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Desmopressin acetate sublingual tablet and preparation method thereof

A technology of desmopressin and sublingual tablets, which is applied in the directions of medical preparations containing active ingredients, pharmaceutical formulas, pills, etc. Advanced problems, to achieve the effect of being conducive to industrialized large-scale production, reducing costs, and good taste

Active Publication Date: 2015-04-22
郑州大明药物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the substitution degree of this solid-phase synthetic resin should not be too high, and the oxidation process is not easy to control. Although the operation is relatively simple, the oxidation yield is low and there are many side reactions.
Purification is difficult and the product quality is not high

Method used

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  • Desmopressin acetate sublingual tablet and preparation method thereof
  • Desmopressin acetate sublingual tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] The desmopressin acetate sublingual tablet of the present invention is based on the specification of 50mg per tablet. The raw material composition of each desmopressin acetate sublingual tablet is: desmopressin acetate 0.1mg, lactose 37.4 mg, malic acid 8.5mg, crospovidone 1.5mg, polyethylene glycol 4000 1.5mg and starch 1mg.

[0032] In this example, based on the above-mentioned raw material composition of 50 mg per tablet, the raw material composition for producing 2000 desmopressin acetate sublingual tablets is: 0.2g desmopressin acetate, 74.8g lactose, and 17g malic acid. Cross-linked povidone 3g, polyethylene glycol 4000 3g and starch 2g.

[0033] The in vitro dissolution rates of three batches of different samples obtained in Example 1 of the present invention under pH 6.8 conditions are shown in the attachment figure 1 .

Embodiment 2

[0035] The desmopressin acetate sublingual lozenge of the present invention, based on the specification of 50mg per tablet, the raw material composition of each desmopressin acetate sublingual lozenge is: desmopressin acetate 0.1mg, glucose 34.9 mg, 9mg malic acid, 2mg crospovidone, 1.5mg polyethylene glycol 6000 and 2.5mg starch.

[0036] In this example, based on the above-mentioned raw material composition of 50 mg per tablet, the raw material composition for producing 2000 desmopressin acetate sublingual tablets is: 0.2g desmopressin acetate, 69.8g glucose, and 18g malic acid. Cross-linked povidone 4g, polyethylene glycol 6000 3g and starch 5g.

Embodiment 3

[0038] The desmopressin acetate sublingual tablet of the present invention is based on the specification of 50mg per tablet. The raw material composition of each desmopressin acetate sublingual tablet is: desmopressin acetate 0.1mg, maltose 34.4 mg, fumaric acid 9mg, crospovidone 2.5mg, polyethylene glycol 8000 1.5mg and dextrin 2.5mg.

[0039] In this example, based on the above-mentioned raw material composition of 50 mg per tablet, the raw material composition for producing 2000 desmopressin acetate sublingual tablets is: 0.2g desmopressin acetate, 68.8g maltose, and 18g fumaric acid , Cross-linked povidone 5g, polyethylene glycol 8000 3g and dextrin 5g.

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Abstract

The invention discloses a desmopressin acetate sublingual tablet and a preparation method thereof. Each desmopressin acetate sublingual tablet comprises a filling, a pH modifier, a disintegrating agent, a lubricant and an adhesive. The preparation method comprises the following steps: diluting desmopressin acetate by using the pH modifier; uniformly mixing the filling agent and the 60 percent disintegrating agent, preparing into paste by adding water in the adhesive; mixing the pasty adhesive with the uniformly mixed filling agent and disintegrating agent to prepare a soft material, pelleting and drying the soft material, and granulating into blank particles after drying; finally, uniformly mixing the diluted desmopressin acetate with the left disintegrating agent, the lubricant and the blank particles, and tabletting to obtain the desmopressin acetate sublingual tablet. The desmopressin acetate sublingual tablet provided by the invention is sublingually administrated, is high in effect taking speed and absorption efficiency, beneficial to administration by a child, capable of greatly lowering the production cost, and beneficial to industrial mass production.

Description

technical field [0001] The invention belongs to the technical field of medicinal chemistry, and in particular relates to a desmopressin acetate sublingual tablet and a preparation method thereof. Background technique [0002] Desmopressin acetate (English name Desmopressin Acetate) is a structural analogue of natural arginine salt vasopressin, which is obtained by making two changes to the chemical structure of the natural hormone, that is, deamination of 1-cysteine and replacing 8-L-arginine with 8-D-arginine. Desmopressin acetate is mainly used in the treatment of central diabetes insipidus, nocturnal enuresis and hemophilia, etc. It is also used in the test of renal urine concentration function and postoperative hemostasis. [0003] Desmopressin acetate can shorten or normalize the excessive bleeding time during clinical invasive treatment or diagnostic operation, or cause uremia, liver cirrhosis, congenital or drug-induced platelet dysfunction, and unknown etiology The...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K38/11A61K47/26A61P7/12A61P13/00A61P7/04A61K38/095
Inventor 刘志庆王翠侠贾晓璐朱赞梅苗海敏张亚惠
Owner 郑州大明药物科技有限公司