CN1872160A - Sloly released tablet of red sage root, and preparation method - Google Patents
Sloly released tablet of red sage root, and preparation method Download PDFInfo
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- CN1872160A CN1872160A CN 200510034826 CN200510034826A CN1872160A CN 1872160 A CN1872160 A CN 1872160A CN 200510034826 CN200510034826 CN 200510034826 CN 200510034826 A CN200510034826 A CN 200510034826A CN 1872160 A CN1872160 A CN 1872160A
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- delayed
- salvia miltiorrhiza
- release sheet
- c36h30o16
- salvianolic acid
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Abstract
A slow-release tablet is prepared from the red sage root's extract containing danshinolic acid B (C36H30O16) and the slow-releasing excipient chosen from hydroxypropyl methylcellulose and methylcellulose stearate. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to a kind of Chinese medicine slow releasing preparation, specifically is Salvia Miltiorrhiza delayed-release sheet and preparation technology and its medical application.
Background technology
At present, red sage formulation mainly contains: Radix Salviae Miltiorrhizae Tabellae, DANSHEN KELI agent, Radix Salviae Miltiorrhizae oral liquid, Radix Salviae Miltiorrhizae orally disintegrating tablet or the like.Various red sage formulations are determined curative effect aspect curative effect, causes people's attention.But all there is defective in varying degrees in all at present red sage formulations, and are oral as Radix Salviae Miltiorrhizae Tabellae, one time 3～4,3 times on the one, as seen the quantity that need take is many, that takes waits shortcoming often.Red sage formulation is mainly treated cardiovascular disease, and patient's great majority of trouble cardiovascular disease are aged patient, heavy inconvenience.Simultaneously, the treatment cardiovascular patient need be taken this medicine for a long time, and therefore, the red sage formulation that exploitation updates becomes people and presses for.
Salvia Miltiorrhiza delayed-release sheet of the present invention is to contain Radix Salviae Miltiorrhizae extract (effective site) to count 5～98% with salvianolic acid B (C36H30O16), uses water-soluble gelation material or stagnates and release agent or the microporous membrane clothing is made the Salvia Miltiorrhiza delayed-release sheet.
Summary of the invention
The purpose of this invention is to provide a kind of Salvia Miltiorrhiza delayed-release sheet, the medical usage of Salvia Miltiorrhiza delayed-release sheet and various common red sage formulation purposes are in full accord, are used for the treatment of and prevent cardiovascular and cerebrovascular disease.The Salvia Miltiorrhiza delayed-release sheet has blood circulation promoting and blood stasis dispelling, is used for blood stasis and closes the thoracic obstruction that stagnates and contract and cause, and disease is seen chest pain, and sore spot is fixed, purplish tongue, and coronary heart disease angor is seen above-mentioned patient.When Salvia Miltiorrhiza delayed-release sheet treatment of the present invention and prevention cardiovascular and cerebrovascular disease, only need take 2 every day.The great advantage of Salvia Miltiorrhiza delayed-release sheet is, when taking the Salvia Miltiorrhiza delayed-release sheet, the effective ingredient of wherein each kind of medicine is in gastrointestinal tract, can discharge medicine on demand in the given time quantitatively, the stable blood concentration that keeps ideal existing therapeutical effect in the body, " peak valley " phenomenon of having avoided the frequent administration of common red sage formulation to occur again.When the blood drug level of " peak valley ", toxic and side effects can appear during peak concentration, then there is not therapeutical effect during paddy concentration.And that the Salvia Miltiorrhiza delayed-release sheet can provide is suitable, persistent, and stable blood concentration can guarantee the therapeutical effect of Salvia Miltiorrhiza delayed-release sheet, reduces the toxic and side effects of medicine as much as possible.This shows the ideal medicament when the Salvia Miltiorrhiza delayed-release sheet is treatment and prevention cardiovascular and cerebrovascular disease.
As seen, the invention provides the Salvia Miltiorrhiza delayed-release sheet except therapeutical effect and common red sage formulation are in full accord, and the Salvia Miltiorrhiza delayed-release sheet has also that the taking another dose consumption is little, administration number of times is few, less toxic side effect and other advantages.
The purpose of this invention is to provide above-mentioned Salvia Miltiorrhiza delayed-release sheet and preparation technology, comprising:
A. the preparation technology of Salvia Miltiorrhiza delayed-release sheet, using water-soluble gelation material such as hypromellose (HPMC) and Radix Salviae Miltiorrhizae extract (effective site), to contain salvianolic acid B (C36H30O16) be principal agent, adopts wet granulation technology or dry process should make the Salvia Miltiorrhiza delayed-release sheet.
B. the preparation technology of Salvia Miltiorrhiza delayed-release sheet, using stagnates releases agent material such as stearic acid and Radix Salviae Miltiorrhizae extract (effective site) to contain salvianolic acid B (C36H30O16) be principal agent, and employing wet granulation technology or dry process should be made the Salvia Miltiorrhiza delayed-release sheet.
C. the preparation technology of Salvia Miltiorrhiza delayed-release sheet, application is released agent material such as stearic acid and contained Radix Salviae Miltiorrhizae extract (effective site) salvianolic acid B (C36H30O16) is principal agent, adopt wet granulation technology or dry process should make Radix Salviae Miltiorrhizae Tabellae, again Radix Salviae Miltiorrhizae Tabellae is wrapped the microporous membrane clothing, made the Salvia Miltiorrhiza delayed-release sheet.
D. Salvia Miltiorrhiza delayed-release sheet drug release determination method of the present invention: press 2000 editions two appendix XC dissolution methods of Chinese Pharmacopoeia, first method.Putting into Salvia Miltiorrhiza delayed-release sheet a slice for every glass, is dissolution medium with water or phosphate buffer 900ml, and rotating speed is that per minute is 100 commentaries on classics, operation in accordance with the law.The 1st, 2, in the time of 4,8 hours, content is measured in sampling, calculates each release constantly.
The specific embodiment
Enumerating 4 examples is below further specified the present invention.
Embodiment 1
Prescription:
Radix Salviae Miltiorrhizae extract (effective site) is in salvianolic acid B (C36H30O16) 50g
Hypromellose 40g
Lactose 100g
Magnesium stearate 2g
Make 1000 altogether
Method for making: above-mentioned Radix Salviae Miltiorrhizae extract (effective site) is contained salvianolic acid B (C36H30O16), hypromellose, lactose, magnesium stearate is mixed, and crosses 60 mesh sieves, tabletting, the hypromellose film-coat that bag is conventional, promptly.
The drug release determination result is as follows:
Time (hour) 1248
Accumulative total release (salvianolic acid B) 25.7% 40.5% 65.5% 81.6%
Embodiment 2
Prescription:
Radix Salviae Miltiorrhizae extract (effective site) is in salvianolic acid B (C36H30O16) 50g
Hypromellose 40g
Lactose 100g
Magnesium stearate 2g
Make 1000 altogether
Method for making: above-mentioned Radix Salviae Miltiorrhizae extract (effective site) is contained salvianolic acid B (C36H30O16), hypromellose, lactose mixes, cross 60 mesh sieves, use 95% alcohol granulation, drying, granulate, after adding the magnesium stearate mix homogeneously, tabletting, the hypromellose film-coat that bag is conventional, promptly.
The drug release determination result is as follows:
Time (hour) 1248
Accumulative total release (salvianolic acid B) 27.6% 42.1% 62.8% 85.6%
Embodiment 3
Prescription:
Radix Salviae Miltiorrhizae extract (effective site) is in salvianolic acid B (C36H30O16) 50g
Stearic acid 55g
Lactose 85g
Magnesium stearate 2g
Make 1000 altogether
Stearic acid
Method for making: above-mentioned Radix Salviae Miltiorrhizae extract (effective site) is contained salvianolic acid B (C36H30O16), lactose, magnesium stearate is mixed, and crosses 60 mesh sieves, tabletting, the hypromellose film-coat that bag is conventional, promptly.
The drug release determination result is as follows:
Time (hour) 1248
Accumulative total release (salvianolic acid B) 28.2% 46.5% 67.2% 84.5%
Embodiment 4
Prescription:
Radix Salviae Miltiorrhizae extract (effective site) is in salvianolic acid B (C36H30O16) 50g
Stearic acid 45g
Lactose 100g
Magnesium stearate 2g
Make 1000 altogether
Method for making: above-mentioned Radix Salviae Miltiorrhizae extract (effective site) is contained salvianolic acid B (C36H30O16), stearic acid, lactose, magnesium stearate is mixed, and crosses 60 mesh sieves, tabletting, bag ethyl cellulose microporous membrane clothing, promptly.
The drug release determination result is as follows:
Time (hour) 1248
Accumulative total release (salvianolic acid B) 24.6% 37.4% 63.8% 75.9%.
Claims (7)
1. to contain Radix Salviae Miltiorrhizae extract (effective site) be 20～100mg with salvianolic acid B (C36H30O16) to the Salvia Miltiorrhiza delayed-release sheet, and optimised quantity is 30～70mg.The salvianolic acid B (C36H30O16) that Radix Salviae Miltiorrhizae extract (effective site) wherein contains, and the content of salvianolic acid B (C36H30O16) is 5～98%, optimum content is 10～90%.It is a kind of durative action preparation that salvianolic acid B of Radix Salviae Miltiorrhizae extract (C36H30O16) and sustained release excipient are made the Salvia Miltiorrhiza delayed-release sheet, oral 2 times of every day.
As claims 1 described its release of Salvia Miltiorrhiza delayed-release sheet in salvianolic acid B (C36H30O16): the 1st hour is 5～50%, and the best is 10～35%, the 2nd hour is 15～70%, and the best is 25～55%, the 4th hour is 35～90%, and the best is 50～80%, and the 8th hour is more than 50%, and the best is more than 75%.
As claims 1 every of described Salvia Miltiorrhiza delayed-release sheet contain hypromellose be sheet heavy 5～40%, the best is 10～30%.
As claims 1 every of described Salvia Miltiorrhiza delayed-release sheet contain stearic acid be sheet heavy 5～40%, the best is 10～30%.
5. the excipient that contains as claims 1 described Salvia Miltiorrhiza delayed-release sheet is various water-soluble gels such as hypromellose, methylcellulose or the like.
6. the excipient that contains as claims 1 described Salvia Miltiorrhiza delayed-release sheet is that various stagnating released agent such as stearic acid or the like.
7. use the microporous membrane clothing as claims 1 described Salvia Miltiorrhiza delayed-release sheet and make, as ethyl cellulose, celluloid, the microporous membrane clothing of cellulose acetate or the like.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510034826 CN1872160A (en) | 2005-05-31 | 2005-05-31 | Sloly released tablet of red sage root, and preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510034826 CN1872160A (en) | 2005-05-31 | 2005-05-31 | Sloly released tablet of red sage root, and preparation method |
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| Publication Number | Publication Date |
|---|---|
| CN1872160A true CN1872160A (en) | 2006-12-06 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200510034826 Pending CN1872160A (en) | 2005-05-31 | 2005-05-31 | Sloly released tablet of red sage root, and preparation method |
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| CN (1) | CN1872160A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101278920B (en) * | 2008-04-25 | 2011-05-04 | 广东药学院 | Salvianolic acid controlled porosity osmotic pump tablets and method of preparing the same |
| CN115607539A (en) * | 2022-10-17 | 2023-01-17 | 广东省第二人民医院（广东省卫生应急医院） | Polyphenol compound medicine and slow release method |
-
2005
- 2005-05-31 CN CN 200510034826 patent/CN1872160A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101278920B (en) * | 2008-04-25 | 2011-05-04 | 广东药学院 | Salvianolic acid controlled porosity osmotic pump tablets and method of preparing the same |
| CN115607539A (en) * | 2022-10-17 | 2023-01-17 | 广东省第二人民医院（广东省卫生应急医院） | Polyphenol compound medicine and slow release method |
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| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |