CN1810284A - Yunnan Rhizoma Paridis extract and its prepn, medicinal use and medicine composition - Google Patents
Yunnan Rhizoma Paridis extract and its prepn, medicinal use and medicine composition Download PDFInfo
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Abstract
The Yunnan Rhizoma Paridis extract is prepared with Yunnan Rhizoma Paridis as material, and through water or alcohol extraction, macroporous adsorption resin column purification, alcohol washing, concentration, alcohol dissolving and filtering. The extract may be combined with one or several kinds of pharmaceutically acceptable carrier and/or excipient to prepare various kinds of medicine for preventing and treating hemorrhage, cancer and pains in high treating effect.
Description
Technical field:
The invention belongs to pharmaceutical field, be specifically related to the pharmaceutical usage of Yunnan Rhizoma Paridis extract, preparation method and pharmaceutical composition
Background technology:
Rhizoma Paridis Paris polyphylla var.yunnannensis (Paris yunnannensisFreanch) belongs to the Liliaceae paris plant on Plant Taxonomy.The main effective ingredient of Rhizoma Paridis is a steroid saponin, also contains flavonoid, plant sterol constituents.
In recent years the water of Rhizoma Paridis and alcohol extract had been carried out some pharmacological researches researchs, the extract of finding Rhizoma Paridis has antiinflammatory, hemostasis, analgesia, effect such as anticancer.
But up to the present, do not see the bibliographical information that Yunnan Rhizoma Paridis extract is prepared into medicine involved in the present invention as yet, the inventor confirms through great deal of experimental, and Yunnan Rhizoma Paridis extract has hemostasis, analgesia, effect such as anticancer, and made medicament, finished the present invention.
Summary of the invention:
The purpose of this invention is to provide a kind of Yunnan Rhizoma Paridis extract.
Another object of the present invention provides a kind of extracting method of Yunnan Rhizoma Paridis extract.
A further object of the present invention provides with Yunnan Rhizoma Paridis extract and uses in preparation prevention and treatment hemostasis, analgesia, antineoplastic.
It is the pharmaceutical composition of primary activity composition that another purpose of the present invention provides with the Yunnan Rhizoma Paridis extract.
Yunnan Rhizoma Paridis extract of the present invention is the material that following method obtained:
With the Rhizoma Paridis is raw material, with 0% to 100% alcohol extraction 1-10 time, preferably uses 70% alcohol extraction; Preferably extract 3 times, or the sedimentary extracting method of water extraction 60%-95% alcohol, reclaim alcohol and also can; Or the extracting method of water extraction alkali precipitation also can, extracting solution merges, and filters, filtrate is through the macroporous adsorptive resins purification, with 0%-20% alcohol be eluted to colourless after, with collecting eluent behind the pure eluting of 10%-100%, best with 70% pure eluting, reclaim alcohol, to there not being the alcohol flavor, be condensed into casual paste or dry powder under the decompression or under the normal pressure, with the dissolving of 0%-95% alcohol, the most handy 70% alcohol dissolving filters, disgorging also reclaims filtrate, obtains required Rhizoma Paridis extract behind the reclaim under reduced pressure alcohol.Analyze through the HPLCf forensic chemistry, the main component of gained Rhizoma Paridis extract has:
| Contents of steroid saponin | Rhizoma Paridis |
| Rhizoma Paridis saponin A | 1.09 |
| Rhizoma Paridis saponin B | 0.92 |
| Dioscin | 1.33 |
| Pennogenin B | 0.34 |
| Pennogenin E | 0.56 |
| Yunnan Rhizoma Paridis saponin A | 0.21 |
| Yunnan Rhizoma Paridis saponin B | 0.23 |
The saponin content of Rhizoma Paridis extract is approximately more than 75%.
The material that said process obtained, except that containing 75% above Rhizoma Paridis total saponins, other compositions also have protein, peptide, aminoacid, polysaccharide, and trace element and volatile oil.It will be appreciated by those skilled in the art that these impurity components bring adverse effect can for basically the pharmacological activity of Rhizoma Paridis extract in the pharmaceutical composition of the present invention.
The preparation method of Yunnan Rhizoma Paridis extract of the present invention is:
1, with the Rhizoma Paridis be raw material, with 0% to 100% alcohol extraction, also available water is extracted the sedimentary method of 60%-95% alcohol, reclaims alcohol again, or the extracting method of water extraction alkali precipitation;
2, extracting solution merges, and filters, and filtrate is through the macroporous adsorptive resins purification;
3, with 0%-20% alcohol be eluted to colourless after, with collecting eluent behind the 10%-100% alcohol eluting, reclaim alcohol, to there not being the alcohol flavor, decompression down or be condensed under the normal pressure and overflow paste or dry powder;
4, with the dissolving of 0%-95% alcohol, filter, disgorging also reclaims filtrate, obtains required Rhizoma Paridis extract behind the reclaim under reduced pressure alcohol.
The medicinal application of Yunnan Rhizoma Paridis extract of the present invention comprises:
Yunnan Rhizoma Paridis extract is in preparation treatment or prevent application in the various hemorrhage medicines;
The application of Yunnan Rhizoma Paridis extract in preparation treatment cancer drug;
The application of Yunnan Rhizoma Paridis extract in the preparation analgesic drug product
The present invention is that the medicine of primary activity composition is with the Yunnan Rhizoma Paridis extract: by Yunnan Rhizoma Paridis extract and one or more pharmaceutically acceptable carriers and/or excipient phase composition.
The part by weight of composition of medicine raw material consumption of the present invention can be to contain the Yunnan Rhizoma Paridis extract of 1%-99% and the excipient of 99%-1%.
The preferred part by weight of composition of medicine raw material consumption of the present invention is to contain the Yunnan Rhizoma Paridis extract of 20%-80% and the excipient of 80%-20%.
Of the present invention is the drug regimen of primary activity composition with the Yunnan Rhizoma Paridis extract.Wherein to account for the optimum weight ratio of said pharmaceutical composition be more than 50% (w/w) to Yunnan Rhizoma Paridis extract, and said Yunnan Rhizoma Paridis extract mainly is made up of steroidal saponin.
Good effect of the present invention is: a kind of respond well treatment cancer, hemorrhage and analgesic pharmaceutically active substance is provided and is the new drug of therapeutic component preparation with this active substance, for above treatment of diseases is widened approach.
What should particularly point out here is, can add one or more natural or synthetic other as required and have the active component of collaborative or assosting effect with Yunnan Rhizoma Paridis extract in pharmaceutical composition of the present invention. the natural or synthetic auxiliary activity composition that these may be added into be well known by persons skilled in the art with can expect.
Of the present invention is the medicine of primary activity material with the Yunnan Rhizoma Paridis extract, can be made into the pharmaceutical composition that is applicable to the different dosage form that uses clinically. for example said compositions can be mixed with and can supply intravenous, the injection of drug administration by injection such as intramuscular, intraperitoneal, subcutaneous, marrowbrain intracavity is perhaps made the tablet, granule, drop pill, electuary, liquid preparation, the powder agent that are suitable for oral administration.Pill, capsule and suspending agent, and the spray, aerosol, cream, ointment and the suppository that are suitable for topical.
In order to prepare the solution that is suitable for the outer approach medicine of gastrointestinal tract, for example can use distilled water, water for injection, isotonic sodium chlorrde solution or glucose solution, perhaps low concentration (for example 1-100mM) phosphate buffered saline (PBS) (PBS) is as carrier or excipient.Can in the preparation of these gastrointestinal tract external administrations, add one or more other auxiliary elements or additives, for example can use ascorbic acid as antioxidant, use sodium benzoate or Metagin cheese as antiseptic, use dimethyl sulfoxide as absorption enhancer.
In order to prepare tablet, the powder agent that is suitable for oral administration, suspending agent or capsule can use sucrose, galactose, corn starch, gelatin, lipid, microcrystalline Cellulose, Pulvis Talci etc. as carrier or excipient.Be suitable for also can containing other proper additive in the preparation of oral administration, for example solubilizing agent, disintegrating agent, lubricant, absorption enhancer, dispersant, surfactant, correctives or coloring agent etc. at these.
Preferably pharmaceutical composition of the present invention is made the various oral dosage forms of cheating medicine that are suitable for, for example tablet, powder agent, capsule, or oral liquid or Emulsion. the unit dose of these oral formulations generally comprises the 30-800mg Yunnan Rhizoma Paridis extract.
Another preferred route of administering of pharmaceutical composition of the present invention is the injection that intravenous or intramuscular injection are suitable for these route of administration.For example for some metrorrhagia or cancer patient, the injection formulation of pharmaceutical composition of the present invention can be added in etc. and ooze in glucose solution or the isotonic sodium chlorrde solution, constantly dropleting medicine-feeding.
Dose: oral 300mg/ day (in the extract scale); Injection 100mg/ day (in the extract scale).
Pharmacology in vivo test research
Antitumor test example
Summary: Rhizoma Paridis extract with 80,30mg/kg dosage gastric infusion, P388 ascitic type and S180 entity sarcoma show significantly active anticancer, and liver ascites is also had certain antitumaous effect.
Medicine: Rhizoma Paridis extract, yellow powder, through screening with dosage 80 30mg/kg,, the time spent is with physiological saline solution, the tween 80 hydrotropy.
Animal: Kunming kind white mice, body weight 18-22g, the male and female dual-purpose is available from new laboratory animal plant of Changchun Lvyuan District section.The quality certification number: lucky kinoplaszm word 10-1015.
Tumor strain: P
388Ascitic type, S
180Entity sarcoma, liver ascites are all available from the institute of oncology, Jilin Province.
Method: get 7-10 days tumor animal of inoculation, take off cervical vertebra and put to death, under aseptic condition, the sterilization skin of abdomen, extract milky tumor liquid, by 1: 2 dilution proportion, inoculate to the intact animal then with normal saline, every 0.2ml, ascitic type is inoculated in the jenny abdominal cavity, and it is subcutaneous that solid type is inoculated in the buck axillary fossa, inoculates to begin the administration of dividing into groups back next day, observation is to the increase in life span of ascitic type and to the tumour inhibiting rate of solid type, and the result handles with statistics t check.See the following form 1.
Table 1: Rhizoma Paridis extract is to the influence of animal transplanting tumor P388
| Group and dosage mg/kg | Number of animals n | The survival natural law (my god; X ± SD) |
| Lotus tumor matched group | 10 | 8.17±1.18 |
| Cyclophosphamide 20 Rhizoma Paridis extracts 80 Rhizoma Paridis extracts 30 | 10 10 10 | 16.5±1.57 *** 13.07±3.15 ** 10.1±2.04 * |
Annotate:
*P＜0.05
*P＜0.01
* *The as follows summary in P＜0.001
Table 2 Rhizoma Paridis extract is to the influence of animal transplanting tumor S180
| Group and dosage mg/kg | Number of animals n | Heavy (the g of tumor; X ± SD) |
| Lotus tumor matched group Cyclophosphamide 20 Rhizoma Paridis extracts 80 Rhizoma Paridis extracts 30 | 10 10 10 10 | 2.23±0.48 1.56±0.35 ** 1.04±0.49 ** 1.22±0.47 ** |
Table 3: Rhizoma Paridis extract is to the influence of animal transplanting tumor Hep-A-22
| Group and dosage mg/kg | Number of animals n | The survival natural law (my god; X ± SD) |
| Lotus tumor matched group | 10 | 16.32±0.89 |
| Cyclophosphamide 30 Rhizoma Paridis extracts 80 Rhizoma Paridis extracts 80 | 10 10 10 | 25.57±2.35 21.69±2.15 17.62±2.44 |
By result in the table as can be known, Rhizoma Paridis extract all demonstrates stronger antitumaous effect to P388 ascitic type and S180 sarcoma, and is remarkable with the matched group comparing difference, and wherein 80mg/kg dosage curative effect is more stable, and the Hep-A-22 ascitic type is also shown certain effect.
Pharmacology in vitro tests research---mtt assay is measured the influence of Rhizoma Paridis extract to different cultured cell in vitro strain cell proliferation
Experiment purpose: mtt assay is tried the proliferation function of Chinese medicine sample to different cells by the quantity of the indirect reflection of depth contrast of color proliferative cell alive thereby detect, and is used for the detection of cells in vitro drug susceptibility.
1 reagent and instrument:
Eagle ' s MEM culture medium (Gibco, USA); Trypsin Trypsin) (Gibco, USA); 96 well culture plates (Costar, USA); Tetramethyl azo azoles salt (MTT, Sigma, USA); Enzyme mark photometer (CliniBio 128C, EC); Hyclone (Chinese Academy of Medical Sciences's Blood Research Institute, lot number: 200004); CO
2(Japan), all the other reagent are homemade AR to incubator for SANYO, MCO-175M.
2 cell strains:
Cervical cancer tumer line (HeLa), MCF-7 (Bcap-37), human lung cancer cell line (A549), Bel7402 (HepG2), SGC-7901 (SGC-7901), human leukemia cell line (K562), above cell line is all available from DSMZ of Wuhan University (CCTCC).
3 given the test agent:
Rhizoma Paridis extract: yellow powder, antitumor are for No. 1 yellow particle.
4 positive control drugs:
Vincristine sulfate (Mingxing Pharmaceutical Factory, Guangzhou, lot number: 010701); Methotrexate (wash rice river Wan Ma pharmaceutcal corporation, Ltd, lot number 010301); Cisplatin (Dezhou, Shandong Province pharmaceutical factory, lot number: 010914).Doxorubicin hydrochloride (Wanle Pharmaceutical Co Ltd, Shenzhen, lot number: 0111E1).
5 cell culture: the routine cultivation of going down to posterity
[1]
6 experimental techniques:
Adopt mtt assay.Get each one bottle in the good above-mentioned cell of growth conditions, make cell suspension, with 1 * 10
4/ hole 100 μ l are seeded in 96 well culture plates, add given the test agent 20 μ l simultaneously, and 10 times are diluted to variable concentrations, and matched group adds the culture fluid 20 μ l that do not contain sample, 37 ℃ in sample and cell, 5%CO
2, under the saturated humidity, cultivate 48h, add MTT20 μ l (1mg/ml), continue to cultivate 4h, abandon liquid, change 100% dimethyl sulfoxide into, automatic enzyme mark photometric determination λ 1=550nm, λ 2=620nm.Measurement result:
Experimental result
Table 4. Rhizoma Paridis extract is to the influence of HeLa cell strain proliferation activity
| Grouping n=4 | Dosage μ g/ml | X ± SD (OD value) |
| No. 1 Rhizoma Paridis extract of control group vincristin amethopterin cis-platinum adriamycin | 0.00 100.00 10.00 1.00 100.00 10.00 1.00 100.00 10.00 1.00 100.00 10.00 1.00 50.00 10.00 1.00 50.00 10.00 1.00 | 0.248±0.041 0.175±0.043 0.162±0.031 * 0.215±0.024 0.169±0.036 ** 0.176±0.030 * 0.159±0.041 * 0.214±0.037 * 0.178±0.015 * 0.187±0.016 * 0.051±0.010 *** 0.221±0.015 0.179±0.015 0.089±0.025 *** 0.181±0.012 * 0.202±0.061 0.114±0.015 ** 0.159±0.009 * 0.214±0.015 |
Each dosing group compares with matched group respectively
* *P＜0.001,
*P＜0.01,
*P＜0.05.
Table 4 is the result show, No. 1, positive control drug and antitumor and Rhizoma Paridis extract all have significant inhibitory effect to the propagation of human cervical carcinoma cell, and wherein the effect of No. 1, amycin and antitumor is stronger.
Table 6, Rhizoma Paridis extract are to the influence of SGC-7901 cell strain proliferation activity
| Grouping n=4 | Dosage μ g/ml | X ± SD (OD value) |
| No. 1 Rhizoma Paridis extract of control group vincristin amethopterin cis-platinum adriamycin | 0.00 100.00 10.00 1.00 100.00 10.00 1.00 100.00 10.00 1.00 100.00 10.00 1.00 50.00 10.00 1.00 50.00 10.00 1.00 | 0.18±90.012 0.141±0.017 0.142±0.006 0.168±0.003 0.147±0.019 0.139±0.011 0.161±0.015 0.160±0.014 0.159±0.012 0.155±0.014 0.018±0.017 *** 0.150±0.006 0.163±0.014 0.163±0.004 0.174±0.017 0.211±0.007 0.109±0.015 ** 0.161±0.008 0.162±0.006 |
Each dosing group compares with matched group respectively
* *P＜0.001,
*P＜0.01,
*P＜0.05.
Table 6 is the result show, except that amycin and Rhizoma Paridis extract have the remarkable inhibitory action gastric carcinoma cells, the inhibitory action of other samples is all not remarkable.
Table 7, Rhizoma Paridis extract are to the influence of K562 cell strain proliferation activity
| Grouping n=4 | Dosage μ g/ml | X ± SD (OD value) |
| No. 1, control group vincristin amethopterin cis-platinum adriamycin | 0.00 100.00 10.00 1.00 100.00 10.00 1.00 100.00 10.00 1.00 100.00 10.00 1.00 50.00 | 0.292±0.025 0.099±0.016 *** 0.212±0.029 * 0.272±0.014 0.231±0.021 0.271±0.027 0.310±0.022 0.246±0.020 0.281±0.041 0.319±0.024 0.084±0.004 *** 0.151±0.036 ** 0.243±0.022 0.138±0.012 ** |
| Rhizoma Paridis extract | 10.00 1.00 50.00 10.00 1.00 | 0.281±0.014 0.295±0.007 0.165±0.008 ** 0.269±0.028 0.331±0.008 |
Each dosing group compares with matched group respectively
* *P＜0.001,
*P＜0.01,
*P＜0.05.
Table 7 is the result show, vincristin, amycin, No. 1, antitumor and Rhizoma Paridis extract have outside the remarkable inhibitory action the leukaemia, and the inhibitory action of other samples is all not remarkable.
Table 8, Rhizoma Paridis extract are to the influence of A549 cell strain proliferation activity
| Grouping n=4 | Dosage μ g/ml | X ± SD (OD value) |
| No. 1 Rhizoma Paridis extract of control group vincristin amethopterin cis-platinum adriamycin | 0.00 100.00 10.00 1.00 100.00 10.00 1.00 100.00 10.00 1.00 100.00 10.00 1.00 50.00 10.00 1.00 50.00 10.00 1.00 | 0.081±0.015 0.064±0.009 0.121±0.011 0.084±0.012 0.082±0.014 0.082±0.017 0.094±0.008 0.090±0.007 0.113±0.012 0.112±0.009 0.091±0.009 0.118±0.013 0.112±0.006 0.031±0.011 * 0.105±0.029 0.101±0.011 0.029±0.008 * 0.119±0.011 0.113±0.010 |
Each dosing group compares with matched group respectively
* *P＜0.001,
*P＜0.01,
*P＜0.05.
Table 8 is the result show, except that No. 1, antitumor and Rhizoma Paridis extract have the remarkable inhibitory action lung carcinoma cell, the inhibitory action of other samples is all not remarkable.
Conclusion
Experimental result shows, Rhizoma Paridis extract dosage has significant inhibitory effect (P＜0.01) to the propagation of cervical cancer, stomach cancer cell, leukaemia and lung carcinoma cell when 50 μ g/ml.
Hemostasis test of pesticide effectiveness example
1. material and method instrument: BFS type blood fiber instrument.
2. animal Kunming kind white mice, body weight 1 9.0 ± SD0 31g; The wistar rat, body weight 179. ± SD3.1g; Rabbit 255 ± SD0 31g.
3 medicines: Yunnan Rhizoma Paridis extract, be white powder, our research department provides.
3. method and result
1) to the anastalsis of normal mouse
(1). the time-effect relationship mice is divided 4 groups, and 1 group is matched group, and all the other 3 groups all gavage Yunnan Rhizoma Paridis extract 150mg/kg, after the administration 1,1.5 and 3 hour respectively, measures the mice amount of bleeding with the docking method.Experimental result shows: 1 hour existing significant anastalsis after the administration of Yunnan Rhizoma Paridis extract 150mg/kg steroid. effect peak after administration 1.5 hours, effect continues more than 3 hours.
(2). dose-effect relationship
4 groups of mices gavage Yunnan Rhizoma Paridis extract 50,100,150mg/kg, and equivalent normal saline solution respectively, with after the administration 1.5 hours, measure the mice amount of bleeding with the docking method.Calculate hemostatic effect. experimental result shows: when dosage is 100mg/kg, existing significant anastalsis, hemostatic effect are 69.35%, and when dosage was 150mg/kg, hemostatic effect was 87.79%, and the dose-effect relationship coefficient is 0.9642.
2). to the anastalsis of normal rat
Give behind the rats gavaged Yunnan Rhizoma Paridis extract 150mg/kg 1 hour, measure the rat amount of bleeding, calculate hemostatic effect by preceding method.The result shows: hemorrhage area 675 ± 265 (mm of matched group
2), hemorrhage area 135 ± 45 (mm of administration group
2), hemostatic effect is 82.36%, P＜0.01, and there were significant differences.
Conclusion
Experimental result shows that Yunnan Rhizoma Paridis extract dosage has significant anastalsis when 150mg/kg, and there were significant differences to compare hemostatic effect with matched group.Bleeding stopping period continues long.
Analgesic effect test example
The pain test is surveyed in electricity irritation
Get female mice, random packet, 10 every group, put mice in fixing ware, with its tail of electricity irritation, be index with the tail action, regulate stimulation voltage, make the mice threshold of pain at 4-5 about second.
Table: Yunnan Rhizoma Paridis extract analgesic activity
| Group | Percentage rate (%) is improved in (min) threshold of pain after the medication | ||||
| 15 | 30 | 60 | 90 | 120 | |
| Normal saline | 5.11±1.26 | 4.78±1.96 | 3.41±2.02 | 1.94±1.15 | 3.96±2.28 |
| Rhizoma Paridis extract | 29.1±2.91 | 40.5±6.20 | 4.90±6.02 | 50.0±6.71 | 35.9±6.91 |
Conclusion (of pressure testing): Yunnan Rhizoma Paridis extract has good analgesic activity.
The specific embodiment:
The following example is intended to further describe for example the present invention, rather than limit the present invention by any way, under the prerequisite that does not deviate from the spirit and principles in the present invention, any change or change that the ability city those of ordinary skill that the present invention did is realized easily all will fall within the claim scope that awaits the reply of the present invention.
Embodiment 1:(Yunnan Rhizoma Paridis extract tablet)
1, gets the water that Rhizoma Paridis 1kg adds 16kg, heated and boiled 2 times, each 1.0 hours;
2, collect and merge the water extract of gained, being concentrated into 50 ℃ of relative densities is 1.10 Baumes;
3, add ethanol in the concentrated solution, make that ethanol content reaches 80% in the solution, filter filtrate recycling ethanol;
4, above-mentioned filtrate is regulated pH value to 10, place, filter;
5, with filtrate by the D101 macroporous adsorptive resins, use 10% ethanol-eluting resin column, be eluted to respectively eluent colourless after, discard eluent, with 80% concentration ethanol eluting resin column, the collection eluent;
6,80% ethanol elution is by cationic resin column and resin anion (R.A.) post, and reclaim under reduced pressure alcohol is condensed into extractum shape or dry powder;
7, dry powder is used 70% dissolve with ethanol solution, be mixed with 5% extract solution, add 1% medicinal carbon, reflux 1 hour filters, fine straining while hot again, decompression filtrate recycling ethanol concentrates and is dried to dry powder, gets content and reaches 80% high-purity Yunnan Rhizoma Paridis extract.
8, above-mentioned Rhizoma Paridis extract powder is pressed the weight ratio of Rhizoma Paridis extract 1, medical starch 0.5, dextrin 1, and added an amount of 50% alcohol granulation, granulate, drying, tabletting.Every 0.3g.Other project should meet under Pharmacopoeia of People's Republic of China version tablet in 2000 item.
Embodiment 2:(Yunnan Rhizoma Paridis extract granule)
1, Rhizoma Paridis 1kg adds the water of an amount of 18kg, heated and boiled 3 times, each 1.5 hours;
2, collect and merge the water extract of gained, being concentrated into 80 ℃ of relative densities is 1.15;
3, add ethanol in the concentrated solution, make that ethanol content reaches 70% in the solution, filter filtrate recycling ethanol;
4, above-mentioned filtrate is regulated pH value to 11, place, filter;
5, with filtrate by the AB-8 macroporous adsorptive resins, use 30% ethanol-eluting resin column, be eluted to respectively eluent colourless after, discard eluent, with 65% concentration ethanol eluting resin column, the collection eluent;
6,65% ethanol elution is by cationic resin column and resin anion (R.A.) post, and reclaim under reduced pressure alcohol is condensed into extractum shape or dry powder;
7, dry powder is used 70% dissolve with ethanol solution, be mixed with 5% Rhizoma Paridis extract solution, add 1% medicinal carbon, reflux 1 hour filters, fine straining while hot again, decompression filtrate recycling ethanol concentrates and is dried to dry powder, gets content and reaches 80% high-purity Rhizoma Paridis extract.
8, above-mentioned Rhizoma Paridis extract powder is added common drug granule dosage form by 8: 2 weight ratio and compose row agent and proper amount of lubricating agent, wait routinely granulating process to make granule.
Embodiment 3:(Yunnan Rhizoma Paridis extract capsule)
1, gets the water that Rhizoma Paridis 1kg adds 22kg, heated and boiled 3 times, each 1.5 hours;
2, collect and merge the water extract of gained, being concentrated into 80 ℃ of relative densities is 1.20;
3, add ethanol in the concentrated solution, make that ethanol content reaches 65% in the solution, filter filtrate recycling ethanol;
4, above-mentioned filtrate is regulated pH value to 12, place, filter;
5, with filtrate by the D21 macroporous adsorptive resins, use 20% ethanol-eluting resin column, be eluted to respectively eluent colourless after, discard eluent, with 70% concentration ethanol eluting resin column, the collection eluent;
6,70% ethanol elution is by cationic resin column and resin anion (R.A.) post, and reclaim under reduced pressure alcohol is condensed into extractum shape or dry powder;
7, dry powder is used 70% dissolve with ethanol solution, be mixed with 5% Rhizoma Paridis extract solution, add 1% medicinal carbon, reflux 1 hour filters, fine straining while hot again, decompression filtrate recycling ethanol concentrates and is dried to dry powder, gets content and reaches 80% high-purity Yunnan Rhizoma Paridis extract.
8, the weight ratio of pressing Rhizoma Paridis extract 1, medical starch 0.5 is mixed, with 80% ethanol wet granulation, granulate, and dress 2# capsule, every 0.2g.Other project should meet under Pharmacopoeia of People's Republic of China version capsule in 2000 item.
The liquid oral agents of embodiment 4:(Yunnan Rhizoma Paridis extract)
1, gets the water that Rhizoma Paridis 1kg adds an amount of 18kg, heated and boiled 3 times, each 1.5 hours;
2, collect and merge the water extract of gained, being concentrated into 80 ℃ of relative densities is 1.15;
3, add ethanol in the concentrated solution, make that ethanol content reaches 70% in the solution, filter filtrate recycling ethanol;
4, above-mentioned filtrate is regulated pH value to 11, place, filter;
5, with filtrate by the AB-8 macroporous adsorptive resins, use 30% ethanol-eluting resin column, be eluted to respectively eluent colourless after, discard eluent, with 65% concentration ethanol eluting resin column, the collection eluent;
6,65% ethanol elution is by cationic resin column and resin anion (R.A.) post, and reclaim under reduced pressure alcohol is condensed into extractum shape or dry powder;
7, dry powder is used 70% dissolve with ethanol solution, be mixed with 5% Rhizoma Paridis extract solution, add 1% medicinal carbon, reflux 1 hour filters, fine straining while hot again, decompression filtrate recycling ethanol concentrates and is dried to dry powder, gets content and reaches 80% Yunnan Rhizoma Paridis extract.
8, will go up extract and be dissolved in water by 1: 1 weight ratio, packing, oral agents is made in sterilization.
Embodiment 5:(Yunnan Rhizoma Paridis extract drop pill)
1, gets the water that Rhizoma Paridis 1kg adds 22kg, heated and boiled 3 times, each 1.5 hours;
2, collect and merge the water extract of gained, being concentrated into 80 ℃ of relative densities is 1.20;
3, add ethanol in the concentrated solution, make that ethanol content reaches 65% in the solution, filter filtrate recycling ethanol;
4, above-mentioned filtrate is regulated pH value to 12, place, filter;
5, with filtrate by the D21 macroporous adsorptive resins, use 20% ethanol-eluting resin column, be eluted to respectively eluent colourless after, discard eluent, with 70% concentration ethanol eluting resin column, the collection eluent;
6,70% ethanol elution is by cationic resin column and resin anion (R.A.) post, and reclaim under reduced pressure alcohol is condensed into extractum shape or dry powder;
7, dry powder is used 70% dissolve with ethanol solution, be mixed with 5% Rhizoma Paridis extract solution, add 1% medicinal carbon, reflux 1 hour filters while hot, fine straining again, and decompression filtrate recycling ethanol concentrates and is dried to dry powder.
8, above-mentioned dry powder is added Polyethylene Glycol by 4: 6 weight ratio, make drop pill by common medicinal dropping ball preparation process.
Embodiment 6 (Yunnan Rhizoma Paridis extract injection 1)
Get Rhizoma Paridis 2kg and add water boil three times, (each 40 minutes) add water 20kg first, add water 15kg later at every turn; Collect and merge the water extract of gained, filter, filtrate is added on the macroporous adsorptive resins of handling with bronsted lowry acids and bases bronsted lowry in advance, wash post with deionized water and do not have color, back 70% ethanol elution up to eluate.Collect 70% ethanol elution, and reclaim under reduced pressure, evaporate to dryness with gained concentrate 70% dissolve with ethanol, is placed, and is filtered, and the filtrate decompression concentrate drying obtains yellow powder shape Rhizoma Paridis extract 100g.Get Rhizoma Paridis extract 100g, make 5% Rhizoma Paridis extract solution with 75% dissolve with ethanol, use activated carbon decolorizing, filter, the concentrating under reduced pressure drying, add the injection water and make the aqueous solution that every ml contains the 20mg Rhizoma Paridis extract, filter to clear and bright autoclaving with microporous filter membrane (φ 0.20 μ m), aseptic subpackaged in cillin bottle, every bottle of 5ml puts lyophilization in the freezer dryer, promptly.
Claims (10)
1, Yunnan Rhizoma Paridis extract is the material that following method obtained:
With the Rhizoma Paridis is raw material, with 0% to 100% alcohol extraction 1-10 time, preferably uses 70% alcohol extraction; Preferably extract 3 times, or the sedimentary extracting method of water extraction 60%-95% alcohol, reclaim alcohol and also can; Or the extracting method of water extraction alkali precipitation also can, extracting solution merges, and filters, filtrate is through the macroporous adsorptive resins purification, with 0%-20% alcohol be eluted to colourless after, with collecting eluent behind the pure eluting of 10%-100%, best with 70% pure eluting, reclaim alcohol, to there not being the alcohol flavor, be condensed into casual paste or dry powder under the decompression or under the normal pressure, with the dissolving of 0%-95% alcohol, the most handy 70% alcohol dissolving filters, disgorging also reclaims filtrate, obtains required Rhizoma Paridis extract behind the reclaim under reduced pressure alcohol.
2, according to the Yunnan Rhizoma Paridis extract of claim 1, it is characterized in that: active component wherein comprises, Rhizoma Paridis saponin A, Rhizoma Paridis saponin B, dioscin, pennogenin B, pennogenin E, seven kinds of monomer components of Yunnan Rhizoma Paridis saponin A, Yunnan Rhizoma Paridis saponin B.
3, the preparation method of Yunnan Rhizoma Paridis extract, its feature has following steps:
(1), be raw material with the Rhizoma Paridis, with 0% to 100% alcohol extraction, also available water is extracted the sedimentary method of 60%-95% alcohol, reclaims alcohol again, or the extracting method of water extraction alkali precipitation;
(2), extracting solution merges filtration, filtrate process macroporous adsorptive resins purification;
(3), with 0%-20% alcohol be eluted to colourless after, with collecting eluent behind the 10%-100% alcohol eluting, reclaim alcohol, to there not being the alcohol flavor, decompression down or be condensed under the normal pressure and overflow paste or dry powder;
(4), with 0%-95% alcohol dissolving, filter, disgorging also reclaims filtrate, obtains required Rhizoma Paridis extract behind the reclaim under reduced pressure alcohol.
4, Yunnan Rhizoma Paridis extract is in preparation treatment or prevent application in the various hemorrhage medicines.
5, the application of Yunnan Rhizoma Paridis extract in preparation treatment cancer drug.
6, the application of Yunnan Rhizoma Paridis extract in the preparation analgesic drug product.
7, with the Yunnan Rhizoma Paridis extract be the pharmaceutical composition of primary activity composition, by Yunnan Rhizoma Paridis extract and one or more the pharmaceutically acceptable carriers and/or the excipient phase composition of effective therapeutic dose.
8, according to claim 7 be the pharmaceutical composition of primary activity composition with the Yunnan Rhizoma Paridis extract, it is characterized in that: the weight ratio of raw material consumption is Yunnan Rhizoma Paridis extract 1%-99%; Pharmaceutical carrier and/or excipient 99%-1%.
9, according to claim 7 be the pharmaceutical composition of primary activity composition with the Yunnan Rhizoma Paridis extract, it is characterized in that: the weight ratio of raw material consumption is Yunnan Rhizoma Paridis extract 20%-80%; Pharmaceutical carrier and/or excipient 80%-20%.
10, according to claim 7 be the pharmaceutical composition of primary activity composition with the Yunnan Rhizoma Paridis extract, it is characterized in that: wherein to account for the optimum weight ratio of said pharmaceutical composition be more than 50% (w/w) to Yunnan Rhizoma Paridis extract.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101904968A (en) * | 2010-07-27 | 2010-12-08 | 天津大学 | Preparation method of Chinese paris rhizome yam type saponin and anti-tumor medicinal preparation thereof |
| CN101912514A (en) * | 2010-07-27 | 2010-12-15 | 天津大学 | Paris rhizome total saponin capsules with anti-tumor effect and preparation method thereof |
| CN107375312A (en) * | 2017-07-07 | 2017-11-24 | 中国医学科学院药用植物研究所 | The application of Dioscin class compound |
| CN107686502A (en) * | 2017-10-20 | 2018-02-13 | 上海源叶生物科技有限公司 | A kind of preparation technology of chonglou saponin series |
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2005
- 2005-01-28 CN CN 200510016555 patent/CN1810284A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101904968A (en) * | 2010-07-27 | 2010-12-08 | 天津大学 | Preparation method of Chinese paris rhizome yam type saponin and anti-tumor medicinal preparation thereof |
| CN101912514A (en) * | 2010-07-27 | 2010-12-15 | 天津大学 | Paris rhizome total saponin capsules with anti-tumor effect and preparation method thereof |
| CN107375312A (en) * | 2017-07-07 | 2017-11-24 | 中国医学科学院药用植物研究所 | The application of Dioscin class compound |
| CN107686502A (en) * | 2017-10-20 | 2018-02-13 | 上海源叶生物科技有限公司 | A kind of preparation technology of chonglou saponin series |
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