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A kind of ceftiofur sodium drug sustained-release colloid powder injection for injection and preparation method thereof

A ceftiofur sodium and injection technology, applied in the field of medicine, can solve the problems of low economic benefit, obvious cost advantage, high cost and other problems of farmers, and achieve the saving of drug cost and animal stress, good acupuncture, and clinical use. handy effect

Active Publication Date: 2019-02-12
甘肃新天马制药有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, ceftiofur injection has obvious disadvantages. The mainstream content specifications in the market are between 2.5% and 10%. That is to say, in addition to drugs, more than 90% of the excipients are organic solvents, resulting in excessive costs and reduced economic benefits for farmers.
Moreover, organic solvents are viscous. This viscosity not only brings slow-release effect to the drug, but also brings about the problem of poor needle penetration. If most of the products of this type on the market use small syringes, it is difficult to pump the drug. come out
The other dosage form is ceftiofur sodium powder injection for ordinary injection. This type of product is the injection powder injection obtained by directly filling the raw material of ceftiofur into a vial, and vacuum aseptic treatment. Just use it. Compared with the injection dosage form, there is one more dilution step, which is a little troublesome, but it does not use expensive organic excipients, and the cost advantage is obvious.
However, the drug is directly soluble in water, absorbed directly after intramuscular injection, and there will be no local sustained release effect, which is also a disadvantage of ordinary powder injections

Method used

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  • A kind of ceftiofur sodium drug sustained-release colloid powder injection for injection and preparation method thereof
  • A kind of ceftiofur sodium drug sustained-release colloid powder injection for injection and preparation method thereof
  • A kind of ceftiofur sodium drug sustained-release colloid powder injection for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-10

[0019] In order to make the description concise, the weight composition of a kind of ceftiofur sodium drug sustained-release colloid powder injection for injection described in Examples 1-10 is given in the form of a table below, as shown in Table 1 for details.

[0020] Each component composition of table 1 embodiment 1-10

[0021] .

[0022] The preparation method of the ceftiofur sodium drug sustained release colloid powder injection for injection described in embodiment 1-10 comprises the following steps:

[0023] 1) Mix ceftiofur sodium, slow-release gel and flow-promoting agent according to the weight stated in the table;

[0024] 2) Aseptically pack the mixture in step 1) into 100 tubes according to the specification of 100ml / bottle.

Embodiment 11

[0025] Embodiment 11 Properties and stability of the product of the present invention

[0026] The product of the present invention is a white or off-white powder with a uniform appearance. The photo of its appearance is shown in figure 1 As shown in the figure on the right; at the same time figure 2 It has been confirmed that the colloidal powder injection of the present invention dissolves well, and compared with the common powder injection, the appearance after dissolution is gelatinous, slightly viscous, and not completely clear and transparent; image 3 It then confirms the appearance of the colloid after the colloid powder injection of the present invention dissolves in water.

[0027] Samples were taken from Examples 1-10 of the present invention, and each sample was placed at room temperature, at 40°C with high temperature and high humidity, at 4°C at low temperature, and at -20°C, and placed at 0d, 15d, 30d, 90d and 180d, respectively. Sampling to observe the prope...

Embodiment 12

[0028] Embodiment 12 drug effect test

[0029] The safety, drug efficacy and acupuncture effect of the drug of the present invention on animals will be further described through the drug safety test and drug effect test.

[0030] Usage and dosage: When in use, dilute to 100ml with normal saline, shake vigorously until the drug is completely dissolved, and the appearance is jelly.

[0031] Intramuscular injection, the recommended dose is 5mg / kg body weight.

[0032] 12.1 Safety test

[0033] A kind of ceftiofur sodium drug sustained-release colloid powder injection for injection prepared in Example 1 was used as a sample to carry out the following safety test.

[0034] Safety test: 80 40-day-old healthy layer chicks were randomly divided into 4 groups, 20 in each group, and the 4 groups were marked as the control group, low-dose group, medium-dose group, and high-dose group, and were raised in the same environmental conditions Down. Among them, the low-dose group uses 2.5 m...

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Abstract

The invention provides ceftiofur sodium drug sustained-release colloid powder injection for injection, belonging to the technical field of medicines. The ceftiofur sodium drug sustained-release colloid powder injection is prepared from the following components in parts by weight: 0.01-10 parts of ceftiofur sodium, 0.1-3.0 parts of sustained-release colloid, and 0.01-0.1 part of a flowing promoter. A preparation method of the ceftiofur sodium drug sustained-release colloid powder injection for injection comprises the following steps: (1) mixing the components at the corresponding ratio; and (2) carrying out aseptic subpackaging on the mixture obtained in the step (1) according to the specification. Compared with the common ceftiofur sodium for injection, the ceftiofur sodium drug sustained-release colloid powder injection has the advantage that after being diluted by normal saline, the medicine rapidly forms a sustained-release colloid solution; after injection, a drug storage is formed at the injection part, slow release is carried out, therefore, the medication times is reduced, the animal stress is reduced, and manpower resources, material resources and financial resources are saved; and meanwhile, the use is safe, the preparation method is simple, and the clinical popularization and application are facilitated.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a slow-release colloid powder injection of ceftiofur sodium for injection and a preparation method thereof. Background technique [0002] Ceftiofur sodium is a cephalosporin class of antibiotics used exclusively for veterinary clinics, and is a broad-spectrum antibacterial drug. It has a strong killing effect on Gram-positive bacteria and Gram-negative bacteria. The molecular structure of ceftiofur sodium can be combined with the surface membrane protein of the bacterial membrane, causing changes in the bacterial morphology. Under the interaction between the drug and the protein, the drug particles quickly enter the bacterial body, reaching a high drug concentration in a short time, and the cell membrane protein synthesis Inhibited, the incompleteness of the membrane wall aggravates the external water molecules entering the bacteria through the osmotic pressure diff...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/14A61K31/546A61K47/36A61K47/10A61P31/04
CPCA61K9/0002A61K9/0019A61K9/146A61K31/546
Inventor 苗耀天刘添泰罗哲学蔺天得亢永久胡冰董伟
Owner 甘肃新天马制药有限责任公司