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前列腺素是广泛存在于人体内脏器官中的重要激素之一,是计划生育工作中应用于中期引产的重要药物。1980年我室进行生物合成前列腺素E无菌乙醇溶液,用于妊娠中期引产及奶牛同步发情,其成功率分别为91.5％与86.6％,经省卫生厅组织同行专家评审并通过技术鉴定,获1980年省政府科技成果三等奖。但无菌乙醇溶液需贮存于低温环境才能保持其稳定性,且对阴道粘膜刺激性较大,而难以推广。针对这一缺点,我室自1984年以来对其剂型进行改革,研制成功前列腺素E无菌冻干粉剂,其特点是易溶于水,对阴道粘膜无刺激性,稳定性好,在室温下保存,其有效期为二年,便于推广,是计划生育工作中有实用价值的药物。现将其工艺介绍如下。
Prostaglandin is one of the most important hormones widely found in the internal organs of the human body and is an important drug used in mid-term labor induction in family planning work. In 1980, my room for biosynthesis of prostaglandin E sterile ethanol for mid-third trimester induction of labor and dairy cows synchronized estrus, the success rates were 91.5% and 86.6%, respectively, by the provincial Health Department organizations peer expert review and through technical appraisal, was 1980 provincial government scientific and technological achievements third place. However, sterile ethanol solution should be stored in a low temperature environment in order to maintain its stability, and more irritating to the vaginal mucosa, and difficult to promote. In view of this shortcoming, our laboratory has carried on the reform to its dosage form since 1984, successfully developed the prostaglandin E sterile freeze-dried powder, which is characterized by being easily soluble in water, non-irritating to the vaginal mucosa and good in stability. Save, valid for two years, easy to promote, is a family planning work has practical value of the drug. Now the process described below.