丙戊酸钠薄膜衣片的制备及稳定性研究

Study on the Stability of Sodium Valproate and Film Preparation

目的研究丙戊酸钠薄膜衣片的制备方法。方法分别用全水型和醇溶型薄膜包衣预混剂对该素片进行包衣,与该品种同规格糖衣片同时进行稳定性考察比较。结果用全水型和醇溶型薄膜包衣预混剂对该产品素片进行包衣后,当增重达到(3.5±0.3)%时,本品6个月时的水分含量分别为6.3%、6.6%,糖衣片为8.9%,其他项目比糖衣片也显出一定的优势,且均符合规定。结论按该工艺生产的丙戊酸钠薄膜衣片符合质量标准要求,工艺稳定可靠,适合大生产需要。

Objective Study on Preparation of sodium valproate fdrn-coated tablets. Methods With full water and alcohol soluble film coating premix is coated on the core, and the varieties of the same specifications sugar-coated tablets and stability comparison. Results With the water and alcohol soluble film coating premix is coated on the tablet core, when the weight reached 3.5%±0.3%, the moisture content of the product at 6 months were 6.3%, 6.6%, sugar-coated tablets for 8.9%, other than sugar coated tablets also shows some advantages, which are in line with the provisions. Conclusions According to valproate film-coated tablets produced by this technology to meet the required quality standards, the technology is stable and reliable, and suitable for the industrial production needs.