CN101829082B - Method for preparing veterinary injection of spectinomycin hydrochloride and lincomycin hydrochloride - Google Patents
Method for preparing veterinary injection of spectinomycin hydrochloride and lincomycin hydrochloride Download PDFInfo
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Abstract
The invention relates to a method for preparing veterinary injection of spectinomycin hydrochloride and lincomycin hydrochloride. The spectinomycin hydrochloride is coated by cyclodextrin to form an inclusion compound, and then the inclusion compound is prepared into compound injection with the lincomycin hydrochloride. The stability of the injection of the spectinomycin hydrochloride and the lincomycin hydrochloride prepared by the method is obviously higher than that of the injection prepared by a conventional method; the injection completely meets the requirements of the quality standard of the injection; and clinical experiments show that the treatment effect of the injection is obviously better than that of the injection prepared by the conventional method. The preparation method of the invention breaks through the key technical difficulty of the compound injection of the spectinomycin hydrochloride and the lincomycin hydrochloride so as to ensure good quality and medicament effect of the product, and can provide a medicament with stable quality and clear treatment effect for clinically treating infections of livestock and poultry bacteria, mycoplasma and the like through veterinarians.
Description
Technical field
The invention belongs to field of antibiotics for animals, relate to the preparation method of a kind of spectinomycin hydrochloride, lincomycin hydrochloride injection.
Background technology
Spectinomycin (spectinomycin) is a kind of aminoglycoside antibiotics that is produced by streptomycete, is used for gram negative bacteria and mycoplasma infection.It is low that spectinomycin has toxicity, to advantages such as the toxic and side effects such as mammiferous liver, lung, kidney are little, becoming one of first-selected kind of veterinary drug in effective dosage ranges.Studies show that, the livestock and poultry that caused by streptococcus, erysipelas filamentous bacteria, staphylococcus aureus, pasteurellosis bacillus, escherichia coli, Salmonella and mycoplasma can effectively be treated and prevent to spectinomycin, especially remarkable to mycoplasma and escherichia coli mixed infection effect.As a kind of Novel veterinary antibiotic, the resistant strain of spectinomycin is few.The spectinomycin intramuscular injection absorbs good, and blood level can reach the peak in about 1h, almost 100% eliminating from urine behind the administration 48h, and residual quantity is extremely low.
Lincomycin (lincomycin) is general saccharide antibiotic, is used for gram positive bacteria and mycoplasma infection.
But spectinomycin and lincomycin mainly reach the extremely effect of pathogenic microorganism by the synthetic of anti-bacteria protein, and both compatibilities are used has synergism, the clinical hydrochlorate of commonly using both.Lincomycin hydrochloride and spectinomycin hydrochloride compatibility have the simultaneously effect of resisting gram-positive bacteria, gram negative bacteria and mycoplasma, and its field of activity is wider than single lincomycin or spectinomycin.
Spectinomycin for animals in the market, the compound preparation of lincomycin are mainly the oral formulations such as pre-mixing agent, soluble powder, but both oral absorption are all relatively poor, and drug administration by injection absorbs then fine.Spectinomycin hydrochloride and lincomycin hydrochloride are made injection can obviously improve bioavailability and tissue distribution, onset is rapider.Therefore except enterobacterial infection, for the treatment of its hetero-organization and the infection of whole body antibacterial or mycoplasma infection disease, then more be necessary to use the injection of spectinomycin hydrochloride, lincomycin hydrochloride, to reach desirable therapeutic effect.
Spectinomycin hydrochloride is insoluble to the organic solvents such as ethanol, chloroform, ether, and is soluble in water, but its aqueous solution is extremely unstable, and spectinomycin hydrochloride is tired in aqueous solution, pH value all can fast-descending, and color burn fades to dark yellow.Preparation method with the injection of routine, although also added some antioxidants commonly used, but still can not prevent the hydrolysis of spectinomycin, can not obtain stable spectinomycin hydrochloride, lincomycin hydrochloride injection, under the accelerated test condition, place the requirement that did not only namely meet quality standard in 1 month.Therefore how solving the stability of spectinomycin hydrochloride in aqueous solution is the stable spectinomycin hydrochloride of preparation, the key of lincomycin hydrochloride injection.
Summary of the invention
The object of the present invention is to provide a kind of stable spectinomycin hydrochloride for animals, the preparation method of lincomycin hydrochloride injection.The present invention carries out enclose with spectinomycin hydrochloride with cyclodextrin, can significantly improve the stability of spectinomycin hydrochloride in aqueous solution, thereby has guaranteed stability and the curative effect of spectinomycin hydrochloride, lincomycin hydrochloride injection.The present invention has broken through the key technology difficult problem of spectinomycin hydrochloride, lincomycin hydrochloride compound injection, preparation method of the present invention has guaranteed quality and the drug effect that this series products is good, be the infection such as veterinary clinic treatment poultry antibacterial, mycoplasma, the medicine of steady quality, determined curative effect is provided.
The objective of the invention is to be achieved through the following technical solutions:
The invention provides the preparation method of a kind of spectinomycin hydrochloride for animals, lincomycin hydrochloride injection, it is characterized in that spectinomycin hydrochloride is carried out enclose with cyclodextrin, the spectinomycin hydrochloride clathrate of making is prepared into compound injection with lincomycin hydrochloride again.
Wherein, the weight proportion of spectinomycin hydrochloride and cyclodextrin be preferably 30: 1～1: 20.
Further, the weight proportion of spectinomycin hydrochloride and cyclodextrin be preferably 15: 1～1: 10.
Used lincomycin hydrochloride and the weight proportion of spectinomycin hydrochloride among the present invention, the weight proportion adding gets final product routinely, but be the synergistic function of better bringing into play the two, reaching preferably clinical effectiveness, the weight proportion of spectinomycin hydrochloride and lincomycin hydrochloride can be 20: 1～and 1: 10.
Further, the weight proportion preferable range of spectinomycin hydrochloride and lincomycin hydrochloride is 10: 1～1: 5.
Further, the weight proportion of spectinomycin hydrochloride and lincomycin hydrochloride is 2: 1.
The used cyclodextrin of the present invention can be in alpha-cyclodextrin, hydroxyethyl-β-cyclodextrin, HP-β-CD, DM-β-CD, TM-β-CD, the gamma-cyclodextrin any one.
The preparation method of spectinomycin hydrochloride for animals of the present invention, lincomycin hydrochloride injection, its preparation process is as follows:
(1) get an amount of water for injection, add by weight ratio cyclodextrin dissolving, add spectinomycin hydrochloride, 40-60 ℃ rapid stirring 20-30 minute;
(2) add lincomycin hydrochloride, stirring and dissolving;
(3) water for injection that takes a morsel adds antioxidant, stirring and dissolving;
(4) merge (2), (3) liquid, use the water for injection standardize solution;
(5) filter embedding, filtering with microporous membrane degerming or Co 60 ray sterilizing.
The preparation method of spectinomycin hydrochloride for animals of the present invention, lincomycin hydrochloride injection, its preparation also can be carried out as follows:
(1) cyclodextrin is made 50 ℃ saturated aqueous solution, added by weight ratio spectinomycin hydrochloride, stirred at least 30 minutes, be cooled to rapidly below 4 ℃, filter, drying namely gets the clathrate of spectinomycin hydrochloride;
(2) get an amount of water for injection, add the spectinomycin hydrochloride clathrate, stirring and dissolving adds the lincomycin hydrochloride stirring and dissolving;
(3) water for injection that takes a morsel adds antioxidant, stirring and dissolving;
(4) merge (2), (3) liquid, use the water for injection standardize solution;
(5) filter embedding, filtering with microporous membrane degerming or Co 60 ray sterilizing.
The present invention is different from the preparation method of traditional compound injection, but with the processing of spectinomycin hydrochloride by cyclodextrin inclusion compound, obtains stable clathrate, again itself and lincomycin hydrochloride is prepared into compound injection.Preparation method of the present invention is passed through to improve the stability of spectinomycin hydrochloride in aqueous solution, thereby has guaranteed the Quality and curative effect of product.Preparation method step of the present invention is simple, but broken through the key technology difficult problem of spectinomycin hydrochloride, lincomycin hydrochloride compound injection, thereby quality and drug effect that this series products is good have been guaranteed, be the infection such as veterinary clinic treatment poultry antibacterial, mycoplasma, the medicine of steady quality, determined curative effect is provided.
, it should be understood that described embodiment only is for the present invention is described, rather than limit the scope of the invention by any way more specific description the present invention by the following example.
The specific embodiment
Embodiment 1
Prescription:
Spectinomycin hydrochloride 10g
Lincomycin hydrochloride 5g
HP-β-CD 5g
Antioxidant is an amount of
Water for injection adds to 100mL
Preparation method:
(1) gets water for injection 70mL, add by weight ratio HP-β-CD, add spectinomycin hydrochloride, 50 ℃ of rapid stirrings 30 minutes;
(2) add lincomycin hydrochloride, stirring and dissolving;
(3) water for injection that takes a morsel adds antioxidant, stirring and dissolving;
(4) merge (2), (3) liquid, use the water for injection standardize solution;
(5) filter embedding, filtering with microporous membrane degerming.
Embodiment 2
Prescription:
Spectinomycin hydrochloride 4g
Lincomycin hydrochloride 2g
Hydroxyethyl-β-cyclodextrin 40g
Antioxidant is an amount of
Water for injection adds to 100mL
Preparation method:
(1) the hydroxyethyl-β-cyclodextrin cyclodextrin is prepared into 50 ℃ of saturated solutions, adds by weight ratio spectinomycin hydrochloride, stirred 30 minutes, be cooled to rapidly below 4 ℃, filter, drying gets the spectinomycin hydrochloride clathrate;
(2) get water for injection 70mL, add the spectinomycin hydrochloride clathrate, stirring and dissolving adds the lincomycin hydrochloride stirring and dissolving;
(3) water for injection that takes a morsel adds antioxidant, stirring and dissolving;
(4) merge (2), (3) liquid, use the water for injection standardize solution;
(5) filter, 60 ray sterilizings are bored in embedding.
Embodiment 3
Prescription:
Spectinomycin hydrochloride 30g
Lincomycin hydrochloride 15g
Gamma-cyclodextrin 1g
Antioxidant is an amount of
Water for injection adds to 100mL
Preparation method:
(1) gets water for injection 70mL, add by weight ratio gamma-cyclodextrin, add spectinomycin hydrochloride, 60 ℃ of rapid stirrings 30 minutes;
(2) add lincomycin hydrochloride, stirring and dissolving;
(3) water for injection that takes a morsel adds antioxidant, stirring and dissolving;
(4) merge (2), (3) liquid, use the water for injection standardize solution;
(5) filter embedding, filtering with microporous membrane degerming.
Embodiment 4
Prescription:
Spectinomycin hydrochloride 2g
Lincomycin hydrochloride 1g
Alpha-cyclodextrin 40g
Antioxidant is an amount of
Water for injection adds to 100mL
Preparation method:
(1) the alpha-cyclodextrin cyclodextrin is prepared into 50 ℃ of saturated solutions, adds by weight ratio spectinomycin hydrochloride, stirred 30 minutes, be cooled to rapidly below 4 ℃, filter, drying gets the spectinomycin hydrochloride clathrate;
(2) get water for injection 70mL, add the spectinomycin hydrochloride clathrate, stirring and dissolving adds the lincomycin hydrochloride stirring and dissolving;
(3) water for injection that takes a morsel adds antioxidant, stirring and dissolving;
(4) merge (2), (3) liquid, use the water for injection standardize solution;
(5) filter embedding, filtering with microporous membrane degerming.
Embodiment 5
Prescription:
Spectinomycin hydrochloride 15g
Lincomycin hydrochloride 7.5g
DM-β-CD 1g
Antioxidant is an amount of
Water for injection adds to 100mL
Preparation method:
(1) gets water for injection 70mL, add by weight ratio DM-β-CD, add spectinomycin hydrochloride, 40 ℃ of rapid stirrings 30 minutes;
(2) add lincomycin hydrochloride, stirring and dissolving;
(3) water for injection that takes a morsel adds antioxidant, stirring and dissolving;
(4) merge (2), (3) liquid, use the water for injection standardize solution;
(5) filter embedding, Co 60 ray sterilizing.
Embodiment 6
Prescription:
Spectinomycin hydrochloride 10g
Lincomycin hydrochloride 5g
TM-β-CD 4g
Antioxidant is an amount of
Water for injection adds to 100mL
Preparation method:
(1) gets water for injection 70mL, add by weight ratio TM-β-CD, add spectinomycin hydrochloride, 50 ℃ of rapid stirrings 30 minutes;
(2) add lincomycin hydrochloride, stirring and dissolving;
(3) water for injection that takes a morsel adds antioxidant, stirring and dissolving;
(4) merge (2), (3) liquid, use the water for injection standardize solution;
(5) filter embedding, filtering with microporous membrane degerming.
Experimental example 1 is according to the spectinomycin hydrochloride of embodiment 1 preparation, the accelerated test study on the stability of lincomycin hydrochloride injection
The preparation of control drug: get water for injection 70mL, add spectinomycin hydrochloride 10g, stirring and dissolving; Add lincomycin hydrochloride 4g, stirring and dissolving; Add with the water-soluble antioxidant of a small amount of injection; Use the water for injection standardize solution; Filter embedding, filtering with microporous membrane degerming.
Test method: the method according to embodiment 1 prepares spectinomycin hydrochloride, lincomycin hydrochloride injection, with the stability of control drug comparison under the accelerated test condition.40 ± 2 ℃ of temperature, placed six months under the condition of relative humidity 75 ± 5%.Sampling in the 1st, 2,3,6 month once, detect by stable high spot reviews project respectively.
Result of the test: the comparative result for preparing the stability of spectinomycin hydrochloride, lincomycin hydrochloride injection and control drug according to the method for embodiment 1 sees Table 1
Table 1 accelerated test result
Experimental example 2 is investigated according to the spectinomycin hydrochloride of embodiment 1 preparation, the long-time stability of lincomycin hydrochloride injection
The preparation of control drug: get water for injection 70mL, add spectinomycin hydrochloride 10g, stirring and dissolving; Add lincomycin hydrochloride 4g, stirring and dissolving; Add with the water-soluble antioxidant of a small amount of injection; Use the water for injection standardize solution; Filter embedding, filtering with microporous membrane degerming.
Test method: the method according to embodiment 1 prepares spectinomycin hydrochloride, lincomycin hydrochloride injection, with the stability of control drug comparison under the long term test condition.25 ± 2 ℃ of temperature, placed 12 months under the condition of relative humidity 60 ± 5%.Sampling in the 3rd, 6,9,12 month once, detect by stable high spot reviews project respectively.
Result of the test: the comparative result for preparing the stability of spectinomycin hydrochloride, lincomycin hydrochloride injection and control drug according to the method for embodiment 1 sees Table 2
Table 2 long-term test results
Experimental example 3 is according to the spectinomycin hydrochloride of embodiment 1 preparation, the Effect tests of lincomycin hydrochloride injection clinical treatment respiratory tract infection
The preparation of control drug: get water for injection 70mL, add spectinomycin hydrochloride 10g, stirring and dissolving; Add lincomycin hydrochloride 4g, stirring and dissolving; Add with the water-soluble antioxidant of a small amount of injection; Be settled to 100mL with water for injection; Filter embedding, filtering with microporous membrane degerming.
Test method: choose body weight 25 ± 5kg, be diagnosed as 90 of the growing and fattening pigs of respiratory tract infection, be divided at random 3 groups, be i.e. I, II, III group, 30 every group.The intramuscular injection of I group is according to spectinomycin hydrochloride, the lincomycin hydrochloride injection of embodiment 1 preparation, and per kilogram of body weight injection 0.1mL once a day, is used in conjunction three days; II group intramuscular injection control drug, per kilogram of body weight injection 0.1mL once a day, is used in conjunction three days.The III group is blank group, not administration.
Result of the test: the clinical test results for preparing spectinomycin hydrochloride, lincomycin hydrochloride injection and control drug according to the method for embodiment 1 sees Table 3
The clinical test results of table 3 treatment respiratory tract infection
| Group | Experiment number (head) | Cure number (head) | Cure rate (%) | Good revolution (head) | Improvement rate (%) | Invalid number | Inefficiency |
| I | 30 | 30 | 100 | 0 | 0 | 0 | 0 |
| II | 30 | 20 | 66.7 | 7 | 23.3 | 3 | 10 |
| III | 30 | 0 | 0 | 3 | 10 | 27 | 90 |
The symptoms of respiratory disease such as the cough of I group pig, rapid breathing obviously alleviate in the process of the test, and the mental status is clearly better, and does not find any adverse effect.II group porcine respiratory disease sx↓, the mental status takes a turn for the better, and does not find obvious adverse effect.III group porcine respiratory disease symptom does not alleviate, and spirit is depressed.
Experimental example 4 is according to the spectinomycin hydrochloride of embodiment 1 preparation, the Effect tests of lincomycin hydrochloride injection clinical treatment piglet diarrhea
The preparation of control drug: get water for injection 70mL, add spectinomycin hydrochloride 10g, stirring and dissolving; Add lincomycin hydrochloride 4g, stirring and dissolving; Add with the water-soluble antioxidant of a small amount of injection; Be settled to 100mL with water for injection; Filter embedding, filtering with microporous membrane degerming.
Test method: choose body weight 14 ± 2kg, 90 of the ablactational baby pig of symptom of diarrhea are arranged, be divided at random 3 groups, be i.e. I, II, III group, 30 every group.The intramuscular injection of I group is according to spectinomycin hydrochloride, the lincomycin hydrochloride injection of embodiment 1 preparation, and per kilogram of body weight injection 0.1mL once a day, is used in conjunction three days; II group intramuscular injection control drug, per kilogram of body weight injection 0.1mL once a day, is used in conjunction three days; The III group is blank group, not administration.
Result of the test: the clinical test results for preparing spectinomycin hydrochloride, lincomycin hydrochloride injection and control drug according to the method for embodiment 1 sees Table 4
The clinical test results of table 4 treatment piglet diarrhea
I group piglet feed intake obviously increases in the process of the test, the mental status is clearly better, and does not find any adverse effect.II group piglet feed intake increases, the mental status slightly take a favorable turn, and does not find obvious adverse effect.III organizes piglet appetite, the mental status is relatively poor.
Experimental example 5 is according to the spectinomycin hydrochloride of embodiment 1 preparation, the Effect tests of lincomycin hydrochloride injection clinical treatment sow triad in puerperal
The preparation of control drug: get water for injection 70mL, add spectinomycin hydrochloride 10g, stirring and dissolving; Add lincomycin hydrochloride 4g, stirring and dissolving; Add with the water-soluble antioxidant of a small amount of injection; Be settled to 100mL with water for injection; Filter embedding, filtering with microporous membrane degerming.
Test method: choose body weight 200 ± 10kg, be diagnosed as 45 of the sows of triad in puerperal, be divided at random 3 groups, be i.e. I, II, III group, 15 every group.The intramuscular injection of I group is according to spectinomycin hydrochloride, the lincomycin hydrochloride injection of embodiment 1 preparation, and per kilogram of body weight injection 0.1mL once a day, is used in conjunction three days; II group intramuscular injection control drug, per kilogram of body weight injection 0.1mL once a day, is used in conjunction three days; The III group is blank group, not administration.
Result of the test: the clinical test results according to spectinomycin hydrochloride, lincomycin hydrochloride injection and the control drug of the preparation of the method for embodiment 1 sees Table 5
The clinical test results of table 5 treatment sow triad in puerperal
| Group | A test sow number | Cure number (head) | Cure rate (%) | Good revolution | Improvement rate | Invalid number | Inefficiency |
| I | 15 | 15 | 100 | 0 | 0 | 0 | 0 |
| II | 15 | 11 | 73.3％ | 3 | 20 | 1 | 6.7 |
| III | 15 | 0 | 0 | 2 | 13.3 | 13 | 86.7 |
I group sow appetite, the mental status are clearly better in the process of the test, do not find any adverse effect.II group sow appetite, the mental status slightly take a favorable turn, and do not find obvious adverse effect.III organizes sow appetite, the mental status is relatively poor.
Claims (6)
1. the preparation method of a spectinomycin hydrochloride for animals, lincomycin hydrochloride injection, it is characterized in that spectinomycin hydrochloride is carried out enclose with cyclodextrin, the spectinomycin hydrochloride clathrate of making is prepared into compound injection with lincomycin hydrochloride again, wherein, the weight proportion of spectinomycin hydrochloride and lincomycin hydrochloride is 20: 1～1: 10, and used cyclodextrin is any one in alpha-cyclodextrin, hydroxyethyl-β-cyclodextrin, HP-β-CD, DM-β-CD, TM-β-CD, the gamma-cyclodextrin.
2. the preparation method of spectinomycin hydrochloride for animals according to claim 1, lincomycin hydrochloride injection, the weight proportion that it is characterized in that spectinomycin hydrochloride and cyclodextrin is 30: 1～1: 20.
3. the preparation method of spectinomycin hydrochloride for animals according to claim 2, lincomycin hydrochloride injection, the weight proportion that it is characterized in that spectinomycin hydrochloride and cyclodextrin is 15: 1～1: 10.
4. the preparation method of spectinomycin hydrochloride for animals according to claim 1, lincomycin hydrochloride injection, the weight proportion that it is characterized in that spectinomycin hydrochloride and lincomycin hydrochloride is 10: 1～1: 5.
5. the preparation method of each described spectinomycin hydrochloride for animals, lincomycin hydrochloride injection according to claim 1-3 is characterized in that step is as follows:
(1) get an amount of water for injection, add by weight ratio cyclodextrin dissolving, add spectinomycin hydrochloride, 40-60 ℃ rapid stirring 20-30 minute;
(2) add lincomycin hydrochloride, stirring and dissolving;
(3) water for injection that takes a morsel adds antioxidant, stirring and dissolving;
(4) merge (2), (3) liquid, use the water for injection standardize solution;
(5) filter embedding, filtering with microporous membrane degerming or Co 60 ray sterilizing.
6. the preparation method of each described spectinomycin hydrochloride for animals, lincomycin hydrochloride injection according to claim 1-3 is characterized in that step is as follows:
(1) cyclodextrin is made 50 ℃ saturated aqueous solution, added by weight ratio spectinomycin hydrochloride, stirred at least 30 minutes, be cooled to rapidly below 4 ℃, filter, drying namely gets the clathrate of spectinomycin hydrochloride;
(2) get an amount of water for injection, add the spectinomycin hydrochloride clathrate, stirring and dissolving adds the lincomycin hydrochloride stirring and dissolving;
(3) water for injection that takes a morsel adds antioxidant, stirring and dissolving;
(4) merge (2), (3) liquid, use the water for injection standardize solution;
(5) filter embedding, filtering with microporous membrane degerming or Co 60 ray sterilizing.
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| CN102048748B (en) * | 2010-12-27 | 2012-08-22 | 华南农业大学 | Lincomycin and spectinomycin compound oil suspension injection and preparation method and application thereof |
| CN102652756B (en) * | 2011-03-04 | 2015-08-12 | 湖北武当动物药业有限责任公司 | Animal compound lincomycin hydrochloride and artemisinin injection and preparation technology thereof |
| CN102793713A (en) * | 2011-07-07 | 2012-11-28 | 上海公谊兽药厂 | Lincomycin hydrochloride-spectinomycin sulfate injection and preparation method thereof |
| CN104473958A (en) * | 2014-12-15 | 2015-04-01 | 洛阳瑞华动物保健品有限公司 | Compound premix and preparation method and application thereof |
| CN106420635A (en) * | 2016-09-29 | 2017-02-22 | 乐山市瑞和祥生物制药有限公司 | Spectinomycin hydrochloride and lincomycin hydrochloride freeze-dried powder injection and preparation method of spectinomycin hydrochloride and lincomycin hydrochloride freeze-dried powder injection |
| CN111973613B (en) * | 2020-07-30 | 2022-04-08 | 瑞普（天津）生物药业有限公司 | Compound spectinomycin powder injection and preparation method thereof |
| CN113995722A (en) * | 2021-12-16 | 2022-02-01 | 四川欧邦生物科技有限公司 | Spectinomycin hydrochloride lincomycin hydrochloride soluble powder and preparation method thereof |
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Effective date of registration: 20220812 Address after: 101407 Beijing city Huairou District Yanqi Economic Development Zone No. 10 North Street Patentee after: Beijing Dabeinong Animal Health Care Technology Co.,Ltd. Patentee after: Shaoshan Dabeinong Animal Medicine Co.,Ltd. Address before: 100080, Zhongguancun building, No. 27 Zhongguancun street, Beijing, Haidian District, China, 14 floor Patentee before: BEIJING DABEINONG TECHNOLOGY GROUP Co.,Ltd. Patentee before: Beijing Dabeinong Animal Health Care Technology Co.,Ltd. Patentee before: Shaoshan Dabeinong Animal Medicine Co.,Ltd. |
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