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Sarafloxacin hydrochloride sustain-released injection and preparation method thereof

A technology for salafloxacin hydrochloride and injection, which can be applied in pharmaceutical formulations, emulsion delivery, medical preparations containing active ingredients, etc., can solve problems such as limitations, reduce labor intensity, reduce stress response, and improve clinical treatment effect of effect

Inactive Publication Date: 2013-09-25
SHANDONG LONGHAI BIOLOGICAL TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the existing clinical dosage forms limit its use and efficacy

Method used

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  • Sarafloxacin hydrochloride sustain-released injection and preparation method thereof
  • Sarafloxacin hydrochloride sustain-released injection and preparation method thereof
  • Sarafloxacin hydrochloride sustain-released injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] The formulation of sarafloxacin hydrochloride sustained-release injection is shown in Table 1.

[0035] The formula of table 1 sarafloxacin hydrochloride sustained-release injection

[0036] raw material name

Formula ratio

Sarafloxacin hydrochloride raw material (g)

5.0

Soybean oil for injection (g)

20.0

EDTA-2Na(g)

0.02

Glycerin (g)

4

Soy Lecithin (g)

3.50

Tween 80 (g)

3.0

VE (g)

0.15

Water for injection (g)

64.33

[0037] Preparation method of sarafloxacin hydrochloride sustained-release injection:

[0038] (1) Micronize sarafloxacin hydrochloride and pass through a 500-mesh sieve;

[0039] (2) Weigh sarafloxacin perhydrochloride raw material drug, VE, soybean oil for injection and soybean lecithin according to the prescription quantity, place it on a constant temperature magnetic stirrer and heat it to 70°C, and mix and stir evenly at a stirring speed of 900r...

Embodiment 2

[0053] The formula of sarafloxacin hydrochloride sustained-release injection is shown in Table 3.

[0054] The formula of table 3 sarafloxacin hydrochloride sustained-release injection

[0055] raw material name

Prescription ratio

Sarafloxacin hydrochloride raw material (g)

2.5

Soybean oil for injection (g)

15.0

EDTA-2Na(g)

0.03

Tween 80 (g)

2.5

CMC-Na(g)

0.2

VE (g)

0.02

Water for injection (g)

79.75

[0056] Preparation method of sarafloxacin hydrochloride sustained-release injection:

[0057] (1) Micronize sarafloxacin hydrochloride and pass through a 600-mesh sieve;

[0058] (2) Weigh sarafloxacin hydrochloride raw material drug, VE and soybean oil for injection according to the prescription quantity, place on a constant temperature magnetic stirrer and heat to 80°C, and mix and stir evenly at a stirring speed of 800r / min to obtain a mixture A .

[0059](3) Weigh CMC-Na acco...

Embodiment 3

[0078] The formula of sarafloxacin hydrochloride sustained-release injection is shown in Table 6.

[0079] Table 6 Sarafloxacin Hydrochloride Sustained Release Injection Formula

[0080] raw material name

Prescription ratio

Sarafloxacin hydrochloride raw material (g)

5.0

Corn oil for injection (g)

28

EDTA-2Na(g)

0.04

Soy Lecithin (g)

5.0

CMC-Na(g)

0.2

VE (g)

0.1

Water for injection (g)

61.66

[0081] Preparation method of sarafloxacin hydrochloride sustained-release injection:

[0082] (1) Micronize sarafloxacin hydrochloride and pass through a 400-mesh sieve;

[0083] (2) Weigh sarafloxacin hydrochloride raw material drug, corn oil for injection, soybean lecithin and VE according to the prescription quantity, heat it on a constant temperature magnetic stirrer to 60°C, and mix and stir evenly at a stirring speed of 1200r / min to obtain Mixture A;

[0084] (3) Weigh CMC-Na accord...

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Abstract

The invention relates to a sarafloxacin hydrochloride sustain-released injection and a preparation method thereof, belongs to a medicinal preparation field. The sarafloxacin hydrochloride sustain-released injection is composed of sarafloxacin hydrochloride, an emulsifier, a suspending agent, a stabilizing agent, an antioxidant, plant oil for injection, and injection water. The preparation method comprises the following steps of: heating sieved sarafloxacin hydrochloride raw material drug, the plant oil for injection, the emulsifier and the antioxidant in a constant temperature magnetic stirrer, to obtain a mixture A; heating the suspending agent, a water-soluble emulsifier, the stabilizing agent and the injection water in the constant temperature magnetic stirrer, to obtain a mixture B; continuously adding the mixture A into the mixture B, mixing and shearing to obtain colostrums; complementing margin of the colostrum with injection water, then homogenizing, loading, and disinfecting with cobalt 60 ray, to obtain the product. The sarafloxacin hydrochloride injection with obvious sustain-released effect on intramuscular injection of livestock and poultry, can reduce stress reaction, mitigates culture labor intensity, and raises economic benefits and social benefits for livestock and poultry culture.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a sarafloxacin hydrochloride sustained-release injection and a preparation method thereof. Background technique [0002] Sarafloxacin hydrochloride is a third-generation fluoroquinolone antibacterial drug specially used for animals. It has a broad antibacterial spectrum and strong antibacterial activity. It has good performance against Gram-negative bacteria, Gram-positive bacteria and mycoplasma. Antibacterial effect, especially for Escherichia coli, Salmonella, Klebsiella, Proteus, Pasteurella multocida, Campylobacter and other enterobacteria. Sarafloxacin hydrochloride absorbs quickly, metabolizes quickly, has almost no residue, and has no cross-resistance with many antibacterial drugs. Rapid absorption after oral administration and injection, serum and tissue concentrations significantly higher than the MIC value for most pathogenic bacteria, wide distribution in t...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/496A61P31/04
Inventor 龙君江李振高振珅
Owner SHANDONG LONGHAI BIOLOGICAL TECH
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