CN109044987A - A kind of hydroxypropul starch Capsules and preparation method thereof - Google Patents
A kind of hydroxypropul starch Capsules and preparation method thereof Download PDFInfo
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- CN109044987A CN109044987A CN201811084081.2A CN201811084081A CN109044987A CN 109044987 A CN109044987 A CN 109044987A CN 201811084081 A CN201811084081 A CN 201811084081A CN 109044987 A CN109044987 A CN 109044987A
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4816—Wall or shell material
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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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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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
- 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
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
-
- 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
- A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
Abstract
The present invention provides a kind of preparation methods of hydroxypropul starch Capsules, the Capsules are mainly made by following raw material: in terms of mass fraction, 30-40 parts of hydroxypropul starch, 20-30 parts of acetate starch, 2-5 parts of castor oil, 1-3 parts of glycerol, 0.5-0.8 parts of avocado oil, 2-4 parts of egg white, 2-4 parts of mannitol.Preparation method, which includes: (A), is configured to starch solution for the magnetized water that all raw materials add 50-60 DEG C, and heat preservation stands and removes bubble removing；(B) the processed starch solution of above-mentioned steps is dipped in into glue, subsequent drying, demoulding at 0 DEG C.The method that the Capsules of the embodiment of the present invention have abandoned previous addition manufacturing of gelatin capsule, and after being compounded in the feed by the different types of oil of addition, egg white, it is more advantageous to the persistence of capsule color, so that the bright degree of capsule is more preferably, quality is more smooth, convenient for the molding of capsule, the stability of storage is increased.
Description
Technical field
The present invention relates to capsule preparation fields, in particular to a kind of hydroxypropul starch Capsules and its preparation side
Method.
Background technique
Gelatin hollow capsule (Empty capsule): the cap that is made by pharmagel plus auxiliary material, two section capsule shells of body
Composition.It is mainly used for containing solid drugs.It such as makes powder, health care product, medicament by oneself, solves difficult entrance, mouthfeel for user
The problem of difference, it is no longer bitter to the taste to be truly realized good medicine.Capsules are becoming increasingly popular, first the elongate form of capsule, are easy to
It swallows, is dosage form most popular with consumers；In addition, capsule can very effectively cover the uncomfortable taste of content
And smell.There are many multiplicity, including No. 00 lengthening, No. 00, No. 0, No. 1, No. 2, No. 3, No. 4 and No. 5 capsules for the size of capsule.Glue
Text, trade mark and pattern can be also stamped on capsule, show unique customization appearance.
The production process of existing Capsules is after dipping in glue, sizing, drying, cutting, fitting in glue using mold
It is formed, since mold is barrel-like structure, if liquid pectin is unable to fast shaping on mold, glue will trickle, and cause to give birth to
Produce failure.The gelatin itself that traditional gelatin hollow capsule uses has the characteristic of gel.That is gelatin glue is taken the photograph 40
When below family name's degree, the strand of gelatin is mutually wound from disordered state, forms reticular structure, flexible is not flowed to be formed
Dynamic similar g., jelly-like is known as gel, and gelatine capsule is exactly to be produced using this characteristic of gelatin.
Hydroxypropul starch needs to be added because itself not having gel-type when configuring oxidized starch glue
Gelling agent or gelling agent take ingredient.But because gelling agent is generally high viscosity colloid, the concentration of glue is seriously affected, has been made
Decline at production efficiency.Gelling agent huge number, capsule contents species are huger, and gelling agent and capsule 's content may be sent out
Raw reaction, causes the potential risk of safety.And the bright degree of capsule that produced in conventional processes comes out is not enough, and storage stability is not
The disadvantages of good, limits its further application.
In view of this, the present invention is specifically proposed.
Summary of the invention
The first object of the present invention is to provide a kind of hydroxypropul starch Capsules, which has abandoned adds in the past
Add the method for manufacturing of gelatin capsule, and in the feed by adding different types of oil, after egg white compounded, more favorably
In the persistence of capsule color, so that the bright degree of capsule is more preferably, quality is more smooth, convenient for the molding of capsule, increases storage
The stability deposited provides a kind of new way for the production of Capsules, significantly improves the quality of capsule itself, is worth
It is widely popularized and is applied.
The second object of the present invention is to provide the preparation method of above-mentioned hydroxypropul starch Capsules, preparation method behaviour
Make simplicity, condition is easily controllable, and save the cost is conducive to large-scale production, by controlling temperature during dipping in adhesive process
At 0 DEG C hereinafter, glue in this way can voluntarily freeze to form gel, the defect of addition gelatin, the hydroxyl being prepared are avoided
Base starch hollow capsule application range is very wide, creates certain economic benefit.
In order to realize above-mentioned purpose of the invention, the following technical scheme is adopted:
The present invention provides a kind of hydroxypropul starch Capsules, are mainly made by following raw material: in terms of mass fraction, hydroxyl
30-40 parts of propyl starch, 20-30 parts of acetate starch, 2-5 parts of castor oil, 1-3 parts of glycerol, 0.5-0.8 parts of avocado oil, egg
It is 2-4 parts, 2-4 parts of mannitol clear.
Gelatin is as the used main material of capsule industry, by the connective tissues such as animal skin, bone, sarolemma, flesh evil spirit
Collagenous portion degradation and become white or faint yellow, translucent, micro-strip gloss thin slice or powder；It is a kind of colorless and odorless,
Non-volatility, transparent hard non-crystalline material, dissolve in hot water, do not dissolve in cold water, but can slowly water swelling soften, bright
The absorbable water for being equivalent to 5-10 times of weight of glue.
Gelatin hollow capsule (Empty capsule) in the prior art: the cap that is made by pharmagel plus auxiliary material,
Two section capsule shells of body composition.It is mainly used for containing solid drugs.It such as makes powder, health care product, medicament by oneself, is solved for user
The problem of difficult entrance, poor taste, it is no longer bitter to the taste to be truly realized good medicine.Capsules are becoming increasingly popular, first the shape of capsule
Shape is elongated, is easy to swallow, and is dosage form most popular with consumers；In addition, capsule can very effectively cover making us for content
Uncomfortable taste and smell.There are many multiplicity, including No. 00 lengthening, No. 00, No. 0, No. 1, No. 2, No. 3, No. 4 for the size of capsule
With No. 5 capsules.Text, trade mark and pattern can be also stamped on capsule, show unique customization appearance.
The production process of existing Capsules is to dip in shape after glue, sizing, drying, cutting, fitting in glue using mold
At, since mold is barrel-like structure, if liquid pectin is unable to fast shaping on mold, glue will trickle, and cause to produce
Failure.The gelatin itself that traditional gelatin hollow capsule uses has the characteristic of gel.That is gelatin glue is Celsius 40
When degree is following, the strand of gelatin is mutually wound from disordered state, formation reticular structure, flexible is not flowed to be formed
Similar g., jelly-like be known as gel, gelatine capsule is exactly to be produced using this characteristic of gelatin.
Hydroxypropul starch needs to be added because itself not having gel-type when configuring oxidized starch glue
Gelling agent or gelling agent take ingredient.But because gelling agent is generally high viscosity colloid, the concentration of glue is seriously affected, has been made
Decline at production efficiency.Gelling agent huge number, capsule contents species are huger, and gelling agent and capsule 's content may be sent out
Raw reaction, causes the potential risk of safety.And the bright degree of capsule that produced in conventional processes comes out is not enough, and storage stability is not
The disadvantages of good, limits its further application.
The raw material hydroxypropul starch that the present invention uses is under strongly alkaline conditions, to be reacted and be made with propylene oxide by starch.
In acid, stable under alkaline conditions, gelatinization point is lower than ative starch, and cold and hot viscosity variation is stablized compared with ative starch.With salt, sucrose
Deng it is mixed on viscosity without influence.After etherificate, freeze-thaw stability and transparency all increase.Due to during making capsule
Do not allow to add other additives such as gelling agent, to reduce the additional injuries to human body, therefore selects hydroxypropul starch as former
Material, the addition of acetate starch fill stable effect also for playing.
Furthermore castor oil, glycerol, avocado oil and egg white be also added in the feed, these four substances are matched with certain
It, can be with than the transparencies of capsule shells, especially smoothness of the egg white in addition to shell can be improved itself can be improved after addition
Oxidation resistance is improved with after the cooperation of other substances, so that capsule keeps better stability, keeps the color of capsule itself fresh
Brightness.
Although avocado oil has excellent color conservation degree, its moisture retention as glycerol is relatively good, if dosage
The too big forming degree that may be unfavorable for Capsules itself, it is therefore desirable to control the dosage of glycerol, avocado oil itself, and with it is certain
After the castor oil of amount, egg white cooperate, the forming degree for both not interfered with capsule itself so is also able to maintain certain forming degree, when
The addition that so a certain amount of acetate starch addition can also just make up other components can reduce asking for capsule forming degree itself
Topic.
It can be seen that above-mentioned substance be by could effectively promote the various aspects quality of capsule after a certain amount of compounding, so that its capsule is each
The performance of a aspect reaches most preferably, the selection of each component be all have it is certain according to property.
Preferably as further enforceable mode, in terms of mass fraction, 32-38 parts of hydroxypropul starch, acetate forms sediment
22-28 parts of powder, 3-4 parts of castor oil, 2-2.8 parts of glycerol, 0.6-0.7 parts of avocado oil, 3-3.5 parts of egg white, mannitol 3-3.5
Part.
Preferably as further enforceable mode, in terms of mass fraction, 36 parts of hydroxypropul starch, acetate starch
26 parts, 3.5 parts of castor oil, 2.5 parts of glycerol, 0.65 part of avocado oil, 3.2 parts of egg white, 3.2 parts of mannitol.
The embodiment of the invention also provides a kind of preparation methods of above-mentioned hydroxypropul starch Capsules, including walk as follows
It is rapid:
(A) magnetized water that all raw materials add 50-60 DEG C is configured to starch solution, heat preservation stands and removes bubble removing；
(B) the processed starch solution of above-mentioned steps is dipped in into glue, subsequent drying, demoulding at 0 DEG C.
Easy to operate in above-mentioned preparation method, condition is easily controllable, and save the cost is conducive to large-scale production, is dipping in glue
In technical process by by temperature control at 0 DEG C hereinafter, in this way glue can voluntarily freeze to form gel, avoid addition gelatin
Defect, the hydroxyl starch hollow capsule application range being prepared is very wide, creates certain economic benefit.
Industrial water by using magnetized water as capsule itself, it is possible to reduce the generation of the substances such as scale.
Preferably, in the step (A), in the starch solution, the additive amount of water is the 2-3 of the gross mass of all raw materials
Times.
Preferably, in the step (A), the temperature of heat preservation is controlled between 60-70 DEG C.
Preferably, in the step (A), the time of standing is controlled in 2-3h.
Preferably, in the step (B), the temperature for dipping in glue is controlled between -40 DEG C~0 DEG C.
Preferably, in the step (B), the temperature of subsequent drying is controlled between 5-10 DEG C.
Preferably, in the step (B), cutting, fitting are further included the steps that after demoulding.
Above-mentioned each operating parameter is controlled in than convenient range, the product for improving the capsule prepared are conducive to
Matter.
Compared with prior art, the invention has the benefit that
(1) hydroxypropul starch Capsules provided in an embodiment of the present invention have abandoned the side of previous addition manufacturing of gelatin capsule
Method, and the lasting of capsule color is more advantageous to by adding different types of oil, after egg white compounded in the feed
Degree, so that the bright degree of capsule is more preferably, quality is more smooth, convenient for the molding of capsule, increases the stability of storage, is hollow
The production of capsule provides a kind of new way, significantly improves the quality of capsule itself, should be widely promoted and applied；
(2) preparation method of hydroxypropul starch Capsules provided in an embodiment of the present invention is easy to operate, and condition is easy to control
System, save the cost are conducive to large-scale production, by controlling temperature at 0 DEG C hereinafter, such glue during dipping in adhesive process
It voluntarily can freeze to form gel, avoid the defect of addition gelatin, the hydroxyl starch hollow capsule application being prepared
Range is very wide, creates certain economic benefit.
Specific embodiment
Embodiment of the present invention is described in detail below in conjunction with embodiment, but those skilled in the art will
Understand, the following example is merely to illustrate the present invention, and is not construed as limiting the scope of the invention.It is not specified in embodiment specific
Condition person carries out according to conventional conditions or manufacturer's recommended conditions.Reagents or instruments used without specified manufacturer is
The conventional products that can be obtained by commercially available purchase.
Embodiment 1
1) it weighs according to production requirement, hydroxypropul starch 30kg, acetate starch 20kg, castor oil 2kg, glycerol
3kg, avocado oil 0.5kg, egg white 4kg, mannitol 2kg；
It 2) is that 50 DEG C of magnetized water is sufficiently stirred as uniform starch solution, heat preservation, quiet by said components addition temperature
Set removing bubble；
3) configured starch solution is put into hollow capsule production line glue groove, mold temperature control subzero 40 DEG C into
Row dips in glue；
4) subsequent 10 DEG C of dryings, demoulding, cutting and fitting after capsule is made；
5) examination and test of products, sorting after being produced；
6) it appearance lettering, inspection, weighing and packs.
Embodiment 2
1) it weighs according to production requirement, hydroxypropul starch 40kg, acetate starch 30kg, castor oil 5kg, glycerol
1kg, avocado oil 0.8kg, egg white 2kg, mannitol 4kg；
2) magnetized water for being 60 DEG C by said components addition temperature, the additive amount of magnetized water are the 2 of the quality of all components
Times, it is sufficiently stirred as uniform starch solution, 70 DEG C of heat preservation 2h, stands 3h removing bubble；
3) configured starch solution is put into hollow capsule production line glue groove, mold temperature control is dipped at 0 DEG C
Glue；
4) subsequent 5 DEG C of dryings, demoulding, cutting and fitting after capsule is made；
5) examination and test of products, sorting after being produced；
6) it appearance lettering, inspection, weighing and packs.
Embodiment 3
1) it weighs according to production requirement, hydroxypropul starch 32kg, acetate starch 28kg, castor oil 3kg, glycerol
2.8kg, avocado oil 0.6kg, egg white 3.5kg, mannitol 3kg；
2) magnetized water for being 55 DEG C by said components addition temperature, the additive amount of magnetized water are the 3 of the quality of all components
Times, it is sufficiently stirred as uniform starch solution, 60 DEG C of heat preservation 3h, stands 2h removing bubble；
3) configured starch solution is put into hollow capsule production line glue groove, mold temperature control subzero 20 DEG C into
Row dips in glue；
4) subsequent 8 DEG C of dryings, demoulding, cutting and fitting after capsule is made；
5) examination and test of products, sorting after being produced；
6) it appearance lettering, inspection, weighing and packs.
Embodiment 4
Concrete operation step and embodiment 3 are consistent, and only difference is the additive amount of raw material: hydroxypropul starch 38kg, vinegar
Acid esters starch 22kg, castor oil 3kg, glycerol 2.8kg, avocado oil 0.7kg, egg white 3kg, mannitol 3.5kg.
Embodiment 5
Concrete operation step and embodiment 3 are consistent, and only difference is the additive amount of raw material: hydroxypropul starch 36kg, vinegar
Acid esters starch 26kg, castor oil 3.5kg, glycerol 2.5kg, avocado oil 0.65kg, egg white 3.2kg, mannitol 3.2kg.
Comparative example 1
Concrete operation step and embodiment 3 are consistent, and hydroxypropul starch 32kg, acetate starch are only contained only in component
28kg, glycerol 2.8kg, mannitol 3kg.
Comparative example 2
Concrete operation step and embodiment 3 are consistent, only avocado oil 2kg in component.
Comparative example 3
Concrete operation step and embodiment 3 are consistent, only egg white 0.5kg.
Experimental example 1
Each embodiment is compared with the performance of the Capsules of comparative example, specific result is as shown in table 1 below, the
The sample of one group of Capsules for corresponding to embodiment 1, embodiment 3 and embodiment 5 to third group, the 4th group to six group pair
It should be the sample of the Capsules of comparative example 1, comparative example 2 and comparative example 3.
Wherein roughness (Sa): thick using the surface of non-planar contact surfaces shape tester (Vertscan) test sample
Rugosity Sa.
Pierce through breakage rate: using a Symbion Bexicap (Beximco Pharma corporation) to Capsules sample
The both ends of product carry out puncture experiment simultaneously.There is 1 or 1 or more fragment in sample, is considered as unqualified；Otherwise it is considered as qualification.
200 experiments are carried out to each sample, disqualification rate is to pierce through breakage rate.Test condition is 25 DEG C, 50%RH.
Medicinal powder-capsule wall adhesion rate: the talcum powder that 100mg number average bead diameter is 50 microns being added into Capsules sample,
The body and cap of sealed capsule simultaneously ensure not powder leakage, and hand holds capsule shells both ends, after overturning 10 times back and forth, capsule are opened, by talcum
Powder is poured out, and is measured the quality m (unit mg) of the talcum powder of outflow, is accurate to 1mg.Adhesion rate S=(100-m)/100 × 100%,
It replication 10 times, is averaged.
The detection of 1 results of property of table
As can be seen from the above table, no matter steady from the color of appearance, molding itself Capsules of the embodiment of the present invention are
On fixed degree, there are also more excellent on smoothness, and it is not easy to adhere to medicinal powder, stability is good, is more favorable for protecting
It deposits.
Compared with prior art, present invention has the advantage that
1) process is simple, is conducive to large-scale production；2) it does not need that gelling agent is added in production, save the cost guarantees edible
Safety；3) it is raw material using hydroxypropul starch, reduces and use biogelatin, to ensure good economics, sociology benefit.4)
Production method is nontoxic, rate of drying is fast and is simple and efficient, safety.
Although illustrate and describing the present invention with specific embodiment, it will be appreciated that without departing substantially from of the invention
Many other change and modification can be made in the case where spirit and scope.It is, therefore, intended that in the following claims
Including belonging to all such changes and modifications in the scope of the invention.
Claims (10)
1. a kind of hydroxypropul starch Capsules, which is characterized in that be mainly made by following raw material: in terms of mass fraction, hydroxypropyl
30-40 parts of base starch, 20-30 parts of acetate starch, 2-5 parts of castor oil, 1-3 parts of glycerol, 0.5-0.8 parts of avocado oil, egg white
2-4 parts, 2-4 parts of mannitol.
2. hydroxypropul starch Capsules according to claim 1, which is characterized in that in terms of mass fraction, hydroxypropyl forms sediment
32-38 parts of powder, 22-28 parts of acetate starch, 3-4 parts of castor oil, 2-2.8 parts of glycerol, 0.6-0.7 parts of avocado oil, egg white 3-
3.5 parts, 3-3.5 parts of mannitol.
3. hydroxypropul starch Capsules according to claim 1, which is characterized in that in terms of mass fraction, hydroxypropyl forms sediment
36 parts of powder, 26 parts of acetate starch, 3.5 parts of castor oil, 2.5 parts of glycerol, 0.65 part of avocado oil, 3.2 parts of egg white, mannitol
3.2 part.
4. the preparation method of the described in any item hydroxypropul starch Capsules of claim 1-3, which is characterized in that including as follows
Step:
(A) magnetized water that all raw materials add 50-60 DEG C is configured to starch solution, heat preservation stands and removes bubble removing；
(B) the processed starch solution of above-mentioned steps is dipped in into glue, subsequent drying, demoulding at 0 DEG C.
5. the preparation method according to claim 4, which is characterized in that in the step (A), in the starch solution, water
Additive amount be 2-3 times of gross mass of all raw materials.
6. the preparation method according to claim 4, which is characterized in that in the step (A), the temperature control of heat preservation exists
Between 60-70 DEG C.
7. the preparation method according to claim 4, which is characterized in that in the step (A), the time of standing is controlled in 2-
3h。
8. according to the described in any item preparation methods of claim 4-7, which is characterized in that in the step (B), dip in the temperature of glue
Control is between -40 DEG C~0 DEG C.
9. according to the described in any item preparation methods of claim 4-7, which is characterized in that in the step (B), subsequent drying
Temperature controls between 5-10 DEG C.
10. according to the described in any item preparation methods of claim 4-7, which is characterized in that in the step (B), after demoulding also
Include the steps that cutting, fitting.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN112174737A (en) * | 2020-10-10 | 2021-01-05 | 河南华智营养科技有限公司 | Micro-fertilizer for foliar spraying of unmanned aerial vehicle |
| CN112586587A (en) * | 2020-12-10 | 2021-04-02 | 浙江艾兰得生物科技有限公司 | Anti-sticking chewable plant gel candy gel rubber |
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