CN105581986B - A kind of andrographolide dry suspensoid agent and preparation method thereof - Google Patents
A kind of andrographolide dry suspensoid agent and preparation method thereof Download PDFInfo
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- CN105581986B CN105581986B CN201610101939.6A CN201610101939A CN105581986B CN 105581986 B CN105581986 B CN 105581986B CN 201610101939 A CN201610101939 A CN 201610101939A CN 105581986 B CN105581986 B CN 105581986B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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Abstract
The invention discloses a kind of andrographolide dry suspensoid agents and preparation method thereof, the andrographolide dry suspensoid agent is the particle obtained by andrographolide and auxiliary material mixed atomizing, the auxiliary material is lower melting-point auxiliary material, the quality of lower melting-point auxiliary material is 0.1 times to 10 times of andrographolide, further includes other at least one auxiliary materials.The andrographolide dry suspensoid agent that the present invention allots is added a small amount of water and can take, convenient to take, good to the flavoring of andrographolide almost without bitter taste, and the patient of children, old man and dysphagia is suitble to take.
Description
Technical field：
The present invention relates to a kind of andrographolide dry suspensoid agents and preparation method thereof.
Background technology：
Either chemical drug or Chinese medicine, the bitter taste that drug has all are one of the reason of it are not accepted, in Herba Andrographitis
Ester is diterpenes diterpenoids lactones compound, has the effect of thermal detoxification of dispelling, anti-inflammatory analgetic, to bacillary and viral infection of upper respiratory tract
And dysentery has special efficacy, is known as natural antibiotics drug.In recent years, andrographolide has developed tablet, capsule, dripping pill etc.
Common dosage forms, however diterpenes diterpenoids lactones compound, are insoluble in water, are usually only capable of being administered orally.In addition to this, due in Herba Andrographitis
The taste of ester is extremely bitter, is unfavorable for patient's medication of children, old man and dysphagia, these dosage forms do not solve this problem.Institute
With, to andrographolide carry out flavoring, be made suitable dosage form very it is necessary to.
Invention content：
In order to solve problem above, the present invention has studied a kind of method that andrographolide is prepared into dry suspensoid agent, leads to
It crosses and carries out hot melt spraying granulation after being mixed with andrographolide using auxiliary material, to have the function that andrographolide taste masking,
The bitter taste that andrographolide can preferably be covered tastes experiment by human body mouth and makes us acceptable hardship degree it is found that having reached, then
Suitable corrigent is added, obtained dry suspensoid agent good mouthfeel is taken suitable for patient.
The primary and foremost purpose of the present invention is to provide a kind of andrographolide dry suspensoid agent, is conducive to children, old man and dysphagia
Patient medication.
Another mesh of the present invention is to provide a kind of andrographolide dry suspensoid agent preparation method, and the method is simple and easy to do, right
The flavoring of drug is with obvious effects.
A kind of andrographolide dry suspensoid agent of the offer of the present invention, wherein the andrographolide dry suspensoid agent is by wearing
Heart lotus lactone and particle obtained by auxiliary material mixed atomizing, the auxiliary material are lower melting-point auxiliary material, the matter of lower melting-point auxiliary material
Amount is 0.1 times to 10 times of andrographolide, further includes other at least one auxiliary materials.
Preferably, wherein the andrographolide is selected from crystalline state andrographolide, amorphous state andrographolide, half hitch
Crystalline state andrographolide, half amorphous state andrographolide and their mixture.
Preferably, wherein the andrographolide is the andrographolide powder by crushing, particle size range
Averagely it is less than 100 μm.
Preferably, it is sweet to be selected from hexadecanol, octadecyl alcolol, glycerin monostearate, behenic acid for the lower melting-point auxiliary material
One or more of grease, stearic acid, beeswax, polyvinyl alcohol, polyethylene glycol.
Preferably, wherein the andrographolide is averagely less than with the lower melting-point auxiliary material spraying gained particle
500μm。
Preferably, Determination of Andrographolide accounts for 1-70% by weight wherein in dry suspensoid agent.
Preferably, wherein described other auxiliary materials of at least one include filler, suspending agent, sweetener, aromatic and tart flavour
Agent.
Preferably, wherein the filler is selected from lactose, microcrystalline cellulose, mannitol, starch, dextrin, maltodextrin, sugarcane
One or more of sugar, sorbierite, xylitol, soluble starch.
Preferably, wherein the suspending agent is selected from xanthans, carragheen, gelatin, Arabic gum, tragacanth, alginic acid
Salt, carboxymethyl cellulose salt, guar gum, pectin, polyvinyl alcohol, hydroxyethyl cellulose class, povidone, polyacrylic acid, methyl are fine
One or more of the plain class of dimension, hydroxypropyl methyl cellulose.
Preferably, wherein the sweetener be selected from neotame, Sucralose, stevioside, honey element, acesulfame potassium, saccharin sodium, Ah
One or more of this Ba Tian, honey.
Preferably, wherein the aromatic is selected from natural or artificial orange flavor, flavoring pineapple essence, strawberry essence, banana incense
One or more of essence, cherry essence, chocolate essence, hawthorn essence.
Preferably, wherein the one kind of the acid in citric acid, tartaric acid, malic acid, sodium carbonate, sodium citrate
Or it is several.
Another object of the present invention is to provide a kind of molten atomizing method of granulating preparing andrographolide dry suspensoid agent, including
Following steps：
Step 1：Lower melting-point auxiliary material is placed in water-bath and is heated, after heating makes auxiliary material melt, by andrographolide plus
Enter wherein, stirs evenly；
Step 2：By the andrographolide stirred evenly and lower melting-point auxiliary material mixed atomizing；
Step 3：Hot melt spray product is collected, andrographolide flavour blend is both obtained；
Step 4：Appropriate filler, suspending agent, sweetener, aromatic, acid are added in the mixture, is uniformly mixed
Andrographolide dry suspensoid agent is made.
Preferably, the molten spray parameters wherein in step 2 are：100-200 DEG C of inlet air temperature, atomizing pressure 0.1-
0.5Kpa, charging rate 30-100ml/min.
It is furthermore preferred that the quality of lower melting-point auxiliary material is 0.5 times to 8 times of andrographolide, it is furthermore preferred that described
The quality of lower melting-point auxiliary material is 0.8 times to 2 times of andrographolide.
It is furthermore preferred that being wherein less than 80 μm, 50 μm, 10 μ by the particle size range of the andrographolide powder crushed
m、1μm、500nm、400nm、300nm、200nm、100nm、50nm。
It is furthermore preferred that wherein Determination of Andrographolide accounts for 10-60% by weight in dry suspensoid agent, it is furthermore preferred that wherein
Determination of Andrographolide accounts for 30-50% by weight in dry suspensoid agent.
It is furthermore preferred that the wherein andrographolide and the lower melting-point auxiliary material spraying gained particle is average small
In 300 μm, 200 μm, 100 μm, 50 μm, 10 μm, 1 μm, 500nm, 400nm, 300nm, 200nm, 100nm, 50nm.
Technical solution using the present invention, wherein andrographolide and the powder after auxiliary material hot melt spraying granulation, grain size
Size is less than 500 μm, and dry suspensoid agent manufactured so just not will produce sand type when taking.
Technical solution using the present invention, wherein the good cover of andrographolide bitter taste is acted in selected auxiliary material,
Test is tasted it is found that without undesirable taste according to human body mouth.
The andrographolide dry suspensoid agent that the present invention allots is added a small amount of water and can take, convenient to take, almost without hardship
Taste, it is good to the flavoring of andrographolide, it is suitble to the patient of children, old man and dysphagia to take.In Vitro Dissolution experiment knot
Fruit shows that andrographolide can well be discharged from agent in vitro.
Description of the drawings：
Fig. 1, the dissolution experimental data figure of embodiment 1.
Fig. 2, the dissolution experimental data figure of embodiment 2.
Fig. 3, the dissolution experimental data figure of embodiment 3.
Fig. 4, the dissolution experimental data figure of embodiment 4.
Fig. 5, the dissolution experimental data figure of embodiment 5.
Fig. 6, the dissolution experimental data figure of embodiment 6.
Fig. 7, the dissolution experimental data figure of embodiment 7.
Fig. 8, the dissolution experimental data figure of embodiment 8.
Fig. 9, the dissolution experimental data figure of embodiment 9.
Specific implementation mode：
For the technology contents that the present invention will be described in detail, the objects and the effects will be to the present invention in the following examples
It is described further, embodiment is not limit the invention in any way, and the purpose and scope of the invention is not limited to these embodiments
Described in actual conditions or details, but limited by claims.All material is that mass percent is dense
Degree.
Embodiment 1
It takes octadecyl alcolol 30g in beaker, beaker is put in 85 DEG C of water-baths and is heated, after its thawing, 10g punchings are added
Lotus lactone, with magnetic stirrer 30 minutes so that andrographolide be suspended in octadecyl alcolol after, carry out hot melt spraying
Granulation.
Molten atomizing parameter is：130 DEG C, atomizing pressure 0.3Kpa, charging rate 80ml/min of inlet air temperature.
Hot melt spray product is collected, andrographolide flavour blend is both obtained.By the filler of mixture and suitable proportion,
Aromatic, sweetener, acid, suspending agent are mixed, and andrographolide dry suspensoid agent has both been obtained.
Andrographolide dry suspensoid agent prescription is as follows：
Andrographolide and octadecyl alcolol mixture：4g
Lactose：15.3g
Xanthans：0.1g
Superfine silica gel powder：0.05g
Neotame：0.2g
Orange flavor：0.2g
Citric acid：0.2g
Dissolution experiment is carried out to above-mentioned product, dissolution experiment parameter is：Method is basket method, dissolution medium 900ml0.5%
The buffer solution of the pH1.2 of SDS, rotating speed 100/min, temperature are 37 DEG C.Dissolution result is shown in attached drawing 1.By result it is found that Herba Andrographitis
The dissolution of lactone is all right.
5 minutes and 10 minutes dissolution andrographolide concentration is also carried out carrying out to product in the buffer salt of pH6.8
Investigation, to simulate its release in the oral cavity.Its result is respectively 4.89 μ g/ml and 10.05 μ g/ml, the results showed that its
Flavoring effect is very notable.
Embodiment 2
It takes glycerin monostearate 30g in beaker, is sealed with preservative film, beaker is put in 85 DEG C of water-baths and is heated,
After its thawing, 10g andrographolides are added, with magnetic stirrer 30 minutes so that andrographolide be suspended in
After in octadecyl alcolol, hot melt spraying granulation is carried out.
Andrographolide dry suspensoid agent prescription is as follows：
Andrographolide and glycerin monostearate mixture：4g
Starch：15.3g
Xanthans：0.1g
Superfine silica gel powder：0.05g
Neotame：0.2g
Orange flavor：0.2g
Citric acid：0.2g
Molten atomizing parameter is：130 DEG C, atomizing pressure 0.3Kpa, charging rate 80ml/min of inlet air temperature.
Hot melt spray product is collected, andrographolide flavour blend is both obtained..By the filling of mixture and suitable proportion
Agent, aromatic, sweetener, acid, suspending agent are mixed, and andrographolide dry suspensoid agent has both been obtained.
Dissolution experiment is carried out to above-mentioned product, dissolution experiment parameter is：Method is basket method, dissolution medium 900ml0.5%
The buffer solution of the pH1.2 of SDS, rotating speed 100/min, temperature are 37 DEG C.Dissolution result is shown in attached drawing 2.By result it is found that Herba Andrographitis
The dissolution of lactone is all right.
5 minutes and 10 minutes dissolution andrographolide concentration is also carried out carrying out to product in the buffer salt of pH6.8
Investigation, to simulate its release in the oral cavity.Its result is respectively 3.75ug/ml and 9.47ug/ml, the results showed that it is rectified
Taste effect is very notable.
Embodiment 3
Octadecyl alcolol is taken in beaker, to be sealed with preservative film with each 10g of glycerin monostearate, beaker is put in 85 DEG C of water-baths
It is heated in pot, after its thawing, 10g andrographolides is added, with magnetic stirrer 30 minutes so that andrographolide is equal
After being suspended in octadecyl alcolol, hot melt spraying granulation is carried out.
Molten atomizing parameter is：130 DEG C, atomizing pressure 0.3Kpa, charging rate 50/min of inlet air temperature.
Hot melt spray product is collected, andrographolide flavour blend is both obtained.By the filler of mixture and suitable proportion,
Aromatic, sweetener, acid, suspending agent are mixed, and andrographolide dry suspensoid agent has both been obtained.
Andrographolide dry suspensoid agent prescription is as follows：
Andrographolide and 18 and glycerin monostearate mixture：4g
Lactose：15.3g
Sodium alginate：0.1g
Superfine silica gel powder：0.05g
Neotame：0.2g
Orange flavor：0.2g
Citric acid：0.2g
Dissolution experiment is carried out to above-mentioned product, dissolution experiment parameter is：Method is basket method, dissolution medium 900ml0.5%
The buffer solution of the pH1.2 of SDS, rotating speed 100/min, temperature are 37 DEG C.Dissolution result is shown in attached drawing 3.By result it is found that Herba Andrographitis
The dissolution of lactone is all right.
5 minutes and 10 minutes dissolution andrographolide concentration is also carried out carrying out to product in the buffer salt of pH6.8
Investigation, to simulate its release in the oral cavity.Its result is respectively 8.06 μ g/ml and 13.19 μ g/ml, the results showed that its
Flavoring effect is very notable.
Embodiment 4
Octadecyl alcolol is taken in beaker, to be sealed with preservative film with each 15g of glycerin monostearate, beaker is put in 85 DEG C of water-baths
It is heated in pot, after its thawing, 10g andrographolides is added, with magnetic stirrer 30 minutes so that andrographolide is equal
After being suspended in octadecyl alcolol, hot melt spraying granulation is carried out.
Molten atomizing parameter is：130 DEG C, atomizing pressure 0.3Kpa, charging rate 50ml/min of inlet air temperature.
Hot melt spray product is collected, andrographolide flavour blend is both obtained.By the filler of mixture and suitable proportion,
Aromatic, sweetener, acid, suspending agent are mixed, and andrographolide dry suspensoid agent has both been obtained.
Andrographolide dry suspensoid agent prescription is as follows：
Andrographolide and octadecyl alcolol and glycerin monostearate mixture：4g
Starch：15.3g
Carragheen：0.1g
Superfine silica gel powder：0.05g
Neotame：0.2g
Orange flavor：0.2g
Citric acid：0.2g
Dissolution experiment is carried out to above-mentioned product, dissolution experiment parameter is：Method is basket method, dissolution medium 900ml0.5%
The buffer solution of the pH1.2 of SDS, rotating speed 100/min, temperature are 37 DEG C.Dissolution result is shown in attached drawing 4.By result it is found that Herba Andrographitis
The dissolution of lactone is all right.
5 minutes and 10 minutes dissolution andrographolide concentration is also carried out carrying out to product in the buffer salt of pH6.8
Investigation, to simulate its release in the oral cavity.Its result is respectively 6.53 μ g/ml and 12.37 μ g/ml, the results showed that its
Flavoring effect is very notable.
Embodiment 5
Octadecyl alcolol is taken in beaker, to be sealed with preservative film with each 20g of glycerin monostearate, beaker is put in 85 DEG C of water-baths
It is heated in pot, after its thawing, 10g andrographolides is added, with magnetic stirrer 30 minutes so that andrographolide is equal
After being suspended in octadecyl alcolol, hot melt spraying granulation is carried out.
Molten atomizing parameter is：130 DEG C, atomizing pressure 0.3Kpa, charging rate 80ml/min of inlet air temperature.
Hot melt spray product is collected, andrographolide flavour blend is both obtained.By the filler of mixture and suitable proportion,
Aromatic, sweetener, acid, suspending agent are mixed, and andrographolide dry suspensoid agent has both been obtained.
Andrographolide dry suspensoid agent prescription is as follows：
Andrographolide and octadecyl alcolol and glycerin monostearate mixture：4g
Lactose：15.3g
Xanthans：0.1g
Superfine silica gel powder：0.05g
Neotame：0.2g
Strawberry essence：0.2g
Citric acid：0.2g
Dissolution experiment is carried out to above-mentioned product, dissolution experiment parameter is：Method is basket method, dissolution medium 900ml0.5%
The buffer solution of the pH1.2 of SDS, rotating speed 100/min, temperature are 37 DEG C.Dissolution result is shown in attached drawing 5.By result it is found that Herba Andrographitis
The dissolution of lactone is all right.
5 minutes and 10 minutes dissolution andrographolide concentration is also carried out carrying out to product in the buffer salt of pH6.8
Investigation, to simulate its release in the oral cavity.Its result is respectively 7.00 μ g/ml and 13.05 μ g/ml, the results showed that its
Flavoring effect is very notable.
Embodiment 6
Octadecyl alcolol is taken in beaker, to be sealed with preservative film with each 25g of glycerin monostearate, beaker is put in 85 DEG C of water-baths
It is heated in pot, after its thawing, 10g andrographolides is added, with magnetic stirrer 30 minutes so that andrographolide is equal
After being suspended in octadecyl alcolol, hot melt spraying granulation is carried out.
Molten atomizing parameter is：130 DEG C, atomizing pressure 0.3Kpa, charging rate 80ml/min of inlet air temperature.
Hot melt spray product is collected, andrographolide flavour blend is both obtained.By the filler of mixture and suitable proportion,
Aromatic, sweetener, acid, suspending agent are mixed, and andrographolide dry suspensoid agent has both been obtained.
Andrographolide dry suspensoid agent prescription is as follows：
Andrographolide and octadecyl alcolol and glycerin monostearate mixture：4g
Lactose：15.3g
Carragheen：0.1g
Superfine silica gel powder：0.05g
Neotame：0.2g
Orange flavor：0.2g
Citric acid：0.2g
Dissolution experiment is carried out to above-mentioned product, dissolution experiment parameter is：Method is basket method, dissolution medium 900ml0.5%
The buffer solution of the pH1.2 of SDS, rotating speed 100/min, temperature are 37 DEG C.Dissolution result is shown in attached drawing 6.By result it is found that Herba Andrographitis
The dissolution of lactone is all right.
5 minutes and 10 minutes dissolution andrographolide concentration is also carried out carrying out to product in the buffer salt of pH6.8
Investigation, to simulate its release in the oral cavity.Its result is respectively 6.57 μ g/ml and 13.59 μ g/ml, the results showed that its
Flavoring effect is very notable.
Embodiment 7
Octadecyl alcolol is taken in beaker, to be sealed with preservative film with each 15g of glycerin monostearate, beaker is put in 85 DEG C of water-baths
It is heated in pot, after its thawing, 10g andrographolides is added, with magnetic stirrer 30 minutes so that andrographolide is equal
After being suspended in octadecyl alcolol, hot melt spraying is carried out.
Molten atomizing parameter is：110 DEG C, atomizing pressure 0.3Kpa, charging rate 50ml/min of inlet air temperature.
Hot melt spray product is collected, andrographolide flavour blend is both obtained.By the filler of mixture and suitable proportion,
Essence, sweetener, acid, suspending agent are mixed, and andrographolide dry suspensoid agent has both been obtained.
Andrographolide dry suspensoid agent prescription is as follows：
Andrographolide and octadecyl alcolol and glycerin monostearate mixture：4g
Mannitol：15.3g
Xanthans：0.1g
Superfine silica gel powder：0.05g
Neotame：0.2g
Orange flavor：0.2g
Citric acid：0.2g
Dissolution experiment is carried out to above-mentioned product, dissolution experiment parameter is：Method is basket method, dissolution medium 900ml0.5%
The buffer solution of the pH1.2 of SDS, rotating speed 100/min, temperature are 37 DEG C.Dissolution result is shown in attached drawing.By result it is found that Herba Andrographitis
The dissolution of lactone is all right.
5 minutes and 10 minutes dissolution andrographolide concentration is also carried out carrying out to product in the buffer salt of pH6.8
Investigation, to simulate its release in the oral cavity.Its result is respectively 6.07 μ g/ml and 12.09 μ g/ml, the results showed that its
Flavoring effect is very notable.
Embodiment 8
Octadecyl alcolol is taken in beaker, to be sealed with preservative film with each 15g of glycerin monostearate, beaker is put in 85 DEG C of water-baths
It is heated in pot, after its thawing, 10g andrographolides is added, with magnetic stirrer 30 minutes so that andrographolide is equal
After being suspended in octadecyl alcolol, hot melt spraying granulation is carried out.
Molten atomizing parameter is：110 DEG C, atomizing pressure 0.25Kpa, charging rate 50ml/min of inlet air temperature.
Hot melt spray product is collected, andrographolide flavour blend is both obtained.By the filler of mixture and suitable proportion,
Aromatic, sweetener, acid, suspending agent are mixed, and andrographolide dry suspensoid agent has both been obtained.
Andrographolide dry suspensoid agent prescription is as follows：
Andrographolide and octadecyl alcolol and glycerin monostearate mixture：4g
Lactose：15.3g
CMC-Na：0.1g
Superfine silica gel powder：0.05g
Neotame：0.2g
Orange flavor：0.2g
Citric acid：0.2g
Dissolution experiment is carried out to above-mentioned product, dissolution experiment parameter is：Method is basket method, dissolution medium 900ml0.5%
The buffer solution of the pH1.2 of SDS, rotating speed 100/min, temperature are 37 DEG C.Dissolution result is shown in attached drawing 8.By result it is found that Herba Andrographitis
The dissolution of lactone is all right.
5 minutes and 10 minutes dissolution andrographolide concentration is also carried out carrying out to product in the buffer salt of pH6.8
Investigation, to simulate its release in the oral cavity.Its result is respectively 5.97 μ g/ml and 13.219 μ g/ml, the results showed that its
Flavoring effect is very notable.
Embodiment 9
Octadecyl alcolol is taken in beaker, to be sealed with preservative film with each 15g of glycerin monostearate, beaker is put in 85 DEG C of water-baths
It is heated in pot, after its thawing, 10g andrographolides is added, with magnetic stirrer 30 minutes so that andrographolide is equal
After being suspended in octadecyl alcolol, hot melt spraying granulation is carried out.
Molten atomizing parameter is：110 DEG C, atomizing pressure 0.25Kpa, charging rate 100ml/min of inlet air temperature.
Hot melt spray product is collected, andrographolide flavour blend is both obtained.By the filler of mixture and suitable proportion,
Essence, sweetener, acid, suspending agent are mixed, and andrographolide dry suspensoid agent has both been obtained.
Andrographolide dry suspensoid agent prescription is as follows：
Andrographolide and octadecyl alcolol and glycerin monostearate mixture：4g
Lactose：15.3g
Sodium alginate：0.1g
Superfine silica gel powder：0.05g
Neotame：0.2g
Strawberry essence：0.2g
Citric acid：0.2g
Dissolution experiment is carried out to above-mentioned product, dissolution experiment parameter is：Method is basket method, dissolution medium 900ml0.5%
The buffer solution of the pH1.2 of SDS, rotating speed 100/min, temperature are 37 DEG C.Dissolution result is shown in attached drawing.By result it is found that Herba Andrographitis
The dissolution of lactone is all right.
5 minutes and 10 minutes dissolution andrographolide concentration is also carried out carrying out to product in the buffer salt of pH6.8
Investigation, to simulate its release in the oral cavity.Its result is respectively 6.88 μ g/ml and 13.63 μ g/ml, the results showed that its
Flavoring effect is very notable.
Claims (14)
1. a kind of andrographolide dry suspensoid agent, the andrographolide dry suspensoid agent is that spray is mixed with auxiliary material by andrographolide
Particle obtained by mist, the auxiliary material are lower melting-point auxiliary material, and the quality of the lower melting-point auxiliary material is andrographolide
0.1 times to 10 times, further include other at least one auxiliary materials, it is hard that the lower melting-point auxiliary material is selected from hexadecanol, octadecyl alcolol, list
One or more of glycerol, Compritol 888 ATO, stearic acid, beeswax, polyvinyl alcohol, polyethylene glycol.
2. dry suspensoid agent according to claim 1, wherein the andrographolide is selected from crystalline state andrographolide, without fixed
Form andrographolide, semi-crystalline andrographolide, half amorphous state andrographolide and their mixture.
3. dry suspensoid agent according to claim 1, wherein the andrographolide is the andrographolide by crushing
Powder, particle size range are averagely less than 100 μm.
4. dry suspensoid agent according to claim 1, wherein the andrographolide and the lower melting-point auxiliary material
Spraying gained particle is averagely less than 500 μm.
5. according to dry suspensoid agent described in claims 1, wherein Determination of Andrographolide accounts for 1- by weight in dry suspensoid agent
70%.
6. dry suspensoid agent according to claim 1, wherein described other auxiliary materials of at least one include filler, suspending agent,
Sweetener, aromatic and acid.
7. dry suspensoid agent according to claim 6, wherein the filler is selected from lactose, microcrystalline cellulose, mannitol, shallow lake
One or more of powder, dextrin, maltodextrin, sucrose, sorbierite, xylitol, soluble starch.
8. dry suspensoid agent according to claim 6, wherein the suspending agent is selected from xanthans, carragheen, gelatin, Arab
Glue, tragacanth, alginate, carboxymethyl cellulose salt, guar gum, pectin, polyvinyl alcohol, hydroxyethyl cellulose class, poly- dimension
One or more of ketone, polyacrylic acid, methylcellulose class, hydroxypropyl methyl cellulose.
9. dry suspensoid agent according to claim 6, wherein the sweetener is selected from neotame, Sucralose, stevioside, sweetness
One or more of element, acesulfame potassium, saccharin sodium, Aspartame, honey.
10. dry suspensoid agent according to claim 6, wherein the aromatic is selected from natural or artificial orange flavor, pineapple
One or more of essence, strawberry essence, flavoring banana essence, cherry essence, chocolate essence, hawthorn essence.
11. dry suspensoid agent according to claim 6, wherein the acid is selected from citric acid, tartaric acid, malic acid, carbon
One or more of sour sodium, sodium citrate.
12. a kind of molten atomizing method of granulating preparing andrographolide dry suspensoid agent described in claim 1, including walk as follows
Suddenly：
Step 1：The lower melting-point auxiliary material is placed in water-bath and is heated, after heating makes auxiliary material melt, by andrographolide plus
Enter wherein, stirs evenly；
Step 2：The andrographolide stirred evenly and the lower melting-point auxiliary material mixed atomizing are pelletized；
Step 3：Hot melt spray product is collected to get andrographolide flavour blend；
Step 4：Appropriate filler, suspending agent, sweetener, fragrance essence, acid are added in the mixture, is uniformly mixed and is made
Andrographolide dry suspensoid agent.
13. molten atomizing method of granulating according to claim 12, the molten atomizing parameter wherein in step 2 are：Inlet air temperature
50-200℃。
14. molten atomizing method of granulating according to claim 12, the molten atomizing parameter wherein in step 2 are：Atomizing pressure
0.1-0.5Kpa, charging rate 30-100ml/min.
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| CN111803453A (en) * | 2020-07-16 | 2020-10-23 | 王天怡 | Taste-masking composition containing andrographolide and preparation method and application thereof |
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| CN102274188A (en) * | 2011-07-12 | 2011-12-14 | 上海中医药大学 | Solid lipid nanoparticles comprising andrographolide and preparation method and application thereof |
| CN103371972A (en) * | 2012-04-21 | 2013-10-30 | 苏州雷纳药物研发有限公司 | Andrographolide suspension and preparation method and medical application thereof |
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|---|---|---|---|---|
| CN102274188A (en) * | 2011-07-12 | 2011-12-14 | 上海中医药大学 | Solid lipid nanoparticles comprising andrographolide and preparation method and application thereof |
| CN103371972A (en) * | 2012-04-21 | 2013-10-30 | 苏州雷纳药物研发有限公司 | Andrographolide suspension and preparation method and medical application thereof |
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