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A kind of clindamycin phosphate composition for injection and preparation method thereof

A technology of clindamycin phosphate and composition, which is applied in the field of clindamycin phosphate composition for injection and its preparation, can solve the problems of decarbonization and filtration difficulties, and achieve the effect of excellent freeze-dried structure

Active Publication Date: 2011-11-30
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the present invention also solves the very difficult problem of decarbonization and filtration of clindamycin phosphate preparation liquid

Method used

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  • A kind of clindamycin phosphate composition for injection and preparation method thereof
  • A kind of clindamycin phosphate composition for injection and preparation method thereof
  • A kind of clindamycin phosphate composition for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0089] prescription:

[0090] Clindamycin Phosphate 3660g

[0091] Sodium hydroxide 146.4g

[0092] Add water for injection to 20Kg

[0093] Preparation: Weigh clindamycin phosphate and sodium hydroxide, put them in a preparation tank, add water for injection, stir to dissolve completely and mix evenly;

[0094] Decarbonization and sterile filtration: Add 0.3% activated carbon for needles by weight of the liquid medicine, continue to stir, heat the liquid medicine to 35°C and keep it warm for 20 minutes, connect a titanium rod filter and a 0.22 μm microporous filter in series, and decarbonize Simultaneously carry out sterile filtration;

[0095] Sterile packaging: the clindamycin phosphate solution filtered into the sterile room is divided into 2 ml / bottle into vials, and half stoppered;

[0096] Vacuum Freeze Drying:

[0097] a. Pre-freezing: Put the subpackaged clindamycin phosphate liquid in a freeze dryer to rapidly reduce the product temperature. When the product tem...

Embodiment 2

[0104] prescription:

[0105] Clindamycin Phosphate 3660g

[0106] Sodium hydroxide 140.8g

[0107] Add water for injection to 20Kg

[0108] Preparation: Weigh clindamycin phosphate and sodium hydroxide, put them in a preparation tank, add water for injection, stir to dissolve completely and mix evenly;

[0109] Decarbonization and sterile filtration: Add 0.3% activated carbon for needles by weight of the liquid medicine, continue to stir, heat the liquid medicine to 35°C and keep it warm for 20 minutes, connect a titanium rod filter and a 0.22 μm microporous filter in series, and decarbonize Simultaneously carry out sterile filtration;

[0110] Sterile packaging: the clindamycin phosphate solution filtered into the sterile room is divided into 2 ml / bottle into vials, and half stoppered;

[0111] Vacuum Freeze Drying:

[0112] a. Pre-freezing: Put the subpackaged clindamycin phosphate liquid into the freeze dryer to rapidly reduce the temperature of the product. When the ...

Embodiment 3

[0119] prescription:

[0120] Clindamycin Phosphate 3660g

[0121] Sodium hydroxide 152.5g

[0122] Add water for injection to 20Kg

[0123] Preparation: Weigh clindamycin phosphate and sodium hydroxide, put them in a preparation tank, add water for injection, stir to dissolve completely and mix evenly;

[0124] Decarbonization and sterile filtration: Add 0.3% activated carbon for needles by weight of the liquid medicine, continue to stir, heat the liquid medicine to 35°C and keep it warm for 20 minutes, connect a titanium rod filter and a 0.22 μm microporous filter in series, and decarbonize Simultaneously carry out sterile filtration;

[0125] Sterile packaging: the clindamycin phosphate solution filtered into the sterile room is divided into 2 ml / bottle into vials, and half stoppered;

[0126] Vacuum Freeze Drying:

[0127] a. Pre-freezing: Put the subpackaged clindamycin phosphate liquid into the freeze dryer to rapidly reduce the temperature of the product. When the te...

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Abstract

The invention relates to a clindamycin phosphate composition for injection. The composition is freeze-dried powder which consists of clindamycin phosphate and sodium hydroxide, wherein the weight ratio of the clindamycin phosphate to the sodium hydroxide is (24-26):1; the average grain diameter of the freeze-dried powder is 70-130nm; and the porosity is 92-98 percent. A preparation method of the composition comprises the following steps of: (1) preparing: weighing the clindamycin phosphate and the sodium hydroxide, filling in a preparation tank, adding water for injection, stirring to fully dissolve the clindamycin phosphate and the sodium hydroxide and uniformly mixing; (2) decarbonizing and performing sterile filtration; (3) performing sterile subpackaging; and (4) freeze-drying under vacuum. The composition has the advantages of simple formula, advanced process, uniform quality and superior stability and meanwhile has better redissolving performance and clinical medication safety.

Description

technical field [0001] The present invention relates to a clindamycin phosphate composition for injection and a preparation method thereof. The clindamycin phosphate composition for injection prepared by the method can be used for gram-positive bacteria and anaerobic bacteria. treatment of various infectious diseases. Background technique [0002] The chemical name of clindamycin phosphate is 6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thiomethyl-7(S)-chloro-6, 7,8-trideoxy-L-threo-α-D-galactopyranoside-2-dihydrogen phosphate. [0003] Its structural formula is: [0004] [0005] Molecular formula: C 18 h 34 ClN 2 O 8 PS [0006] Molecular weight: 504.97. [0007] Clindamycin Phosphate is the third generation of lincomycin antibiotics. It is a chlorine-containing derivative of lincomycin, which is synthesized by replacing the 7th hydroxyl group in the lincomycin molecule with chloride ions. Clindamycin phosphate has antibacterial effect on Gram-posit...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/7056A61K47/02A61P31/04
Inventor 戴建国叶东王孝雯
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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