黄芩苷双层片制备工艺研究

目的：建立黄芩苷双层片制备工艺方法的研究。方法：用HPLC法测定双层片中黄芩苷的含量。用湿法制粒压制双层片。结果：黄芩苷在0.03~0.15μg范围内呈线性关系（r=0.9997）,平均回收率98.4%,RSD为1.58%,所制得的片剂,速释层在2 min内崩解完全,双层片崩解持续8 h以上,硬度适中。结论：所制定的含测方法适合黄芩苷双层片质量控制,双层片质量可控,制备工艺简单易行,达到设计要求。

Studies on Preparation of Baicalin Bilayer Tablets

Objective ： To study the preparation method of Baicalin Bilayer Tablets. Method ： The content of baicalin bilayer tablets was determined by HPLC method. The wet granulation production of double layer tablets was used. Results ： Baiealin was linear in the range of 0.03-0.15 μ g （ r=0.9997 ）, and the average recovery was 98.4%, RSD was 1.58%. The prepared tablets, a quick release layer within 2 rain completed disintegration. Bilayer tablet disintegration time lasted 8 hours and the hardness was moderate. Conclusion ： The quality control method for Baiealin Bilayer Tablets quality control is suitable for double-layer tablets and it is a simple preparation process which meets the design requirements.