两种结合雌激素缓释制剂体外释放的比较

目的考察自制结合雌激素缓释片与美国产Prem arin缓释片的体外释放度并进行比较。方法采用《中国药典》2000年附录浆法进行体外溶出实验,用高效液相色谱法进行含量测定,计算累积释放百分率。通过计算相似因子F2比较两种缓释片释药行为的相似性。结果两种缓释片的相似因子F2值均大于50。结论两种缓释片的体外释放相似,提示新疆特丰药业股份有限公司研制的“葆丽”结合雌激素片是一个具有良好释放特性的口服缓释制剂其与Prem arin具有类似的释药行为。

Comparative study on Two Controlled Release Preparations Conjugate Estrogens of in vitro Release

OBJECTIVE To compare the release rate of controlled release tablets congjugat estrogens,i.e.self-controlled and Premarin(made in America),in vitro.METHODS The release test in the pharmacopoeia of Chinese 2002 was used.HPLC method was used to determine the concentration and calculate the accumulative release based on the labeled amount.The similarity of two preparation's release behavior was compared by calculating the F2. RESULTS The F2 values in two preparation's are both greater than 50.CONCLUSION The self-controlled conjugat estrogen tablet is a preparation with good release characters and its release behavior is similar with Premarin.