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Clindamycin phosphate for injection and preparation method thereof

A technology for clindamycin phosphate and injection, which is used in pharmaceutical formulations, devices for making medicines into special physical or taking forms, and drug delivery. Avoid the effect of decomposition

Active Publication Date: 2009-11-04
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the prior art, there is no literature on the special control of the process of preparing the pre-frozen solution of this product. Therefore, there are still potential quality and safety hazards in the process of preparing this product into a freeze-dried preparation.

Method used

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  • Clindamycin phosphate for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Take 300 g of clindamycin phosphate, 2 g of sodium pyrophosphate, and add water for injection to 2000 ml.

[0037] Preparation of pre-freezing solution:

[0038] a. Add clindamycin phosphate to 800ml of water for injection to disperse the main ingredient in the water to obtain a mixed solution ①;

[0039] b. Adjust the pH value of the mixed solution ① to 6.5 to obtain the mixed solution ②;

[0040] c. Heat the mixed solution ② to 80°C and stir to dissolve the clindamycin phosphate to obtain the solution ③;

[0041] d. Cool the solution ③ to below 40°C, add activated carbon, stir evenly, and filter to obtain a pre-frozen solution.

[0042] Add water for injection to the pre-frozen solution to 2000ml, stir, and filter through a 0.22 μm microporous membrane until the clarity meets the requirements of the Chinese Pharmacopoeia 2005 edition to obtain a solution ④. Put the solution ④ into a freeze dryer, and carry out the pre-freezing stage, the pre-freezing constant tempe...

Embodiment 2

[0044] Other steps are the same as in Example 1, only in step c of the preparation stage of the pre-frozen solution, the mixed solution ② is heated to 75°C.

Embodiment 3

[0046] Other steps are the same as in Example 1, only in step c of the preparation stage of the pre-frozen solution, the mixed solution ② is heated to 78°C.

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Abstract

The invention relates to a method for preparing clindamycin phosphate for injection. The invention also provides the clindamycin phosphate for injection which has safe quality and good stability. The invention mainly provides a freeze-dried powder pre-freezing solution and a preparation method thereof, and overcomes the disadvantage of unsteady preheating of the clindamycin phosphate.

Description

technical field [0001] The invention relates to a preparation method of clindamycin phosphate for injection, and simultaneously provides a clindamycin phosphate for injection with safe quality and good stability. Background technique [0002] Clindamycin was synthesized for the first time in 1966 by Magerlein et al. who replaced the 7th hydroxyl group in the lincomycin molecule with chlorine. Compared with lincomycin, the antibacterial activity of clindamycin was enhanced by 4 to 8 times, and adverse reactions Low. The drug has been widely used at home and abroad. [0003] Clindamycin phosphate is a chemically semi-synthesized clindamycin derivative. It has no antibacterial activity in vitro, but it is rapidly hydrolyzed into clindamycin after entering the body to display its pharmacological activity. Therefore, the antibacterial spectrum, antibacterial activity and therapeutic effect are the same as clindamycin, but its fat solubility and permeability are better than clin...

Claims

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Application Information

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IPC IPC(8): A61J3/00A61K9/00
Inventor 孙峰京吕伟卢秀莲李大涛
Owner CISEN PHARMA
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