Process for preparing clindamycin phosphate injection

A technology of clindamycin phosphate and injection, which is used in medical preparations containing active ingredients, drug delivery, antibacterial drugs, etc., to achieve the effect of reducing the probability of bacterial infection

Inactive Publication Date: 2007-05-30
沈阳金峰医药科技有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

And this defect cannot be solved by the traditional clindamycin phosphate injection production process

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0010] Embodiment 1: Clindamycin Phosphate Injection

[0011] Prescription: active ingredient clindamycin phosphate 714g (equivalent to clindamycin 600g)

[0012] Other components Sodium hydroxide Appropriate amount

[0013] Water for injection 4000ml

[0014] Preparation: Dissolve the clindamycin phosphate raw material in water for injection, add clindamycin phosphate and sodium hydroxide alternately, maintain the pH value between 6.0 and 6.4, stir evenly, and dilute to 4000ml with water for injection. Add 0.05% (g / ml) needles to the medicinal solution and adsorb with activated carbon for 15 minutes, then use a 0.45 μm microporous membrane for coarse filtration, and then use a 0.22 μm microporous membrane for fine filtration to sterilize. 4ml / bottle, fill and seal to get 1000 pieces of this product. After inspection, the content of related substances in the finished product is 3.0%.

Embodiment 2

[0015] Embodiment 2, clindamycin phosphate injection

[0016] Prescription: active ingredient clindamycin phosphate 714g (equivalent to clindamycin 600g)

[0017] Other components Sodium hydroxide Appropriate amount

[0018] Water for injection 4000ml

[0019] Preparation: Dissolve the clindamycin phosphate raw material in water for injection, add clindamycin phosphate and sodium hydroxide alternately, maintain the pH value between 6.0 and 6.4, stir evenly, and dilute to 4000ml with water for injection. Add 0.05% (g / ml) needles to the medicinal solution and adsorb with activated carbon for 15 minutes, then use a cartridge filter with a 0.45 μm filter element for coarse filtration, and then use a cartridge filter with a 0.22 μm filter element for fine filtration to sterilize. Under the 100-level condition, 4ml / bottle is used, and 1,000 pieces of this product can be obtained by filling and sealing. After inspection, the content of related substances in t...

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PUM

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Abstract

The invention discloses a making method of clindamycinum phosphate injection, which is characterized by the following: dissolving certain quantity of clindamycinum phosphate into water; adding clindamycinum phosphate and sodium hydroxide alternately; maintaining pH value between 6.0 and 6.4; stirring evenly; setting constant volume to the density of injection; adding 0.05% needle active carbon to adsorb the injection; filtering through 0.45um micropore film or corresponding cylinder filter; sterilizing; canning; sealing; obtaining the product.

Description

technical field [0001] The invention relates to a broad-spectrum antibiotic clindamycin phosphate injection (6-(1-methyl-4-propyl-2-pyrrolidine carbonamido)-1-thio-methyl-7-chloro -6,7,8-trideoxy-L-threo-α-D-galactopyranoside-2-dihydrogen phosphate) aseptic filling clindamycin phosphate injection preparation process, and It is used in the clinical treatment of Gram-positive bacteria and anaerobic infections. Background technique [0002] Clindamycin is a semi-synthetic derivative of lincomycin. In 1966, Magerlein first replaced the 7th hydroxyl group in the lincomycin molecule with chloride ions to improve lincomycin and become a new antibiotic. Compared with lincomycin, the antibacterial activity of clindamycin was increased by 4.8 times. The former U.S. General Pharmaceuticals (now Pharmacia) first launched the product in the world in 1975. It can act not only on many anaerobic bacteria such as Bacteroides, but also on Gram-positive aerobic bacteria. Clindamycin enter...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7056A61K9/08A61P31/04
Inventor 李祝华
Owner 沈阳金峰医药科技有限公司
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