CN104146977B - A kind of pantoprazole sodium enteric tablet and preparation method thereof - Google Patents
A kind of pantoprazole sodium enteric tablet and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a kind of pantoprazole sodium enteric tablet and preparation method thereof, the present invention is by prescription, the production technology to pantoprazole sodium enteric tablet label, study with sealing coat, enteric layer art for coating, obtain the process choice of best prescription, optimised process prescription and sealing coat, enteric coat layer, the pantoprazole sodium enteric tablet made on this basis, good stability, acid-resistant strength and release well, improve bioavailability.And simple process, stable, be applicable to the requirement of the large production of technology.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, particularly, relate to a kind of pantoprazole sodium enteric tablet and preparation method thereof.
Background technology
Pantoprazole (Pantoprazole), its chemistry is by name, 5-difluoro-methoxy-2-[(3,4-dimethoxy-2-pyridinyl) methyl] sulfinyl-1H-benzimidazole, and chemical structural formula is as follows:
Molecular formula: C
16h
15f
2n
3o
4s molecular weight: 383.37.Be the 3rd the PPI medicine developed by German Byk Gulden pharmaceutical factory, October nineteen ninety-five, pantoprazole specific effect, in gastric mucosa parietal cell, reduced H in parietal cell first in Germany's listing
+-K
+-atpase activity, thus gastric acid secretion inhibiting effectively.The clinical treatment for gastric ulcer, duodenal ulcer, Reflux exophagitis.
Pantoprazole is to proton pump H
+-K
+-ATP enzyme has high selectivity and irreversible inhibitory action, the activity of inhibitory enzyme, effectively gastric acid secretion inhibiting.Alleviate the pain symptom of duodenal ulcer patients simultaneously, to ulcer adjoint feel sick, the symptom such as abdominal distention, acid regurgitation, belch improves significantly, and promotes the reparation of ulcer.Under neutral or solutions of weak acidity (pH value is 3.5 ~ 7.4) comparatively omeprazole stablize, and under strongly acidic conditions can prompt activation, effect strengthens, and to the affinity of liver cytochrome P 450, comparatively omeprazole is low, is few with other by the interaction of the medicine of enzymes metabolism.
Pantoprazole Sodium, its chemical name is the sub-Huang Xian Ji ﹜-1H-benzimidazole sodium-water of 5-=difluoro-methoxy-2-﹛ " (3,4-=dimethoxy-2-pyridinyl) methyl " and thing.Chemical structural formula is as follows:
Molecular formula: C
16h
14f
2n
3naO
4sH
2o, molecular weight: 423.38.
Pantoprazole Sodium is unstable, easy to change under neutrality and acid condition; Hygroscopicity is strong, all comparatively responsive to light, heat, so the preparation method adopting conventional plain sheet enteric coated, tablet is easy to change, and release is unstable.Therefore, urgently improve the preparation technology of pantoprazole sodium enteric tablet, thus improve acid-resistant strength and release, make its quality keep stable.
Summary of the invention
The present invention is directed to problems of the prior art, by the prescription to pantoprazole sodium enteric tablet label, production technology, study with sealing coat, enteric layer art for coating, obtain the process choice of best prescription, optimised process prescription and sealing coat, enteric coat layer, the pantoprazole sodium enteric tablet made on this basis, good stability, acid-resistant strength and release well, improve bioavailability.And simple process, stable, be applicable to the requirement of the large production of technology.
Technical solution of the present invention is as follows: Pantoprazole Sodium and pharmaceutically acceptable auxiliaries are made label, and label first carries out sealing coat coating, finally carries out enteric layer coating again, and described label comprises medicine and the excipient ingredients of following weight proportion:
Described sealing coat and enteric layer film coating:
Pantoprazole sodium enteric tablet preparation technology of the present invention is as follows:
(1) cross 100 mesh sieves after first being pulverized by natrium carbonicum calcinatum, hydroxypropyl cellulose (HPC) crosses l00 mesh sieve; Calculate the amount of required supplementary material according to prescription and batch, take raw material Pantoprazole Sodium, mix in wet mixing pelletizer with adjuvant natrium carbonicum calcinatum, hydroxypropyl cellulose, mannitol, polyvinylpolypyrrolidone etc., incorporation time 3 minutes;
(2) add purified water, soft material processed, 60 seconds wet mixing time, from wet mixing pelletizer, release wet granular, cross 16 mesh sieves and make granule;
(3) wet granular is put 50 DEG C of oven dry, granule after oven dry is crossed 18 mesh sieve cylinder granulate;
(4) after uniform particles, weigh, be put in mixer, the magnesium stearate of additional grain amount 1%, mixing, incorporation time 10 minutes;
(5) measure granule content after mixing, calculate the theoretical tablet weight;
(6) with diameter 8mm shallow concave punch tabletting, and the project conformance with standard regulations such as test film weight, outward appearance, release, content;
(7) film coating: first prepare sealing coat and enteric layer coating solution according to prescription and tabletting quantity: then get plain sheet and be placed in coating pan, first carry out sealing coat coating, then carry out enteric layer coating.
In the present invention, sealing coat used and enteric layer pharmaceutical films coating premixing auxiliary material are commercially available prod, wherein the compound method of sealing coat coating solution is: calculate with every 1000 Pantoprazole Sodiums element sheet, by isolated layer film coating premixing auxiliary material 12.8g, slowly add in 60% alcoholic solution 147.2g, add in 3-5min, after stirring 45-60min, adjustment mixing speed is to coating solution at integral-rotation, and stirring is maintained to coating spray and terminates.The compound method of enteric layer coating solution is: calculate with every 1000 Pantoprazole Sodiums element sheet, by enteric layer film-coating premixing auxiliary material 19.19g, slowly add in 80% alcoholic solution 220.69g, add in 3-5min, after stirring 1h-2h, adjustment mixing speed is to coating solution at integral-rotation, and stirring is maintained to coating spray and terminates.Coating solution pH value is between 6.5-7.5.
Described sealing coat and enteric layer coating process parameters are: rotating speed is that 2-8 per minute turns, kettle temperature is 40-80 DEG C, on continuous spray sealing coat coating solution to plain sheet, sheet bed tempertaure 40-50 DEG C, atomizing pressure 0.2-0.3MPa, spouting velocity 20-30ml/min, evenly wraps thin film clothing, and coating to sealing coat weightening finish is 6%-8%; Then according to above-mentioned steps spray enteric coating layer, inlet temperature 37-43 DEG C, atomizing pressure 0.25MPa, spouting velocity 30-50ml/min, enteric layers weightening finish 10% after coating.
Present inventors studied the impact of processing parameter on pantoprazole sodium enteric tablet release.The quality of label quality directly affects coating whether success and end product quality.With diameter 8mm shallow concave punch tabletting in the present invention, label is shallow camber, and unilateral so do not exist the caducous sharp corner of appearance, slice, thin piece can not wear and tear in coating process, in coating pan, easily evenly rolling, makes every a slice can receive the coating solution of sprinkling, keeps good coating effect.If label corner collapses scarce more in coating process, then directly can have influence on the Antacid effectiveness of enteric coating layer.
According to the requirement of enteric coated tablet dosage form and adjuvant performance, in the certain thickness enteric coating layer of label surface coverage, enteric coatel tablets could be resisted the erosion of hydrochloric acid solution (0.1mol/L) long period and the change of the aspect such as variable color, crackle can not occur.The present inventor repeatedly research in determine coating weight gain the suitableeest be 10%.
Enteric layer coating temperature also can have a certain impact to the quality of enteric coatel tablets.The present inventor finds, when temperature is lower than 35 DEG C, easily occurs bonding die phenomenon, higher than easily occurring when 43 DEG C that spraying dry, product do not increase weight or increase weight phenomenon bigger than normal, is 37 DEG C-43 DEG C by repetition test determination coating preference temperature.
The present invention is also to sealing coat, casing liquid and coating process parameters, the parameters such as spray velocity, atomisation pressure, coating pan rotating speed are adjusted, the coating weight gain after plain sheet parcel sealing coat is controlled at 6%-8% by these adjustment, loss on drying controls within 2%, and enteric coating weightening finish is 10%.The pantoprazole sodium enteric tablet that the present invention obtains has good acid-resistant strength and release, and finished product acid-resistant strength reaches more than 95%, and release, more than 90%, meets " Chinese Pharmacopoeia " version in 2010 to the requirement of enteric coatel tablets.Product quality keeps stable, is convenient to store and transport, is beneficial to clinical practice.The inventive method is simple, is suitable for suitability for industrialized production, has larger using value.
Moreover, the present inventor finds that adding alginic acid and/or sodium alginate and/or chitosan/sodium alginate complex when preparing label plays beyond thought effect under study for action.The present inventor studies and finds that alginic acid is as disintegrating agent, adds the release that can significantly improve pantoprazole sodium enteric tablet in label.The effect that sodium alginate not only has binding agent also has the effect promoting disintegration of tablet.Chitin-sodium alginate composite powder is unformed shape, its good hygroscopicity, can improve the stability of Pantoprazole Sodium in film-making process, and disintegrating property is good, improves the release of enteric coatel tablets.Alginic acid or sodium alginate or chitosan/sodium alginate complex is added in pelletization, technical process is simple, not only release is higher for obtained tablet, the mechanical strength of label is also larger, plain tablet quality is obtained higher when tabletting, be more conducive to carrying out smoothly of next step art for coating, the high-quality enteric coatel tablets of final acquisition.
Therefore, the label of pantoprazole sodium enteric tablet of the present invention can also be, comprises medicine and the excipient ingredients of following weight proportion:
As previously mentioned, difference only adds one or more in alginic acid, sodium alginate, chitosan/sodium alginate complex in step (1), jointly mixes in mixer-granulator for sealing coat used and enteric layer film coating and preparation technology.
The present invention has following beneficial effect:
1, safety is good
For better ensureing the quality of this product, the present invention adopts principal agent first to mix with adjuvant, and Pantoprazole Sodium is wrapped up by adjuvant, then adds purified water granulation.This technique is simple, feasible, and avoids pantoprazole sodium raw materials and adjuvant mixing wet granulation to impact that is wet, light and heat, can better ensure the steady quality of Pantoprazole Sodium sheet.The moisture absorption of principal agent Pantoprazole Sodium can be effectively avoided to decompose, especially after adding chitin-sodium alginate composite powder, due to chitin-sodium alginate composite powder good hygroscopicity, can moisture in absorbing environmental, fully ensure Drug safety and effectiveness.
2, effective component content is high
Pantoprazole sodium enteric tablet active ingredient of the present invention is with pantoprazole (C
16h
15f
2n
3o
4s) count, and current existing kind is with Pantoprazole Sodium (C
16h
14f
2n
3naO
4sH
2o) count, the present invention is many compared with existing kind active ingredient, better ensure that the effectiveness of this product, improves its bioavailability.
3, release is good
In general enteric coating layer weightening finish is larger, and acid-resistant strength is stronger, but release can be made to reduce simultaneously; Coating temperature is too low, occurs bonding die, and coating temperature is higher, and acid-resistant strength is more weak, and release is larger.So art for coating has considerable influence for pantoprazole sodium enteric tablet stability and release.The present invention has filtered out the process choice of best prescription, optimised process prescription and sealing coat, enteric coat layer, the pantoprazole sodium enteric tablet made on this basis, and carried out influence factor's test, accelerated test, long term test, content and related substance have no obvious change, and release is good.It is easy that this law prepares pantoprazole sodium enteric tablet formulation and technology, stable, is applicable to the requirement of the large production of technology.
4, cost is low
The present invention's adjuvant used is few, and cheap and easy to get, both can ensure drug quality, and again reduce cost of drugs, meets people's medication demand.
Detailed description of the invention
Now further describe beneficial effect of the present invention by following examples, embodiment is only for the object of illustration, do not limit the scope of the invention, the simultaneously apparent change made according to the present invention of those of ordinary skill in the art and modification are also contained within the scope of the invention.In the present invention, component used is commercially available finished product.
Embodiment 1, a kind of pantoprazole sodium enteric tablet, every 1000 composed as follows,
Label:
Sealing coat and enteric layer film coating:
Preparation technology is as follows:
(1) cross 100 mesh sieves after first being pulverized by natrium carbonicum calcinatum, hydroxypropyl cellulose (HPC) crosses l00 mesh sieve; Calculate the amount of required supplementary material according to prescription and batch, take raw material Pantoprazole Sodium, mix in wet mixing pelletizer with adjuvant natrium carbonicum calcinatum, hydroxypropyl cellulose, mannitol, polyvinylpolypyrrolidone etc., incorporation time 3 minutes;
(2) add purified water, soft material processed, 60 seconds wet mixing time, from wet mixing pelletizer, release wet granular, cross 16 mesh sieves and make granule;
(3) wet granular is put 50 DEG C of oven dry, granule after oven dry is crossed 18 mesh sieve cylinder granulate;
(4) after uniform particles, weigh, be put in mixer, the magnesium stearate of additional grain amount 1%, mixing, incorporation time 10 minutes;
(5) measure granule content after mixing, calculate the theoretical tablet weight;
(6) with diameter 8mm shallow concave punch tabletting, and the project conformance with standard regulations such as test film weight, outward appearance, release, content;
(7) film coating: first prepare sealing coat and enteric layer coating solution according to prescription and tabletting quantity: the preparation of sealing coat coating solution, calculate with every 1000 Pantoprazole Sodiums element sheet, by isolated layer film coating premixing auxiliary material 12.8g, slowly add in 60% alcoholic solution 147.2g, add in 3-5min, after stirring 45-60min, adjustment mixing speed is to coating solution at integral-rotation, and stirring is maintained to coating spray and terminates; The preparation of enteric layer coating solution, calculate with every 1000 Pantoprazole Sodiums element sheet, by enteric layer film-coating premixing auxiliary material 19.19g, slowly add in 80% alcoholic solution 220.69g, add in 3-5min, after stirring 1h-2h, adjustment mixing speed is to coating solution at integral-rotation, and stirring is maintained to coating spray and terminates.Then getting plain sheet is placed in coating pan, rotating speed is that 2-8 per minute turns, kettle temperature is 40-80 DEG C, on continuous spray sealing coat coating solution to plain sheet, sheet bed tempertaure 40-50 DEG C, atomizing pressure 0.2-0.3MPa, spouting velocity 20-30ml/min, evenly wrap thin film clothing, coating to sealing coat weightening finish is 6%-8%.Then according to above-mentioned steps spray enteric coating layer, inlet temperature 37-43 DEG C, atomizing pressure 0.25MPa, spouting velocity 30-50ml/min, enteric layers weightening finish 10% after coating.
Embodiment 2, a kind of pantoprazole sodium enteric tablet, every 1000 composed as follows,
Label:
Sealing coat and enteric layer film coating:
Preparation technology is identical with embodiment one.
Embodiment 3, a kind of pantoprazole sodium enteric tablet, every 1000 composed as follows,
Label:
Sealing coat and enteric layer film coating:
Preparation technology is identical with embodiment one.
Embodiment 4, a kind of pantoprazole sodium enteric tablet, every 1000 composed as follows,
Label:
Sealing coat and enteric layer film coating:
Preparation technology is identical with embodiment one.
Embodiment 5, a kind of pantoprazole sodium enteric tablet, every 1000 composed as follows,
Label:
Sealing coat and enteric layer film coating:
Preparation technology is identical with embodiment one.
Embodiment 6, a kind of pantoprazole sodium enteric tablet, every 1000 composed as follows,
Label:
Sealing coat and enteric layer film coating:
Preparation technology is identical with embodiment one.
Wherein chitosan used/sodium alginate complex preparation method: the HAc-NaAc buffer solution of preparation PH=5, dissolve chitosan, sodium alginate respectively, stirring is spent the night, and makes the solution of w=0.5%.Chitosan solution is slowly added in sodium alginate soln, stirring is spent the night, obtain complex gel, complex gel vacuum dehydration, then powder is loaded in bag filter, dialyse to remove the inorganic salt be mingled with in complex in pure water, vacuum drying is pulverized again, crosses 80 mesh sieves and obtains chitosan/sodium alginate composite powder.
Embodiment 7, a kind of pantoprazole sodium enteric tablet, every 1000 composed as follows,
Label:
Sealing coat and enteric layer film coating:
Preparation technology is identical with embodiment one.
Test example one, investigation enteric coating layer coating weight gain are on the impact of pantoprazole sodium enteric tablet release
According to the requirement of enteric coated tablet dosage form and adjuvant performance, in the certain thickness enteric coating layer of label surface coverage, enteric coatel tablets could be resisted the erosion of hydrochloric acid solution (0.1mol/L) long period and the change of the aspect such as variable color, crackle can not occur.Adopt proportioning and the technique of embodiment 1, design coating weight gain is respectively 8%, 9%, 10%, 11%, 12%, investigates the release of coated tablet.Result is as shown in table 1:
The pantoprazole sodium enteric tablet release of the different enteric coating layer coating weight gain of table 1
Research find, coating weight gain lower than 9% time, coating material can not cover label comprehensively, and part tablet, when doing acid resistance test, produces variable color and crackle in hydrochloric acid solution, cannot reach enteric requirement; When coating weight gain is excessive, tablet disintegration time in buffer extends, and release reduces until undesirable.So determine in the present invention coating weight gain the suitableeest be 10%.
Test example two, investigation enteric coating layer coating temperature are on the impact of pantoprazole sodium enteric tablet release
Adopt the proportioning of embodiment 1 and technique, coating temperature is set to 30 DEG C respectively, 35 DEG C, 37 DEG C, 39 DEG C, 41 DEG C, 43 DEG C, 45 DEG C, according to preceding method coating of the present invention, investigates the release of medicine at different coating temperature.Result is as shown in table 2
The pantoprazole sodium enteric tablet release of table 2 different enteric coating layer coating temperature
Research finds, when temperature is lower than 35 DEG C, easily occurs bonding die phenomenon, higher than easily occurring when 43 DEG C that spraying dry, product do not increase weight or increase weight phenomenon bigger than normal.When release result shows that coating temperature is between 37 DEG C-43 DEG C, release is good, and at this range of temperature on release almost without affecting.Therefore determine that coating preference temperature is 37 DEG C-43 DEG C.
Test example three, influence factor's test
Get the pantoprazole sodium enteric tablet that the present invention is made, test as follows:
(1) air exposure test: sample thief, unlap, exposes under room temperature condition, respectively at sampling in 0,5,10 day, detects by stability high spot reviews project.Result of the test is in table 3.
(2) hot test: sample thief, unlap, places under temperature 60 C condition, respectively at sampling in 0,5,10 day, detects by stability high spot reviews project.Result of the test is in table 4.
(3) high humility test: sample thief, unlap, sample is put in constant humidity hermetic container, sample opening 25 DEG C respectively at relative humidity 90% ± 5% condition under place, respectively at sampling in the 0th, 5,10 day, by stability high spot reviews item inspection and mensuration, and compare with the result of 0 day, observe sample stability under high humidity conditions.Result of the test is in table 5.
(4) strong illumination test: sample thief, unlap, 4500Lx illumination under room temperature condition, respectively at sampling in 0,5,10 day, detects by stability high spot reviews project.Result of the test is in table 6.
Table 3 air exposure result of the test
Table 4 hot test (60 DEG C) result
Table 5 high humility test (90% ± 5%) result
Table 6 strong illumination test (4500LX ± 500LX) result
Result of the test shows, under strong illumination, hot conditions, except related substance slightly raise, except content slightly declines, the change of other project is less.As can be seen here, all batch sample indices obtained through above-mentioned prescription all meet the requirements, and illustrate that present invention process repeatability is good, are suitable for large-scale industrial production.
Test example four, investigation add alginic acid and/or sodium alginate and/or chitosan/sodium alginate complex to the impact of pantoprazole sodium enteric tablet release
1, prescription composition
2, drug release determination
Drug release determination method is according to [Chinese Pharmacopoeia version in 2010 two annex XD second methods (2)], Pantoprazole Sodium sheet is put into phosphate buffer (pH6.8) 1000ml of heat to 37 DEG C in advance, adopt dissolution method first method device, rotating speed be the minute 100 turns.Operate in accordance with the law, through 45 minutes time, get solution 20ml, filter, get subsequent filtrate, according to spectrophotography (Chinese Pharmacopoeia version in 2010 two annex IV A), measure trap; Another precision takes pantoprazole reference substance 15mg, puts in 1000ml measuring bottle, adds methanol 2ml and makes dissolving, and be diluted to scale with phosphate buffer (pH6.8), shake up, product solution, is measured in the same method in contrast.Calculate the release percentage rate of every sheet, the results are shown in Table 7:
The Pantoprazole Sodium sheet release of the different prescription of table 7
Result adds alginic acid or sodium alginate or chitosan/sodium alginate composite and plays beyond thought effect when showing to prepare label.Dissolution significantly improves.
Sodium alginate just takes in American Pharmacopeia as far back as 1938.Alginic acid is at 1963 annual income British Pharmacopoeias.Alginic acid is water insoluble, but puts into water and can expand, and usual alginic acid is used as the disintegrating agent of fast-release tablet, and sodium alginate is used as the binding agent of tablet.And the present inventor finds to add the disintegrate that alginic acid and sodium alginate all can promote tablet in enteric coatel tablets.And alginic acid and/or sodium alginate add in the process of granulating, instead of add in the form of a powder after granulation, such manufacturing process is simpler.Compared with not adding the tablet of alginic acid and/or sodium alginate, made mechanical strength in blocks is larger.And sodium alginate acid labile, medicine can be made from the attack of gastric acid, and medicine can be made in small intestinal with the speed expected release.
Chitosan and sodium alginate can pass through electrostatic interaction compound.Sodium alginate is a kind of natural polyanions compound, contains α-Isosorbide-5-Nitrae structure L-type guluronic acid and β-Isosorbide-5-Nitrae structure D type mannuronic acid two kinds of construction units in its strand.Chitosan is a kind of Natural polycations compound, and it and sodium alginate can form compound polyelectrolyte by electrostatic interaction.Both are natural polymer, have the advantages such as nontoxic, good biocompatibility.Chitin-sodium alginate composite powder is unformed shape, good hygroscopicity, and saturated hygroscopicity is more than 70%, and the present inventor finds that it can improve the stability of Pantoprazole Sodium in film-making process, and disintegrating property is good, improves the release of enteric coatel tablets.
Claims (3)
1. a pantoprazole sodium enteric tablet, makes label by Pantoprazole Sodium and pharmaceutically acceptable auxiliaries, and label first carries out sealing coat coating, finally carries out enteric layer coating again, and described label comprises medicine and the excipient ingredients of following weight proportion:
Wherein the content of Pantoprazole Sodium is with C
16h
15f
2n
3o
4s counts;
Described sealing coat and enteric layer film coating:
Pantoprazole Sodium element sheet 1000
Sealing coat pharmaceutical films coating premixing auxiliary material 12.8g, prepares with 60% alcoholic solution 147.2g
Enteric layer pharmaceutical films coating premixing auxiliary material 19.19g, prepares with 80% alcoholic solution 220.69g.
2. pantoprazole sodium enteric tablet as claimed in claim 1, it is characterized in that, described label comprises medicine and the excipient ingredients of following weight proportion:
Wherein the content of Pantoprazole Sodium is with C
16h
15f
2n
3o
4s counts.
3. the preparation method of pantoprazole sodium enteric tablet as claimed in claim 1 or 2, it is characterized in that, technique is as follows:
(1) cross 100 mesh sieves after first being pulverized by natrium carbonicum calcinatum, hydroxypropyl cellulose crosses l00 mesh sieve; The amount of required supplementary material is calculated according to prescription and batch, take raw material Pantoprazole Sodium, with adjuvant natrium carbonicum calcinatum, hydroxypropyl cellulose, mannitol, polyvinylpolypyrrolidone, one or more in alginic acid, sodium alginate, chitosan/sodium alginate complex mix in wet mixing pelletizer, incorporation time 3 minutes;
(2) add purified water, soft material processed, 60 seconds wet mixing time, from wet mixing pelletizer, release wet granular, cross 16 mesh sieves and make granule;
(3) wet granular is put 50 DEG C of oven dry, granule after oven dry is crossed 18 mesh sieve cylinder granulate;
(4) after uniform particles, weigh, be put in mixer, the magnesium stearate of additional grain amount 1%, mixing, incorporation time 10 minutes;
(5) measure granule content after mixing, calculate the theoretical tablet weight;
(6) with diameter 8mm shallow concave punch tabletting, and test film weight, outward appearance, release, content project conformance with standard regulation;
(7) film coating: first prepare sealing coat and enteric layer coating solution according to prescription and tabletting quantity: then get plain sheet and be placed in coating pan, first carry out sealing coat coating, then carry out enteric layer coating;
The compound method of described sealing coat coating solution is: calculate with every 1000 Pantoprazole Sodiums element sheet, by isolated layer film coating premixing auxiliary material 12.8g, slowly add in 60% alcoholic solution 147.2g, add in 3-5min, after stirring 45-60min, adjustment mixing speed is to coating solution at integral-rotation, and stirring is maintained to coating spray and terminates;
The compound method of described enteric layer coating solution is: calculate with every 1000 Pantoprazole Sodiums element sheet, by enteric layer film-coating premixing auxiliary material 19.19g, slowly add in 80% alcoholic solution 220.69g, add in 3-5min, after stirring 1h-2h, adjustment mixing speed is to coating solution at integral-rotation, and stirring is maintained to coating spray and terminates;
Described sealing coat and enteric layer coating process parameters are: coating pan rotating speed is that 2-8 per minute turns, kettle temperature is 40-80 DEG C, on continuous spray sealing coat coating solution to plain sheet, sheet bed tempertaure 40-50 DEG C, atomizing pressure 0.2-0.3MPa, spouting velocity 20-30ml/min, evenly wraps thin film clothing, and coating to sealing coat weightening finish is 6%-8%; Then according to above-mentioned steps spray enteric coating layer, inlet temperature 37-43 DEG C, atomizing pressure 0.25MPa, spouting velocity 30-50 ml/min, enteric layers weightening finish 10% after coating.
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| CN110585166A (en) * | 2019-10-16 | 2019-12-20 | 武汉润欣科技股份有限公司 | Pantoprazole sodium enteric-coated micro-tablet capsule and preparation method thereof |
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| 泮托拉唑钠肠溶片工艺改进研究;佟健;《锦州医学院学报》;20061231;第27卷(第6期);83-84 * |
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