CN101711753A - Preparation method of lansoprazole solid preparation - Google Patents

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

The preparation method of lansoprazole solid preparation

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, removes symptom rapidly, effectively: because of 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 the effect of inhibition proton pump is more complete, the gastric acid inhibitory secretion is faster, more obvious.

2, cure rate height: to the cure rate of duodenal ulcer and reflux esophagitis all above 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 behind lansoprazole raw material, microcrystalline Cellulose, sodium hydrogen phosphate, anhydrous sodium sulfite, sodium lauryl sulphate, the L arginine mixing, makes powder behind wetting agent and the mixing with 10% polyvidone and makes coating behind the active ball core; Or hypromellose is dissolved in the pure water, stir settled solution, slowly add lansoprazole again and get living solution, living solution is sprayed on the celphere, coating gets final product again.Because lansoprazole is unstable in gastric acid, influences the preparation bioavailability, this method gained enteric coated capsule improves preparation stability by adding sealing coat, improves bioavailability, but the preparation method complexity, 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 made up of lansoprazole, dispersant, edible vegetable oil, magnesium oxide or magnesium carbonate, emulsifying agent, poloxamer, natural glue, sodium citrate; Preparation method is for crossing lansoprazole the 200-300 mesh sieve respectively, 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, the mixture with edible vegetable oil, emulsifying agent, magnesium oxide or magnesium carbonate, poloxamer, natural glue, sodium citrate adds wherein again, carries out colloid mill after the mixing, obtains the lansoprazole medicine; Reinstall enteric hollow capsule, seal as the capsule capping of joint filling material after fill with 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 the vegetable oil, avoids lansoprazole to contact with oxygen with airborne moisture, improves storage process quality stability; Lansoprazole is insoluble in water with vegetable oil in addition, has added the dissolution that emulsifying agent or cosolvent improve 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, magnesium oxide or magnesium carbonate have been added during preparation as basic auxiliary, prevent that fatty acid is to the influence of lansoprazole in the vegetable oil, improve the stability of product, but the adjuvant of using in the preparation method because of enteric coated capsule is more, steps such as each adjuvant needs to pulverize, sieves, colloid mill, the technology relative complex.

Chinese patent application CN1883458A (200610047197.X) discloses Lansoprazole sodium enteric coated preparation and preparation method thereof, and this enteric coated preparation is made up 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 is with mix homogeneously behind Lansoprazole sodium and disintegrating agent, the diluent crushing screening, adds wetting agent or binding agent is made soft material, granulates, and drying, granulate, adds stamping after the mix lubricant, 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 influence, medicine stability is improved greatly medicine, Lansoprazole sodium enteric coated preparation that easy operating in the production process, product quality are easy to control and preparation method thereof.But the inventor finds that the product content uniformity of this method manufacturing is bad.

Summary of the invention

Technical problem solved by the invention provides a kind of preparation method, makes that the uniformity of dosage units of lansoprazole solid preparation is good.This method is to be finished by following steps:

A, alkaline matter, lansoprazole are dissolved in the 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 about 10 (being under the alkali condition).Therefore, in prescription, add the stability that certain alkali can improve lansoprazole.Therefore, alkaline matter can adopt NaOH, the KOH etc. can pharmaceutically adoptable alkaline matter.The present inventor finds by a large amount of experimental studies, because the consumption of principal agent lansoprazole is less relatively, if with add binding agent again after adjuvant such as other filler mixes, uneven situation can appear mixing, cause uniformity of dosage units bad, the tablet drug content that has after testing surpasses labelled amount, and the tablet that has does not almost have principal agent.Final inventor finds earlier principal agent to be dissolved in the binding agent dehydrated alcohol, mixes with filler again, can improve the quality problems of finished product uniformity of dosage units, more helps the principal agent lansoprazole and is evenly distributed in the solid preparation.

Can add polyvidone again and be dissolved in the dehydrated alcohol in steps A, dissolving is followed successively by alkaline matter, polyvidone, lansoprazole in proper order.Polyvidone adopts the most frequently used 30 POVIDONE K 30 BP/USP 30 (being called for short PVP K30).

Further, the weight proportion of NaOH and lansoprazole is in the solid preparation: 0.05～0.15 part of NaOH, 1 part of lansoprazole.Screening test shows that along with the increase of NaOH consumption, the release of lansoprazole in buffer salt is big more, illustrate that NaOH can promote the release of lansoprazole effectively, but NaOH is many more, label through 60 ℃ quicken 5 days after change color big more, and release decline spoke degree also becomes big.Accelerated test shows that content is all up to specification.

Screen filler through the inventor, with mixture the best 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.In filler, add an amount of lactose, not only can improve unilateral fineness, and more help the tablet forming technique operation.Screening test shows that the plain sheet release that adopts crystallite and lactose to prepare according to a certain percentage is also higher, more satisfactory.

Particularly, the weight proportion relation of key component NaOH, 30 POVIDONE K 30 BP/USP 30, lansoprazole, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, lactose is in the solid preparation:

NaOH0.05～0.15 part, 300.1～0.35 parts of 30 POVIDONE K 30 BP/USPs, 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, 300.2 parts of 30 POVIDONE K 30 BP/USPs, 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, 30 POVIDONE K 30 BP/USP 30, lansoprazole, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, each component of lactose all should be crossed 60 orders-100 mesh sieve, are convenient to the 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, carry out Cotton seeds again and get final product; Sealing coat is the 6-10% Opadry in its coating solution, 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 prevent in the process of coating the aqueous solution in the enteric layer and principal agent (the lansoprazole hydrolabil that reacts effectively, meeting water can redden), wrap one deck enteric layer again and can prevent effectively that acid in the gastric acid is to the destruction of principal agent (lansoprazole is unstable to acid), therefore guaranteed that lansoprazole in small intestinal dissolving and absorption, has improved the bioavailability of lansoprazole effectively.

The used adjuvant of the preparation method of solid preparation of the present invention is few, and technology is simple, is convenient to operation, and through after the long-term production practice, 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 select the foundation of respective components and consumption by screening test explanation solid preparation of the present invention, 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 about 10 (being under the alkali condition).Therefore, in prescription, add the stability that certain alkali can improve lansoprazole.Sodium hydroxide is a highly basic, therefore, adds a spot of sodium hydroxide and can make that just pH value reaches about 10.Therefore first-selected sodium hydroxide is as stabilizing agent.By 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 that the stability of keeping Lansoprazole enteric-coated tablet is had better action.

Only just more stable under alkali condition in view of lansoprazole, so the amount of NaOH is bigger for the influence of the stability of whole prescription, and in this stage, mainly the consumption to NaOH screens.Investigated 0.4g respectively, 0.6g, 0.8g, four factors of 1g, prescription designs 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 that the NaOH consumption is more little in the process of screening NaOH consumption, the dissolubility of lansoprazole in binding agent is poor more, when the amount of NaOH is 0.4g, 0.6g, adopts the technology on producing, and binding agent then becomes the milky suspension, the lansoprazole indissoluble.

Behind above technology tabletting, label is detected, 60 ℃ are quickened to detect relevant item once more after 5 days, investigate the influence of different N aOH to 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 big more, illustrate that NaOH can promote the release of lansoprazole effectively, but NaOH is many more, label through 60 ℃ quicken 5 days after change color big more, and release decline spoke degree also becomes greatly, quickens that afterwards content is all up to specification.When the amount of NaOH is 1g, find that through 60 ℃ of accelerated tests label easily turns to be yellow.Therefore, finally the amount of definite NaOH is 0.8g (500 a 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; influence bulk density, thereby influence ballast difference, lactose, mannitol have good effect to the mouldability of tablet; therefore, the kind and the ratio of filler are screened.Adopt lactose, mannitol, microcrystalline Cellulose to screen according to a certain percentage, it is as follows to write out a prescription:

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 that again the slice, thin piece that extrudes is very hard, influence 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 the 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, in prescription, add a certain amount of lactose, not only can improve unilateral fineness, and more help tablet forming technique operation, show also that 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 the buffer salt (%)	Color (placing after 1 day)
			??R1(CCMC-Na)	??96.5	Class is white

Prescription	Release in the buffer salt (%)	Color (placing after 1 day)
			??R2(CMS-Na)	??96.0	Class is white
??R3(L-HPC)	??93.5	Class is white

As shown in Table 6, investigate, find that R1 all is better than R2, R3, illustrate, add a certain amount of CCMC-Na, therefore, in this scheme, consider reservation CCMC-Na unilateral and to discharge the influence that causes less by outward appearance and release to above three prescriptions.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 the result

From the intuitive analysis result, the ratio of lactose and microcrystalline Cellulose is bigger to the influence of lansoprazole release, secondly is the consumption of NaOH, is CCMC-Na at last.By above result as can be seen, the release of R1-R6 is all lower, even does not reach standard individually.Therefore, R7, R8, R9 are quickened 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, more than three prescriptions compare, R7 quickens back release and change color minimum, therefore, tentatively adopts R7.

Four, technology is investigated

The present invention prepares the method for lansoprazole solid preparation and the difference of existing preparation maximum is: earlier principal agent is dissolved in the binding agent, mixes with filler again,, make product even through the mixed method and the interpolation of supplementary material are adjusted in proper order, and stable.Technology 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

Technology 1: the lansoprazole, PVP K30, the NaOH that 1. get recipe quantity put in the 25ml dehydrated alcohol, stir to make the dissolving clarification, and be as binding agent, standby; 2. get microcrystalline Cellulose, the cross-linking sodium carboxymethyl cellulose of recipe quantity, after the mixing, add binding agent system soft material, granulate, dry about 1h, the control moisture is below 3%.3. granulate adds an amount of magnesium stearate and Pulvis Talci, behind the mix homogeneously, and tabletting, promptly.

Technology 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 behind the lansoprazole mix homogeneously, add binding agent system soft material, granulate, mistake 24 mesh sieves, 40 ℃ of nearly 1h of drying, with moisture Control below 3%.3. granulate adds an amount of magnesium stearate and Pulvis Talci, behind the mix homogeneously, and tabletting, promptly.

Two technology releases of table 11 testing result

By above result as can be known, the release of the label of adopting process 1 preparation is good than technology 2, by analysis, mainly is owing in the technology 2 lansoprazole is mixed with lactose, MCC, may cause mixing inhomogeneous, and influences the release of medicine.Therefore, adopting process 1.

The dissolving of the first step is followed successively by NaOH, 30 POVIDONE K 30 BP/USP 30, lansoprazole in proper order in the technology 1, and order changes might influence stability of drug or releasing effect.Earlier dissolving NaOH is in order to improve the stability of lansoprazole, and lansoprazole adds at last, is to contact with air prematurely and chemical reaction takes place for fear of it.

Preparation method of the present invention compare prescription with Chinese patent application CN1883458A and technology all different, supplementary product consumption is few in the prescription, preparation technology is simple, because the principal agent addition is few, adopts the hybrid technique of preparation of the present invention, helps the dissolving of principal agent lansoprazole evenly.

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 the dehydrated alcohol successively, stir to make the dissolving clarification, and be as binding agent, standby;

2. get MCC, the CCMC-Na of recipe quantity, after the mixing, one-step palletizing, the control moisture is below 3%.

3. granulate is crossed 16 mesh sieves, adds an amount of magnesium stearate and Pulvis Talci, behind the mix homogeneously, and tabletting, promptly.

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

Principal agent and adjuvant	Consumption
		??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 plain sheet of the lansoprazole of embodiment 1-4 preparation is smooth, smooth, do not have piebaldism, fall the limit, and friability is up to specification, and 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 the enteric layer and principal agent react in the process of coating, wrap one deck enteric layer again and can prevent effectively that acid in the gastric acid is to the destruction of principal agent, therefore guaranteed that lansoprazole in small intestinal dissolving and absorption, has improved the bioavailability of lansoprazole effectively.

Claims (10)

1. the preparation method of lansoprazole solid preparation, it is characterized in that: it is to be finished by following steps:

A, alkaline matter, lansoprazole are dissolved in the 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.

2. the preparation method of lansoprazole solid preparation according to claim 1, it is characterized in that: described alkaline matter is NaOH, and the weight proportion of NaOH and lansoprazole is: 0.05～0.15 part of NaOH, 1 part of lansoprazole.

3. the preparation method of lansoprazole solid preparation according to claim 1 and 2, it is characterized in that: add polyvidone again and be dissolved in the dehydrated alcohol in steps A, dissolving is followed successively by alkaline matter, polyvidone, lansoprazole in proper order.

4. the preparation method of lansoprazole solid preparation according to claim 3, it is characterized in that: described filler is the mixture of microcrystalline Cellulose, lactose, wherein, the weight proportion of microcrystalline Cellulose and lactose is: 1 part of microcrystalline Cellulose, 0.1～1 part of lactose.

5. the preparation method of lansoprazole solid preparation according to claim 3, it is characterized in that: 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:

0.05～0.15 part of NaOH, 0.1～0.35 part of polyvidone, 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.

6. the preparation method of lansoprazole solid preparation according to claim 5, it is characterized in that: the weight proportion of NaOH, polyvidone, lansoprazole, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, lactose is in the solid preparation:

0.107 part of NaOH, 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.

7. the preparation method of lansoprazole solid preparation according to claim 1, it is characterized in that: described solid preparation is tablet, capsule or granule.

8. the preparation method of lansoprazole solid preparation according to claim 7, it is characterized in that: described tablet is an enteric coated tablet, and in the plain sheet outer coatings of step C gained, sealing coat is the 6-10% Opadry in the coating solution, and solvent is 95% ethanol; Enteric layer is the 16-24% Opadry, and solvent is a water; Weightening finish 20～24%.

9. the preparation method of lansoprazole solid preparation according to claim 7, it is characterized in that: described capsule is an enteric coated capsule, and in step C gained capsule outer coatings, sealing coat is the 6-10% Opadry in the coating solution, and solvent is 95% ethanol; Enteric layer is the 16-24% Opadry, and solvent is a water; Weightening finish 20～24%.

10. according to Claim 8 or the preparation method of 9 described lansoprazole solid preparations, it is characterized in that: sealing coat is 8% Opadry in the coating solution, and solvent is 95% ethanol; Enteric layer is 20% Opadry, and solvent is a water; Weightening finish 20～24%.

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