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Preparation method of clindamycin phosphate freeze-dried powder injection for injection

A technology of clindamycin phosphate and freeze-dried powder injection, which is applied in the field of preparation of clindamycin phosphate freeze-dried powder injection to achieve the effect of avoiding the precipitation of impurities, avoiding decomposition and reducing hydrolysis

Active Publication Date: 2021-07-09
HAINAN JINRUI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, the stability study of clindamycin phosphate for injection needs further study

Method used

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  • Preparation method of clindamycin phosphate freeze-dried powder injection for injection
  • Preparation method of clindamycin phosphate freeze-dried powder injection for injection
  • Preparation method of clindamycin phosphate freeze-dried powder injection for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Embodiment 1 A kind of preparation method of clindamycin phosphate freeze-dried powder for injection

[0038] This embodiment is a preparation method of clindamycin phosphate freeze-dried powder for injection. The specific preparation process includes the following steps carried out in sequence:

[0039] 1) refining of clindamycin phosphate

[0040] Take 5L of methanol aqueous solution with a temperature of 20°C and a methanol content of 71.5vol%, add 1 kg of crude clindamycin phosphate [purity 98.10%, according to "Chinese Pharmacopoeia" (2015 edition of four general rules 0512), using high performance liquid chromatography Determination], stir and fully disperse in methanol aqueous solution, slowly add 20wt% sodium hydroxide aqueous solution dropwise at a rate of 0.5L / h, keep the system temperature at 20°C during the dropping process, and stir to fully dissolve clindamycin phosphate After the crude ester, add aqueous sodium hydroxide solution dropwise until the crude...

Embodiment 2～6

[0060] Example 2-6 The preparation method of clindamycin phosphate freeze-dried powder for injection

[0061] Examples 2 to 6 are respectively a preparation method of clindamycin phosphate freeze-dried powder for injection, and their steps are basically the same as those in Example 1, except that the amount of raw materials and process parameters are different. See Table 3:

[0062] List of various technological parameters in table 3 embodiment 2~6

[0063]

[0064]

[0065]

[0066] The content of the other parts of Examples 2-6 is the same as that of Example 1.

[0067] The clindamycin phosphate freeze-dried powder for injection prepared in Examples 1-6 has good stability and clarity, high main drug content, less impurities, smooth surface, good appearance and excellent resolubility.

experiment example 1

[0068] Influencing factors in experimental example 1 clindamycin phosphate refining method

[0069] Using the same batch of clindamycin phosphate crude product (purity 98.10%), comparative examples 1~10 and the comparative test of clindamycin phosphate refining process in embodiment 1, the difference is only in:

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Abstract

The invention provides a preparation method of clindamycin phosphate freeze-dried powder injection for injection, and belongs to the technical field of medicine preparation. The preparation method comprises the steps that water for injection with the temperature smaller than or equal to 25 DEG C is taken, clindamycin phosphate is added in batches, meanwhile, an alkali solution is slowly dropwise added, the system temperature is maintained to be smaller than or equal to 25 DEG C, and the aqueous alkali is dropwise added until the clindamycin phosphate is dissolved and the pH value of the system is 6.0-6.4, and decoloration, degerming filtration and freeze drying is carried out to obtain the clindamycin phosphate freeze-dried powder injection for injection. By adjusting the feeding mode and the dissolving temperature of the clindamycin phosphate and finally adjusting the pH value, the hydrolysis reaction of the clindamycin phosphate is effectively reduced, the stability of the clindamycin phosphate is improved, the impurity content of the finished product is reduced, and the problem that the impurity content of the finished product is relatively high is solved.

Description

technical field [0001] The invention relates to the preparation of freeze-dried powder injection, in particular to a preparation method of clindamycin phosphate freeze-dried powder injection. Background technique [0002] Clindamycin phosphate (Clindamycin phosphate) is a semi-synthetic clindamycin derivative, which has no antibacterial activity in vitro, and rapidly hydrolyzes into clindamycin in the body to show its pharmacological activity, so the antibacterial spectrum, antibacterial activity and treatment The effect is the same as that of clindamycin, but its fat solubility and permeability are significantly better than that of clindamycin. At the same time, the antibacterial effect of clindamycin phosphate is 4 to 8 times stronger than that of lincomycin, and the adverse reactions are reduced. Therefore, clindamycin phosphate is often used clinically to achieve therapeutic effects. Clindamycin Phosphate for Injection is suitable for the treatment of the following infe...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/7056A61P31/04A61J3/02F26B5/06C07H15/16C07H1/06
CPCA61K31/7056A61K9/19A61K9/0019A61P31/04A61J3/02F26B5/06C07H15/16C07H1/06
Inventor 钟洪生吴金霞云惟锦
Owner HAINAN JINRUI PHARMA CO LTD
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