CN101439038B - Medicinal preparation composed of non-steroidal anti-inflammatory medicine and misoprostol - Google Patents
Medicinal preparation composed of non-steroidal anti-inflammatory medicine and misoprostol Download PDFInfo
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- CN101439038B CN101439038B CN2008101368994A CN200810136899A CN101439038B CN 101439038 B CN101439038 B CN 101439038B CN 2008101368994 A CN2008101368994 A CN 2008101368994A CN 200810136899 A CN200810136899 A CN 200810136899A CN 101439038 B CN101439038 B CN 101439038B
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Abstract
The invention discloses a pharmaceutical preparation composed of non-steroidal anti-inflammatory drug and misoprostol. Non-steroidal anti-inflammatory drug coated pellets and misoprostol pellets are prepared into tablets, double-layer tablets or capsules by utilizing a pellet tabletting technique; and the non-steroidal anti-inflammatory drug coated pellets are casing pellets or delayed release coated pellets. The preparation provided by the invention belongs to a multi-unit drug feeding system and are uniformly distributed in a gastrointestinal tract after the preparation is taken; the work of the gastrointestinal tract suffers little affection from food conveying rhythm; few differences exist in individual drug and among different drugs; compliance in patients is satisfactory, and stimulation and untoward reaction which are caused by partially high drug concentration can be reduced; during the production, due to granularity similarity, the non-steroidal anti-inflammatory drug coated pellets and the misoprostol pellets can be easily and uniformly mixed, and the misoprostol pellets can be easily and uniformly mixed with other pellet preparations, so that the drug quality is improved; and an ordinary tablet machine can be used for tabletting so as to reduce the production cost of the drug.
Description
One, technical field
The medicine of being made up of NSAID (non-steroidal anti-inflammatory drug) and misoprostol that the present invention relates to specifically is a kind of pharmaceutical preparation of being made up of NSAID (non-steroidal anti-inflammatory drug) and misoprostol.
Two, background technology
NSAID (non-steroidal anti-inflammatory drug) is the medicine of a class extensive use clinically, is mainly used in treatment osteoarthritis and rheumatic arthritis.But NSAID (non-steroidal anti-inflammatory drug) is the inhibitor of Cycloxygenase, can suppress the synthetic of prostaglandin, oral application, and particularly prolonged application has the ulcer function of causing.The ulcer that NSAID (non-steroidal anti-inflammatory drug) causes has potential danger, because this ulcer is seldom or without any symptom, up to causing serious injury of gastrointestinal tract.Some prostaglandins medicine for example misoprostol can reduce or prevent that NSAID (non-steroidal anti-inflammatory drug) is to this damage of gastrointestinal.Before the evidence NSAID (non-steroidal anti-inflammatory drug) discharges in vivo, supplemented with exogenous prostaglandins medicine can prevent the damage of NSAID (non-steroidal anti-inflammatory drug) to gastrointestinal tract mucosa, therefore NSAID (non-steroidal anti-inflammatory drug) and misoprostol are made a kind of compound preparation, and NSAID (non-steroidal anti-inflammatory drug) is carried out coating to delay its release, perhaps NSAID (non-steroidal anti-inflammatory drug) is packed casing it is discharged at intestinal, can reduce or avoid NSAID (non-steroidal anti-inflammatory drug) that gastrointestinal is damaged.This outer coatings can also be as the screen layer between NSAID (non-steroidal anti-inflammatory drug) and the misoprostol, to prevent the influence of NSAID (non-steroidal anti-inflammatory drug) to misoprostol stability.
Existing at present this type of medicine comes out, and wet gram difficult to understand is exactly the double-layer tablet of NSAID (non-steroidal anti-inflammatory drug) diclofenac and misoprostol compacting.The documents and materials of relevant this medicine are seen U.S. Pat P6,319,519.Enteric coated particles is made with diclofenac by this patent system, and is pressed into down synusia behind other pharmaceutic adjuvant mixing, and misoprostol and other pharmaceutic adjuvant mixing that will be distributed to then in the hydroxypropyl emthylcellulose powder are pressed into synusia.This technology relates to special equipment and special pharmaceutic adjuvant, and adopts the direct powder compression technology.After this patent, it is as follows that USPO has ratified some relevant patents again in succession:
USP6,787,155, the coated granule that postpones release is made with NSAID (non-steroidal anti-inflammatory drug) by this patent system, makes capsule or multilayer tablet with the misoprostol or other prostate class medicine that are distributed in the hydroxypropyl emthylcellulose powder then; This film-making technology is direct powder compression, also relates to special equipment and special pharmaceutic adjuvant.The innovative point of this technology is NSAID (non-steroidal anti-inflammatory drug) is made the coated granule that postpones release.
USP6,740,340, NSAID (non-steroidal anti-inflammatory drug) is made in the tablet that postpones release by this patent system, misoprostol or other prostate class medicine that will be distributed to then in the hydroxypropyl emthylcellulose powder are made quick-release tablet, at last with two kinds of tablets again with other pharmaceutic adjuvant mixing film-making.This technology is direct powder compression, also relates to special equipment and special pharmaceutic adjuvant.The innovative point of this technology is NSAID (non-steroidal anti-inflammatory drug) and misoprostol are made independently small pieces respectively earlier, is being pressed into a tablet then.
USP6,656,603, enteric coated tablets is made with NSAID (non-steroidal anti-inflammatory drug) by this patent system, then hydroxypropyl emthylcellulose, Polyethylene Glycol and misoprostol are dissolved in dichloromethane and the ethanol mixed solvent, NSAID (non-steroidal anti-inflammatory drug) casing sheet are repeated coating as coating solution.Misoprostol is present in the outer coating.This technology needs heating in the process of coating, may the stability of misoprostol be exerted an influence.
USP7,303,761, NSAID (non-steroidal anti-inflammatory drug) is made the drug particles that postpones release by this patent system, with the misoprostol or other prostate class drug powder mixing that are distributed in the hydroxypropyl emthylcellulose, make tablet or capsule, wherein tablet is a direct powder compression, also relates to special equipment and special pharmaceutic adjuvant.
Up to the present in the disclosed abroad patent, remove USP6,656, the 603rd, misoprostol is dissolved in the coating solution, to the casing sheet of NSAID (non-steroidal anti-inflammatory drug) coating and reach and use conventional method to prepare outside the compound preparation of NSAID (non-steroidal anti-inflammatory drug) and misoprostol once more, remaining patent is all used the direct powder compression technology.
Three, summary of the invention
The objective of the invention is provides a kind of pharmaceutical preparation of being made up of NSAID (non-steroidal anti-inflammatory drug) and misoprostol at the problems referred to above; Another goal of the invention of the present invention provides the preparation method of misoprostol micropill.
The technical scheme that the foregoing invention purpose is adopted is: prepare a kind of medicinal tablet, bilayer tablet or capsule of being made up of NSAID (non-steroidal anti-inflammatory drug) and misoprostol, contained NSAID (non-steroidal anti-inflammatory drug) is the NSAID (non-steroidal anti-inflammatory drug) coated micropill of making in this pharmaceutical preparation, and misoprostol is misoprostol micropill or the granule of making.The NSAID (non-steroidal anti-inflammatory drug) coated micropill is the coated micropill that casing micropill or delay discharge.
The representative medicine of NSAID (non-steroidal anti-inflammatory drug) is diclofenac and salt thereof, contains diclofenac 25～100mg in every or each capsule; Contain misoprostol 50～400ug.
NSAID (non-steroidal anti-inflammatory drug) also comprises aceclofenac, clofenamic acid, meclofenamic acid, meclofenamate sodium, tiaprofenic acid, meloxicam, piroxicam, ibuprofen, ketoprofen, fenbufen, flurbiprofen, sulindac, naproxen, nabumetone, glad, the oxaprozin of indole U.S..
The present invention adopts the preparation of following method to contain the tablet or the capsule of NSAID (non-steroidal anti-inflammatory drug) and misoprostol: 1), promptly cushion tabletting behind micropill and other adjuvant mix homogeneously with NSAID (non-steroidal anti-inflammatory drug) coated micropill, misoprostol micropill or granule and with the blank micropill that pharmaceutic adjuvants such as microcrystalline Cellulose are made.2), the tablet of bottom will be pressed into after NSAID (non-steroidal anti-inflammatory drug) coated micropill and buffering micropill and suitable adjuvant such as adhesive, filler, disintegrating agent, the mix lubricant; Misoprostol micropill or granule are mixed the tablet that is pressed into top with buffering micropill and the adjuvant that suits.3), will incapsulate behind NSAID (non-steroidal anti-inflammatory drug) coated micropill, buffering micropill, misoprostol micropill or granule and other adjuvant mix homogeneously.4), NSAID (non-steroidal anti-inflammatory drug) coated micropill, buffering micropill and other suitable adjuvant mix homogeneously are pressed into lozenge, again misoprostol micropill or granule, buffering micropill and suitable auxiliary materials and mixing are pressed into lozenge, in the same capsule of then NSAID (non-steroidal anti-inflammatory drug) lozenge and misoprostol lozenge being packed into.
The preparation use of NSAID (non-steroidal anti-inflammatory drug) coated micropill is extruded spheronization and is prepared ball core, fluidized bed process coating or coating pan coating.The purpose of coating is the release that is used to delay principal agent, in the process of preparation NSAID (non-steroidal anti-inflammatory drug) coated micropill, note suitably increasing the toughness of micropill coating, and fracture appears in coating in the tabletting process to avoid.When giving the micropill coating, should in coating solution, add an amount of plasticizer and make the micropill of making have certain pliability for this reason, when pressurized, can produce slight distortion, break avoiding.But can not be too soft, produce to prevent excessive deformation and to break or damage.
For prevent that further the NSAID (non-steroidal anti-inflammatory drug) coated micropill from occurring breaking and set up screen layer at NSAID (non-steroidal anti-inflammatory drug) layer and misoprostol interlayer in the tabletting process, the present invention adds the blank micropill that the buffering micropill of being made by pharmaceutic adjuvant does not promptly contain NSAID (non-steroidal anti-inflammatory drug) and misoprostol component in technology, the buffering micropill is made up of pharmaceutic adjuvants such as microcrystalline Cellulose and stearic acid.This buffering micropill has triple role, prevents that promptly the NSAID (non-steroidal anti-inflammatory drug) coated micropill from breaking; Screen layer between NSAID (non-steroidal anti-inflammatory drug) layer and the misoprostol layer; Make the tablet smooth surface.
In the pharmaceutical preparation that relevant misoprostol of reporting in the known patent documentation and NSAID (non-steroidal anti-inflammatory drug) are formed, in order to guarantee the stable of misoprostol, misoprostol is dispersed in the hydroxypropyl emthylcellulose, when the preparation tablet, direct powder compression be need adopt, special installation and technology required to use.The present invention adopts a new technique, under the situation that does not influence misoprostol stability, misoprostol is made micropill.Secondly, after the misoprostol micropill was made tablet, this pellet tablet belonged to the multiple-unit drug-supplying system, helped improving curative effect, reduced untoward reaction.Its three, after misoprostol micropill and NSAID (non-steroidal anti-inflammatory drug) micropill and buffering micropill mix, available common tablet machine tabletting.At last, in process of production, NSAID (non-steroidal anti-inflammatory drug) micropill, the easy mix homogeneously of misoprostol micropill help improving the quality of product.
The preparation of misoprostol powder among the present invention: adopt USP4,301,146 method is dispersed in misoprostol in hydroxypropyl emthylcellulose or the polyethylene pyrrole network alkane ketone, and concentration is 1%.Or misoprostol is dispersed in the mixture of hydroxypropyl emthylcellulose and polyethylene pyrrole network alkane ketone, the concentration of misoprostol is 1%.
1), will be dispersed in misoprostol powder and polyethylene pyrrole network alkane ketone and microcrystalline Cellulose mixing in the hydroxypropyl emthylcellulose misoprostol micropill or particulate preparation among the present invention:, with the dehydrated alcohol is that spheronization is extruded in the wetting agent use or marumerization prepares misoprostol micropill or granule, and the concentration that contains misoprostol in the misoprostol powder is 1%.Misoprostol powder, polyethylene pyrrole network alkane ketone and the blended ratio of microcrystalline Cellulose are from 20: 5: 75 to 20: 50: 30, and the ratio of recommendation is 20: 20: 60.2), with 1% misoprostol hydroxypropyl emthylcellulose powder and microcrystalline Cellulose mixing, polyethylene pyrrole network alkane ketone is dissolved in the dehydrated alcohol, make 20% polyethylene pyrrole network alkane ketone ethanol solution and make adhesive, spheronization is extruded in use or marumerization is made misoprostol micropill or granule.The ratio of 1% misoprostol hydroxypropyl emthylcellulose powder and microcrystalline Cellulose is 20: 20 to 20: 80 in the micropill, and the ratio of recommendation is 20: 60.3), misoprostol is dispersed in the polyethylene pyrrole network alkane ketone, make 1% misoprostol polyethylene pyrrole network alkane ketone powder.With 1% misoprostol polyethylene pyrrole network alkane ketone powder and microcrystalline Cellulose mixing, make wetting agent with ethanol solution, spheronization is extruded in use or marumerization is made misoprostol micropill or granule.The ratio of 1% misoprostol polyethylene pyrrole network alkane ketone powder and microcrystalline Cellulose is 20: 20 to 20: 100 in the micropill, and the ratio of recommendation is 20: 80.
The diameter of micropill generally between 0.25mm～1.5mm, is preferably between 0.8mm～1.2mm, in this diameter range, can avoid breaking because of tension force produces the coating of micropill.Particulate diameter is 2～5mm.
The tablet that contains NSAID (non-steroidal anti-inflammatory drug) coated micropill and misoprostol micropill is to use the process preparation of conventional preparation tablet, comprising: 1), with common compacting after NSAID (non-steroidal anti-inflammatory drug) coated micropill, buffering micropill, misoprostol micropill or granule and other auxiliary materials and mixing in flakes.2), the tablet of bottom will be pressed into behind NSAID (non-steroidal anti-inflammatory drug) coated micropill, buffering micropill and suitable adjuvant such as adhesive, filler, disintegrating agent, the lubricant mixing; Misoprostol micropill or granule and suitable auxiliary materials and mixing are pressed into the tablet on top.
Containing NSAID (non-steroidal anti-inflammatory drug) coated micropill and misoprostol micropill or particulate capsule is to adopt the capsular process preparation of conventional preparation, comprising: 1, in the capsule that the hydroxypropyl emthylcellulose of packing into after NSAID (non-steroidal anti-inflammatory drug) coated micropill, buffering micropill, misoprostol micropill or granule and other auxiliary materials and mixing is made.2, NSAID (non-steroidal anti-inflammatory drug) coated micropill, buffering micropill and suitable adjuvant mixing are pressed into lozenge, again misoprostol micropill or granule are mixed being pressed into lozenge with suitable adjuvant, in the capsule of the same hydroxypropyl emthylcellulose making of then NSAID (non-steroidal anti-inflammatory drug) lozenge and misoprostol lozenge being packed into.Other adjuvants comprise preparation capsule adjuvant such as filler and coloring agent etc. commonly used.Because misoprostol is in the process of storing, conventional capsule is that gelatine capsule may absorb water and influences its stability, and therefore the capsule of hydroxypropyl emthylcellulose preparation is used in suggestion.
Containing NSAID (non-steroidal anti-inflammatory drug) in every or each capsule in tablet of making or the capsule is normal therapeutic dosage.With the diclofenac is example, and every contains diclofenac 20～100mg; Contain misoprostol 50～400ug.According to the rheumatismal dosage of clinical treatment, every or each capsular content are defined as containing diclofenac 50mg or 100mg; Contain misoprostol 200ug.
The good effect that the present invention has: the present invention makes coated micropill with NSAID (non-steroidal anti-inflammatory drug), and misoprostol is made micropill, then NSAID (non-steroidal anti-inflammatory drug) coated micropill and misoprostol micropill is made tablet or capsule with the micropill tablet forming technique; After taking, medicine is evenly distributed at gastrointestinal tract, belongs to the multiple-unit drug-supplying system, be subjected to food to carry the influence of the rhythm and pace of moving things few in the gastrointestinal transhipment, little with interindividual variation in the individuality of medicine, patient's compliance is good, can reduce the zest and the untoward reaction that cause because of local drug concentration is too high; In the production process, the granularity of two kinds of medicines is close, easy mix homogeneously, and misoprostol micropill and the easy mix homogeneously of other pellet are improved the quality of medicine, and can use common tablet machine tabletting, reduce the production cost of medicine.
Four, the specific embodiment
Embodiment 1: preparation Diclofenac Sodium/Misoprosrol sheet
1, the composition content of tablet
A, diclofenac sodium coated micropill contain diclofenac sodium 100mg
B, misoprostol micropill contain misoprostol 200ug
C, the buffering micropill an amount of
D, carboxymethyl starch sodium are an amount of
E, magnesium stearate are an amount of
2, the preparation of micropill
Diclofenac sodium and microcrystalline Cellulose are got in the preparation of a, diclofenac sodium coated micropill, and be even by 1: 1 mixed, makes wetting agent with 2% sodium lauryl sulphate, extrude spheronization and make micropill, the ball core that sieves and choose 0.8～1.2mm is put in the coating pan, with enteric acrylic resin coating.
1% misoprostol hydroxypropyl emthylcellulose powder and microcrystalline Cellulose (ratio is 20: 60) mixing are got in the preparation of b, misoprostol micropill, polyethylene pyrrole network alkane ketone is dissolved in the dehydrated alcohol, make 20% polyethylene pyrrole network alkane ketone ethanol solution and make adhesive, extrude spheronization and make the misoprostol micropill.
Microcrystalline Cellulose and stearic acid (7: 3) mixing are got in the preparation of c, buffering micropill, and 2% sodium lauryl sulphate is made wetting agent, extrudes spheronization and makes micropill.
3, press the conventional preparation method film-making of tablet, the heavy 0.45g of the tablet of making, every contains diclofenac sodium 100mg, misoprostol 200ug.
Embodiment 2: preparation Diclofenac Sodium/Misoprosrol double-layer tablet
1, constituent content
A, diclofenac sodium coated micropill contain diclofenac sodium 50mg
B, misoprostol micropill contain misoprostol 200ug
C, the buffering micropill an amount of
D, carboxymethyl starch sodium are an amount of
E, hydrogenated cottonseed oil are an amount of
2, the preparation of micropill is with embodiment 1.
3, the preparation of double-layer tablet with diclofenac sodium coated micropill and an amount of c, d, e mixing, with misoprostol micropill and an amount of c, d, e mixing, is used the bi-layer tablet press tabletting.The heavy 0.45g of sheet.
Embodiment 3: preparation Diclofenac Sodium/Misoprosrol capsule
1, constituent content
A, the fragrant sodium coated micropill of two chlorine contain diclofenac sodium 100mg
B, misoprostol micropill contain misoprostol 200ug
C, the buffering micropill an amount of
2, the preparation of micropill is with embodiment 1.
3, the conventional preparation method of pressing capsule is said medicine and auxiliary materials and mixing, the hydroxypropyl methylcellulose capsules of packing into, the heavy 0.45g of capsule.
Embodiment 4: preparation Diclofenac Sodium/Misoprosrol capsule
1, constituent content
A, diclofenac sodium coated micropill contain diclofenac sodium 100mg
B, misoprostol micropill contain misoprostol 200ug
C, the buffering micropill an amount of
D, carboxymethyl starch sodium are an amount of
E, magnesium stearate are an amount of
2, the preparation of micropill is with embodiment 1.
3,,, be pressed into lozenge respectively, in the same hydroxypropyl methylcellulose capsules of packing into misoprostol micropill and an amount of c, d, e mixing with diclofenac casing micropill and an amount of c, d, e mixing.The heavy 0.55g of capsule.
Embodiment 5: preparation ketoprofen/misoprostol sheet
1, the composition content of tablet
A, ketoprofen coated micropill contain ketoprofen 20mg
B, misoprostol granule contain misoprostol 200ug
C, the buffering micropill an amount of
D, carboxymethyl starch sodium are an amount of
E, magnesium stearate are an amount of
2, the preparation of micropill
Ketoprofen and microcrystalline Cellulose are got in the preparation of a, ketoprofen micropill, and be even by 1: 1 mixed, makes wetting agent with 2% sodium lauryl sulphate, extrude spheronization and make micropill, the ball core that sieves and choose 0.8～1.2mm is put in the coating pan, with enteric acrylic resin coating.
1% misoprostol hydroxypropyl emthylcellulose powder, polyethylene pyrrole network alkane ketone and microcrystalline Cellulose (ratio is 20: 20: 60) mixing is got in b, the particulate preparation of misoprostol, makees wetting agent with dehydrated alcohol and makes the misoprostol granule.
The preparation of c, buffering micropill is with example 1.
3, press the conventional preparation method film-making of tablet, the tablet of making is 0.3g, and every contains ketoprofen 20mg, misoprostol 200ug.
Embodiment 6: preparation ketoprofen/misoprostol capsule
1, constituent content
A, ketoprofen coated micropill contain ketoprofen 50mg
B, misoprostol granule contain misoprostol 200ug
C, the buffering micropill an amount of
2, micropill or particulate preparation
Ketoprofen and microcrystalline Cellulose are got in the preparation of a, ketoprofen micropill, and be even by 1: 1 mixed, makes wetting agent with 2% sodium lauryl sulphate, extrude spheronization and make micropill, the ball core that sieves and choose 0.8～1.2mm is put in the coating pan, with enteric acrylic resin coating.
B, the particulate preparation of misoprostol get 1% misoprostol polyethylene pyrrole network alkane ketone powder, with microcrystalline Cellulose (ratio is 20: 80) mixing, make wetting agent with dehydrated alcohol and make the misoprostol granule.
The preparation of c, buffering micropill is with example 1.
3, with ketoprofen casing micropill and an amount of c, d, e mixing, with misoprostol granule and an amount of c, d, e mixing, be pressed into lozenge respectively, in the same hydroxypropyl methylcellulose capsules of packing into, the heavy 0.45g of capsule.
Claims (13)
1. pharmaceutical preparation of forming by NSAID (non-steroidal anti-inflammatory drug) and misoprostol, be conventional tablet, bilayer tablet or capsule, wherein contained NSAID (non-steroidal anti-inflammatory drug) is the NSAID (non-steroidal anti-inflammatory drug) coated micropill of making, misoprostol is misoprostol micropill or the granule of making, the NSAID (non-steroidal anti-inflammatory drug) coated micropill is casing micropill or delayed release coating micropill, it is characterized in that: misoprostol micropill or particulate preparation are earlier misoprostol to be dispersed in the hydroxypropyl emthylcellulose, make 1% misoprostol hydroxypropyl emthylcellulose powder; Preparation tablet and capsule are preceding to be wetting agent with the dehydrated alcohol, and with 1% misoprostol hydroxypropyl emthylcellulose powder, polyethylene pyrrole network alkane ketone and microcrystalline Cellulose mixing, spheronization is extruded in use or marumerization is made misoprostol micropill or granule; The ratio of 1% misoprostol hydroxypropyl emthylcellulose powder and polyethylene pyrrole network alkane ketone and microcrystalline Cellulose is from 20: 5: 75 to 20: 50: 30 in micropill or the granule.
2. the pharmaceutical preparation of being made up of NSAID (non-steroidal anti-inflammatory drug) and misoprostol according to claim 1 is characterized in that: the ratio of 1% misoprostol hydroxypropyl emthylcellulose powder and polyethylene pyrrole network alkane ketone and microcrystalline Cellulose is 20: 20: 60 in micropill or the granule.
3. the pharmaceutical preparation of being made up of NSAID (non-steroidal anti-inflammatory drug) and misoprostol according to claim 1 is characterized in that: described conventional tablet is that buffering micropill and other proper auxiliary materials made with NSAID (non-steroidal anti-inflammatory drug) coated micropill, misoprostol micropill or granule, by pharmaceutic adjuvant are mixed the back compacting in flakes.
4. the pharmaceutical preparation of being made up of NSAID (non-steroidal anti-inflammatory drug) and misoprostol according to claim 1 is characterized in that: described bilayer tablet is with NSAID (non-steroidal anti-inflammatory drug) coated micropill and the tablet that is pressed into the bottom after buffering micropill and suitable adjuvant mix; Misoprostol micropill or granule, buffering micropill are mixed the tablet that is pressed into top with suitable adjuvant; Described suitable adjuvant is selected from adhesive, filler, disintegrating agent, lubricant.
5. the pharmaceutical preparation of forming by NSAID (non-steroidal anti-inflammatory drug) and misoprostol according to claim 1, it is characterized in that: described capsule contains the homogeneous mixture of NSAID (non-steroidal anti-inflammatory drug) coated micropill, misoprostol micropill or granule and other pharmaceutic adjuvant for using the hard capsule of hydroxypropyl emthylcellulose preparation in the capsule.
6. the pharmaceutical preparation of being made up of NSAID (non-steroidal anti-inflammatory drug) and misoprostol according to claim 1 is characterized in that: hard capsule contains the NSAID (non-steroidal anti-inflammatory drug) coated micropill and mixes the lozenge that is pressed into and misoprostol micropill or granule, buffering micropill with buffering micropill and suitable adjuvant and mix with the adjuvant that suits and be pressed into lozenge.
7. the pharmaceutical preparation of being made up of NSAID (non-steroidal anti-inflammatory drug) and misoprostol according to claim 1 is characterized in that: NSAID (non-steroidal anti-inflammatory drug) is selected from diclofenac and salt thereof, aceclofenac, clofenamic acid, meclofenamic acid, meclofenamate sodium, tiaprofenic acid, meloxicam, piroxicam, ibuprofen, ketoprofen, fenbufen, flurbiprofen, sulindac, naproxen, nabumetone, glad, the oxaprozin of indole U.S..
8. the pharmaceutical preparation of being made up of NSAID (non-steroidal anti-inflammatory drug) and misoprostol according to claim 7 is characterized in that: the representative medicine of NSAID (non-steroidal anti-inflammatory drug) is diclofenac and salt thereof, contains diclofenac 25～100mg in every or each capsule; Contain misoprostol 50～400 μ g.
9. according to the described pharmaceutical preparation of being made up of NSAID (non-steroidal anti-inflammatory drug) and misoprostol of one of claim 1-8, it is characterized in that: the diameter of micropill is 0.25～1.5mm, and particulate diameter is 2～5mm.
10. the pharmaceutical preparation of forming by NSAID (non-steroidal anti-inflammatory drug) and misoprostol according to claim 1, it is characterized in that: with misoprostol micropill or the particulate preparation method in the following steps replacement claim 1, for earlier misoprostol being dispersed in the hydroxypropyl emthylcellulose, make 1% misoprostol hydroxypropyl emthylcellulose powder; Before preparation tablet and the capsule, with 1% misoprostol hydroxypropyl emthylcellulose powder and microcrystalline Cellulose mixing, polyethylene pyrrole network alkane ketone is dissolved in the dehydrated alcohol, make 20% polyethylene pyrrole network alkane ketone ethanol solution and make adhesive, spheronization is extruded in use or marumerization is made misoprostol micropill or granule; The ratio of 1% misoprostol hydroxypropyl emthylcellulose powder and microcrystalline Cellulose is 20: 5 to 20: 100 in micropill or the granule.
11. the pharmaceutical preparation of being made up of NSAID (non-steroidal anti-inflammatory drug) and misoprostol according to claim 10 is characterized in that: the ratio of 1% misoprostol hydroxypropyl emthylcellulose powder and microcrystalline Cellulose is 20: 60 in micropill or the granule.
12. the pharmaceutical preparation of forming by NSAID (non-steroidal anti-inflammatory drug) and misoprostol according to claim 1, it is characterized in that: with misoprostol micropill or the particulate preparation method in the following steps replacement claim 1, for earlier misoprostol being dispersed in the polyethylene pyrrole network alkane ketone, make 1% misoprostol polyethylene pyrrole network alkane ketone powder; Before preparation tablet and the capsule, with 1% misoprostol polyethylene pyrrole network alkane ketone powder and microcrystalline Cellulose mixing, make wetting agent with dehydrated alcohol, spheronization is extruded in use or marumerization is made misoprostol micropill or granule; The ratio of 1% misoprostol polyethylene pyrrole network alkane ketone powder and microcrystalline Cellulose is 20: 10 to 20: 100 in micropill or the granule.
13. the pharmaceutical preparation of being made up of NSAID (non-steroidal anti-inflammatory drug) and misoprostol according to claim 12 is characterized in that: the ratio of 1% misoprostol polyethylene pyrrole network alkane ketone powder and microcrystalline Cellulose is 20: 80 in micropill or the granule.
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| CN2008101368994A CN101439038B (en) | 2008-08-08 | 2008-08-08 | Medicinal preparation composed of non-steroidal anti-inflammatory medicine and misoprostol |
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| CN2008101368994A CN101439038B (en) | 2008-08-08 | 2008-08-08 | Medicinal preparation composed of non-steroidal anti-inflammatory medicine and misoprostol |
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| CN101439038B true CN101439038B (en) | 2011-04-13 |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6319519B2 (en) * | 1998-07-07 | 2001-11-20 | Norton Healthcare Ltd. | Anti-inflammatory pharmaceutical formulations |
| CN101181245A (en) * | 2007-12-19 | 2008-05-21 | 北京星昊医药股份有限公司 | Compound diclofenac natrium capsule |
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2008
- 2008-08-08 CN CN2008101368994A patent/CN101439038B/en not_active Expired - Fee Related
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6319519B2 (en) * | 1998-07-07 | 2001-11-20 | Norton Healthcare Ltd. | Anti-inflammatory pharmaceutical formulations |
| CN101181245A (en) * | 2007-12-19 | 2008-05-21 | 北京星昊医药股份有限公司 | Compound diclofenac natrium capsule |
Non-Patent Citations (2)
| Title |
|---|
| 祁小乐等.双氯芬酸钠肠溶微丸型片剂的研制.药学学报.2008,第43卷(第1期),97-101. * |
| 翁鹏飞.奥湿克与芬必得临床应用比较.海峡药学.1997,第9卷(第4期),66-67. * |
Also Published As
| Publication number | Publication date |
|---|---|
| CN101439038A (en) | 2009-05-27 |
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