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Method for preparing medicinal invert sugar by sugar hydrolysis

A technology for invert sugar and medicinal use, which is applied in the field of directly preparing medicinal invert sugar aqueous solution by sucrose hydrolysis, can solve the problems of prolonged hydrolysis time, increased impurity content in the reaction liquid, easy discoloration and the like, and achieves the effect of reducing production cost

Active Publication Date: 2010-11-17
HAISCO PHARMA GRP INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But as the brix of the sucrose solution (the concentration of sucrose is represented by the brix Bx), the color of the reaction solution will deepen
Sucrose hydrolysis reaction In the case of low acidity (such as pH value 1.0), sucrose is easy to change color during hydrolysis, resulting in a decrease in product quality; as the acidity increases, the hydrolysis rate of sucrose decreases, and the hydrolysis time increases, resulting in an increase in related substances
In the sucrose hydrolysis reaction, as the temperature of the reaction solution increases, the hydrolysis rate increases significantly, and at the same time, the hydrolysis balance moves to the direction of invert sugar. The content of impurities in the liquid increases

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] (1) Preparation of hydrochloric acid aqueous solution

[0015] Add 6250ml of water for injection into the 20L reaction vessel, then add 6ml of 35% concentrated hydrochloric acid solution and stir evenly. The pH value of the solution is checked by a pH meter and adjusted to 192.

[0016] (2) Acid-catalyzed hydrolysis of sucrose

[0017] Turn on the constant temperature water bath, heat the aqueous hydrochloric acid solution to 80°C, add a certain amount of medicinal sucrose, adjust the sucrose hammer to 80°Bx, and control the speed at 150-200r / m (no bubbles are generated during stirring). The reaction was followed by liquid phase tracking every 30 min. The hydrolysis reaction was stirred for 3.0 hours.

[0018] (3) Terminate the hydrolysis reaction

[0019] Add 3000 ml of water for injection at 5°C to the reaction solution and cool to below 40°C to obtain a high-quality invert sugar aqueous solution. The product was analyzed, and the sucrose content was 0.039%, and the 5-hydrox...

Embodiment 2

[0023] (1) Preparation of hydrochloric acid aqueous solution

[0024] Add 6250ml of water for injection into the 20L reaction kettle, then add 6ml of 35% concentrated hydrochloric acid solution and stir evenly. The pH value of the solution is checked by a pH meter and adjusted to 1.96.

[0025] (2) Acid-catalyzed hydrolysis of sucrose

[0026] Turn on the constant temperature water bath, heat the aqueous hydrochloric acid solution to 80°C, add a certain amount of medicinal sucrose, adjust the sucrose hammer to 80°Bx, and control the speed at 150-200r / m (no bubbles are generated during stirring). The reaction was followed by liquid phase tracking every 30 min. The hydrolysis reaction was stirred for 2.5 hours.

[0027] (3) Terminate the hydrolysis reaction

[0028] Add 3000 ml of water for injection at 5°C to the reaction solution and cool to below 40°C to obtain a high-quality invert sugar aqueous solution. The product was analyzed and found that sucrose was 0.065%, and the absorbanc...

Embodiment 3

[0032] (1) Preparation of hydrochloric acid aqueous solution

[0033] Add 6250ml of water for injection into the 20L reaction kettle, then add 6ml of 35% concentrated hydrochloric acid solution and stir evenly. The pH value of the solution is checked by a pH meter and adjusted to 1.92.

[0034] (2) Acid-catalyzed hydrolysis of sucrose

[0035] Turn on the constant temperature water bath, heat the aqueous hydrochloric acid solution to 85°C, add a certain amount of medicinal sucrose, adjust the sucrose hammer to 80°Bx, and control the speed at 150-200r / m (no bubbles are generated during stirring). The reaction was followed by liquid phase tracking every 30 min. The hydrolysis reaction was stirred for 2.5 hours.

[0036] (3) Terminate the hydrolysis reaction

[0037] Add 3000 ml of water for injection at 5°C to the reaction solution and cool to below 40°C to obtain a high-quality invert sugar aqueous solution. The product was analyzed, and the sucrose content was 0.032%, and the 5-hydro...

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PUM

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Abstract

The invention relates to a method for preparing medicinal invert sugar by sugar hydrolysis, which belongs to the technical field of preparation technology of medicaments and solves the problem that the invert sugar directly prepared by the sugar hydrolysis in the prior art cannot meet the medicinal standard. The method for preparing aqueous solution of medicinal invert sugar by directly hydrolyzing the sugar comprises the following steps of: adding 35 percent solution of concentrated hydrochloric acid into water for injection to adjust the pH value to a proper value; controlling a proper internal temperature and adding a proper amount of medicinal sugar to react for a certain time; and adding the injection water at the temperature of between 5 and 10 DEG C to rapidly reduce the temperature so as to obtain the aqueous solution of the medicinal invert sugar. The aqueous solution of the medicinal invert sugar prepared by the method can be used for preparing medicinal invert sugar injection and medicinal invert sugar electrolyte injection.

Description

Invention field [0001] The invention relates to the technical field of medicine preparation technology, in particular to a method for directly preparing an aqueous solution of medicinal invert sugar by hydrolysis of sucrose. Background technique [0002] Sucrose is a non-reducing sugar that is easily hydrolyzed into glucose and fructose by acid or enzymes. This hydrolysis reaction is called "inversion" and the resulting product is called invert sugar. At present, the invert sugar solution obtained by direct acidification and hydrolysis of sucrose in industry cannot meet the pharmaceutical grade standards, and can only meet the standards required by the food industry. The reason is that the sucrose hydrolysis reaction is affected by the experimental conditions, and improper control will cause the related substances to exceed the standard, which is not suitable for medicinal use. [0003] For example, in the sucrose hydrolysis reaction, under a certain acidity and temperature, the c...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/7004A61P3/02A61P3/12C13K3/00
Inventor 王俊民
Owner HAISCO PHARMA GRP INC
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