CN103110611A - Inhalant, preparation method thereof, and application of inhalantas inhalant carrier with pullulan - Google Patents
Inhalant, preparation method thereof, and application of inhalantas inhalant carrier with pullulan Download PDFInfo
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- CN103110611A CN103110611A CN2012105292562A CN201210529256A CN103110611A CN 103110611 A CN103110611 A CN 103110611A CN 2012105292562 A CN2012105292562 A CN 2012105292562A CN 201210529256 A CN201210529256 A CN 201210529256A CN 103110611 A CN103110611 A CN 103110611A
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Abstract
The invention discloses inhalant, a preparation method thereof, and application of the inhalant as an inhalant carrier with pullulan. The particle diameter of drug particles for lung inhalation in the dry-powder inhalant disclosed by the invention is 0.1-50 mu m, preferably 0.3-15 mu m, more preferably 0.5-5 mu m. Generally, the dosage of drugs inhaled for each time is 0.1 mu g to 500 mg. The effective deposition rate of the inhalant in the lung is increased by 16-400%. The inhalant has high bioavailability and can be used for treating local or systemic diseases. The inhalant disclosed by the invention has important value for increasing the pulmonary delivery efficiency of drugs.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, particularly inhalant and preparation method thereof and the application of pulullan as the inhalant carrier.
Background technology
Pulmonary delivery system (PDDS) refers to can be with the drug-supplying system of drug delivery to pulmonary, generation part or whole body therapeutic effect.Lung is determined by its physiological structure as new drug delivery place: the adult has 3～400,000,000 alveolars, and the gross area reaches 70～100m
2, and alveolar epithelial cells very thin (0.1～0.2 μ m), the blood capillary that gathers on every side, medicine can be rapidly absorbed and directly enter the body circulation, realizes the purpose of whole body/targeted therapy.Suck form administration with lung, have obvious advantage: 1. without liver first-pass effect, without the gastrointestinal tract Degradation; 2. medicine sucks rapidly, and is rapid-action; 3. can be used for treatment part and whole body property disease; 4. pulmonary's enzymes metabolism activity is low, is the good Non-parenteral Delivery Routes of biomacromolecule, and increases compliance and toleration.5. dosage obviously reduces, and reduces toxic and side effects.
The inhalation-type drug administration approach is the academic therapy for the treatment of respiratory system disease, has been widely used in treatment locality disease such as pneumonia, pulmonary carcinoma, asthma, emphysema, pulmonary cystic fibrosis, chronic obstructive pulmonary disease etc.Found again in the last few years that pulmonary administration is the good approach that realizes that the biomacromolecules such as proteins and peptides are sent, and can realize the effective treatment to systemic disease, and effectively improve patient's compliance.At present, pulmonary is as the drug systemic administration route of the macromolecular drugs such as protein, polypeptide, the vaccine person's that becomes the pharmacy work hot research content, the lung of having developed the biomacromolecules such as insulin, recombinant human somatropin, salmon calcitonin see calcimar, parathyroid hormone, Measles Vaccine sucks preparation and is used for clinical research, and its development space is huge.
The pulmonary administration mode comprises spray (Nebulizer), metered dose inhalation aerosol (pMDI) and Foradil Aerolizer formoterol fumarate (DPI).The spray device is larger, not portable and use; The biological macromolecule solns preparation that sucks for spraying needs cold chain storage and transportation, and is in use easily waited destruction and affect therapeutic effect by ultrasonic.The pMDI preparation needs propellant, although adopt at present hydrofluoroalkane (HFA) replacement fluorine Lyons (CFC) as having eliminated this risk that damages the ozone layer after propellant, but still the tool greenhouse effect; Propellant is influential to the physicochemical property of biomacromolecule isoreactivity medicine, be unsuitable for sending of biomolecule medicine, need the air-breathing cooperative effect that goes out granule with the preparation impelling of patient just can reach good effect when using pMDI, this is for young and old patient and be difficult for row.And DPI is without propellant, to respiratory tract non-stimulated and to environment without any infringement; The ejection of its granule relies on patient's inspiratory airflow to cause fully, thereby has eliminated the air-breathing synergism that causes with device of patient of pMDI; And the biomolecule medicine can more stable preservation under dry powder.Thereby dry powder formulations (claiming again powder spray) is referred to as lung suction preparation of future generation.
Powder spray preparation composition has important function for its dispersibility and lung suction efficiency.The powder spray of using in the market, its adjuvant is lactose.Because lactose has stronger adhesive attraction, cause the lung suction efficiency low, in general, the dosage that in fact can reach pulmonary only has sets 10%～30% of dosage.Therefore, provide a kind of new inhalant adjuvant to have important value for what improve medicine through the lung delivery efficiency.
Summary of the invention
The object of the present invention is to provide inhalant and preparation method thereof and the application of pulullan as the inhalant carrier, Foradil Aerolizer formoterol fumarate of the present invention, be used for the particle diameter of lung suction granule at 0.1～50 μ m, effective deposition has improved 16%～400% in pulmonary, can treat part or whole body property disease.
For achieving the above object, technical scheme provided by the invention is that pulullan is as the application of the carrier of medicine inhalant.
Preferably, described medicine is selected from one or more in chemicals, biomolecule medicine, genomic medicine.Preferably, described biomolecule medicine is biopharmaceutical macromolecular drug.
Preferably, described chemicals contain albuterol, fumaric acid FF, budesonide, ciclesonide, not for one or more in Kazon, salmaterol, ipratropium bromide, terbutaline, beclometasone, nitroglycerin;
Preferably, described biomolecule medicine contains one or more in insulin, alkali phosphatase, adenosine deaminase, Radix Asparagi amidase, recombinant human somatropin, salmon calcitonin see calcimar, parathyroid hormone, interleukin, octreotide acetate, Lanreotide, triptorelin, urokinase, streptokinase, oxytocin, alpha-interferon, leuprorelin, Measles Vaccine, influenza vaccines, bacillus calmette-guerin vaccine, Hepatitis B virus vaccine, white hundred broken triple vaccinies;
Preferably, described genomic medicine is functioning gene and/or gene outcome; Preferably, described genomic medicine contains gene segment and/or micromolecule nucleic acid.
The invention provides pulullan and suck the application of pharmaceutical adjunct as lung, pulullan is the natural polysaccharide that utilizes saccharine material to obtain through microbial fermentation.Its advantage is as follows.The margin amount of safety: LD 50 (half lethal dose) is 15 gram/kilograms.Water-soluble: unlimited, dissolution velocity fast, solution neutral, viscosity and other polysaccharide lower.Film property: can form the tough thin film of water white transparency, increase lustrous surface.Digestibility: be the indigestibility polysaccharide, decompose without obvious in the short time under the digestive enzyme effect.Stability: acidproof, alkaline-resisting, heat-resisting, salt tolerant.Lubricity a: fluid of being born in the year of cattle, the good lubricity of tool.
Prior art does not have pulullan to suck the application of pharmaceutical adjunct as lung, does not have pulullan to suck any technology enlightenment of the application of pharmaceutical adjunct as lung yet.
For achieving the above object, the present invention also provides a kind of inhalant, contains pharmacological active substance and pulullan.
Preferably, described inhalant also contains adjuvant.
Preferably, described inhalant contains the pharmacological active substance of 0.1～30 weight portion, the pulullan of 0.5～40 weight portion and the adjuvant of 0～40 weight portion.
Preferably, described pharmacological active substance is selected from one or more in chemicals, biomolecule medicine, genomic medicine; Preferably, described biomolecule medicine is biopharmaceutical macromolecular drug.
Preferably, described chemicals contain albuterol, fumaric acid FF, budesonide, ciclesonide, not for one or more in Kazon, salmaterol, ipratropium bromide, terbutaline, beclometasone, nitroglycerin;
Preferably, described biomolecule medicine contains one or more in insulin, alkali phosphatase, adenosine deaminase, Radix Asparagi amidase, recombinant human somatropin, salmon calcitonin see calcimar, parathyroid hormone, interleukin, octreotide acetate, Lanreotide, triptorelin, urokinase, streptokinase, oxytocin, alpha-interferon, leuprorelin, Measles Vaccine, influenza vaccines, bacillus calmette-guerin vaccine, Hepatitis B virus vaccine, white hundred broken triple vaccinies;
Preferably, described genomic medicine is functioning gene and/or gene outcome; Preferably, described genomic medicine contains gene segment and/or micromolecule nucleic acid;
Preferably, described adjuvant contains one or more in aminoacid, monosaccharide, disaccharide, oligosaccharide, polysaccharide.
For achieving the above object, the present invention also provides a kind of preparation method of inhalant: the raw material that will contain pharmacological active substance and pulullan mixes, spray drying, obtains the combination drug granule.Preferably, described raw material also contains adjuvant.
For achieving the above object; the present invention also provides a kind of preparation method of inhalant: the raw material that will contain pharmacological active substance mixes spray-dried or other known method acquisition drug particles again; and then the pulullan granule mechanical mixture that obtains with pulullan spray-dried granules or other known method, obtain the combination drug granule.Preferably, described raw material also contains adjuvant.
For achieving the above object, the present invention also provides a kind of preparation method of inhalant:
Raw materials by weight, with the first mix homogeneously of raw material, then spray drying, last packing;
Described raw material contains the pharmacological active substance of 0.1～30 weight portion, the pulullan of 0.5～40 weight portion and the adjuvant of 0～40 weight portion;
Described pharmacological active substance is selected from one or more in chemicals, biomolecule medicine, genomic medicine; Preferably, described biomolecule medicine is biopharmaceutical macromolecular drug.
Described chemicals contains albuterol, fumaric acid FF, budesonide, ciclesonide, not for one or more in Kazon, salmaterol, ipratropium bromide, terbutaline, beclometasone, nitroglycerin;
Described biomolecule medicine contains one or more in insulin, alkali phosphatase, adenosine deaminase, Radix Asparagi amidase, recombinant human somatropin, salmon calcitonin see calcimar, parathyroid hormone, interleukin, octreotide acetate, Lanreotide, triptorelin, urokinase, streptokinase, oxytocin, alpha-interferon, leuprorelin, Measles Vaccine, influenza vaccines, bacillus calmette-guerin vaccine, Hepatitis B virus vaccine, white hundred broken triple vaccinies;
Preferably, described genomic medicine is functioning gene and/or gene outcome; Preferably, described genomic medicine contains gene segment and/or micromolecule nucleic acid;
Described adjuvant contains one or more in aminoacid, monosaccharide, disaccharide, oligosaccharide, polysaccharide.
Drug particles of the present invention also can by pharmacological active substance through other known methods acquisitions, then obtain the combination drug granule with the pulullan granule mechanical mixture that pulullan spray-dried granules or other known methods obtain.
Advantage of the present invention and beneficial effect are: inhalant and preparation method thereof and the application of pulullan as the inhalant carrier are provided, Foradil Aerolizer formoterol fumarate of the present invention, be used for lung and suck the particle diameter of granule at 0.1～50 μ m, effective deposition has improved 16%～400% in pulmonary, can treat part or whole body property disease.
Foradil Aerolizer formoterol fumarate of the present invention, its drug particles particle diameter that is used for the lung suction are optimized particle diameter 0.3-15 μ m, then are optimized particle diameter 0.5-5 μ m at 0.1～50 μ m.General each Sucked medicine dosage 0.1 μ g～500mg can be used for treating part or systemic disease.During use by administrator through patient's active inspiration, medicine is sucked by respiratory tract fully, and has improved 16%～400% in the effective deposition of pulmonary, bioavailability is high, can effectively produce part or whole body therapeutic effect.
The specific embodiment
The invention discloses inhalant and preparation method thereof and the application of pulullan as the inhalant carrier, those skilled in the art can use for reference this paper content, suitably improve technological parameter and realize.Special needs to be pointed out is, all similarly replace and change apparent to those skilled in the art, and they all are deemed to be included in the present invention.Method of the present invention and application are described by preferred embodiment, the related personnel obviously can change methods and applications as herein described within not breaking away from content of the present invention, spirit and scope or suitably change and combination, realizes and use the technology of the present invention.
Raw materials used and the reagent of the present invention all can be buied by market.The drug particles that is used for the lung suction can be prepared by methods such as Mechanical Method (as comminution by gas stream, high-energy ball milling method), spray drying method, supercritical methanol technology, crystallization processs.
Spray drying standard operation state: hot-air flow velocity 100%, Compressed Gas flow velocity 600L/hr, 180 ℃ of inlet temperatures, 70 ℃ of outlet temperatures.
In-vitro simulated pulmonary deposition standard operation is as follows: the drug particles of collecting is sub-packed in the HPMC capsule on request, and simulation is grown up respiratory air flow when 60mL/min,
Connect multistage impinger (NGI) as administrator and carry out the pulmonary deposition extracorporeal simulating experiment.Wherein grain diameter is referred to as microparticle less than 4.5 μ m.
Below in conjunction with embodiment, the specific embodiment of the present invention is further described.Following examples only are used for technical scheme of the present invention more clearly is described, and can not limit protection scope of the present invention with this.
Embodiment 1
Pulullan in following table 1 and pharmacological active substance are dissolved in the water by certain weight ratio, then under reference operating condition spray drying generating medicine granule, can get powder spray 1.Obtain its pulmonary deposition efficient under in-vitro simulated pulmonary deposition standard operation, represent with the microparticle ratio, as table 1.
The composition of table 1 powder spray 1 Chinese medicine granule and microparticle ratio
Embodiment 2
Pharmacological active substance in table 2 and pulullan are dissolved in same aqueous solution by certain weight ratio, then add as required the adjuvant of corresponding weight ratio in this solution, spray drying generating medicine granule, can get powder spray 2 under the standard operation state.Obtain its pulmonary deposition efficient under in-vitro simulated pulmonary deposition standard operation, represent with the microparticle ratio, as table 2.
The composition of table 2 powder spray 2 Chinese medicine granules and microparticle ratio
Embodiment 3
Pharmacological active substance in table 3 is dissolved in water, then adds as required the adjuvant of corresponding weight ratio, spray drying generating medicine granule under the standard operation state; Spray-dried or other the known method (as ball milling, jet powder, atomizing freeze drying) of pulullan granule acquisition.Drug particles and pulullan granule are obtained the combination drug granule by certain weight ratio mechanical mixture, can get powder spray 3.The detection method of application standard is measured its pulmonary deposition efficient, represents with the microparticle ratio, as table 3.
The composition of table 3 powder spray 3 Chinese medicine granules and microparticle ratio
Embodiment 4
With the pharmacological active substance in table 4 through known method (as ball milling, jet powder, atomizing freeze drying, supercritical pelletize) acquisition; the pulullan granule that drug particles and pulullan spray-dried granules or other known methods (as ball milling, jet powder, atomizing freeze drying) are obtained obtains the combination drug granule by certain weight ratio mechanical mixture, can get powder spray 4.The detection method of application standard is measured its pulmonary deposition efficient, represents with the microparticle ratio, as table 4.
The composition of table 4 powder spray 4 Chinese medicine granules and microparticle ratio
The above is only the preferred embodiment of the present invention; should be pointed out that for those skilled in the art, under the prerequisite that does not break away from the technology of the present invention principle; can also make some improvements and modifications, these improvements and modifications also should be considered as protection scope of the present invention.
Claims (11)
1. pulullan is as the application of the carrier of medicine inhalant.
2. application according to claim 1 is characterized in that: described medicine is selected from one or more in chemicals, biomolecule medicine, genomic medicine.
3. application according to claim 2 is characterized in that:
Described chemicals contains albuterol, fumaric acid FF, budesonide, ciclesonide, not for one or more in Kazon, salmaterol, ipratropium bromide, terbutaline, beclometasone, nitroglycerin;
Described biomolecule medicine contains one or more in insulin, alkali phosphatase, adenosine deaminase, Radix Asparagi amidase, recombinant human somatropin, salmon calcitonin see calcimar, parathyroid hormone, interleukin, octreotide acetate, Lanreotide, triptorelin, urokinase, streptokinase, oxytocin, alpha-interferon, leuprorelin, Measles Vaccine, influenza vaccines, bacillus calmette-guerin vaccine, Hepatitis B virus vaccine, white hundred broken triple vaccinies;
Described genomic medicine is functioning gene and/or gene outcome, contains gene segment and/or micromolecule nucleic acid.
4. an inhalant, is characterized in that: contain pharmacological active substance and pulullan.
5. inhalant according to claim 4, is characterized in that: also contain adjuvant.
6. inhalant according to claim 4, is characterized in that: contain the pharmacological active substance of 0.1～30 weight portion, the pulullan of 0.5～40 weight portion and the adjuvant of 0～40 weight portion.
7. according to claim 5 or 6 described inhalant is characterized in that:
Described pharmacological active substance is selected from one or more in chemicals, biomolecule medicine, genomic medicine;
Described chemicals contains albuterol, fumaric acid FF, budesonide, ciclesonide, not for one or more in Kazon, salmaterol, ipratropium bromide, terbutaline, beclometasone, nitroglycerin;
Described biomolecule medicine contains one or more in insulin, alkali phosphatase, adenosine deaminase, Radix Asparagi amidase, recombinant human somatropin, salmon calcitonin see calcimar, parathyroid hormone, interleukin, octreotide acetate, Lanreotide, triptorelin, urokinase, streptokinase, oxytocin, alpha-interferon, leuprorelin, Measles Vaccine, influenza vaccines, bacillus calmette-guerin vaccine, Hepatitis B virus vaccine, white hundred broken triple vaccinies;
Described genomic medicine is functioning gene and/or gene outcome, contains gene segment and/or micromolecule nucleic acid;
Described adjuvant contains one or more in aminoacid, monosaccharide, disaccharide, oligosaccharide, polysaccharide.
8. the preparation method of an inhalant, is characterized in that: will contain raw material mixing, the spray drying of pharmacological active substance and pulullan, and obtain the combination drug granule.
9. the preparation method of an inhalant; it is characterized in that: the raw material that will contain pharmacological active substance mixes spray-dried or other known method acquisition drug particles again; and then the pulullan granule mechanical mixture that obtains with pulullan spray-dried granules or other known method, obtain the combination drug granule.
10. the preparation method of according to claim 8 or 9 described inhalant, it is characterized in that: described raw material also contains adjuvant.
11. the preparation method of an inhalant is characterized in that:
Raw materials by weight, with the first mix homogeneously of raw material, then spray drying, last packing;
Described raw material contains the pharmacological active substance of 0.1～30 weight portion, the pulullan of 0.5～40 weight portion and the adjuvant of 0～40 weight portion;
Described pharmacological active substance is selected from one or more in chemicals, biomolecule medicine, genomic medicine;
Described chemicals contains albuterol, fumaric acid FF, budesonide, ciclesonide, not for one or more in Kazon, salmaterol, ipratropium bromide, terbutaline, beclometasone, nitroglycerin;
Described biomolecule medicine contains one or more in insulin, alkali phosphatase, adenosine deaminase, Radix Asparagi amidase, recombinant human somatropin, salmon calcitonin see calcimar, parathyroid hormone, interleukin, octreotide acetate, Lanreotide, triptorelin, urokinase, streptokinase, oxytocin, alpha-interferon, leuprorelin, Measles Vaccine, influenza vaccines, bacillus calmette-guerin vaccine, Hepatitis B virus vaccine, white hundred broken triple vaccinies;
Described genomic medicine is functioning gene and/or gene outcome, contains gene segment and/or micromolecule nucleic acid;
Described adjuvant contains one or more in aminoacid, monosaccharide, disaccharide, oligosaccharide, polysaccharide.
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Cited By (9)
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| CN105451716A (en) * | 2013-07-18 | 2016-03-30 | 曼金德公司 | Heat-stable dry powder pharmaceutical compositions and methods |
| CN105616390A (en) * | 2016-03-24 | 2016-06-01 | 李浩莹 | Application of pullulan polysaccharide and derivative thereof to preparation of slow and controlled release drug particle |
| CN106727448A (en) * | 2016-12-12 | 2017-05-31 | 广州中大南沙科技创新产业园有限公司 | Octreotide acetate dry powder inhaler formulations and preparation method thereof |
| US10046031B2 (en) | 2008-08-11 | 2018-08-14 | Mannkind Corporation | Use of ultrarapid acting insulin |
| US10130685B2 (en) | 2004-08-23 | 2018-11-20 | Mannkind Corporation | Diketopiperazine salts for drug delivery and related methods |
| US10143655B2 (en) | 2005-09-14 | 2018-12-04 | Mannkind Corporation | Method of drug formulation |
| US10258664B2 (en) | 2011-10-24 | 2019-04-16 | Mannkind Corporation | Methods and compositions for treating pain |
| US10307464B2 (en) | 2014-03-28 | 2019-06-04 | Mannkind Corporation | Use of ultrarapid acting insulin |
| US10806770B2 (en) | 2014-10-31 | 2020-10-20 | Monash University | Powder formulation |
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Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10130685B2 (en) | 2004-08-23 | 2018-11-20 | Mannkind Corporation | Diketopiperazine salts for drug delivery and related methods |
| US10143655B2 (en) | 2005-09-14 | 2018-12-04 | Mannkind Corporation | Method of drug formulation |
| US10046031B2 (en) | 2008-08-11 | 2018-08-14 | Mannkind Corporation | Use of ultrarapid acting insulin |
| US10258664B2 (en) | 2011-10-24 | 2019-04-16 | Mannkind Corporation | Methods and compositions for treating pain |
| CN105451716A (en) * | 2013-07-18 | 2016-03-30 | 曼金德公司 | Heat-stable dry powder pharmaceutical compositions and methods |
| US10307464B2 (en) | 2014-03-28 | 2019-06-04 | Mannkind Corporation | Use of ultrarapid acting insulin |
| US10806770B2 (en) | 2014-10-31 | 2020-10-20 | Monash University | Powder formulation |
| CN105616390A (en) * | 2016-03-24 | 2016-06-01 | 李浩莹 | Application of pullulan polysaccharide and derivative thereof to preparation of slow and controlled release drug particle |
| CN105616390B (en) * | 2016-03-24 | 2019-07-23 | 李浩莹 | The application of pulullan polysaccharide and derivative in preparation slow release drug granule |
| CN106727448A (en) * | 2016-12-12 | 2017-05-31 | 广州中大南沙科技创新产业园有限公司 | Octreotide acetate dry powder inhaler formulations and preparation method thereof |
| CN106727448B (en) * | 2016-12-12 | 2020-10-13 | 广州中大南沙科技创新产业园有限公司 | Octreotide acetate dry powder inhalation preparation and preparation method thereof |
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Application publication date: 20130522 |