CN112156011A - Preparation method for producing cefquinome sulfate injection by using emulsification stirring tank and colloid mill in combined manner - Google Patents
Preparation method for producing cefquinome sulfate injection by using emulsification stirring tank and colloid mill in combined manner Download PDFInfo
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- CN112156011A CN112156011A CN202010835613.2A CN202010835613A CN112156011A CN 112156011 A CN112156011 A CN 112156011A CN 202010835613 A CN202010835613 A CN 202010835613A CN 112156011 A CN112156011 A CN 112156011A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
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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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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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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Abstract
The invention discloses a preparation method for producing cefquinome sulfate injection by combining an emulsification stirring tank and a colloid mill, which comprises the following steps: (1) adding suspending agent into injectable solvent, and stirring in emulsifying and stirring tank; (2) adding cefquinome sulfate, an emulsifier and an antioxidant into the mixture obtained in the step (1); (3) dissolving with injectable solvent to sufficient amount, and grinding for 30 min; (4) and (4) after the project is qualified, performing sterile filtration and subpackaging to obtain the finished product. The combined use of the emulsifying tank and the colloid mill solves the problems that the solvent is sterilized in the preparation process of the cefquinome sulfate injection in the production process, the preparation, the emulsification and the shearing of the preparation are completed in the emulsifying tank without adding high-speed shearing equipment and shearing at low temperature, the circulation link of the medicine is reduced, and the yield of the product is improved.
Description
Technical Field
The invention relates to the technical field of preparation of cefquinome sulfate injection, in particular to a preparation method for producing cefquinome sulfate injection by combining an emulsification stirring tank and a colloid mill.
Background
Cefquinome sulfate (C)23H24N6O5S2·H2SO4) Is 1- [ (6R,7R) -7- [ (2Z) - (2-amino-4-thiazolyl) (methoxyimino) acetyl ] amino ] -2-carboxy-8-oxo-5-thia-1-azaHetero-bicyclo [4.2.0]Oct-2-en-3-yl ] methyl ] -5,6,7, 8-tetrahydroquinolinium sulfate, molecular weight 626.61; developed by Hoechst corporation of germany in 80 s of the 20 th century, and marketed in 1993, the market was distributed: the cefquinome sulfate for injection is slightly soluble in water, has unstable property in water and is easy to decompose.
Pharmacodynamics cefquinome is a cephalosporin antibiotic. The bactericidal effect is achieved by inhibiting the synthesis of cell walls, and the bactericidal composition has broad-spectrum antibacterial activity and is stable to penicillinase and beta-lactamase. In vitro bacteriostatic tests show that cefquinome is effective against common gram-positive and gram-negative bacteria including Escherichia coli, Citrobacter, Klebsiella, Pasteurella, Proteus, Salmonella, Serratia marcescens, Haemophilus bovis, Actinomyces pyogenes, bacteria of the genus Bacillus, Corynebacterium, Staphylococcus aureus, Streptococcus, Bacteroides, Clostridium, bacteria of the genus Clostridium, Prevotella, Actinobacillus and erysipelothrix rhusiopathiae.
The pharmacokinetic pig injected with cefquinome 2mg intramuscularly per 1kg body weight reached a peak blood concentration after 0.4 hour, Cmax was 5.93 μ g/ml, T1/2 was about 1.4 hour, and area under the curve (AUC) was 12.34 + -2.0 μ g.h/ml. In addition, the literature reports that 1mg of cefquinome is injected into cattle per 1kg of body weight intramuscularly or subcutaneously, the blood concentration reaches the peak value within 1.5-2 hours, the Cmax is 2.96 mu g/ml (subcutaneous) and 2.98 mu g/ml (intramuscular), the subcutaneous t1/2 is 2.5 hours, and the intramuscular t1/2 is 2.6 hours. The binding rate of the protein was less than 5% and was excreted through urine as the prototype. Is mainly used for treating porcine respiratory diseases caused by Pasteurella multocida or Actinobacillus pleuropneumoniae.
The production process of cefquinome sulfate injection in the existing market mainly comprises the following steps: firstly, preparing in a preparation tank, then shearing or low-temperature shearing, and finally grinding by a colloid mill to prepare the product; the requirements on pharmaceutical environment are harsh, and the drug circulation links are too many, so that the problems of long drug preparation time, poor stability of drug quality and low yield are caused.
Disclosure of Invention
Aiming at the defects of the prior art, the invention provides a preparation method for producing cefquinome sulfate injection by combining an emulsification stirring tank and a colloid mill, and solves the problems of poor stability of medicine quality and low yield caused by long medicine preparation time.
The invention solves the technical problems through the following technical means:
a preparation method for producing cefquinome sulfate injection by combining an emulsification stirring tank and a colloid mill comprises the following steps:
(1) adding suspending agent into injectable solvent, stirring in emulsifying stirring tank, heating steam interlayer to 121 deg.C, stirring, keeping constant temperature for 30 min, cooling to room temperature with drinking water interlayer, starting emulsifying device on emulsifying tank, and emulsifying for 30 min;
(2) adding cefquinome sulfate, an emulsifier and an antioxidant into the mixture obtained in the step (1), and starting an emulsifier in an emulsifying tank to emulsify for 30 minutes;
(3) circularly grinding the emulsified liquid medicine for 30 minutes by a colloid mill, dissolving the liquid medicine to a sufficient amount by using a solvent for injection, and circularly grinding for 30 minutes;
(4) and (4) determining the granularity, related substances, water, dispersibility, sedimentation, content and other items of the ground liquid medicine to be qualified, performing sterile filtration, and subpackaging to obtain the finished product.
The addition amount of the raw material of the cefquinome sulfate is 2.5-5% (g/ml) of the total volume of the injection;
the injection solvent is ethyl oleate, and accounts for 50-80% (v/v) of the total volume;
the suspending agent is: aluminum stearate 2.0-3.0% (g/v);
the emulsifier is as follows: lecithin 1.0-2.0% (g/v);
the antioxidant is as follows: vitamin E0.2-0.5% (g/v).
Production equipment:
the emulsifying and stirring tank (model: RHG-300 Nanjing Shuaibo mechanical equipment factory).
② a colloid mill (model: JM-150 Wenzhou Xiaojie mechanical Co., Ltd.).
The invention has the advantages that: the invention relates to a preparation method for producing cefquinome sulfate injection by combining an emulsification stirring tank and a colloid mill, which utilizes the combination of the emulsification stirring tank and the colloid mill, solves the problem of solvent sterilization in the preparation process of the cefquinome sulfate injection in the production process, completes preparation, emulsification and shearing in the emulsification tank without adding high-speed shearing equipment, does not need shearing at low temperature (2-8 ℃), reduces the circulation link of medicines, reduces the time of exposing the medicines in the air, saves the equipment cost, ensures the quality stability of the medicines, and improves the yield of products. The product has the characteristics of good fluidity, strong dispersibility, fine granularity, no wall hanging, difficult oxidation and no degradation when being stored at normal temperature, and the like.
Of course, it is not necessary for any product in which the invention is practiced to achieve all of the above-described advantages at the same time.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the description of the embodiments will be briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art that other drawings can be obtained according to the drawings without creative efforts.
FIG. 1-1: example a solution is shown in a microscopic examination for 0 months.
FIGS. 1-2: example one solution 0 month the sum of the peak areas of each impurity is plotted.
FIGS. 1 to 3: example a solution 0 month cefquinome peak profile.
FIGS. 1 to 4: example a solution was examined at microscopic level for 3 months to show a graph.
FIGS. 1 to 5: example one solution for 3 months the peak area and peak profile for each impurity.
FIGS. 1 to 6: example a solution 3 month cefquinome peak profile.
FIGS. 1 to 7: example a solution was examined at microscopic level for 6 months to show a graph.
FIGS. 1 to 8: example one solution 6 months the peak area and peak profile of each impurity.
FIGS. 1 to 9: example a 6 month peak profile of cefquinome in solution.
FIGS. 1 to 10: example a solution was examined at microscopic level for 9 months to show a graph.
FIGS. 1 to 11: example one solution for 9 months the peak area and peak profile for each impurity.
FIGS. 1 to 12: example a solution 9 month cefquinome peak profile.
FIGS. 1 to 13: example a solution was examined at 12 months for a display.
FIGS. 1 to 14: example one solution for 12 months the peak area and peak profile for each impurity.
FIGS. 1 to 15: example a 12 month peak profile of cefquinome in solution.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
In the description of the present invention, it is to be understood that the terms "opening," "upper," "lower," "thickness," "top," "middle," "length," "inner," "peripheral," and the like are used in an orientation or positional relationship that is merely for convenience in describing and simplifying the description, and do not indicate or imply that the referenced component or element must have a particular orientation, be constructed and operated in a particular orientation, and thus should not be considered as limiting the present invention.
Implementing one step:
a preparation method for producing cefquinome sulfate injection by combining an emulsification stirring tank and a colloid mill comprises the following steps: the composition is prepared by the following steps of: 2.5 percent (g/ml) of cefquinome sulfate; aluminum stearate 2.0% (g/v); lecithin 1.0% (g/v); vitamin E0.2% (g/v); injection grade ethyl oleate plus the total volume.
1. Adding aluminum stearate into injection-grade ethyl oleate (80% v/v), stirring uniformly in an emulsification stirring tank, heating a steam interlayer to 121 ℃, stirring continuously, keeping the temperature for 30 minutes, cooling to room temperature by using a drinking water interlayer, starting an emulsifier on the emulsification tank, and emulsifying for 30 minutes.
2. Adding the cefquinome sulfate, the lecithin and the vitamin E into the mixture obtained in the step (1), and starting an emulsifier in an emulsifying tank to emulsify for 30 minutes.
3. And circularly emulsifying the emulsified liquid medicine by a colloid mill, grinding for 30 minutes, standing for 1 hour, dissolving the liquid medicine to a sufficient amount by using ethyl oleate, and circularly emulsifying and grinding for 30 minutes.
4. And (4) determining the granularity, related substances, water, dispersibility, sedimentation, content and other items of the ground liquid medicine to be qualified, performing sterile filtration, and subpackaging to obtain the finished product.
Storing at room temperature for 0 month, three months, six months, nine months, twelve months (fig. 1-1, fig. 1-2, fig. 1-3, fig. 1-4, fig. 1-5, fig. 1-6, fig. 1-7, fig. 1-8, fig. 1-9, fig. 1-10, fig. 1-11, fig. 1-12, fig. 1-13, fig. 1-14, fig. 1-15);
case one product stored at room temperature for 0 month, three months, six months, nine months and twelve months
The second embodiment:
the composition is prepared by the following steps of: 5% (g/ml) of cefquinome sulfate; aluminum stearate 3% (g/v); lecithin 2% (g/v); vitamin E0.5% (g/v); injection grade ethyl oleate plus the total volume.
1. Adding aluminum stearate into injection-grade ethyl oleate (80% v/v), stirring uniformly in an emulsification stirring tank, heating a steam interlayer to 121 ℃, stirring continuously, keeping the temperature for 30 minutes, cooling to room temperature by using a drinking water interlayer, starting an emulsifier on the emulsification tank, and emulsifying for 30 minutes.
2. Adding the cefquinome sulfate, the lecithin and the vitamin E into the mixture obtained in the step (1), and starting an emulsifier in an emulsifying tank to emulsify for 30 minutes.
3. And circularly emulsifying the emulsified liquid medicine by a colloid mill, grinding for 30 minutes, standing for 1 hour, dissolving the liquid medicine to a sufficient amount by using ethyl oleate, and circularly emulsifying and grinding for 30 minutes.
4. And (4) determining the granularity, related substances, water, dispersibility, sedimentation, content and other items of the ground liquid medicine to be qualified, performing sterile filtration, and subpackaging to obtain the finished product.
Testing at room temperature for 0 month, three months, six months, nine months, and twelve months
Case two products were tested at room temperature for 0 month, three months, six months, nine months, and twelve months
The preparation method for producing the cefquinome sulfate injection by combining the emulsifying stirring tank and the colloid mill has the advantages of simple process operation, short manufacturing time, few liquid medicine circulation links, high yield, good stability, strong dispersion reproducibility, difficult oxidation, stable product property within two-year validity period, and capabilities of overcoming the defects of complicated equipment, harsh requirements on pharmaceutical environment and excessive medicine circulation links in the production of the cefquinome sulfate injection in the prior art, reducing the risk of medicine quality, providing the preparation method for producing the cefquinome sulfate injection by combining the emulsifying stirring tank and the colloid mill, and having great practical significance on industrial production of the cefquinome sulfate injection.
In the description herein, references to the description of "one embodiment," "an example," "a specific example" or the like are intended to mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, the schematic representations of the terms used above do not necessarily refer to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.
The preferred embodiments of the invention disclosed above are intended to be illustrative only. The preferred embodiments are not intended to be exhaustive or to limit the invention to the precise embodiments disclosed. Obviously, many modifications and variations are possible in light of the above teaching. The embodiments were chosen and described in order to best explain the principles of the invention and the practical application, to thereby enable others skilled in the art to best utilize the invention. The invention is limited only by the claims and their full scope and equivalents.
Claims (2)
1. A preparation method for producing cefquinome sulfate injection by combining an emulsification stirring tank and a colloid mill is characterized by comprising the following steps: comprises the following steps of (a) carrying out,
(1) adding suspending agent into injectable solvent, stirring in emulsifying stirring tank, heating steam interlayer to 121 deg.C, stirring, keeping constant temperature for 30 min, cooling to room temperature with drinking water interlayer, starting emulsifying device on emulsifying tank, and emulsifying for 30 min;
(2) adding cefquinome sulfate, an emulsifier and an antioxidant into the mixture obtained in the step (1), and starting an emulsifier in an emulsifying tank to emulsify for 30 minutes;
(3) circularly grinding the emulsified liquid medicine for 30 minutes by a colloid mill, dissolving the liquid medicine to a sufficient amount by using a solvent for injection, and circularly grinding for 30 minutes;
(4) and (4) determining the granularity, related substances, water, dispersibility, sedimentation, content and other items of the ground liquid medicine to be qualified, performing sterile filtration, and subpackaging to obtain the finished product.
2. The preparation method for producing cefquinome sulfate injection by using the emulsification agitator tank and the colloid mill in combination according to claim 1, is characterized in that: the addition amount of the raw material of the cefquinome sulfate is 2.5-5% (g/ml) of the total volume of the injection;
the injection solvent is ethyl oleate, and accounts for 50-80% (v/v) of the total volume;
the suspending agent is: aluminum stearate 2.0-3.0% (g/v);
the emulsifier is as follows: lecithin 1.0-2.0% (g/v);
the antioxidant is as follows: vitamin E0.2-0.5% (g/v).
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Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102319210A (en) * | 2011-09-29 | 2012-01-18 | 武汉回盛生物科技有限公司 | A kind of long-acting veterinary cefquinome sulfate injection and preparation method thereof |
| CN104127419A (en) * | 2014-08-12 | 2014-11-05 | 中国药科大学 | Stable cefquinome sulfate oil suspension injection |
| CN104473868A (en) * | 2014-12-01 | 2015-04-01 | 上海同仁药业有限公司 | Cefquinome sulfate suspension injection and preparation method thereof |
| CN106491532A (en) * | 2016-11-01 | 2017-03-15 | 四川美嘉龙生物科技有限公司 | A kind of cefquinome sulfate injection and preparation technology |
| CN107334730A (en) * | 2017-06-30 | 2017-11-10 | 广东温氏大华农生物科技有限公司 | A kind of cefquinome sulfate injection and its low temperature high shear preparation method |
| CN109044970A (en) * | 2018-11-08 | 2018-12-21 | 遂宁市中通实业集团动物药业有限公司 | A kind of cefquinome sulfate injection and preparation method thereof |
-
2020
- 2020-08-19 CN CN202010835613.2A patent/CN112156011A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102319210A (en) * | 2011-09-29 | 2012-01-18 | 武汉回盛生物科技有限公司 | A kind of long-acting veterinary cefquinome sulfate injection and preparation method thereof |
| CN104127419A (en) * | 2014-08-12 | 2014-11-05 | 中国药科大学 | Stable cefquinome sulfate oil suspension injection |
| CN104473868A (en) * | 2014-12-01 | 2015-04-01 | 上海同仁药业有限公司 | Cefquinome sulfate suspension injection and preparation method thereof |
| CN106491532A (en) * | 2016-11-01 | 2017-03-15 | 四川美嘉龙生物科技有限公司 | A kind of cefquinome sulfate injection and preparation technology |
| CN107334730A (en) * | 2017-06-30 | 2017-11-10 | 广东温氏大华农生物科技有限公司 | A kind of cefquinome sulfate injection and its low temperature high shear preparation method |
| CN109044970A (en) * | 2018-11-08 | 2018-12-21 | 遂宁市中通实业集团动物药业有限公司 | A kind of cefquinome sulfate injection and preparation method thereof |
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