CN108148144A - A kind of improvement of the preparation method of medicinal pregelatinized starch - Google Patents

A kind of improvement of the preparation method of medicinal pregelatinized starch Download PDF

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CN108148144A
CN108148144A CN201611095337.0A CN201611095337A CN108148144A CN 108148144 A CN108148144 A CN 108148144A CN 201611095337 A CN201611095337 A CN 201611095337A CN 108148144 A CN108148144 A CN 108148144A
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pregelatinized starch
preparation
starch
mixed
medicinal
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帅放文
王向峰
章家伟
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Hunan Er Kang Pharmaceutical Co Ltd
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Hunan Er Kang Pharmaceutical Co Ltd
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    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08BPOLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B30/00Preparation of starch, degraded or non-chemically modified starch, amylose, or amylopectin
    • C08B30/12Degraded, destructured or non-chemically modified starch, e.g. mechanically, enzymatically or by irradiation; Bleaching of starch
    • C08B30/14Cold water dispersible or pregelatinised starch
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
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  • Pharmacology & Pharmacy (AREA)
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  • General Health & Medical Sciences (AREA)
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  • Polymers & Plastics (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Fodder In General (AREA)
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Abstract

The present invention is a kind of improvement of the preparation method of medicinal pregelatinized starch.The preparation method of the improved medicinal pregelatinized starch of the present invention includes:1st, material is weighed;2nd, the pretreatment of material;3rd, the mixing of material;The extrusion of 4 materials;5th, the drying of material;6th, the cutting and grinding of material.The preparation method is simple for process, easy to operate, and the structure for the pregelatinized starch produced is more uniformly distributed, water-soluble higher, the more preferable and splendid mobility of compressibility.And the preparation method is environmentally protective, and three wastes generate, and are conducive to environmental protection.

Description

A kind of improvement of the preparation method of medicinal pregelatinized starch
Technical field
The invention belongs to starch physical modification fields, are related to a kind of modified starch, particularly improve a kind of medicinal pregelatinated The preparation method of starch.
Background technology
Starch(starch)It is a kind of polysaccharide, is one of the natural polymer of nature yield maximum, is higher plant master The carbohydrate component wanted, minor (C6H10O5) n, it can be by the amyloid substances such as corn, sweet potato, wild acorn nut and pueraria lobata It extracts and obtains.Starch can be regarded as the high polymer of glucose.Starch is commercially used for paste producing essence, maltose, Portugal in addition to edible Grape sugar, alcohol etc. are also used for modulation printing paste, the starching of textile, the gluing of paper, compacting of medicinal tablet etc..Therefore, it is Preferably play the role of these, certain special natures of starch(Such as water solubility, stability, mobility, viscosity, gelatification And shear strength etc.)It is indispensable.
Pregelatinized starch is the derivative of starch, also known as amylum pregelatinisatum, belongs to two class of pharmaceutic adjuvant.Pregelatinized starch Preparation method be to be obtained some or all of rupture of starch granules with chemical method or Physical, only change its physical property Without changing original chemical constitution.Therefore pregelatinized starch has good mobile performance and mouldability energy, and with good Good lubricating action, can share the lubricant in direct powder compression with other auxiliary materials in drug production process, can also use Make the adhesive of wet granulation, it may also be used for the auxiliary material of other solid materials such as capsule.
Pregelatinized starch on open market can be divided into full pregelatinized starch and part pregelatinated according to pregelatinated degree Starch.Pregelatinated degree is different, then function is also different.The product of major part company is part pre-gel both at home and abroad, wherein That more well-known is the product Starch1500 of the happy Kanggong department of card.France Roquette Freres then have all with part pregelatinated Two kinds of products of starch.It has significant advantage in the world market share of pregelatinized starch.Full pregelatinized starch can be complete Fully dissolved directly prepares starch slurry in water, for that can not be heated during wet granulation, therefore can together add with main ingredient, excipient Enter in facility for granulating, then plus water is as wetting agent.Partially pregelatinized starch contains soluble(Gelation)With can not melt into Point, because with disintegration properties are had concurrently in addition to stickiness, and with good mobility.
What production pregelatinized starch generally used at present is all wet method processing technology to prepare.However conventional machining process is given birth to The pregelatinized starch poor quality of production, the scope of application are small.The pregelatinized starch prepared with method of chemical treatment, which easily generates, human body Harmful substance, and production technology is complicated, unstable product quality is uniform.
Invention content
The primary and foremost purpose of the present invention is to overcome the difficulty and deficiency of the prior art, improves a kind of medicinal pregelatinized starch Preparation method, the problem of can effectively solve the problem that stickiness, mobility, stability and the poorly water-soluble of existing pregelatinized starch, The deficiencies of uniform existing production technology unstable product quality, poor fluidity, uncontrollable pregelatinated degree can effectively be overcome it Place, and the application performance of medicinal pregelatinized starch can be effectively improved.
The present invention is handled starch, and at low temperature using grinding, ultrasonic vibration mixed method and extruding technology It is molded after cooling is dry using cutting machine pelletizing.The quality for making pregelatinized starch by ultrasonic vibration mixed method is more uniform steady Fixed, mobility improves, and compressibility can be more preferable, and the process conditions such as the rotating speed of the proportioning of control material and extruder, temperature are come Control the pregelatinated degree of starch.
Ultrasonic vibration hybrid technology refers to material under the conditions of existing for certain frequency ultrasonic wave, using high-speed mixer machine What group was mixed, enable material more uniform, stable in the process of mixing.
It is an object of the invention to for existing for insufficient and pregelatinized starch properties of product existing for existing production technology Ultrasonic vibration mixed method is applied in starch conversion, improves a kind of method for preparing medicinal pregelatinized starch by defect.Packet Include following steps:
A, material is weighed:Weigh a certain amount of food-grade starches and purified water;
B, the pretreatment of material:Load weighted material is placed in 40 ~ 60min of grinding in grinder;
C, the mixing of material:Ground material is placed in mixed at high speed unit, and mixed at high speed unit is made to be placed in ultrasonic wave ring Under border, 30 ~ 50min is mixed, the moisture of material is 10% ~ 40% after control mixing;
D, the extrusion of material:The material mixed is added into extruder charging hopper, opens extruder, controls extruder temperature, It is squeezed out at a temperature of 60 DEG C ~ 100 DEG C;
E, material is cooled down into drying under the conditions of 0 DEG C ~ 10 DEG C;
F, dried material will be cooled down and carry out cutting and grinding with pelleter, pulverizer is crushed to grain needed for medicinal pregelatinized starch Diameter range.
Further, the source of raw foods grade starch of the present invention is potato or cereal starch.
Further, the quality proportioning of starch of the present invention and purified water is 1:0.06~0.32.
Further, need to heat 1 ~ 3h in the present invention before ground material mixing under the conditions of infrared, temperature is 80 ~ 120℃。
Further, the frequency of ultrasonic wave is 30000Hz ~ 800000Hz in the present invention.
Further, the draw ratio of extruder screw is 16 in the present invention, and rotating speed is 120 ~ 160r/min.
The present invention uses cold water solubility(Solution temperature is 25 DEG C)Characterize the pregelatinated degree of pregelatinized starch.
For the present invention using the mobility of angle of repose characterization pregelatinized starch, angle of repose typically refers to the freedom of powder stack layer The maximum angular that inclined-plane is formed with horizontal plane.Angle of repose is smaller, and frictional force is smaller, and mobility is better, it is considered that during θ≤30 degree Good fluidity, whens θ≤40 degree, can meet the need for liquidity in production process.The mobility of powder to granule, capsule, The weight differential of the preparations such as tablet and normal operating are affected.Angle of repose is tested using powder tester for overall characteristic.
The present invention characterizes the compressibility of pregelatinized starch using carr coefficients(compressibility index), Carr Index=(Tap density-bulk density)/ tap density, it has reacted compressibility, it is considered that, 5~15% compressibility are very Good, 12~16% compressibility are good, and 18~21% compressibility are general, and 23~35% compressibility are poor,>40% compressibility is very poor. Carr coefficients also reflect the mobility of pregelatinized starch simultaneously.
The present invention uses《Chinese Pharmacopoeia》The 2010 editions second pregelatinized starch quality standard included carries out comprehensive matter Amount is examined.
It is of the invention to be had the following advantages compared with existing pregelatinized starch production technology and significant progress:
(1)Material is pre-processed using grinding hair.In process of lapping, starch granules becomes more tiny uniform, makes shallow lake Powder is easier to be uniformly mixed, while decline the crystallinity of starch in mixed process.
(2)It can effectively solve the problem that present in currently employed single mixed at high speed unit mixing using ultrasonic vibration hybrid technology Mixing is not uniform enough, the problem of quality is unstable, obtained material particles stable structure is uniform after mixing, and mobility is more It is high.
(3)By infrared, ultrasonic mixing processing, gained pregelatinized starch has higher plasticity, is conducive to produce Various products.
(4)This preparation method also have it is simple for process, it is easy to operate, the advantages that energy conservation and environmental protection.
Specific embodiment:
Further details of theory is made to other goals of the invention, technical solution and the advantageous effect of the present invention below in conjunction with embodiment It is bright, but embodiment should not be considered as the restriction of right of the present invention.
Embodiment 1
100g food-grades cereal starch and 6g purified waters are weighed, is placed in mill and grinds 40min, infrared processing 1h, temperature is 80 DEG C, the mixed at high speed unit mixing 30min being placed under 30000Hz Ultrasonic Conditions is then transferred to, after mixing by object Material is added in extruder, and control screw speed is 120r/min, is squeezed out at 60 DEG C, then by extruded material at 0 DEG C It is molded after lower cooling is dry with cutting machine pelletizing, is crushed to required particle size range, finally obtain cooling water solubility is 55.2% Pregelatinized starch.
Embodiment 2
200g food-grades cereal starch and 64g purified waters are weighed, is placed in mill and grinds 60min, infrared processing 1.5h, temperature It is 85 DEG C, is then transferred to the mixed at high speed unit mixing 50min being placed under 40000Hz Ultrasonic Conditions, after mixing will Material is added in extruder, and control screw speed is 120r/min, is squeezed out at 60 DEG C, then by extruded material 10 It is molded after drying is cooled down at DEG C with cutting machine pelletizing, is crushed to required particle size range, finally obtain cooling water solubility 89.7% pregelatinized starch.
Embodiment 3
300g food-grades cereal starch and 60g purified waters are weighed, is placed in mill and grinds 50min, infrared processing 1h, temperature is 100 DEG C, the mixed at high speed unit mixing 50min being placed under 50000Hz Ultrasonic Conditions is then transferred to, after mixing by object Material is added in extruder, and control screw speed is 160r/min, is squeezed out at 100 DEG C, then by extruded material 10 It is molded after drying is cooled down at DEG C with cutting machine pelletizing, is crushed to required particle size range, finally obtain cooling water solubility is 91% Pregelatinized starch.
Embodiment 4
200g food-grades cereal starch and 20g purified waters are weighed, is placed in mill and grinds 40min, infrared processing 2h, temperature is 90 DEG C, the mixed at high speed unit mixing 50min being placed under 80000Hz Ultrasonic Conditions is then transferred to, after mixing by object Material is added in extruder, and control screw speed is 140r/min, is squeezed out at 100 DEG C, then by extruded material 10 It is molded after drying is cooled down at DEG C with cutting machine pelletizing, is crushed to required particle size range, finally obtain cooling water solubility 88.1% pregelatinized starch.
Embodiment 5
250g food-grades cereal starch and 25g purified waters are weighed, is placed in mill and grinds 40min, infrared processing 1.5h, temperature It is 110 DEG C, is then transferred to the mixed at high speed unit mixing 50min being placed under 30000Hz Ultrasonic Conditions, after mixing will Material is added in extruder, and control screw speed is 150r/min, is squeezed out at 100 DEG C, then by extruded material 0 It is molded after drying is cooled down at DEG C with cutting machine pelletizing, is crushed to required particle size range, finally obtain cooling water solubility 91.9% pregelatinized starch.
Embodiment 6
500g food-grades cereal starch and 160g purified waters are weighed, is placed in mill and grinds 60min, infrared processing 3h, temperature It is 100 DEG C, is then transferred to the mixed at high speed unit mixing 50min being placed under 80000Hz Ultrasonic Conditions, after mixing will Material is added in extruder, and control screw speed is 160r/min, is squeezed out at 100 DEG C, then by extruded material 0 It is molded after drying is cooled down at DEG C with cutting machine pelletizing, is crushed to required particle size range, finally obtain cooling water solubility 99.7% pregelatinized starch.
Embodiment 7
100g food-grades cereal starch and 20g purified waters are weighed, is placed in mill and grinds 50min, infrared processing 2.5h, temperature It is 120 DEG C, is then transferred to the mixed at high speed unit mixing 50min being placed under 30000Hz Ultrasonic Conditions, after mixing will Material is added in extruder, and control screw speed is 140r/min, is squeezed out at 80 DEG C, then by extruded material 10 It is molded after drying is cooled down at DEG C with cutting machine pelletizing, is crushed to required particle size range, finally obtain cooling water solubility 96.5% pregelatinized starch.
Embodiment 8
300g food-grades cereal starch and 96g purified waters are weighed, is placed in mill and grinds 30min, infrared processing 1.5h, temperature It is 100 DEG C, is then transferred to the mixed at high speed unit mixing 40min being placed under 40000Hz Ultrasonic Conditions, after mixing will Material is added in extruder, and control screw speed is 120r/min, is squeezed out at 60 DEG C, then by extruded material 10 It is molded after drying is cooled down at DEG C with cutting machine pelletizing, is crushed to required particle size range, finally obtain cooling water solubility 88.9% pregelatinized starch.
Embodiment 9
100g food-grades cereal starch and 20g purified waters are weighed, is placed in mill and grinds 40min, infrared processing 2.5h, temperature It is 90 DEG C, is then transferred to the mixed at high speed unit mixing 40min being placed under 40000Hz Ultrasonic Conditions, after mixing will Material is added in extruder, and control screw speed is 120r/min, is squeezed out at 60 DEG C, then by extruded material 10 It is molded after drying is cooled down at DEG C with cutting machine pelletizing, is crushed to required particle size range, finally obtain cooling water solubility 86.2% pregelatinized starch.
Embodiment 10
400g food-grades cereal starch and 80g purified waters are weighed, is placed in mill and grinds 60min, infrared processing 3.0h, temperature It is 110 DEG C, is then transferred to the mixed at high speed unit mixing 50min being placed under 50000Hz Ultrasonic Conditions, after mixing will Material is added in extruder, and control screw speed is 160r/min, is squeezed out at 100 DEG C, then extruded material exists It is molded after drying is cooled down at 10 DEG C with cutting machine pelletizing, is crushed to required particle size range, finally obtain cooling water solubility 98.4% pregelatinized starch.
Embodiment 11
100g food-grades cereal starch and 60g purified waters are weighed, is placed in mill and grinds 60min, infrared processing 3h, temperature is 120 DEG C, the mixed at high speed unit mixing 50min being placed under 800000Hz Ultrasonic Conditions is then transferred to, after mixing will Material is added in extruder, and control screw speed is 160r/min, is squeezed out at 100 DEG C, then extruded material exists It is molded after drying is cooled down at 10 DEG C with cutting machine pelletizing, is crushed to required particle size range, finally obtain cooling water solubility 43.2% pregelatinized starch.
Embodiment 12
100g food-grades cereal starch and 15g purified waters are weighed, is placed in mill and grinds 40min, infrared processing 3h, temperature is 115 DEG C, the mixed at high speed unit mixing 30min being placed under 80000Hz Ultrasonic Conditions is then transferred to, after mixing by object Material is added in extruder, and control screw speed is 160r/min, is squeezed out at 100 DEG C, then by extruded material at 0 DEG C It is molded after lower cooling is dry with cutting machine pelletizing, is crushed to required particle size range, finally obtain cooling water solubility is 98.9% Pregelatinized starch.
Comparative example 1
According to implementation described in Chinese patent CN CN102614518A embodiments, pregelatinized starch finished product is obtained.
Embodiment 13
The pregelatinized starch sample of Example 2,4,6,8,10,12 and comparative example 1,2, foundation《Chinese Pharmacopoeia 2015 Version two》The content carries out quality full inspection, the results are shown in Table 1.
Embodiment 14
Powder fluidity is tested, test method:Using powder tester for overall characteristic in whole embodiments and comparative example Pregelatinized starch powder angle of repose be measured, the results are shown in Table 2.
Powder compressibility is tested, test method:Using use powder tester for overall characteristic to whole embodiments and comparison Pregelatinized starch powder compressibility in embodiment is measured, and the results are shown in Table 2.
The quality test results of 1 pregelatinized starch of table
2 powder fluidity of table and compressibility test result
The above, the quality test results of medicinal pregelatinized starch that the present invention is produced are qualified, powder fluidity The product prepared by other production methods can be all significantly better than with compressibility, there is significant advantage.

Claims (6)

1. a kind of preparation method of medicinal pregelatinized starch, which is characterized in that include the following steps:
A, material is weighed:Weigh a certain amount of food-grade starches and purified water;
B, the pretreatment of material:Load weighted material is placed in 40 ~ 60min of grinding in mill;
C, the mixing of material:Then ground material is placed in mixed at high speed unit, and mixed at high speed unit is made to be placed in ultrasound Under wave environment, 30 ~ 50min is mixed, the moisture of material is 15% ~ 35% after control mixing;
D, the extrusion of material:The material mixed is added into extruder charging hopper, opens extruder, controls extruder temperature, 60oC~100oIt is squeezed out at a temperature of C;
E, by material 0oC~10oDrying is cooled down under the conditions of C;
F, dried material will be cooled down to be cut with pelleter, pulverizer is crushed to grain size model needed for medicinal pregelatinized starch It encloses.
2. the preparation method of medicinal pregelatinized starch according to claim 1, which is characterized in that the starch for potato, Cereal starch or their mixture.
3. the preparation method of medicinal pregelatinized starch according to claim 1, which is characterized in that the matter of starch and purified water Amount proportioning is 1:0.06~0.32.
4. according to the preparation method of medicinal pregelatinized starch according to claim 1, it is characterised in that ground material 1 ~ 3h is heated before mixing under the conditions of infrared, temperature is 80 ~ 120oC。
5. according to the preparation method of medicinal pregelatinized starch according to claim 1, which is characterized in that the frequency of ultrasonic wave For 30000Hz ~ 800000Hz.
6. the preparation method of medicinal pregelatinized starch according to claim 1, which is characterized in that the major diameter of extruder screw Than being 16, rotating speed is 120 ~ 160r/min.
CN201611095337.0A 2016-12-02 2016-12-02 A kind of improvement of the preparation method of medicinal pregelatinized starch Pending CN108148144A (en)

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CN112076166A (en) * 2020-09-21 2020-12-15 湖州展望药业有限公司 Direct-pressed starch and production method thereof
CN113121713A (en) * 2021-03-31 2021-07-16 湖北人福药用辅料股份有限公司 Pregelatinized starch and preparation method and application thereof

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112076166A (en) * 2020-09-21 2020-12-15 湖州展望药业有限公司 Direct-pressed starch and production method thereof
CN113121713A (en) * 2021-03-31 2021-07-16 湖北人福药用辅料股份有限公司 Pregelatinized starch and preparation method and application thereof
CN113121713B (en) * 2021-03-31 2023-08-15 湖北人福药用辅料股份有限公司 Pregelatinized starch and preparation method and application thereof

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