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Method for preparing adhesive solution in wet granulation process

A binder solution, wet granulation technology, applied in the field of pharmacy, can solve the problems of complex binder components, difficult realization of clear solution, poor water solubility, etc.

Pending Publication Date: 2021-11-05
上海合全医药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Generally speaking, the water solubility of most APIs is relatively poor. In order to promote the dissolution of the API, the general adhesive system will contain a variety of excipients, such as the surfactant poloxamer P407, the pH regulator meglumine, sodium hydroxide etc., the composition of the adhesive is complex, and it is not easy to obtain a clear solution, and poor control of the dosing sequence and method will increase the difficulty of judging the end point of API dissolution

Method used

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  • Method for preparing adhesive solution in wet granulation process
  • Method for preparing adhesive solution in wet granulation process
  • Method for preparing adhesive solution in wet granulation process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] It is weighted 450 g of purified water, and the purified water is stirred to form a vortex, weigh 25.4 g of the poloxham P407, and the stirred water is slowly added, stirred to form a uniform transparent solution. The purified water of 25 g was added, 0.7 g NaOH was added, stirred until dissolved. The aqueous sodium hydroxide solution was slowly added to a container containing a water solution of a water, and a beaker of the NaOH solution was dissolved with 25 g of water, and 17.4 g of glucamine was added, then 17.4 g of glucamine, continued to stir up and finally obtained a clear clear clarification. Solution (see figure 1 3 cups).

Embodiment 2

[0039] Example 2 Comparison of clarity

[0040] The solution obtained from the Solution 1, 2, 3 and Example 1 was placed in the absorbent tank of the spectrophotometer, and the absorbance was determined at 550 nm, and the results were shown in Table 1 and image 3 .

[0041] Table 1, 4 samples of ultraviolet visible light absorbance and relative turbidity at 550 nm

[0042]

[0043] The test results indicate that the solution obtained in Example 1 was crystal clear, and the difference was significant.

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Abstract

The invention provides a method for preparing an adhesive solution in a wet granulation process. The formula of the adhesive solution comprises 1.0-10.0 parts of sodium hydroxide, 24.8-50.0 parts of meglumine, 36.0-73.0 parts of poloxamer P407 and water, and the mass of the water is 19-60 times that of the poloxamer P407. The method comprises the following steps: firstly, respectively dissolving poloxamer P407 and sodium hydroxide with water to obtain a poloxamer P407 aqueous solution and a sodium hydroxide aqueous solution; and mixing the poloxamer P407 aqueous solution and the sodium hydroxide aqueous solution, adding meglumine into the mixture, and stirring the mixture to obtain an adhesive solution. The adhesive solution containing the poloxamer P407, the meglumine and the sodium hydroxide is obtained by the method, the solution is clear and transparent, and the dissolution end point of the solution is easier to judge when raw auxiliary materials or active drugs of other prescription components are subsequently dissolved, so that great convenience is brought to judgment of the dissolution end point.

Description

Technical field [0001] The invention belongs to the field of pharmaceutical, and more particularly to a method of formulating a binder solution in a wet granulation process. Background technique [0002] Wet granulation is a method of adding a powder to a bridge or bonding action of an adhesive or a bridge or bonding action of a binder to prepare a particle. The particles after wet method have good fluidity, aesthetic, strong wear resistance, and good compression moldability. This process is suitable for most drugs, and is widely used in the preparation of oral solid preparation. When preparing a preparation by a wet method, a suitable binder solution is prepaid, especially for a lot of low-specific raw materials (APIs), or in order to make the API free state into salts in the granulation. In order to achieve a good mixing one degree in the formulation, it is necessary to fully dissolve the API in the adhesive. If the drug is completely dissolved, it will directly affect the qual...

Claims

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Application Information

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IPC IPC(8): A61K47/26A61K47/02A61K9/16
CPCA61K47/02A61K47/26A61K9/16
Inventor 薛茜邢炼朱家明张帅
Owner 上海合全医药有限公司