CN113368043A - Compound amoxicillin breast injectant and preparation method thereof - Google Patents
Compound amoxicillin breast injectant and preparation method thereof Download PDFInfo
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- CN113368043A CN113368043A CN202110652836.XA CN202110652836A CN113368043A CN 113368043 A CN113368043 A CN 113368043A CN 202110652836 A CN202110652836 A CN 202110652836A CN 113368043 A CN113368043 A CN 113368043A
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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
- A61K9/10—Dispersions; Emulsions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/425—Thiazoles
- A61K31/429—Thiazoles condensed with heterocyclic ring systems
- A61K31/43—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems
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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)
- A61K36/63—Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
- A61K36/638—Ligustrum, e.g. Chinese privet
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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
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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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
- A61K9/0041—Mammary glands, e.g. breasts, udder; Intramammary administration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/14—Drugs for genital or sexual disorders; Contraceptives for lactation disorders, e.g. galactorrhoea
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
Abstract
The invention relates to a veterinary compound amoxicillin breast injectant, which is characterized in that main drugs of the veterinary compound amoxicillin breast injectant comprise amoxicillin and glossy privet fruit extracts, and after a wetting agent and a suspending agent are added for dispersion, the main drugs are easy to be uniformly mixed, and drug components are stably and uniformly dispersed in soybean oil, so that the sustained-release effect is obvious. The compound Chinese and western medicine composition is used for treating the mastitis of the dairy cow in the lactation period, and has the advantages that the compound Chinese and western medicine composition has the functions of increasing the sterilization effect, enhancing the sterilization effect of amoxicillin, improving the clinical treatment effect and the like.
Description
Technical Field
The invention belongs to the field of veterinary medicine preparations, and particularly relates to a formula of a compound amoxicillin breast injectant and a preparation method thereof
Background
Cow mastitis has become one of the most difficult diseases to be completely cured in the dairy cow industry, and it has been reported that economic losses due to cow mastitis are as high as $ 350 billion annually worldwide, billions of dollars are lost in this respect annually in the united states, which is a large cow breeding country, and there are cow mastitis in places where a group of cows exists. Most developed countries have disastrous economic losses due to mastitis of dairy cows, wherein the loss caused by the reduction of milk yield accounts for about 70 percent, the loss caused by the illness accounts for 14 percent, and the loss caused by the mixed bacteria and other pathogenic bacteria accounts for 7 percent, so that the breeding and development of animal husbandry are seriously influenced. Among these factors, pathogenic microorganisms are important factors causing mastitis, and hundreds of bacteria cause mastitis. The main pathogens include Streptococcus agalactiae, Escherichia coli, Staphylococcus aureus, and enterococcus from environmental sources.
Amoxicillin is the most commonly used semisynthetic broad-spectrum beta-lactam antibiotic, and has strong bactericidal effect and strong capability of penetrating cell membranes. Can be quickly combined with transpeptidase in thallus to make it inactive, and can cut off the only way for making thallus use of transpeptidase to synthesize glycopeptide to construct cell wall, and can make bacterial cell quickly become spherical body and break and dissolve, and the thallus can be broken and died due to cell wall loss and continuous permeation of water, but its drug resistance problem, dosage is large and drug-stopping period is long, so that it can seriously limit its development.
According to the literature report, the Chinese herbal medicine has the characteristics of antibiosis, antiphlogosis, difficult generation of drug resistance, low toxicity, no residue or low residue and the like. The normal metabolism of bacteria is destroyed or disturbed by the combined action of multiple components in the Chinese herbal medicine, thereby achieving the treatment effect. Chinese herbal medicine resources are rich, the cost is low, and the application prospect is good. According to the research, the glossy privet fruit extract obtained by combining the anti-infection traditional Chinese medicine extract and the amoxicillin can effectively inhibit the growth of staphylococcus aureus and escherichia coli, the dry mature fruit of glossy privet fruit, which is a plant of oleaceae, is light in smell, sweet in taste and slightly bitter and astringent, and the main chemical component in the glossy privet fruit is a triterpenoid, wherein the triterpenoid is high in content and wide in action. In the prior art, the compound traditional Chinese medicine components have slow effect and insignificant curative effect on the mastitis of the dairy cows. The dosage is too large, and the development value of the product is low. The product adopts a preparation form of Chinese and western compound compatibility, and mainly aims to reduce the dosage of the amoxicillin on the premise of ensuring the treatment effect of the amoxicillin, further reduce the withdrawal period and slow down the situation that the amoxicillin drug resistance is worsened day by day.
Disclosure of Invention
Aiming at the problems in the prior art, the invention provides a compound amoxicillin breast injectant, which is prepared by screening the proportion of a traditional Chinese medicine glossy privet fruit extract and western medicine amoxicillin and interacting other auxiliary materials.
The invention provides a compound amoxicillin hydrochloride breast injectant, each 100g of which contains 6.6g of amoxicillin, 4g of glossy privet fruit extract, 1g of suspending agent, 1g of wetting agent, 0.01g of antioxidant and 100g of nonaqueous solvent.
In a preferable scheme of the invention, the compound amoxicillin breast injectant is prepared by mixing amoxicillin and glossy privet fruit extracts in a mass ratio of 1.5: 1.
In a preferred embodiment of the present invention, the non-aqueous medium is at least one of soybean oil for injection, medium chain triglyceride, isopropyl myristate, ethyl oleate, and liquid paraffin, and is preferably soybean oil for injection.
In a preferred embodiment of the present invention, the wetting agent is at least one or more of polysorbate-80, sorbitan monolaurate and hydrogenated castor oil, preferably hydrogenated castor oil.
In a preferred embodiment of the present invention, the suspending agent is at least one or more of beeswax, tragacanth and glyceryl monostearate, preferably glyceryl monostearate.
The invention also provides a method for preparing the compound amoxicillin breast injectant, which comprises the following steps:
step 1: heating soybean oil with the prescription amount of 70 percent, maintaining the temperature at 80 ℃, adding the glyceryl monostearate and the hydrogenated castor oil, mixing the two, continuously stirring the mixture evenly, raising the temperature to 110 ℃ until the two are completely fused, and enabling the solution to be transparent and clear;
step 2: continuously cooling the mixed solution to about 40 ℃, and adding vitamin E into the mixed solution in the process of rapidly stirring the mixed solution until the antioxidant is dissolved; standby;
and step 3: slowly adding the glossy privet fruit extract raw material into the solution, fully stirring, adding amoxicillin with the formula amount, and metering the volume of the soybean oil to 100 g: and connecting a colloid mill cooling water system. The prepared liquid is injected into a colloid mill, and the solution is fully dispersed to be in a uniform state.
And 4, step 4: and (3) passing the mixture obtained in the step (3) through a high-pressure homogenizer, shearing for 10 minutes at the speed of 40 kg/hour and under the pressure of 500bar, filling, and performing irradiation sterilization on cobalt 60 to obtain the product.
The invention also provides the effect of the prepared compound amoxicillin breast injectant in treating cow mastitis.
The technical scheme of the invention has the following advantages:
(1) the traditional Chinese medicinal materials not only have culture inheritance for thousands of years and rich clinical medication experience, but also have the advantages of multiple targets, broad treatment spectrum, safety, greenness and the like, and are popular with developers. The study combines the traditional Chinese medicine glossy privet fruit extract and amoxicillin, so that the sterilization effect of amoxicillin can be enhanced, the dosage is reduced, and the harm degrees of antibiotic residue, drug resistance and the like are controlled to a certain extent, thereby better inhibiting series infection diseases caused by clinically drug-resistant staphylococcus aureus, and the application prospect is considerable.
(2) The product prepared by the invention uses the oily solvent as a dispersion medium of the injection, effectively solves the problem that amoxicillin is easy to degrade in an aqueous solution, and the oily suspension can slow down the metabolism speed of the drug in local tissues, so that the drug is more long-lasting and lasting.
(3) The preparation method of the compound amoxicillin breast injectant adopts a high-pressure homogenizer shearing technology, reduces the damage of heat generated by high shearing to the stability of amoxicillin, and the prepared product has small particle size, good uniformity, fineness, smoothness and uniform dispersion.
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Detailed Description
The present invention is further illustrated by the following examples, which do not limit the present invention in any way, and any modifications or changes that can be easily made by a person skilled in the art to the present invention will fall within the scope of the claims of the present invention without departing from the technical solution of the present invention. The preparation method comprises the following steps:
example 1
(1) The prescription of 100g of compound amoxicillin breast injectant is as follows:
amoxicillin 6.6g
Glossy privet fruit extract 2g
Hydrogenated Castor oil 1g
Glyceryl monostearate 1g
Vitamin E0.1 g
Adding soybean oil for injection to 100g
(2) Filtering soybean oil for injection with the prescription amount of 70%, and heating the treated soybean oil to 80 ℃ for later use.
(3) Adding hydrogenated castor oil as suspending agent and glyceryl monostearate as surfactant into the injectable soybean oil until completely dissolved.
(4) Continuously cooling the mixed solution to about 30 ℃, and adding vitamin E into the mixed solution in the process of rapidly stirring the mixed solution until the antioxidant is dissolved; standby;
(5) adding amoxicillin and glossy privet fruit extracts with the prescription amount, and then adding the soybean oil for injection after filtration treatment to 100 g.
(6) Treating the prepared solution with a high-pressure homogenizer, shearing at a speed of 40 kg/h and a pressure of 500bar for 10 minutes, filling, and performing cobalt 60 irradiation sterilization to obtain the product.
Example 2
The prescription of each 100g of compound amoxicillin breast injectant is as follows:
amoxicillin 6.6g
Glossy privet fruit extract 3g
Hydrogenated Castor oil 1g
Glyceryl monostearate 1g
Vitamin E0.1 g
Adding soybean oil for injection to 100g
Other embodiments are the same as the first embodiment
Example 3
The prescription of each 100g of compound amoxicillin breast injectant is as follows:
amoxicillin 6.6g
Fructus Ligustri Lucidi extract 4g
Hydrogenated Castor oil 1g
Glyceryl monostearate 1g
Vitamin E0.1 g
Adding soybean oil for injection to 100g
Other embodiments are the same as the first embodiment
Example 4
The prescription of each 100g of compound amoxicillin breast injectant is as follows:
amoxicillin 6.6g
Glossy privet fruit extract 5g
Hydrogenated Castor oil 1g
Glyceryl monostearate 1g
Vitamin E0.1 g
Adding soybean oil for injection to 100g
Other embodiments are the same as the first embodiment
Example 5
The prescription of each 100g of compound amoxicillin breast injectant is as follows:
amoxicillin 4g
Glossy privet fruit extract 3g
Hydrogenated Castor oil 1g
Glyceryl monostearate 1g
Vitamin E0.1 g
Adding soybean oil for injection to 100g
Other embodiments are the same as the first embodiment
Example 6
The prescription of each 100g of compound amoxicillin breast injectant is as follows:
amoxicillin 4g
Fructus Ligustri Lucidi extract 4g
Hydrogenated Castor oil 1g
Glyceryl monostearate 1g
Vitamin E0.1 g
Adding soybean oil for injection to 100g
Other embodiments are the same as the first embodiment
Example 7
The prescription of each 100g of compound amoxicillin breast injectant is as follows:
amoxicillin 4g
Glossy privet fruit extract 5g
Hydrogenated Castor oil 1g
Glyceryl monostearate 1g
Vitamin E0.1 g
Adding soybean oil for injection to 100g
Other embodiments are the same as the first embodiment
Volume ratio of sedimentation
Carrying out a sedimentation volume ratio experiment on the prepared product according to pharmacopeia standards: measuring 50mL of a test article by using a measuring cylinder with a plug, sealing the test article, vigorously shaking for 1min, recording the starting height H0 of the suspension, standing for 3H, recording the final height H of the suspension, and calculating according to the following formula:
sedimentation volume ratio of H/H0
A sedimentation volume ratio of less than 0.9 is unacceptable. The results are shown in Table 1.
Test for redispersibility
One week after the breast injectant preparation, the redispersibility was measured. The graduated tube with the various prescribed breast infusions is inverted 180 degrees. The number of flips required to return to the as-made state is measured. The required number of times was 1, and the redispersibility was 100%, after which the dispersibility decreased by 5% for every 1 increase. The results are shown in Table 1.
TABLE 1 examination of properties of examples
The result evaluation shows that the prepared breast injectant has the settlement ratio higher than the pharmacopeia standard by more than 0.9, good stability, no delamination after standing and uniform and fine texture.
In vitro bacteriostasis test
The experimental method comprises the following steps: adding 0.1m L bacterial liquid on the prepared nutrient agar plate, and uniformly coating the bacterial liquid by using a coater; uniformly and vertically placing oxford cups on the surface of the culture medium, and slightly pressurizing to ensure that the oxford cups are in contact with the culture medium without gaps; the culture was carried out at 37 ℃ for 24 hours and the results were observed. The diameter of the inhibition zone is measured by taking the area around the oxford cup where bacteria can not be seen by naked eyes as the inhibition zone, and the average value of the diameters of the 3 plates of each example is calculated. The results are shown in Table 2
TABLE 2 antimicrobial Effect (unit mm) of Oxford cup method in each example
Results evaluation, according to the size of the diameter of the inhibition zone, the inhibition effect of example 3 on staphylococcus aureus and escherichia coli is better than that of other examples in the above examples.
In conclusion, the clinical experiment is carried out by selecting the best ratio in the example 3.
Clinical trial
The experimental animal 30 cows of a certain farm in Jilin province are clinically diagnosed as cow mastitis stage II
The experimental method comprises the following steps: the cows diagnosed with mastitis were divided into three groups, untreated group, control group and experimental group, each group having 10 cows. Untreated group 10, no treatment; in the control group 10, the commercial amoxicillin breast injectant is adopted, one (3g) of each breast area is used, and the amoxicillin breast injectant is used twice a day and 3 times in succession; the treatment method adopted by the experimental group is to take the breast injectant of the invention in the example 3, one breast (3g) per breast area, twice a day and 3 times in a combined way. The invention adopts CMT method to judge the number of somatic cells.
Criteria for therapeutic effect
1) Recovering appetite of cured cattle, recovering normal breast area after administration, and eliminating red, swelling, heat, pain, etc.; the lactation yield is recovered to be normal, the milk character is recovered to be normal, and the somatic cell number SCC is less than 40 ten thousand/mL.
2) The appetite of the sick cattle is recovered to be normal effectively, and the symptoms of red, swollen, hot, painful and the like in the breast area after the medicine is taken are obviously improved; the lactation yield tends to be normal, the milk abnormal characters are recovered, and the somatic cell count SCC is between 40 and 120 ten thousand/mL.
3) The ineffective sick cattle have low appetite, and the symptoms of red, swollen, hot, painful and the like of the applied breast area are not converted or even worsened; the milk yield is continuously reduced and even milk is stopped, the milk character is still obviously abnormal, and the somatic cell number SCC is more than 120 ten thousand/mL.
Results of the experiment
Compared with the control group, the state of the dairy cow is obviously improved. The clinical use effect of the compound amoxicillin breast injectant prepared by the invention is obviously higher than that of a single amoxicillin breast injectant product obtained by target animal experiments, the effective rate is 100%, and the cure rate reaches 80%. (see Table 3)
TABLE 3 clinical therapeutic effect of the animal experiment of this example
| Grouping | High efficiency | Cure rate | Inefficiency of |
| Untreated group | 0 | 0 | 100％ |
| Control group | 70％ | 60％ | 30％ |
| Experimental group | 100％ | 80％ | 0 |
Therefore, the traditional Chinese medicine composition for treating the cow mastitis has the advantages of definite clinical application effect, high cure rate and the like, and has good application value.
Claims (2)
1. A compound amoxicillin breast injectant is characterized in that: the formula consists of the following components in parts by mass: 6.6 parts of amoxicillin, 4 parts of glossy privet fruit extract (oleanolic acid with the content of 80%), 1 part of suspending agent, 1 part of wetting agent and 0.1 part of antioxidant. The soybean oil for injection is supplemented to 100 parts.
2. The preparation method comprises the following steps: (1) heating 40% of soybean oil, maintaining at 80 deg.C, adding suspending agent and wetting agent, mixing, stirring, and heating to 110 deg.C until the two are completely fused to obtain transparent and clear solution; (2) adding an antioxidant into the obtained mixed solution in the process of rapid stirring until the antioxidant is dissolved; (3) continuously cooling the mixed solution to about 40 ℃, continuously adding the glossy privet fruit extract raw material, uniformly stirring, adding amoxicillin with the prescription amount under the aseptic condition, and uniformly dispersing by using high shear after carrying out a colloid mill; (4) sealing and packaging to obtain a finished product; in the preparation method, the solid dispersion is soybean oil for injection, the wetting agent is hydrogenated castor oil, the suspending agent is glyceryl monostearate, and the antioxidant is vitamin E.
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Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1666744A (en) * | 2004-03-11 | 2005-09-14 | 南京农业大学 | Dry cow mamma perfusion agent for preventing and curing cow mastitis and preparation method thereof |
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| US20150164926A1 (en) * | 2012-06-29 | 2015-06-18 | Bayer Animal Health Gmbh | Pharmaceutical compositions and treatment of mastitis |
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| CN108740433A (en) * | 2018-02-11 | 2018-11-06 | 四川达邦生物科技有限公司 | A kind of Chinese herbal feed additive for three inflammation and mastitis for milk cows of sow postpartum |
-
2021
- 2021-06-11 CN CN202110652836.XA patent/CN113368043A/en active Pending
Patent Citations (7)
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|---|---|---|---|---|
| CN1666744A (en) * | 2004-03-11 | 2005-09-14 | 南京农业大学 | Dry cow mamma perfusion agent for preventing and curing cow mastitis and preparation method thereof |
| US20150164926A1 (en) * | 2012-06-29 | 2015-06-18 | Bayer Animal Health Gmbh | Pharmaceutical compositions and treatment of mastitis |
| CN104382898A (en) * | 2014-10-22 | 2015-03-04 | 郑州后羿制药有限公司 | Compound breast injectant with amoxicillin and preparation method thereof |
| CN105770113A (en) * | 2014-12-23 | 2016-07-20 | 天津集合科技有限公司 | Traditional Chinese medicine compound granule capable of improving disease resistance of cow |
| CN105560177A (en) * | 2016-02-25 | 2016-05-11 | 中国农业大学 | Veterinary mixed suspension with amoxicillin and baicalein and preparation method of veterinary mixed suspension |
| CN106266284A (en) * | 2016-08-30 | 2017-01-04 | 黄锡琦 | A kind of Chinese medicine for oral administration treating mammitis of cow |
| CN108740433A (en) * | 2018-02-11 | 2018-11-06 | 四川达邦生物科技有限公司 | A kind of Chinese herbal feed additive for three inflammation and mastitis for milk cows of sow postpartum |
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| Title |
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| 邓凯伟，等: "中草药对大别山地区奶牛隐性乳腺炎病原菌的抑菌试验", 《上海畜牧兽医通讯》 * |
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