CN101081242A - Notoginseng extract for treating cardiovascular disease and method for making same - Google Patents
Notoginseng extract for treating cardiovascular disease and method for making same Download PDFInfo
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- CN101081242A CN101081242A CN 200710026318 CN200710026318A CN101081242A CN 101081242 A CN101081242 A CN 101081242A CN 200710026318 CN200710026318 CN 200710026318 CN 200710026318 A CN200710026318 A CN 200710026318A CN 101081242 A CN101081242 A CN 101081242A
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Abstract
The new notoginseng extract containing notoginseng trialcohol and no tannin, protein and other sensitizer may be applied in preparing arasaponin tablet, arasaponin granule, arasaponin injection and other notoginseng extract preparations. The new notoginseng extract is extracted by using new type strong polar macroporous SA-1 resin, and has high purity, light color and high safety. The notoginseng extract preparations have controllable preparation process, stable quality and high medicinal effect.
Description
Technical field:
The invention belongs to the field of Chinese medicines, relate to a kind of new be the pharmaceutical composition in source and preparation method thereof with the Radix Notoginseng.
Background technology:
Radix Notoginseng is the root of Araliaceae herbaceos perennial Radix Notoginseng Ranax notoginseng (Burk) F.H.Chen, and main product is called Radix Notoginseng, Radix Notoginseng in Yunnan, Guangxi and other places.The main active of Radix Notoginseng is that (Panax Notoginseng Saponins, PNS), it is about 12% to contain saponin in its tuber, isolates 20 kinds of dammarane type saponin from each position of Radix Notoginseng at present for Radix Notoginseng total arasaponins.Both at home and abroad particularly the research of cardiovascular and cerebrovascular vessel pharmacology effect is very active to the pharmacological action of Radix Notoginseng total arasaponins, and Radix Notoginseng total arasaponins trade name and prescription name have Radix Notoginseng total arasaponins tablet, Radix Notoginseng total arasaponins electuary, Radix Notoginseng total arasaponins injection, XUESAITONG PIAN, XUESAITONG JIAONANG, XUESAITONG RUANJIAONANG, XUESAITONG ZHUSHEYE, the safe injectable powder in Lip river, XUESHUANTONG ZHUSHEYE, Fructus Liquidambaris injection etc.Radix Notoginseng total glucosides (PNS) is the effective ingredient of Chinese medicine Radix Notoginseng, promptly generates panoxadiol and panaxatriol after its contained panaxoside monomer hydrolysis.The PNS preparation that people extract from the crude drug Radix Notoginseng is compared with the crude drug in whole Radix Notoginseng, have steady quality, bioavailability height, easy to use, effect rapidly, toxicity is low and safety is good advantage.It can lower surface activity of blood platelet, antioxidation, removing oxygen-derived free radicals, improve blood circulation, anoxia enduring, so protection cardiac muscle is arranged, protect blood vessel endothelium, improve effect such as cardiac function.Treat ischemic heart desease, hypertension, high sticky blood and hyperlipemia etc. with it, evident in efficacy.
The extract formulation of Radix Notoginseng is more, be widely used clinically, previous Radix Notoginseng extract preparation is subjected to the restriction of technical merit at that time, and ubiquity purity is low, impurity component is many, color is dark, complex process, also exists the high problem of potential safety hazard for ejection preparation.Recent study personnel studies show that further that to Radix Notoginseng effective ingredient is three alcohol moieties in the Radix Notoginseng total arasaponins, so the content influence of notoginseng triol the curative effect of Radix Notoginseng extract preparation.We are applied to novel strong polar macroporous adsorption resin technology in the middle of the extraction purification of Radix Notoginseng, have solved the problems referred to above well.
Summary of the invention:
One of purpose of the present invention provides a kind of new Radix Notoginseng extract, and another object of the present invention provides this preparation method of extract.
In order to achieve the above object, the present invention has taked following technological means:
We provide a kind of Radix Notoginseng extract for the treatment of cardiovascular and cerebrovascular disease, contain the notoginseng triol of 80-99.9%, do not contain tanning, protein.
We can prepare by described Radix Notoginseng extract according to the following steps:
1) the recipe quantity Radix Notoginseng powder is broken into coarse granule, adds 8-15 and doubly measures the 65-85% ethanol extraction, merges
Extracting liquid filtering;
2) extracting solution adds aqueous dispersion after reclaiming ethanol, and cold preservation is spent the night, and filters, and subsequent filtrate is standby;
3) the SA-1 macroporous adsorbent resin that pretreatment is good on the subsequent filtrate, after the water flushing, 70-85% concentration
Ethanol elution, eluent reclaim ethanol, dry Radix Notoginseng extract.
Wherein more preferably scheme is that extraction step is the ethanol extraction three times that recipe quantity Radix Notoginseng coarse granule adds 10 times of amounts 75%, each 2 hours.
SA-1 macroporous adsorbent resin described in the preparation technology is the functional macroporous adsorbent resin of SDEB styrene diethylenebenzene skeleton that strong polarity contains amido link, is developed by Tianjin ALLRED bio tech ltd.
More preferably resin purification technology is after going up absorption with macroporous adsorbent resin, and with the water rinse resin of 2 times of bed volumes, the ethanol elution of 2 times of bed volumes 80% of reuse, flow velocity are 2 hours each bed volumes earlier.
We also provide the purposes of Radix Notoginseng extract in preparation treatment cardiovascular and cerebrovascular diseases medicament, can be used to prepare Radix Notoginseng total arasaponins tablet, Radix Notoginseng total arasaponins electuary, Radix Notoginseng total arasaponins injection, XUESAITONG PIAN, XUESAITONG JIAONANG, XUESAITONG RUANJIAONANG, XUESAITONG ZHUSHEYE, the safe injectable powder in Lip river, XUESHUANTONG ZHUSHEYE, Fructus Liquidambaris injection etc.
The preparation of success of the present invention new Radix Notoginseng extract, and this extract further is prepared into the safe injectable powder of Radix Notoginseng total arasaponins tablet, Radix Notoginseng total arasaponins electuary, Radix Notoginseng total arasaponins injection, XUESAITONG PIAN, XUESAITONG JIAONANG, XUESAITONG RUANJIAONANG, XUESAITONG ZHUSHEYE, Lip river, XUESHUANTONG ZHUSHEYE, Fructus Liquidambaris injection etc.Use this extract of novel strong polar macroporous adsorption resin SA-1 resins to overcome that Radix Notoginseng extract preparation purity was lower in the past, color is dark, complex process, during in particular for ejection preparation because there is sensitizer to cause the high problem of hidden danger.Facts have proved, it is controlled that new Radix Salviae Miltiorrhizae Lignum Dalbergiae Odoriferae extract is used to prepare Radix Notoginseng extract preparation process such as Radix Notoginseng total arasaponins tablet, Radix Notoginseng total arasaponins electuary, Radix Notoginseng total arasaponins injection, XUESAITONG PIAN, XUESAITONG JIAONANG, XUESAITONG RUANJIAONANG, XUESAITONG ZHUSHEYE, the safe injectable powder in Lip river, XUESHUANTONG ZHUSHEYE, Fructus Liquidambaris injection, steady quality, favorable reproducibility, pharmacological evaluation proof drug effect is better than former prepared thing.
Further specify the present invention with specific embodiment below, but can not be used for unique qualification the present invention.
Specific embodiment:
Embodiment 1: the preparation of new Radix Notoginseng extract
Get the 1000g Radix Notoginseng and cross pulverizer and break into coarse granule, add 10 liter of 70% ethanol extraction three times, each 2 hours, merge extractive liquid, filtered.Subsequent filtrate continues to be concentrated to relative density 1.15-1.20 (40 ℃) (measured value 1.18) after reclaiming ethanol, adds 4 times of water gagings under fully stirring and disperses, and cold preservation is spent the night, and filters.The standby good SA-1 macroporous adsorbent resin of pretreatment of going up of subsequent filtrate, 2 hours/BV of flow velocity, after the flushing of 2BV water, 4BV80% concentration ethanol eluting, eluent reclaims ethanol, dry Radix Notoginseng extract.
Sample number into spectrum: SQTQW-1
Embodiment 2: the preparation of Radix Notoginseng extract
Get the 1000g Radix Notoginseng and cross pulverizer and break into coarse granule, add 15 liter of 75% ethanol extraction secondary, each 2 hours, merge extractive liquid, filtered.Subsequent filtrate continues to be concentrated to relative density 1.15-1.20 (40 ℃) (measured value 1.16) after reclaiming ethanol, adds 5 times of water gagings under fully stirring and disperses, and cold preservation is spent the night, and filters.The standby good SA-1 macroporous adsorbent resin of pretreatment of going up of subsequent filtrate, 2 hours/BV of flow velocity, after the flushing of 2BV water, 3BV80% concentration ethanol eluting, eluent reclaims ethanol, dry Radix Notoginseng extract.
Sample number into spectrum: SQTQW-2
Embodiment 3: the preparation of Radix Salviae Miltiorrhizae Lignum Dalbergiae Odoriferae extract
Get the 1000g Radix Notoginseng and cross pulverizer and break into coarse granule, add 12 liter of 80% ethanol extraction three times, each 3 hours, merge extractive liquid, filtered.Subsequent filtrate continues to be concentrated to relative density 1.15-1.20 (40 ℃) (measured value 1.19) after reclaiming ethanol, adds 5 times of water gagings under fully stirring and disperses, and cold preservation is spent the night, and filters.The standby good SA-1 macroporous adsorbent resin of pretreatment of going up of subsequent filtrate, 2 hours/BV of flow velocity, after the flushing of 2BV water, 3BV80% concentration ethanol eluting, eluent reclaims ethanol, dry Radix Notoginseng extract.
Sample number into spectrum: SQTQW-3
Embodiment 4: the preparation of XUESHUANTONG ZHUSHEYE
Get the Radix Notoginseng extract SQTQW-1 of embodiment 1 preparation, add 600ml water for injection, heating condition is fully dissolving down, put into 0-4 ℃ of freezer cold preservation after the cooling and spend the night, get supernatant liquid filtering after the taking-up, subsequent filtrate adds 1ml soil temperature 80, replenish water for injection to 1100ml, be heated to 80 ℃, add the 5g active carbon, insulation 30min, decarburization is crossed 0.22 micron microporous filter membrane, embedding, sterilization, both.
Embodiment 5: the preparation of XUESAITONG ZHUSHEYE
Get the Radix Notoginseng extract SQTQW-2 of embodiment 2 preparations, add 500ml water for injection, heating condition is fully dissolving down, put into 0-4 ℃ of freezer cold preservation after the cooling and spend the night, get supernatant liquid filtering after the taking-up, subsequent filtrate adds 1ml soil temperature 80, replenish water for injection to 1000ml, be heated to 80 ℃, add the 5g active carbon, insulation 30min, decarburization is crossed 0.22 micron microporous filter membrane, embedding, sterilization, both.
Embodiment 6: the preparation of Fructus Liquidambaris injection
Get the Radix Notoginseng extract SQTQW-3 of embodiment 3 preparations, add 500ml water for injection, heating condition is fully dissolving down, put into 0-4 ℃ of freezer cold preservation after the cooling and spend the night, get supernatant liquid filtering after the taking-up, subsequent filtrate adds 1ml soil temperature 80, replenish water for injection to 1000ml, be heated to 80 ℃, add the 5g active carbon, insulation 30min, decarburization is crossed 0.22 micron microporous filter membrane, embedding, sterilization, both.
Embodiment 7: the new thrombosis of the present invention is separated the outer Sanguis Leporis seu oryctolagi bolt dissolution experiment of injecting fluid
The experiment medicine: the new thrombosis of the present invention is separated injection.
Former thrombosis is separated injection and is got 10ml, adds normal saline 40ml and is prepared into injection of danshen solution.
Laboratory animal: 2 of 1.0-1.5kg new zealand rabbits
Experimental technique: get blood in rabbit jugular vein, get intravenous rabbit blood 30ml (from footpath 0.34cm) in polyvinyl chloride pipe, allow it solidify under the room temperature, release grumeleuse with syringe behind the 60min, it is standby to be cut into the 0.15cm3 size, prepares 12 altogether, makes the whole blood grumeleuse.Get intravenous rabbit blood 30ml, use the sodium citrate anticoagulant, with the centrifugal 10min of 800r/min, collect upper plasma and middle level platelet, add thrombin then, add the 0.1ml (dosage of thrombin of 10 μ/ml) by every milliliter of blood plasma, in plate, form grumeleuse behind the mixing, the fritter that is cut into 0.15cm3 is standby, prepares 12 altogether, makes the platelet-rich plasma grumeleuse.Getting concentration is the pure fiber egg original solution 2ml of 20mg/ml (not containing fibrinolysin and plasminogen), add the 2ml (thrombin of 10 μ/ml), be to form grumeleuse in the small test tube of 0.5cm from the footpath, grumeleuse is shaken out gently, the fritter that is cut into 0.15cm3 is standby, prepare 12 altogether, make pure fibrin clot.With the new thrombosis of the present invention that rabbit whole blood grumeleuse, rabbit platelet-rich plasma grumeleuse and the pure fibrin clot that makes drops into high and low concentration respectively separate injection, former thrombosis is separated in injection solution positive control solution and the normal saline negative controls and (is 600 μ l solution), put and be incubated and observe its dissolving situation in 37 ℃ of thermostatted water solution, write down its complete dissolution time, each experiment repeats to do 3 times.
Experimental result sees Table 1:
Table 1: each organize the consoluet time ratio of thrombosis (
)
| Experimental subject | The solution thrombus time of the present invention (h) | Former thrombosis is separated the injection thrombus time (h) | The normal saline contrast thrombus time | |
| Low concentration group | The high concentration group | |||
| The pure fibrin clot of rabbit whole blood grumeleuse rabbit platelet-rich plasma grumeleuse | 1.85±0.03 **1.40±0.03 **1.12±0.03 ** | 1.25±0.03 **1.02±0.03 **0.86±0.03 ** | 3.40±0.03 3.12±0.03 2.95±0.03 | Observe that 3 kinds of grumeleuse sizes there is no significant change after 18 hours |
Annotate: injection thrombosis EGCT of the present invention and former thrombosis are separated relatively * * P＜0.01 of injection matched group
Embodiment 8: utilize the thrombosis method to measure XUESAITONG ZHUSHEYE of the present invention to the thrombotic influence of rat
Experiment medicine: XUESAITONG ZHUSHEYE of the present invention.
Former XUESAITONG ZHUSHEYE.
40 of the SD rat of laboratory animal: body weight 300-400 gram, male and female half and half.Be divided into blank, former XUESAITONG ZHUSHEYE matched group, XUESAITONG ZHUSHEYE low dosage of the present invention, XUESAITONG ZHUSHEYE high dose four components of the present invention at random, 10 every group.
Experimental technique: with the rat administration, dosage, XUESAITONG ZHUSHEYE solution low dose group of the present invention, XUESAITONG ZHUSHEYE solution high dose group of the present invention, former XUESAITONG ZHUSHEYE matched group is irritated stomach.Capacity normal saline such as blank group, the filling gastric solubleness is long-pending to be 6ml/kg, once a day, totally 5 days.Rat administration the 5th day, after 1 hour, animal is weighed after the last administration, iv 3% sodium pentobarbital 1ml/kg anesthesia.Dorsal position is fixed, get the neck median incision, separate trachea, separate the total A of bilateral neck, V wears 6cm5 0 silk thread in polyethylene tube, be full of polyethylene tube with heparin-saline solution, after an end of polyethylene tube inserts the left side external jugular vein, inject anticoagulant heparin accurately by polyethylene tube, again the polyethylene tube other end is inserted right carotid artery, open bulldog clamp, cause the A-V bypass, open blood flow 15min takes out silica gel tube, extract silk thread (containing thrombosis) out, by number placing the little culture dish of having weighed, analytical balance takes by weighing wet weight of thrombus, and gross weight deducts silk thread weight and promptly gets thrombus weight.
The results are shown in Table 2:
Table 2: the thrombus weight comparison of each administration group (x ± s)
| Group | Number of animals (only) | Wet weight of thrombus (mg) |
| Sal water group lyophilizing solution of the present invention (low) dosage group lyophilizing solution of the present invention (height) dosage group Radix Salviae Miltiorrhizae Injection group | 10 10 10 10 | 45.32±0.42 15.20±0.30 **ΔΔ 9.50±0.25 **ΔΔ 25.62±0.36 ** |
Annotate: compare * * P＜0.01 with the normal saline matched group
Compare Δ Δ P＜0.01 with the Radix Salviae Miltiorrhizae Injection matched group
Claims (7)
1, a kind of Radix Notoginseng extract for the treatment of cardiovascular and cerebrovascular disease contains the notoginseng triol of 80-99.9%, does not contain tanning, protein.
2, the Radix Notoginseng extract of treatment cardiovascular and cerebrovascular disease as claimed in claim 1 prepares according to the following steps:
1) the recipe quantity Radix Notoginseng powder is broken into coarse granule, adds 8-15 and doubly measures the 65-85% ethanol extraction, and merge extractive liquid, filters;
2) extracting solution adds aqueous dispersion after reclaiming ethanol, and cold preservation is spent the night, and filters, and subsequent filtrate is standby;
3) behind the SA-1 macroporous adsorbent resin that pretreatment is good on the subsequent filtrate, water flushing, 70-85% concentration ethanol eluting, eluent reclaims ethanol, dry Radix Notoginseng extract.
3, the preparation method of Radix Notoginseng extract as claimed in claim 2 is characterized in that preparing according to the following steps:
1) the recipe quantity Radix Notoginseng powder is broken into coarse granule, adds 8-15 and doubly measures the 65-85% ethanol extraction, and merge extractive liquid, filters;
2) extracting solution adds aqueous dispersion after reclaiming ethanol, and cold preservation is spent the night, and filters, and subsequent filtrate is standby;
3) behind the SA-1 macroporous adsorbent resin that pretreatment is good on the subsequent filtrate, water flushing, 70-85% concentration ethanol eluting, eluent reclaims ethanol, dry Radix Notoginseng extract.
4, the preparation method of Radix Notoginseng extract as claimed in claim 3 is characterized in that extraction step is the ethanol extraction three times that recipe quantity Radix Notoginseng coarse granule adds 10 times of amounts 75%, each 2 hours.
5, the preparation method of Radix Notoginseng extract as claimed in claim 4 is characterized in that the SA-1 macroporous adsorbent resin is the functional macroporous adsorbent resin of SDEB styrene diethylenebenzene skeleton that strong polarity contains amido link.
6, the preparation method of Radix Notoginseng extract as claimed in claim 3 is characterized in that the flow velocity of last macroporous adsorbent resin in the 3rd step is 2 hours each bed volumes, first water rinse resin with 2 times of bed volumes, the ethanol elution of 2 times of bed volumes 80% of reuse.
7, the purposes of Radix Notoginseng extract as claimed in claim 1 or 2 in preparation treatment cardiovascular and cerebrovascular diseases medicament can be used to prepare Radix Notoginseng total arasaponins tablet, Radix Notoginseng total arasaponins electuary, Radix Notoginseng total arasaponins injection, XUESAITONG PIAN, XUESAITONG JIAONANG, XUESAITONG RUANJIAONANG, XUESAITONG ZHUSHEYE, the safe injectable powder in Lip river, XUESHUANTONG ZHUSHEYE, Fructus Liquidambaris injection.
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| CN 200710026318 CN101081242A (en) | 2007-01-16 | 2007-01-16 | Notoginseng extract for treating cardiovascular disease and method for making same |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102100761A (en) * | 2011-01-25 | 2011-06-22 | 广州中医药大学 | Plant extract composition for preventing and treating lipidmetabolic disorder and preparation method thereof |
| CN105079062A (en) * | 2015-08-11 | 2015-11-25 | 昆明圣火药业（集团）有限公司 | Xuesaitong soft capsules and preparation and detecting methods thereof |
| CN107976492A (en) * | 2017-11-01 | 2018-05-01 | 广西壮族自治区食品药品检验所 | The detection method of protein-based large biological molecule in a kind of XUESHUANTONG ZHUSHEYE |
-
2007
- 2007-01-16 CN CN 200710026318 patent/CN101081242A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102100761A (en) * | 2011-01-25 | 2011-06-22 | 广州中医药大学 | Plant extract composition for preventing and treating lipidmetabolic disorder and preparation method thereof |
| CN102100761B (en) * | 2011-01-25 | 2013-11-13 | 广州中医药大学 | Plant extract composition for preventing and treating lipidmetabolic disorder and preparation method thereof |
| CN105079062A (en) * | 2015-08-11 | 2015-11-25 | 昆明圣火药业（集团）有限公司 | Xuesaitong soft capsules and preparation and detecting methods thereof |
| CN105079062B (en) * | 2015-08-11 | 2018-07-20 | 昆明圣火药业（集团）有限公司 | A kind of soft capsule for removing thromboembolism and preparation method thereof and detection method |
| CN107976492A (en) * | 2017-11-01 | 2018-05-01 | 广西壮族自治区食品药品检验所 | The detection method of protein-based large biological molecule in a kind of XUESHUANTONG ZHUSHEYE |
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Open date: 20071205 |