A kind of urotropine hippurate composition and preparation method thereof

A technology of urotropine hippurate and composition, which is applied in the direction of drug combination, active ingredients of heterocyclic compounds, urinary system diseases, etc., and can solve problems such as failure to meet tablet quality standards, difficulty in success, and decline in tablet dissolution indicators , to achieve the effect of being suitable for large-scale production, simple production process and controllable quality

Active Publication Date: 2021-03-26
HUNAN MINGRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But at the same time, the dissolution index of the tablet has also dropped significantly, and the test according to the quality standard is no longer within the qualified range. Even if the co-solvent sodium saccharin is added, the problem cannot be solved.
Commonly used solution also has coating moisture-proof, but because urotropine hippuric acid tablet attracts moisture strong, need to use the solvent (water, ethanol) in the coating agent to also erode the surface of plain tablet when tablet coating, The surface of the coated tablet is not smooth, which does not meet the quality standard of the tablet
[0005] If other excipients are used, a large number of prescription screening tests are required, such as compatibility tests, stability studies, dissolution curve comparisons, clinical pharmacodynamic tests and other related studies, which are difficult to succeed and cost too much

Method used

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  • A kind of urotropine hippurate composition and preparation method thereof
  • A kind of urotropine hippurate composition and preparation method thereof
  • A kind of urotropine hippurate composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1 Preparation of urotropine hippurate sheet, made into 1000 prescriptions

[0024]

[0025] Among them, purified water is used when making the adhesive, and the purified water will be removed during the drying process.

[0026] Preparation Process:

[0027] 1) Pre-treatment: urotropine hippurate and magnesium stearate are respectively passed through 80 mesh sieves;

[0028] 2) Adhesive preparation: add povidone K30 to the purified water of the prescribed amount, stir to dissolve, then add sodium saccharin, stir to dissolve;

[0029] 3) Mixing: adding urotropine hippurate to the adhesive prepared above, and mixing evenly;

[0030] 4) Freeze-drying: Put the above uniformly mixed materials into a tray, put them in a vacuum freeze dryer for freeze-drying, and freeze-dry according to the procedure to obtain dry powder;

[0031] Freeze-drying procedure: pre-freeze to -30°C, then evacuate to 0.3mbar, keep the vacuum state during the freeze-drying process, increas...

Embodiment 2

[0036] Example 2 Preparation of urotropine hippurate sheet, made into 1000 prescriptions

[0037]

[0038]

[0039] Among them, purified water is used when making the adhesive, and the purified water will be removed during the drying process.

[0040] Preparation Process:

[0041] 1) Pre-treatment: urotropine hippurate and magnesium stearate are respectively passed through 80 mesh sieves;

[0042] 2) Adhesive preparation: add povidone K30 to the purified water of the prescribed amount, stir to dissolve, then add sodium saccharin, stir to dissolve;

[0043] 3) Mixing: adding urotropine hippurate to the adhesive prepared above, and mixing evenly;

[0044] 4) Freeze-drying: Put the above uniformly mixed materials into a tray, put them in a vacuum freeze dryer for freeze-drying, and freeze-dry according to the procedure to obtain dry powder;

[0045] Freeze-drying procedure: pre-freeze to -40°C, then evacuate to 0.2mbar, keep the vacuum state during the freeze-drying proc...

Embodiment 3

[0050] Embodiment 3 (control group) urotropine hippurate sheet and preparation, make the prescription of 1000

[0051]

[0052] Among them, purified water is used when making the adhesive, and the purified water will be removed during the drying process.

[0053] Preparation Process:

[0054] 1) Pretreatment: urotropine hippurate and magnesium stearate are respectively passed through 80 mesh sieves;

[0055] 2) Adhesive preparation: add povidone K30 to the purified water of the prescribed amount, stir to dissolve, then add sodium saccharin, stir to dissolve;

[0056] 3) Mixing: adding urotropine hippurate to the adhesive prepared above, and mixing evenly;

[0057] 4) Granulation: put the above homogeneously mixed material into a swinging granulator to granulate;

[0058] 5) Drying: drying the above granules in an oven at 50°C;

[0059] 6) Blending: the above granules and magnesium stearate are mixed evenly;

[0060] 7) Tablet compression: compress the mixed material with...

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PUM

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Abstract

The invention discloses a methenamine hippurate composition and a preparation method thereof. According to the method, methenamine hippurate and pharmaceutically acceptable dissolving solvents and bonding agents are mixed and are then subjected to freeze drying; dry granulation is adopted; after flow aids are added, tableting is performed. The preparation is a tablet which is not provided with a coating; under the conditions of not needing special dampproof auxiliary materials and not needing special dampproof packages, through the treatment in the preparation process, the preparation has reinforced dampproof performance; the product friability is improved; high stability and controllability are realized; the methenamine hippurate composition is applicable to large-scale production and issuitable for the final use by a user.

Description

technical field [0001] The present invention relates to a preparation combination of urotropine hippurate tablet and a preparation method thereof, in particular to a urotropine hippurate prepared by mixing the following auxiliary materials, freeze-drying, granulating and tableting by dry method Tablet preparation, the main materials are: urotropine hippurate, solubilizer, binder, glidant; specific steps: add urotropine hippurate to binder and solubilizer, mix evenly, freeze-dry, powder dry method After granulation, add a glidant and mix evenly, compress into tablets, pack inside and outside, and get ready. Background technique [0002] Methenamine Hippurate Tablets was launched in the United States by Validus Pharmaceuticals in 1976 for preventive or suppressive treatment of frequent recurrent urinary tract infections. It was first listed in China by Hunan Mingrui Pharmaceutical Co., Ltd. in 1996. It is a prophylactic drug for lower urinary tract infection, and it is suitab...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/53A61P13/02A61P31/00
CPCA61K9/2027A61K9/2095A61K31/53
Inventor 蔡辉李晓斌陈斌
Owner HUNAN MINGRUI PHARMA
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