黄体酮阴道缓释凝胶的药学研究-药物工程专业论文.docxVIP

大连理工大学硕士学位论文Pharmaceutical 大连理工大学硕士学位论文 Pharmaceutical Research of Vaginal Sustained—release Progesterone Gel Abstract Normal luteal function is essential to maintain pregnancy and embryo implantation．The controlled ovarian stimulation and follicular aspiration in assisted reproductive technology wiU reduce hormone levels luteal phase，resulting in luteal insufficiency，pregnancy rate decreased and the abortion rate increased，more effective treatment．So luteal support in assisted reproductive technology has become conventional therapy．In order to provide luteal support effectively，recreasing the systemic side effects，improving patient compliance，the formulation， preparation procedure and quality standards of the progesterone vaginal sustained-release gel was studied． On the base of the formula and adjuvant’S property of correlative product inabroad，the formulation of sustained’release progesterone vaginal gel Was determined．Using micro—phase structure，in vitro release and dynamic viscosity as index，the composition and preparation procedure of progesterone gel were optimized．The sustained-release progesterone vaginal gel containing 8％(w／w)micronized progesterone in an oil-in-water emulsion on a polycarbophil base，delivered via a special applicator．The polycarbophil base ensures that the gel adheres to the vaginal epithelium，while the emulsion provides an oily depot from which progesterone is continuously released into the aqueous phase and hence into the tissue．Using the mixed shearing process，the exquisiteand white progesterone gel Can be prepared．Under the same release conditions，the similarity factor f2 of the release profile between sample and control Was 74．82，greater than 50，showing no difference． According to the Chinese Pharmacopoeia(20 1 5)and the technical guidance from CDE， the gel quality control methods were established，including the determination of drugs content， the determination of related substances，the test of microorganisms and the conditions of dis