CN104523790A - Prepared pseudo-ginseng, as well as preparation method and application thereof - Google Patents

Prepared pseudo-ginseng, as well as preparation method and application thereof Download PDF

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CN104523790A
CN104523790A CN201510023537.4A CN201510023537A CN104523790A CN 104523790 A CN104523790 A CN 104523790A CN 201510023537 A CN201510023537 A CN 201510023537A CN 104523790 A CN104523790 A CN 104523790A
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ginsenoside
radix notoginseng
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content
cooked radix
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CN104523790B (en
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张海
苏柘僮
张帅杰
纪奇森
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Ya'an Xun Kang Pharmaceutical Co., Ltd.
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CHENGDU TIANXIN PHARMACEUTICAL HEALTH CARE Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/25Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/258Panax (ginseng)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7028Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
    • A61K31/7034Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
    • A61K31/704Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin

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Abstract

The invention provides prepared pseudo-ginseng, as well as a preparation method and application thereof. Based on weight percentage, the total amount of notoginsenoside R1, ginsenoside Rg1 and ginsenoside Rb1 in the prepared pseudo-ginseng is not less than 5.0 percent, wherein the content of notoginsenoside R1 is not less than 0.4 percent, the content of ginsenoside Rg1 is not less than 2.0 percent and the content of ginsenoside Rb1 is not less than 1.5 percent; the total amount of ginsenoside Rh4, ginsenoside 20(S)-Rg3 and ginsenoside 20(R)-Rg3 is not less than 0.5 percent, wherein the content of ginsenoside Rh4 is not less than 0.3 percent, the content of ginsenoside 20(S)-Rg3 is not less than 0.06 percent, and the content of ginsenoside 20(R)-Rg3 is not less than 0.03 percent.

Description

A kind of cooked Radix Notoginseng and its production and use
Technical field
The present invention relates to a kind of cooked Radix Notoginseng and preparation method thereof, belong to field of medicaments.
Background technology
Radix Notoginseng, another name: Panax pseudoginseng Wall., Panax pseudoginseng, Typhonium flagelliforme (Lodd.) Blume, mountain paint, Radix Notoginseng, Classification system: Panax notoginseng (Burk.) F.H.Chen, Umbellales, Araliaceae, Panax herbaceos perennial, root stock is short, and fleshy tap root is cylindrical, palmately compound leaf, umbel top is raw, brightly yellowish green; Calyx cup-shaped.Be distributed in the ground such as Yunnan, Guangxi, Jiangxi, Sichuan.Radix Notoginseng is used as medicine with its root, and it is warm in nature, acrid in the mouth, has significant blood circulation promoting and blood stasis dispelling, subduing swelling and relieving pain effect, has the good reputation of " Radix Stephaniae Sinicae (Radix Stephaniae Dielsianae) ", " southern part of the country SHENCAO ".Excavating in season in winter in spring two because being everlasting, being divided into again " spring seven " and " winter seven ".
The concocting method of Radix Notoginseng is: pick most impurity, smash to pieces, grinds into powder or moistens section and dry.The fresh Radix Notoginseng of gathering before blooming more than 3 years, removes stem and leaf earth, takes reed head, side root, fibrous root, separately size, shine to six, seventy percent dry time, with rice husk blending, solarization limit, limit is crumpled, and makes its body constitution solid, then shines to foot dry.Summer picks flowers, and dries in the shade or fumigate to dry.
Cooked Radix Notoginseng falls apart, and is cleaned by Radix Notoginseng, steams 3 hours, dry, pulverize into fine powder, sieve with steam, obtain (see standard WS-11219 (ZD-1219)-2002).This standard also discloses the preparation of cooked Radix Notoginseng, gets Radix Notoginseng (clip) 7 parts, Radix Notoginseng (rib) 3 parts, and mixing is broken into fritter, puts in steamer and steams 3 hours with saturated vapor, to obtain final product.The main method of function that cooked Radix Notoginseng is loose is benefiting blood and regulating blood circulation, for anemia, weakness of losing blood, menoxenia, puerperal stagnant blood not to the utmost.Disclosed in this standard, concocting method owes specification; And quality control monitoring index is similar to pharmacopeia raw sangqi ginseng, the index components being quality control with the saponins (ginsenoside Rg1) that content in crude drug is more, can not embody raw ripe difference, can not reach the object of quality control.
Cooked Radix Notoginseng of the prior art mainly obtains by steaming, such as Chinese patent literature CN101036676A discloses, a kind of Radix Notoginseng processing method and products thereof, it is characterized in that by fresh Radix Notoginseng under ground portion cleaning preferably, flowing steam through 45 ~ 150 DEG C of temperature steams 10 minutes ~ 48 hours, dries or dry to form under 20 ~ 120 DEG C of conditions.
But, steam the optimised process not preparing cooked Radix Notoginseng, such as Chinese patent literature CN102416028A discloses, Radix Notoginseng steam the participation needing moisture, the Radix Notoginseng that existing steaming method is dry or Radix Notoginseng powder steam, first need to make dry raw material to be infiltrated by moisture steaming in process, considerably increase and steam required time, thus energy consumption is also higher; And steaming in process, the infiltration of moisture is a process gradually, and the moisture in the inside and outside portion of raw material and heat are distributed all heterogeneities, thus makes the transforming degree of saponin constituent also inconsistent, product quality is not easily stablized.When steaming with Radix Notoginseng powder, because Radix Notoginseng contains much starch, surface easily produces gelatinizing, steam can be stoped to penetrate inside further, not only extend steaming time, and increase energy consumption, also exacerbate inequality of being heated, product quality is wayward.
Therefore, a kind of method preparing cooked Radix Notoginseng that can obtain the activity index composition of expectation is selected to become the urgent needs of current Chinese medicine enterprise.
Summary of the invention
An object of the present invention is to provide a kind of cooked Radix Notoginseng with good index active component.
An object of the present invention is to provide a kind of method preparing cooked Radix Notoginseng, can obtain better index active component by the method.
The object of this invention is to provide a kind of cooked Radix Notoginseng, it is based on weight percent meter, total amount containing arasaponin R1, ginsenoside Rg1, ginsenoside Rb1 three must not be less than 5.0%, and wherein arasaponin R1 content is no less than 0.4%, Determination of Content of Ginsenoside Rg_1 is no less than 2.0%, ginsenoside Rb1's content is no less than 1.5%; Total amount containing Ginsenoside Rh4., ginsenoside 20 (S)-Rg3, ginsenoside 20 (R)-Rg3 three must not be less than 0.5%, and wherein Ginsenoside Rh4 .'s content is no less than 0.3%, ginsenoside 20 (S)-Rg3 content is no less than 0.06%, ginsenoside 20 (R)-Rg3 content is no less than 0.03%.
In preferred embodiments,
Cooked Radix Notoginseng of the present invention, based on weight percent meter, the total amount containing arasaponin R1, ginsenoside Rg1, ginsenoside Rb1 three is 5.0 ~ 9.0%; Total amount containing Ginsenoside Rh4., ginsenoside 20 (S)-Rg3, ginsenoside 20 (R)-Rg3 three is 0.5 ~ 2.0%.
Wherein, the weight ratio of described arasaponin R1, ginsenoside Rg1, ginsenoside Rb1 is:
Arasaponin R1 0.4 ~ 0.9 part, ginsenoside Rg1 2.0 ~ 5.4 parts, ginsenoside Rb1 1.5 ~ 4.5 parts;
The weight ratio of described Ginsenoside Rh4., ginsenoside 20 (S)-Rg3, ginsenoside 20 (R)-Rg3 is: Ginsenoside Rh4. 0.3 ~ 1.6 part, ginsenoside 20 (S)-Rg30.06 ~ 0.5 part, ginsenoside 20 (R)-Rg30.03 ~ 0.24 part.
An object of the present invention is to provide a kind of method preparing cooked Radix Notoginseng, comprises the following steps:
Get pseudo-ginseng, clean, run through with the water of medical material weight 30 ~ 40%, with pure steam temperature 110 ~ 120 DEG C, steam 2 ~ 5 hours, dry, pulverize into most fine powder, to obtain final product.
Present invention also offers described cooked Radix Notoginseng and prepare the purposes in anti-tumor drug.
Present invention also offers the purposes of described cooked Radix Notoginseng in preparation tumor adjuvant drug thing.
The specification of the present invention concocting method of cooked Radix Notoginseng, improves process of preparing quality; Quality standard is more perfect, while meeting States Pharmacopoeia specifications component content, also take into account the composition that after concocting, cooked Radix Notoginseng is newly-increased, have the rare saponin component Ginsenoside Rh4. of very strong physiologically active, ginsenoside 20 (S)-Rg3, ginsenoside 20 (R)-Rg3; Experiment proves, cooked Radix Notoginseng has antineoplastic action, can improve immunity, for tumor adjuvant drug, fully demonstrates the raw ripe effect of Radix Notoginseng processed product different, respectively has its merit.
Accompanying drawing explanation
Fig. 1 cooked Radix Notoginseng is on the impact of Lewis lung cancer tumor-bearing mice body weight
Detailed description of the invention
the test mode of embodiment 1 cooked Radix Notoginseng powder
[character] this product is the powder of light yellowish brown to yellowish-brown; Gas is fragrant, bitter in the mouth Hui Tian.
This product is got in [discriminating] (1), puts basis of microscopic observation: starch grain gelatinizing, without obvious demarcation line; Simple grain is similar round, polygon or irregular shape, and composite grain is made up of 2-5 gradation.Resin canal fragment, includes yellow secretions.Conduit is common with reticulate pattern, and calcium oxalate cluster crystal is rare, and its corner angle are more blunt.
(2) get this product powder 0.5g, add water 5, stir evenly, water saturated n-butyl alcohol 5ml in addition again, close plug, jolting 10 minutes, place 2 hours, centrifugal, get supernatant, add the water that 3 times amount n-butyl alcohol are saturated, shake up, place and make layering (centrifugal if desired), get n-butanol layer, evaporate to dryness, residue adds methanol 1ml makes dissolving, as need testing solution.Separately get Radix Notoginseng control medicinal material, ginsenoside Rb1's reference substance, ginsenoside Rg1's reference substance and arasaponin R1 reference substance, add methanol and make every 1ml respectively containing the mixed solution of 1mg, product solution in contrast.Test according to thin layer chromatography (" Chinese Pharmacopoeia " version in 2010 annex), draw each 5 μ l of above-mentioned two kinds of solution to put respectively on same silica gel g thin-layer plate, the lower floor's solution placed with chloroform-less than 10 DEG C, acetate-methanol-water (15:40:22:10) is for developing solvent, launch, take out, dry, spray with sulfuric acid solution (1 → 10), be heated to spot development clear.In test sample chromatograph, on the position corresponding to reference substance chromatograph, the speckle of aobvious same color; Inspect under putting ultra-violet lamp (365nm), aobvious identical fluorescence speckle.
[inspection] moisture must not cross 9.0%.
Total ash must not cross 6.0%.
Acid-insoluble ash must not cross 3.0%.
Granularity measures according to granulometry (" Chinese Pharmacopoeia " version in 2010 annex, single sieve method), by the powder weight of No. 7 sieves, must not be less than 95%.
Heavy metal and harmful element are according to lead, cadmium, arsenic, hydrargyrum, copper algoscopy (" Chinese Pharmacopoeia " version in 2010 annex IX B) atomic absorption spectrophotometry or inductively coupled plasma mass spectrometry) measure, lead must not cross 5/1000000ths; Cadmium must not cross 3/10000000ths; Arsenic must not cross 2/1000000ths; Hydrargyrum must not cross 2/10000000ths; Copper must not cross 20/1000000ths.
Residual Levels of Organochlorine Pesticides is according to persticide residue algoscopy (" Chinese Pharmacopoeia " version in 2010 annex IX Q) the organic chlorine agriculture chemicals determination of residual amount) measure, Gamma Hexaochlorocyclohexane (total BHC) must not cross 2/10000000ths; Clofenotane (total DDT) must not cross 2/10000000ths; Pentachloronitrobenzene (PCNB) must not cross 1/10000000th.
Microbial limit measures according to microbial limit test (" Chinese Pharmacopoeia " version in 2010 annex XIIIC microbial limit test), and the every 1g of bacterial population must not cross 10000cfu; The every 1g of yeast and mold number must not cross 100cfu; The every 1g of escherichia coli must not detect; The every 1g of coliform should be less than 100.
[extractum] ethanol-soluble extractives measures according to the hot dipping under ethanol-soluble extractives algoscopy (" Chinese Pharmacopoeia " annex) item, with methanol as solvent, must not be less than 16.0%.
[assay]
Chromatographic condition and system suitability take octadecylsilane chemically bonded silica as filler; Take acetonitrile as mobile phase A; Water is Mobile phase B, and the regulation according to the form below carries out gradient elution; Column temperature is 30 DEG C, and determined wavelength is 203nm.Number of theoretical plate calculates by number of theoretical plate should be not less than 7000 by arasaponin R1 peak.
Table 1 gradient elution program
The preparation precision of reference substance solution takes arasaponin R1 reference substance, ginsenoside Rg1's reference substance, ginsenoside Rb1's reference substance, Ginsenoside Rh4 .'s reference substance, ginsenoside 20 (S)-Rg3 reference substance, ginsenoside 20 (R)-Rg3 reference substance are appropriate, add methanol and make the mixed solution of every 1ml containing arasaponin R1 0.3mg, ginsenoside Rg1 1.0mg, ginsenoside Rb1 1.0mg, Ginsenoside Rh4. 0.2mg, ginsenoside 20 (S)-Rg30.1mg, ginsenoside 20 (R)-Rg30.06mg, to obtain final product.
This product powder 1g is got in the preparation of need testing solution, and accurately weighed, precision adds methanol 20ml, weighed weight, and placement is spent the night, put and 80 DEG C of water-baths keep micro-boil 2 hours, let cool, more weighed weight, the weight of less loss is supplied with methanol, shake up, filter, get subsequent filtrate, to obtain final product.
Algoscopy is accurate respectively draws reference substance solution and each 10 μ l of need testing solution, injection liquid chromatography, measures, to obtain final product.
The every 1g of this product is containing arasaponin R1 (C 47h 80o 18), ginsenoside Rg1 (C 42h 72o 14), ginsenoside Rb1 (C 54h 92o 23) total amount must not be less than 5.0%; Containing Ginsenoside Rh4. (C 36h 60o 8), ginsenoside 20 (S)-Rg3 (C 42h 72o 13), ginsenoside 20 (R)-Rg3 (C 42h 72o 13) total amount must not be less than 0.5%.
[nature and flavor with return through] sweet, micro-hardship, temperature.Return liver, stomach warp.
[function with cure mainly] benefiting blood and regulating blood circulation, QI invigorating, strengthens immunity.For anemia, weakness of losing blood, menoxenia, puerperal stagnant blood not to the utmost, and all diseases of deficiency of qi and blood that tumor chemoradiotherapy causes.
What [process of preparing Chinese medicine object], in the clinical practice of centuries, Radix Notoginseng all had " ripe benefit is driven in life away " says; Pharmacological testing research also shows that steaming Radix Notoginseng has multiple physiologically active such as enhancing immunologic function, Tumor suppression etc.Therefore, by concocting the range of application expanding Radix Notoginseng, the object of Chinese medicine processing is met.
[usage and consumption] is oral: 3 ~ 5g, 3 times on the one.Decoction being taken at a draught or gradation clothes.Or follow the doctor's advice.
The preparation of embodiment 2a cooked Radix Notoginseng powder
[source] this product is the dry root and rhizome of panax araliaceae plant Panax notoginseng (Burk.) F.H.Che.
[when adopting and processing] excavated before autumn, the flowers are in blossom, cleaned, and separately main root, a root and rhizome, dry.
[process of preparing Chinese medicine] gets pseudo-ginseng, cleans, and cleans, runs through, with pure steam temperature 105 DEG C, steam 4 hours with the water of medical material weight 30%, dry, pulverize into most fine powder, to obtain final product.
This product is 8.4% containing the total amount of arasaponin R1, ginsenoside Rg1, ginsenoside Rb1, and wherein arasaponin R1 content is 0.73%, Determination of Content of Ginsenoside Rg_1 is 4.57%, ginsenoside Rb1's content is 3.10%; Total amount containing Ginsenoside Rh4., ginsenoside 20 (S)-Rg3, ginsenoside 20 (R)-Rg3 is 0.57%, and wherein Ginsenoside Rh4 .'s content is 0.41%, ginsenoside 20 (S)-Rg3 content is 0.11%, ginsenoside 20 (R)-Rg3 content is 0.05%.
The preparation of embodiment 2b cooked Radix Notoginseng powder
[source] this product is the dry root and rhizome of panax araliaceae plant Panax notoginseng (Burk.) F.H.Che.
[when adopting and processing] excavated before autumn, the flowers are in blossom, cleaned, and separately main root, a root and rhizome, dry.
[process of preparing Chinese medicine] gets pseudo-ginseng, cleans, and cleans, runs through, with pure steam temperature 110 DEG C, steam 3 hours with the water of medical material weight 35%, dry, pulverize into most fine powder, to obtain final product.
This product is 7.3% containing the total amount of arasaponin R1, ginsenoside Rg1, ginsenoside Rb1, and wherein arasaponin R1 content is 0.62%, Determination of Content of Ginsenoside Rg_1 is 3.54%, ginsenoside Rb1's content is 3.14%; Total amount containing Ginsenoside Rh4., ginsenoside 20 (S)-Rg3, ginsenoside 20 (R)-Rg3 is 1.42%, and wherein Ginsenoside Rh4 .'s content is 0.99%, ginsenoside 20 (S)-Rg3 content is 0.27%, ginsenoside 20 (R)-Rg3 content is 0.16%.
The preparation of embodiment 2c cooked Radix Notoginseng powder
[source] this product is the dry root and rhizome of panax araliaceae plant Panax notoginseng (Burk.) F.H.Che.
[when adopting and processing] excavated before autumn, the flowers are in blossom, cleaned, and separately main root, a root and rhizome, dry.
[process of preparing Chinese medicine] gets pseudo-ginseng, cleans, and cleans, runs through, with pure steam temperature 115 DEG C, steam 2 hours with the water of medical material weight 40%, dry, pulverize into most fine powder, to obtain final product.
This product is 5.6% containing the total amount of arasaponin R1, ginsenoside Rg1, ginsenoside Rb1, and wherein arasaponin R1 content is 0.52%, Determination of Content of Ginsenoside Rg_1 is 2.85%, ginsenoside Rb1's content is 2.23%; Total amount containing Ginsenoside Rh4., ginsenoside 20 (S)-Rg3, ginsenoside 20 (R)-Rg3 is 1.8%, and wherein Ginsenoside Rh4 .'s content is 1.25%, ginsenoside 20 (S)-Rg3 content is 0.36%, ginsenoside 20 (R)-Rg3 content is 0.19%.
comparative example 1
Chinese patent literature CN101036676A discloses, a kind of Radix Notoginseng processing method and products thereof, it is characterized in that the flowing steam through 45 ~ 150 DEG C of temperature steams 10 minutes ~ 48 hours, dries or dry to form under 20 ~ 120 DEG C of conditions by preferred for fresh Radix Notoginseng under ground portion cleaning.
comparative example 2
Chinese patent literature CN102416028A discloses, Radix Notoginseng steam the participation needing moisture, the Radix Notoginseng that existing steaming method is dry or Radix Notoginseng powder steam, and first need dry raw material is infiltrated by moisture steaming in process, considerably increase and steam required time, thus energy consumption is also higher; And steaming in process, the infiltration of moisture is a process gradually, and the moisture in the inside and outside portion of raw material and heat are distributed all heterogeneities, thus makes the transforming degree of saponin constituent also inconsistent, product quality is not easily stablized.When steaming with Radix Notoginseng powder, because Radix Notoginseng contains much starch, surface easily produces gelatinizing, steam can be stoped to penetrate inside further, not only extend steaming time, and increase energy consumption, also exacerbate inequality of being heated, product quality is wayward.
comparative example 3a
Get pseudo-ginseng, clean, clean, run through with the water of medical material weight 15%, with pure steam temperature 105 ~ 115 DEG C, steam 2 ~ 4 hours, dry, pulverize into most fine powder, to obtain final product.
comparative example 3b
Get pseudo-ginseng, clean, clean, run through with the water of medical material weight 50%, with pure steam temperature 105 ~ 115 DEG C, steam 2 ~ 4 hours, dry, pulverize into most fine powder, to obtain final product.
Adopt the detection method of the embodiment of the present invention 1, following result can be obtained:
Wherein, for Radix Notoginseng extract steams described in comparative example 2 patent documentation, nothing is steamed with Radix Notoginseng in the present invention
Method contrasts.
Conclusion: the activity index of product of the present invention is better.
beneficial effect of the present invention is proved below by way of pharmacodynamics test.
The pharmacodynamic experiment research that test example 1 cooked Radix Notoginseng affects Lewis tumor-bearing mice
One, experiment material
1. laboratory animal
SPF level C57BL/6 mice, 18 ~ 22g, male and female half and half.Da Shuo bio tech ltd, Chengdu provides, the animal quality certification number: real dynamic pipe matter SCXK (river) 2013-24 in river.
2. Laboratory Animal Facility condition
Animal observation ward of pharmaceutical college of Chengdu University of Traditional Chinese Medicine, the Laboratory Animal Facility condition quality certification number: the real dynamic pipe in river makes No. 2009-124.
3. tumor tissues
Mice Bearing Lewis Lung Cancer tumor tissues, is provided by West China Center of Medical Sciences of Sichuan University tumor biotherapy laboratory.
4. Experimental agents
1. commercially available cooked Radix Notoginseng powder: commercially available; Yellowish-brown powder, is placed in exsiccator and preserves.2. cyclophosphamide (Cyclophosphamide, CTX), 200mg/ props up, Hengrui Medicine Co., Ltd., Jiangsu Prov., the accurate word H32020857 of traditional Chinese medicines, product batch number: 13113025.3. sodium chloride injection: Kelun Pharm Ind Co., Ltd., Sichuan, product batch number: M14031521.4. 75% ethanol for disinfection: Yi Shi medical science and technology company limited of Sichuan Province, product batch number: 140605.5. cooked Radix Notoginseng powder, is prepared by embodiment of the present invention 2b.
5. experimental apparatus
Analytical balance, Beijing Sai Duolisi instrument system company limited.
Two, experimental technique
1. lotus tumor kind Mus preparation
Taken out from liquid nitrogen by Lewis lung cancer tissue, 37 DEG C thaw rapidly, concentration are adjusted to 1 × 10 8individual/mL is for injection.Get 10 C57BL/6 mices, by 5 × 10 6individual (0.2mL) Lewis lung cancer cell is inoculated in every mice armpit skin, for subsequent use as kind of Mus.
Prepared by 2.Lewis lung cancer model
Put to death by C57BL/6 tumor-bearing mice after 10d, strip tumor tissue under aseptic condition, tumor quality (g) and normal saline (mL) being prepared according to the homogenate of 1:3 ratio becomes suspension, and every mice is inoculated in left armpit skin according to 0.2mL.
3. animal grouping and administration
After mouse inoculation tumor cell, next day is divided into 8 groups at random according to body weight, often organize 13 ~ 14, i.e. dosage group, cooked Radix Notoginseng low dose group in dosage group and commercially available cooked Radix Notoginseng low dose group, cooked Radix Notoginseng high dose group, cooked Radix Notoginseng in model group (0.5%CMC-Na solution), positive controls (cyclophosphamide), commercially available cooked Radix Notoginseng high dose group, commercially available cooked Radix Notoginseng.Dosage is in table 2.
Table 2 cooked Radix Notoginseng tumour inhibiting rate determination experiment drug administration scheme
4. the mensuration of tumour inhibiting rate
Except cyclophosphamide group, all the other respectively organize mice successive administration 15d.16d puts to death mice, gets tumor tissues and claims tumor weight, calculates tumour inhibiting rate.
The average tumor heavy × 100% of tumour inhibiting rate (%)=(the average tumor weight-treatment group average tumor weight of model group)/model group
5. body weight, body weight ratio (FBW/IBW), death condition before and after mice administration
IBW is Mouse Weight before administration, and when FBW is 16d, mice removes the heavy body weight of tumor.FBW/IBW ratio size is adopted to weigh the toxic action size of medicine.FBW/IBW>0.85, the toxic and side effects of prompting medicine is not obvious, and mice can tolerate; Ratio <0.85 then points out medicine to have certain toxic and side effects to mice; Treatments period, if the death of administration treated animal is more than 20%, represents that medicine has toxic reaction.
6. statistical method
Data acquisition uses " mean ± standard deviation " represent, adopt SPSS19.0 statistical package to analyze, variance adopts T to check together, and those who do not meet adopt the analysis of DPS3.1 non parametric tests KruskalWallis method.
Three, experimental result
1. tumour inhibiting rate measurement result
In table 3.Dosage (1170mg/kg) gastric infusion 15d continuously in cooked Radix Notoginseng, significantly can alleviate tumor heavy (p<0.05), tumour inhibiting rate is 41.70%, and when showing 1170mg/kg dosage, cooked Radix Notoginseng has the effect suppressing Lewis tumor growth preferably.It is 22.10% that commercially available cooked Radix Notoginseng high dose (2340mg/kg) organizes tumour inhibiting rate, though there is significant difference, its tumour inhibiting rate less than 30%, without actual clinical meaning.All the other tumor killing effects respectively organized are not obvious.
Table 3 cooked Radix Notoginseng is on the impact of Lewis lung cancer tumor-bearing mice tumour inhibiting rate
Compare with model control group: *p < 0.05, *p < 0.05.
2. body weight result of variations before and after mice administration
See Fig. 1.Commercially available cooked Radix Notoginseng and each dosed administration group of cooked Radix Notoginseng all have Tumor suppression to cause laboratory animal body weight downward trend during administration.When testing 15d, cooked Radix Notoginseng high dose group (2340mg/kg) the weight of animals is apparently higher than positive drug group (p<0.05).
3. mice administration forebody-afterbody anharmonic ratio value (FBW/IBW) and death rate measurement result
In table 4.Along with the increase of dosage, commercially available cooked Radix Notoginseng each administration treated animal FBW/IBW value is on a declining curve, in commercially available cooked Radix Notoginseng, (1170mg/kg), high dose (2340mg/kg) are organized FBW/IBW value and are less than 0.85, and commercially available cooked Radix Notoginseng high dose group FBW/IBW value is starkly lower than model group (p<0.05), show that, in 1170 ~ 2340mg/kg dosage range, commercially available cooked Radix Notoginseng shows certain toxic and side effects.Along with the increase of dosage, cooked Radix Notoginseng each administration group FBW/IBW value is in rising trend.The continuous gastric infusion 15d of each administration group, except operate miss factor, do not cause the death of animal to show, dosage (1170mg/kg) group because animal fights lethal 1 in commercially available cooked Radix Notoginseng, dosage group (1170mg/kg) because gavage operate miss causes dead 1 in cooked Radix Notoginseng, still have 1 lethal because accidentally metapedes being stuck in mouse cage.In addition, because of the error (inferring that Cell sap leaks outside) of inoculation operation, cause individual mice without tumor growth, when carrying out data statistics, do not count the weight data of these mices.
Table 4 cooked Radix Notoginseng is on the impact of Lewis lung cancer tumor-bearing mice body weight and death rate
Compare with model control group: *p < 0.05, *p < 0.05.
Four, experiment conclusion
1. in cooked Radix Notoginseng, dosage, commercially available cooked Radix Notoginseng high dose group have the effect suppressing Mouse With Lewis Lung Cancer.Wherein commercially available cooked Radix Notoginseng high dose tumor-inhibiting action is slightly weak, is worth (tumour inhibiting rate is less than 30%) and has obvious side effect (FBW/IBW<0.85) without actual clinical.
2., time in 585 ~ 2340mg/kg dosage range, along with dosage raises, cooked Radix Notoginseng group promotes the weight of animals effect and strengthens gradually, and FBW/IBW also raises gradually; Time in 585 ~ 1170mg/kg dosage range, its antitumor action strengthens gradually; Time in 1170 ~ 2340mg/kg dosage range, cooked Radix Notoginseng shows the trend promoting animal tumor growth.
3., time in 585 ~ 2340mg/kg dosage range, along with the increase of dosage, the effect of commercially available cooked Radix Notoginseng group Tumor suppression growth has enhancing trend, but its side effect is also strengthened gradually.
From the pharmacodynamic experiment result that cooked Radix Notoginseng affects Lewis tumor-bearing mice, cooked Radix Notoginseng can Tumor suppression growth, for providing experiment basis to the treatment of tumor and auxiliary treatment clinically.

Claims (9)

1. a cooked Radix Notoginseng, it is characterized in that: based on its weight percent meter, total amount containing arasaponin R1, ginsenoside Rg1, ginsenoside Rb1 three must not be less than 5.0%, and wherein arasaponin R1 content is no less than 0.4%, Determination of Content of Ginsenoside Rg_1 is no less than 2.0%, ginsenoside Rb1's content is no less than 1.5%; Total amount containing Ginsenoside Rh4., ginsenoside 20 (S)-Rg3, ginsenoside 20 (R)-Rg3 three must not be less than 0.5%, and wherein Ginsenoside Rh4 .'s content is no less than 0.3%, ginsenoside 20 (S)-Rg3 content is no less than 0.06%, ginsenoside 20 (R)-Rg3 content is no less than 0.03%.
2. cooked Radix Notoginseng according to claim 1, is characterized in that: based on weight percent meter, the total amount containing arasaponin R1, ginsenoside Rg1, ginsenoside Rb1 three is 5.0 ~ 9.0%; Total amount containing Ginsenoside Rh4., ginsenoside 20 (S)-Rg3, ginsenoside 20 (R)-Rg3 three is 0.5 ~ 2.0%.
3. cooked Radix Notoginseng according to claim 2, is characterized in that: the weight ratio of described arasaponin R1, ginsenoside Rg1, ginsenoside Rb1 is:
Arasaponin R1 0.4 ~ 0.9 part, ginsenoside Rg1 2.0 ~ 5.4 parts, ginsenoside Rb1 1.5 ~ 4.5 parts;
The weight ratio of described Ginsenoside Rh4., ginsenoside 20 (S)-Rg3, ginsenoside 20 (R)-Rg3 is: Ginsenoside Rh4. 0.3 ~ 1.6 part, ginsenoside 20 (S)-Rg3 0.06 ~ 0.5 part, ginsenoside 20 (R)-Rg3 0.03 ~ 0.24 part.
4. prepare a method for the cooked Radix Notoginseng described in claim 1-3 any one, it is characterized in that comprising the following steps:
Get pseudo-ginseng, clean, run through with the water of medical material weight 30 ~ 40%, with either pure steam at temperature 105 ~ 115 DEG C, steam 2 ~ 4 hours, dry, pulverize into most fine powder, to obtain final product.
5. method according to claim 4, is characterized in that: described profit controlling the water circulation amount is 30%.
6. method according to claim 4, is characterized in that: baking temperature is 50 ~ 80 DEG C, and drying time is 10 ~ 30 hours; Drying mode is hot air drying.
7. the cooked Radix Notoginseng described in claim 1-3 any one is preparing the purposes in anti-tumor drug.
8. purposes according to claim 7, is characterized in that: described medicine is the medicine of anti-pulmonary carcinoma.
9. the purposes of the cooked Radix Notoginseng described in claim 1-3 any one in preparation tumor adjuvant drug thing.
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CN105699570A (en) * 2016-03-10 2016-06-22 湖南德康制药股份有限公司 Quality control method of stasis-removal and pain-relief traditional Chinese medicine capsules
CN106138141A (en) * 2016-08-08 2016-11-23 四川仟源中药饮片有限公司 A kind of cooked Radix Notoginseng and preparation method thereof
CN106421089A (en) * 2016-07-13 2017-02-22 四川联成迅康医药股份有限公司 Processing method for radix rehmanniae preparata
CN106491678A (en) * 2016-10-11 2017-03-15 文山学院 A kind of processing method of cooked Radix Notoginseng and purposes
CN107625798A (en) * 2017-09-18 2018-01-26 青海七彩花生物科技有限公司 One kind steams pseudo-ginseng and improves rare ginsenoside RG5The method of content
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CN108938695A (en) * 2018-08-01 2018-12-07 安徽金国源中药股份有限公司 A kind of manufacture craft of ripe Radix Notoginseng powder

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US20180133273A1 (en) * 2015-05-15 2018-05-17 Li Fu Use of Ginseng Extract, Ginsenoside and Ginsenoside Derivative in the Preparation of Medicine or Health Care Product for Treating Cytomegalovirus Infection Disorders
US10675317B2 (en) * 2015-05-15 2020-06-09 Li Fu Use of ginseng extract, ginsenoside and ginsenoside derivative in the preparation of medicine or health care product for treating cytomegalovirus infection disorders
CN105699570A (en) * 2016-03-10 2016-06-22 湖南德康制药股份有限公司 Quality control method of stasis-removal and pain-relief traditional Chinese medicine capsules
CN106421089A (en) * 2016-07-13 2017-02-22 四川联成迅康医药股份有限公司 Processing method for radix rehmanniae preparata
CN106421089B (en) * 2016-07-13 2020-04-10 四川联成迅康医药股份有限公司 Processing method of prepared rehmannia root
CN106138141A (en) * 2016-08-08 2016-11-23 四川仟源中药饮片有限公司 A kind of cooked Radix Notoginseng and preparation method thereof
CN106138141B (en) * 2016-08-08 2019-09-13 四川仟源中药饮片有限公司 A kind of ripe Radix Notoginseng and preparation method thereof
CN106491678A (en) * 2016-10-11 2017-03-15 文山学院 A kind of processing method of cooked Radix Notoginseng and purposes
CN107625798A (en) * 2017-09-18 2018-01-26 青海七彩花生物科技有限公司 One kind steams pseudo-ginseng and improves rare ginsenoside RG5The method of content
CN108938695A (en) * 2018-08-01 2018-12-07 安徽金国源中药股份有限公司 A kind of manufacture craft of ripe Radix Notoginseng powder

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