一种胸腺法新缓释微球制剂及其制备方法技术

本发明专利技术提供了一种胸腺法新缓释微球制剂及其制备方法。一种的胸腺法新缓释微球制剂，包括胸腺法新、乙交酯丙交酯共聚物，其质量百分比分别为：胸腺法新0.1%-10%，乙交酯丙交酯共聚物85%-99%，所述的乙交酯丙交酯共聚物是乙交酯：丙交酯为25:75-75:25的共聚物，其分子量为5000-25000道尔顿，特性粘度为0.1-0.5dL/g。本发明专利技术的外水相的pH值为3.0-5.0，可以采用醋酸、盐酸、硫酸等调节pH。发明专利技术人发现，通过控制外水相的pH值可以提高胸腺法新的稳定性，还可以提高制备过程中的包封率，从而提高缓释微球的载药量。

Thymus gland new slow releasing microsphere preparation and preparation method thereof

The present invention provides a thymic new sustained-release microsphere preparation and a preparation method thereof. A new method for sustained-release microspheres of thymus, including thymalfasin, glycolide lactide copolymer, its mass percentage is: the new 0.1%-10% thymus, PLGA 85%-99%, PLGA is the glycolide lactide copolymer: 25:75-75: 25, its molecular weight is 5000-25000 Dalton, the intrinsic viscosity 0.1-0.5dL/g. The pH value of the external water phase of the invention is 3.0-5.0, and acetic acid, hydrochloric acid and sulfuric acid can be used to regulate pH. The inventor found that by controlling the pH value of the external water phase, the new stability of the thymus method can be improved, and the encapsulation efficiency in the preparation process can also be improved, thereby increasing the drug loading of the sustained release microsphere.

【技术实现步骤摘要】

【技术保护点】
１．一种胸腺法新缓释微球制剂，其特征在于，包括胸腺法新、乙交酯丙交酯共聚物，其质量百分比分别为：胸腺法新０．１％－１０％，乙交酯丙交酯共聚物８５％－９９％，所述的乙交酯丙交酯共聚物是乙交酯：丙交酯为２５：７５－７５：２５的共聚物，其分子量为５０００－２５０００道尔顿，特性粘度为０．１－０．５ｄＬ／ｇ。

【技术特征摘要】

【专利技术属性】
技术研发人员：陶安进，袁建成，马亚平，郑春莲，
申请(专利权)人：深圳翰宇药业股份有限公司，
类型：发明
国别省市：94