CN104288136B - A kind of milk cow chlorhexidine acetate uterus injectant and preparation method thereof - Google Patents
A kind of milk cow chlorhexidine acetate uterus injectant and preparation method thereof Download PDFInfo
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- CN104288136B CN104288136B CN201410181360.6A CN201410181360A CN104288136B CN 104288136 B CN104288136 B CN 104288136B CN 201410181360 A CN201410181360 A CN 201410181360A CN 104288136 B CN104288136 B CN 104288136B
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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
- A61K31/13—Amines
- A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
- A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
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- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
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- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
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- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- General Chemical & Material Sciences (AREA)
- Gynecology & Obstetrics (AREA)
- Reproductive Health (AREA)
- Urology & Nephrology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The invention discloses a kind of milk cow chlorhexidine acetate uterus injectant and preparation method thereof, belong to technical field of veterinary.Contain the component of following quality per 100mL chlorhexidine acetate uterus injectants：2~5g of chlorhexidine acetate, 1~2g of naturally occurring emulsifying agent, 0~1.2g of surfactant, 1~4g of suspending agent, 0.1~0.5g of antioxidant, 1~3g of camphor, balance of injection soybean oil；Wherein, naturally occurring emulsifying agent, surfactant and suspending agent preferably soya lecithin, Span 80 and aluminum stearate successively, can delay or prevent particulate from increasing, and the biocompatibility of suspension is greatly improved, stability enhancing.The drug ingedient of chlorhexidine acetate uterus injectant is uniform in the present invention, medicine is present in oil phase in solid particulate form, sedimentation volume ratio is more than 0.9, it is not susceptible to caking phenomenon, stability and good biocompatibility, slow release effect is notable, and preparation process is simple, low cost, is suitable to large-scale industrial production.
Description
Technical field
The present invention relates to a kind of milk cow chlorhexidine acetate uterus injectant, and the uterus injectant preparation method,
Belong to technical field of veterinary.
Background technology
Chlorhexidine acetate is biguanide compound, the effect of (suppression) bacterium is killed with good, to gram-negative bacteria and positive bacteria
Very strong suppression killing action is respectively provided with, is a kind of good antiseptic.
At present, chlorhexidine acetate is one of active ingredient of numerous disinfectant preparations and health care compound preparation, with very
Good kills the effect of bacterium, mould and trichomonad, and has the effect such as anti-inflammatory, antipruritic, mould proof, deodorant concurrently.Common formulations have solution
Various formulations such as agent, suppository, ointment, spray, uterus injectant, gel.
The shortcomings of chlorhexidine acetate uterus injectant prepared by common process has poor stability, poor biocompatibility,
The quality of product is influenceed, active constituent content is low, and therapeutic effect is undesirable, and great inconvenience is caused to clinical treatment.
The content of the invention
It is an object of the invention to provide a kind of milk cow chlorhexidine acetate uterus injectant.
Meanwhile, the present invention also provides a kind of preparation method of milk cow chlorhexidine acetate uterus injectant.
In order to realize the above object the technical solution adopted in the present invention is：
A kind of milk cow chlorhexidine acetate uterus injectant, the component of following quality is contained per 100mL：Chlorhexidine acetate 2
~5g, 1~2g of naturally occurring emulsifying agent, 0~1.2g of surfactant, 1~4g of suspending agent, 0.1~0.5g of antioxidant, camphor 1~
3g, balance of injection soybean oil.
Described naturally occurring emulsifying agent and surfactant (surfactant-based emulsifying agent) belong to emulsifying agent class.Genuine milk
Agent is mainly including Arabic gum, lecithin (such as soybean lecithin), soybean lecithin.Surfactant-based emulsifying agent is preferably non-
Ionic surfactant, including fatty glyceride, sorbitan fatty acid ester (Span series, such as Span-80), pool Lip river
Husky nurse etc..
Described suspending agent is sodium carboxymethylcellulose, microcrystalline cellulose sodium carboxymethylcellulose, rilanit special, tristearin
Sour aluminium etc..
The preferred lipophilic antioxidant propylgallate of described antioxidant, tocopherol (VE) etc..
Preferably, a kind of milk cow chlorhexidine acetate uterus injectant, the component of following quality is contained per 100mL：Acetic acid
2~5g of Chlorhexidine, 1~2g of soybean lecithin, Span-800~1.2g, 1~4g of aluminum stearate, VE0.1~0.5g, camphor 1~
3g, balance of injection soybean oil.
It is furthermore preferred that a kind of milk cow chlorhexidine acetate uterus injectant, the component of following quality is contained per 100mL：Vinegar
Sour 2~5g of Chlorhexidine, 1~2g of soybean lecithin, Span-800.1~0.5g, 2~4g of aluminum stearate, VE0.1~0.5g, camphor
1~3g, balance of injection soybean oil.
More there is choosing, a kind of milk cow chlorhexidine acetate uterus injectant contains the component of following quality per 100mL：Vinegar
Sour Chlorhexidine 4g, soybean lecithin 1.2g, Span-800.1g, aluminum stearate 2g, VE0.5g, camphor 2.1g, balance of injection
Soybean oil.
A kind of milk cow preparation method of chlorhexidine acetate uterus injectant, comprises the following steps：In injection soybean oil
Middle addition naturally occurring emulsifying agent, surfactant, suspending agent, antioxidant and camphor add chlorhexidine acetate after stirring evenly, and stir evenly
Emulsification stirring afterwards is obtained final product.According to the dissolubility of each raw material, selectively heated, stir process, aforesaid operations are ability
Domain conventional technical means.
Specifically, a kind of milk cow preparation method of chlorhexidine acetate uterus injectant, comprises the following steps：
(1) the sterilized injection soybean oil in part (the 20~30% of full dose), heating stirring are taken, while adding suspending agent
(aluminum stearate), 115~125 DEG C are risen to by temperature, and clear gel system to be formed, i.e. factice stop stirring, keep 20~40
Stop heating after minute；
(2) treat that factice temperature is down to 95~105 DEG C, add naturally occurring emulsifying agent (soybean lecithin), stirring and dissolving is added
Partial syringe dilutes (the 30~40% of full dose) with soybean oil, cools down standby；
(3) treat that temperature is down to 25~35 DEG C, add surfactant (Span-80), antioxidant (VE) and camphor, stir evenly
After add chlorhexidine acetate, the injection soybean oil constant volume of surplus is added after stirring evenly, then emulsify stirring and obtain final product.
Emulsification stirring can use high-speed shearing emulsion machine in the step (3), the breast under 6000~10000r/min rotating speeds
Change stirring 0.5~1 hour.Then dispense, seal, sterilizing (irradiation sterilization) is obtained final product.
Beneficial effects of the present invention：
In the present invention chlorhexidine acetate for uterus injectant active component, add naturally occurring emulsifying agent, surfactant and
After suspending agent dispersion, it is easy to mix uniformly, drug ingedient is uniformly dispersed, and uniformity is high, and medicine is present in solid particulate form
In oil phase, sedimentation volume ratio is more than 0.9, is not susceptible to caking phenomenon, stability and good biocompatibility, and slow release effect is notable.
Preferably naturally occurring emulsifying agent soybean lecithin, surfactant Span-80 and suspending agent aluminum stearate of the invention, can prolong
Delay or prevent particulate from increasing, the biocompatibility of suspension is greatly improved, stability enhancing.In addition, the application is using at a high speed
Emulsification pretreatment machine emulsion dispersion, compare traditional mixer, the suspension that colloid mill is obtained " particle diameter " it is smaller, uniformity is higher,
Active ingredient emission and bioavilability are effectively improved.
The preparation process is simple of chlorhexidine acetate uterus injectant, low cost in the present invention, are suitable to large-scale industry metaplasia
Produce.
Specific embodiment
Following embodiments are only described in further detail to the present invention, but do not constitute any limitation of the invention.
Embodiment 1
Milk cow chlorhexidine acetate uterus injectant in the present embodiment, the component of following quality is contained per 1000mL：Acetic acid
Chlorhexidine 20g, soybean lecithin 10g, Span-803g, aluminum stearate 20g, VE1g, camphor 10g, balance of injection soybean
Oil.
The milk cow preparation method of chlorhexidine acetate uterus injectant, comprises the following steps in the present embodiment：
(1) the injection soybean oil of 200ml filtration sterilizations, heating stirring are added in material-compound tank, while adding stearic
Sour aluminium, 120 DEG C are risen to by temperature, and clear gel system to be formed, i.e. factice stop stirring, and heating is stopped after being kept for 30 minutes；
(2) treat that factice temperature is down to 100 DEG C, add soybean lecithin, stirring and dissolving adds 300ml injection soybean
Oil dilution, ON cycle water accelerates cooling；
(3) treat that temperature is down to 30 DEG C, to Span-80, VE and camphor is added in the factice that step (2) dilutes, after stirring evenly again
Chlorhexidine acetate is added, the injection soybean oil constant volume of surplus is added after stirring evenly, then be placed in high-speed shearing emulsion machine,
The emulsified stirring of 8000r/min rotating speeds 0.5 hour, packing, sealing, irradiation sterilization is obtained final product.
Embodiment 2
Milk cow chlorhexidine acetate uterus injectant in the present embodiment, the component of following quality is contained per 1000mL：Acetic acid
Chlorhexidine 30g, soybean lecithin 12g, Span-803g, aluminum stearate 25g, VE3g, camphor 21g, balance of injection soybean oil.
The milk cow preparation method of chlorhexidine acetate uterus injectant, comprises the following steps in the present embodiment：
(1) the injection soybean oil of 300ml filtration sterilizations, heating stirring are added in material-compound tank, while adding stearic
Sour aluminium, 115 DEG C are risen to by temperature, and clear gel system to be formed, i.e. factice stop stirring, and heating is stopped after being kept for 35 minutes；
(2) treat that factice temperature is down to 95 DEG C, add soybean lecithin, stirring and dissolving adds 350ml injection soybean oils
Dilution, ON cycle water accelerates cooling；
(3) treat that temperature is down to 25 DEG C, to Span-80, VE and camphor is added in the factice that step (2) dilutes, after stirring evenly again
Chlorhexidine acetate is added, the injection soybean oil constant volume of surplus is added after stirring evenly, then be placed in high-speed shearing emulsion machine,
The emulsified stirring of 6000r/min rotating speeds 1 hour, packing, sealing, irradiation sterilization is obtained final product.
Embodiment 3
Milk cow chlorhexidine acetate uterus injectant in the present embodiment, the component of following quality is contained per 1000mL：Acetic acid
Chlorhexidine 40g, soybean lecithin 12g, Span-801g, aluminum stearate 20g, VE5g, camphor 21g, balance of injection soybean
Oil.
The milk cow preparation method of chlorhexidine acetate uterus injectant, comprises the following steps in the present embodiment：
(1) the injection soybean oil of 250ml filtration sterilizations, heating stirring are added in material-compound tank, while adding stearic
Sour aluminium, 125 DEG C are risen to by temperature, and clear gel system to be formed, i.e. factice stop stirring, and heating is stopped after being kept for 25 minutes；
(2) treat that factice temperature is down to 105 DEG C, add soybean lecithin, stirring and dissolving adds 400ml injection soybean
Oil dilution, ON cycle water accelerates cooling；
(3) treat that temperature is down to 35 DEG C, to Span-80, VE and camphor is added in the factice that step (2) dilutes, after stirring evenly again
Chlorhexidine acetate is added, the injection soybean oil constant volume of surplus is added after stirring evenly, then be placed in high-speed shearing emulsion machine,
The emulsified stirring of 10000r/min rotating speeds 0.5 hour, packing, sealing, irradiation sterilization is obtained final product.
Embodiment 4
Milk cow chlorhexidine acetate uterus injectant in the present embodiment, the component of following quality is contained per 1000mL：Acetic acid
Chlorhexidine 50g, soybean lecithin 20g, Span-801g, aluminum stearate 30g, VE5g, camphor 21g, balance of injection soybean
Oil.
The milk cow preparation method of chlorhexidine acetate uterus injectant is with embodiment 1 in the present embodiment.
Embodiment 5
Milk cow chlorhexidine acetate uterus injectant in the present embodiment, the component of following quality is contained per 1000mL：Acetic acid
Chlorhexidine 50g, soybean lecithin 20g, Span-805g, aluminum stearate 40g, VE5g, camphor 30g, balance of injection soybean
Oil.
The milk cow preparation method of chlorhexidine acetate uterus injectant is with embodiment 1 in the present embodiment.
Embodiment 6
Milk cow chlorhexidine acetate uterus injectant in the present embodiment, the component of following quality is contained per 1000mL：Acetic acid
Chlorhexidine 50g, soybean lecithin 12g, Span-805g, aluminum stearate 20g, VE5g, camphor 30g, balance of injection soybean oil.
The milk cow preparation method of chlorhexidine acetate uterus injectant is with embodiment 1 in the present embodiment.
Embodiment 7
Milk cow chlorhexidine acetate uterus injectant in the present embodiment, the component of following quality is contained per 1000mL：Acetic acid chlorine
Oneself determines 50g, soybean lecithin 20g, Span-805g, fatty glyceride 30g, VE5g, camphor 30g, balance of injection soybean oil.
The milk cow preparation method of chlorhexidine acetate uterus injectant is with embodiment 1 in the present embodiment.
Test example
(1) selection of suspending agent
Primary election aluminum stearate, rilanit special fix other components such as emulsifying agent, antioxidant etc. as suspending agent.Knot
Fruit display addition rilanit special can not form transparent gel rubber system, and suspension layering is serious, suspending effect on driving birds is not good, therefore excellent
Select aluminum stearate as suspending agent, the consumption selection of aluminum stearate is shown in Table 1.
The consumption of the aluminum stearate of table 1
(2) the consumption selection of soybean lecithin
Soybean lecithin is amophoteric surface active emulsifying agent, it is possible to decrease particle interfacial surface tension, reduces wadding and sinks, while soybean
Lecithin is yellow, waxy solid, can be coloured to suspension, and the selection of its consumption is shown in Table 2.
The consumption of the soybean lecithin of table 2
(3) embodiment 1~5 prepares content detection and the long-time stability investigation of chlorhexidine acetate uterus injectant
Chlorhexidine acetate uterus injectant prepared by Example 1~5, reference《Veterinary drug national standard compilation-veterinary drug place
Standard rises national standard》(the 3rd) carries out content detection respectively and long-time stability are investigated, and the results are shown in Table 3.
The uterus injectant content detection of table 3 and long-time stability investigate result
| Sample | Content detection | Proterties | Room temperature is deposited 6 months |
| Embodiment 1 | 98.1% | Yellow oily suspension | Content 98.0%, proterties is constant, settling ratio 0.96 |
| Embodiment 2 | 98.5% | Yellow oily suspension | Content 98.5%, proterties is constant, settling ratio 0.95 |
| Embodiment 3 | 99.0% | Yellow oily suspension | Content 99.0%, proterties is constant, settling ratio 0.97 |
| Embodiment 4 | 98.0% | Yellow oily suspension | Content 98.0%, proterties is constant, settling ratio 0.96 |
| Embodiment 5 | 96.8% | Yellow oily suspension | Content 96.9%, proterties is constant, settling ratio 0.94 |
| Embodiment 6 | 97.5% | Yellow oily suspension | Content 97.4%, proterties is constant, settling ratio 0.91 |
| Embodiment 7 | 96.7% | Yellow oily suspension | Content 96.2%, proterties is constant, settling ratio 0.93 |
Claims (7)
1. a kind of milk cow chlorhexidine acetate uterus injectant, it is characterised in that：Contain the component of following quality per 100mL：Vinegar
Sour 2~5g of Chlorhexidine, 1~2g of naturally occurring emulsifying agent, 0.1~1.2g of surfactant, 1~4g of suspending agent, antioxidant 0.1~
0.5g, 1~3g of camphor, balance of injection soybean oil；
The naturally occurring emulsifying agent be lecithin, soybean lecithin in one or two；
The surfactant is sorbitan fatty acid ester；
Described suspending agent is aluminum stearate.
2. milk cow according to claim 1 chlorhexidine acetate uterus injectant, it is characterised in that：Described antioxidant
For one or two in propylgallate, tocopherol.
3. milk cow according to claim 1 chlorhexidine acetate uterus injectant, it is characterised in that：Per 100mL contain with
The component of lower quality：2~5g of chlorhexidine acetate, 1~2g of soybean lecithin, 0.1~1.2g of Span-80,1~4g of aluminum stearate,
0.1~0.5g of VE, 1~3g of camphor, balance of injection soybean oil.
4. milk cow according to claim 3 chlorhexidine acetate uterus injectant, it is characterised in that：Per 100mL contain with
The component of lower quality：2~5g of chlorhexidine acetate, 1~2g of soybean lecithin, 0.1~0.5g of Span-80,2~4g of aluminum stearate,
0.1~0.5g of VE, 1~3g of camphor, balance of injection soybean oil.
5. milk cow according to claim 4 chlorhexidine acetate uterus injectant, it is characterised in that：Per 100mL contain with
The component of lower quality：Chlorhexidine acetate 4g, soybean lecithin 1.2g, Span-80 0.1g, aluminum stearate 2g, VE 0.5g, camphor
2.1g, balance of injection soybean oil.
6. a kind of milk cow as claimed in claim 1 or 2 preparation method of chlorhexidine acetate uterus injectant, its feature exists
In：Comprise the following steps：Naturally occurring emulsifying agent, surfactant, suspending agent, antioxidant and camphor tree are added in injection soybean oil
Brain, chlorhexidine acetate is added after stirring evenly, and stirring is emulsified after stirring evenly and is obtained final product.
7. a kind of milk cow as any one of claim 3~5 preparation method of chlorhexidine acetate uterus injectant, its
It is characterised by：Comprise the following steps：
（1）20~30% sterilized injection soybean oils are taken, temperature, while adding aluminum stearate, is risen to 115 by heating stirring
~125 DEG C, stirring is stopped after factice to be formed, heating is stopped after being kept for 20~40 minutes；
（2）Treat that factice temperature is down to 95~105 DEG C, add soybean lecithin, stirring and dissolving adds 30~40% injections big
Soya-bean oil dilutes, and cools down standby；
（3）Treat that temperature is down to 25~35 DEG C, add Span-80, VE and camphor, chlorhexidine acetate is added after stirring evenly, after stirring evenly
The injection soybean oil constant volume of surplus is added, then emulsifies stirring and obtained final product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410181360.6A CN104288136B (en) | 2014-04-30 | 2014-04-30 | A kind of milk cow chlorhexidine acetate uterus injectant and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410181360.6A CN104288136B (en) | 2014-04-30 | 2014-04-30 | A kind of milk cow chlorhexidine acetate uterus injectant and preparation method thereof |
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| CN104288136A CN104288136A (en) | 2015-01-21 |
| CN104288136B true CN104288136B (en) | 2017-06-23 |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1463699A (en) * | 2002-06-07 | 2003-12-31 | 北京立时达药业有限公司 | A composition for treating animal endometritis |
| CN102512366A (en) * | 2011-12-28 | 2012-06-27 | 广州市和生堂动物药业有限公司 | Toltrazuril suspension emulsion and preparation method thereof |
| CN103230365A (en) * | 2013-03-19 | 2013-08-07 | 中国牧工商(集团)总公司 | Novel slow-release breast perfusion agent for preventing cow subclinical mastitis in milk shortage stage |
-
2014
- 2014-04-30 CN CN201410181360.6A patent/CN104288136B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1463699A (en) * | 2002-06-07 | 2003-12-31 | 北京立时达药业有限公司 | A composition for treating animal endometritis |
| CN102512366A (en) * | 2011-12-28 | 2012-06-27 | 广州市和生堂动物药业有限公司 | Toltrazuril suspension emulsion and preparation method thereof |
| CN103230365A (en) * | 2013-03-19 | 2013-08-07 | 中国牧工商(集团)总公司 | Novel slow-release breast perfusion agent for preventing cow subclinical mastitis in milk shortage stage |
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| CN104288136A (en) | 2015-01-21 |
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Address after: Minggang office, Zhengzhou Airport Economic Comprehensive Experimental Zone, Zhengzhou City, Henan Province Patentee after: Zhengzhou Bary Animal Pharmaceutical Co., Ltd. Address before: 450000, Henan Province, Zhengzhou City, Xinzheng Province on the north side of the eight thousand rural new highway Patentee before: Zhengzhou Bary Animal Pharmaceutical Co., Ltd. |
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