CN107320494A - A kind of Paracetamol and Amantadine Compound composition and preparation method thereof - Google Patents
A kind of Paracetamol and Amantadine Compound composition and preparation method thereof Download PDFInfo
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
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- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
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- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
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- A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
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Abstract
The present invention relates to a kind of Paracetamol and Amantadine Compound composition, it is made up of the component of following parts by weight：200 300 parts of paracetamol, 80 120 parts of amantadine hydrochloride, 12 18 parts of caffeine, 8 12 parts of calculus bovis factitius, 13 parts of chlorphenamine maleate, 200 400 parts of algal polysaccharides.The present invention on the basis of conventional paracetamol and amantadine hydrochloride composition medicine component by adjusting usage ratio; and add the algal polysaccharides of special ratios; eligible compositions can immunological liver injury caused by paracetamol have good protective effect, reduce hepatic injury degree caused by paracetamol.
Description
Technical field
The present invention relates to a kind of Paracetamol and Amantadine Compound composition and preparation method thereof, belong to field of medicine preparing technology.
Background technology
Drug induced hepatic injury refers to after using certain or several drugses, as medicine in itself or liver caused by its metabolite
Dirty damage.It is reported that in the chemical combination or biomedicinal of application has been listed, the medicine for having more than 1100 kinds has potentially
Hepatotoxicity wind agitation；Excipient, Chinese herbal medicine and the health care medicinal of many medicines also have the possibility for causing hepatic injury.Drug induced hepatic injury can
The acute or chronic liver diseases of any types known today are shown as, wherein it is most common with acute liver damage, account for report disease
The fulminant of life-threatening or severe liver failure can occur for more than the 90% of number of cases, small number of patients, be that use in medicament-induced hepatotoxicity is faced
Bed monitoring and the emphasis of preventing and treating.
Paracetamol is non-toxic under a kind of gentle analgesic-antipyretic, therapeutic dose, but for susceptible person, then can be into
For strong Hepatoxic substance, cause lesion and the damage of hepatic tissue cell.In pharmaceutical research, it is small that paracetamol is induced
Mouse hepatic injury is often used as the research that Drug acute hepatic injury model carries out hepatic effect.Phenylalanine ammonia group-transfer
Enzyme (ALT) and Aspartate aminotransferase (AST) are the major function enzymes in liver, in liver organization damage and necrosis, enzyme
Blood is overflowed into from intracellular so that the level of serum correlation transaminase is significantly raised.
Food and medicine Surveillance Authority of the U.S. (FDA) issue report claims, and limitation acetparaminosalol phenols medicine can reduce trouble
Person can cause liver failure even dead because of the risk that major Liver is damaged caused by excessive use, liver damage.Root
Counted according to FDA, the whole America there are 1600 acute liver failures every year, and wherein paracetamol excessive use is maximum cause.
However, yet there are no the correlative study that the medicine containing paracetamol is effectively improved hepatic injury.
Algal polysaccharides are a kind of natural active matters, there is good biocompatibility, nontoxic, with it is hypoglycemic, anti-oxidant,
Strengthen the effect such as immunocompetence.Can as cell cold-resistant protective agent, be commonly used for thickener, breast on bioadhesive polymer, or preparation
Agent or filler (such as CN104606232A), it is also possible to make encapsulating material.But so far, for the other of algal polysaccharides
Function not yet has further exploitation.
The content of the invention
The present invention carries out more in-depth study for what existing paracetamol and amantadine hydrochloride composition was present to hepatic injury situation, proposes
A kind of new paracetamol and amantadine hydrochloride composition containing algal polysaccharides.
The present invention develops the new application of algal polysaccharides, and experiment proves that only under the premise of specific compatibility, marine alga
Polysaccharide acts synergistically with other components competence exertion in paracetamol and amantadine hydrochloride composition, and then to being immunized as caused by paracetamol
Property hepatic injury has good protective effect, reduces hepatic injury degree caused by paracetamol, achieves unexpected
Technique effect.
The present invention adopts the following technical scheme that realization：
A kind of Paracetamol and Amantadine Compound composition, is made up of the component of following parts by weight：1-3 parts of chlorphenamine maleate, people
8-12 parts of work cow-bezoar, 12-18 parts of caffeine, 80-120 parts of amantadine hydrochloride, 200-300 parts of paracetamol, marine alga is more
It is sugared 200-400 parts.
Preferably, the Paracetamol and Amantadine Compound composition, is made up of the component of following parts by weight：Chlorphenamine maleate 1-
3 parts, 9-11 parts of calculus bovis factitius, 14-16 parts of caffeine, 90-110 parts of amantadine hydrochloride, 240-260 parts of paracetamol,
240-360 parts of algal polysaccharides.
Preferably, the Paracetamol and Amantadine Compound composition, is made up of the component of following parts by weight：Chlorphenamine maleate 2
Part, 10 parts of calculus bovis factitius, 15 parts of caffeine, 100 parts of amantadine hydrochloride, 250 parts of paracetamol, algal polysaccharides 240-
360 parts.
Preferably, the Paracetamol and Amantadine Compound composition, is made up of the component of following parts by weight：Chlorphenamine maleate 2
Part, 10 parts of calculus bovis factitius, 15 parts of caffeine, 100 parts of amantadine hydrochloride, 250 parts of paracetamol, algal polysaccharides 240-
250 parts.
Preferably, the Paracetamol and Amantadine Compound composition, is made up of the component of following parts by weight：Chlorphenamine maleate 2
Part, 10 parts of calculus bovis factitius, 15 parts of caffeine, 100 parts of amantadine hydrochloride, 250 parts of paracetamol, algal polysaccharides 290-
310 parts.
Preferably, the Paracetamol and Amantadine Compound composition, is made up of the component of following parts by weight：Chlorphenamine maleate 2
Part, 10 parts of calculus bovis factitius, 15 parts of caffeine, 100 parts of amantadine hydrochloride, 250 parts of paracetamol, algal polysaccharides 350-
360 parts.
The present invention also provides application of the above-mentioned Paracetamol and Amantadine Compound composition in treatment flu disorder agent.The medicine
It can be made into conventional solid orally ingestible understood by one of ordinary skill in the art, such as capsule, tablet, granule.
As one of preferred embodiment of the present invention, the capsule preparation flow is：Crushing material → sieving → title
Amount → mixing → softwood processed → extrusion spheronization pelletization → drying → whole ball → total mixing.
The specific preparation process of the capsule is as follows：
(1) first by each crushing material, sieve, weigh；
(2) chlorphenamine maleate, calculus bovis factitius, caffeine are well mixed, add amantadine hydrochloride, acetyl ammonia
Base phenol, algal polysaccharides, are mixed；Softwood is made in guiding humid medium after gained mixed powder is further crushed, and sieves, granulation；
In this step, it will first account for the less component of gross weight and mix, the larger component of accounting weight is added, so that it is guaranteed that respectively
Component mixing is abundant；The wetting agent refers generally to the common agents such as water, ethanol.
(3) using purified water as wetting agent, particle obtained by step (2) is added in coating granulator and rolls pill, fluid bed
Dry (preferably 45 degree), whole grain obtains the piller of 16-30 mesh sieves, and the piller after whole grain is well mixed, examine, filling is produced
Fufang Anfenwanan capsules.
The consumption such as auxiliary material and female ball pill, concrete operation step etc. are this in capsule preparation technology of the present invention
Conventional technical means known to art personnel.
The present invention adds the algal polysaccharides of specific proportioning on the basis of existing conventional paracetamol and amantadine hydrochloride composition component, is obtained
Composition hepatic injury degree is obviously reduced.
Embodiment
Following examples are used to illustrate the present invention, but are not limited to the scope of the present invention.
Embodiment 1
A kind of Paracetamol and Amantadine Compound composition, is formulated and is：Chlorphenamine maleate 20g, calculus bovis factitius 100g, caffeine
150g, amantadine hydrochloride 1000g, paracetamol 2500g, algal polysaccharides 3000g.
Making programme：Crushing material → sieving → weighing → mixing → softwood processed → extrusion spheronization pelletization → drying → whole ball
→ always mixing.
Comprise the following steps that：
First by each crushing material, sieve, weigh, chlorphenamine maleate, calculus bovis factitius, caffeine are well mixed, then
Amantadine hydrochloride, paracetamol, algal polysaccharides are added in above-mentioned mixed powder and are well mixed, by obtained mixed powder powder
Add wetting agent that softwood is made after broken, sieve, after granulation, produced particle is added into pill in coating granulator, using purified water
For wetting agent, be gradually added supplementary material medicinal powder and roll pill, carry out 45 degree dryings of fluid bed, whole grain (obtain 16 mesh to 30 mesh sieves it
Between piller), the piller for haveing suffered grain is well mixed, through examine, filling produce Fufang Anfenwanan capsules.
Embodiment 2
A kind of Paracetamol and Amantadine Compound composition, is formulated and is：Chlorphenamine maleate 20g, calculus bovis factitius 100g, caffeine
150g, amantadine hydrochloride 1000g, paracetamol 2500g, algal polysaccharides 2400g.
Making programme：Crushing material → sieving → weighing → mixing → softwood processed → extrusion spheronization pelletization → drying → whole ball
→ always mixing.
Comprise the following steps that：
First by each crushing material, sieve, weigh, chlorphenamine maleate, calculus bovis factitius, caffeine are well mixed, then
Amantadine hydrochloride, paracetamol, algal polysaccharides are added in above-mentioned mixed powder and are well mixed, by obtained mixed powder powder
Add wetting agent that softwood is made after broken, sieve, after granulation, produced particle is added into pill in coating granulator, using purified water
For wetting agent, be gradually added supplementary material medicinal powder and roll pill, carry out 45 degree dryings of fluid bed, whole grain (obtain 16 mesh to 30 mesh sieves it
Between piller), the piller for haveing suffered grain is well mixed, through examine, filling produce Fufang Anfenwanan capsules.
Embodiment 3
A kind of Paracetamol and Amantadine Compound composition, is formulated and is：Chlorphenamine maleate 20g, calculus bovis factitius 100g, caffeine
150g, amantadine hydrochloride 1000g, paracetamol 2500g, algal polysaccharides 3600g.
Making programme：Crushing material → sieving → weighing → mixing → softwood processed → extrusion spheronization pelletization → drying → whole ball
→ always mixing.
Comprise the following steps that：
First by each crushing material, sieve, weigh, chlorphenamine maleate, calculus bovis factitius, caffeine are well mixed, then
Amantadine hydrochloride, paracetamol, algal polysaccharides are added in above-mentioned mixed powder and are well mixed, by obtained mixed powder powder
Add wetting agent that softwood is made after broken, sieve, after granulation, produced particle is added into pill in coating granulator, using purified water
For wetting agent, be gradually added supplementary material medicinal powder and roll pill, carry out 45 degree dryings of fluid bed, whole grain (obtain 16 mesh to 30 mesh sieves it
Between piller), the piller for haveing suffered grain is well mixed, through examine, filling produce Fufang Anfenwanan capsules.
Comparative example 1 (the Paracetamol and Amantadine Compound composite formula for not containing algal polysaccharides)
Existing Paracetamol and Amantadine Compound composition, is formulated and is：Chlorphenamine maleate 20g, calculus bovis factitius 100g, caffeine
150g, amantadine hydrochloride 1000g, paracetamol 2500g, dextrin 80g.
Making programme：Crushing material → sieving → weighing → mixing → softwood processed → extrusion spheronization pelletization → drying → whole ball
→ always mixing.Be the same as Example 1.
Comprise the following steps that：
First by each crushing material, sieve, weigh, dextrin, chlorphenamine maleate, calculus bovis factitius, caffeine are mixed equal
It is even, then amantadine hydrochloride, paracetamol, algal polysaccharides are added in above-mentioned mixed powder and are well mixed, it is mixed by what is obtained
Close after powder is crushed plus softwood is made in wetting agent, sieve, after granulation, produced particle is added into pill in coating granulator, used
Purified water is wetting agent, is gradually added supplementary material medicinal powder and rolls pill, carries out 45 degree of dryings of fluid bed, and whole grain (obtains 16 mesh to 30
Piller between mesh sieve), the piller for haveing suffered grain is well mixed, through examining, filling produces Fufang Anfenwanan capsules.
Comparative example 2 (the Paracetamol and Amantadine Compound composite formula containing a small amount of algal polysaccharides)
Existing Paracetamol and Amantadine Compound composition, is formulated and is：Chlorphenamine maleate 20g, calculus bovis factitius 100g, caffeine
150g, amantadine hydrochloride 1000g, paracetamol 2500g, algal polysaccharides 60g, dextrin 80g.
Making programme：Crushing material → sieving → weighing → mixing → softwood processed → extrusion spheronization pelletization → drying → whole ball
→ always mixing.Be the same as Example 1.
Comprise the following steps that：
First by each crushing material, sieve, weigh, dextrin, chlorphenamine maleate, calculus bovis factitius, caffeine are mixed equal
It is even, then amantadine hydrochloride, paracetamol, algal polysaccharides are added in above-mentioned mixed powder and are well mixed, it is mixed by what is obtained
Close after powder is crushed plus softwood is made in wetting agent, sieve, after granulation, produced particle is added into pill in coating granulator, used
Purified water is wetting agent, is gradually added supplementary material medicinal powder and rolls pill, carries out 45 degree of dryings of fluid bed, and whole grain (obtains 16 mesh to 30
Piller between mesh sieve), the piller for haveing suffered grain is well mixed, through examining, filling produces Fufang Anfenwanan capsules.
Comparative example 3 (presently commercially available common Paracetamol and Amantadine Compound composite formula)
Existing Paracetamol and Amantadine Compound composition, is formulated and is：Chlorphenamine maleate 20g, calculus bovis factitius 100g, caffeine
150g, amantadine hydrochloride 1000g, paracetamol 2500g, sucrose 100g.
Making programme：Crushing material → sieving → weighing → mixing → softwood processed → extrusion spheronization pelletization → drying → whole ball
→ always mixing.Be the same as Example 1.
Comprise the following steps that：
First by each crushing material, sieve, weigh, dextrin, chlorphenamine maleate, calculus bovis factitius, caffeine are mixed equal
It is even, then amantadine hydrochloride, paracetamol, algal polysaccharides are added in above-mentioned mixed powder and are well mixed, it is mixed by what is obtained
Close after powder is crushed plus softwood is made in wetting agent, sieve, after granulation, produced particle is added into pill in coating granulator, used
Purified water is wetting agent, is gradually added supplementary material medicinal powder and rolls pill, carries out 45 degree of dryings of fluid bed, and whole grain (obtains 16 mesh to 30
Piller between mesh sieve), the piller for haveing suffered grain is well mixed, through examining, filling produces Fufang Anfenwanan capsules.
The test of pesticide effectiveness：Influence to mice serum transaminase level
The male ICR mouse for taking body weight to be 22-24g, is randomly divided into 8 groups, control group, model group and tested each group (are implemented
1 group of example, 2 groups of embodiment, 3 groups of embodiment, 1 group of comparative example, 2 groups of comparative example, 3 groups of comparative example), every group 10, each group before experiment
Animal fasting 24h overnight, model group gavage gives 0.6g/kg paracetamol, and tested each group gavage gives composition (phase
When in 0.6g/kg paracetamol), control group gavage is given all animals after dextrin (1.5g/kg), administration 24h and won
Eyeball takes blood, serum is separated, with kit measurement Serum ALT (glutamic-pyruvic transaminase), AST (glutamic-oxalacetic transaminease) value.It the results are shown in Table
1。
The influence of AST, ALT content in the mice serum of table 1
| AST(U/L) | ALT(U/L) | |
| Control group | 61.7±10.8 | 39.2±7.8 |
| Model group | 239.7±18.5 | 85.6±11.3 |
| Embodiment 1 | 159.2±17.6 | 65.5±10.1 |
| Embodiment 2 | 175.6±18.1 | 67.5±13.1 |
| Embodiment 3 | 158.1±16.3 | 67.2±12.4 |
| Comparative example 1 | 232.0±19.6 | 81.9±15.5 |
| Comparative example 2 | 230.9±18.7 | 82.3±13.6 |
| Comparative example 3 | 229.1±20.3 | 83.6±15.2 |
The result of table 1 shows that (1) is given after paracetamol, and AST, ALT content of model group are significantly raised, and right
Compared according to group with significant difference statistically, illustrate modeling success.
(2) each embodiment group transaminase content compared with model group is decreased obviously, poor with conspicuousness statistically
It is different；
(3) each comparative example group transaminase content compared with model group has no significant change, and illustrates the addition of algal polysaccharides
Only it is only possible to play with other components under specific conditions of mixture ratios and acts synergistically, realizes reduction paracetamol to hepatic injury
Effect of degree.
Relative to other components, transaminase changes of contents becomes algal polysaccharides between 200-400 parts in composition proportioning
Slow, the change more than 400 parts is not obvious, and paracetamol tends towards stability to hepatic injury degree reduction degree.
Although above the present invention is described in detail with a general description of the specific embodiments,
On the basis of the present invention, it can be made some modifications or improvements, this will be apparent to those skilled in the art.Cause
This, these modifications or improvements, belong to the scope of protection of present invention without departing from theon the basis of the spirit of the present invention.
Claims (9)
1. a kind of Paracetamol and Amantadine Compound composition, it is characterised in that be made up of the component of following parts by weight：Chlorphenamine maleate
1-3 parts, 8-12 parts of calculus bovis factitius, 12-18 parts of caffeine, 80-120 parts of amantadine hydrochloride, paracetamol 200-300
Part, 200-400 parts of algal polysaccharides.
2. Paracetamol and Amantadine Compound composition according to claim 1, it is characterised in that by the component group of following parts by weight
Into：1-3 parts of chlorphenamine maleate, 9-11 parts of calculus bovis factitius, 14-16 parts of caffeine, 90-110 parts of amantadine hydrochloride, to second
240-260 parts of acylamino- phenol, 240-360 parts of algal polysaccharides.
3. Paracetamol and Amantadine Compound composition according to claim 1, it is characterised in that by the component group of following parts by weight
Into：2 parts of chlorphenamine maleate, 10 parts of calculus bovis factitius, 15 parts of caffeine, 100 parts of amantadine hydrochloride, paracetamol
250 parts, 240-360 parts of algal polysaccharides.
4. Paracetamol and Amantadine Compound composition according to claim 1, it is characterised in that by the component group of following parts by weight
Into：2 parts of chlorphenamine maleate, 10 parts of calculus bovis factitius, 15 parts of caffeine, 100 parts of amantadine hydrochloride, paracetamol
250 parts, 240-250 parts of algal polysaccharides.
5. Paracetamol and Amantadine Compound composition according to claim 1, it is characterised in that by the component group of following parts by weight
Into：2 parts of chlorphenamine maleate, 10 parts of calculus bovis factitius, 15 parts of caffeine, 100 parts of amantadine hydrochloride, paracetamol
250 parts, 290-310 parts of algal polysaccharides.
6. Paracetamol and Amantadine Compound composition according to claim 1, it is characterised in that by the component group of following parts by weight
Into：2 parts of chlorphenamine maleate, 10 parts of calculus bovis factitius, 15 parts of caffeine, 100 parts of amantadine hydrochloride, paracetamol
250 parts, 350-360 parts of algal polysaccharides.
7. a kind of preparation containing any Paracetamol and Amantadine Compound compositions of claim 1-6, it is characterised in that formulation is solid
Body oral formulations, preferably capsule, tablet, granule.
8. a kind of preparation method of the capsule containing any Paracetamol and Amantadine Compound compositions of claim 1-6, its feature
It is, comprises the following steps：
(1) first by each crushing material, sieve, weigh；
(2) chlorphenamine maleate, calculus bovis factitius, caffeine are well mixed, add amantadine hydrochloride, acetparaminosalol
Phenol, algal polysaccharides are mixed, and softwood is made after obtained mixed powder is further crushed, and are sieved, granulation；
(3) particle obtained by step (2) is rolled into pill, dried, whole grain obtains the piller of 16-30 mesh sieves, examined, filling, i.e.,
.
9. application of any Paracetamol and Amantadine Compound compositions of claim 1-6 in treatment flu disorder agent is prepared.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108578477A (en) * | 2018-06-19 | 2018-09-28 | 吉林百年汉克制药有限公司 | A kind of Compound injection of paracetamol pharmaceutical composition and its preparation method and application |
| CN110237097A (en) * | 2019-07-19 | 2019-09-17 | 江西铜鼓仁和制药有限公司 | A kind of Fufang Anfenwanan capsules pellet and preparation method thereof |
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2017
- 2017-05-25 CN CN201710381370.8A patent/CN107320494A/en active Pending
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN108578477A (en) * | 2018-06-19 | 2018-09-28 | 吉林百年汉克制药有限公司 | A kind of Compound injection of paracetamol pharmaceutical composition and its preparation method and application |
| CN110237097A (en) * | 2019-07-19 | 2019-09-17 | 江西铜鼓仁和制药有限公司 | A kind of Fufang Anfenwanan capsules pellet and preparation method thereof |
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