CN104622854A - Tablet containing ambroxol hydrochloride and salbutamol sulfate - Google Patents

Abstract

The invention provides a tablet containing ambroxol hydrochloride and salbutamol sulfate, and belongs to the technical field of medicines. The tablet provided by the invention mainly comprises the following auxiliary materials: a filler, a disintegrating agent, a lubricant and an adhesive. The tablet provided by the invention is capable of treating diseases of a respiratory system, such as acute and chronic bronchitis, asthmatic bronchitis and bronchial asthma; sputum is easy to cough up when trachea is expanded; the tablet is simple in prescription, and good in curative effect; and the preparation technology is suitable for industrialized mass production.

Description

Tablet containing ambroxol hydrochloride and salbutamol sulfate

Technical field

The invention belongs to medical art, relate to a kind of tablet containing ambroxol hydrochloride and salbutamol sulfate.The invention provides a kind of safe and effective, steady quality, is convenient for carrying the tablet being used for the treatment of the respiratory system disease such as acute/chronic bronchitis and asthma of storage.

Background technology

Ambroxol hydrochloride is mucolytic agent, its can improve respiratory mucosa tissue function, increase respiratory tract liquid measure while reduce the viscosity of mucus, ciliary movement can be increased in addition, promote Pulmonary Surfactant Secretion, these effects integrate and make mucus be easy to mobile, obtain lubricating with respiratory tract wall and work in coordination with mutually, make sputum be easy to expectoration.Salbutamol sulfate is bronchodilator, and it is by the β on the exciting bronchial smooth muscle of selectivity ₂adrenoceptor, and play bronchiectatic activity.With β ₂the combination of adrenoceptor makes adenyl cyclase be activated, and intracellular loops adenosine phosphate concentration raises, and result makes bronchial smooth muscle relax, and suppresses the release medium such as mastocyte simultaneously.Ambroxol hydrochloride and salbutamol sulfate share and can dissolve sticky expectorant while expansion bronchus, reach better therapeutic effect.CN103251577A, CN103239431A relate separately to tablet composition and the capsule composition of a kind of ambroxol hydrochloride and salbutamol sulfate, but in the two prescription, salbutamol sulfate amount is less, expansion bronchus weak effect, and then affect its drug effect; CN102018694A relates to the tablet capsule being filled with Ambroxol Hydrochloride Tablets and Salbutamol Sulfate in Tablet in a kind of capsule, and it needs after taking could absorb through capsule and the dual disintegrate of tablet, and effect is poor; CN101204386B relates to the liquid combination of a kind of ambroxol hydrochloride and salbutamol sulfate, but liquid preparation has certain limitation, as poor chemical stability, storage are carried inconvenience, easily go mouldy, become sour, the method with the addition of stabilizing agent, pH adjusting agent, sodium chloride, aromatic, and prescription is complicated and additive is more.

Though existing compositions is many, all there is the defect of curative effect or stability aspect, this method prescription is simple, and dose is accurate, and preparation method is simple, and can keep its stability, and quality is good, and impurity is few, safe and effective, is applicable to industrialized great production.

Summary of the invention

In order to solve above-mentioned technological deficiency, the present invention is on a large amount of experiment basis, and provide a kind of safe and effective, steady quality, is applicable to the tablet being used for the treatment of the respiratory system disease such as acute/chronic bronchitis and asthma of industrialized great production.

The invention provides a kind of tablet containing ambroxol hydrochloride and salbutamol sulfate, it is characterized in that: prescription is: ambroxol hydrochloride 7.5g, salbutamol sulfate 2.4g, lactose 50.0g, microcrystalline Cellulose 50.0g, hypromellose 1.5g, magnesium stearate 1.0g, make 1000.

The method for preparing tablet thereof that the present invention relates to comprises the steps:

A. supplementary material crosses 100 mesh sieves respectively, for subsequent use;

B. take recipe quantity hypromellose, be made into 3% solution by purified water, for subsequent use;

C. take the ambroxol hydrochloride of recipe quantity and salbutamol sulfate equivalent to progressively increase method mix homogeneously; Its mixture is mixed homogeneously according to the equivalent method of progressively increasing with the mixture of lactose and microcrystalline Cellulose, with 3% hypromellose cellulose solution soft material, 20 mesh sieves are granulated, wet granular was in 60 DEG C of forced air dryings 2 hours, and dry granule crosses 18 mesh sieve granulate, added the magnesium stearate mix homogeneously of recipe quantity, tabletting, packaging, inspection, qualified warehouse-in.

This method prescription is simple, and take lactose as filler, microcrystalline Cellulose is filler and disintegrating agent, and hypromellose is binding agent, and magnesium stearate is lubricant.Can keep its stability, quality is good, and impurity is few, safe and effective, rapid-action and mouthfeel good, is applicable to industrialized great production.

Detailed description of the invention

Ambroxol hydrochloride 7.5g

Salbutamol sulfate 2.4g

Lactose 50.0g

Microcrystalline Cellulose 50.0g

Hypromellose 1.5g

Magnesium stearate 1.0g

Make 1000

Preparation method:

Supplementary material crosses 100 mesh sieves respectively, for subsequent use; Take recipe quantity hypromellose, be made into 3% solution by purified water, for subsequent use; Take the ambroxol hydrochloride of recipe quantity and salbutamol sulfate equivalent to progressively increase method mix homogeneously; Its mixture is mixed homogeneously according to the equivalent method of progressively increasing with the mixture of lactose and microcrystalline Cellulose, with 3% hypromellose cellulose solution soft material, 20 mesh sieves are granulated, wet granular was in 60 DEG C of forced air dryings 2 hours, and dry granule crosses 18 mesh sieve granulate, added the magnesium stearate mix homogeneously of recipe quantity, tabletting, packaging, inspection, qualified warehouse-in.

Stability experiment and result

1, influence factor's test

The ambroxol albuterol sheet prepared as stated above is set high respectively temperature (60 DEG C, 40 DEG C), high light (4500lx), lower 10 days of high humidity (RH92.5%, RH75%) condition, detected every quality index respectively at 0,5,10 day, the results are shown in Table 1.

Table 1 ambroxol albuterol sheet influence factor result of the test

Result shows: ambroxol albuterol sheet is placed 10 days under high temperature (60 DEG C, 40 DEG C), high light (4500lx), high humidity (RH92.5%, RH75%) condition, detect every quality index, compared with 0 day, except under high temperature (60 DEG C), high light (4500lx) condition, related substance increases to some extent, under high humidity (RH92.5%) condition outside sample moisture absorption obviously, other have no significant change.Show that this product needs shading, sealing is preserved.

2, accelerated test

Get three to pull on and state sample and adopt composite membrane for packaging medicine packaging, 40 DEG C, the constant temperature of RH75%, to place 6 months in constant humidity cabinet, measured every quality index respectively at 0,1,2,3,6 month, the results are shown in Table 2.

Table 2 ambroxol albuterol sheet accelerated test result

Result shows: in three batches of ambroxol albuterol sheets, test agent adopts composite membrane for packaging medicine packaging, 40 DEG C, place 6 months under the accelerated test condition of RH75%, every quality index compared with 0 month and has no significant change, and met the pertinent regulations in quality standard.

3, long term test

Pull on three and state sample and adopt composite membrane for packaging medicine packaging, 25 DEG C, the constant temperature of RH60%, to place in constant humidity condition, sample respectively at when 0,3,6,9,12,18 month, measure every quality index, the results are shown in Table 3.

Table 3 compound ambroxol hydrochloride sheet long-term test results

Result shows: in three batches of ambroxol albuterol sheets, test agent adopts composite membrane for packaging medicine packaging, 25 DEG C, place 18 months in RH60% environment, every quality index compared with 0 month and has no significant change, and met the pertinent regulations in quality standard.

Claims (2)

1. one kind contains the tablet of ambroxol hydrochloride and salbutamol sulfate, it is characterized in that: prescription is: ambroxol hydrochloride 7.5g, salbutamol sulfate 2.4g, lactose 50.0g, microcrystalline Cellulose 50.0g, hypromellose 1.5g, magnesium stearate 1.0g, make 1000.

2. prepare a method for tablet according to claim 1, it is characterized in that, the method comprises the steps:

A. supplementary material crosses 100 mesh sieves respectively, for subsequent use;

B. take recipe quantity hypromellose, be made into 3% solution by purified water, for subsequent use;

C. take the ambroxol hydrochloride of recipe quantity and salbutamol sulfate equivalent to progressively increase method mix homogeneously; Its mixture is mixed homogeneously according to the equivalent method of progressively increasing with the mixture of lactose and microcrystalline Cellulose, with 3% hypromellose cellulose solution soft material, 20 mesh sieves are granulated, wet granular was in 60 DEG C of forced air dryings 2 hours, and dry granule crosses 18 mesh sieve granulate, added the magnesium stearate mix homogeneously of recipe quantity, tabletting, packaging, inspection, qualified warehouse-in.