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Preparation method for tulathromycin emulsifable injection

A technology of teramycin and injection, applied in the field of emulsifiable oil injection, can solve the problems of high irritation, poor quick-acting, low drug loading, etc., achieve good stability, good biocompatibility, and reduce drug residues amount of effect

Active Publication Date: 2014-10-15
王玉万 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In order to overcome the shortcomings of the disclosed injections, such as high irritation, low drug loading, or poor quick effect, the present invention combines telamycin and poloxamer 188 (P188), disperses them in an oily medium, and prepares an oil substance injection

Method used

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  • Preparation method for tulathromycin emulsifable injection
  • Preparation method for tulathromycin emulsifable injection
  • Preparation method for tulathromycin emulsifable injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1、16

[0029] Example 1. Composition, preparation and in vitro emulsification performance inspection of 16% telamycin injection

[0030] (1) Preparation composition: based on the preparation of 100ml, the ingredients of preparations 1-9 are shown in the table below.

[0031] ingredients

P188(g)

HCO (g)

Soy lecithin (g)

Glyceryl formaldehyde (ml)

Ethyl oleate (ml)

Preparation 1

3

0.3

0.15

6.6

20

Preparation 2

6

0.5

0.3

6.6

20

Preparation 3

9

0.7

0.5

6.6

20

Preparation 4

3

0.3

-

6.6

20

Preparation 5

6

0.5

-

6.6

20

Preparation 6

9

0.7

-

6.6

20

Preparation 7

3

-

-

6.6

20

Preparation 8

6

-

-

6.6

20

Preparation 9

9

-

-

6.6

20

[0032] Note: Add BHT0.02g, BHA0.01g, PG0.005g to preparations 1-9: add benzyl benzoate to ...

Embodiment 2

[0043] Example 2, Composition, preparation and in vitro emulsification performance experiment of 6% telamycin injection

[0044] (1) Preparation composition: Based on the preparation of 100ml, the ingredients of preparations 10 to 15 are shown in the table below.

[0045] ingredients

Tyramycin (g)

P188(g)

HCO (g)

Soy Lecithin (g)

Preparation 10

6

3

0.3

0.4

Preparation 11

6

6

0.5

0.7

Preparation 12

6

12

0.7

0.9

Preparation 13

6

3

-

-

Preparation 14

6

6

-

-

Preparation 15

6

12

-

-

[0046] Note: All preparations in the table are added with antioxidants BHT0.02g, BHA0.01g, PG0.005g, and ethyl oleate to 100ml.

[0047] (2) Preparation method

[0048] a. Put the drug and P188 into the reflux bottle, add 6ml of ethanol, dissolve it in a water bath at 80-85°C, then distill under reduced pressure to remove most of th...

Embodiment 3

[0059] Embodiment 3, composition and preparation of telamycin injection and telamycin / lactic acid TMP injection

[0060] (1) Preparation composition: Based on the preparation of 100ml, the ingredients of preparation 16-21 are shown in the table below.

[0061] ingredients

Preparation 16

Preparation 17

Preparation 18

Preparation 19

Preparation 20

Preparation 21

Tyramycin g

10

13

16

10

13

16

Lactate TMP g

2.5

3.3

4

-

-

-

P188g

12

8

6

12

8

6

HCO g

0.4

0.6

0.8

-

-

0.45

Soy phospholipids g

0.6

0.8

1.0

0.6

0.9

-

Antioxidant g

0.035

0.035

0.035

0.035

0.035

0.035

IPM ml

to 100

to 100

to 100

to 100

to 100

to 100

[0062] Note: Antioxidant is BHT+BHA+PG=0.02+0.01+0.005=0.035

[0063] (2) Preparation method

[0064] Mix Tyramycin, lac...

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Abstract

Poloxamer 188 and an oily medium are composed to prepare an oily injection containing tulathromycin; defined amount of hydrogenated castor oil and soya lecithin can be further added in the prepared oily injection containing tulathromycin; the oily injection containing tulathromycin is mainly characterized in that the prepared oily injection is emulsified when encountering water or liquid to generate a mixed system with emulsion droplets and oil; the quick releasing effect and long-acting effect are achieved and the prepared oily injection is defined as an emulsifable oily injection. The prepared oily injection has the characteristics that the drug loading capacity is high, the stability is good and the biocompatibility is excellent and the like.

Description

technical field [0001] The invention belongs to the preparation technology of veterinary drug preparations, and relates to the preparation of telamycin-containing emulsifiable oily injection by combining poloxamer 188 with an oily medium. Background technique [0002] Tulathromycin (Tulathromycin) is a semi-synthetic antibiotic specially used for animals. It has broad antibacterial spectrum, high activity, less clinical dosage, low toxicity, low residue, no teratogenicity, and the entire treatment process can be completed with one administration, etc. Many advantages. Therefore, since Tyramycin was launched on the market, it has attracted widespread attention from all over the world. The commercially available telamycin product is an injection, which is a water-miscible solution type injection. Most of the technologies disclosed in patents use organic solvent / water co-solvent and acidic conditions to prepare telamycin injection (CN1429232A, CN101422479A, CN102048747A, CN10...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K31/7052A61K47/34A61K47/44A61P31/04
Inventor 王玉万潘贞德彭欣郭强戴晓曦任雅楠沈力
Owner 王玉万
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