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Lipoic acid tablets with few types and small dose of accessories and preparation method thereof

A technology of lipoic acid tablets and excipient tablets, which can be applied to medical preparations with no active ingredients, medical preparations containing active ingredients, and devices that make medicines into special physical or ingestible forms, and can solve the problem of stains that are prone to appear , easy sticking and other problems, to achieve the effect of reducing the dosage of a single dose, reducing the cost of raw materials, and improving the uniformity of color and stability

Active Publication Date: 2015-06-10
南京海鲸药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] In order to overcome the technical problems that the drying process in the conventional granulation method in the preparation of lipoic acid tablets may affect the performance of the activity, it is easy to stick to the tablet when it is pressed, and it is easy to appear stains when it is directly pressed, and at the same time, it does not introduce too many additives To ensure the high content of the main drug in the tablet and improve the patient's compliance, the invention provides a lipoic acid tablet with a small amount of auxiliary materials and a preparation method thereof

Method used

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  • Lipoic acid tablets with few types and small dose of accessories and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] (1) Preparation of excipient tablets Weigh 1.5kg of starch and 0.15kg of hydroxypropyl cellulose to prepare excipient tablets with a diameter of 5mm-6mm according to the method of wet granulation and tabletting;

[0032] (2) Spray the main drug layer. Put the prepared auxiliary material tablet in a high-efficiency coating pan, weigh 8.5kg of lipoic acid and sieve it, and spray the sodium carboxymethyl cellulose solution with a concentration of 1%-1.5% with a spray gun. As a spray, spray the sieved lipoic acid powder layer by layer on the auxiliary material sheet, the rotation speed of the high-efficiency coating pan is 40 rpm, the air inlet temperature is 30°C-35°C, and the spray gun pressure is 0.4MPa. 120 layers, dried at 30°C-35°C for 35 minutes, then placed in a constant temperature room at 20°C-30°C for 6 hours to dry.

Embodiment 2

[0034] (1) Preparation of excipient tablets Weigh 3.0kg of dextrin and 0.25kg of starch slurry to prepare excipient tablets with a diameter of 5mm-6mm by dry granulation and tabletting;

[0035] (2) Spray the main drug layer. Put the prepared auxiliary material tablet in a high-efficiency coating pan, weigh 6.5kg of lipoic acid and sieve it, and spray the sodium carboxymethyl cellulose solution with a concentration of 1%-1.5% with a spray gun. As a spray, spray the sieved lipoic acid powder layer by layer on the auxiliary material sheet, the rotation speed of the high-efficiency coating pan is 45 rpm, the air inlet temperature is 30°C-35°C, and the pressure of the spray gun is 0.5MPa. 100 layers, dried at 30°C-35°C for 45 minutes, then placed in a constant temperature room at 20°C-30°C for 8 hours to dry.

Embodiment 3

[0037] (1) Preparation of excipient tablets Weigh 2.0kg of lactose and 0.2kg of hypromellose to prepare excipient tablets with a diameter of 5mm-6mm according to the direct powder compression method;

[0038](2) Spray the main drug layer. Put the prepared auxiliary material tablet in a high-efficiency coating pan, weigh 8.0kg of lipoic acid and sieve it, and use a spray gun to spray the sodium carboxymethyl cellulose solution with a concentration of 1%-1.5%. As a spray, spray the sieved lipoic acid powder layer by layer on the auxiliary material sheet, the rotation speed of the high-efficiency coating pan is 45 rpm, the air inlet temperature is 30°C-35°C, and the spray gun pressure is 0.45MPa. 115 layers, dried at 30°C-35°C for 40 minutes, then placed in a constant temperature room at 20°C-30°C for 7 hours to dry.

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Abstract

The invention provides lipoic acid tablets with few types and small dose of accessories and a preparation method thereof. The preparation method comprises the steps of weighing filler and an adhesive, and preparing accessory tablets by a conventional tabletting process; putting the prepared accessory tablets into an efficient coating pan; weighing lipoic acid and sieving; spraying the sieved lipoic acid powder to coat the accessory tablets layer by layer by a spray gun by taking a sodium carboxymethylcellulose solution as a spray; drying and airing in a thermostatic chamber to obtain the lipoic acid tablets. The content of main drug is high, and the compliance is improved; by adopting few types and small dose of accessories, the adverse effect of the accessories is reduced, and the cost of raw materials is also reduced; the temperature of the operation process is strictly controlled, and the sticking phenomenon generated in lipoic acid tabletting is avoided by pressing the accessory tablets not containing lipoic acid; by adopting the spraying-coating process, color spots are avoided; moreover, the content uniformity, friability, chroma uniformity and stability of the lipoic acid tablets are all remarkably improved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a lipoic acid tablet with a small amount of excipients and a preparation method thereof. Background technique [0002] Alpha lipoic acid is a water-insoluble yellow or light yellow crystal, which is widely distributed in biological tissues such as animals and plants. It was first isolated from pig liver by Reed et al. in the United States in 1950. It is widely used in clinical medicine in Europe and America, such as liver dysfunction, subacute necrotic encephalopathy, neurological diseases, radiation injury and other diseases. In the 1970s, Germany approved it as a drug for the treatment of hepatitis, and in the 1990s it was approved for the treatment of type II diabetes. The U.S. FDA approved lipoic acid as a health care product in 1997. Recent studies by German scientists have further confirmed that the combination of lipoic acid drugs and othe...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/385A61K47/38A61P1/16A61P25/00A61P3/10A61P25/28A61P17/16A61J3/10
Inventor 时文祥叶靖张斌
Owner 南京海鲸药业股份有限公司
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