Daidzein-containing tablet composition and preparation method thereof

A technology of daidzein and aglycone tablets, which can be applied to medical preparations containing active ingredients, medical preparations without active ingredients, and drug combinations, etc., can solve the problem of affecting clinical efficacy and clinical application scope, and restricting the route of administration. and dosage forms, poor dissolution of oral preparations, etc., to achieve the effect of benefiting human absorption, improving dissolution, and ensuring drug safety

Active Publication Date: 2014-10-15
山西国润制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to its own structural characteristics, daidzein has a relatively large shortcoming and deficiency, that is, its water solubility is poor, and it cannot be dissolved in water, which results in poor dissolution of oral preparations, resulting in low bioavailability. At the same time, injection administration cannot be administered, which limits the route of administration and dosage form, and greatly affects the clinical curative effect and clinical application range.

Method used

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  • Daidzein-containing tablet composition and preparation method thereof
  • Daidzein-containing tablet composition and preparation method thereof
  • Daidzein-containing tablet composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Example 1 Preparation of daidzein tablets

[0040]

[0041] The preparation process is as follows:

[0042] (1) Take daidzein, 35% arginine, and 20% disintegrating agent according to the prescription, mix well and make soft material with ethanol solution of 30% binder in the prescription amount, sieve with 20 meshes to make wet granules, 60 Dry at ℃ for 2h;

[0043] (2) Take the remaining arginine, the prescribed amount of diluent and 15% disintegrant, mix and add the ethanol solution of the remaining binder to make a soft material, sift through a 20-mesh sieve to make wet granules, and dry at 60°C for 2 hours;

[0044] (3) Mix the granules obtained in step 1 and step 2, add the remaining disintegrant and the prescribed amount of lubricant at the same time, mix well and press into tablets, the specification is 50mg / tablet.

Embodiment 2

[0045] Example 2 Preparation of daidzein tablets

[0046]

[0047]

[0048] The preparation process is as follows:

[0049] (1) Take daidzein, 30% arginine, and 10% disintegrant according to the prescription, mix well and make a soft material with an ethanol solution of 25% binder in the prescription amount, sieve through a 20-mesh sieve to make wet granules, 60 Dry at ℃ for 2h;

[0050] (2) Take the remaining arginine, the diluent of the prescribed amount and 20% of the disintegrating agent, mix and add the ethanol solution of the remaining binder to make a soft material, sieve through 20 meshes to make wet granules, and dry at 60°C for 2 hours;

[0051] (3) Mix the granules obtained in step 1 and step 2, add the remaining disintegrant and the prescribed amount of lubricant at the same time, mix well and press into tablets, the specification is 50mg / tablet.

Embodiment 3

[0052] Example 3 Preparation of daidzein tablets

[0053]

[0054] The preparation process is as follows:

[0055] (1) Take daidzein, 35% arginine, and 20% disintegrant according to the prescription, mix well, make soft material with ethanol solution of 30% binder in the prescription amount, and sieve through 20 meshes to make wet granules. Spread the wet granules on an enamel plate, put them in a blower constant temperature drying oven, and dry them at 60°C for 2 hours;

[0056](2) Take the remaining arginine, the prescribed amount of diluent and 18% disintegrant, mix and add the ethanol solution of the remaining binder to make a soft material, and sieve through a 20-mesh sieve to make wet granules. Spread the wet granules on an enamel plate, put them in a blower constant temperature drying oven, and dry them at 60°C for 2 hours;

[0057] (3) Mix the granules obtained in step 1 and step 2, add the remaining disintegrant and the prescribed amount of lubricant at the same ...

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PUM

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Abstract

A provided daidzein-containing tablet composition comprises daidzein and arginine with the weight ratio of 1:2.5-4. The tablet composition comprises, in parts by weight, 16 parts of daidzein, 40-64 parts of arginine, 5-7 parts of a disintegrating agent, 14-38 parts of a diluent, 0.2-1.0 parts of a lubricant and 0.9-1.6 parts of an adhesive. By employing the above technical scheme, the water-soluble daidzein-containing tablet composition containing daidzein and arginine with the weight ratio of 1:2.5-4 is provided. The invention further provides a specific prescription and a preparation method. An added weak base enables daidzein to relatively well form a relatively stable easily-soluble salt, and thus improvement of dissolution rate is facilitated, and absorption by human body is facilitated. The technology is simple and the prescription quality is reliable, and batch production of the daidzein tablet can be realized.

Description

technical field [0001] The invention relates to a pharmaceutical composition with daidzein as an active ingredient, in particular to a tablet composition containing daidzein and a preparation method thereof. Background technique [0002] Common name: daidzein [0003] Formerly used name: Pueraria daidzein [0004] English name: Daidzein [0005] Pinyin: Huangdouganyuan [0006] Chemical name: 4,7-Dihydroxyisoflavone [0007] Chemical Structure: [0008] [0009] Molecular formula: C 15 o 10 h 4 [0010] Molecular weight: 254.24 [0011] Daidzein API and its preparations (tablets, capsules) are independently developed in my country and are the world's first chemically synthesized drugs for the treatment of cardiovascular and cerebrovascular diseases; women's climacteric syndrome; osteoporosis and other diseases. On December 1, 2001, the State Food and Drug Administration officially approved it as a national drug standard, and it has been put into the market and u...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/352A61K47/18A61P9/00A61P15/12A61P19/10A61P9/12A61P7/02A61P9/06A61P1/08A61P27/16
Inventor 杨立志王亮
Owner 山西国润制药有限公司
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