Cyclobenzaprine hydrochloride sustained-release capsule and preparation method thereof

A technology of cyclobenzaprine hydrochloride and sustained-release capsules, which is applied in the direction of microcapsules, capsule delivery, and pharmaceutical formulations, and can solve the problems of short half-life, poor compliance, and slow elimination of cyclobenzaprine hydrochloride, and prolong the effective time of action , stable quality, uniform and slow drug release effect

Pending Publication Date: 2022-06-24
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, cyclobenzaprine hydrochloride has a short half-life in the body and slow elimination. Its common dosage form needs to be used several times a day to achieve the curative effect. The medication is more frequent, and the compliance of patients with medication is poor.

Method used

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  • Cyclobenzaprine hydrochloride sustained-release capsule and preparation method thereof
  • Cyclobenzaprine hydrochloride sustained-release capsule and preparation method thereof
  • Cyclobenzaprine hydrochloride sustained-release capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1 A kind of cyclobenzaprine hydrochloride sustained-release capsule and preparation method thereof

[0030] The cyclobenzaprine hydrochloride was pulverized using a pulverizer and passed through a 100-mesh sieve; 30g of cyclobenzaprine hydrochloride, 20g of hydroxypropyl methylcellulose E5, and 90g of microcrystalline cellulose PH101 were weighed and added to the wet granulator and mixed Evenly, add an appropriate amount of aqueous solution to obtain a suitable soft material, the stirring speed is 400 rpm, and the cutting speed is 400 rpm; the soft material is extruded and spheronized to obtain wet skeleton pellets, the extrusion speed is 30 rpm, the spheronization speed is 1000 pm, and the spheronization time is 5 minutes to obtain wet skeleton pellets. Pill core; place the wet pill in a fluidized bed to dry for 10 minutes, sieve to obtain a 20-40 mesh pill core; weigh 10g Eudragit RS100, 2g triethyl citrate, 2g povidone k30, 5g stearic acid Magnesium is dis...

Embodiment 2

[0031] Embodiment 2 A kind of cyclobenzaprine hydrochloride sustained-release capsule and preparation method thereof

[0032] The cyclobenzaprine hydrochloride was pulverized using a pulverizer and passed through a 100-mesh sieve; 30g of cyclobenzaprine hydrochloride, 20g of hydroxypropyl methylcellulose E5, and 90g of microcrystalline cellulose PH101 were weighed and added to the wet granulator and mixed Evenly, add an appropriate amount of aqueous solution to obtain a suitable soft material, the stirring speed is 400 rpm, and the cutting speed is 400 rpm; the soft material is extruded and spheronized to obtain wet skeleton pellets, the extrusion speed is 30 rpm, the spheronization speed is 1000 pm, and the spheronization time is 5 minutes to obtain wet skeleton pellets. Pill core; place the wet pill in a fluidized bed to dry for 10 minutes, sieve to obtain a 20-40 mesh pill core; weigh 10g Eudragit NE30D, 2g triethyl citrate, 2g povidone k30, 5g stearin Magnesium acid is dis...

Embodiment 2

[0035] Comparative Example 2 Single film-controlled sustained-release capsule and preparation method thereof

[0036]The cyclobenzaprine hydrochloride was pulverized by a pulverizer, and passed through a 100-mesh sieve; 30 g of cyclobenzaprine hydrochloride and 110 g of microcrystalline cellulose PH101 were weighed into a wet granulator and mixed evenly, and then an appropriate amount of aqueous solution was added to prepare a suitable soft granulator. material, stirring speed 400rpm, chopping speed 400rpm; extruding and spheronizing the soft material to obtain wet skeleton pills, extrusion speed 30rpm, spheronization speed 1000pm, spheronization time 5 minutes, to obtain wet pill cores; put the wet pills in a fluidized Dry in the bed for 10 minutes, sieve to obtain 20-40 mesh pill cores; weigh 10g Eudragit RS100, 2g triethyl citrate, 2g povidone k30, 5g magnesium stearate and disperse them in 90% ethanol, stir evenly , the preparation concentration is 5% coating liquid; the o...

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Abstract

The invention relates to a cyclobenzaprine hydrochloride sustained-release capsule and a preparation method thereof, and belongs to the technical field of sustained-release preparations. The cyclobenzaprine hydrochloride sustained-release capsule is obtained by filling a sustained-release pellet, the sustained-release pellet is composed of a drug-containing pellet core and a coating layer, and the pellet core contains cyclobenzaprine hydrochloride, a filler and a sustained-release framework material; the coating layer contains a sustained-release film-forming material, a plasticizer, a pore-foaming agent and an anti-sticking agent, and the sustained-release pellet consists of a plurality of small unit pellets and is a skeleton type and film control type dual-combined sustained-release capsule. Compared with the prior art, the sustained-release capsule provided by the invention has the advantages of stable quality, more uniform and slow drug release, obviously improved safety, effectiveness and compliance of the drug, simple preparation process, low technical difficulty and suitability for large-scale production.

Description

technical field [0001] The invention relates to a cyclobenzaprine hydrochloride sustained-release capsule and a preparation method thereof, belonging to the technical field of sustained-release preparations. Background technique [0002] Many patients have chronic low back pain with skeletal muscle spasms. While the causes of this intractable pain are varied, many are caused by direct muscle and ligament injuries, such as neck strain syndrome (neck sprain). Specific localized pain areas (trigger points) in skeletal muscles are often associated with lumbar and cervical pain. Various scholars refer to the combination of pain, muscle spasms, and trigger points as "myofascial syndrome" or "interstitial myofibritis." If the pain-spasm-pain cycle persists, the condition may be difficult to manage. Current treatment options include physical therapy, pain relievers, centrally active muscle relaxants, transcutaneous nerve stimulation anesthesia, and local anesthetics and steroid i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K31/135A61K47/38A61K47/32A61P21/02A61P29/00
CPCA61K31/135A61K9/5047A61K9/5042A61K9/5026A61P29/00A61P21/02
Inventor 李宝杰王雪郭洪涛徐颖
Owner LUNAN PHARMA GROUP CORPORATION
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