CN101036633A - Enteric coated omeprazole pellets capsule and the preparing method thereof - Google Patents
Enteric coated omeprazole pellets capsule and the preparing method thereof Download PDFInfo
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- CN101036633A CN101036633A CN 200710068255 CN200710068255A CN101036633A CN 101036633 A CN101036633 A CN 101036633A CN 200710068255 CN200710068255 CN 200710068255 CN 200710068255 A CN200710068255 A CN 200710068255A CN 101036633 A CN101036633 A CN 101036633A
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Abstract
The invention relates to an omeprazole enteric micropill capsule and a process for preparing the same. The content of the capsule is omeprazole enteric micropill including a blank pill core; an activity medicine layer having an alkaline component; a separator containing magnesia and titanium pigment; and an enteric coat layer. According to synergistic reaction, stability of the medicine is distinctly improved. The omeprazole enteric micropill capsule of the invention has period of validity of the preparation to three years or more.
Description
Technical field
The invention belongs to pharmaceutical preparation, be specifically related to a kind of enteric coated omeprazole pellets capsule and preparation method thereof.
Background technology
Omeprazole is a proton pump inhibitor class antiulcerative, can treat duodenal ulcer, gastric ulcer and esophagitis, and can eliminate the intractable ulcer crisis, and treatment Zhuo-Ai two syndromes are also very effective.Proton pump inhibitor compares histamine H
2Receptor blocking agent (as ranitidine, famotidine) to press down the acid effect more powerful and lasting, splendid to peptic ulcer and the backflow curative effect of ulcer of serious esophagus that routine treatment can not onset, and side effect is rarely found.
The omeprazole less stable is easy to degraded in acid and neutral medium.Its stability also is subjected to the influence of light, humidity, heat, organic solvent (even trace).Therefore overcome the weakness of raw material itself by the formulation and technology technology, preparation good stability, the omeprazole preparation that bioavailability is high seem most important.
Because omeprazole is unstable under acidic condition, destroyed easily in gastric acid, so clinically use all are omeprazole enteric-coated preparations.
But (25 ℃ of temperature under normal storage service condition, humidity is about 40 ~ 75%), it is found that the passing in time of conventional omeprazole preparation is unsettled, often observe the variable color of preparation, this just means the degraded of omeprazole and the appearance of harmful catabolite.
WO98/52564 discloses the proton pump inhibitor granule, it comprises the layer that active substance combines with alkaline matter, and the barrier layer of forming by lyophobic dust and the inert core of enteric layer coating, lyophobic dust is poly-alkylsiloxane, mineral oil, stearic acid, magnesium oxide, magnesium stearate, and alkaline matter is ammonia, ammonium hydroxide or ammonium carbonate.CN1160062C discloses the pharmaceutical formulation that comprises omeprazole, comprises antistatic additive such as magnesium stearate, titanium dioxide, Pulvis Talci etc. in its sealing coat.CN1093855C discloses the new composition and method of making the same that contains the unsettled omeprazole of acid, and it comprises inner core, intermediate layer and the enteric coat layer that contains the unsettled omeprazole active component of acid, and silicon dioxide is contained in described intermediate layer.
But still very dissatisfied aspect stable, aspect accelerated stability test and long-term stable experiment, exist not enough.
Summary of the invention
In order to overcome above-mentioned the deficiencies in the prior art, provide a kind of more stable, the omeprazole enteric-coated preparation that effect duration is longer, make things convenient for patient's medication, the invention provides a kind of enteric coated omeprazole pellets capsule and preparation method thereof, it includes celphere, contains active medicine layer, sealing coat and the enteric coating layer of alkali components.Sealing coat contains with magnesium oxide and titanium dioxide simultaneously as the protection composition, increases stability of drug by synergism.Contain omeprazole (micropowder), disintegrating agent, binding agent, alkali compounds, surfactant, Pulvis Talci in this capsule active medicine layer, these compositions have guaranteed rapid release and the efficient absorption of omeprazole at human body effectively.This capsule with sealing coat with the omeprazole active medicine layer of alkalescence be tart enteric material and keep apart; protected medicament active composition effectively; simultaneously increase magnesium oxide and titanium dioxide as the protection composition, improved stability of drug significantly by synergism at sealing coat.
Enteric coated omeprazole pellets capsule prepared in accordance with the present invention, in 40 ± 2 ℃, the climatic chamber of relative humidity 75 ± 5%, quicken to investigate 6 months and under 25 ± 2 ℃, the condition of relative humidity 60 ± 10%, deposited 3 years, the appearance character of enteric coated omeprazole pellets capsule, related substance, release and content and relatively had no significant change in 0 month.Can infer clearly that the enteric coated omeprazole pellets capsule that makes by the present invention can make preparation effect duration reach more than 3 years.
Enteric coated omeprazole pellets capsule components by weight percentage of the present invention is as follows:
A, celphere 16 ~ 65%
B, active medicine layer
Omeprazole 4 ~ 20%
Disintegrating agent 0.1 ~ 2%
Binding agent 0.5% ~ 6%
Alkali compounds 0.06 ~ 3%
Surfactant 0 ~ 2%
Pulvis Talci 0 ~ 2%
C, sealing coat
Coating materials 2 ~ 10%
Magnesium oxide 1 ~ 6%
Titanium dioxide 0.5 ~ 3%
Pulvis Talci 2 ~ 12%
D, enteric coating layer
Enteric material 10 ~ 30%
Pulvis Talci 3 ~ 15%
Plasticizer 0.8 ~ 6%.
In the enteric coated omeprazole pellets capsule of the present invention, celphere can be starch celphere, microcrystalline Cellulose celphere, sucrose starch celphere (sugar pill).The particle diameter of celphere is preferably 0.4 ~ 3mm, more preferably 0.6 ~ 2mm.
In the enteric coated omeprazole pellets capsule of the present invention, the active medicine layer is made up of omeprazole, disintegrating agent, binding agent, alkaline compositions, surfactant, Pulvis Talci.The omeprazole material fineness is preferably less than 160 microns, more preferably 50 ~ 120 microns; Disintegrating agent can be selected from one or more the combination in low-substituted hydroxypropyl cellulose (L-HPC), crospolyvinylpyrrolidone (PPVP), carboxymethyl starch sodium (CMS-Na), the cross-linking sodium carboxymethyl cellulose (crosslinked CMC-Na); Binding agent can be selected from one or more the combination in hypromellose, syrup, sodium carboxymethyl cellulose, polyvinylpyrrolidone, the starch slurry, preferred hypromellose; Alkali compounds can be selected from one or more the combination in sodium hydrogen phosphate, sodium phosphate, sodium dihydrogen phosphate, the sodium hydroxide; Optional one or both the combination in polyoxyethylene sorbitan monoleate, sodium lauryl sulphate of surfactant.
In the enteric coated omeprazole pellets capsule of the present invention, sealing coat is made up of coating materials, magnesium oxide, titanium dioxide, Pulvis Talci.Coating materials can be selected from one or both the combination in hypromellose, the polyvinyl alcohol (PVA), preferred hypromellose.
In the enteric coated omeprazole pellets capsule of the present invention, enteric coating layer is made up of enteric material, Pulvis Talci, plasticizer.Enteric material can be selected from one or more the combination in crylic acid resin enteric material, Hydroxypropyl methyl cellulose phtalate (HPMCP), the cellulose acetate phthalate (CAP), wherein the crylic acid resin enteric material is preferably You Teqi series, as the strange L100-55 of You Te, the strange L30D-55 of You Te, the strange L100 of You Te, the more preferably strange L30D-55 of You Te; Plasticizer can be selected from one or more the combination in triethyl citrate, polyethylene glycol 6000, tributyl citrate, certain herbaceous plants with big flowers two dibutyl phthalates, the diethyl phthalate, is preferably triethyl citrate or polyethylene glycol 6000.
The preparation method of a kind of enteric coated omeprazole pellets capsule preparation provided by the invention; this capsule 's content is an omeprazole enteric-coated micro-pill, can adopt centrifugal coating pelletizing machine, extrudes spheronizator, fluidized bed coating granulator, atresia or the thin coating pan preparation of porose high performance membrane.Concrete preparation method is as described below:
1) preparation of celphere: can adopt centrifugal coating pelletizing machine, extrude spheronizator, the preparation of fluidized bed coating granulator;
2) bag active medicine layer: earlier with omeprazole, disintegrating agent, binding agent, alkali compounds, adding do not add surfactant, adding or do not add Pulvis Talci, purified water is made into the omeprazole suspension, spray is wrapped on the celphere again, can adopt the thin coating pan preparation of centrifugal coating pelletizing machine, fluidized bed coating granulator, atresia or porose high performance membrane;
3) bag sealing coat: earlier coating materials, magnesium oxide, titanium dioxide, Pulvis Talci are made into suspension with purified water, spray is wrapped on the above-mentioned pill again, can adopt the thin coating pan preparation of centrifugal coating pelletizing machine, fluidized bed coating granulator, atresia or porose high performance membrane;
4) enteric-coating layer: earlier enteric material, Pulvis Talci, plasticizer are made into enteric coating liquid, spray is wrapped on the pill that wraps sealing coat again, can adopt the thin coating pan preparation of centrifugal coating pelletizing machine, fluidized bed coating granulator, atresia or porose high performance membrane;
5) incapsulate by standard quantity, promptly get enteric coated omeprazole pellets capsule.
Enteric coated omeprazole pellets capsule prepared in accordance with the present invention (is got sodium chloride 1g, is added hydrochloric acid 3.5ml with the hydrochloric acid solution of sodium chloride, adding water to 500ml) 500ml is dissolution medium, rotating speed was 100 to change, through 2 hours, do not find the apparent significant change of this preparation, acid-resistant strength reaches more than 90%; The release test shows, according to 2005 editions drug release determination methods of Chinese Pharmacopoeia, the slurry method, 100 change, in the hydrochloric acid solution 500ml of 37 ± 0.5 ℃ of sodium chloride after 2 hours, adding is preheated to 37 ℃ 0.235mol/L disodium phosphate soln 400ml, and in the time of 45 minutes, sampling records release and reaches more than 85%.
Enteric coated omeprazole pellets capsule prepared in accordance with the present invention, in 40 ± 2 ℃, the climatic chamber of relative humidity 75 ± 5%, quicken to investigate 6 months and under 25 ± 2 ℃, the condition of relative humidity 60 ± 10%, deposited 3 years, the appearance character of enteric coated omeprazole pellets capsule, related substance, release and content and relatively had no significant change in 0 month.
Specific embodiment
Embodiment 1:
This pharmaceutical formulation is made up of following component: (make 1000 altogether, other embodiment and comparing embodiment are all made 1000)
A, sucrose starch ball core 72.0g
B, active medicine layer (suspension)
Omeprazole 20g
Carboxymethyl starch sodium 0.8g
Hypromellose 6.3g
Sodium dihydrogen phosphate 0.9g
Sodium hydroxide 0.54g
Polyoxyethylene sorbitan monoleate 1.4g
Pulvis Talci 0.8g
Purified water 200g
C, sealing coat (coating solution)
Hypromellose 10.0g
Magnesium oxide 4.8g
Titanium dioxide 2.5g
Pulvis Talci 9.0g
Purified water 220g
D, enteric coating layer (coating solution)
You Teqi L30-D55 100.5g
Pulvis Talci 11.0g
Triethyl citrate 3.9g
Purified water 177g
Preparation method:
1) preparation of sucrose starch ball core: adopt centrifugal coating to make machine or extrude spheronizator or fluidized bed coating granulator (side spray mode), the sucrose starch mixture is made (containing sucrose more than 50%) the sucrose starch ball core of 0.6 ~ 2mm;
2) bag active medicine layer: in fluidized bed coating comminutor or centrifugal coating pelletizing machine or atresia or the thin coating pan of porose high performance membrane, the spray of active medicine layer suspension is wrapped on the sucrose starch ball core;
3) bag sealing coat: the sealing coat coating solution is wrapped in spray on above-mentioned pill;
4) enteric-coating layer: wrap enteric coating liquid again;
5) dry back incapsulates by standard quantity, promptly gets enteric coated omeprazole pellets capsule.
Embodiment 2:
This pharmaceutical formulation is made up of following component:
A, microcrystalline Cellulose ball core 55.0g
B, active medicine layer (suspension)
Omeprazole 10g
Low-substituted hydroxypropyl methylcellulose 3g
Sodium carboxymethyl cellulose 1.0g
Sodium phosphate 2.2g
Sodium lauryl sulphate 3.0g
Purified water 200g
C, sealing coat (coating solution)
Polyvinyl alcohol 4.0g
Magnesium oxide 2.5g
Titanium dioxide 1.0g
Pulvis Talci 8.0g
Purified water 100g
D, enteric coating layer (coating solution)
You Teqi L30-D55 150g
Pulvis Talci 23.0g
Polyethylene glycol 6000 8.0g
Purified water 300g
Preparation method:
1) preparation of microcrystalline Cellulose ball core: adopt centrifugal coating to make machine or extrude spheronizator or fluidized bed coating granulator (side spray mode), microcrystalline Cellulose is made the sucrose starch ball core of 0.6 ~ 2mm;
2) bag active medicine layer: in fluidized bed coating comminutor or centrifugal coating pelletizing machine or atresia or the thin coating pan of porose high performance membrane, the spray of active medicine layer suspension is wrapped on the microcrystalline Cellulose ball core;
3) bag sealing coat: the sealing coat coating solution is wrapped in spray on above-mentioned pill;
4) enteric-coating layer: wrap enteric coating liquid again;
5) dry back incapsulates by standard quantity, promptly gets enteric coated omeprazole pellets capsule.
Embodiment 3:
This pharmaceutical formulation is made up of following component:
A, starch celphere 40.0g
B, active medicine layer (suspension)
Omeprazole 40.0g
Carboxymethyl starch sodium 0.3g
Low-substituted hydroxypropyl cellulose 0.3g
Hypromellose 12.0g
Sodium hydrogen phosphate 6.0g
Polyoxyethylene sorbitan monoleate 2.4g
Pulvis Talci 4.0g
Purified water 250g
C, sealing coat (coating solution)
Hypromellose 19.0g
Magnesium oxide 12.0g
Titanium dioxide 6.0g
Pulvis Talci 22.0g
Purified water 400g
D, enteric coating layer (coating solution)
You Teqi L30-D55 135g
Pulvis Talci 22.0g
ETHYL CTTRATE 4.5g
Purified water 270g
Preparation method:
1) preparation of starch celphere: adopt centrifugal coating to make machine or extrude spheronizator or fluidized bed coating granulator (side spray mode), starch is made the starch ball core of 0.6 ~ 2mm;
2) bag active medicine layer: in fluidized bed coating comminutor or centrifugal coating pelletizing machine or atresia or the thin coating pan of porose high performance membrane, the spray of active medicine layer suspension is wrapped on the starch ball core;
3) bag sealing coat: the sealing coat coating solution is wrapped in spray on above-mentioned pill;
4) enteric-coating layer: wrap enteric coating liquid again;
5) dry back incapsulates by standard quantity, promptly gets enteric coated omeprazole pellets capsule.
Embodiment 4:
This pharmaceutical formulation is made up of following component:
A, sucrose starch ball core 140.0g
B, active medicine layer (suspension)
Omeprazole 10g
Carboxymethyl starch sodium 0.3g
Hypromellose 2.3g
Sodium hydroxide 0.2g
Pulvis Talci 0.8g
Purified water 200g
C, sealing coat (coating solution)
Hypromellose 10.0g
Magnesium oxide 4.0g
Titanium dioxide 2.0g
Pulvis Talci 8.0g
Purified water 200g
D, enteric coating layer (coating solution)
You Teqi L30-D55 88.5g
Pulvis Talci 11.0g
Triethyl citrate 2.2g
Purified water 177g
Preparation method:
1) preparation of sucrose starch ball core: adopt centrifugal coating to make machine or extrude spheronizator or fluidized bed coating granulator (side spray mode), the sucrose starch mixture is made (containing sucrose more than 50%) the sucrose starch ball core of 0.6 ~ 2mm;
2) bag active medicine layer: in fluidized bed coating comminutor or centrifugal coating pelletizing machine or atresia or the thin coating pan of porose high performance membrane, the spray of active medicine layer suspension is wrapped on the sucrose starch ball core;
3) bag sealing coat: the sealing coat coating solution is wrapped in spray on above-mentioned pill;
4) enteric-coating layer: wrap enteric coating liquid again;
5) dry back incapsulates by standard quantity, promptly gets enteric coated omeprazole pellets capsule.
Embodiment 5:
This pharmaceutical formulation is made up of following component:
A, sucrose starch ball core 120.0g
B, active medicine layer (suspension)
Omeprazole 20g
Crospolyvinylpyrrolidone 0.6g
Cross-linking sodium carboxymethyl cellulose 0.6g
Hypromellose 5.3g
Sodium dihydrogen phosphate 0.7g
Sodium hydroxide 0.44g
Polyoxyethylene sorbitan monoleate 1.2g
Pulvis Talci 0.8g
Purified water 200g
C, sealing coat (coating solution)
Hypromellose 15.0g
Magnesium oxide 7.5g
Titanium dioxide 3.8g
Pulvis Talci 15.0g
Purified water 300g
D, enteric coating layer (coating solution)
You Teqi L30-D55 130.0g
Pulvis Talci 16.0g
Triethyl citrate 4.3g
Purified water 260.0g
Preparation method:
1) preparation of sucrose starch ball core: adopt centrifugal coating to make machine or extrude spheronizator or fluidized bed coating granulator (side spray mode), the sucrose starch mixture is made (containing sucrose more than 50%) the sucrose starch ball core of 0.6 ~ 2mm;
2) bag active medicine layer: in fluidized bed coating comminutor or centrifugal coating pelletizing machine or atresia or the thin coating pan of porose high performance membrane, the spray of active medicine layer suspension is wrapped on the sucrose starch ball core;
3) bag sealing coat: the sealing coat coating solution is wrapped in spray on above-mentioned pill;
4) enteric-coating layer: wrap enteric coating liquid again;
5) dry back incapsulates by standard quantity, promptly gets enteric coated omeprazole pellets capsule.
Comparing embodiment:
Comparing embodiment 1
Enteric coated omeprazole pellets capsule component according to prior art is as follows:
A, sucrose starch ball core 72.0g
B, active medicine layer (suspension)
Omeprazole 20g
Carboxymethyl starch sodium 0.8g
Hypromellose 6.3g
Sodium dihydrogen phosphate 0.9g
Sodium hydroxide 0.54g
Polyoxyethylene sorbitan monoleate 1.4g
Pulvis Talci 0.8g
Purified water 200g
C, sealing coat (coating solution)
Hypromellose 10.0g
Pulvis Talci 9.0g
Purified water 220g
D, enteric coating layer (coating solution)
You Teqi L30-D55 100.5g
Pulvis Talci 11.0g
Triethyl citrate 3.9g
Purified water 177g
Preparation method:
1) preparation of sucrose starch ball core: adopt centrifugal coating to make machine or extrude spheronizator or fluidized bed coating granulator (side spray mode), the sucrose starch mixture is made (containing sucrose more than 50%) the sucrose starch ball core of 0.6 ~ 2mm;
2) bag active medicine layer: in fluidized bed coating comminutor or centrifugal coating pelletizing machine or atresia or the thin coating pan of porose high performance membrane, the spray of active medicine layer suspension is wrapped on the sucrose starch ball core;
3) bag sealing coat: the sealing coat coating solution is wrapped in spray on above-mentioned pill;
4) enteric-coating layer: wrap enteric coating liquid again;
5) dry back incapsulates by standard quantity, promptly gets enteric coated omeprazole pellets capsule.
Comparing embodiment 2
Enteric coated omeprazole pellets capsule component according to prior art is as follows:
A, sucrose starch ball core 72.0g
B, active medicine layer (suspension)
Omeprazole 20g
Carboxymethyl starch sodium 0.8g
Hypromellose 6.3g
Sodium dihydrogen phosphate 0.9g
Sodium hydroxide 0.54g
Polyoxyethylene sorbitan monoleate 1.4g
Pulvis Talci 0.8g
Purified water 200g
C, sealing coat (coating solution)
Hypromellose 10.0g
Magnesium oxide 5.0g
Pulvis Talci 9.0g
Purified water 220g
D, enteric coating layer (coating solution)
You Teqi L30-D55 100.5g
Pulvis Talci 11.0g
Triethyl citrate 3.9g
Purified water 177g
Preparation method:
1) preparation of sucrose starch ball core: adopt centrifugal coating to make machine or extrude spheronizator or fluidized bed coating granulator (side spray mode), the sucrose starch mixture is made (containing sucrose more than 50%) the sucrose starch ball core of 0.6 ~ 2mm;
2) bag active medicine layer: in fluidized bed coating comminutor or centrifugal coating pelletizing machine or atresia or the thin coating pan of porose high performance membrane, the spray of active medicine layer suspension is wrapped on the sucrose starch ball core;
3) bag sealing coat: the sealing coat coating solution is wrapped in spray on above-mentioned pill;
4) enteric-coating layer: wrap enteric coating liquid again;
5) dry back incapsulates by standard quantity, promptly gets enteric coated omeprazole pellets capsule.
Comparing embodiment 3
Enteric coated omeprazole pellets capsule component according to prior art is as follows:
A, sucrose starch ball core 72.0g
B, active medicine layer (suspension)
Omeprazole 20g
Carboxymethyl starch sodium 0.8g
Hypromellose 6.3g
Sodium dihydrogen phosphate 0.9g
Sodium hydroxide 0.54g
Polyoxyethylene sorbitan monoleate 1.4g
Pulvis Talci 0.8g
Purified water 200g
C, sealing coat (coating solution)
Hypromellose 10.0g
Titanium dioxide 2.5g
Pulvis Talci 9.0g
Purified water 220g
D, enteric coating layer (coating solution)
You Teqi L30-D55 100.5g
Pulvis Talci 11.0g
Triethyl citrate 3.9g
Purified water 177g
Preparation method:
1) preparation of sucrose starch ball core: adopt centrifugal coating to make machine or extrude spheronizator or fluidized bed coating granulator (side spray mode), the sucrose starch mixture is made (containing sucrose more than 50%) the sucrose starch ball core of 0.6 ~ 2mm;
2) bag active medicine layer: in fluidized bed coating comminutor or centrifugal coating pelletizing machine or atresia or the thin coating pan of porose high performance membrane, the spray of active medicine layer suspension is wrapped on the sucrose starch ball core;
3) bag sealing coat: the sealing coat coating solution is wrapped in spray on above-mentioned pill;
4) enteric-coating layer: wrap enteric coating liquid again;
5) dry back incapsulates by standard quantity, promptly gets enteric coated omeprazole pellets capsule.
Estimation of stability:
One, accelerated test
The foregoing description is carried out influence factor's test, promptly place open glass drying oven respectively, in illumination (placed ten days under 4500 ± 500Lx), 40 ℃, RH92% condition, investigate 0 day, 10 days indexs such as micropill color, impurity, content, its stability result is as follows:
| Embodiment | The placement condition | Color | Impurity (%) | Acid-resistant strength (%) |
| Embodiment 1 | 0 day | Off-white color | 0.54 | 97.66 |
| Illumination 10 days | Off-white color | 0.47 | 96.37 | |
| 40 ℃ 10 days | Off-white color | 0.56 | 94.27 | |
| RH92%10 days | Off-white color | 0.70 | 92.01 | |
| Comparing embodiment 1 | 0 day | Off-white color | 0.58 | 94.50 |
| Illumination 10 days | Off-white color | 1.50 | 91.34 | |
| 40 ℃ 10 days | Canescence | 1.24 | 88.37 | |
| RH92%10 days | A large amount of red points are arranged | 3.91 | 78.67 | |
| Comparing embodiment 2 | 0 day | Off-white color | 0.64 | 93.46 |
| Illumination 10 days | Off-white color | 1.87 | 87.37 | |
| 40 ℃ 10 days | Canescence | 2.56 | 84.47 | |
| RH92%10 days | Red point is arranged | 2.43 | 83.01 | |
| Relatively implement | 0 day | Off-white color | 0.65 | 94.5 |
| Example 3 | Illumination 10 days | Off-white color | 1.01 | 80.60 |
| 40 ℃ 10 days | Canescence | 1.24 | 84.38 | |
| RH92%10 days | Red point is arranged | 2.91 | 81.45 |
The result shows: by the embodiment 1 of the present invention's preparation in illumination (after placing ten days under 4500 ± 500Lx), 40 ℃, RH92% condition, micropill color no change, impurity does not have obvious increase, less than 1%, acid-resistant strength is still greater than 90%.And by the comparing embodiment 1-3 of prior art for preparing after placing ten days under 40 ℃, RH92% condition, the micropill color has significant change, impurity is significantly increased, greater than 1%, have in addition greater than 3%, acid-resistant strength obviously reduces, have less than 80%.
Two, the test that keeps sample for a long time
To the foregoing description test that keeps sample for a long time, be about to the foregoing description simulation listing packing, place room temperature condition under and placed 3 years, indexs such as investigation micropill color, impurity, content, its stability result is as follows:
| Embodiment | Standing time | Color | Impurity (%) | Acid-resistant strength (%) |
| Embodiment 1 | 0 day | Off-white color | 0.54 | 97.66 |
| 1 year | Off-white color | 0.73 | 97.32 | |
| 2 years | Off-white color | 0.99 | 96.81 | |
| 3 years | Off-white color | 1.14 | 93.82 | |
| Embodiment 2 | 0 day | Off-white color | 0.58 | 97.31 |
| 1 year | Off-white color | 0.67 | 96.89 | |
| 2 years | Off-white color | 0.97 | 95.78 | |
| 3 years | Off-white color | 1.05 | 93.65 | |
| Embodiment 3 | 0 day | Off-white color | 0.60 | 98.05 |
| 1 year | Off-white color | 0.65 | 97.56 | |
| 2 years | Off-white color | 0.89 | 96.12 | |
| 3 years | Off-white color | 0.99 | 93.10 | |
| Embodiment 5 | 0 day | Off-white color | 0.58 | 96.56 |
| 1 year | Off-white color | 0.89 | 95.32 | |
| 2 years | Off-white color | 0.99 | 94.81 | |
| 3 years | Off-white color | 1.14 | 92.82 | |
| Comparing embodiment 1 | 0 day | Off-white color | 0.58 | 94.50 |
| 1 year | Off-white color | 1.23 | 90.52 |
| 2 years | Off-white color | 2.19 | 88.12 | |
| 3 years | Canescence | 3.08 | 82.27 | |
| Comparing embodiment 2 | 0 day | Off-white color | 0.64 | 93.46 |
| 1 year | Off-white color | 1.07 | 92.09 | |
| 2 years | Off-white color | 1.87 | 90.24 | |
| 3 years | Canescence | 2.69 | 84.02 | |
| Comparing embodiment 3 | 0 day | Off-white color | 0.65 | 94.50 |
| 1 year | Off-white color | 1.14 | 92.36 | |
| 2 years | Off-white color | 1.95 | 89.96 | |
| 3 years | Canescence | 2.65 | 84.52 |
The result shows: by the embodiment of the present invention's preparation in room temperature condition is long-term down place 3 years after, micropill color no change, impurity is little increase, but less than 1.5%, acid-resistant strength is still greater than 90%.And by the comparing embodiment 1-3 of prior art for preparing in room temperature condition is long-term down place 3 years after, the micropill color changes, impurity is significantly increased, greater than 2%, have in addition greater than 3%, acid-resistant strength obviously reduces, all less than 85%.
Significantly, adopt the enteric coated omeprazole pellets capsule of the technology of the present invention preparation aspect stable, to increase significantly than preparation by prior art for preparing, adopt the enteric coated omeprazole pellets capsule of the present invention's preparation to place at ambient temperature 3 years, its related substance is less than 1.5%, the micropill color does not have significant change, meet the requirement of medicinal standard, estimate that its effect duration can reach more than 3 years.
Claims (10)
1, a kind of enteric coated omeprazole pellets capsule is characterized in that: its content is an omeprazole enteric-coated micro-pill, includes celphere, contains active medicine layer, sealing coat and the enteric coating layer of alkali components, and components by weight percentage is as follows:
A, celphere 16 ~ 65%
B, active medicine layer
Omeprazole (micropowder) 4 ~ 20%
Disintegrating agent 0.1 ~ 2%
Binding agent 0.5% ~ 6%
Alkali compounds 0.06 ~ 3%
Surfactant 0 ~ 2%
Pulvis Talci 0 ~ 2%
C, sealing coat
Coating materials 2 ~ 10%
Magnesium oxide 1 ~ 6%
Titanium dioxide 0.5 ~ 3%
Pulvis Talci 2 ~ 12%
D, enteric coating layer
Enteric material 10 ~ 30%
Pulvis Talci 3 ~ 15%
Plasticizer 0.8 ~ 6%.
2, enteric coated omeprazole pellets capsule preparation as claimed in claim 1 is characterized in that: celphere can be selected from starch celphere, microcrystalline Cellulose celphere, sucrose starch celphere (sugar pill).
3, enteric coated omeprazole pellets capsule preparation as claimed in claim 1 is characterized in that: disintegrating agent can be selected from one or more the combination in low-substituted hydroxypropyl cellulose (L-HPC), crospolyvinylpyrrolidone (PPVP), carboxymethyl starch sodium (CMS-Na), the cross-linking sodium carboxymethyl cellulose (crosslinked CMC-Na); Binding agent can be selected from one or more the combination in hypromellose, syrup, sodium carboxymethyl cellulose, polyvinylpyrrolidone, the starch slurry; Alkali compounds can be selected from one or more the combination in sodium hydrogen phosphate, sodium phosphate, sodium dihydrogen phosphate, the sodium hydroxide; Optional one or both the combination in polyoxyethylene sorbitan monoleate, sodium lauryl sulphate of surfactant.
4, enteric coated omeprazole pellets capsule preparation as claimed in claim 3 is characterized in that: binding agent is a hypromellose.
5, enteric coated omeprazole pellets capsule preparation as claimed in claim 1 is characterized in that: coating materials can be selected from one or both the combination in hypromellose, the polyvinyl alcohol (PVA).
6, enteric coated omeprazole pellets capsule preparation as claimed in claim 5 is characterized in that: coating materials is a hypromellose.
7, enteric coated omeprazole pellets capsule preparation as claimed in claim 1 is characterized in that: enteric material can be selected from one or more the combination in crylic acid resin enteric material, Hydroxypropyl methyl cellulose phtalate (HPMCP), the cellulose acetate phthalate (CAP); Plasticizer can be selected from one or more the combination in triethyl citrate, polyethylene glycol 6000, tributyl citrate, certain herbaceous plants with big flowers two dibutyl phthalates, the diethyl phthalate.
8, enteric coated omeprazole pellets capsule preparation as claimed in claim 7 is characterized in that: enteric material is You Teqi (Eudragit) series.
9, enteric coated omeprazole pellets capsule preparation as claimed in claim 8 is characterized in that: enteric material is the strange L30D-55 of You Te.
10, preparation is as the method for the described enteric coated omeprazole pellets capsule preparation of claim 1-9, and its concrete steps are as follows:
1) preparation of celphere: can adopt centrifugal coating pelletizing machine, extrude spheronizator, the preparation of fluidized bed coating granulator;
2) bag active medicine layer: earlier with omeprazole, disintegrating agent, binding agent, alkali compounds, adding do not add surfactant, adding or do not add Pulvis Talci, purified water is made into the omeprazole suspension, spray is wrapped on the celphere again, can adopt the thin coating pan preparation of centrifugal coating pelletizing machine, fluidized bed coating granulator, atresia or porose high performance membrane;
3) bag sealing coat: earlier coating materials, magnesium oxide, titanium dioxide, Pulvis Talci are made into suspension with purified water, spray is wrapped on the above-mentioned pill again, can adopt the thin coating pan preparation of centrifugal coating pelletizing machine, fluidized bed coating granulator, atresia or porose high performance membrane;
4) enteric-coating layer: earlier enteric material, Pulvis Talci, plasticizer are made into enteric coating liquid with purified water, spray is wrapped on the pill that wraps sealing coat again, can adopt the thin coating pan preparation of centrifugal coating pelletizing machine, fluidized bed coating granulator, atresia or porose high performance membrane;
5) incapsulate by standard quantity, promptly get enteric coated omeprazole pellets capsule.
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