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Clindamycin phosphate compound liquid and preparation method thereof

A clindamycin phosphate and liquid preparation technology, which is applied in the field of pharmaceutical inventions, can solve problems such as strong viscosity of clindamycin phosphate, difficulty in ensuring product uniformity, and increased difficulty in dissolving raw materials, so as to improve sterility assurance level, eliminate the oxidation process, and improve the effect of dissolution uniformity

Active Publication Date: 2019-03-22
GUIZHOU JINGFENG INJECTION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] The purpose of the present invention is to solve the following problems: 1. The traditional feeding method and temperature control method have a long dissolving time and large energy consumption, which leads to high production cost; it is unfavorable for large-scale production operations; 2. After clindamycin phosphate is dissolved The viscosity is strong, and it is easy to agglomerate if it is not dissolved in time. After agglomeration, it is more difficult to dissolve and the product uniformity is difficult to guarantee; 3. The temperature of the dissolution process is too low, the difficulty of raw material dissolution is increased, the dissolution time is prolonged, and the product uniformity is difficult to guarantee

Method used

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  • Clindamycin phosphate compound liquid and preparation method thereof
  • Clindamycin phosphate compound liquid and preparation method thereof
  • Clindamycin phosphate compound liquid and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Ingredients: Clindamycin Phosphate 500g, Sodium Hydroxide 35g, Water for Injection 1700g, Activated Carbon 2g.

[0051] Made by any of the following preparation methods:

[0052] Preparation method (1)

[0053] (1) Prepare each ingredient according to the formula ratio;

[0054] (2) Get the sodium hydroxide of formula quantity earlier, add water for injection and be configured into 20% sodium hydroxide solution;

[0055] (3) Turn on the chilled water system, add cooled water for injection into the liquid distribution tank, cool down to 18±2°C, close the chilled water system, and start stirring; 4.2g: Add 1ml of 20% sodium hydroxide solution gradually. After adding the materials, stir until the main ingredient is completely dissolved. Do not lower the temperature during the dissolution process. PH value is 6.1-6.7;

[0056] (4) Add activated carbon, add water for injection to the total amount of the solution, fill the solution tank with nitrogen filtered through a 0....

Embodiment 2

[0074] Ingredients: Clindamycin Phosphate 700g, Sodium Hydroxide 55g, Water for Injection 3000g, Activated Carbon 10g.

[0075] Embodiment 2 is made by any of the following preparation methods

[0076] Preparation method (1)

[0077] (1) Prepare each ingredient according to the formula ratio;

[0078] (2) Get the sodium hydroxide of formula quantity earlier, add water for injection and be configured into 20% sodium hydroxide solution;

[0079] (3) Turn on the chilled water system, add cooled water for injection into the liquid distribution tank, cool down to 18±2°C, close the chilled water system, and start stirring; 4.2g: Add 1ml of 20% sodium hydroxide solution gradually. After adding the materials, stir until the main ingredient is completely dissolved. Do not lower the temperature during the dissolution process. PH value is 6.1-6.7;

[0080] (4) Add activated carbon, add water for injection to the total amount of the solution, fill the solution tank with nitrogen filte...

Embodiment 3

[0098] Ingredients: Clindamycin Phosphate 550g, Sodium Hydroxide 40g, Water for Injection 2000g, Activated Carbon 4g.

[0099] Embodiment 3 is made by any of the following preparation methods

[0100] Preparation method (1)

[0101] (1) Prepare each ingredient according to the formula ratio;

[0102] (2) Get the sodium hydroxide of formula quantity earlier, add water for injection and be configured into 20% sodium hydroxide solution;

[0103] (3) Turn on the chilled water system, add cooled water for injection into the liquid distribution tank, cool down to 18±2°C, close the chilled water system, and start stirring; 4.2g: Add 1ml of 20% sodium hydroxide solution gradually. After adding the materials, stir until the main ingredient is completely dissolved. Do not lower the temperature during the dissolution process. PH value is 6.1-6.7;

[0104] (4) Add activated carbon, add water for injection to the total amount of the solution, fill the solution tank with nitrogen filter...

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Abstract

The invention discloses a clindamycin phosphate compound liquid and a preparation method thereof. The clindamycin phosphate compound liquid is prepared from the following components in proportions: 500-700 parts of clindamycin phosphate, 35-55 parts of sodium hydroxide, 1700-3000 parts of water for injection and 2-10 parts of activated carbon; the clindamycin phosphate dose is prepared by adding raw materials and a PH regulator gradually according to the proportions, dissolving and other processes. By adopting the preparation method, the uniformity of medicinal liquid dissolution is greatly improved, the oxidation process of a product is eliminated, the sterility assurance level in the production process of the product is improved, and the amount of air bubbles in an injection is reduced;in addition, the dissolution time and the filtration time in the liquid preparation process are greatly shortened and the production cost is reduced; therefore, the preparation method is especially suitable for industrial production; the dissolution method is not only applicable to the liquid preparation process of the clindamycin phosphate for injection, but also applicable to the liquid preparation process of other products using the clindamycin phosphate as a raw material and sodium hydroxide as the pH regulator.

Description

technical field [0001] The invention relates to the field of medical inventions, in particular to a clindamycin phosphate formulation and a preparation method thereof. Background technique [0002] This product is 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo Formula - α-D-galactopyranosyl-2-dihydrogen phosphate. Calculated on anhydrous basis, containing clindamycin (C 18 h 33 ClN 2 o 5 S) must not be less than 77.0%. Molecular formula: C 18 h 34 ClN 2 o 8 PS, molecular weight: 504.97. The structural formula is as follows:. [0003] [0004] The molecular structure of clindamycin phosphate contains active groups such as ester bonds, thiomethyl groups, and halogens, which are prone to hydrolysis, oxidation, substitution, elimination, and rearrangement reactions. The molecule contains a sulfur atom, which is easily oxidized to produce high-valent sulfur, or the phosphate bond and thiomethyl group are easily hydroly...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/7056A61K47/02A61P31/04
CPCA61K9/0019A61K9/08A61K31/7056A61K47/02A61P31/04
Inventor 陈君冯世明
Owner GUIZHOU JINGFENG INJECTION
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