CN1268327C - Brufen arginine pseudoephedrine hydrochloride compound formulation - Google Patents

Brufen arginine pseudoephedrine hydrochloride compound formulation Download PDF

Info

Publication number
CN1268327C
CN1268327C CN 200410016053 CN200410016053A CN1268327C CN 1268327 C CN1268327 C CN 1268327C CN 200410016053 CN200410016053 CN 200410016053 CN 200410016053 A CN200410016053 A CN 200410016053A CN 1268327 C CN1268327 C CN 1268327C
Authority
CN
China
Prior art keywords
parts
pseudoephedrine
ibuprofen
arginine
ibuprofen arginine
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
CN 200410016053
Other languages
Chinese (zh)
Other versions
CN1557293A (en
Inventor
陆峰
胡雅芳
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
HANGZHOU RONGLI MEDICINE SCIENCE & TECHNOLOGY Co Ltd
Original Assignee
HANGZHOU RONGLI MEDICINE SCIENCE & TECHNOLOGY Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by HANGZHOU RONGLI MEDICINE SCIENCE & TECHNOLOGY Co Ltd filed Critical HANGZHOU RONGLI MEDICINE SCIENCE & TECHNOLOGY Co Ltd
Priority to CN 200410016053 priority Critical patent/CN1268327C/en
Publication of CN1557293A publication Critical patent/CN1557293A/en
Application granted granted Critical
Publication of CN1268327C publication Critical patent/CN1268327C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Landscapes

  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The present invention provides a compound preparation of ibuprofen arginine pseudoephedrine. The preparation contains ibuprofen arginine and pseudoephedrine or pseudoephedrine salts acceptable to medicine, wherein the mass proportion of the ibuprofen arginine to the pseudoephedrine or pseudoephedrine salts acceptable to medicine is from 1 to 40:1. The water solubility of ibuprofen is improved due to the combination of ibuprofen and arginine. On one hand, in vivo absorption rate is increased, and on the other hand, stimulation to the gastrointestinal tract is reduced. Moreover, the obtained compound preparation takes effect rapidly, and the medicinal effects of the compound preparation are stable and lasting.

Description

Ibuprofen arginine pseudoephedrine compound preparation
(1) technical field
The present invention relates to contain the compound preparation of acceptable salt composite on ibuprofen arginine and pseudoephedrine or its medicine.
(2) background technology
Pseudoephedrine or its pharmaceutically acceptable salt (for example pseudoephedrine hydrochloride, pseudoephedrine sulfate) are taken as the sympathomimetic drug for the treatment of nasal congestion effectively by those skilled in the art.That also known ibuprofen (a kind of NSAID (non-steroidal anti-inflammatory drug)) has is analgesic, antiinflammatory, analgesic activity.So, not only contained ibuprofen but also contained pseudoephedrine or the Orally administered composition of its pharmaceutically acceptable salt is applicable to that treatment shows as symptoms such as the headache, fever, laryngopharynx swelling and pain, joint, the whole body and the limb muscle ache that are caused by flu, allergic rhinitis, nasal obstruction, watery nasal discharge, sneeze.
But the ibuprofen in the said composition is because water-soluble hardly, pharmacokinetic parameters T Max(reaching the time of maximum plasma concentration) value is 1.5-2h, and the same with other oral NSAID (NSAID (non-steroidal anti-inflammatory drug)), onset is slower relatively, and gastrointestinal tract is had certain stimulation.And the pseudoephedrine onset is very fast relatively, and its pharmaceutically acceptable salt (example hydrochloric acid pseudoephedrine, pseudoephedrine sulfate) is after oral, and general the absorption all peaked in 1 hour.0.5 average blood drug level is 274 ± 33 μ g/ml (are example with oral 60mg once) between~2 hours.How to make each prescription in the drug regimen bring into play its effect simultaneously, as early as possible, becoming such medicine mainly needs the technological difficulties that solve.
(3) summary of the invention
The present invention for a kind of rapid-action, efficacy stability is provided and lastingly and is easily promptly contained the compound preparation that ibuprofen contains pseudoephedrine or its pharmaceutically acceptable salt by what patient received, and this compound preparation is the compound preparation of ibuprofen arginine and pseudoephedrine or its pharmaceutically acceptable salt.
The present invention reaches the technical scheme that goal of the invention adopts to be:
It is 1~40: 1 ibuprofen arginine and pseudoephedrine or its pharmaceutically acceptable salt that a kind of ibuprofen arginine pseudoephedrine compound preparation, described preparation contain mass ratio.Ibuprofen has improved the water solublity of ibuprofen because of arginic combination, and absorption rate increases in the body on the one hand, and also having reduced on the other hand stimulates gastrointestinal.
Further, described preparation is that 1~40: 1 ibuprofen arginine and pseudoephedrine or its pharmaceutically acceptable salt and pharmaceutical excipient or carrier are formed by mass ratio.
The fragrant arginine in described Lip river and pseudoephedrine or its pharmaceutically acceptable salt mass ratio preferred 3~30: 1, more preferably 8~15: 1.
Described ibuprofen arginine pseudoephedrine compound preparation can be made into one of following dosage forms:
1. 2. 3. 4. slow releasing capsule of slow releasing tablet of capsule of tablet.
The quality proportioning of described ibuprofen arginine pseudoephedrine compound tablet is:
240~600 parts of ibuprofen arginines
30 parts of pseudoephedrine hydrochlorides
37.5 parts of lactose
37.5 parts of starch
15 parts of microcrystalline Cellulose
25 parts of 2% polyvidone aqueous solutions
2.8 parts of Pulvis Talci
0.9 part of magnesium stearate
Described ibuprofen arginine pseudoephedrine compound tablet can prepare as follows:
(1) former, adjuvant are crossed 80 mesh sieves respectively;
(2) get ibuprofen arginine and pseudoephedrine hydrochloride recipe quantity and starch mixing, add lactose, microcrystalline Cellulose mixing again;
(3) add 2% polyvidone aqueous solution and make soft material, drying adds Pulvis Talci, magnesium stearate mix homogeneously, tabletting behind the 16 order granulate.
The content quality proportioning of described ibuprofen arginine pseudoephedrine compound capsule is:
240~600 parts of ibuprofen arginines
30 parts of pseudoephedrine hydrochlorides
10 parts of low-substituted hydroxypropyl celluloses
5 parts of starch
5 parts of micropowder silica gels
Described ibuprofen arginine pseudoephedrine compound capsule can prepare as follows:
(1) gets ibuprofen arginine and 40 mesh sieves, mix homogeneously are crossed in pseudoephedrine recipe quantity, low-substituted hydroxypropyl cellulose, starch, micropowder silica gel.
(2) step (1) gained granule is encapsulated.
The compound sustained-released tablet of described ibuprofen arginine pseudoephedrine is made up of slow release label, release layer and dyed layer;
Described slow release label quality proportioning is:
240~600 parts of ibuprofen arginines
30 parts of lactose
60 parts of HPMC
20 parts of ethyl celluloses
8.2 parts of magnesium stearate
Described release layer quality proportioning is:
500 parts of ibuprofen arginines
30 parts of pseudoephedrine hydrochlorides
Described dyed layer is:
45 parts of Opadries (Opadry)
The compound sustained-released tablet of described ibuprofen arginine pseudoephedrine can prepare as follows:
(1) by above-mentioned prescription, the ethanol with 75% is wetting agent, and the slow releasing tablet core component is made granule after according to the recipe quantity mix homogeneously, and the adding magnesium stearate is a lubricant, and tabletting obtains the slow release label;
(2) label is added described release layer component according to recipe quantity in coating pan and carry out coating, make plain sheet;
(3) with above plain sheet further with recipe quantity the Opadry coating, promptly get the compound sustained-released tablet of described ibuprofen arginine pseudoephedrine.
The content of described ibuprofen arginine pseudoephedrine compound sustained release capsules is made up of fast release micropill and slow-release micro-pill;
Described fast release micropill quality proportioning is:
240~600 parts of ibuprofen arginines
30 parts of pseudoephedrine hydrochlorides
8 parts of 2% polyvidone aqueous solutions
100 parts of ethanol
65 parts of celphere
Described slow-release micro-pill quality proportioning is:
240~600 parts of ibuprofen arginines
30 parts of pseudoephedrine hydrochlorides
15 parts of 2% polyvidone aqueous solutions
150 parts of ethanol
180 parts of celphere
Described ibuprofen arginine pseudoephedrine compound sustained release capsules can prepare as follows:
(1) according to above-mentioned recipe quantity, celphere is put in the fluid bed, by hot-air celphere is suspended, ibuprofen arginine, pseudoephedrine hydrochloride solution (contain PVP, solvent is 50% ethanol) are sprayed onto drying on the celphere, make required fast release micropill;
(2) celphere is put in the fluid bed, celphere is suspended, ibuprofen arginine and pseudoephedrine hydrochloride solution (contain PVP, solvent is 50% ethanol) are sprayed onto drying on the celphere according to above-mentioned recipe quantity, make slow release ball ball core by hot-air.Reuse ethyl cellulose, phthalic acid diethanol, talcous acetone/isopropanol liquid spray coating, drying, get final product slow-release micro-pill.
(3) slow-release micro-pill and fast release micropill are mixed, the cover capsule can obtain described ibuprofen arginine pseudoephedrine compound sustained release capsules.
The beneficial effect of ibuprofen arginine pseudoephedrine compound preparation of the present invention is mainly reflected in: (1) ibuprofen has improved the water solublity of ibuprofen because of arginic combination, has improved the human absorptivity; (2) rapid-action, the efficacy stability of preparation and lasting.
(4) specific embodiment
Embodiment 1: preparation ibuprofen arginine pseudoephedrine compound tablet
Prescription (per 1000 meters):
Ibuprofen arginine 370g
Pseudoephedrine hydrochloride 30g
Lactose 37.5g
Starch 37.5g
Microcrystalline Cellulose 15g
2% polyvidone aqueous solution 25ml
Pulvis Talci 2.8g
Magnesium stearate 0.9g
Technology:
(1) former, adjuvant are crossed 80 mesh sieves respectively;
(2) get ibuprofen arginine and pseudoephedrine hydrochloride recipe quantity and starch mixing, add lactose, microcrystalline Cellulose mixing again;
(3) add 2% polyvidone aqueous solution and make soft material, 70 ℃ of dryings add Pulvis Talci, magnesium stearate mix homogeneously behind the 16 order granulate, measure granule content, tabletting.
Embodiment 2: preparation ibuprofen arginine pseudoephedrine compound capsule
Prescription (per 1000 meters):
Ibuprofen arginine 570g
Pseudoephedrine hydrochloride 30g
Cellulose ethyl hydroxypropyl ether 10g
Starch 5g
Micropowder silica gel 5g
Technology:
(1) gets ibuprofen arginine and 40 mesh sieves, mix homogeneously are crossed in pseudoephedrine recipe quantity, Cellulose ethyl hydroxypropyl ether, starch, micropowder silica gel.
(2) encapsulated.
Embodiment 3: the compound sustained-released tablet of preparation ibuprofen arginine pseudoephedrine
Prescription (per 1000 meters)
The slow release label:
Ibuprofen arginine 400g
Lactose 30g
HPMC 60g
(hydroxypropyl emthylcellulose)
Ethyl cellulose 20g
Magnesium stearate 8.2g
Release layer:
Ibuprofen arginine 500g
Pseudoephedrine hydrochloride 30g
Dyed layer:
Opadry (Opadry) 45g
Technology:
(1) by above-mentioned prescription, the ethanol with 75% is wetting agent, and the slow releasing tablet core component is made granule after according to the recipe quantity mix homogeneously, and the adding magnesium stearate is a lubricant, and tabletting obtains the slow release label;
(2) label is added described release layer component according to recipe quantity in coating pan and carry out coating, make plain sheet;
(3) with above plain sheet further with recipe quantity the Opadry coating, promptly get the compound sustained-released tablet of described ibuprofen arginine pseudoephedrine.
Embodiment 4: preparation ibuprofen arginine pseudoephedrine compound sustained release capsules
1) preparation of fast release micropill
Prescription (per 1000 meters):
Ibuprofen arginine 500g
Pseudoephedrine hydrochloride 30g
2% polyvidone aqueous solution 8g
Ethanol 100ml
Celphere 65g
Technology:
According to above-mentioned recipe quantity, celphere is put in the fluid bed, by hot-air celphere is suspended, with ibuprofen arginine, pseudoephedrine hydrochloride solution (contain PVP, solvent is 50% ethanol), be sprayed onto drying on the celphere, make described fast release micropill.
2) preparation of slow-release micro-pill
Prescription (per 1000 meters):
Ibuprofen arginine 500g
Pseudoephedrine hydrochloride 30g
2% polyvidone aqueous solution 15g
Ethanol 150ml
Celphere 180g
Technology:
Celphere is put in the fluid bed, celphere is suspended, ibuprofen arginine and pseudoephedrine hydrochloride solution (contain PVP, solvent is 50% ethanol) are sprayed onto drying on the celphere according to above-mentioned recipe quantity, make required slow release ball ball core by hot-air.Reuse ethyl cellulose, phthalic acid diethanol, talcous acetone/isopropanol liquid spray coating, drying, get final product slow-release micro-pill.
3) slow-release micro-pill and No. 0 capsule of fast release micropill mixing capsule can be obtained ibuprofen arginine pseudoephedrine compound sustained release capsules.
Embodiment 5: preparation stability is investigated
Embodiment 1 gained tablet is carried out illumination, hot test and accelerated test, investigate its stability.
1) exposure experiments to light
Get embodiment 1 gained tablet, under light intensity 4000Lx, shine, place sample thief observation mensuration after 0,5,10 day respectively, the results are shown in Table 1.
Table 1. ibuprofen arginine Defed exposure experiments to light result
The result shows that this product every index under illumination condition is basicly stable.
2) hot test
Embodiment 1 gained tablet is placed in 60 ℃ of electrothermostats, places sampling observation and mensuration after 5,10 days respectively, result and comparison in 0 day see Table 2.
Table 2. ibuprofen arginine Defed hot test result
The result shows: this product related substance under 60 ℃ of hot conditionss slightly increases, but all less than 1.0%, all the other indexs are basicly stable.
3) accelerated test
Getting embodiment 1 gained tablet, is 40 ℃ ± 2 ℃ in temperature; Relative humidity is to carry out accelerated test under 75% ± 5% condition, the results are shown in Table 3.
Table 3. ibuprofen arginine Defed accelerated test result
Figure C20041001605300132
000822 White tablets 0.16 109 103.5
March 000818 White tablets 0.13 106 101.6
000821 White tablets 0.12 102 103.0
000822 White tablets 0.12 111 102.8
June 000818 White tablets 0.31 105 100.8
000821 White tablets 0.29 105 100.7
000822 White tablets 0.36 101 102.8
The result shows, this product is quickened to investigate six months, every index and relatively having no significant change in 0 month.Can be obtained by above test, the ibuprofen arginine Defed has good stability.
Embodiment 6: the antiinflammatory test
Get body weight 140~160g rat, male and female half and half, random packet, 8 every group.Negative control group (normal saline 25ml/kg), positive controls (ibuprofen pseudoephedrine 34.5mg/kg, wherein contain ibuprofen 30mg, pseudoephedrine contains 4.5mg, and limited company produces by the prosperous enlightening Pharmaceutical of Hubei encyclopaedia), embodiment is prepared into ibuprofen arginine Defed low dose group (5.4mg/kg), middle dosage group (54mg/kg), high dose group (270mg/kg).By the above-mentioned dosage gastric infusion (ig) of respectively organizing, behind the 1h, the sterile working, injection causes scorching thing (1% carrageenin 0.1ml) under every sufficient plantar aponeurosis in a rat left side.Cause scorching back 1h, 3h measures left and right sides ankle joint girth with special moccasin chi.With the difference of left and right sides ankle joint girth as the swelling degree, contrast between organizing, the poor opposite sex).The results are shown in Table 4.
Table 4. ibuprofen arginine pseudoephedrine on Carrageenan causes scorching antiinflammatory action
Group Dosage (mg/kg) Number of animals (only) Swelling degree (mm) r ± s The P value
Cause scorching back 1h Cause scorching back 3h Compare with saline Compare with the ibuprofen pseudoephedrine
Normal saline 8 6.00±1.25 6.81±0.90
The ibuprofen pseudoephedrine 34.5 8 2.75±0.65 2.72±0.92 <0.01
The ibuprofen arginine pseudoephedrine 5.4 8 3.18±1.16 2.50±0.59 <0.01 >0.05
54 8 1.50±1.20 2.52±0.62 <0.01 >0.05
270 8 1.23±0.82 1.20±0.67 <0.01 <0.05
By last table result as can be seen: during high dose group, effect obviously is better than the ibuprofen pseudoephedrine to the antiinflammatory action of ibuprofen arginine pseudoephedrine about 1h and in giving.
Embodiment 7: the analgesic test
Get 60 of body weight 17~22g mices, male and female half and half, random packet, 12 every group.If the group situation reaches and respectively organizes gastric infusion dosage with embodiment 6.Ip0.6% acetic acid behind the 30min (0.2ml/ only) causes pain, raises to causing indicator reaction bitterly with mouse writhing (abdominal part caves in, trunk uphold with hind leg) buttocks.Turn round the body number of times behind the self-supporting acetic acid of observed and recorded in the 15min.The results are shown in Table 5.
Table 5. ibuprofen arginine pseudoephedrine is to the analgesic activity of mice
Group Dosage (mg/kg) Number of animals (only) Swelling degree (g) x ± S The P value
Compare with saline Compare with the ibuprofen pseudoephedrine
Normal saline 12 20.60±5.23
The ibuprofen pseudoephedrine 34.5 12 5.76±1.52 <0.05
The ibuprofen arginine pseudoephedrine 5.4 12 6.23±2.30 <0.01 >0.05
54 12 5.12±2.19 <0.01 >0.05
270 12 2.85±0.47 <0.01 <0.05
By last table result as can be seen: ibuprofen arginine pseudoephedrine compound tablet is when middle dosage, and its analgesic activity is suitable with the ibuprofen pseudoephedrine, and when giving high dose, analgesic activity obviously is better than the ibuprofen pseudoephedrine.
Embodiment 8: separate heat test
Get 40 of body weight 1.6~2.0kg rabbit, male and female half and half, random packet, 8 every group.Ibuprofen arginine Defed low dose group (3.5mg/kg), middle dosage group (16.8mg/kg), the high dose group (78.5mg/kg) of negative control group (normal saline 1ml/kg), positive controls (ibuprofen pseudoephedrine 17.5mg/kg), embodiment 1 preparation.After measuring the rabbit normal body temperature, injection colibacillus deactivating liquid (about 1012/kg antibacterial, reduced turbidity calculates) pyrogenicity.Take temperature is as the fever index behind 3~4h.Reduce number as separating heating index with each time point body temperature behind the gastric infusion.Compare with the body temperature before the back administration that heats up, the results are shown in Table 6.
Table 6 ibuprofen arginine pseudoephedrine is to the influence of rabbit body temperature
Group Dosage (mg/kg) Give behind the bacterium before the administration elevated temperature ℃ Different time body temperature reduction value after the administration (℃) x ± S
60min 90min 120min 150min
Normal saline 1.53±0.13 0.11±0.10 0.15±0.10 0.075±0.10 0.35±0.20
The ibuprofen pseudoephedrine 17.5 1.23±0.07 0.13±0.10 0.61±0.10 0.92±0.10 1.03±0.20
The ibuprofen arginine pseudoephedrine 3.5 1.55±0.18 0.26±0.10 0.47±0.20 0.80±0.20 0.89±0.20
16.8 1.29±0.08 0.72±0.10 0.84±0.20 0.99±0.10 1.09±0.20
78.5 1.69±0.14 0.92±0.10 1.08±0.20 1.25±0.29 1.39±0.10
By last table result as can be seen: in giving ibuprofen arginine pseudoephedrine compound tablet during dosage, its for the body-temp. reducing effect of rabbit obviously faster than the ibuprofen pseudoephedrine.But the body-temp. reducing effect basically identical after two hours.
Embodiment 9: clinical efficacy
Picked at random has 60 of the flu volunteer patients of symptoms such as nasal obstruction, rhinorrhea, sneeze, myalgia, nasal mucosa hyperemia, be divided into two groups, each 30 the ibuprofen arginine pseudoephedrine compound tablet that give ibuprofen pseudoephedrine and embodiment 1 preparation respectively, observe it respectively at 0.5h, 1.5h the curative effect when reaching 5h the results are shown in Table 7.
Yellow alkali of table 7. ibuprofen arginine pseudoephedrine and ibuprofen pseudoephedrine clinical efficacy are relatively
Group Symptom Produce effects (%) Effective percentage (%) Total effective rate (%)
0.5h 1.5h 5h 0.5h 1.5h 5h 0.5h 1.5h 5h
The ibuprofen pseudoephedrine Nasal obstruction 5.2 12.9 35.9 10.2 15.3 61.2 15.4 28.2 97.1
The pseudo-Herba Ephedrae cave of ibuprofen arginine 33.6 36.2 36.5 60.2 60.8 62.8 93.8 97.0 99.3
The ibuprofen pseudoephedrine Nasal mucus 5.0 7.6 30.5 9.3 15.9 68.5 14.3 23.5 99.0
The ibuprofen arginine pseudoephedrine 32.7 33.2 33.9 62.2 65.2 65.2 94.9 98.4 99.1
The ibuprofen pseudoephedrine Sneeze 6.2 7.1 30.8 5.6 10.3 65.8 11.8 17.4 96.6
The ibuprofen arginine pseudoephedrine 32.6 32.9 33.4 61.3 65.2 66.2 93.9 98.1 99.6
The ibuprofen pseudoephedrine Myalgia 2.0 3.5 40.8 4.8 12.5 59.2 6.8 16.0 100.0
The ibuprofen arginine pseudoephedrine 44.7 49.7 49.7 46.8 48.2 48.9 91.5 97.9 98.6
The ibuprofen pseudoephedrine Nasal mucosa hyperemia 30.2 31.5 44.6 5.3 21.3 47.6 35.5 52.8 92.2
The ibuprofen arginine pseudoephedrine 44.7 44.8 44.9 46.8 47.6 47.7 91.5 92.4 92.6
By last table result as can be seen, ibuprofen arginine pseudoephedrine compound tablet performance drug action is obviously faster than the ibuprofen pseudoephedrine.

Claims (9)

1. ibuprofen arginine pseudoephedrine compound preparation is characterized in that it is 1~40: 1 ibuprofen arginine and pseudoephedrine hydrochloride that described preparation contains mass ratio.
2. ibuprofen arginine pseudoephedrine compound preparation as claimed in claim 1 is characterized in that described preparation is that 1~40: 1 ibuprofen arginine and pseudoephedrine hydrochloride and pharmaceutical excipient or carrier are formed by mass ratio.
3. ibuprofen arginine pseudoephedrine compound preparation as claimed in claim 2 is characterized in that described ibuprofen arginine and pseudoephedrine hydrochloride mass ratio are 3~30: 1.
4. ibuprofen arginine pseudoephedrine compound preparation as claimed in claim 3 is characterized in that described ibuprofen arginine and pseudoephedrine hydrochloride mass ratio are 8~15: 1.
5. as the described ibuprofen arginine pseudoephedrine of claim 1~4 compound preparation, it is characterized in that described preparation can be made into one of following dosage forms:
1. 2. 3. 4. slow releasing capsule of slow releasing tablet of capsule of tablet.
6. ibuprofen arginine pseudoephedrine compound preparation as claimed in claim 5 is characterized in that the quality proportioning of described tablet is:
240~600 parts of ibuprofen arginines
30 parts of pseudoephedrine hydrochlorides
37.5 parts of lactose
37.5 parts of starch
15 parts of microcrystalline Cellulose
25 parts of 2% polyvidone aqueous solutions
2.8 parts of Pulvis Talci
0.9 part of magnesium stearate
7. ibuprofen arginine pseudoephedrine compound preparation as claimed in claim 5 is characterized in that described capsular content quality proportioning is:
240~600 parts of ibuprofen arginines
30 parts of pseudoephedrine hydrochlorides
10 parts of low-substituted hydroxypropyl celluloses
5 parts of starch
5 parts of micropowder silica gels
8. ibuprofen arginine pseudoephedrine compound preparation as claimed in claim 5 is characterized in that described slow releasing tablet is made up of slow release label, release layer and dyed layer;
Described slow release label quality proportioning is:
240~600 parts of ibuprofen arginines
30 parts of lactose
60 parts of HPMC
20 parts of ethyl celluloses
8.2 parts of magnesium stearate
Described release layer quality proportioning is:
500 parts of ibuprofen arginines
30 parts of pseudoephedrine hydrochlorides
Described dyed layer is 45 parts of Opadries (Opadry)
Described slow releasing tablet prepares as follows:
(1) by above-mentioned prescription, the ethanol with 75% is wetting agent, and the slow releasing tablet core component is made granule after according to the recipe quantity mix homogeneously, and the adding magnesium stearate is a lubricant, and tabletting obtains the slow release label;
(2) label is added described release layer component according to recipe quantity in coating pan and carry out coating, make plain sheet;
(3) with above plain sheet further with recipe quantity the Opadry coating, promptly get the compound sustained-released tablet of described ibuprofen arginine pseudoephedrine.
9. ibuprofen arginine pseudoephedrine compound preparation as claimed in claim 5 is characterized in that the content of described slow releasing capsule is made up of fast release micropill and slow-release micro-pill;
Described fast release micropill quality proportioning is:
240~600 parts of ibuprofen arginines
30 parts of pseudoephedrine hydrochlorides
8 parts of 2% polyvidone aqueous solutions
100 parts of ethanol
65 parts of celphere;
Described slow release ball core quality proportioning is:
240~600 parts of ibuprofen arginines
30 parts of pseudoephedrine hydrochlorides
15 parts of 2% polyvidone aqueous solutions
150 parts of ethanol
180 parts of celphere.
CN 200410016053 2004-01-18 2004-01-18 Brufen arginine pseudoephedrine hydrochloride compound formulation Expired - Lifetime CN1268327C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN 200410016053 CN1268327C (en) 2004-01-18 2004-01-18 Brufen arginine pseudoephedrine hydrochloride compound formulation

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN 200410016053 CN1268327C (en) 2004-01-18 2004-01-18 Brufen arginine pseudoephedrine hydrochloride compound formulation

Publications (2)

Publication Number Publication Date
CN1557293A CN1557293A (en) 2004-12-29
CN1268327C true CN1268327C (en) 2006-08-09

Family

ID=34351672

Family Applications (1)

Application Number Title Priority Date Filing Date
CN 200410016053 Expired - Lifetime CN1268327C (en) 2004-01-18 2004-01-18 Brufen arginine pseudoephedrine hydrochloride compound formulation

Country Status (1)

Country Link
CN (1) CN1268327C (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101756981B (en) * 2008-12-16 2013-04-10 北京科信必成医药科技发展有限公司 Brufen loratadine pseudoephedrine release preparation and preparation method thereof
CN102920691A (en) * 2012-10-23 2013-02-13 中美天津史克制药有限公司 Compound sustained-release capsule containing ibuprofen and pseudo ephedrine

Also Published As

Publication number Publication date
CN1557293A (en) 2004-12-29

Similar Documents

Publication Publication Date Title
CN1142780C (en) Pharmaceutical compositions
CN100339078C (en) Solid drug for oral use
CN87105828A (en) The quick-acting compositionss of sulindac or sodium sulindac and alkali
CN1762357A (en) Oral medicinal formulation of moxifloxacin and its preparation method
CN101057862A (en) Medicinal composition for treating senile osteoarthropathy
CN1155369C (en) Modified release oral pharmaceutical composition contg. 5-ASA and method for treatment of bowel diseases
CN1148188C (en) Analgesics
CN1296052C (en) Non-injection preparation containing medium and/or low molecular weight chondroitin sulfate
CN1799543A (en) Telmisartan dispersible tablet and its preparation method
CN1268327C (en) Brufen arginine pseudoephedrine hydrochloride compound formulation
CN1265793C (en) Oral compound levocetirizine pseudoephedrine formulation and its preparation
CN1217721A (en) Method for treating or preventing interstitial cystitis
CN1915216A (en) New usage of tandospirone and its derivative, and composition containing tandospirone
CN1166362C (en) Solution agent of antiallergi medicine contg. levocetirizine
CN1943561A (en) Oral disintegration tablet of prulifloxacin and its preparing method
CN1273137C (en) Compound prepn. contg. Brufen arginine codeine
CN1634087A (en) Sustained release formulation of glucosamine salt, its preparation and usage
CN1194691C (en) Composition for curing hyperlipemia
CN1283240C (en) Pharmaceutical use of COX-2 inhibitors in angiogenesis-mediated ocular disorders
CN101028518A (en) Medicinal composition containing silver ester medicine and ibobulodine
CN1680390A (en) Halogenated dihydroartemisine, preparation and use thereof
CN1634299A (en) Application of fenugreek total alkali extract in preparing medicine for ulcerative colitis and preparation method of colon targeted preparation
CN1810242A (en) Slow-released vincamine capsule and its prepn process
CN101062039A (en) Medical combination for treating nervous system diseases
CN1720911A (en) Pharmaceutical composition containing ambroxol and erdosteine or acetylcysteine and application thereof

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
C14 Grant of patent or utility model
GR01 Patent grant
CX01 Expiry of patent term

Granted publication date: 20060809

CX01 Expiry of patent term