 1 was added to the solution. The final concentration of gelatin in the solution will be selected as about 8% (weight / weight, based on bulk gelatin powder), and the total amount of rehydration aid in the solution will be as in Examples 9-44 (Tables 1 and 2 ) selected. After the gelatin is dissolved, pour the solution into the Teflon coated metal pans and dry. Dried gelatin sheets are ground into "modified gelatin powder".

[0028] Alternatively, suspend the strip of cowhide in a sodium hydroxide solution with a concentration of 1M-2M, keep it at room temperature for 1 hour, neutralize it with phosphoric acid, and then wash it. The treated strips were then resuspended in deionized water, adjusted to pH 7-8, and heated to 70°C. Use a homogenizer...

Embodiment 3

[0029] Embodiment 3: prepare cross-linked gelatin powder from "modified gelatin powder"

[0030] 600 mL of 0.2M phosphate buffer (pH 9.2±0.2) was cooled to a temperature below 12°C. Add 0.32mL glutaraldehyde (25%) in this buffer solution, then add 20g modified gelatin powder again, make the concentration of glutaraldehyde be 4000ppm (the ratio of glutaraldehyde and modified gelatin body weight). Use a stir bar to suspend the gelatin in the glutaraldehyde solution. The pH of each suspension was adjusted to a range of 9.2±0.2 and then maintained at a temperature of 9-12° C. and a pH of 9.2±0.2 for 19 hours.

[0031] The suspension was filtered and the filter cake was washed 3 times with deionized water by completely submerging the filter cake with deionized water and then sucking the rinse water into the filter cake using a vacuum. During each wash, the filter cake remains in the funnel.

[0032] Dissolve 0.2g NaBH4 in 600mL of 25mM phosphate buffer in a beaker, the pH value ...

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Abstract

A method for preparing a substantially dry cross-linked gelatin powder is described. The method comprises providing a solution of a non-cross-linked gelatin and then cross-linking the non-cross-linked gelatin while in solution in the presence of a rehydration aid. The cross-linked gelatin is then washed to remove at least 50% w / w of the rehydration aid, dried and the dry solid ground to produce a cross-linked gelatin powder typically having a moisture content below 20% w / w. A composition comprising a cross-linked gelatin powder that was cross-linked in the presence of a re-hydration aid is also described. The powder has an aqueous re-hydration rate of at least 3.0 g / g.

Description

[0001] This application is a divisional application of an invention patent application with an application date of June 21, 2002, an application number of 02818207.3, and an invention title of "dry hemostatic composition and its preparation method". Background of the invention [0002] 1. Field of invention [0003] The present invention generally relates to collagen and collagen-derived compositions and methods for their preparation. In particular, the present invention relates to a method of producing dry crosslinked gelatin or other collagen or collagen-derived compositions capable of absorbing water at a higher rate. [0004] Fusion Medical Technologies, the assignee of this application, manufactures a hemostatic composition under the trade name FloSeal . FloSeal The product is sold in a pack consisting of 2 syringes. The first syringe is filled with cross-linked bovine gelatin particles prehydrated with a buffer solution. The gelatin hydrogel contains about 85% (w...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L15/32C08J3/24C08L89/00C08K5/053C08K5/07A61K38/48A61L15/16A61F2/02A61K38/39A61L24/00A61L24/10C09H9/00
CPCA61L24/104A61L2400/04A61K38/4833A61L24/0031A61P7/04A61K9/14
Inventor Z·钱E·A·奥萨瓦C·J·赖克
Owner BAXTER INT INC