CN112870159A - Veterinary ceftiofur hydrochloride injection for clearing heat, detoxifying and reducing fever and preparation method thereof - Google Patents
Veterinary ceftiofur hydrochloride injection for clearing heat, detoxifying and reducing fever and preparation method thereof Download PDFInfo
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- CN112870159A CN112870159A CN202110147123.8A CN202110147123A CN112870159A CN 112870159 A CN112870159 A CN 112870159A CN 202110147123 A CN202110147123 A CN 202110147123A CN 112870159 A CN112870159 A CN 112870159A
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- Prior art keywords
- oil
- ceftiofur hydrochloride
- injection
- hydrochloride injection
- reducing fever
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Classifications
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- A61K31/545—Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine
- A61K31/546—Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine containing further heterocyclic rings, e.g. cephalothin
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Abstract
The invention discloses a veterinary ceftiofur hydrochloride injection for clearing heat, removing toxicity and reducing fever and a preparation method thereof, which increase the effects of clearing heat, removing toxicity, relieving fever and easing pain of the ceftiofur hydrochloride injection, improve the curative effect of the product, increase the application range and reduce the labor intensity of cultivation. The invention solves the single pharmacological action of the traditional ceftiofur hydrochloride injection. The pharmacological action of clearing heat, detoxicating and reducing fever is increased, and the prevention and control of farmers on animal epidemic diseases are facilitated; and the addition of the flocculant/deflocculant enables the charged particles of the main drug to keep a stable balance state in the re-solvent, so that the re-suspension property and the needle permeability of the preparation are very superior.
Description
Technical Field
The invention belongs to the technical field of veterinary medicines, and relates to a veterinary ceftiofur hydrochloride injection for clearing heat, detoxifying and reducing fever and a preparation method thereof.
Background
With the continuous improvement of the intensive process of the livestock breeding industry, the number of stocked commercial pork pigs, beef cattle, beef goats and dairy goats is increased; the number of managed persons per unit is increased, and the labor intensity is increased. In order to reduce labor intensity, reduce stress to livestock, and simultaneously improve control to infectious pleuropneumonia, mycoplasma pneumonia and other diseases of pigs, cows and sheep and the accompanying fever symptoms; ceftiofur hydrochloride injection is mainly adopted for prevention and treatment at present. The ceftiofur hydrochloride injection is evolved gradually from foreign import standards, the main drug is single ceftiofur hydrochloride, and the prescription is single; in use, the lung infection of livestock is often accompanied with fever symptoms, so when the products are applied, some antipyretic and antipyretic medicines are required to be used together, which not only can increase the breeding cost and increase the labor intensity, but also can cause the situations that the two medicines can not be mixed for use and the like.
Disclosure of Invention
In order to solve the problem of ceftiofur hydrochloride injection in use, the invention provides a veterinary ceftiofur hydrochloride injection for clearing heat, detoxifying and reducing fever and a preparation method thereof.
The invention is realized by the following technical scheme:
a veterinary ceftiofur hydrochloride injection for clearing away heat and toxic material and reducing fever comprises a main drug ceftiofur hydrochloride, plant essential oil serving as an effective component/solvent, an injection solvent and auxiliary materials; wherein 60-90ml of injection solvent comprises: 5.5-6.0 g of ceftiofur hydrochloride, 10-30ml of plant essential oil, 0.5-2 g of suspending agent, 0.5-2 ml of wetting agent, 0.3-2 g of flocculating agent/deflocculating agent and 0.5-1 ml of antioxidant.
The plant essential oil is extracted by redistillation and has one or more of the effects of clearing away heat and toxic materials, relieving cough, relieving asthma, inhibiting bacteria and resisting inflammation.
The plant essential oil is one or more of oleum Viticis negundo, limonene, Eucalyptus lobular oil, bupleuri radix oil, herba asari oil, and herba Houttuyniae oil.
The plant essential oil comprises 10ml of bupleurum oil and one or more of asarum oil, vitex oil, houttuynia cordata oil and vitex oil;
the plant essential oil comprises: 10ml of bupleurum oil and 10ml of asarum oil;
or the following steps: 10ml of bupleurum oil, 10ml of vitex oil and 510ml of asarum oil;
or the following steps: 10ml of bupleurum oil, 10ml of houttuynia oil and 5ml of asarum oil.
The plant essential oil comprises 10ml of houttuynia cordata oil and one or more of asarum oil, vitex oil, limonene and eucalyptus lobular oil.
The suspending agent is one or more of aluminum distearate, aluminum monostearate, colloidal silicon dioxide, phospholipid, sodium carboxymethylcellulose and xanthan gum;
the humectant is one or more of tween-80, tween-60, glycerol, propylene glycol, polyethylene glycol 300, and polyethylene glycol 400;
the flocculant/deflocculant is one or two of tartaric acid/sodium tartrate and citric acid/sodium citrate;
the antioxidant is one or more of vitamin E, chlorobutanol and benzyl alcohol;
the oily injection solvent is injectable soybean oil, refined oleum Maydis, oleum Olivarum, oleum Camelliae, polyethylene glycol stearate or isopropyl myristate.
The preparation method of the veterinary ceftiofur hydrochloride injection for clearing heat, removing toxicity and reducing fever comprises the following operations:
step 1: heating the solvent for injection to 140 ℃ for sterilization for 1 hour, stopping heating, adding the suspending agent when the temperature is reduced to 110-120 ℃, and uniformly stirring to form oil sol;
step 2: when the temperature is reduced to room temperature, taking part of the prepared oil sol, adding the wetting agent, ceftiofur hydrochloride, the flocculating/deflocculating agent and the antioxidant, stirring until the oil sol is uniformly dispersed and has no lumps or particles, and then adding the plant essential oil;
and step 3: adding the rest oil sol to make the total volume reach the constant volume, continuously stirring for 5 minutes, and homogenizing for 30 minutes in a colloid mill or a pipeline type shearing machine or a high-pressure homogenizer;
and 4, step 4: filtering, subpackaging and packaging to obtain the veterinary ceftiofur hydrochloride injection for clearing heat, removing toxicity and reducing fever.
Compared with the prior art, the invention has the following beneficial technical effects:
in order to solve the problem of using the ceftiofur hydrochloride injection, the invention provides the ceftiofur hydrochloride injection containing plant essential oil (traditional Chinese medicine volatile oil) by adopting a compound mode, and the ceftiofur hydrochloride injection selects the traditional Chinese medicine volatile oil with the functions of clearing heat and reducing fever on the basis of the prescription medicine of ceftiofur hydrochloride: oleum Viticis negundo, limonene, Eucalyptus lobutrari oil, bupleuri radix oil, herba asari oil, and herba Houttuyniae oil; then screening and blending by proper auxiliary materials; the Chinese medicinal volatile oil is used as a solvent of medicaments in the preparation, has the treatment effects of clearing heat, removing toxicity and reducing fever, greatly improves the treatment effect of the ceftiofur hydrochloride injection, has simple and convenient use method, and reduces the injection stress to livestock.
The ceftiofur hydrochloride injection for animals, which has the effects of clearing heat, removing toxicity and reducing fever, is scientific and reasonable, is simple and convenient to operate, has good product stability, improves the curative effect of the product, increases the application range, reduces the labor intensity of cultivation (only one-time injection is needed), simplifies the application steps, and avoids incompatibility caused by drug matching; is beneficial to better controlling the occurrence of epidemic diseases and improves the economic benefit.
Detailed Description
The application of the raw materials and auxiliary materials of the invention is as follows:
1. ceftiofur hydrochloride: (6R,7R) -7- [2- (2-aminothiazol-4-yl) (methoxyimino) acetamido ] -3- [ (2-furylcarbonyl) thiomethyl ] -8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid hydrochloride. Beta-lactam antibiotics. The product has broad-spectrum antibacterial effect, and is effective on gram-positive bacteria and gram-negative bacteria (including lactamase-producing bacteria). The sensitive bacteria mainly comprise Pasteurella multocida, Pasteurella hemolyticus, Actinobacillus pleuropneumoniae, Salmonella, Escherichia coli, streptococcus, staphylococcus, Haemophilus, and the like, and some Pseudomonas aeruginosa and enterococcus.
2. Redistilled extracted plant essential oil: oleum Viticis negundo, limonene, Eucalyptus lobutrari oil, bupleuri radix oil, herba asari oil, and herba Houttuyniae oil by making into preparation.
1) Vitex oil: the product is volatile oil obtained by steam distilling fresh leaves of Vitex negundo L.var.cannabifolia (Sieb.etZucc.) hand-Mazz. The product is a light yellow to orange yellow clear liquid. Has special fragrance and slightly spicy taste. Can be mixed with anhydrous alcohol, chloroform or diethyl ether, and is almost insoluble in water. The relative density is 0.890-0.910 at 25 ℃; the main components are as follows: vitexin; the pharmacological action is as follows: dispel phlegm, relieve cough and relieve dyspnea. Can be used for treating chronic bronchitis.
2) Limonene: 1-methyl-4-isopropyl cyclohexene, alias limonene, monoterpene compounds, orange red, orange yellow or colorless oily liquid, and has specific lemon-like fragrance. Molecular formula C10H16Molecular mass 136.23, is a monocyclic monoterpene mainly present in orange peel essential oil. Miscible in ethanol and most non-volatile oils; slightly soluble in glycerol and insoluble in water and propylene glycol. Limonene has two configurations, D and L, and exists predominantly as the D-isomer. The D-limonene is mainly contained in essential oil such as orange peel oil, shaddock oil, lemon oil and the like, and is particularly rich in the orange peel oil (more than 90 percent).
D-limonene can significantly inhibit the activity of gram-negative and positive bacteria and fungi. Has good effects of relieving cough, eliminating phlegm and inhibiting bacteria, and the compound limonene can be clinically used for cholagogue, dissolving stone, promoting secretion of digestive juice and eliminating intestinal pneumatosis.
3) Eucalyptus lobular oil: is prepared from folium Eucalypti Globueli and ramulus Eucalypti Globueli by steam distillation. Eucalyptus oil is a colorless to pale yellow liquid, and has camphor-and borneol-like odors. The main component of eucalyptus oil refining is cineole, the content of which reaches 70% -90%, and a small amount of aldehyde, terpene and the like. Eucalyptus oil is used for preparing antitussive, mouthwash, and ointment of pesticide, and essence for toothpaste, dentifrice, candy, etc.
4) Bupleurum oil: colorless or pale yellow volatile essential oil with special fragrance of bupleuri radix, and contains saikosaponin 35%, stigmasterol, and stigmalimonene. The bupleurum oil has good functions of clearing away heat, relieving inflammation and easing pain.
5) Asarum oil: light yellow liquid with the special fragrance of asarum. The main component is beta pinene; has antitussive, expectorant, antiasthmatic, spasmolytic, tranquilizing, antiepileptic, blood lipid reducing, and lipid benefiting effects, and has antibacterial effects on growth of Diplococcus pneumoniae, Staphylococcus aureus, and Escherichia coli. The traditional Chinese medicine composition is clinically used for treating chronic bronchitis, bronchial asthma, pneumonia, chronic obstructive pulmonary disease with acute inflammation of lung, epileptic seizure, hyperlipidemia and the like.
6) Houttuynia cordata oil: the herba Houttuyniae, commonly known as nostril Sus Domestica and Pleurotus Ostreatus root, is root or whole plant of houttuynia cordata Thunb of Saururaceae. The product has homology of medicine and food, and the houttuynia cordata is taken as the wild vegetable for eating before more than two thousand years in China. The herba Houttuyniae essential oil is yellow liquid extracted from herba Houttuyniae, has special fragrance of Chinese herbal medicine, and is slightly cold and bitter. The main components are as follows: 26% houttuynin, methyl nonanone, lauraldehyde, caryophyllene, etc. The preparation method comprises the following steps: in summer, stems and leaves flourish, and the flower ears are harvested in many hours, impurities are removed, and the whole grass is distilled by water vapor. The pharmacological action is as follows: clear heat and remove toxicity, induce diuresis and alleviate edema. Treating pneumonia, lung abscess, dysentery, malaria, edema, gonorrhea, leucorrhea, carbuncle, swelling, hemorrhoid, rectocele, eczema, alopecia, scabies and tinea.
3. Suspending agent: one or more of aluminum distearate, aluminum monostearate, colloidal silicon dioxide, phospholipid, sodium carboxymethylcellulose and xanthan gum.
4. Wetting agent: tween-80, tween-60, glycerol, propylene glycol, polyethylene glycol 300, and polyethylene glycol 400.
5. Flocculant/deflocculant: one or more of tartaric acid, sodium tartrate, citric acid, and sodium citrate.
Deflocculation is mainly used to solve the problem of physical stability of the particle dispersion. Through the test, the following results are found: the different oils for injection have great difference of dynamic viscosity, thereby leading the main drug to have obvious difference of suspension property and resuspension property; the invention adjusts the polymerization of the main drug by adding the flocculant/deflocculant, thereby improving the resuspension of the preparation, meeting the requirements of drug standards and being more convenient to use in practical clinical application.
6. Oil for injection: soybean oil for injection, refined corn oil, olive oil, tea oil, polyethylene glycol stearate and isopropyl myristate.
7. Antioxidant: vitamin E, chlorobutanol and benzyl alcohol.
The formula and the preparation method of the ceftiofur hydrochloride injection for clearing away heat and toxic material and reducing fever are concretely illustrated as follows:
the raw materials comprise:
| composition (I) | Percentages (g or ml/ml) |
| Ceftiofur hydrochloride | 5.6g |
| Plant essential oil | 10-30ml |
| Suspending aid | 0.5-2g |
| Wetting agent | 0.5-2ml |
| Flocculant/deflocculant | 0.3-2g |
| Antioxidant agent | 0.5-1ml |
| Injection solvent | 60-90ml |
Step 1: placing the solvent for injection in a jacketed kettle, heating to 140 deg.C, sterilizing for 1 hr, stopping heating, cooling to 110 deg.C and 120 deg.C, heating the suspending agent, and stirring to obtain oil sol;
step 2: cooling to room temperature, adding appropriate amount (about 40-50% of the total amount) of the sol obtained in step 1 into humectant, main drug, flocculation/deflocculant, and antioxidant, stirring to disperse uniformly, and adding plant essential oil;
and step 3: adding the sol prepared in the step (1) to ensure that the total volume reaches the constant volume, continuously stirring for 5 minutes, and homogenizing for 30 minutes in a colloid mill or a pipeline type shearing machine or a high-pressure homogenizer.
And 4, step 4: and 3, filtering the liquid medicine obtained in the step 3, subpackaging and packaging to obtain the traditional Chinese medicine.
By the invention we solve:
1. contains Chinese medicinal plant essential oil with heat-clearing, detoxicating and antipyretic effects; solves the single pharmacological action of the traditional ceftiofur hydrochloride injection. Increases the pharmacological action of clearing away heat and toxic material and reducing fever, and is more beneficial to preventing and controlling animal epidemic diseases for farmers.
2. By adding the flocculating agent/deflocculating agent, the charged particles of the main drug are kept in a stable balanced state in the re-solvent, so that the re-suspension property and the needle permeability of the preparation are very excellent.
Example 1
Preparation method of ceftiofur hydrochloride injection with heat-clearing, detoxifying and fever-reducing functions
Prescription:
| composition (I) | Percentages (g or ml/ml) |
| Ceftiofur hydrochloride | 5.6g |
| Vitex oil | 10ml |
| Suspending aid | Colloidal silica 0.3g, Xanthan Gum 0.7g |
| Wetting agent | Tween-601 ml |
| Flocculating and deflocculating agents | Tartaric acid/sodium tartrate 0.3g |
| Antioxidant agent | Vitamin E0.5ml |
| Soybean oil for injection | 90 (about) ml |
The preparation process comprises the following steps:
step 1: heating soybean oil for injection in a jacketed kettle to 140 deg.C for sterilizing for 1 hr, stopping heating, cooling to 110 deg.C and 120 deg.C, heating the suspending agent, and stirring to form oil sol;
step 2: cooling to room temperature, adding appropriate amount (40-50% of total amount) of the sol obtained in step 1 into tween-60, main drug, flocculating/deflocculating agent, and antioxidant, stirring to disperse uniformly, and adding oleum Viticis negundo;
and step 3: adding the sol prepared in the step (1) to ensure that the total volume reaches the constant volume, continuously stirring for 5 minutes, and homogenizing for 30 minutes in a colloid mill or a pipeline type shearing machine or a high-pressure homogenizer.
And 4, step 4: and 3, filtering the liquid medicine obtained in the step 3, subpackaging and packaging to obtain the traditional Chinese medicine.
Example 2
Ceftiofur hydrochloride injection for clearing away heat and toxic materials and reducing fever and preparation method thereof
Prescription:
| composition (I) | Percentages (g or ml/ml) |
| Ceftiofur hydrochloride | 5.6g |
| Houttuynia cordata oil | 15ml |
| Suspending aid | Aluminum distearate 1.0g and aluminum monostearate 0.5g |
| Wetting agent | Tween-800.8 ml and glycerol 0.2ml |
| Flocculating and deflocculating agents | Citric acid/sodium citrate 0.5g |
| Antioxidant agent | Benzyl alcohol 1ml |
| Refined corn oil | 85 (about) |
The preparation process comprises the following steps:
step 1: heating refined corn oil in a jacketed kettle to 140 deg.C for sterilizing for 1 hr, stopping heating, cooling to 110 deg.C and 120 deg.C, heating the suspending agent, and stirring to obtain oil sol;
step 2: cooling to room temperature, adding appropriate amount (40-50% of total amount) of the sol obtained in step 1 into tween-80, main drug, flocculating/deflocculating agent, and antioxidant, stirring to disperse uniformly, and adding herba Houttuyniae oil;
and step 3: adding the sol prepared in the step (1) to ensure that the total volume reaches the constant volume, continuously stirring for 5 minutes, and homogenizing for 30 minutes in a colloid mill or a pipeline type shearing machine or a high-pressure homogenizer.
And 4, step 4: and 3, filtering the liquid medicine obtained in the step 3, subpackaging and packaging to obtain the traditional Chinese medicine.
Example 3
Preparation method of ceftiofur hydrochloride injection with heat-clearing, detoxifying and fever-reducing functions
| Composition (I) | Percentages (g or ml/ml) |
| Ceftiofur hydrochloride | 5.6g |
| Radix bupleuri oil | 20ml |
| Suspending aid | Sodium carboxymethylcellulose 0.6, xanthan gum 0.4g |
| Wetting agent | 3000.5ml of polyethylene glycol and 4000.5ml of polyethylene glycol |
| Flocculating and deflocculating agents | Tartaric acid/sodium tartrate 0.1g, citric acid/sodium citrate 0.2g |
| Antioxidant agent | 0.5ml of chlorobutanol |
| Soybean oil for injection | 80 (about) ml |
The preparation process comprises the following steps:
step 1: heating soybean oil for injection in a jacketed kettle to 140 deg.C for sterilizing for 1 hr, stopping heating, cooling to 110 deg.C and 120 deg.C, heating the suspending agent, and stirring to form oil sol;
step 2: cooling to room temperature, adding appropriate amount (40-50% of total amount) of the sol obtained in step 1 into tween-60, main drug, flocculating/deflocculating agent, and antioxidant, stirring to disperse uniformly, and adding bupleuri radix oil;
and step 3: adding the sol prepared in the step (1) to ensure that the total volume reaches the constant volume, continuously stirring for 5 minutes, and homogenizing for 30 minutes in a colloid mill or a pipeline type shearing machine or a high-pressure homogenizer.
And 4, step 4: and 3, filtering the liquid medicine obtained in the step 3, subpackaging and packaging to obtain the traditional Chinese medicine.
Example 4
Preparation method of ceftiofur acid injection with salt having functions of clearing heat, removing toxicity and reducing fever
Prescription:
| composition (I) | Percentages (g or ml/ml) |
| Ceftiofur hydrochloride | 5.6g |
| Asarum oil | 10ml |
| Suspending aid | Phospholipid 1g |
| Wetting agent | 1ml of glycerol and 1ml of propylene glycol |
| Flocculating and deflocculating agents | Citric acid/sodium citrate 0.3g |
| Antioxidant agent | Vitamin E0.25 ml and chlorobutanol 0.25ml |
| Soybean oil for injection | 90 (about) ml |
The preparation process comprises the following steps:
step 1: heating soybean oil for injection in a jacketed kettle to 140 deg.C for sterilizing for 1 hr, stopping heating, cooling to 110 deg.C and 120 deg.C, heating the suspending agent, and stirring to form oil sol;
step 2: cooling to room temperature, adding appropriate amount (40-50% of total amount) of the sol obtained in step 1 into tween-60, main drug, flocculating/deflocculating agent, and antioxidant, stirring to disperse uniformly, and adding oleum asari;
and step 3: adding the sol prepared in the step (1) to ensure that the total volume reaches the constant volume, continuously stirring for 5 minutes, and homogenizing for 30 minutes in a colloid mill or a pipeline type shearing machine or a high-pressure homogenizer.
And 4, step 4: and 3, filtering the liquid medicine obtained in the step 3, subpackaging and packaging to obtain the traditional Chinese medicine.
Example 5
Preparation method of ceftiofur hydrochloride injection with heat-clearing, detoxifying and fever-reducing functions
Prescription:
| composition (I) | Percentages (g or ml/ml) |
| Ceftiofur hydrochloride | 5.6g |
| Radix bupleuri oil | 10ml |
| Asarum oil | 10ml |
| Suspending aid | Phospholipid 0.2g and xanthan gum 0.8g |
| Wetting agent | Tween-601 ml |
| Flocculating and deflocculating agents | Tartaric acid/sodium tartrate 0.3g |
| Antioxidant agent | Vitamin E0.5ml |
| Soybean oil for injection | 80 (about) ml |
The preparation process comprises the following steps:
step 1: heating soybean oil for injection in a jacketed kettle to 140 deg.C for sterilizing for 1 hr, stopping heating, cooling to 110 deg.C and 120 deg.C, heating the suspending agent, and stirring to form oil sol;
step 2: cooling to room temperature, adding appropriate amount (40-50% of total amount) of the sol obtained in step 1 into tween-60, main drug, flocculating/deflocculating agent, and antioxidant, stirring to disperse uniformly, and adding bupleuri radix oil and herba asari oil;
and step 3: adding the sol prepared in the step (1) to ensure that the total volume reaches the constant volume, continuously stirring for 5 minutes, and homogenizing for 30 minutes in a colloid mill or a pipeline type shearing machine or a high-pressure homogenizer.
And 4, step 4: and 3, filtering the liquid medicine obtained in the step 3, subpackaging and packaging to obtain the traditional Chinese medicine.
Example 6
Preparation method of ceftiofur hydrochloride injection with heat-clearing, detoxifying and fever-reducing functions
Prescription:
| composition (I) | Percentages (g or ml/ml) |
| Ceftiofur hydrochloride | 5.6g |
| Vitex oil | 10ml |
| Radix bupleuri oil | 10ml |
| Suspending aid | Sodium carboxymethylcellulose 1g |
| Wetting agent | Tween-801 ml |
| Flocculating and deflocculating agents | Citric acid/sodium citrate 0.5g |
| Antioxidant agent | Benzyl alcohol 0.5ml |
| Soybean oil for injection | 80 (about) ml |
The preparation process comprises the following steps:
step 1: heating soybean oil for injection in a jacketed kettle to 140 deg.C for sterilizing for 1 hr, stopping heating, cooling to 110 deg.C and 120 deg.C, heating the suspending agent, and stirring to form oil sol;
step 2: cooling to room temperature, adding appropriate amount (40-50% of total amount) of the sol obtained in step 1 into tween-60, main drug, flocculating/deflocculating agent, and antioxidant, stirring to disperse uniformly, and adding oleum Viticis negundo and oleum bupleuri chinensis;
and step 3: adding the sol prepared in the step (1) to ensure that the total volume reaches the constant volume, continuously stirring for 5 minutes, and homogenizing for 30 minutes in a colloid mill or a pipeline type shearing machine or a high-pressure homogenizer.
And 4, step 4: and 3, filtering the liquid medicine obtained in the step 3, subpackaging and packaging to obtain the traditional Chinese medicine.
Example 7
Preparation method of ceftiofur hydrochloride injection with heat-clearing, detoxifying and fever-reducing functions
Prescription:
| composition (I) | Percentages (g or ml/ml) |
| Ceftiofur hydrochloride | 5.6g |
| Houttuynia cordata oil | 10ml |
| Radix bupleuri oil | 10ml |
| Suspending aid | Xanthan gum 1g |
| Tween-60 | 1ml |
| Flocculating and deflocculating agents | Tartaric acid/sodium tartrate 0.4g |
| Antioxidant agent | 0.5ml of chlorobutanol |
| Soybean oil for injection | 80 (about) ml |
The preparation process comprises the following steps:
step 1: heating soybean oil for injection in a jacketed kettle to 140 deg.C for sterilizing for 1 hr, stopping heating, cooling to 110 deg.C and 120 deg.C, heating the suspending agent, and stirring to form oil sol;
step 2: cooling to room temperature, adding appropriate amount (40-50% of total amount) of the sol obtained in step 1 into tween-60, main drug, flocculating/deflocculating agent, and antioxidant, stirring to disperse uniformly, and adding herba Houttuyniae oil and bupleuri radix oil;
and step 3: adding the sol prepared in the step (1) to ensure that the total volume reaches the constant volume, continuously stirring for 5 minutes, and homogenizing for 30 minutes in a colloid mill or a pipeline type shearing machine or a high-pressure homogenizer.
And 4, step 4: and 3, filtering the liquid medicine obtained in the step 3, subpackaging and packaging to obtain the traditional Chinese medicine.
Example 8
Preparation method of ceftiofur hydrochloride injection with heat-clearing, detoxifying and fever-reducing functions
Prescription:
| composition (I) | Percentages (g or ml/ml) |
| Ceftiofur hydrochloride | 5.6g |
| Vitex oil | 10ml |
| Radix bupleuri oil | 10ml |
| Asarum oil | 5ml |
| Suspending aid | Aluminum distearate 1g |
| Wetting agent | Glycerol 1ml |
| Flocculating and deflocculating agents | Citric acid/sodium citrate 0.2g |
| Antioxidant agent | Vitamin E0.4ml, chlorobutanol 0.2ml |
| Soybean oil for injection | 75 (about) ml |
The preparation process comprises the following steps:
step 1: heating soybean oil for injection in a jacketed kettle to 140 deg.C for sterilizing for 1 hr, stopping heating, cooling to 110 deg.C and 120 deg.C, heating the suspending agent, and stirring to form oil sol;
step 2: cooling to room temperature, adding appropriate amount (40-50% of total amount) of the sol obtained in step 1 into tween-60, main drug, flocculating/deflocculating agent, and antioxidant, stirring to disperse uniformly, and adding oleum Viticis negundo, oleum bupleuri radix, and oleum asari;
and step 3: adding the sol prepared in the step (1) to ensure that the total volume reaches the constant volume, continuing stirring for 5 minutes, adding the mixture into a colloid mill or a pipeline type shearing machine or a high-pressure homogenizer, and homogenizing for 30 minutes.
And 4, step 4: and 3, filtering the liquid medicine obtained in the step 3, subpackaging and packaging to obtain the traditional Chinese medicine.
Example 9
Preparation method of ceftiofur hydrochloride injection with heat-clearing, detoxifying and fever-reducing functions
Prescription:
| composition (I) | Percentages (g or ml/ml) |
| Ceftiofur hydrochloride | 5.6g |
| Houttuynia cordata oil | 10ml |
| Radix bupleuri oil | 10ml |
| Asarum oil | 5ml |
| Suspending aid | Sodium carboxymethylcellulose 1.5g |
| Wetting agent | Polyethylene glycol 4002ml |
| Flocculating and deflocculating agents | Tartaric acid/sodium tartrate 0.25g |
| Antioxidant agent | Vitamin E0.5ml |
| Soybean oil for injection | 75 (about) ml |
The preparation process comprises the following steps:
step 1: heating soybean oil for injection in a jacketed kettle to 140 deg.C for sterilizing for 1 hr, stopping heating, cooling to 110 deg.C and 120 deg.C, heating the suspending agent, and stirring to form oil sol;
step 2: cooling to room temperature, adding appropriate amount (40-50% of total amount) of the sol obtained in step 1 into tween-60, main drug, flocculation/deflocculating agent, and antioxidant, stirring to disperse uniformly, and adding herba Houttuyniae oil, bupleuri radix oil, and herba asari oil;
and step 3: adding the sol prepared in the step (1) to ensure that the total volume reaches the constant volume, continuously stirring for 5 minutes, and homogenizing for 30 minutes in a colloid mill or a pipeline type shearing machine or a high-pressure homogenizer.
And 4, step 4: and 3, filtering the liquid medicine obtained in the step 3, subpackaging and packaging to obtain the traditional Chinese medicine.
The plant essential oils of the examples of the present invention are explained below:
the beneficial effects of the invention are illustrated by way of experimental examples:
experimental example 1 sedimentation volume ratio of ceftiofur hydrochloride injection with heat-clearing, detoxifying and fever-reducing functions
The sedimentation volume ratio should not be less than 0.90
Measuring the sample 50ml with a measuring cylinder with a plug, sealing, shaking for minutes, and recording the initial height H of the suspension0Standing for 3 hours, recording the final height H of the suspension, and calculating according to the following formula:
sedimentation volume ratio of H/H0
The results are shown in Table 1
Experimental example 2 the present invention relates to a ceftiofur hydrochloride injection with heat-clearing, detoxifying and fever-reducing functions
The sample is taken, shaken and then sucked by a 9-gauge needle, and the volume of the sample is not less than 2ml in 1 minute.
The results are shown in Table 1
Experimental example 3 redispersibility of ceftiofur hydrochloride injection with heat-clearing, detoxifying and fever-reducing functions
Referring to the centrifugal standard of the emulsion, the sample is centrifuged at 4000r/min for 15min and then shaken to be easily dispersed. The results are shown in Table 1
TABLE 1 sedimentation volume ratio, penetration and redispersibility results for the examples
Experimental example 4 stability test of ceftiofur hydrochloride injection with heat-clearing, detoxifying and fever-reducing functions
The ceftiofur hydrochloride injection containing the Chinese medicinal plant essential oil in examples 3 and 6 was placed in an environment of 6 ℃, 26 ℃, 40 ℃ and 60 ℃ for 3 months, and then 3 batches of samples were tested after being placed in an environment of 60 ℃ for 3 months.
The content is detected by referring to the quality standard of ceftiofur hydrochloride injection (New veterinary drug review center of agriculture department, the compilation of veterinary drug quality standards [ S ]. China agricultural publication color, 2013), wherein the content of the product is qualified, easy to disperse and does not change after the product is placed at 60 ℃ for 3 months, which indicates that the product can be placed at normal temperature (25 ℃) for 2-3 years, and the content is qualified, easy to disperse and does not change color.
The results are shown in tables 2, 3 and 4.
TABLE 2 example 3 stability test at different temperatures of 6 deg.C, 26 deg.C, 40 deg.C, 60 deg.C
TABLE 3 stability test of example 6 at different temperatures of 6 deg.C, 26 deg.C, 40 deg.C, 60 deg.C
The results in tables 2 and 3 show that the product has good stability, and the content, the needle penetration, the sedimentation volume ratio and the redispersibility are not obviously different after being placed in different environments for 3 months.
As a result, after the ceftiofur hydrochloride injection with the functions of clearing heat, removing toxicity and reducing fever is placed at 60 ℃ for 3 months, the content is qualified, the ceftiofur hydrochloride injection is easy to disperse and does not change color, and 3 batches of samples are detected to find that each sample has good quality and is completely qualified, so that the ceftiofur hydrochloride injection can be placed at normal temperature (25 ℃) for 2-3 years, has qualified content, is easy to disperse and does not change color, and does not have the phenomena of flocculation, poor needle permeability, agglomeration after sedimentation and the like, and the product is superior to the existing ceftiofur hydrochloride injection sold in the market.
Experimental example 5 animal experiment of ceftiofur hydrochloride injection with heat-clearing, detoxifying and fever-reducing functions
Animal administration tests are carried out on the samples in the example 6 and the commercially available common single ceftiofur hydrochloride injection, and the comparison between the ceftiofur hydrochloride injection sample containing the Chinese medicinal plant essential oil and the control sample in the treatment of the porcine infectious pleuropneumonia, the medication cost and the operation difficulty are examined.
Sample preparation: example 6A 5% ceftiofur hydrochloride injection containing Vitex oil and bupleurum oil
Example 6 group: the use method of the 5 percent ceftiofur hydrochloride injection containing the vitex oil and the bupleurum oil comprises the following steps: 3.68ml each time, 1 time daily for 3 consecutive days.
Control 1: the use method of the pure 5% ceftiofur hydrochloride injection is adopted: 3.68ml each time, 1 time daily for 3 consecutive days.
Control 2: the method for using the mixture of 5% ceftiofur hydrochloride injection and 5% flunixin meglumine injection comprises the following steps: each 3.68ml of ceftiofur hydrochloride was mixed with 1.84ml of flunixin meglumine injection 1 time a day for 3 consecutive days.
Control 3: the method for separately applying and using 5% ceftiofur hydrochloride injection and 5% flunixin meglumine comprises the following steps: 3.68ml of ceftiofur hydrochloride and 1.84ml of flunixin meglumine injection are respectively injected into each head for 1 time a day for 3 consecutive days.
The tested pigs are raised for 100 days, the average weight is 46kg, 10 tested pigs in each group are examined to investigate the cure condition, the operation is difficult and easy, and the effect of reducing fever of the ceftiofur hydrochloride injection containing the Chinese medicinal plant essential oil in a sample is compared with that of chemical flunixin meglumine. The results are shown in Table 4
TABLE 4 comparison of ceftiofur hydrochloride injection containing vitex oil and bupleurum oil with commercially available ceftiofur hydrochloride injection
| Grouping | High efficiency | Fever reducing effect | Relieving cough and asthma | The operation is difficult and easy |
| Example 6 | 100％ | Is very good | Superior food | Simple |
| Control 1 | 60％ | Has no fever reducing effect | Is free of | Simple |
| Control 2 | — | — | — | Can not be used in a mixed way, |
| control 3 | 80％ | Good taste | Is free of | Complexity of |
As can be seen from the above table, the 5% ceftiofur hydrochloride injection containing the vitex oil and the bupleurum oil in the example 6 has good fever reducing and fever relieving functions, can quickly recover the body temperature of the pig and promote ingestion; the composition also has the functions of relieving cough and asthma which are not possessed by a reference substance, and the single medicine is used, so that the operation is simple and easy;
the flunixin meglumine injection is an aqueous product, and cannot be uniformly mixed with ceftiofur hydrochloride injection serving as an oil agent, and the beta lactam ring of the ceftiofur hydrochloride is hydrolyzed and opened when meeting water, so that the antibacterial effect of the ceftiofur hydrochloride is lost;
the ceftiofur hydrochloride injection and the flunixin meglumine are respectively injected, although the injection is feasible, the operation is complex, the two injections cause the stress of the pigs, and the effects of relieving cough and asthma are not achieved.
In conclusion, the ceftiofur hydrochloride injection with the functions of clearing heat, detoxifying and reducing fever has the advantages of ensuring good physical stability, needle permeability and redispersibility, solving the pathological manifestations of fever, cough and asthma of livestock on the premise of qualified samples, no flocculation, poor needle permeability, agglomeration after sedimentation and the like, along with better cure rate, simpler and easier operation and the like.
Claims (8)
1. A veterinary ceftiofur hydrochloride injection for clearing heat, detoxicating and reducing fever is characterized by comprising a main drug ceftiofur hydrochloride, plant essential oil serving as an effective component/solvent, an injection solvent and auxiliary materials; wherein 60-90ml of injection solvent comprises: 5.5-6.0 g of ceftiofur hydrochloride, 10-30ml of plant essential oil, 0.5-2 g of suspending agent, 0.5-2 ml of wetting agent, 0.3-2 g of flocculating agent/deflocculating agent and 0.5-1 ml of antioxidant.
2. The ceftiofur hydrochloride injection for animals for clearing heat, removing toxicity and reducing fever according to claim 1, wherein the plant essential oil is extracted by redistillation and has one or more of the efficacies of clearing heat, removing toxicity, relieving cough, relieving asthma, inhibiting bacteria and resisting inflammation.
3. The ceftiofur hydrochloride injection for animals for clearing away heat and toxic material and reducing fever according to claim 1 or 2, wherein the plant essential oil is one or a mixture of more of vitex oil, limonene, eucalyptus lobular oil, bupleurum oil, asarum oil and houttuynia cordata oil.
4. The ceftiofur hydrochloride injection for animals for clearing away heat and toxic material and reducing fever according to claim 1 or 2, wherein the plant essential oil comprises 10ml of bupleurum oil and one or more of asarum oil, negundo chastetree oil, houttuynia cordata oil and negundo chastetree oil.
5. The veterinary ceftiofur hydrochloride injection for clearing heat, removing toxicity and reducing fever according to claim 4, wherein the plant essential oil is: 10ml of bupleurum oil and 10ml of asarum oil;
or the following steps: 10ml of bupleurum oil, 10ml of vitex oil and 510ml of asarum oil;
or the following steps: 10ml of bupleurum oil, 10ml of houttuynia oil and 5ml of asarum oil.
6. The veterinary ceftiofur hydrochloride injection for clearing away heat and toxic material and reducing fever according to claim 1 or 2, wherein the plant essential oil comprises 10ml of houttuynia cordata oil and one or more of asarum oil, vitex oil, limonene and eucalyptus lobular oil.
7. The ceftiofur hydrochloride injection for animals for clearing away heat and toxic material and reducing fever according to claim 1 or 2, wherein the suspending agent is one or more of aluminum distearate, aluminum monostearate, colloidal silicon dioxide, phospholipid, sodium carboxymethylcellulose and xanthan gum;
the humectant is one or more of tween-80, tween-60, glycerol, propylene glycol, polyethylene glycol 300, and polyethylene glycol 400;
the flocculant/deflocculant is one or two of tartaric acid/sodium tartrate and citric acid/sodium citrate;
the antioxidant is one or more of vitamin E, chlorobutanol and benzyl alcohol;
the oily injection solvent is injectable soybean oil, refined oleum Maydis, oleum Olivarum, oleum Camelliae, polyethylene glycol stearate or isopropyl myristate.
8. The preparation method of ceftiofur hydrochloride injection for animals for clearing heat, removing toxicity and reducing fever according to claim 1, which is characterized by comprising the following operations:
step 1: heating the solvent for injection to 140 ℃ for sterilization for 1 hour, stopping heating, adding the suspending agent when the temperature is reduced to 110-120 ℃, and uniformly stirring to form oil sol;
step 2: when the temperature is reduced to room temperature, taking part of the prepared oil sol, adding the wetting agent, ceftiofur hydrochloride, the flocculating/deflocculating agent and the antioxidant, stirring until the oil sol is uniformly dispersed and has no lumps or particles, and then adding the plant essential oil;
and step 3: adding the rest oil sol to make the total volume reach the constant volume, continuously stirring for 5 minutes, and homogenizing for 30 minutes in a colloid mill or a pipeline type shearing machine or a high-pressure homogenizer;
and 4, step 4: filtering, subpackaging and packaging to obtain the veterinary ceftiofur hydrochloride injection for clearing heat, removing toxicity and reducing fever.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20040015622A (en) * | 2002-08-13 | 2004-02-19 | 대한뉴팜(주) | Injectable Composition Comprising Ceftiofur Sodium as Active Ingredient |
| CN101953889A (en) * | 2010-09-07 | 2011-01-26 | 西北农林科技大学 | Compound ceftiofur suspension emulsion injection and preparation method thereof |
| CN107049943A (en) * | 2017-05-10 | 2017-08-18 | 郑州百瑞动物药业有限公司 | Milk cow Ceftiofur Hydrochloride injecta and preparation method thereof |
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2021
- 2021-02-03 CN CN202110147123.8A patent/CN112870159A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20040015622A (en) * | 2002-08-13 | 2004-02-19 | 대한뉴팜(주) | Injectable Composition Comprising Ceftiofur Sodium as Active Ingredient |
| CN101953889A (en) * | 2010-09-07 | 2011-01-26 | 西北农林科技大学 | Compound ceftiofur suspension emulsion injection and preparation method thereof |
| CN107049943A (en) * | 2017-05-10 | 2017-08-18 | 郑州百瑞动物药业有限公司 | Milk cow Ceftiofur Hydrochloride injecta and preparation method thereof |
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| Title |
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| 党晓林: "复方头孢噻呋混悬剂的研制及药物动力学研究", 《中国优秀博硕士学位论文全文数据库(硕士)农业科技辑》 * |
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