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Sustained-release preparation containing piracetam

A technology of sustained-release preparations and piracetam, which is applied to medical preparations containing active ingredients, medical preparations without active ingredients, and pill delivery, which can solve the problems of carrying, inconvenient use, high frequency of administration, and repetitive It is suitable for large-scale promotion and application, with good compliance and less adverse reactions.

Inactive Publication Date: 2020-06-30
乐普药业(北京)有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although ordinary tablets and capsules are convenient to take, the frequency of administration is high, requiring 0.8-1.6g (2-4 tablets) each time, 3 times a day. For patients with retrograde amnesia caused by hypoxia or hypoxia, multiple administrations can easily lead to repeated medication or forgotten medication
Although the injection has a quicker effect, it is inconvenient to carry and use

Method used

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  • Sustained-release preparation containing piracetam
  • Sustained-release preparation containing piracetam
  • Sustained-release preparation containing piracetam

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Sustained-release tablet preparation of different specifications of embodiment 1

[0050]

[0051] Weigh piracetam, hypromellose K100LV, and lactose according to the above formula, place them in a wet granulator, turn on the stirring paddle and the shear paddle, both at low speed, mix for 10 minutes, add purified water to wet granulate, and then Place in a fluidized bed to dry and control the moisture to be no more than 3.0%, granulate with 20 meshes, add magnesium stearate to the dry granules, and compress with a rotary tablet machine. The tablet is film-coated in a high-efficiency coating machine, and the coating solution is ethyl cellulose aqueous dispersion (Surelease) coating, and the coating weight gain is 3-6%. One-sided punching, the finished product after packaging.

Embodiment 2

[0052] Sustained-release tablet preparation of embodiment 2 different polymer ratios

[0053]

[0054]Weigh piracetam, hypromellose K100LV, hypromellose E4M, and lactose according to the above formula, place them in a wet granulator, turn on the stirring paddle and shearing paddle, both at low speed, mix for 10 minutes, add Wet granulation with purified water, and then placed in a fluidized bed to dry to control the moisture content not to exceed 3.0%, granulated to 20 mesh, magnesium stearate was added to the dry granules, and tabletted with a rotary tablet machine. Film-coat the tablets in a high-efficiency coating machine. The coating solution is ethylcellulose aqueous dispersion (Surelease) mixed with Opadry at a ratio of 70 / 30 and then coated. The weight gain of the coating is about the weight of the tablet. 5%. The film is perforated on both sides, and the finished product is obtained after packaging.

[0055] The punching in embodiment 1 and embodiment 2 is followi...

Embodiment 3

[0057] Example 3: Pharmacokinetics study in Beagle dogs

[0058] 6 healthy Beagle dogs, 3 males and 3 females, with a body weight of 8 to 10 kg, were randomly divided into two groups, each group of 3, and one group carried out release preparation (self-made tablets in embodiment 1, specification 1.2g / sheet , 1 tablet in total) single-dose administration test, the drug dosage is 1.2g / ; , specification: 0.4g / tablet, 3 tablets in total) multiple administration test, administration once every 6 hours, a total of 3 times, the dosage is 0.4g / time / piece, a total of 1.2g / piece. Each Beagle dog took 2ml of blood from the forelimb vein on one side of the dog before taking the medicine (0h), 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, and 48 hours after taking the medicine. Transfer to a heparinized test tube, centrifuge (5000rpm, 10min), separate the plasma, and freeze it at -20°C until use;

[0059] The concentration of piracetam in plasma was determined by liquid chromatography-tand...

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Abstract

The invention relates to a sustained-release preparation containing piracetam or medicinal derivatives thereof. The sustained-release preparation can achieve a slow drug release effect after being given an effective dose in a form of the sustained-release preparation. The invention further relates to a preparation method of the sustained-release preparation containing the piracetam or the medicinal derivatives thereof. The sustained-release preparation containing the piracetam or the medicinal derivatives thereof has the advantages that stable blood concentration can be maintained for a long period of time, and the sustained-release preparation is convenient to take, good in patient compliance, few in adverse reactions and suitable for large-scale popularization and application.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a slow-release preparation containing piracetam or a pharmaceutical derivative thereof and a preparation method thereof. Background technique [0002] Piracetam is a cyclized derivative of α-aminorolac, which has anti-brain function damage caused by physical and chemical factors, improves learning, memory and recall, and can improve retrograde amnesia caused by hypoxia. It affects the excitatory transmission of cholinergic neurons and promotes the synthesis of acetylcholine. In addition, it can also increase the release of dopamine and increase memory ability. [0003] The approved dosage forms include piracetam tablets, capsules and injections, all of which are immediate-release preparations. Although ordinary tablets and capsules are convenient to take, the frequency of administration is high, requiring 0.8-1.6g (2-4 tablets) each time, 3 times a day, and it is effe...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K9/22A61K9/44A61K47/38A61K31/4015A61P25/00
CPCA61K9/2054A61K9/2072A61K9/2866A61K31/4015A61P25/00
Inventor 李泳孙宇王刚刘涛韩应宏
Owner 乐普药业(北京)有限责任公司
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