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A kind of compound α-keto acid tablet and its preparation process

A technology of ketoacid tablets and compound preparations, which is applied in the field of medicine, can solve problems such as unstable product production, inconvenient cleaning of instruments, and complicated production processes, and achieve the effects of ensuring batch-to-batch stability, reducing equipment investment, and optimizing production processes

Active Publication Date: 2015-08-05
SHENYANG PHARMA UNIVERSITY +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the amount of talcum powder in the prescription has reached 33mg. If there is too much asbestos in the talcum powder, it will expose the problem of drug safety.
[0008] At present, the existing patents for compound α-ketoacid tablet preparations are all prepared by wet granulation. In the wet granulation process, the proportion of binders added, the serious moisture absorption of raw materials, the drying time of granules, and the control of organic Explosion-proof reagents, complex production procedures, high energy consumption, and increased production costs; and the calcium ketoacid component in the raw material medicine is highly viscous. After wet granulation, the material is easy to adhere to the equipment, which brings inconvenience to instrument cleaning. The sewage will also have a certain impact on environmental pollution. After the preparation is wet granulated and dried, the fluffiness of the particles is not the same, resulting in unstable production

Method used

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  • A kind of compound α-keto acid tablet and its preparation process
  • A kind of compound α-keto acid tablet and its preparation process
  • A kind of compound α-keto acid tablet and its preparation process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Example 1: (provided by the present invention, dry granulation, magnesium stearate is added in two proportions)

[0041]

[0042] The preparation method is:

[0043] (1) Weigh α-racemic ketoisoleucine calcium, α-ketoleucine calcium, α-ketophenylalanine calcium, α-ketovaline calcium, α-racemic hydroxymethionine Calcium, L-Lysine Acetate, L-Threonine, L-Tryptophan, L-Histidine, L-Tyrosine, Pregelatinized Starch, PVP, Stearin 0.5% by Tablet Weight Magnesium acid, through an 80 mesh sieve, is added in equal amounts and mixed evenly. Carry out dry granulation with a dry granulator, pulverize the obtained preliminary shaped tablet, pass through a 30-mesh sieve for granulation. Add the prescribed amount of polyethylene glycol, micropowder silica gel and 2.5% magnesium stearate of the tablet weight, mix well, and stamp the tablets with special shapes to obtain tablet cores;

[0044] (2) Add gastric-soluble Opadry Dissolve in 85% ethanol to prepare a coating liquid, coat...

Embodiment 2

[0045] Example 2: (provided by the present invention, dry granulation, adding magnesium stearate at one time)

[0046]

[0047]

[0048] The preparation method is:

[0049] (1) Weigh α-racemic ketoisoleucine calcium, α-ketoleucine calcium, α-ketophenylalanine calcium, α-ketovaline calcium, α-racemic hydroxymethionine Calcium, L-lysine acetate, L-threonine, L-tryptophan, L-histidine, L-tyrosine, pregelatinized starch, PVP, 80 mesh sieve, equal delivery Add and mix well. Carry out dry granulation with a dry granulator, pulverize the obtained preliminary shaped tablet, pass through a 30-mesh sieve for granulation. Add the prescribed amount of polyethylene glycol, micropowder silica gel and magnesium stearate, mix well, and punch out special-shaped tablets to obtain tablet cores;

[0050] (2) Add gastric-soluble Opadry Dissolve in 85% ethanol to prepare a coating liquid, coat the tablet core in a coating pan, and dry it with air at 60°C for half an hour after coating, t...

Embodiment 3

[0051] Embodiment 3: (dry granulation, no polyethylene glycol)

[0052]

[0053]

[0054] The preparation method is:

[0055] (1) Weigh α-racemic ketoisoleucine calcium, α-ketoleucine calcium, α-ketophenylalanine calcium, α-ketovaline calcium, α-racemic hydroxymethionine Calcium, L-Lysine Acetate, L-Threonine, L-Tryptophan, L-Histidine, L-Tyrosine, Pregelatinized Starch, PVP, Stearin 0.5% by Tablet Weight Magnesium acid, through an 80 mesh sieve, is added in equal amounts and mixed evenly. Carry out dry granulation with a dry granulator, pulverize the obtained preliminary shaped tablet, pass through a 30-mesh sieve for granulation. Add the prescription amount of micropowdered silica gel and 0.5% magnesium stearate of the tablet weight, mix well, and punch the tablets with special shapes to obtain tablet cores;

[0056] (2) Add gastric-soluble Opadry Dissolve in 85% ethanol to prepare a coating liquid, coat the tablet core in a coating pan, and dry it with air at 60°...

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PUM

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Abstract

The invention relates to a compound alpha-ketoacid tablet free from talcum powder and a preparation method of the tablet. The tablet prepared by using the preparation method is good in compressibility, beautiful in appearance, high in disintegration speed, high in dissolution rate and high in long storage stability. According to the preparation method provided by the invention, a dry granulation method is used, all the ingredients are prevented from contacting water or other wetting agent, and therefore, the tablet can be stably stored for long time, and the content of effective ingredient is ensured. The content of the polyethylene glycol in the prescription is optimized, the talcum powder or the analogue with composition similar with that of the talcum powder are not contained in the prescription, no disintegrating agent needs to be added, the problems of clustering phenomenon and quite large viscidity in a wet granulation process in the traditional production are solved, the medication safety is ensured, and the product can be stably produced with quality and high safety.

Description

technical field [0001] The invention belongs to the field of medicine, and relates to a compound α-keto acid tablet and a preparation process thereof, in particular to a talc-free compound α-keto acid tablet and a preparation process thereof. Background technique [0002] Chronic kidney disease is a relatively benign disease that develops slowly, but if it is not diagnosed and treated in time, it can lead to the deterioration and progression of the disease or the progression of the disease, developing into chronic renal insufficiency, renal failure, and eventually uremia. At present, its incidence is increasing, and most patients are often unaware of their condition, which seriously endangers human health. [0003] Compound α-ketoacid tablet is a drug with significant curative effect on chronic kidney disease, and it is used to prevent and treat damage caused by protein metabolism disorder caused by chronic renal insufficiency. The drug is designed with the ratio of essenti...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4172A61K9/28A61K47/12A61K47/36A61K47/34A61P13/12A61K31/405A61K31/198A61K31/19A61K31/192A61K47/10A61K47/32
Inventor 张天虹李广京王俊峰孙英华于坤坤朱萌何仲贵
Owner SHENYANG PHARMA UNIVERSITY
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