CN104758306A - Application and medicine of 20(R)-ginsenoside Rg3 to preparing medicine for remitting and/or treating gastric ulcer - Google Patents
Application and medicine of 20(R)-ginsenoside Rg3 to preparing medicine for remitting and/or treating gastric ulcer Download PDFInfo
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Abstract
The invention discloses a new application of 20(R)-ginsenoside Rg3 to preparing a medicine for remitting and/or treating gastric ulcer. Tests prove that the treatment effect of the 20(R)-ginsenoside Rg3 on treating the gastric ulcer is obvious, effect taking is rapid, the toxic and side effect is small, and the gastric ulcer treating medicine is safe, efficient, stable and simple in preparing process, is suitable for industrial production, and is easy to popularize. A new medicine resource is provided for preventing and treating the gastric ulcer and complications of the gastric ulcer.
Description
Technical field
The invention belongs to field of medicaments, relate to a kind of medicine or health food for the treatment of gastric ulcer, particularly a kind of Chinese medicine Radix Ginseng extract component is being alleviated or/and treat the application in Gastric Ulcer Treatment or health food.
Background technology
Peptic ulcer (peptic ulcer, PU) is a kind of commonly encountered diseases, frequently-occurring disease, is again kind of the Chronic gastrointestinal diseases easily recurred simultaneously.Its sickness rate accounts for about 10% of total population according to relevant statistics.The pathogenesis of peptic ulcer is illustrated so far not yet completely, Etiological comprise gastric acid and pepsic effect, helicobacter pylori (Hp) infection, NSAID (non-steroidal anti-inflammatory drug), inherited genetic factors, harmonization of the stomach duodenum power abnormality, stress with Nervous and Mental Factors, smoking, diet, viral infection etc.The treatment of primary disease mainly relied on antacid and anticholinergic agent the seventies in the past, the appearance of histamine receptor inhibitor (H2RA) after the seventies, the eighties in 20th century identifies H+/K+-ATP enzyme proton pump and the exploitation of proton pump inhibitor thereafter and clinical practice from parietal cell, acid suppression is treated more thorough, and the ulcer that can heal very soon, alleviating pain.But most ulcer still can recur after drug withdrawal, ulcer year relapse rate can up to 60% ~ 80%, within 2 years, relapse rate is then up to 100%.From the beginning of the eighties Hp discovery and effect in peptic ulcer determined, the great change that made people to the noegenesis of peptic ulcer, turn to the treatment into acid suppression and eradicating Hp from simple acid suppression treatment, this is the significant change for the treatment of of peptic ulcer.The process of Hp dependency ulcer is reached common understanding in the world: no matter namely ulcer is sent out or recurred, no matter movable or static, no matter with or without complication history, anti-Hp treatment all should be carried out.Research shows that the real elimination of Hp can make ulcer recurrence rate significantly reduce.But due to the existence of the problems such as expense, side effect, drug resistance, patient dependence, finally make this palindromia rate still remain high, and it is irrelevant to also have the generation of peptic ulcer greatly and Hp to infect.
Gastric ulcer belongs to the categories such as the traditional Chinese medical science " stomach institute pain ", and gastric ulcer occurs and recurrence is all on insufficiency of the spleen basis, and addiction and heat are fought and tied, and flesh slough is rotten, sends out as ulcer, and insufficiency of the spleen is this, and addiction heat is mark.Numerous research also confirms: Chinese medicine better can not only solve the damage factor and enhancing gastric mucosal protection factor of eliminating Peptic Ulcers; and while healing Peptic Ulcers; can also adjust the digestive function of its disorder; improve healing quality; this respect has fully demonstrated Chinese medicine from entirety, plays the advantage that compound recipe too many levels, the multipath mechanism of action and side effect are little.Therefore, explore curative effect further high, side reaction is little, thoroughly can eradicate effective ways or the active drug of peptic ulcer, improves the late result of peptic ulcer, is still one of difficult problem in this disease treatment at present.
Rare medicinal herbs in Radix Ginseng Chinese medicine, modern medicine study shows that the primary efficacy of Radix Ginseng and effect have: for the effect of central nervous system, anticancer antitumor action, Immunologic Functions, diabetes effect, strengthens liver function effect, and cardiovascular and cerebrovascular vessel obstacle improves, arteriosclerosis effect, Blood pressure regulation, and climacteric obstacle and function of resisting osteoporosis, resisting fatigue, antioxidation, suppresses aging etc.Ginsenoside is as the principle active component of Radix Ginseng, be widely studied and use, wherein noticeable with 20 (R)-ginsenoside Rg3s, it is as the principle active component of Radix Ginseng, safety is good, being made into antitumor oral formulations is applied to clinical, is furtherd investigate as injection.
The present inventor adopts advanced separating and purifying technology from ginseng crude drug, extract effective ingredient 20 (the R)-ginsenoside Rg3 of its treatment gastric ulcer, can provide a kind of medicine of high-efficiency low-toxicity for patients w ith peptic ulcer disease.
Summary of the invention
Primary and foremost purpose of the present invention is for above-mentioned treatment gastric ulcer prior art Problems existing, 20 (R)-ginsenoside Rg3s are provided to alleviate or/and treat performance and effect of gastric ulcer, and provide 20 (R)-ginsenoside Rg3s new pharmaceutical usage, the new opplication namely in the medicine treating, nurse one's health and alleviate gastric ulcer or health food.
For achieving the above object, one aspect of the present invention provides a kind of 20 (R)-ginsenoside Rg3s to alleviate or/and application in the medicine for the treatment of gastric ulcer or health product in preparation.
Have in screening in the process of the active skull cap components for the treatment of gastric ulcer effect, inventor finds that in the chemical composition of Radix Ginseng, 20 (R)-ginsenoside Rg3s have the effect of the symptom of stronger improvement Stomach in Patients ulcer.
Wherein, described medicine is made up of 20 (R)-ginsenoside Rg3s and pharmaceutically acceptable carrier.
Wherein, 20 described (R)-ginsenoside Rg3 content are 1% ~ 98%; Be preferably 30 ~ 80%, more preferably 60%.
Particularly, 20 described (R)-ginsenoside Rg3 content >=1%, are preferably >=30%, more preferably >=60%, be further preferably >=80%, be more further preferably >=98%.
Particularly, pharmaceutically acceptable carrier is used for this purpose by sanitarian's accreditation and usually as the non-active ingredient of medicament.About pharmaceutically acceptable carrier compilation can (Handbook of Pharmaceutical excipients, be edited by A.Wade and P.J.Weller by the 2nd edition in " handbook of pharmaceutical excipients "; American Pharmaceutical Association publishes, Washington and The PharmaceuticalPress, London, 1994) etc. find in reference book.
Especially, described carrier comprises excipient, as starch, water etc.; Lubricant, as magnesium stearate etc.; Disintegrating agent, as microcrystalline Cellulose etc.; Filler, as lactose etc.; Binding agent, as pregelatinized Starch, dextrin etc.; Sweeting agent; Antioxidant; Antiseptic, correctives, spice etc.;
Wherein, described medicine exists with tablet, capsule, pill, powder, granule, syrup, solution, Emulsion, injection, spray, aerosol, gel-type, cream, tincture, cataplasma, rubber plaster unguentum or emplastrum form.
Particularly, 20 described (R)-ginsenoside Rg3 content >=1%, are preferably >=30%, more preferably >=60%, be further preferably >=80%, be more further preferably >=98%.
Particularly, described gastric ulcer is pyloric ligation ulcers ulcer.
The present invention provides a kind of alleviation containing 20 (R)-ginsenoside Rg3s or/and treat medicine or the health product of gastric ulcer on the other hand.
Wherein, 20 described (R)-ginsenoside Rg3 content >=1%, are preferably 1% ~ 98%; Be preferably 30 ~ 80%, be further preferably 60%.
Particularly, 20 described (R)-ginsenoside Rg3 content >=1%, are preferably >=30%, more preferably >=60%, be further preferably >=80%, be more further preferably >=98%.
Particularly, the ratio of the gross weight of the weight of described 20 (R)-ginsenoside Rg3s and described medicine or health product is 0.01 ~ 10:100, is preferably 0.1 ~ 10:100, more preferably 1 ~ 10:100.
Particularly, Rhizoma Dioscoreae, Rhizoma Dioscoreae extract, Poria, Poria extract, Radix Glycyrrhizae, Radix Glycyrrhizae extract is also comprised in described medicine or health product, SEMEN COICIS, SEMEN COICIS extract, Fructus Jujubae, Fructus Jujubae extract, Rhizoma Nelumbinis, Nelumbo nucifera extract, Oryza glutinosa, Oryza glutinosa extract, one or more in Fructus Hordei Vulgaris, Fructus Hordei Vulgaris extract, Semen Sesami Nigrum extract, plants essential oil, vitamin C and derivant thereof or vitamin E and derivant thereof.
Described medicine can adopt method well known in the art to make various dosage form, as tablet, capsule, pill, powder, granule, syrup etc.
Present invention also offers a kind of method for the treatment of gastric ulcer, comprise the pharmaceutical composition giving 20 (the R)-ginsenoside Rg3s treating effective dose to experimenter, its treatment effective dose is 0.06 ~ 12mg/kg.d, be preferably 1 ~ 6mg/kg.d, more preferably 1.5 ~ 3mg/kg.d.
Unless otherwise indicated, term used herein " treatment effective dose " is for needing the consumption of the medicine producing useful effect; " treatment effective dose " can adjust and change, and is finally determined by medical worker, and its factor considered comprises character and the order of severity of the character of route of administration and preparation, the ordinary circumstance such as body weight, age of receiver and institute's disease therapy.
Compared with prior art, the present invention has following obvious advantage:
1, the present invention has excavated new medical value to known compound 20 (R)-ginsenoside Rg3, use it for alleviation, treatment gastric ulcer, and can be prepared into for alleviating or/and treat medicine or the health food of gastric ulcer, thus open up a new field for the application of ginseng crude drug.
2, campaign research proof 20 (R)-ginsenoside Rg3 of the present invention has effect of significant alleviation, treatment gastric ulcer, significantly can improve the quality of life of patients w ith peptic ulcer disease, strengthen patient's muscle power.
3,20 (R)-ginsenoside Rg3s of the present invention to treat the pharmacological action of gastric ulcer strong, for effect of alleviating, nurse one's health and treating gastric ulcer significantly, instant effect, toxic and side effects are little, safety good, can long-term taking, have good prospect in medicine.
4, products material abundance of the present invention, inexpensive, Clinical practice safety, preparation technology is simple, can be made into various dosage form, and dosing is little, easy to use, is therefore easy to promote.
5, the present invention both can adopt the medicine of 20 of single component (R)-ginsenoside Rg3 active fraction preparations one-tenth for alleviating and treat gastric ulcer, 20 (R)-ginsenoside Rg3s and other active component can be adopted again (such as with Rhizoma Dioscoreae and extract thereof, Poria and extract thereof, Radix Glycyrrhizae and extract thereof, SEMEN COICIS and extract thereof, Fructus Jujubae and extract thereof, Rhizoma Nelumbinis and extract thereof, Oryza glutinosa and extract thereof, Fructus Hordei Vulgaris and extract thereof, Semen Sesami Nigrum extract, plants essential oil, one or more in vitamin C and derivant thereof or vitamin E and derivant thereof) common prescription, the compound medicine of preparation treatment gastric ulcer disease.
Detailed description of the invention
Further describe the beneficial effect of formula of the present invention below by detailed description of the invention, these embodiments are only exemplary, do not form any restriction to scope of the present invention.It will be understood by those skilled in the art that and do not departing under formula thinking of the present invention, purposes scope and can modify to the details of technical solution of the present invention and form or replace, but these amendments and replacement all fall within the scope of protection of the present invention.
Embodiment 1 Rg3 tablet
Rg3 tablet is prepared according to following proportioning:
Ginsenoside Rg3's (content 98%) 500g
Starch 1000g
Pulvis Talci 1%(15g)
Magnesium stearate 1%(15g)
After ginsenoside Rg3 and starch mix homogeneously, make granule, after adding Pulvis Talci and magnesium stearate mix homogeneously, be pressed into 10000.
Embodiment 2 Rg3 granule
Rg3 granule is prepared according to following proportioning:
Ginsenoside Rg3's (content 63%) 200g
Microcrystalline Cellulose 1000g
After ginsenoside Rg3 and microcrystalline Cellulose mix homogeneously, make granule pack, make 10000 bags.
Embodiment 3 Rg3 capsule
Rg3 capsule is prepared according to following proportioning:
Ginsenoside Rg3's (content 98%) 10g
Starch 1000g
After ginsenoside rg3 and starch mix homogeneously, in incapsulating, make 10000.
Embodiment 4 Rg3 tablet
Rg3 tablet is prepared according to following proportioning:
By ginsenoside Rg3, granulate after Radix Glycyrrhizae extract, vitamin C, starch, mix homogeneously, after adding Pulvis Talci, magnesium stearate mix homogeneously, be pressed into 10000.
Embodiment 5 Rg3 capsule
Rg3 capsule is prepared according to following proportioning:
Ginsenoside Rg3's (content 63%) 30g
SEMEN COICIS extract 30g
Vitamin C 600g
Starch 1000g
After ginsenoside rg3, SEMEN COICIS extract, vitamin C and starch mix homogeneously, load gelatine capsule, make 10000.
Embodiment 6 Rg3 granule
Rg3 granule is prepared according to following proportioning:
After ginsenoside Rg3, Fructus Hordei Vulgaris extract, Oryza glutinosa, vitamin C and cane sugar powder mix homogeneously, make granule pack, make 10000 bags.
Embodiment 7 Rg3 oral liquid
Rg3 oral liquid is prepared according to following proportioning:
Ginsenoside Rg3's (content 98%) 4%
Rhizoma Dioscoreae extract 3%
Semen Sesami Nigrum extract 3%
Dextrose syrup 5%
Full side finally adds deionized water to 100%.
Get ginsenoside Rg3 with after a small amount of dissolve with ethanol, add Rhizoma Dioscoreae extract, Semen Sesami Nigrum extract and dextrose syrup, finally add deionized water to 100%, to obtain final product.
The anti-rat gastric ulcer experimentation of test example 1 Rg3
1 experiment material
1.1 medicines and reagent
Ginsenoside Rg3, Dalian Fu Sheng natural drug development corporation, Ltd. produces, lot number: 2012303; The ginsenoside Rg3's standard control provided with Nat'l Pharmaceutical & Biological Products Control Institute also carries out HPLC demarcation, and content is 98.2%;
Positive control drug: cimetidine, Hebei Rui Sen pharmaceutcal corporation, Ltd, lot number: 2011-0705.
Ether Guangzhou Chemical Reagent Factory;
Phenolphthalein Guangzhou Chemical Reagent Factory;
Sodium carboxymethyl cellulose Wenzhou City, Zhejiang Province Dong Sheng chemical reagent factory;
1.2 animal
SD rat, female, body weight 200 ~ 250g, purchased from Dalian Medical Univ's Experimental Animal Center, the certification of fitness number: SCXK (13) 2012-0003.
1.3 experimental technique
1.3.1 Rg3 Chinese People's Anti-Japanese Military and Political College Mus Pylorus Ligated Gastric Ulcer effect
1.3.1.1 animal divides into groups:
Get body weight 180 ~ 220g male and female half and half SD rat 60, after weighing, be divided into 6 groups at random, be i.e. dosage group, Rg3 administration low dose group, positive drug (cimetidine) matched group in blank group, model control group, Rg3 administration high dose group, Rg3 administration.
1.3.1.2 the preparation of gavage medicinal liquid and administrations
After medicine Rg3, cimetidine are pulverized, become suitable concentration with 0.5% sodium carboxymethyl cellulose (CMC-Na) solution dilution respectively, be stored in refrigerator for subsequent use.
The dosage of the high, medium and low dosage group of Rg3 is respectively 6mg/kg, 3mg/kg, 1.5mg/kg; It is 36mg/kg/d that the dosage of positive drug cimetidine group is converted rear by people and rat body surface area.All the other groups are filled with by body weight with equal-volume 0.5%CMC-Na.By 10ml/kg gavage medicine, namely blank group and model control group give 0.5%CMC-Na solution 10ml/kg/d/, Rg3 high dose group gives Rg3 suspension 6mg/kg/d, in Rg3, dosage group gives Rg3 suspension 3mg/kg/d, Rg3 low dose group gives Rg3 suspension 1.5mg/kg/d, cimetidine group gives cimetidine suspension 36mg/kg/d, successive administration 3 days.Modeling is started after last administration 2h.
1.3.1.3 the preparation of animal model and the collection of specimen
By each group of experimental rat fasting 72h after last administration 2h, can freely drink water during fasting.Fasting except blank group, after all the other respectively group rat etherization, was lain on the back and is fixed on Mus plate after 72 hours.Cut stomach wall hair, with iodine tincture, ethanol routine disinfection, median incision 2 ~ 3cm is made along ventrimeson under ensiform process of sternum, duodenum is ticked gently below the liver of right side with curved hemostat, at costal margin position, left side, pushing away with pointing the right side gently, exposing stomach in otch, then stomach is moved to outside abdomen gently, at stomach pylorus underpass (not injuring blood vessel) by pylorus ligation.Stomach is sent back to gently, closes abdomen, suturing them otch.Again sterilize after otch with iodine tincture, ethanol, rat is put back in cage.Fasting prohibited water after 17 hours again, puts to death, open abdomen by it, ligation cardia, takes out stomach, first extracts part gastric juice with syringe, an osculum is cut again at greater gastric curvature place, collect gastric juice in hard plastic in vitro, the centrifugal 15min of 3000r/min, Aspirate supernatant, after record gastric juice amount, supernatant is put into the memotron of 5ml ,-20 DEG C of cryogenic refrigerators are preserved, gastric acid to be measured; Then along greater gastric curvature, stomach is cut off, clean with ice normal saline flushing, stomach is launched naturally, filter paper blots, the situation of stomach mucosal surface ulcer before observing, measure by the maximum vertical footpath of the ulcer at ulcer center and maximum transverse diameter with slide gauge, calculate ulcer area, ulcer area computing formula is as follows: ulcer area=π × vertical footpath/2 × transverse diameter/2(note: area <1mm
2ulcer point, 10 are equivalent to ulcer area 1mm
2.) calculate ulcer inhibition percentage according to ulcer area.
Gastric juice determining adopts determination of acid-basetitration.1. getting clear gastric juice 1 ~ 2ml puts in conical flask, adds each 2 of Fu Shi indicator of starting going to a nursery, phenolphthalein indicator, becomes cherry red, as yellowly then indicates without free acid containing during free acid.2. slowly use 0.02mol/LNaOH titration with burette, constantly shake simultaneously, just disappear to red, till there is ginger color, be free acid titration end-point, record consumes the milliliter number of NaOH solution.3. continue to be titrated to gastric juice with NaOH to transfer in blush 2 second and not moving back, be total acidity titration end-point.Record the total milliliter of number of the NaOH that twice titration consumes.4. result calculates: milliliter number × 10 of the NaOH solution that free acid (mEq/L)=free acid titration end-point consumes; Milliliter number × 10(the note of the NaOH solution that total acidity (mEq/L)=twice titration consumes: indicator is prepared: holder Fu Shi indicator: get dimethyl yellow (butter yellow) 0.5g and be dissolved in 100ml95% ethanol, be made into the solution of 0.5; Phenolphthalein indicator: get phenolphthalein 1.0g and be dissolved in 100ml95% ethanol, be made into 1% phenolphthalein solution).
1.3.1.4 Testing index and method
1.3.1.4.1 the mensuration of ulcer index (UI)
The calculating of measurement and ulcer area that ulcer indulges footpath and transverse diameter is shown in above-mentioned.According to Okabe method, the summation of rat ulcer area be divided into five grades as ulcer index, namely as ulcer area (mm
2) be 1 ~ 12,13 ~ 25,26 ~ 37,38 ~ 50,>=50 or perforation time, ulcer index is respectively 1,2,3,4,5.
1.3.1.4.2 ulcer inhibition percentage
Ulcer inhibition percentage=(model control group ulcer index-administration group ulcer index/model control group ulcer index) × 100%
1.4 experimental result
1.4.1 on the impact of ulcer index (UI)
Table 1 Rg3 is on the impact (x ± s) of pyloric ligation ulcers Ulcer Models ulcer index
Note: compare * *: P<0.01, * * *: P<0.001 with model control group
Result of the test shows, the high, medium and low dosage group of RG3 compares with model control group, and rat ulcer index obviously declines (P<0.001, P<0.01, P<0.01), have highly significant sex differernce, its effect is in dose-effect relationship.Illustrate that RG3 has obviously reduction pyloric ligation ulcers rat stomach and glues the effect of touching damage.
1.4.2 on the impact of gastric juice free acid and total acidity
Table 2 Rg3 is on the impact (x ± s) of pyloric ligation ulcers Ulcer Models gastric juice free acid, total acidity
Note: compare *: P<0.05, * * *: P<0.001 with model control group
The result of the test of table 2 shows, the high, medium and low dosage group of ginsenoside Rg3 compares with model control group, gastric juice free acid all obviously reduces (P<0.05), high, the middle dosage group of Rg3 compares total acidity and all obviously reduces (P<0.001) with model control group, cimetidine group compares with model control group, and free acid and total acidity all obviously reduce (P<0.05).These results suggest that, Rg3 has the effect reducing gastric juice free acid and total acidity.
Claims (10)
1.20 (R)-ginsenoside Rg3s for the preparation of alleviating or/and application in the treatment medicine of gastric ulcer or health product.
2. application according to claim 1, is characterized in that described medicine is made up of 20 (R)-ginsenoside Rg3s and pharmaceutically acceptable carrier.
3. application according to claim 1 and 2, is characterized in that described medicine exists with tablet, capsule, pill, powder, granule, syrup, solution, Emulsion, injection, spray, aerosol, gel-type, cream, tincture, cataplasma, rubber plaster unguentum or emplastrum form.
4. application according to claim 1 and 2, is characterized in that content >=1% of 20 described (R)-ginsenoside Rg3s.
5. application according to claim 4, is characterized in that the content of 20 described (R)-ginsenoside Rg3s is 1% ~ 98%.
6. alleviate or/and treat medicine or the health product of gastric ulcer, it is characterized in that containing 20 (R)-ginsenoside Rg3s.
7. medicine according to claim 6 or health product, is characterized in that the ratio of the gross weight of the weight of described 20 (R)-ginsenoside Rg3s and described medicine or health product is 0.01-10:100.
8. medicine according to claim 6 or health product, is characterized in that the content of 20 described (R)-ginsenoside Rg3s is >=1%.
9. medicine according to claim 8 or health product, is characterized in that the content of 20 described (R)-ginsenoside Rg3s is 1% ~ 98%.
10. medicine according to claim 6 or health product, it is characterized in that also comprising Rhizoma Dioscoreae and extract, Poria and extract thereof, Radix Glycyrrhizae and extract thereof, SEMEN COICIS and extract, Fructus Jujubae and extract thereof, Rhizoma Nelumbinis and extract, Oryza glutinosa and extract thereof, one or more in Fructus Hordei Vulgaris and extract, Semen Sesami Nigrum extract, plants essential oil, vitamin C and derivant thereof or vitamin E and derivant thereof.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106974952A (en) * | 2017-04-10 | 2017-07-25 | 通化鑫业生物科技研发有限公司 | Application of the fresh ginseng activity extract in treatment oral cavity and digestive tract ulcer medicine is prepared |
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| US20030190377A1 (en) * | 2002-04-08 | 2003-10-09 | Ginseng Science Inc. | Novel use of the extract of processed Panax genus plant and saponin compound isolated therefrom |
| CN104622877A (en) * | 2013-11-14 | 2015-05-20 | 富力 | Application of 20(R)-ginsenoside Rg3 in preparation of medicine for treating hyperlipidemia |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20030190377A1 (en) * | 2002-04-08 | 2003-10-09 | Ginseng Science Inc. | Novel use of the extract of processed Panax genus plant and saponin compound isolated therefrom |
| CN104622877A (en) * | 2013-11-14 | 2015-05-20 | 富力 | Application of 20(R)-ginsenoside Rg3 in preparation of medicine for treating hyperlipidemia |
Non-Patent Citations (1)
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| 张南生 等: "人参皂苷Rg3的研究进展", 《医药导报》 * |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106974952A (en) * | 2017-04-10 | 2017-07-25 | 通化鑫业生物科技研发有限公司 | Application of the fresh ginseng activity extract in treatment oral cavity and digestive tract ulcer medicine is prepared |
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Application publication date: 20150708 |