Compound alpha keto acid medicine composition and preparation method thereof

A composition and drug technology, applied in the directions of drug combination, anhydride/acid/halide active ingredients, pharmaceutical formulations, etc., can solve the problems of affecting the disintegration and dissolution of preparations, unable to ensure uniform mixing, and large differences in auxiliary materials, etc. To achieve the effect of reducing types and quantities, low energy consumption, and easy operation

Inactive Publication Date: 2014-05-21
NEW FOUNDER HLDG DEV LLC +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Chinese patent application publication CN102018704A discloses a compound preparation for treating chronic kidney disease and a preparation method thereof. The compound preparation includes two parts of calcium ketoacid and amino acid, and improves the composition of the granulation process by adding polyethylene glycol and talcum powder. Agglomeration phenomenon, so that the prepared particles can meet the requirements of tableting. This process uses the direct mixing of powdered main ingredients and auxiliary materials. The main ingredients are hygroscopic, and there are more than 10 types of mixing, and the dosage of each ingredient varies greatly. Uniform mixing cannot be guaranteed. At the same time, the excipients used in the two parts of calcium ketoacid and amino acid are quite different, which may affect the disintegration and dissolution of the preparation in the body, thereby affecting the efficacy of the drug

Method used

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  • Compound alpha keto acid medicine composition and preparation method thereof
  • Compound alpha keto acid medicine composition and preparation method thereof
  • Compound alpha keto acid medicine composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] Example 1 Compound Alpha Ketoacid Tablets

[0068] Calcium ketoate is partially composed of:

[0069] Calcium Alpha-Rac-Keto-Isoleucine 670g,

[0070] Calcium alpha-ketoleucine 1010g,

[0071] Calcium Alpha-Ketophenylinate 680g,

[0072] Alpha-Ketovaline Calcium 860g,

[0073] Calcium alpha-racemic hydroxymethionine 590g,

[0074] Povidone K 30 136g,

[0075] Starch 600g;

[0076] The amino acid moiety is composed of:

[0077] L-Lysine Acetate 1050g,

[0078] L-Threonine 530g,

[0079] L-Tryptophan 230g,

[0080] L-histidine 380g,

[0081] L-Tyrosine 300g,

[0082] Povidone K 30 88g,

[0083] Starch 300g;

[0084] and

[0085] Talc powder 200g;

[0086] Magnesium stearate 100g;

[0087] Crospovidone 50g.

[0088] Preparation:

[0089] (1) Granule A preparation: α-racemic ketoisoleucine calcium, α-ketoleucine calcium, α-ketophenylalanine calcium, α-ketovaline calcium, α-racemic hydroxymethionine Calcium and starch are roug...

Embodiment 2

[0095] Embodiment 2 compound alpha keto acid capsule

[0096] Calcium ketoate is partially composed of:

[0097] Calcium Alpha-Rac-Keto-Isoleucine 670g,

[0098] Calcium alpha-ketoleucine 1010g,

[0099] Calcium Alpha-Ketophenylinate 680g,

[0100] Alpha-Ketovaline Calcium 860g,

[0101] Calcium alpha-racemic hydroxymethionine 590g,

[0102] Povidone K 30 136g,

[0103] Starch 600g;

[0104] The amino acid moiety is composed of:

[0105] L-Lysine Acetate 1050g,

[0106] L-Threonine 530g,

[0107] L-Tryptophan 230g,

[0108] L-histidine 380g,

[0109] L-Tyrosine 300g,

[0110] Povidone K 30 88g,

[0111] Starch 300g;

[0112] and

[0113] Talc powder 450g;

[0114] Magnesium stearate 150g;

[0115] Crospovidone 20g.

[0116] Preparation:

[0117] (1) Granule A preparation: α-racemic ketoisoleucine calcium, α-ketoleucine calcium, α-ketophenylalanine calcium, α-ketovaline calcium, α-racemic hydroxymethionine Calcium and starch are roug...

Embodiment 3

[0121] Example 3 Compound α Keto Acid Tablets

[0122] Calcium ketoate is partially composed of:

[0123] Calcium Alpha-Rac-Keto-Isoleucine 61g,

[0124] Calcium alpha-ketoleucine 96g,

[0125] Calcium Alpha-Ketophenylinate 66g,

[0126] Alpha-Ketovaline Calcium 81g,

[0127] Calcium alpha-racemic hydroxymethionine 56g,

[0128] Povidone K 30 15g,

[0129] Starch 49g;

[0130] The amino acid moiety is composed of:

[0131] L-Lysine Acetate 101g,

[0132] L-Threonine 54g,

[0133] L-Tryptophan 22g,

[0134] L-Histidine 32g,

[0135] L-Tyrosine 27g,

[0136] Povidone K 30 10g,

[0137] Starch 20g;

[0138] and

[0139] Micronized silica gel 15g;

[0140] Magnesium stearate 5g;

[0141] Crospovidone 8g.

[0142] Preparation:

[0143](1) Granule A preparation: α-racemic ketoisoleucine calcium, α-ketoleucine calcium, α-ketophenylalanine calcium, α-ketovaline calcium, α-racemic hydroxymethionine Roughly mix calcium and starch, pulverize the ...

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Abstract

The invention discloses a compound alpha keto acid medicine composition and a preparation method thereof. According to the invention, a calcium ketone part and an amino acid part are respectively prepared; and the two parts are mixed with a flow aid, a lubricant and a disintegrating agent, such that the medicine composition is obtained. According to the invention, the compound alpha-keto acid medicine composition is prepared with an auxiliary medicine addition method, such that mixture variety and number during a granulation process are reduced; uniform mixing can be easily achieved; energy consumption is low; operation is simple; and the method is suitable for industrialized productions. The obtained compound alpha-keto acid medicine composition has the advantages of uniform content, good stability, high dissolution, and capability of long-time storage.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a compound alpha ketoacid pharmaceutical composition and a preparation method thereof. Background technique [0002] The compound α-ketoacid pharmaceutical composition contains 4 kinds of keto amino acid calcium, 1 kind of hydroxyamino acid calcium and 5 kinds of amino acids, which are respectively: α-racemic ketoisoleucine calcium, α-ketoleucine calcium, α - Calcium Ketophenylalanine, Calcium Alpha-Ketovaline, Calcium Alpha-Rac Hydroxymethionine, L-Lysine Acetate, L-Threonine, L-Tryptophan, L-Histidine, L - Tyrosine. The preparation is used in conjunction with a low-protein diet to prevent and treat damage caused by protein metabolism disorders caused by chronic renal insufficiency. [0003] The compound α-ketoacid pharmaceutical composition is a nutritional therapy drug, which is clinically used in the nutrition of patients with chronic renal failure, de...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4172A61K31/405A61K31/19A61K31/192A61K31/198A61P3/02A61P13/12
Inventor 谢小飞孟宏涛丁继军兰静易崇勤王振国任爱国
Owner NEW FOUNDER HLDG DEV LLC
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