CN1059107C - Medicinal composition for treating chronic obstructive disease of lung and its preparing process - Google Patents

Medicinal composition for treating chronic obstructive disease of lung and its preparing process Download PDF

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CN1059107C
CN1059107C CN97100465A CN97100465A CN1059107C CN 1059107 C CN1059107 C CN 1059107C CN 97100465 A CN97100465 A CN 97100465A CN 97100465 A CN97100465 A CN 97100465A CN 1059107 C CN1059107 C CN 1059107C
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weight portion
rhizoma
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weight portions
bletillae
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CN1191125A (en
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张金磊
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Abstract

The present invention relates to a traditional Chinese composition for treating chronic obstructive pulmonary diseases, which comprises active ingredients prepared from blackberrylily rhizome, tuber of hyacinth bletilla, silkworm larva, common aucklandia root, red peony root, tendrilleaf fritillary bulb, liquorice, hemlock parsley, amomun fruit and pinellia tuber, and/or additives which can be accepted in the pharmacy. The composition has the efficiency of promoting the dispersing function of the lung, relieving asthma, relieving cough and eliminating phlegm; the composition can change airway obstruction and hypersensitivity state by repairing pathological change tissue of air passages, and treat chronic obstructive pulmonary disease by eliminating cough, phlegm and asthma symptoms, especially chronic bronchitis, bronchial asthma and obstructive emphysema.

Description

A kind of pharmaceutical composition for the treatment of chronic obstructive disease of lung and preparation method thereof
The present invention relates to a kind of pharmaceutical composition for the treatment of chronic obstructive disease of lung, specifically, is a kind of pharmaceutical composition for the treatment of chronic bronchitis, bronchial asthma and obstructive emphysema, the invention still further relates to the preparation method of said composition.
Chronic obstructive disease of lung generally comprises chronic bronchitis, bronchial asthma and obstructive emphysema, because the pathogeny of these diseases is not illustrated as yet fully, makes Chinese and western medicine in treatment very big limitation be arranged.The traditional Chinese medical science generally adopts the drink that reduces phlegm, cough-relieving is breathed heavily and the method for strengthening spleen, tonifying kidney, adopt ERCHEN TANG, XIAOQINGLONG TANG, JINGUI SHENQI WAN etc., but curative effect is of short duration more, low and easy recurrence of cure rate; Doctor trained in Western medicine only at sensitinogen, anaphylaxis is abnormal and the clinical symptoms that showed, the method that adopts antiinflammatory, antiallergic and spasmolytic to relieving asthma uses aminophylline, beta receptor analeptic, cholinolytic class, hormones and medium to discharge medicines such as retardance class; Can only the respite symptom, owing to can not effect a radical cure, make the patient have to take for a long time, thereby cause side effect such as hormone dependence, obesity, endocrine regulation.The inventor finds that through long term studies existing these medicines have all been ignored the repairing and treating that the respiratory tract part is dyed the inflamed ulcer focus that causes because of dislike; The treatment of the disturbance of blood circulation that respiratory tract local inflammation (inflammatory damage capillary network, lung tissue swelling compressing blood capillary, blood be sticking, coagulate, aggregation increases etc.) is caused; Cause interstitial pulmonary fibrosis to cause gas-exchange membrane to thicken and the treatment of gas dispersion merit obstacle and respiratory tract local patholoic change (airway obstruction, gas are more bad, histoorgan anoxia and function reduction) cause allomeric function to go down to respiratory repeated infection, thereby body function go down and influence not only the repairing and treating of respiratory tract local patholoic change never effectively these diseases of treatment but also the less medicine of side effect really clinically conversely.
The present invention just provides a kind of like this lung qi dispersing Dingchuan and eliminating phlegm and stopping cough effect less Chinese medicine composition of side effect again that has, it can be by repairing the air flue pathological tissues, changing airway obstruction and hypersensitive state, elimination are coughed, expectorant, symptoms of asthma are treated chronic obstructive disease of lung, especially chronic bronchitis, bronchial asthma and obstructive emphysema.
The present invention also provides the preparation method of this Chinese medicine composition simultaneously.
Chinese medicine composition of the present invention mainly comprises the active component that the Chinese crude drug by following proportioning makes: (by weight) Rhizoma Belamcandae 3-20 part, Pseudobulbus Bletillae (Rhizoma Bletillae) 1-10 part, Bombyx Batryticatus 3-20 part, Radix Aucklandiae 3-15 part, Radix Paeoniae Rubra 3-15 part, Bulbus Fritillariae Cirrhosae 10-50 part, Radix Glycyrrhizae 3-15 part, Rhizoma Chuanxiong 3-20 part, Fructus Amomi 3-15 part, Rhizoma Pinelliae 3-20 part.Wherein be preferably: (by weight) Rhizoma Belamcandae 9-20 part, Pseudobulbus Bletillae (Rhizoma Bletillae) 4-10 part, Bombyx Batryticatus 5-15 part, Radix Aucklandiae 5-10 part, Radix Paeoniae Rubra 5-10 part, Bulbus Fritillariae Cirrhosae 20-40 part, Radix Glycyrrhizae 6-12 part, Rhizoma Chuanxiong 7-13 part, Fructus Amomi 5-11 part, Rhizoma Pinelliae 9-15 part.Wherein the best is: 15 parts of (by weight) Rhizoma Belamcandae, 8 parts of the Pseudobulbus Bletillae (Rhizoma Bletillae)s, 10 parts of Bombyx Batryticatus, 8 parts of the Radix Aucklandiae, 7 parts of Radix Paeoniae Rubra, 35 parts of Bulbus Fritillariae Cirrhosaes, 10 parts in Radix Glycyrrhizae, 9 parts of Rhizoma Chuanxiongs, 8 parts of Fructus Amomis, 12 parts of the Rhizoma Pinelliaes.
Active component in pharmaceutical composition of the present invention can be the extract of acetone, chloroform, ether, ethyl acetate, alcohol or the water of said ratio Chinese crude drug, be preferably the extract of water or alcohol, more preferably ethanol extraction, wherein concentration of ethanol is 50-99%, preferred 95% ethanol.The percolation that extracting method is carried for conventional Chinese crude drug extracting method warm macerating as usual, reflux extraction etc. have a detailed description in the 65-72 page or leaf in Cao Chunlin chief editor " pharmaceutics of Chinese drugs ".
When the active component of preparation in the pharmaceutical composition of the present invention, when extracting solvent and be water, generally adopt decocting method to extract twice, the 3-30 that each consumption all be a Chinese crude drug doubly, preferred 25 times, extraction time is 1-5 hour for the first time, be 0.2-5 hour the second time.When the extraction solvent is alcohol, generally adopt reflux extraction to extract once, solvent load is 10-40 a times of Chinese crude drug weight, extraction time is 2-6 hour, extracting temperature is 50-80 ℃, reclaims solvent, and this extracting solution is condensed into the thick paste that relative density is 1-1.5 (50 ℃ of heat is surveyed).
The present composition is preferably the Bombyx Batryticatus of whole consumptions, the 1-60% of the 1-60% of the 1-60% of the 1-60% of Bulbus Fritillariae Cirrhosae consumption, Pseudobulbus Bletillae (Rhizoma Bletillae) consumption, Rhizoma Belamcandae consumption and Fructus Amomi consumption pulverizes, mix, cross 140 mesh sieves and make powder, the concentrated thick paste mixing of the extracting solution of the water of the 80-90% of this powder and other residue medical materials or alcohol, pill also carries out the ground floor coating with remaining powder, and the Haematitum powder of reuse 1% carries out second layer coating, polishing.
The present composition can also comprise pharmaceutically acceptable various additives such as wetting agent, antiseptic, disintegrating agent, lubricant, diluent or excipient etc., and the conventional method that can adopt this area is made various dosage forms such as tablet, pill, capsule, oral liquid, syrup, electuary etc. to said composition.
The present composition has the effect of lung qi dispersing Dingchuan and eliminating phlegm and stopping cough, take orally and can treat chronic obstructive disease of lung, especially chronic bronchitis, bronchial asthma and obstructive emphysema can repair the air flue pathological tissues, change airway obstruction and hypersensitive state, elimination are coughed, expectorant, symptoms of asthma.Clinically, medicine of the present invention for the treatment chronic obstructive disease of lung palliative, with the treatment chronic obstructive disease of lung consolidate medicine and face the control medicine unite use, the clinical observation through 18 years, effective percentage is 99.33%, cure rate is 81.33%.
Embodiment 1
A) take by weighing Rhizoma Belamcandae 150 grams, the Pseudobulbus Bletillae (Rhizoma Bletillae) 80 grams, Bombyx Batryticatus 100 grams, the Radix Aucklandiae 80 grams, Radix Paeoniae Rubra 70 grams, Bulbus Fritillariae Cirrhosae 350 grams, Radix Glycyrrhizae 100 grams, Rhizoma Chuanxiong 90 grams, Fructus Amomi 80 grams, the Rhizoma Pinelliae 120 grams;
B) wherein 100 gram Bombyx Batryticatus, the Bulbus Fritillariae Cirrhosae of 120 grams, the Fructus Amomi of the 140 gram Pseudobulbus Bletillae (Rhizoma Bletillae)s, 60 gram Rhizoma Belamcandae and 32 grams is pulverized, and it is standby to cross 140 mesh sieves;
C) will remain medical material and use 95% ethanol lixiviate twice, and add 25 times for the first time and extracted 5 hours, and add 15 times for the second time and extracted 2.5 hours, merge extractive liquid, filters, and being condensed into relative density is the thick paste of 1-1.5 (50 ℃ of heat are surveyed);
D) 80% of the medicated powder that makes in the step b) with step c) in the thick paste mixing that makes, pill and first 20% coating with the medicated powder that makes in the step b), 50-100 ℃ of drying, the Haematitum powder coating of reuse 1%, polishing promptly, the trade name of resulting Chinese medicine composition is called " lung qi dispersing anti-asthma pill " again.Test example 1 medicine of the present invention is to bronchial asthma therapeutical effect method:
This test is adopted and is continued artificial ventilation, quick air flue obturation techniques, measures lung resistance (R L) and lung compliance (C L), the tonicity of understanding airway smooth muscle, the cytology who makes bronchoalveolar lavage fluid after the test measures, and the inflammatory of understanding air flue and alveolar changes.The test grouping:
Select common rabbit (2.0 ± 0.4kg) 20 of body weight for use, divide medicine group and matched group, every group 10, earlier two groups of rabbit atomizings are sucked 4 weeks of 1% acetylcholine, 2 times/day, the about 8-10um of atomizing particle, the atomization gas flow is 4.5L/min, to the medicine group, matched group is not given medicine, measures lung resistance and lung compliance the trial drug nasal feeding in 1 all backs.Animal is prepared:
Give the quiet notes 20% urethane 15-20ml of auricular vein of experimental rabbits.After animal is fully anaesthetized, lying on the back is fixed on the workbench, and the circulation of qi promoting cannula connects animal and uses the respirator artificial ventilation, tidal volume is 50ml, ventilatory frequency 30 times/minute, arterial cannulation monitoring blood pressure, but quiet kind of Luo Ning 0.1mg, make muscular flaccidity, heating cushion keeps body temperature, connects physiology of respiration instrument (U.S. produces 3400s/DASA) through pick off, measures and presses through lung.Ventilation volume, flow.Test data deposits the corresponding calculated machine in, with monitor monitoring test wave mode.Medicine:
Lung qi dispersing anti-asthma pill (being the medicine that embodiment 1 makes) bronchoalveolar lavage fluid cytology measures:
After the off-test, with 15ml normal saline lavation 6 times (total amount 80ml), bronchoalveolar lavage fluid is at 1000rpm, and under 4 ℃ of conditions centrifugal 5 minutes, cellular layer added in the 4ml normal saline, gets 50ul cell irrigating solution and makes cell counting and sort check.Eosinophilic granulocyte peroxidase (EPO) is measured:
With the content of the OPO method mensuration bronchoalveolar lavage fluid supernatant EPO that improves, with the Log value representation of measured value.Statistical method:
All data X ± SD represent, compare each sample average with variance analysis, and P<0.05 is considered to difference significance.The result:
1. trial drug is to bringing out the effect of shrinking air flue:
Medicine group and matched group compare, and lung resistance descends (P<0.05) and lung compliance increases (P<0.05), the results are shown in Table 1.This shows that medicine of the present invention can reduce lung resistance, improves compliance, and the air flue of contraction is brought out in diastole.
Table 1
Measurement index The medicine group Matched group
Lung resistance (R L) 69.8±7.3 85.6±8.5
Lung compliance (C L) 3.8±0.8 4.5±1.1
2. trial drug is to the effect of air flue inflammatory cell:
Medicine group and matched group compare, and total cellular score descends, and eosinophilic granulocyte descends (P<0.05), and pulmonary alveolar macrophage, medium-sized grain cell and lymphocyte there was no significant difference (P>0.05) the results are shown in Table 2.
Table 2
The medicine group Matched group
Total cellular score 8.6±0.9 10.3±0.9
Pulmonary alveolar macrophage 7.8±0.8 7.9±1.4
Eosinophilic granulocyte 0.36±0.23 2.01±0.63
Neutrophilic granulocyte 0.15±0.12 0.17±0.15
Lymphocyte 0.3±0.13 0.31±0.14
3. trial drug is to the effect of acidophil peroxidase (EPO)
Medicine group and matched group compare, and the content of EPO descends (P<0.05), shows that trial drug can reduce the release of airway inflammation medium, alleviate the airway epithelia damage, the results are shown in Table 3.
Table 3
The medicine group Matched group
LogEPO 1.32±0.4 1.81±0.3
The bronchitis of asthma relates generally to hypertrophy, eosinophilic granulocyte and lymphocyte, and wherein eosinophilic granulocyte is main function cells, and various inflammatory mediators such as leukotriene (LTC can be synthesized and discharge to eosinophilic granulocyte 4, LTD 4) and PAF, cause that tracheal smooth muscle shrinks, blood capillary infiltration and mucous gland secretion increase, PAF promotes the effect of gathering, activation and the release toxic protein of eosinophilic granulocyte in addition, the peroxidase of eosinophilic granulocyte (EPO) is that eosinophilic granulocyte produces and discharges a kind of in the toxic protein, its energy coup injury airway epithelia causes epithelium to peel off.The key of therefore effecting a radical cure asthma and control recurrence is the number that alleviates the air flue inflammatory cell, the release of the inflammatory mediator of reduction air flue and the reactivity of air flue, from above-mentioned test as can be seen, trial drug can reduce the lung resistance that brings out the contraction air flue and improve lung compliance, diastole central authorities and peripheral airways, reduce the quantity of alveolar and air flue eosinophilic granulocyte, reduce the eosinophilic granulocyte activation and discharge inflammatory mediator acidophil peroxidase (EPO), reduce the sensitivity of air flue.The clinical observation on the therapeutic effect materials and methods of test example 2 trial drugs of the present invention:
746 routine bronchial asthma patients, male's 410 examples wherein, women's 354 examples, minimum 2 years old of age, maximum 81 years old, 42 years old mean age.The diagnosis of all cases and therapeutic evaluation all are divided into two group by randomized principle with case according to Chinese Medical Association's pneumatology meeting " diagnosis of bronchial asthma, by stages and efficacy assessment standard " (2), and wherein 600 examples are organized in treatment, matched group 164 examples.
Table 4 764 routine bronchial asthma mutual affection cloth situations
Type The treatment group Matched group Add up to
Slightly 108 18.0 32 19.5 140
Moderate 376 62.7 99 60.4 475
Severe 116 19.3 33 20.1 149
Add up to 600 100 164 100 764
x 2Two groups of no significance difference of state of an illness distribution are analysed in=1.554 P>0.05 credit by statistics.The shortest person of the course of disease not enough half a year, elder surpass 40 years, asthma person's 751 examples are arranged, cough person's 592 examples among the 746 routine patients, expectoration person's 615 examples, the person's of breathing hard 229 examples merge chronic bronchitis 102 examples, merge emphysema 184 examples, merge pulmonary heart disease 12 examples, merge pulmonary tuberculosis person's 20 examples.Therapeutic Method:
Treatment divides local treatment and two stages of wholistic therapy function, and 3 totally months is a course of treatment.The simple general 1-2 of property asthma course of treatment, 2-3 course of treatment of Secondary cases emphysema person.
Topical therapeutic medicine: lung qi dispersing anti-asthma pill (making among the embodiment 1).Usage: take 12 grams, every day four times, taking medicine after meal serve on 30 days, reaches the controlled degree of symptom at every turn.
Matched group all adopts antiinflammatory (erythromycin, SMZ penicillin etc.), antiallergic (oral hismanal etc.), relievings asthma (oral aminophylline, add when being in a bad way with isoproterenol, hormone etc.) therapy, adds carbetapentane citrate, bromhexine hydrochloride if any the expectoration symptom.The result:
Short term effect: behind the topical therapeutic of 1-2 the course of treatment, the most patients symptom is controlled, and credit is analysed by statistics, and treatment group clinical symptoms control rate is higher than matched group, and difference has the significance meaning.See Table 5.
Table 5 liang group patient local treatment effect analysis
The treatment group Matched group
Slightly Moderate Severe Meter Slightly Moderate Severe Meter
Add up to 108 376 116 600 32 99 33 164
Face control 102 312 94 508 22 54 10 86
Produce effects 6 48 18 72 4 19 9 32
Take a turn for the better - 14 2 16 3 11 5 19
Invalid - 2 2 4 3 15 9 27
Face control rate (%) 94.44 82.98 81.03 84.67 68.75 54.55 30.30 52.44
Effective percentage (%) 100 99.47 98.28 99.33 90.63 84.85 72.73 83.54
Two groups of control rates compare X 2=91.24 P<0.01.Table 6 treatment group different symptoms control situation
The symptom characteristic The example number Curative effect The example number Total effective rate
Cough 464 Face control 442 95.25 100
Produce effects 16 3.45
Take a turn for the better 6 1.29
Invalid - -
Expectorant 482 Face control 442 95.95 100
Produce effects 14 2.90
Take a turn for the better 6 2.25
Invalid - -
Breathe heavily 600 Face control 490 81.67 99.33
Produce effects 96 16
Take a turn for the better 10 1.67
Invalid 4 0.67
Wheezing sound 483 Face control 396 81.99 97.10
Produce effects 36 7.45
Take a turn for the better 38 7.87
Invalid 14 2.90

Claims (8)

1. pharmaceutical composition for the treatment of chronic obstructive disease of lung, it is characterized in that it comprises active component and/or the pharmaceutically acceptable additives of being made by following raw materials according: Rhizoma Belamcandae 3-20 weight portion, Pseudobulbus Bletillae (Rhizoma Bletillae) 1-10 weight portion, Bombyx Batryticatus 3-20 weight portion, Radix Aucklandiae 3-15 weight portion, Radix Paeoniae Rubra 3-15 weight portion, Bulbus Fritillariae Cirrhosae 10-50 weight portion, Radix Glycyrrhizae 3-15 weight portion, Rhizoma Chuanxiong 3-20 weight portion, Fructus Amomi 3-15 weight portion, Rhizoma Pinelliae 3-20 weight portion.
2. according to the pharmaceutical composition of claim 1, active component is wherein made by following raw materials according: Rhizoma Belamcandae 9-20 weight portion, Pseudobulbus Bletillae (Rhizoma Bletillae) 4-10 weight portion, Bombyx Batryticatus 5-15 weight portion, Radix Aucklandiae 5-10 weight portion, Radix Paeoniae Rubra 5-10 weight portion, Bulbus Fritillariae Cirrhosae 20-40 weight portion, Radix Glycyrrhizae 6-12 weight portion, Rhizoma Chuanxiong 7-13 weight portion, Fructus Amomi 5-11 weight portion, Rhizoma Pinelliae 9-15 weight portion.
3. according to the pharmaceutical composition of claim 1, active component is wherein made by following raw materials according: Rhizoma Belamcandae 15 weight portions, the Pseudobulbus Bletillae (Rhizoma Bletillae) 8 weight portions, Bombyx Batryticatus 10 weight portions, the Radix Aucklandiae 8 weight portions, Radix Paeoniae Rubra 7 weight portions, Bulbus Fritillariae Cirrhosae 35 weight portions, Radix Glycyrrhizae 10 weight portions, Rhizoma Chuanxiong 9 weight portions, Fructus Amomi 8 weight portions, the Rhizoma Pinelliae 12 weight portions.
4. method for preparing the pharmaceutical composition for the treatment of chronic obstructive disease of lung, it comprises the following steps: a) to press the row weight portion and takes by weighing: Rhizoma Belamcandae 3-20 part, Pseudobulbus Bletillae (Rhizoma Bletillae) 1-10 part, Bombyx Batryticatus 3-20 part, Radix Aucklandiae 3-15 part, Radix Paeoniae Rubra 3-15 part, Bulbus Fritillariae Cirrhosae 10-50 part, Radix Glycyrrhizae 3-15 part, Rhizoma Chuanxiong 3-20 part, Fructus Amomi 3-15 part, Rhizoma Pinelliae 3-20 part is standby; B) 1-60% of the 1-60% of the 1-60% of the 1-60% of the Bombyx Batryticatus of whole consumptions, Bulbus Fritillariae Cirrhosae consumption, Pseudobulbus Bletillae (Rhizoma Bletillae) consumption, Rhizoma Belamcandae consumption and Fructus Amomi consumption is pulverized, mixing is crossed 140 mesh sieves and made powder, and is standby; C) remaining Chinese crude drug being made 50 ℃ of heat through water or alcohol extraction, to survey relative densities be the water of 1-1.5 or the concentrated thick paste of alcohol extract, when wherein extracting solvent and being water, adopt decocting method to extract twice, the 3-30 that each consumption all is a Chinese crude drug doubly, extraction time is 1-5 hour for the first time, be 0.2-5 hour for the second time, merge decocting liquid twice, concentrate; When the extraction solvent is alcohol, adopt reflux extraction to extract once, solvent load is 10-40 a times of Chinese crude drug weight, and extraction time is 2-6 hour, and the extraction temperature is 50-80 ℃, reclaims solvent, concentrates; D) the thick paste mixing that makes in the 80-90% of the medicated powder that makes in the step b) and the step c), pill also earlier carries out the ground floor coating with remaining medicated powder in the step b), and the Haematitum powder of reuse 1% carries out second layer coating, polishing.
5. preparation method according to claim 4, wherein the raw material consumption is: Rhizoma Belamcandae 9-20 weight portion, Pseudobulbus Bletillae (Rhizoma Bletillae) 4-10 weight portion, Bombyx Batryticatus 5-15 weight portion, Radix Aucklandiae 5-10 weight portion, Radix Paeoniae Rubra 5-10 weight portion, Bulbus Fritillariae Cirrhosae 20-40 weight portion, Radix Glycyrrhizae 6-12 weight portion, Rhizoma Chuanxiong 7-13 weight portion, Fructus Amomi 5-11 weight portion, Rhizoma Pinelliae 9-15 weight portion.
6. preparation method according to claim 4, wherein the raw material consumption is: Rhizoma Belamcandae 15 weight portions, the Pseudobulbus Bletillae (Rhizoma Bletillae) 8 weight portions, Bombyx Batryticatus 10 weight portions, the Radix Aucklandiae 8 weight portions, Radix Paeoniae Rubra 7 weight portions, Bulbus Fritillariae Cirrhosae 35 weight portions, Radix Glycyrrhizae 10 weight portions, Rhizoma Chuanxiong 9 weight portions, Fructus Amomi 8 weight portions, the Rhizoma Pinelliae 12 weight portions.
7. according to any one the described preparation method among the claim 4-6, wherein said alcohol is the ethanol of 50-99%.
8. preparation method according to claim 7, wherein said alcohol are 95% ethanol.
CN97100465A 1997-02-17 1997-02-17 Medicinal composition for treating chronic obstructive disease of lung and its preparing process Expired - Fee Related CN1059107C (en)

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CN102688386B (en) * 2012-06-14 2013-11-06 李良 Chinese honeylocust seed Chinese medicinal decoction for treating asthma and preparation method
CN106880805A (en) * 2015-12-15 2017-06-23 韦翔鹏 A kind of Chinese medicine composition for treating tuberculosis
CN114436889A (en) 2020-11-02 2022-05-06 湖北金湘宁化工科技有限公司 Ammoximation reaction and separation integrated method and device thereof

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