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Slow release preparation of tizanidine

A sustained-release preparation, tizanidine technology, applied in the field of tizanidine sustained-release preparations and its preparation, can solve the problem of unclear active ingredients, increased preparation difficulty, solubility, partition coefficient, stability, and binding rate. and other issues, to achieve the effect of reducing the number of medications, improving effectiveness or adaptability

Inactive Publication Date: 2007-07-25
刘凤鸣
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Traditional Chinese medicine is relatively complicated in this regard, and the active ingredients of traditional Chinese medicine preparations are often not clear, resulting in the solubility, partition coefficient, stability in digestive juice, binding rate between the body and plasma, drug pK value and biofilm permeability. The relationship is not clear, thus increasing the difficulty of preparation, but some mature varieties have been used clinically, such as Zhengqing Fengtongning sustained-release tablets, sodium aescin gel sustained-release preparations, etc.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] The preparation of embodiment 1-tizanidine sustained-release tablet (1)

[0050] Method: Take 2 grams of tizanidine, 50 grams of hydroxypropyl cellulose, 15 grams of hypromellose, 10 grams of lactose, 10 grams of microcrystalline cellulose, 1 gram of carbomer, and 30 grams of polyethylene glycol 4000 gram, mixed evenly, dry granulated, mixed with magnesium stearate, compressed into tablets to obtain the finished product, with a drug content of 2 mg / tablet. Then measure the dissolution rate of tizanidine sustained-release tablet (1) in 900ml water at 37°C. After release measurement, the results are shown in Table 1, which meets the requirements.

[0051] The dissolution rate of table 1 tizanidine sustained-release tablet (1)

[0052] Sampling time (hours)

Embodiment 2

[0053] The preparation of embodiment 2-tizanidine slow-release tablet (2)

[0054] Method: Take 2 grams of tizanidine, 10 grams of hydroxypropyl cellulose, 20 grams of stearyl alcohol, 15 grams of hypromellose, 1 gram of carbomer, and 10 grams of lactose, pass through 80-mesh sieve, grind Mix evenly, add 95% ethanol solution of 10% polyvinylpyrrolidone as a binder and stir to make a soft material, granulate through a 16-mesh sieve, dry the granules at room temperature for 2 hours, granulate with a 16-mesh sieve, and then add hard 4.5 grams of magnesium fatty acid, 2 grams of micropowder silica gel, mixed evenly, and tableted to obtain a finished product, with a drug content of 2 mg / tablet. Then measure the dissolution rate of tizanidine sustained-release tablet (2) in 900ml water at 37°C. After release measurement, the results are shown in Table 2, which meets the requirements.

[0055] The dissolution rate of table 2 tizanidine sustained-release tablet (...

Embodiment 3

[0057] The preparation of embodiment 3-tizanidine slow-release tablet (3)

[0058] Method: Take 2g of tizanidine, 35g of hypromellose, 5g of microcrystalline cellulose, and 1g of carbomer respectively, pass through 80 mesh sieves, mix well, add 95% ethanol with a concentration of 10% polyvinylpyrrolidone The solution is used as a binder and stirred to make a soft material, granulated through a 16-mesh sieve, dried at 60°C for 1 hour, granulated through a 16-mesh sieve, added with 2.5 grams of magnesium stearate, mixed evenly, and compressed to obtain a finished product, containing Drug dosage is 2mg / tablet. Then measure the dissolution rate of tizanidine sustained-release tablet (3) in 900ml water at 37°C. After release measurement, the results are shown in Table 3, meeting the requirements.

[0059] The dissolution rate of table 3 tizanidine sustained-release tablet (3)

[0060] Sampling time (hours)

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Abstract

A slowly-released medicine of tizanidine in the form of dispersing solid is prepared from tizanidine and slow-releasing skeleton.

Description

[0001] [Technical field] The present invention relates to the sustained-release formulation of tizanidine and its preparation method. [Background technique] [0002] The research and development of sustained-release preparations has a history of more than 40 years. It releases slowly and at a non-constant rate as required in a prescribed environment. Prolonged formulation. This kind of preparation can make the human body maintain this kind of blood drug concentration for a long time, instead of dropping rapidly like ordinary preparations, so as to avoid the "peak and valley" phenomenon that occurs when common preparations are frequently administered, and ensure the safety of the drug. Sexuality, effectiveness or adaptability have been improved, thereby reducing the number of medications, which greatly facilitates patients, especially patients who have been taking medication for a long time. Commonly used oral dosage forms include matrix tablets, microporous coated surface fil...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K9/48A61K47/02A61K47/12A61K47/34A61K47/38A61K47/42A61K47/44A61K31/433A61P21/02A61K47/10A61K47/32
Inventor 刘凤鸣
Owner 刘凤鸣
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