CN104721207B - A kind of pharmaceutical composition - Google Patents
A kind of pharmaceutical composition Download PDFInfo
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- CN104721207B CN104721207B CN201410350801.0A CN201410350801A CN104721207B CN 104721207 B CN104721207 B CN 104721207B CN 201410350801 A CN201410350801 A CN 201410350801A CN 104721207 B CN104721207 B CN 104721207B
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- liquiritin
- monohydrate
- recipe quantity
- pvp
- microcrystalline cellulose
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- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
A kind of pharmaceutical composition.Technical field: the present invention relates to a kind of preparation compositions of monohydrate containing liquiritin, belong to pharmaceutical technology field.Chinese patent 200610016770.0,200610016771 individually discloses application of the liquiritin in the myocardial ischemia drug caused by filling property arrhythmia cordis again and anti-isoprel that resists myocardial ischemia.Due to technical problem, the safe and effective liquiritin preparation that the suitable mankind take orally never emerges.The present invention provides a kind of safe and effective liquiritin oral preparations.The technical scheme is that a kind of Radix Glycyrrhizae glycoside composition, contains liquiritin monohydrate 45%~71.1%, when croscarmellose sodium is 3%-9.2%, water soluble adjuvant 6%-35%.
Description
Technical field
The present invention relates to a kind of preparation compositions of monohydrate containing liquiritin, belong to pharmaceutical technology field.
Background technique
In recent years, cardiovascular and cerebrovascular disease, which has become, threatens healthy elder and long-lived number one killer, be the mankind three substantially
One of dead reason.Cardiovascular and cerebrovascular disease needs long-term administration, and Western medicine is constantly present various side effects, long-term use pair
Human body has certain damage.Therefore, the drug for finding safe and effective treatment cardiovascular and cerebrovascular disease becomes current research heat
Point.
Chinese patent 200610016770.0 discloses liquiritin in the filling property antiarrhythmic medicament again that resists myocardial ischemia
Using；200610016771 disclose application of the liquiritin in the myocardial ischemia drug caused by anti-isoprel.Radix Glycyrrhizae
It is traditional Chinese medicine, large area artificial growth, adequately develops it, the medicinal material can be enable to comprehensively utilize, opened up
New application market has castering action to the plantation of medicinal material, production, processing and related industry.Meanwhile the heart is found from Chinese medicine
Blood vessel drug eluting also has good Social benefit and economic benefit.
Existing alcohol extracting or extraction process by water preparation liquiritin in the form of liquiritin monohydrate existing for.One water of liquiritin
Close object (molecular formula: C21H22O9·H2It O) can be by pulse family Glycyrrhiza various plants glycyrrhizic legume, swollen fruit Radix or glycyrrhiza glabra
Drying root and rhizome in extract be made, belong to flavonoid glycoside.Liquiritin is dissolved in methanol, ethyl alcohol, dilute sodium hydroxide, is insoluble in
Water, viscosity is big, easy balling.
Although existing knowledge discloses the medical usage of liquiritin and liquiritin, the application of the project only rests on body
Outer experimental stage, due to technical problem, the safe and effective liquiritin preparation that the suitable mankind take orally never emerges.
The technical problem to be solved by the present invention is to solve the problems, such as that liquiritin oral preparation dissolution rate is low and piece can press
Property difference problem.A kind of safe and effective liquiritin oral preparation is provided for clinic.
Summary of the invention
The object of the present invention is to provide a kind of safe and effective liquiritin oral preparations；Another object of the present invention
It is to provide a kind of Radix Glycyrrhizae glycoside composition of high-dissolution；Another object of the present invention is to solve liquiritin tablet compressibility and crisp
Broken degree problem.
The present composition is because specification is big, and production technology and finished product acceptor's pharmacological property matter are affected, and especially tablet is deposited
In the high problem of unilateral unsmooth, poor compressibility and friability, meanwhile, there is also dissolution rate is slow in tablet, dissolution rate is low
The problem of.
Through a series of prescription screening, present inventor have discovered that when the weight of croscarmellose sodium in prescription accounts for group
When polymer weight percentage is 3%-9.2%, and the weight of water soluble adjuvant accounts for the 6%-35% of pharmaceutical composition weight percent
When, the solubility of active constituent greatly improves.
The technical scheme is that a kind of Radix Glycyrrhizae glycoside composition, it is characterised in that containing liquiritin monohydrate 45%~
71.1%, when croscarmellose sodium is 3%-9.2%, water soluble adjuvant 6%-35%, the percentage is quality percentage
Than.
Currently preferred technical solution, the 100~300mg of monohydrate containing liquiritin in composition.
Currently preferred technical solution, D90≤10 μm of liquiritin monohydrate in composition.More preferably D90
≤8μm。
Currently preferred technical solution is:
A kind of Radix Glycyrrhizae glycoside composition, it is characterised in that the liquiritin monohydrate 45%~71% containing D90≤10um, sweet dew
Alcohol 4.5%~32%, microcrystalline cellulose 4.5%~32%.
Currently preferred technical solution also contains croscarmellose sodium 3%~9.2%, surfactant 0.3%
~1%.
Currently preferred technical solution, the surfactant are selected from lauryl sodium sulfate.
Currently preferred technical solution also contains fumed silica 1%, magnesium stearate 1%.
The above percentage is mass percent.
Currently preferred technical solution is: a kind of pharmaceutical composition, which is characterized in that every 1,000 one water containing liquiritin
Close 100~300 g(D90 of object≤10um), mannitol 70g, microcrystalline cellulose 20g, lauryl sodium sulfate 1.35g, povidone
K30 5g, croscarmellose sodium 20g, 2.17~4.20g of fumed silica, 2.17~4.20g of magnesium stearate.
Currently preferred technical solution is a kind of liquiritin monohydrate composition, which is characterized in that every 1000 contain
Liquiritin monohydrate 150g(D90≤8um), mannitol 45g, microcrystalline cellulose 45g, lauryl sodium sulfate 1.35g gather dimension
Ketone K30 5g, croscarmellose sodium 20g, fumed silica 2.60g, magnesium stearate 2.60g.
Currently preferred technical solution, the surfactant can also be nonionic surfactant polyethylene glycol
Class, Tweens.
The preparation method of invigorating heart plain piece of the present invention, it is characterised in that:
Liquiritin monohydrate is micronized to D90≤10um using airslide disintegrating mill by the first step.
Second step weighs recipe quantity PVP K30 and is added in purified water, is configured to 10% PVP K30 aqueous solution (W/W),
Stirring and dissolving to be uniformly mixed, it is spare.
Third step weighs liquiritin monohydrate, mannitol, microcrystalline cellulose, the crosslinking carboxylic of the first step preparation of recipe quantity
The fumed silica (interior to add) of sodium carboxymethylcellulose pyce, lauryl sodium sulfate and half recipe quantity.
Load weighted material is placed in wet mixing pelletizer by the 4th step, is uniformly mixed, and 10% poly- dimension of recipe quantity is added
Ketone k30 aqueous solution is uniformly mixed, the granulation of 24 meshes.
5th step wet granular, 40~50 DEG C of dryings in baking oven.
6th step is by (additional) the investment oscillating granulation of the fumed silica of the material dried and half recipe quantity
In machine, with 24 mesh screen whole grains.
The magnesium stearate of particle and recipe quantity that the 6th step of 7th step obtains is added in three-dimensional motion mixer, and mixing is equal
It is even.
8th step tabletting.
The present composition the utility model has the advantages that
By reasonable compatibility and process, the present composition is overcome because specification is big, and finished product quality is by main ingredient
Property and state influence big problem, overcome problem of the existing technology, provide the mouth of a kind of stabilization, safety for clinic
Take tablet composition.
The present composition is 2 times/day, 1 piece/times.
Embodiment 1, liquiritin monohydrate 100g(D90≤10um), mannitol 70g, microcrystalline cellulose 20g, dodecane
Base sodium sulphate 1.35g, 10% PVP K30 aqueous solution 50g, croscarmellose sodium 20g, fumed silica 2.62g,
Magnesium stearate 2.62g.1000 are prepared by the preparation method of technical solution part.
Embodiment 2, liquiritin monohydrate 150g(D90≤8um), mannitol 45g, microcrystalline cellulose 45g, dodecyl
Sodium sulphate 1.35g, 10% PVP K30 aqueous solution 50g, croscarmellose sodium 10g, fumed silica 2.71g, firmly
Fatty acid magnesium 2.71g.1000 are prepared by the preparation method of technical solution part.
Embodiment 3, prescription use 3% hypromellose E5 aqueous solution for adhesive with embodiment 2.By technical side
The preparation method of case part prepares 1000.
Embodiment 4, liquiritin monohydrate 300g(D90≤8um), mannitol 70g, microcrystalline cellulose 20g, dodecyl
Sodium sulphate 1.35g, 10% PVP K30 aqueous solution 55g, croscarmellose sodium 20 g, fumed silica 4.20g, firmly
Fatty acid magnesium 4.20g.1000 are prepared by the preparation method of technical solution part.
Reference examples 1, prescription are with embodiment 1, but liquiritin monohydrate D90=13~26um.
Surfactant sodium hexadecyl sulfate is not added with embodiment 1 in reference examples 2, prescription.
Reference examples 3, prescription use purified water to replace 10% PVP K30 aqueous solution for adhesive with embodiment 1.
Reference examples 4, liquiritin monohydrate 100g, lactose 68g, starch 60 g, talcum powder 20g.Take the art
Well known method for preparing tablet thereof, mixes all components in appropriate vessel, and particle is made, and adds magnesium stearate 2g, mixes, pressure
Piece prepares 1000.
Test example 1: pressing 2010 editions pharmacopeia, and the second method of annex XC measures the molten of embodiment 1 to 4 and 1 to 4 product of reference examples
Out-degree, data record is in table 1.
1. dissolution comparison test result of table (medium is water)
1 data of table explanation: 60 minutes dissolution rates of Examples 1 to 4 product are apparently higher than reference examples 1~4, illustrate the present invention
Composition solves the problems, such as that dissolution rate is low.
Test example 2 observes the appearance of embodiment 1-4 and reference examples 1-4 piece, is recorded in table 2.
Table 2
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | Reference examples 1 | Reference examples 2 | Reference examples 3 | Reference examples 4 | |
| Piece appearance | It is smooth | It is smooth | It is smooth | It is smooth | There is point | There is point | Sticking, spottiness | There is point |
2 data of table explanation, the appearance of 1-4 product of the embodiment of the present invention are significantly better than the appearance of reference examples 1-4 product.
Test example 3: the highest hardness of measurement Examples 1 to 4 product and 1~4 product of reference examples, it is attached by 2010 editions pharmacopeia
It records XG method and measures tablet friability, data record is in table 3
3. compressibility of table and friability test result
Data illustrate in table 3: 1, under the same operating conditions, the piece appearance of Examples 1 to 4 is significantly better than reference examples
1-4 illustrates that the compressibility of technical solution of the present invention is better than reference examples 1~4.
, Examples 1 to 4 friability numerical value be significantly lower than reference examples 1-4.After illustrating that piece of the embodiment of the present invention is impacted
Piece weight and appearance do not change substantially.
To sum up, technical solution of the present invention has reached purpose, provides the oral preparation of a kind of stabilization, safety for clinic.
Claims (5)
1. a kind of Radix Glycyrrhizae glycoside composition, which is characterized in that contain liquiritin monohydrate 45%~71.1%, cross-linked carboxymethyl fiber
When plain sodium 3%-9.2%, water soluble adjuvant 6%-35%, the percentage is mass percent, wherein the Radix Glycyrrhizae that D90 is≤10 μm
Glycosides 100~300mg of monohydrate, i.e., every 1,000 100~300 g of liquiritin monohydrate containing D90≤10 μm, mannitol
70g, microcrystalline cellulose 20g, lauryl sodium sulfate 1.35g, PVP K30 5g, croscarmellose sodium 20g.
2. composition described in claim 1, which is characterized in that the D90 of liquiritin monohydrate is≤8 μm.
3. composition described in claim 1, which is characterized in that the liquiritin monohydrate 45%~71% containing D90≤10um, it is sweet
Reveal alcohol 4.5%~32%, microcrystalline cellulose 4.5%~32%.
4. composition described in claim 1, which is characterized in that the every 1000 liquiritin monohydrate 150g containing D90≤8um,
Mannitol 45g, microcrystalline cellulose 45g, lauryl sodium sulfate 1.35g, PVP K30 5g, croscarmellose sodium
20g。
5. the preparation method of composition described in claim 1, which is characterized in that
Liquiritin monohydrate is micronized to D90≤10 μm using airslide disintegrating mill by the first step；
Second step weighs recipe quantity PVP K30 and is added in purified water, is configured to 10% PVP K30 aqueous solution (W/W), stirs
Be dissolved to it is uniformly mixed, it is spare；
Third step weighs liquiritin monohydrate, the mannitol, microcrystalline cellulose, cross-linked carboxymethyl of the first step preparation of recipe quantity
The fumed silica of sodium cellulosate, lauryl sodium sulfate and half recipe quantity；
Load weighted material is placed in wet mixing pelletizer by the 4th step, is uniformly mixed, 10% povidone of recipe quantity is added
K30 aqueous solution is uniformly mixed, the granulation of 24 meshes；
5th step wet granular, 40~50 DEG C of dryings in baking oven；
6th step puts into the fumed silica of the material dried and half recipe quantity in oscillating granulator, with 24 mesh
Sieve whole grain；
The magnesium stearate of particle and recipe quantity that the 6th step of 7th step obtains is added in three-dimensional motion mixer, is uniformly mixed；
8th step tabletting.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410350801.0A CN104721207B (en) | 2014-07-23 | 2014-07-23 | A kind of pharmaceutical composition |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410350801.0A CN104721207B (en) | 2014-07-23 | 2014-07-23 | A kind of pharmaceutical composition |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN104721207A CN104721207A (en) | 2015-06-24 |
| CN104721207B true CN104721207B (en) | 2019-03-05 |
Family
ID=53446006
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201410350801.0A Expired - Fee Related CN104721207B (en) | 2014-07-23 | 2014-07-23 | A kind of pharmaceutical composition |
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| Country | Link |
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Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107714667A (en) * | 2017-11-20 | 2018-02-23 | 威海贯标信息科技有限公司 | A kind of Dapagliflozin agent composition |
| CN107744512A (en) * | 2017-12-04 | 2018-03-02 | 威海贯标信息科技有限公司 | A kind of canagliflozin composition |
| CN107811983A (en) * | 2017-12-04 | 2018-03-20 | 威海贯标信息科技有限公司 | A kind of tofogliflozin composition |
| CN107898764A (en) * | 2017-12-12 | 2018-04-13 | 威海贯标信息科技有限公司 | A kind of net compositions of Ai Gelie |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101032505A (en) * | 2006-04-17 | 2007-09-12 | 李超生 | Treatment medicine and healthy product including liquiritin |
| CN101032504A (en) * | 2006-04-17 | 2007-09-12 | 李超生 | Application of liquiritin in medicines |
| CN101518542A (en) * | 2009-04-07 | 2009-09-02 | 浙江大学 | Liquiritin preparation and application thereof |
-
2014
- 2014-07-23 CN CN201410350801.0A patent/CN104721207B/en not_active Expired - Fee Related
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101032505A (en) * | 2006-04-17 | 2007-09-12 | 李超生 | Treatment medicine and healthy product including liquiritin |
| CN101032504A (en) * | 2006-04-17 | 2007-09-12 | 李超生 | Application of liquiritin in medicines |
| CN101518542A (en) * | 2009-04-07 | 2009-09-02 | 浙江大学 | Liquiritin preparation and application thereof |
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|---|---|
| CN104721207A (en) | 2015-06-24 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C41 | Transfer of patent application or patent right or utility model | ||
| TA01 | Transfer of patent application right |
Effective date of registration: 20160623 Address after: Economic and Technological Development Zone of Shandong Province, Weihai City, Gushan Town, 264205 No. 18 South Road, No. 19 North Road, No. 3 East Road, the west five Applicant after: Weihai Disu Pharmaceutical Co., Ltd. Applicant after: Disha Pharmaceutical Industry Group Corp., Ltd. Address before: 264205, Weihai economic and Technological Zone, Shandong Province, Qingdao South Road, No. 1 Applicant before: Disha Pharmaceutical Industry Group Corp., Ltd. Applicant before: WEIHAI DIJIA PHARMACEUTICAL CO., LTD. |
|
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant | ||
| TR01 | Transfer of patent right | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20191107 Address after: 264205 Guangzhou East Road South and an East Road East, Wendeng economic and Technological Development Zone, Weihai City, Shandong Province Co-patentee after: Weihai Disu Pharmaceutical Co., Ltd. Patentee after: Dijia Pharmaceutical Group Co., Ltd Co-patentee after: Disha Pharmaceutical Industry Group Corp., Ltd. Address before: Economic and Technological Development Zone of Shandong Province, Weihai City, Gushan Town, 264205 No. 18 South Road, No. 19 North Road, No. 3 East Road, the west five Co-patentee before: Disha Pharmaceutical Industry Group Corp., Ltd. Patentee before: Weihai Disu Pharmaceutical Co., Ltd. |
|
| CF01 | Termination of patent right due to non-payment of annual fee | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20190305 Termination date: 20200723 |