Clindamycin phosphate injection preparation and preparation method thereof

A clindamycin phosphate and injection technology, which is applied in the field of medical invention, can solve the problems of not being able to use children's intramuscular injection, insufficient nitrogen filling in production, and low production efficiency, so as to improve the efficiency of liquid preparation and the stability of liquid medicine , good pH value, and the effect of reducing production costs

Active Publication Date: 2021-07-23
广东金城金素制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] In order to overcome the above technical problems, the present invention provides a clindamycin phosphate injection preparation, which can solve the problem that the product cannot be used for intramuscular injection in children; at the same time, it can solve the problem of insufficient nitrogen filling in production and improve the stability of the preparation; It can solve the problem of low production efficiency, improve the stability of the liquid medicine, and reduce the production cost

Method used

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  • Clindamycin phosphate injection preparation and preparation method thereof
  • Clindamycin phosphate injection preparation and preparation method thereof
  • Clindamycin phosphate injection preparation and preparation method thereof

Examples

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Embodiment 1

[0048] A clindamycin phosphate injection preparation, in every 1000ml injection, comprising:

[0049] Clindamycin Phosphate 130g, Thioglycerol 0.3g, Sodium Hydroxide 8g.

[0050] The preparation method of described clindamycin phosphate injection preparation, comprises the following steps:

[0051] (1) Get sodium hydroxide and dissolve it with 30°C water for injection to prepare a 10% sodium hydroxide solution;

[0052] (2) Add water for injection at 10°C into the liquid mixing tank, add thioglycerol, stir at 100 rpm for 40 minutes until completely dissolved, and make a thioglycerol solution;

[0053] (3) Get clindamycin phosphate and 10% sodium hydroxide solution and add them to the thioglycerol solution in 8 times;

[0054] (4) Dilute to 1000ml with water for injection, stir until the solution is evenly mixed, check the pH value, first filter once through a filter membrane with a pore size of 0.45 μm, and then filter twice through a filter membrane with a pore size of 0.22...

Embodiment 2

[0059] A clindamycin phosphate injection preparation, in every 1000ml injection, comprising:

[0060] Clindamycin Phosphate 170g, Thioglycerol 0.8g, Sodium Hydroxide 16g.

[0061] The preparation method of described clindamycin phosphate injection preparation, comprises the following steps:

[0062] (1) Get sodium hydroxide and dissolve it with water for injection at 10°C to prepare a 10% sodium hydroxide solution;

[0063] (2) Add water for injection at 30°C into the liquid mixing tank, add thioglycerol, stir at 150 rpm for 30 minutes until completely dissolved, and make a thioglycerol solution;

[0064] (3) Get clindamycin phosphate and 10% sodium hydroxide solution and add them to the thioglycerol solution in 8 times;

[0065] (4) Dilute to 1000ml with water for injection, stir until the solution is evenly mixed, check the pH value, first filter once through a filter membrane with a pore size of 0.45 μm, and then filter twice through a filter membrane with a pore size of ...

Embodiment 3

[0070] A clindamycin phosphate injection preparation, in every 1000ml injection, comprising:

[0071] Clindamycin Phosphate 150g, Thioglycerol 0.5g, Sodium Hydroxide 12g.

[0072] The preparation method of described clindamycin phosphate injection preparation, comprises the following steps:

[0073] (1) Get sodium hydroxide, dissolve and be mixed with the sodium hydroxide solution that concentration is 10% with the water for injection of 20 ℃;

[0074] (2) Add water for injection at 20°C into the liquid mixing tank, add thioglycerol, stir at 150 rpm for 60 minutes until completely dissolved, and make a thioglycerol solution;

[0075] (3) Get clindamycin phosphate and 10% sodium hydroxide solution and add them to the thioglycerol solution in 8 times;

[0076] (4) Dilute to 1000ml with water for injection, stir until the solution is evenly mixed, check the pH value, first filter once through a filter membrane with a pore size of 0.45 μm, and then filter twice through a filter ...

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Abstract

The invention relates to the field of medicine invention, in particular to a clindamycin phosphate injection preparation and a preparation method thereof. According to the clindamycin phosphate injection preparation and the preparation method thereof, the clindamycin phosphate injection preparation is prepared from 130-170 g of clindamycin phosphate, 0.3-0.8 g of thioglycerol and 8-16 g of sodium hydroxide, and water for injection is added to fix the volume to 1000ml. The thioglycerol has the effect of a bacteriostatic agent and can replace benzyl alcohol in the prescription of an original developed preparation; meanwhile, thioglycerol has the effect of an antioxidant and can replace nitrogen charging in the production process, the problem that nitrogen charging is difficult due to the fact that the headspace of an injection penicillin bottle is too small is solved, and therefore the product stability is improved; and the clindamycin phosphate and the sodium hydroxide are added multiple times, the liquid preparation efficiency is very low, the thioglycerol has a pH buffering effect, the clindamycin phosphate and the sodium hydroxide can be quantitatively added multiple times and can be controlled within a target pH value range, the solution stability is improved, the dissolution time in the liquid preparation process is greatly shortened, and the production cost is reduced.

Description

technical field [0001] The invention relates to the field of medical inventions, in particular to a clindamycin phosphate injection preparation and a preparation method thereof. Background technique [0002] Clindamycin phosphate is 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L - threo-a-D-galactopyranoside-2-dihydrogen phosphate, calculated as anhydrous, containing clindamycin (C 18 h 33 ClN 2 o 5 S) Not less than 77.0%. Molecular formula: C 18 h 34 ClN 2 o 8 PS, molecular weight: 504.97. Structural formula 1 is as follows: [0003] [0004] Clindamycin phosphate is a chemically semi-synthesized clindamycin derivative. It has no antibacterial activity in vitro, but it is rapidly hydrolyzed into clindamycin in the body to display its pharmacological activity. The molecular structure of clindamycin phosphate contains active groups such as ester bonds, thiomethyl groups, and halogens, which are prone to hydrolysis, oxidat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/7056A61K47/02A61K47/20A61P31/04
CPCA61K31/7056A61K9/08A61K9/0019A61K47/20A61K47/02A61P31/04
Inventor 朱旭伟毕秀莲程立华龙海东刘杰李雪珍金莎虹傅苗青
Owner 广东金城金素制药有限公司
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