CN100423722C - Oral enteric micro-pills contg. pantoprazole or its salts and preparing process thereof - Google Patents
Oral enteric micro-pills contg. pantoprazole or its salts and preparing process thereof Download PDFInfo
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- CN100423722C CN100423722C CNB2004100971308A CN200410097130A CN100423722C CN 100423722 C CN100423722 C CN 100423722C CN B2004100971308 A CNB2004100971308 A CN B2004100971308A CN 200410097130 A CN200410097130 A CN 200410097130A CN 100423722 C CN100423722 C CN 100423722C
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Abstract
The present invention discloses an enteric micro pill which contains pantoprazole or salt of pantoprazole and a preparation technology thereof. The present invention relates to an oral enteric preparation which contains pantoprazole or salt of pantoprazole. The enteric micro pill of the present invention comprises a pill core, a bottom coating layer, a medicine layer, a buffering layer, an isolation layer and an enteric layer from the inner part to the outer part, wherein the gain in weight of the bottom coating layer is from 0.5 to 20%, the gain in weight of the medicine layer is from 40% to 85%, the gain in weight of the buffering layer is from 2-30%, the gain in weight of the isolation layer is from 5 to 20%, and the gain in weight of the enteric layer is from 25 to 90%. The enteric micro pill which contains pantoprazole or salt of pantoprazole of the present invention has the characteristics of stable quality, high dissolution speed and high biological availability.
Description
Technical field
The present invention relates to the oral enteric preparation of pantoprazole or its salt, be specifically related to the oral enteric micro-pills and the preparation technology thereof of pantoprazole or its salt.
Background technology
Pantoprazole is a proton pump inhibitor, and it is mainly used in peptic ulcer and the digestive system disorder disease relevant with gastric acid clinically, has good effect, short treating period, the advantage that untoward reaction is few.
Pantoprazole is an alkaline compound, its aqueous solution instability, see that light easily decomposes, and pantoprazole or its salt also easily decompose under acid condition, therefore, during preparation pantoprazole oral formulations, must wrap up enteric coating to prevent too early the contacting of pantoprazole and gastric juice, because enteric coating is also for to be made by acid material, thereby can not directly use the enteric coating packaging medicine, reduce along with the prolongation of time to prevent its content, in order to overcome the problem of acid instability, normal suggestion and basic matterial mix, to improve its stability.
CN1546025 discloses a kind of pantoprazole enteric coated micropill, because the unstability of pantoprazole or its salt, be preparation quality stable pantoprazole or its salt enteric coated micropill, must use the adjuvant of more kind, otherwise the stability that active component dissolves holder azoles or its salt can not get effective guarantee, but increasing with excipient substance kind and consumption, active component dissolution rate in its micropill is slack-off, and bioavailability also decreases.
At present, though there is preparation to dissolve dilatory azoles enteric coated micropill technical literature report, it still exists certain effective ingredient instability, and disintegration rate is slow, the technological deficiency that bioavailability is low.
Summary of the invention
At above technological deficiency, provide a kind of more stable quality, the pantoprazole that bioavailability is high or its salt enteric coated micropill and preparation technology thereof.
The enteric coated micropill of pantoprazole of the present invention or its salt comprises ball core, end clothing layer, medicine layer, cushion, sealing coat and enteric layer from inside to outside;
The ball core can adopt the celphere that the discord active component of the present invention of this area routine reacts among the present invention, the disintegration rate of ball core will satisfy the specification requirement of this area routine at least, can select the celphere of corresponding different-grain diameter among the present invention according to the product of preparation different size.
The particle diameter of ball core preferably adopts 25-30 mesh sieve scope in pantoprazole of the present invention or its salt enteric coated micropill, and the ball core among the present invention can adopt the preparation technology of this area routine to be prepared, but preferably adopts following method preparation:
Get appropriate amount of starch and Icing Sugar homogeneous mixture and be dropped in bottom spraying type coating machine, start blower fan, and adjusting machine rotational speed, keep 28-33 ℃ of temperature of charge, spray into the aqueous solution of an amount of hydroxypropyl emthylcellulose, spray speed 9～15ml/ branch, intensification maintains about 45 ℃, oven dry is got 25-30 mesh sieve scope sugar pill, promptly.
Chinese traditional medicine layer of the present invention comprises that mainly active component dissolves dilatory azoles or its salt, and the medicine layer also should be active component of the present invention simultaneously provides stable environment; Cushion also will not only have the effect that makes active component of the present invention stable, also will play quickly disintegrated effect; Sealing coat prevents that mainly enteric layer from directly contacting with the medicine layer, also will play quickly disintegrated effect simultaneously.
The enteric coated micropill that dilatory azoles or its salt are dissolved in the present invention further preferably comprises ball core and end clothing layer, medicine layer, cushion, sealing coat, enteric layer, protective layer and damp-proof layer from inside to outside;
Wherein protective layer and damp-proof layer are mainly used in the stable in properties that keeps active component and enteric coating among the present invention, avoid the generation of unfavorable factor.
From prior art as can be known, in the pantoprazole enteric coated micropill not only the selection of the number of plies directly have influence on the stability and the disintegration rate of pantoprazole, and the selection of each layer thickness also directly has influence on pantoprazole and salt-stable thereof and bioavailability, as, the stability and the disintegration rate that how much directly have influence on pantoprazole of the use amount of intermediate layer adhesive and stabilizing agent, the thickness of enteric layer also directly has influence on the stable and rate of release of pantoprazole, if the too thin meeting of thickness is decomposed the active component in the pantoprazole micropill in gastric juice, if it is too thick then effective ingredient dissolution rate in intestinal juice is slack-off, influence the absorption of intestinal wall, reduced bioavailability of medicament, each layer of therefore selecting suitable depth to the stability of active component of the present invention and bioavailability seem extremely important.
In pantoprazole of the present invention or its salt enteric coated micropill, be preferably: the gain in weight of end clothing layer is that the gain in weight of 0.5-20%, medicine layer is that the gain in weight of 40%-85%, cushion is that the gain in weight of 2-30%, sealing coat is that the gain in weight of 5-20%, enteric layer is that the gain in weight of 25-90%, protective layer is that the gain in weight of 1.0-8.0%, damp-proof layer is 1-30%.
Further preferably elect as: the gain in weight of end clothing layer is that the gain in weight of 2-6%, medicine layer is that the gain in weight of 65%-74%, cushion is that the gain in weight of 13-18%, sealing coat is that the gain in weight of 8-12%, enteric layer is that the gain in weight of 48-55%, protective layer is that the gain in weight of 2.0-4.0%, damp-proof layer is 9-16%;
The best is preferably: the gain in weight of end clothing layer is 4%, the gain in weight of medicine layer is 70%, the gain in weight of cushion is 16%, the gain in weight of sealing coat is 10%, the gain in weight of enteric layer is 53%, the gain in weight of protective layer is 3%, the gain in weight of damp-proof layer is 14%.
The computational methods of gain in weight are the weight before (weight behind the weight-coating before the coating) ÷ coating among the present invention.
End clothing layer is made up of binding agent and lubricant in pantoprazole of the present invention or its salt enteric coated micropill; The medicine layer is made up of pantoprazole or its salt, binding agent, stabilizing agent and lubricant; Cushion is made up of binding agent, stabilizing agent and lubricant; Sealing coat is made up of binding agent, opacifier and lubricant; Enteric layer is made up of enteric film material, plasticizer and lubricant; Protective layer is made up of binding agent and lubricant; Damp-proof layer is made up of barrier material, plasticizer and pigment.
Among the present invention in pantoprazole or its salt enteric coated micropill, when selecting pantorazole salt, be the pharmaceutical salts of various pantoprazole such as Pantoprazole Sodium, pantoprazole-magnesium, be preferably Pantoprazole Sodium among the present invention.
Binding agent can be selected the medicinal adhesive of this area routine for use among the present invention, but should react with discord active component of the present invention, and do not influence its stability and be prerequisite, the present invention is preferably a kind of, two or more combination in hydroxypropyl emthylcellulose, hydroxypropyl cellulose, polyvinylpyrrolidone, the polyvinyl alcohol.
Enteric film material and barrier material can be selected the various adjuvants of the suitable medicine of the present invention of this area routine for use, but the present invention is preferably a kind of, two or more combination in acrylic resin, Hydroxypropyl Methylcellulose Phathalate and the Cellacefate;
Plasticizer can be selected the various plasticizers of the suitable medicine of the present invention of this area routine for use among the present invention, but the present invention is preferably a kind of, two or more combination in diethyl phthalate, dibutyl sebacate, glycerol triacetate and the triethyl citrate;
Lubricant can be selected the various lubricants of the suitable medicine of the present invention of this area routine for use, but the present invention is preferably sodium stearyl fumarate, magnesium stearate, docosane acid glyceride or Pulvis Talci;
Stabilizing agent can be selected the various stabilizing agents of this area suitable medicine of the present invention commonly used for use, as: various alkaline matters such as inorganic base, organic base, strong base-weak acid salt or basic amino acid, but the present invention is preferably a kind of, two or more combination in sodium hydroxide, magnesium hydroxide, sodium bicarbonate and the sodium carbonate;
Opacifier can be selected the various opacifiers of the suitable active component of the present invention of this area routine for use, but the present invention is preferably titanium dioxide.
Binding agent is preferably 27 weight portions in the end clothing layer of pantoprazole of the present invention or its salt enteric coated micropill, and lubricant is preferably 11 weight portions.
Pantoprazole or its salt are preferably 441 weight portions, binding agent and are preferably that 49 weight portions, stabilizing agent are preferably 63 weight portions, lubricant is preferably 100 weight portions in the medicine layer of pantoprazole of the present invention or its salt enteric coated micropill.
Wherein carry out after the coating of medicine layer, the weight percentage of pantoprazole or its salt should be at 20-40%, and its Calculation Method is (weight behind the weight of pantoprazole or its salt/medicine layer coating) * 100%.
Binding agent in the medicine layer of pantoprazole of the present invention or its salt enteric coated micropill is preferably the combination of hydroxypropyl emthylcellulose and hydroxypropyl cellulose, and more preferably the weight ratio of hydroxypropyl emthylcellulose and hydroxypropyl cellulose is preferably 8-12: 1; The best is 10: 1.
Binding agent is preferably that 111 weight portions, stabilizing agent are preferably 107 weight portions, lubricant is preferably 32 weight portions in the cushion of pantoprazole of the present invention or its salt enteric coated micropill.
Stabilizing agent in pantoprazole of the present invention or its salt enteric coated micropill Chinese traditional medicine layer and the cushion is preferably the combination of magnesium hydroxide and sodium hydroxide, and more preferably the weight ratio of magnesium hydroxide and sodium hydroxide is preferably 25-27: 1.
Binding agent in the sealing coat of pantoprazole of the present invention or its salt enteric coated micropill is preferably 74 weight portions, opacifier is preferably 92 weight portions and lubricant is preferably 26 weight portions.
Enteric material is preferably that 671 weight portions, plasticizer are preferably 67 weight portions, lubricant is preferably 335 weight portions in the enteric layer of pantoprazole of the present invention or its salt enteric coated micropill.
The enteric material of pantoprazole of the present invention or its salt enteric coated micropill is the acrylic resin of preferred eudragitL of employing or eudragit S type different size, as eudragitL100, eudragitL100-55, eudragitL12.5, eudragitS100, eudragitS12.5, can select a kind of, two or more combination in them for use, but the further preferred eudragitL100-55 that adopts of the present invention; Wherein the plasticizer in the enteric layer of pantoprazole or its salt enteric coated micropill preferably adopts triethyl citrate among the present invention.
Binding agent is preferably 62 weight portions in the protective layer of pantoprazole of the present invention or its salt enteric coated micropill, lubricant is preferably 25 weight portions.
Barrier material is preferably that 319 weight portions, plasticizer are preferably 32 weight portions, opacifier is preferably 96 weight portions in the damp-proof layer of pantoprazole of the present invention or its salt enteric coated micropill.
Wherein, the barrier material in the pantoprazole enteric coated micropill damp-proof layer of the present invention preferably adopts acrylic resin (eudragit) E100 or E12.5 or both combinations.
The preparation technology of pantoprazole of the present invention or its salt enteric coated micropill can adopt the preparation technology of this area routine to be prepared; but the present invention preferably adopts following technology to be prepared: the blank sugar pill of recipe quantity is dropped in the bottom spraying type coating machine; start blower fan; regulate air quantity and sleeve position to suitable fluidized state; set inlet temperature and atomizing flow; regulating hydrojet speed makes bed temperature remain on 35-38 ℃; carry out the coating of end clothing layer, medicine layer, cushion, sealing coat, enteric layer, protective layer and damp-proof layer successively, be drying to obtain.
Among the preparation technology of pantoprazole of the present invention or its salt enteric coated micropill, the preparation of each layer suspension all adopts alcoholic solution or water as solvent in the micropill, and alcoholic solution such as alcoholic solution, propanol solution etc. preferably adopt the alcoholic solution of volumetric concentration 40%-85%.
The present invention can be made pantoprazole or its salt enteric coated micropill adds suitable adjuvant and is pressed into tablet or directly it is incapsulated.
The present invention can not only keep pantoprazole or its salt more stable with respect to prior art, and dissolution rate is fast, effective, and has the bioavailability height, the technical characterstic that side effect is low.
The specific embodiment
The invention will be further elaborated with the test example by following examples in the present invention, but therewith not limited,
Embodiment 1
(1) end clothing layer:
| Material name | Consumption (g) |
| Blank sugar pill | 900 |
| Hydroxypropyl emthylcellulose (HPMC E6) | 27 |
| Pulvis Talci | 10.8 |
| Ethanol | In right amount |
1. the preparation of end clothing layer suspension: in the alcoholic solution in the recipe quantity HPMC E6 adding stirring, make dissolving, add Pulvis Talci, stir, standby.
2. upper base clothing layer operation: the blank sugar pill of recipe quantity is dropped in the bottom spraying type coating machine, start blower fan, regulate air quantity and sleeve position, set inlet temperature and atomizing flow, regulate hydrojet speed and make bed temperature remain on 35-38 ℃ to suitable fluidized state.
(2) medicine layer:
| Material name | Consumption (g) |
| Pantoprazole Sodium sesquialter hydrate | 441 |
| Hydroxypropyl emthylcellulose (HPMC E6) | 44 |
| Hydroxypropyl cellulose | 4.4 |
| Magnesium hydroxide | 61 |
| Sodium hydroxide | 2.3 |
| Pulvis Talci | 100.3 |
| Ethanol | In right amount |
The preparation of medicine layer suspension and coating operation are the same;
(3) cushion:
| Material name | Consumption (g) |
| Hydroxypropyl emthylcellulose (HPMC E6) | 111.3 |
| Magnesium hydroxide | 103.4 |
| Sodium hydroxide | 3.8 |
| Pulvis Talci | 31.8 |
| Ethanol | In right amount |
The preparation of cushion suspension and coating operation are the same;
(4) sealing coat:
| Material name | Consumption (g) |
| Hydroxypropyl emthylcellulose (Methocel E6) | 73.6 |
| Titanium dioxide | 92 |
| Pulvis Talci | 25.8 |
| Ethanol | In right amount |
The preparation of sealing coat suspension and coating operation are the same;
(5) enteric layer
| Material name | Consumption (g) |
| Eudragit?L100-55 | 670.7 |
| Triethyl citrate (TEC) | 67.1 |
| Pulvis Talci | 335.3 |
| Ethanol | In right amount |
The preparation of enteric layer suspension and coating operation are the same;
(6) protective layer:
| Material name | Consumption (g) |
| Hydroxypropyl emthylcellulose (HPMC E6) | 62.1 |
| Pulvis Talci | 24.8 |
| Water | In right amount |
The preparation of protective layer suspension and coating operation are the same;
(7) damp-proof layer:
| Material name | Consumption (g) |
| Eudragit?E100 | 319.2 |
| Dibutyl sebacate (DBS) | 31.9 |
| Opadry (Opadry) | 95.8 |
| Ethanol | In right amount |
The preparation of damp-proof layer suspension and coating operation are the same; Incapsulate packing, check at last.
Embodiment 2
(1) end clothing layer:
| Material name | Consumption (g) |
| Blank sugar pill | 900 |
| Polyvinylpyrrolidone | 15 |
| Pulvis Talci | 5 |
| Ethanol | In right amount |
(2) medicine layer:
| Material name | Consumption (g) |
| Pantoprazole Sodium sesquialter hydrate | 463 |
| Hydroxypropyl emthylcellulose (HPMC E6) | 46.3 |
| Hydroxypropyl cellulose | 4.6 |
| Magnesium hydroxide | 64.1 |
| Sodium hydroxide | 2.4 |
| Pulvis Talci | 105 |
| Ethanol | In right amount |
(3) cushion:
| Material name | Consumption (g) |
| Hydroxypropyl emthylcellulose (HPMC E6) | 111.3 |
| Sodium carbonate | 120.4 |
| Pulvis Talci | 31.8 |
| Ethanol | In right amount |
(4) sealing coat:
| Material name | Consumption (g) |
| Polyvinyl alcohol | 73.6 |
| Titanium dioxide | 92 |
| Pulvis Talci | 25.8 |
| Ethanol | In right amount |
(5) enteric layer
| Material name | Consumption (g) |
| Eudragit?L100-55 | 670.7 |
| Dibutyl sebacate | 67.1 |
| Pulvis Talci | 335.3 |
| Ethanol | In right amount |
(6) protective layer:
| Material name | Consumption (g) |
| Hydroxypropyl emthylcellulose (HPMC E6) | 62.1 |
| Stearic acid U.S. | 24.8 |
| Water | In right amount |
(7) damp-proof layer:
| Material name | Consumption (g) |
| Eudragit?E12.5 | 319.2 |
| Dibutyl sebacate (DBS) | 31.9 |
| Opadry (Opadry) | 95.8 |
| Aqueous isopropanol | In right amount |
Preparation method: identical with embodiment 1
Embodiment 3
(1) end clothing layer:
| Material name | Consumption (g) |
| Blank sugar pill | 100 |
| Hydroxypropyl emthylcellulose (HPMC E6) | 3 |
| Pulvis Talci | 1.2 |
| Ethanol | In right amount |
(2) medicine layer:
| Material name | Consumption (g) |
| Pantoprazole Sodium sesquialter hydrate | 47.2 |
| Hydroxypropyl emthylcellulose (HPMC E6) | 4.7 |
| Hydroxypropyl cellulose | 0.47 |
| Magnesium hydroxide | 6.5 |
| Sodium hydroxide | 0.25 |
| Pulvis Talci | 10.7 |
| Ethanol | In right amount |
(3) cushion:
| Material name | Consumption (g) |
| Hydroxypropyl emthylcellulose (HPMC E6) | 7 |
| Magnesium hydroxide | 6.5 |
| Sodium hydroxide | 0.24 |
| Pulvis Talci | 2 |
| Ethanol | In right amount |
(4) sealing coat:
| Material name | Consumption (g) |
| Hydroxypropyl emthylcellulose (Methocel E6) | 4 |
| Titanium dioxide | 5 |
| Pulvis Talci | 1.4 |
| Ethanol | In right amount |
(5) enteric layer
| Material name | Consumption (g) |
| Eudragit?L100-55 | 33 |
| Triethyl citrate (TEC) | 3.3 |
| Pulvis Talci | 16.5 |
| Ethanol | In right amount |
(6) protective layer:
| Material name | Consumption (g) |
| Hydroxypropyl emthylcellulose (HPMC E6) | 2 |
| Pulvis Talci | 0.8 |
| Water | In right amount |
(7) damp-proof layer:
| Material name | Consumption (g) |
| Eudragit?E100 | 10 |
| Dibutyl sebacate (DBS) | 1 |
| Opadry (Opadry) | 3 |
| Ethanol | In right amount |
Preparation method: identical with embodiment 1
Claims (19)
1. the enteric coated micropill of a pantoprazole or its salt, it is characterized in that comprising from inside to outside the ball core, end clothing layer, the medicine layer, cushion, sealing coat, enteric layer, wherein the gain in weight of end clothing layer is 0.5-20%, the gain in weight of medicine layer is 40%-85%, the gain in weight of cushion is 2-30%, the gain in weight of sealing coat is 5-20%, the gain in weight of enteric layer is 25-90%, wherein the clothing layer is made up of binding agent and lubricant at the end, the medicine layer is by pantoprazole or its salt, binding agent, stabilizing agent and lubricant are formed, described stabilizing agent is a sodium hydroxide, magnesium hydroxide, a kind of in sodium bicarbonate and the sodium carbonate, two or more combination, cushion is by binding agent, stabilizing agent and lubricant are formed, sealing coat is by binding agent, opacifier and lubricant are formed, and enteric layer is by the enteric film material, plasticizer and lubricant are formed.
2. pantoprazole according to claim 1 or its salt enteric coated micropill; it is characterized in that comprising from inside to outside ball core, end clothing layer, medicine layer, cushion, sealing coat, enteric layer, protective layer and damp-proof layer, wherein the gain in weight of end clothing layer is that the gain in weight of 0.5-20%, medicine layer is that the gain in weight of 40%-85%, cushion is that the gain in weight of 2-30%, sealing coat is that the gain in weight of 5-20%, enteric layer is 25-90%, protective layer weightening finish 1.0-8.0%, damp-proof layer weightening finish 1-30%.
3. pantoprazole according to claim 2 or its salt enteric coated micropill, the gain in weight that it is characterized in that end clothing layer are that the gain in weight of 2-6%, medicine layer is that the gain in weight of 65%-74%, cushion is that the gain in weight of 13-18%, sealing coat is that the gain in weight of 8-12%, enteric layer is that the gain in weight of 48-55%, protective layer is that the gain in weight of 2.0-4.0%, damp-proof layer is 9-16%.
4. pantoprazole according to claim 3 or its salt enteric coated micropill, the gain in weight that it is characterized in that end clothing layer are 4%, the gain in weight of medicine layer is 70%, the gain in weight of cushion is 16%, the gain in weight of sealing coat is 10%, the gain in weight of enteric layer is 53%, the gain in weight of protective layer is 3%, the gain in weight of damp-proof layer is 14%.
5. according to the arbitrary described pantoprazole of claim 2-4 or its salt enteric coated micropill, it is characterized in that in the enteric coated micropill: protective layer is made up of binding agent and lubricant; Damp-proof layer is made up of barrier material, plasticizer and pigment.
6. according to the described pantoprazole of claim 5 or its salt enteric coated micropill, it is characterized in that binding agent is a kind of, two or more combination in hydroxypropyl emthylcellulose, hydroxypropyl cellulose, polyvinylpyrrolidone, the polyvinyl alcohol; Enteric film material and barrier material are a kind of, two or more combination in acrylic resin, Hydroxypropyl Methylcellulose Phathalate and the Cellacefate; Plasticizer is a kind of, two or more combination in diethyl phthalate, dibutyl sebacate, glycerol triacetate and the triethyl citrate; Lubricant is sodium stearyl fumarate, magnesium stearate, docosane acid glyceride or Pulvis Talci; Stabilizing agent is a kind of, two or more combination in sodium hydroxide, magnesium hydroxide, sodium bicarbonate and the sodium carbonate; Opacifier is a titanium dioxide.
7. pantoprazole according to claim 5 or its salt enteric coated micropill is characterized in that binding agent is 27 weight portions in the end clothing layer, and lubricant is 11 weight portions.
8. pantoprazole according to claim 5 or its salt enteric coated micropill is characterized in that in the medicine layer that pantoprazole or its salt are that 441 weight portions, binding agent are 49 weight portions, and stabilizing agent is 63 weight portions, and lubricant is 100 weight portions.
9. pantoprazole according to claim 8 or its salt enteric coated micropill is characterized in that the binding agent in the medicine layer is the combination of hydroxypropyl emthylcellulose and hydroxypropyl cellulose, and wherein the weight ratio of hydroxypropyl emthylcellulose and hydroxypropyl cellulose is 10: 1.
10. pantoprazole according to claim 5 or its salt enteric coated micropill is characterized in that binding agent is 111 weight portions in the cushion, and stabilizing agent is 107 weight portions, and lubricant is 32 weight portions.
11. according to Claim 8 or 10 described pantoprazole or its salt enteric coated micropill, it is characterized in that the stabilizing agent in medicine layer and the cushion is the combination of magnesium hydroxide and sodium hydroxide, wherein the weight ratio of magnesium hydroxide and sodium hydroxide is 25-27: 1.
12. pantoprazole according to claim 5 or its salt enteric coated micropill is characterized in that binding agent is that 74 weight portions, opacifier are that 92 weight portions, lubricant are 26 weight portions in the sealing coat.
13. pantoprazole according to claim 5 or its salt enteric coated micropill is characterized in that the enteric membrane material is that 671 weight portions, plasticizer are that 67 weight portions, lubricant are 335 weight portions in the enteric layer.
14. pantoprazole according to claim 13 or its salt enteric coated micropill is characterized in that the enteric film material is that acrylic resin L100-55, plasticizer are triethyl citrate.
15. pantoprazole according to claim 5 or its salt enteric coated micropill is characterized in that binding agent is that 62 weight portions, lubricant are 25 weight portions in the protective layer.
16. pantoprazole according to claim 5 or its salt enteric coated micropill is characterized in that barrier material is Eudragit E 100 or E12.5 or both combinations.
17. pantoprazole according to claim 1 or its salt enteric coated micropill is characterized in that the particle diameter of ball core should be in 25-30 mesh sieve scope.
18. pantoprazole according to claim 1 or its salt enteric coated micropill is characterized in that the weight content of pantoprazole or its salt should be 25-30%.
19. the preparation technology of pantoprazole according to claim 1 or its salt enteric coated micropill, it is characterized in that recipe quantity ball core is dropped in the bottom spraying type coating machine, start blower fan, regulate air quantity and sleeve position to suitable fluidized state, set inlet temperature and atomizing flow, regulate hydrojet speed and make bed temperature remain on 35-38 ℃, carry out the coating of end clothing layer, medicine layer, cushion, sealing coat, enteric layer successively.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100971308A CN100423722C (en) | 2004-12-10 | 2004-12-10 | Oral enteric micro-pills contg. pantoprazole or its salts and preparing process thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100971308A CN100423722C (en) | 2004-12-10 | 2004-12-10 | Oral enteric micro-pills contg. pantoprazole or its salts and preparing process thereof |
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| CN1785186A CN1785186A (en) | 2006-06-14 |
| CN100423722C true CN100423722C (en) | 2008-10-08 |
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| CN105534935B (en) * | 2015-12-30 | 2018-09-18 | 广州共禾医药科技有限公司 | Pantoprazole microplate, preparation method, multiple unit type Pantoprazole enteric sustained-release preparation and preparation method thereof |
| CN105816436B (en) * | 2016-03-22 | 2019-10-22 | 广州共禾医药科技有限公司 | A kind of Pantoprazole enteric-coated micro-pill, Pantoprazole enteric slow-release tablet agent and preparation method thereof |
| CN106176669B (en) * | 2016-08-26 | 2017-11-07 | 湖北唯森制药有限公司 | A kind of pantoprazole sodium enteric-pellets capsules and preparation method |
| CN114569579B (en) | 2020-12-02 | 2023-10-31 | 丽珠医药集团股份有限公司 | Enteric coated pellets, process for their preparation and formulations containing them |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1371681A (en) * | 2002-03-05 | 2002-10-02 | 深圳海王药业有限公司 | Method for coating slow releasing coat of Ibudilast sustained micropill |
| CN1543953A (en) * | 2003-11-21 | 2004-11-10 | 复旦大学 | Colon targeted fluorouracil minipills prepartion |
| CN1546025A (en) * | 2003-12-12 | 2004-11-17 | 南京长澳医药科技有限公司 | Enteric-coated pantoprazole sodium minipill |
-
2004
- 2004-12-10 CN CNB2004100971308A patent/CN100423722C/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1371681A (en) * | 2002-03-05 | 2002-10-02 | 深圳海王药业有限公司 | Method for coating slow releasing coat of Ibudilast sustained micropill |
| CN1543953A (en) * | 2003-11-21 | 2004-11-10 | 复旦大学 | Colon targeted fluorouracil minipills prepartion |
| CN1546025A (en) * | 2003-12-12 | 2004-11-17 | 南京长澳医药科技有限公司 | Enteric-coated pantoprazole sodium minipill |
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| CN1785186A (en) | 2006-06-14 |
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