A kind of clindamycin phosphate injection preparation and preparation method thereof

A technology for clindamycin phosphate and injection, which is applied in the field of pharmaceutical inventions, can solve the problems of inability to use intramuscular injection for children, low production efficiency, insufficient nitrogen filling in production, etc., so as to improve the dispensing efficiency and the stability of the medicinal solution. , good pH value, the effect of reducing production cost

Active Publication Date: 2022-02-25
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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  • A kind of clindamycin phosphate injection preparation and preparation method thereof
  • A kind of clindamycin phosphate injection preparation and preparation method thereof
  • A kind of 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 in 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 μ...

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 medical inventions, in particular to a clindamycin phosphate injection preparation and a preparation method thereof. The clindamycin phosphate injection preparation and its preparation method include: 130g-170g clindamycin phosphate, 0.3g-0.8g thioglycerol, 8g-16g sodium hydroxide, and dilute water to 1000ml . Thioglycerol has antibacterial effect and can replace benzyl alcohol in the original formulation; at the same time, thioglycerol has antioxidant effect, and the use of thioglycerol can replace nitrogen filling in the production process to solve the small headspace of injection vials Nitrogen filling is difficult, so as to improve product stability; this product is fed with clindamycin phosphate and sodium hydroxide several times, and the dosing efficiency is very low. Thioglycerol has a pH buffering effect and can be added quantitatively in batches Both clindamycin phosphate and sodium hydroxide can be controlled within the target pH value range, which improves the stability of the solution, greatly shortens the dissolution time in the liquid preparation process, and reduces the production cost.

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 Patents(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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