CN107028994A - The direct oral traditional Chinese medicine medicine materical crude slice of Radix Notoginseng powder - Google Patents
The direct oral traditional Chinese medicine medicine materical crude slice of Radix Notoginseng powder Download PDFInfo
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- CN107028994A CN107028994A CN201710234868.1A CN201710234868A CN107028994A CN 107028994 A CN107028994 A CN 107028994A CN 201710234868 A CN201710234868 A CN 201710234868A CN 107028994 A CN107028994 A CN 107028994A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/10—Preparation or pretreatment of starting material
- A61K2236/15—Preparation or pretreatment of starting material involving mechanical treatment, e.g. chopping up, cutting or grinding
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Abstract
The invention provides a kind of direct oral traditional Chinese medicine medicine materical crude slice of Radix Notoginseng powder, its preparation technology is as follows：1）By pseudo-ginseng crude drug net system, washing, crushed after being dried, intermediate is obtained；2）Electron beam irradiation sterilization is carried out after examining intermediate, packaging；3）Finished product is obtained after carrying out standard test, packaging；Described step 1）In, pulverization conditions are as follows：In D grades of clean areas, using dust-collecting type freeze grinding technology, pseudo-ginseng crude drug is ground into 100 300 mesh；Described step 2）In, the exposure dose of electron beam irradiation sterilization is 3 10 kGy.The present invention can make Radix Notoginseng powder product compared with《Chinese Pharmacopoeia》Fine powder standard（100 mesh）Water extraction total amount and water extraction in total saposins dissolution total amount improve 20~30%, Microbe restriction test result can then comply fully with the standard that associated straight connects oral medicinal slice.
Description
Technical field
The present invention relates to a kind of direct oral traditional Chinese medicine medicine materical crude slice of Radix Notoginseng powder, belong to pharmaceutical technology field.
Background technology
Pseudo-ginseng (Panax notoginseng (B u r k.) F.H.C h e n), also known as radix notoginseng, pseudo-ginseng, Sedum uizoon,
Blood mountain grass, pouring in June, nilgiri nettle, ancient times are also known as clear ginseng, blood ginseng, Panax pseudoginseng, Typhonium flagelliforme (Lodd.) Blume, mountain paint, Radix Notoginseng etc., belong to Araliaceae
Panax herbaceos perennial, be《Chinese Pharmacopoeia》One of important conventional Chinese medicine that one version in 2015 is recorded, is Chinese special
Some rare traditional Chinese medicines, are also one of earliest medicinal and edible plant of China.Because digging in its after planting 3 to seven years is adopted and every plant
Long three petioles, each petiole gives birth to seven blades, therefore named pseudo-ginseng.
The efficacy effect of pseudo-ginseng is very big, and its is warm-natured, pungent, with scattered silt hemostasis, effect of detumescence ding-tong, available for treating
Bleeding from five sense organs or subcutaneous tissue, have blood in stool, uterine bleeding, spitting of blood, haematemesis, traumatism and bleeding, the disease such as chest and abdomen shouting pain.And the flavone compound in pseudo-ginseng have change
Kind myocardial blood supply, increase blood vessel elasticity, effect of coronary artery dilator, sitosterol and Daucosterol energy reducing blood lipid.Often to eat pseudo-ginseng,
There is preventive and therapeutic action to cardiovascular and cerebrovascular diseases such as coronary heart diseases and angina pectoris, and with beautification function.
There is main chemical composition contained by pseudo-ginseng：1st, saponin(e：Saponin(e is the main effective active composition of pseudo-ginseng, is also to grind at present
Study carefully the chemical substance of more system.So far, from the isolated 54 kinds of monomer saponin compositions of different parts of pseudo-ginseng, these
20 (S)-protopanaxadiol-types and 20- (S) protopanaxatriol type of most of the monomer saponin composition for dammarane type.Pseudo-ginseng
(the S)-protopanaxadiol-type saponin(e of under ground portion existing 20, also containing 20 (S) protopanaxatriol type saponin(es.The aerial part of pseudo-ginseng
Based on 20 (S)-protopanaxadiol-type saponin(es.The primary efficacy of pseudo-ginseng is promoting blood circulation, also exactly the role of saponin(e；2nd, it is yellow
Ketone compounds：Flavone compound is one of pseudo-ginseng effective active composition.At present from pseudo-ginseng it is isolated have pseudo-ginseng flavone A
With pseudo-ginseng flavones B2 kinds, these compositions have the fragility of reduction blood vessel, and permeability, reduction blood fat and the courage of improvement blood vessel are consolidated
Alcohol, for preventing and treating senile hypertension and cerebral hemorrhage；3rd, dencichine：Japanese Scientists in 1981 are found that from pseudo-ginseng with hemostasis
The composition of activity, is named as dencichine.It is a kind of special amino acid in fact., several important Chinese medicines of Panax contain
Hemostatic compositions dencichine, but with content highest (0.90%) in pseudo-ginseng, ginseng takes second place (0.50%), and American Ginseng is minimum
(0.31%).The hemostasia effect of pseudo-ginseng is exactly that dencichine works；4th, carbohydrate content：Sugar and its derivative are wide in nature
It is general to exist.Contain rhamnose, xylose and glucose, oligosaccharide and polysaccharide in pseudo-ginseng.1985, there must be enhancing machine from pseudo-ginseng
The active polysaccharide (2A-1) of body immunity function effectiveness, 1987, and a kind of polysaccharide component is isolated to from pseudo-ginseng, it is named as three
Seven Polysaccharide As (Sanchinan A, SA).2A-1 and SA have anti-aging, antifatigue effect；5th, aminoacid ingredient：Pseudo-ginseng contains 19
The amino acid of the above is planted, there are 8 kinds of amino acid needed by human；6th, volatile oil：Separation identifies 34 from notoginseng essential oil total oil
Plant compound, mainly ketone alkene cycloalkane sesquiterpenoids fatty acid ester benzene substituent naphthalene substituent.
《Chinese Pharmacopoeia》2015 editions pseudo-ginseng【Process】Medicine materical crude slice product under is Radix Notoginseng powder, that is, takes pseudo-ginseng, is cleaned, and is done
It is dry, fine powder is ground into, its usage is to swallow (directly oral).Fine powder is pressed《Chinese Pharmacopoeia》Standard for 95% pass through No. six sieve (150
μm ± 6.6 μm, i.e. 100 sieve meshes).
The preparation of " extract " and assay sample in Radix Notoginseng powder quality standard, is all often to use alcohol or organic molten
Agent, therefore, the result determined can only reflect the quality of itself, it is impossible to after illustrating index components or active ingredient by oral administration
In vivo can dissolution or discharge " amount " truth, make Radix Notoginseng powder as the optimal production technology of direct oral medicinal slice design with
Selection lacks scientific basis, and thus, the healthcare function and clinical efficacy of Radix Notoginseng powder are also greatly affected or cannot ensured.
The sterilizing of herb powder is always a great problem in herbal pharmaceutical industry.The physical sterilization method such as xeothermic, high steam,
There is significant deficiency in the chemical sterilizations such as oxirane, and the grade gamma sterilization method of cobalt -60, if any sterilizing methods
Sterilization effect is not good enough, and what is had produces destruction to the active ingredient contained by Chinese medicine, and what is had leaves residual, and what is had then has dirt
Dye, and so on.
Direct oral traditional Chinese medicine medicine materical crude slice is the new modern CMM processing piece of country has just defined in recent years a class, except《In
State's pharmacopeia》2015 editions four are shown outside limitation standard in microbe to direct oral medicinal slice, still straight without unification of the motherland so far
The interface prepared slice quality that takes traditional Chinese medicine performs standard, and Radix Notoginseng powder product is no exception.Further, since chemistry contained by per taste Chinese medicine into
Divide extremely complex, the place of production is different in addition, quality is different, its content quality requirement is often with its index components or active ingredient
Content reach more than a certain value (except toxic component), add active ingredient and mostly store in its cell, such various reasons,
Radix Notoginseng powder does not have " term of validity " of science yet so far as medicine.
The content of the invention
The purpose of the present invention is to overcome the deficiencies in the prior art there is provided a kind of direct oral traditional Chinese medicine medicine materical crude slice of Radix Notoginseng powder.
The direct oral traditional Chinese medicine medicine materical crude slice of Radix Notoginseng powder of the present invention, its preparation technology is as follows：
1) by pseudo-ginseng crude drug net system, washing, crushed after being dried, intermediate is obtained；
2) electron beam irradiation sterilization is carried out after examining intermediate, packaging；
3) finished product is obtained after carrying out standard test, packaging；
Described step 1) in, pulverization conditions are as follows：In D grades of clean areas, using dust-collecting type freeze grinding technology, by pseudo-ginseng
Crude drug is ground into 100-300 mesh；
Described step 2) in, the exposure dose of electron beam irradiation sterilization is 3-10kGy.
Preferably,
Described step 1) in, pulverization conditions are as follows：In D grades of clean areas, using dust-collecting type freeze grinding technology, by pseudo-ginseng
Crude drug is ground into 200-300 mesh.
Described step 2) in, the exposure dose of electron beam irradiation sterilization is 3kGy.
The present invention is, by modern Natural Medicine Analysis means and method, to simulate 37 DEG C of body temperature, to different fineness (sieve
Mesh number) Radix Notoginseng powder carry out water logging experiment (more can truly reflect Radix Notoginseng powder in vivo dissolution or release be available for absorbing into
The situation of dividing), in identical 10, in each period of 30,60,90 and 120 minutes, the Radix Notoginseng powder of different fineness is gone out with water logging respectively
Ginsenoside Rg in thing total amount and water extractionl(C12H72O14), ginsenoside Rbl(C54H92O23) and Panax Notoginseng saponin R1
(C47H80O18) dissolution total amount be index, it is determined that the optimal smashing fineness of " Radix Notoginseng powder ", and utilize quick, low temperature, height
Effect, pollution-free, noresidue and will not destroy active ingredient electron beam irradiation sterilization technology optimal GMP production technologies.Meanwhile,
The quality for establishing " Radix Notoginseng powder " the directly oral traditional Chinese medicine medicine materical crude slice for meeting the related drug standards of existing country performs standard.The present invention
Can make Radix Notoginseng powder product compared with《Chinese Pharmacopoeia》Fine powder standard (100 mesh) water extraction total amount and total saposins in water extraction
Dissolution total amount improves 20~30%, and (amount of leachable total genuine soap glycosides by body absorption of every 3 grams of " Radix Notoginseng powder " products first time reaches
More than 95 milligrams), Microbe restriction test result can then comply fully with the standard that associated straight connects oral medicinal slice, meanwhile, by new
Medicine accelerates to investigate experimental method, using the total saponin content in " Radix Notoginseng powder " as index, its product of preliminary examinations【The term of validity】.
Brief description of the drawings
Fig. 1 is that front and rear water immersion (37 ± 1 DEG C) the extract weight (milligram) of Radix Notoginseng powder (3 grams) different fineness sterilizing is compared；
Fig. 2 is water immersion (37 ± 1 DEG C) extract total saposins (R before and after the sterilizing of Radix Notoginseng powder (3 grams) different fineness1、Rb1、
Rg1) weight (milligram) compares；
Fig. 3 is Radix Notoginseng powder through HPLC characteristic spectrum (pillars before and after electron beam irradiation sterilization (3kGy, room temperature) PROCESS FOR TREATMENT：
Phenomenex,C18,3μm,4.6x 250mm)；
Fig. 4 is Radix Notoginseng powder through the storage different from undressed Radix Notoginseng powder product of electron beam irradiation sterilization (3kGy) PROCESS FOR TREATMENT
Hide (40 ± 2 DEG C) time HPLC characteristic spectrum (pillar：Phenomenex,C18,3μm,4.6x250mm)
Fig. 5 investigates for the accelerated stability of Radix Notoginseng powder；
Fig. 5 investigates for the accelerated stability of Radix Notoginseng powder.
Fig. 6 is the characteristic spectrum of Radix Notoginseng powder.
Table 1 is water logging (37 ± 1 DEG C) extract weight (milligram) before Radix Notoginseng powder (100 mesh, 3 grams) sterilizing；
Table 2 is water logging (37 ± 1 DEG C) extract weight (milligram) before Radix Notoginseng powder (150 mesh, 3 grams) sterilizing；
Table 3 is water logging (37 ± 1 DEG C) extract weight (milligram) before Radix Notoginseng powder (200-300 mesh, 3 grams) sterilizing；
Table 4 is water logging (37 ± 1 DEG C) extract weight (milligram) after Radix Notoginseng powder (100 mesh, 3 grams) sterilizing；
Table 5 is water logging (37 ± 1 DEG C) extract weight (milligram) after Radix Notoginseng powder (150 mesh, 3 grams) sterilizing；
Table 6 is water logging (37 ± 1 DEG C) extract weight (milligram) after Radix Notoginseng powder (200-300 mesh, 3 grams) sterilizing；
Table 7 is water extraction (37 ± 1 DEG C) total saponin content (milligram) before Radix Notoginseng powder (100 mesh, 3 grams) sterilizing；
Table 8 is water extraction (37 ± 1 DEG C) total saponin content (milligram) before Radix Notoginseng powder (150 mesh, 3 grams) sterilizing；
Table 9 is water extraction (37 ± 1 DEG C) total saponin content (milligram) before Radix Notoginseng powder (200-300 mesh, 3 grams) sterilizing；
Table 10 is water extraction (37 ± 1 DEG C) total saponin content (milligram) after Radix Notoginseng powder (100 mesh, 3 grams) sterilizing；
Table 11 is water extraction (37 ± 1 DEG C) total saponin content (milligram) after Radix Notoginseng powder (150 mesh, 3 grams) sterilizing；
Table 12 is water extraction (37 ± 1 DEG C) total saponin content (milligram) after Radix Notoginseng powder (150 mesh, 3 grams) sterilizing；
Table 13 is sterilization effect of the electron beam irradiation dosage to the Radix Notoginseng powder of different fineness (sieve mesh)；
Table 14 checks for Radix Notoginseng powder microbial limit stability；
Table 15 is total saponin content (%) after Radix Notoginseng powder sterilizing；
Table 16 is total saponin content (%) before Radix Notoginseng powder sterilizing.
Embodiment
In the present invention, Radix Notoginseng powder Sanqifen is described as follows：
【Source】This product for panax araliaceae plant Panax notoginseng (Burk.) F.H.Chen dry root and
Rhizome.
【Process】This product is pressed《Chinese Pharmacopoeia》Version pseudo-ginseng in 2015【Process】Item descends specification through net system, drying (liftoff), touched
The inner wrapping Radix Notoginseng powder (direct oral traditional Chinese medicine medicine materical crude slice) that the technique such as broken, crushing, dry, packaging, sterilizing is made.
【Finished product character】This product is lark powder.Gas is micro-, bitter Hui Tian.
【Content uniformity】± 7%.
【Differentiate】
(1) this product powder lark.Amylum body is a lot of, simple grain circle, semicircle or circle polygonal, 4~30 μm of diameter；It is multiple
Grain is made up of more than 2~10 gradation.Resin canal fragment secretion containing yellow.Scalariform duct, reticulate vessel and spiral duct diameter 15-
55μm.Calcium oxalate cluster crystal is rare, 50~80 μm of diameter.
(2) this product powder 0.5g is taken, add water 5 drops, stirs evenly, then is subject to water saturated n-butanol 5ml, close plug shakes 10 points
Clock, is placed 2 hours, and centrifugation takes supernatant, plus 3 times of amounts are shaken up with the water of n-butanol saturation, placement make layering (if necessary from
The heart), n-butanol layer is taken, is evaporated, residue adds methanol 1ml to make dissolving, is used as need testing solution.Separately take ginsenoside Rb1Reference substance,
Ginsenoside Re's reference substance, ginsenoside Rg1Reference substance and Panax Notoginseng saponin R1Reference substance, plus methanol are made every 1ml and respectively contain 0.5mg
Mixed solution, be used as reference substance solution.According to thin-layered chromatography (《Chinese Pharmacopoeia》Four general rules 0502 of version in 2015) experiment, inhale
Each 1 μ l of above two solution are taken, are put respectively on same silica gel g thin-layer plate, with chloroform-acetate-methanol-water (15:
40:22:L0) l0 DEG C of lower floor's solution arranged below is solvent, is deployed, and takes out, dries, and is sprayed with sulfuric acid solution (1 → 10),
L05 DEG C to be heated to spot development clear.In test sample chromatogram, on position corresponding with reference substance chromatogram, show same color
Spot；Put and inspected under ultraviolet lamp (365nm), show identical fluorescence spot.
【Check】
Moisture must not cross 14.0% (《Chinese Pharmacopoeia》The method of four general rules of version in 2015 0832 second).
Total ash must not cross 6.0% (《Chinese Pharmacopoeia》Four general rules 2302 of version in 2015).
Acid-insoluble ash must not cross 3.0% (《Chinese Pharmacopoeia》Four general rules 2302 of version in 2015).
Sulfur dioxide residual quantity according to sulfur dioxide residual quantity determination method (《Chinese Pharmacopoeia》Four general rules 2331 of version in 2015)
Determine, 150mg/kg must not be crossed.
【Extract】According to ethanol soluble extractives determination method (《Chinese Pharmacopoeia》Four general rules 2201 of version in 2015) heat under item
Leaching method is determined, and with methanol as solvent, must not be less than 16.0%.
【Assay】According to high performance liquid chromatography (《Chinese Pharmacopoeia》Four general rules 0512 of version in 2015) determine.
Chromatographic condition is with system suitability using octadecylsilane chemically bonded silica as filler；Using acetonitrile as flowing
Phase A, using water as Mobile phase B, the regulation according to the form below carries out gradient elution；Detection wavelength is 203nm.Number of theoretical plate presses pseudo-ginseng soap
Glycosides R1Peak, which is calculated, should be not less than 4000.
| Time (minute) | Mobile phase A (%) | Mobile phase B (%) |
| 0~12 | 19 | 81 |
| 12~60 | 19→36 | 81→64 |
The preparation precision of reference substance solution weighs ginsenoside Rg1Reference substance, ginsenoside Rb1Reference substance and notoginsenoside
R1Every lml is made containing ginsenoside Rg in appropriate reference substance, plus methanol10.4mg, ginsenoside Rbl0.4mg, notoginsenoside
R10.lmg mixed solution, is produced.
The preparation of need testing solution takes this product powder (crossing No. four sieves) 0.6g, and accurately weighed, precision adds methanol 50ml,
Weighed weight, is stood overnight, and puts and micro-boiling is kept in 80 DEG C of water-baths 2 hours, lets cool, then weighed weight, and less loss is supplied with methanol
Weight, shakes up, filtration, takes subsequent filtrate, produces.
Determination method is accurate respectively to draw reference substance solution and each 10 μ l of need testing solution, injects liquid chromatograph, determines,
Produce.
This product is calculated by dry product, containing ginsenoside Rgl(C12H72O14), ginsenoside Rbl(C54H92O23) and notoginsenoside
R1(C47H80O18) total amount must not be less than 5.0%
【Characteristic spectrum】Press【Assay】Method, determines the characteristic spectrum of high performance liquid chromatography (HPLC).Such as Fig. 6 institutes
Show.
【Limit test of microbe】The acceptable maximum bacterium number of aerobic bacteria sum is 103cfu/g；Yeast and mold sum
Acceptable maximum bacterium number is 102cfu/g；Detection of Salmonella (10g) must not be detected；Bile tolerance gram-negative bacteria should be less than 103cfu
(1g)。
【Nature and flavor and channel tropism】Sweet, slight bitter, temperature.Return liver, stomach.
【Function is with curing mainly】Dissipate stasis of blood hemostasis, detumescence ding-tong.For spitting blood, spit blood, bleeding from five sense organs or subcutaneous tissue is had blood in stool, uterine bleeding, traumatism and bleeding,
Chest and abdomen shouting pain, tumbling and swelling.
【Specification】3 grams every bag, or 1 gram every bag, or 2 grams every bag.
【Usage and consumption】3~9g；Powder is swallowed, a 1~3g.Suitable amount used externally.
【Storage】It is closed, put at shady and cool dry.
【Note】Pregnant woman uses with caution.
【Storage】Put at shady and cool dry, it is mothproof.
【The term of validity】5 years.
Basis of compilation：《Chinese Pharmacopoeia》The lower standard of version one pseudo-ginseng in 2015, and《Chinese Pharmacopoeia》Version four in 2015
Portion's relevant criterion；
Content uniformity foundation《Chinese Pharmacopoeia》The lower standard of four powders of general rule 0115 of version in 2015, this product specification is every bag
3 grams, loading amount is shown according to the lower sign of powder：1.5g should be ± 7% with up to 6g, content uniformity limit.
Limit test of microbe foundation《Chinese Pharmacopoeia》The non-sterile medicine microbial limit of four general rules 1107 of version in 2015
Standard, aerobic bacteria sum, the yeast and mold sum of non-sterile medicine shine " non-sterile product limit test of microbe：Micro- life
Thing counting method (general rule 1105) " examines Check；The control bacterium of non-sterile medicine is according to " non-sterile product microbial limit examines Check：Control bacterium
Inspection technique (general rule 1106) " is checked.
Embodiment 1
100 kilograms of pseudo-ginseng crude drug, point 3 experimentai batches (per 33.3 kilograms of batch), by drug's GMP specification, is passed through respectively
Net system, washing, drying, crushing (D grades of clean areas, using dust-collecting type freeze grinding technology, be respectively crushed into 100,150,200-
300 mesh), intermediate (inspection), quantitative package (3 grams/bag, D grades of clean areas), electron beam irradiation sterilization it is (remaining quantitative per batch
The 30% of packaging is without sterilization process), resulting product (test sample) is for the optimal GMP production technologies of Radix Notoginseng powder of the invention
And its quality standard experimental study is used.
The optimal production technology of 1 ﹑ " Radix Notoginseng powder " directly oral traditional Chinese medicine medicine materical crude slice products：
(1) optimum fineness (grit number) production technology：
Rhizomes of Panax notoginseng cell size, through more than ten to tens microns, is in be straight《Chinese Pharmacopoeia》Corresponding 200 sieve mesh standard with
It is interior.《Chinese Pharmacopoeia》2015 editions pseudo-ginseng【Process】The fineness standard of medicine materical crude slice product Radix Notoginseng powder under is fine powder, i.e., 100
Mesh, is directly passed through much larger than Radix Notoginseng cell, thus, and intracellular active ingredient is difficult dissolution or release, the active ingredient of pseudo-ginseng is existed
It can not be absorbed or be absorbed completely in vivo not exclusively, the result is that the healthcare function and clinical efficacy of pseudo-ginseng are have impact on, and it is unrestrained
The resource of pseudo-ginseng crude drug is taken.
The product of the present invention is that, based on 37 DEG C of body temperature of simulation, the Radix Notoginseng powder to different fineness (mesh number) carries out water logging reality
Test, so more can truly reflect that dissolution or release are available for the composition situation absorbed to Radix Notoginseng powder in vivo.Identical 10,
In each period of the 30th, 60,90 and 120 minutes (water temperature is kept for 37 ± 1 DEG C), difference is ground into through dust-collecting type freeze grinding technology
The Radix Notoginseng powder of fineness is respectively with ginsenoside Rg in water extraction total amount and water extractionl(C12H72O14), ginsenoside Rbl
(C54H92O23) and Panax Notoginseng saponin R1(C47H80O18) dissolution total amount be index, it is determined that " Radix Notoginseng powder " optimal smashing fineness (sieve
Mesh number) it is 200-300 mesh.
By above-mentioned experimental study (being shown in Table 1-3, table 7-9, Fig. 1-2), its result is shown：Using the present invention research into
Really, in 37 ± 1 DEG C of water, ginsenoside Rg in the water extraction total amount (milligram) and water extraction of Radix Notoginseng powderl(C12H72O14)、
Ginsenoside Rbl(C54H92O23) and Panax Notoginseng saponin R1(C47H80O18) dissolution total amount (milligram) with Radix Notoginseng powder fineness increase
(100 mesh, 150,200-300 mesh) and increase, the water extraction total amount (milligram) of 200-300 mesh fineness and notoginsenoside dissolution are total
Measure (milligram) and improve 20~35% compared with 100 mesh, show in 200-300 mesh, the cell of Radix Notoginseng powder has largely been crushed, content
Easily it is leached.
(2) electron beam irradiation sterilization technique
Electron beam irradiation sterilization technology is highly developed, and the high electron beam irradiation produced with electron accelerator can make
Material produces physics, chemistry and biology effect, and can effectively kill germ, virus and insect.This technology is extensive
Applied to the material modification in industrial production, new material making, environmental protection, processing, medical and hygiene article sterilization
It is fresh-keeping etc. with food sterilizing.It is the same with cobalt source irradiation, is operated with normal temperature, not damaged, without residual hazard, environmental protection, low energy consumption, operation
Easy, automaticity is high, the features such as be suitable for large-scale industrial production.Compared with cobalt source, its great advantage is irradiation beams
Oriented in adfluxion, fully, irradiation efficiency is high, does not produce radwaste for using energy source.Irradiation device for electronic accelerator has bright
Aobvious price and economic advantages.To instruct the correct application with specification irradiation technique in Chinese medicine sterilizing, it is ensured that Chinese medicine medicine
Safely, effectively, steady quality, state food pharmaceuticals administration general bureau formulates in November, 2015《Chinese medicine irradiation sterilization skill
Art guideline》, Chinese medicine irradiation sterilization should be carried out Chinese medicine individual and the targetedly comparative study after predose, including institute
Comparative study of the situation of change of species containing composition or content, fingerprint or characteristic spectrum etc..Based on above-mentioned guideline, this hair
Fingerprint or characteristic spectrum, water logging go out before and after bright exposure dose to Radix Notoginseng powder electron beam irradiation sterilization, sterilization effect, and sterilizing
Thing weight, the change of content of the total saponins in radix notoginseng have carried out detailed investigate.
1. the exposure dose and sterilization effect of electron beam irradiation sterilization:
Respectively using 3,5,10kGy exposure dose to the Radix Notoginseng powders of different meshes (100,150,200-300 mesh) (3 grams/
Bag) it is irradiated, and carry out sterilization effect investigation (being shown in Table 13) after pre-irradiation.
As a result show, be entirely capable of reaching using the present invention 3,5,10kGy electron beam irradiation dosage《Chinese Pharmacopoeia》2015
Four limitation standard in microbe to direct oral medicinal slice of version.To reduce irradiation to Radix Notoginseng powder ingredient species and changes of contents
The influence being likely to result in, present invention determine that the optimal exposure dose of the electron beam irradiation sterilization of Radix Notoginseng powder is 3kGy.
2. influence of the electron beam irradiation sterilization to Radix Notoginseng powder water extraction amount and total saposins stripping quantity：
High-energy electron beam irradiation can make some biological cell bodies produce physics, chemistry and biology effect, can especially make
Cell membrane produces trace or broken, promotes dissolution of cellular content.
Press《Chinese Pharmacopoeia》Version one pseudo-ginseng descend content assaying method within 2015, respectively measure 100,150,200-300
Ginsenoside Rg in water extraction total amount (milligram) and water extraction before and after purpose Radix Notoginseng powder (3 grams) electron beam irradiation sterilizationl
(C12H72O14), ginsenoside Rbl(C54H92O23) and Panax Notoginseng saponin R1(C47H80O18) dissolution total amount (milligram), the present invention investigate
Influence (be shown in Table 1-12, Fig. 1-2) of the electron beam irradiation sterilization to Radix Notoginseng powder water extraction amount and total saposins stripping quantity.As a result show
Show, using electron beam irradiation (3kGy exposure doses) sterilization process of the present invention, be remarkably improved the three of corresponding different fineness
The water extraction amount and total saposins stripping quantity (P ﹤ 0.05 or 0.01) of seven powder are (except 200-300 mesh, because in this fineness, big portion
Radix Notoginseng cell is divided all to crush).
3. influence of the electron beam irradiation sterilization to the Radix Notoginseng powder term of validity：
To investigate electron beam irradiation sterilization to the change of Radix Notoginseng powder ingredient species or content, the long-time stability of quality
Deng influence of the term of validity with product about factor, the research method of the accelerated stability of present invention application new drug, at 40 ± 2 DEG C
Deposited 9 months in the environment of temperature and 65% relative humidity, every month presses the content assaying method in quality standard, determine pseudo-ginseng
In total saponin content, meanwhile, different months are selected, according to direct oral medicinal slice microbial limit tests to the micro- life of Radix Notoginseng powder
Thing limit is tested, and measurement result illustrates (being shown in Table 14-16, Fig. 3-5), and electron beam irradiation sterilization technique is to " Radix Notoginseng powder " product
Long-time stability do not influence, using " Radix Notoginseng powder " directly oral medicinal slice product of the production of GMP production technologies of the present invention
The term of validity was up to 10 years.
2 ﹑ " Radix Notoginseng powder " directly oral traditional Chinese medicine prepared slice quality standards：
It is higher than it is contemplated that setting up《Chinese Pharmacopoeia》Under 2015 editions pseudo-ginseng,《Chinese Pharmacopoeia》2015 editions four phases
" Radix Notoginseng powder " for closing direct oral traditional Chinese medicine medicine materical crude slice standard, new efficient liquid phase (HPLC) characteristic pattern for inserting Radix Notoginseng powder and the term of validity is straight
The interface prepared slice quality that takes traditional Chinese medicine performs standard, to ensure " Radix Notoginseng powder " directly oral traditional Chinese medicine prepared slice quality.
《Chinese Pharmacopoeia》It is common medicine materical crude slice standard that quality under 2015 editions pseudo-ginseng, which performs standard, according under this
Standard,《Chinese Pharmacopoeia》2015 editions four direct oral medicinal slice limit test of microbe standards and relevant criterion, have formulated complete
The quality for meeting " Radix Notoginseng powder " directly oral traditional Chinese medicine medicine materical crude slice of the relevant direct oral medicinal slice drug standards of existing country entirely performs mark
It is accurate.
By the lower requirement of " Radix Notoginseng powder " directly oral traditional Chinese medicine prepared slice quality standard items, three batches of quantity-produced are examined
" Radix Notoginseng powder " product, regulation all should be met.
Water logging (37 ± 1 DEG C) extract weight (milligram) before table 1, Radix Notoginseng powder (100 mesh, 3 grams) sterilizing
(37 ± 1 DEG C) extract weight (milligram) before table 2, Radix Notoginseng powder (150 mesh, 3 grams) water logging sterilizing
Water logging (37 ± DEG C) extract weight (milligram) before table 3, Radix Notoginseng powder (200~300 mesh, 3 grams) sterilizing
Water logging (37 ± 1 DEG C) extract weight (milligram) after table 4, Radix Notoginseng powder (100 mesh, 3 grams) sterilizing
After table 5, Radix Notoginseng powder (150 mesh, 3 grams) water logging sterilizing (37 ± DEG C) extract weight (milligram)
Water logging (37 ± 1 DEG C) extract weight (milligram) after table 6, Radix Notoginseng powder (200~300 mesh, 3 grams) sterilizing
Water extraction (37 ± 1 DEG C) total saponin content (milligram) before table 7, Radix Notoginseng powder (100 mesh, 3 grams) sterilizing
Water extraction (37 ± 1 DEG C) total saponin content (milligram) before table 8, Radix Notoginseng powder (150 mesh, 3 grams) sterilizing
Water extraction (37 ± 1 DEG C) total saponin content (milligram) before table 9, Radix Notoginseng powder (200~300 mesh, 3 grams) sterilizing
Water extraction (37 ± 1 DEG C) total saponin content (milligram) after table 10, Radix Notoginseng powder (100 mesh, 3 grams) sterilizing
Water extraction (37 ± 1 DEG C) total saponin content (milligram) after table 11, Radix Notoginseng powder (150 mesh, 3 grams) water logging sterilizing
Water extraction (37 ± 1 DEG C) total saponin content (milligram) after table 12, Radix Notoginseng powder (200~300 mesh, 3 grams) sterilizing
Claims (3)
1. the direct oral traditional Chinese medicine medicine materical crude slice of Radix Notoginseng powder, it is characterised in that its preparation technology is as follows：
1）By pseudo-ginseng crude drug net system, washing, crushed after being dried, intermediate is obtained；
2）Electron beam irradiation sterilization is carried out after examining intermediate, packaging；
3）Finished product is obtained after carrying out standard test, packaging；
Described step 1）In, pulverization conditions are as follows：In D grades of clean areas, using dust-collecting type freeze grinding technology, by pseudo-ginseng active compound
Material is ground into 100-300 mesh；
Described step 2）In, the exposure dose of electron beam irradiation sterilization is 3-10 kGy.
2. the direct oral traditional Chinese medicine medicine materical crude slice of Radix Notoginseng powder according to claim 1, it is characterised in that described step 1）In, powder
Fringe part is as follows：In D grades of clean areas, using dust-collecting type freeze grinding technology, pseudo-ginseng crude drug is ground into 200-300 mesh.
3. the direct oral traditional Chinese medicine medicine materical crude slice of Radix Notoginseng powder according to claim 1, it is characterised in that described step 2）In, electricity
The exposure dose of beamlet irradiation sterilization is 3 kGy.
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| CN112190725A (en) * | 2020-11-20 | 2021-01-08 | 湖南湘华华大生物科技有限公司 | Radiation sterilization method for traditional Chinese medicine powder |
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