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Tizanidine hydrochloride disintegrating tablet and preparation method thereof

An orally disintegrating tablet and hydrochloric acid technology is applied in the direction of pharmaceutical formulations, medical preparations containing active ingredients, and pill delivery. It can solve problems such as easy breakage, fragile products, and too sweet taste, and achieve no gritty feeling and easy swallowing , excellent taste effect

Inactive Publication Date: 2019-05-28
SICHUAN CREDIT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Aiming at the deficiencies in the prior art, the present invention aims to provide a kind of tizanidine hydrochloride orally disintegrating tablet and preparation method thereof, to overcome the above-mentioned defects existing in the prior art, and to solve the problems of too sweet taste, The product is fragile, easy to break and other technical problems

Method used

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  • Tizanidine hydrochloride disintegrating tablet and preparation method thereof
  • Tizanidine hydrochloride disintegrating tablet and preparation method thereof
  • Tizanidine hydrochloride disintegrating tablet and preparation method thereof

Examples

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Effect test

Embodiment 1

[0033] Embodiment 1 tizanidine hydrochloride orally disintegrating tablet (2mg specification, calculated as tizanidine)

[0034] prescription:

[0035]

[0036] Made in 1000 pieces.

[0037] Preparation:

[0038] (1) each component is crossed 100 mesh sieves respectively;

[0039] (2) Get the tizanidine hydrochloride of prescription quantity and mix homogeneously with equal amount of low-substituted hydroxypropyl cellulose, continue to add the balance of low-substituted hydroxypropyl cellulose in equal amount, mix homogeneously; then add mannitol, citrate Citric acid, aspartame, microcrystalline cellulose, mix well; finally add menthol, magnesium stearate, mix well;

[0040] (3) Measure the content, calculate the tablet weight, and press the mixed powder into tablets with a rotary tablet press to control the hardness to 2.5-4.0kg;

[0041] (4) Inspection, packaging, storage.

Embodiment 2

[0042] Embodiment 2 tizanidine hydrochloride orally disintegrating tablet (2mg specification, calculated as tizanidine)

[0043] prescription:

[0044]

[0045]

[0046] Made in 1000 pieces.

[0047] The preparation method is the same as that in Example 1.

Embodiment 3

[0048] Example 3 Tizanidine Hydrochloride Orally Disintegrating Tablets (2mg Specification, Calculated in Tizanidine)

[0049] prescription:

[0050]

[0051] Made in 1000 pieces.

[0052] The preparation method is the same as that in Example 1.

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Abstract

The invention relates to the field of pharmaceutical preparations, and discloses a tizanidine hydrochloride disintegrating tablet and a preparation method thereof. The tizanidine hydrochloride disintegrating tablet comprises the following components in parts by weight: 1 to 4 parts of tizanidine hydrochloride, 8 to 15 parts of disintegrant, 80 to 105 parts of filler, 5 to 9 parts of flavoring agent, and 0.5 to 4 parts of lubricant. The tizanidine hydrochloride disintegrating tablet disclosed by the invention can rapidly disintegrate in the oral cavity, has fast absorption, high bioavailability, good mouthfeel, no gritty feeling, no discomfort, convenient carrying and transportation, and can be stored for a long time. The preparation method of the tizanidine hydrochloride disintegrating tablet disclosed by the invention has the advantages of simple preparation process, no special equipment requirement, and easy control, and is suitable for large-scale production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a tizanidine hydrochloride orally disintegrating tablet and a preparation method thereof. Background technique [0002] Tizanidine hydrochloride (Tizanidine hydrochloride) chemical name is 5-chloro-4-(2-imidazoline-2-amino)-2,1,3-benzylthiothiazide hydrochloride, which is the only one with gastric Novel centrally acting skeletal muscle relaxants with gut protective effects. Tizanidine hydrochloride was first developed by Novartis in Switzerland. It was first launched in Denmark and Switzerland in 1988, and subsequently obtained sales licenses in more than 20 countries including Europe, the United States, and Japan. It is clinically used to treat diseases such as increased skeletal muscle tension, muscle spasm and muscle rigidity caused by central injury. It has good effect on tension headache, trigeminal neuralgia and myofascial pain syndrome. It can also be used as ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/433A61P21/02A61P25/00A61P25/02A61P29/00A61P19/04A61P21/00A61P23/00A61P23/02A61P25/20
Inventor 张永红廖丽萍李晓莉陈刚
Owner SICHUAN CREDIT PHARMA
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