CN105581985A - Andrographolide dry suspension prepared by fusion spraying and preparation method thereof - Google Patents
Andrographolide dry suspension prepared by fusion spraying and preparation method thereof Download PDFInfo
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- CN105581985A CN105581985A CN201610101553.5A CN201610101553A CN105581985A CN 105581985 A CN105581985 A CN 105581985A CN 201610101553 A CN201610101553 A CN 201610101553A CN 105581985 A CN105581985 A CN 105581985A
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- andrographolide
- dry suspensoid
- auxiliary material
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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
Abstract
The invention discloses an andrographolide dry suspension which is particles prepared from andrographolide and accessories by mixing and spraying, wherein the accessories have relatively low melting points and are any two of hexadecanol, octadecanol, glyceryl monostearate, glyceryl behenate, stearic acid, beewax, polyvinyl alcohol and polyethylene glycol; the total mass of the accessories with relatively low melting points is 0.1-10 times that of andrographolide; and the accessories also include at least one other accessory. The andrographolide dry suspension disclosed by the invention is convenient to take simply by adding a little water; and with little bitterness, the andrographolide dry suspension realizes a good taste modifying effect on andrographolide and is suitable for children, old people and patients suffering dysphagia.
Description
Technical field:
The present invention relates to a kind of andrographolide dry suspensoid agent and preparation method thereof.
Background technology:
No matter be chemical drug or Chinese medicine, the bitter taste that medicine has is all one of its reason not being accepted, punchingLotus lactone is diterpenes diterpenoids lactones compound, has the thermal detoxification of dispelling, and effect of anti-inflammatory analgetic, to bacillary and viralThe property infection of the upper respiratory tract and dysentery have special efficacy, are described as natural antibiotics medicine. In recent years, in Herba AndrographitisEster has been developed the common formulations such as tablet, capsule, dripping pill, but diterpenes diterpenoids lactones compound is insoluble in water, logicalOften only can oral administration. In addition,, because the taste of andrographolide is extremely bitter, be unfavorable for children, Lao RenjiThe patient of dysphagia takes medicine, and these formulations are unresolved this problem all. So, andrographolide is rectifiedTaste, makes suitable formulation and is extremely necessary.
Summary of the invention:
In order to overcome the above problems, the present invention has studied a kind of side that andrographolide is prepared into dry suspensoid agentMethod is carried out hot melt spraying granulation, thereby is reached in Herba Andrographitis after using auxiliary material to mix with andrographolideThe effect of ester taste masking, can better cover the bitter taste of andrographolide, tastes experiment known by human body mouth, reachesMake us the bitter degree that can accept, then add suitable flavouring, prepared dry suspensoid agent good mouthfeel, suitableShould patient take.
Primary and foremost purpose of the present invention is to provide a kind of andrographolide dry suspensoid agent, is beneficial to children, old man and swallowsThe patient of difficulty takes medicine.
Another object of the present invention is to provide a kind of andrographolide dry suspensoid agent preparation method, and the method is easy easilyOK, the flavoring successful to medicine.
A kind of andrographolide dry suspensoid agent providing of the present invention, described andrographolide dry suspensoid agent is by wearingHeart lotus lactone and auxiliary material mixed atomizing gained particulate, described auxiliary material is the auxiliary material that fusing point is lower, described fusing pointLower auxiliary material is selected from hexadecanol, 18 alcohol, glycerin monostearate, Compritol 888 ATO, stearic acid, honeybeeIn wax, polyvinyl alcohol, polyethylene glycol any two kinds, between the lower auxiliary material of described any two kinds of fusing pointsMass ratio is 0.1:0.9-0.9:0.1, also comprises at least one other auxiliary material.
Preferably, wherein said andrographolide be selected from crystalline state andrographolide, amorphous state andrographolide,Half hitch crystalline state andrographolide, half amorphous state andrographolide and their mixture.
Preferably, wherein said andrographolide is the andrographolide powder through pulverizing, and its particle diameter distributesScope is on average less than 100 μ m.
0.1 times that the gross mass of the auxiliary material that preferably, wherein said two kinds of fusing points are lower is andrographolide to 10Doubly.
Preferably, the auxiliary material molten atomizing gained particle that wherein said andrographolide and fusing point are lower is all less than500μm。
Preferably, wherein Determination of Andrographolide accounts for 1-70% by weight in dry suspensoid agent.
Preferably, wherein said at least one other auxiliary material comprise filler, suspending agent, sweetener, aromaticAnd acid.
Preferably, wherein said filler is selected from lactose, microcrystalline cellulose, sweet mellow wine, starch, dextrin, wheatOne or more in bud dextrin, sucrose, sorbierite, xylitol, soluble starch.
Preferably, wherein said suspending agent be selected from xanthans, carragheen, gelatin, Arabic gum, tragacanth,Alginate, carboxymethyl cellulose salt, guar gum, pectin, polyvinyl alcohol, hydroxyethylcellulose class, poly-dimensionOne or more in ketone, polyacrylic acid, methylcellulose class, hydroxypropyl methylcellulose.
Preferably, wherein said sweetener be selected from that knob is sweet, Sucralose, stevioside, honey element, acesulfame potassium,One or more in saccharin sodium, Aspartame, honey.
Preferably, wherein said aromatic be selected from natural or artificial orange flavor, flavoring pineapple essence, strawberry essence,One or more in flavoring banana essence, cherry essence, chocolate essence, hawthorn essence.
Preferably, wherein said acid be selected from citric acid, tartaric acid, malic acid, sodium carbonate, natrium citricum,One or more in natrium citricum.
The present invention also provides a kind of molten atomizing method of granulating of making described andrographolide dry suspensoid agent, comprisesFollowing steps:
Step 1: described two kinds of lower auxiliary materials of fusing point are placed in to water-bath and heat, heating makes, after auxiliary material fusing, will wearHeart lotus lactone adds wherein, stirs;
Step 2: by the andrographolide stirring and the lower auxiliary material mixed atomizing of fusing point;
Step 3: collect hot melt spray product, obtain andrographolide flavour blend;
Step 4: add appropriate filler, suspending agent, sweetener, aromatic, acid in mixture, mixEvenly make andrographolide dry suspensoid agent.
Preferably, wherein the molten spray parameters in step 2 is: EAT 100-200 DEG C, atomizing pressure0.1-0.5Kpa, charging rate 30-100ml/min.
Preferred, the mass ratio between the lower auxiliary material of described any two kinds of fusing points is 0.2:0.7-0.7:0.2, preferred, the mass ratio between the lower auxiliary material of described any two kinds of fusing points is 0.3:0.5-0.5:0.3。
Preferred, wherein through the particle size scope of andrographolide powder of pulverizing be less than 80 μ m,50μm、10μm、1μm、500nm、400nm、300nm、200nm、100nm、50nm。
Preferred, wherein in dry suspensoid agent, Determination of Andrographolide accounts for 10-60% by weight, preferred,Wherein in dry suspensoid agent, Determination of Andrographolide accounts for 30-50% by weight.
Preferred, the auxiliary material spraying gained particle that wherein said andrographolide and described fusing point are lower is flatAll be less than 300 μ m, 200 μ m, 100 μ m, 50 μ m, 10 μ m, 1 μ m, 500nm, 400nm, 300nm,200nm、100nm、50nm。
Adopt technical scheme of the present invention, the wherein powder after andrographolide and auxiliary material hot melt spraying granulation, itsParticle size distribution range is on average being less than 500 μ m, just can not produce gravel when the dry suspensoid agent of making is like this takenSense.
Adopt technical scheme of the present invention, wherein in selected auxiliary material to andrographolide bitter taste good cover workWith, according to human body mouth taste test known, there is no bad taste.
The andrographolide dry suspensoid agent that the present invention allots adds a small amount of water to take, and taking convenience, does not almost haveHave bitter taste, good to the flavoring of andrographolide, the patient who is applicable to children, old man and dysphagia takes.In Vitro Dissolution experimental result shows, andrographolide can be from the external good release of preparation.
Brief description of the drawings:
Fig. 1, the stripping experimental data figure of embodiment 1.
Fig. 2, the stripping experimental data figure of embodiment 2.
Fig. 3, the stripping experimental data figure of embodiment 3.
Fig. 4, the stripping experimental data figure of embodiment 4.
Fig. 5, the stripping experimental data figure of embodiment 5.
Fig. 6, the stripping experimental data figure of embodiment 6.
Fig. 7, the stripping experimental data figure of embodiment 7.
Fig. 8, the stripping experimental data figure of embodiment 8.
Fig. 9, the stripping experimental data figure of embodiment 9.
Detailed description of the invention:
For describing technology contents of the present invention in detail, institute's object that realizes and effect, will be to this in the following examplesInvention is described further, and embodiment does not limit the present invention in any way, and aim of the present invention and scope are not limitActual conditions or details described in these embodiment, but limited by claim protection domain. AllMaterial is mass percent concentration.
Embodiment 1
Get hexadecanol and the each 15g of 18 alcohol in beaker, beaker is put in 85 DEG C of water-baths and is heated, treat itAfter thawing, add 10g andrographolide, use magnetic stirrer 30 minutes, make andrographolide equalAfter being suspended in 18 alcohol, carry out hot melt spraying.
Molten atomizing parameter is: 130 DEG C of EATs, atomizing pressure 0.3Kpa, charging rate 80ml/min.
Collect hot melt spray product, both obtained andrographolide flavour blend. By filling out of mixture and suitable proportionFill agent, essence, sweetener, acid, suspending agent and mix, both obtained andrographolide dry suspensoid agent.
Andrographolide dry suspensoid agent prescription is as follows:
Andrographolide and hexadecanol, 18 alcohol mixtures: 4g
Lactose: 15.3g
Xanthans: 0.1g
Superfine silica gel powder: 0.05g
Knob is sweet: 0.2g
Orange flavor: 0.2g
Citric acid: 0.2g
Above-mentioned product is carried out to stripping experiment, and stripping experiment parameter is: method is basket method, and dissolution medium is 900mlThe buffer solution of the pH1.2 of 0.5%SDS, rotating speed is 100/min, temperature is 37 DEG C. Stripping the results are shown in accompanying drawing 1.From result, the stripping of andrographolide is all right.
Product is also carried out carrying out in the buffer salt of pH6.8 in the stripping Herba Andrographitis of 5 minutes and 10 minutesThe investigation of ester concentration, in order to simulate its release in oral cavity. Its result be respectively 4.88 μ g/ml and10.06 μ g/ml, result shows that its flavoring effect is very remarkable.
Embodiment 2
Get the each 15g of glycerin monostearate and Compritol 888 ATO in beaker, with preservative film sealing, by beakerBe put in 85 DEG C of water-baths and heat, after it melts, add 10g andrographolide, stir with magnetic stirring apparatusMix 30 minutes, make andrographolide all be suspended in 18 alcohol 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
Knob is sweet: 0.2g
Orange flavor: 0.2g
Citric acid: 0.2g
Molten atomizing parameter is: 130 DEG C of EATs, atomizing pressure 0.3Kpa, charging rate 80ml/min.
Collect hot melt spray product, both obtained andrographolide flavour blend. . By mixture and suitable proportionFiller, essence, sweetener, acid, suspending agent mix, and have both obtained andrographolide dry suspensoid agent.
Above-mentioned product is carried out to stripping experiment, and stripping experiment parameter is: method is basket method, and dissolution medium is 900mlThe buffer solution of the pH1.2 of 0.5%SDS, rotating speed is 100/min, temperature is 37 DEG C. Stripping the results are shown in accompanying drawing 2.From result, the stripping of andrographolide is all right.
Product is also carried out carrying out in the buffer salt of pH6.8 in the stripping Herba Andrographitis of 5 minutes and 10 minutesThe investigation of ester concentration, in order to simulate its release in oral cavity. Its result be respectively 3.77ug/ml and9.46ug/ml, result shows that its flavoring effect is very remarkable.
Embodiment 3
Get the each 10g of 18 alcohol and glycerin monostearate in beaker, with preservative film sealing, beaker is put inIn 85 DEG C of water-baths, heat, after it melts, add 10g andrographolide, by magnetic stirrer 30Minute, make andrographolide all be suspended in 18 alcohol after, carry out hot melt spraying.
Molten atomizing parameter is: 130 DEG C of EATs, atomizing pressure 0.3Kpa, charging rate 50ml/min.
Collect hot melt spray product, both obtained andrographolide flavour blend. By filling out of mixture and suitable proportionFill agent, essence, sweetener, acid, suspending agent and mix, both obtained andrographolide dry suspensoid agent.
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
Knob is sweet: 0.2g
Orange flavor: 0.2g
Citric acid: 0.2g
Above-mentioned product is carried out to stripping experiment, and stripping experiment parameter is: method is basket method, and dissolution medium is 900mlThe buffer solution of the pH1.2 of 0.5%SDS, rotating speed is 100/min, temperature is 37 DEG C. Stripping the results are shown in accompanying drawing 3.From result, the stripping of andrographolide is all right.
Product is also carried out carrying out in the buffer salt of pH6.8 in the stripping Herba Andrographitis of 5 minutes and 10 minutesThe investigation of ester concentration, in order to simulate its release in oral cavity. Its result be respectively 8.06 μ g/ml and13.19 μ g/ml, result shows that its flavoring effect is very remarkable.
Embodiment 4
Get the each 15g of 18 alcohol and stearic acid in beaker, with preservative film sealing, beaker is put in to 85 DEG C of water-bathsHeating in pot, after it melts, adds 10g andrographolide, uses magnetic stirrer 30 minutes, makesAndrographolide all be suspended in 18 alcohol after, carry out hot melt spraying.
Molten atomizing parameter is: 130 DEG C of EATs, atomizing pressure 0.3Kpa, charging rate 50ml/min.
Collect hot melt spray product, both obtained andrographolide flavour blend. By filling out of mixture and suitable proportionFill agent, essence, sweetener, acid, suspending agent and mix, both obtained andrographolide dry suspensoid agent.
Andrographolide dry suspensoid agent prescription is as follows:
Andrographolide and 18 alcohol and stearic acid mixture: 4g
Starch: 15.3g
Carragheen: 0.1g
Superfine silica gel powder: 0.05g
Knob is sweet: 0.2g
Orange flavor: 0.2g
Citric acid: 0.2g
Above-mentioned product is carried out to stripping experiment, and stripping experiment parameter is: method is basket method, and dissolution medium is 900mlThe buffer solution of the pH1.2 of 0.5%SDS, rotating speed is 100/min, temperature is 37 DEG C. Stripping the results are shown in accompanying drawing 4.From result, the stripping of andrographolide is all right.
Product is also carried out carrying out in the buffer salt of pH6.8 in the stripping Herba Andrographitis of 5 minutes and 10 minutesThe investigation of ester concentration, in order to simulate its release in oral cavity. Its result be respectively 6.51 μ g/ml and12.36 μ g/ml, result shows that its flavoring effect is very remarkable.
Embodiment 5
Get the each 20g of beeswax and glycerin monostearate in beaker, with preservative film sealing, beaker is put in to 85 DEG CIn water-bath, heat, after it melts, add 10g andrographolide, use magnetic stirrer 30 minutes,Make andrographolide all be suspended in 18 alcohol after, carry out hot melt spraying.
Molten atomizing parameter is: 130 DEG C of EATs, atomizing pressure 0.3Kpa, charging rate 80ml/min.
Collect hot melt spray product, both obtained andrographolide flavour blend. By filling out of mixture and suitable proportionFill agent, essence, sweetener, acid, suspending agent and mix, both obtained andrographolide dry suspensoid agent.
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
Knob is sweet: 0.2g
Strawberry essence: 0.2g
Citric acid: 0.2g
Above-mentioned product is carried out to stripping experiment, and stripping experiment parameter is: method is basket method, and dissolution medium is 900mlThe buffer solution of the pH1.2 of 0.5%SDS, rotating speed is 100/min, temperature is 37 DEG C. Stripping the results are shown in accompanying drawing 5.From result, the stripping of andrographolide is all right.
Product is also carried out carrying out in the buffer salt of pH6.8 in the stripping Herba Andrographitis of 5 minutes and 10 minutesThe investigation of ester concentration, in order to simulate its release in oral cavity. Its result be respectively 7.02 μ g/ml and13.07 μ g/ml, result shows that its flavoring effect is very remarkable.
Embodiment 6
Get the each 25g of polyvinyl alcohol and glycerin monostearate in beaker, with preservative film sealing, beaker is put inIn 85 DEG C of water-baths, heat, after it melts, add 10g andrographolide, by magnetic stirrer 30Minute, make andrographolide all be suspended in 18 alcohol after, carry out hot melt spraying.
Molten atomizing parameter is: 130 DEG C of EATs, atomizing pressure 0.3Kpa, charging rate 80ml/min.
Collect hot melt spray product, both obtained andrographolide flavour blend. By filling out of mixture and suitable proportionFill agent, essence, sweetener, acid, suspending agent and mix, both obtained andrographolide dry suspensoid agent.
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
Knob is sweet: 0.2g
Orange flavor: 0.2g
Citric acid: 0.2g
Above-mentioned product is carried out to stripping experiment, and stripping experiment parameter is: method is basket method, and dissolution medium is 900mlThe buffer solution of the pH1.2 of 0.5%SDS, rotating speed is 100/min, temperature is 37 DEG C. Stripping the results are shown in accompanying drawing 6.From result, the stripping of andrographolide is all right.
Product is also carried out carrying out in the buffer salt of pH6.8 in the stripping Herba Andrographitis of 5 minutes and 10 minutesThe investigation of ester concentration, in order to simulate its release in oral cavity. Its result be respectively 6.57 μ g/ml and13.69 μ g/ml, result shows that its flavoring effect is very remarkable.
Embodiment 7
The each 15g of taking polyethylene glycol and glycerin monostearate, in beaker, with preservative film sealing, is put in beakerIn 85 DEG C of water-baths, heat, after it melts, add 10g andrographolide, by magnetic stirrer 30Minute, make andrographolide all be suspended in 18 alcohol after, carry out hot melt spraying.
Molten atomizing parameter is: 110 DEG C of EATs, atomizing pressure 0.3Kpa, charging rate 50ml/min.
Collect hot melt spray product, both obtained andrographolide flavour blend. By filling out of mixture and suitable proportionFill agent, essence, sweetener, acid, suspending agent and mix, both obtained andrographolide dry suspensoid agent.
Andrographolide dry suspensoid agent prescription is as follows:
Andrographolide and polyethylene glycol and glycerin monostearate mixture: 4g
Sweet mellow wine: 15.3g
Xanthans: 0.1g
Superfine silica gel powder: 0.05g
Knob is sweet: 0.2g
Orange flavor: 0.2g
Citric acid: 0.2g
Above-mentioned product is carried out to stripping experiment, and stripping experiment parameter is: method is basket method, and dissolution medium is 900mlThe buffer solution of the pH1.2 of 0.5%SDS, rotating speed is 100/min, temperature is 37 DEG C. Stripping the results are shown in accompanying drawing 7.From result, the stripping of andrographolide is all right.
Product is also carried out carrying out in the buffer salt of pH6.8 in the stripping Herba Andrographitis of 5 minutes and 10 minutesThe investigation of ester concentration, in order to simulate its release in oral cavity. Its result be respectively 6.38 μ g/ml and12.58 μ g/ml, result shows that its flavoring effect is very remarkable.
Embodiment 8
Get polyvinyl alcohol, the each 15g of polyethylene glycol in beaker, with preservative film sealing, beaker is put in to 85 DEG CIn water-bath, heat, after it melts, add 10g andrographolide, use magnetic stirrer 30 minutes,Make andrographolide all be suspended in 18 alcohol after, carry out hot melt spraying.
Molten atomizing parameter is: 110 DEG C of EATs, atomizing pressure 0.25Kpa, charging rate 50ml/min.
Collect hot melt spray product, both obtained andrographolide flavour blend. By filling out of mixture and suitable proportionFill agent, essence, sweetener, acid, suspending agent and mix, both obtained andrographolide dry suspensoid agent.
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
Knob is sweet: 0.2g
Orange flavor: 0.2g
Citric acid: 0.2g
Above-mentioned product is carried out to stripping experiment, and stripping experiment parameter is: method is basket method, and dissolution medium is 900mlThe buffer solution of the pH1.2 of 0.5%SDS, rotating speed is 100/min, temperature is 37 DEG C. Stripping the results are shown in accompanying drawing 8.From result, the stripping of andrographolide is all right.
Product is also carried out carrying out in the buffer salt of pH6.8 in the stripping Herba Andrographitis of 5 minutes and 10 minutesThe investigation of ester concentration, in order to simulate its release in oral cavity. Its result be respectively 6.35 μ g/ml and12.57 μ g/ml, result shows that its flavoring effect is very remarkable.
Embodiment 9
Get the each 15g of polyvinyl alcohol and glycerin monostearate in beaker, with preservative film sealing, beaker is put inIn 85 DEG C of water-baths, heat, after it melts, add 10g andrographolide, by magnetic stirrer 30Minute, make andrographolide all be suspended in 18 alcohol after, carry out hot melt spraying.
Molten atomizing parameter is: 110 DEG C of EATs, atomizing pressure 0.25Kpa, charging rate 100ml/min.
Collect hot melt spray product, both obtained andrographolide flavour blend. By filling out of mixture and suitable proportionFill agent, essence, sweetener, acid, suspending agent and mix, both obtained andrographolide dry suspensoid agent.
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
Knob is sweet: 0.2g
Strawberry essence: 0.2g
Citric acid: 0.2g
Above-mentioned product is carried out to stripping experiment, and stripping experiment parameter is: method is basket method, and dissolution medium is 900mlThe buffer solution of the pH1.2 of 0.5%SDS, rotating speed is 100/min, temperature is 37 DEG C. Stripping the results are shown in accompanying drawing 9.From result, the stripping of andrographolide is all right.
Product is also carried out carrying out in the buffer salt of pH6.8 in the stripping Herba Andrographitis of 5 minutes and 10 minutesThe investigation of ester concentration, in order to simulate its release in oral cavity. Its result be respectively 6.36 μ g/ml and12.56 μ g/ml, result shows that its flavoring effect is very remarkable.
Claims (15)
1. an andrographolide dry suspensoid agent, described andrographolide dry suspensoid agent is by andrographolide and auxiliary material mixed atomizing gained particulate, described auxiliary material is the auxiliary material that fusing point is lower, the auxiliary material that described fusing point is lower is selected from any two kinds in hexadecanol, 18 alcohol, glycerin monostearate, Compritol 888 ATO, stearic acid, beeswax, polyvinyl alcohol, polyethylene glycol, mass ratio between the lower auxiliary material of described any two kinds of fusing points is 0.1:0.9-0.9:0.1, also comprises at least one other auxiliary material.
2. dry suspensoid agent according to claim 1, wherein said andrographolide is selected from crystalline state andrographolide, amorphous state andrographolide, half hitch crystalline state andrographolide, half amorphous state andrographolide and their mixture.
3. dry suspensoid agent according to claim 1, wherein said andrographolide is the andrographolide powder through pulverizing, its particle size distribution range is on average less than 100 μ m.
4. dry suspensoid agent according to claim 1, the gross mass of the auxiliary material that wherein said two kinds of fusing points are lower is andrographolide 0.1 times to 10 times.
5. according to the dry suspensoid agent described in claims 1, the auxiliary material molten atomizing gained particle that wherein said andrographolide and fusing point are lower is on average less than 500 μ m.
6. according to dry suspensoid agent described in claims 1, wherein in dry suspensoid agent, Determination of Andrographolide accounts for 1-70% by weight.
7. dry suspensoid agent according to claim 1, wherein said at least one other auxiliary material comprise filler, suspending agent, sweetener, aromatic and acid.
8. dry suspensoid agent according to claim 7, wherein said filler is selected from one or more in lactose, microcrystalline cellulose, sweet mellow wine, starch, dextrin, maltodextrin, sucrose, sorbierite, xylitol, soluble starch.
9. dry suspensoid agent according to claim 7, wherein said suspending agent is selected from one or more in xanthans, carragheen, gelatin, Arabic gum, tragacanth, alginate, carboxymethyl cellulose salt, guar gum, pectin, polyvinyl alcohol, hydroxyethylcellulose class, PVP, polyacrylic acid, methylcellulose class, hydroxypropyl methylcellulose.
10. dry suspensoid agent according to claim 7, wherein said sweetener is selected from that knob is sweet, one or more in Sucralose, stevioside, honey element, acesulfame potassium, saccharin sodium, Aspartame, honey.
11. dry suspensoid agents according to claim 7, wherein said aromatic is selected from one or more in natural or artificial orange flavor, flavoring pineapple essence, strawberry essence, flavoring banana essence, cherry essence, chocolate essence, hawthorn essence.
12. dry suspensoid agents according to claim 7, wherein said acid is selected from one or more in citric acid, tartaric acid, malic acid, sodium carbonate, natrium citricum, natrium citricum.
Prepare the molten atomizing method of granulating of andrographolide dry suspensoid agent described in claim 1, comprise the steps: for 13. 1 kinds
Step 1: described two kinds of lower auxiliary materials of fusing point are placed in to water-bath and heat, heating makes, after auxiliary material fusing, andrographolide to be added wherein, stirs;
Step 2: by the andrographolide stirring and the lower auxiliary material mixed atomizing of fusing point;
Step 3: collect hot melt spray product, both obtained andrographolide flavour blend;
Step 4: add appropriate filler, suspending agent, sweetener, essence, acid in mixture, mix and make andrographolide dry suspensoid agent.
14. according to the molten atomizing method of granulating of claim 13, and wherein the molten atomizing parameter in step 2 is: EAT 50-200 DEG C.
15. according to the molten atomizing method of granulating of claim 13, and wherein the molten atomizing parameter in step 2 is: atomizing pressure 0.1-0.5Kpa, charging rate 30-100ml/min.
Priority Applications (1)
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN110507636A (en) * | 2019-09-29 | 2019-11-29 | 黄山中皇制药有限公司 | Andrographolide dry suspensoid agent preparation method |
| CN110638785A (en) * | 2019-09-29 | 2020-01-03 | 黄山中皇制药有限公司 | 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 |
-
2016
- 2016-02-25 CN CN201610101553.5A patent/CN105581985B/en active Active
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 |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN110507636A (en) * | 2019-09-29 | 2019-11-29 | 黄山中皇制药有限公司 | Andrographolide dry suspensoid agent preparation method |
| CN110638785A (en) * | 2019-09-29 | 2020-01-03 | 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 |
| CN110638785B (en) * | 2019-09-29 | 2021-09-24 | 黄山中皇制药有限公司 | Andrographolide dry suspension |
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| CN105581985B (en) | 2018-07-27 |
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