CN1615980A - Active extract of lamtophlomis rotata and its preparing method and use - Google Patents
Active extract of lamtophlomis rotata and its preparing method and use Download PDFInfo
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Abstract
The medicine plant material Lamiophlomis rotata or its root is alcohol or water extracted to obtain the extract liquid, and the extract liquid is further separated and purified to obtain active extract, which contains total flavone in 50-80 wt% counted in rutin and luteolin in 1.0-5.0 wt%. The present invention has raised curative effect and reduced taken amount, and is used in treating various kinds of pain, hemorrhage, etc. The active extract may be added with pharmaceutically acceptable supplementary material to prepare various orally taken preparation, preferably dripping pill.
Description
Technical field
The invention belongs to field of medicaments, relating in particular to single plant Radix Lamiophlomidis Rotatae is the activity extract that contains total flavones that raw material extracts.The invention still further relates to the Preparation method and use of this activity extract.
Background technology
Radix Lamiophlomidis Rotatae sheet and Radix Lamiophlomidis Rotatae capsule are a kind of traditional Chinese patent medicines, and it is to be made by the processing of the herb of single plant Radix Lamiophlomidis Rotatae or root, records in Chinese Pharmacopoeia, and it has promoting blood circulation and stopping pain, and the function of removing stasis to stop bleeding is used for the edge of a knife pain behind the multiple surgical operation.Hemorrhage, surgery fracture, muscles and bones are sprained, rheumatic arthralgia and metrorrhagia, dysmenorrhea, gingival swelling and pain, hemorrhage etc.Chinese patent application number 0213469.9 discloses a kind of dispersible tablet of Radix Lamiophlomidis Rotatae, but these three kinds of preparations all are to make with the water extract that adopts Radix Lamiophlomidis Rotatae, and there is the big shortcoming of dose in it, generally need oral one time 3, every 300mg three times on the one, is equivalent to the 9g crude drug.
Summary of the invention
The dosage form that the objective of the invention is to overcome existing common lamiophlomis root preparation is few, the shortcoming that dose is big, and the effective medicinal part of development and use Radix Lamiophlomidis Rotatae is made treatment is truly had curative effect, the novel drugs that taking dose is few.
For reaching the technical scheme that the object of the invention adopts be: adopt labiate Radix Lamiophlomidis Rotatae (Phlomis rotata Benth), comprise the activity extract that root or herb obtain through extraction, so adopt the root of Radix Lamiophlomidis Rotatae medical material and/or the herb extracting solution after alcohol extraction and water thereof are carried, further separation and purification obtains activity extract, the dry product of its activity extract contains total flavones, and to reach percent by weight in rutin be 50-80%, and containing luteolin, to reach percent by weight be 1.0-5.0%.
The assay method of total flavones is reference substance with reference to two appendix spectrophotometries of Chinese Pharmacopoeia with the rutin in the activity extract, measures trap at 500nm wavelength place, calculates content of total flavone.The assay method of luteolin is with reference to two appendix high effective liquid chromatography for measuring of Chinese Pharmacopoeia:
Chromatographic condition and system: with octadecylsilane chemically bonded silica is filler; With methanol-0.4% phosphoric acid solution (50: 50) is mobile phase; The detection wavelength is 350nm; Number of theoretical plate calculates by the luteolin peak should be not less than 1500.With the luteolin is reference substance.
The preparation method of the activity extract of this Radix Lamiophlomidis Rotatae, be that the extracting solution that adopts the root of Radix Lamiophlomidis Rotatae medical material and/or herb to obtain by the general decoction and alcohol sedimentation technique of pharmaceutical technology or ethanol extract from water precipitation or alcohol percolation extraction method separates through a, macroporous resin adsorption or b. polyamide adsorbing separation or c. silica gel adsorption separate the solution that obtains, obtain activity extract after reclaiming solvent.
The Radix Lamiophlomidis Rotatae medical material that adopts can be separately with its root or use herb separately, also can be that root and herb use by the arbitrary proportion mixture, with the mixed proportion of root and herb is 1: 0.1～5 for good, is 1: 0.5～2 better through the test of pesticide effectiveness with the mixed proportion of root and herb.
Said isolation and purification method in the preparation method of above-mentioned activity extract, in order to be fit to consider the preferred macroporous resin adsorption separation method of production cost, be that extracting solution with Radix Lamiophlomidis Rotatae passes through macroporous resin adsorption, liquid to be extracted is all by behind the resin column, water flushing resin column, to water elution liquid near colourless till, continuously carry out eluting with 20～80% ethanol, collect ethanol elution.The type of macroporous resin is a lot, can adopt polar resin, nonpolar or low pole resin, and preferred macroporous resin nonpolar or low pole is good, as HPD-100, HPD-450, WLD, AB-8, ZTC-5 etc.
Narrate preparation method of the present invention below:
One, extract: the said decoction and alcohol sedimentation technique of a. is to take by weighing medicinal material coarse powder, mix homogeneously decocts with water 1～3 time, merges each time decocting liquid, concentrate, add ethanol and regulate determining alcohol to 30～70%, leave standstill, treat that precipitation fully after, incline and supernatant, filter, medicinal liquid is concentrated into 1: 0.5～2 concentration of suitable medical material amount, and is standby;
B. said ethanol extract from water precipitation is to take by weighing medicinal material coarse powder, adds 40%～90% alcohol reflux, reclaims ethanol, and medicinal liquid concentrates, add the suitable quantity of water mixing and stirring, leave standstill, treat that precipitation fully after, inclining supernatant, and medicinal liquid is concentrated into 1: 0.5～2 concentration of suitable medical material amount, and is standby;
C. said alcohol percolation extraction method is to take by weighing the Radix Lamiophlomidis Rotatae medicinal material coarse powder, after adding soak with ethanol, carry out diafiltration, collect percolate, reclaim ethanol, medicinal liquid concentrates, and adds the suitable quantity of water mixing and stirring, leaves standstill, after treating that precipitation fully, inclining supernatant, and medicinal liquid is concentrated into 1: 0.5～2 concentration of suitable medical material amount, and is standby;
Two, the above-mentioned further separation and purification of extracting solution:
A. above-mentioned medicinal liquid is passed through macroporous resin adsorption, treat that filtrate is all by behind the resin column, water flushing resin column, to water elution liquid near colourless till, continue and the material that adsorbs on the resin column is carried out eluting with 20～80% ethanol, collect ethanol elution, promptly obtain the activity extract of Chinese medicine Radix Lamiophlomidis Rotatae behind the decompression and solvent recovery; Macroporous resin can adopt nonpolar or the low pole resin, is good with HPD-100, HPD-450, WLD, AB-8, ZTC-5.(excessive certain density Radix Lamiophlomidis Rotatae extracting solution respectively by the good resin column of pretreatment of different model, is carried out dynamic adsorption.After crossing post, wash earlier that to be eluted to eluent closely colourless with water, the ethanol-eluting resin column of reuse 70% is with the ethanol elution evaporate to dryness.Calculate respectively than upper column quantity, than adsorbance, eluting rate and purity)
B. polyamide adsorbing separation polyamide adsorbing separation: above-mentioned medicinal liquid is concentrated, adsorb by polyamide, with methanol or ethanol by 10% graded to 95% eluting, collect middle polarity position (30%～80% methanol or 30%～95% ethanol), promptly obtain the activity extract of Chinese medicine Radix Lamiophlomidis Rotatae behind the decompression and solvent recovery.
C. silica gel adsorption separates: above-mentioned medicinal liquid is concentrated, and by silica gel adsorption, to 100% methanol, graded is to 10% methanol again by 4: 1 graded of chloroform-methanol for eluant; Or by 3: 1 graded of chloroform-ethanol to 95% ethanol, graded is to 10% ethanol again.(its eluant scope is: 2: 1 graded of chloroform-methanol are to 100% methanol, and graded is to 30% methanol again to collect the position of medium and high polarity; Or by 2: 1 graded of chloroform-ethanol to 95% ethanol, graded is to 30% ethanol again), the concentrate behind the decompression and solvent recovery promptly obtains the activity extract of Chinese medicine Radix Lamiophlomidis Rotatae.
Medicinal liquid 200ml with the alcohol extracting-water precipitating process is extracted passes through HPD-100 resin, 60～200 order silica gel and 60～200 order polyamide respectively.Carry out separation and purification by separately separation method.Collect eluent, survey general flavone content.And, measure the general flavone content in the dry substance with behind the eluent evaporate to dryness.
Three kinds of isolation and purification method experimental results
| Adsorption stuffing | Eluent general flavone content (mg) | Dry substance general flavone content (%) |
| The HPD-100 resin | ????1386.1 | ????72.38 |
| 60～200 order silica gel | ????1126.2 | ????77.62 |
| 60～200 order polyamide | ????1287.4 | ????79.13 |
Reclaim the activity extract that obtains behind the solvent, in order to extend the shelf life and to prepare the convenience and the convenient transportation of medicine, its activity extract is good to make dry product, so reclaim the concentrate that obtains behind the solvent, the further preferred dry powder that adopts spray drying to make activity extract.
Three, spray drying
With the above-mentioned ethanol elution that obtains through separation, reclaim ethanol, when being evaporated to relative density 1.05-1.1, spray drying is collected xeraphium, is the dry powder of the activity extract of Radix Lamiophlomidis Rotatae.
Another object of the present invention is the edge of a knife pain, hemorrhage after the activity extract of this Radix Lamiophlomidis Rotatae is used to prepare the treatment surgical operation, the medicine of various pain such as exogenous injury and disease such as hemorrhage.
Said medicine can be with conventional method of Chinese medicinal, add the adjuvant that pharmaceutically allows make the medicine of any oral formulations such as tablet, dispersible tablet, granule, capsule, mixture, oral liquid, syrup, pill, etc.Wherein preferred drop pill, the weight of each component is in its drop pill: 1 part in Radix Lamiophlomidis Rotatae activity extract dry powder, 0.5～4 part of Polyethylene Glycol.
Carry out the test of pesticide effectiveness with Radix Lamiophlomidis Rotatae extract below activity extract of the present invention and purposes are described.
One. analgesic experiment:
1, mice acetic acid twisting method:
Animal: Kunming kind white mice, body weight 18-22g, male and female half and half.
Test method: animal is divided into blank, 4 sample sets and positive drug matched group at random, weigh, labelling, successive administration 3 days, after the last administration 30 minutes, lumbar injection 0.6% acetic acid 0.1ml/ only, observe cause in 10 minutes turn round the body number of times.
Result: see the following form
Table 1 is turned round the different extracts of body measuring to the analgesic effect of mice (X ± SD)
| Group | Dosage (g/kg) | Number of animals | Turn round the body number of times | ??P |
| Normal control | 12 | ??42.33±9.3 | ||
| Dolantin | 0.05 | 12 | ??10.5±3.8 | ??＜0.01 |
| Pharmacopeia Radix Lamiophlomidis Rotatae capsule sample (Guangzhou factory product) | 1.2 | 12 | ??29.8±8.8 | ??＞0.05 |
| Radix Lamiophlomidis Rotatae root extract dry powder | 0.06 | 12 | ??18.16±6.3 | ??＜0.01 |
| Radix Lamiophlomidis Rotatae herb extract dry powder | 0.06 | 12 | ??23.08±7.3 | ??＜0.01 |
| Radix Lamiophlomidis Rotatae root: the extract dry powder of 1: 0.1 mixture of herb | 0.06 | 12 | ??18.56±5.3 | ??＜0.01 |
| Radix Lamiophlomidis Rotatae root: the extract dry powder of 1: 1 mixture of herb | 0.06 | 12 | ??10.58±3.8 | ??＜0.01 |
| Radix Lamiophlomidis Rotatae root: the extract dry powder of 1: 2 mixture of herb | 0.06 | 12 | ??17.24±6.8 | ??＜0.01 |
| Radix Lamiophlomidis Rotatae root: the extract dry powder of 1: 5 mixture of herb | 0.06 | 12 | ??19.34±4.9 | ??＜0.01 |
Show that each extract of Radix Lamiophlomidis Rotatae of the present invention all can reduce the writhing response number of times of mice, analgesic activity is arranged, and the analgesic effect of the activity extract of Radix Lamiophlomidis Rotatae root and herb mixture is better, has compared notable difference with normal group.
2, hot plate method:
Animal: Kunming kind white mice, body weight 18-22g all is male.
Test method: animal is divided into blank, 4 sample sets and positive drug matched group at random, weighs, labelling, and each organized according to dosage successive administration 7 days, and list of references uses hot plate method, measures the mice pain threshold of last administration respectively.
Result: see Table 2
Table 2 hot plate method is measured different extracts to the analgesic effect of mice (X ± SD)
| Group | Dosage (g/kg) | Number of animals | Lick the sufficient time (S) | P |
| Normal control | 12 | ??15.4±8.6 | ||
| Dolantin | 0.05 | 12 | ??35.9±15.2 | ＜0.01 |
| Pharmacopeia Radix Lamiophlomidis Rotatae capsule sample (Guangzhou factory product) | 1.2 | 12 | ??21.8±12.9 | ＞0.05 |
| Radix Lamiophlomidis Rotatae root extract dry powder | 0.06 | 12 | ??25.8±6.30 | ＜0.05 |
| Radix Lamiophlomidis Rotatae herb extract dry powder | 0.06 | 12 | ??26.6±19.8 | ＜0.05 |
| Radix Lamiophlomidis Rotatae root: 1: 0.1 mixed extract dry powder of herb | 0.06 | 12 | ??26.82±11.3 | ＜0.05 |
| Radix Lamiophlomidis Rotatae root: 1: 1 mixed extract dry powder of herb | 0.06 | 12 | ??33.2±18.6 | ＜0.01 |
| Radix Lamiophlomidis Rotatae root: 1: 2 mixture extract dry powder of herb | 0.06 | 12 | ??27.2±7.2 | ＜0.05 |
| Radix Lamiophlomidis Rotatae root: 1: 5 mixture extract dry powder of herb | 0.06 | 12 | ??25.2±18.6 | ＜0.05 |
The result shows, it is obvious that activity extract provided by the invention and former officinal Radix Lamiophlomidis Rotatae extract are compared analgesic effect, and the activity extract analgesic effect of the mixture of root and herb is obvious.
Two, hemostasis experiment
Cut the tail method: the results are shown in following table:
The different extracts of table 3 are to the influence in normal mouse bleeding time (X ± SD)
| Group | Dosage (g/kg) | Number of animals | Bleeding stopping period (S) | ??P |
| Normal control | 12 | ??100.1±20.1 | ||
| Pharmacopeia Radix Lamiophlomidis Rotatae capsule sample (Guangzhou factory product) | 1.2 | 12 | ??85.6±20.8 | ??＞0.05 |
| Radix Lamiophlomidis Rotatae root extract dry powder | 0.06 | 12 | ??73.3±23.0 | ??＜0.05 |
| Radix Lamiophlomidis Rotatae herb extract dry powder | 0.06 | 12 | ??80.4±18.4 | ??＜0.05 |
| Radix Lamiophlomidis Rotatae root: 1: 0.1 mixture extract dry powder of herb | 0.06 | 12 | ??75.2±16.2 | ??＜0.05 |
| Radix Lamiophlomidis Rotatae root: 1: 1 mixture extract dry powder of herb | 0.06 | 12 | ??62.6.2±18.6 | ??＜0.01 |
| Radix Lamiophlomidis Rotatae root: 1: 2 mixture extract dry powder of herb | 0.06 | 12 | ??74.61±12.3 | ??＜0.05 |
| Radix Lamiophlomidis Rotatae root: 1: 5 mixture extract dry powder of herb | 0.06 | 12 | ??79.25±8.9 | ??＜0.05 |
Animal: get healthy Kunming kind white mice, body weight 18-22g, male and female half and half.
Test method: animal is divided into blank, 4 sample sets and normal saline matched group at random, weigh, labelling, successive administration 7 days, fixing after the last administration, measure Mus tail length and labelling, respectively that mouse tail point 3mm place is cross-section after 30-40 minute, treating that blood overflows voluntarily picks up counting, inhale to dehematize with filter paper every 30s and drip, stop naturally, calculate the bleeding time until blood.
The result shows that the haemostatic effect of activity extract of Radix Lamiophlomidis Rotatae is better, with blank group matched group obvious difference.
Its root is compared with other group with 1: 1 group extract with the herb mixture, and haemostatic effect is best.
2, slide method
Animal: get 130 of healthy Kunming kind white mice, body weight 18-22g, male and female half and half.
Test method: animal is divided into blank, 6 sample sets and normal saline matched group at random, weigh, labelling, each sample mice is established 3 oral doses, after the last administration 30 minutes, each eyeball of mouse blood is used manual time-keeping immediately in the microscope slide two ends, and whether observed every 30 seconds has the blood streak to produce, the record clotting time is got its meansigma methods.
Result: see Table 4
The different extracts of table 4 are to the influence of normal clotting time of mice (X ± sD)
| Group | Dosage (g/kg) | Number of animals | Clotting time (S) | ????P |
| Normal control | 12 | ??135.83±19.77 | ||
| Pharmacopeia Radix Lamiophlomidis Rotatae capsule sample (Guangzhou factory product) | 1.2 | 12 | ??102.50±8.29 | ????＜0.01 |
| Radix Lamiophlomidis Rotatae root extract dry powder | 0.06 | 12 | ??95.8±6.30 | ????＜0.01 |
| Radix Lamiophlomidis Rotatae herb extract dry powder total flavones | 0.06 | 12 | ??111.67±9.86 | ????＞0.01 |
| Radix Lamiophlomidis Rotatae root: 1: 0.1 mixture extract dry powder of herb | 0.06 | 12 | ??97.3±8.58 | ????＜0.01 |
| Radix Lamiophlomidis Rotatae root: 1: 1 mixture extract dry powder of herb | 0.06 | 12 | ??75.42±24.19 | ????＜0.01 |
| Radix Lamiophlomidis Rotatae root: 1: 2 mixture extract dry powder of herb | 0.06 | 12 | ??89.42±14.13 | ????＜0.01 |
| Radix Lamiophlomidis Rotatae root: 1: 5 mixture extract dry powder of herb | 0.06 | 12 | ??105.42±24.19 | ????＞0.01 |
The result shows that activity extract provided by the invention is compared the clotting time that can obviously shorten mice with matched group.
The invention has the beneficial effects as follows:
1, the crude extract of medical material is purified to effective site further the separation, has improved curative effect of medication, reduced each dose of patient.
2, the characteristics of this medicine are: be used for the edge of a knife pain, hemorrhage behind the surgical operation, various pain such as exogenous injury and hemorrhage etc. sick, but not only pain relieving but also can stop blooding.
3, preparation method provided by the invention is suitable for industrialized mass production.
Set forth technical scheme of the present invention below in conjunction with embodiment
The specific embodiment
One, extract three kinds of processes of Radix Lamiophlomidis Rotatae medical material:
Embodiment 1, decoction and alcohol sedimentation technique: take by weighing the herb of Radix Lamiophlomidis Rotatae and the coarse powder of root (1: 1), mix homogeneously decocts with water 2 times, merges each time decocting liquid, concentrates, and adds ethanol and regulates determining alcohol to 60%, leaves standstill.After treating that precipitation fully, inclining supernatant, filters, and medicinal liquid is concentrated into 1: 2 concentration of suitable medical material amount, and is standby;
Embodiment 2, ethanol extract from water precipitation: take by weighing the herb of Radix Lamiophlomidis Rotatae and the coarse powder of root (1: 1), mix homogeneously adds 60% alcohol reflux 3 times, merges alcohol extract, reclaims ethanol, and medicinal liquid is concentrated into relative density 1.0-1.2, adds the suitable quantity of water mixing and stirring, leaves standstill.After treating that precipitation fully, inclining supernatant, filters, and medicinal liquid is concentrated into 1: 2 concentration of suitable medical material amount, and is standby;
Embodiment 3, alcohol percolation extraction method: take by weighing the herb of Radix Lamiophlomidis Rotatae and the coarse powder of root (1: 1), mix homogeneously, add 70% soak with ethanol after, carry out diafiltration with 5ml/ minute speed, collect percolate, reclaim ethanol, medicinal liquid is concentrated into relative density 1.2, adds the suitable quantity of water mixing and stirring, leaves standstill.After treating that precipitation fully, inclining supernatant, filters, and medicinal liquid is concentrated into 1: 2 concentration of suitable medical material amount, and is standby;
With the medicinal liquid of embodiment 1,2,3, the three kind of process for extracting macropore resin isolation eluting that used the same method respectively, be condensed into extractum after reclaiming ethanol, spray drying obtains dry powder, and measurement result sees the following form;
Three kinds of extracting method measurement results of table 5
| Process | Inventory | Concentrated solution | Dry powder | General flavone content |
| Embodiment 1 | ????20Kg | ??40L | ????1015g | ????70.3％ |
| Embodiment 2 | ????20Kg | ??40L | ????982g | ????74.1％ |
| Embodiment 3 | ????20Kg | ??40L | ????935g | ????67.9％ |
Two, further isolation and purification method
Embodiment 4, the further separation and purification of extraction concentrated solution of getting the foregoing description 2:
Above-mentioned medicinal liquid 200ml is carried out dynamic adsorption by AB-8 macroporous resin 15g, flow velocity is about 1ml/min, treat filtrate all by behind the resin column, water flushing resin column, to water elution liquid near colourless till, continue and the material that adsorbs on the resin column is carried out eluting with 70% ethanol, elution flow rate is 1ml/min, collects ethanol elution, promptly obtains the activity extract of Radix Lamiophlomidis Rotatae behind the decompression and solvent recovery, and further dry, obtain dry powder.
Embodiment 5, the further separation and purification of extraction concentrated solution of getting the foregoing description 2:
Above-mentioned medicinal liquid 200ml is carried out dynamic adsorption by HPD-100 macroporous resin 15g, treat filtrate all by behind the resin column, water flushing resin column, to water elution liquid near colourless till, continue and with 20% ethanol the material that adsorbs on the resin column is carried out eluting, other is operated with embodiment 4.
Embodiment 6, the further separation and purification of extraction concentrated solution of getting the foregoing description 2: above-mentioned medicinal liquid 200ml is carried out dynamic adsorption by WLD, macroporous resin 15g, treat that filtrate is all by behind the resin column, water flushing resin column, to water elution liquid near colourless till, continue and the material that adsorbs on the resin column is carried out eluting with 80% ethanol, collect ethanol elution, other is operated with embodiment 4.
Embodiment 7, the further separation and purification of extraction concentrated solution of getting the foregoing description 2: above-mentioned medicinal liquid 200ml is carried out dynamic adsorption by HPD-450 macroporous resin 15g, treat that filtrate is all by behind the resin column, water flushing resin column, to water elution liquid near colourless till, continue and with 50% ethanol the material that adsorbs on the resin column is carried out eluting, other is operated with embodiment 4.
Embodiment 8, the further separation and purification of extraction concentrated solution of getting the foregoing description 2:
Above-mentioned medicinal liquid 200ml is carried out dynamic adsorption by the ZTC-5 macroporous resin, treat filtrate all by behind the resin column, water flushing resin column, to water elution liquid near colourless till, continue and with 50% ethanol the material that adsorbs on the resin column is carried out eluting, other is operated with embodiment 4.
Embodiment 9, the further separation and purification of extraction concentrated solution of getting the foregoing description 2:
Above-mentioned medicinal liquid 200ml is carried out dynamic adsorption by AB-8 macroporous resin 15g, treat filtrate all by behind the resin column, water flushing resin column, to water elution liquid near colourless till, continue and with 50% ethanol the material that adsorbs on the resin column is carried out eluting, other is operated with embodiment 4.
The results are shown in following table
| Embodiment | Dry powder (g) | General flavone content (%) | Content of luteolin (%) |
| ????4 | ????5.54 | ????79.36 | ????4.10 |
| ????5 | ????5.38 | ????67.21 | ????1.83 |
| ????6 | ????4.25 | ????70.87 | ????3.12 |
| ????7 | ????5.67 | ????53.11 | ????0.62 |
| ????8 | ????3.71 | ????50.12 | ????2.39 |
| ????9 | ????5.68 | ????76.26 | ????2.86 |
Three, spray drying
Embodiment 10, the extraction concentrated solution that the foregoing description 2 is obtained are crossed the ethanol elution behind the macroporous resin, method is as embodiment 4, reclaim ethanol, when being evaporated to relative density 1.05-1.1, spray drying is collected xeraphium, promptly obtains the dry powder 982g of Radix Lamiophlomidis Rotatae activity extract, content of total flavone is 74.1%, content of luteolin 2.12%
Spray drying condition: inlet temperature: 85 ℃; 135 ℃ of leaving air temps.
Content of total flavone is measured and the content of luteolin assay method is seen Chinese Pharmacopoeia.
Set forth purposes of the present invention with embodiment below.
Embodiment A, tablet:
Take by weighing dry powder 150 grams of the Radix Lamiophlomidis Rotatae activity extract that embodiment 10 makes, mixes pulverizings in right amount, mistake 100 mesh sieves, ethanol wet granulation, an amount of magnesium stearate mixed pressuring plate of adding behind the dry granulate with 95% with 15% carboxymethyl starch sodium, PVP etc.Make 1000, every heavily about 0.3g, oral, each a slice, every day 3 times.
Embodiment B, capsule:
Take by weighing the dry powder 150g of the Radix Lamiophlomidis Rotatae activity extract that embodiment 10 makes, add an amount of adjuvant, cross 100 mesh sieves, dry pressing or wet granulation, oven dry pours into capsule No. 1, makes 1000, every heavily about 0.25g, each 1, every day 3 times.
Embodiment C, dispersible tablet
Take by weighing dry powder 150 grams of the Radix Lamiophlomidis Rotatae activity extract that embodiment 10 makes, mix pulverizing with 10% carboxymethyl starch sodium, cross 100 mesh sieves, add an amount of low substituted hydroxy-propyl methylcellulose, with polyvinylpyrrolidone ethanol liquid system soft material, wet granulation adds an amount of magnesium stearate mixed pressuring plate behind the dry granulate.Make 1000, every heavily about 0.3g, oral, each a slice, every day 3 times.Press the inspection of Chinese Pharmacopoeia method disintegration, sample should disintegrate in 3 minutes.
Embodiment D, oral liquid
Take by weighing behind the concentrated solution after embodiment 3 extracts the about 15g of extractum that the method separation and purification with embodiment 4 obtains, add the small amount of thermal water dissolution, stir evenly, add an amount of simple syrup, add water to 1000ml, regulate pH value to 6～7, filtration, embedding is sterilized, promptly.Specification: 10ml/ props up, and is oral, and each one, every day 3 times.
Embodiment E, drop pill
Get the dry powder 250g of the Radix Lamiophlomidis Rotatae activity extract of embodiment 10, pulverize, cross 120 mesh sieves, join in the mixed liquor of the fused polyethylene glycol 6000 of about 350g and 4000, fully mix, on the drop pill machine, drip and make 10000 drop pill, every heavily about 60mg with 70～90 ℃ fluid temperature.Oral, each 6, every day 3 times.
Embodiment F, syrup:
Take by weighing behind the concentrated solution after embodiment 3 extracts the about 15g of extractum that the method separation and purification with embodiment 4 obtains, add the small amount of thermal water dissolution, stir evenly, add an amount of simple syrup, add water to 1000ml, regulate pH value to 6～7, filtration, embedding is sterilized, promptly.Specification: the 100ml/ bottle, oral, each oral 10ml, every day 3 times.
Embodiment G, granule
Take by weighing behind the concentrated solution after embodiment 3 extracts the about 75g of extractum that the method separation and purification with embodiment 4 obtains, add an amount of lactose and dextrin mix homogeneously, wet granulation, dry granulate, branch is packed.Make 1000g, every bag 2g.Oral, each bag, every day 3 times.
Claims (10)
1, a kind of activity extract of Radix Lamiophlomidis Rotatae, be by labiate Radix Lamiophlomidis Rotatae medical material, comprise the activity extract that root or dry herb obtain through extraction, it is characterized in that: adopt the root of Radix Lamiophlomidis Rotatae medical material and/or the herb extracting solution after alcohol extraction or water are carried, further separation and purification obtains activity extract, the dry product of its activity extract contains total flavones, and to reach percent by weight in rutin be 50-80%, and containing luteolin, to reach percent by weight be 0.5-5.0%.
2, according to the preparation method of the activity extract of the said Radix Lamiophlomidis Rotatae of claim 1, it is characterized in that: the extracting solution that adopts the root of Radix Lamiophlomidis Rotatae medical material and/or herb to obtain by the general decoction and alcohol sedimentation technique of pharmaceutical technology or ethanol extract from water precipitation or alcohol percolation extraction method separates through a. macroporous resin adsorption or b. polyamide adsorbing separation or c. silica gel adsorption separate the solution that obtains, and obtains activity extract after reclaiming solvent.
3, according to the preparation method of the activity extract of the said Radix Lamiophlomidis Rotatae of claim 2, it is characterized in that: said Radix Lamiophlomidis Rotatae medical material is the mixture of its root and herb, and mixed proportion is 1: 0.1～5.
4, according to the preparation method of the activity extract of the said Radix Lamiophlomidis Rotatae of claim 2, it is characterized in that: said Radix Lamiophlomidis Rotatae medical material is the mixture of its root and herb, and mixed proportion is 1: 0.5～2.
5, according to the preparation method of the activity extract of the said Radix Lamiophlomidis Rotatae of claim 2, it is characterized in that: said macroporous resin adsorption separation method, be that extracting solution with Radix Lamiophlomidis Rotatae passes through macroporous resin adsorption, liquid to be extracted is all by behind the resin column, water flushing resin column, to water elution liquid near colourless till, continuously carry out eluting with 20～80% ethanol, collect ethanol elution.
6, according to the preparation method of the activity extract of the said Radix Lamiophlomidis Rotatae of claim 2, it is characterized in that: said macroporous resin is the macroporous resin that adopts nonpolar or low pole.
7, according to the preparation method of the activity extract of the said Radix Lamiophlomidis Rotatae of claim 2, it is characterized in that: reclaim the concentrate that obtains behind the solvent, further carry out the dry powder that spray drying makes activity extract.
8,, it is characterized in that preparing edge of a knife pain behind the treatment surgical operation, hemorrhage, the medicine of various pain such as exogenous injury and disease such as hemorrhage according to the purposes of the activity extract of the said Radix Lamiophlomidis Rotatae of claim 1.
9, the purposes of the activity extract of said Radix Lamiophlomidis Rotatae according to Claim 8, it is characterized in that said medicine for conventional method of Chinese medicinal, adds the medicine that the adjuvant that pharmaceutically allows is made any oral formulations: tablet, dispersible tablet, granule, capsule, mixture, oral liquid, syrup, pill, drop pill.
10, according to the purposes of the activity extract of the said Radix Lamiophlomidis Rotatae of claim 9, it is characterized in that the weight of each component in the said drop pill is: 1 part in Radix Lamiophlomidis Rotatae activity extract dry powder, 0.5～4 part of Polyethylene Glycol.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100540014C (en) * | 2005-06-10 | 2009-09-16 | 广州陈李济药厂 | A kind of plant extract and its Preparation method and use |
| CN101380356B (en) * | 2008-10-14 | 2012-12-19 | 沈阳药科大学 | Tibetan medicine Duyiwei total flavone extract and extraction method and use thereof |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1502328A (en) * | 2002-11-26 | 2004-06-09 | 李雪晶 | Lamiophlomis rotate dispersion table preparation process |
| CN1526421A (en) * | 2003-03-07 | 2004-09-08 | 周美华 | Prepn of single ingredient granule |
| CN1255100C (en) * | 2004-04-20 | 2006-05-10 | 成都优他制药有限责任公司 | Soft capsule preparation of Tibet medicine 'unique taste' |
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2004
- 2004-09-29 CN CNB2004100516609A patent/CN100450502C/en active Active
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100540014C (en) * | 2005-06-10 | 2009-09-16 | 广州陈李济药厂 | A kind of plant extract and its Preparation method and use |
| CN101380356B (en) * | 2008-10-14 | 2012-12-19 | 沈阳药科大学 | Tibetan medicine Duyiwei total flavone extract and extraction method and use thereof |
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| CN100450502C (en) | 2009-01-14 |
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