一种高稳定型泰万菌素肠溶颗粒及其制备方法

Through a core particle design optimized by specific formulation and process, the instability and low bioavailability of tylosin preparations in the gastric acid environment have been solved, achieving high stability and ideal release performance, thus improving therapeutic efficacy.

CN121287649BActive Publication Date: 2026-07-17SHENYANG VICA BIOTECHNOLOGY CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
SHENYANG VICA BIOTECHNOLOGY CO LTD
Filing Date
2025-10-30
Publication Date
2026-07-17

AI Technical Summary

Technical Problem

Existing tylosin formulations are unstable in the acidic environment of the stomach, resulting in low bioavailability. Furthermore, existing enteric-coated formulations have complex preparation methods or limited stability improvements, and slow dissolution rates, which affect therapeutic efficacy.

Method used

The core particles are designed with a specific formulation, including tylosin tartrate, fillers, disintegrants, lubricants, flow aids and binders, combined with an isolation layer and an enteric coating layer. By optimizing process parameters such as spheroidization, coating temperature and grinding process, a highly efficient porous network and a stable enteric membrane are formed.

Benefits of technology

It significantly improves the stability and release performance of tylosin in the gastric acid environment, enhances bioavailability, and achieves a clinical cure rate of 80%, which is significantly better than commercially available formulations.

✦ Generated by Eureka AI based on patent content.

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Abstract

本发明属于兽药制剂技术领域,具体涉及一种高稳定型泰万菌素肠溶颗粒及其制备方法。以重量百分比计,所述肠溶颗粒的核芯颗粒包含以下组分:酒石酸泰万菌素25‑35%,填充剂55‑65%,崩解剂5‑10%,润滑剂0.5‑2%,助流剂0.3‑1%,粘合剂适量,所述肠溶颗粒的核芯颗粒依次包覆隔离层和肠溶层,其中:隔离层增重5‑12%,肠溶层增重15‑25%。本发明肠溶颗粒通过核心处方、隔离层设计,粘合剂选择及关键工艺参数的协同优化,显著提高了产品的稳定性、释放性能和工艺重现性。
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