CN112263567B - Ibuprofen sustained-release capsule and preparation method thereof - Google Patents
Ibuprofen sustained-release capsule and preparation method thereof Download PDFInfo
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- CN112263567B CN112263567B CN202011118333.6A CN202011118333A CN112263567B CN 112263567 B CN112263567 B CN 112263567B CN 202011118333 A CN202011118333 A CN 202011118333A CN 112263567 B CN112263567 B CN 112263567B
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- ibuprofen
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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
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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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
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
-
- 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
-
- 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]
Abstract
The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to an ibuprofen sustained-release capsule and a preparation method thereof. The capsule is prepared by preparing ibuprofen and a sustained-release carrier into a solid dispersion by a spray drying method, adding a lubricant, mixing and filling. The preferable slow-release carrier is polyacrylic resin-polyethylene glycol. The capsule has good sustained-release effect and good process reproducibility, and is suitable for large-scale production.
Description
Technical Field
The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to an ibuprofen sustained-release capsule and a preparation method thereof.
Background
Ibuprofen (Ibuprofen) is a non-steroidal anti-inflammatory drug with antipyretic and analgesic effects. The product has effects of relieving pain and inflammation by inhibiting cyclooxygenase, reducing synthesis of prostaglandin; acting as a antipyretic through the hypothalamic thermoregulatory center. The analgesic effect is 16-32 times larger than that of aspirin, the anti-inflammatory effect is weaker, and the antipyretic effect is similar to that of aspirin but has a more lasting effect. Ibuprofen is a racemic mixture of the S (+) and R (-) enantiomers, the chemical name of 2- (4-isobutylphenyl) benzoic acid, molecular weight 206.28, and its structural formula:
ibuprofen is white crystalline powder, slightly peculiar smell and almost tasteless. It is soluble in ethanol, acetone, chloroform or diethyl ether, and is insoluble in water, and has a blood drug concentration peak and a plasma half-life of 1.8-2 hr. At present, common preparations on the market at home need frequent administration. The side effects of dyspepsia, nausea and the like can be caused by long-term administration. The slow release preparation can effectively solve the problem, and has the advantages of lasting curative effect, convenient use and good patient compliance.
The patent CN107184565B uses the porous characteristic of mesoporous silicon dioxide to adsorb ibuprofen dissolved in an organic solvent, and the solvent is coated with hypromellose phthalate after being volatilized to prepare the ibuprofen sustained-release capsule. However, various organic solvents such as methanol and acetone are used in the preparation process, which is not beneficial to the safe production of workshops and the labor protection of workers. In addition, the dissolution amount of the capsule prepared by the invention is still less than 10 percent in the first 2 hours, the effect of the medicine is slow, and the practicability is poor although the slow release effect is good.
The patent CN102114011B discloses a method for preparing an ibuprofen sustained-release capsule by layering and applying drugs to pellets, wherein the method has high requirement on material fluidity during applying drugs, but the ibuprofen has poor fluidity, and the micronized ibuprofen is directly added into a coating pan during applying drugs, so that the drug application of the pellet core is not uniform easily, and the drug application end point is difficult to grasp. The medicine layer and the adhesive layer are alternately carried out in the process, and the continuity is poor. The release of the drug is carried out in a coating film control mode, the process is complex, and the difference of the release degree among batches is easy to generate in industrial production. Patent CN106265601A discloses an ibuprofen sustained-release capsule, which adopts a centrifugal granulation method to prepare granules, and hydroxypropyl methylcellulose and ibuprofen are scattered in the process, so that the phenomenon of uneven medicine application on the pill core also exists. Hydroxypropyl methylcellulose is used as a framework type slow-release material, so that the problems of irregular drug release, difficulty in complete drug release and the like easily occur. The micro pills with 16-26 meshes are screened for capsule filling, the yield is low, and the cost is increased.
The solid dispersion sustained-release technology plays a significant role in the pharmaceutical field in recent years, and the drugs in the solid dispersion can be highly dispersed in the auxiliary materials, thereby ensuring the reproducibility of drug dissolution. The invention creatively adopts the spray drying technology to solve the technical problems exposed by the traditional sustained-release pellets by combining the physicochemical property of the ibuprofen.
Disclosure of Invention
In view of the deficiencies of the prior art, the inventors provide a ibuprofen spray-dried solid dispersion sustained release capsule. The ibuprofen and the sustained-release carrier are prepared into solid dispersoid by a spray drying method, and then the solid dispersoid is mixed with the lubricant and filled into capsules. Ibuprofen is highly dispersed in a carrier material in a molecular or amorphous state, so that the capsule has stable drug release, complete dissolution and good sustained release effect.
The invention is realized by the following technical scheme:
an ibuprofen solid dispersion sustained-release capsule, which consists of a sustained-release solid dispersion and a lubricant.
The sustained-release solid dispersion comprises ibuprofen and a sustained-release carrier; the slow release carrier is selected from one or more of ethyl cellulose, polyethylene glycol, polyacrylic resin, poloxamer, povidone and hydroxypropyl methylcellulose phthalate.
Preferably, the slow release carrier is a mixture of ethyl cellulose and povidone, a mixture of polyacrylic resin and polyethylene glycol.
Further preferably, the slow release carrier is polyacrylic resin and polyethylene glycol.
Examples of such lubricants and glidants include, but are not limited to, magnesium stearate, zinc stearate, calcium stearate, stearic acid, sodium stearyl fumarate, sodium benzoate, talc, and aerosil.
Preferably, the weight ratio of ibuprofen to ethylcellulose-povidone in the solid dispersion is 1:0.8-3.0, and the weight ratio of ethylcellulose to povidone is 1: 0.2-3.0.
Preferably, the weight ratio of ibuprofen to polyacrylic resin-polyethylene glycol in the solid dispersion is 1:0.2-2.0, and the weight ratio of polyacrylic resin to polyethylene glycol is 1: 0.3-2.5.
Preferably, the lubricant in the ibuprofen sustained-release capsule accounts for 0.2-0.8% of the weight of the content of the capsule.
The invention also provides a preparation method of the ibuprofen sustained-release capsule, which comprises the following steps:
(1) a solid dispersion was prepared.
Weighing ibuprofen with the formula amount, adding the ibuprofen into ethanol, stirring for dissolving, adding a slow release carrier ethanol solution, uniformly mixing, carrying out spray drying, collecting materials, and cooling to obtain the ibuprofen solid dispersion.
Preferably, the solid content of the ibuprofen ethanol solution and the sustained-release carrier ethanol solution is 7-10% (w/w).
Preferably, the air inlet temperature of spray drying is 90-110 ℃, the atomization pressure is 1.2-1.5bar, the spray speed is 8-12r/min, and the air outlet temperature is 50-60 ℃.
(2) Preparing the sustained-release capsule
And (3) adding a lubricant into the solid dispersion prepared in the step (1), uniformly mixing, and filling into capsules.
Compared with the prior art, the invention has the following advantages:
(1) the capsule has good slow release effect, complete dissolution and good drug release reproducibility. The medicine is highly dispersed in the carrier material in a molecular or amorphous state by selecting insoluble ethyl cellulose and water-soluble povidone, insoluble polyacrylic resin and water-soluble polyethylene glycol as carriers, on one hand, a release medium permeates through micropores of the carrier material to gradually dissolve the medicine to be diffused outwards, and on the other hand, a water-soluble polymer is also in corrosion and simultaneously releases the medicine. The optimal slow release effect is adjusted by changing the ratio of the insoluble auxiliary materials to the soluble auxiliary materials.
(2) The dissolution rate of the medicine within 1 hour can reach more than 20 percent, and the sustained release and quick onset concentration can be achieved.
(3) The preparation process is simple, the process reproducibility is good, and the production efficiency is high. The spray drying technology avoids high-temperature operation, is beneficial to medicament protection, and the prepared dispersion particles do not need to be crushed, have high yield and are suitable for industrial production.
Detailed Description
The advantages of the present invention are further described below by way of examples, it being properly understood that: the examples of the present invention are given for illustrative purposes only and are not intended to limit the present invention. Therefore, simple modifications of the present invention in the process of the present invention are within the scope of the claimed invention.
Example 1
1) Prescription
2) Preparation process
Mixing the ibuprofen ethanol solution and the sustained-release carrier ethanol solution according to the prescription amount uniformly, wherein the solid content of the ethanol solution is 8%, and carrying out spray drying at the air inlet temperature of 95 ℃, the atomizing pressure of 1.4bar, the atomizing speed of 8r/min and the air outlet temperature of 52 ℃. Adding zinc stearate into the obtained solid dispersion, mixing, and encapsulating.
Example 2
1) Prescription
2) Preparation process
Mixing the ibuprofen ethanol solution and the sustained-release carrier ethanol solution according to the prescription amount uniformly, wherein the solid content of the ethanol solution is 8%, and carrying out spray drying under the conditions that the air inlet temperature is 100 ℃, the atomizing pressure is 1.5bar, the atomizing speed is 8r/min and the air outlet temperature is 58 ℃. Adding silica gel micropowder into the obtained solid dispersion, mixing, and making into capsule.
Example 3
1) Prescription
2) Preparation process
Mixing the ibuprofen ethanol solution and the sustained-release carrier ethanol solution according to the prescription amount uniformly, wherein the solid content of the ibuprofen ethanol solution is 8%, the solid content of the sustained-release carrier ethanol solution is 10%, carrying out spray drying, setting the air inlet temperature at 100 ℃, the atomization pressure at 1.5bar, the spray speed at 9r/min and the air outlet temperature at 55 ℃. Adding sodium stearate fumarate into the obtained solid dispersion, mixing, and making into capsule.
Example 4
1) Prescription
2) Preparation process
Mixing the ibuprofen ethanol solution and the sustained-release carrier ethanol solution according to the prescription amount uniformly, wherein the solid content of the ethanol solution is 8%, and carrying out spray drying at the air inlet temperature of 105 ℃, the atomization pressure of 1.4bar, the spray speed of 9r/min and the air outlet temperature of 59 ℃. Adding stearic acid into the prepared solid dispersion, mixing uniformly, and filling into capsules.
Example 5
1) Prescription
2) Preparation process
Mixing the ibuprofen ethanol solution and the sustained-release carrier ethanol solution according to the prescription amount uniformly, wherein the solid content of the ethanol solution is 9%, and carrying out spray drying under the conditions that the air inlet temperature is 110 ℃, the atomizing pressure is 1.2bar, the atomizing speed is 8r/min and the air outlet temperature is 60 ℃. Adding magnesium stearate into the obtained solid dispersion, mixing, and encapsulating.
Example 6
1) Prescription
2) Preparation process
The ibuprofen ethanol solution and the sustained-release carrier ethanol solution with the prescription amount are uniformly mixed, the solid content of the ethanol solution is 8%, and the ibuprofen ethanol solution is subjected to spray drying, wherein the air inlet temperature is set to be 90 ℃, the atomization pressure is set to be 1.2bar, the spray speed is set to be 8r/min, and the air outlet temperature is set to be 52 ℃. Adding stearic acid into the prepared solid dispersion, mixing uniformly, and filling into capsules.
Comparative example 1
1) Prescription
2) Preparation process
Mixing the ibuprofen ethanol solution and the sustained-release carrier ethanol solution according to the prescription amount uniformly, wherein the solid content of the ethanol solution is 8%, and carrying out spray drying under the conditions that the air inlet temperature is 120 ℃, the atomizing pressure is 1.2bar, the spraying speed is 11r/min and the air outlet temperature is 63 ℃. Adding stearic acid into the prepared solid dispersion, mixing uniformly, and filling into capsules.
Comparative example 2
1) Prescription
2) Preparation process
Preparing granules by a centrifugal granulation method, pouring blank pill cores into a centrifugal granulator, starting a centrifugal turntable, setting the rotating speed at 100rpm, starting a peristaltic pump, spraying povidone ethanol solution, simultaneously spraying ibuprofen and hydroxypropyl methylcellulose for medicine application, drying after the medicine application is finished, sieving with a 20-mesh sieve, and encapsulating.
Verification examples
1. Dissolution test
The dissolution rates of the ibuprofen sustained release capsules obtained in examples 1 to 6 and comparative examples 1 to 2 were measured by the following methods.
Taking the product, determining according to dissolution and release, taking 900ml of phosphate buffer (taking 68.05g of monopotassium phosphate, adding 56ml of lmol/L sodium hydroxide solution, diluting to 10000ml with water, shaking uniformly, and adjusting pH value to be 6.0 +/-0.05) as a dissolution medium, rotating at 30 r/min, operating according to the method, taking 5ml of solution after 1 h, 2 h, 4 h and 7 h, immediately supplementing dissolution medium with the same temperature and volume, filtering, taking 20 mu L of subsequent filtrate according to chromatographic conditions under the content determination item, injecting into a liquid chromatograph, and recording a chromatogram; taking about 15mg ibuprofen reference substance, precisely weighing, placing in a 50ml measuring flask, adding 2ml methanol for dissolving, diluting with dissolution medium to scale, shaking, and measuring by the same method. The elution amount of each granule at different time is calculated respectively. The dissolution amount of each granule of the product in 1 hour, 2 hours, 4 hours and 7 hours is 10-35%, 25-55%, 50-80% and more than 75% of the marked amount respectively, and the dissolution amounts are in accordance with the regulations.
TABLE 1 dissolution test results
Claims (5)
1. The ibuprofen slow release capsule is characterized in that the content of the capsule consists of a solid dispersion and a lubricant, the solid dispersion comprises ibuprofen and a slow release carrier, the slow release carrier in the solid dispersion is Eudragit RS-polyethylene glycol 4000, the weight ratio of the ibuprofen to the Eudragit RS-polyethylene glycol 4000 is 1:0.2-2.0, the weight ratio of the Eudragit RS to the polyethylene glycol 4000 is 1:0.3-2.5, and the preparation method of the solid dispersion comprises the following steps: weighing ibuprofen with the formula amount, adding the ibuprofen into ethanol, stirring for dissolving, adding a slow release carrier ethanol solution, uniformly mixing, carrying out spray drying, collecting materials, and cooling to obtain the ibuprofen solid dispersion.
2. The ibuprofen sustained-release capsule according to claim 1, wherein the weight ratio of ibuprofen to Eudragit RS-PEG 4000 in said solid dispersion is 1:0.4-1.0, and the weight ratio of Eudragit RS to PEG 4000 is 1: 0.6-1.5.
3. The ibuprofen sustained-release capsule according to claim 1, wherein the lubricant is one or more of magnesium stearate, zinc stearate, aerosil, stearic acid, and sodium stearyl fumarate.
4. The ibuprofen sustained-release capsule according to claim 1, wherein the lubricant comprises 0.2% to 0.8% by weight of the capsule contents.
5. The ibuprofen sustained-release capsule according to claim 1, wherein the solid contents of the ibuprofen ethanol solution and the sustained-release carrier ethanol solution are 7-10% (w/w), the air inlet temperature of spray drying is 90-110 ℃, the atomization pressure is 1.2-1.5bar, the spray speed is 8-12r/min, and the air outlet temperature is 50-60 ℃.
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