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CN1698584A - Nose nebulizing gelling agent containing active component - Google Patents

Nose nebulizing gelling agent containing active component Download PDF

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Publication number
CN1698584A
CN1698584A CN 200510043402 CN200510043402A CN1698584A CN 1698584 A CN1698584 A CN 1698584A CN 200510043402 CN200510043402 CN 200510043402 CN 200510043402 A CN200510043402 A CN 200510043402A CN 1698584 A CN1698584 A CN 1698584A
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China
Prior art keywords
agent
nose
nebulizing
gelling agent
active component
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Pending
Application number
CN 200510043402
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Chinese (zh)
Inventor
于云涛
李铁军
郭文娟
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JINGWEI PHARMACEUTICAL CO Ltd SHANDONG
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JINGWEI PHARMACEUTICAL CO Ltd SHANDONG
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Priority to CN 200510043402 priority Critical patent/CN1698584A/en
Publication of CN1698584A publication Critical patent/CN1698584A/en
Pending legal-status Critical Current

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Abstract

The invention discloses a nose nebulizing gelling agent containing active component, which comprises principal medicines and medicinal supplementary materials, wherein the principal medicines include at least one of glucocorticoid, antihistamine and allergic reaction medium retardant or their mixture, and medicinal supplementary materials comprises moistening agent and / or anti-oxidant agent and / or glue-forming agent and / or preservative agent and / or solvent and / or pH modifier and one of the dosage forms dressed in various nasal administered medicines such as solvent, suspending agent, drop, spray and gelling agent, and the gelling agent is the first choice for patients.

Description

The nose nebulizing gelling agent that contains active component
Technical field:
The invention belongs to treatment rhinitis drug world, relate to the pharmaceutical composition and the manufacture method thereof of nose administration.
Background technology:
Allergic rhinitis is allergic rhinitis again, is the local symptom of systemic anaphylaxis at nasal membrane, and its cause of disease is that the cold wind in the environment is attacked, dust, pollen, animal wool, food (as fish, shrimp) and medicine etc. are all multifactor.Because of the time that contact allergy is former different with patient's body reaction, be divided into catarrhus perennialis and seasonal allergic rhinitis clinically.Susceptible disease in general winter takes place in time, often with other anaphylactic diseases of whole body and deposit.The latter then betides anaphylactogen season, as spring, autumn in the time of polliniferous, so claim " pollen rhinitis " again.Disease time is a few hours, a couple of days, and its symptom is the continuous sneeze of paroxysmal, the daystart of being everlasting aggravation, intranasal is itched, but whole body seldom has symptom: in sneeze simultaneously with symptoms such as nasal mucus are continuous.Allergic rhinitis is general relevant with allergic constitution, is a kind of common frdquently encountered disease.Show that according to epidemiological survey Asia allergic rhinitis sickness rate is higher, about 30% this disease of trouble of being grown up.
Aerosol is most commonly used to pulmonary's inhalation and body surface topical administration, is known by people already.But because aerosol contains propellant, can cause environmental pollution, and aerosol will use pressure vessel, production technology is than the spray complexity, in nasal-cavity administration, use at present not as spray general.
Spray is not contain propellant, only the power that produces by compressed air by atomising device makes a kind of dosage form of medical liquid atomizing and ejection, because it does not contain propellant, does not use pressure vessel, use more and more widely the domestic existing special manufacturer that produces this sprayer unit at present.Its advantage is that the droplet of ejection is thinner, be evenly distributed at nasal cavity, be difficult for run off, absorb fast, bioavailability is high.
Gel is to add water-soluble fluidity high molecular polymer to increase solution viscosity in the solution of medicine, and reaching increases medicine in the retention time of nasal cavity, the purpose of raising bioavailability.Gel nasal drop granularity is little and even, good dispersion, and room temperature storage is stable, is effective to the treatment of diseases such as allergic rhinitis.
Nasal spray is compared with nasal drop, has easy to use, advantages such as dosage accurate, good effect, the relative minimizing of side effect.But nasal spray is if the purified aqueous adjuvant, and good fluidity easily flows out, and pollution clothes, and drug treating time easily and actuating quantity are all not fully up to expectations.
Original nose nebulizing gelling agent breathability is poor, and zest is strong, and action effect is not fully up to expectations.
Summary of the invention:
In order to overcome the deficiency that original nasal gel exists, the inventor has carried out basic improvement to the accessory formula of existing nasal gel, increased the use of inclusion agents, it is that it is to the toxicity of nasal mucosa cilium and the short absorption problem of macromolecular drug that nasal-cavity administration is deposited big greatest problem, how to alleviate or eliminate the cilium toxicity of medicine and additives thereof, discovery and selection low toxicity absorption enhancer efficiently are our vital tasks.Now developed a kind of stable novel nose nebulizing gelling agent of dosage form that contains active component.
The nose nebulizing gelling agent that contains active component of the present invention is a kind of pharmaceutical composition of nose administration, it comprises principal agent and pharmaceutic adjuvant, its principal agent comprises glucocorticoid, antihistaminic class, at least a in the class medicines such as anaphylaxis medium blocker or their mixture; Pharmaceutic adjuvant comprises: wetting agent and/or antioxidant and/or gelatinizing agent and/or antiseptic and/or solvent and/or pH regulator agent and a kind of inclusion agents: beta-schardinger dextrin-.
Glucocorticoid in the above-mentioned principal agent is selected from beclometasone, flunisolide, fluticasone, mometasone, budesonide etc., its pharmaceutically receivable salt and their mixture.
Above-mentioned principal agent is selected from the antihistaminic class
Above-mentioned principal agent is selected from anaphylaxis medium blocker
Wetting agent in the above-mentioned pharmaceutic adjuvant is glycerol, sorbitol, propylene glycol, tween 80, Polyethylene Glycol or its mixture:
Gelatinizing agent is xanthan gum, microcrystalline Cellulose, sodium carboxymethyl cellulose, chitosan, hydroxypropyl cellulose, hydroxy methocel, hydroxypropyl emthylcellulose, carboxymethyl cellulose, hydroxyethyl-cellulose, hydroxyl polyvinyl, Ka Bomo etc., or their pharmaceutical salts, also can use the mixture of this class gelatinizing agent.
Antioxidant is sodium sulfite, vitamins
Inclusion agents is a beta-schardinger dextrin-
Antiseptic is p-hydroxybenzoic acid esters, phenethyl alcohol, thiomersalate, chlorobutanol, phenylmercuric acetate or Benzalkonii Chloridum.
The pH value regulator is an acid regulator: as potassium dihydrogen phosphate, and sodium dihydrogen phosphate, hydrochloric acid, phosphoric acid, sulphuric acid
Alkaline conditioner: as sodium hydroxide, sodium carbonate, sodium bicarbonate
Solvent is a water
The weight % scope of above-mentioned principal agent consumption is: 0.01-5%
The weight % scope of above-mentioned pharmaceutic adjuvant consumption is: wetting agent 0-40%, antioxidant 0-0.1%, inclusion agents 1-5%, gelatinizing agent 0-5%, antiseptic 0-1%, solvent 40-90%, pH regulator agent: acid regulator 0-5%, alkaline conditioner 0-5%.
The present invention also provides the preparation method of above-mentioned nose nebulizing gelling agent, and this method may further comprise the steps:
(1) processing of container: washed container, standby.
(2) according to each the amounts of components requirement of nose nebulizing gelling agent pharmaceutical composition, measure acidic ph modifier, and alkaline conditioner, add water to full dose and be mixed with buffer.
(3) require to take by weighing respectively principal agent, wetting agent, gelatinizing agent, antioxidant, inclusion agents, antiseptic according to each amounts of components of nose nebulizing gelling agent pharmaceutical composition.
(4) get the buffer of half amount, add the principal agent that is taken by weighing, stir and make dissolving, as first liquid; Other gets remaining buffer, adds the wetting agent, gelatinizing agent, antioxidant, inclusion agents, the antiseptic that are taken by weighing, stirs and makes dissolving, as second liquid; Under the stirring second liquid slowly being added in the first liquid fast, stir, promptly cause required nose nebulizing gelling agent.
(5) carry out assay.
(6) packing
In the dosage form such as solution, suspending agent, drop, spray and gel of various nose administrations, gel is patient's first-selection.Gel and skin coupling effect are excellent, can absorptive tissue transudate, be beneficial to the eliminating of secretions, it is comfortable to be applied to the skin aftersensation, no greasy feeling, not pollution clothes, and stretchability is good, is easy to clean, Transdermal absorption is faster, and bioavailability is higher, can fully guarantee patient's compliance.And guaranteed its action time to human body.Particularly the inventor has increased beta-schardinger dextrin-newly on traditional prescription, plays the effect of enclose principal agent, has increased the stability of dosage form, has reduced zest.Used buffer salt solution, principal agent and adjuvant can fully be dissolved, also reduced stimulation simultaneously skin.The long-term pH that keeps is stable, preparation stabilization.
The inventor has carried out about the use compliance of nose spray gel and nasal spray and the investigation of effect.The result is as follows:
Group ＜65 years old
Spray (100 example) Gel (100 example)
Adhere to patient's number of using
Patient's number Comply with rate % Patient's number Comply with rate %
30 days 100 ?100 100 ?100
60 days 72 ?72 91 ?91
90 days 51 ?51 80 ?80
Effective patient: by 90 days observation
Patient's number (51 example) Effective percentage % Patient's number (80 example) Effective percentage %
Invalid 0 ?100％ 0 ?0
Alleviate 49 ?49 21 ?21
Produce effects 2 ?2 59 ?59
Use the patient of novel nose spray gel, the patient compliance leads obvious patient compliance than the common nasal spray of use and leads height, and obvious effective rate is than using common nasal spray height.
The specific embodiment:
Now the concrete composition component consumption screening and assessment example that contains the nose nebulizing gelling agent of active component in conjunction with the present invention further specifies the specific embodiment of the present invention.
Contain anaphylaxis medium blocker, as: the composition and the quality evaluation of each prescription of the nose spray gel of sodium cromoglicate
The supplementary material title Prescription 1 Prescription 2 Prescription 3 Prescription 4
Sodium cromoglicate (g) 1 ?1 ?1 ?1
Sodium sulfite (g) / ?/ ?0.025 ?0.025
Cyclodextrin / ?0.25 ?0.25 ?0.25
Glycerol (g) 0.75 ?0.75 ?0.75 ?0.75
Sodium carboxymethyl cellulose (g) 0.25 ?0.25 ?0.25 ?0.25
Potassium dihydrogen phosphate (g) / ?/ ?/ ?0.34
0.1% sodium hydroxide (ml) / ?/ ?/ ?7.6
Benzalkonii Chloridum (mg) 5 ?5 ?5 ?5
Add purified water extremely 50ml ?50ml ?50ml ?50ml
Stable There is small amount of crystalline to separate out The flavescence color Ph reduces Very
Each prescription analysis
Sodium cromoglicate is because self chemical property, and purification of aqueous solutions is unstable under acidic condition, is index screening with the stability of solution when the prescription design therefore, from the screening situation
Sodium cromoglicate can dissolve fully in the prescription 1, and placement a period of time has crystallization to separate out, and abandons
Prescription 2 adds beta-schardinger dextrin-on the basis of prescription 1, beta-schardinger dextrin-and sodium cromoglicate form clathrate to increase stability of drug
Prescription 3 adds sodium sulfite on the basis of prescription 2, placed 5 days, has good stability, and no crystallization is separated out, but the solution becomes yellow is abandoned
Prescription 4 considers that sodium cromoglicate is unstable under acidic condition on the basis of prescription 3, make the PH of principal agent be stabilized in 5.0-7.0 with phosphate buffered solution (pH=6.5), under 40 ℃ ± 2 conditions, placed 10 days, have good stability, PH is little to changing, and illustrates that this prescription is good
Through relatively comprehensive, the final prescription 4 of selecting, sodium sulfite can prevent the sodium cromoglicate oxidation Decomposition in the prescription 4: beta-schardinger dextrin-and sodium cromoglicate form clathrate and increase stability of drug, play the Nasal Mucosa Absorption facilitation simultaneously: glycerol, sodium carboxymethyl cellulose itself have the bioadhesion activity, can increase the holdup time of medicine at nasal cavity, the prolong drug curative effect: phosphate buffer (PH=6.5) is made the purified water sodium cromoglicate and remained on pH value 5.0-7.0: Benzalkonii Chloridum is as antiseptic.
Contain the composition and the quality evaluation of each prescription of nose spray gel of glucocorticoids
The supplementary material title Prescription 1 Prescription 2 Prescription 3 Prescription 4
Beclometasone (mg) 50 ??50 ?50 ?50
Ethanol 2 ??2 ?/ ?/
Beta-schardinger dextrin- / ??0.5 ?0.5 ?0.75
Glycerol (g) 0.75 ??0.75 ?0.75 ?0.75
Sodium carboxymethyl cellulose (g) / ??/ ?0.5 ?0.75
Tween 80 (ml) 1 ??1.5 ?1.5 ?1.5
Benzalkonii Chloridum (mg) 10 ??10 ?10 ?10
Add purified water extremely 50ml ??50ml ?50ml ?50ml
The settling volume ratio 0.78 ??0.80 ?0.84 ?0.92
Each prescription analysis
The beclometasone glucocoricoid is insoluble to purified water, at prescription with serve as main investigation index during technological design, screens with suspension stability, from the screening situation:
Settling volume is than assay method: according to " 10 following methods of two appendix of Chinese Pharmacopoeia 〉=2000 year version are measured, and the settling volume ratio should be not less than 0.90.
Method of inspection: apparatus plug graduated cylinder is contained this product 50ml, close plug, and firmly jolting is 1 minute, writes down the beginning height H of suspended matter o, static 3 hours, write down the suspended matter height H, be calculated as follows: settling volume ratio=H/H o
In the prescription 1 is purified water with ethanol, and beclometasone can dissolve fully, adds 1% tween 80, increases stability of drug with surfactant, adds Benzalkonii Chloridum, adds purified water to full dose, and settling volume is abandoned than 0.78.
In conjunction with the beclometasone physicochemical property, make its dissolving with ethanol in the prescription 2, strengthen the tween 80 consumption, add cyclodextrin, to increase its dissolubility, add Benzalkonii Chloridum, add purified water to full dose, settling volume is abandoned than 0.80.
Prescription 3 is abandoned ethanol on the basis of prescription 2, add sodium carboxymethyl cellulose, and suspension stability better adds Benzalkonii Chloridum, adds purified water to full dose, and the settling volume ratio is 0.84, abandons.
Prescription 4 is on the basis of prescription 3, strengthens beta-schardinger dextrin-, and the consumption of sodium carboxymethyl cellulose adds Benzalkonii Chloridum, adds purified water to full dose, and the settling volume ratio is 0.92, and this prescription is better.
Through party comprehensive relatively, the final prescription 4 of selecting, beta-schardinger dextrin-plays the Nasal Mucosa Absorption facilitation in the prescription 4: tween 80 plays the surface activity effect, and increase the stability of medicine suspendible: sodium carboxymethyl cellulose is a gel-type vehicle, and can play the suspending effect simultaneously: Benzalkonii Chloridum is as antiseptic.The nose spray gel that this prescription is made can reach the clinical application standard that the general rule under Chinese Pharmacopoeia version spray in 2000 item requires and formulated.
The test of cyclodextrin amount ranges: gelatinizing agent, antioxidant, wetting agent, antiseptic, purified water consumption are fixed, and the adjustable ring dextrin dosage is measured the stability of writing out a prescription.
Beta-schardinger dextrin- Prescription 1 Prescription 2 Prescription 3 Prescription 4 Prescription 5
Consumption (g) 0.75 ?1.0 ?2.0 ?2.5 ?3
Ratio (%) 1.5 ?2 ?4 ?5 ?6
The sedimentation rate of suspended matter 0.92 ?0.95 ?0.96 ?0.94 ?0.89
So cyclodextrin amount ranges 1-5%, preferred 2-5%
Embodiment:
Embodiment 1:
Sodium cromoglicate 20g
Glycerol 150g
Sodium sulfite 5.0g
Beta-schardinger dextrin-65g
Sodium carboxymethyl cellulose 65g
Potassium dihydrogen phosphate 88.4g
Benzalkonii Chloridum 20g
0.1% sodium hydroxide 1.0L
Purified water adds to 13000ml
Method:
The processing of 1 container: washed container, standby.
2 take by weighing the recipe quantity potassium dihydrogen phosphate, measure recipe quantity 0.1mol/L sodium hydroxide and add purified water to full dose and be mixed with phosphate buffer.
3 take by weighing sodium cromoglicate, glycerol, sodium carboxymethyl cellulose, sodium sulfite, beta-schardinger dextrin-, Benzalkonii Chloridum by prescription.
4 get the phosphate buffer of 20% recipe quantity, add the sodium cromoglicate of recipe quantity, stir and make dissolving, as first liquid; Other gets the phosphate buffer of 80% recipe quantity, adds glycerol, sodium carboxymethyl cellulose, sodium sulfite, the beta-schardinger dextrin-of recipe quantity, stirs and makes dissolving, as second liquid; Under the stirring second liquid slowly being added in the first liquid fast, stir.
5 intermediate carry out assay.
6 fills.
Embodiment 2:
Budesonide 20g
Glycerol 300g
Sodium sulfite 8.0g
Beta-schardinger dextrin-325g
Sodium carboxymethyl cellulose 325g
Purified water adds to 13000ml
Method:
The processing of 1 container: washed container, standby.
2 sodium carboxymethyl cellulose that take by weighing recipe quantity, Benzalkonii Chloridum add in 90% the purified water of recipe quantity, and stirring and dissolving is standby as first liquid
3 take by weighing budesonide by prescription, and beta-schardinger dextrin-places homogenizer, add tween 80 and all make 30 minutes, standby as second liquid.
4 under the stirring second liquid slowly being added in the first liquid fast, stirs.
5 intermediate carry out assay.
6 fills.
Embodiment 3:
Fluticasone 20g
Chlorphenamine 10g
Glycerol 300g
Sodium sulfite 8.0g
Beta-schardinger dextrin-325g
Sodium carboxymethyl cellulose 325g
Benzalkonii Chloridum 2g
Purified water adds to 13000ml
Method:
The processing of 1 container: washed container, standby.
2 sodium carboxymethyl cellulose that take by weighing recipe quantity, Benzalkonii Chloridum add in 90% the purified water of recipe quantity, and stirring and dissolving is standby as first liquid
3 take by weighing fluticasone by prescription, chlorphenamine, and beta-schardinger dextrin-places homogenizer, adds tween 80 and all makes 30 minutes, and is standby as second liquid.
4 under the stirring second liquid slowly being added in the first liquid fast, stirs.
5 intermediate carry out assay.
6 fills.
Embodiment 4
Beclometasone 20g
Glycerol 200g
Sodium sulfite 8.0g
Beta-schardinger dextrin-400g
Sodium carboxymethyl cellulose 200g
Tween 80 400g
Phenethyl alcohol 2.6g
Purified water adds to 13000ml
Method:
The processing of 1 container: washed container, standby.
2 sodium carboxymethyl cellulose that take by weighing recipe quantity, Benzalkonii Chloridum, sodium sulfitees add in 90% the purified water of recipe quantity, and stirring and dissolving is standby as first liquid
3 take by weighing beclometasone by prescription, and beta-schardinger dextrin-places homogenizer, add tween 80 and all make 30 minutes, standby as second liquid.
4 under the stirring second liquid slowly being added in the first liquid fast, stirs.
5 intermediate carry out assay.
6 fills.
Embodiment 5:
Ketotifen 150g
Glycerol 230g
Sodium sulfite 10.0g
Cyclodextrin 120g
Sodium carboxymethyl cellulose 120g
Benzalkonii Chloridum 5g
Potassium dihydrogen phosphate 210g
0.1mol/l sodium hydroxide 2.0L
Purified water adds to 13000ml
Method:
The processing of 1 container: washed container, standby.
2 take by weighing the recipe quantity potassium dihydrogen phosphate, measure recipe quantity 0.1mol/L sodium hydroxide and add purified water to full dose and be mixed with phosphate buffer.
3 take by weighing ketotifen, glycerol, sodium carboxymethyl cellulose, sodium sulfite, beta-schardinger dextrin-by prescription.
4 get the phosphate buffer of 80% recipe quantity, add the sodium cromoglicate of recipe quantity, stir and make dissolving, as first liquid; Other gets the phosphate buffer of 20% recipe quantity, adds glycerol, sodium carboxymethyl cellulose, sodium sulfite, the beta-schardinger dextrin-of recipe quantity, stirs and makes dissolving, as second liquid; Under the stirring second liquid slowly being added in the first liquid fast, stir.
5 intermediate carry out assay.
6 fills.

Claims (10)

  1. The nose nebulizing gelling agent of active component it comprise principal agent and pharmaceutic adjuvant, it is characterized in that principal agent comprises glucocorticoid, at least a in antihistaminic and the anaphylaxis medium retarder medicaments or their mixture; Pharmaceutic adjuvant comprises wetting agent and/or antioxidant and/or gelatinizing agent and/or antiseptic and/or solvent and/or pH regulator agent and a kind of inclusion agents.
  2. 2. the nose nebulizing gelling agent that contains active component as claimed in claim 1, it is characterized in that the glucocorticoid in the said principal agent is selected from beclometasone, flunisolide, fluticasone, mometasone, budesonide, its pharmaceutically receivable salt and their mixture;
    Or said principal agent is selected from anaphylaxis medium blocker or said principal agent is selected from antihistaminic.
  3. 3. the nose nebulizing gelling agent that contains active component as claimed in claim 1 is characterized in that the wetting agent in the said pharmaceutic adjuvant is glycerol, sorbitol, propylene glycol, tween 80, Polyethylene Glycol or its mixture; Gelatinizing agent is xanthan gum, microcrystalline Cellulose, sodium carboxymethyl cellulose, chitosan, hydroxypropyl cellulose, hydroxy methocel, hydroxypropyl emthylcellulose, carboxymethyl cellulose, hydroxyethyl-cellulose, hydroxyl polyvinyl, Ka Bomo etc., or their pharmaceutical salts, also can use the mixture of this class gelatinizing agent; Antioxidant is sodium sulfite, vitamins; Antiseptic is p-hydroxybenzoic acid esters, phenethyl alcohol, thiomersalate, chlorobutanol, phenylmercuric acetate or Benzalkonii Chloridum; The pH value regulator is an acid regulator: as potassium dihydrogen phosphate, and sodium dihydrogen phosphate, hydrochloric acid, phosphoric acid, sulphuric acid; Alkaline conditioner: as sodium hydroxide, sodium carbonate, sodium bicarbonate; Solvent is a water.
  4. 4. the nose nebulizing gelling agent that contains active component as claimed in claim 1 is characterized in that the weight % scope of said principal agent consumption is: 0.01-5%
    The weight % scope of pharmaceutic adjuvant consumption is: wetting agent 0-40%, antioxidant 0-0.1%, inclusion agents 1-5%, gelatinizing agent 0-5%, antiseptic 0-1%, solvent 40-90%, pH regulator agent: acid regulator 0-5%, alkaline conditioner 0-5%.
  5. 5. as claim 1 or the 3 described nose nebulizing gelling agents that contain active component, it is characterized in that the weight % scope of the consumption of said inclusion agents beta-schardinger dextrin-is preferably 2-5%.
  6. 6. the nose nebulizing gelling agent that contains active component as claimed in claim 1 is characterized in that the component of said nose nebulizing gelling agent pharmaceutical composition and the weight % of consumption are:
    1.3 parts-650 parts of sodium cromoglicate
    Glycerol 0-2600 part
    Sodium sulfite 0-13 part
    Beta-schardinger dextrin-130-650 part
    Sodium carboxymethyl cellulose 0-650 part
    Potassium dihydrogen phosphate 0-650 part
    Benzalkonii Chloridum 0-130 part
    Sodium hydroxide 0-650 part
    Purified water adds to 13000 parts.
  7. 7, the nose nebulizing gelling agent that contains active component as claimed in claim 1 is characterized in that the component of said nose nebulizing gelling agent pharmaceutical composition and the weight % of consumption are:
    Budesonide 1.3-650 part
    Glycerol 0-2600 part
    Sodium sulfite 0-13 part
    Beta-schardinger dextrin-130-650 part
    Sodium carboxymethyl cellulose 0-650 part
    Purified water adds to 13000 parts.
  8. 8. the nose nebulizing gelling agent that contains active component as claimed in claim 1 is characterized in that the component of said nose nebulizing gelling agent pharmaceutical composition and the weight % of consumption are:
    Fluticasone 0.65-325 part
    Chlorphenamine 0.65-325 part
    Glycerol 0-2600 part
    Sodium sulfite 0-13 part
    Beta-schardinger dextrin-130-650 part
    Sodium carboxymethyl cellulose 0-650 part
    Benzalkonii Chloridum 0-130 part
    Purified water adds to 13000 parts.
  9. 9. the nose nebulizing gelling agent that contains active component as claimed in claim 1 is characterized in that the component of said nose nebulizing gelling agent pharmaceutical composition and the weight % of consumption are:
    Beclometasone 1.3-650 part
    Glycerol 0-1300 part
    Sodium sulfite 0-13 part
    Beta-schardinger dextrin-130-650 part
    Sodium carboxymethyl cellulose 0-650 part
    Tween 80 0-1300 part
    Phenethyl alcohol 0-130 part
    Purified water adds to 13000ml.
  10. 10. the preparation method that contains the nose nebulizing gelling agent of active component as claimed in claim 1 is characterized in that this method may further comprise the steps:
    (1) processing of container: washed container, standby;
    (2) according to each the amounts of components requirement of nose nebulizing gelling agent pharmaceutical composition, measure acidic ph modifier, and alkaline conditioner, add water to full dose and be mixed with buffer;
    (3) require to take by weighing respectively principal agent, wetting agent, gelatinizing agent, antioxidant, inclusion agents, antiseptic according to each amounts of components of nose nebulizing gelling agent pharmaceutical composition;
    (4) get the buffer of half amount, add the principal agent that is taken by weighing, stir and make dissolving, as first liquid; Other gets remaining buffer, adds the wetting agent, gelatinizing agent, antioxidant, inclusion agents, the antiseptic that are taken by weighing, stirs and makes dissolving, as second liquid; Under the stirring second liquid slowly being added in the first liquid fast, stir, promptly make required nose nebulizing gelling agent;
    (5) carry out assay;
    (6) packing.
CN 200510043402 2005-04-30 2005-04-30 Nose nebulizing gelling agent containing active component Pending CN1698584A (en)

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Publication Number Publication Date
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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008120795A (en) * 2006-10-18 2008-05-29 Taisho Pharmaceutical Co Ltd Mucosal fluid
AU2018325461B2 (en) * 2017-09-02 2020-06-11 Iview Therapeutics, Inc. In situ gel-forming pharmaceutical compositions and uses thereof for sinus diseases
CN114191417A (en) * 2021-12-17 2022-03-18 上海清芮科技有限公司 Atomizing inhalant for pets
CN114306237A (en) * 2022-01-06 2022-04-12 江苏爱朋医疗科技股份有限公司 Nasal cavity nursing spray and preparation method and application thereof
US20220257642A1 (en) * 2019-06-04 2022-08-18 Thirty Respiratory Limited Methods and compositions for generating nitric oxide and uses thereof to deliver nitric oxide via the respiratory tract
WO2023193075A1 (en) * 2022-04-08 2023-10-12 Eurofarma Laboratórios S.A. Bioadhesive nasal spray composition, preparation method and use
CN118415982A (en) * 2024-04-15 2024-08-02 山东京卫制药有限公司 2- (4-Methylthiazol-5-yl) ethyl nitrate hydrochloride nasal spray and preparation method thereof
IT202300021669A1 (en) * 2023-10-18 2025-04-18 Farmalabor S R L "PHARMACEUTICAL VEHICLE AND PHARMACEUTICAL COMPOSITION COMPRISING THE SAME"

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008120795A (en) * 2006-10-18 2008-05-29 Taisho Pharmaceutical Co Ltd Mucosal fluid
AU2018325461B2 (en) * 2017-09-02 2020-06-11 Iview Therapeutics, Inc. In situ gel-forming pharmaceutical compositions and uses thereof for sinus diseases
US11547659B2 (en) 2017-09-02 2023-01-10 Iview Therapeutics, Inc. In situ gel-forming pharmaceutical compositions and uses thereof for sinus diseases
US20220257642A1 (en) * 2019-06-04 2022-08-18 Thirty Respiratory Limited Methods and compositions for generating nitric oxide and uses thereof to deliver nitric oxide via the respiratory tract
CN114191417A (en) * 2021-12-17 2022-03-18 上海清芮科技有限公司 Atomizing inhalant for pets
CN114306237A (en) * 2022-01-06 2022-04-12 江苏爱朋医疗科技股份有限公司 Nasal cavity nursing spray and preparation method and application thereof
WO2023193075A1 (en) * 2022-04-08 2023-10-12 Eurofarma Laboratórios S.A. Bioadhesive nasal spray composition, preparation method and use
IT202300021669A1 (en) * 2023-10-18 2025-04-18 Farmalabor S R L "PHARMACEUTICAL VEHICLE AND PHARMACEUTICAL COMPOSITION COMPRISING THE SAME"
WO2025083738A1 (en) * 2023-10-18 2025-04-24 Università Degli Studi Di Bari "Aldo Moro" Pharmaceutical carrier and pharmaceutical composition comprising the same
CN118415982A (en) * 2024-04-15 2024-08-02 山东京卫制药有限公司 2- (4-Methylthiazol-5-yl) ethyl nitrate hydrochloride nasal spray and preparation method thereof

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