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Micronized roxatidine acetate pharmaceutical salt pellets and preparation method and applications thereof

A technology of roxatidine acetate and salt pellets, which is applied in the direction of pharmaceutical formulations, medical preparations containing no active ingredients, and medical preparations containing active ingredients, etc. The problem of low drug loading in the layer coating can achieve good stability and improve the effect of sustained release.

Active Publication Date: 2019-06-04
北京轩升制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Another object of the present invention is to solve the problem that the drug-loaded coating of the drug-loaded layer of roxatidine acetate sustained-release pellets is low
Another object of the present invention is to solve the problem of drug-loaded pellet coating compaction of roxatidine acetate sustained-release pellets

Method used

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  • Micronized roxatidine acetate pharmaceutical salt pellets and preparation method and applications thereof
  • Micronized roxatidine acetate pharmaceutical salt pellets and preparation method and applications thereof
  • Micronized roxatidine acetate pharmaceutical salt pellets and preparation method and applications thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Example 1 Preparation of Roxatidine Hydrochloride Acetate-loaded Pellets

[0058]

[0059] Mechanically pulverize the raw material, weigh 95% ethanol in the prescribed amount, add hydroxypropyl cellulose-SL and the main ingredient under stirring, add talcum powder after stirring evenly, stir, sieve, and set aside. Use a fluidized bed granulation coating machine to spray the drug-loaded coating solution onto the blank pellet core. The fluidized bed coating conditions are: air intake air volume: 120-160m 3 / h, air inlet temperature: 30-50°C, atomization pressure 1.6-2.2kg / cm 2 . During the coating process, the coating pellets were cohesive and hardened, and the coating could not be completed and the theoretical weight gain could not be achieved.

Embodiment 2

[0060] Example 2 Preparation of Roxatidine Hydrochloride Acetate-loaded Pellets

[0061]

[0062] Mechanically pulverize the raw materials, weigh the prescribed amount of absolute ethanol, add hydroxypropyl cellulose-SL under stirring, stir until dissolved, add the main ingredient, stir evenly, then add talcum powder, stir evenly, sieve, and set aside . Spray the drug-loaded coating solution onto the blank pellet core with a fluidized bed granulator, dry and sieve to obtain the drug-loaded pellets. The coating conditions are the same as in Example 1, the absolute ethanol is chemically pure or above, and the weight fraction of ethanol alcohol is greater than 99.5%.

Embodiment 3

[0063] Example 3 Roxatidine Hydrochloride Acetate Loaded Pellets

[0064]

[0065]

[0066] Mechanically pulverize the raw materials, weigh the prescribed amount of absolute ethanol, add hydroxypropyl cellulose-L while stirring, stir until dissolved, add the main ingredient, stir evenly, then add talcum powder, stir evenly, sieve, and set aside . Using a fluidized bed granulation coating machine, using the same conditions as in Example 2, the drug-loaded coating solution was sprayed onto the blank core, dried and sieved to obtain drug-loaded pellets.

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Abstract

The invention relates to micronized roxatidine acetate pharmaceutical salt pellets. The pellets comprise a blank pellet core and a drug-loading layer, wherein the drug-loading layer contains micronized rosatidine acetate pharmaceutical salt, the rosatidine acetate pharmaceutical salt can improve the actual content of active ingredients in the drug-loading pellets after micronization treatment, thetechnical problem that the actual drug-loading amount of the drug-loading coating is relatively low, and the content stability of a final product is improved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations. Specifically, the invention relates to a roxatidine acetate pharmaceutical salt pellet, a preparation method thereof and an application thereof. Background technique [0002] Roxatidine aidcetate hydrochlore (ROX) is another H 2 A selective antagonist of the receptor, it can block the histamine H2 receptor of the parietal cell of the gastric mucosa to show continuous inhibition of gastric acid secretion, and also has mucosal protection. It is clinically suitable for the treatment of peptic ulcer disease and has moderate acid suppression ideal drug. Compared with proton pump inhibitors (PPI), roxatidine acetate hydrochloride has many clinical advantages: ① It acts on the histamine activation pathway, moderately inhibits gastric acid secretion, and has a definite preventive effect on stress ulcers in hospitalized patients , effectively prevent and treat stress ulcers, and its preventive...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K47/38A61K47/32A61K31/4453A61P1/04A61P7/04
Inventor 程森高慧琴李巧霞
Owner 北京轩升制药有限公司
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