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Cyclobenzaprine hydrochloride sustained-release preparation

A cyclobenzaprine hydrochloride and slow-release preparation technology, which is applied in the direction of pill delivery, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., can solve the problem of short half-life of cyclobenzaprine hydrochloride, frequent medication, Affect the patient's medication compliance and other issues, to achieve the effect of good stability and ideal release speed

Active Publication Date: 2019-01-22
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, due to the short half-life of cyclobenzaprine hydrochloride in the body, its common dosage form needs to be used multiple times a day, and the medication is relatively frequent, which affects the compliance of patients with medication. Therefore, it is of great significance to develop cyclobenzaprine hydrochloride sustained-release preparations.

Method used

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  • Cyclobenzaprine hydrochloride sustained-release preparation
  • Cyclobenzaprine hydrochloride sustained-release preparation
  • Cyclobenzaprine hydrochloride sustained-release preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] The preparation of embodiment 1 cyclobenzaprine hydrochloride bag chip

[0022] According to the formula (g / tablet) in Table 1, the inner chip was pressed first, then coated, and finally the coated chip was pressed to prepare cyclobenzaprine hydrochloride coated chip Examples 1-7.

[0023] Table 1 Cyclobenzaprine hydrochloride packet chip formula (1)

[0024]

[0025]

Embodiment 2

[0026] The screening of embodiment 2 cyclobenzaprine hydrochloride package chip sustained-release agent

[0027] The cyclobenzaprine hydrochloride-coated chips of Examples 1 to 7 were subjected to a dissolution test. The test method was blue-turning method, the rotation speed was 50 rpm, the test solution was 900 mL of water, and the test temperature was 37±0.5° C. The results are shown in Table 2.

[0028] Table 2 Dissolution test results of cyclobenzaprine hydrochloride package chip of different sustained-release materials

[0029]

[0030] According to the above formula, it can be seen that the cyclobenzaprine hydrochloride-coated chip of the present invention is provided with the same slow-release agent in the inner chip and the outer layer, and the coating layer also adopts the same slow-release agent. According to the dissolution test results, it can be seen that when hydroxypropylmethylcellulose is used alone as a sustained-release agent, the release rate is too fas...

Embodiment 3

[0031] The preparation of embodiment 3 cyclobenzaprine hydrochloride bag chip

[0032] Select cross-linked sodium alginate and chitosan as sustained release agent, according to the formula (g / tablet) of table 3, first compress inner chip, then coat, finally compress and wrap chip, prepare cyclobenzaprine hydrochloride bag chip embodiment 8 to 10.

[0033] Table 3 Cyclobenzaprine hydrochloride packet chip formula (two)

[0034]

[0035]

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Abstract

The invention relates to a cyclobenzaprine hydrochloride sustained-release preparation, and belongs to the field of pharmaceutical preparations. The invention provides cyclobenzaprine hydrochloride press-coated tablets, wherein an inner core piece consists of an active component cyclobenzaprine hydrochloride, a sustained-release agent, a diluent, an adhesive, a disintegrating agent and a lubricant, a middle layer is a sustained-release coating layer, and an outer layer has the same composition as the inner core piece. The cyclobenzaprine press-coated tablets of the invention use cross-linked sodium alginate and chitosan as the sustained-release agent, and the release rate is ideal. The release rate is gentle within 24 hours, and the release is basically completed within 24 hours. The testresults of an influencing factor test, an accelerated test and a long-term sample retention test at room temperature show that the stability of the press-coated tablets is good. The cyclobenzaprine hydrochloride press-coated tablets of the invention well solve the problem that cyclobenzaprine hydrochloride is frequently used because of short half-life in vivo, thus affecting the drug compliance ofpatients.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a sustained-release preparation of cyclobenzaprine hydrochloride. Background technique [0002] Cyclobenzaprine hydrochloride (cyclobenzaprine hydrochloride, 1), the chemical name is 5 ~ (3 ~ dimethylaminopropylene) dibenzo [a, d] cycloheptene hydrochloride, is a muscle drug developed by Merck Company of the United States. The relaxant is now on the market in many countries, and the trade name is Flexeril. [0003] Cyclobenzaprine hydrochloride is a central muscle relaxant, and its action site may be in the brainstem, not a ganglion muscle blocking agent. After administration, skeletal muscle relaxation occurs. Cyclobenzaprine hydrochloride also has an anticholinergic effect. It can relieve the symptoms of local muscle spasms without interfering with the normal function of muscles, and is ineffective for muscle spasms caused by central nervous system diseases. Clinica...

Claims

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Application Information

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IPC IPC(8): A61K9/24A61K31/135A61K47/36A61P21/02A61K9/36
CPCA61K9/205A61K9/209A61K9/286A61K31/135A61P21/02
Inventor 陈阳生王明刚孙桂玉刘晓霞杜昌余王清亭刘振玉臧云龙
Owner CP PHARMA QINGDAO CO LTD
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