CN103585130B - Lansoprazole enteric capsule and preparation method thereof - Google Patents
Lansoprazole enteric capsule and preparation method thereof Download PDFInfo
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Abstract
The invention relates to the preparation field, in particular to a lansoprazole enteric capsule and a preparation method thereof, and aims to provide the ansoprazole enteric capsule and the preparation method thereof, reduce the complicated degree of an existing process and achieve purposes of stable release of the capsule at the small intestine part, stable and reliable quality and high bioavailability. The technical key point of the ansoprazole enteric capsule lies in material selection of a micro-capsule and control of the particle size of a capsule core material. The capsule core and a capsule material comprise components in parts by weight as follows: the capsule core comprises 45-50 parts of lansoprazole micro powder; and the capsule material comprises 4-6 parts of chitosan, 2-4 parts of Arabic gum and 3-5 parts of phthalic acid hydroxypropyl methyl cellulose. The capsule core material is a micronized lansoprazole active ingredient, optimally, the particle sizes of 95% of the micronized lansoprazole active ingredients are smaller than 6 mu m, the prepared capsule is high in encapsulation efficiency, drug loading efficiency and main drug dissolution rate and good in fluidity when the particle size of the lansoprazole active ingredient is micronized to be smaller than 6 mu m, and the releasing rate and the bioavailability of the drug can be improved.
Description
Technical field
The present invention relates to formulation art, be specifically related to a kind of lansoprazole intestine dissolving capsule and preparation method thereof.
Background technology
Lansoprazole; chemical name 2-(((3-methyl-4-(2; 2; 2-trifluoro ethoxy)-2-pyridine radicals) methyl) sulfinyl)-1H-benzimidazole, character is brownish white crystalline powder, is soluble in dimethylformamide; dissolve in methanol; be insoluble in ethanol, ether, water-soluble hardly, molecular formula: C
16h
14f
3n
3o
2s, molecular weight: 369.37, its structural formula is:
Lansoprazole is the 2nd the proton pump inhibitor class antiulcerative after omeprazole developed by Japanese Wu Tian Co., Ltd..Within 1992, first formally put on market in France by Japanese Wu Tian medicine Co., Ltd. and Houde company, obtain FDA approval May nineteen ninety-five and go on the market in the U.S..The clinical upper gastrointestinal hemorrhage be widely used in caused by Stomach duodenum pathological changes, can control ulcer symptoms rapidly and make ulcer healing, and indication has gastric ulcer, duodenal ulcer, reflux esophagitis, assistant one Emhorn syndrome etc.
Lansoprazole is extremely unstable in acid condition, under low pH environment in short-term in be namely degraded to non-active ingredient, therefore easily degrade in gastric acid environment.For improving the bioavailability of this medicine, enteric coated preparation need be prepared as and use.
Lansoprazole intestine dissolving capsule dosage form is one of most widely used dosage form, and the preparation technology of current lansoprazole intestine dissolving capsule agent loads capsule shells after being commonly and celphere coating three times (being respectively medicine clothing layer, contagion gown layer and enteric coating layer) being prepared as pastille enteric coated micropill and obtains.
Microcapsule technology a kind ofly utilizes macromolecule filming material (capsule material) that is natural or synthesis liquid or solid medicine (capsule core material) to be wrapped the technology of embedding formation diameter 1 ~ 5000 μm of tiny capsules, medicine can be made in vivo by spread and the form such as infiltration discharges in the position of setting, reach the effect of controlled release, drug effect can be played better.And the control of the selection of capsule material and capsule core material particle diameter plays vital impact to microcapsule success rate.
Coating of pellets technological requirement is higher, and preparation process is very complicated (needing coating three layers) comparatively, and microcapsule technology then can reduce technologic loaded down with trivial details, and reaches same also or better controlled-release effect.Therefore, inventor provides a kind of new lansoprazole intestine dissolving capsule preparation in conjunction with microcapsule technology.
Summary of the invention
Technical problem solved by the invention there is provided a kind of lansoprazole intestine dissolving capsule and preparation method thereof, reduces the fussy degree of existing technique, realizes in small intestine site Stable Release, steady quality is reliable, bioavailability is high object.
The key problem in technology point of lansoprazole intestine dissolving capsule of the present invention is that the capsule material of microcapsule is selected and controls capsule core material particle diameter.
The mixture of the preferred arabic gum of capsule material of the present invention, chitosan, Hydroxypropyl Methylcellulose Phathalate three, the weight proportion relation of mixture is: arabic gum 4 ~ 6 parts, chitosan 2 ~ 4 parts, Hydroxypropyl Methylcellulose Phathalate 3 ~ 5 parts, when applying the capsule material of this proportion relation, microencapsulation rate is high, carrying drug ratio is high, preparation controlled capability is excellent, can realize well substantially not discharging under one's belt, at the drug release behavior that small intestine site discharges rapidly.
Capsule core material of the present invention is micronized lansoprazole bulk drug, the preferred 95%<6 μm of its particle diameter, when crude drug micronization so far particle diameter time, preparation and the microencapsulation rate that obtains is high, carrying drug ratio is high, mobility is good, principal agent dissolution rate is high, can improve release and the bioavailability of medicine.
The concrete preparation method of lansoprazole intestine dissolving capsule of the present invention is as follows:
Lansoprazole intestine dissolving capsule, is characterized in that: the capsule heart and capsule material weight proportion as follows:
Described water is distilled water or deionized water;
Prepare capsule material and adopt proper amount of acetic acid solidification capsule material; Adopt appropriate sodium hydroxide adjust pH; Add suitable quantity of water as solvent and centrifugal water washing liquid.
Further preferably, the capsule heart and capsule material weight proportion as follows:
1) get chitosan with 2-5%(preferably 2%) acetum or 2-5%(preferably 2%) dissolve with hydrochloric acid solution, temperature controls at 45 ~ 50 DEG C;
Wherein, select acetic acid or hydrochloric acid to be convenient to chitosan and dissolve, further, acetate dissolution effect is better than hydrochloric acid.
2) separately get Arabic gelatin, Hydroxypropyl Methylcellulose Phathalate dissolves to obtain colloidal solution with suitable quantity of water, and in this colloidal solution, add micronized lansoprazole bulk drug be uniformly mixed;
3) by step 2) in obtained mixed liquor add rapidly in the chitosan solution that step 1) obtains, continue stirring 15 ~ 20min; Then adding temperature is 45 ~ 50 DEG C, and addition is the purified water of 2 ~ 3 times of volumes, and constantly stirs, and treats its natural cooling;
4) after its cooling, 10% ~ 20%(preferably 10% is added) acetic acid, add to mixed liquor pH value to 3.5 ~ 4.5, solidification 15 ~ 20min, then add 30% ~ 40% sodium hydroxide solution adjust ph to 9 ~ 10, continue to stir to obtain microcapsule solution, leave standstill 4 ~ 5h;
Judging to stir terminal, is whether obtain microcapsule solution by microscopic examination.
5) centrifugal after leaving standstill, rotating speed is 2400 ~ 3200r/min, centrifugation time 15 ~ 20min, rear abandoning supernatant; Add water again, centrifugal;
6) centrifugal for the step 5) precipitate obtained is placed in baking oven dry, baking temperature is 45 ~ 50 DEG C, obtains the solid-state microcapsule powder of lansoprazole, for subsequent use;
7) the microcapsule powder getting step 6) obtained is filled in capsule shells, to obtain final product.
Illustrate:
The acetum of 2-5% refers to percent by volume, namely refers to that 2 ~ 5ml glacial acetic acid is dissolved in 100ml water; The acetum of 2%, 10% ~ 20% acetic acid, 10% acetic acid all adopts percent by volume to represent.
The hydrochloric acid solution of 2-5% refers to percent by volume, namely refers to that 2 ~ 5ml concentrated hydrochloric acid is dissolved in 100ml water; The hydrochloric acid solution of 2% also all adopts percent by volume to represent.
30%-40% sodium hydroxide solution refers to percent weight in volume, namely refers to that 30-40g sodium hydroxide is dissolved in 100ml water.
Lansoprazole intestine dissolving capsule of the present invention can realize large-scale production, and production equipment is easier, and without the need to installations and facilities such as the fluid beds needed for current micropill technology, operation is comparatively simple, and all more excellent in release and bioavailability, and steady quality is reliable.
Detailed description of the invention
It is below the detailed description of the invention of lansoprazole intestine dissolving capsule of the present invention.
Lansoprazole intestine dissolving capsule of the present invention, the capsule heart and capsule material weight proportion as follows:
Described water is distilled water or deionized water; Prepare capsule material and adopt proper amount of acetic acid solidification capsule material; Adopt appropriate sodium hydroxide adjust pH; Add suitable quantity of water as solvent and centrifugal water washing liquid.
Further preferably, the capsule heart and capsule material weight proportion as follows:
1) get chitosan with 2-5%(preferably 2%) acetum or 2-5%(preferably 2%) dissolve with hydrochloric acid solution, temperature controls at 45 ~ 50 DEG C;
Wherein, select acetic acid or hydrochloric acid to be convenient to chitosan and dissolve, further, acetate dissolution effect is better than hydrochloric acid.
2) separately get Arabic gelatin, Hydroxypropyl Methylcellulose Phathalate dissolves to obtain colloidal solution with suitable quantity of water, and in this colloidal solution, add micronized lansoprazole bulk drug be uniformly mixed;
3) by step 2) in obtained mixed liquor add rapidly in the chitosan solution that step 1) obtains, continue stirring 15 ~ 20min; Then adding temperature is 45 ~ 50 DEG C, and addition is the purified water of 2 ~ 3 times of volumes, and constantly stirs, and treats its natural cooling;
4) after its cooling, 10% ~ 20%(preferably 10% is added) acetic acid, add to mixed liquor pH value to 3.5 ~ 4.5, solidification 15 ~ 20min, then add 30% ~ 40% sodium hydroxide solution adjust ph to 9 ~ 10, continue to stir to obtain microcapsule solution, leave standstill 4 ~ 5h; Judging to stir terminal, is whether obtain microcapsule solution by microscopic examination.
5) centrifugal after leaving standstill, rotating speed is 2400 ~ 3200r/min, centrifugation time 15 ~ 20min, rear abandoning supernatant; Add water again, centrifugal;
6) centrifugal for the step 5) precipitate obtained is placed in baking oven dry, baking temperature is 45 ~ 50 DEG C, obtains the solid-state microcapsule powder of lansoprazole, for subsequent use;
7) the microcapsule powder getting step 6) obtained is filled in capsule shells, to obtain final product.
Illustrate:
The acetum of 2-5% refers to percent by volume, namely refers to that 2 ~ 5ml glacial acetic acid is dissolved in 100ml water; The acetum of 2%, 10% ~ 20% acetic acid, 10% acetic acid all adopts percent by volume to represent.
The hydrochloric acid solution of 2-5% refers to percent by volume, namely refers to that 2 ~ 5ml concentrated hydrochloric acid is dissolved in 100ml water; The hydrochloric acid solution of 2% also all adopts percent by volume to represent.
30%-40% sodium hydroxide solution refers to percent weight in volume, namely refers to that 30-40g sodium hydroxide is dissolved in 100ml water.
Key technology point of the present invention is: the composition of capsule material and proportion relation thereof, larger to the enteric performance impact of the envelop rate of microcapsule, carrying drug ratio and preparation, therefore with microencapsulation rate, carrying drug ratio and vitro release for evaluation index, carry out contrast test investigation to the embodiment of different ratio relation capsule material and comparative example, result of the test refers to table 6 and table 9; 2. the micronized particle size range of capsule core material lansoprazole, larger on the impact of the mobility of microcapsule, the vitro release of preparation and bioavailability, therefore with microcapsule powder angle of repose, vitro release and bioavailability for evaluation index, carry out contrast test investigation to the embodiment and comparative example that use different-grain diameter scope principal agent, result of the test refers to table 7 ~ 9.
Embodiment 1 prescription:
Table 1 embodiment 1 prescription
Make 10000 altogether
Embodiment 2 prescription:
Table 2 embodiment 2 prescription
Make 10000 altogether
Embodiment 3 prescription:
Table 3 embodiment 3 prescription
Make 10000 altogether
Following comparative example 1 ~ 4 only capsule material component ratio is different from the present invention, and all the other components and consumption and preparation method are all consistent with embodiment, and its capsule material ratio refers to table 4; Comparative example 5 ~ 8 is that principal agent lansoprazole micronization particle diameter is different, all the other components and consumption and preparation method all consistent with embodiment, its particle size range refers to table 5:
Table 4
| Sample | Arabic gum (part) | Chitosan (part) | Hydroxypropyl Methylcellulose Phathalate (part) |
| Comparative example 1 | 4 | 3 | 3 |
| Comparative example 2 | 1 | 1 | 1 |
| Comparative example 3 | 2 | 1 | 1 |
| Comparative example 4 | 2 | 1 | 2 |
Table 5
| Sample | Comparative example 5 | Comparative example 6 | Comparative example 7 | Comparative example 8 |
| Principal agent particle size range | 95%<4μm | 95%<5μm | 95%<7μm | 95%<8μm |
The investigation of one, microencapsulation rate and carrying drug ratio:
Take the microcapsule powder before loading capsule shells in right amount in beaker, add assay mobile phase, supersound process 15 ~ 20min, measure drug content in microcapsule by HPLC method, and calculating microcapsules medicine amount, the ratio of the quality of microcapsules medicine amount and microcapsule is the carrying drug ratio of microcapsule; To calculate gained microcapsules medicine amount than total dosage, obtain the envelop rate of microcapsule.
The microcapsule carrying drug ratio of embodiment 1 ~ 3 and comparative example 1 ~ 4 and envelop rate experimental result are in table 6:
Table 6
| Sample | Carrying drug ratio (%) | Envelop rate (%) |
| Embodiment 1 | 69.27 | 82.13 |
| Embodiment 2 | 71.02 | 80.91 |
| Embodiment 3 | 70.58 | 80.28 |
| Comparative example 1 | 64.37 | 68.26 |
| Comparative example 2 | 42.59 | 45.29 |
| Comparative example 3 | 53.86 | 62.45 |
| Comparative example 4 | 55.02 | 67.80 |
The above results shows, and embodiment of the present invention microcapsule carrying drug ratio reaches more than 70% substantially, and envelop rate is more than 80%, and obviously comparatively embodiment is low for comparative example, can judge that the inventive method controls on microcapsule carrying drug ratio and envelop rate all right, obviously be better than comparative example.
Two, microcapsule mobility
Injection method (material is flowed out to fall within plane by funnel and forms cone, and cone base angle is angle of repose) is adopted to measure the angle of repose of microcapsule powder prepared by embodiment and comparative example in this research.
The microcapsule mobility experimental result of embodiment 1 ~ 3 and comparative example 5 ~ 8 is in table 7:
Table 7
| Sample | Embodiment 1 | Embodiment 2 | Embodiment 3 | Comparative example 5 | Comparative example 6 | Comparative example 7 | Comparative example 8 |
| Angle of repose | 25° | 25° | 23° | 37° | 32° | 22° | 20° |
The above results shows, and the mobile phase of embodiment 1 ~ 3 and comparative example 7,8 is all better, and the mobile phase of comparative example 5,6 is a bit weaker.
Three, bioavailability study
With commercially available product lansoprazole intestine dissolving capsule (Takepron, Tianjin Wu Tian medicine company limited) be reference preparation, adopt single dose dual crossing experimental design, grouping is to NAM snibject, medication dose is 30mg/ people, overnight fasting (more than 12h) before taking medicine, and second day morning is with 200mL warm water delivery service medicine, can drink water again after 2h, the laggard unified meal of 4h; And respectively at before taking medicine and after taking medicine 0.5,1,1.5,2,2.5,3,4,5,6,8,10,12h takes a blood sample 5mL respectively, puts in heparinised tubes, leaves standstill 30min, centrifugal, get blood plasma put preserve in-20 DEG C of refrigerators to be measured.Adopt DAS software kit to carry out date processing, relative bioavailability computing formula is:
F={[D
R×AUC
(0-12)T]/[D
T×AUC
(0-12)R]}×100%
The bioavailability experimental result of embodiment 1 ~ 3 and comparative example 5 ~ 8 is in table 8:
Table 8
| Sample | Reference preparation | Embodiment 1 | Embodiment 2 | Embodiment 3 | Comparative example 5 | Comparative example 6 | Comparative example 7 | Comparative example 8 |
| Fr(%) | 100 | 98 | 97 | 96 | 91 | 89 | 85 | 82 |
The above results shows, the bioavailability of the embodiment of the present invention is substantially consistent with current commercially available product, and the relative bioavailability of the comparative example 5 ~ 8 of lansoprazole bulk drug micronization particle size range not within the scope of application claims is slightly lower, therefore can think that comparative example bioavailability is not as good as the embodiment of the present invention.
Four, vitro release experiment
Instruct requirement with reference to delayed release formulation in 2010 editions Chinese Pharmacopoeias two annex XIX D slow release, controlled release and delayed release formulation guidelines, carry out the test of vitro drug release degree.
Experimental design is main to carry out with reference to the method 1 in 2010 editions Chinese Pharmacopoeias, two annex X D drug release determination method second methods: measure 0.1mol/L hydrochloric acid solution 750ml(and simulate simulated gastric fluid) inject each stripping rotor, constant temperature is at 37 DEG C ± 0.5 DEG C, get 6 respectively drop into turn in basket, rotating speed 150r/min, sample after 2h, calculate release in the acid of every; After in above-mentioned acid solution, add the 0.2mol/L sodium radio-phosphate,P-32 solution 250ml that temperature is 37 DEG C ± 0.5 DEG C, and be that 6.8 ± 0.05(simulates simulated intestinal fluid with 5mol/L hydrochloric acid or 5mol/L sodium hydroxide adjust pH), operate with method, sample respectively at after 0.5h, 1h, calculate every sheet release in buffer (pH6.8).
Embodiment 1 ~ 3 and comparative example 1 ~ 8 vitro release experimental result are in table 9:
Table 9
The above results shows, and embodiment 1 ~ 3 prepared by the present invention is without release in acid solution, and in the buffer of pH6.8, release increases rapidly, and after the release after 30min reaches more than 85%, 1h substantially, release reaches more than 95% substantially; Comparative example 1 ~ 4 capsule material formula ratio is not within the scope of application claims, and its In Vitro Dissolution differs greatly, and even have situation about discharging in acid solution to occur, the buffer 1h cumulative release amount of pH6.8 is all not as good as the embodiment of the present invention; Comparative example 5 ~ 8 be principal agent crude drug micronization particle diameter not within the scope of application claims, wherein comparative example 5,6 release behavior can manage it, and the buffer 1h cumulative release amount of pH6.8 can reach more than 91%; Then comparatively embodiment is slightly poor for the release of comparative example 7,8.Therefore comparative example release in vitro effect is not as good as the embodiment of the present invention.
To sum up, the microencapsulation rate of lansoprazole intestine dissolving capsule of the present invention is high, carrying drug ratio is high, microcapsule mobility is good, release in vitro behavior good stable, bioavailability are high.
Claims (8)
1. lansoprazole intestine dissolving capsule, is characterized in that: weight proportion is as follows:
The preparation method step of described lansoprazole intestine dissolving capsule is as follows:
1) get chitosan with 2-5% acetum or 2-5% dissolve with hydrochloric acid solution, temperature controls at 45 ~ 50 DEG C;
2) separately get arabic gum, Hydroxypropyl Methylcellulose Phathalate dissolves to obtain colloidal solution with suitable quantity of water, and in this colloidal solution, add micronized lansoprazole bulk drug be uniformly mixed;
3) by step 2) in obtained mixed liquor add step 1 rapidly) in the chitosan solution that obtains, continue stirring 15 ~ 20min; Then adding temperature is 45 ~ 50 DEG C, and addition is the purified water of 2-3 times of volume, and constantly stirs, and treats its natural cooling;
4) after its cooling, add 10% ~ 20% acetic acid, add to mixed liquor pH value to 3.5 ~ 4.5, solidification 15 ~ 20min, then add 30-40% sodium hydroxide solution adjust ph to 9 ~ 10, continue to stir to obtain microcapsule solution, leave standstill 4 ~ 5h;
5) centrifugal after leaving standstill, rotating speed is 2400 ~ 3200r/min, centrifugation time 15 ~ 20min, rear abandoning supernatant; Add water again, centrifugal;
6) by step 5) to be placed in baking oven dry for the centrifugal precipitate obtained, and baking temperature is 45 ~ 50 DEG C, obtains the solid-state microcapsule powder of lansoprazole, for subsequent use;
7) step 6 is got) obtained microcapsule powder is filled in capsule shells, to obtain final product.
2. lansoprazole intestine dissolving capsule according to claim 1, is characterized in that: described lansoprazole grain size of micropowder is 95%<6 μm.
3. the preparation method of the lansoprazole intestine dissolving capsule described in claim 1 or 2, is characterized in that: step is as follows:
1) get chitosan with 2-5% acetum or 2-5% dissolve with hydrochloric acid solution, temperature controls at 45 ~ 50 DEG C;
2) separately get arabic gum, Hydroxypropyl Methylcellulose Phathalate dissolves to obtain colloidal solution with suitable quantity of water, and in this colloidal solution, add micronized lansoprazole bulk drug be uniformly mixed;
3) by step 2) in obtained mixed liquor add step 1 rapidly) in the chitosan solution that obtains, continue stirring 15 ~ 20min; Then adding temperature is 45 ~ 50 DEG C, and addition is the purified water of 2-3 times of volume, and constantly stirs, and treats its natural cooling;
4) after its cooling, add 10% ~ 20% acetic acid, add to mixed liquor pH value to 3.5 ~ 4.5, solidification 15 ~ 20min, then add 30-40% sodium hydroxide solution adjust ph to 9 ~ 10, continue to stir to obtain microcapsule solution, leave standstill 4 ~ 5h;
5) centrifugal after leaving standstill, rotating speed is 2400 ~ 3200r/min, centrifugation time 15 ~ 20min, rear abandoning supernatant; Add water again, centrifugal;
6) by step 5) to be placed in baking oven dry for the centrifugal precipitate obtained, and baking temperature is 45 ~ 50 DEG C, obtains the solid-state microcapsule powder of lansoprazole, for subsequent use;
7) step 6 is got) obtained microcapsule powder is filled in capsule shells, to obtain final product.
4. the preparation method of lansoprazole intestine dissolving capsule according to claim 3, is characterized in that: step 1) get chitosan and dissolve with 2-5% acetum.
5. the preparation method of lansoprazole intestine dissolving capsule according to claim 4, is characterized in that: step 1) get chitosan and dissolve with 2% acetum.
6. the preparation method of lansoprazole intestine dissolving capsule according to claim 3, is characterized in that: step 4) adopt 10% acetic acid adjust pH to 3.5 ~ 4.5; Adopt 40% sodium hydroxide solution adjust pH to 9 ~ 10.
7. the preparation method of lansoprazole intestine dissolving capsule according to claim 3, is characterized in that: step 5) centrifugal condition: rotating speed is 2400r/min, centrifugation time 15min.
8. the preparation method of lansoprazole intestine dissolving capsule according to claim 3, is characterized in that: step 3) adopt the purified water of addition 2 times of volumes.
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