CN106580898A - Breviscapine dispersible tablet and preparing method thereof - Google Patents
Breviscapine dispersible tablet and preparing method thereof Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
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- A—HUMAN NECESSITIES
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- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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Abstract
The invention provides a breviscapine dispersible tablet. The dispersible tablet is prepared from, by weight, 30-50 parts of breviscapine, 20-60 parts of calcium hydrophosphate, 50-100 parts of microcrystalline cellulose, 4-12 parts of crosslinking sodium carboxymethylcellulose, 0.5-3 parts of sodium lauryl sulfate, 20-50 parts of 30-50% ethanol water, 5-12 parts of sodium bicarbonate, 0.5-5 parts of superfine silica powder and 0.3-5 parts of magnesium stearate. In addition, the invention further discloses a preparing method of the dispersible tablet. The dispersible tablet has the advantages of being more excellent in dissolvability and uniformity.
Description
Technical field
The invention belongs to Chinese medicine/natural medicine technical field, relates in particular to a kind of for treating cardiovascular and cerebrovascular disease
Erigeron breviscapus dispersion tablet and preparation method thereof.
Background technology
Cardiovascular disease be it is a kind of serious threaten the mankind, the particularly commonly encountered diseases of middle-aged and elderly people health, with high prevalence,
The characteristics of high disability rate and high mortality, even if using treatment meanss most advanced, perfect at present, it would still be possible to have more than 50%
The life of cerebrovas-cularaccident survivor can not take care of oneself completely, and the whole world dies from every year the number of cardiovascular and cerebrovascular disease and is up to 15,000,000
People, occupies the various causes of the death the first.
Chinese herbal medicine motion is gone all out with 20 century 70s, the whole nation, and Yunnan institute of materia medica expatriate personnel go deep into collection list among the people
Side, it is found that Herba Erigerontiss can be used to treat brain hemiparalysis.Herba Erigerontiss, are recorded in earliest《The southern regions of the Yunnan Province book on Chinese herbal medicine》One book.Yunnan institute of materia medica
Isolate flavone constituents-breviscapine on this basis, its mainly containing scutellarin (4 ', 5,6,7- kaempferols-
7-O- glucuronides), a small amount of breviscapine and other flavones ingredients, clinical trial proves that the extract of this plant is used for
The diseases such as treatment brain hemiparalysis, coronary heart disease, cerebral thrombosiss, cerebral hemorrhage, cerebral embolism, microcirculation disturbance have significant curative effect.
Breviscapine has extensive formulation application, including：
1. injection
Kunming pharmaceutical factory has applied for the Chinese patent CN93106319.1 of breviscapine injection for 1993.Injection is acted on
It is rapid reliable, do not affected by pH, enzyme, food etc., without first pass effect, whole body or local positioning effect can be played, it is adaptable to unsuitable
Oral drugs and patient that can not be oral, but injection development and production process are complicated, and safety and organism adaptation are poor, cost
It is higher.
2. tablet
Patent CN200410014387.2 discloses a kind of Breviscapine and preparation method thereof, including chewable tablet and mouth
Buccal tablet.Though its original intention is preferably to play the pharmacological action of breviscapine, Clinical practice scope is expanded, its emphasis is tablet
More convenient for transport, carry.
Patent CN03135878.0 discloses a kind of erigeron breviscapus dispersion tablet and preparation method thereof, solves injection, general
The shortcomings of carrying of logical tablet, transport and adaptability problem.Breviscapine is flavones ingredient, is practically insoluble in water, ordinary tablet
Agent affects fully absorbing for medicine because disintegrate is slow, and dispersible tablet is referred to can a kind of homodisperse piece of rapid disintegrate in water
Agent, is a kind of quick-effective preparation developed in recent years, and dispersible tablet has general tablet difficult on dissolution and dispersing uniformity
With and advantage.
Since two thousand, the research about erigeron breviscapus dispersion tablet is increasing, and erigeron breviscapus dispersion tablet has dispersion
State is good, and disintegration time is short, the advantages of drug-eluting is rapid.Chinese patent literature CN02153445 reports " breviscapine point
Discrete piece and preparation method thereof ", CN03135878 disclose " erigeron breviscapus dispersion tablet and preparation method thereof ", and the former is breviscapine
First prescription and preparation patent of dispersible tablet, the latter gives raising on drug content, the Lactose in adjuvant is carried out
Replace, expand the scope of application of patient.Erigeron breviscapus dispersion tablet technology is very ripe.
In addition to above-mentioned dosage form, the dosage forms such as effervescent tablet, dry suspension, drop pill are also disclosed in Patents.All
In Breviscapine, tablet and injection account for more than the 90% of kind sum.Various preparation techniques are no longer to hinder Herba Erigerontiss
The barrier of plain clinical practice, but drug quality how is improved for the development of preparation is also important direction.
The content of the invention
Present inventor is when erigeron breviscapus dispersion tablet is studied, it was surprisingly found that a kind of auxiliary material combination, makes
Can obtain longer dispersible tablet stable period.
It is an object of the invention to provide the erigeron breviscapus dispersion tablet that a kind of stable period is longer.
It is an object of the invention to provide the preparation method of above-mentioned erigeron breviscapus dispersion tablet.
In one embodiment of the present invention, the invention provides a kind of erigeron breviscapus dispersion tablet, the dispersible tablet be by
The component of following weight portion is formulated：
In a preferred embodiment of the invention, the invention provides a kind of erigeron breviscapus dispersion tablet, the dispersible tablet be by
The component of following weight portion is formulated：
In the more preferred of the present invention, the invention provides a kind of erigeron breviscapus dispersion tablet, the dispersible tablet is
It is formulated by the component of following weight portion：
In a preferred embodiment of the invention, a kind of erigeron breviscapus dispersion tablet that the present invention is provided, wherein, the crystallite
The preferred model of cellulose can be M101；The ethanol water is the ethanol water of 30 volumes %.
In particularly preferred embodiment of the invention, the invention provides a kind of erigeron breviscapus dispersion tablet, the dispersible tablet
It is to be formulated by the component of following weight portion：
In particularly preferred embodiment of the invention, the invention provides a kind of erigeron breviscapus dispersion tablet, the dispersible tablet
It is to be formulated by the component of following weight portion：
In particularly preferred embodiment of the invention, the invention provides a kind of erigeron breviscapus dispersion tablet, the dispersible tablet
It is to be formulated by the component of following weight portion：
On the other hand, the invention provides the preparation method of above-mentioned erigeron breviscapus dispersion tablet, comprises the steps：
(1) raw material and adjuvant are sieved for subsequent use respectively；
(2) breviscapine, calcium hydrogen phosphate, Microcrystalline Cellulose, Croscarmellose Sodium and lauryl sulphate acid are weighed
Sodium mix homogeneously；
(3) mixture that step (2) is obtained is made into soft material with 30 volume %～50 volume % ethanol waters, is pelletized,
It is dried, granulate, adds sodium bicarbonate, micropowder silica gel and magnesium stearate, mixes；
(4) tabletting, packaging is obtained final product.
In a preferred embodiment of the invention, the above-mentioned erigeron breviscapus dispersion tablet preparation method that the present invention is provided, wherein,
Described the sieving of step (1) referred to 100 mesh sieves.
In a preferred embodiment of the invention, the above-mentioned erigeron breviscapus dispersion tablet preparation method that the present invention is provided, wherein,
Step (3) granulation referred to that 20 mesh sieves were pelletized.
In a preferred embodiment of the invention, the above-mentioned erigeron breviscapus dispersion tablet preparation method that the present invention is provided, wherein,
Step (3) drying refers to 40-70 DEG C of drying 3～5 hours, moisture≤3.0%.
In a preferred embodiment of the invention, the above-mentioned erigeron breviscapus dispersion tablet preparation method that the present invention is provided, wherein,
Granulate referred to 20 mesh sieve granulate described in step (3).
In a preferred embodiment of the invention, the above-mentioned erigeron breviscapus dispersion tablet preparation method that the present invention is provided, wherein,
Control tablet weight variation is less than ± 6.0% in step (4), and Stress control is in 12-18kN, control sheet thickness 3.35mm-3.65mm.
Compared with prior art, the erigeron breviscapus dispersion tablet that the present invention is provided has following beneficial effect：
1. the dissolution and dispersing uniformity of the erigeron breviscapus dispersion tablet of the present invention are more excellent, and dissolution than ordinary tablet with
And commercially available dispersible tablet is all good.
2. the probability of tabletting sticking is reduced.
3. long-term storage is stablized, and either the content of dissolution or breviscapine can meet medicinal requirement.
Specific embodiment
Embodiment of the present invention is further described below by embodiment, the example is not constituted to present invention protection model
The restriction enclosed.Under the teachings of the present invention, for some technical characteristics are optimized and improve the protection model for still falling within the present invention
In enclosing.
In embodiments of the invention, according to 2015 editions Chinese Pharmacopoeias, dissolution, dispersing uniformity to dispersible tablet,
Weight differential, microbial limit are tested.
Dispersing uniformity：Check according to 2015 editions Chinese Pharmacopoeias method disintegration (general rule 0921), the sieve of stainless steel cloth
Hole internal diameter is 710 μm, and water temperature is 15～25 DEG C；Test sample 6 is taken, should not have whole disintegrates at 3 minutes and by screen cloth.
Dissolution test：Dissolution is determined with reference to the first method in pharmacopeia general rule 0931.
Embodiment 1
Erigeron breviscapus dispersion tablet, prescription (makes 1000)
Preparation method is：
1. supplementary material is crossed respectively 100 mesh sieves, it is standby；
2. breviscapine, calcium hydrogen phosphate, Microcrystalline Cellulose (M101), Croscarmellose Sodium, dodecyl are weighed
In sodium sulfate input Wet mixed granulating machine, mix homogeneously；
3. the mixture that step 2 is obtained is made into soft material, the granulation of 20 mesh sieves with 30 volume % ethanol waters；
4. wet granular is dried below 40～70 DEG C, crosses 20 mesh sieve granulate；
5. sodium bicarbonate, micropowder silica gel, the magnesium stearate of recipe quantity are added in dry particl, is mixed；
6. tabletting, controls tablet weight variation and is less than ± 6.0%, and Stress control is in 12kN, control sheet thickness 3.45mm.Packaging is
Obtain this product.
Embodiment 2
Erigeron breviscapus dispersion tablet, prescription (makes 1000)
Preparation method is：
1. supplementary material is crossed respectively 100 mesh sieves, it is standby；
2. breviscapine, calcium hydrogen phosphate, Microcrystalline Cellulose (M101), Croscarmellose Sodium, dodecyl are weighed
In sodium sulfate input Wet mixed granulating machine, mix homogeneously；
3. the mixture that step 2 is obtained is made into soft material, the granulation of 20 mesh sieves with 30 volume % ethanol waters；
4. wet granular is dried below 40～70 DEG C, crosses 20 mesh sieve granulate；
5. sodium bicarbonate, micropowder silica gel, the magnesium stearate of recipe quantity are added in dry particl, is mixed；
6. tabletting, controls tablet weight variation and is less than ± 6.0%, and Stress control is in 12kN, control sheet thickness 3.45mm.Packaging is
Obtain this product.
Embodiment 3
Erigeron breviscapus dispersion tablet, prescription (makes 1000)
Preparation method is：
1. supplementary material is crossed respectively 100 mesh sieves, it is standby；
2. breviscapine, calcium hydrogen phosphate, Microcrystalline Cellulose (M101), Croscarmellose Sodium, dodecyl are weighed
In sodium sulfate input Wet mixed granulating machine, mix homogeneously；
3. the mixture that step 2 is obtained is made into soft material, the granulation of 20 mesh sieves with 30 volume % ethanol waters；
4. wet granular is dried below 40～70 DEG C, crosses 20 mesh sieve granulate；
5. sodium bicarbonate, micropowder silica gel, the magnesium stearate of recipe quantity are added in dry particl, is mixed；
6. tabletting, controls tablet weight variation and is less than ± 6.0%, and Stress control is in 12kN, control sheet thickness 3.35mm.Packaging is
Obtain this product.
Comparative example 1
Erigeron breviscapus dispersion tablet, prescription (makes 1000)
Preparation method is：
1. supplementary material is crossed respectively 100 mesh sieves, it is standby；
2. it is wet that breviscapine, Lactose, Microcrystalline Cellulose (M101), carboxymethylstach sodium, sodium lauryl sulphate input are weighed
In method hybrid particles machine, mix homogeneously；
3. the mixture that step 2 is obtained is made into soft material, the granulation of 20 mesh sieves with 30 volume % ethanol waters；
4. wet granular is dried below 40～70 DEG C, crosses 20 mesh sieve granulate；
5. micropowder silica gel, the magnesium stearate of recipe quantity are added in dry particl, is mixed；
6. tabletting, controls tablet weight variation and is less than ± 6.0%, and Stress control is in 12kN, control sheet thickness 3.55mm.Packaging is
Obtain this product.
Comparative example 2
Erigeron breviscapus dispersion tablet, prescription (makes 1000)
Preparation method is：
1. supplementary material is crossed respectively 100 mesh sieves, it is standby；
2. weigh breviscapine, calcium hydrogen phosphate, Microcrystalline Cellulose (M101), carboxymethylstach sodium, sodium lauryl sulphate to throw
In entering Wet mixed granulating machine, mix homogeneously；
3. the mixture that step 2 is obtained is made into soft material, the granulation of 20 mesh sieves with 30 volume % ethanol waters；
4. wet granular is dried below 40～70 DEG C, crosses 20 mesh sieve granulate；
5. micropowder silica gel, the magnesium stearate of recipe quantity are added in dry particl, is mixed；
6. tabletting, controls tablet weight variation and is less than ± 6.0%, and Stress control is in 13kN, control sheet thickness 3.40mm.Packaging is
Obtain this product.
Comparative example 3
Erigeron breviscapus dispersion tablet, prescription (makes 1000)
Preparation method is：
1. supplementary material is crossed respectively 100 mesh sieves, it is standby；
2. breviscapine, starch, Microcrystalline Cellulose (M101), crosslinked polyethylene pyrrole network alkanone, lauryl sulphate acid are weighed
In sodium input Wet mixed granulating machine, mix homogeneously；
3. the mixture that step 2 is obtained is made into soft material, the granulation of 20 mesh sieves with 30 volume % ethanol waters；
4. wet granular is dried below 40～70 DEG C, crosses 20 mesh sieve granulate；
5. micropowder silica gel, the magnesium stearate of recipe quantity are added in dry particl, is mixed；
6. tabletting, controls tablet weight variation and is less than ± 6.0%, and Stress control is in 12kN, control sheet thickness 3.41mm.Packaging is
Obtain this product.
Test example 1
The embodiment of table 1 is contrasted with the technical parameter of comparative example
As a result show that the good fluidity of granule, hardness are moderate in embodiment 1-3, the dispersing uniformity of tablet meets medicine
The regulation of allusion quotation is required.
Dispersible tablet that relatively prepared by the embodiment of the present invention 2, erigeron breviscapus dispersion tablet (embodiment 2 in patent CN03135878
Method be obtained), ordinary tablet (according to《Pharmacopeia》Into square standard prepare) dissolution, be shown in Table 2：
The dissolution of the embodiment of the present invention 2 of table 2, the erigeron breviscapus dispersion tablet of patent CN03135878 embodiment 2 and ordinary tablet
Degree compares
The above results show：The dispersible tablet dissolution of the embodiment of the present invention 2 is better than ordinary tablet, while a little higher than patent
The dissolution of the dispersible tablet of CN03135878 embodiments 2.
Test example 2
The embodiment of the present invention 2 is compared with the prescription rejected after calcium hydrogen phosphate, sodium bicarbonate, and accelerated test (accelerates examination
Test 40 DEG C ± 2 DEG C of condition, RH75% ± 5%) the results are shown in Table 3：
The impact of the calcium hydrogen phosphate of table 3 and sodium bicarbonate to erigeron breviscapus dispersion tablet dissolution and content
As a result show：The dissolution and dispersing uniformity of the prescription of phosphoric acid hydrogen calcium and sodium bicarbonate is superior to not phosphoric acid
The prescription of hydrogen calcium and sodium bicarbonate, illustrate calcium hydrogen phosphate and sodium bicarbonate addition improve erigeron breviscapus dispersion tablet dissolution and
Dispersing uniformity.
Test example 3
One embodiment 2 in the embodiment of the present invention 1 and patent CN03135878 as a comparison, with advantages below：
1. the adhesion on wet granulator is reduced, the cleaning amount of labour is reduced；
2. pregelatinized Starch is reduced as filler using calcium hydrogen phosphate and take the risk that works the mischief to human body in a large number；
3. the probability that sticking occurs in tableting processes is reduced.
Test example 4
In order to detect for a long time the present invention stability, with CN03135878 in one embodiment 2 as a comparison, carry out
Keep sample for a long time test, the results are shown in Table 4：
Remarks：Dissolution limit specifies：70% must not be less than
Dispersing uniformity：Disintegrate in 3 minutes passes through screen cloth
Assay：32.4mg must not be less than per piece
As a result show：In stability test, the dissolution of the present invention still conformed to require that other inventions are molten at 36 months
Out-degree is undesirable at 36 months；The dispersing uniformity of the present invention is superior to other inventions；The content invented with other
The content of contrast, embodiments of the invention 1 and embodiment 3 has the difference (p ＜ 0.01) of pole significance, and embodiment 2 has aobvious
Write sex differernce (p ＜ 0.05).The stability of erigeron breviscapus dispersion tablet is more than 24 months less than 36 months, and the present invention stablizes
Property data can prop up the stability of 36 months, be better than General Decentralized tablet stability.
Claims (10)
1. a kind of erigeron breviscapus dispersion tablet, the dispersible tablet is formulated by the component of following weight portion：
2. dispersible tablet as claimed in claim 1, the dispersible tablet is formulated by the component of following weight portion：
3. dispersible tablet as claimed in claim 2, the dispersible tablet is formulated by the component of following weight portion：
4. the dispersible tablet as any one of claim 1-3, wherein, model M101 of the Microcrystalline Cellulose；It is described
Ethanol water is 30 volume % ethanol waters.
5. dispersible tablet as claimed in claim 3, the dispersible tablet is formulated by the component of following weight portion：
6. dispersible tablet as claimed in claim 3, the dispersible tablet is formulated by the component of following weight portion：
7. dispersible tablet as claimed in claim 3, the dispersible tablet is formulated by the component of following weight portion：
8. the preparation method of the dispersible tablet as any one of claim 1-7, comprises the steps：
(1) raw material and adjuvant are sieved for subsequent use respectively；
(2) weigh breviscapine, calcium hydrogen phosphate, Microcrystalline Cellulose, Croscarmellose Sodium and sodium lauryl sulphate to mix
Close uniform；
(3) mixture that step (2) is obtained is made into soft material with ethanol water, is pelletized, be dried, granulate, addition sodium bicarbonate,
Micropowder silica gel and magnesium stearate, mix；
(4) tabletting, packaging is obtained final product.
9. preparation method as claimed in claim 8, wherein, described the sieving of step (1) referred to 100 mesh sieves.
10. preparation method as claimed in claim 8, wherein, step (3) granulation referred to that 20 mesh sieves were pelletized.
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| CN201611166390.5A CN106580898B (en) | 2016-12-15 | 2016-12-15 | A kind of erigeron breviscapus dispersion tablet and preparation method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107213132A (en) * | 2017-05-26 | 2017-09-29 | 合肥华方医药科技有限公司 | A kind of Breviscapinun osmotic pump controlled release tablet and preparation method thereof |
| CN112618504A (en) * | 2020-11-19 | 2021-04-09 | 云南生物谷药业股份有限公司 | Medicinal composition containing erigeron breviscapus extract and borneol and preparation method thereof |
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|---|---|---|---|---|
| CN1416817A (en) * | 2002-11-29 | 2003-05-14 | 北京天衡药物研究院 | Breviscapine dispersing tablet and its prepn |
| CN1807440A (en) * | 2006-01-26 | 2006-07-26 | 周卓和 | Sodium menadiol diphosphate ester and its pharmaceutical formulation |
| CN103494786A (en) * | 2013-10-18 | 2014-01-08 | 山东省医药工业研究所 | Medicinal composition containing moxifloxacin hydrochloride |
-
2016
- 2016-12-15 CN CN201611166390.5A patent/CN106580898B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1416817A (en) * | 2002-11-29 | 2003-05-14 | 北京天衡药物研究院 | Breviscapine dispersing tablet and its prepn |
| CN1807440A (en) * | 2006-01-26 | 2006-07-26 | 周卓和 | Sodium menadiol diphosphate ester and its pharmaceutical formulation |
| CN103494786A (en) * | 2013-10-18 | 2014-01-08 | 山东省医药工业研究所 | Medicinal composition containing moxifloxacin hydrochloride |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107213132A (en) * | 2017-05-26 | 2017-09-29 | 合肥华方医药科技有限公司 | A kind of Breviscapinun osmotic pump controlled release tablet and preparation method thereof |
| CN107213132B (en) * | 2017-05-26 | 2021-02-02 | 合肥华方医药科技有限公司 | Breviscapine osmotic pump controlled release tablet and preparation method thereof |
| CN112618504A (en) * | 2020-11-19 | 2021-04-09 | 云南生物谷药业股份有限公司 | Medicinal composition containing erigeron breviscapus extract and borneol and preparation method thereof |
| CN112618504B (en) * | 2020-11-19 | 2022-08-16 | 云南生物谷药业股份有限公司 | Medicinal composition containing erigeron breviscapus extract and borneol and preparation method thereof |
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| Publication number | Publication date |
|---|---|
| CN106580898B (en) | 2019-09-20 |
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