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Donepezil hydrochloride pharmaceutical composition and preparation method thereof

The technology of donepezil hydrochloride and adhesive is applied in the field of donepezil hydrochloride pharmaceutical composition and preparation thereof, which can solve the problems of high packaging and storage costs, and achieve the effects of improving in vitro dissolution rate, prolonging storage period and reducing drug storage conditions.

Active Publication Date: 2021-03-05
JIANGSU HANSOH PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the large disintegration dose and strong hygroscopicity of dispersible tablets, the requirements for the moisture resistance effect of packaging materials are higher, and the storage conditions are also higher than those for ordinary tablets, so the packaging and storage costs are higher.

Method used

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  • Donepezil hydrochloride pharmaceutical composition and preparation method thereof
  • Donepezil hydrochloride pharmaceutical composition and preparation method thereof
  • Donepezil hydrochloride pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] prescription:

[0032]

[0033] The particle size of the donepezil hydrochloride raw material used in different prescriptions (Malvern 2000 laser particle size analyzer, measured by dry method) is as follows:

[0034]

[0035] Among them, the raw materials of donepezil hydrochloride used in prescriptions 1 and 2 have not been micronized, and the raw materials of donepezil hydrochloride used in prescriptions 3-6 have been micronized.

[0036] Coating Solution Prescription:

[0037] Raw material name / specification Dosage Film coating premix (gastric solution type) / Y-1-7000 3.00g ethanol 34.5g purified water 12.3g

[0038] Preparation Process:

[0039] (1) Premixing: add low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, donepezil hydrochloride, lactose, and microcrystalline cellulose in the wet granulator, and initially mix evenly;

[0040] (2) Preparation of the adhesive solution: add the prescribed amount of p...

Embodiment 2

[0051] prescription:

[0052]

[0053] Carry out tabletting and coating according to the preparation technology of embodiment 1, and carry out dissolution measurement according to the assay method of embodiment 1, assay result is as follows:

[0054] Prescription 7 Prescription 8 Prescription 9 Prescription 10 Prescription 11 Prescription 12 10min 62.22 62.27 62.45 62.51 62.23 62.34 15min 100.87 100.45 100.34 100.56 100.51 100.46 30min 101.31 100.92 101.21 101.15 100.88 100.88

Embodiment 3

[0056] prescription:

[0057]

[0058]Carry out tabletting and coating according to the preparation technology of embodiment 1, and carry out dissolution measurement according to the assay method of embodiment 1, assay result is as follows:

[0059] Prescription 13 Prescription 14 Prescription 15 Prescription 16 Prescription 17 Prescription 18 10min 63.23 62.37 63.44 63.41 63.24 63.34 15min 100.83 100.43 100.32 100.42 100.34 100.43 30min 101.32 100.93 101.24 101.15 100.86 100.87

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Abstract

The invention relates to a donepezil hydrochloride pharmaceutical composition and a preparation method thereof, in particular to a donepezil hydrochloride tablet, which contains donepezil hydrochloride, a disintegrant, a filler, a binder, a lubricant and a flow aid. The donepezil hydrochloride tablet provided by the invention has good stability and dissolution rate, simple preparation process, low requirements on storage conditions, and is very suitable for industrial production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a donepezil hydrochloride pharmaceutical composition and a preparation method thereof. Background technique [0002] The aging trend has increased the number of patients with senile dementia, and my country will enter an aging society. At the same time, it is accompanied by a problem that cannot be ignored-the incidence of AD is increasing year by year. The survey found that the average age of AD in northern my country is 75 or 76 years old, and the rate of AD among people over 65 years old is over 15%. The ability of daily life of AD patients declines, they do not know their spouses and children, they cannot take care of themselves in dressing, eating, defecating, especially taking medicine; some have auditory hallucinations, which bring endless pain to themselves and the people around them and troubles. The average survival period of AD patients is 5.5 years. After ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/445A61K47/36A61K47/38A61P25/28
CPCA61K9/2054A61K9/2059A61K31/445
Inventor 陈刚胜胡春勇王瑞军李琴
Owner JIANGSU HANSOH PHARMA CO LTD
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