CN105687150A - Revaprazan hydrochloride composition and preparing method - Google Patents
Revaprazan hydrochloride composition and preparing method Download PDFInfo
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- CN105687150A CN105687150A CN201610148377.0A CN201610148377A CN105687150A CN 105687150 A CN105687150 A CN 105687150A CN 201610148377 A CN201610148377 A CN 201610148377A CN 105687150 A CN105687150 A CN 105687150A
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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
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
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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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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Abstract
A revaprazan hydrochloride composition comprises revaprazan hydrochloride, surface active agent and one or more of filler, binder, disintegrant and lubricant serving as auxiliary materials. The composition is characterized in that co-micronization is conducted on revaprazan hydrochloride and the surface active agent till the grain size D90 is 1-10 microns. According to the composition, raw material aggregation and adhesion are avoided, the preparation moldability of the revaprazan hydrochloride raw material is improved, problems such as sticking in industrial production are solved, and the stability of a revaprazan hydrochloride preparation is improved.
Description
Technical field
The present invention relates to a kind of Revaprazan hydrochloride compositions and preparation method, belong to art of pharmacy。
Background technology
Gastric ulcer (GastricUlcer, and duodenal ulcer (DuodenalUlcer, DU) claim peptic ulcer (PepticUlcer, PU) GU), being one of global modal chronic gastrointestinal function confusion disease, sickness rate may be up to 10%。Revaprazan hydrochloride (also referred to as: hydrochloric acid revaprzan) it is a kind of reversible proton pump antagonist of new generation for gastric acid related disease, it is also called acid pump antagonist (APA, and potassium ion competitiveness acid pump inhibitor acidpumpantagonist), structural formula is as it is shown in figure 1, chemical name is 5,6-dimethyl-2-(4-fluoroanilino)-4-(1 (R, S)-methyl isophthalic acid, 2,3,4-tetrahydroisoquinoline-2-bases) pyrimidine hydrochloride。Its mechanism of action is competitive Reversible binding K+Site, it is suppressed that K+Enter parietal cell exchange H+, thus suppressing H+/K+The activity of-ATP enzyme, blocks gastric acid secretion。Revaprazan hydrochloride is gastric acid secretion inhibiting both, also protects gastric cells simultaneously, and it, by inducing COX-2mRNA to express, increases the synthesis of prostaglandin, thus playing the effect of protection gastric mucosa。
But, the raw material of Revaprazan hydrochloride has strong attachment and assembles character, there is serious sticking problem, has relatively low preparations shaping performance, bring bigger difficulty to production process。
Summary of the invention
In order to improve gathering and the tack of Revaprazan hydrochloride raw material, avoid the sticking in formulation process and the problem solving preparations shaping difference, the invention provides the compositions of a kind of Revaprazan hydrochloride, described compositions is by preparing Revaprazan hydrochloride through micronization processes altogether with surfactant。
The first aspect of the invention, a kind of Revaprazan hydrochloride compositions is provided, including Revaprazan hydrochloride, surfactant and optional one or more in following adjuvant: filler, binding agent, disintegrating agent and lubricant, it is characterised in that Revaprazan hydrochloride and surfactant are through micronization processes altogether to particle diameter D90For 1-10 μm。
Preferably, in above-mentioned composition, the percentage by weight of each component is as follows:
Preferably, the powder compounds particle diameter D of above-mentioned Revaprazan hydrochloride and surfactant90For 1-10 μm, it is preferable that D90For 1-5 μm。
Preferably, combinations of the above thing, it is characterised in that:
Described surfactant selected from but be not limited to that carbomer, poloxamer, sodium lauryl sulphate, dodecylbenzene sodium sulfonate, lecithin, Polysorbate, fatty acid Pyrusussuriensis be smooth, at least one in cholesterol, sucrose fatty acid ester, polyoxyethylene fatty acid ester；
Described filler is selected from but is not limited at least one in microcrystalline Cellulose, starch, pregelatinized Starch, mannitol, dextrin, calcium carbonate, lactose, sucrose；
Described binding agent is selected from but is not limited at least one in starch, methylcellulose, polyvidone, hypromellose, hydroxypropyl cellulose, sodium carboxymethyl cellulose, ethyl cellulose, Polyethylene Glycol, gelatin；
Described disintegrating agent is selected from but is not limited at least one in low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, sodium bicarbonate, sodium carboxymethyl cellulose, carboxymethylstach sodium, cross-linking sodium carboxymethyl cellulose；
Described lubricant is selected from but is not limited at least one in magnesium stearate, Pulvis Talci, micropowder silica gel, hydrogenated vegetable oil, polyethylene glycols, sodium laurylsulfate。
Preferably, combinations of the above thing, it is characterised in that in every 1000, containing Revaprazan hydrochloride 100g, microcrystalline Cellulose 95.2g, PVP K30 38.68g, carbomer 934 32.96g, polyvinylpolypyrrolidone 40.12g, sodium bicarbonate 37.00g, sodium lauryl sulphate 44.04g, magnesium stearate 12g。
Preferably, combinations of the above thing, it is characterised in that in every 1000, containing Revaprazan hydrochloride 40g, microcrystalline Cellulose 94.76g, PVP K30 38.68g, lecithin 81.48g, polyvinylpolypyrrolidone 30.40g, carboxymethyl starch sodium 24.08g, PLURONICS F87 78.60g, magnesium stearate 12g。
Preferably, combinations of the above thing, it is characterised in that in every 1000, containing Revaprazan hydrochloride 160g, microcrystalline Cellulose 93.09g, PVP K30 58.68g, polyvinylpolypyrrolidone 32.00g, carboxymethyl starch sodium 24.08g, poloxamer188 20.15g, magnesium stearate 12g。
Preferably, combinations of the above thing, it is characterised in that the mode of described micronization processes altogether includes low-temperature grinding, comminution by gas stream and/or ball mill pulverizing。
The second aspect of the invention, the preparation method that a kind of combinations of the above thing is provided, it is characterized in that, preparation process includes: form according to prescription, Revaprazan hydrochloride and surfactant are carried out common micronization and obtains common micronizing materials, by described micronizing materials altogether, filler and disintegrating agent mixing, add binder solution and granulate, add lubricant, prepare Revaprazan hydrochloride compositions。
More specifically, above-mentioned preparation process includes:
1) Revaprazan hydrochloride raw material is mixed with surfactant, carry out common micronization processes to particle diameter D90Micronizing materials must be total to for 1-10 μm；
2) binding agent of recipe quantity is added in purified water, be configured to the binder solution of 5-15% (w/w)；
3) according to prescription, by step 1) described in common micronizing materials, filler, disintegrating agent mixing add in wet granulator, add binding agent or step 2) described binder solution granulates; dry; add lubricant, mixing, prepare Revaprazan hydrochloride compositions。
The third aspect of the invention, it is provided that a kind of Revaprazan hydrochloride composition tablet, it is characterised in that described coated tablet is prepared by bag film coating after combinations of the above thing tabletting。
Preferably, above-mentioned coating adjuvant is selected fromamb、fxTM、At least one in II type。
The Revaprazan hydrochloride compositions of the present invention, by by Revaprazan hydrochloride and surfactant after common micronization processes, significantly improve gathering and the tack of Revaprazan hydrochloride raw material, avoid the sticking phenomenon in formulation process, the problem solving preparations shaping difference, the present invention adopts the method for simplicity to obtain good effect, avoid the complex process of prior art, impurity is many, poor stability, the big series of problems producing difficulty。
Detailed description of the invention
Hereinafter the specific embodiment of the present invention is described in detail。It should be appreciated that being merely cited for property of the detailed description of the invention described herein ground description and interpretation present invention, it is not limited to the present invention。
Table 1 embodiment 1～3 and comparative example 1 prescription (400g/1000 sheet)
Embodiment 1
By Revaprazan hydrochloride, carbomer 934 and sodium lauryl sulphate mix homogeneously, 180 seconds (D pulverized by jet mill (QS100)90: 2.92 μm) micronizing materials must be total to, standby；Weigh PVP K30 in purified water, be stirred to dissolve, be configured to the binder solution of 5% (w/w)；Successively above-mentioned micronizing materials altogether, microcrystalline Cellulose, polyvinylpolypyrrolidone, sodium bicarbonate are joined and add binder solution granulation in wet mixing pelletizer; wet granular is put in fluid bed (FLZB-5) dry; inlet temperature 50-60 DEG C, outlet temperature 40-50 DEG C; dry granule after drying is carried out pelletizing machine granulate; magnesium stearate is joined in above-mentioned material; mix with V-Mixer, prepare Revaprazan hydrochloride compositions。Bag film coating pre-mix dose after described Revaprazan hydrochloride compositions tabletting-In II type, R85F605000 series, obtains Revaprazan hydrochloride composition tablet。
Embodiment 2
Revaprazan hydrochloride, carbomer 934 and sodium lauryl sulphate mix homogeneously, 120 seconds (D pulverized by jet mill (QS100)90: 5.40 μm) micronizing materials must be total to, standby。All the other are operated by preparation technology in embodiment 1。
Embodiment 3
By Revaprazan hydrochloride, carbomer 934 and sodium lauryl sulphate mix homogeneously, 60 seconds (D pulverized by jet mill (QS100)90: 9.92 μm) micronizing materials must be total to, standby。All the other are operated by preparation technology in embodiment 1。
Comparative example 1
Revaprazan hydrochloride is crossed 60 mesh sieve (D90: 18.66 μm), standby；Weigh carbomer 934, sodium lauryl sulphate is dissolved in the water, add Revaprazan hydrochloride stirring and form suspension, at rotating speed 10, homogenizing 10 minutes under 000rpm, utilize the solid dispersion of spray drying acquisition Revaprazan hydrochloride when fluid bed inlet temperature 110-130 DEG C and injection pressure 1.0-2.0bar；Weigh PVP K30 in purified water, be stirred to dissolve, be configured to the binder solution of 5% (w/w)；Successively the solid dispersion of microcrystalline Cellulose, polyvinylpolypyrrolidone, sodium bicarbonate and Revaprazan hydrochloride is joined and wet mixing pelletizer adds binding agent granulation; wet granular is put in fluid bed dry; dry granule after drying is carried out pelletizing machine granulate; magnesium stearate is joined in above-mentioned material; mix with V-Mixer, prepare Revaprazan hydrochloride compositions。Bag film coating pre-mix dose after described Revaprazan hydrochloride compositions tabletting-In II type, R85F605000 series, obtains Revaprazan hydrochloride composition tablet。
Table 2 embodiment 4 and comparative example 2,3 prescription (400g/1000 sheet)
Embodiment 4
By Revaprazan hydrochloride, lecithin and PLURONICS F87 mix homogeneously, 60 seconds (D pulverized by jet mill (QS100)90: 9.92 μm) micronizing materials must be total to, standby；Weigh PVP K30 in purified water, be stirred to dissolve, be configured to the binder solution of 5% (w/w)；Successively above-mentioned micronizing materials altogether, microcrystalline Cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium are joined and add binder solution granulation in wet mixing pelletizer; wet granular is put in fluid bed (FLZB-5) dry; dry granule after drying is carried out pelletizing machine granulate; magnesium stearate is joined in above-mentioned material; mix with V-Mixer, prepare Revaprazan hydrochloride compositions。Bag film coating pre-mix dose after described Revaprazan hydrochloride compositions tabletting-In II type, R85F605000 series, obtains Revaprazan hydrochloride composition tablet。
Comparative example 2
Revaprazan hydrochloride is crossed 60 mesh sieve (D90: 18.66 μm), standby；Weigh PVP K30 in purified water, it is stirred to dissolve, the preparation binder solution into about 5% (w/w), lecithin and PLURONICS F87 is added in above-mentioned solution, stirring and dissolving, successively by Revaprazan hydrochloride, microcrystalline Cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium joins and adds binding agent granulation in wet mixing pelletizer, wet granular is put in fluid bed (FLZB-5) dry, dry granule after drying is carried out pelletizing machine granulate, magnesium stearate is joined in above-mentioned material, mix with V-Mixer, prepare Revaprazan hydrochloride compositions。Bag film coating pre-mix dose after described Revaprazan hydrochloride compositions tabletting-In II type, R85F605000 series, obtains Revaprazan hydrochloride composition tablet。
Comparative example 3
Revaprazan hydrochloride raw material jet mill (QS100) is pulverized 60 seconds (D90: 9.92 μm), standby, weigh PVP K30 in purified water, be stirred to dissolve, the preparation binder solution into about 5% (w/w)；Lecithin and PLURONICS F87 is added in above-mentioned solution; stirring and dissolving; successively Revaprazan hydrochloride, microcrystalline Cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium are joined and add binding agent granulation in wet mixing pelletizer; wet granular is put in fluid bed (FLZB-5) dry; dry granule after drying is carried out pelletizing machine granulate; magnesium stearate is joined in above-mentioned material, carry out mixing prepared Revaprazan hydrochloride compositions with V-Mixer。Bag film coating pre-mix dose after described Revaprazan hydrochloride compositions tabletting-In II type, R85F605000 series, obtains Revaprazan hydrochloride composition tablet。
Table 3 embodiment 5 and comparative example 4,5 prescription (400g/1000 sheet)
Embodiment 5
By Revaprazan hydrochloride and poloxamer188 mix homogeneously, 60 seconds (D pulverized by jet mill (QS100)90: 9.92 μm) micronizing materials must be total to, standby；Weigh PVP K30 in purified water, be stirred to dissolve, be configured to the binder solution of 5% (w/w)；Successively above-mentioned micronizing materials altogether, microcrystalline Cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium are joined and add binder solution granulation in wet mixing pelletizer; wet granular is put in fluid bed (FLZB-5) dry; dry granule after drying is carried out pelletizing machine granulate; magnesium stearate is joined in above-mentioned material; mix with V-Mixer, prepare Revaprazan hydrochloride compositions。Bag film coating pre-mix dose after described Revaprazan hydrochloride compositions tabletting- In II type, R85F605000 series, obtains Revaprazan hydrochloride composition tablet。
Comparative example 4
Revaprazan hydrochloride is crossed 60 mesh sieve (D90: 18.66 μm), standby；Weigh PVP K30 in purified water; it is stirred to dissolve; it is configured to the binder solution of 5% (w/w); poloxamer188 is added in binder solution; stirring and dissolving; successively Revaprazan hydrochloride, microcrystalline Cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium are joined and add binder solution granulation in wet mixing pelletizer; wet granular is put in fluid bed (FLZB-5) dry; dry granule after drying is carried out pelletizing machine granulate; magnesium stearate is joined in above-mentioned material, carry out mixing prepared Revaprazan hydrochloride compositions with V-Mixer。Bag film coating pre-mix dose after described Revaprazan hydrochloride compositions tabletting-In II type, R85F605000 series, obtains Revaprazan hydrochloride composition tablet。
Comparative example 5
Revaprazan hydrochloride raw material jet mill (QS100) is pulverized 60 seconds (D90: 9.92 μm), standby, weigh PVP K30 in purified water, it is stirred to dissolve, it is configured to the binder solution of 5% (w/w), poloxamer188 is added in binder solution, stirring and dissolving, successively by Revaprazan hydrochloride, microcrystalline Cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium joins and adds binding agent granulation in wet mixing pelletizer, wet granular is put in fluid bed (FLZB-5) dry, dry granule after drying is carried out pelletizing machine granulate, magnesium stearate is joined in above-mentioned material, carry out mixing prepared Revaprazan hydrochloride compositions with V-Mixer。Bag film coating pre-mix dose after described Revaprazan hydrochloride compositions tabletting- In II type, R85F605000 series, obtains Revaprazan hydrochloride composition tablet。
Table 4 embodiment 1～5 and comparative example 1～5 preparations shaping result table
As shown in Table 4, and Revaprazan hydrochloride is not carried out by comparative example 1～5 micronization or by compared with single for Revaprazan micronization, the present invention by by Revaprazan hydrochloride with surfactant through micronization processes altogether to particle diameter D90For 1-10 μm, there is not raw material clustering phenomena in prepared Revaprazan hydrochloride compositions, does not have sticking in formulation process, the problem solving preparations shaping difference。
Table 5 embodiment 1～5 and comparative example 1～5 preparation high-temperature stability result table
Table 6 embodiment 1～5 and comparative example 1～5 preparation light durability result table
Table 7 embodiment 1～5 and comparative example 1～5 preparation high humidity stability result table
By table 5,6,7 it can be seen that with solid dispersion method in comparative example 1～5 or Revaprazan hydrochloride is not carried out micronization or by compared with single for Revaprazan micronization, the present invention by by Revaprazan hydrochloride with surfactant through micronization processes altogether to particle diameter D90For 1-10 μm, prepared Revaprazan hydrochloride preparation high temperature, illumination, high humidity influence factor when more stable。
The preferred embodiment of the present invention described in detail above; but, the present invention is not limited to the detail in above-mentioned embodiment, in the technology concept of the present invention; technical scheme can being carried out multiple simple variant, these simple variant belong to protection scope of the present invention。
Claims (10)
1. a Revaprazan hydrochloride compositions, including Revaprazan hydrochloride, surfactant and optional one or more in following adjuvant: filler, binding agent, disintegrating agent and lubricant, it is characterised in that Revaprazan hydrochloride and surfactant are through micronization processes altogether to particle diameter D90For 1-10 μm。
2. by the compositions described in claim 1, it is characterised in that in described compositions, the percentage by weight of each component is as follows:
3. the compositions as according to any one of claim 1-2, it is characterised in that described particle diameter D90For 1-10 μm, it is preferable that D90For 1-5 μm。
4. the compositions as according to any one of claim 1-3, it is characterised in that:
Described surfactant selected from but be not limited to that carbomer, poloxamer, sodium lauryl sulphate, dodecylbenzene sodium sulfonate, lecithin, Polysorbate, fatty acid Pyrusussuriensis be smooth, at least one in cholesterol, sucrose fatty acid ester, polyoxyethylene fatty acid ester；
Described filler is selected from but is not limited at least one in microcrystalline Cellulose, starch, pregelatinized Starch, mannitol, dextrin, calcium carbonate, lactose, sucrose；
Described binding agent is selected from but is not limited at least one in starch, methylcellulose, polyvidone, hypromellose, hydroxypropyl cellulose, sodium carboxymethyl cellulose, ethyl cellulose, Polyethylene Glycol, gelatin；
Described disintegrating agent is selected from but is not limited at least one in low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, sodium bicarbonate, sodium carboxymethyl cellulose, carboxymethylstach sodium, cross-linking sodium carboxymethyl cellulose；
Described lubricant is selected from but is not limited at least one in magnesium stearate, Pulvis Talci, micropowder silica gel, hydrogenated vegetable oil, polyethylene glycols, sodium laurylsulfate。
5. the compositions as according to any one of claim 1-4, it is characterized in that, in every 1000, containing Revaprazan hydrochloride 100g, microcrystalline Cellulose 95.2g, PVP K30 38.68g, carbomer 934 32.96g, polyvinylpolypyrrolidone 40.12g, sodium bicarbonate 37.00g, sodium lauryl sulphate 44.04g, magnesium stearate 12g。
6. the compositions as according to any one of claim 1-4, it is characterized in that, in every 1000, containing Revaprazan hydrochloride 40g, microcrystalline Cellulose 94.76g, PVP K30 38.68g, lecithin 81.48g, polyvinylpolypyrrolidone 30.40g, carboxymethyl starch sodium 24.08g, PLURONICS F87 78.60g, magnesium stearate 12g。
7. the compositions as according to any one of claim 1-4, it is characterised in that in every 1000, containing Revaprazan hydrochloride 160g, microcrystalline Cellulose 93.09g, PVP K30 58.68g, polyvinylpolypyrrolidone 32.00g, carboxymethyl starch sodium 24.08g, poloxamer188 20.15g, magnesium stearate 12g。
8. the compositions as according to any one of claim 1-7, it is characterised in that the mode of described micronization processes altogether includes low-temperature grinding, comminution by gas stream and/or ball mill pulverizing。
9. the preparation method of the compositions as according to any one of claim 1-8, it is characterized in that, preparation process includes: Revaprazan hydrochloride and surfactant are carried out common micronization and obtains common micronizing materials, by described micronizing materials altogether, filler and disintegrating agent mixing, add binder solution to granulate, add lubricant, prepare Revaprazan hydrochloride compositions；Preferably, described preparation process includes:
1) Revaprazan hydrochloride is mixed with surfactant, carry out common micronization processes to D90Micronizing materials must be total to for 1-10 μm；
2) binding agent is added in wetting agent (as selected from purified water, ethanol), be configured to the binder solution of 5-15% (w/w)；
3) by step 1) described in common micronizing materials, filler, disintegrating agent mixing add in wet granulator, add step 2) described binder solution granulates, dry, adds lubricant, mixing, prepares Revaprazan hydrochloride compositions。
10. a Revaprazan hydrochloride tablet, it is characterised in that described tablet compositions described in any one of claim 1-8 carries out tabletting；Preferably, carry out film coating after tabletting and prepare coated tablet；It is highly preferred that described coating adjuvant is selected from amb、fxTM、At least one in II type。
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| CN106361721A (en) * | 2016-08-31 | 2017-02-01 | 佛山市弘泰药物研发有限公司 | Revaprazan hydrochloride capsule and preparation method |
| CN107823162A (en) * | 2017-12-13 | 2018-03-23 | 南京迈迪信泽医药科技开发有限公司 | A kind of Sulpiride tablet and preparation method thereof |
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| CN106361721A (en) * | 2016-08-31 | 2017-02-01 | 佛山市弘泰药物研发有限公司 | Revaprazan hydrochloride capsule and preparation method |
| CN107823162A (en) * | 2017-12-13 | 2018-03-23 | 南京迈迪信泽医药科技开发有限公司 | A kind of Sulpiride tablet and preparation method thereof |
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| Publication number | Publication date |
|---|---|
| CN105687150B (en) | 2019-12-10 |
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