CN103751189A - Pharmaceutical composition for treating rhinitis - Google Patents
Pharmaceutical composition for treating rhinitis Download PDFInfo
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- CN103751189A CN103751189A CN201410000039.3A CN201410000039A CN103751189A CN 103751189 A CN103751189 A CN 103751189A CN 201410000039 A CN201410000039 A CN 201410000039A CN 103751189 A CN103751189 A CN 103751189A
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Abstract
The invention provides a pharmaceutical composition for treating rhinitis. The pharmaceutical composition contains sodium cromoglycate, naphazoline hydrochloride and chlorpheniramine maleate. The composite is a spraying agent, active ingredients in the preparation can realize fast onset of action by rapid absorption through nasal mucosa, and the composition has the advantages of high bioavailability, good compliance, convenience in carrying and use and the like.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of rhinitis, belong to field of medicaments.
Background technology
On current market, rhinitis is common frdquently encountered disease, and wherein allergic rhinitis is more common.Allergic rhinitis is again allergic rhinitis, is that systemic anaphylaxis occurs in nasal membrane local symptom, all many factors such as its cause of disease mostly is that cold wind in environment is attacked, dust, pollen, animal wool, food (as fish, shrimp) and medicine.Because of the time that contact allergy is former different from patient's body reaction, be divided into clinically catarrhus perennialis and seasonal allergic rhinitis.The former can occur at any time; Latter betides anaphylactogen season, as spring, polliniferous time in autumn.During seizure of disease, often produce nasal obstruction, rhinorrhea, hyposmia, the symptom such as ambiguous of speaking, these symptoms often can affect normal rest and sleep, hinder people's health and normal work, infant nasal cavity also can affect suckling while stopping up.Treat these nose diseasess, topical treatment is a kind of good route of administration.Nasal cavity topical is rapid-action, effective, can reduce again the side effect that medicine brings to whole body, its objective is that to make nasal cavity unobstructed, is conducive to the drain of the many secretions of intranasal, recovers the normal function of nose.
Sodium cromoglicate is in the anti-allergic drug of exploitation listing in 1969 by Fisons company.It is anaphylaxis medium sustained-release agent, can stablize the cell membrane of mastocyte, stops mast cell degranulation, suppresses the release of the anaphylaxis media such as histamine, 5-hydroxy tryptamine, slow reacting substance, prevents the untoward reaction of anaphylaxis medium to tissue.Anaphylactic type, delayed hypersensitivity are had to good preventive and therapeutic action.Naphcon, is adrenomimetic, has vasoconstrictive effect, can make nasal mucosa vessels shrink, and has hemostasis, alleviates hyperemia, the effect of alleviation nasal obstruction.Chlorphenamine maleate is H1 receptor antagonist.Clinically for various anaphylactic reactions.
In Chinese patent literature 94103562.x, disclosed containing sodium cromoglicate, naphcon and three kinds of active component of chlorphenamine maleate for improving the pharmaceutical composition of allergic rhinitis, and topical formulations is also disclosed as nasal drop.But because excipient used in nasal drop is limit, its therapeutic effect is also not obvious, but also cause the serious side effects such as the inner blood capillary atrophy of nasal cavity.
Therefore, the present invention provides the pharmaceutical preparation of a kind of instant effect and the little treatment rhinitis of side effect on to the improved basis of prior art (Chinese patent literature 94103562.x).
Summary of the invention
One of object of the present invention, provides the especially pharmaceutical preparation of allergic rhinitis of the little treatment rhinitis of a kind of instant effect and side effect.
Spray to be a kind of pressure by manual pump disengage content preparation with the form such as vaporific; Or medicine and suitable propellant are packaged in to the preparation of making in the pressure vessel with special valve system jointly.For a kind of administrated method of Energy and comfort is provided to patient.
One of object of the present invention, provides a kind of especially pharmaceutical composition of allergic rhinitis of rhinitis for the treatment of, and comprises: sodium cromoglicate, naphcon, chlorphenamine maleate and absorption enhancer.
One of object of the present invention, provides a kind of especially nasal spray of allergic rhinitis of rhinitis for the treatment of, and comprises: sodium cromoglicate, naphcon, chlorphenamine maleate and absorption enhancer.
Nasal mist of the present invention; absorption enhancer used is selected from cyclodextrin and derivant thereof, sodium ethylene diamine tetracetate, sodium taurocholate, NaTDC, tween, propylene glycol, polyoxyethylene-5-octyl ether, Polyethylene Glycol (PEG) 12-hydroxy stearic acid ester (Solutol HS-15), caprylate, laurate, but is not limited to this.
In the preferred technical scheme of the present invention, 1000 those quick nasal sprays of Zhi Segan naphthalene first comprise following composition:
In nasal spray of the prior art, conventionally use phosphate buffer can promote the absorption of nasal mucosa to medicine, phosphate buffer is formed and is formed buffer system by sodium dihydrogen phosphate and sodium hydrogen phosphate; Wherein sodium dihydrogen phosphate acidity is stronger, and life-time service is unfavorable for the recovery of nasal membrane, even causes breaking of blood capillary.
Innovative point of the present invention is, only adopts absorption enhancer to prepare spray, and specific absorption enhancer is not only beneficial to drug absorption, and for nasal membrane not damaged.
By experiment, when inventor is surprised to find Polyethylene Glycol (PEG) 12-hydroxy stearic acid ester for technical scheme of the present invention, can also strengthen the active function of " sodium cromoglicate, naphcon, chlorphenamine maleate "; Reduced the side effect of nasal cavity blood capillary atrophy.
In the preferred technical scheme of the present invention, 1000 those quick nasal sprays of Zhi Segan naphthalene first comprise following composition:
In the preferred technical scheme of the present invention, 1000 those quick nasal sprays of Zhi Segan naphthalene first comprise following composition:
PH value is 5.5-6.5.
Spray of the present invention, aims at nasal cavity in use, presses sprayer unit, sucks, and each sprays about 0.5ml, can three times on the one during treatment, and each 1-3 sprays.
The specific embodiment
Following examples are to further illustrate of the present invention, but never limit the scope of the present invention.Below with reference to embodiment, further elaborate the present invention, but it will be appreciated by those skilled in the art that the present invention is not limited to the preparation method of these embodiment and use.And those skilled in the art can be equal to replacement, combination, improvement or modify the present invention according to description of the invention, but these all will comprise within the scope of the invention.
That quick nasal spray of embodiment 1 color Gan Naijia
Prescription: 1000
Preparation technology: get the sodium cromoglicate, naphcon, chlorphenamine maleate, Polyethylene Glycol (PEG) 12-hydroxy stearic acid ester of recipe quantity in appropriate container, add purified water, stir at normal temperatures, after above-mentioned material dissolution, add purified water to full dose, with the microporous filter membrane of 0.22 μ m, filter, that quick solution of Dry Sack Gan Naijia, pH value is 6.4, is sub-packed in qualified spray bottle check, packing keeping away under bacterium condition.
That quick nasal spray of embodiment 2 color Gan Naijia
Prescription: 1000
| Sodium cromoglicate | 150.0g |
| Naphcon | 5g |
| Chlorphenamine maleate | 30g |
| Polyethylene Glycol (PEG) 12-hydroxy stearic acid ester | 100g |
| Purified water | Add to 10000ml |
Preparation technology: get the sodium cromoglicate, naphcon, chlorphenamine maleate, Polyethylene Glycol (PEG) 12-hydroxy stearic acid ester of recipe quantity in appropriate container, add purified water, stir at normal temperatures, after above-mentioned material dissolution, finally add purified water to full dose, with the microporous filter membrane of 0.22 μ m, filter, that quick solution of Dry Sack Gan Naijia, pH value is 5.7, is sub-packed in qualified spray bottle check, packing keeping away under bacterium condition.
That quick nasal spray of embodiment 3 color Gan Naijia
Prescription: 1000
| Sodium cromoglicate | 100.0g |
| Naphcon | 2.5g |
| Chlorphenamine maleate | 25.0g |
| Polyethylene Glycol (PEG) 12-hydroxy stearic acid ester | 55g |
| Purified water | Add to 10000ml |
Preparation technology: get the sodium cromoglicate, naphcon, chlorphenamine maleate, Polyethylene Glycol (PEG) 12-hydroxy stearic acid ester of recipe quantity in appropriate container, add purified water, stir at normal temperatures, after above-mentioned material dissolution, add purified water to full dose, with the microporous filter membrane of 0.22 μ m, filter, that quick solution of Dry Sack Gan Naijia, pH value is 5.6, is sub-packed in qualified spray bottle check, packing keeping away under bacterium condition.
The stability test of embodiment 4 those quick nasal sprays of color Gan Naijia
The present invention has also carried out study on the stability to the most preferred medicinal liquid of the present invention, and result is as follows:
(1) this preparation (embodiment 3) is placed in respectively under 3000 lux illumination, 92.5%RH (25 ℃), the condition of 60 ℃, respectively at sampling in 0,5,10 day, investigate the variation of outward appearance, pH value, clarity of solution and color, related substance and content, result shows that this preparation is stable under these conditions.(2) accelerate experiment, by this preparation (embodiment 1) as for containing in the exsiccator of saturated sodium-chloride water solution, exsiccator is placed in the calorstat of 40 ± 1 ℃, respectively at sampling in 0,1,2,3,4,6 month, observe outward appearance, pH value, clarity of solution and color, measure related substance and content.Result shows, this preparation is under 40 ℃, the condition of relative humidity 75%, through 6 months, basically identical with the analysis result of batch sample before the outward appearance of preparation, pH value, related substances and assay and experiment, and this preparation stabilization is described.(3) room temperature keeps sample, this preparation is protected to (embodiment 2) and be stored in after room temperature placement a period of time, the analytical data contrast of the same batch sample before sampling and experiment, result shows, this preparation keeps sample 18 months in greenhouse, and its outward appearance, pH value, related substances and assay result are basically identical.Above-mentioned experimental result shows that this preparation stability is good.
The pharmacodynamics test of embodiment 5 those quick nasal sprays of color Gan Naijia
Screen Allergic Rhinitis 40 examples that meet allergic rhinitis diagnostic criteria, be pressed into successively random assortment of group to test group or positive controls, wherein test group 20 examples, positive controls 20 examples, test group completes 19 examples, and matched group completes 18 examples.The test group application embodiment of the present invention 3 preparations are given and treatment, and concrete grammar is: sooner or later respectively once, each 2 sprays of every side nasal cavity, be one week the course for the treatment of.Matched group adopts the spray treatment that in Chinese patent literature 94103562.x, embodiment 1 composition is made, and concrete grammar is sooner or later respectively once, each 2 sprays of every side nasal cavity, and be one week the course for the treatment of.According to China's allergic rhinitis standards of grading, finish rear experimenter to be carried out to S&S score with treatment before respectively at treatment.Score standard is as follows: symptom point system is in Table 1.Table 1
| Classification is scored | Sneeze * | Watery nasal discharge △ | Nasal obstruction | Rhinocnesmus |
| 1 point | 3-5 | ≤4 | Sensation when air-breathing consciously | Be interrupted |
| 2 points | 6-10 | 5-9 | Intermittence or interactivity | The sense of ant row, but can stand |
| 3 points | ≥11 | ≥10 | Almost whole day mouth breathing | The sense of ant row, unbearably |
Note: * 1 continuous sneeze number; △ blowing the nose every day number of times
Sign score standard: at the bottom of concha nasalis inferior and nose, nasal septum near, can not see concha nasalis or middle nasal concha mucosa Polypoid changes, polyp formation, be recorded as 3 points; Concha nasalis inferior and nasal septum (or at the bottom of nose) near, at the bottom of concha nasalis inferior and nose, between (or nasal septum), still have small gap, be recorded as 2 points; Concha nasalis mild swelling, nasal septum, middle nasal concha are still visible, are recorded as 1 point
After calculating as follows medication, comprehensive therapeutic effect improves percentage rate (the rear total score of total score-treatment before treatment)/curative effect of total score × 100% evaluation persistence allergic rhinitis before treating.Result: the recent effective percentage of test group and matched group is respectively 95.6%, 73.5%, and treatment group curative effect is better than matched group.The present invention can significantly improve the symptoms such as the nasal obstruction, sneeze, rhinocnesmus of allergic rhinitis, and allergic rhinitis are had to good efficacy.Meanwhile, after drug withdrawal 1 week and 1 month, test group had not been found the symptom of nasal cavity blood capillary atrophy; And matched group has 2 examples after 1 week, within 1 month, there is the symptom of 15 routine nasal cavity blood capillary atrophys afterwards.
Claims (5)
1. treat a pharmaceutical composition for rhinitis, it is characterized in that comprising: sodium cromoglicate, naphcon, chlorphenamine maleate.
2. according to the pharmaceutical composition of the treatment rhinitis of claim 1, it is characterized in that being preferably spray.
3. according to the spray of claim 2, it is characterized in that 1000 sprays comprise following composition:
。
4. according to the spray of claim 2, it is characterized in that described absorption enhancer is selected from Polyethylene Glycol (PEG) 12-hydroxy stearic acid ester.
5. the application in preparation treatment of allergic rhinitis according to the spray of claim 2 or 4.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410000039.3A CN103751189B (en) | 2014-01-01 | 2014-01-01 | A kind of pharmaceutical composition for the treatment of rhinitis |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410000039.3A CN103751189B (en) | 2014-01-01 | 2014-01-01 | A kind of pharmaceutical composition for the treatment of rhinitis |
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| CN103751189A true CN103751189A (en) | 2014-04-30 |
| CN103751189B CN103751189B (en) | 2016-02-03 |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1104498A (en) * | 1993-04-01 | 1995-07-05 | 藤泽药品工业株式会社 | A topical dosage form |
| CN101347436A (en) * | 2007-07-20 | 2009-01-21 | 天津药业集团有限公司 | Uses of methylprednisolone and derivatives thereof in preparing medicament for treating allergic rhinitis |
| CN103751188A (en) * | 2013-12-31 | 2014-04-30 | 山东天顺药业股份有限公司 | Sodium cromoglycate, naphazoline hydrochloride and chlorpheniramine maleate nasal spray |
| CN103893174A (en) * | 2013-12-31 | 2014-07-02 | 山东天顺药业股份有限公司 | Nasal spray for treating allergic rhinitis |
-
2014
- 2014-01-01 CN CN201410000039.3A patent/CN103751189B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1104498A (en) * | 1993-04-01 | 1995-07-05 | 藤泽药品工业株式会社 | A topical dosage form |
| CN101347436A (en) * | 2007-07-20 | 2009-01-21 | 天津药业集团有限公司 | Uses of methylprednisolone and derivatives thereof in preparing medicament for treating allergic rhinitis |
| CN103751188A (en) * | 2013-12-31 | 2014-04-30 | 山东天顺药业股份有限公司 | Sodium cromoglycate, naphazoline hydrochloride and chlorpheniramine maleate nasal spray |
| CN103893174A (en) * | 2013-12-31 | 2014-07-02 | 山东天顺药业股份有限公司 | Nasal spray for treating allergic rhinitis |
Non-Patent Citations (1)
| Title |
|---|
| 吴广荣等: "变应性鼻炎的药物治疗", 《新医学》, vol. 31, no. 6, 30 June 2000 (2000-06-30), pages 359 - 360 * |
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| CN103751189B (en) | 2016-02-03 |
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Inventor after: Li Benchao Inventor after: Jiang Yan Inventor after: Liang Xia Inventor after: Xu Yitie Inventor after: Ma Zhiguo Inventor after: Yang Jinling Inventor before: Qin Qingfu Inventor before: Li Benchao Inventor before: Xu Yitie Inventor before: Liang Xia Inventor before: Ma Zhiguo |
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Free format text: CORRECT: INVENTOR; FROM: QIN QINGFU LI BENCHAO XU YITIE LIANG XIA MA ZHIGUO TO: LI BENCHAO JIANG YAN LIANG XIA XU YITIE MA ZHIGUO YANG JINLING |
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Application publication date: 20140430 Assignee: Shandong Tianshun Pharmaceutical Technology Co.,Ltd. Assignor: SHANDONG TIANSHUN PHARMACEUTICAL Co.,Ltd. Contract record no.: X2022980023696 Denomination of invention: A pharmaceutical composition for treating rhinitis Granted publication date: 20160203 License type: Common License Record date: 20221201 |