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目的:对结合雌激素阴道软胶囊内容物处方进行筛选。方法:通过辅料影响因素试验以主药含量为指标,辅料与软胶囊囊皮相互作用试验以囊皮崩解、融变时限为指标,筛选内容物辅料种类;通过正交试验,以内容物稳定性、流动性为指标筛选内容物辅料用量,确定CE阴道软胶囊内容物处方。结果:筛选出质量稳定符合软胶囊质量要求的内容物处方。结论:CE阴道软胶囊内容物处方组成合理、工艺稳定,可用于工业化生产。
OBJECTIVE: To screen the prescription of estrogen-containing vaginal soft capsule. Methods: According to the main ingredient content of the excipients, the excipient and the soft capsule capsule skin interaction test were conducted to determine the types of the excipients by using the capsule disintegration and thawing time limit as the index. By orthogonal test, the content was stable Sex, liquidity as an indicator of the amount of screening materials and accessories to determine the content of CE vaginal soft capsule prescription. Results: Screening out the content of stable quality consistent with the requirements of soft capsule prescriptions. Conclusion: The prescription of CE vaginal soft capsule has a reasonable composition and stable technology and can be used in industrialized production.