CN113209015A - Long-acting ceftiofur hydrochloride suspension injection and preparation process thereof - Google Patents
Long-acting ceftiofur hydrochloride suspension injection and preparation process thereof Download PDFInfo
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- CN113209015A CN113209015A CN202010081438.2A CN202010081438A CN113209015A CN 113209015 A CN113209015 A CN 113209015A CN 202010081438 A CN202010081438 A CN 202010081438A CN 113209015 A CN113209015 A CN 113209015A
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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
- A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
- A61K31/542—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with heterocyclic ring systems
- 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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- 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
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- 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
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- Animal Behavior & Ethology (AREA)
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Abstract
The invention relates to a long-acting ceftiofur hydrochloride suspension injection and a preparation process thereof, which are characterized by comprising the following components in parts by weight: 1-10 parts of ceftiofur hydrochloride, 1-3 parts of dispersing agent, 1-2 parts of suspending agent, 1-2 parts of antioxidant and 1-83 parts of injection-grade solvent; the preparation process comprises the following steps: step one, heating an injection-grade solvent to 80-90 ℃, respectively and sequentially adding a dispersing agent and a suspending agent, and stirring to dissolve; step two, adding ceftiofur hydrochloride, stirring and dissolving, adding an antioxidant, and stirring uniformly; supplementing the injection-grade solvent to the full amount, stirring uniformly, passing through a homogenizer, and sterilizing to obtain the long-acting ceftiofur hydrochloride suspension injection; the medicament release in vivo is improved, the medicament is promoted to be slowly absorbed after entering the body, the effect of prolonging the duration time of effective blood concentration is achieved, the defects of reduced medicament content and short action time in the sterilization process caused by medicament instability are overcome, a good preparation with long action time and high stability is provided, and convenience is provided for clinical medication.
Description
Technical Field
The invention belongs to the technical field of veterinary medicines, and particularly relates to a long-acting ceftiofur hydrochloride suspension injection and a preparation process thereof.
Background
Ceftiofur (Ceftiofur), also known as seidefu, was originally formed by Bernard long-acting Ceftiofur hydrochloride suspension injection Labeeuw et al, which was first combined with long-acting Ceftiofur hydrochloride suspension injection in 1984, and was a third-generation cephalosporin antibiotic special for first livestock and poultry; then, the compound is prepared into freeze-dried powder of sodium salt and suspension of hydrochloride (trade names Naxcel and excelel) by Pharmacia long-acting ceftiofur hydrochloride suspension injection and long-acting ceftiofur hydrochloride suspension injection Upjohn and is used for treating diseases of the animal long-acting ceftiofur hydrochloride suspension injection.
Ceftiofur is quickly absorbed and has high bioavailability; the combination rate with the protein in the body is high, the stock bactericidal power is formed, the semidecay long-acting ceftiofur hydrochloride suspension injection has long period, and the drug effect is durable; compared with other antibiotics, the medicine has the unique characteristic that the content of the medicine in an infected tissue is 2-4 times higher than that of a non-long-acting ceftiofur hydrochloride suspension injection infected tissue, the medicine is in targeted concentrated distribution, and the bactericidal effect is exerted.
Ceftiofur kills bacteria mainly by acting on transpeptidase to block the synthesis of bacterial cell walls; has strong antibacterial activity on various gram-positive long-acting ceftiofur hydrochloride suspension injection liquid bacteria (such as staphylococcus), gram-negative bacteria (such as escherichia coli, salmonella and pseudomonas aeruginosa) and some anaerobic bacteria long-acting ceftiofur hydrochloride suspension injection. The ceftiofur has low residue in tissues, good safety and stable molecular structure, can not be damaged by beta-long-acting ceftiofur hydrochloride suspension injection lactamase, is not easy to generate drug resistance and cross drug resistance, is an antibiotic with the strongest bactericidal power for livestock on the market at present, and has multiple advantages over other antibiotics popular in the veterinary drug market at present.
Disclosure of Invention
In view of the above, the invention aims to provide a long-acting ceftiofur hydrochloride suspension injection and a preparation process thereof, which solve the defects of reduced drug content and short action time in the sterilization process caused by unstable drugs, provide a good preparation with long action time and high stability for farmers in China, provide convenience for clinical medication, ensure that the liquid medicine is not adhered to the wall, does not change color after long-term storage, is suspended permanently, has good needle-through performance, can effectively improve the bioavailability, also improve the release of the drugs in vivo, promote the slow absorption of the drugs after entering the body, prolong the duration of effective blood concentration, achieve the effects of enhanced curative effect and low toxic and side effects, and simultaneously reduce the frequency of drug administration.
In order to achieve the purpose, the technical scheme of the invention is realized as follows:
the long-acting ceftiofur hydrochloride suspension injection is characterized by comprising the following components in parts by weight: 1-10 parts of ceftiofur hydrochloride, 1-3 parts of dispersing agent, 1-2 parts of suspending agent, 1-2 parts of antioxidant and 1-83 parts of injection-grade solvent.
The long-acting ceftiofur hydrochloride suspension injection is characterized by comprising the following components in parts by weight: 5.2 parts of ceftiofur hydrochloride, 3 parts of dispersing agent, 2 parts of suspending agent, 1 part of antioxidant and 88.8 parts of injection-grade solvent.
The long-acting ceftiofur hydrochloride suspension injection and the preparation process thereof are characterized by comprising the following steps of:
step one, heating injection-grade solvent to 80-90 ℃, respectively and sequentially adding dispersing agent and suspending agent, and then stirring to dissolve;
step two, adding ceftiofur hydrochloride, stirring and dissolving, adding an antioxidant, and stirring uniformly;
and step three, supplementing the injection-grade solvent to the full amount, stirring uniformly, passing through a homogenizer, and sterilizing to obtain the long-acting ceftiofur hydrochloride suspension injection.
Wherein, the dispersant in the first step is one or more of ethyl cellulose, span-60, sorbitan oleate, diacetin and tween-80, the suspending agent is one or more of aluminum monostearate, hydrogenated castor oil, lecithin and beeswax, and the injection solvent is one of soybean oil, olive oil or cottonseed oil for injection.
The long-acting ceftiofur hydrochloride suspension injection and the preparation process thereof are characterized in that the antioxidant in the second step is one or the mixture of BHA and BHT, and the stirring time is 20 min.
The long-acting ceftiofur hydrochloride suspension injection and the preparation process thereof are characterized in that the adding amount of the injection-grade solvent in the step one is 60 parts, and the stirring time is 10 min.
The long-acting ceftiofur hydrochloride suspension injection and the preparation process thereof are characterized in that after the ceftiofur hydrochloride is dissolved, stirring is required for 30min, and then an antioxidant is added.
The long-acting ceftiofur hydrochloride suspension injection and the preparation process thereof are characterized in that the speed of the homogenizer is 1500-.
The long-acting ceftiofur hydrochloride suspension injection and the preparation process thereof are characterized in that the sterilization is ultra-high temperature sterilization for 20-30 min.
Compared with the prior art, the long-acting ceftiofur hydrochloride suspension injection has the following advantages:
(1) the defects of low drug content and short action time in the sterilization process caused by unstable drugs are overcome, and the preparation has long action time and high stability and is convenient for clinical medication.
(2) Improves the release of the medicine in the body, promotes the medicine to be slowly absorbed after entering the body, prolongs the duration of effective blood concentration, achieves the enhancement of curative effect and low toxic and side effect, reduces the medicine taking times, and is well received by the majority of farmers.
(3) The liquid medicine is not adhered to the wall, does not change color after long-term storage, is suspended for a long time, has excellent needle-through performance and can effectively improve the bioavailability.
Detailed Description
Unless defined otherwise, technical terms used in the following examples have the same meanings as commonly understood by one of ordinary skill in the art to which the present invention belongs. The test reagents used in the following examples, unless otherwise specified, are all conventional biochemical reagents; the experimental methods are conventional methods unless otherwise specified.
The present invention will be described in detail with reference to examples.
Examples
The long-acting ceftiofur hydrochloride suspension injection consists of the following components in parts by weight: 5.2 parts of ceftiofur hydrochloride, 1 part of ethyl cellulose, 60.1 parts of span-60, 1 part of diacetin, 2 parts of hydrogenated castor oil, 0.5 part of BHA, 0.5 part of BHT and 88.8 parts of soybean oil for injection; the specific operation steps are as follows:
(1) heating 60 parts of soybean oil for injection to about 85 ℃, respectively and sequentially adding 1 part of ethyl cellulose, 1 part of span-60.1 parts of diacetin and 2 parts of hydrogenated castor oil, and stirring for 10min to dissolve;
(2) adding 5.2 parts of ceftiofur hydrochloride, stirring for 30min, adding 0.5 part of BHA and 0.5 part of BHT, and stirring for 20min to completely dissolve;
(3) supplementing injectable oil to full dose, stirring, passing through homogenizer at 2000r/min for 50min, and sterilizing at 105 deg.C for 30min to obtain milky suspension.
The following are experimental analyses and quality evaluations of the products obtained by the examples of the present application:
first, animal experiment
1. Test samples: the long-acting ceftiofur hydrochloride suspension injection is prepared.
2. The test method comprises the following steps: 20 healthy duroc x white binary hybrid pigs weighing 30kg +/-2.5 kg are selected and randomly divided into 2 groups of 10 pigs each, and each half of the male and female pigs are selected. A first group: intramuscular injection of 5% ceftiofur hydrochloride suspension injection; second group: the prepared long-acting ceftiofur hydrochloride suspension injection is injected intramuscularly. The intramuscular injection mode is that the neck is injected with ceftiofur hydrochloride suspension injection at one time; before administration, each pig is weighed, a sampling time point and an interval time of intramuscular injection are determined according to the rule of absorption, distribution and elimination of the medicament in vivo after pre-test, and 5% ceftiofur hydrochloride suspension injection and long-acting ceftiofur hydrochloride suspension injection are injected intramuscularly in the neck at the dose of 6mg/kg body weight. Feeding management of each test group is the same, water drinking and food intake are free, the feed is full-value daily ration without antibacterial drugs, and pharmacokinetic parameters of each test pig group are counted.
3. The test results are shown in the table:
as can be seen from the table, the long-acting ceftiofur hydrochloride suspension injection is absorbed quickly, the elimination half-life period is 23.17, and the elimination half-life period of the long-acting ceftiofur hydrochloride suspension injection is prolonged by about 11 hours compared with the elimination half-life period of 12.19 hours of the ceftiofur hydrochloride suspension injection prepared from the pflug.
Second, quality evaluation
1. The long-acting ceftiofur hydrochloride suspension injection prepared by the method is compared with ceftiofur hydrochloride suspension injection (5%) produced by Qiangpu company in the United states, and the comparison and detection are carried out after the ceftiofur hydrochloride suspension injection and the ceftiofur hydrochloride suspension injection are placed for 3 days under the same conditions.
2. Measuring 50ml of a test sample by using a measuring cylinder with a plug 50ml of a sedimentation volume ratio, sealing the plug, vigorously shaking for 1 minute, recording the starting height H0 of the suspension, standing for 3 hours, recording the final height H of the suspension, and expressing the sedimentation volume ratio by F-H/H0; taking the evenly shaken sample of the granularity, and determining according to the granularity and granularity distribution determination method; dispersively taking 100ml of a sample to be tested, placing the sample in a measuring cylinder with a plug and 100ml, shaking for 30 seconds with force, and recording the phenomenon; the content measurement is performed by high performance liquid chromatography.
3. Taking a proper amount of the related substances (about containing 3mg of ceftiofur), precisely weighing, adding 10ml of 50% acetonitrile solution and 10ml of n-hexane, shaking for 2 minutes, centrifuging, and taking the lower layer as a test solution (the preparation of the test solution needs to be completed within 20 minutes before sample injection); 10ml of 50% acetonitrile solution and 10ml of n-hexane were further taken, shaken for 2 minutes, centrifuged, and the lower layer was taken as a blank solution. Performing high performance liquid chromatography determination, using octadecylsilane chemically bonded silica as filler, water-acetonitrile-trifluoroacetic acid (950: 50: 1) as mobile phase A, and water-acetonitrile-trifluoroacetic acid (200: 800: 1) as mobile phase B, and performing linear gradient elution according to specification; the detection wavelength was 254 nm. And (4) respectively injecting the sample solution and the blank solution by 20 mu l into a liquid chromatograph, and recording the chromatogram.
4. The results of the stability test after 3 months of acceleration are shown in tables 1 and 2:
table 1 physical stability test data
Table 2 chemical stability test data
According to the stability test data of 5% of the sample and 5% of the reference substance after accelerating for 3 months, the sample prepared by the invention has slow sedimentation, good redispersion, smooth needle passing and slower impurity change compared with the reference substance.
The experimental data show that the beneficial effects of the application are as follows:
(1) the defects of low drug content and short action time in the sterilization process caused by unstable drugs are overcome, and the preparation has long action time and high stability and is convenient for clinical medication.
(2) Improves the release of the medicine in the body, promotes the medicine to be slowly absorbed after entering the body, prolongs the duration of effective blood concentration, achieves the enhancement of curative effect and low toxic and side effect, reduces the medicine taking times, and is well received by the majority of farmers.
(3) The liquid medicine is not adhered to the wall, does not change color after long-term storage, is suspended for a long time, has excellent needle-through performance and can effectively improve the bioavailability.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.
Claims (8)
1. The long-acting ceftiofur hydrochloride suspension injection is characterized by comprising the following components in parts by weight: 1-10 parts of ceftiofur hydrochloride, 1-3 parts of dispersing agent, 1-2 parts of suspending agent, 1-2 parts of antioxidant and 1-83 parts of injection-grade solvent.
2. The long-acting ceftiofur hydrochloride suspension injection according to claim 1, wherein the long-acting ceftiofur hydrochloride suspension injection comprises the following components in parts by weight: 5.2 parts of ceftiofur hydrochloride, 3 parts of dispersing agent, 2 parts of suspending agent, 1 part of antioxidant and 88.8 parts of injection-grade solvent.
3. The long-acting ceftiofur hydrochloride suspension injection and the preparation process thereof according to claim 1, wherein the preparation process comprises the following steps:
step one, heating injection-grade solvent to 80-90 ℃, respectively and sequentially adding dispersing agent and suspending agent, and then stirring to dissolve;
step two, adding ceftiofur hydrochloride, stirring and dissolving, adding an antioxidant, and stirring uniformly;
and step three, supplementing the injection-grade solvent to the full amount, stirring uniformly, passing through a homogenizer, and sterilizing to obtain the long-acting ceftiofur hydrochloride suspension injection.
Wherein, the dispersant in the first step is one or more of ethyl cellulose, span-60, sorbitan oleate, diacetin and tween-80, the suspending agent is one or more of aluminum monostearate, hydrogenated castor oil, lecithin and beeswax, and the injection solvent is one of soybean oil, olive oil or cottonseed oil for injection.
4. The long-acting ceftiofur hydrochloride suspension injection and the preparation process thereof according to claim 2, wherein the antioxidant in the second step is one or two of BHA and BHT, and the stirring time is 20 min.
5. The long-acting ceftiofur hydrochloride suspension injection and the preparation process thereof according to claim 3, wherein the injection-grade solvent is added in 60 parts in the step one, and the stirring time is 10 min.
6. The long-acting ceftiofur hydrochloride suspension injection and the preparation process thereof according to claim 3, wherein the ceftiofur hydrochloride is dissolved and then needs to be stirred for 30min, and then an antioxidant is added.
7. The long-acting ceftiofur hydrochloride suspension injection and the preparation process thereof as claimed in claim 3, wherein the speed of the homogenizer is 1500-.
8. The long-acting ceftiofur hydrochloride suspension injection and the preparation process thereof according to claim 3, wherein the sterilization is ultra-high temperature sterilization for 20-30 min.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010081438.2A CN113209015A (en) | 2020-01-21 | 2020-01-21 | Long-acting ceftiofur hydrochloride suspension injection and preparation process thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202010081438.2A CN113209015A (en) | 2020-01-21 | 2020-01-21 | Long-acting ceftiofur hydrochloride suspension injection and preparation process thereof |
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Citations (11)
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| US20040022815A1 (en) * | 2002-08-05 | 2004-02-05 | Orchid Health Care | Novel pharmaceutical composition of ceftiofur |
| KR20040015622A (en) * | 2002-08-13 | 2004-02-19 | 대한뉴팜(주) | Injectable Composition Comprising Ceftiofur Sodium as Active Ingredient |
| AU2007293068A1 (en) * | 2006-09-07 | 2008-03-13 | Boehringer Ingelheim Animal Health USA Inc. | Soft chewable, tablet, and long-acting injectable veterinary antibiotic formulations |
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2020
- 2020-01-21 CN CN202010081438.2A patent/CN113209015A/en active Pending
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Application publication date: 20210806 |