CN107913261A - A kind of sivelestat sodium Foradil Aerolizer formoterol fumarate and preparation method thereof - Google Patents
A kind of sivelestat sodium Foradil Aerolizer formoterol fumarate and preparation method thereof Download PDFInfo
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- CN107913261A CN107913261A CN201610873587.6A CN201610873587A CN107913261A CN 107913261 A CN107913261 A CN 107913261A CN 201610873587 A CN201610873587 A CN 201610873587A CN 107913261 A CN107913261 A CN 107913261A
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- inhalant
- sodium
- sivelestat sodium
- sivelestat
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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
- A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
- A61K31/222—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin with compounds having aromatic groups, e.g. dipivefrine, ibopamine
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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
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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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
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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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
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Abstract
The invention belongs to pharmaceutical technology field, discloses a kind of sivelestat sodium Foradil Aerolizer formoterol fumarate and preparation method thereof.The sivelestat sodium Foradil Aerolizer formoterol fumarate is made of active ingredient sivelestat sodium, dispersant, glidant and diluent, takes Foradil Aerolizer formoterol fumarate buccal administration or nasal-cavity administration form.The process of the present invention is simple, is adapted to industrialized scale, and has the characteristics that administration is easy, drug effect is rapid, easy to carry.It can be effectively used to acute lung injury.
Description
Technical field
The present invention relates to pharmaceutical field on drug preparation technique, a kind of sivelestat sodium Foradil Aerolizer formoterol fumarate and its preparation side
Method.
Background technology
Sivelestat sodium（Sivelestat sodium）It is a small molecule neutrophil elastase
（Neutrophil Elastase, NE）Inhibitor, can invertibity, Reverse transcriptase NE.Its N- { 2- [4- (2,2- dimethyl propylene
Acyloxy) benzenesulfonamido-] benzoyl } amion acetic acid sodium salt tetrahydrate, chemical structural formula is as follows：
Sivelestat sodium product is that Japanese little Ye Pharmaceutical Co., Ltd (Ono Pharmaceutical) develops earliest, the production
Product be used for treat with systemic toxin (Systemic Inflammatory Response Syndrome,
SIRS ALI), on April 11st, 2002 Japan obtain production permit, on June 17th, 2002 ElaspolTMListed in Japan.
Clinical indication is the medicine for treating the acute lung injury with SIRS.Specification is freeze-dried powder, every bottle of 100mg.
The change of systemic inflammatory response syndrome basic pathology be proinflammatory in body-anti-inflammatory from it is steady it is unbalance caused by, with
Immune defense function decline, continue uncontrolled inflammatory reaction, be due to infection, burn, wound, operation, pancreatitis with
A kind of and systemic inflammatory reaction caused by many factors such as ischemia-reper.
Acute lung injury（Acute Lung Injury, ALI）Fundamental cause be pulmonary vascular high-permeability, its fall ill
Mechanism not yet understands completely, may mainly be caused by the neutrophil leucocyte release oxygen radical and protease that activate.Clinic is ground
Study carefully proof, the elastoser that sivelestat sodium is discharged by suppressing neutrophil leucocyte, improves comprehensive with systemic inflammatory reaction
Close disease（Systemic Inflammatory Response Syndrome, SIRS）ALI patient respiratory function, shorten suffer from
Person use lung ventilator time, patient is got out of danger as early as possible, from intensive care unit (Intensive Care Unit,
ICU withdrawn from), reduce the death rate.This product can improve SIRS and idiopathic pulmonary fibrosis (idiopathic pulmonary
Fibrosis, IPF) etc. initiation acute lung injury.In addition, sivelestat sodium is except on pulmonary lesion and pulmonary infection
Outside purposes, the clinical research of acute pancreatitis, acute nephritis is also being carried out, there will be more extensive clinical application.
Clinical research finds the acute lung injury that sivelestat sodium can be used for treatment with systemic toxin.
Its pharmacological action and mechanism of action are as follows：
1st, Neutrophil elastase inhibitory action Neutrophil elastase is a kind of protease,
Its separate out from the neutrophil cell for be gathered in lung, makes lung's connective tissue（Interstitial lung）Decompose, pulmonary capillaries are led to
Permeability strengthens, and causes acute pulmonary function injury.In addition, Neutrophil elastase is also promoting neutrophil cell to become
Change the generation of the factor, strengthen inflammatory reaction and cause and risen with acute lung injury of systemic toxin etc.
Important function；
Sivelestat sodium is the selective depressant of Neutrophil elastase；To the neutrophil(e) granule of various human or animals
Cell elastase activity has strong Antagonism inhibitory action, to other serine proteases, cysteine protein
Enzyme and metalloproteinases almost do not show inhibitory action.
2nd, it is intravenous to be administered continuously and measure in hamster acute lung injury model caused by the thermophilic middle grain elastoser of people
Suppress bronchovesicular bleeding to effect dependence（Inhibitory action has dose-effect dependence）；Cause in cobra-venom or endotoxin
Hamster acute lung injury model in, it is intravenous be administered continuously can suppress blood plasma with dose-effect dependence or bronchovesicular washes out
Elastase activity in liquid, display sivelestat sodium have the related injury of lungs that suppresses to act on.
The formulation that sivelestat sodium lists at present is injection freeze-dried powder preparation, is researched and developed by Japanese little Ye companies, uses agent
Measure as 5mg/kg/ days.
Lung suction preparation is developed rapidly in recent years.In addition to obtaining effective general action, lung inhalation approach is
The most direct therapeutic modality of the pulmonary diseases such as asthma, pulmonary emphysema, chronic obstructive pulmonary disease, acute lung injury.Medicine can be direct
Target site is reached, it is rapid-action, reduce dosage and toxicity and adverse reaction.There are more than one hundred million a alveolars in lung, and absorption area is big；Blood
Flow is big, is conducive to the absorption of medicine；Blood circulation is directly entered after the transpulmonary absorption of medicine, avoids the first pass effect of liver,
The bioavilability of medicine is improved, many pulmonary inhalation listings existing at present.The technology of Pulmonary inhalation mainly has 3 kinds：
(1) nebulizer；(2) metered dose inhaler；(3) Foradil Aerolizer formoterol fumarate.Nebulizer needs ultrasonic atomizing device, uses
It is inconvenient.Disabled containing propellant freon in metered dose inhaler, the term of validity is short, easily leakage.Foradil Aerolizer formoterol fumarate is in recent years
The research hotspot formulation of pulmonary administration, its advantage are drug substance stable (solid states), easily enter lung tissue deep, are absorbed fast
Speed, targeting positioning, carry and it is easy to use.
Due to the usual state of an illness of patient with acute lung injury or acute respiratory distress syndrome than more serious, it is necessary to immediately
It is administered and plays a role, is treated using the preparation of parenteral administration route；The inhalant of direct oral cavity or nasal-cavity administration has
Many features：Medicine through suction can rapid subsidence in lung, be avoided that or reduce the toxic side effect to other positions；Pulmonary absorption
Surface area is big, and membrane permeability is high, and blood flow enriches, and drug absorption is rapid；Lung's enzymatic activity is relatively low, and without liver first-pass effect, carries
High bioavilability.There are many successful examples, such as Tiotropium Bromide at present.
The content of the invention
It is described this to contain sivelestat it is an object of the invention to provide a kind of inhalant containing sivelestat sodium
The inhalant of sodium be it is a kind of absorb rapidly, conveniently, safely and effectively drug-delivery preparation.
Present invention also offers the preparation method of this inhalant.
In the present invention, it is necessary to by medicine and antistatic additive and other medicinal connect during the realization of Foradil Aerolizer formoterol fumarate
Mixed by auxiliary material.
Further, active ingredient sivelestat sodium accounts for the 0.01%~1% of medicament gross weight, and it is total that antistatic additive accounts for medicament
The 0%~2% of weight.
Further, antistatic additive is physiologically acceptable antistatic additive.
Further, these auxiliary materials include levulose glycosides, alpha-cyclodextrin, gamma-cyclodextrin, sorbierite, chitin, methylol
Sodium starch, methylcellulose, hydroxypropyl methyl cellulose, sodium alginate, microcrystalline cellulose, sucrose, lactose, glucose, fructose,
Raffinose, maltitol, mannitol, hydroxypropyl-β-cyclodextrin, threonine, glutamic acid, leucine, glycine, xylitol, third
Propylhomoserin, L-aminobutanedioic acid, polyvinylpyrrolidone one or more therein.
If it is necessary, also need to add suitable surface active ingredient, such as Dilauroyl Phosphatidylcholine, cholesterol, two
Palmitoylphosphatidyl choline etc..If it is necessary, also need to add suitable surface active ingredient, such as poloxamer, two lauroyl
Phosphatidyl choline, cholesterol, dipalmitoylphosphatidylcholine, can also add appropriate polymer substance, as pregelatinized starch,
One or more in Arabic gelatin, starch, polyethylene glycol, polylactic acid, polylactic acid monohydroxy acetic acid；
Further, since through pulmonary administration, which has to pass through differentiation processing, west dimension is come for the present invention
The grain size of micropowder of sodium and its auxiliary material is taken charge of preferably between 0.5~100 μm, preferably 1-50 μm, more preferably 4-10 μm,
Further, after micronization processes, capsule-type, vesicle type can be taken or be directly loaded in Diskus.
The preparation of this inhalant can be accomplished by following approach：
Method one
Sivelestat sodium is crossed into 100 mesh sieves, is mixed respectively three times according to equivalent gradually-increased with other medicinal acceptable auxiliary materials,
It is put into again in ball mill and grinds 1h, when its particle diameter reaches 0.5-50 μm, loads in capsule, vesicle or Diskus；
Method two
Sivelestat sodium is dissolved in must be in solvent medium；By other pharmaceutic adjuvants after mixing, the ethanol is added
Solution prepares softwood, and granulation, drying, cross 100 mesh sieves, then are put into ball mill grinding 1h, when its particle diameter reaches 0.5-50 μm
When, its powder is taken, is loaded in capsule, vesicle or Diskus；
The sivelestat sodium inhalant of the obtained fabulous absorption characteristic of tool may be conveniently used acute lung damage by the present invention
The treatment of wound, and the medicine of limited amount can be simply given to required position rapidly.In addition, inhalant administration does not produce
To body-stimulating, also without pain, and the inhalant needs to remove when locally using and when need not be such as using ointment
Medicine, thus be very convenient when in use.
4th, embodiment：
It is below the embodiment of the present invention, embodiment is to further describe the present invention rather than the limitation present invention.It is all
Equivalent technical solution belongs to protection scope of the present invention with the present invention.
Embodiment 1
| Components Name | Shared part by weight |
| Sivelestat sodium | 0.44% |
| Glycine | 11.06% |
| Lactose | 88.49% |
| Superfine silica gel powder | 1.11% |
Preparation method：
Sivelestat sodium is crossed into 100 mesh sieves, lactose, glycine, superfine silica gel powder cross 100 mesh sieves respectively, according to equivalent gradually-increased point
Do not mix three times, then be put into ball mill and grind 1h, when its particle diameter reaches 0.5-50 μm, be placed in capsule filling machine
Filling No. 3 capsules.
Embodiment 2
| Components Name | Shared part by weight |
| Sivelestat sodium | 0.98% |
| Moor Lip river sand Mei | 0.62% |
| Microcrystalline cellulose | 98.40% |
| 90% ethanol | In right amount |
Preparation method：
Poloxamer, microcrystalline cellulose are crossed into 100 mesh sieves respectively, sivelestat sodium is dissolved in 90% ethanol；It is husky to moor Lip river
Nurse, microcrystalline cellulose according to equivalent gradually-increased mix respectively three times, add other pharmaceutic adjuvants after mixing, adding should
The ethanol solution of the active component of ethanol solution prepares softwood, crosses the granulation of 30 mesh sieves, 60 DEG C of dryings, crosses 100 mesh sieve whole grains, then
Ball mill grinding 1h is put into, when its particle diameter reaches 0.5-50 μm, is placed in filling No. 3 capsules in capsule filling machine.
Embodiment 3
| Components Name | Shared part by weight |
| Sivelestat sodium | 0.64% |
| Hydroxypropyl methyl cellulose | 3.97% |
| Left-handed glucosides | 15.89% |
| Sorbierite | 79.5% |
| 90% ethanol | In right amount |
Preparation method：
Sivelestat sodium is dissolved in ethanol；Hydroxypropyl methyl cellulose, left-handed glucosides, sorbierite are according to equivalent gradually-increased
Mix respectively three times, add the ethanol solution dissolved with active ingredient and prepare softwood, cross the granulation of 40 mesh sieves, 60 DEG C of dryings, cross 100
Mesh sieve whole grain, then ball mill grinding 1h is put into, when its particle diameter reaches 0.5-50 μm, its powder is taken, quantitatively loads vesicle
In.
Embodiment 4
| Components Name | Shared part by weight |
| Sivelestat sodium | 0.40% |
| Leucine | 49.8% |
| Alpha-cyclodextrin | 49.8% |
Preparation method：
Sivelestat sodium is crossed into 100 mesh sieves, α-cyclodextrin, leucine are crossed 100 mesh sieves, distinguished according to equivalent gradually-increased respectively
Mix three times, then be put into ball mill grinding 1h, when its particle diameter reaches 0.5-50 μm, take its powder, quantitatively load vesicle
In.
Embodiment 5
| Components Name | Shared part by weight |
| Sivelestat sodium | 3.10% |
| Arabic gelatin | 19.38% |
| Methylcellulose | 77.52% |
Preparation method：
By sivelestat sodium, Arabic gelatin, methylcellulose through spiral jet pulverizer air-flow crushing, with there is polymer inner liner
Rotary blender is reunited, and is sprayed into a small amount of ethanol and is made adhesive, fluffy aggregate is made, is directly loadable into Diskus.
Embodiment 6
| Components Name | Shared part by weight |
| Sivelestat sodium | 0.57% |
| Sodium carboxymethyl starch | 3.55% |
| Sodium alginate | 14.2% |
| Mannitol | 3.2% |
| Chitin | 71.02% |
| Beta-cyclodextrin | 7.46% |
| 90% ethanol | In right amount |
Preparation method：
Sivelestat sodium is dissolved in ethanol；Sodium Hydroxymethyl Stalcs, sodium alginate, chitin, β-cyclodextrin, mannitol are pressed
Mixed respectively according to equivalent gradually-increased three times, add the ethanol solution dissolved with active ingredient and prepare softwood, cross the granulation of 40 mesh sieves,
60 DEG C of dryings, cross 100 mesh sieve whole grains, then are put into ball mill grinding 1h, when its particle diameter reaches 0.5-50 μm, take its powder
Body, is quantitatively fitted into vesicle.
Embodiment 7
| Components Name | Shared part by weight |
| Sivelestat sodium | 0.57% |
| Pregelatinized starch | 3.56% |
| Gamma-cyclodextrin | 14.26% |
| Dipalmitoyl phosphate ester phatidylcholine | 71.28% |
| Glutamic acid | 2.45% |
| Cholesterol | 7.88% |
| Ethanol | In right amount |
Preparation method
Sivelestat sodium is dissolved in ethanol；Pregelatinized starch, γ-cyclodextrin, dipalmitoyl phosphate ester phatidylcholine, paddy ammonia
Acid, cholesterol mix three times respectively according to equivalent gradually-increased, add the ethanol solution dissolved with active ingredient and prepare softwood, cross 40
Mesh sieve granulation, 60 DEG C of dryings, cross 100 mesh sieve whole grains, then are put into ball mill grinding lh, when its particle diameter reaches 0.5-50 μm
When, its powder is taken, is quantitatively fitted into vesicle.
As described above, medicine can be provided rapidly by the inhalant as active constituents of medicine containing sivelestat sodium of the present invention
Act on and effectively increase its medical usage.
Claims (9)
1. the present invention is a kind of Foradil Aerolizer formoterol fumarate, for being sucked by oral cavity suction or nasal cavity.
2. the inhalant as described in claim 1, it is characterised in that it is using sivelestat sodium dry powder as active ingredient, pharmacy
Upper acceptable auxiliary material is mixed to form Pharmaceutical composition, the grain size of micropowder of the sivelestat sodium and its auxiliary material 0.5~
Between 100 μm, preferably 1-50 μm, more preferably 4-10 μm.
3. the inhalant as described in claim 2, it is characterised in that some pharmaceutic adjuvants must be added, these auxiliary materials include a left side
It is fine to revolve glucosides, alpha-cyclodextrin, gamma-cyclodextrin, sorbierite, chitin, Sodium Hydroxymethyl Stalcs, methylcellulose, hydroxypropyl methyl
Dimension element, sodium alginate, microcrystalline cellulose, sucrose, lactose, glucose, fructose, raffinose, maltitol, mannitol, hydroxypropyl-
Beta-cyclodextrin, threonine, glutamic acid, leucine, glycine, xylitol, alanine, L-aminobutanedioic acid, polyvinylpyrrolidone its
In one or more.
4. the inhalant as described in claim 2, it is characterised in that if it is necessary, also need to add suitable surface-active into
Point, such as cholesterol, poloxamer, Dilauroyl Phosphatidylcholine, dipalmitoylphosphatidylcholine, appropriate height can also be added
Molecular substance, such as one in pregelatinized starch, Arabic gelatin, starch, polyethylene glycol, polylactic acid, polylactic acid monohydroxy acetic acid
Kind is several.
5. the inhalant as described in claim 2, it is characterised in that need to add a certain amount of antistatic additive.
6. the inhalant as described in claim 2, it is characterised in that active ingredient sivelestat sodium accounts for medicament gross weight
0.01%~1%, antistatic additive accounts for the 0%~2% of medicament gross weight.
7. the inhalant as described in claim 2, it is characterised in that take capsule-type, vesicle type or be directly loaded on dry powder suction
Enter in device.
8. the inhalant as described in claim 2, it is characterised in that it is described by sivelestat sodium and antistatic additive, it is medicinal auxiliary
During material is mixed, excipient is added into mixture, the particle diameter of the excipient is more excellent at 150 μm~300 μm
Select 150 μm~200 μm.
9. the inhalant as described in claim 1, it is characterised in that preparation method is as follows：
Method 1
Sivelestat sodium is dissolved in certain solvent medium；By antistatic additive and other pharmaceutic adjuvants after mixing,
Add the ethanol solution and prepare softwood, granulation, drying, cross 100 mesh sieves, then are put into ball mill grinding 1h, when its particle diameter reaches
During to 0.5-50 μm, its powder is taken, is loaded in capsule, vesicle or Diskus；
Method 2
Sivelestat sodium is crossed into 100 mesh sieves, with antistatic additive and other medicinal acceptable auxiliary materials according to equivalent gradually-increased point
Do not mix three times, then be put into ball mill and grind 1h, when its particle diameter reaches 0.5-50 μm, load capsule, vesicle or dry
Powder inhalator.
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| CN201610873587.6A CN107913261A (en) | 2016-10-08 | 2016-10-08 | A kind of sivelestat sodium Foradil Aerolizer formoterol fumarate and preparation method thereof |
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| CN201610873587.6A CN107913261A (en) | 2016-10-08 | 2016-10-08 | A kind of sivelestat sodium Foradil Aerolizer formoterol fumarate and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2022143722A1 (en) | 2020-12-31 | 2022-07-07 | 上海汇伦生物科技有限公司 | Pharmaceutical composition for inhalation |
| CN114886883A (en) * | 2022-05-09 | 2022-08-12 | 首都医科大学 | Application of sevelamer sodium in preparation of medicine for treating adverse pregnancy caused by dengue virus infection |
| CN116115589A (en) * | 2023-01-29 | 2023-05-16 | 江苏百奥信康医药科技有限公司 | Sivelesta sodium pharmaceutical composition for inhalation and preparation method thereof |
-
2016
- 2016-10-08 CN CN201610873587.6A patent/CN107913261A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2022143722A1 (en) | 2020-12-31 | 2022-07-07 | 上海汇伦生物科技有限公司 | Pharmaceutical composition for inhalation |
| CN114886883A (en) * | 2022-05-09 | 2022-08-12 | 首都医科大学 | Application of sevelamer sodium in preparation of medicine for treating adverse pregnancy caused by dengue virus infection |
| CN116115589A (en) * | 2023-01-29 | 2023-05-16 | 江苏百奥信康医药科技有限公司 | Sivelesta sodium pharmaceutical composition for inhalation and preparation method thereof |
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Application publication date: 20180417 |