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A kind of citicoline sodium tablet and its powder direct compression preparation method

A technology for citicoline sodium and powder is applied in the pharmaceutical field, which can solve the problems of poor powder fluidity, and achieve the effects of good powder fluidity, small difference in tablet weight, and good content uniformity.

Active Publication Date: 2020-06-26
FUJIAN MINDONG REJUVENATION PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Aiming at the deficiencies of the prior art wet granulation preparation method, the inventor intends to prepare citicoline sodium tablets by using powder direct compression method, but in the preparation process encountered the problem of poor powder fluidity, the inventor through a lot of groping And repeated research, solved this problem, improved the weight stability, content uniformity and dissolution uniformity of citicoline sodium tablets, and improved the quality stability of citicoline sodium tablets

Method used

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  • A kind of citicoline sodium tablet and its powder direct compression preparation method
  • A kind of citicoline sodium tablet and its powder direct compression preparation method
  • A kind of citicoline sodium tablet and its powder direct compression preparation method

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] The impact of embodiment 1 different fillers and the content of fillers on citicoline sodium tablets

[0028] In this embodiment, the influence of different fillers and filler contents on citicoline sodium tablets was tested.

[0029] Table 1. The selection prescription table of different fillers and filler content of Citicoline Sodium Tablets

[0030]

[0031] Preparation Process:

[0032] 1) Take citicoline sodium and cross-linked polyvinylpyrrolidone XL to pass through a 60-mesh sieve respectively, and then take lactose, spray-dried lactose Flowlac100, microcrystalline cellulose Avicel PH102, and cellactose80 to pass through a 60-mesh sieve respectively, and set aside.

[0033] 2) Take 1 / 2 citicoline sodium and add lactose and microcrystalline cellulose Avicel PH102 in the prescription, spray-dried lactose Flowlac100 and microcrystalline cellulose Avicel PH102, or cellactose80 respectively in the blender at 20r / min, mix for 10 minutes, spare.

[0034] 3) Take...

Embodiment 2

[0046] Embodiment 2: the impact of different glidants / lubricants on citicoline sodium tablets

[0047]In this embodiment, test the influence of different glidants / lubricants on citicoline sodium tablets.

[0048] Table 3. Citicoline Sodium Tablets Glidant / Lubricant Dosage Selection Prescription Form

[0049]

[0050] Preparation Process:

[0051] 1) Take citicoline sodium and cross-linked polyvinylpyrrolidone XL to pass through a 60-mesh sieve respectively, and then take cellactose 80 to pass through a 60-mesh sieve for later use.

[0052] 2) Take 1 / 2 citicoline sodium and add micropowder silica gel and cellactose80 in the prescription to the blender at 20r / min, mix for 10 minutes, and set aside.

[0053] 3) Take the above-mixed powder, add the remaining 1 / 2 citicoline sodium, cross-linked polyvinylpyrrolidone XL and magnesium stearate to the blender at 20r / min, mix for 20 minutes, and carry out intermediate inspection.

[0054] 4) Compress the tablet with a die with a...

Embodiment 3

[0060] Embodiment 3: the impact of different disintegrants on citicoline sodium tablets

[0061] Table 5: Prescription table for selection of different disintegrants for citicoline sodium tablets

[0062]

[0063]

[0064] Preparation Process:

[0065] 1) Take citicoline sodium, cross-linked polyvinylpyrrolidone XL, sodium carboxymethyl starch, and low-substituted hydroxypropyl cellulose to pass through a 60-mesh sieve, and then take cellactose 80 to pass through a 60-mesh sieve for later use.

[0066] 2) Take 1 / 2 citicoline sodium and add micropowder silica gel and cellactose80 in the prescription to the blender at 20r / min, mix for 10 minutes, and set aside.

[0067] 3) Take the above mixed powder, add the remaining 1 / 2 citicoline sodium, cross-linked polyvinylpyrrolidone XL (or sodium carboxymethyl starch or low-substituted hydroxypropyl cellulose) and magnesium stearate to the total 20r / min in the mixer, mix for 20 minutes, and check the intermediate.

[0068] 4)...

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Abstract

The invention provides citicoline sodium tablets and a preparation method for directly compressing powder of citicoline sodium into tablets. The citicoline sodium tablets provided by the invention are prepared from citicoline sodium, cellactose 80, sodium carboxymethyl starch, magnesium stearate and micro-powder silica gel. The tablets provided by the invention are prepared by adopting a powder direct tablet compression method and the problem that citicoline sodium granulated by a traditional wet process is easy to hydrolyze is solved; meanwhile, the conditions that the tablet weight different is relatively great and the dissolution uniformly is relatively poor, which are easily caused by direct powder compression, are solved through screening prescriptions and setting technological parameters; the quality stability and the safety of products are greatly improved.

Description

technical field [0001] The invention relates to a citicoline sodium tablet and a preparation method thereof, belonging to the field of pharmacy. Background technique [0002] Citicoline Sodium was developed by Takeda Pharmaceutical Company of Japan. It was launched in 1967 under the trade name "Nicholin" (Nicolin), and it was imported into China in 1988. Domestically marketed preparations are in the form of injections, ordinary tablets or capsules. Its molecular formula is C 14 h 25 N 4 NaO ll P 2 , is the monosodium salt of choline cytidine diphosphate, is a nucleoside derivative, the chemical name is the monosodium salt of choline cytidine diphosphate, and the sodium citicoline in the dry product is not less than 98%. Citicoline sodium is mainly used for the treatment of neurological sequelae caused by craniocerebral injury and cerebrovascular accident, and can be used for the treatment of Parkinson's syndrome, and also has a certain effect on senile dementia; , Im...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/7068A61P25/00A61P25/16A61P25/28A61P39/06A61P9/10
CPCA61K9/2059A61K9/2095A61K31/7068
Inventor 张亚珊林鹏飞王海燕孟书舫李琳
Owner FUJIAN MINDONG REJUVENATION PHARMA
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