CN104415130A - Reduning injection and preparation method thereof - Google Patents
Reduning injection and preparation method thereof Download PDFInfo
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- CN104415130A CN104415130A CN201310408684.4A CN201310408684A CN104415130A CN 104415130 A CN104415130 A CN 104415130A CN 201310408684 A CN201310408684 A CN 201310408684A CN 104415130 A CN104415130 A CN 104415130A
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- injection
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- reduning
- herba artemisiae
- artemisiae annuae
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- 238000002347 injection Methods 0.000 title claims abstract description 35
- 239000007924 injection Substances 0.000 title claims abstract description 35
- 239000009839 reduning Substances 0.000 title claims abstract description 30
- 238000002360 preparation method Methods 0.000 title claims abstract description 14
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 27
- 239000000843 powder Substances 0.000 claims abstract description 21
- 238000000034 method Methods 0.000 claims abstract description 8
- 241000205585 Aquilegia canadensis Species 0.000 claims abstract description 7
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 30
- XEKOWRVHYACXOJ-UHFFFAOYSA-N Ethyl acetate Chemical compound CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 claims description 30
- 239000000243 solution Substances 0.000 claims description 30
- LRHPLDYGYMQRHN-UHFFFAOYSA-N N-Butanol Chemical compound CCCCO LRHPLDYGYMQRHN-UHFFFAOYSA-N 0.000 claims description 25
- 238000003756 stirring Methods 0.000 claims description 25
- 241000628997 Flos Species 0.000 claims description 22
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 20
- GEHJYWRUCIMESM-UHFFFAOYSA-L sodium sulfite Chemical compound [Na+].[Na+].[O-]S([O-])=O GEHJYWRUCIMESM-UHFFFAOYSA-L 0.000 claims description 20
- 239000000706 filtrate Substances 0.000 claims description 16
- 238000000605 extraction Methods 0.000 claims description 15
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- 238000005516 engineering process Methods 0.000 claims description 4
- 239000000047 product Substances 0.000 claims description 3
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- RFVNOJDQRGSOEL-UHFFFAOYSA-N 2-hydroxyethyl octadecanoate Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCCO RFVNOJDQRGSOEL-UHFFFAOYSA-N 0.000 claims 1
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Classifications
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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)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/282—Artemisia, e.g. wormwood or sagebrush
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- A—HUMAN NECESSITIES
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- 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)
- A61K36/35—Caprifoliaceae (Honeysuckle family)
- A61K36/355—Lonicera (honeysuckle)
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- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/74—Rubiaceae (Madder family)
- A61K36/744—Gardenia
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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
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- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
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Abstract
The invention discloses a Reduning injection and a preparation method thereof. The Reduning injection comprises herba artemisiae annuae, honeysuckle, fructus gardenia, HS-15, sodium hydrogen sulfite and injection water. When a traditional Chinese medicine composition is prepared, the different components are subjected to distillation, decoction and ethanol extraction so as to take effects of effective ingredients. The preparation method of the Reduning injection comprises the steps of firstly preparing honeysuckle, herba artemisiae annuae dry paste powder and fructus gardenia dry paste powder, and adding HS-15, sodium hydrogen sulfite and injection water according to the procedure of the preparation so as to prepare the Reduning injection. Compared with commercially available Reduning injections, the Reduning injection has the prominent advantages that by utilizing new prescription and process, the prepared product meets pharmacopeia standards, and untoward effects caused by the Reduning injection are obviously reduced.
Description
Technical field
The present invention relates to pharmaceutical preparation technology field, particularly a kind of Reduning injection and preparation method thereof.
Background technology
Reduning injection is made up of Herba Artemisiae Annuae, Flos Lonicerae, Fructus Gardeniae.Herba Artemisiae Annuae induces sweat heat clearing away, removing dampness by means of aromatics, has antipyretic, antiviral, suppression endotoxin, promotes immunization of cell.Flos Lonicerae can heat-clearing and toxic substances removing, again can dispelling wind-heat.Fructus Gardeniae energy clearing away heat-damp and promoting diuresis, pathogenic fire purging relieving restlessness, removing pathogenic heat from blood and toxic substance from the body, both have infection, resisting pathogenic microbes effect.But Reduning injection directly can kill rotavirus, improve infant heating paresthesia, improve immunity of organisms; There is facilitation, relaxing smooth muscle to the regeneration of impaired intestinal epithelial cell and Mucous rehabilitation simultaneously, reduce enterokinesia, suppress intestinal fluid secretion, promote the absorption of Water-Electrolyte, evident in efficacy in the treatment of rotavirus enteritis.Reduning injection is widely used in clinical treatment upper respiratory tract infection, influenza, bronchitis, pneumonia, viral enteritis, herpes zoster etc.
Along with the extensive use that Reduning injection is clinical, the Reporting of harms caused by it increases gradually, and some untoward reaction is comparatively serious.Mediate to Xinjiang worker's hospital, the researcheres at Jilin Province's food and medicine assessment centers and State Food and Drug Administration's drug assessment center carry out analysis by the document 20 routine Reduning injections being caused to adverse drug reaction and find, Reduning injection causes untoward reaction and dosage has nothing to do, serious adverse reaction mostly occurs at the medication initial stage, wherein anaphylaxis is the untoward reaction that Redujing Granules is given prominence to the most, clinical practice should strengthen monitoring, closely takes precautions against the generation of untoward reaction.Therefore improving and reducing Reduning injection untoward reaction has become Reduning injection and has been widely used in clinical key point.Through investigation, its solubilizing agent of Existing commercial Redujing Granules injection mostly is poly-three pear esters 80 (tween 80), relevant pharmacological research finds: 2% tween 80 is to occurring after a Cavia porcellus 1ml/ intravenous injection that raw health is crooked, the manifest symptom such as drowsiness, 5% tween 80 Cavia porcellus all occurs that ear is blue, instability of gait, health are crooked, lies on one's side, the obviously symptom such as drowsiness; Beagle dog vein slow injection tween 80, dosage is reduced to 0.02% tween 80, when giving with 4ml/ volume, animal still there will be very aobvious symptoms of allergic (Sun Li, Liu Xiaomeng etc., J Toxicol August 2007 Vo1.21 No.4), other documents and materials also definitely prove that tween 80 is the main cause that untoward reaction (anaphylaxis) occurs when causing its clinical application.In view of above research the present invention adopts HS-15 to replace Tween 80, safety test (whole body is hypersensitive test initiatively) shows that the present invention significantly improves the drug safety of Reduning injection.
Summary of the invention
The object of the invention is to provide the Reduning injection of a kind of brand-new prescription and preparation technology, make Reduning injection not only steady quality but also have higher clinical drug safety.In order to reach upper above-mentioned purpose, the present invention adopts following technical scheme: first prepare Flos Lonicerae, Herba Artemisiae Annuae dried cream powder and Fructus Gardeniae dried cream powder, then adds HS-15 according to preparation process, sodium sulfite, water for injection makes Redujing Granules injection.
Reduning injection preparation method, extracting honeysuckle 750g, extracting in water 2 times, 90 DEG C, each 1 hour, amount of water is 15 times respectively, 10 times, extracting solution is separately put, getting Herba Artemisiae Annuae 1250g adds after 4 times of water gagings run through, steam distillation extracts volatile oil in 6 hours, volatile oil is separately put, extract Flos Lonicerae extractive solution and Herba Artemisiae Annuae extracting solution, considered, being evaporated to 60 DEG C of relative densities is 1.10, adding ethanol makes alcohol content be 75%, leave standstill 24 hours, filter, it is 1.20(60 DEG C that worry liquid is evaporated to relative density), pH value is adjusted to be 2.0 with hydrochloric acid, with equivalent extraction into ethyl acetate 10 times, get extraction liquid, be evaporated to without ethyl acetate taste, incline and concentrated solution, vacuum drying, obtain Flos Lonicerae, Herba Artemisiae Annuae dried cream powder, Fructus Gardeniae 600g is ground into coarse powder, with 6 times amount 80% alcohol heating reflux 2 times, and each 1 hour, merge medicinal liquid, filter, filtrate recycling ethanol is also concentrated into 1:1, adjust pH value 3.0,100 DEG C heating 1 hour with hydrochloric acid, add the solid Gypsum Fibrosum of 1% medical material amount, stir, cold preservation 12 hours, filter, the n-butanol extraction of filtrate equivalent 6 times, be evaporated to without n-butyl alcohol taste, vacuum drying, obtain Fructus Gardeniae dried cream powder, the Herba Artemisiae Annuae of preparation, Flos Lonicerae intermediate and Fructus Gardeniae intermediate for subsequent use, inject and use water 1000ml, boil, drop into above-mentioned 2 kinds of intermediate and Fructus Gardeniae intermediate, stir evenly, seethe with excitement 4 minutes, be cooled to room temperature, cold preservation was filtered after 24 hours, filtrate adjusts pH value to be 2-3, add 1% active carbon, boil 10 minutes, be cooled to room temperature, cold preservation 48 hours, filter, add 0.5g sodium sulfite, stir, from wherein getting solution 50ml, be heated to 30-40 DEG C and add 2.0ml-8.0ml HS-15, stir evenly, add volatile oil, merge solution to stir evenly, (molecular weight is 30,000 to filter ultrafiltration, 10000), filter the microporous filter membrane of 0.22 μm, obtain, this product overall process is aseptically carried out, adopt non-final sterilization process, this product overall process is aseptically carried out, adopt non-final sterilization process.
Safety experiment proves: the present invention's (anaphylaxis) in safety is obviously better than commercially available Reduning injection.
Detailed description of the invention
embodiment 1reduning injection, forms formulated by 1250g Herba Artemisiae Annuae, 750g Flos Lonicerae, 600g Fructus Gardeniae, 2.0ml HS-15,0.5g sodium sulfite and water for injection.
Embodiment 1 extracting honeysuckle 750g, extracting in water 2 times, 90 DEG C, each 1 hour, amount of water is 15 times respectively, 10 times, extracting solution is separately put, getting Herba Artemisiae Annuae 1250g adds after 4 times of water gagings run through, steam distillation extracts volatile oil in 6 hours, volatile oil is separately put, extract Flos Lonicerae extractive solution and Herba Artemisiae Annuae extracting solution, considered, being evaporated to 60 DEG C of relative densities is 1.10, adding ethanol makes alcohol content be 75%, leave standstill 24 hours, filter, it is 1.20(60 DEG C that worry liquid is evaporated to relative density), pH value is adjusted to be 2.0 with hydrochloric acid, with equivalent extraction into ethyl acetate 10 times, get extraction liquid, be evaporated to without ethyl acetate taste, incline and concentrated solution, vacuum drying, obtain Flos Lonicerae, Herba Artemisiae Annuae dried cream powder, Fructus Gardeniae 600g is ground into coarse powder, with 6 times amount 80% alcohol heating reflux 2 times, and each 1 hour, merge medicinal liquid, filter, filtrate recycling ethanol is also concentrated into 1:1, adjust pH value 3.0,100 DEG C heating 1 hour with hydrochloric acid, add the solid Gypsum Fibrosum of 1% medical material amount, stir, cold preservation 12 hours, filter, the n-butanol extraction of filtrate equivalent 6 times, be evaporated to without n-butyl alcohol taste, vacuum drying, obtain Fructus Gardeniae dried cream powder, the Herba Artemisiae Annuae of preparation, Flos Lonicerae intermediate and Fructus Gardeniae intermediate for subsequent use, inject and use water 1000ml, boil, drop into above-mentioned 2 kinds of intermediate and Fructus Gardeniae intermediate, stir evenly, seethe with excitement 4 minutes, be cooled to room temperature, cold preservation was filtered after 24 hours, filtrate adjusts pH value to be 2-3, add 1% active carbon, boil 10 minutes, be cooled to room temperature, cold preservation 48 hours, filter, add 0.5g sodium sulfite, stir, from wherein getting solution 50ml, be heated to 30-40 DEG C and add 2.0mlHS-15, stir evenly, add volatile oil, merge solution to stir evenly, (ultrafiltration molecular weight is 30,000 to filter ultrafiltration, 10000), filter the microporous filter membrane of 0.22 μm, obtain.
embodiment 2reduning injection, forms formulated by 1250g Herba Artemisiae Annuae, 750g Flos Lonicerae, 600g Fructus Gardeniae, 4.0ml HS-15,0.5g sodium sulfite and water for injection.
Embodiment 2 extracting honeysuckle 750g, extracting in water 2 times, 90 DEG C, each 1 hour, amount of water is 15 times respectively, 10 times, extracting solution is separately put, getting Herba Artemisiae Annuae 1250g adds after 4 times of water gagings run through, steam distillation extracts volatile oil in 6 hours, volatile oil is separately put, extract Flos Lonicerae extractive solution and Herba Artemisiae Annuae extracting solution, considered, being evaporated to 60 DEG C of relative densities is 1.10, adding ethanol makes alcohol content be 75%, leave standstill 24 hours, filter, it is 1.20(60 DEG C that worry liquid is evaporated to relative density), pH value is adjusted to be 2.0 with hydrochloric acid, with equivalent extraction into ethyl acetate 10 times, get extraction liquid, be evaporated to without ethyl acetate taste, incline and concentrated solution, vacuum drying, obtain Flos Lonicerae, Herba Artemisiae Annuae dried cream powder, Fructus Gardeniae 600g is ground into coarse powder, with 6 times amount 80% alcohol heating reflux 2 times, and each 1 hour, merge medicinal liquid, filter, filtrate recycling ethanol is also concentrated into 1:1, adjust pH value 3.0,100 DEG C heating 1 hour with hydrochloric acid, add the solid Gypsum Fibrosum of 1% medical material amount, stir, cold preservation 12 hours, filter, the n-butanol extraction of filtrate equivalent 6 times, be evaporated to without n-butyl alcohol taste, vacuum drying, obtain Fructus Gardeniae dried cream powder, the Herba Artemisiae Annuae of preparation, Flos Lonicerae intermediate and Fructus Gardeniae intermediate for subsequent use, inject and use water 1000ml, boil, drop into above-mentioned 2 kinds of intermediate and Fructus Gardeniae intermediate, stir evenly, seethe with excitement 4 minutes, be cooled to room temperature, cold preservation was filtered after 24 hours, filtrate adjusts pH value to be 2-3, add 1% active carbon, boil 10 minutes, be cooled to room temperature, cold preservation 48 hours, filter, add 0.5g sodium sulfite, stir, from wherein getting solution 50ml, be heated to 30-40 DEG C and add 4.0ml HS-15, stir evenly, add volatile oil, merge solution to stir evenly, (ultrafiltration molecular weight is 30,000 to filter ultrafiltration, 10000), filter the microporous filter membrane of 0.22 μm, obtain.
embodiment 3reduning injection, forms formulated by 1250g Herba Artemisiae Annuae, 750g Flos Lonicerae, 600g Fructus Gardeniae, 8.0ml HS-15,0.5g sodium sulfite and water for injection.
Embodiment 3 extracting honeysuckle 750g, extracting in water 2 times, 90 DEG C, each 1 hour, amount of water is 15 times respectively, 10 times, extracting solution is separately put, getting Herba Artemisiae Annuae 1250g adds after 4 times of water gagings run through, steam distillation extracts volatile oil in 6 hours, volatile oil is separately put, extract Flos Lonicerae extractive solution and Herba Artemisiae Annuae extracting solution, considered, being evaporated to 60 DEG C of relative densities is 1.10, adding ethanol makes alcohol content be 75%, leave standstill 24 hours, filter, it is 1.20(60 DEG C that worry liquid is evaporated to relative density), pH value is adjusted to be 2.0 with hydrochloric acid, with equivalent extraction into ethyl acetate 10 times, get extraction liquid, be evaporated to without ethyl acetate taste, incline and concentrated solution, vacuum drying, obtain Flos Lonicerae, Herba Artemisiae Annuae dried cream powder, Fructus Gardeniae 600g is ground into coarse powder, with 6 times amount 80% alcohol heating reflux 2 times, and each 1 hour, merge medicinal liquid, filter, filtrate recycling ethanol is also concentrated into 1:1, adjust pH value 3.0,100 DEG C heating 1 hour with hydrochloric acid, add the solid Gypsum Fibrosum of 1% medical material amount, stir, cold preservation 12 hours, filter, the n-butanol extraction of filtrate equivalent 6 times, be evaporated to without n-butyl alcohol taste, vacuum drying, obtain Fructus Gardeniae dried cream powder, the Herba Artemisiae Annuae of preparation, Flos Lonicerae intermediate and Fructus Gardeniae intermediate for subsequent use, inject and use water 1000ml, boil, drop into above-mentioned 2 kinds of intermediate and Fructus Gardeniae intermediate, stir evenly, seethe with excitement 4 minutes, be cooled to room temperature, cold preservation was filtered after 24 hours, filtrate adjusts pH value to be 2-3, add 1% active carbon, boil 10 minutes, be cooled to room temperature, cold preservation 48 hours, filter, add 0.5g sodium sulfite, stir, from wherein getting solution 50ml, be heated to 30-40 DEG C and add 8.0ml HS-15, stir evenly, add volatile oil, merge solution to stir evenly, (ultrafiltration molecular weight is 30,000 to filter ultrafiltration, 10000), filter the microporous filter membrane of 0.22 μm, obtain.
Claims (4)
1. a Reduning injection, is made up of Flos Lonicerae, Herba Artemisiae Annuae dried cream powder and Fructus Gardeniae dried cream powder, solubilizing agent, antioxidant and water for injection.
2. Reduning injection as claimed in claim 1, is characterized in that solubilizing agent adopts HS-15(15-hydroxy stearic acid macrogol ester).
3. Reduning injection as claimed in claim 1, is characterized in that antioxidant adopts sodium sulfite.
4. the Reduning injection as described in claim 1-3, is characterized in that adopting following preparation technology:
1. extracting honeysuckle 750g, extracting in water 2 times, 90 DEG C, each 1 hour, amount of water is 15 times respectively, 10 times, extracting solution is separately put, getting Herba Artemisiae Annuae 1250g adds after 4 times of water gagings run through, steam distillation extracts volatile oil in 6 hours, volatile oil is separately put, extract Flos Lonicerae extractive solution and Herba Artemisiae Annuae extracting solution, filter, being evaporated to 60 DEG C of relative densities is 1.10, adding ethanol makes alcohol content be 75%, leave standstill 24 hours, filter, filtrate reduced in volume to relative density is 1.20(60 DEG C), pH value is adjusted to be 2.0 with hydrochloric acid, with equivalent extraction into ethyl acetate 10 times, get extraction liquid, be evaporated to without ethyl acetate taste, incline and concentrated solution, vacuum drying, obtain Flos Lonicerae, Herba Artemisiae Annuae dried cream powder,
2. Fructus Gardeniae 600g is ground into coarse powder, with 6 times amount 80% alcohol heating reflux 2 times, and each 1 hour, merge medicinal liquid, filter, filtrate recycling ethanol is also concentrated into 1:1, adjust pH value 3.0,100 DEG C heating 1 hour with hydrochloric acid, add the solid Gypsum Fibrosum of 1% medical material amount, stir, cold preservation 12 hours, filter, the n-butanol extraction of filtrate equivalent 6 times, be evaporated to without n-butyl alcohol taste, vacuum drying, obtain Fructus Gardeniae dried cream powder;
3. the Herba Artemisiae Annuae prepared, Flos Lonicerae intermediate and Fructus Gardeniae intermediate for subsequent use, inject and use water 1000ml, boil, drop into above-mentioned 2 kinds of intermediate and Fructus Gardeniae intermediate, stir evenly, seethe with excitement 4 minutes, be cooled to room temperature, cold preservation was filtered after 24 hours, filtrate adjusts pH value to be 2-3, add 1% active carbon, boil 10 minutes, be cooled to room temperature, cold preservation 48 hours, filter, add 0.5g sodium sulfite, stir, from wherein getting solution 50ml, be heated to 30-40 DEG C and add 2.0ml-8.0ml HS-15, stir evenly, add volatile oil, merge solution to stir evenly, filter ultrafiltration, molecular weight is 30,000, 10000, filter the microporous filter membrane of 0.22 μm, obtain, this product overall process is aseptically carried out, adopt non-final sterilization process.
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| CN114053343A (en) * | 2020-07-30 | 2022-02-18 | 江苏康缘药业股份有限公司 | Traditional Chinese medicine composition, preparation method and application |
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| CN111973671B (en) * | 2020-09-07 | 2021-12-31 | 临沂大学 | Inhalation powder inhalation of "Reduning" and preparation method thereof |
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