CN108392639A - A kind of pharmaceutical composition and preparation method thereof containing sildenafil citrate - Google Patents
A kind of pharmaceutical composition and preparation method thereof containing sildenafil citrate Download PDFInfo
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- CN108392639A CN108392639A CN201810329130.8A CN201810329130A CN108392639A CN 108392639 A CN108392639 A CN 108392639A CN 201810329130 A CN201810329130 A CN 201810329130A CN 108392639 A CN108392639 A CN 108392639A
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/69—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
- A61K47/6949—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/10—Drugs for genital or sexual disorders; Contraceptives for impotence
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
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Abstract
The invention belongs to field of pharmaceutical preparations, and in particular to a kind of pharmaceutical composition containing sildenafil citrate, including sildenafil citrate mesoporous molecular screen composite and other pharmaceutically acceptable auxiliary materials；The pharmaceutically acceptable auxiliary material includes filler, disintegrant, adhesive, corrigent, lubricant and colorant, is calculated as 0.1 1 parts of 280 parts of sildenafil citrate mesoporous molecular screen composite, 150 250 parts of filler, 1 10 parts of adhesive, 10 50 parts of disintegrant, 1 10 parts of corrigent, 2 10 parts of lubricant and colorant by weight.The present invention also provides a kind of preparation methods of the pharmaceutical composition containing sildenafil citrate.Pharmaceutical composition provided by the invention containing sildenafil citrate does not need water when taking and need not chew yet, and can be disintegrated rapidly in the oral cavity, and drug compliance is good, rapid-action, and bioavilability is high, and in good taste.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, and in particular to a kind of pharmaceutical composition containing sildenafil citrate and its
Preparation method.
Background technology
Oral preparation is since its is easy to use, and the features such as safety is good, is the widest preparation of current clinical application, still
Most drug has different degrees of bitter taste, causes mouthfeel bad, and patient is difficult to receive, poor compliance.Drug will be covered
The technology of bitter taste is divided into four classes by its principle：Obscure the brain sense of taste and covers bitter taste of drug；Delay or drug prevented to be discharged in oral cavity,
Contact of the drug with taste bud is isolated；It benumbs gustatory and improves bitter by threshold value；The combination of bitterness receptors and bitters is prevented,
Shutoff signal is conducted.Delay or drug is prevented to be discharged in oral cavity, contact common method of the isolation drug with taste bud has addition to rectify
The auxiliary materials such as taste agent, prepare micro-capsule or microballoon taste masking, prepare solid dispersions etc. the transformation of bitter drug chemical constitution.Add auxiliary material
It is to mitigate bitter taste by interfering taste bud, method is most simple, at low cost, but effect is limited, is imitated to extremely bitter and facile hydrolysis drug
Fruit is bad, and prodrug is made in medicines structure modification, poor taste, technology are overcome again while keeping bitter drug curative effect
Difficulty is larger.
Sildenafil citrate, sildenafil citrate, entitled 1- [4- ethyoxyls -3- [5- (6, the 7- dihydro -1- first of chemistry
Base -7- oxos -3- propyl -1H- pyrazolos [4,3d] pyrimidine)] benzene sulfonyl] -4- methylpiperazine citrates, the following institute of structural formula
Show：
Sildenafil citrate is developed by Pfizer drugmaker, in March, 1998 to treat male erection function barrier
The indication hindered obtains the listing license of Federal Food and drug administration.And have a large amount of clinical datas both at home and abroad
It has been shown that, silaenafil, which is used alone or is used in combination with other drugs, can treat various types of pulmonary hypertension diseases.2005
In June in year, it is first drug taken orally for treating early stage pulmonary hypertension that U.S. FDA, which ratifies it,.
However sildenafil citrate itself has strong bitter taste, and hygroscopicity is strong, and it is easy to moisture absorption rotten under normality.Its
Listing dosage form is tablet.For the patient for having the patient of aphetite disorder or difficulty, water intaking inconvenient, the clinical application of this tablet by
Limitation.By masking methods such as conventional auxiliary material dilution, corrigents, it is difficult to realize complete, good taste masking.
Invention content
It is an object of the invention to overcome odor mask taste masking effect used in sildenafil citrate in the prior art not
It is good, and the defect that cost is more high, provide it is a kind of it is rapid-action, bioavilability is high, it is in good taste containing citric acid west ground that
Non- pharmaceutical composition.
To solve the above problems, the technical solution adopted by the present invention is as follows：A kind of drug containing sildenafil citrate
Composition, including sildenafil citrate-mesoporous molecular screen composite and other pharmaceutically acceptable auxiliary materials；The pharmacy
Upper acceptable auxiliary material includes filler, disintegrant, adhesive, corrigent, lubricant and colorant；The auxiliary material is by weight
Part is calculated as 150-250 parts of filler, 1-10 parts of adhesive, 10-50 parts of disintegrant, 1-10 parts of corrigent, 2-10 parts of lubricant,
0.1-1 parts of toner.
Preferably, the auxiliary material be calculated as by weight 180-230 parts of filler, 2-4 parts of adhesive, 22-38 parts of disintegrant,
3.2-4.0 parts of corrigent, 5.5-8.0 parts of lubricant, 0.3-0.4 parts of colorant
Preferably, the filler is selected from the following one or more：Microcrystalline cellulose, mannitol, erythrite and mountain
Pears alcohol.
Preferably, the disintegrant is selected from the following one or more：Sodium carboxymethyl starch, cross-linked carboxymethyl cellulose
Sodium and crosslinked polyvinylpyrrolidone.
Preferably, the corrigent is used to improve the mouthfeel of tablet, increases the compliance of patient, can be selected from the following
It is one or more：Aspartame, menthol, sucrose, fructose, STEVIA REBAUDIANA element, glycyrrhizin and fruity essence.
Preferably, the lubricant can be selected from below one or more to increase the mobility of drug：Stearic acid
Magnesium, stearic acid, talcum powder, superfine silica gel powder and lauryl sodium sulfate.
The adhesive is selected from the following one or more：Hydroxypropyl methylcellulose, polyvinylpyrrolidone and carboxymethyl
Sodium cellulosate.
The colorant is selected from the following one or more：Blue color indigo, yellow iron oxide and black iron oxide.
Mesopore molecular sieve is to utilize the physics such as sol-gel, emulsification or microemulsified and change using surfactant as template
Process assembles a kind of ordered porous material of aperture in 2-50nm of generation by the interface interaction between organic matter and inorganic matter
Material has huge surface area and Kong Rong, and parmacodynamics-less activity and toxicity.Mesopore molecular sieve drugloading rate is big, can solve big
The low problem of dosage bitter drug taste masking efficiency.Currently preferred mesopore molecular sieve is selected from the following one or more：HMS、
MSU, SBA-1 and MCM-41, wherein it is preferred that MCM-41.HMS (Hexagonal Mesoporous Silica) is in acid condition
Under using primary amine as template, what is synthesized by interaction of hydrogen bond has regular pore canal, and the mesoporous molecular that hole wall is thicker
Sieve；MSU (Michigan State University material) is in neutral conditions with biodegradable nonionic
Surfactant is the single mesopore molecular sieve of the pore-size distribution of template synthesis；SBA-n series (Santa Barbara
USA), it is serial mesopore molecular sieve that University of California Stucky et al. is developed, be with the amphiphilic goods and materials of Shuangzi ammonium class is template,
Synthesize in highly acid system.MCM-41 is to use mould of the supermolecule surfactant quaternary ammonium salt as porous silicate
Plate agent has synthesized a kind of novel mesopore molecular sieve, and pore-size distribution is narrow, and duct is uniform, is in six side's ordered arrangements, specific surface area
(＞ 700m greatly2/ g), big (the ＞ 0.7cm of adsorption capacity3/g).MCM-41 mesopore molecular sieves are applied to because of its excellent performance
The fields such as catalysis, absorption and separation；
The second object of the present invention is to provide a kind of preparation method of the pharmaceutical composition containing sildenafil citrate,
Include the following steps：
(1) preparation of mesopore molecular sieve；
(2) preparation of sildenafil citrate-mesoporous molecular screen composite；
(3) filler, disintegrant, corrigent and colorant are crossed into 60 mesh sieve, lubricant is crossed into 20 mesh sieve, it is spare；
(4) sildenafil citrate-mesoporous molecular screen composite, filler and colorant is weighed to be uniformly mixed；
(5) disintegrant of recipe quantity is weighed, corrigent is uniformly mixed with step (4) powder；
(6) lubricant for weighing recipe quantity is uniformly mixed with step (5) powder, tabletted.
Preferably, the preparation method of the pharmaceutical composition containing sildenafil citrate further includes following steps：
It weighs cetyl trimethylammonium bromide to be dissolved in deionized water, ammonium hydroxide is added after clarification, stir, positive silicic acid is added dropwise
Ethyl ester stirs 1 hour at room temperature.Then dress 100 DEG C of kettle crystallization 24 hours filters, and deionized water is rinsed to pH neutrality, precipitation
550 DEG C of roastings, 6 hours burn off templates, temperature program are 1 DEG C/min, and mesostructured material is made.
The concrete operations of step (2) are as follows：It weighs sildenafil citrate to be dissolved in deionized water, be added after dissolving clarification
Molecular sieve is placed on magnetic stirring apparatus after stirring 2~3 hours and centrifuges at room temperature, and washing is primary, and gained precipitation is citric acid west
That non-mesoporous molecular screen composite of ground.
The advantageous effect of technical solution using the present invention is：Drug provided by the invention containing sildenafil citrate
Water is not needed when composition is taken need not also chew, and can be disintegrated rapidly in the oral cavity, and drug compliance is good, rapid-action, biology
Availability is high, and in good taste.
Specific implementation mode
The present invention is further described specifically with reference to embodiments, but not limited to this.
Embodiment 1：The preparation of mesostructured material
It weighs 1.2g cetyl trimethylammonium bromides to be dissolved in 24mL deionized waters, 12mL ammonium hydroxide is added after clarification, stirs
15min is mixed, ethyl orthosilicate 6mL is added dropwise, is stirred 1 hour at room temperature.Then dress 100 DEG C of kettle crystallization 24 hours filters, deionization
Water is rinsed to pH neutrality, precipitates 550 DEG C of roastings, 6 hours burn off templates, temperature program is 1 DEG C/min, obtains mesopore molecular sieve
MCM-41。
Embodiment 2：The preparation of sildenafil citrate-mesoporous molecular screen composite
Precision weighs sildenafil citrate 2g and sets in container, and 200mL deionized waters are added, keep sildenafil citrate complete
After fully dissolved, 2g MCM-41 mesopore molecular sieves are added, is placed on magnetic stirring apparatus after stirring 2.5 hours and centrifuges at room temperature, washes
Once, gained precipitation is sildenafil citrate-mesoporous molecular screen composite.0.45 micron of miillpore filter mistake of supernatant
Filter measures absorbance at 292nm after adding water suitably to dilute.Sildenafil citrate-mesopore molecular sieve is calculated using minusing
Medicament contg in compound further calculates its drugloading rate.
Drugloading rate=(W1-W2)/W0× 100%
In formula：W1Gross mass is added for sildenafil citrate before inclusion
W2For sildenafil citrate gross mass in solution after inclusion
W0For the MCM-41 gross masses of addition.
Experimental result is：W1=2g；W2=1.02g；W0=2g
Drugloading rate=(2-1.02)/2*100=49.0%.
Embodiment 3
Oral disintegrating tablet is made in sildenafil citrate-mesoporous molecular screen composite obtained in above-described embodiment 2, specification is
100mg.Its prescription is as follows：
Composition (is made 1000) altogether：
| Supplementary material | Weight (g) |
| Sildenafil citrate-mesoporous molecular screen composite | 285.71 |
| Microcrystalline cellulose | 100 |
| Sorbierite | 130 |
| Hydroxypropyl methylcellulose | 1.98 |
| Sodium carboxymethyl starch | 22 |
| Aspartame | 1.60 |
| Orange essence | 1.60 |
| Blue color indigo | 0.32 |
| Magnesium stearate | 5.50 |
Preparation process：
(1) by microcrystalline cellulose, sorbierite, hydroxypropyl methylcellulose, sodium carboxymethyl starch, aspartame, orange essence and
Blue color indigo crosses 60 mesh sieve, and magnesium stearate is crossed 20 mesh sieve, spare；
(2) sildenafil citrate-mesoporous molecular screen composite, microcrystalline cellulose and blue color indigo is weighed to be uniformly mixed；
(3) weigh sorbierite, hydroxypropyl methylcellulose, sodium carboxymethyl starch, aspartame and the orange essence of recipe quantity with
Step (2) powder is uniformly mixed；
(4) magnesium stearate for weighing recipe quantity is uniformly mixed with step (3) powder, tabletted.
The oral disintegrating tablet containing sildenafil citrate prepared by the present embodiment can be in 15 seconds completely in 37 DEG C of water
Disintegration, and can be by 300-710 μm of sieve, and in good taste, no bitter taste, no feeling of grittiness.
Embodiment 4
Oral disintegrating tablet is made in sildenafil citrate-mesoporous molecular screen composite obtained in above-described embodiment 2, specification is
100mg.Its prescription is as follows：
Composition (is made 1000) altogether：
Preparation process：
(1) by microcrystalline cellulose, mannitol, hydroxypropyl methylcellulose, croscarmellose sodium, aspartame, orange
Essence and blue color indigo cross 60 mesh sieve, and magnesium stearate is crossed 20 mesh sieve, spare；
(2) sildenafil citrate-mesoporous molecular screen composite, microcrystalline cellulose and blue color indigo is weighed to be uniformly mixed；
(3) mannitol, hydroxypropyl methylcellulose, croscarmellose sodium, aspartame and the orange of recipe quantity are weighed
Essence is uniformly mixed with step (2) powder；
(4) magnesium stearate for weighing recipe quantity is uniformly mixed with step (3) powder, tabletted.
The oral disintegrating tablet containing sildenafil citrate prepared by the present embodiment can be in 15 seconds completely in 37 DEG C of water
Disintegration, and can be by 300-710 μm of sieve, and in good taste, no bitter taste, no feeling of grittiness.
Mesoporous molecular screen composite such as adds the ion exchange resin of pharmaceutical grade compared to other taste masking means, has and carries
The feature that dose is big, nonhazardous, cost are more cheap.
Claims (10)
1. a kind of pharmaceutical composition containing sildenafil citrate, including sildenafil citrate-mesoporous molecular screen composite
With other pharmaceutically acceptable auxiliary materials；The pharmaceutically acceptable auxiliary material include filler, disintegrant, adhesive,
Corrigent, lubricant and colorant are calculated as 280 parts of sildenafil citrate-mesoporous molecular screen composite, filler by weight
150-250 parts, 1-10 parts of adhesive, 10-50 parts of disintegrant, 1-10 parts of corrigent, 2-10 parts of lubricant and colorant 0.1-1
Part.
2. the pharmaceutical composition according to claim 1 containing sildenafil citrate, which is characterized in that the filling
Agent is selected from the following one or more：Microcrystalline cellulose, mannitol, erythrite and sorbierite.
3. the pharmaceutical composition according to claim 1 containing sildenafil citrate, which is characterized in that the disintegration
Agent is selected from the following one or more：Sodium carboxymethyl starch, croscarmellose sodium and crosslinked polyvinylpyrrolidone.
4. the pharmaceutical composition according to claim 1 containing sildenafil citrate, which is characterized in that the flavoring
Agent is selected from the following one or more：Aspartame, menthol, sucrose, fructose, STEVIA REBAUDIANA element, glycyrrhizin and fruit are savory
Essence.
5. the pharmaceutical composition according to claim 1 containing sildenafil citrate, which is characterized in that the lubrication
Agent is selected from the following one or more：Magnesium stearate, stearic acid, talcum powder, superfine silica gel powder and lauryl sodium sulfate.
6. the pharmaceutical composition according to claim 1 containing sildenafil citrate, which is characterized in that the bonding
Agent is selected from the following one or more：Hydroxypropyl methylcellulose, polyvinylpyrrolidone and sodium carboxymethylcellulose.
7. the pharmaceutical composition according to claim 1 containing sildenafil citrate, which is characterized in that the coloring
Agent is selected from the following one or more：Blue color indigo, yellow iron oxide and black iron oxide.
8. containing the pharmaceutical composition of sildenafil citrate according to claim 1 ~ 7 any one of them, which is characterized in that institute
The mesopore molecular sieve one kind selected from the following stated：HMS, MSU, SBA-1 and MCM-41.
9. containing the preparation method of the pharmaceutical composition of sildenafil citrate according to claim 1 ~ 7 any one of them, wrap
Include following steps：
（1）The preparation of mesopore molecular sieve；
（2）The preparation of sildenafil citrate-mesoporous molecular screen composite；
（3）Filler, disintegrant, corrigent and colorant are crossed into 60 mesh sieve, lubricant is crossed into 20 mesh sieve, it is spare；
（4）Sildenafil citrate-mesoporous molecular screen composite, filler and colorant is weighed to be uniformly mixed；
（5）Weigh the disintegrant, corrigent and step of recipe quantity（4）Powder is uniformly mixed；
（6）Weigh the lubricant and step of recipe quantity（5）Powder is uniformly mixed, tabletted.
10. the preparation method of the pharmaceutical composition according to claim 9 containing sildenafil citrate, feature exist
In step（2）Concrete operations it is as follows：
It weighs sildenafil citrate to be dissolved in deionized water, molecular sieve is added after dissolving clarification, is placed in magnetic agitation at room temperature
It is centrifuged after being stirred 2 ~ 3 hours on device, washing is primary, and gained precipitation is sildenafil citrate-mesoporous molecular screen composite.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810329130.8A CN108392639A (en) | 2018-04-13 | 2018-04-13 | A kind of pharmaceutical composition and preparation method thereof containing sildenafil citrate |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201810329130.8A CN108392639A (en) | 2018-04-13 | 2018-04-13 | A kind of pharmaceutical composition and preparation method thereof containing sildenafil citrate |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115531334A (en) * | 2022-10-26 | 2022-12-30 | 广州朗圣药业有限公司 | Sildenafil citrate tablet and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2013058496A1 (en) * | 2011-10-21 | 2013-04-25 | Daewoong Pharmaceutical Co., Ltd. | Taste-masked pharmaceutical composition for oral administration and a process for the preparation thereof |
| CN106860404A (en) * | 2017-04-13 | 2017-06-20 | 中国药科大学 | A kind of sildenafil citrate taste masking resin complexes and its application |
-
2018
- 2018-04-13 CN CN201810329130.8A patent/CN108392639A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2013058496A1 (en) * | 2011-10-21 | 2013-04-25 | Daewoong Pharmaceutical Co., Ltd. | Taste-masked pharmaceutical composition for oral administration and a process for the preparation thereof |
| CN106860404A (en) * | 2017-04-13 | 2017-06-20 | 中国药科大学 | A kind of sildenafil citrate taste masking resin complexes and its application |
Non-Patent Citations (2)
| Title |
|---|
| JI-HEE LEE等: "A nanohybrid system for taste masking of sildenafil", 《INTERNATIONAL JOURNAL OF NANOMEDICINE》 * |
| 李莹莹: "介孔分子筛对西替利嗪掩味作用的研究", 《中国优秀硕士学位论文全文数据库 医药卫生科技辑》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115531334A (en) * | 2022-10-26 | 2022-12-30 | 广州朗圣药业有限公司 | Sildenafil citrate tablet and preparation method thereof |
| CN115531334B (en) * | 2022-10-26 | 2023-09-08 | 广州朗圣药业有限公司 | Sildenafil citrate tablet and preparation method thereof |
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Application publication date: 20180814 |