The Study On Preparation Of Conjugated Estrogens Vaginal Soft Capsules

Objectives: The purpose of the research is to develop the new Conjugated Estrogens (CE) vaginal soft capsule based on the same type of cream (name: Bao Li Cream) produced by Xinjiang Tefeng Pharmaceutical Co., Ltd. Methods: (1) The stress' test were conducted to raw material and excipients, the content of CE as the indicator, experiments were conducted to affect all excipients and the shell of the capsule, the disintegration of the shell of the capsule as the indicator to select the type of excipients; orthogonal experiments were conducted, use the stability and mobility of the quality of the content to confirm the prescription of the content; orthogonal experiments were conducted , the dissolution rate of the shell of capsules as the indicator to optimize the prescription of CE vaginal soft capsule shell; the capsule were produced through pressing, the technological standard was pre-set. (2) CE vaginal soft capsule were examined to test the quality of the product and set up the quality standard, comparing research was conducted between CE vaginal soft capsule and the reference preparation. (3) Accelerating and Long-term tests were conducted according to guidelines regarding the experiments of stability of medicine from the Chinese Pharmacopoeia (Edition 2005) (as attached XIX C) to evaluate the stability of the product. (4) The initial pharmacodynamics of the capsule was evaluated through examining the uterus weight of mice to measure the female hormone activity of the CE vaginal soft capsule compare to Premarin and Bao Li Cream. (5) Vaginal stimulating and acute toxicity was examined through applying the capsule to the vagina of domestic rabbits. Results: (1) The...