CN1321651C - Oral cavity spray containing two effective parts of compound red sage root formula and its preparation process - Google Patents
Oral cavity spray containing two effective parts of compound red sage root formula and its preparation process Download PDFInfo
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- CN1321651C CN1321651C CNB2005100320369A CN200510032036A CN1321651C CN 1321651 C CN1321651 C CN 1321651C CN B2005100320369 A CNB2005100320369 A CN B2005100320369A CN 200510032036 A CN200510032036 A CN 200510032036A CN 1321651 C CN1321651 C CN 1321651C
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- salviae miltiorrhizae
- radix salviae
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- red sage
- sage root
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Abstract
The present invention discloses an oral cavity spray agent containing two effective parts of compound red sage root formula and the preparation process thereof. The spray agent is composed of a solution A and a solution B which are used simultaneously, and the percent of raw materials by weight are that red sage root is of 94% to 99%, panax notoginseng saponins is of 0.8% to 5%, and borneolis of 0.1% to 1.5%. The solution A uses water as solvent, and the quantity of the solvent is 15% to 25% of that of the three drugs; ethylparaben is used as preservative, and the quantity of the ethylparaben is 0.01% to 0.03% of that of the dosage of finished goods. The solution B uses ethanol of 40% to 60% as solvent, and the quantity of the solvent is 15% to 25% of that of the three drugs. The preparation process is that the red sage root is made into red sage root fatsoluble effective parts with the main components of tanshinone by CO2 supercritical extraction method; residue is extracted with water and alcohol of different concentration; macroporous resin is made into red sage root water-soluble effective parts with the main components of salvianolic acid class by purification, and is dissolved with the panax notoginseng saponins by water so that the solution A can be obtained by adding auxiliary material-the ethylparaben. The solution B can be obtained by dissolving the red sage root fatsoluble effective parts and the borneol with ethanol of 20% to 60%. The solution A and the solution B are respectively filled into two mutually isolated cavities of a spray apparatus which can realize two-cavity spraying at the same time, and the present invention can be obtained.
Description
Technical field
The present invention relates to a kind of treatment and feel oppressed in the heart, anginal new drug---the two effective parts of compound red sage root formula oral spray.
Background technology
Enter 21 century, the research of international plant amedica is a dark horse, international plant amedica market is with the speed increment in every year about 10% to 20%, " the midocean medicine " of China's import increases substantially, but very regrettably, China uses big country as Chinese medicine cradle and Chinese medicine, on international plant amedica market, only account for share less than 5%, and based on the Chinese crude drug outlet, recent years, the Chinese patent medicine outlet of China is also on a declining curve, the main cause that causes this situation is that the Chinese patent medicine overwhelming majority that China produces is " treating different things alike ", its effective ingredient, the mechanism of action is all unclear, difficult quality control, the curative effect instability, change this unfavorable situation, should start with, utilize advanced technology and method from the very clear and definite classical prescription of curative effect, it is developed into to become to distinguish one from the other, quality controllable, mechanism is clear and definite, modern Chinese medicine safely and effectively is to adapt to the needs of modern Chinese medicine development.
The treatment that compound red sage root formula is made up of Radix Salviae Miltiorrhizae, Radix Notoginseng, Borneolum Syntheticum three flavor medicines is felt oppressed in the heart, anginal classical Chinese medicinal formulae, and its curative effect is very sure.Gong Ying dosage form is mainly tablet and drop pill in the market, but all there is certain limitation in these two dosage forms.At first, this two classes preparation is made by extract, and taking dose is big, uses inconvenient; Secondly, can not bring into play the whole body therapeutic effect by quick acting; In addition, research now proves, water solublity salvianolic acid class and fat-soluble TANSHINONES two constituents all are effective ingredient in the compound red sage root formula, and FUFANG DANSHEN PIAN ignored the former (water solublity salvianolic acid constituents), FUFANG DANSHEN DIWAN has then been ignored latter's (fat-soluble tanshinone component).Therefore, it is very necessary that compound red sage root formula is carried out two profound degree exploitations, especially for the formulation development of first aid.
The non-single chemical constituent that effective site means from single medicinal material or extracts in the compound recipe, as total flavones, total alkaloids etc., its content reaches more than 50% of total extract, and this class or a few class known chemical composition are considered to effective ingredient, the new Chinese medicine made from this kind extract is the effective site new drug, the effective ingredient in Chinese preparation both purification the extraction composition, embodied the characteristics of Chinese medicine multicomponent, many target spots generation effect again, now become important content of the modernization of Chinese medicine.
Usually deriving from Chinese herbal medicine and other natural goods gained medicinal raw materials are divided into three levels: extract, effective site, effective ingredient.And from Chinese medicine, extract single active ingredient, not only research, production cost height, and can not embody the characteristics of Chinese medicine multicomponent, many target spots generation effect, its curative effect is difficult to guarantee that theory and practice proves that all it is not the main developing direction of Chinese medicine.At present, the Chinese patent medicine overwhelming majority of supplying on the market is extract formulation, because extract formulation composition, curative effect are indeterminate, difficult quality control, the mechanism of action is difficult to further investigation, international market particularly western developed country market is difficult to approval, and this problem has become the bottleneck of China's Chinese medicine career development.
Research has had bigger progress to compound red sage root formula both at home and abroad in recent years, its composition and drug effect are clear, particularly 973 projects---compound red sage root formula material base and Study on mechanism confirm, there is the cooperative compensating effect behind Radix Salviae Miltiorrhizae and the Radix Notoginseng compatibility, danshensu that Radix Salviae Miltiorrhizae is contained and TANSHINONES all have the effect that resists myocardial ischemia, and emphasize particularly on different fields again.
At present, the administration of Chinese medicine quick-effective preparation mainly concentrates on mouth mucosa drug administration, and mouth mucosa drug administration has convenient drug administration, and onset is rapid, easily by characteristics such as patient's acceptance.We have developed hospital preparation-compound red sage root spray in 2002, through clinical application for many years, confirm that its acute attack effect for allevating angina pectoris is obvious, and applied for patent, number of patent application is: 200310120817.4, and publication number is: CN 1554414A.
But there is the deficiency of two aspects in said preparation, and at first, owing to be extract formulation, active constituent content is low, and taking dose is big, uses inconvenience.Secondly, because the preparation solvent is a water-soluble solvent, fat-soluble active constituent content is low excessively, has influenced the due curative effect of compound red sage root formula.
Summary of the invention
The problem of the technology that the present invention will solve is: at the defective of above prior art existence, provide and take into account water solublity salvianolic acid and fat-soluble TANSHINONES two effective constituents, its process repeatability is better, its effective ingredient is more complete, content is higher, test shows obvious, the easy to use Oral cavity spray containing two effective parts of compound red sage root formula and its preparation process of drug effect.
Technical scheme of the present invention is: a kind of two effective parts of compound red sage root formula oral spray, it is characterized in that it is made up of A liquid that can use simultaneously and B liquid, its raw materials by weight is a Radix Salviae Miltiorrhizae 94%～99%, Radix Notoginseng total arasaponins 0.8%～5%, Borneolum Syntheticum 0.1%～1.5%, A liquid is made solvent with water, and the solvent amount is 15%～25% (g:ml) of three flavor medicine inventorys, and ethyl hydroxybenzoate is made antiseptic (0.01～0.03%); B liquid is solvent with 40～60% ethanol, and the solvent amount is 15%～25% (g:ml) of three flavor medicine inventorys.Its preparation method is, gets Radix Salviae Miltiorrhizae, uses CO
2Supercritical extraction makes the fat-soluble effective site of Radix Salviae Miltiorrhizae (main component is a tanshinone component), and residue is water and Different concentrations of alcohol extraction again, and purification with macroreticular resin makes salvia-soluble effective site (main component is the salvianolic acid constituents); With salvia-soluble effective site and Radix Notoginseng total arasaponins water dissolution, add the adjuvant ethyl hydroxybenzoate and make A liquid, the fat-soluble effective site of Radix Salviae Miltiorrhizae and Borneolum Syntheticum are made B liquid with the dissolve with ethanol of 20%-60%, A, B liquid are irritated respectively in the mutual isolated dress A sap cavity and dress B sap cavity of the sprayer unit that can realize the spraying of two chambeies simultaneously, promptly.
A kind of preparation technology of two effective parts of compound red sage root formula oral spray is characterized in that: Radix Salviae Miltiorrhizae 88%～99% by weight percentage, Radix Notoginseng total arasaponins 1%～5%, Borneolum Syntheticum 0.5%～1.5%.Take by weighing raw material, Radix Salviae Miltiorrhizae is pulverized, cross 20 mesh sieves, get the Radix Salviae Miltiorrhizae coarse granule, use CO
2Supercritical extraction technique extracts tanshinone effective component group in the Radix Salviae Miltiorrhizae; Extracting pressure: 15～25Mpa, extraction temperature: 38～52 ℃, separation temperature: 32～38 ℃, separating pressure: 3～6Mpa, entrainer: dehydrated alcohol.60～70 ℃ of decompression and solvent recoveries of extract obtain the fat-soluble effective site of Radix Salviae Miltiorrhizae to about 50ml; Will be through CO
2Radix Salviae Miltiorrhizae behind the supercritical extraction is at first used the water of 6～9 times of amounts or 30%～65% ethanol extraction 2 times, and each 45～60 minutes, merge extractive liquid,, be concentrated into about 200ml, the ethanol precipitation impurity with 70%～95% filters, 75 ℃ of decompression and solvent recoveries of filtrate, be about 1.05 fluid extract to proportion, the fluid extract purification with macroreticular resin washes impurity earlier with water, reuse 50%-70% ethanol elution, collect eluent, concentrate, obtain salvia-soluble effective site.With water dissolution salvia-soluble effective site, Radix Notoginseng total arasaponins and ethyl hydroxybenzoate, make A liquid; Fat-soluble effective site of dissolve with ethanol Radix Salviae Miltiorrhizae and Borneolum Syntheticum with 20%～60% are made B liquid, and A, B liquid are irritated respectively in the mutual isolated dress A sap cavity of sprayer unit that can realize the spraying of two chambeies simultaneously and dress B sap cavity.
The present invention be an effective ingredient comprehensively, enrichment, impurity component be few, good effect, rapid-action new medicine compound effective component preparation, and have two classes effective site of different nature is a brand-new new product of Chinese medicine.
The specific embodiment
Below in conjunction with example explanation the present invention, the scheme of embodiment described here does not limit the present invention, and one of skill in the art can improve and change according to the present invention, and described these improvement and variation should be considered as in the scope of the present invention.
Embodiment 1:
Prescription:
Radix Salviae Miltiorrhizae 2400g
Radix Notoginseng total arasaponins 72g
Borneolum Syntheticum 32g
Get Radix Salviae Miltiorrhizae 600g, pulverize, cross 20 mesh sieves, get the Radix Salviae Miltiorrhizae coarse granule, use CO
2Tanshinone effective component group in the supercritical extraction technique extraction Radix Salviae Miltiorrhizae (extracting pressure: 15, extraction temperature: 38 ℃, separation temperature: 35 ℃, separating pressure: 5MPa, entrainer: dehydrated alcohol), 65 ℃ of decompression and solvent recoveries of extract obtain the fat-soluble effective site of Radix Salviae Miltiorrhizae to about 50ml; Will be through CO
2Radix Salviae Miltiorrhizae behind the supercritical extraction is at first got 2 times indescribably with the moisture of 8 times of amounts, and each 45 minutes, merge extractive liquid,, be concentrated into about 200ml, the ethanol precipitation impurity with 85% filters, 75 ℃ of decompression and solvent recoveries of filtrate are about 1.05 fluid extracts, the fluid extract purification with macroreticular resin to proportion, wash impurity earlier with water, reuse 50% ethanol elution is collected 50% ethanol elution, reclaims ethanol, concentrate, obtain salvia-soluble effective site.With water dissolution salvia-soluble effective site, Radix Notoginseng total arasaponins and ethyl hydroxybenzoate 4ml, make A liquid 400ml, A liquid is irritated in the dress A of sprayer unit sap cavity every bottle of 5ml; Fat-soluble effective site of dissolve with ethanol Radix Salviae Miltiorrhizae and Borneolum Syntheticum with 20% are made B liquid 400ml, irritate in the dress B of sprayer unit sap cavity every bottle of 5ml.
Embodiment 2:
Prescription:
Radix Salviae Miltiorrhizae 2320g
Radix Notoginseng total arasaponins 120g
Borneolum Syntheticum 24g
Get Radix Salviae Miltiorrhizae 600g, pulverize, cross 20 mesh sieves, get the Radix Salviae Miltiorrhizae coarse granule, use CO
2Tanshinone effective component group in the supercritical extraction technique extraction Radix Salviae Miltiorrhizae (extracting pressure: 20, extraction temperature: 45, separation temperature: 35 ℃, separating pressure: 5MPa, entrainer: dehydrated alcohol), 65 ℃ of decompression and solvent recoveries of extract obtain the fat-soluble effective site of Radix Salviae Miltiorrhizae to about 50ml; Will be through CO
2Radix Salviae Miltiorrhizae behind the supercritical extraction is with 50% ethanol extraction of 6 times of amounts 2 times, each 60min, merge extractive liquid,, be concentrated into about 200ml, the ethanol precipitation impurity with 75% filters, 75 ℃ of decompression and solvent recoveries of filtrate are about 1.05 fluid extracts, the fluid extract purification with macroreticular resin to proportion, wash impurity earlier with water, reuse 70% ethanol elution is collected 70% ethanol elution, reclaims ethanol, concentrate, obtain salvia-soluble effective site.With water dissolution salvia-soluble effective site, Radix Notoginseng total arasaponins and ethyl hydroxybenzoate 8ml, make A liquid 400ml, A liquid is irritated in the dress A of sprayer unit sap cavity every bottle of 5ml; Fat-soluble effective site of dissolve with ethanol Radix Salviae Miltiorrhizae and Borneolum Syntheticum with 50% are made B liquid 400ml, irritate in sprayer unit dress B sap cavity every bottle of 5ml.
Embodiment 3:
Prescription:
Radix Salviae Miltiorrhizae 2300g
Radix Notoginseng total arasaponins 20g
Borneolum Syntheticum 4g
Get Radix Salviae Miltiorrhizae 600g, pulverize, cross 20 mesh sieves, get the Radix Salviae Miltiorrhizae coarse granule, use CO
2Tanshinone effective component group in the supercritical extraction technique extraction Radix Salviae Miltiorrhizae (extracting pressure: 20, extraction temperature: 45, separation temperature: 35 ℃, separating pressure: 5MPa, entrainer: dehydrated alcohol), 65 ℃ of decompression and solvent recoveries of extract obtain the fat-soluble effective site of Radix Salviae Miltiorrhizae to about 50ml; Will be through CO
2Radix Salviae Miltiorrhizae behind the supercritical extraction is with 65% ethanol extraction of 8 times of amounts 2 times, each 45min, merge extractive liquid,, be concentrated into about 200ml, the ethanol precipitation impurity with 90% filters, 75 ℃ of decompression and solvent recoveries of filtrate are about 1.05 fluid extracts, the fluid extract purification with macroreticular resin to proportion, wash impurity earlier with water, reuse 60% ethanol elution is collected 60% ethanol elution, reclaims ethanol, concentrate, obtain salvia-soluble effective site.With water dissolution salvia-soluble effective site, Radix Notoginseng total arasaponins and ethyl hydroxybenzoate 15ml, make A liquid 500ml, A liquid is irritated in the dress A of sprayer unit sap cavity every bottle of 5ml; Fat-soluble effective site of dissolve with ethanol Radix Salviae Miltiorrhizae and Borneolum Syntheticum with 30% are made B liquid 500ml, irritate in the dress B of sprayer unit sap cavity every bottle of 5ml.
Embodiment 4:
Prescription:
Radix Salviae Miltiorrhizae 2600g
Radix Notoginseng total arasaponins 72g
Borneolum Syntheticum 40g
Get Radix Salviae Miltiorrhizae 600g, pulverize, cross 20 mesh sieves, get the Radix Salviae Miltiorrhizae coarse granule, use CO
2Tanshinone effective component group in the supercritical extraction technique extraction Radix Salviae Miltiorrhizae (extracting pressure: 22, extraction temperature: 42, separation temperature: 34 ℃, separating pressure: 4MPa, entrainer: dehydrated alcohol), 65 ℃ of decompression and solvent recoveries of extract obtain the fat-soluble effective site of Radix Salviae Miltiorrhizae to about 50ml; Will be through CO
2Radix Salviae Miltiorrhizae behind the supercritical extraction is earlier with the water extraction of 8 times of amounts 1 time, 45min, 50% ethanol extraction of 8 times of amounts of reuse 1 time, merge extractive liquid, is concentrated into about 200ml, the ethanol precipitation impurity with 85%, filter, 75 ℃ of decompression and solvent recoveries of filtrate are about 1.05 fluid extracts to proportion, the fluid extract purification with macroreticular resin washes impurity earlier with water, reuse 50% ethanol elution, collect 50% ethanol elution, reclaim ethanol, concentrate, obtain salvia-soluble effective site.With water dissolution salvia-soluble effective site, Radix Notoginseng total arasaponins and ethyl hydroxybenzoate 10ml, make A liquid 500ml, A liquid is irritated in the dress A of sprayer unit sap cavity every bottle of 5ml; Fat-soluble effective site of dissolve with ethanol Radix Salviae Miltiorrhizae and Borneolum Syntheticum with 60% are made B liquid 500ml, irritate in the dress B of sprayer unit sap cavity every bottle of 5ml.
Medicine effect of the present invention is learned experimental result:
1, medicine of the present invention has good anti-tentative myocardial ischemia effect, improves the ischemic electrocardiogram and changes, the incidence rate of the chamber arrhythmia that the minimizing ischemia causes.
2, can obviously suppress the inductive platelet aggregation of ADP, reduce the whole blood viscosity of blood stasis model rabbit, change the hemorheology situation.
3, obvious coronary blood flow increasing lowers myocardial oxygen consumption.
Claims (2)
1, a kind of two effective parts of compound red sage root formula oral spray is characterized in that it is made up of the A liquid and the B liquid that use simultaneously, and its raw materials by weight is a Radix Salviae Miltiorrhizae 94%～99%, Radix Notoginseng total arasaponins 0.8%～5%, Borneolum Syntheticum 0.1%～1.5%; A liquid is made solvent with water, and the solvent amount is 15%～25% of three flavor medicine inventorys, and ethyl hydroxybenzoate is 0.01～0.03% of a finished product consumption as antiseptic; B liquid is solvent with 40～60% ethanol, and the solvent amount is 15%～25% of three flavor medicine inventorys, and its preparation method is, gets Radix Salviae Miltiorrhizae, uses CO
2Supercritical extraction makes the fat-soluble effective site of Radix Salviae Miltiorrhizae, and main component is a tanshinone component, and residue is water and Different concentrations of alcohol extraction again, and purification with macroreticular resin makes salvia-soluble effective site, and main component is the salvianolic acid constituents; With salvia-soluble effective site and Radix Notoginseng total arasaponins water dissolution, add the adjuvant ethyl hydroxybenzoate and make A liquid, the fat-soluble effective site of Radix Salviae Miltiorrhizae and Borneolum Syntheticum are made B liquid with 20%～60% dissolve with ethanol, A, B liquid are irritated respectively in the mutual isolated dress A sap cavity and dress B sap cavity of the sprayer unit that can realize the spraying of two chambeies simultaneously, promptly.
2, a kind of preparation technology of two effective parts of compound red sage root formula oral spray is characterized in that: Radix Salviae Miltiorrhizae 88%～99% by weight percentage, Radix Notoginseng total arasaponins 1%～5%, Borneolum Syntheticum 0.5%～1.5% takes by weighing raw material, and Radix Salviae Miltiorrhizae is pulverized, cross 20 mesh sieves, get the Radix Salviae Miltiorrhizae coarse granule, use CO
2Supercritical extraction technique extracts tanshinone effective component group in the Radix Salviae Miltiorrhizae; Extracting pressure: 15～25Mpa, extraction temperature: 38～52 ℃, separation temperature: 32～38 ℃, separating pressure: 3～6Mpa, entrainer: dehydrated alcohol, 60～70 ℃ of decompression and solvent recoveries of extract obtain the fat-soluble effective site of Radix Salviae Miltiorrhizae to about 50ml; Will be through CO
2Radix Salviae Miltiorrhizae behind the supercritical extraction is at first used the water of 6～9 times of amounts or 30%～65% ethanol extraction 2 times, and each 45～60 minutes, merge extractive liquid,, be concentrated into about 200ml, the ethanol precipitation impurity with 70%～95% filters, 75 ℃ of decompression and solvent recoveries of filtrate, be about 1.05 fluid extract to proportion, the fluid extract purification with macroreticular resin washes impurity earlier with water, reuse 50%-70% ethanol elution, collect eluent, concentrate, obtain salvia-soluble effective site; With water dissolution salvia-soluble effective site, Radix Notoginseng total arasaponins and ethyl hydroxybenzoate, make A liquid; Fat-soluble effective site of dissolve with ethanol Radix Salviae Miltiorrhizae and Borneolum Syntheticum with 20%～60% are made B liquid, and A, B liquid are irritated respectively in the mutual isolated dress A sap cavity of sprayer unit that can realize the spraying of two chambeies simultaneously and dress B sap cavity.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100320369A CN1321651C (en) | 2005-08-19 | 2005-08-19 | Oral cavity spray containing two effective parts of compound red sage root formula and its preparation process |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100320369A CN1321651C (en) | 2005-08-19 | 2005-08-19 | Oral cavity spray containing two effective parts of compound red sage root formula and its preparation process |
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| CN1733069A CN1733069A (en) | 2006-02-15 |
| CN1321651C true CN1321651C (en) | 2007-06-20 |
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Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1895353B (en) * | 2006-06-27 | 2010-05-26 | 美晨集团股份有限公司 | Preparation of compound Danshen tablets |
| CN102240322B (en) * | 2011-07-01 | 2013-04-17 | 天圣制药集团股份有限公司 | Compound red sage root tablet and preparing process thereof |
| CN104274534A (en) * | 2013-07-03 | 2015-01-14 | 周伯扬 | Preparation technology of total-component mulberry leaf extract |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1424089A (en) * | 2002-12-23 | 2003-06-18 | 北京采瑞医药有限公司 | Composite red sage root spray for cardio-cerebral diseases and its preparing method |
| CN1554414A (en) * | 2003-12-29 | 2004-12-15 | 洪 袁 | Compound red sage root spray |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1424089A (en) * | 2002-12-23 | 2003-06-18 | 北京采瑞医药有限公司 | Composite red sage root spray for cardio-cerebral diseases and its preparing method |
| CN1554414A (en) * | 2003-12-29 | 2004-12-15 | 洪 袁 | Compound red sage root spray |
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Assignee: Hunan Shentaichun Pharmaceutical Co.,Ltd. Assignor: Yuan Hong|Yang Guoping Contract fulfillment period: 2007.9.15 to 2015.9.15 contract change Contract record no.: 2009430000100 Denomination of invention: Oral cavity spray containing two effective parts of compound red sage root formula and its preparation process Granted publication date: 20070620 License type: Exclusive license Record date: 20091019 |
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