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A drug-loaded pellet of roxatidine acetate medicinal salt and its preparation method and application

A technology of roxatidine acetate and medicinal salts, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, and medical preparations containing active ingredients, etc. The problem of low drug loading of the layer coating has achieved the effect of definite preventive effect, inhibition of gastric acid secretion, and good stability

Active Publication Date: 2022-02-18
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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  • A drug-loaded pellet of roxatidine acetate medicinal salt and its preparation method and application
  • A drug-loaded pellet of roxatidine acetate medicinal salt and its preparation method and application
  • A drug-loaded pellet of roxatidine acetate medicinal salt and its preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Example 1 Preparation of hydrochloride glycidic acid

[0058] Sucrose pill core 65mg

[0059] Rose deck butter butter acetate 75mg

[0060] Hydroxypropyl cellulose-SL 3.75 mg

[0061] Tie powder 15mg

[0062] 95% ethanol 656.25mg

[0063] The raw material is mechanically pulverized, weighing the amount of 95% ethanol at the same amount of ethanol, stirred with hydroxypropyl cellulose-SL and main drug, stir uniform, and then adding talc, stir, sieve, spare. Spray the pharmaceutical coating liquid to the white pills with a fluid bed granule machine, fluidized bed coating conditions: import air volume: 120-160m 3 / h, air air temperature: 30-50 ° C, atomization pressure 1.6-2.2kg / cm 2 . During the coating process, the bonding plate between the coating micropile is unable to complete the coating and reach the theoretical weight.

Embodiment 2

[0064] Example 2 Preparation of hydrochloride glycidic acid

[0065] Sucrose pill core 65mg

[0066] Rose deck butter butter acetate 75mg

[0067] Hydroxypropyl cellulose-SL 3.75 mg

[0068] Tie powder 15mg

[0069] No water ethanol 656.25mg

[0070] The raw material mechanism is pulverized, weighing the equivalent anhydrous ethanol, mixing hydroxypropylcellulose-SL, stirred, stirred to dissolve, adding the main medicine, stir well, then add talc, stir well, sieve, spare . The drum-jacket liquid was allowed to spray the pharmaceutical coating liquid on the white pill core, dried over the sieve, and produced drug pellets. The coating conditions are in Example 1, anhydrous ethanol is chemically pure and above, wherein the amount of ethanol glycol is greater than 99.5%.

Embodiment 3

[0071] Example 3 Rose deck buthac acid

[0072] Sucrose pill core 65mg

[0073] Rose deck butter butter acetate 75mg

[0074] Hydroxypropyl cellulose-L 3.75mg

[0075] Tie powder 15mg

[0076] No water ethanol 656.25mg

[0077] The raw material mechanism is pulverized, weighing the equivalent anhydrous ethanol, mixing hydroxypropylcellulose-L, stirring, stirring to dissolve, adding the main medicine, stir well, and sieve, spare . The pharmaceutical coating liquid is sprayed onto the blank pellet core with a fluidized bed granules, and the dried sieve is dried, and the dried glass is dried.

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Abstract

A medicine-loaded salt pellet of roxatidine acetate, comprising a blank core and a drug-loaded layer, uses more than 95% by weight of ethanol water solvent or absolute ethanol as a coating solvent for the drug-loaded layer, which can improve The defect of coating hardening during the preparation of roxatidine acetate pharmaceutical salt-loaded pellets can also improve the stability of active ingredients in the drug-loaded pellets.

Description

Technical field [0001] The present invention belongs to the field of medical preparations. Background technique [0002] RoxAtidine Aidteate Hydrochlore, ROX is another Hik 2 The selective antagonist of the receptor, it can block the gastric mucosae cells and the hypermine h2 receptor showed continuous gastric acid secretion inhibitory effect, and also has mucous membrane protection, and has a prevention of peptic gastric ulcer. Effect of ideal drugs. Compared with the proton pump inhibitor (PPI), hydrochloride has a lot of clinical advantages: 1 function in the activation pathway of histamine, moderately inhibits gastric acid secretion, and prevents the prevention and treatment of thickening ulcer in hospital patients Effectively prevent shoulder ulcers, and its control effect is equivalent to Lansolazole, and it is equivalent to Renibis; 2 flexible carbon chains in hydrochloride structure It is possible to stimulate the stomach mucosa cell secretion binder and mucus, unique gas...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/52A61K47/10A61K31/4453A61K45/06A61P31/04A61P1/04A61P7/04
Inventor 程森高慧琴李巧霞
Owner 北京轩升制药有限公司
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