CN103239507A - Medicinal composition capable of being rapidly disintegrated and dissolved in oral cavity and preparation method thereof - Google Patents
Medicinal composition capable of being rapidly disintegrated and dissolved in oral cavity and preparation method thereof Download PDFInfo
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- CN103239507A CN103239507A CN2013102133535A CN201310213353A CN103239507A CN 103239507 A CN103239507 A CN 103239507A CN 2013102133535 A CN2013102133535 A CN 2013102133535A CN 201310213353 A CN201310213353 A CN 201310213353A CN 103239507 A CN103239507 A CN 103239507A
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- salviae miltiorrhizae
- oral cavity
- membrane
- borneolum syntheticum
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Abstract
The invention discloses a medicinal composition capable of being rapidly disintegrated and dissolved in an oral cavity, i.e. a composite salvia miltiorrhiza film agent, and provides a preparation method of the medicinal composition. The medicinal composition is characterized by consisting of salvia miltiorrhiza extract, radix notoginseng extract, a borneol inclusion compound and pharmaceutically acceptable disintegrating agent and film forming material. The medicinal composition is disintegrated and dissolved in the mouth of a user in 5 to 30 seconds and has a high response speed after being taken orally. The preparation is convenient to carry, does not need to be taken by water and is particularly suitable for people difficult in swallowing to use and is also particularly suitable to use under emergency conditions.
Description
Technical field
The invention belongs to field of medicaments, be specifically related to a kind of molten pharmaceutical composition that in the oral cavity, collapses fast, i.e. compound Salviae Miltiorrhizae membrane, and its preparation method is provided.
Background technology
Cardiovascular system diseases is a human the most common class disease, is the No.1 killer who threatens human health at present, has become the first dead cause of disease of world today's population.In China, along with aged tendency of population is accelerated, people's dirt running water is flat to be improved, rhythm of life is accelerated, and dietary structure is to hyperpyrexia, high fat development, and cardiovascular system diseases such as coronary heart disease, angina pectoris has also become one of serious disease of harm humans health and dirt life among the crowd, cardiovascular patient sharply increases, die from reaching more than 2,400,000 people of cardiovascular disease every year, account for 34% of disease death rate, and in rising trend.
Compound red sage root preparation is made by Radix Salviae Miltiorrhizae, Radix Notoginseng and Borneolum Syntheticum, and Radix Salviae Miltiorrhizae, Radix Notoginseng have promoting tissue regeneration by removing blood stasis, reducing swelling and alleviating pain, and promoting blood circulation to restore menstrual flow, the function of the relieving restlessness that clears away heart-fire, Borneolum Syntheticum then has the refreshment of having one's ideas straightened out, the dispel effect of pain of heat clearing away.Three medicines share, and can give full play to blood circulation promoting and blood stasis dispelling, the effect of regulating QI to relieve pain.Clinical Practice confirms except being applied to cardiovascular and cerebrovascular disease in recent years, compound red sage root preparation is to determined curative effects such as bronchial asthma, trigeminal neuralgia, senile dementias, these diseases all have onset threat to life when anxious, serious, need to alleviate fast disease, general character such as patient's dysphagia during morbidity.Patent 200410072941.2 provides the preparation method of novel pharmaceutical formulation FUFANG DANSHEN DIWAN, but this dosage form drug loading is little, takes all about 10 at every turn, and it is also inconvenient to take medicine.Patent 200510036067.1 has been introduced the preparation process of compound Salviae Miltiorrhizae soft capsule, dispersible tablet, oral cavity disintegration tablet and effervescent tablet, not mentioned compound Salviae Miltiorrhizae membrane.Patent 200510104934.0 provides compound red sage root spray and preparation method thereof, though the transportation inconvenience is comparatively fast carried in the spray onset, and has explosive potential safety hazard.Provided by the inventionly a kind ofly can collapse molten compound Salviae Miltiorrhizae membrane fast and belong to the oral administration solid quick releasing formulation, shape of product and stamp are similar, in the oral cavity, can collapse molten fast, and swallow with normal swallowing act, the patient can take under the situation that need not to drink water, thereby realize the quick release of effective ingredient in emergency circumstances, especially be fit to dysphagia or critical patient uses such as child, old man.
Summary of the invention
The purpose of this invention is to provide a kind of molten pharmaceutical composition, i.e. compound Salviae Miltiorrhizae membrane of in the oral cavity, collapsing fast.
Another object of the present invention provides a kind of preparation method that collapses molten compound Salviae Miltiorrhizae membrane in the oral cavity fast.
Characteristics of the present invention and innovative point are describedly to collapse molten compound Salviae Miltiorrhizae membrane fast be made up of activating agent Radix Salviae Miltiorrhizae extract, activating agent Radix Notoginseng extract, activating agent Borneolum Syntheticum clathrate and pharmaceutically acceptable disintegrating agent and filmogen in the oral cavity.Owing to added disintegrating agent in membrane, it is molten that it can be collapsed in 5 seconds to 30 seconds in the mouth of user, oral after onset rapidly.Need not to use water delivery service, be particularly suitable for dysphagia crowd and use in emergency circumstances.
Radix Salviae Miltiorrhizae extract described in the present invention and Radix Notoginseng extract can use salvia piece and notoginseng decoction piece respectively or mix by water and carry or the alcohol extraction acquisition.Common way can be with reference to " Chinese pharmacopoeia: get an amount of salvia piece, notoginseng decoction piece decocts with water, decocting liquid filters, and filtrate concentrates, and adds ethanol, leaves standstill and makes precipitation, gets supernatant, reclaims ethanol, is condensed into thick paste, and is standby.
The present invention is achieved in that
Collapse the Radix Salviae Miltiorrhizae extract of molten compound Salviae Miltiorrhizae membrane and the quality standard that Radix Notoginseng extract need meet Chinese Pharmacopoeia among the present invention fast, contain salvianolic acid B 〉=10% in the Radix Salviae Miltiorrhizae extract usually, tanshinone 〉=12% contains Radix Notoginseng total arasaponins 〉=75% in the Radix Notoginseng extract.
Collapse the molten used acceptable accessories of compound Salviae Miltiorrhizae membrane among the present invention fast and mainly formed by disintegrating agent and filmogen, can absorb fillers under the necessary situation, flavoring agent and plasticizer.
Collapsing the molten used disintegrating agent of compound Salviae Miltiorrhizae membrane among the present invention fast mainly is made up of one or more mixture in microcrystalline Cellulose, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, pregelatinized Starch, the starch.
Collapsing molten compound Salviae Miltiorrhizae membrane used film forming material among the present invention fast mainly is made up of one or more mixture in gelatin, arabic gum, xanthan gum, sodium alginate, polyvinyl alcohol-polyethylene glycol copolymer, hypromellose, methylcellulose, sodium carboxymethyl cellulose, the hydroxypropyl cellulose.
In case of necessity, collapsing the used filler of molten compound Salviae Miltiorrhizae membrane among the present invention fast mainly is made up of one or more mixture in mannitol, lactose, sorbitol, microcrystalline Cellulose, dextrin, the starch.
In case of necessity, collapsing the used flavoring agent of molten compound Salviae Miltiorrhizae membrane among the present invention fast mainly is made up of one or more mixture in Herba Menthae essence, xylitol, aspartame, stevioside, glycyrrhizin, sucralose, the maltose.
In case of necessity, collapsing the molten used plasticizer of compound Salviae Miltiorrhizae membrane among the present invention fast mainly is made up of one or more mixture in glycerol, propylene glycol, the Polyethylene Glycol.
The preparation method that collapses molten compound Salviae Miltiorrhizae membrane among the present invention fast is:
(1) preparation Borneolum Syntheticum clathrate: cyclodextrin is made enclose solution, after Borneolum Syntheticum is dissolved in ethanol, is added drop-wise in the enclose solution, stir 0.5h～1.5h after, filter, with clathrate in 40 ℃ of dryings, namely.The preferred beta-schardinger dextrin-of cyclodextrin wherein, preferred 1: 3～1: 5 of the weight ratio of Borneolum Syntheticum and cyclodextrin.
(2) take by weighing an amount of Radix Salviae Miltiorrhizae extract, Radix Notoginseng extract and Borneolum Syntheticum clathrate, an amount of disintegrating agent, filler after the dispersion of 30% glycerite, add the solution of an amount of filmogen preparation, mix to stir the back degassing and handle, with above-mentioned mixed glue solution film, dry, cutting namely.
Collapsing molten compound Salviae Miltiorrhizae membrane among the present invention fast collapsed molten in the mouth of user in 5 seconds to 30 seconds.
" collapse molten " and refer to that the solid membrane dissolves at intraoral disintegration, namely no longer keep solid membrane shape, be dispersed into the state that to swallow naturally with saliva.
The specific embodiment
Below in conjunction with the specific embodiment the present invention is described in further detail.But the present invention is not limited in following examples, under the inventive method prerequisite simple modifications of the present invention or modification is all belonged to the claimed scope of the present invention.
Embodiment 1
Specific operation process: take by weighing an amount of Borneolum Syntheticum, that beta-schardinger dextrin-prepares Borneolum Syntheticum clathrate is standby; Take by weighing an amount of Radix Salviae Miltiorrhizae extract, Radix Notoginseng extract, add Borneolum Syntheticum clathrate, microcrystalline Cellulose, 30% glycerol disperses to add 5% polyvinyl alcohol-polyethylene glycol aqueous copolymers solution, 0.3% xanthan gum solution behind the mixing, mix, add Herba Menthae essence, add an amount of ethanol degassing after stirring, with the above-mentioned uniform coating film forming of compound Salviae Miltiorrhizae suspendible glue, heat drying, cutting namely gets and collapses molten compound Salviae Miltiorrhizae membrane fast.
This membrane is yellow green, and pliability is good, free from extraneous odour, and entrance dissolving is fast, collapses to be limited to 15s when molten.
Embodiment 2
Specific operation process: take by weighing an amount of Borneolum Syntheticum, that beta-schardinger dextrin-prepares Borneolum Syntheticum clathrate is standby; Radix Salviae Miltiorrhizae, Radix Notoginseng are prepared into extractum according to the Chinese Pharmacopoeia method, add Borneolum Syntheticum clathrate, microcrystalline Cellulose, 30% glycerol disperses to add 3% hydroxypropyl methylcellulose aqueous solution behind the mixing, mix, add Herba Menthae essence, add an amount of ethanol degassing after stirring, with the above-mentioned uniform coating film forming of compound Salviae Miltiorrhizae suspendible glue, heat drying, cutting namely gets and collapses molten compound Salviae Miltiorrhizae membrane fast.
This membrane is yellow green, and pliability is good, free from extraneous odour almost, and the entrance dissolving is fast, collapses to be limited to 16s when molten.
Comparative Examples 1
Specific operation process: Radix Salviae Miltiorrhizae, Radix Notoginseng are prepared into extractum according to the Chinese Pharmacopoeia method, microcrystalline Cellulose disperses to add 1% sodium alginate sodium water solution behind the mixing with 30% glycerol, mix, add Borneolum Syntheticum, Herba Menthae essence, add an amount of ethanol degassing after stirring, with the above-mentioned uniform coating film forming of compound Salviae Miltiorrhizae suspendible glue, heat drying, cutting namely gets the compound Salviae Miltiorrhizae membrane.
This membrane is yellow green, spottiness, and the Borneolum Syntheticum abnormal smells from the patient is thin out, bitterness slightly, the entrance dissolving is clamminess slowly, collapses to be limited to 25s when molten.
Comparative Examples 2
Specific operation process: take by weighing an amount of Borneolum Syntheticum, that beta-schardinger dextrin-prepares Borneolum Syntheticum clathrate is standby; Take by weighing an amount of Radix Salviae Miltiorrhizae extract, Radix Notoginseng extract, add Borneolum Syntheticum clathrate, microcrystalline Cellulose, 30% glycerol disperses to add 5% polyvinyl alcohol-polyethylene glycol aqueous copolymers solution, 0.3% xanthan gum solution behind the mixing, mix, add Herba Menthae essence, add an amount of ethanol degassing after stirring, with the above-mentioned uniform coating film forming of compound Salviae Miltiorrhizae suspendible glue, heat drying, cutting namely gets the compound Salviae Miltiorrhizae membrane.
This membrane is yellow green, and pliability is poor, free from extraneous odour, and entrance dissolving is slow, collapses to be limited to 115s when molten.
Table one prescription contrast conclusive table
Claims (6)
1. one kind collapses molten pharmaceutical composition fast in the oral cavity, and namely the compound Salviae Miltiorrhizae membrane is characterized in that being made up of activating agent Radix Salviae Miltiorrhizae extract, activating agent Radix Notoginseng extract, activating agent Borneolum Syntheticum clathrate and pharmaceutically acceptable disintegrating agent and filmogen.
2. according to claim 1ly collapse molten compound Salviae Miltiorrhizae membrane fast in the oral cavity, wherein said Borneolum Syntheticum clathrate is obtained by the cyclodextrin inclusion compound Borneolum Syntheticum, preferred 1: 3～1: 5 of the weight ratio of Borneolum Syntheticum and cyclodextrin.
3. according to claim 1ly collapse molten compound Salviae Miltiorrhizae membrane fast in the oral cavity, wherein said disintegrating agent mainly is made up of one or more mixture in microcrystalline Cellulose, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose and the pregelatinized Starch.
4. according to claim 1ly collapse molten compound Salviae Miltiorrhizae membrane fast in the oral cavity, wherein said filmogen mainly is made up of one or more mixture in polyvinyl alcohol-polyethylene glycol copolymer, hypromellose, sodium carboxymethyl cellulose, hydroxypropyl cellulose gelatin, xanthan gum, sodium alginate, methylcellulose, arabic gum, the pectin.
5. according to claim 1ly in the oral cavity, collapse molten compound Salviae Miltiorrhizae membrane fast, its preparation method is: take by weighing an amount of Radix Salviae Miltiorrhizae extract, Radix Notoginseng extract and Borneolum Syntheticum clathrate, after an amount of disintegrating agent disperses with 30% glycerite, the solution that adds an amount of filmogen preparation, mix to stir the back degassing and handle, with above-mentioned mixed glue solution film, dry, cutting namely.
According among the claim 1-5 any one describedly in the oral cavity, collapse molten compound Salviae Miltiorrhizae membrane fast, it collapsed molten in the mouth of user in 5 seconds to 30 seconds.
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| Application Number | Priority Date | Filing Date | Title |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104224757A (en) * | 2014-09-26 | 2014-12-24 | 天津市聚星康华医药科技有限公司 | Instant gastrodin oral membrane and preparation method thereof |
| CN106659751A (en) * | 2014-07-17 | 2017-05-10 | 赫克萨尔股份公司 | Orodispersible film |
| CN106913617A (en) * | 2017-02-21 | 2017-07-04 | 安徽安龙基因医学检验所有限公司 | A kind of components in danshen oral quick-dissolving film preparation and preparation method thereof |
| CN107375945A (en) * | 2017-08-29 | 2017-11-24 | 沈阳药科大学 | A kind of donepezil cyclodextrin inclusion compound and the oral instant film containing this inclusion compound |
| CN108451935A (en) * | 2018-04-12 | 2018-08-28 | 天津双硕医药科技有限公司 | A kind of solid composite medicament containing Mitiglinide Calcium |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1424096A (en) * | 2002-12-31 | 2003-06-18 | 北京采瑞医药有限公司 | Composite red sage root micro-capsules for cardio-cerebral diseases and its preparing method |
| CN1460517A (en) * | 2003-07-02 | 2003-12-10 | 北京博尔达生物技术开发有限公司 | Compound danshen oral disintegrant tablet and its preparation method |
| CN1543971A (en) * | 2003-07-02 | 2004-11-10 | 北京博尔达生物技术开发有限公司 | Oral disintegrating tablet and its preparation of compound red sage root |
-
2013
- 2013-05-31 CN CN2013102133535A patent/CN103239507A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1424096A (en) * | 2002-12-31 | 2003-06-18 | 北京采瑞医药有限公司 | Composite red sage root micro-capsules for cardio-cerebral diseases and its preparing method |
| CN1460517A (en) * | 2003-07-02 | 2003-12-10 | 北京博尔达生物技术开发有限公司 | Compound danshen oral disintegrant tablet and its preparation method |
| CN1543971A (en) * | 2003-07-02 | 2004-11-10 | 北京博尔达生物技术开发有限公司 | Oral disintegrating tablet and its preparation of compound red sage root |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106659751A (en) * | 2014-07-17 | 2017-05-10 | 赫克萨尔股份公司 | Orodispersible film |
| CN106659751B (en) * | 2014-07-17 | 2020-12-25 | 赫克萨尔股份公司 | Orodispersible films |
| CN104224757A (en) * | 2014-09-26 | 2014-12-24 | 天津市聚星康华医药科技有限公司 | Instant gastrodin oral membrane and preparation method thereof |
| CN106913617A (en) * | 2017-02-21 | 2017-07-04 | 安徽安龙基因医学检验所有限公司 | A kind of components in danshen oral quick-dissolving film preparation and preparation method thereof |
| CN107375945A (en) * | 2017-08-29 | 2017-11-24 | 沈阳药科大学 | A kind of donepezil cyclodextrin inclusion compound and the oral instant film containing this inclusion compound |
| CN108451935A (en) * | 2018-04-12 | 2018-08-28 | 天津双硕医药科技有限公司 | A kind of solid composite medicament containing Mitiglinide Calcium |
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Address after: 300384 Tianjin Huayuan Industrial Zone Haitai development six road 6 C Haitai green industry base 502 Applicant after: TIANJIN JUXING KANGHUA MEDICAL TECHNOLOGY CO.,LTD. Address before: Thai branch three road off the coast of 300384 Tianjin City Huayuan Industrial Zone Xiqing District No. 1, building 4, 2 ring gate 901 Applicant before: TIANJIN JUXING KANGHUA MEDICAL TECHNOLOGY CO.,LTD. |
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Application publication date: 20130814 |