CN114191375A - Cefuroxime sodium for injection and preparation method thereof - Google Patents
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- CN114191375A CN114191375A CN202111563798.7A CN202111563798A CN114191375A CN 114191375 A CN114191375 A CN 114191375A CN 202111563798 A CN202111563798 A CN 202111563798A CN 114191375 A CN114191375 A CN 114191375A
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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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- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
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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 cefuroxime sodium for injection and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. The cefuroxime sodium for injection is composed of 90-110 parts of cefuroxime sodium and 2-20 parts of sorbitol according to parts by weight. Sorbitol is added into cefuroxime sodium for injection to replace a headspace nitrogen filling process in the production process of the preparation, so that the problem of unstable nitrogen filling caused by nitrogen filling level difference of a production line is solved, the color and clarity of the product can be effectively improved, impurities of related substances and cefuroxime sodium polymers are reduced, the stability of the preparation is improved, and the quality of the product is improved.
Description
Technical Field
The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to cefuroxime sodium for injection and a preparation method thereof.
Background
Cefuroxime sodium is white to light yellow solid or crystalline powder, is easily soluble in water, is a second-generation cephalosporin and has broad-spectrum antibacterial activity. Is quite stable to beta-lactamase produced by staphylococcus and gram-negative bacilli. 1-2mg/L can inhibit all the staphylococcus aureus which is sensitive and resistant to penicillin. In addition, the product has strong antibacterial activity to haemophilus influenzae, and is sensitive to proteus mirabilis, escherichia coli and the like. Cefuroxime sodium is well distributed in various body fluids and tissue fluids and can enter inflammatory cerebrospinal fluid.
Cefuroxime sodium raw material is easily affected by environmental factors, such as: the pH value, the temperature, the illumination and the like are easy to degrade and polymerize after being stored for a long time or being placed, so that the color and luster are changed, and related substances, cefuroxime polymer and other impurities are generated. In the mainstream view, these impurities are allergens causing allergic reactions of cefuroxime sodium drugs. Therefore, several approaches have been taken to improve the stability of cefuroxime sodium for injection. Nitrogen charging preservation in the inner packaging material for improving stability is one of common means, but the nitrogen charging level of the aseptic subpackaging process cannot be accurately controlled, which has a great risk for the stability of the preparation.
The chinese patent application CN201280007724.8 discloses a cefuroxime sodium new crystal form compound and a composition powder injection thereof, relating to the technical field of medicines and preparation methods thereof, wherein the cefuroxime sodium new crystal form compound belongs to a new crystal form: and (4) amorphous. The aseptic powder is prepared by reacting cefuroxime acid with sodium bicarbonate, adding activated carbon into a solution generated by the reaction for decolorization, filtering and sterilizing through 0.45-micron and 0.22-micron filter membranes, quickly freezing at the temperature of-40-50 ℃ for 2 hours, and drying in vacuum (the drying temperature is below 15 ℃, the vacuum degree is 10-20 Pa, and the time is 30-35 hours). The cefuroxime sodium composition powder needle comprises the following components: 95-100 parts of cefuroxime sodium new crystal compound and 5-10 parts of mannitol. The composition is subpackaged into powder injection preparation for injection of 0.25 g, 0.75 g, 1.5 g, 2.25 g or 2.5 g for clinical application.
Chinese patent application CN200910230402.X discloses a cefuroxime sodium suspension powder injection which is prepared from the following components in parts by weight: 1 part of cefuroxime sodium, 2-10 parts of surfactant and 3-18 parts of freeze-drying supporting agent, wherein the surfactant is a combination of cholesterol and tween-80 in a weight ratio of 6: 1-4: 1. The invention solves the problem of poor stability of cefuroxime sodium by using a specific surfactant, applying an emulsifying suspension technology and preparing the powder injection by freeze drying.
Sorbitol is D-sorbitol, which is named as sorbitol completely, and is also named as glucitol, rose alcohol, herbal tea alcohol, hexahydroxy alcohol, etc., and sorbitol belongs to one of sugar alcohols. Sugar alcohols are colorless crystalline solids, generally having a sweet taste, and common sugar alcohols are: xylitol, mannitol, sorbitol, maltitol, lactitol, and the like. The aqueous solution of sugar alcohol has complexation effect and can chelate various metal ions. Compared with the prior art, the cefuroxime sodium for injection has better stability, is compounded only by using sorbitol and cefuroxime sodium, and has simpler composition and safer components.
Disclosure of Invention
The invention aims to provide cefuroxime sodium for injection and a preparation method thereof, wherein sorbitol is added into the cefuroxime sodium for injection to replace a headspace nitrogen filling process in the production process of a preparation, so that the problem of insufficient nitrogen filling in production can be solved, the problems of product color and clarity can be improved, related substances and cefuroxime sodium polymer impurities are reduced, the stability of the preparation is improved, and the quality of the product is improved.
In order to achieve the purpose, the technical scheme of the invention is as follows:
in one aspect, the invention provides cefuroxime sodium for injection, which consists of cefuroxime sodium and sorbitol.
Preferably, the cefuroxime sodium injection consists of 90-110 parts of cefuroxime sodium and 2-20 parts of sorbitol according to parts by weight.
Further preferably, the cefuroxime sodium powder comprises 95-110 parts of cefuroxime sodium and 5-10 parts of sorbitol by weight.
Still more preferably, the cefuroxime sodium powder comprises 98-105 parts of cefuroxime sodium and 6-9 parts of sorbitol by weight.
Most preferably, it is composed of 100 parts by weight of cefuroxime sodium and 8 parts by weight of sorbitol.
In another aspect, the present invention provides a method for preparing a formulation comprising the above, comprising the steps of:
and (3) crushing and mixing the cefuroxime sodium and sorbitol according to the formula dosage to obtain the cefuroxime sodium for injection.
Preferably, the cefuroxime sodium and sorbitol are weighed at 15-30 ℃ and at a humidity of less than 60% RH, and further preferably at a humidity of 30-60% RH.
Preferably, the pulverization is to a particle size of less than 200 μm, more preferably less than 100 μm.
Preferably, the pulverization manner includes, but is not limited to, jet milling, ultramicro milling, grinding milling, steam kinetic energy grinding, crushing and the like. In one embodiment of the invention, the jet mill is selected for milling for 5-15 min.
Preferably, the mixing is carried out in a double-helix conical mixer for 10-60min so as to ensure that the components are uniformly mixed.
Preferably, the obtained preparation also undergoes the steps of filling, stoppering, capping and packaging.
Further preferably, the filling step is: adding the obtained preparation into a screw racking machine, adjusting the racking speed to 60-500 bottles/min, and filling into penicillin bottles.
The invention has the beneficial effects that:
(1) sorbitol is added into cefuroxime sodium for injection to replace a headspace nitrogen charging process, so that the problem of insufficient nitrogen charging in production is solved.
(2) Improve the color and clarity of the product, reduce related substances and cefuroxime sodium polymer impurities, increase the stability of the preparation and improve the quality of the product.
Drawings
FIG. 1 example 1 relates to substance profiles.
FIG. 2 is a diagram of the related substances of the original preparation.
Detailed Description
The following non-limiting examples are presented to enable those of ordinary skill in the art to more fully understand the present invention and are not intended to limit the invention in any way. The following is merely an exemplary illustration of the scope of the invention as claimed, and various changes and modifications of the invention of the present application may be made by those skilled in the art based on the disclosure, which also fall within the scope of the invention as claimed.
The present invention will be further described below by way of specific examples. The various chemicals used in the examples of the present invention were obtained by conventional commercial routes unless otherwise specified.
In the following examples, the substances involved were detected by the following methods:
test solution: taking appropriate amount of the content of the product, dissolving with solvent, and diluting to obtain solution containing 0.5mg per 1 ml.
Diluent agent: and (3) water.
Chromatographic conditions are as follows: octadecylsilane bonded silica gel as a packing (Waters XTreraRPCl 8 column, 4.6 mm. times.250 mm, 3.5 μm or equivalent performance column); mobile phase A: pH3.4 acetate buffer; mobile phase B: acetonitrile; gradient elution was performed according to the following table; the flow rate is 1.0ml per minute, and the column temperature is 65 ℃; the detection wavelength is 273 nm; the injection volume was 100. mu.l.
TABLE 1 gradient of mobile phase
The determination method comprises the following steps: precisely measuring the test solution and the reference solution, respectively injecting into a liquid chromatograph, and recording the chromatogram.
System applicability requirements: the separation between cefuroxime and cefuroxime axetil peak should not be less than 3.0. The separation between the cefuroxime peak and the next adjacent impurities should meet the requirement.
Limitation: if the sample solution has impurity peaks, the peak area of cefuroxime is calculated according to an external standard method with correction factors, and the limit of each impurity is shown in the table. The reporting limit is 0.05%.
TABLE 2 impurity limits of cefuroxime sodium for injection
| Name of impurity | RRT | Limit of |
| Impurity A | 0.85 | 1.0％ |
| Impurity E | 1.73 | 1.0％ |
| Impurity H | 1.94 | 1.0％ |
| Other single impurities | / | 0.2％ |
| Total miscellaneous | / | 3.0％ |
Example 1
The components: 100 parts of cefuroxime sodium and 8 parts of sorbitol.
The preparation method comprises the following steps:
(1) weighing: accurately weighing cefuroxime sodium and sorbitol according to the formula proportion under the conditions of 26 ℃ of temperature and 42% RH of humidity;
(2) crushing: respectively crushing the raw materials and the auxiliary materials for 15min by a jet mill until the particle size ranges from 100 um;
(3) mixing: respectively adding the pulverized cefuroxime sodium and sorbitol into a double-helix conical mixer, mixing for 30min, and uniformly mixing;
(4) filling: adding the uniformly mixed cefuroxime sodium and sorbitol into a screw racking machine, adjusting the corresponding racking speed to 120 bottles/min, and filling into penicillin bottles;
(5) plugging: plugging the composition which is subpackaged into the penicillin bottles;
(6) and (3) rolling a cover: capping the composition in the plugged penicillin bottle;
(7) packaging: and packaging the composition in the penicillin bottle after the cover is rolled.
Example 2
The components: 100 parts of cefuroxime sodium and 2 parts of sorbitol.
The preparation method comprises the following steps: the same as in example 1.
Example 3
The components: 100 parts of cefuroxime sodium and 20 parts of sorbitol.
The preparation method comprises the following steps: the same as in example 1.
Example 4
The components: 95 parts of cefuroxime sodium and 10 parts of sorbitol.
The preparation method comprises the following steps: the same as in example 1.
Example 5
The components: 110 parts of cefuroxime sodium and 5 parts of sorbitol.
The preparation method comprises the following steps: the same as in example 1.
And (4) detecting a result: the product prepared in the example is mixed with the original preparation
Quality comparisons were made and the results are detailed in the table below.
TABLE 3 comparison of the quality of the examples with the quality of the original products
TABLE 4 comparison of the quality of the examples with the quality of the original products
The results show that the products prepared by the embodiment are compared with the original preparation, and the related substances, properties, acidity, color and content of the products are all equal to or superior to the original preparation. Among them, the embodiment 1 has the best effect. The related substance map of example 1 is shown in detail in FIG. 1, and the original developer map is shown in FIG. 2.
Comparative example 1
The preparation method is the same as that of example 1, except that the product only contains cefuroxime sodium.
Comparative example 2
The preparation method is the same as that of example 1, except that the cefuroxime sodium is contained only, and nitrogen is filled in the preparation process.
Comparative example 3
The preparation method is the same as that of example 1, except that mannitol is used instead of sorbitol.
The stability retentations were performed on the samples prepared in example 1 and comparative examples 1 to 3 and the original developers, and the results are shown in the following table.
TABLE 5 quality comparison of influencing factors of examples, comparative examples and original products
The results show that the substances, properties, acidity, color, content and substances of example 1 are equal to or better than those of comparative example 1, comparative example 2 and comparative example 3.
When the above conditions are analyzed, the impurity E, the unknown single impurity and the total impurity of the comparative examples 1 and 2 exceed the limit values, and the impurity E, the unknown single impurity and the total impurity of the examples 1 and 3 do not exceed the limit values, but the increase of the comparative example 3 is more obvious than that of the example 1. Example 1 differs from comparative example 1 only in that sorbitol is added in example 1, and not only is the impurity of example 1 significantly better than that of comparative example 1, but the growth trend of cefuroxime polymer is also significantly flat. Comparative examples 2 and 3 differ from example 1 in that the sorbitol addition process is replaced by nitrogen charging and mannitol addition, respectively, to increase product stability. From the stability data it can be seen that: the stability results of comparative examples 2, 3 are both worse than example 1. The addition of sorbitol is proved to inhibit the oxidation reaction of the effective components, further effectively control the growth of related substances and effectively prevent the polymerization reaction of the raw material medicaments, so that the addition of sorbitol is inferred to improve the stability of the preparation and the quality of the product.
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 (10)
1. A cefuroxime sodium for injection is characterized by comprising cefuroxime sodium and sorbitol.
2. Cefuroxime sodium for injection according to claim 1, which comprises 90 to 110 parts by weight of cefuroxime sodium and 2 to 20 parts by weight of sorbitol.
3. Cefuroxime sodium for injection according to claim 2, which comprises 95-110 parts by weight of cefuroxime sodium and 5-10 parts by weight of sorbitol.
4. Cefuroxime sodium for injection according to claim 3, which comprises 98-105 parts by weight of cefuroxime sodium and 6-9 parts by weight of sorbitol.
5. Cefuroxime sodium for injection according to claim 4, which comprises 100 parts of cefuroxime sodium and 8 parts of sorbitol by weight.
6. The process for preparing cefuroxime sodium for injection according to any one of claims 1 to 5, comprising the steps of: and (3) crushing and mixing the cefuroxime sodium and sorbitol according to the formula dosage to obtain the cefuroxime sodium for injection.
7. The method for preparing cefuroxime sodium for injection according to claim 6, wherein the cefuroxime sodium and sorbitol are weighed at 15-30 ℃ and at a humidity of less than 60% RH, preferably at a humidity of 30-60% RH.
8. The process for preparing cefuroxime sodium for injection according to claim 6, wherein the pulverization is carried out to a particle size of less than 200 μm, preferably less than 100 μm.
9. The method for preparing cefuroxime sodium for injection according to claim 6, wherein the mixing is performed in a twin-screw conical mixer for 10-60min to achieve uniform mixing.
10. The process for preparing cefuroxime sodium for injection according to any one of claims 6 to 9, wherein the cefuroxime sodium for injection is further subjected to filling, stoppering, capping and packaging,
preferably, the filling step is: adding the obtained cefuroxime sodium for injection into a screw racking machine, adjusting the racking speed to be 60-500 bottles/min, and filling into penicillin bottles.
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Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR19990073761A (en) * | 1998-03-03 | 1999-10-05 | 윤재승 | Oral Solid Dispersion Composition of Sepuroxime Axetyl |
| WO1999062559A1 (en) * | 1998-05-29 | 1999-12-09 | Bernard Charles Sherman | Pharmaceutical tablets comprising cefuroxime axetil |
| CN102525949A (en) * | 2012-01-17 | 2012-07-04 | 山东罗欣药业股份有限公司 | Cefaclor composition particles and preparation method thereof |
| CN102743389A (en) * | 2012-07-06 | 2012-10-24 | 深圳信立泰药业股份有限公司 | Cefuroxime sodium pharmaceutical composition, powder-injection thereof and method for producing cefuroxime sodium pharmaceutical composition |
| CN103142617A (en) * | 2013-03-29 | 2013-06-12 | 山东罗欣药业股份有限公司 | Cefuroxime lysine medicinal composition |
| CN103271878A (en) * | 2012-12-18 | 2013-09-04 | 张宏民 | Ceftezole sodium agent and preparation method thereof |
-
2021
- 2021-12-20 CN CN202111563798.7A patent/CN114191375B/en active Active
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR19990073761A (en) * | 1998-03-03 | 1999-10-05 | 윤재승 | Oral Solid Dispersion Composition of Sepuroxime Axetyl |
| WO1999062559A1 (en) * | 1998-05-29 | 1999-12-09 | Bernard Charles Sherman | Pharmaceutical tablets comprising cefuroxime axetil |
| CN102525949A (en) * | 2012-01-17 | 2012-07-04 | 山东罗欣药业股份有限公司 | Cefaclor composition particles and preparation method thereof |
| CN102743389A (en) * | 2012-07-06 | 2012-10-24 | 深圳信立泰药业股份有限公司 | Cefuroxime sodium pharmaceutical composition, powder-injection thereof and method for producing cefuroxime sodium pharmaceutical composition |
| CN103271878A (en) * | 2012-12-18 | 2013-09-04 | 张宏民 | Ceftezole sodium agent and preparation method thereof |
| CN103142617A (en) * | 2013-03-29 | 2013-06-12 | 山东罗欣药业股份有限公司 | Cefuroxime lysine medicinal composition |
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