Clindamycin phosphate injection solution and preparation method thereof

By using Zn-OC bonded activated carbon, the contradiction between impurity removal and drug purity in clindamycin phosphate injection solution was resolved, achieving effective impurity removal and drug content maintenance, thus improving the preparation process.

CN122097259APending Publication Date: 2026-05-29NANYANG PUKANG HENGWANG PHARM CO LTD
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Patent Information

Application Number
CN202610399016.7
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-03-30
Publication Date
2026-05-29

AI Technical Summary

Technical Problem

In the preparation of existing clindamycin phosphate injection solutions, although increasing the amount of activated carbon can reduce impurities, it also leads to a decrease in the clindamycin phosphate content, making it difficult to effectively remove impurities while ensuring drug purity.

Method used

Zn-OC bonded activated carbon is used. The activated carbon is oxidized at low temperature with low concentration of nitric acid and carboxyl/hydroxyl groups are introduced. Combined with ZnO nanoparticles, a stable Zn-OC bonded interface is formed by calcination. This interface adsorbs acidic/neutral impurities and hinders the selective adsorption of clindamycin phosphate.

Benefits of technology

This effectively reduced the impurity content in clindamycin phosphate injection solution while maintaining or increasing the clindamycin phosphate content, thus achieving high-purity drug preparation.

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Abstract

The invention belongs to the technical field of injections. The invention provides a clindamycin phosphate injection solution and a preparation method thereof.The preparation method comprises the steps that S1, 75-85 mL of water for injection is taken, 0.5-0.6 g of clindamycin phosphate is added into the water for injection and stirred to be dissolved, then a stabilizer is added, stirring continues to be conducted for dissolution, and a substrate solution is obtained; and S2, adding Zn-O-C bonded activated carbon into the substrate solution, adjusting the pH value to 5.3-5.5, adding 15-25 mL of water for injection, stirring, and filtering to obtain the product. According to the method, the content of clindamycin phosphate is increased while related substances (total impurities) are reduced by increasing the dosage of the activated carbon.
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