CN101396382A - Composite isatis root orally disintegrating tablet and preparation method thereof - Google Patents
Composite isatis root orally disintegrating tablet and preparation method thereof Download PDFInfo
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- CN101396382A CN101396382A CNA2007100464538A CN200710046453A CN101396382A CN 101396382 A CN101396382 A CN 101396382A CN A2007100464538 A CNA2007100464538 A CN A2007100464538A CN 200710046453 A CN200710046453 A CN 200710046453A CN 101396382 A CN101396382 A CN 101396382A
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Abstract
The invention relates to a preparation method of a compound isatis root orally disintegrating tablet which is obtained by the supercritical fluid extraction and the conventional extraction of isatis root and dyers woad leaf. The compound isatis root orally disintegrating tablet improves the content of the active components indirubin and indigotin greatly, enhances the curative effect of drug and is more applicable to the clinical treatment and is used for warm disease fever, spot, wind hot cold, swollen and ulcered throat, epidemic encephalitis B, hepatitis and parotitis, and the compound isatis root orally disintegrating tablet has very high social benefit and economic benefit.
Description
Technical field
The invention belongs to field of traditional Chinese, be specifically related to a kind of composite isatis root orally disintegrating tablet and preparation method thereof.
Technical background
Radix Isatidis is the dry root of cruciferae isatis Isatis indigotica Fort..Radix Isatidis is cold in nature, bitter in the mouth.The effect of tool heat-clearing and toxic substances removing, removing heat from blood sore-throat relieving, heat-clearing and toxic substances removing, removing heat from blood sore-throat relieving.Be used for maculae caused by violent heat pathogen, crimson tongue is purple dark, mumps, sore throat, scarlet fever, major part pestilence, erysipelas, carbuncle.
Folium Isatidis is the dried leaves of cruciferae isatis Isatis indigotica Fort..Cold in nature, the bitter in the mouth of Folium Isatidis.Has heat-clearing and toxic substances removing, blood cooling and ecchymoses removing.Be used for pathogenic warmth and join the army, unconsciousness due to high fever is sent out the speckle dermexanthesis, jaundice, hematodiarrhoea, mumps, sore throat, erysipelas, carbuncle.
Composite capsule of radix isatidis (WS-10295 (ZD-0295)-2002) is prepared from through extraction by Radix Isatidis, Folium Isatidis, has heat-clearing and toxic substances removing, removing heat from blood.Be used for the epidemic febrile disease heating, go out speckle, anemopyretic cold, swelling throat is mashed, epidemic encephalitis type B, hepatitis, parotitis.
Radix Isatidis among the composite capsule of radix isatidis preparation technology, Folium Isatidis are with ethanol and water extraction, there is certain problem, because in Radix Isatidis and the Folium Isatidis indirubin and indigo be liposoluble constituent, water or ethanol can not extract fully, extract temperature required height in addition, heat time heating time is long, and the effective ingredient failure loss will be bigger relatively, so influenced the curative effect of medicine to a certain extent.Therefore we carry out process modification to composite isatis root orally disintegrating tablet, thereby increase content of effective, strengthen the curative effect of medicine.
Summary of the invention
The present invention combines China's Chinese medicine with the modern pharmaceutical technology, adopt advanced supercritical carbon dioxide extraction method, fully extracts active ingredient, and combines with traditional extraction technology, has increased effective component content.It is characterized in that:
Its prescription (by weight percentage) is: Radix Isatidis 40.00%, Folium Isatidis 60.00% above medical material are commercially available.
Its preparation technology is:
1) Radix Isatidis extraction
Take by weighing Radix Isatidis 40.00% by formula ratio, Folium Isatidis 60.00% is pulverized, and adds the 80%-95% soak with ethanol 0.5-15h that 0.5-2 doubly measures, and use supercritical carbon dioxide extraction 1-2h under 20-80 ℃, 10-40MPa, and the extract collection is standby.
2) ethanol extraction
Above-mentioned Radix Isatidis extraction slag and Folium Isatidis extraction slag merge, and add 60% ± 20 alcohol reflux twice, and each 1.5 ± 0.5 hours, extracting solution merged, and filtered, and is standby.
3) water extract-alcohol precipitation
Above-mentioned ethanol extraction slag adds twice of pure water reflux, extract,, each 2 ± 0.5 hours, extracting solution merges, and filters, and is concentrated into proportion 1.2 ± 0.2, cooling, add 85% ± 10 ethanol to alcoholic degree 70% ± 15 under stirring fast, placed 12 hours, alcohol deposit fluid and Radix Isatidis, Folium Isatidis extract and ethanol extract merge, reclaim ethanol and be concentrated into proportion 1.2 ± 0.2, standby.
4) finished product preparation
Above three kinds of extracts are mixed drying, pulverize, it is measured in 1, takes by weighing citric acid 15 ± 5%, sodium bicarbonate 15 ± 5%, crosslinked carboxymethyl fecula sodium 15 ± 10%, microcrystalline Cellulose 20 ± 5%, lactose 20 ± 8%, all adjuvants are mixed evenly with extract, be pressed into tablet, promptly.
The preparation for preparing with the inventive method:
1, character: this product is yellowish-brown to brown, and color and luster is even, any surface finish.
2, the intraoral disintegration time limit: disintegrate in 1 minute.
3, composite isatis root orally disintegrating tablet of the present invention and composite capsule of radix isatidis are compared technology quality index such as following table:
| Project name | Former preparation (composite capsule of radix isatidis) | The inventive method (composite isatis root orally disintegrating tablet) |
| Disintegration time | Gastric 60 minutes | In the oral cavity 1 minute |
| Enter in the blood | Through oral cavity → stomach → duodenum digestion → little intestinal absorption → blood (omnidistance more than 8 hours) | (1 minute) disintegrate of moment in the oral cavity, most of by oral mucosa absorption → blood |
To sum up, technology of the present invention is with supercritical extraction method Radix Isatidis, Folium Isatidis to be extracted fully earlier, the indirubin of having avoided long-time extraction of former process high-temperature and having caused is decomposed destruction, and the content of the compound Salviae Miltiorrhizae soft capsule content indirubin that makes is significantly increased.
The composite isatis root orally disintegrating tablet content that makes with the inventive method is carried out the assay of active component indirubin, adenosine as test sample, and measurement result is indirubin 56 μ g/g; Indigo 35 μ g/g.Than the composite capsule of radix isatidis content indirubin 30 μ g/g that make with former technology; Indigo 20 μ g/g content exceed one times nearly.
Composite isatis root orally disintegrating tablet content of the present invention, adopt supercritical carbon dioxide extraction method, the active ingredient indirubin in the prescription, indigo content are improved greatly, strengthened the curative effect of medicine, be applicable to that more clinical treatment is used for the epidemic febrile disease heating, go out speckle, anemopyretic cold, swelling throat is mashed, epidemic encephalitis type B, hepatitis, parotitis has very high social benefit and economic benefit.
The specific embodiment
Below the present invention is further described.
Embodiment 1
Prescription: Radix Isatidis 600g, Folium Isatidis 900g.
Preparation method: take by weighing Radix Isatidis 600g, Folium Isatidis 900g respectively by formula ratio, pulverize, add the 50% soak with ethanol 0.5h of 300g, under 30 ℃, 15MPa, use supercritical carbon dioxide extraction 1h, the extract collection, standby; Merge with above-mentioned Radix Isatidis, Folium Isatidis extraction slag, add 50% alcohol reflux twice, each 1 hour, extracting solution merged, and filtered, and is standby; Above-mentioned ethanol extraction slag adds twice of pure water reflux, extract,, each 1.5 hours, extracting solution merges, and filters, and is concentrated into proportion 1.05, cooling, add 75% ethanol to alcoholic degree 70% under stirring fast, placed 12 hours, alcohol deposit fluid and Radix Isatidis, Folium Isatidis extract and ethanol extract merge, reclaim ethanol and be concentrated into proportion 1.05, standby; Above three kinds of extracts are mixed drying, pulverize, it is measured in 1, takes by weighing citric acid 15.75%, sodium bicarbonate 15.75%, crosslinked carboxymethyl fecula sodium 16.5%, microcrystalline Cellulose 21%, lactose 21.6%, all adjuvants are mixed evenly with extract, be pressed into tablet, promptly.
Embodiment 2
Prescription: Radix Isatidis 600g, Folium Isatidis 900g.
Preparation method: take by weighing Radix Isatidis 600g, Folium Isatidis 900g respectively by formula ratio, pulverize, add the 75% soak with ethanol 1h of 600g, under 20 ℃, 20MPa, use supercritical carbon dioxide extraction 1.5h, the extract collection, standby; Merge with above-mentioned Radix Isatidis, Folium Isatidis extraction slag, add 50% alcohol reflux twice, each 1.5 hours, extracting solution merged, and filtered, and is standby; Above-mentioned ethanol extraction slag adds twice of pure water reflux, extract,, each 2 hours, extracting solution merges, and filters, and is concentrated into proportion 1.10, cooling, add 85% ethanol to alcoholic degree 70% under stirring fast, placed 12 hours, alcohol deposit fluid and Radix Isatidis, Folium Isatidis extract and ethanol extract merge, reclaim ethanol and be concentrated into proportion 1.10, standby; Above three kinds of extracts are mixed drying, pulverize, it is measured in 1, takes by weighing citric acid 15.00%, sodium bicarbonate
15.00%, crosslinked carboxymethyl fecula sodium 15.00%, microcrystalline Cellulose 20.00%, lactose 20.00% mixes all adjuvants evenly with extract, is pressed into tablet, promptly.
Embodiment 3
Prescription: Radix Isatidis 600g, Folium Isatidis 900g.
Preparation method: take by weighing Radix Isatidis 600g, Folium Isatidis 900g respectively by formula ratio, pulverize, add the 95% soak with ethanol 1.5h of 900g, under 40 ℃, 30MPa, use supercritical carbon dioxide extraction 2h, the extract collection, standby; Merge with above-mentioned Radix Isatidis, Folium Isatidis extraction slag, add 50% alcohol reflux twice, each 2.5 hours, extracting solution merged, and filtered, and is standby; Above-mentioned ethanol extraction slag adds twice of pure water reflux, extract,, each 2.5 hours, extracting solution merges, and filters, and is concentrated into proportion 1.15, cooling, add 95% ethanol to alcoholic degree 70% under stirring fast, placed 12 hours, alcohol deposit fluid and Radix Isatidis, Folium Isatidis extract and ethanol extract merge, reclaim ethanol and be concentrated into proportion 1.15, standby; Above three kinds of extracts are mixed drying, pulverize, it is measured in 1, takes by weighing citric acid 14.25%, sodium bicarbonate 14.25%, crosslinked carboxymethyl fecula sodium 13.50%, microcrystalline Cellulose 19.00%, lactose 18.40%, all adjuvants are mixed evenly with extract, be pressed into tablet, promptly.
Claims (1)
1, a kind of preparation method of composite isatis root orally disintegrating tablet content is characterized in that:
Its prescription (by weight percentage) is: Radix Isatidis 40.00%, Folium Isatidis 60.00%, above medical material is commercially available.
Its preparation technology is:
1) Radix Isatidis, Folium Isatidis extraction
Take by weighing Radix Isatidis 40.00%, Folium Isatidis 60.00% by formula ratio, pulverize, add 0.5-2 and doubly measure 80%-95% soak with ethanol 0.5-15h, under 20-80 ℃, 10-40MPa, use supercritical carbon dioxide extraction 1-2h, the extract collection, standby.
2) ethanol extraction
Above-mentioned Radix Isatidis extraction slag and Folium Isatidis extraction slag merge, and add 60% ± 20 alcohol reflux twice, and each 1.5 ± 0.5 hours, extracting solution merged, and filtered, and is standby.
3) water extract-alcohol precipitation
Above-mentioned ethanol extraction slag adds twice of pure water reflux, extract,, each 2 ± 0.5 hours, extracting solution merges, and filters, and is concentrated into proportion 1.2 ± 0.2, cooling, add 85% ± 10 ethanol to alcoholic degree 70% under stirring fast, placed 12 hours, alcohol deposit fluid and Radix Isatidis, Folium Isatidis extract and ethanol extract merge, reclaim ethanol and be concentrated into proportion 1.2 ± 0.2, standby.
4) finished product preparation
Above three kinds of extracts are mixed drying, pulverize, it is measured in 1, takes by weighing citric acid 15 ± 5%, sodium bicarbonate 15 ± 5%, crosslinked carboxymethyl fecula sodium 15 ± 10%, microcrystalline Cellulose 20 ± 5%, lactose 20 ± 8%, all adjuvants are mixed evenly with extract, be pressed into tablet, promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007100464538A CN101396382A (en) | 2007-09-27 | 2007-09-27 | Composite isatis root orally disintegrating tablet and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007100464538A CN101396382A (en) | 2007-09-27 | 2007-09-27 | Composite isatis root orally disintegrating tablet and preparation method thereof |
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| Publication Number | Publication Date |
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| CN101396382A true CN101396382A (en) | 2009-04-01 |
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| CNA2007100464538A Pending CN101396382A (en) | 2007-09-27 | 2007-09-27 | Composite isatis root orally disintegrating tablet and preparation method thereof |
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102174009A (en) * | 2011-03-09 | 2011-09-07 | 中国科学院近代物理研究所 | Method for preparing indigo and indirubin from dyers woad leaf |
| CN102614242A (en) * | 2012-04-13 | 2012-08-01 | 孙长海 | Dropping pill of isatis root and folium isatidis and preparing method thereof |
| CN103316056A (en) * | 2013-06-24 | 2013-09-25 | 江苏鹏鹞药业有限公司 | Radix isatidis coating dispersible tablet and preparation method thereof |
| WO2014118040A1 (en) * | 2013-01-29 | 2014-08-07 | Axel Brattstroem | Extract from indigo tinctoria for the topical treatment and prophylaxis of skin disorders |
| CN104173601A (en) * | 2014-08-20 | 2014-12-03 | 赵燕翼 | Radix isatidis and folium isatidis tablet and preparation method thereof |
| CN104983691A (en) * | 2015-06-28 | 2015-10-21 | 赵明亮 | Preparation method and application of compound indigowoad root granules |
| CN107349247A (en) * | 2017-05-23 | 2017-11-17 | 回音必集团安徽制药有限公司 | A kind of Radix Isatidis Optimized Extraction Process |
| CN113230305A (en) * | 2021-03-29 | 2021-08-10 | 广东和平君乐药业有限公司 | Isatis root granules and preparation method thereof |
| CN114470108A (en) * | 2022-02-22 | 2022-05-13 | 徐昊 | Compound isatis root buccal tablet and processing method thereof |
-
2007
- 2007-09-27 CN CNA2007100464538A patent/CN101396382A/en active Pending
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102174009A (en) * | 2011-03-09 | 2011-09-07 | 中国科学院近代物理研究所 | Method for preparing indigo and indirubin from dyers woad leaf |
| CN102174009B (en) * | 2011-03-09 | 2013-08-21 | 中国科学院近代物理研究所 | Method for preparing indigo and indirubin from dyers woad leaf |
| CN102614242A (en) * | 2012-04-13 | 2012-08-01 | 孙长海 | Dropping pill of isatis root and folium isatidis and preparing method thereof |
| CN102614242B (en) * | 2012-04-13 | 2013-06-12 | 孙长海 | Dropping pill of isatis root and folium isatidis and preparing method thereof |
| WO2014118040A1 (en) * | 2013-01-29 | 2014-08-07 | Axel Brattstroem | Extract from indigo tinctoria for the topical treatment and prophylaxis of skin disorders |
| CN103316056A (en) * | 2013-06-24 | 2013-09-25 | 江苏鹏鹞药业有限公司 | Radix isatidis coating dispersible tablet and preparation method thereof |
| CN103316056B (en) * | 2013-06-24 | 2015-07-08 | 江苏鹏鹞药业有限公司 | Radix isatidis coating dispersible tablet and preparation method thereof |
| CN104173601A (en) * | 2014-08-20 | 2014-12-03 | 赵燕翼 | Radix isatidis and folium isatidis tablet and preparation method thereof |
| CN104983691A (en) * | 2015-06-28 | 2015-10-21 | 赵明亮 | Preparation method and application of compound indigowoad root granules |
| CN107349247A (en) * | 2017-05-23 | 2017-11-17 | 回音必集团安徽制药有限公司 | A kind of Radix Isatidis Optimized Extraction Process |
| CN113230305A (en) * | 2021-03-29 | 2021-08-10 | 广东和平君乐药业有限公司 | Isatis root granules and preparation method thereof |
| CN114470108A (en) * | 2022-02-22 | 2022-05-13 | 徐昊 | Compound isatis root buccal tablet and processing method thereof |
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| WD01 | Invention patent application deemed withdrawn after publication |
Open date: 20090401 |