CN108096341A - Semen Ziziphi Spinosae (parched) powder Chinese medicine is taken after being infused in hot water or decoction medicine materical crude slice - Google Patents
Semen Ziziphi Spinosae (parched) powder Chinese medicine is taken after being infused in hot water or decoction medicine materical crude slice Download PDFInfo
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- A—HUMAN NECESSITIES
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- 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)
- A61K36/72—Rhamnaceae (Buckthorn family), e.g. buckthorn, chewstick or umbrella-tree
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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Abstract
It is taken after being infused in hot water or decoction medicine materical crude slice the present invention provides a kind of Semen Ziziphi Spinosae (parched) powder Chinese medicine, preparation process is as follows：1）Semen Ziziphi Spinosae (parched) is removed into impurity, after net system, dry, pulverize, obtain intermediate；2）Intermediate is examined, electron beam irradiation sterilization is carried out after packaging；3）Standard test is carried out, finished product is obtained after packaging；The step 1）In, pulverization conditions are as follows：In D grades of clean areas, using dust-collecting type freeze grinding technology, Semen Ziziphi Spinosae (parched) is ground into 60 120 mesh after net system；The step 2）In, the exposure dose of electron beam irradiation sterilization is 3 10 kGy.The present invention be by modern Natural Medicine Analysis means and pharmaceutical technology (tcd), traditional Chinese medicine medicine materical crude slice Semen Ziziphi Spinosae (parched) is made meet the related drug act of existing country,《Chinese Pharmacopoeia》Version in 2015 one and four ministerial standards, without decocting, the Semen Ziziphi Spinosae (parched) taken can be brewed with boiling water（Powder）Chinese medicine is taken after being infused in hot water or decoction medicine materical crude slice.
Description
Technical field
It is taken after being infused in hot water or decoction medicine materical crude slice the present invention relates to a kind of Semen Ziziphi Spinosae (parched) powder Chinese medicine, belongs to pharmaceutical technology field.
Background technology
Semen Ziziphi Spinosae (parched) is Rhamnaceae plant acid rate Ziziphus jujuba Mill.var.spinosa (Bunge) Huex
The dry mature seed of H.F.Chou, which shines, fries the prepared slices of Chinese crude drugs made of concocting method.Nature and flavor：Sweet and neutral；The thoughts of returning home, spleen, Liver Channel, courage
Through；With antitoxic heart-soothing and sedative；Nourishing the liver；Arrest sweating function；Restlessness of asrhenia type and insomnia is cured mainly, palpitation, physically weak spontaneous perspiration, night sweat etc. of palpitating with fear, it is also《In
State's pharmacopeia》The natural hypnotic important simply that version in 2015 is recorded.
Spina date seed contains alkaloid：Spina date seed alkali (sanjoinine) A, B, D, E, F, G1, G2, Ia, Ib, K, wherein alkali A is just
It is frangufoline (frangu-foline), alkali E is exactly Nuciferine (nuciferine), and alkali Ia is exactly miltanthin (nornu-
Ciferine), alkali Ib is exactly norisocorydine (norisocorydine), and alkali K is exactly the coclaurine of dextrorotation
(coclaurine), N- methyl asimilobine (N-methylasimilo-bine), sour Lee's alkali (zizyphusine), 5- hydroxyls -6-
Methoxyl group removes first aporphine (caaver-ine, 5-hydroxy-6-methoxynoraporphine), amphibin D
(amphibine)D.Also cyclic peptide containing spina date seed (sanjoinenine).Also contain triterpenes：Betulic acid (betulinic
Acid), betulin (betulin), ceanothic acid (ceanothic acid), wheat pearl (alphitolic acid), wild jujube
Saponin (jujuboside) A, B and Daucosterol (daucosterol).Contain flavonoids again：Spinosin (spinosin),
It is 2 "-O- β-D- glucopyranosyls swertisins (2 "-O- β-D-glucopyrano-sylswertisin), wild jujube flavine
(zivulgarin), 6 " ＇-mustard seed acyl spinosin (6 " ＇-sinapoylspinosin), 6 " ＇-asafoetide acyl spinosin
(6 " ＇-feruloylspinosin), 6 " ＇-to coumaric acyl spinosin (6 " ＇-p-coumaroylspinosin), swertisin
(swer-tisin), 6,8-, bis--C- glucosyl groups apiolins (vicenin II), apiolin -6-C- [(6-O- para hydroxybenzene first
Acyl)-β-D- glucopyranosyls (1 → 2)]-β-D- glucopyanosides [apigenin-6-C- [(6-O-p-
Hydroxybenzoyl)-β-D-glucopyranosyl (1 → 2)]-β-D-glucopyranoside] etc..Also contain threonine
(threonine), valine (valine), methionine (methionine), leucine (leucine), isoleucine
(isoleucine), 17 kinds of amino acid such as lysine (lysine), phenylalanine (phenylalanine) and potassium, sodium, calcium,
The Determination of multiple metal elements such as zinc, iron, copper, manganese.(ferulic acid) containing forulic acid again, vitamin C and phytosterol, cycli phosphate
Adenosine (cyclic adenosine 3 ＇, 5 ＇-monophosphate) etc..Spina date seed has sedative-hypnotic effect：Pentetrazole
Caused convulsions has antagonism, the mice convulsion effect caused by anti-strychnine；Antiarrhythmic effect；It resists myocardial ischemia and resists
Anoxia functions；Microvascular diameter expands extremely notable, hypotensive activity；Mitigate the local oedema effect of burn；Immune-enhancing effect is made
With etc..
《Chinese Pharmacopoeia》Under 2015 editions Semen Ziziphi Spinosae (parched) items【It processes】Method is takes net spina date seed, according to the method for frying (general rule
0213) fry to heaving, color is slightly variable depth.Used time smashs to pieces (crushing).The present invention pertains only to Semen Ziziphi Spinosae (parched) powder.Due to its traditional medicine materical crude slice
Instructions of taking is that decocting is taken, and traditional instructions of taking is made troubles to patient；Chinese medicine spina date seed often in its growth and stored
Cheng Zhongyi is by mould contamination, so as to bring risk to its drug safety.
The appearance of " be taken after being infused in hot water or decoction medicine materical crude slice " title be《Chinese Pharmacopoeia》2015 editions four are shown microbial limit to the medicine materical crude slice that is taken after being infused in hot water or decoction
In standard, standard is performed without the quality of such medicine materical crude slice of unification of the motherland so far, Semen Ziziphi Spinosae (parched) powder product is no exception.In addition,
Since the chemical composition contained by every taste Chinese medicine is extremely complex, the place of production is different in addition, and quality is different, and content quality requirement is past
Toward being to reach more than a certain value (except toxic component) with the content of its index components or active ingredient, in addition active ingredient is mostly
It stores in its cell, active ingredient is not easy to dissolve out, and does not have more comprehensive science data to include its stability to its quality so far
(term of validity) is comprehensively assessed.
The content of the invention
The purpose of the present invention is overcome the deficiencies of the prior art and provide a kind of Semen Ziziphi Spinosae (parched) powder Chinese medicine to be taken after being infused in hot water or decoction medicine materical crude slice.
The common medicine materical crude slice of the Semen Ziziphi Spinosae (parched) for needing decoction is made meet medicine materical crude slice drug specification without decoct, can brewed in hot water
The Semen Ziziphi Spinosae (parched) powder Chinese medicine taken is taken after being infused in hot water or decoction medicine materical crude slice product.Applicants have unexpectedly found that Semen Ziziphi Spinosae (parched) is ground into 60-120 mesh, utilize
Exposure dose is the electron beam irradiation sterilization of 3-10kGy, can make (80-90 DEG C) immersion extract total amount of Semen Ziziphi Spinosae (parched) powder hot water
And Saponin A and spinosin amount dissolution rate compared with traditional Chinese medicine medicine materical crude slice Semen Ziziphi Spinosae (parched) decocting be respectively increased 20% and 25% with
On, achieve the effect that improve clinical efficacy so as to improve the absorptivity of its active ingredient.Meanwhile product Microbe restriction test
As a result correlation can be complied fully with to be taken after being infused in hot water or decoction medicine materical crude slice standard, and stability study shows the term of validity of its product up to 5 years or more.
The Semen Ziziphi Spinosae (parched) powder Chinese medicine of the present invention is taken after being infused in hot water or decoction medicine materical crude slice, and preparation process is as follows：
1) Semen Ziziphi Spinosae (parched) is removed into impurity, after net system, dry, pulverize, obtain intermediate；
2) intermediate is examined, electron beam irradiation sterilization is carried out after packaging；
3) standard test is carried out, finished product is obtained after packaging；
In the step 1), pulverization conditions are as follows：In D grades of clean areas, using dust-collecting type freeze grinding technology, through net system
Semen Ziziphi Spinosae (parched) is ground into 60-120 mesh afterwards；
In the step 2), the exposure dose of electron beam irradiation sterilization is 3-10kGy.
Preferably,
In the step 1), Semen Ziziphi Spinosae (parched) is ground into 100 mesh after net system.
In the step 2), the exposure dose of electron beam irradiation sterilization is 5kGy.
In use, fine powder finished product can be fitted into packing box in appended air filter bag, be brewed and taken with boiling water.
The present invention is by modern Natural Medicine Analysis means and pharmaceutical technology (tcd), by traditional Chinese medicine medicine materical crude slice Semen Ziziphi Spinosae (parched)
Be made meet the related drug act of existing country,《Chinese Pharmacopoeia》Version in 2015 one and four ministerial standards, without decocting, boiling can be used
Water brews " Semen Ziziphi Spinosae (parched) (the powder) " Chinese medicine taken and is taken after being infused in hot water or decoction medicine materical crude slice." Semen Ziziphi Spinosae (parched) (powder) " Chinese medicine of the present invention is taken after being infused in hot water or decoction medicine materical crude slice GMP
Production technology and its prepared slice quality that is taken after being infused in hot water or decoction perform standard, and (80-90 DEG C) of the hot water of " Semen Ziziphi Spinosae (parched) (powder) " product can be made to impregnate leaching
Go out object total amount and Saponin A and spinosin amount dissolution rate and be respectively increased 20% compared with traditional Chinese medicine medicine materical crude slice Semen Ziziphi Spinosae (parched) decocting
And more than 25%, product Microbe restriction test result can then comply fully with correlation and be taken after being infused in hot water or decoction medicine materical crude slice standard, and stability study
Show the term of validity of its product up to 5 years or more, be suitble to manufacturing enterprise's production with related drug's GMP qualification.
Description of the drawings
Fig. 1 impregnates (80-90 DEG C) extract weight (milligram) for spina date seed (powder) (10 grams, 100 mesh) decocting with boiling water to be compared
Compared with
Fig. 2 is decocted and brewed in hot water water extraction spinosin comparision contents for spina date seed (powder) (100 mesh, 10 grams) water
(milligram)；
Fig. 3 investigates (40 ± 2 DEG C) for Semen Ziziphi Spinosae (parched) powder (10 grams/bag) product sterilizing fore-and-aft stability.
Table 1 is decoction extract weight (milligram) before spina date seed (powder) (100 mesh, 10 grams) sterilizing；
Table 2 is decoction extract weight (milligram) after spina date seed (powder) (100 mesh, 10 grams) sterilizing；
Table 3 steeps extract weight (milligram) for boiling water before spina date seed (powder) (100 mesh, 10 grams) sterilizing；
Table 4 steeps extract weight (milligram) for boiling water after spina date seed (powder) (100 mesh, 10 grams) sterilizing
Table 5 compares the sterilization effect of Semen Ziziphi Spinosae (parched) powder for electron beam exposure dose.
Specific embodiment
In the present invention, Semen Ziziphi Spinosae (parched) (powder) ChaoSuanZaoRen (Fen) is described as follows：
【Source】For rhamnaceae plant wild jujube Ziziphus jujuba Mill.var.spinosa (Bunge) Huex
The dry mature seed photograph of H.F.Chou fries concocting method and is made
【It processes】This product presses spina date seed【It processes】It under, is fried according to the method for frying (general rule 0213) to heaving, color is slightly variable depth, does
It is dry, it crushes, packs, sterilizing, manufactured inner wrapping Semen Ziziphi Spinosae (parched) (powder).
【Finished product character】This product is powder dark brown red.Slightly burnt odor gas, it is lightly seasoned.
【Content uniformity】± 5% [reference《Chinese Pharmacopoeia》Four general rules 0115 of version in 2015].
【Differentiate】(1) this product powder dark brown red.Polygonal, about 15 μ of diameter are seen in kind skin palisade cells brownish red, surface
M, wall thickness, woodization, cell are small；Elongated, outer wall thickening is seen in side, on side wall, middle part it is very thick, lower part is gradually thin；Antapical view class
Polygonal or circle polygonal.The intracutaneous epidermal cell brown color of kind, rectangle is seen on surface or class is square, and anticline beaded thickens,
Woodization.Cotyledon epidermal cell contains tiny calcium oxalate cluster crystal and prismatic crystal.
(2) take this product powder lg, add methanol 30ml, be heated to reflux 1 it is small when, filtration, filtrate is evaporated, and residue adds methanol
0.5ml makes dissolving, as test solution.Saponin A reference substance, Spine Date Seed jujubosideB reference substance separately are taken, methanol is added to be made
Per the mixed solution of each g of m containing l of lml, as reference substance solution.It tests, draws above-mentioned according to thin-layered chromatography (general rule 0502)
Each 5 μ 1 of two kinds of solution puts respectively on same silica gel g thin-layer plate, using water saturated n-butanol as solvent, is unfolded, takes out, dry in the air
It is dry, it sprays with 1% vanillin-sulfuric acid solution, inspects immediately.In test sample chromatography, on position corresponding with reference substance chromatography, show
The spot of same color.
(3) this product powder lg is taken, adds petroleum ether (6090 DEG C) 30ml, be heated to reflux 2 it is small when, filtration, discard petroleum ether
Liquid, the dregs of a decoction volatilize, and add methanol 30ml, be heated to reflux 1 it is small when, filtration, filtrate is evaporated, and residue adds methanol 2ml to make dissolving, as confession
Test sample solution.Spina date seed control medicinal material lg separately is taken, is made in the same way of control medicinal material solution.Spinosin reference substance is taken again, adds methanol
Every solution of the l ml containing 0.5mg is made, as reference substance solution.It is tested according to thin-layered chromatography (general rule 0502), draws above-mentioned three
Kind each 2 μ l of solution put respectively on same silica gel g thin-layer plate, using water saturated n-butanol as solvent, are unfolded, take out, dry in the air
It is dry, it sprays with 1% vanillin-sulfuric acid solution, puts and inspected under ultraviolet lamp (365nm).In test sample chromatography, with comparison medicine wood color
In spectrum and the corresponding position of reference substance chromatography, identical blue-fluorescence spot is shown.
【It checks】Impurity must not cross 5% (general rule 2301).
Moisture must not cross 7.0% (0,832 second method of general rule).
Total ash must not cross 4.0% (general rule 2302).
Sulfur dioxide residual quantity according to sulfur dioxide residual quantity measuring method (《Chinese Pharmacopoeia》Four general rules of version in 2015
2331) measure, 150mg/kg must not be crossed.
The acceptable maximum bacterium number of limit test of microbe aerobic bacteria sum is 103cfu；Yeast and mold sum can
The maximum bacterium number of receiving is 102cfu；Detection of Salmonella (10g) must not be detected；Bile tolerance gram-negative bacteria should be less than 104cfu(1g)。
【Assay】Saponin A is measured according to high performance liquid chromatography (general rule 0512).Chromatographic condition is fitted with system
It is tested with property using octadecylsilane chemically bonded silica as filler；Using acetonitrile as mobile phase A, using water as Mobile phase B；According to the form below
Regulation carry out gradient elution；Evaporative light scattering detector detects.Number of theoretical plate should be not less than by the calculating of Saponin A peak
2000。
Time (minute) mobile phase A (%) Mobile phase B (%)
015 20—40 80—60
1528 40 60
2830 40—70 60—30
3032 70—100 30—0
The preparation of reference substance solution takes Saponin A reference substance appropriate, accurately weighed, adds methanol that every lml is made and contains
The solution of 0.l mg to get.
The preparation of test solution takes this product powder (crossing No. four sieves) about lg, accurately weighed, puts in apparatus,Soxhlet's, adds
Petroleum ether (6090 DEG C) in right amount, be heated to reflux 4 it is small when, discard petroleum ether liquid, the dregs of a decoction fling to solvent, are transferred in conical flask,
Add 70% ethyl alcohol 20ml of people, be heated to reflux 2 it is small when, filtration, filter residue wash with 70% ethyl alcohol 5ml, merging washing lotion and filtrate, time
Solvent is received to doing, residue adds methanol to dissolve, and is transferred in 5m l measuring bottles, and methanol is added to shake up to scale, filter, take subsequent filtrate, i.e.,
.
Measuring method is accurate respectively to draw reference substance solution 5y, 20Ml, and test solution lO μ l note people's liquid chromatograph, survey
It is fixed, with external standard two-point method logarithmic equation calculate to get.This product is calculated by dry product, must not be less than containing Saponin A
0.030%.
Spinosin is measured according to high performance liquid chromatography (general rule 0512).
Chromatographic condition and system suitability are using octadecylsilane chemically bonded silica as filler, using acetonitrile as stream
Dynamic phase A, using water as Mobile phase B, the regulation according to the form below carries out gradient elution；Detection wavelength is 335nm.Number of theoretical plate presses this skin
Promise element peak, which calculates, should be not less than 2000.
Time (minute) mobile phase A (%) Mobile phase B (%)
010 12—19 88—81
1016 19—20 81—80
1622 20—100 80—0
2230 100 0
The preparation of reference substance solution takes spinosin reference substance appropriate, accurately weighed, adds methanol that every lml is made containing 0.2m
The solution of g to get.The preparation of test solution takes the subsequent filtrate under Saponin A (assay) item, molten as test sample
Liquid.Measuring method is accurate respectively to draw reference substance solution and each 10 μ l of test solution, notes people's liquid chromatograph, measure to get.This
Product are calculated by dry product, and 0.080% must not be less than containing spinosin.Medicine materical crude slice
【Nature and flavor and channel tropism】It is sweet, sour, it puts down.Return liver, courage, the heart channel of Hang-Shaoyin.
【Function is with curing mainly】Nourishing heart tonifying liver, antitoxic heart-soothing and sedative, arrest sweating promote the production of body fluid.For restlessness of asrhenia type and insomnia, horrified to much dream is physically weak more
Sweat, injury thirst.
【Usage and dosage】1015g。
【Storage】It puts at shady and cool drying, it is mothproof.
【The term of validity】5 years.
Basis of compilation：《Chinese Pharmacopoeia》Standard under the one Semen Ziziphi Spinosae (parched) item of version in 2015；Content uniformity foundation《Middle traditional Chinese medicines
Allusion quotation》Standard under four general rules of version in 2015,0115 powder item, limit test of microbe foundation《Chinese Pharmacopoeia》Version four in 2015
1107 non-sterile drug limitation standard in microbe of general rule, aerobic bacteria sum, the yeast and mold of non-sterile drug are total according to " non-
Sterile product limit test of microbe：Microorganism count method (general rule 1105) " examines Check；The control bacterium of non-sterile drug shines " non-nothing
Bacterium product microbial limit examines Check：Control bacteria examination method (general rule 1106) " checks.
Embodiment 1
Semen Ziziphi Spinosae (parched) 120 kg, point 3 experimentai batches (40 kilograms of every batch of) are dry by drug's GMP specification, using suction
Dirt formula freeze grinding technology crushes (D grades of clean areas), packs, sterilizing, manufactured inner wrapping Semen Ziziphi Spinosae (parched) (powder).
Semen Ziziphi Spinosae (parched) is respectively crushed into 100 mesh, intermediate (inspection), quantitative package (10 grams/bag, D grades of clean areas), electronics
Beam irradiation sterilization (every batch of is left the 5% of quantitative package without sterilization process), obtained product (test sample) supplies this hair
Bright Semen Ziziphi Spinosae (parched) powder GMP production technologies and its quality standard experimental study.
(1) decocting (100 DEG C) and hot water (80-90 DEG C) water logging comparative experiments：
The present invention product be based on to Semen Ziziphi Spinosae (parched) powder (100 mesh) carry out decocting (100 DEG C) with hot water (80-90
DEG C) water logging comparative experiments, using water extraction total weight and its spinosin it is water-soluble go out total amount as index, compare Semen Ziziphi Spinosae (parched) powder warp
Both its decocting and brewed in hot water index difference that may be present after electron beam irradiation sterilization.
Pass through above-mentioned experimental study (being shown in Table 1-4, Fig. 1-2), the results show of the invention：100 purpose " Semen Ziziphi Spinosae (parched)s
(80-90 DEG C) of the hot water of (powder) " product impregnates extract total amount and spinosin stripping quantity compared with traditional Chinese medicine medicine materical crude slice Semen Ziziphi Spinosae (parched)
Decocting is respectively increased more than 20%, i.e., Semen Ziziphi Spinosae (parched) (powder) as the medicine materical crude slice that is taken after being infused in hot water or decoction it is water-soluble go out object amount and index ingredient Si Pinuo
The decocting of the stripping quantity of element medicine materical crude slice more traditional than it greatly improves.
Therefore, present invention Semen Ziziphi Spinosae (parched) (powder) the convenient to take medicine materical crude slice that is taken after being infused in hot water or decoction is entirely capable of substituting traditional decocting Semen Ziziphi Spinosae (parched)
Powder medicine materical crude slice.
(2) exposure dose and sterilization effect of electron beam irradiation sterilization:
Electron beam irradiation sterilization technology is highly developed, and the high electron beam irradiation generated with electron accelerator can make
Substance generates physics, chemistry and biology effect, and can effectively kill germ, virus and pest.This technology is extensive
Applied to material modification, new material making, environmental protection, processing, the medical and hygiene article sterilization in industrial production
It is fresh-keeping etc. with food sterilizing.It is the same with cobalt source irradiation, have room temperature, it is not damaged, operated without residual hazard, environmental protection, low energy consumption, operation
Simplicity, high degree of automation are suitable for the features such as large-scale industrial production.Compared with cobalt source, great advantage is irradiation beams
It is oriented in adfluxion, using energy source is abundant, and irradiation efficiency is high, does not generate radwaste.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, ensure Chinese medicine drug
Safely, effectively, stable quality, state food pharmaceuticals administration general bureau formulate 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 ingredient or content, fingerprint or characteristic spectrum etc..Based on above-mentioned guideline, this hair
It is bright to the exposure dose of Semen Ziziphi Spinosae (parched) powder electron beam irradiation sterilization, sterilization effect and sterilizing before and after water extraction weight, index
The variation of ingredient stripping quantity has carried out detailed investigate.
The present invention respectively using 3,5, the exposure dose of 10kGy to the Semen Ziziphi Spinosae (parched) powder (10 grams/bag of packagings) of 100 mesh into
Row irradiation, and carry out sterilization effect investigation (being shown in Table 4) after pre-irradiation.The result shows that it is irradiated using the electron beam of 5kGy of the present invention
Dosage is entirely capable of reaching《Chinese Pharmacopoeia》2015 editions four limitation standard in microbe to the medicine materical crude slice that is taken after being infused in hot water or decoction.Present invention determine that spina date seed
The optimal exposure dose of the electron beam irradiation sterilization of powder is 5 kGy.
(3) research of stability (term of validity)：
The present invention carries out the term of validity to Semen Ziziphi Spinosae (parched) powder (100 mesh) product using new drug accelerated stability research method and grinds
Study carefully, result of study shows the term of validity of Semen Ziziphi Spinosae (parched) powder (100 mesh) product up to 5 years or more (see Fig. 3).
(4) Semen Ziziphi Spinosae (parched) (powder) " Chinese medicine is taken after being infused in hot water or decoction prepared slice quality standard：
It is higher than it is contemplated that establishing《Chinese Pharmacopoeia》Under 2015 editions Semen Ziziphi Spinosae (parched) items,《Chinese Pharmacopoeia》2015 editions
Four correlations medicine materical crude slice standard, new " spina date seed (powder) " Chinese medicine for inserting the term of validity etc. prepared slice quality that is taken after being infused in hot water or decoction that is taken after being infused in hot water or decoction performs standard, with
Ensure that " be taken after being infused in hot water or decoction spina date seed (powder ") prepared slice quality.
Claims (3)
- The medicine materical crude slice 1. Semen Ziziphi Spinosae (parched) powder Chinese medicine is taken after being infused in hot water or decoction, which is characterized in that its preparation process is as follows：1）Semen Ziziphi Spinosae (parched) is removed into impurity, after net system, dry, pulverize, obtain intermediate；2）Intermediate is examined, electron beam irradiation sterilization is carried out after packaging；3）Standard test is carried out, finished product is obtained after packaging；The step 1）In, pulverization conditions are as follows：It, will after net system using dust-collecting type freeze grinding technology in D grades of clean areas Semen Ziziphi Spinosae (parched) is ground into 60-120 mesh；The step 2）In, the exposure dose of electron beam irradiation sterilization is 3-10 kGy.
- The medicine materical crude slice 2. Semen Ziziphi Spinosae (parched) powder Chinese medicine according to claim 1 is taken after being infused in hot water or decoction, which is characterized in that the step 1）In, only Semen Ziziphi Spinosae (parched) is ground into 100 mesh after system.
- The medicine materical crude slice 3. Semen Ziziphi Spinosae (parched) powder Chinese medicine according to claim 1 is taken after being infused in hot water or decoction, which is characterized in that the step 2）In, electricity The exposure dose of beamlet irradiation sterilization is 5 kGy.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110857939A (en) * | 2018-08-23 | 2020-03-03 | 完美（中国）有限公司 | Detection method of traditional Chinese medicine composition with sleep improvement function |
| CN112057600A (en) * | 2020-10-26 | 2020-12-11 | 北京沃德中医药研究院 | Traditional Chinese medicine component for treating adenoid tonsil hypertrophy of children and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107158156A (en) * | 2016-12-16 | 2017-09-15 | 江苏苏轩堂药业有限公司 | Agalloch eaglewood powder Chinese medicine is taken after being infused in hot water or decoction medicine materical crude slice |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107158156A (en) * | 2016-12-16 | 2017-09-15 | 江苏苏轩堂药业有限公司 | Agalloch eaglewood powder Chinese medicine is taken after being infused in hot water or decoction medicine materical crude slice |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110857939A (en) * | 2018-08-23 | 2020-03-03 | 完美（中国）有限公司 | Detection method of traditional Chinese medicine composition with sleep improvement function |
| CN110857939B (en) * | 2018-08-23 | 2022-03-18 | 完美（中国）有限公司 | Detection method of traditional Chinese medicine composition with sleep improvement function |
| CN112057600A (en) * | 2020-10-26 | 2020-12-11 | 北京沃德中医药研究院 | Traditional Chinese medicine component for treating adenoid tonsil hypertrophy of children and preparation method thereof |
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Application publication date: 20180601 |