CN110151737A - A kind of salviandic acid A capsule type inhalation aerosol powder and preparation method thereof - Google Patents
A kind of salviandic acid A capsule type inhalation aerosol powder and preparation method thereof Download PDFInfo
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- CN110151737A CN110151737A CN201910390093.6A CN201910390093A CN110151737A CN 110151737 A CN110151737 A CN 110151737A CN 201910390093 A CN201910390093 A CN 201910390093A CN 110151737 A CN110151737 A CN 110151737A
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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
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
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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
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
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Abstract
The invention discloses a kind of salviandic acid A capsule type inhalation aerosol powders, it is made of salviandic acid A micro mist and carrier micro mist, it it is characterized by: the particle size of the salviandic acid A micro mist is d10=0.5-1.5 μm, d50=1.5-4.0 μm, d90=2.5-8.0 μm, and is more than particle size < 10 μm of the 95% salviandic acid A micro mist；The particle size of the carrier micro mist is d10=15-50 μm, d50=80-120 μm, d90=120-200 μm, and the weight ratio of the salviandic acid A and the carrier micro mist is 1:1~1000.The invention also discloses the preparation methods of salviandic acid A capsule type inhalation aerosol powder.The present invention can be improved the pulmonary deposition ratio of salviandic acid A in powder spray, avoids carrier micro mist in the deposition of lung, increases the stability of composition.
Description
Technical field
The present invention relates to technical field of medicine, are related to a kind of inhalation powder spray, especially a kind of salviandic acid A capsule-type
Inhalation powder spray and preparation method thereof.
Background technique
The dosage forms such as tablet, granule, capsule, the injection that conventional drug is divided into, they belong to general metabolism
The influence for the problems such as dosage of drug, performance drug effect will receive absorption simultaneously because it belongs to general metabolism drug, thus is held
Easily cause the side reactions such as allergy.Pulmonary inhalation is the treatment simple and effective administration route of pulmonary disease.Furthermore drug passes through
The metabolism that received of liver reduces the bioavailability and curative effect of drug, therefore and can then human body be generated by increasing dosage
More side effects.
Compared with other administration route, pulmonary administration has sorbent surface product big, and absorption site blood flow is abundant, is avoided that liver
Dirty first pass effect, enzymatic activity is low, the advantage that epithelial barrier is relatively thin and membrane permeability is high.Pulmonary inhalation dosage form is generally divided into three
Kind, i.e. spray, metered dose inhalation aerosol and Foradil Aerolizer formoterol fumarate (inhalation powder spray).
However, in the prior art, drug exists in spray and metered dose inhalation aerosol with liquid, and medicine stability is poor,
Metered dose inhalation aerosol must also use the fluorine hydrogen alkanes substances such as propellant-freon, not only result in environmental pollution, and
It can stimulate in use pharyngeal, cause or aggravate pharyngeal follicular hyperplasia.In addition, pulmonary deposition ratio height also influences drug effect
Performance.
Therefore, it is necessary to design a kind of high and significant in efficacy powder spray of the bioavailability of drug to carry out meet demand.
Summary of the invention
One aspect of the present invention technical problems to be solved are to provide a kind of salviandic acid A capsule type inhalation aerosol powder, the dust cloud
The bioavailability of agent is high and significant in efficacy.
In order to solve the above-mentioned technical problem, the technical solution of the present invention is as follows:
A kind of salviandic acid A capsule type inhalation aerosol powder, is made of salviandic acid A micro mist and carrier micro mist, it is characterised in that: institute
The particle size for stating salviandic acid A micro mist is d10=0.5-1.5 μm, d50=1.5-4.0 μm, d90=2.5-8.0 μm, and is more than
Particle size < 10 μm of the 95% salviandic acid A micro mist；The particle size of the carrier micro mist is d10=15-50 μm, d50
The weight ratio of=80-120 μm, d90=120-200 μm, the salviandic acid A and the carrier micro mist is 1:1~1000.
Preferably, the particle size of the carrier micro mist is d10=20-40 μm, d50=90-110 μm, d90=120-
180μm。
Preferably, the carrier micro mist is one or more of carbohydrate and amino acid.
The carrier micro mist is one or more of carbohydrate, amino acid, the carbohydrate include monosaccharide, disaccharides and/or
Its derived carbohydrate, the monosaccharide include but is not limited to mannitol, fructose, glucose.
The disaccharides includes but is not limited to maltose, trehalose, cellobiose, lactose, sucrose.
It is furthermore preferred that the carrier micro mist is one or more of lactose, glycine, mannitol.
Particularly preferred, the carrier micro mist is lactose.
The lactose is alpha-lactose monohydrate, β-Lactis Anhydrous, amorphous spray-dried lactose, crystallizing and drying lactose
One or more of, particularly preferred crystallizing and drying lactose.
The amino acid includes but is not limited to glycine, valine.
Preferably, the carrier micro mist further includes additives, and the additives contain but be not limited to surfactant, lubrication
One or more of agent, antiplastering aid, antistatic agent.The dosage of the additives can be with reference to any well known existing with type
Technology and document.
It is furthermore preferred that the surfactant is poloxamer, the weight ratio of the salviandic acid A and the poloxamer
For 1:0.1~5.
Poloxamer is also used as antistatic agent.The lubricant, antiplastering aid can also include but are not limited to magnesium stearate,
One or more of superfine silica gel powder, talcum powder, dosage are the 0.01%~1% of carrier micropowder weight.
Preferably, the weight ratio of the salviandic acid A and the carrier micro mist is 1:1~200.
Another aspect of the present invention technical problems to be solved are to provide a kind of preparation of salviandic acid A capsule type inhalation aerosol powder
Method, comprising the following steps:
S1, salviandic acid A micronization: spray drying process, fluidized bed supersonic jet mill method, high speed grinding method, ball are used
Salviandic acid A micro mist chemical conversion granular size is d10=0.5-1.5 μm, d50=by mill method, fluid energy mill method, one kind of solvent method
1.5-4.0 μm, d90=2.5-8.0 μm of micro mist；
S2, carrier micronization: additives first are added toward carrier and are micronized, carrier micro mist is made；
S3, mixing: it after salviandic acid A micro mist and carrier micro mist are mixed, is divided in capsule, salviandic acid A capsule-type is made
Inhalation powder spray；
S4, packing: salviandic acid A capsule type inhalation aerosol powder obtained is divided in by glue using the packing mode of capsule
In capsule, the content of each capsule is 1~100mg.
Preferably, the salviandic acid A micronization uses fluidized bed supersonic jet mill method, the content of each capsule
For 10~50mg.
Salviandic acid A capsule type inhalation aerosol powder provided by the invention can be carried out using well known powder spray capsule inhaler
It sucks, disclosed in the inhalator such as WO94/28958.
By adopting the above technical scheme, due to the preferred particle size range of carrier, so that the salviandic acid A of micronization is at the time of inhalation
Better pulmonary deposition ratio can be reached, so as to improve curative effect or reduce the dosage for reducing salviandic acid A potential
Side effect.In addition, coming since different salviandic acid A micro mists has different physical property and surface nature for powder spray
It says, it is characterized in that salviandic acid A directly absorbs action in lung, avoids the first-pass metabolism effect of liver, equally reduce pellet
The side effect of phenolic acid A improves the bioavilability and curative effect of salviandic acid A.In addition, the problem of micro mist aggregation easy to produce static electricity,
The storage being more favorable under the long-term and higher environment of humidity.
Specific embodiment
Specific embodiments of the present invention will be further explained below.It should be noted that for these implementations
The explanation of mode is used to help understand the present invention, but and does not constitute a limitation of the invention.In addition, invention described below
Technical characteristic involved in each embodiment can be combined with each other as long as they do not conflict with each other.
Well known mechanical crushing method or spray drying process can be used in micronization process of the invention.Mechanical crushing method refers to
Salviandic acid A and carrier are ground into required partial size respectively using the method for fluid energy mill.Spray drying process refers to salviandic acid A
Or carrier is dissolved in entirely in organic solvent such as ethyl alcohol, by spray dryer (such as Buli Minispray, 190 types, Germany or
QW-500, Xishan city Lin Zhou drying machine factory), required partial size is made in solid material.Using can be with when spray drying process
Surfactant such as poloxamer etc. is added.Packing uses No. 3 plant capsules (production of sino-america joint-venture Suzhou Capsule Co., Ltd),
Trade name: Vcaps), each embodiment feeds intake according to 1000 capsules.The capsule loading bubble-cap type of powder spray is aluminum-plastic packaged, makes
Used time takes out, and is packed into powder spray inhalator and uses.
Embodiment 1
Particle size is set to reach d10=0.5-1.5 by fluidized bed supersonic jet mill method the salviandic acid A of 5.0g
μm, d50=1.5-4.0 μm, d90=2.5-8.0 μm, take 0.5g to be dissolved in ethyl alcohol, after filtering, filtrate spray drying；Take particle ruler
It is very little for d10=15-50 μm, d50=80-120 μm, d90=120-200 μm of lactose 10g, in pelletizing machine with above-mentioned danshinolic acid
A micro mist is divided in capsule after mixing.
Embodiment 2
According to the formula of embodiment 1, the micronization of salviandic acid A fluid energy mill is allowed to particle size and reaches d10=0.5-1.5
μm, d50=1.5-4.0 μm, d90=2.5-8.0 μm, by carrier change into particle size be d10=20-40 μm, d50=90-
110 μm, d90=120-180 μm of lactose, prepare powder spray according to the technique of embodiment 1.
Embodiment 3
Particle size is set to reach d10=0.5-1.5 by fluidized bed supersonic jet mill method the salviandic acid A of 5.0g
μm, d50=1.5-4.0 μm, d90=2.5-8.0 μm, take 0.1g to be dissolved in ethyl alcohol, after filtering, filtrate spray drying；Take particle ruler
It is very little for d10=15-50 μm, d50=80-120 μm, d90=120-200 μm of lactose 20g, in pelletizing machine with above-mentioned danshinolic acid
A micro mist is divided in capsule after mixing.
Process conditions are as follows: inlet temperature is 105 DEG C, and outlet temperature is 68 DEG C, throughput 90%, and jet expansion internal diameter is
0.1cm, nozzle air flow velocity 800ml/min, sample introduction speed 50mL/h.
Embodiment 4
Particle size is set to reach d10=0.5- by fluidized bed supersonic jet mill method according to the formula of embodiment 3
1.5 μm, d50=1.5-4.0 μm, d90=2.5-8.0 μm, take 0.1g to be dissolved in ethyl alcohol, after filtering, filtrate spray drying；By carrier
Change into particle size be d10=20-40 μm, d50=90-110 μm, d90=120-180 μm of lactose, according to embodiment 3
Technique prepares powder spray.
Embodiment 5
Particle size is set to reach d10=0.5-1.5 by fluidized bed supersonic jet mill method the salviandic acid A of 5.0g
μm, d50=1.5-4.0 μm, d90=2.5-8.0 μm, take 0.1g to be dissolved in ethyl alcohol, after filtering, filtrate spray drying；Take particle ruler
It is very little for d10=15-50 μm, d50=80-120 μm, d90=120-200 μm of lactose 5g, in pelletizing machine with above-mentioned salviandic acid A
Micro mist is divided in capsule after mixing.
Process conditions are as follows: inlet temperature is 105 DEG C, and outlet temperature is 68 DEG C, throughput 90%, and jet expansion internal diameter is
0.1cm, nozzle air flow velocity 800ml/min, sample introduction speed 50mL/h.
Embodiment 6
Particle size is set to reach d10=0.5-1.5 by fluidized bed supersonic jet mill method the salviandic acid A of 5.0g
μm, d50=1.5-4.0 μm, d90=2.5-8.0 μm, take 0.05g to be dissolved in ethyl alcohol, after filtering, filtrate spray drying；Take particle ruler
It is very little for d10=15-50 μm, d50=80-120 μm, d90=120-200 μm of lactose 40g, in pelletizing machine with above-mentioned danshinolic acid
A micro mist is divided in capsule after mixing.
Embodiment 7
Particle size is set to reach d10=0.5-1.5 by fluidized bed supersonic jet mill method the salviandic acid A of 5.0g
μm, d50=1.5-4.0 μm, d90=2.5-8.0 μm, take 0.2g to be dissolved in ethyl alcohol, after filtering, filtrate spray drying；Take particle ruler
It is very little for d10=15-50 μm, d50=80-120 μm, d90=120-200 μm of glycine 20g, in pelletizing machine with above-mentioned red phenol
Sour A micro mist is divided in capsule after mixing.
Embodiment 8
0.1g poloxamer is taken, it is according to the formula of embodiment 1, poloxamer is complete molten into salviandic acid A ethanol solution, it presses
Powder spray is prepared according to the technique of embodiment 3.
Embodiment 9
The poloxamer for taking 0.2g, it is according to the formula of embodiment 3, poloxamer is complete molten into salviandic acid A ethanol solution,
Powder spray is prepared according to the technique of embodiment 5.
Embodiment 10
0.05g poloxamer is taken, it is according to the formula of embodiment 5, poloxamer is complete molten into salviandic acid A ethanol solution,
Powder spray is prepared according to the technique of embodiment 6.
Embodiment 11
0.25g poloxamer is taken, it is according to the formula of embodiment 6, poloxamer is complete molten into salviandic acid A ethanol solution,
Powder spray is prepared according to the technique of embodiment 7.
12 aerodynamic size of embodiment is distributed the measurement of (pulmonary deposition ratio)
Dust cloud agent capsules made from Example 1~11 respectively, each 20, according to Chinese Pharmacopoeia four general rules of version in 2015
The pulmonary deposition ratio of method measurement powder spray disclosed in 0111, every group of experimental result are averaged.
The content of effective component is measured using liquid chromatography, and chromatographic condition is as follows:
It is the chromatographic column of filler that chromatographic column, which selects octadecylsilane chemically bonded silica,；
With -0.15% phosphoric acid water of acetonitrile (30:70) for mobile phase, flow velocity 1ml/min；Detection wavelength is 285nm；Column
Temperature: 30 DEG C.It the results are shown in Table 1:
Table 1: the pulmonary deposition ratio measurement result of powder spray
The measurement of 13 Emptying Rate of embodiment
Implement 1~11 according to the measurement of method disclosed in Chinese Pharmacopoeia Chinese Pharmacopoeia four general rules 0111 of version in 2015 to be made
Dust cloud agent capsules Emptying Rate, as a result table 2:
Table 2: dust cloud agent capsules Emptying Rate measurement result
The test of 13 powder spray capsule stability of embodiment
Test drug: control group is used according to technical solution (direct object disclosed in the invention patent specification embodiment 4
Manage mixing method) made from dust cloud agent capsules, capsule used be No. 3 capsules.Gained dust cloud agent capsules every contains 100 μ g danshinolic acids
A, lactose 20mg.
Experimental group is as shown in table 3 using dust cloud agent capsules situation obtained by the embodiment of the present invention:
Experimental method: taking control group and experimental group capsule each 20 respectively, and each group first takes 10 measurement lungs heavy at random
Product rate, each group remaining 10, in 40 DEG C ± 5 DEG C, are protected from light storage 15 days under conditions of relative humidity 75% ± 5%, measurement lung is heavy
Product rate.And front and back pulmonary deposition ratio data will be stored and carry out t inspection with spss.
Experimental result is shown in Table 4:(X ± s, n=10)
Table 4: storage front and back pulmonary deposition ratio carries out the result of t inspection with spss
| Control group | Experimental group 1 | Experimental group 2 | Experimental group 3 | Experimental group 4 | Experimental group 5 | |
| Before storage | 24.36±1.13 | 26.3±1.26 | 26.9±1.29 | 26.9±1.08 | 25.5±1.09 | 25.6±1.21 |
| After storage | 18.20±2.65 | 25.8±1.61 | 26.4±1.23 | 22.9±1.19 | 24.0±1.01 | 24.8±1.10 |
From experimental data as can be seen that control group storage front and back pulmonary deposition ratio is decreased significantly (P < 0.05), and test
Group storage front and back pulmonary deposition ratio illustrates preparation method spray drying process better than physical mixed method without being remarkably decreased.
Above the embodiments of the present invention are described in detail, but the present invention is not limited to described embodiments.It is right
For those skilled in the art, in the case where not departing from the principle of the invention and spirit, these embodiments are carried out more
Kind change, modification, replacement and modification, still fall in protection scope of the present invention.
Claims (10)
1. a kind of salviandic acid A capsule type inhalation aerosol powder, is made of, it is characterised in that: described salviandic acid A micro mist and carrier micro mist
The particle size of salviandic acid A micro mist is d10=0.5-1.5 μm, d50=1.5-4.0 μm, d90=2.5-8.0 μm, and is more than
Particle size < 10 μm of the 95% salviandic acid A micro mist；The particle size of the carrier micro mist is d10=15-50 μm, d50
The weight ratio of=80-120 μm, d90=120-200 μm, the salviandic acid A and the carrier micro mist is 1:1~1000.
2. salviandic acid A capsule type inhalation aerosol powder according to claim 1, it is characterised in that: of the carrier micro mist
Particle size is d10=20-40 μm, d50=90-110 μm, d90=120-180 μm.
3. salviandic acid A capsule type inhalation aerosol powder according to claim 1 or 2, it is characterised in that: the carrier micro mist is
One or more of carbohydrate and amino acid.
4. salviandic acid A capsule type inhalation aerosol powder according to claim 3, it is characterised in that: the carrier micro mist is cream
One or more of sugar, glycine, mannitol.
5. salviandic acid A capsule type inhalation aerosol powder according to claim 4, it is characterised in that: the carrier micro mist is lactose.
6. salviandic acid A capsule type inhalation aerosol powder according to claim 5, it is characterised in that: the carrier micro mist further includes attached
Add agent, the additives contain one or more of surfactant, lubricant, antiplastering aid, antistatic agent.
7. salviandic acid A capsule type inhalation aerosol powder according to claim 6, it is characterised in that: the surfactant
For poloxamer, the weight ratio of the salviandic acid A and the poloxamer is 1:0.1~5.
8. salviandic acid A capsule type inhalation aerosol powder according to claim 7, it is characterised in that: the salviandic acid A with it is described
The weight ratio of carrier micro mist is 1:1~200.
9. such as the preparation method of the salviandic acid A capsule type inhalation aerosol powder as described according to any one of claim 8, feature exists
In: the following steps are included:
S1, salviandic acid A micronization: using spray drying process, fluidized bed supersonic jet mill method, high speed grinding method, ball-milling method,
Salviandic acid A micro mist chemical conversion granular size is d10=0.5-1.5 μm, d50=1.5-4.0 μ by fluid energy mill method, one kind of solvent method
M, d90=2.5-8.0 μm of micro mist；
S2, carrier micronization: additives first are added toward carrier and are micronized, carrier micro mist is made；
S3, mixing: after salviandic acid A micro mist and carrier micro mist are mixed, being divided in capsule, and the sucking of salviandic acid A capsule-type is made
Powder spray；
S4, packing: salviandic acid A capsule type inhalation aerosol powder obtained is divided in by capsule using the packing mode of capsule
In, the content of each capsule is 1~100mg.
10. the preparation method of salviandic acid A capsule type inhalation aerosol powder according to claim 9, it is characterised in that: the pellet
Phenolic acid A micronization uses fluidized bed supersonic jet mill method, and the content of each capsule is 10~50mg.
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Cited By (1)
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| CN111067879A (en) * | 2020-01-20 | 2020-04-28 | 珠海瑞思普利生物制药有限公司 | Anti-tumor composition powder inhalation and preparation method thereof |
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