Improved dimethicone-containing injection

A technology of simethicone and injection, which is applied in medical preparations with non-active ingredients, medical preparations containing active ingredients, liquid delivery, etc. It can solve problems such as simethicone residue and achieve good redispersibility, Small irritation, good suspension of the preparation

Active Publication Date: 2014-02-05
中农华威制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In order to overcome the disadvantage that simethicone is left in the injection site by simply using simethicone as a medium for injections, the present invention introduces an improved veterinary injection using simethicone as a sustained-release material. Simethicone reduced to 5-35% in the injection still has the expected sustained release effect, and it can be administered by intramuscular injection

Method used

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  • Improved dimethicone-containing injection
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  • Improved dimethicone-containing injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Embodiment 1, preparation 10% doxycycline hydrochloride injection

[0035] Preparation composition: Each 100ml injection contains doxycycline hydrochloride 10g, SAIB 17g, viscosity 5cs simethicone 25ml, IPM added to 100ml.

[0036] Preparation method: (1) Dissolving SAIB in IPM to prepare SAIB / IPM solution; (2) Mixing doxycycline hydrochloride and simethicone oil, grinding through a colloid mill until the particle size of doxycycline is less than 10 μm, and then mixing with SAIB / IPM is mixed and homogenized several times with a high-shear homogenizer at 15,000-21,000 rpm to prepare an injection with a particle size of less than 10 μm.

Embodiment 2

[0037] Embodiment 2, preparation 18% doxycycline hydrochloride injection

[0038] Preparation composition: Each 100ml injection contains doxycycline hydrochloride 18g, SAIB 20g, aluminum stearate 0.4g, BHA 0.01g, BHT 0.01g, viscosity 5cs simethicone 10ml, IPM added to 100ml.

[0039] Preparation method: (1) Add aluminum stearate to IPM, stir and heat (95-100°C) to prepare aluminum stearate-containing oil gel; (2) Dissolve SAIB in oil gel to prepare SAIB / Oil gel solution; (3) Doxycycline hydrochloride is mixed with oil gel, and the particle size of doxycycline hydrochloride is less than 8 μ m through sand mill grinding, then add simethicone and antioxidant, and use high shear After homogenization by the homogenizer several times under the condition of 15000-21000rpm, an injection with a particle size of less than 8 μm is prepared.

Embodiment 3

[0040] Embodiment 3, stability test and blood drug concentration determination

[0041] (1) Sedimentation rate and redispersibility: the sedimentation volume ratio of the preparation of Example 2 after standing for 3 hours was 94%; the redispersibility test results showed that the preparation was easily dispersed after shaking, and there was no sediment at the bottom of the bottle.

[0042] (2) Stability test: the formulation of Example 2 was sealed in a 20ml ampoule and stored in the dark at 28-32°C for 6 months. The sedimentation volume ratio of the formulation was 68-76%, and it was easily dispersed after shaking. Precipitate. The doxycycline content in the preparation was reduced by 1.63-2.75% (percentage of initial amount).

[0043] (3) Determination of blood drug concentration: choose 15 healthy pigs with a body weight of 25-30 kg, divide them into three groups, 5 pigs in each group, inject the preparation of Example 2 intramuscularly respectively, and the dosage is 10 ...

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Abstract

The invention relates to a method for preparing an economical and efficient veterinary long-acting injection by adding a proper sustained-release material in an oil-based medium to improve the traditional oil-based injection. The method comprises the following specific steps: dissolving sucrose acetate isobutyrate and dimethicone with viscosity less than 20cs in isopropyl myristate or dissolving the dimethicone with viscosity less than 20cs and aluminum stearate in the isopropyl myristate to prepare the veterinary long-acting injection containing antibacterial agents or containing anti-parasitic drugs or containing non-steroidal anti-inflammatory drugs. The preparation is good in sustained release effect, stable in character, good in tissue compatibility and easy to prepare.

Description

technical field [0001] The invention belongs to the preparation technology of veterinary drug preparations, and specifically relates to adding an appropriate amount of simethicone oil or / and other slow-release materials to isopropyl myristate (IPM) to prepare veterinary injections with sustained-release effects. Background technique [0002] Patent CN 1256948 C and patent CN 1297319 C respectively disclose the preparation of injections containing antiparasitic drugs or antimicrobial drugs using simethicone as a medium. The veterinary injection prepared with dimethicone as a medium is an oily suspension with excellent sustained-release effect and good stability, and the subcutaneous injection has no tissue damage to the injection site and no stress response obvious. Although simethicone is extremely inert in terms of physiological activity, it is a non-toxic, non-antigenic, non-pyrogenic, non-irritating, and odorless chemical substance, but because simethicone is not easy to...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K45/00A61K47/14A61K47/26A61K47/34
Inventor 王玉万潘贞德戴晓曦徐飞沈力任亚楠
Owner 中农华威制药股份有限公司
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