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Compound a-keto acid tablet and preparation processes thereof

A ketoacid tablet and compound technology, which is applied in the direction of pharmaceutical formulations, medical preparations containing active ingredients, pill delivery, etc., can solve the problems of low drug dissolution and poor drug stability, etc.

Inactive Publication Date: 2012-06-13
武汉同源药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The purpose of the present invention is aimed at the defects of the prior art, to provide a compound a-ketoacid tablet and a new preparation process thereof, to solve the problems of low drug dissolution and poor stability of the drug in the compound a-ketoacid tablet

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Embodiment 1 Preparation 1 of compound a-ketoacid tablets

[0055] Prescription: (1000 tablets)

[0056] Ketovaline Calcium 86g

[0057] Calcium rac-Keto-Isoleucine 67g

[0058] Calcium Ketoleucine 101g

[0059]Calcium R-Hydroxymethionine 59g

[0060] Calcium Ketophenylalanine 68g

[0061] Lysine acetate 105g

[0062] Histidine 38g

[0063] Threonine 53g

[0064] Tryptophan 23g

[0065] Tyrosine 30g

[0066] Starch 40g

[0067] Crosslinked PVP 40g

[0068] PVP 33g

[0069] Talc powder 10g

[0070] Magnesium stearate 8g

[0071] Preparation Process:

[0072] 1) Pass the above-mentioned raw and auxiliary materials in parts by mass through an 80-mesh sieve;

[0073] 2) Mix the above mass parts of ketovaline calcium, racemic ketoisoleucine calcium, ketoleucine calcium, racemic hydroxymethionine calcium, phenylalanine calcium, lysine acetate, and histidine , add 30g of starch, 35g of cross-linked PVP, and further mix to obtain a mixture;

[0074] Add 28g o...

Embodiment 2

[0080] Embodiment 2 Preparation 2 of compound a-ketoacid tablets

[0081] Prescription: (1000 tablets)

[0082] Ketovaline Calcium 86g

[0083] Calcium rac-Keto-Isoleucine 67g

[0084] Calcium Ketoleucine 101g

[0085] Calcium R-Hydroxymethionine 59g

[0086] Calcium Ketophenylalanine 68g

[0087] Lysine acetate 105g

[0088] Tyrosine 30g

[0089] Histidine 38g

[0090] Threonine 53g

[0091] Tryptophan 23g

[0092] Tyrosine 30g

[0093] Starch 40g

[0094] Crosslinked PVP 40g

[0095] PVP 33g

[0096] Talc powder 10g

[0097] Magnesium stearate 8g

[0098] Preparation Process:

[0099] 1) Pass the above-mentioned raw and auxiliary materials in parts by mass through an 80-mesh sieve;

[0100] 2) Under the condition of avoiding light, mix 67 g of racemic ketoisoleucine calcium and 101 g of ketoleucine calcium, add 10 g of starch and 12 g of cross-linked PVP, and further mix to obtain a mixture;

[0101] Add 9.3g of PVP into 120ml of isopropanol, stir well, th...

Embodiment 3

[0110] Example 3 Comparative Study of Compound α-Ketoacid Tablets

[0111] 1. We prepared compound a-ketoacid tablets according to the formula and process of Example 1, and obtained A sample.

[0112] 2. According to the formula of Example 1, the process is in accordance with the method of total blending and granulation to obtain sample B. The preparation process is as follows:

[0113] 1) Pass the above-mentioned raw and auxiliary materials in parts by mass through an 80-mesh sieve;

[0114] 2) The above sieved calcium ketovaline, calcium ketoisoleucine, calcium ketoleucine, calcium ketone racemic hydroxymethionine, calcium phenylalanine, lysine acetate, histidine, Mix threonine, tryptophan and tyrosine, add 40g of starch and 40g of cross-linked PVP, and further mix to obtain a mixture;

[0115] Add 33g of PVP into 424ml of isopropanol, stir evenly, then add to the above mixture, granulate with 20 mesh, and air-dry at 70°C for 2 hours to obtain granules;

[0116] 3) Add ...

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PUM

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Abstract

The invention relates to a compound a-keto acid tablet and preparation processes thereof. One of the preparation processes comprises the following steps of respectively mixing and granulating slightly alkaline medicines and slightly acidic medicines, mixing the slightly alkaline medicines and the slightly acidic medicines together and carrying out tabletting and coating, and the process enables dissolubility of the compound a-keto acid tablet to be enhanced and stability of the medicines to be improved. The other of the preparation processes comprises the following steps of granulating calcium 3-methyl-2-oxovalerate and ketoleucine calcium under a dark condition, respectively granulating other slightly alkaline medicines and slightly acidic medicines, mixing all the medicines together andcarrying out tabletting and coating, and the process enables dissolubility of the compound a-keto acid tablet and stability of the medicines to be further improved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a compound a-ketoacid tablet and a preparation process thereof. Background technique [0002] In modern society, the incidence of chronic kidney disease is increasing day by day, and a large part of chronic kidney disease will eventually deteriorate into uremia. Drugs for the treatment of chronic kidney disease have received widespread attention. [0003] Compound a-keto acid tablets are a good drug for treating chronic kidney disease. Compound α-ketoacid tablets can supplement compound α-ketoacids and essential amino acids, which can improve amino acid and protein metabolism disorders in the body and promote protein synthesis; cooperate with a low-protein diet to reduce hyperfiltration of glomeruli, protect nephrons, and slow chronic disease. Kidney failure worsens. [0004] In practical application, it is found that the disintegration rate of the tablet is slow and t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4172A61K31/405A61K31/198A61K31/195A61K9/20A61K9/28A61P13/12
Inventor 黄毅黄层霄彭俊张宇玄熊昕
Owner 武汉同源药业有限公司