CN105581985B - The andrographolide dry suspensoid agent and preparation method thereof prepared using molten atomizing - Google Patents
The andrographolide dry suspensoid agent and preparation method thereof prepared using molten atomizing Download PDFInfo
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- CN105581985B CN105581985B CN201610101553.5A CN201610101553A CN105581985B CN 105581985 B CN105581985 B CN 105581985B CN 201610101553 A CN201610101553 A CN 201610101553A CN 105581985 B CN105581985 B CN 105581985B
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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
- A61K9/14—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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- 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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- 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
- A61K9/14—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
It is the particle obtained by andrographolide and auxiliary material mixed atomizing the invention discloses a kind of andrographolide dry suspensoid agent, the auxiliary material is lower melting-point auxiliary material, arbitrary two kinds in hexadecanol, octadecyl alcolol, glycerin monostearate, Compritol 888 ATO, stearic acid, beeswax, polyvinyl alcohol, polyethylene glycol of the lower melting-point auxiliary material, the gross mass of lower melting-point auxiliary material wherein used 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.
It is a further object of the present invention to provide a kind of andrographolide dry suspensoid agent preparation methods, and the method is simple and easy to do,
It is with obvious effects to the flavoring of drug.
A kind of andrographolide dry suspensoid agent of the offer of the present invention, the andrographolide dry suspensoid agent is by Herba Andrographitis
Lactone and particle obtained by auxiliary material mixed atomizing, the auxiliary material are lower melting-point auxiliary material, lower melting-point auxiliary material choosing
From in hexadecanol, octadecyl alcolol, glycerin monostearate, Compritol 888 ATO, stearic acid, beeswax, polyvinyl alcohol, polyethylene glycol
Arbitrary two kinds, the mass ratio between arbitrary two kinds of lower melting-point auxiliary materials is 0.1：0.9-0.9：0.1, further include at least
Other a kind of 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 distribution range
Averagely it is less than 100 μm.
Preferably, wherein the gross mass of described two lower melting-point auxiliary materials is 0.1 times to 10 times of andrographolide.
Preferably, wherein the andrographolide is respectively less than 500 μ with particle obtained by lower melting-point auxiliary material molten atomizing
m。
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 acid is selected from citric acid, tartaric acid, malic acid, sodium carbonate, sodium citrate, citric acid
One or more of sodium.
The present invention also provides a kind of molten atomizing method of granulating of system andrographolide dry suspensoid agent, including it is as follows
Step：
Step 1：Described two lower melting-point auxiliary materials are placed in water-bath and are heated, after heating makes auxiliary material melt, by punching
Lotus lactone is added thereto, and is stirred evenly；
Step 2：By the andrographolide stirred evenly and lower melting-point auxiliary material mixed atomizing；
Step 3：Hot melt spray product is collected to get andrographolide flavour blend；
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 mass ratio between arbitrary two kinds of lower melting-point auxiliary materials is 0.2：0.7-0.7：0.2, more
Preferably, the mass ratio between arbitrary two kinds of lower melting-point auxiliary materials is 0.3：0.5-0.5：0.3.
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
Distribution is average 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 hexadecanol and each 15g of octadecyl alcolol in beaker, 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 octadecyl alcolol after,
Carry out hot melt spraying.
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,
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 hexadecanol, 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 4.88 μ g/ml and 10.06 μ g/ml, the results showed that its
Flavoring effect is very notable.
Embodiment 2
It takes glycerin monostearate and each 15g of Compritol 888 ATO in beaker, is sealed with preservative film, beaker is put in 85
It is heated in DEG C water-bath, after its thawing, 10g andrographolides is added, with magnetic stirrer 30 minutes so that Herba Andrographitis
Lactone be suspended in octadecyl alcolol after, carry out hot melt spraying.
Andrographolide dry suspensoid agent prescription is as follows：
Andrographolide and glycerin monostearate, Compritol 888 ATO 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, essence, 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 3.77ug/ml and 9.46ug/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 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,
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 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
It takes octadecyl alcolol in beaker, to be sealed with preservative film with each 15g of stearic acid, beaker is put in 85 DEG C of water-baths and is added
10g andrographolides were added after its thawing in heat, with magnetic stirrer 30 minutes so that andrographolide with suspension
After in octadecyl alcolol, hot melt spraying 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,
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 stearic acid 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 6.51 μ g/ml and 12.36 μ g/ml, the results showed that its
Flavoring effect is very notable.
Embodiment 5
Beeswax 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
10g andrographolides were added after its thawing in middle heating, with magnetic stirrer 30 minutes so that andrographolide with
After being suspended in octadecyl alcolol, hot melt spraying 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,
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 beeswax 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 7.02 μ g/ml and 13.07 μ g/ml, the results showed that its
Flavoring effect is very notable.
Embodiment 6
Polyvinyl alcohol 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
It is heated in bath, after its thawing, 10g andrographolides is added, with magnetic stirrer 30 minutes so that andrographolide
Be suspended in octadecyl alcolol after, carry out hot melt spraying.
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,
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 polyvinyl alcohol 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 13.69 μ g/ml, the results showed that its
Flavoring effect is very notable.
Embodiment 7
Taking polyethylene glycol in beaker, is sealed with preservative film with each 15g of glycerin monostearate, beaker is put in 85 DEG C of water
It is heated in bath, after its thawing, 10g andrographolides is added, with magnetic stirrer 30 minutes so that andrographolide
Be suspended in octadecyl alcolol after, carry out hot melt spraying.
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 polyethylene glycol 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 7.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 6.38 μ g/ml and 12.58 μ g/ml, the results showed that its
Flavoring effect is very notable.
Embodiment 8
It takes each 15g of polyvinyl alcohol, polyethylene glycol in beaker, is sealed with preservative film, beaker is put in 85 DEG C of water-baths
10g andrographolides were added after its thawing in heating, with magnetic stirrer 30 minutes so that andrographolide with it is mixed
After being suspended in octadecyl alcolol, hot melt spraying 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,
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 polyvinyl alcohol, polyethylene glycol 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 6.35 μ g/ml and 12.57 μ g/ml, the results showed that its
Flavoring effect is very notable.
Embodiment 9
Polyvinyl alcohol 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
It is heated in bath, after its thawing, 10g andrographolides is added, with magnetic stirrer 30 minutes so that andrographolide
Be suspended in octadecyl alcolol after, carry out hot melt spraying.
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 polyvinyl alcohol 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 9.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 6.36 μ g/ml and 12.56 μ g/ml, the results showed that its
Flavoring effect is very notable.
Claims (15)
1. a kind of andrographolide dry suspensoid agent, the andrographolide dry suspensoid agent is by andrographolide and the auxiliary material heat of mixing
It is meltblown particle obtained by mist, the auxiliary material is lower melting-point auxiliary material, and the lower melting-point auxiliary material is selected from hexadecanol, 18
It is arbitrary two kinds in alcohol, glycerin monostearate, Compritol 888 ATO, stearic acid, beeswax, polyvinyl alcohol, polyethylene glycol, described
Arbitrary two kinds of lower melting-point auxiliary materials between mass ratio be 0.1：0.9-0.9：0.1, further include other at least one auxiliary materials.
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 distribution range are averagely less than 100 μm.
4. dry suspensoid agent according to claim 1, wherein the gross mass of described two lower melting-point auxiliary materials is Herba Andrographitis
0.1 times to 10 times of lactone.
5. dry suspensoid agent according to claim 1, wherein the andrographolide is melted with lower melting-point auxiliary material
Spraying gained particle is averagely less than 500 μm.
6. according to dry suspensoid agent described in claims 1, wherein Determination of Andrographolide accounts for 1- by weight in dry suspensoid agent
70%.
7. dry suspensoid agent according to claim 1, wherein described other auxiliary materials of at least one include filler, suspending agent,
Sweetener, aromatic and acid.
8. dry suspensoid agent according to claim 7, wherein the filler is selected from lactose, microcrystalline cellulose, mannitol, shallow lake
One or more of powder, dextrin, maltodextrin, sucrose, sorbierite, xylitol, soluble starch.
9. dry suspensoid agent according to claim 7, 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.
10. dry suspensoid agent according to claim 7, wherein the sweetener is selected from neotame, Sucralose, stevioside, sweet tea
One or more of sweet element, acesulfame potassium, saccharin sodium, Aspartame, honey.
11. dry suspensoid agent according to claim 7, 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.
12. dry suspensoid agent according to claim 7, wherein the acid is selected from citric acid, tartaric acid, malic acid, carbon
One or more of sour sodium, sodium citrate, sodium citrate.
13. a kind of molten atomizing method of granulating preparing andrographolide dry suspensoid agent described in claim 1, including walk as follows
Suddenly：
Step 1：Described two lower melting-point auxiliary materials are placed in water-bath and are heated, it, will be in Herba Andrographitis after heating makes auxiliary material melt
Ester is added thereto, and is stirred 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, essence, acid are added in the mixture, is uniformly mixed to be made and wear
Heart lotus lactone dry suspensoid agent.
14. molten atomizing method of granulating according to claim 13, the molten atomizing parameter wherein in step 2 are：Inlet air temperature
50-200℃。
15. molten atomizing method of granulating according to claim 13, the molten atomizing parameter wherein in step 2 are：Atomizing pressure
0.1-0.5Kpa, charging rate 30-100ml/min.
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| CN107536807A (en) * | 2017-09-11 | 2018-01-05 | 潘正茂 | A kind of dry mix suspension grain of Berberine hydrochloride and preparation method thereof |
| CN110638785B (en) * | 2019-09-29 | 2021-09-24 | 黄山中皇制药有限公司 | Andrographolide dry suspension |
| CN110507636B (en) * | 2019-09-29 | 2021-09-24 | 黄山中皇制药有限公司 | Method for preparing andrographolide dry suspension |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102614133A (en) * | 2012-04-10 | 2012-08-01 | 沈阳药科大学 | Andrographolide ground suspending liquid, preparation method thereof, and application of pharmaceutical preparation |
| CN102716080A (en) * | 2012-06-18 | 2012-10-10 | 河南大学 | Suspension containing andrographolide solid lipid nanoparticles as well as preparation method and application of suspension |
| 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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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102614133A (en) * | 2012-04-10 | 2012-08-01 | 沈阳药科大学 | Andrographolide ground suspending liquid, preparation method thereof, and application of pharmaceutical preparation |
| 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 |
| CN102716080A (en) * | 2012-06-18 | 2012-10-10 | 河南大学 | Suspension containing andrographolide solid lipid nanoparticles as well as preparation method and application of suspension |
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