CN105998024B - A kind of flunarizine hydrochloride pharmaceutical composition - Google Patents
A kind of flunarizine hydrochloride pharmaceutical composition Download PDFInfo
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- CN105998024B CN105998024B CN201610431834.7A CN201610431834A CN105998024B CN 105998024 B CN105998024 B CN 105998024B CN 201610431834 A CN201610431834 A CN 201610431834A CN 105998024 B CN105998024 B CN 105998024B
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- Prior art keywords
- flunarizine hydrochloride
- flunarizine
- tablet composition
- lactose
- magnesium stearate
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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
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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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
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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
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- General Health & Medical Sciences (AREA)
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- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
A kind of flunarizine hydrochloride pharmaceutical composition belongs to pharmaceutical technology field the present invention relates to a kind of flunarizine hydrochloride pharmaceutical composition and preparation method thereof.The technical scheme is that a kind of flunarizine hydrochloride composition, it is characterized in that, in every thousand tablet composition, contain flunarizine hydrochloride 5.9g, lactose 62.5-82.5g, microcrystalline cellulose 70-90g, sodium carboxymethylcellulose 3.2-12.8g, silica 0.8g, magnesium stearate 0.8g, docusate sodium 1-1.6g.The present invention provides a kind of tablet that dissolution rate RSD is small by reasonable compatibility, and prepared tablet stores stabilization for a long time, provides drug of fine quality for clinic.
Description
Technical field
The present invention relates to a kind of flunarizine hydrochloride pharmaceutical compositions and preparation method thereof, belong to pharmaceutical technology field.
Background technique
Flunarizine hydrochloride is a kind of calcium channel blocker, intracelluar rationality calcium caused by capable of preventing because of reasons such as ischemics
Overload and caused by cell damage.It is listed in China within the medicine 1989, the medical instrument is effective in cure by force, safety is good, side effect is low,
Many advantages, such as patient compliance is good.In the prophylactic treatment of typical (having tendency) or atypia (absence of aura) migraine and by preceding
The symptomatic treatment field of dizziness caused by the dysfunction of front yard, welcome of the flunarizine hydrochloride preparation by numerous doctors and patient,
Global marketing volume rises year by year.
Commercially available Flunarizine Hydrochloride Tablets are 5mg(in terms of flunarizine) specification, belong to small dimension preparation.There is dissolution rates
RSD big problem.In addition, finding that piece seed cell is gentle with the extension of resting period and putting 8 months or so, there is piece to fluff scattered show
As influencing clinical application.
Summary of the invention
Goal of the invention: solving the problems, such as that drug dissolution is inhomogenous, and stores the scattered phenomenon that fluffs for a long time.
Technical solution:
The technical scheme is that a kind of flunarizine hydrochloride composition, which is characterized in that in every thousand tablet composition,
Containing flunarizine hydrochloride 5.9g, lactose 62.5-82.5g, microcrystalline cellulose 70-90g, sodium carboxymethylcellulose 3.2-12.8g,
Silica 0.8g, magnesium stearate 0.8g, docusate sodium 1-1.6g.
Currently preferred technical solution, which is characterized in that granularity≤20 micron of flunarizine hydrochloride.
Currently preferred technical solution, which is characterized in that in every thousand tablet composition, containing flunarizine hydrochloride 5.9g,
Lactose 65-80g, microcrystalline cellulose 76-88g, sodium carboxymethylcellulose 3.8-10g, silica 0.8g, magnesium stearate 0.8g,
Docusate sodium 1-1.6g.
Currently preferred technical solution, which is characterized in that in every thousand tablet composition, containing flunarizine hydrochloride 5.9g,
Lactose 70g, microcrystalline cellulose 80g, sodium carboxymethylcellulose 5g, silica 0.8g, magnesium stearate 0.8g, docusate sodium
1.3g。
Currently preferred technical solution, which is characterized in that in every thousand tablet composition, containing flunarizine hydrochloride 5.9g,
Lactose 78g, microcrystalline cellulose 78g, sodium carboxymethylcellulose 7g, silica 0.8g, magnesium stearate 0.8g, docusate sodium
1.4g。
The preparation method of the present composition, phase be characterized in that,
Step 1: main ingredient is crushed to partial size D90≤20 micron, auxiliary material sieves with 100 mesh sieve son；
Step 2: main ingredient and auxiliary material after weighing the sieving of recipe quantity respectively, put into mixer-granulator, it is sufficiently mixed
It is even.
Step 3: mixed material is set in dry granulating machine, 16 mesh particles are made.
Step 4: tabletting, packaging.
The utility model has the advantages that technical solution of the present invention provides a kind of tablet that dissolution rate RSD is small, institute by reasonable compatibility
The tablet of preparation stores stabilization for a long time.Drug of fine quality is provided for clinic.
In technical solution of the present invention, the addition of lactose solves the problems, such as part sliver during storage；Docusate sodium adds
Enter and thoroughly solves the problems, such as sliver and the big problem of dissolution rate RSD.
Another beneficial effect of the invention is: using dry granulation, eliminates in wet-granulation process, acid is to equipment
Corrosion.
Specific embodiment
Embodiment 1
Flunarizine hydrochloride 5.9g, lactose 62.5g, microcrystalline cellulose 70g, sodium carboxymethylcellulose 3.2g, silica
0.8g, magnesium stearate 0.8g, docusate sodium 1g prepare 1000 by preparation method described in technical solution.
Embodiment 2
Flunarizine hydrochloride 5.9g, lactose 82.5g, microcrystalline cellulose 90g, sodium carboxymethylcellulose 12.8g, silica
0.8g, magnesium stearate 0.8g, docusate sodium 1.6g prepare 1000 by preparation method described in technical solution.
Embodiment 3, flunarizine hydrochloride 5.9g, lactose 70g, microcrystalline cellulose 80g, sodium carboxymethylcellulose 5g, dioxy
SiClx 0.8g, magnesium stearate 0.8g, docusate sodium 1.3g prepare 1000 by preparation method described in technical solution.
Embodiment 4, flunarizine hydrochloride 5.9g, lactose 78g, microcrystalline cellulose 78g, sodium carboxymethylcellulose 7g, dioxy
SiClx 0.8g, magnesium stearate 0.8g, docusate sodium 1.4g prepare 1000 by preparation method described in technical solution.
Embodiment 5, flunarizine hydrochloride 5.9g, lactose 68g, microcrystalline cellulose 85g, sodium carboxymethylcellulose 6g, dioxy
SiClx 0.8g, magnesium stearate 0.8g, docusate sodium 1-1.6g.
Reference examples 1, flunarizine hydrochloride 5.9g, microcrystalline cellulose 150g, sodium carboxymethylcellulose 5g, silica
0.8g, magnesium stearate 0.8g prepare 1000 by preparation method described in technical solution.(3 prescription of reference implementation example)
Reference examples 2, flunarizine hydrochloride 5.9g, lactose 70g, microcrystalline cellulose 80g, sodium carboxymethylcellulose 5g, dioxy
SiClx 0.8g, magnesium stearate 0.8g prepare 1000 by preparation method described in technical solution.(3 prescription of reference implementation example)
Reference examples 3, flunarizine hydrochloride 5.9g, microcrystalline cellulose 150g, sodium carboxymethylcellulose 5g, silica
0.8g, magnesium stearate 0.8g, monostearate 1.3g prepare 1000 by preparation method described in technical solution.(reference implementation example 3
Prescription)
Test example 1, the Rotating shaker by States Pharmacopoeia specifications, testing example 1-5, the dissolution rate of reference examples 1-3 will dissolve out respectively
Degree evidence and RSD value are recorded in table 1.
Table 1, dissolution curve comparative test result
1 data of table explanation, product of the present invention solve the problems, such as that original prescription dissolution rate difference is big.
Test example 2 deposits in the tablet of 1-5 of the embodiment of the present invention, reference examples 1-3 in climatic chamber, 20 storages, point
Not in 8 months, 12 months, 20 months observation piece appearances.Visual inspection data record is in table 2.
Table 2
| 8 months | 12 months | 20 months | |
| Embodiment 1 | It is unchanged | It is unchanged | It is unchanged |
| Embodiment 2 | It is unchanged | It is unchanged | It is unchanged |
| Embodiment 3 | It is unchanged | It is unchanged | It is unchanged |
| Embodiment 4 | It is unchanged | It is unchanged | It is unchanged |
| Embodiment 5 | It is unchanged | It is unchanged | It is unchanged |
| Reference examples 1 | There is loose pieces situation | ||
| Reference examples 2 | Slightly there is loose pieces situation | ||
| Reference examples 3 | There is loose pieces situation |
2 data of table explanation, product of the present invention tablet appearance stablize, solve original prescription store for a long time piece loosely ask
Topic.
Claims (5)
1. a kind of Flunarizine hydrochloride tablet composition, which is characterized in that micro- containing granularity D90≤20 in every thousand tablet composition
Flunarizine hydrochloride 5.9g, lactose 62.5-82.5g, microcrystalline cellulose 70-90g, the sodium carboxymethylcellulose 3.2-12.8g of rice,
Silica 0.8g, magnesium stearate 0.8g, docusate sodium 1-1.6g.
2. Flunarizine hydrochloride tablet composition described in claim 1, which is characterized in that in every thousand tablet composition, contain hydrochloric acid
Flunarizine 5.9g, lactose 65-80g, microcrystalline cellulose 76-88g, sodium carboxymethylcellulose 3.8-10g, silica 0.8g,
Magnesium stearate 0.8g, docusate sodium 1-1.6g.
3. Flunarizine hydrochloride tablet composition described in claim 1, which is characterized in that in every thousand tablet composition, contain hydrochloric acid
Flunarizine 5.9g, lactose 70g, microcrystalline cellulose 80g, sodium carboxymethylcellulose 5g, silica 0.8g, magnesium stearate
0.8g, docusate sodium 1.3g.
4. Flunarizine hydrochloride tablet composition described in claim 1, which is characterized in that in every thousand tablet composition, contain hydrochloric acid
Flunarizine 5.9g, lactose 78g, microcrystalline cellulose 78g, sodium carboxymethylcellulose 7g, silica 0.8g, magnesium stearate
0.8g, docusate sodium 1.4g.
5. the preparation method of Flunarizine hydrochloride tablet composition described in claim 1, which is characterized in that
Step 1: main ingredient is crushed to D90≤20 micron, auxiliary material sieves with 100 mesh sieve son；
Step 2: main ingredient and auxiliary material after weighing the sieving of recipe quantity respectively, put into mixer-granulator, it is sufficiently mixed uniformly；
Step 3: mixed material is set in dry granulating machine, 16 mesh particles are made；
Step 4: tabletting.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610431834.7A CN105998024B (en) | 2016-06-15 | 2016-06-15 | A kind of flunarizine hydrochloride pharmaceutical composition |
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| CN201610431834.7A CN105998024B (en) | 2016-06-15 | 2016-06-15 | A kind of flunarizine hydrochloride pharmaceutical composition |
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| CN105998024A CN105998024A (en) | 2016-10-12 |
| CN105998024B true CN105998024B (en) | 2019-07-12 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110467586B (en) * | 2019-08-30 | 2023-02-28 | 迪嘉药业集团股份有限公司 | Preparation method of flunarizine hydrochloride crystal |
| CN115381791B (en) * | 2022-09-21 | 2023-06-16 | 迪沙药业集团有限公司 | Flunarizine hydrochloride pharmaceutical composition |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101249080A (en) * | 2008-02-21 | 2008-08-27 | 徐建平 | Acetylkitasamycin dispersible tablet and method of preparing the same |
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2016
- 2016-06-15 CN CN201610431834.7A patent/CN105998024B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101249080A (en) * | 2008-02-21 | 2008-08-27 | 徐建平 | Acetylkitasamycin dispersible tablet and method of preparing the same |
Non-Patent Citations (4)
| Title |
|---|
| 影响片剂溶出度的因素探讨;李芳美;《广东药学》;20020430 |
| 提高片剂溶出度的主要途径;张经立;《菏泽医学报》;19950228;第7卷(第2期) |
| 提高片剂溶出度的几种方法;王鹏宇;《华西药学杂志》;19950415;第10卷(第4期) |
| 片剂溶出度影响因素分析;闫丽;《黑龙江医药》;20060531;第19卷(第5期) |
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Effective date of registration: 20191104 Address after: 264205 No. 1 South Qingdao Road, Weihai economic and Technological Development Zone, Shandong, China Co-patentee after: Dijia Pharmaceutical Group Co.,Ltd. Patentee after: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Co-patentee after: WEIHAI DISU PHARMACEUTICAL Co.,Ltd. Address before: 264205 No. 1 South Qingdao Road, Weihai economic and Technological Development Zone, Shandong, China Co-patentee before: WEIHAI DISU PHARMACEUTICAL Co.,Ltd. Patentee before: DISHA PHARMACEUTICAL GROUP Co.,Ltd. |
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Effective date of registration: 20210705 Address after: No.1 Qingdao South Road, Weihai Economic and Technological Development Zone, Shandong Province Patentee after: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Patentee after: Dijia Pharmaceutical Group Co.,Ltd. Address before: No.1 Qingdao South Road, Weihai Economic and Technological Development Zone, Shandong Province Patentee before: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Patentee before: Dijia Pharmaceutical Group Co.,Ltd. Patentee before: WEIHAI DISU PHARMACEUTICAL Co.,Ltd. |
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Denomination of invention: A flunarizine hydrochloride pharmaceutical composition Effective date of registration: 20220721 Granted publication date: 20190712 Pledgee: Bank of China Limited Weihai Branch Pledgor: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Registration number: Y2022980010828 |
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