CN109330993A - A kind of cyclobenzaprine hydrochloride spansule and preparation method thereof - Google Patents
A kind of cyclobenzaprine hydrochloride spansule and preparation method thereof Download PDFInfo
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- CN109330993A CN109330993A CN201811421532.7A CN201811421532A CN109330993A CN 109330993 A CN109330993 A CN 109330993A CN 201811421532 A CN201811421532 A CN 201811421532A CN 109330993 A CN109330993 A CN 109330993A
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- cyclobenzaprine hydrochloride
- cyclobenzaprine
- spansule
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
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- General Health & Medical Sciences (AREA)
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- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Emergency Medicine (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The present invention relates to field of pharmaceutical preparations, and in particular to a kind of cyclobenzaprine hydrochloride spansule and preparation method thereof.Cyclobenzaprine hydrochloride spansule of the invention includes active constituent, slow-release material, diluent, adhesive, disintegrating agent and lubricant, and the active constituent includes cyclobenzaprine hydrochloride and C14H10Cl2NNaO2.Screening is optimized to the formula of cyclobenzaprine hydrochloride spansule in the present invention, the composition of each auxiliary material has been determined, cyclobenzaprine hydrochloride and C14H10Cl2NNaO2 is selected to prepare spansule as active constituent, on the one hand solving cyclobenzaprine hydrochloride and C14H10Cl2NNaO2 half-life short needs the defect of frequent drug administration, it finds that cyclobenzaprine hydrochloride and C14H10Cl2NNaO2 drug combination can be improved analgesic effect simultaneously, achieves unexpected technical effect.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, and in particular to a kind of cyclobenzaprine hydrochloride spansule and preparation method thereof.
Background technique
Cyclobenzaprine hydrochloride (cyclobenzaprine hydrochloride, 1), (3- dimethylamino is sub- by the entitled 5- of chemistry
Propyl) dibenzo [a, d] cycloheptyl pinene hyhrochloride, it is the muscle relaxant of Merck company of U.S. research and development, in multinational listing,
Trade name Flexeril.
Cyclobenzaprine hydrochloride is central muscle relaxant, and site of action may not be the resistance of neuromere muscle in brain stem
, there is skeletal muscle relaxation effect, cyclobenzaprine hydrochloride also has cholinolytic effect, can alleviate local muscles in disconnected agent after administration
Spasm symptom, while the normal function of muscle is not interfered, muscle epidemic disease contraction caused by Central nervous systemic disease is invalid.Clinic is main
It is used to treat the adjuvant drug of painful part muscle cramp.
The high sensitiveness of muscle in several animal models can be alleviated or be eliminated to cyclobenzaprine hydrochloride.Zooscopy mentions
Show, cyclobenzaprine hydrochloride is unable to direct interference animal muscle nervous function or directly affects skeletal muscle function, mainly makees
For the brain part of central nervous system, and not directly control muscle cramp and the open-minded flesh of relaxation bone.It prompts on evidence, hydrochloric acid
Cyclobenzaprine reduces abnormalities muscular movement, reaches flesh pine effect by influencing motor fibre.
C14H10Cl2NNaO2 (diclofenac sodium, 1) belongs to the potent non-steroid anti-inflammatory drug of the third generation, it mainly leads to
Inhibition cyclooxygenase is crossed to inhibit arachidonic metabolism, so that the synthesis of prostaglandin and the generation of blood platelet are reduced, with
And inhibit lipoxygenase to a certain extent and reduce the generations of the products such as leukotriene, bradykinin, the especially suppression to leukotriene β 4
Production is with more obvious, by the inhibition to these pro-inflammatory cytokines to play antipyretic-antalgic antiinflammation.C14H10Cl2NNaO2 is controlled
The mechanism for treating neurogenic pain is by inhibiting before highly expressed peroxidase activity is reduced in injured nerve and spinal cord
The generation of column parathyrine, to make Arg-Pro-Lys-Pro-Gln-Gln-Phe-Phe-Gly-Leu-Met-NH2 (SP) in dorsal root ganglion and cornu dorsale medullae spinalis shallow-layer, calcitonin gene-related peptide (CGRP)
Expression accordingly reduce, and then play analgesic activity.
C14H10Cl2NNaO2 is Arylacetic acids non-steroid antiphlogistic, is widely used in all kinds of chronic bone joint pains, and same
Class drug is compared, and analgesia, anti-inflammatory and refrigeration function are 2~2.5 times stronger than Indomethacin, 26~50 times stronger than aspirin, is
A kind of novel potent anti-inflammatory antalgesic.
But cyclobenzaprine hydrochloride and C14H10Cl2NNaO2 all have that oral absorption is fast, biological half-life is short, it is general
Obstruction-removing prescription type is multiple per medication day by day, and medication is more frequent, affects the compliance of patient medication.There is presently no about hydrochloric acid ring
Benzene pricks woods and C14H10Cl2NNaO2 combines the research for preparing sustained release preparation and report.
Summary of the invention
The object of the present invention is to provide a kind of cyclobenzaprine hydrochloride spansule and preparation method thereof that analgesic effect is excellent.
The technical solution that the present invention solves the technical problem is a kind of cyclobenzaprine hydrochloride spansule, it includes activity at
Divide, slow-release material, diluent, adhesive, disintegrating agent and lubricant.
The active constituent includes cyclobenzaprine hydrochloride and C14H10Cl2NNaO2, the cyclobenzaprine hydrochloride and C14H10Cl2NNaO2
Weight part ratio be 1~5:1~10.
The slow-release material includes ethylene-vinyl acetate copolymer and polylactic acid-acrylic copolymer, the ethylene-vinegar
Sour ethylene copolymer and polylactic acid-acrylic copolymer ratio are 1-5:2-10.
The diluent includes one of starch, Icing Sugar, dextrin, microcrystalline cellulose and lactose or a variety of.
Described adhesive includes one of povidone, gelatin, sucrose, pregelatinized starch and glucose or a variety of.
The disintegrating agent includes one of dried starch, sodium carboxymethyl starch, crospovidone and calcium carboxymethylcellulose
Or it is a variety of.
The lubricant includes one in talcum powder, magnesium stearate, superfine silica gel powder, sldium lauryl sulfate and hydrogenated vegetable oil
Kind is a variety of.
The weight of cyclobenzaprine hydrochloride spansule each component of the invention are as follows: 1-5 parts of cyclobenzaprine hydrochloride, double
Fragrant sour 1-3 parts of the sodium of chlorine, 15-22 parts of slow-release material, 20-30 parts of diluent, 1-6 parts of adhesive, 12-18 parts of disintegrating agent and lubricant
0.5-2 parts.
Invention also provides the preparation methods of above-mentioned cyclobenzaprine hydrochloride spansule, comprising the following steps:
(1) raw material is weighed by formula rate；
(2) active ingredient hydrochloric acid cyclobenzaprine and C14H10Cl2NNaO2 are uniformly mixed with slow-release material；
(3) be added diluent, adhesive, disintegrating agent and lubricant, granulation, it is filling to get.
Beneficial effects of the present invention:
Screening is optimized to the formula of cyclobenzaprine hydrochloride spansule in the present invention, it is determined that the composition of each auxiliary material,
It selects cyclobenzaprine hydrochloride and C14H10Cl2NNaO2 to prepare spansule as active constituent, on the one hand solves cyclobenzaprine hydrochloride
The defect of frequent drug administration is needed with C14H10Cl2NNaO2 half-life short, while finding cyclobenzaprine hydrochloride and C14H10Cl2NNaO2 drug combination
It can be improved analgesic effect, achieve very unexpected technical effect.
Detailed description of the invention
Fig. 1 is cyclobenzaprine hydrochloride spansule analgesic effect ag(e)ing test figure
Specific embodiment
Present invention will be further explained below with reference to specific examples.It should be understood that these embodiments are merely to illustrate the present invention
Rather than it limits the scope of the invention.In the following examples, the experimental methods for specific conditions are not specified, usually according to conventional strip
Part or according to the normal condition proposed by manufacturer.Unless otherwise stated, otherwise all percentage, ratio, ratio or number is pressed
Poidometer.
Unless otherwise defined, all professional and scientific terms as used herein and meaning familiar to those skilled in the art
Justice is identical.In addition, any method similar to or equal to what is recorded and material can be applied to the method for the present invention.Wen Zhong
The preferred implement methods and materials are for illustrative purposes only.
The preparation of embodiment cyclobenzaprine hydrochloride spansule
Cyclobenzaprine hydrochloride spansule is prepared according to the formula of table 1, weighs cyclobenzaprine hydrochloride, double chlorine by formula rate
Fragrant acid sodium, ethylene~acetate ethylene copolymer, polylactic acid-acrylic copolymer, starch, lactose, povidone, carboxymethyl starch
Sodium, magnesium stearate are total by cyclobenzaprine hydrochloride and C14H10Cl2NNaO2 and ethylene-vinyl acetate copolymer and polylactic acid-acrylic acid
Polymers is uniformly mixed, and is added starch, lactose, povidone, sodium carboxymethyl starch and magnesium stearate, granulation, it is filling to get.
1 cyclobenzaprine hydrochloride spansule formula of table
Test example cyclobenzaprine hydrochloride spansule hot plate method in mice analgesic effect ag(e)ing test
Kunming kind female mice is placed on (55 ± 1) DEG C hot plate pain threshold detector, is clocked at once, until occurring licking metapedes for the first time
Or stopping timing when stamping metapedes, the gained time is the basic threshold of pain.Select 60 Basic Pain Thresholds greater than 5 seconds and small less than 30 seconds
Mouse, is randomly divided into 6 groups, every group 10, respectively with the cyclobenzaprine hydrochloride spansule of embodiment 1-3 and comparative example 1-3 with
The dosage of 0.2mgkg-1 is administered, and 1,2,4,8,12,20 and is for 24 hours measuring the threshold of pain after administration, itself is being compared with administration front and back
Calculate may maximum analgesia percentage (possible maximal analgesic%, PMAP), do not occur licking with 60s metapedes or
Stamp metapedes for analgesia a hundred percent, calculation formula is as follows:
As a result as shown in Figure 1.
As can be seen from FIG. 1, Examples 1 to 3 is spansule, and the analgesic effect duration is long, is shown since 4 hours
Analgesic effect outstanding is shown, and analgesic effect can be continued for 24 hours, in contrast, comparative example 1~3 is common glue
Capsule, analgesic effect is rapid-action, and comparative example 1 showed best analgesic effect at 4~8 hours, but analgesia effect after 8 hours
Fruit decline, comparative example 2~3 also show best analgesic effect after 4 hours respectively, but analgesic effect after 8 hours
Decline, illustrates that the formula of the application achieves excellent slow release effect.
The town Shi Qi is applied in combination in cyclobenzaprine hydrochloride and C14H10Cl2NNaO2 in addition, being also found that according to experimental result
Pain effect is preferable, even the analgesic effect of cyclobenzaprine hydrochloride and C14H10Cl2NNaO2 is used in combination in comparative example 1~3
It is better than the capsule that cyclobenzaprine hydrochloride or C14H10Cl2NNaO2 is used alone, and in the formula of spansule, salt is used in combination
Its analgesic effect of the spansule of sour cyclobenzaprine and C14H10Cl2NNaO2 goes back body other than embodying the advantage of duration length
The analgesic effect that be substantially better than the spansule that cyclobenzaprine hydrochloride or C14H10Cl2NNaO2 is used alone is revealed.
The present invention is described in detail above, specific case used herein is to the principle of the present invention and implementation
Mode is expounded, and the above description of the embodiment is only used to help understand the method for the present invention and its core ideas, including
Best mode, and but also any person skilled in the art can practice the present invention, including any dress of manufacture and use
It sets or system, and implements the method for any combination.It should be pointed out that for those skilled in the art, not
, can be with several improvements and modifications are made to the present invention under the premise of being detached from the principle of the invention, these improvement and modification are also fallen into
In the protection scope of the claims in the present invention.The range of the invention patent protection is defined by the claims, and may include this
Field technical staff it is conceivable that other embodiments.If these other embodiments, which have, is not different from claim text
The structural element of statement, or if they include the equivalent structural elements with the character express of claim without essence difference,
So these other embodiments should also be included in the scope of the claims.
Claims (10)
1. a kind of cyclobenzaprine hydrochloride spansule, which is characterized in that it includes active constituent, slow-release material, diluent, bondings
Agent, disintegrating agent and lubricant, the active constituent include cyclobenzaprine hydrochloride and C14H10Cl2NNaO2.
2. cyclobenzaprine hydrochloride spansule according to claim 1, which is characterized in that the cyclobenzaprine hydrochloride and double
The weight part ratio of the fragrant sour sodium of chlorine is 1-5:1-10.
3. cyclobenzaprine hydrochloride spansule according to claim 1 or 2, which is characterized in that the slow-release material includes
Ethylene-vinyl acetate copolymer and polylactic acid-acrylic copolymer.
4. cyclobenzaprine hydrochloride spansule according to claim 3, which is characterized in that the ethene-vinyl acetate is total
Polymers and polylactic acid-acrylic copolymer ratio are 1-5:2-10.
5. cyclobenzaprine hydrochloride spansule according to claim 1 or 2, which is characterized in that the diluent includes forming sediment
One of powder, Icing Sugar, dextrin, microcrystalline cellulose and lactose are a variety of.
6. cyclobenzaprine hydrochloride spansule according to claim 1 or 2, which is characterized in that described adhesive includes poly-
Tie up one of ketone, gelatin, sucrose, pregelatinized starch and glucose or a variety of.
7. cyclobenzaprine hydrochloride spansule according to claim 1 or 2, which is characterized in that the disintegrating agent includes dry
One of starch, sodium carboxymethyl starch, crospovidone and calcium carboxymethylcellulose are a variety of.
8. cyclobenzaprine hydrochloride spansule according to claim 1 or 2, which is characterized in that the lubricant includes sliding
One of mountain flour, magnesium stearate, superfine silica gel powder, sldium lauryl sulfate and hydrogenated vegetable oil are a variety of.
9. cyclobenzaprine hydrochloride spansule according to claim 1, which is characterized in that the weight of each component
Are as follows: 1-5 parts of cyclobenzaprine hydrochloride, 1-3 parts of C14H10Cl2NNaO2,15-22 parts of slow-release material, 20-30 parts of diluent, adhesive 1-6
Part, 12-18 parts and lubricant 0.5-2 parts of disintegrating agent.
10. the preparation method of -9 described in any item cyclobenzaprine hydrochloride spansule according to claim 1, it is characterised in that packet
Include following steps:
(1) raw material is weighed by formula rate；
(2) active ingredient hydrochloric acid cyclobenzaprine and C14H10Cl2NNaO2 are uniformly mixed with slow-release material；
(3) be added diluent, adhesive, disintegrating agent and lubricant, granulation, it is filling to get.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811421532.7A CN109330993A (en) | 2018-11-26 | 2018-11-26 | A kind of cyclobenzaprine hydrochloride spansule and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201811421532.7A CN109330993A (en) | 2018-11-26 | 2018-11-26 | A kind of cyclobenzaprine hydrochloride spansule and preparation method thereof |
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| CN109330993A true CN109330993A (en) | 2019-02-15 |
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| CN201811421532.7A Pending CN109330993A (en) | 2018-11-26 | 2018-11-26 | A kind of cyclobenzaprine hydrochloride spansule and preparation method thereof |
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Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102274200A (en) * | 2011-08-10 | 2011-12-14 | 深圳致君制药有限公司 | Diclofenac sodium sustained release tablets and preparation process thereof |
| CN102860987A (en) * | 2012-09-20 | 2013-01-09 | 南京长澳制药有限公司 | Diclofenac sodium sustained-release capsule and preparation method thereof |
| WO2012075455A3 (en) * | 2010-12-02 | 2013-06-27 | Aptalis Pharmatech, Inc. | Rapidly dispersing granules, orally disintegrating tablets and methods |
| CN104523655A (en) * | 2014-12-22 | 2015-04-22 | 青岛正大海尔制药有限公司 | Cyclobenzaprine hydrochloride sustained-release capsules |
| CN107920987A (en) * | 2015-05-26 | 2018-04-17 | 艾萨·欧蒂迪 | Control delays to discharge Pregabalin |
| CN108078988A (en) * | 2018-02-13 | 2018-05-29 | 山西省太原晋阳制药厂 | C14H10Cl2NNaO2 and the compound sustained-released composition of codeine phosphate and preparation method thereof |
-
2018
- 2018-11-26 CN CN201811421532.7A patent/CN109330993A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2012075455A3 (en) * | 2010-12-02 | 2013-06-27 | Aptalis Pharmatech, Inc. | Rapidly dispersing granules, orally disintegrating tablets and methods |
| CN102274200A (en) * | 2011-08-10 | 2011-12-14 | 深圳致君制药有限公司 | Diclofenac sodium sustained release tablets and preparation process thereof |
| CN102860987A (en) * | 2012-09-20 | 2013-01-09 | 南京长澳制药有限公司 | Diclofenac sodium sustained-release capsule and preparation method thereof |
| CN104523655A (en) * | 2014-12-22 | 2015-04-22 | 青岛正大海尔制药有限公司 | Cyclobenzaprine hydrochloride sustained-release capsules |
| CN107920987A (en) * | 2015-05-26 | 2018-04-17 | 艾萨·欧蒂迪 | Control delays to discharge Pregabalin |
| CN108078988A (en) * | 2018-02-13 | 2018-05-29 | 山西省太原晋阳制药厂 | C14H10Cl2NNaO2 and the compound sustained-released composition of codeine phosphate and preparation method thereof |
Non-Patent Citations (3)
| Title |
|---|
| HANAN F KAKISH等: "A novel approach for the preparation of highly loaded polymeric controlled release dosage forms of diltiazem HCl and diclofenac sodium", 《EUR J PHARM BIOPHARM》 * |
| JAMUNADHEVI V等: "Formulation and in vitro evaluation of bi-layer tablet of cyclobenzaprine hydrochloride ER and diclofenac potassium IR – A novel fixed dose combination", 《INT. J. RES. PHARM. SCI》 * |
| 孟胜男: "《药剂学 在线学习版》", 31 January 2016, 中国医药科技出版社 * |
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