CN112142865A - Modified pregelatinized starch and production method thereof - Google Patents
Modified pregelatinized starch and production method thereof Download PDFInfo
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
- C08B30/00—Preparation of starch, degraded or non-chemically modified starch, amylose, or amylopectin
- C08B30/12—Degraded, destructured or non-chemically modified starch, e.g. mechanically, enzymatically or by irradiation; Bleaching of starch
- C08B30/14—Cold water dispersible or pregelatinised starch
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
- C08B30/00—Preparation of starch, degraded or non-chemically modified starch, amylose, or amylopectin
- C08B30/12—Degraded, destructured or non-chemically modified starch, e.g. mechanically, enzymatically or by irradiation; Bleaching of starch
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L3/00—Compositions of starch, amylose or amylopectin or of their derivatives or degradation products
- C08L3/02—Starch; Degradation products thereof, e.g. dextrin
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L2205/00—Polymer mixtures characterised by other features
- C08L2205/02—Polymer mixtures characterised by other features containing two or more polymers of the same C08L -group
- C08L2205/025—Polymer mixtures characterised by other features containing two or more polymers of the same C08L -group containing two or more polymers of the same hierarchy C08L, and differing only in parameters such as density, comonomer content, molecular weight, structure
Abstract
The invention discloses a modified pregelatinized starch and a production method thereof, and the production method of the modified pregelatinized starch comprises the following steps: preparing the first natural starch into soluble starch after acidolysis or enzymolysis treatment; and carrying out pre-gelatinization treatment on the soluble starch and the second natural starch to prepare the modified pre-gelatinized starch. The modified pregelatinized starch is prepared from soluble starch and natural starch through pregelatinization treatment, has good compactibility and fluidity, and is suitable for being used as an excipient for tablet direct compression, a diluent or a filler for capsules, a binder for particle granulation and the like. The production method of the modified pregelatinized starch is simple, the process operability is strong, and the batch industrial production can be realized.
Description
Technical Field
The invention relates to the technical field of biological medicines, in particular to modified pregelatinized starch and a production method thereof.
Background
Starch and its derivatives have been widely used as pharmaceutical excipients in the production of pharmaceutical dosage forms, their functional diversity being mainly due to their biocompatibility, biodegradability, various inherent physicochemical properties and relative ease of modification. Starches from different plant sources have properties that are transformed into their functional and application properties, which properties, after modification, change their physicochemical and functional properties. The method of starch modification can be tailored to the specific application and has been achieved by a variety of physical techniques (e.g., gelatinization and moisture treatment), chemical methods (e.g., depolymerization, cross-linking and substitution reactions), and enzymatic treatments.
In conventional pharmaceutical production, natural starch is generally used mainly as a binder and a disintegrant in the preparation of tablets by a wet granulation method. However, tablet direct compression is a popular choice because it provides the shortest, most efficient and simplest way to produce tablets, which is a characteristic not found in native starch. The basic attributes of direct compression excipients are good compactibility and flowability, which are properties lacking in native starch, which is therefore unsuitable as a direct compression excipient. The production of starch derivatives with enhanced flowability and direct compression capability is yet to be fully developed in view of the diverse sources of starch and its modification potential, since only a few starch derivatives with direct compression use are available.
Disclosure of Invention
In order to overcome the above-mentioned disadvantages of the prior art, it is an object of the present invention to provide a modified pregelatinized starch and a method for producing the same.
In order to solve the problems, the invention adopts the following technical scheme:
a method for producing a modified pregelatinized starch, comprising the steps of:
preparing the first natural starch into soluble starch after acidolysis or enzymolysis treatment;
and carrying out pre-gelatinization treatment on the soluble starch and second natural starch to prepare the modified pre-gelatinized starch.
Preferably, the mass ratio of the soluble starch to the second natural starch is (5-30): (70-95).
Preferably, the bulk density of the modified pregelatinized starch is 0.5-0.7 g/mL, the angle of repose is 30-40 degrees, and the solubility in water at 0-20 ℃ is 5-30 wt%.
Preferably, the pre-gelling treatment comprises a physical mixing, extrusion, heat treatment process.
Preferably, the pregelatinization treatment is performed in any one of a screw extruder, a kneader, a differential roll extruder, an air dry powder mixer, a ribbon mixer, a fluidized bed granulation dryer, a spray granulation dryer, a rake dryer, and a rotary vacuum dryer.
Preferably, the pre-gelling treatment is carried out in a double-screw extruder, and the extrusion temperature is 60-90 ℃.
Preferably, the pre-gelling treatment is carried out in a kneader, and the jacket heating temperature is 70-90 ℃.
Preferably, the pre-gelling treatment is carried out in a high-speed centrifugal spray granulation dryer, the air inlet temperature is 160 ℃, and the air outlet temperature is 70-90 ℃.
Preferably, the pre-gelling treatment is carried out in an airflow dry powder mixer, and the temperature of mixed hot air is 70-90 ℃.
Preferably, the acidolysis time is 4-6 h, the acidolysis temperature is 20-70 ℃, and the acid liquor concentration is 0.1-2 mol/L.
Preferably, the acid hydrolysis is performed using hydrochloric acid.
Preferably, the enzymatic hydrolysis uses a pullulanase, which can enzymatically hydrolyze the first native starch into amylose.
Preferably, the pullulanase is pullulanase.
Preferably, the amount of the pullulanase is 0.1-0.6% of the mass of the first natural starch.
Preferably, the enzymolysis temperature is 20-70 ℃, and the enzymolysis time is 2-12 h.
Preferably, the first natural starch is any one of corn starch, potato starch, tapioca starch, pea starch, rice starch and wheat starch; the second natural starch is any one of corn starch, potato starch, cassava starch, pea starch, rice starch and wheat starch.
The invention also provides the modified pregelatinized starch prepared by the production method of the modified pregelatinized starch.
Preferably, the bulk density of the modified pregelatinized starch is 0.5-0.7 g/mL, the angle of repose is 30-40 degrees, and the solubility in water at 0-20 ℃ is 5-30 wt%.
The invention also provides a pharmaceutical excipient which contains the modified pregelatinized starch.
Compared with the prior art, the invention has the technical effects that:
the modified pregelatinized starch is prepared from soluble starch and natural starch through pregelatinization treatment, has good compactibility and fluidity, and is suitable for being used as an excipient for tablet direct compression, a diluent or a filler for capsules, a binder for particle granulation and the like. The production method of the modified pregelatinized starch is simple, the process operability is strong, and the batch industrial production can be realized.
Detailed Description
The embodiments of the present invention are described below with reference to specific embodiments, and other advantages and effects of the present invention will be easily understood by those skilled in the art from the disclosure of the present specification. The invention is capable of other and different embodiments and of being practiced or of being carried out in various ways, and its several details are capable of modification in various respects, all without departing from the spirit and scope of the present invention.
It is to be understood that the processing equipment or apparatus not specifically identified in the following examples is conventional in the art.
Furthermore, it is to be understood that one or more method steps mentioned in the present invention does not exclude that other method steps may also be present before or after the combined steps or that other method steps may also be inserted between these explicitly mentioned steps, unless otherwise indicated; moreover, unless otherwise indicated, the numbering of the various method steps is merely a convenient tool for identifying the various method steps, and is not intended to limit the order in which the method steps are arranged or the scope of the invention in which the invention may be practiced, and changes or modifications in the relative relationship may be made without substantially changing the technical content.
The embodiment of the invention provides a production method of modified pregelatinized starch, which comprises the following steps:
(1) preparing the first natural starch into soluble starch after acidolysis or enzymolysis treatment;
(2) and carrying out pre-gelatinization treatment on the soluble starch and the second natural starch to prepare the modified pre-gelatinized starch.
Preferably, the acidolysis time in the step (1) is 4-6 h, the acidolysis temperature is 20-70 ℃, the acid solution concentration is 0.1-2 mol/L, the acidolysis temperature is preferably 50 ℃, and hydrochloric acid is preferably used as the acid for acidolysis.
Preferably, the enzymatic hydrolysis in step (1) uses pullulanase, which can enzymatically hydrolyze the first native starch into amylose. More preferably, the pullulanase is pullulanase. Furthermore, the dosage of the pullulanase is 0.1-0.6% of the mass of the first natural starch. Furthermore, the enzymolysis temperature is 20-70 ℃, and the enzymolysis time is 2-12 h. In the embodiment of the invention, the preferred enzymolysis temperature is 60 ℃, and the enzymolysis time is 4-6 h.
Preferably, the pre-gelling treatment in step (2) comprises physical mixing, extrusion and heating treatment processes. Preferably, the pre-gelling treatment process may be performed in any one of a screw extruder, a kneader, a differential roll extruder, an air dry powder mixer, a ribbon mixer, a fluidized bed granulation dryer, a spray granulation dryer, a rake dryer, and a rotary vacuum dryer. In a preferred embodiment of the invention, the pre-gelling treatment is carried out in a twin-screw extruder, and the extrusion temperature is 60-90 ℃. In a preferred embodiment of the present invention, the pregelatinization treatment is carried out in a kneader with a jacket heating temperature of 70 to 90 ℃. In a preferred embodiment of the invention, the pre-gelling treatment is carried out in a high-speed centrifugal spray granulation dryer, the air inlet temperature is 160 ℃, and the air outlet temperature is 70-90 ℃. In a preferred embodiment of the invention, the pre-gelling treatment is carried out in an air flow dry powder mixer, and the temperature of mixed hot air is 70-90 ℃.
Preferably, the mass ratio of the soluble starch to the second natural starch in the step (2) is (5-30): (70-95).
More preferably, the prepared modified pregelatinized starch has the bulk density of 0.5-0.7 g/mL, the angle of repose of 30-40 degrees and the solubility of 5-30 wt% in water at 0-20 ℃, so that the modified pregelatinized starch has good compactibility and fluidity, can be directly used as an excipient for tablet compression, and can also be used as a diluent or a filler of capsules, a binder for particle granulation and the like.
Wherein, the first natural starch in the step (1) is any one of corn starch, potato starch, tapioca starch, pea starch, rice starch and wheat starch; in the step (2), the second natural starch is any one of corn starch, potato starch, tapioca starch, pea starch, rice starch and wheat starch. The first native starch and the second native starch may be the same or different; preferably, the first native starch and the second native starch are the same native starch. Corn starch is preferably used in embodiments of the invention.
The production method of the modified pregelatinized starch is simple, the process operability is strong, and the batch industrial production can be realized.
The modified pregelatinized starch prepared by the embodiment of the invention has the bulk density of 0.5-0.7 g/mL, the angle of repose of 30-40 degrees and the solubility of 5-30 wt% in water at the temperature of 0-20 ℃. The modified pregelatinized starch prepared by the embodiment of the invention has good compactibility and fluidity, and is suitable for being used as an excipient for tablet direct compression, a diluent or a filler of a capsule, a binder for granulation and the like.
The following is a further description with reference to specific examples.
Example 1
40kg of tap water is added into a 1.50L glass kettle, stirring is started, 15kg of corn starch is added, and stirring is carried out in a water bath at 50 ℃. Adding 0.6kg of hydrochloric acid, and stirring for 4-6 hours.
2. Adding sodium bicarbonate to neutralize the pH value to 5-6, and stirring to obtain about 50kg of slurry for later use.
3. Corn starch (35 kg/h) and the slurry (0.85 kg/min) obtained in the previous step are constantly conveyed into a double-screw extruder (model SHJ-42, screw phi 42mm, three modules of 45 degrees, two modules of 60 degrees and the balance of conveying modules), and are mixed and extruded at the temperature of 60-90 ℃.
4. And drying, crushing and sieving the extruded material by a 80-mesh sieve to obtain the modified pregelatinized starch.
Example 2
40kg of tap water is added into a 1.50L glass kettle, stirring is started, 15kg of corn starch is added, and stirring is carried out in a water bath at 50 ℃. Adding 0.6kg of hydrochloric acid, and stirring for 4-6 hours.
2. Adding sodium bicarbonate to neutralize the pH value to 5-6, and stirring to obtain about 50kg of slurry for later use.
3. Adding 85kg of corn starch into a 300L kneader, heating the corn starch to an internal temperature of 70-90 ℃ by a jacket, adding the slurry obtained in the previous step in the mixing process, mixing for 1-3 hours, and then drying, crushing and sieving by a 80-mesh sieve to obtain the modified pregelatinized starch.
Example 3
20kg of tap water is added into a 1.50L glass kettle, stirring is started, 7.5kg of corn starch is added, and stirring is carried out in a water bath at 50 ℃. Adding 0.6kg of hydrochloric acid, and stirring for 4-6 hours.
2. Adding sodium bicarbonate to neutralize until the pH is 5-6.
3. Then 20kg of water and 17.5kg of corn starch are added and stirred evenly at the temperature of 60-70 ℃.
4. The air inlet temperature of a high-speed centrifugal spray granulation dryer (LPG 50, water evaporation capacity of 50 kg/h) is 160 ℃, the spray drying is carried out by feeding at the speed of 0.5-1.0 kg/min, and the air outlet temperature is 70-90 ℃.
5. Collecting the materials and sieving the materials with a 80-mesh sieve to obtain the modified pregelatinized starch.
Example 4
30kg of tap water is added into a 1.100L stainless steel kettle, stirring is started, 10kg of corn starch is added, the temperature is raised to 90 ℃, and stirring and pasting are carried out for 30 minutes.
2. Cooling to 60 ℃, adding 15g of pullulanase (dissolved in 1L of water), and continuously stirring for 4-6 hours.
3. Then 30kg of water and 25kg of corn starch are added, and the mixture is stirred uniformly at the temperature of 50-60 ℃.
4. The air inlet temperature of a high-speed centrifugal spray granulation dryer (LPG 50, water evaporation capacity of 50 kg/h) is 160 ℃, the spray drying is carried out by feeding at the speed of 0.5-1.0 kg/min, and the air outlet temperature is 70-90 ℃.
5. Collecting the materials and sieving the materials with a 80-mesh sieve to obtain the modified pregelatinized starch.
Example 5
30kg of tap water is added into a 1.100L stainless steel kettle, stirring is started, 10kg of corn starch is added, the temperature is raised to 90 ℃, and stirring and pasting are carried out for 30 minutes.
2. Cooling to 60 ℃, adding 60g of pullulanase (dissolved by 1L of water), and continuously stirring for 4-6 hours to obtain about 40kg of slurry for later use.
3. Corn starch (35 kg/h) and the slurry (0.85 kg/min) obtained in the previous step are constantly conveyed into a double-screw extruder (model SHJ-42, screw phi 42mm, three modules of 45 degrees, two modules of 60 degrees and the balance of conveying modules), and are mixed and extruded at the temperature of 60-90 ℃.
4. And drying, crushing and sieving the extruded material by a 80-mesh sieve to obtain the modified pregelatinized starch.
Example 6
30kg of tap water is added into a 1.100L stainless steel kettle, stirring is started, 10kg of corn starch is added, the temperature is raised to 90 ℃, and stirring and pasting are carried out for 30 minutes.
2. Cooling to 60 ℃, adding 60g of pullulanase (dissolved by 1L of water), and continuously stirring for 4-6 hours to obtain about 40kg of slurry for later use.
3. Adding 85kg of corn starch into a 300L kneader, heating the corn starch to an internal temperature of 70-90 ℃ by a jacket, adding the slurry obtained in the previous step in the mixing process, mixing for 1-3 hours, and then drying, crushing and sieving by a 80-mesh sieve to obtain the modified pregelatinized starch.
Example 7
20kg of tap water is added into a 1.100L stainless steel kettle, stirring is started, 10kg of corn starch is added, the temperature is raised to 90 ℃, and stirring and pasting are carried out for 30 minutes.
2. Cooling to 60 ℃, adding 60g of pullulanase (dissolved by 1L of water), and continuously stirring for 4-6 hours to obtain about 30kg of slurry for later use.
3. Adding 85kg of corn starch into a 200L airflow dry powder mixer, spraying the mixed hot air at the temperature of 70-90 ℃ at the speed of 5kg/h into the slurry obtained in the previous step, continuously blowing hot air for mixing for 1-3 hours after the mixture is finished, discharging and sieving the mixture by using a 80-mesh sieve (crushing the coarse material by using a crusher and then sieving the crushed coarse material) to obtain the modified pregelatinized starch.
Example 8
20kg of tap water is added into a 1.100L stainless steel kettle, stirring is started, 10kg of corn starch is added, the temperature is raised to 90 ℃, and stirring and pasting are carried out for 30 minutes.
2. Cooling to 60 ℃, adding 60g of pullulanase (dissolved by 1L of water), and continuously stirring for 4-6 hours to obtain about 30kg of slurry for later use.
3. Adding 85kg of corn starch into a 200L ribbon mixer, introducing steam into a jacket to enable the internal temperature to reach 70-90 ℃, adding the slurry obtained in the previous step in a spraying mode at the speed of 5kg/h, continuously mixing and drying for 1-3 hours after the addition is finished, discharging and sieving through a 80-mesh sieve (coarse materials are crushed by a crusher and then sieved), and obtaining the modified pregelatinized starch.
The modified pregelatinized starch prepared in the embodiments 1 to 8 of the present invention was subjected to physical and chemical property tests, and the test results are shown in table 1. Wherein, the method for measuring the 10% viscosity comprises the following steps: 40g of the modified pregelatinized starch was added to 320g of water, stirred uniformly and left for 4 hours, and measured at 20 ℃ with a rotary viscometer. The disintegration time of the straight pressed plain tablets is measured according to the following method: taking the modified pregelatinized starch, adding 0.4wt% of colloidal silicon dioxide and 0.3wt% of magnesium stearate, mixing uniformly and directly tabletting.
The present invention is not limited to the above-described specific embodiments, and various modifications and variations are possible. Any modifications, equivalents, improvements and the like made to the above embodiments in accordance with the technical spirit of the present invention should be included in the scope of the present invention.
Claims (19)
1. A method for producing a modified pregelatinized starch, comprising the steps of:
preparing the first natural starch into soluble starch after acidolysis or enzymolysis treatment;
and carrying out pre-gelatinization treatment on the soluble starch and second natural starch to prepare the modified pre-gelatinized starch.
2. The method for producing the modified pregelatinized starch of claim 1, wherein the mass ratio of the soluble starch to the second natural starch is (5-30): (70-95).
3. The method for producing a modified pregelatinized starch, according to claim 2, wherein the modified pregelatinized starch has a bulk density of 0.5 to 0.7g/mL, an angle of repose of 30 to 40 °, and a solubility in water at 0 to 20 ℃ of 5 to 30 wt%.
4. The method for producing a modified pregelatinized starch according to claim 1, wherein the pregelatinization treatment comprises physical mixing, extrusion, and heat treatment.
5. The method for producing a modified pregelatinized starch according to claim 4, wherein the pregelatinized treatment is performed in any one of a screw extruder, a kneader, a differential roller extruder, an air dry powder mixer, a ribbon mixer, a fluidized bed granulation dryer, a spray granulation dryer, a rake dryer, and a rotary vacuum dryer.
6. The method for producing the modified pregelatinized starch of claim 5, wherein the pregelatinized treatment is performed in a twin-screw extruder, and the extrusion temperature is 60-90 ℃.
7. The method for producing a modified pregelatinized starch according to claim 5, wherein the pregelatinized treatment is performed in a kneader, and the jacket heating temperature is 70 to 90 ℃.
8. The method for producing the modified pregelatinized starch according to claim 5, wherein the pregelatinized treatment is performed in a high-speed centrifugal spray granulation dryer, and the inlet air temperature is 160 ℃ and the outlet air temperature is 70-90 ℃.
9. The method for producing the modified pregelatinized starch of claim 5, wherein the pregelatinized treatment is performed in an air flow dry powder mixer, and the temperature of the mixed hot air is 70-90 ℃.
10. The method for producing the modified pregelatinized starch, according to claim 1, wherein the acid hydrolysis time is 4 to 6 hours, the acid hydrolysis temperature is 20 to 70 ℃, and the acid solution concentration is 0.1 to 2 mol/L.
11. The method for producing a modified pregelatinized starch of claim 10, wherein the acid hydrolysis is performed by using hydrochloric acid.
12. The method of claim 1, wherein the enzymatic hydrolysis uses pullulanase, which enzymatically cleaves the first native starch into amylose.
13. The method for producing a modified pregelatinized starch according to claim 12, wherein the pullulanase is pullulanase.
14. The method for producing a modified pregelatinized starch according to claim 13, wherein the amount of pullulanase is 0.1 to 0.6% by mass of the first natural starch.
15. The method for producing the modified pregelatinized starch according to claim 14, wherein the enzymolysis temperature is 20-70 ℃ and the enzymolysis time is 2-12 h.
16. The method for producing a modified pregelatinized starch according to any one of claims 1 to 15, wherein the first natural starch is any one of corn starch, potato starch, tapioca starch, pea starch, rice starch and wheat starch; the second natural starch is any one of corn starch, potato starch, cassava starch, pea starch, rice starch and wheat starch.
17. The modified pregelatinized starch prepared by the method for producing the modified pregelatinized starch according to any one of claims 1 to 16.
18. The modified pregelatinized starch prepared by the production method of the modified pregelatinized starch of claim 17, wherein the bulk density of the modified pregelatinized starch is 0.5-0.7 g/mL, the angle of repose is 30-40 °, and the solubility in water at 0-20 ℃ is 5-30 wt%.
19. A pharmaceutical excipient comprising the modified pregelatinized starch of claim 18.
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