CN107648226A - A kind of pharmaceutical composition for treating antimigraine and preparation method thereof - Google Patents
A kind of pharmaceutical composition for treating antimigraine and preparation method thereof Download PDFInfo
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- CN107648226A CN107648226A CN201711088897.8A CN201711088897A CN107648226A CN 107648226 A CN107648226 A CN 107648226A CN 201711088897 A CN201711088897 A CN 201711088897A CN 107648226 A CN107648226 A CN 107648226A
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- pharmaceutical composition
- methylcellulose
- indomethacin
- magnesium stearate
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- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
- A61K31/404—Indoles, e.g. pindolol
- A61K31/405—Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
- A61K31/404—Indoles, e.g. pindolol
- A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
-
- 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
-
- 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
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention belongs to pharmaceutical technology field, specifically disclose a kind of pharmaceutical composition for treating antimigraine and preparation method thereof, the pharmaceutical composition of the treatment antimigraine, count, be made up of 25 parts of 10 50 parts of Indomethacin, 10 20 parts of sumatriptan, 5 15 parts of pregelatinized starch, 28 parts of Ac-Di-Sol, 0.1 1 parts of magnesium stearate, 0.1 0.5 parts of Arabic gum, 0.1 0.5 parts of ascorbic acid, 25 parts of methylcellulose and polyethylene glycol in parts by weight.The present invention is raw material from clinical common single dose medicine, and each component maximum level is no more than States Pharmacopoeia specifications, safe to use, scientific formulation, non-evident effect, and cost is cheap.
Description
Technical field
The invention belongs to field of medical technology, and in particular to a kind of pharmaceutical composition for treating antimigraine and its preparation side
Method.
Background technology
Antimigraine (Migraine) refers to the one or both sides pulsatile headache of recurrent exerbation, for clinical common idiopathic
Headache.It is a kind of Primary Intracranial vasomotion and the not normal caused recurrent disease of nervous function regulation, has the course of disease
Long, intermittent recurrent exerbation, it is touching refractory the features such as.The ratio between incidence of disease men and women of antimigraine is 1: 4.Its pathogenesis is not yet complete
It is complete to understand, may be relevant with the factor such as heredity, endocrine, metabolism, diet and spirit.At present, the incidence of disease of antimigraine is in America and Europe
Country is 10%-15%, and China is 0.06%.Scholarly forecast, to 2017, antimigraine will turn into China's incidence of disease highest disease
One of disease, it has had a strong impact on the quality of life of people.
Sumatriptan (Sumatriptan) is a kind of medicine for being used to treat antimigraine, and its chemical name is 3- [2- (two
Methylamino) ethyl]-N- methyl indol -5- Methanesulfonamides.Sumatriptan is a kind of 5-HT1 receptor stimulating agents, can highly be selected
Property excitement blood vessel 5-HT1 acceptors, shrink entocranial artery, blood redistribution makes brain blood flow supply be improved, therefore can mitigate
Neurogenic inflammation in endocranium, it helps improve antimigraine.Listing formulation mainly has injection, tablet at present.
But because the therapy mechanism of above-mentioned single preparations of ephedrine is single, clinical effectiveness is also undesirable, also needs to find and more effectively control
Treat migraine remedy.
The content of the invention
In order to solve the above problems, the present invention provides a kind of pharmaceutical composition for treating antimigraine and preparation method thereof, from
A variety of mechanism of action treat antimigraine, find the best combination of Indomethacin and sumatriptan, and research and design clinical effectiveness is good,
The small combination formula of toxic side effect.
The present invention is only applicable to nervous migraine patient, there is other diseases or hepatic and kidney function obstacle person disabling.
The technical scheme that the present invention solves above-mentioned technical problem is as follows：A kind of pharmaceutical composition for treating antimigraine, by weight
Number meter is measured, by Indomethacin 10-50 parts, sumatriptan 10-20 parts, pregelatinized starch 5-15 parts, cross-linked carboxymethyl cellulose
Sodium 2-8 parts, magnesium stearate 0.1-1 parts, Arabic gum 0.1-0.5 parts, ascorbic acid 0.1-0.5 parts, methylcellulose 2-5 parts and
Polyethylene glycol 2-5 parts form.
On the basis of above-mentioned technical proposal, the present invention can also do following improvement.
Preferably, a kind of pharmaceutical composition for treating antimigraine, is counted in parts by weight, by 10 parts of Indomethacin, Shu Mapu
Smooth 20 parts, 10 parts of pregelatinized starch, 8 parts of Ac-Di-Sol, 0.5 part of magnesium stearate, 0.3 part of Arabic gum, anti-ring
2 parts of 0.1 part of hematic acid, 5 parts of methylcellulose and polyethylene glycol compositions.
Preferably, a kind of pharmaceutical composition for treating antimigraine, is counted in parts by weight, by 30 parts of Indomethacin, Shu Mapu
Smooth 15 parts, 5 parts of pregelatinized starch, 5 parts of Ac-Di-Sol, 0.8 part of magnesium stearate, 0.1 part of Arabic gum, anti-ring blood
5 parts of 0.3 part of acid, 2 parts of methylcellulose and polyethylene glycol compositions.
Preferably, a kind of pharmaceutical composition for treating antimigraine, is counted in parts by weight, by 40 parts of Indomethacin, Shu Mapu
Smooth 15 parts, 5 parts of pregelatinized starch, 5 parts of Ac-Di-Sol, 0.5 part of magnesium stearate, 0.3 part of Arabic gum, anti-ring blood
5 parts of 0.2 part of acid, 2 parts of methylcellulose and polyethylene glycol compositions.
Preferably, a kind of pharmaceutical composition for treating antimigraine, is counted in parts by weight, by 50 parts of Indomethacin, Shu Mapu
Smooth 15 parts, 5 parts of pregelatinized starch, 5 parts of Ac-Di-Sol, 1 part of magnesium stearate, 0.5 part of Arabic gum, ascorbic acid
5 parts of 0.5 part, 5 parts of methylcellulose and polyethylene glycol compositions.
The present invention also provides a kind of preparation method for the pharmaceutical composition for treating antimigraine, comprises the following steps：
A. count in parts by weight, take following raw material：Indomethacin 10-50 parts, sumatriptan 10-20 parts, pregelatinized starch
5-15 parts, Ac-Di-Sol 2-8 parts, magnesium stearate 0.1-1 parts, Arabic gum 0.1-0.5 parts, ascorbic acid 0.1-
0.5 part, methylcellulose 2-5 parts and polyethylene glycol 2-5 parts；
B. by Indomethacin, sumatriptan, Ac-Di-Sol, Arabic gum, ascorbic acid, methylcellulose
It is well mixed with polyethylene glycol, is pelletized with 5% pregelatinized starch solution, is placed in 60 DEG C of oven for drying, whole grain of sieving；
C. magnesium stearate is added into particle described in step b, be well mixed, direct tablet compressing, piece weight 0.2g.
Compared with prior art, the beneficial effects of the invention are as follows：
The present invention is ground based on cognition of the modern medicine study to migraine attack mechanism and principle of reatment with reference to modern medicines
Study carefully, have selected the medicine containing various active ingredients, form compound medicine, it is comprehensive to play regulation neural blood vessel systolic and diastolic function, solution
Except vasopasm, so as to reach the purpose of control and prevention of migraine breaking-out.The present invention is original from clinical common single dose medicine
Material, each component maximum level is no more than States Pharmacopoeia specifications, safe to use, scientific formulation, non-evident effect, and cost is cheap.
Embodiment
The principles and features of the present invention are described below, and the given examples are served only to explain the present invention, is not intended to limit
Determine the scope of the present invention.
Embodiment 1
A kind of preparation for the pharmaceutical composition for treating antimigraine, comprises the following steps：
A. by weight, following raw material is taken：Indomethacin 10g, sumatriptan 20g, pregelatinized starch 10g, crosslinking carboxylic first
Base sodium cellulosate 8g, magnesium stearate 0.5g, Arabic gum 0.3g, ascorbic acid 0.1g, methylcellulose 5g and polyethylene glycol 2g；
B. by Indomethacin, sumatriptan, Ac-Di-Sol, Arabic gum, ascorbic acid, methylcellulose
It is well mixed with polyethylene glycol, is pelletized with 5% pregelatinized starch solution, is placed in 60 DEG C of oven for drying, whole grain of sieving；
C. magnesium stearate is added into particle described in step b, be well mixed, direct tablet compressing, piece weight 0.2g.
Embodiment 2
A kind of preparation for the pharmaceutical composition for treating antimigraine, comprises the following steps：
A. by weight, following raw material is taken：Indomethacin 30g, sumatriptan 15g, pregelatinized starch 5g, cross-linked carboxymethyl
Sodium cellulosate 5g, magnesium stearate 0.8g, Arabic gum 0.1g, ascorbic acid 0.3g, methylcellulose 2g and polyethylene glycol 5g；
B. by Indomethacin, sumatriptan, Ac-Di-Sol, Arabic gum, ascorbic acid, methylcellulose
It is well mixed with polyethylene glycol, is pelletized with 5% pregelatinized starch solution, is placed in 60 DEG C of oven for drying, whole grain of sieving；
C. magnesium stearate is added into particle described in step b, be well mixed, direct tablet compressing, piece weight 0.2g.
Embodiment 3
A kind of preparation for the pharmaceutical composition for treating antimigraine, comprises the following steps：
A. by weight, following raw material is taken：Indomethacin 40g, sumatriptan 15g, pregelatinized starch 5g, cross-linked carboxymethyl
Sodium cellulosate 5g, magnesium stearate 0.5g, Arabic gum 0.3g, ascorbic acid 0.2g, methylcellulose 2g and polyethylene glycol 5g；
B. by Indomethacin, sumatriptan, Ac-Di-Sol, Arabic gum, ascorbic acid, methylcellulose
It is well mixed with polyethylene glycol, is pelletized with 5% pregelatinized starch solution, is placed in 60 DEG C of oven for drying, whole grain of sieving；
C. magnesium stearate is added into particle described in step b, be well mixed, direct tablet compressing, piece weight 0.2g.
Embodiment 4
A kind of preparation for the pharmaceutical composition for treating antimigraine, comprises the following steps：
A. by weight, following raw material is taken：Indomethacin 50g, sumatriptan 15g, pregelatinized starch 5g, cross-linked carboxymethyl
Sodium cellulosate 5g, magnesium stearate 1g, Arabic gum 0.5g, ascorbic acid 0.5g, methylcellulose 5g and polyethylene glycol 5g；
B. by Indomethacin, sumatriptan, Ac-Di-Sol, Arabic gum, ascorbic acid, methylcellulose
It is well mixed with polyethylene glycol, is pelletized with 5% pregelatinized starch solution, is placed in 60 DEG C of oven for drying, whole grain of sieving；
C. magnesium stearate is added into particle described in step b, be well mixed, direct tablet compressing, piece weight 0.2g.Comparative example
A kind of preparation for the pharmaceutical composition for treating antimigraine, comprises the following steps：
A. by weight, following raw material is taken：Sumatriptan 15g, pregelatinized starch 5g, Ac-Di-Sol 5g,
Magnesium stearate 1g, Arabic gum 0.5g, ascorbic acid 0.5g, methylcellulose 5g and polyethylene glycol 5g；
B. by sumatriptan, Ac-Di-Sol, Arabic gum, ascorbic acid, methylcellulose and poly- second two
Alcohol is well mixed, and is pelletized with 5% pregelatinized starch solution, is placed in 60 DEG C of oven for drying, whole grain of sieving；
C. magnesium stearate is added into particle described in step b, be well mixed, direct tablet compressing, piece weight 0.2g.
The pharmaceutical composition of the treatment antimigraine prepared to embodiment 1 has carried out clinical test, as a result as follows:1st, research pair
As
Selection meets the case 252 of antimigraine diagnostic criteria, selected case age 22-67 year, average age 39.7 years old,
Medical history 1-19, above-mentioned patient is randomly divided into experimental group and control group, every group of 126 people.
2nd, treatment method
1. control group：Control group takes the pharmaceutical composition of the treatment antimigraine prepared in comparative example of the present invention, and daily two
It is secondary, each two panels.
2. experimental group takes the pharmaceutical composition of the treatment antimigraine prepared in the embodiment of the present invention 1, twice daily, every time
Two panels.
Two groups with 10 days for a course for the treatment of, 1 course for the treatment of of medication.
3rd, curative effect determinate standard
Have a headache after one course for the treatment of terminates or in drug administration process and disappear, without recidivist to cure in 3 months；If inclined head in 3 months
Pain recurs, and headache disappearance is as effective after a course for the treatment of is taken；After one course for the treatment of terminates
4th, treatment results
The test result of observation group and control group is shown in Table 1.
The test result table of comparisons of table 1
| Cure | It is effective | Effectively | It is invalid | Total effective rate | |
| Observation group (126 people) | 48 | 32 | 29 | 17 | 86.5% |
| Control group (126 people) | 35 | 39 | 21 | 31 | 75.4% |
5th, conclusion
The present invention is raw material from clinical common single dose medicine, and each component maximum level is no more than States Pharmacopoeia specifications, uses peace
Entirely, efficient height, scientific formulation, non-evident effect, and cost is cheap.
Claims (6)
1. a kind of pharmaceutical composition for treating antimigraine, it is characterised in that count, by Indomethacin 10-50 parts, relax in parts by weight
Ma Putan 10-20 parts, pregelatinized starch 5-15 parts, Ac-Di-Sol 2-8 parts, magnesium stearate 0.1-1 parts, Arab
Glue 0.1-0.5 parts, ascorbic acid 0.1-0.5 parts, methylcellulose 2-5 parts and polyethylene glycol 2-5 parts composition.
A kind of 2. pharmaceutical composition for treating antimigraine according to claim 1, it is characterised in that count in parts by weight,
By 10 parts of Indomethacin, 20 parts of sumatriptan, 10 parts of pregelatinized starch, 8 parts of Ac-Di-Sol, magnesium stearate 0.5
Part, 0.3 part of Arabic gum, 0.1 part of ascorbic acid, 5 parts of methylcellulose and 2 parts of compositions of polyethylene glycol.
A kind of 3. pharmaceutical composition for treating antimigraine according to claim 1, it is characterised in that count in parts by weight,
By 30 parts of Indomethacin, 15 parts of sumatriptan, 5 parts of pregelatinized starch, 5 parts of Ac-Di-Sol, magnesium stearate 0.8
Part, 0.1 part of Arabic gum, 0.3 part of ascorbic acid, 2 parts of methylcellulose and 5 parts of compositions of polyethylene glycol.
A kind of 4. pharmaceutical composition for treating antimigraine according to claim 1, it is characterised in that count in parts by weight,
By 40 parts of Indomethacin, 15 parts of sumatriptan, 5 parts of pregelatinized starch, 5 parts of Ac-Di-Sol, magnesium stearate 0.5
Part, 0.3 part of Arabic gum, 0.2 part of ascorbic acid, 2 parts of methylcellulose and 5 parts of compositions of polyethylene glycol.
A kind of 5. pharmaceutical composition for treating antimigraine according to claim 1, it is characterised in that count in parts by weight,
By 50 parts of Indomethacin, 15 parts of sumatriptan, 5 parts of pregelatinized starch, 5 parts of Ac-Di-Sol, 1 part of magnesium stearate,
5 parts of 0.5 part of Arabic gum, 0.5 part of ascorbic acid, 5 parts of methylcellulose and polyethylene glycol compositions.
6. a kind of preparation method for the pharmaceutical composition for treating antimigraine, it is characterised in that comprise the following steps：
A. count in parts by weight, take following raw material：Indomethacin 10-50 parts, sumatriptan 10-20 parts, pregelatinized starch 5-15
Part, Ac-Di-Sol 2-8 parts, magnesium stearate 0.1-1 parts, Arabic gum 0.1-0.5 parts, ascorbic acid 0.1-0.5
Part, methylcellulose 2-5 parts and polyethylene glycol 2-5 parts；
B. by Indomethacin, sumatriptan, Ac-Di-Sol, Arabic gum, ascorbic acid, methylcellulose and poly-
Ethylene glycol is well mixed, and is pelletized with 5% pregelatinized starch solution, is placed in 60 DEG C of oven for drying, whole grain of sieving；
C. magnesium stearate is added into particle described in step b, be well mixed, direct tablet compressing, piece weight 0.2g.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711088897.8A CN107648226A (en) | 2017-11-08 | 2017-11-08 | A kind of pharmaceutical composition for treating antimigraine and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711088897.8A CN107648226A (en) | 2017-11-08 | 2017-11-08 | A kind of pharmaceutical composition for treating antimigraine and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN107648226A true CN107648226A (en) | 2018-02-02 |
Family
ID=61120047
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201711088897.8A Withdrawn CN107648226A (en) | 2017-11-08 | 2017-11-08 | A kind of pharmaceutical composition for treating antimigraine and preparation method thereof |
Country Status (1)
| Country | Link |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102014625A (en) * | 2008-04-28 | 2011-04-13 | 佐吉尼克斯股份有限公司 | Novel formulations for treatment of migraine |
| CN102266563A (en) * | 2011-07-13 | 2011-12-07 | 赵磊 | Compound analgesic composition and preparation method thereof |
| CN102370639A (en) * | 2010-08-20 | 2012-03-14 | 上海医药科技发展有限公司 | Compound preparation of naproxen and sumatriptan |
| CN103989671A (en) * | 2014-05-20 | 2014-08-20 | 朱金强 | Indometacin capsule and preparation method thereof |
-
2017
- 2017-11-08 CN CN201711088897.8A patent/CN107648226A/en not_active Withdrawn
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102014625A (en) * | 2008-04-28 | 2011-04-13 | 佐吉尼克斯股份有限公司 | Novel formulations for treatment of migraine |
| CN102370639A (en) * | 2010-08-20 | 2012-03-14 | 上海医药科技发展有限公司 | Compound preparation of naproxen and sumatriptan |
| CN102266563A (en) * | 2011-07-13 | 2011-12-07 | 赵磊 | Compound analgesic composition and preparation method thereof |
| CN103989671A (en) * | 2014-05-20 | 2014-08-20 | 朱金强 | Indometacin capsule and preparation method thereof |
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