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Gel forming method for sucralfate gel having particle size of 100-500 nm

A technology of sucralfate and particle size, which is applied in the direction of pharmaceutical formulations, organic active ingredients, and inorganic ineffective ingredients, etc., can solve problems such as fluidity that cannot meet oral needs and drug efficacy, and achieve strong adhesion and long-term Adhesion time, effect of protection destruction

Active Publication Date: 2019-03-08
KUNMING JIDA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When the sucralfate gel particle size is lower than 100nm, the fluidity cannot meet the oral needs, and when the sucralfate gel particle size is higher than 500nm, the drug effect cannot be satisfied

Method used

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  • Gel forming method for sucralfate gel having particle size of 100-500 nm
  • Gel forming method for sucralfate gel having particle size of 100-500 nm
  • Gel forming method for sucralfate gel having particle size of 100-500 nm

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0013] Orthogonal experiment

[0014] Table 1. Average particle size (nm) when controlling N to 0.010 / min

[0015]

[0016] Table 2. Average particle size (nm) when controlling N to 0.011 / min

[0017]

[0018] Table 3. Average particle size (nm) when controlling N to 0.012 / min

[0019]

[0020] Table 4. Average particle size (nm) when controlling N to 0.013 / min

[0021]

[0022] As can be seen from Experimental Example 1, three key control parameters for sucralfate gelling have been determined through orthogonal experiments, namely temperature (T), sodium hydroxide concentration (M), flow rate and ratio of bottom material volume (N), When T is 19-23°C, M is 1.1-1.2mol / L, and N is 0.011-0.012 / min, the gelled particle size of sucralfate will be 100-500nm.

Embodiment 1

[0024] A kind of particle diameter is the gelation method of the sucralfate gel of 100nm-500nm, comprises the following steps:

[0025] (1) Ingredients: Prepare the required materials according to the formula, including sucralfate, concentrated hydrochloric acid, sodium hydroxide, sodium chloride, essence and preservatives;

[0026] (2) Dissolution: suspend sucralfate in purified water, add concentrated hydrochloric acid and stir, and sucralfate will dissolve into a clear solution in a strong acid environment;

[0027] (3) Gelling: Control the temperature at 19-23°C, add sodium hydroxide aqueous solution with a concentration of 1.1-1.2mol / L into the tank at a certain flow rate, neutralize concentrated hydrochloric acid, and the strong acid environment gradually moves to neutral. When the pH is close to neutral, the solubility of the amphoteric compound sucralfate decreases and is precipitated to form particles with uniform particle size. The ratio of the flow rate of the sodiu...

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Abstract

The invention belongs to the technical field of pharmaceutical engineering and specifically relates to a gel forming method for sucralfate gel having a particle size of 100-500 nm. The gel forming method for sucralfate gel having the particle size of 100-500 nm comprises the following steps: burdening, dissolving, gel forming and performing centrifugal washing. The sucralfate gel having the particle size of 100-500 nm is prepared according to a liquid phase granulating technology, and compared with common medicinal sucralfate suspension, the prepared sucralfate gel has the advantage that the mean particle size is reduced by 10-20 times; moreover, after entering gastric mucosa, the prepared sucralfate gel has strong adhesive power and long adhesion time and can be adhered to the ulcer surface, and further damage of the gastric mucosa is avoided.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical engineering, and in particular relates to a method for forming sucralfate gel with a particle diameter of 100nm-500nm. Background technique [0002] Sucralfate is an effective anti-peptic ulcer drug, which can protect the ulcer surface and promote ulcer healing. Its mechanism of action is that in an acidic environment, this product dissociates sucrose sulfate compound ions, and the compound ions polymerize into insoluble negatively charged colloids, which can combine with positively charged protein exudates on the ulcer surface to form a protective layer. The membrane covers the ulcer surface to promote ulcer healing. It also has the function of adsorbing pepsin and bile acid; promoting the synthesis of endogenous prostaglandins and adsorbing epidermal growth factor (EGF), making it concentrated in the ulcer to facilitate mucosal regeneration. When the particle size of the sucralfate gel ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K31/7024A61P1/04
CPCA61K47/02A61P1/04A61K9/06A61K31/7024
Inventor 赖涛李家伟张勇程雪飞张雪晶郑雪瑶罗燕芸
Owner KUNMING JIDA PHARMA
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