CN102716128A - Pharmaceutical composition for treating asthma - Google Patents
Pharmaceutical composition for treating asthma Download PDFInfo
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- CN102716128A CN102716128A CN201210225704XA CN201210225704A CN102716128A CN 102716128 A CN102716128 A CN 102716128A CN 201210225704X A CN201210225704X A CN 201210225704XA CN 201210225704 A CN201210225704 A CN 201210225704A CN 102716128 A CN102716128 A CN 102716128A
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- ambroxol hydrochloride
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Abstract
The invention discloses a pharmaceutical composition taking ambroxol hydrochloride and montelukast sodium as active ingredients and the application of the pharmaceutical composition. The composition can be made into oral preparations including tablets, capsules, granules, chewable tablets, oral solutions and dry suspensions. As the ambroxol hydrochloride and the montelukast sodium are synergistic, the composition has an unexpected effect of treating asthma and is very good in application prospect.
Description
Technical field
The present invention relates to a kind of Pharmaceutical composition of treating asthma and uses thereof, particularly relating to a kind of is Pharmaceutical composition of active component and uses thereof with ambroxol and Menglusitena, belongs to field of medicaments.
Background technology
Asthma is a kind of commonly encountered diseases, frequently-occurring disease.At present, about 300,000,000 people of global asthmatic patient, Chinese asthmatic patient about 3,000 ten thousand.Compare with other countries, asthma is lower in the prevalence of China, but mortality rate is very high, and has only 3% asthma patient to reach control fully.If asthma control is not good, will influence patient's quality of life more than major diseases such as diabetes, hypertension.Asthma is to influence the able-bodied important diseases of people, treats untimely, lack of standardization possible fatal.But alternative clinically medicine is also few, and onset is slower.
Ambroxol hydrochloride (Ambroxol Hydrochloride), chemical name: trans 4-[(amino-3, the 5 two bromo-phenyl of 2-) methyl-amino] Hexalin hydrochlorate; Be the main active substances of the internal metabolism of Bisolvon,, can act on secretory cell for a kind of glutinous expectorant lytic agent; Regulate serosity and mucous secretion, serous secretion is increased, the mucolytic dilution; And can strengthen the swing of cilium, and increase the removing ability of mucus transportation system, make sputum be easy to discharge.Ambroxol hydrochloride also is a kind of respiratory system protective agent, has antioxidation, the release of inflammation-inhibiting medium, and lax airway smooth muscle promotes the effects such as synthetic and secretion of pulmonary surfactant.Ambroxol hydrochloride can also increase the drug level of antibiotic in air flue, thereby improves antibiotic curative effect.Ambroxol hydrochloride is applicable to the acute and chronic pulmonary disease of and expectoration dysfunction undesired with the sputum secretion clinically.At present; The ambroxol hydrochloride single preparations of ephedrine of state, inside and outside listing has liquid drugs injection, transfusion, freeze-dried powder, oral fluid agent, oral solid formulation (comprising normal release dosage form and controlled release agent type), and compound preparation has ambroxol hydrochloride Amoxicillin Capsules, ambroxol hydrochloride roxithromycin capsules, ambroxol hydrochloride loratadine capsule, ambroxol hydrochloride albuterol oral administration solution etc.
Menglusitena (Montelukast Sodium); Chemical name [R-(E)]-1-[[[1-[3-[2-(7-chloro-2-quinoline) vinyl] phenyl-3-[2-(1-hydroxyl-1-Methylethyl) phenyl] propyl group] sulfur] methyl] cyclopropaneacetic acid sodium; Be a kind of orally active selectivity leukotriene receptor antagonist, can suppress cysteinyl leukotriene receptor by specificity, suppress air flue acidophil inflammation; Inflammation-inhibiting medium and release of cytokines suppress air flue LTC
4Discharge, improve pulmonary function, reduce BHR; Prevention and long-term treatment with childhood asthma are used to be grown up; Comprise the prevention SOA at daytime and night, treatment is to the asthmatic patient of aspirin sensitive and prevent also to be used to alleviate the symptom that allergic rhinitis causes because of kinetic bronchoconstriction.The montelukast preparation of sodium of listing has tablet, chewable tablet, dispersible tablet both at home and abroad.
Yet not having with ambroxol hydrochloride and Menglusitena both at home and abroad as yet is active component, interact, and Synergistic, composition of prescription is used to treat the report of aspect such as asthma disease.
Summary of the invention
The purpose of this invention is to provide a kind of Pharmaceutical composition of treating asthma, said composition is an active component with ambroxol hydrochloride and Menglusitena, combines with acceptable accessories.
The Pharmaceutical composition of above-mentioned treatment asthma, wherein the consumption of ambroxol hydrochloride is 0.1mg--120mg for per unit dosage.
The Pharmaceutical composition of above-mentioned treatment asthma, wherein the consumption of Menglusitena is 0.1mg--30mg for per unit dosage.
Pharmaceutical composition of the present invention can be processed oral formulations according to the processing method of the routine of pharmaceutics, comprises tablet, capsule, dispersible tablet, chewable tablet, granule, dry suspension, oral cavity disintegration tablet or oral solution.Oral formulations can be normal release dosage form, also can be the controlled release agent type.
Pharmaceutical composition of the present invention can be selected acceptable accessories for use when processing oral formulations, adjuvant comprises filler, binding agent, disintegrating agent, lubricant etc.Supplementary product kind and consumption are decided according to concrete situation.
It is the purposes of Pharmaceutical composition aspect the medicine of preparation treatment asthma of active component with ambroxol and Menglusitena that another object of the present invention has provided a kind of.Pharmaceutical composition of the present invention is an active component with ambroxol hydrochloride and Menglusitena, the two-way interaction, and Synergistic has beyond thought effect aspect the treatment asthma disease.Usage and dosage: oral formulations, be grown up 2-3 time on the one, each dosage ambroxol-hydrochloride-containing 10-30mg contains montelukast 5-10mg, preferably makes dose titration by user's age and body weight.
Below come further to set forth the beneficial effect of Pharmaceutical composition of the present invention through experimental example.
The pharmacological evaluation of experimental example 1 pharmaceutical composition
Experiment material: 0.9% normal saline, commercial; Ambroxol hydrochloride, commercial; Menglusitena, commercial; The present composition (embodiment 1-prescription 2), self-control.
Key instrument: 722 type spectrophotometers.
Animal subject: healthy Kunming mouse, male, 72.
Experimental technique: get 60 of mices, be divided into 5 groups at random, be respectively blank group, ambroxol hydrochloride group, basic, normal, high three dose groups of compositions, 12 every group.Each organizes administration, every day gastric infusion, dosage is seen table 1, successive administration 3 days, the blank group is irritated stomach and is given normal saline.Last administration fasting in preceding 1 day, 0.5 hour lumbar injection 5.0% phenol red solution 300mg/kg after the last administration gave excessive anesthetics after 0.5 hour and puts to death animal; Separate trachea; Insert injection, use the 2ml normal saline flushing, flushing liquor adds 1M sodium hydroxide solution 0.1ml colour developing; In 546nm wavelength colorimetric, calculate phenol red content with 722 type spectrophotometers.
Experimental result: show that each administration group can both obviously increase the phenol red secretory volume in mouse breathing road; Basic, normal, high three dose groups of compositions wherein of the present invention are compared the effect enhancing with single with the ambroxol hydrochloride group; Significant difference; And action effect is relevant with the dosage of each compositions, and effect of high dosage is best.
Table 1 pharmaceutical composition is to the influence of the phenol red secretory volume in mouse breathing road (X ± SD)
| Group | Dosage (mg/kg) | Phenol red amount (μ g/ml) | Increment rate (%) |
| Blank control group | -- | 0.38±0.23 | -- |
| The ambroxol hydrochloride group | 40 | 0.50±0.28 # | 31.92 |
| Compositions group (low dosage) | 20 | 0.54±0.20 #& | 42.38 |
| Compositions group (middle dosage) | 40 | 0.58±0.45 ##& | 51.77 |
| Compositions group (high dose) | 80 | 0.79±0.30 ##& | 101.1 |
Annotate:
#P＜0.05,
##P＜0.01 is compared with the blank group;
&P＜0.05 is compared with the ambroxol hydrochloride group.
The clinical efficacy of experimental example 2 Pharmaceutical compositions of the present invention
Physical data: bronchial asthma infant 90 examples so that Pediatric Clinic, Asthma Clinic are accepted for medical treatment are divided into the Menglusitena group at random.Drug combination group, compositions group; Each organizes sex, age, asthma degree etc. there are no significant difference (p＞0.05); Not statistically significant, all patients all meet " the conventional diagnostic criteria of childhood asthma control " of pediatrics branch of Chinese Medical Association pneumatology group revision in 2008.
Therapeutic Method:
Menglusitena group: oral montelukast sheet 5mg, 1 time every night, 6 months courses of treatment, the natural law of time, the every month acute attack of panting during the record acute attack and number of times and the natural law that used in every month.
The drug combination group: use the treatment of Menglusitena associating hydrochloric acid ammonia bromine, 1 time every night, oral Menglusitena sheet 5mg, people, 6 months courses of treatment are inhaled in 8 times on the 1st ambroxol injection 30mg atomizings.Record pant during acute attack natural law and the number of times of time, every month acute attack and the natural law that used in every month.
The compositions group: every night once, an a slice, oral Menglusitena/ambroxol hydrochloride 5mg/30mg (embodiment 1-prescription 2, self-control).6 months courses of treatment.Record pant during acute attack natural law and the number of times of time, every month acute attack and the natural law that used in every month.
Efficacy evaluation:
Control in the recent period: asthmatic patient outbreak symptom is alleviated fully, when idol has the mild asthma outbreak, does not also need medication just can alleviate.
Produce effects: the outbreak of the asthmatic patient state of an illness obviously alleviates before the treatment, still needs bronchodilator.
Effectively: the asthmatic patient symptom alleviates to some extent, still needs bronchodilator.
Invalid: the asthmatic patient clinical symptoms does not have improvement or increases the weight of on the contrary.
Result: see table 2.Menglusitena group total effective rate is 53.33%, and drug combination group total effective rate is 86.67%, compositions group total effective rate 96.67%.Each item index of compositions group all is superior to other two groups, compares with other two groups all to have significant difference, and statistical significance (p＜0.05) is arranged.
Three groups of curative effects comparisons of table 2 (example/%)
The specific embodiment
With specific embodiment the present invention is done detailed explanation below, should not be construed as the restriction to claim of the present invention of going up in all senses.
Embodiment 1: the preparation of Pharmaceutical composition tablet of the present invention
1, prescription:
Prescription 1,
Prescription 2,
Prescription 3,
2, preparation technology:
(1), takes by weighing supplementary material according to recipe quantity.Hypromellose 2% the aqueous solution processed soluble in water is subsequent use.
(2), with Pharmaceutical composition, starch, microcrystalline Cellulose mix homogeneously, it is an amount of to add the 2%HPMC aqueous solution, stirs, and processes suitable soft material.
(3), cross 20 mesh sieve system granules.
(4), granule is dried under 60 ℃ condition.
(5), dry good granule adds magnesium stearate and carboxymethylstach sodium, mistake 18 mesh sieve granulate, mix homogeneously.
(6), take a sample the semi-finished product chemical examination.
(7), the sheet weight sheet of confirming according to chemical examination.
(8), finished product is examined the packing warehouse-in entirely.
Embodiment 2: the preparation of Pharmaceutical composition capsule of the present invention
1, prescription:
Prescription 1,
Prescription 2,
Prescription 3,
2, preparation technology:
(1), takes by weighing supplementary material according to recipe quantity.Hypromellose 2% the aqueous solution processed soluble in water is subsequent use.
(2), with Pharmaceutical composition, starch, microcrystalline Cellulose mix homogeneously, it is an amount of to add the 2%HPMC aqueous solution, stirs, and processes suitable soft material.
(3), cross 20 mesh sieve system granules.
(4), granule is dried under 60 ℃ condition.
(5), dry good granule adds magnesium stearate, mistake 18 mesh sieve granulate, mix homogeneously.
(6), take a sample the semi-finished product chemical examination.
(7), the loading amount of confirming according to chemical examination incapsulates.
(8), finished product is examined the packing warehouse-in entirely.
The preparation of embodiment 3 Pharmaceutical composition granules of the present invention
1, prescription:
Prescription 1,
Prescription 2,
Prescription 3,
2, preparation technology:
(1), it is subsequent use sucrose to be pulverized 100 mesh sieves.
(2), take by weighing supplementary material according to recipe quantity.
(3), with the method mix homogeneously that Pharmaceutical composition and sucrose progressively increase with equivalent, it is an amount of to add the 2%HPMC50% alcoholic solution, stirs, and processes suitable soft material,
(4), cross 20 mesh sieve system granules.
(5), granule is dried under 60 ℃ condition.
(6), dried granule is crossed 18 mesh sieve granulate.
(7), sampling, the content of principal agent is confirmed loading amount in the semi-finished product chemical examinations granule.
(8), packing, finished product is examined entirely, packing warehouse-in.
Embodiment 4: the preparation of Pharmaceutical composition oral liquid of the present invention
1, prescription:
Prescription 1,
Prescription 2,
Prescription 3,
2, preparation technology: get purified water 4500ml, add propylene glycol, stir, add citric acid, sodium citrate and sucralose, stir and make dissolving, add principal agent, stirring and dissolving, subsequent use.Get ethanol, add methyl hydroxybenzoate and ethyl hydroxybenzoate, stirring and dissolving is poured in the medicinal liquid, stirs, and adds essence, stirs.Filter, filtrating adds purified water to 7000ml, packing.
The preparation of embodiment 5 Pharmaceutical composition syrups of the present invention
1, prescription:
Prescription 1,
Prescription 2,
Prescription 3,
2, preparation technology: get purified water 4500ml, add propylene glycol, stir, add principal agent, stirring and dissolving; Add citric acid and sodium benzoate, stir and make dissolving, the adding sodium citrate is an amount of, regulates PH to 3-4; Add essence, filter, in filtrating, add simple syrup to 7000ml, packing.
Claims (5)
1. a Pharmaceutical composition of treating asthma is characterized in that it is an active component with ambroxol hydrochloride and Menglusitena, combines with acceptable accessories.
2. Pharmaceutical composition as claimed in claim 1 is characterized in that the consumption of described ambroxol hydrochloride is 0.1mg--120mg for per unit dosage.
3. Pharmaceutical composition as claimed in claim 1 is characterized in that the consumption of described Menglusitena is 0.1mg--30mg for per unit dosage.
4. Pharmaceutical composition as claimed in claim 1 is characterized in that it is an oral formulations.
5. like the described arbitrary Pharmaceutical composition of claim 1--4, it is characterized in that its application aspect the medicine of preparation treatment asthma.
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| CN201210225704XA CN102716128A (en) | 2012-07-03 | 2012-07-03 | Pharmaceutical composition for treating asthma |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210225704XA CN102716128A (en) | 2012-07-03 | 2012-07-03 | Pharmaceutical composition for treating asthma |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104644605A (en) * | 2013-11-25 | 2015-05-27 | 天津汉瑞药业有限公司 | Stable capsule preparation containing montelukast and preparation method of capsule preparation |
| JP2017516849A (en) * | 2014-05-23 | 2017-06-22 | ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング | Cough syrup containing ambroxol hydrochloride |
| CN112546007A (en) * | 2020-12-31 | 2021-03-26 | 浙江诺得药业有限公司 | Oral solid tablet containing montelukast sodium and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102058587A (en) * | 2009-11-13 | 2011-05-18 | 天津金世制药有限公司 | Solid preparation for treating asthma |
-
2012
- 2012-07-03 CN CN201210225704XA patent/CN102716128A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102058587A (en) * | 2009-11-13 | 2011-05-18 | 天津金世制药有限公司 | Solid preparation for treating asthma |
Non-Patent Citations (4)
| Title |
|---|
| 《西北药学杂志》 20100228 唐利群 孟鲁司特联合氨溴索雾化防治儿童支气管哮喘 49-50页 1-5 第25卷, 第01期 * |
| S V PAGAR ET AL.: "Simultaneous quantification of levocetrizine dihydrochloride, montelukast sodium and ambroxol hydrochloride using high performance thin layer chromatography", 《INVENTI RAPID: PHARM ANALYSIS & QUALITY ASSURANCE》 * |
| 唐利群: "孟鲁司特联合氨溴索雾化防治儿童支气管哮喘", 《西北药学杂志》 * |
| 陈啸洪等: "氨溴特罗联合孟鲁司特对儿童咳嗽变异性哮喘的症状评分和肺功能的影响", 《中国全科医学》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104644605A (en) * | 2013-11-25 | 2015-05-27 | 天津汉瑞药业有限公司 | Stable capsule preparation containing montelukast and preparation method of capsule preparation |
| JP2017516849A (en) * | 2014-05-23 | 2017-06-22 | ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング | Cough syrup containing ambroxol hydrochloride |
| CN112546007A (en) * | 2020-12-31 | 2021-03-26 | 浙江诺得药业有限公司 | Oral solid tablet containing montelukast sodium and preparation method thereof |
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Application publication date: 20121010 |