CN105012245A - Phlegm-dispersing drug ambroxol hydrochloride composition granules and preparing method thereof - Google Patents
Phlegm-dispersing drug ambroxol hydrochloride composition granules and preparing method thereof Download PDFInfo
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- CN105012245A CN105012245A CN201510485070.5A CN201510485070A CN105012245A CN 105012245 A CN105012245 A CN 105012245A CN 201510485070 A CN201510485070 A CN 201510485070A CN 105012245 A CN105012245 A CN 105012245A
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Abstract
The invention relates to phlegm-dispersing drug ambroxol hydrochloride composition granules and a preparing method thereof and belongs to the technical field of medicine. The composition granules are prepared from ambroxol hydrochloride, carboxymethyl starch sodium, microcrystalline cellulose, meglumine, starch, purified water, talcum powder and steviosin. The ambroxol hydrochloride is a new crystal-form composition, an X-ray powder diffraction diagram obtained by using Cu-Ka rays for measurement is shown as the graph one, the ambroxol hydrochloride is different from that reported in the prior art, it is proved by tests that the ambroxol hydrochloride composition has good solubility and high stability, various preparations can be prepared conveniently, the preparing method for the granules prepared from the ambroxol hydrochloride crystal-form composition is simple, and the stability is good.
Description
Technical field
The invention belongs to medical art, relate to a kind of Apophlegmatisant ambroxol hydrochloride composition granule.
Background technology
Ambroxol hydrochloride (Ambroxol Hydrochloride) has another name called Ambroxol Hydrochloride, a kind of respiratory tract lubrication expectorant and mucolytic, ambroxol hydrochloride, chemical name is trans-4-[(2-amino-3,5-dibromo-benzyl) amino] cyclohexanol HCI, for white is to micro-yellow crystalline powder; Ambroxol hydrochloride has the characteristic that mucus is got rid of facilitation and dissolved secretions, and it can promote the eliminating of thick secretions in respiratory tract and reduce the delay of mucus, thus significantly promotes expectoration, improves breath state.The secretion of pulmonary surfactant, the secretion of air flue liquid and ciliary movement can be promoted.Ambroxol hydrochloride is widely used in the thick sputum, dys-expectoration etc. that various acute and chronic respiratory tract disease causes clinically.
At present, the polymorphic about ambroxol hydrochloride has disclosed a lot of patent and document.
The pharmaceutical composition that patent ZL201210513123.6 discloses a kind of ambroxol hydrochloride crystal formation and obtained by this crystal formation, described ambroxol hydrochloride crystal formation in the X-ray powder diffraction pattern represented with the 2 θ ± 0.2 ° angle of diffraction at 6.9 °, 7.2 °, 12.8 °, 15.6 °, 17.5 °, 20 °, 21 °, 22 °, 24 ° of places demonstrate characteristic diffraction peak.
Patent ZL201210231927.7 relates to a kind of unformed ambroxol compound and preparation method thereof, and the X-ray powder diffraction pattern of this unformed powder is without obvious characteristic peak.
Patent application 201410071920.2 relates to a kind of ambroxol compound and oral cavity disintegration tablet.The X-ray powder diffraction pattern that ambroxol hydrochloride of the present invention uses the measurement of Cu-K alpha ray to obtain as shown in Figure 1.Containing ambroxol hydrochloride 10-30 weight portion, filler 50-80 weight portion, disintegrating agent 10-15 weight portion, fluidizer 0.3-1.6 weight portion, lubricant 0.4-1.6 weight portion, correctives 8-16 weight portion in Orally disintegrating tablet of ambroxol hydrochloride.
Ambroxol hydrochloride is insoluble in water, very large difficulty is brought to the preparation of preparation, the present invention proposes a kind of new hydrochloric acid ammonia bromine compounds, there is good dissolubility and higher stability, facilitate the preparation of various preparation, utilize and the invention provides that the process for producing granula that ambroxol hydrochloride crystal-form compound makes is simple, good stability.
Summary of the invention
Goal of the invention of the present invention is to provide a kind of Apophlegmatisant ambroxol hydrochloride composition granule.
In order to complete object of the present invention, the technical scheme of employing is:
The present invention relates to a kind of Apophlegmatisant ambroxol hydrochloride composition granule, described composition granule is made up of ambroxol hydrochloride, carboxymethylstach sodium, microcrystalline Cellulose, meglumine, starch, purified water, Pulvis Talci, steviosin; Described ambroxol hydrochloride is crystal, and the X-ray powder diffraction pattern that the measurement of use Cu-K alpha ray obtains as shown in Figure 1.
First optimal technical scheme of the present invention is: with parts by weight, and described composition granule is made up of the ambroxol hydrochloride of 1.5-2.5 weight portion, the carboxymethylstach sodium of 2.25-2.65 weight portion, the microcrystalline Cellulose of 10.3-10.9 weight portion, the meglumine of 1.00-1.10 weight portion, the starch of 0.10-0.20 weight portion, the purified water of 2.65-3.05 weight portion, the Pulvis Talci of 0.20-0.30 weight portion, the steviosin of 0.3-0.7 weight portion.
Second optimal technical scheme of the present invention is: with parts by weight, and described compositions is made up of the ambroxol hydrochloride of 2 weight portions, the carboxymethylstach sodium of 2.45 weight portions, the microcrystalline Cellulose of 10.6 weight portions, the meglumine of 1.05 weight portions, the starch of 0.15 weight portion, the purified water of 2.85 weight portions, the Pulvis Talci of 0.25 weight portion, the steviosin of 0.5 weight portion.
3rd optimal technical scheme of the present invention is that the preparation method of described composition granule comprises the following steps:
1) supplementary material process: raw material ambroxol hydrochloride to be sieved 80 orders with vibrating screen classifier;
2) prepare burden: weigh supplementary material according to technology preparation amount;
3) prepare 5% starch slurry: the purified water of recipe quantity is placed in tilting-type reaction pot, open Steam Heating, add the starch of recipe quantity while stirring, stirring and dissolving boiling cooling is for subsequent use;
4) mixing granulation: the ambroxol hydrochloride of recipe quantity, carboxymethylstach sodium, microcrystalline Cellulose, meglumine, steviosin are added in wet mixing pelletizer, open stirring motor and be dry mixed 10 minutes, add the starch slurry prepared, wet mixing 140-200 soft material second, selects 18 order stainless steel meshs to be arranged in spinning comminutor and granulates;
5) drying and screening: regulate boiling drier inlet temperature 60-65 DEG C, wet granular is placed in boiling drier and carries out drying, be dried to moisture < 4.5%, granule shaking screen after drying is sieved the granule got between 16 order-30 orders;
6) always mix: the Pulvis Talci of the dry granule after granulate and recipe quantity is joined in mixer, motor rotation frequency 200r/min is set, open mixer and mix 15 minutes;
7) pack: granule is joined particles packing machine intermediate package, control content uniformity and meet inner quality standard.
4th optimal technical scheme of the present invention is that the preparation method of the crystal of described ambroxol hydrochloride comprises the following steps:
(1) ground by ambroxol hydrochloride crude product, cross 80 mesh sieves, then joining volume is that in the methanol of 7 times of ambroxol hydrochloride weight and the mixed solution of 2-picoline, the volume ratio of methanol and 2-picoline is 4.5:1, and 110 revs/min are stirred 5 minutes;
Add the N-ethyl acetamide that volume is 5 times of ambroxol hydrochloride weight under (2) 60 revs/min of stirrings, be warming up to 35 DEG C simultaneously;
(3) after solution adds, leave standstill 3 hours, drip the isopropyl alcohol of 0 DEG C under 120 revs/min of conditions stirred, the volume of isopropyl alcohol is 12 times of ambroxol hydrochloride weight, at the uniform velocity dropwises in 2h;
(4) be cooled to-10 DEG C after being added dropwise to complete, continue to stir 2h under the stir speed (S.S.) of 90 revs/min, leave standstill 0.5h crystallize out, filter, washing, vacuum drying obtains ambroxol hydrochloride crystal.
Below technical scheme of the present invention is made further explanation:
The present invention is by the precise controlling to crystallization condition, and prepared a kind of ambroxol hydrochloride novel crystal forms unlike the prior art, the X-ray powder diffraction pattern of this ambroxol hydrochloride crystal unlike the prior art.Simultaneously due to the ins and outs of this crystal formation, find through test, ambroxol compound of the present invention has good dissolubility and higher stability, facilitate the preparation of various preparation, utilize and the invention provides that the process for producing granula that ambroxol hydrochloride crystal-form compound makes is simple, good stability.
Accompanying drawing explanation
Fig. 1 is the X-ray powder diffraction that the ambroxol hydrochloride crystal of the embodiment of the present invention 1 preparation uses the measurement of Cu-K alpha ray to obtain.
Detailed description of the invention
Below by specific embodiment, summary of the invention of the present invention is described in further detail, but does not therefore limit content of the present invention.
embodiment 1:the preparation of ambroxol hydrochloride crystal
(1) ground by ambroxol hydrochloride crude product, cross 80 mesh sieves, then joining volume is that in the methanol of 7 times of ambroxol hydrochloride weight and the mixed solution of 2-picoline, the volume ratio of methanol and 2-picoline is 4.5:1, and 110 revs/min are stirred 5 minutes;
Add the N-ethyl acetamide that volume is 5 times of ambroxol hydrochloride weight under (2) 60 revs/min of stirrings, be warming up to 35 DEG C simultaneously;
(3) after solution adds, leave standstill 3 hours, drip the isopropyl alcohol of 0 DEG C under 120 revs/min of conditions stirred, the volume of isopropyl alcohol is 12 times of ambroxol hydrochloride weight, at the uniform velocity dropwises in 2h;
(4) be cooled to-10 DEG C after being added dropwise to complete, continue to stir 2h under the stir speed (S.S.) of 90 revs/min, leave standstill 0.5h crystallize out, filter, washing, vacuum drying obtains ambroxol hydrochloride crystal.
As shown in Figure 1, its purity of high-performance liquid chromatogram determination is 99.9% to the X-ray powder diffraction pattern that the ambroxol hydrochloride crystal prepared uses the measurement of Cu-K alpha ray to obtain.
embodiment 2:the preparation of ambroxol hydrochloride granula, step is as follows:
Prescription: with parts by weight, the ambroxol hydrochloride crystal-form compound 2 parts that embodiment 1 is obtained, carboxymethylstach sodium 2.25 parts, microcrystalline Cellulose 10.3 parts, meglumine 1.00 parts, starch 0.1 part, purified water 2.65 parts, Pulvis Talci 0.20 part, steviosin 0.3 part.
Preparation method:
1) supplementary material process: raw material ambroxol hydrochloride to be sieved 80 orders with vibrating screen classifier;
2) prepare burden: weigh supplementary material according to technology preparation amount;
3) prepare 5% starch slurry: the purified water of recipe quantity is placed in tilting-type reaction pot, open Steam Heating, add the starch of recipe quantity while stirring, stirring and dissolving boiling cooling is for subsequent use;
4) mixing granulation: the ambroxol hydrochloride of recipe quantity, carboxymethylstach sodium, microcrystalline Cellulose, meglumine, steviosin are added in wet mixing pelletizer, open stirring motor and be dry mixed 10 minutes, add the starch slurry prepared, wet mixing 140-200 soft material second, selects 18 order stainless steel meshs to be arranged in spinning comminutor and granulates;
5) drying and screening: regulate boiling drier inlet temperature 60-65 DEG C, wet granular is placed in boiling drier and carries out drying, be dried to moisture < 4.5%, granule shaking screen after drying is sieved the granule got between 16 order-30 orders;
6) always mix: the Pulvis Talci of the dry granule after granulate and recipe quantity is joined in mixer, motor rotation frequency 200r/min is set, open mixer and mix 15 minutes;
7) pack: granule is joined particles packing machine intermediate package, control content uniformity and meet inner quality standard.
embodiment 3:the preparation of ambroxol hydrochloride granula, step is as follows:
Prescription: with parts by weight, the ambroxol hydrochloride crystal-form compound 2 parts that embodiment 1 is obtained, carboxymethylstach sodium 2.45 parts, microcrystalline Cellulose 10.6 parts, meglumine 1.05 parts, starch 0.15 part, purified water 2.85 parts, Pulvis Talci 0.25 part, steviosin 0.5 part.
Preparation method:
1) supplementary material process: raw material ambroxol hydrochloride to be sieved 80 orders with vibrating screen classifier;
2) prepare burden: weigh supplementary material according to technology preparation amount;
3) prepare 5% starch slurry: the purified water of recipe quantity is placed in tilting-type reaction pot, open Steam Heating, add the starch of recipe quantity while stirring, stirring and dissolving boiling cooling is for subsequent use;
4) mixing granulation: the ambroxol hydrochloride of recipe quantity, carboxymethylstach sodium, microcrystalline Cellulose, meglumine, steviosin are added in wet mixing pelletizer, open stirring motor and be dry mixed 10 minutes, add the starch slurry prepared, wet mixing 140-200 soft material second, selects 18 order stainless steel meshs to be arranged in spinning comminutor and granulates;
5) drying and screening: regulate boiling drier inlet temperature 60-65 DEG C, wet granular is placed in boiling drier and carries out drying, be dried to moisture < 4.5%, granule shaking screen after drying is sieved the granule got between 16 order-30 orders;
6) always mix: the Pulvis Talci of the dry granule after granulate and recipe quantity is joined in mixer, motor rotation frequency 200r/min is set, open mixer and mix 15 minutes;
7) pack: granule is joined particles packing machine intermediate package, control content uniformity and meet inner quality standard.
embodiment 4:the preparation of ambroxol hydrochloride granula, step is as follows:
Prescription: with parts by weight, the ambroxol hydrochloride crystal-form compound 2 parts that embodiment 1 is obtained, carboxymethylstach sodium 2.65 parts, microcrystalline Cellulose 10.9 parts, meglumine 1.10 parts, starch 0.20 part, purified water 3.05 parts, Pulvis Talci 0.3 part, steviosin 0.7 part.
Preparation method:
1) supplementary material process: raw material ambroxol hydrochloride to be sieved 80 orders with vibrating screen classifier;
2) prepare burden: weigh supplementary material according to technology preparation amount;
3) prepare 5% starch slurry: the purified water of recipe quantity is placed in tilting-type reaction pot, open Steam Heating, add the starch of recipe quantity while stirring, stirring and dissolving boiling cooling is for subsequent use;
4) mixing granulation: the ambroxol hydrochloride of recipe quantity, carboxymethylstach sodium, microcrystalline Cellulose, meglumine, steviosin are added in wet mixing pelletizer, open stirring motor and be dry mixed 10 minutes, add the starch slurry prepared, wet mixing 140-200 soft material second, selects 18 order stainless steel meshs to be arranged in spinning comminutor and granulates;
5) drying and screening: regulate boiling drier inlet temperature 60-65 DEG C, wet granular is placed in boiling drier and carries out drying, be dried to moisture < 4.5%, granule shaking screen after drying is sieved the granule got between 16 order-30 orders;
6) always mix: the Pulvis Talci of the dry granule after granulate and recipe quantity is joined in mixer, motor rotation frequency 200r/min is set, open mixer and mix 15 minutes;
7) pack: granule is joined particles packing machine intermediate package, control content uniformity and meet inner quality standard.
experimental example 1:mobility is tested
The mobility of this experimental example to the ambroxol compound of the embodiment of the present invention 1 detects, adopt fixed funnel method, funnel is placed in the suitable height on graph paper, ambroxol compound is freely flowed down from bell mouth, until the cone top formed contacts with bell mouth, measure hypotenuse and the horizontal angle (θ angle of repose) of ambroxol compound accumulation horizon.Experimental result is as shown in table 1.Table 1: mobility experimental result
From the interpretation of table 1, the mobility of the ambroxol compound that the embodiment of the present invention 1 prepares is fine.
experimental example 2: dissolubility contrast test
the dissolubility of following ambroxol hydrochloride is detected,
Comparative example 1: commercially available ambroxol hydrochloride (Wuhan English and pharmaceutical Co. Ltd);
Comparative example 2: prepare according to the embodiment 1 of patent ZL201210513123.6;
Comparative example 3: prepare according to the embodiment 1 of patent ZL201210231927.7;
Comparative example 4: prepare according to the embodiment 1 of patent application 201410071920.2;
1. be determined at the quality of ambroxol hydrochloride in 100g water saturation solution under 20 DEG C of conditions; Experimental result is as shown in table 2.
Table 2 dissolubility comparative test result
As can be seen from Table 2, the water solublity of ambroxol hydrochloride of the present invention improves greatly, brings conveniently to preparation preparation.
experimental example 3:influence factor tests
1. hot test
The granule that Example 3 prepares, simulation listing packaging, puts in sealing clean container, places 10 days at 40 ± 2 DEG C of temperature, and in the 5th day and sampling in the 10th day, detect by stability high spot reviews project, result of the test compared with 0 day.
2. high humility test
The granule that Example 3 prepares, simulation listing packaging, puts in sealing clean container, place 10 days under the condition of 25 ± 2 DEG C of relative humiditys 90% ± 5%, in the 5th day and sampling in the 10th day, detect by stability high spot reviews project, result of the test compared with 0 day.
3. strong illumination test
The granule that Example 3 prepares, simulation listing packaging, puts in sealing clean container, and being placed in illumination is place 10 days under the condition of 4500lx, and in the 5th day and sampling in the 10th day, detect by stability high spot reviews project, result compared with 0 day.The results are shown in following table:
Table 3 influence factor result of the test
Result shows: the ambroxol hydrochloride granula that the present invention prepares, its good stability, and under high temperature, high humidity, high light conditions, equal retention is stablized.Influence factor's experiment is carried out to the ambroxol hydrochloride granula that other embodiments of the invention prepare, obtains identical experimental result.
Claims (5)
1. an Apophlegmatisant ambroxol hydrochloride composition granule, is characterized in that: described composition granule is made up of ambroxol hydrochloride, carboxymethylstach sodium, microcrystalline Cellulose, meglumine, starch, purified water, Pulvis Talci, steviosin; Described ambroxol hydrochloride is crystal, and the X-ray powder diffraction pattern that the measurement of use Cu-K alpha ray obtains as shown in Figure 1.
2. Apophlegmatisant ambroxol hydrochloride composition granule according to claim 1, it is characterized in that: with parts by weight, described composition granule is made up of the ambroxol hydrochloride of 1.5-2.5 weight portion, the carboxymethylstach sodium of 2.25-2.65 weight portion, the microcrystalline Cellulose of 10.3-10.9 weight portion, the meglumine of 1.00-1.10 weight portion, the starch of 0.10-0.20 weight portion, the purified water of 2.65-3.05 weight portion, the Pulvis Talci of 0.20-0.30 weight portion, the steviosin of 0.3-0.7 weight portion.
3. Apophlegmatisant ambroxol hydrochloride composition granule according to claim 2, it is characterized in that: with parts by weight, described compositions is made up of the ambroxol hydrochloride of 2 weight portions, the carboxymethylstach sodium of 2.45 weight portions, the microcrystalline Cellulose of 10.6 weight portions, the meglumine of 1.05 weight portions, the starch of 0.15 weight portion, the purified water of 2.85 weight portions, the Pulvis Talci of 0.25 weight portion, the steviosin of 0.5 weight portion.
4. prepare a method for the arbitrary described Apophlegmatisant ambroxol hydrochloride composition granule of claim 1-3, it is characterized in that comprising the following steps:
1) supplementary material process: raw material ambroxol hydrochloride to be sieved 80 orders with vibrating screen classifier;
2) prepare burden: weigh supplementary material according to technology preparation amount;
3) prepare 5% starch slurry: the purified water of recipe quantity is placed in tilting-type reaction pot, open Steam Heating, add the starch of recipe quantity while stirring, stirring and dissolving boiling cooling is for subsequent use;
4) mixing granulation: the ambroxol hydrochloride of recipe quantity, carboxymethylstach sodium, microcrystalline Cellulose, meglumine, steviosin are added in wet mixing pelletizer, open stirring motor and be dry mixed 10 minutes, add the starch slurry prepared, wet mixing 140-200 soft material second, selects 18 order stainless steel meshs to be arranged in spinning comminutor and granulates;
5) drying and screening: regulate boiling drier inlet temperature 60-65 DEG C, wet granular is placed in boiling drier and carries out drying, be dried to moisture < 4.5%, granule shaking screen after drying is sieved the granule got between 16 order-30 orders;
6) always mix: the Pulvis Talci of the dry granule after granulate and recipe quantity is joined in mixer, motor rotation frequency 200r/min is set, open mixer and mix 15 minutes;
7) pack: granule is joined particles packing machine intermediate package, control content uniformity and meet inner quality standard.
5. Apophlegmatisant ambroxol hydrochloride composition granule according to claim 1, it is characterized in that, the preparation method of the crystal of described ambroxol hydrochloride comprises the following steps:
(1) ground by ambroxol hydrochloride crude product, cross 80 mesh sieves, then joining volume is that in the methanol of 7 times of ambroxol hydrochloride weight and the mixed solution of 2-picoline, the volume ratio of methanol and 2-picoline is 4.5:1, and 110 revs/min are stirred 5 minutes;
Add the N-ethyl acetamide that volume is 5 times of ambroxol hydrochloride weight under (2) 60 revs/min of stirrings, be warming up to 35 DEG C simultaneously;
(3) after solution adds, leave standstill 3 hours, drip the isopropyl alcohol of 0 DEG C under 120 revs/min of conditions stirred, the volume of isopropyl alcohol is 12 times of ambroxol hydrochloride weight, at the uniform velocity dropwises in 2h;
(4) be cooled to-10 DEG C after being added dropwise to complete, continue to stir 2h under the stir speed (S.S.) of 90 revs/min, leave standstill 0.5h crystallize out, filter, washing, vacuum drying obtains ambroxol hydrochloride crystal.
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Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2001097856A (en) * | 1999-09-30 | 2001-04-10 | Taisho Pharmaceut Co Ltd | Antitussive |
| WO2005113492A1 (en) * | 2004-05-20 | 2005-12-01 | Jiangsu Hansen Pharmaceutical Co., Ltd. | Cysteine analogues salts of ambroxol, preparation methods and uses thereof |
| CN101219124A (en) * | 2008-02-04 | 2008-07-16 | 山东罗欣药业股份有限公司 | Hydrochloric acid cefetamet pivoxil dispersible tablet and method for preparing the same |
| CN101590043A (en) * | 2009-07-03 | 2009-12-02 | 北京华禧联合科技发展有限公司 | A kind of compound preparation for the treatment of respiratory tract infection and preparation method thereof |
| CN102391188A (en) * | 2011-09-30 | 2012-03-28 | 山东罗欣药业股份有限公司 | Ornidazole hydrate crystal, preparation method thereof and crystal-containing composition tablets |
| CN104800221A (en) * | 2015-05-15 | 2015-07-29 | 苗怡文 | Medicinal cefetamet pivoxil hydrochloride composition for treating sensitive bacteria infectious diseases |
-
2015
- 2015-08-10 CN CN201510485070.5A patent/CN105012245A/en not_active Withdrawn
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2001097856A (en) * | 1999-09-30 | 2001-04-10 | Taisho Pharmaceut Co Ltd | Antitussive |
| WO2005113492A1 (en) * | 2004-05-20 | 2005-12-01 | Jiangsu Hansen Pharmaceutical Co., Ltd. | Cysteine analogues salts of ambroxol, preparation methods and uses thereof |
| CN101219124A (en) * | 2008-02-04 | 2008-07-16 | 山东罗欣药业股份有限公司 | Hydrochloric acid cefetamet pivoxil dispersible tablet and method for preparing the same |
| CN101590043A (en) * | 2009-07-03 | 2009-12-02 | 北京华禧联合科技发展有限公司 | A kind of compound preparation for the treatment of respiratory tract infection and preparation method thereof |
| CN102391188A (en) * | 2011-09-30 | 2012-03-28 | 山东罗欣药业股份有限公司 | Ornidazole hydrate crystal, preparation method thereof and crystal-containing composition tablets |
| CN104800221A (en) * | 2015-05-15 | 2015-07-29 | 苗怡文 | Medicinal cefetamet pivoxil hydrochloride composition for treating sensitive bacteria infectious diseases |
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Application publication date: 20151104 |