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Method for preparing polyethylene glycol 4000 powder

A polyethylene glycol and solvent technology, which is applied in pharmaceutical formulations, medical preparations with non-active ingredients, and active ingredients of artificially synthesized polymeric materials, etc. It can improve the compliance of clinical use and improve the efficiency of mass production.

Inactive Publication Date: 2020-01-14
CHONGQING PHARSCIN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, since the active ingredients of this product usually account for about 98% of the entire prescription, and the total amount of excipients only accounts for about 2% of the entire prescription, the total quality control of this product usually only focuses on the content uniformity and content of the main drug polyethylene glycol 4000. However, the conventional mixing method cannot guarantee the good mixing of excipients, flavorings and flavors. It is very likely that there will be incidents that affect the taste of patients due to uneven mixing of excipients, which will eventually lead to poor clinical compliance.
For example, the conventional mixing method—equal incremental method, not only cannot obtain products with uniform content of excipients through the equal incremental method, but also the method is cumbersome to operate, which is not conducive to industrial mass production
[0005] Therefore, it is necessary to find an improved new preparation method, mainly the mixing method of auxiliary materials and main drug, to overcome the defects of uneven mixing of auxiliary materials in the prior art, and achieve the purpose of improving the clinical use compliance of this product

Method used

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  • Method for preparing polyethylene glycol 4000 powder
  • Method for preparing polyethylene glycol 4000 powder
  • Method for preparing polyethylene glycol 4000 powder

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] prescription:

[0023]

[0024] Preparation Process:

[0025] Weigh the prescription amount of essence and sodium saccharin into the batching tank, add 16000g of purified water, stir to fully dissolve the auxiliary materials, and transfer them into the material chamber of the spray gun. Weigh 1,000,000 g of polyethylene glycol 4,000 into a double-cone mixer, and start stirring. Open the valve of the spray gun and spray 10% of the total volume of the auxiliary material solution per minute. After spraying, continue to stir for about 10 minutes, and then transfer the material to the packaging machine to complete packaging of 100,000 (100,000) bags.

[0026] The test results of uniformity of excipients: Since the essence and sodium saccharin are sprayed into polyethylene glycol 4000 in the form of a solution, the content uniformity index of sodium saccharin is used to characterize the uniformity of the mixture. Respectively randomly take 5 bags of each of the initial,...

Embodiment 2

[0029] prescription:

[0030]

[0031]

[0032] Preparation Process:

[0033] Weigh the prescription amount of essence and sodium saccharin into a 500ml beaker, add 256g of purified water, stir to fully dissolve the auxiliary materials, and transfer them into the material cavity of the spray gun. Weigh 10000g polyethylene glycol 4000 into the three-dimensional cone mixer, and start stirring. Open the spray gun valve and spray 20% of the total volume of the auxiliary material solution per minute. After spraying, continue to stir for about 10 minutes, and then transfer the material to the packaging machine to complete packaging of 1000 bags.

[0034] Excipient material homogeneity measurement result: detection method is with embodiment 1, and result is as follows:

[0035]

Embodiment 3

[0037] prescription:

[0038]

[0039] Preparation Process:

[0040] Weigh the prescription amount of essence and sodium saccharin into a 500ml beaker, add 192g of purified water, stir to fully dissolve the auxiliary materials, and transfer them into the material chamber of the spray gun. Weigh 10000g polyethylene glycol 4000 into the swing cone mixer and start stirring. Open the spray gun valve and spray 15% of the total volume of the auxiliary material solution per minute. After spraying, continue to stir for about 10 minutes, and then transfer the material to the packaging machine to complete packaging of 1000 bags.

[0041] Excipient material homogeneity measurement result: detection method is with embodiment 1, and result is as follows:

[0042]

[0043]

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PUM

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Abstract

The invention discloses a method for preparing polyethylene glycol 4000 powder. The prescription of the polyethylene glycol 4000 powder consists of active ingredients of polyethylene glycol 4000, andinactive ingredients of saccharin sodium and essence. The method comprises the following steps: firstly, dissolving the saccharin sodium and the essence into a solution by using a proper solvent, thenuniformly mixing the solution with the polyethylene glycol 4000 in a spray feeding manner, and finally, completing packaging to obtain the polyethylene glycol 4000 powder. According to the method, the technical problem of non-uniform mixing of auxiliary materials in the preparation process of the polyethylene glycol 4000 powder is well solved, and the clinical use compliance of the product is improved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a method for preparing polyethylene glycol 4000 powder. Background technique [0002] Constipation is the most common digestive disorder in clinical practice, mainly referring to dry stool, difficulty or incomplete defecation, and decreased frequency of defecation. A survey shows that the incidence of chronic constipation is as high as 15% to 20% among the elderly over 60 years old in Beijing, Tianjin and Xi'an. In the Beijing area, a survey conducted on adults aged 18 to 70 showed that the incidence of chronic constipation was 6.07%, and women were more than 4 times that of men. The incidence of constipation is about 10% of the general population, especially among women. [0003] The active ingredient of polyethylene glycol 4000 powder is macromolecular linear long-chain polymer polyethylene glycol 4000, which can be used for the treatment of constipation. Soften th...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K47/22A61K31/77A61P1/10
CPCA61K9/145A61K31/77A61P1/10
Inventor 魏洪岗侯玉梅范林周帮建李姣李召汪斌
Owner CHONGQING PHARSCIN PHARM CO LTD
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