Penicillin V potassium capsule and preparation method thereof

By combining modified polylactic acid glycolic acid copolymer microspheres with fumed silica and anhydrous calcium hydrogen phosphate, the problems of poor stability and flowability of penicillin V potassium capsules in high temperature and high humidity environments were solved, achieving high drug stability and uniformity, and reducing electrostatic adhesion and powder return rate.

CN122229795APending Publication Date: 2026-06-19SICHUAN PHARMA
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Patent Information

Application Number
CN202610669732.2
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-05-15
Publication Date
2026-06-19

AI Technical Summary

Technical Problem

Existing technologies for preparing penicillin V potassium capsules suffer from problems such as layering during mixing, drug agglomeration, electrostatic adsorption and wall adhesion, and poor flowability, resulting in poor drug stability and content, and the drug is prone to degradation, especially in high temperature and high humidity environments.

Method used

Modified polylactic acid glycolic acid copolymer microspheres are used. Through dual modification with povidone and ethyl cellulose, combined with fumed silica and anhydrous calcium hydrogen phosphate, a complex of elastic regulation and rigid framework is formed, which improves the mixing uniformity, flowability and antistatic properties of the drug, reduces water absorption, and solves the problems of electrostatic adhesion and powder return.

Benefits of technology

In high-temperature and high-humidity environments, the quality stability and mixing uniformity of penicillin V potassium capsules are significantly improved, the flowability is improved, electrostatic desorption and stratification are reduced, the return powder rate is reduced, and the drug content remains stable.

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Abstract

The invention discloses a penicillin V potassium capsule and a preparation method thereof. The preparation method comprises the following steps: preparing modified poly (lactic-co-glycolic acid) microspheres; mixing penicillin V potassium micro powder with the modified polylactic acid-glycolic acid copolymer microspheres, adding fumed silica and anhydrous calcium hydrogen phosphate, and continuously blending to obtain a blend; granulating the blend by adopting a dry granulation method; and filling the obtained particles into capsules, polishing and packaging. Povidone and ethyl cellulose are adopted to modify a poly (lactic-co-glycolic acid) copolymer to obtain the modified poly (lactic-co-glycolic acid) microsphere. The poly (lactic-co-glycolic acid) microspheres subjected to double modification by povidone and ethyl cellulose are designed, the drug loading fluidity is better, the mixing uniformity is more stable, and the fluidity of the microspheres is obviously improved compared with that of penicillin V potassium powder; the antistatic property is further improved; and the powder returning rate is reduced.
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