CN106038498A - Bromhexine hydrochloride tablet and preparation method thereof - Google Patents
Bromhexine hydrochloride tablet and preparation method thereof Download PDFInfo
- Publication number
- CN106038498A CN106038498A CN201610457108.2A CN201610457108A CN106038498A CN 106038498 A CN106038498 A CN 106038498A CN 201610457108 A CN201610457108 A CN 201610457108A CN 106038498 A CN106038498 A CN 106038498A
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- bromhexine hydrochloride
- hydrochloride tablet
- stirring
- tablet
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F27/00—Mixers with rotary stirring devices in fixed receptacles; Kneaders
- B01F27/05—Stirrers
- B01F27/07—Stirrers characterised by their mounting on the shaft
- B01F27/074—Stirrers characterised by their mounting on the shaft having two or more mixing elements being concentrically mounted on the same shaft
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F27/00—Mixers with rotary stirring devices in fixed receptacles; Kneaders
- B01F27/05—Stirrers
- B01F27/11—Stirrers characterised by the configuration of the stirrers
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F27/00—Mixers with rotary stirring devices in fixed receptacles; Kneaders
- B01F27/05—Stirrers
- B01F27/11—Stirrers characterised by the configuration of the stirrers
- B01F27/19—Stirrers with two or more mixing elements mounted in sequence on the same axis
- B01F27/191—Stirrers with two or more mixing elements mounted in sequence on the same axis with similar elements
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F27/00—Mixers with rotary stirring devices in fixed receptacles; Kneaders
- B01F27/80—Mixers with rotary stirring devices in fixed receptacles; Kneaders with stirrers rotating about a substantially vertical axis
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F2101/00—Mixing characterised by the nature of the mixed materials or by the application field
- B01F2101/22—Mixing of ingredients for pharmaceutical or medical compositions
Abstract
The invention relates to a bromhexine hydrochloride tablet, which belongs to the technical field of preparation of western medicine. The bromhexine hydrochloride tablet is prepared from the following components: 5 to 15 parts of bromhexine hydrochloride, 20 to 40 parts of fructose, 30 to 50 parts of calcium carbonate and 10 and 20 parts of L-ascorbyl palmitate, and the components are mixed by a specific particle mixer. The bromhexine hydrochloride tablet has the advantage of smoothness in slow release.
Description
Technical field
The invention belongs to Western medicine preparation technical field, particularly to a kind of bromhexine hydrochloride tablet.
Background technology
Bromhexine hydrochloride tablet, indication is that this product is mainly used in the viscous expectorant that chronic bronchitis, asthma etc. causes and is difficult to cough
The patient gone out.Existing bromhexine hydrochloride tablet all uses compressing dry granulation technique or uses the methods such as inclusion to increase the stability of preparation,
Dissolution is unstable, usually produces some side effect when patient takes clinically.
Summary of the invention
In order to overcome the deficiencies in the prior art, adjuvant screening, process optimization and equipment are changed by the present invention by lot of experiments
Enter, it is provided that a kind of bromhexine hydrochloride tablet.This tablet slow release, gastrointestinal side-effect are little, and preparation technology is simple.
The object of the present invention is achieved like this:
A kind of bromhexine hydrochloride tablet, by tablet total weight amount percentages, consists of the following composition: Bisolvon 5-15
Part, fructose 20-40 part, calcium carbonate 30-50 part, Ascorbyl Palmitate 10-20 part, sodium alginate 10-20 part, hydroxypropyl
Methylcellulose 15-25 part, Radix Acaciae senegalis 5-15 part, polyvinylpolypyrrolidone 5-10 part, magnesium stearate 0.5-2.0 part.
Described bromhexine hydrochloride tablet, by tablet total weight amount percentages, consists of the following composition: Bisolvon 10 parts,
30 parts of fructose, calcium carbonate 40 parts, Ascorbyl Palmitate 15 parts, sodium alginate 15 parts, hydroxypropyl methyl cellulose 20 parts,
Radix Acaciae senegalis 10 parts, polyvinylpolypyrrolidone 8 parts, magnesium stearate 1 part.
Described bromhexine hydrochloride tablet, preparation method comprises the following steps: to take Bisolvon crude drug, and hydrochloric acid bromine is own
New raw material medicine is placed in disintegrating apparatus pulverizing；Bisolvon crude drug after pulverizing according to quantity stirs at granule with above-mentioned adjuvant
Mix homogeneously in machine, pelletizes according to a conventional method, tabletting, packs to obtain finished product.
Described bromhexine hydrochloride tablet, Particle mixer in preparation method, including agitator, it is arranged in described agitator
Shaft be arranged on described agitator the stirring motor being connected with described shaft, described shaft is provided with stirring
Oar, it is characterised in that: on described stirring paddle, it is provided with open-work, the inwall of described open-work is provided with annular groove, at described ring
It is provided with ring rotation block in connected in star, in described stirring paddle, is provided with the driving chamber being connected with described annular groove, described
Drive intracavity to be provided with micro-machine, the main shaft of described micro-machine is provided with driving fluted disc, outside described ring rotation block
Anchor ring is provided with the teeth groove mutually ratcheting with described driving fluted disc, is uniformly provided with at least three on the inner ring surface of described ring rotation block
Individual stirring bar, described stirring bar under the drive of described micro-machine in described open-work Stirring.
Described bromhexine hydrochloride tablet, granule stirs evenly two sides of stirring paddle in device and is horn-like setting and horn-like
Center be connected with open-work.
Described bromhexine hydrochloride tablet, granule stirs evenly shaft in device and is provided with upset motor, the master of described upset motor
Axle is connected with the end of described stirring paddle, drives stirring paddle to realize turning operation during described upset electric motor starting.
Described bromhexine hydrochloride tablet, granule stirs evenly stirring cylinder in device and is provided with the control being connected with described micro-machine
The speed governing knob that button processed is connected with described upset motor.
Compared with prior art, the bromhexine hydrochloride tablet that the present invention relates to has a most useful technique effect:
(1) release is steadily.(2) preparation technology is simple, Particle mixer simple in construction, simple operation, passes through when stirring
Medical material is stirred by stirring paddle, it is possible to make medicine pass from open-work, rotarily drives stirring bar now by ring rotation block
Rotate, thus the medicine through open-work is stirred further, such that it is able to be greatly improved the efficiency of stirring and be easier to medicine
Thing stirs, and stability in use is strong and practicality good.The bromhexine hydrochloride tablet of present invention screening is suitable for industrialized great production.
Accompanying drawing explanation
Fig. 1 is the structural representation of Particle mixer
Detailed description of the invention
The foregoing of the present invention is described in further detail by form more by the following examples, but should this not managed
The scope for the above-mentioned theme of the present invention that solves is only limitted to Examples below, and all technology realized based on foregoing of the present invention all belong to
In the scope of the present invention.
Embodiment 1
Weigh Bisolvon 10 parts, 30 parts of fructose, calcium carbonate 40 parts, Ascorbyl Palmitate 15 parts, alginic acid
15 parts of sodium, hydroxypropyl methyl cellulose 20 parts, Radix Acaciae senegalis 10 parts, polyvinylpolypyrrolidone 8 parts, magnesium stearate 1 part.
Preparation technology: Bisolvon crude drug is placed in disintegrating apparatus pulverizing；Hydrochloric acid bromine after pulverizing according to quantity is own
New raw material medicine is mixed homogeneously in Particle mixer with above-mentioned adjuvant, pelletizes according to a conventional method, tabletting, packs to obtain finished product.
Above-mentioned Particle mixer, is shown in Fig. 1, the shaft 2 that including agitator 1, is arranged in described agitator 1 and being arranged on
The stirring motor 3 being connected with described shaft 2 on described agitator 1, is provided with stirring paddle 4, described on described shaft 2
Stirring paddle 4 is provided with open-work 5, is provided with annular groove 6 on the inwall of described open-work 5, is provided with annular in described annular groove 6
Spill spin block 7, is provided with the driving chamber 8 being connected with described annular groove 6 in described stirring paddle 4, is provided with in described driving chamber 8
Micro-machine 9, is provided with driving fluted disc 10 on the main shaft of described micro-machine 9, sets on the outer ring surface of described ring rotation block 7
There is the teeth groove 11 mutually ratcheting with described driving fluted disc 10, the inner ring surface of described ring rotation block 7 is uniformly provided with at least three
Stirring bar 12, described stirring bar under the drive of described micro-machine in described open-work Stirring.When stirring by stirring
Mixing oar to be stirred by medical material, it is possible to make medical material pass from open-work, the stirring bar that rotarily drives now by ring rotation block revolves
Turn, thus the medical material through open-work is stirred further, such that it is able to be greatly improved the efficiency of stirring and be easier to medical material
Stir.
Two sides of described stirring paddle 4 are horn-like setting and trumpet-shaped center is connected with open-work.Use loudspeaker
Shape, make stirring paddle agitation time, medical material can try one's best more than pass through in open-work.
Described shaft 2 is provided with upset motor 13, the main shaft of described upset motor 13 and the end of described stirring paddle 4
It is connected, during described upset electric motor starting, drives stirring paddle to realize turning operation.As required stirring paddle can also be turned over
Turn, thus be greatly improved the efficiency of agitation.
Described stirring cylinder 1 is provided with the control knob 14 being connected with described micro-machine and described upset motor
The speed governing knob 15 being connected.Line for convenience in the present embodiment, can centrally disposed for hollow by shaft, then will
Wear from shaft centrally through, it can be configured line according to the technical experience of technical staff, and it also requires arrange
Bucket door.
Comparative example 2
Weigh Bisolvon 5 parts, 40 parts of fructose, calcium carbonate 30 parts, Ascorbyl Palmitate 20 parts, sodium alginate
10 parts, hydroxypropyl methyl cellulose 25 parts, Radix Acaciae senegalis 5 parts, polyvinylpolypyrrolidone 10 parts, magnesium stearate 0.5 part.
Preparation technology is ibid.
Comparative example 3
Weigh Bisolvon 15 parts, 20 parts of fructose, calcium carbonate 50 parts, Ascorbyl Palmitate 10 parts, alginic acid
20 parts of sodium, hydroxypropyl methyl cellulose 15 parts, Radix Acaciae senegalis 15 parts, polyvinylpolypyrrolidone 5 parts, magnesium stearate 2.0 parts.
Preparation technology is ibid.
Comparative example 4
Weigh Bisolvon 10 parts, 30 parts of fructose, calcium carbonate 40 parts, Ascorbyl Palmitate 15 parts, alginic acid
15 parts of sodium, hydroxypropyl methyl cellulose 20 parts, Radix Acaciae senegalis 10 parts, polyvinylpolypyrrolidone 8 parts, magnesium stearate 1 part.
Using plain particles blender in preparation technology, other steps are ibid.
The release research of embodiment 5 bromhexine hydrochloride tablet
Take the embodiment of the present invention 1 respectively, tablet prepared by comparative example 2-4, according to drug release determination method [version 5 in 2005
Chinese Pharmacopoeia (two) annex XD the first method], with 0.1mol/L hydrochloric acid solution 900mL as dissolution medium, in 37 ± 0.5 DEG C of conditions
Under, rotating speed is 50r/min, respectively at 2,6,10,20,30,45,60min sampling 5mL (supplements simultaneously and is preheated to 37 DEG C
0.1mol/L hydrochloric acid solution 5mL), immediately through 0.8um filtering with microporous membrane, take subsequent filtrate and measure according to determination, use external standard
Method calculates cumulative defaultlogic by labelled amount.Dissolution determination result such as table 1
Dissolution of sustained-release tablets measurement result prepared by each embodiment of table 1
| Sample source | 1h (%) | 3h (%) | 6h (%) | 9h (%) | 12h (%) | 24h (%) |
| Embodiment 1 | 23.7 | 52.4 | 77.1 | 85.6 | 97.4 | 100.2 |
| Comparative example 2 | 58.1 | 94.5 | 93.2 | 96.8 | 98.7 | 99.9 |
| Comparative example 3 | 67.4 | 92.9 | 97.5 | 101.5 | 99.3 | 98.4 |
| Comparative example 4 | 58.2 | 93.7 | 94.5 | 102.3 | 99.1 | 98.9 |
According to the result of the test of table 1, the bromhexine hydrochloride tablet release of the embodiment of the present invention 1 preparation is steadily；Contrast is real
Executing example 2-3 different due to supplementary material ratio, discharge too fast, Bisolvon is used plain particles blender by comparative example 4
Mixing, owing in the granule of preparation, Bisolvon is not fully wrapped up by adjuvant, therefore discharges too fast.
Claims (7)
1. a bromhexine hydrochloride tablet, it is characterised in that by tablet total weight amount percentages, consist of the following composition: hydrochloric acid bromine is own
New 5-15 part, fructose 20-40 part, calcium carbonate 30-50 part, Ascorbyl Palmitate 10-20 part, sodium alginate 10-20 part,
Hydroxypropyl methyl cellulose 15-25 part, Radix Acaciae senegalis 5-15 part, polyvinylpolypyrrolidone 5-10 part, magnesium stearate 0.5-2.0 part.
2. bromhexine hydrochloride tablet as claimed in claim 1, it is characterised in that by tablet total weight amount percentages, by following component group
Become: Bisolvon 10 parts, 30 parts of fructose, calcium carbonate 40 parts, Ascorbyl Palmitate 15 parts, sodium alginate 15 parts, hydroxyl
Propyl methocel 20 parts, Radix Acaciae senegalis 10 parts, polyvinylpolypyrrolidone 8 parts, magnesium stearate 1 part.
3. bromhexine hydrochloride tablet as claimed in claim 1, it is characterised in that it is own that preparation method comprises the following steps: to take hydrochloric acid bromine
New raw material medicine is placed in disintegrating apparatus pulverizing；Bisolvon crude drug after pulverizing according to quantity stirs at granule with above-mentioned adjuvant
Mix homogeneously in machine, pelletizes according to a conventional method, tabletting, packs to obtain finished product.
4. as claimed in claim 3 bromhexine hydrochloride tablet, it is characterised in that Particle mixer in preparation method, including agitator,
The shaft being arranged in described agitator be arranged on described agitator the stirring motor being connected with described shaft,
Described shaft is provided with stirring paddle, it is characterised in that: on described stirring paddle, it is provided with open-work, the inwall of described open-work sets
There is annular groove, in described annular groove, be provided with ring rotation block, be provided with in described stirring paddle and described annular groove phase
The driving chamber of connection, is provided with micro-machine at described driving intracavity, is provided with driving fluted disc on the main shaft of described micro-machine,
The outer ring surface of described ring rotation block is provided with the teeth groove mutually ratcheting with described driving fluted disc, at the internal ring of described ring rotation block
Being uniformly provided with at least three stirring bar on face, described stirring bar rotates in described open-work under the drive of described micro-machine and stirs
Mix.
Bromhexine hydrochloride tablet the most according to claim 4, it is characterised in that granule stirs evenly two sides of stirring paddle in device
It is horn-like setting and trumpet-shaped center is connected with open-work.
Bromhexine hydrochloride tablet the most according to claim 4, it is characterised in that granule stirs evenly shaft in device and is provided with upset
Motor, the main shaft of described upset motor is connected with the end of described stirring paddle, drives stirring paddle during described upset electric motor starting
Realize turning operation.
Bromhexine hydrochloride tablet the most according to claim 4, it is characterised in that granule stir evenly stirring cylinder in device be provided with
The speed governing knob that the control knob that described micro-machine is connected is connected with described upset motor.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610457108.2A CN106038498A (en) | 2016-06-22 | 2016-06-22 | Bromhexine hydrochloride tablet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610457108.2A CN106038498A (en) | 2016-06-22 | 2016-06-22 | Bromhexine hydrochloride tablet and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN106038498A true CN106038498A (en) | 2016-10-26 |
Family
ID=57169270
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610457108.2A Withdrawn CN106038498A (en) | 2016-06-22 | 2016-06-22 | Bromhexine hydrochloride tablet and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN106038498A (en) |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103145564A (en) * | 2013-03-15 | 2013-06-12 | 湖北美林药业有限公司 | Bromhexine hydrochloride compound and pharmaceutical composition thereof |
| US20130230587A1 (en) * | 2010-11-10 | 2013-09-05 | Rubicon Research Private Limited | Sustained release compositions |
| CN203342694U (en) * | 2013-06-28 | 2013-12-18 | 普罗旺斯番茄制品（天津）有限公司 | Stirring mechanism of stirring tank |
-
2016
- 2016-06-22 CN CN201610457108.2A patent/CN106038498A/en not_active Withdrawn
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20130230587A1 (en) * | 2010-11-10 | 2013-09-05 | Rubicon Research Private Limited | Sustained release compositions |
| CN103145564A (en) * | 2013-03-15 | 2013-06-12 | 湖北美林药业有限公司 | Bromhexine hydrochloride compound and pharmaceutical composition thereof |
| CN203342694U (en) * | 2013-06-28 | 2013-12-18 | 普罗旺斯番茄制品（天津）有限公司 | Stirring mechanism of stirring tank |
Non-Patent Citations (4)
| Title |
|---|
| 朱宏吉，等: "《制药设备与工程设计》", 31 July 2004, 北京：化学工业出版社 * |
| 胡容峰: "《工业药剂学》", 31 August 2010, 北京：中国中医药出版社 * |
| 艾秀娟: "盐酸溴己新缓释片的制备及体外释放度研究", 《海峡药学》 * |
| 金青哲: "《功能性脂质》", 31 August 2013, 中国轻工业出版社 * |
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Application publication date: 20161026 |