CN101711753B - Preparation method of lansoprazole solid preparation - Google Patents
Preparation method of lansoprazole solid preparation Download PDFInfo
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Abstract
The invention belongs to the field of pharmacy, relating to a preparation method of a lansoprazole solid preparation, and solving the technical problem of providing a preparation method capable of ensuring a favorable content uniformity of the lansoprazole solid preparation. The preparation method comprises the following steps of: A, sequentially dissolving an alkaline material and the lansoproazole into anhydrous ethyl alcohol to obtain a mixed solution for later use; B, dissolving a bulking agent into the mixed solution obtained in the step A, and pelletizing; and C, preparing a solid preparation by processing particles obtained from the pelletizing according to a traditional method. The preparation method of the solid preparation has the advantages of little used auxiliary material, simple process, and convenient operation; and after long-time production practice, the content uniformity and stability of products can be commendably controlled.
Description
Technical field
The invention belongs to pharmaceutical field, relate to the preparation method of lansoprazole solid preparation.
Background technology
Lansoprazole is compared with first generation proton pump inhibitor omeprazole and is had the following advantages:
1, remove symptom rapidly, effectively: because having imported fluorine element in its molecular structure, thereby make its bioavailability increase by 25%; Chemical stability and fat-solublely also increase, thus make its active function can faster onset; This medicine and proton pump have 3 binding sites, so suppress that the effect of proton pump is more complete, gastric acid secretion inhibiting is faster, more obvious.
2, cure rate is high: to the cure rate of duodenal ulcer and reflux esophagitis all over 90%.
3, take medicine conveniently: but administration every day 1 time (30mg).
4, cost performance is good: medical expense is all lower than omeprazole or ranitidine.
The preparation method of a kind of lansoprazole intestine dissolving capsule of Chinese patent application CN1907281A (200610029942.8), two kinds of methods that prepare enteric coated capsule are disclosed, one is with after lansoprazole raw material, microcrystalline Cellulose, sodium hydrogen phosphate, anhydrous sodium sulfite, sodium lauryl sulphate, L arginine mixing, makes powder after wetting agent and mixing with 10% polyvidone and makes coating after active ball core; Or hypromellose is dissolved in pure water, stir to get settled solution, more slowly add lansoprazole to get living solution, living solution is sprayed on celphere, then coating gets final product.Because lansoprazole is unstable in gastric acid, affect the preparation bioavailability, the method gained enteric coated capsule improves preparation stability by adding sealing coat, improve bioavailability, but preparation method is complicated, and operating procedure is many, and adjuvant is more.
Chinese patent application CN101156852A (CN200710030343.2) discloses Lansoprazole intestine solution capsule and manufacture method thereof, and this intestine solution capsule is comprised of lansoprazole, dispersant, edible vegetable oil, magnesium oxide or magnesium carbonate, emulsifying agent, poloxamer, natural glue, sodium citrate; Preparation method is for crossing lansoprazole respectively the 200-300 mesh sieve, and dispersant, emulsifying agent, magnesium oxide or magnesium carbonate, poloxamer, natural glue and sodium citrate are crossed the 100-300 mesh sieve; After lansoprazole and dispersant, then the mixture of edible vegetable oil, emulsifying agent, magnesium oxide or magnesium carbonate, poloxamer, natural glue, sodium citrate is added wherein, carry out colloid mill after mixing, obtain the lansoprazole medicine; Reinstall enteric hollow capsule, with the capsule capping sealing after with fill as joint filling material of the acrylic resin alcoholic solution of 5-30%.The purpose of this invention avoids manufacture process to introduce moisture for providing a kind of manufacturing process simple, and the preparation of better bin stability is arranged.This intestine solution capsule agent is suspended in lansoprazole in vegetable oil, avoids lansoprazole to contact with oxygen with airborne moisture, improves storage process quality stability; Another lansoprazole is insoluble in water with vegetable oil, has added emulsifying agent or cosolvent to improve the dissolution of lansoprazole during preparation; Lansoprazole and dispersant can be solved the problem that lansoprazole easily gathers, can make lansoprazole have higher dissolution as adopting pregelatinized Starch; For avoiding lansoprazole rotten under acid condition, added magnesium oxide or magnesium carbonate as basic auxiliary during preparation, prevent the impact of fatty acid on lansoprazole in vegetable oil, improve the stability of product, but the adjuvant of using in the preparation method because of enteric coated capsule is more, the steps such as each adjuvant needs to pulverize, sieves, colloid mill, the technique relative complex.
Chinese patent application CN1883458A (200610047197.X) discloses enteric coated preparation of lansoprazole sodium and preparation method thereof, and this enteric coated preparation is comprised of Lansoprazole sodium 15-30 part, diluent 150-300 part, wetting agent or binding agent 20-110 part, disintegrating agent 5-25 part, lubricant 5-15 part and coating materials 30-100 part.Preparation method adds wetting agent or binding agent to make soft material for Lansoprazole sodium and disintegrating agent, diluent being pulverized and sieved rear mix homogeneously, and granulation, adds stamping after mix lubricant at drying, granulate, and coating gets final product.But the purpose of this invention is for providing a kind of oral medication, taking convenience, be convenient to store and transportation, can guarantee that the active component Lansoprazole sodium is in the higher intestinal absorption of pH value, avoided the degraded of Lansoprazole sodium in gastric acid, also can avoid light, wet, hot impact on medicine, medicine stability is improved greatly, enteric coated preparation of lansoprazole sodium that easy operating in production process, product quality are easy to control and preparation method thereof.But the inventor finds that the product content uniformity of the method manufacturing is bad.
Summary of the invention
Technical problem solved by the invention is to provide a kind of preparation method, makes the uniformity of dosage units of lansoprazole solid preparation good.The method is to be completed by following steps:
A, alkaline matter, lansoprazole are dissolved in dehydrated alcohol successively, mixed liquor is standby;
B, filler is dissolved in the mixed liquor that steps A obtains, granulates;
C, granulation gained granule is made solid preparation more according to a conventional method.
Lansoprazole is to warm, to acid, hydrolabil, and is and the most stable when pH value 10 left and right (being under alkali condition).Therefore, add certain alkali can improve the stability of lansoprazole in prescription.Therefore, alkaline matter can adopt the pharmaceutically adoptable alkaline matter such as NaOH, KOH.The present inventor studies discovery by lot of experiments, because the consumption of principal agent lansoprazole is relatively less, if with add again binding agent after the adjuvants such as other filler mix, inhomogeneous situation can appear mixing, cause uniformity of dosage units bad, the tablet drug content that has after testing surpasses labelled amount, and some tablets are almost without principal agent.Final inventor finds first principal agent to be dissolved in the binding agent dehydrated alcohol, then mixes with filler, can improve the quality problems of the finished product content uniformity, more is conducive to the principal agent lansoprazole and is evenly distributed in solid preparation.
Can add polyvidone to be dissolved in dehydrated alcohol in steps A, dissolving sequentially is followed successively by alkaline matter, polyvidone, lansoprazole again.Polyvidone adopts the most frequently used PVP K30 (being called for short PVP K30).
Further, in solid preparation, the weight proportion of NaOH and lansoprazole is: 0.05～0.15 part of NaOH, 1 part of lansoprazole.Screening test shows, along with the increase of NaOH consumption, the release of lansoprazole in buffer salt is larger, illustrate that NaOH can promote the release of lansoprazole effectively, but NaOH is more, label through 60 ℃ accelerate 5 days after change color larger, and release decline spoke degree also becomes large.Accelerated test shows that content is all up to specification.
Screen filler through the inventor, best with the mixture of microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, lactose, wherein, the weight proportion of microcrystalline Cellulose and lactose is: 1 part of microcrystalline Cellulose, 0.1～1 part of lactose.Add appropriate lactose in filler, not only can improve unilateral fineness, and more be conducive to the tablet forming technique operation.The screening test demonstration, the plain sheet release that adopts crystallite and lactose to prepare according to a certain percentage is also higher, more satisfactory.
Particularly, in solid preparation, the weight proportion relation of key component NaOH, PVP K30, lansoprazole, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, lactose is:
NaOH0.05～0.15 part, 0.1～0.35 part of PVP K30,1 part of lansoprazole, 3.4～6 parts of microcrystalline Cellulose, 0.12～0.3 part of cross-linking sodium carboxymethyl cellulose, 0.65～3.4 part of lactose.
The preferred weight proportioning is: 0.107 part of NaOH, 0.2 part of PVP K30,1 part of lansoprazole, 4.67 parts of microcrystalline Cellulose, 0.27 part of cross-linking sodium carboxymethyl cellulose, 2 parts of lactose.
Above-mentioned NaOH, PVP K30, lansoprazole, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, each component of lactose all should be crossed 60 orders-100 mesh sieve, are convenient to more good dissolving and the mixing of supplementary material.Preferred 80 mesh sieves.
Solid preparation of the present invention can be tablet, capsule or granule.Wherein, preferably make enteric coated preparation, as can be made into enteric coated tablet or enteric coated capsule, after solid preparation of the present invention is granulated through steps A dissolving and step B, according to conventional method add the lubricant tabletting or encapsulated after, then carry out Cotton seeds and get final product; In its coating solution, sealing coat is the 6-10% Opadry, and solvent is 95% ethanol (preferred 8% Opadry of sealing coat); Enteric layer is the 16-24% Opadry, and solvent is water (preferred 20% Opadry of enteric layer); Weightening finish 20～24%.
Adopt the sealing coat of 8% Opadry bag, can effectively prevent in the process of coating the aqueous solution in enteric layer and principal agent (the lansoprazole hydrolabil that reacts, meeting water can redden), wrap again one deck enteric layer and can prevent effectively that acid in gastric acid is to the destruction (lansoprazole is unstable to acid) of principal agent, therefore guaranteed that lansoprazole dissolves and absorbs at small intestinal, has improved the bioavailability of lansoprazole effectively.
The preparation method of solid preparation of the present invention adjuvant used is few, and technique is simple, convenient operation, and through after long-term production practices, the uniformity of dosage units of product and stability can be well controlled.
Description of drawings
Fig. 1 enteric coatel tablets preparation flow figure.
The specific embodiment
Below illustrate that by screening test solid preparation of the present invention selects the foundation of respective components and consumption, so as to the beneficial effect of explanation solid preparation preparation method of the present invention.
One, the screening of NaOH consumption:
Lansoprazole is to warm, to acid, hydrolabil, and is and the most stable when pH value 10 left and right (being under alkali condition).Therefore, add certain alkali can improve the stability of lansoprazole in prescription.Sodium hydroxide is highly basic, therefore, adds a small amount of sodium hydroxide just can make pH value reach 10 left and right.Therefore first-selected sodium hydroxide is as stabilizing agent.By the screening to the amount of sodium hydroxide, determined best amount, the long-time stability experimental result also shows, uses a certain amount of sodium hydroxide to the stability of keeping Lansoprazole enteric-coated tablet, effect preferably to be arranged.
Only just more stable under alkali condition in view of lansoprazole, so the amount of NaOH is larger for the impact of the stability of whole prescription, at this one-phase, mainly the consumption of NaOH is screened.Investigated respectively 0.4g, 0.6g, 0.8g, four factors of 1g, Formulation such as table 1:
The prescription composition table of table 1NaOH consumption screening (recipe quantity: 500, unit: g)
| Prescription | MCC | Lactose | CCMC-Na | NaOH | PVP K30 | Pulvis Talci | Magnesium stearate |
| R1 | 25 | 25 | 2 | 1 | 1.5 | 0.62 | - |
| R2 | 25 | 25 | 2 | 0.8 | 1.5 | 0.62 | - |
| R3 | 25 | 25 | 2 | 0.6 | 1.5 | 0.62 | - |
| R4 | 25 | 25 | 2 | 0.4 | 1.5 | 0.62 | - |
Note: lansoprazole 7.5g
Find in the process of screening NaOH consumption, the NaOH consumption is less, and the dissolubility of lansoprazole in binding agent is poorer, when the amount of NaOH is 0.4g, 0.6g, adopts the technique on producing, and binding agent becomes the milky suspension, the lansoprazole indissoluble.
After above technique tabletting, label is detected, 60 ℃ are accelerated again to detect relevant item after 5 days, investigate different N aOH to the impact of lansoprazole stability.The results are shown in Table 2:
The accelerated test result of table 2NaOH consumption
As seen from Table 2, increase along with the NaOH amount, the release of lansoprazole in buffer salt is larger, illustrate that NaOH can promote the release of lansoprazole effectively, but NaOH is more, label through 60 ℃ accelerate 5 days after change color larger, and release decline spoke degree also becomes greatly, accelerates that content is all up to specification afterwards.When the amount of NaOH is 1g, accelerate experiment through 60 ℃ and find, label easily turns to be yellow.Therefore, finally the amount of definite NaOH is 0.8g (500 tablet recipe amount).
Two, the investigation of filler:
Microcrystalline Cellulose (MCC) has disintegration preferably; can promote the agent of collapsing of tablet; but because the density of crystallite is less; in pelletization usually a lot of fine powders can appear; affect bulk density, thereby affect ballast difference, lactose, mannitol have good effect to the mouldability of tablet; therefore, kind and the ratio of filler are screened.Adopt lactose, mannitol, microcrystalline Cellulose to screen according to a certain percentage, write out a prescription as follows:
The prescription composition table of table 3 filler screening (recipe quantity: 500, unit: g)
| Prescription | MCC | Lactose | Mannitol | CCMC-Na | NaOH | PVP k30 | Pulvis Talci | Magnesium stearate |
| R1 | 25 | 25 | - | 2 | 1 | 1.5 | 0.62 | - |
| R2 | 25 | - | 25 | 2 | 1 | 1.5 | 0.62 | - |
| R3 | - | 50 | - | 2 | 1 | 1.5 | 0.62 | - |
| R4 | - | - | 50 | 2 | 1 | 1.5 | 0.62 | - |
| R5 | 50 | - | - | 2 | 1 | 1.5 | 0.315 | 0.315 |
Note: lansoprazole 7.5g
Interpretation of result: by the screening of above 5 prescriptions, found that, single lactose (R3) and mannitol (R4) of adopting is as diluent, in the process of granulating, after binding agent adds, lactose congeals into one, makes the pelletization difficulty, if reduce the consumption of dehydrated alcohol, can make again the slice, thin piece of extrusion very hard, affect disintegrate, therefore, abandon R3 and R4.The drug release determination result of R1, R2, R5 is as follows:
Table 4 filler the selection result
| Prescription | Release in buffer salt (%) | Granulation situation and unilateral outward appearance |
| R1 crystallite: lactose (1: 1) | 98.0 | Uniform particles, and unilateral bright and clean, the fine control of hardness is off-white color |
| R2 crystallite: mannitol (1: 1) | 97.1 | Granularity is more even, and is unilateral bright and clean, is off-white color |
| R5 | 95.4 | The granule fine powder is more, is off-white color |
Note: lansoprazole 7.5g
In sum as can be known, add a certain amount of lactose in prescription, not only can improve unilateral fineness, and more be conducive to tablet forming technique operation, also shown by above data, the slice, thin piece release that adopts crystallite and lactose to prepare according to a certain percentage is also higher, more satisfactory.
Three, the screening of disintegrating agent:
Disintegrating agent is screened, mainly investigate CCMC-Na, carboxymethyl starch sodium (CMS-Na), three kinds of disintegrating agents of low-substituted hydroxypropyl cellulose (L-HPCL), prescription is respectively R1, R2, R3, and technical process is produced with R, the results are shown in Table 5 and table 6:
The prescription composition table of table 5 disintegrating agent screening (recipe quantity: 500, unit: g)
| Prescription | MCC | CCMC-Na | CMS-Na | L-HPC | NaOH | PVP k30 | Pulvis Talci | Magnesium stearate |
| R1 | 50 | 2 | - | - | 1 | 1.5 | 0.315g | 0.315g |
| R2 | 50 | - | 2 | - | 1 | 1.5 | 0.315g | 0.315g |
| R3 | 50 | - | - | 2 | 1 | 1.5 | 0.315g | 0.315g |
Note: lansoprazole 7.5g
Table 6 disintegration the selection result
| Prescription | Release in buffer salt (%) | Color (placing after 1 day) |
| R1(CCMC-Na) | 96.5 | Class is white |
| R2(CMS-Na) | 96.0 | Class is white |
| R3(L-HPC) | 93.5 | Class is white |
As shown in Table 6, investigate by outward appearance and release to above three prescriptions, find that R1 all is better than R2, R3, illustrate, add a certain amount of CCMC-Na less on impact unilateral and that release causes, therefore, in this scheme, consider to keep CCMC-Na.In the investigation of next stage, diluent is investigated.
Amount to above three adjuvants is carried out quadrature analysis, and the design of factor level table sees Table 7:
Table 7 orthogonal test factor level design table (recipe quantity: 500)
Note: lansoprazole 7.5g
According to following factor level table, adopting process 1 carries out orthogonal test, the results are shown in Table 8:
Table 8 orthogonal test is investigated result
From the intuitive analysis result, the ratio of lactose and microcrystalline Cellulose is larger on the impact of lansoprazole release, is secondly the consumption of NaOH, is CCMC-Na at last.Can be found out by above result, the release of R1-R6 is all lower, does not reach even individually standard.Therefore, R7, R8, R9 are accelerated to investigate, the results are shown in Table 9:
R7, R8, R9 accelerated test result in table 9 orthogonal test
As shown in Table 10, above three prescriptions are compared, and after R7 accelerates, release and change color are minimum, therefore, tentatively adopt R7.
Four, technique is investigated
The present invention prepares the method for lansoprazole solid preparation and the difference of existing preparation maximum is: first principal agent is dissolved in binding agent, then mixes with filler, mixed method and order of addition adjustment through to supplementary material make product even, and be stable.Technique is investigated as follows:
Table 10 recipe quantity: 1000
| Principal agent and adjuvant | Consumption |
| Lansoprazole | 15g |
| Microcrystalline Cellulose (import) | 70g |
| Lactose | 30g |
| Cross-linking sodium carboxymethyl cellulose | 4g |
| NaOH | 1.6 |
| PVP K30 | 3.0g |
| Magnesium stearate | In right amount |
| Pulvis Talci | In right amount |
Technique 1: the lansoprazole, PVP K30, the NaOH that 1. get recipe quantity put in the 25ml dehydrated alcohol, are stirred to dissolve clarification, and be as binding agent, standby; 2. get microcrystalline Cellulose, the cross-linking sodium carboxymethyl cellulose of recipe quantity, after mixing, add binding agent soft material processed, granulate, dry approximately 1h controls moisture below 3%.3. granulate, add appropriate magnesium stearate and Pulvis Talci, after mix homogeneously, and tabletting, and get final product.
Technique 2: the 1. NaOH of weighing recipe quantity, PVP K30, be dissolved in the 25ml dehydrated alcohol, fully dissolving makes the solvent clarification, and is as binding agent, standby.2. the lactose of weighing recipe quantity, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, after the lansoprazole mix homogeneously, add binding agent soft material processed, granulates, and crosses 24 mesh sieves, 40 ℃ of nearly 1h of drying, with moisture Control below 3%.3. granulate, add appropriate magnesium stearate and Pulvis Talci, after mix homogeneously, and tabletting, and get final product.
Two technique release testing results of table 11
By above result as can be known, the release of the label of adopting process 1 preparation is good than technique 2, by analysis, is mainly owing in technique 2, lansoprazole being mixed with lactose, MCC, may cause mixing inhomogeneous, and affects the release of medicine.Therefore, adopting process 1.
In technique 1, the dissolving of the first step sequentially is followed successively by NaOH, PVP K30, lansoprazole, and order changes stability or the releasing effect that might affect medicine.First dissolve NaOH and be in order to improve the stability of lansoprazole, lansoprazole adds at last, is contact with air prematurely and chemical reaction occurs for fear of it.
Preparation method of the present invention compare prescription from Chinese patent application CN1883458A and technique all different, in prescription, supplementary product consumption is few, preparation technology is simple, because the principal agent addition is few, adopts the hybrid technique of preparation of the present invention, is conducive to the principal agent lansoprazole and is uniformly dissolved.
Embodiment 1:
1, the composition of label, as table 12:
Table 12 recipe quantity: 1000
| Principal agent and adjuvant | Consumption |
| Lansoprazole | 15g |
| Microcrystalline Cellulose (import) | 70g |
| Lactose | 30g |
| Cross-linking sodium carboxymethyl cellulose | 4g |
| NaOH | 1.6 |
| PVP K30 | 3.0g |
| Magnesium stearate | In right amount |
| Pulvis Talci | In right amount |
2, label preparation method:
1. NaOH, PVP K30, the lansoprazole of getting recipe quantity are dissolved in dehydrated alcohol successively, are stirred to dissolve clarification, and be as binding agent, standby;
2. get MCC, the CCMC-Na of recipe quantity, after mixing, one-step palletizing is controlled moisture below 3%.
3. granulate, cross 16 mesh sieves, adds appropriate magnesium stearate and Pulvis Talci, after mix homogeneously, and tabletting, and get final product.
3, art for coating:
Opadry sealing coat+enteric layer (8%+20%), concentration is respectively 8%, 20%, and solvent is respectively 95% ethanol and purified water, and actual weightening finish is 20-24%.
Embodiment 2:
1, the composition of label, as table 13:
Table 13 recipe quantity: 1000
| Principal agent and adjuvant | Consumption |
| Lansoprazole | 15g |
| Microcrystalline Cellulose (import) | 50g |
| Lactose | 50g |
| Cross-linking sodium carboxymethyl cellulose | 4g |
| NaOH | 2 |
| PVP K30 | 3.0g |
| Magnesium stearate | In right amount |
| Pulvis Talci | In right amount |
2, label preparation method and art for coating are with embodiment 1.
Embodiment 3:
1, the composition of label, as table 14:
Table 14 recipe quantity: 1000
| Principal agent and adjuvant | Consumption |
| Lansoprazole | 15g |
| Microcrystalline Cellulose (import) | 50g |
| Lactose | 50g |
| Cross-linking sodium carboxymethyl cellulose | 4g |
| NaOH | 1.2 |
| PVP K30 | 3.0g |
| Magnesium stearate | In right amount |
| Pulvis Talci | In right amount |
2, label preparation method and art for coating are with embodiment 1.
Embodiment 4:
1, the composition of label, as table 15:
Table 15 recipe quantity: 1000
| Principal agent and adjuvant | Consumption |
| Lansoprazole | 15g |
| Microcrystalline Cellulose (import) | 70g |
| Lactose | 30g |
| Cross-linking sodium carboxymethyl cellulose | 4g |
| NaOH | 2 |
| PVP K30 | 3.0g |
| Magnesium stearate | In right amount |
| Pulvis Talci | In right amount |
2, label preparation method and art for coating are with embodiment 1.
The lansoprazole element sheet of embodiment 1-4 preparation is smooth, smooth, without piebaldism, fall the limit, friability is up to specification, drug content is the 96.0-104.0% of labelled amount.Adopt the sealing coat of 8% Opadry bag, can prevent effectively that the aqueous solution in enteric layer and principal agent react in the process of coating, wrap again one deck enteric layer and can prevent effectively that acid in gastric acid is to the destruction of principal agent, therefore guaranteed that lansoprazole dissolves and absorbs at small intestinal, has improved the bioavailability of lansoprazole effectively.
Claims (5)
1. the preparation method of lansoprazole solid preparation, it is characterized in that: it is to be completed by following steps:
A, alkaline matter, lansoprazole are dissolved in dehydrated alcohol successively, mixed liquor is standby;
B, filler is dissolved in the mixed liquor that steps A obtains, granulates;
C, granulation gained granule is made solid preparation more according to a conventional method;
Add polyvidone to be dissolved in dehydrated alcohol in steps A, dissolving sequentially is followed successively by alkaline matter, polyvidone, lansoprazole again; Described alkaline matter is NaOH; Described filler is the mixture of microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, lactose; Wherein the weight proportion of NaOH, polyvidone, lansoprazole, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, lactose is: NaOH0.107 part, 0.2 part of polyvidone, 1 part of lansoprazole, 4.67 parts of microcrystalline Cellulose, 0.27 part of cross-linking sodium carboxymethyl cellulose, 2 parts of lactose.
2. the preparation method of lansoprazole solid preparation according to claim 1, it is characterized in that: described solid preparation is tablet, capsule or granule.
3. the preparation method of lansoprazole solid preparation according to claim 2, it is characterized in that: described tablet is enteric coated tablet, and in step C gained element sheet outer coatings, in coating solution, sealing coat is the 6-10% Opadry, and solvent is 95% ethanol; Enteric layer is the 16-24% Opadry, and solvent is water; Weightening finish 20～24%.
4. the preparation method of lansoprazole solid preparation according to claim 2, it is characterized in that: described capsule is enteric coated capsule, and in step C gained capsule outer coatings, in coating solution, sealing coat is the 6-10% Opadry, and solvent is 95% ethanol; Enteric layer is the 16-24% Opadry, and solvent is water; Weightening finish 20～24%.
5. the preparation method of according to claim 3 or 4 described lansoprazole solid preparations, it is characterized in that: in coating solution, sealing coat is 8% Opadry, solvent is 95% ethanol; Enteric layer is 20% Opadry, and solvent is water; Weightening finish 20～24%.
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| CN102772387B (en) * | 2012-08-09 | 2014-02-12 | 广东帅广医药有限公司 | Lansoprazole composition enteric capsule and preparation method thereof |
| KR102227486B1 (en) * | 2017-06-30 | 2021-03-12 | 롯데정밀화학 주식회사 | Oral solid formulation composition comprising proton pump inhibitor, oral solid formulation comprising the same and manufacturing method thereof |
| CN109806234B (en) * | 2019-03-07 | 2021-11-09 | 山东新华制药股份有限公司 | Preparation method of proton pump inhibitor enteric-coated tablet core |
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| 张正全，等.兰索拉唑肠溶片处方及工艺的改进.《华西药学杂志》.2007,第22卷(第6期),第643-645页. * |
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